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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 1
CIVIL ACTION NO, 07- CI-01303
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Ex hibit No. 9 .. .... ... . .. ... ............... ... 73
(Memo dated 12-14-93 from James Komorowski to
OxyContin Project Team re Project Team Meeting
Minutes of 11-30-93)
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COMMONWEALTH OF KENTUCKY, ex rel.
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PLAINTIFF
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vs.
VIDEO DEPOSillON FOR THE PLAINTIFF
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PURDUE PHARMA L.P., et al.
DEFENDANTS
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* * *
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DATE:
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AUGUST 28, 2015
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* * *
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Coulter Reporting, LLC
101 East Kentucky Street
Suite 200
Louisville, Kentucky 40203
(502) 582-1627
FAX: (502) 587-6299
.
E-MAIL: lgootee@coulterreporting.com
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Page: 1
Richard Sackler, M.D.
Exhibit No. 10 ... . ... .... ... ..... . ... ... ... ... 74
(Memo dated 8-10-92 to Distribution from
R. Reder re Oxycodone Project Team Meeting
Minutes of 8-4-92)
Exhibit No. 11.. ............ .. .. ..... ......... 77
(E-mail dated 5-28-97 from Richard Sackler
to Michael Friedman)
Exhibit No. 12 .... .... ................ ........ 86
(Memo dated 6-12- 97 from Richard Sackler to
Michael Friedman re OxyContin Team Meeting
Minutes)
Exhibit No . 13 .. ... .. ..... .......... .... .. .... 103
(Interoffice Memorandum dated 12-29-94 to
Mortimer Sackler, Raymond Sackler and
Richard Sackler from Michael Friedman re
Product Pipeline and Strategy)
Ex hibit No. 14 ..... .......... .. ..... ...... .... 109
(Memo dated 4-23-97 from Richard Sackler to
Michael Friedman re San Antonio)
Exhibit No. 15 ... .... ........... ... .. ... ... ... 110
(Memo dated 4-2-93 from E. Natz to
Distribution re PFRC R&D Meeting of 3-22-93)
Exhibit No. 16 ................. .. ... .......... 117
(Memo dated 8-30-93 from James Komorowski
to OxyContin Project Team re Project Team
Meeting Minutes of 8-17-93)
Exhibit No. 17 ....................... .. ....... 122
(Article in Teamlink, Winter 1996, titled
"OxyContin: The Most Significant Launch in
Purdue History)
Exhibit No. 18 ....... ... ... ........ ........... 127
(Medical Officer Review, Integrated Summary
of Efficacy Oxycodone Controlled-Release)
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Page 2
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Page. 4
INDEX
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Exhibit No. 19 ...... ... ... .. . .. .. .. . .. ..... .. . 134
(Memo dated 4-13-94 from James .Komorowski to
OxyContin Project Team re Project Team
Meeting Minutes of 3-22- 94)
Examination by Mr. Thompson . ... ........... .. .. 10
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Reporter's Certificate ... ........... ...... .. .. 337
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EXHIBITS
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Exhibit No. 1.. .. .. ... . .. .. .. ... . ... .. ....... . 29
(Memo dated 7-16-90 from Robert Kaiko to
Richard Sackler and Michael Friedman re
Controlled-Release Oxycodone)
Exhibit No. 2 .. ..... ..... .... ....... .......... 29
(E-mail dated 5-31-99 from Richard Sackler to
EdM at PurdueUS re New Office)
Exhibit No. 3 ....... ....... . ... . .. ............ 32
(Memo dated 5-31-99 from Richard Sackler to
EdM at PurdueUS re New Office)
Exhibit No. 4 .............. ...... .. .. .. ....... 38
(Memorandum dated 7- 15-92 from Dr. JW Watkins
re Minutes of Analgesics Compendium Meeting
with Shionogi 6-24-92)
Exhibit No. 5 ... .. ... .... .... .... ..... ... ..... 39
(Untitled document re "Our meeting ended
with a question and comment period ... ")
Ex hibit No. 6 ... ..... ......................... 43
(Letter dated 7-5-07 to Randy Ramseyer from
Brent Gurney re Profit Calculations)
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Page 3
Exhibit No. 7 ..... .. ...... ......... .. ... . ..... 48
(Memo dated 3-15-97 from Paul Goldenheim to
Richard Sackler re Is this an opening to
descheduling the agent?)
Exhibit No. 8 .......... ............ .......... . 54
(E-mail chain dated 4-4-97 from Robert
Kaiko to Michael Friedman, Howard Udell,
Richard Sackler, Paul Goldenheim and Robert
Reder re Oxycodone)
Coulter Reporting, LLC
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Exhibit No. 20 ................................ 135
(Memo dated 6-22-94 from James Komorowski
to OxyContin Tablets Project Team re
Project Team Meeting Minutes of 6-8-94)
Exhibit No. 21.. ... ..... .................... .. 141
(Confidential Minutes of International
R & D Meeting Held at 86 Park Lane, London
11-2-94)
Exhibit No. 22 ................................ 154
(Memo dated 9-25-95 from Alfonso at
Norwalk re Rescue use in OxyContin PI)
Exhibit No. 23 .......... ... ... .......... ...... 164
(Memo dated 4-20-2000 from Richard Sackler
to Mark Alfonso re Recommendations of 4-7)
Exhibit No. 24 .... . ..... .. ...... .. ... ....... .. 173
. (Memo dated 4-4-95 from Lydia Johnson to
OxyContin Launch Team re Launch Team
Meeting 3-31-95 minutes)
Exhibit No. 25 ... .. .. ... .. ....... ... ....... ... 177
(Memo dated 3-7-96 from Ellen Ingber and
Linda Harrison to OxyContin Product Team
re Minutes of the OxyContin Product Team
Meeting of 2-22-96)
Exhibit No. 26 ...... .... ...... ................ 200
(OxyContin Launch Plan)
Exhibit No. 27 .. .. ............ .......... .. .... 200
(Memo dated 10-23-96 from Friedman to
Alfonso re Phase IV OxyContin Team Minutes)
Exhibit No. 28 ... ..... ......... ............. .. 204
(Memo dated 6-9-99 from Richard Sackler to
Stuart Baker, Edward Albright, Michael
Friedman, James Dolan, Mark Alfonso and
Edward Mahoney re Promotion of OxyContin
byAbbott)
www.cou lterreporti ng .com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 5
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Exhibit No. 29 ................... ...... ...... . 205
(Memo dated 6-16-97 from E. Chickering and
L. Harrison to Distribution re Phase IV
Oxycontin Tablets Team Meeting of 6-13-97)
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Exhibit No. 30 ......... . ............ . ......... 218
(GAO Report to Congressional Requesters
December 2003 titled Prescription Drugs
OxyContin Abuse and Diversion and Efforts
to Address the Problem)
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Exhibit No. 31.. .. ............. .. .......... ... 220
(E-mail chain dated 9-4-96 from Richard
Sackler to Friedman and Alfonso re Press
Release or similar promotion)
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10 Exhibit No. 32 ....... .... . .. ... ........ .. ..... 226
(5-17-05 letter to Gregory Stumbo from
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Howard Udell)
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Page:2
Richard Sackler, M.D.
APPEARANCES
Dolt, Thompson, Shepherd & Kinney
13800 Lake Point Circle
Louisville, Kentucky 40202
tthompson@kytrial.com
aellis@kytrial.com
Assistant Deputy Attorney General
Office of the Attorney General
The Capital Bu ilding
700 Capitol Avenue, Suite 118
Frankfort, Kentucky 40601
mitchell .denham@ag .ky.gov
11
Exhibit No. 33 ................. ............... 226
(Agreed Statement of Facts re United States
of America v. The Purdue Frederick Company)
13
Exhibit No. 34 ....... ....... .. ........ .. ... ... 247
(Memo dated 1-25-01 from Mark Alfonso to
Michael Friedman re Hydrocodone)
14
15
Exhibit No. 35 ........................ . ....... 278
(Memo dated 12-8-99 from Michael Friedman
to Paul Goldenheim, David Haddox, Paul
Goldenheim, Robert Kaiko, Robert Reder re
Oxycontin abuse-Jacksonville, FL)
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Exhibit No. 36 ................................ 286
(Memo dated 8-29-97 from Joann Coletta to
Richard Sackler re Send some Betadine to)
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2O
Exhibit No. 37 ................................ 287
(Memo dated 5-15-96 from Claudia Bobillier
To Claydon, Goldenheim, Fleischer, Howell,
Kaiko, Kuster, Manners, A.J. Miller, R.B.
Miller, Sackler and Wimmer re Minutes of
Meeting with Prof. Dayer in Geneva 5-6-96)
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PHARMA, INC., THE PURDUE FREDERICK COMPANY, INC. d/b/a
L.P. and P.F. LABORATORIES, Ii'~ C.:
Chadbourne & Parke, LLP
1301 Avenue of the Americas
New York, New York 10019
dstrau ber@chad bou rne. com
Stites & Harbison, PLLC
250 West Main Street
Suite 2300
Lexington, Kentucky 40507-17 58
ddanford@stites.com
Chadbourne & Parks, LLP
350 South Grand Avenue, 32nd Floor
Los Angeles, CA 90071
Louisville, Kentucky 40202
jhenneberry@chadbourne.com
Page 6
Page 8
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Exhibit No. 38 ...... .. ........ .... . ........... 324
(Memo dated 1-14-97 from Richard Sackler to
Michael Friedman, James Lang, Paul
Goldenheim, Robert Kaiko and Robert Reder
re Merck-Medco)
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Exhibit No. 39 ...... .. ....................... . 327
(Memo dated 9-30-96 from Alfonso to John
Stewart, Friedman, Lang, Sackler, Darke,
Jeffery, Stables and Franco re Analgesic
Plans)
Exhibit No. 40 ......................... . ...... 331
(Sales Bulletin to Prescription Sales Force
From Russ Gasdia of 1-25-99, First Quarter
Bonus Payouts Oxycontin and MS Contin)
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CERTIFIED
QUESTION
Page 298, Line 11
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Venable, LLP
750 E. Pratt Street, Suite 900
Baltimore, MD 21202
jsayers@Venable.com
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* * *
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GEORGE PARKER
* * *
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Coulter Reporting, LLC
VIDEOGRAPHER:
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Purdue
Associate General Counsel
One Stamford Forum
Stamford, CT 06901 - 3431
rich a rd .silbert@pha rma . com
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www.coulterreporting.com
502-582-1627
Page: 3
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 11
Page 9
The video deposition of RICHARD SACKLER,
1
And you are here today to give
Q.
1
2
M.D., taken in the offices of Dolt, Thompson, Shepherd
2
testimony in a case pending against Purdue, various
3
& Kinney, 13800 Lake Point Circle, Louisville,
3
entities by the State of Kentucky.
4
Kentucky, on Friday, the 28th day of August, 2015, at
4
5
approximately 9 : 11 a.m.; said deposition being taken
Are you aware of that?
5
A.
Q.
6
pursuant to Notice for use in accordance with the
6
7
Kentucky Rules of Civil Procedure.
7
That's my understanding.
And you've given --
MR. STRAUBER: Mr. Thompson, before
8 you get started, I'd just like to note that I expect
8
* * *
9
9
we will be designating portions of this transcript as
1 o confidential pursuant to the order.
10
VIDEOGRAPHER: We are on the record at
11
MR. THOMPSON: Is that correct,
11
12
9 :12 a.m., August 28th, 2015 in the matter of
12
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Commonwealth of Kentucky, Pike _
C ircuit Court, Division
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Mitchell?
MR. DENHAM: Yeah, they can designate
14
2, Civil Action No. 07-CI-01303, Tfi e Commonwealth of
14
15
Kentucky versus Purdue Pharma. This is the deposition
15 about challenging them.
16 of Dr. Richard S. Sackler.
17
their name into the record .
19
2 o ahead and read the list of the names?
21
VIDEOGRAPHER: Just read the list?
22
MR. THOMPSON: I'll tell you what,
23
25
MR. DANFORD: There's a 30-day period
in the rule. We'll get you a copy of the agreed
2 O protective order.
MR. THOMPSON: And just so you know - -
21
22 I know you're not from Kentucky; is that correct?
let's just go ahead, let's just say our names.
MR. SAYERS: Jason Sayers on behalf of
24
until you-all designate and we respond.
18
MR. THOMPSON: Do you want to just go
19
MR. THOMPSON: We won't disseminate
16
If I could have the attorneys state
17
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portions confidential, and then there's provisions
Abbott.
23
MR. STRAUBER: That's correct.
24
MR. THOMPSON: All objections, other
25
than to the form of the question, are preserved in
Page 10
2
MR. STRAUBER: Donald Strauber on
behalf of the various Purdue defendants.
MR. SILBERT: Oh, sorry. Richard
5
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Silbert in-house at Purdue.
MR. HENNEBERRY: Jay Henneberry on
7
8
behalf of the Purdue defendants.
MR. THOMPSON: Tyler Thompson on
9
1 o behalf of the State of Kentucky.
MR. ELLIS: Anthony Ellis on behalf of
11
12
the State of Kentucky.
MR. DENHAM: And Mitchell Denham from
13
14 the Attorney General's Office on behalf of
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Kentucky.
Kentucky on video.
MR. STRAUBER: Thank you .
2
3
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6
What is your current role at Purdue?
Q.
MR. STRAUBER: Excuse me. I -- there
5
are a number of defendants that bear some portion of
7
the Purdue name, and the distinction can be
8
sign ificant. So I'd ask when you phrase your
9
questions, specify which Purdue entity you are talking
10 about.
11
12
Well, let's -- let's talk about the
Q.
number of Purdue entities there are.
How many Purdue entities are there?
13
14
A.
I don't know.
15
Q.
I've seen upwards of 69 different
16 corporations, perhaps, that the Sackler family owns.
16
RICHARD SACKLER, M.D., after first
17
18
1
the Purdue defendants.
3
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Page 12
MR. DANFORD : Dan Danford on behalf of
1
being duly sworn, was examined and testified as
1 7 Is that correct?
18
A.
If you've counted them. I can't
19 follows :
19 differ with you. I don't know the answer.
20
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EXAMINATION
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23
Q.
There are a number of Purdue entities.
21 The Purdue Frederick Company, Inc., does it still
exist?
23
A.
I don 't know.
24
Q.
Would you state your name, please.
24
Q.
Tell me what companies that you
25
A.
Richard Sackler.
2 5 currently have a role with that involve Purdue.
Coulter Reporting, LLC
www. cou lterreporting. com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma LP., et al.
Page:4
Richard Sackler, M.D.
8/28/2015
Page 13
Page 15
1
A.
Purdue Pharma.
1
2
Q.
Do you sit on the board of any other
2
3
Purdue companies?
4
A.
5
6
7
9
Southern District of West Virginia.
And does that appear to be your name
3
Not to my knowledge.
4
Q.
What about Mundipharma?
5
A.
That does.
A.
I sit on the board of a consulting
6
Q.
And it's dated July 30th, 2014. It
firm which consults to Mundipharma.
Q.
8
This is an affidavit filed in the
Q.
7
Does the Sackler family own
10
11
Q.
12
A.
says "Declaration of Dr. Richard S. Sackler. I am a
8 director of Purdue Pharma, Inc., the general partner
Mundipharma?
A.
(indicating)?
9
Yes.
of Purdue Pharma, LP. I've held this position since
10
1990."
What about -- what is Mundipharma?
11
A.
Mundipharma is -- is a name that is
12 what it says.
13
attached to many different companies, such as -- just
14
similar to Purdue.
13
14
If that's what it says, then that's
How involved are you in the production
Q.
and marketing and promotion and the training and
15
Q.
Is that company over in Germany?
15
management of Purdue sales representatives for
16
A.
There is a Mundipharma company in
16
OxyContin?
17 Germany.
18
Q.
MR. STRAUSER: I object to the form of
17
What about Roxane? Does Purdue own
18 the question.
Roxane?
19
A.
20
A.
No.
20
Q.
21
Q.
Did they own Roxane in the past?
21
19
Should I answer?
Go ahead.
MR. STRAUSER: You can answer.
22
A.
Never.
22
A.
It depends on the time.
23
Q.
All right. Do you know how many
23
Q.
Okay. And when you say "it depends on
24
current companies are owned by the Sackler family?
25
A.
No.
1
Q.
All right. In discussing OxyContin,
24
25
the time," why do you say that?
A.
Because I was involved in the areas at
Page 16
Page 14
1
2
how many companies were involved in the production,
3
manufacturing or distribution of OxyContin?
a supervisory level, not as an active level, for a
2
period of time that began with the launching of
3
OxyContin and ended in early 2003.
4
A.
Could you specify the geography?
4
5
Q.
In the world.
5 supervisory level but not the active level, how much
6
A.
Many. I've never counted them.
6
7
Q.
Does Purdue do licensing agreements
7
8 with other companies to sell OxyContin?
8
When you were involved on the
Q.
of your day-to-day activity was devoted to OxyContin?
A.
It varied enormously.
Q.
In this declaration it says, "During
9
A.
10
Q.
Do they own parts of those companies?
10
1996 to 2009, I was not directly involved with the
11
A.
No.
11
day-to-day marketing or promoting of OxyContin, the
12
Q.
How many companies does Purdue own
12
training or management of Purdue sales
13
representatives, or the scientific research into the
It does.
13 that distributes or dispenses OxyContin?
9
the time period set forth in the amended complaint,
14
A.
Many.
14 conversion ratio from MS Contin to OxyContin. Those
15
Q.
Can you tell me the names of them?
15
responsibilities principally fell to Purdue senior
16
A.
A few of them, but not all of them.
16
management in research and development, regulatory
17
Q.
Are you still the director of Purdue
17 affairs, sales training and marketing, among others."
18
19
20
21
Pharma, Inc.?
I'm not sure.
19
Q.
Are you still a general partner of
20
Purdue Pharma, LP.?
22
A.
I am not. It is owned by two trusts.
23
Q.
On July 30th of 2014, were you a
24
25
director of Purdue Pharma, Inc.?
A.
Not that I'm aware.
Coulter Reporting, LLC
Is that accurate?
18
A.
21
A.
Yes.
Q.
I want to show you an e-mail,
Dr. Sackler, dated Monday, May 31st, 1999.
Do you know who Cornelia --
22
23
Dr. Cornelia Hentzsch is?
24
A.
I do.
25
Q.
And who is that?
www. cou lterreporting. com
502-582-1627
Page:5
Richard Sackler, M. D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 17
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2
3
A.
She was general manager of Mundipharma
1
And to give this a little bit of
3
Australia .
Q.
context, you-all had a drug called MS Cantin, morphine
4
5
sulfate, that was an immediate-release narcotic
5
6
opioid -- or narcotic; is that correct?
7
8
Q.
It was controlled release.
11
12
13
Do you recall that one of the concerns
Q.
that Purdue's senior management had -- and I'm using
6
"Purdue" in relation to Purdue companies that are
7
involved with OxyContin. And rather than just sit
9 say "Purdue," I'm referring to Purdue companies of all
1 o patients or malignant pain patients; is that correct?
A.
date, no.
8 here and name them all out, can we agree that when I
Controlled release. I'm sorry.
And that was used primarily for cancer
9
I'm -- I'm not certain that I know the
A.
2
4
A.
Page 19
set to expire?
1 o the OxyContin?
The majority of use, yes; but not -- I
MR. STRAUSER: Mr. Thompson, I have to
11
don't think "primarily" conveys an accurate picture.
12
object to that because I said at the outset there are
Majority of use was for?
13
different Purdue entities that are defendants in the
Q.
14
A.
Over 50 percent.
14 case, and the distinction between them may at times be
15
Q.
And it was sort of felt by Purdue
15 significant. And so if you lump them all together
16
Pharma that morphine had a stigma attached to it that
16 under "Purdue," we're going to get a record that will
17
kept doctors from prescribing it across the board; is
17
18 that accurate?
not be easily decipherable at the end.
Q.
18
Well, let's -- let's talk about it
19
A.
Yes.
19 then.
20
Q.
And you-all had a --
20
21
A.
May I amend that?
21
22
Q.
Yes.
22
23
A.
It didn't prevent doctors from
23
Pharma were involved in the early years of selling the
Which Purdue companies were involved
in the sale and distribution of OxyContin?
Both Purdue Frederick and Purdue
A.
24
prescribing it across the board. It was an inhibition
24
product.
25
to the use of a product in every application .
25
Q.
Okay. Were there any other Purdue
Page 20
Page 18
1
Q.
1
Have you ever gone back and studied
2 the history of addiction and how it has played out in
3
4
5
2
A.
Not in the U.S.
Who had the exclusive right to sell
3
Q.
A.
I'm not a student of that literature.
4
MS Cantin?
Q.
All right. What was your
5
A.
6
Q.
And --
A.
I don't know at what point Purdue
the 19th and 20th centuries?
6
understanding of why doctors did not want to prescribe
7
morphine for anything or had a stigma about
7
8
prescribing it for anything other than cancer and
8
9
malignant pain?
10
A.
As I said before, the stigma prevented
11 many physicians from prescribing it for any pain.
12
13
14
At first it was Purdue Frederick.
Pharma acquired rights to sell it or if it did at all.
What is the distinction between Purdue
Q.
9
10
Frederick and Purdue Pharma?
Purdue Frederick was the original
A.
11
12
company that my father and uncle acquired in 1952. It
I'm not a student of the issue, but I
13
was a shell company and it was the first
believe the stigma existed because of a popular
14
pharmaceutical company that they owned.
Q.
Why do you think that stigma existed?
A.
15 understanding shared by both professionals and by
15
16
laymen that morphine was an end-of-life drug, if it
16
17
was to be used at all.
18
companies involved in the selling of the product?
Q.
Were there concerns about addiction
19 and dependence with respect to morphine?
20
A.
Some people had those concerns.
21
Q.
So going back to bu_ilding our context
Purdue Pharma was established in the
early 1990s to take on new products and to also take
17
on the risk of -- well, take on the risk of new
18
products and also a few established products, but not
19
all.
20
Q.
Were there any actions taken with
21
respect to Purdue -- or with respect to OxyContin that
22 here. You-all had a drug called MS Cantin that you
22
would not fall under the Purdue Pharma umbrella?
23
23
had the exclusive right to sell; is that correct?
24
A.
That's correct.
24
25
Q.
Do you know when that exclusivity was
25
Coulter Reporting, LLC
A.
I'm sorry, could you repeat the
question?
Q.
Yeah. Are you -- are you maintaining
www.coulterreporting.com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page:6
Richard Sackler, M.D.
Page 21
1
Page 23
that there are any actions done with respect to
2 OxyContin, its -- its creation, production, marketing,
1
Dr. Sackler has explained briefly, they were two
2
entities that did different things at different times,
3 sales, that do not fall under the Purdue Pharma
3
and if you lump the two together, inevitably there's
4
4
going to be confusion in terms of the witness's
5
answer.
6
Q.
umbrella?
Its creation was done in Purdue
A.
5
6
Frederick --
Okay. Let's do this. I'm going to
7
Q.
Okay.
7
refer to Purdue as Purdue Pharma, L.P. and also Purdue
8
A.
-- until the early '90s when that
8
Frederick, L.P. If at some point you feel like it's
9
only Purdue Frederick or only Purdue Pharma, you let
9
responsibility was transferred to Purdue Pharma.
And then Purdue Frederick continued to
Q.
10
10 me know. Okay?
11 exist, though, correct?
A.
It did.
12
13
Q.
Okay. And was Purdue Frederick also a
It's kind of a burden, but with the
A.
11
12
help of my attorney ...
13
Q.
Sure.
14 company involved with marketing, promoting, sales and
14
A.
Because there may be issues. It's
15 production of OxyContin?
15
going to be -- it tests my memory to separate the two.
16
So I'm sorry for the confusion, but it is important.
I'm trying to give you an accurate
A.
16
17
answer because this is confusing and complex.
18
There was a period of time in which
For instance -- let me ask you this.
Q.
17
18 Sales reps. Were sales reps employed by Purdue
19 once Purdue Pharma became involved that Purdue
19
20
Frederick was involved, but Purdue Frederick was never
20
21
involved nor Purdue Pharma in manufacturing the drug,
21
sales rep was employed by one, but not necessarily the
22
which was when it was developed, was manufactured by a
22
other.
23
company named P.F. Laboratories.
25
23
Okay. Other than the manufacture, did
Q.
24
24
Purdue Frederick and Purdue Pharma both play a role in
Frederick or Purdue Pharma?
For a period of time they were -- each
A.
Do you know which sales reps were
Q.
employed by Purdue Frederick versus Purdue Pharma?
25
A.
I don't know.
1
Q.
Do you know if they received different
Page 24
Page 22
1 the production of it?
2 training?
I can't recall in detail whether they
A.
2
3
both played a role or whether when Purdue Pharma took
3
4
on the project it carried most of the weight or all of
4
5
5 it.
I believe the training was the same.
Q.
Well, I'll tell you what, I'm going to
refer to when I say "Purdue" as Purdue Frederick. If
6 you feel like it's Purdue Pharma, you let me know.
Is there any difference between the
Q.
6
7
A.
employees of Purdue Frederick and Purdue Pharma?
7
Okay?
8
A.
There were differences.
8
A.
Okay.
9
Q.
Okay. Any difference in the board of
9
Q.
All right. So back in 19 -- early
1 o '90s when you were developing MS Cantin, this
1 o directors?
11
12
13
14
A.
That would test my memory, and I'm not
11
12
going to expire and there was going to be competition
Q.
All right. Well, let me go back to --
13
from generic companies, correct?
sure.
let's talk about OxyContin. And I'm going to use the
15 term "Purdue" for both Purdue Frederick and Purdue
14
exclusive license that you had to sell MS Cantin was
Well, the product MS Contin was
A.
15 developed in the late '70s and early '80s. And -- so
16 Pharma. If at some point you feel like there's a
16 are you discussing development or are you discussing a
1 7 distinction to be made, you let me know. Okay? But
17
18 at a time when --
18
19
MR. STRAUBER: Mr. Thompson, I object
19
2 o to your combining the two under the name "Purdue." If
20
21
you're going to do it, then I'd like to have a
21
22
standing objection to that combination.
23
24
25
MR. THOMPSON: What is your reason for
the objection?
MR. STRAUBER: My reason is, as
Coulter Reporting, LLC
22
23
later time?
Q.
The later time when its license is
about to expire.
A.
Eventually we knew that there would be
competition for MS Cantin.
Q.
And one of the things in developing
Oxycodone Controlled-Release, one of the -- one of the
24
concerns was how to position it in the market and
25
whether you were going to position it an obsolete
www.coulterreporting .com
502-582-1627
Page:7
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 27
Page 25
1
MS Contin or try to position it alongside MS Contin.
2 Do you recall that issue?
2
MR. STRAUBER: I object to the form of
3
MR. THOMPSON: Sure. That's why I was
1
holding it over here.
MR. STRAUBER: It's hard to read from
3
4
the question. Could you repeat it? I'm not sure I
4
5
understood the question.
5
MR. ELLIS: Here's an extra copy.
6
MR. THOMPSON: Great.
MR. THOMPSON: Yes.
6
7
Q.
One of the concerns when you were
that distance.
MR. STRAUBER: Do you have a copy for
7
8
developing Oxycodone -- I'm sorry -- OxyContin
8
9
Controlled-Release was how you were going to position
9
me, also?
MR. ELLIS: (Passing document.)
1 o it for market share and whether you were going to
10
11
position it and make MS Contin obsolete and take that
11
12
market share that MS Contin had, or whether you were
12
13
going to position it alongside MS Cantin and sell them
13
A.
14
Q.
Yeah. I'll tell you where to go.
15
A.
Okay.
Q.
So the second highlighted portion,
14 both together.
Do you recall that concern?
15
16
17
I recall discussions, but that wasn't
A.
16
the principal driver. The principal -- the principal
17
MR. STRAUBER: Thank you .
So do you see down there the second
Q.
highlighted portion that says "Rationale."
Mine is not highlighted.
"Rationale for another controlled-release opioid
18 goal was to produce the best product we could, and we
18 analgesic." And do you see the first sentence below
19
19 that?
believed when we started it and subsequently ...
20
A.
Oh, I see. That's a cross-title.
21
Q.
No, no.
21
Q.
Yes.
22
A.
We believed it was and is a better
22
A.
I was looking at the text.
23
Q.
And the text below that says,
Should I stop?
20
23
24
25
product than MS Cantin.
Q.
Here's a memo dated -- to Richard S.
Sackler from Robert Kaiko.
24
"MS Cantin may eventually face such serious generic
25
competition that other controlled-release opioids must
Page 26
Page 28
1
Do you know Dr. Kaiko?
1
2
A.
be considered. Other pharmaceutical firms are thought
2 to be -- to also be developing other
I do .
3
Q.
He's a Ph.D.?
3
4
A.
He is.
4
5
Q.
What was his role?
6
A.
He was the person who undertook or ran
controlled-release opioid analgesics."
Did I read that correctly?
5
A.
You did.
6
Q.
And was that a concern at that time?
7
the project and was involved -- the project of
7
A.
It was a secondary or tertiary driver.
8
developing OxyContin -- and was -- as a clinical
8
Q.
And then if you'll turn to the next
9
pharmacologist was deeply involved in selecting
9
1 o formulations that would be most likely to achieve the
11
desired effect.
12
Q.
13
1 o that. It says, "While we have reason to believe that
11
other pharmaceutical firms are formulating
12 controlled-release morphine and controlled-release
And under here it says, "Rationale for
13
Another Controlled-Release Opioid Analgesic."
hydromorphone, there is no evidence to date that this
14 is being done with Oxycodone. A controlled-release
This is Bates number -- it's actually
14
15
page and look at the second paragraph. And I'll read
15 Oxycodone is, thus, less likely to initially have
got two Bates stamps. So it's PDD9520805292.
16 generic competition."
16
But it says, "Rationale for Another
17
Controlled-Release Opioid Analgesic: MS Cantin may
Was that a consideration when deciding
17
18 eventually face such serious generic competition that
18 to come out with Oxycodone -- or OxyContin?
19
19
A.
Not for me.
2 o Other pharmaceutical firms are thought to also be
20
Q.
All right. Now, we read your
21
developing other controlled-released opioid
21
paragraph 11 where you discuss that you had limited
22
analgesics."
22
role in the --
other controlled-release opioids must be considered.
MR. STRAUBER: Mr. Thompson, if you're
23
23
24
reading from a document, could you show it to the
24
25
witness?
25
Coulter Reporting, LLC
MR. DANFORD: Do you have a copy of
that so he can take a look at that?
MR. THOMPSON: Yes. Paragraph 11.
www. cou lterreporti ng. com
502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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Page 29
deposition.
(DEPOSITION EXHIBIT NO. 1 MARKED)
4
And this declaration said that you
Q.
5
6
MS Contin, to pay perhaps more attention than I
2 thought she was paying to the prospects of potential
Let's make this Exhibit 1 to the
2
3
1
(Passing document.)
1
3
for OxyContin. So this was in the spirit of
4
motivating her.
It was true that I was very gladdened
5
6
were not directly involved with the day-to-day
to see that OxyContin was meeting with so -- with such
7 marketing or promotion of OxyContin, the training or
7 a strong positive reception by both physicians and
8 management of Purdue sales representatives, or the
8
patients, and I was working hard at the business. But
9
it -- if you -- you would misinterpret this if you
9
scientific research into the conversion ratio of
1 o thought that I was working only on OxyContin. That
1 o MS Contin to OxyContin. Is that correct?
11
A.
That is correct.
11 was not the case.
12
Q.
I want to show you an e-mail. Let's
12
13 encouraged by the number of physicians that were
13 mark this Exhibit 2 to the deposition.
(DEPOSITION EXHIBIT NO. 2 MARKED)
14
Okay. When you say you were
Q.
14 selling it -15
A.
Prescribing it.
16 emphasizing "directly involved." I didn't do any of
16
Q.
-- prescribing it, you were not aware
1 7 the work. I didn't do any of the training. I was not
1 7 at this time, were you -- or were you aware -- that
18 a salesperson.
18 your company was committing a felony in how they were
15
I need to just clarify. I'm
A.
19
Q.
Okay.
19 marketing and branding the drug?
20
A.
But as a senior executive, I certainly
20
MR. STRAUBER: I object to the form of
21 was aware of what was going on and I consulted with
21 the question.
22
other senior executives about what was going on and
22
23
what should be going on and so on.
23
saying. And when I say I was heartened by physicians'
24
reception, when I did speak to physicians at
25
meetings -- I didn't go on sales calls -- but at some
24
25
Okay. And then this e-mail that was
Q.
just handed to you a few moments ago says -- again,
I was not aware at all of what you're
A.
Page 30
1
Page 32
1 meetings and conferences, they were extremely
it's Cornelia Hentzsch. It's dated May 29th, 1999.
2 It says -- if you'll read the highlighted portion. It
2 enthusiastic about the effectiveness and the safety
3
3
and the reception their patients had, the response
says -- this is an e-mail from you to her, correct?
4
A.
Yes.
4
they had to the product. That was what I was
5
Q.
It says, "You won't believe how
5
referring to. Because, as I had told you before, our
6
committed I am to make OxyContin a huge success. It
6 goal was to make a better product than MS Contin, and
7
is almost that I dedicated my life to it. After the
7 I believe we -- this was one of the ratifications of
8 initial launch phase, I will have to catch up with my
9
8
private life again."
MR. THOMPSON: Let's mark this Exhibit
9
Did I read that correctly?
10
that.
10 3.
11
A.
You did.
11
(DEPOSITION EXHIBIT NO. 3 MARKED)
12
Q.
When you say you dedicated your life
12
MR. STRAUBER : May I have a copy?
13
MR. ELLIS: You already have it.
14 what were your day-to-day activities with respect to
14
MR. STRAUBER: The witness has it.
15 OxyContin?
15 I'd like to have a copy .
13 to it and that you have no time for your private life,
16
A.
May I read the -- the whole document?
1 7 I haven't seen this for 16 years.
18
Q.
Have you read your deposition in the
19 Endo litigation?
MR. ELLIS: I think you have it in
16
1 7 front of you and your hand is physically on it.
MR. STRAUBER: You tell me. I don't
18
19 see it.
20
A.
No . In preparation for this?
20
MR. ELLIS: You're holding it.
21
Q.
Yes.
21
MR. STRAUBER: I'm holding 1 and 2 .
22
A.
No.
22
23
The context of this was to encourage
your hand on. We may have just marked it twice. That
may be the problem.
24
Dr. Hentzsch, who was the head of the Australian
24
25
business and was meeting with great success with
25
Coulter Reporting, LLC
MR. ELLIS: That e-mail that you have
23
MR. STRAUBER: You've marked it twice.
www.coulterreporting.com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma LP., et al.
8/28/2015
Page: 9
Richard Sackler, M.D.
Page 33
1
2
MR. ELLIS : Yeah.
3
MR. STRAUBER: Okay. Then I have it
4
5
Page 35
3 and 2 are the same?
because I have 2.
2
investigation as soon as you learned there was a
3
problem?
5
weeks. I can't recall. It was 16 -- 15, 16 years
ago.
6
later on, but you're aware that Purdue pied guilty to
6
7
a felony charge of misbranding a drug, which was
7
8
OxyContin, with the intent to defraud or mislead? You
8
9
are aware of that, correct?
9
MR. STRAUBER: That is Purdue -- that
10
11
is -- pursuant to your earlier statement, that is
12
Purdue Frederick; is that right?
13
14
15
16
A.
Yes. With in -- within months or
A.
4
And we'll get into this a little more
Q.
And did you-all launch this
Q.
1
Q.
Do you -- who is Michael Friedman?
A.
Michael Friedman is the -- was at that
time the head of sales and marketing.
Have you seen his presentation
Q.
10
11 At Purdue that he - - do you know what At Purdue is,
12
your-all's internal newsletter that goes out to all
MR. THOMPSON : Yes.
13
the employees?
MR. STRAUBER: Okay.
14
Okay. So when you said "Purdue," you
15 At Purdue from him .
meant Purdue Frederick?
16
I don't believe I saw a presentation
A.
All right. We'll get to that later.
Q.
Q.
Purdue Frederick Company, Inc.
18
A.
Yes, I am aware.
18
1992, "Meeting with Shionogi held Wednesday July 24th,
19
Q.
Did you -- is it your understanding
19
1992" from Dr. J.W. Watkins, and there's a
17
This is a memorandum dated July 15th,
17
2 o that the fraud only occurred with respect to the
2 O distribution list.
21
Purdue Frederick Company and not with respect to
21
22
Purdue Pharma, L.L.P.?
22
23
24
25
That's my understanding. But I'm not
A.
23
an attorney and that's a very deep legal question.
24
Did you do any investigation to find
Q.
25
I'll assume you are Dr. R.S. Sackler;
is that correct?
A.
That would be me.
Q.
And if you would turn to page 6 of
this document that is PDD1701546226. And to give it a
Page 34
Page 36
1
out whether sales reps employed by Purdue Pharma were
1
little context, Shionogi, is that a Japanese company?
2
exceeding what they were allowed to do when they were
2
A.
It is.
3
marketing, that they were making claims that were
3
Q.
And at one time were you-all talking
4
untrue?
4
about doing some sort of business with them involving
5
potentially OxyContin Controlled-Release?
MR. STRAUBER: Objection to form. He
5
6
can answer.
7
A.
8
When you say "you," are you referring
to me personally or are you referring to the company?
9
Q.
I'm referring to you personally.
10
A.
I did not conduct or manage any
6
A.
Yes.
7
Q.
And did you do business with them
8
involving OxyContin Controlled-Release?
9
A.
Yes.
10
Q.
Let's look at page 6, if you would,
11
investigation. But from the time we learned at top
11 the -- it looks like maybe the third paragraph down
12
management levels that there was an abuse and
12
that begins with "Dr. Kaiko .. . " Do you see that?
13
diversion program, which was years before the
13
A.
Yes.
14
settlement with the government, we launched multiple
14
Q.
"Dr. Kaiko presented two options
15
investigations both with inside resources and people
15
16
and with external attorneys and others to identify --
16
17
and this was before any charges were made -- to
17
18
identify if we had in any sense mislead or caused this
18
19
to happen.
19
20
More important, we spent enormous
20
identified for positioning OxyContin AcroContin ... "
Now, is that the controlled-release?
A.
That was our working title of the
controlled-release system.
Q.
" ... versus MST Contin Tablets in the
U.S. The first was relevant if PF" -- who is PF?
21
resources to try to mitigate the problem whatever the
21
A.
Purdue Frederick.
22
cost was, and that effort, which was launched sometime
22
Q.
-- "did not suffer substantial erosion
23
in 2000 or 2001, continued right through the period
23
of its MS Contin market by generic competition. This
24
that you're referring to of the plea with the U.S.
24
envisioned using Oxycodone AcroContin Tablets over the
25
government.
25
entire spectrum of pain in patients whose treatment
Coulter Reporting, LLC
www.coulterreporting.com
502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 39
Page 37
1
1
had been initiated with this product, whilst MS Contin
2 Tablets would be used as therapy for chronic severe
3
pain in patients who were changed from other
4
medication including Oxycodone AcroContin Tablets.
5
"An alternative scenario would apply
6
if MS Cantin Tablets were subject to erosion by
Did I read that correctly?
2
7 generic competitors. In this case Oxycodone
3
A.
You did .
4
Q.
And who is Lydia Johnson?
5
A.
I don't know.
6
Q.
This department, it looks like it's
7 the marketing department; is that right?
8 AcroContin Tablets would be promoted for use across
8
9 the entire pain spectrum, including those patients who
9
I just see a distribution list. I
A.
don't see a source. I don't know -- it says that the
1 o department is marketing, but I don't know Lydia
10 might otherwise receive controlled-release morphine."
Did I read that correctly?
11
efforts now to a successful launch of OxyContin."
11 Johnson.
Was it your belief that it was of
12
A.
You did .
12
13
Q.
Okay. And was it your intent to
13 extreme timely importance that OxyContin be
Q.
14 promote OxyContin Controlled-Release across the entire
14 established because AB generics were going to arrive
15 pain spectrum?
15 and compete with MS Cantin?
16
A.
No.
1 7 which is where Shionogi either had or was negotiating
17
Q.
All right. Let's mark this as
18 a license for OxyContin.
18 Exhibit 4.
A.
16
Q.
19
Where? You're referring to Japan,
Was it also your intent in the U.S. to
2 o promote it across the entire pain spectrum?
A.
21
It was our hope that it would be
19
MR. STRAUBER: We already have a 4.
20
MR. THOMPSON: Then this would be 5.
(DEPOSITION EXHIBIT NO. 5 MARKED)
21
Dr. Sackler, do you know how much
22 well-received for pain -- moderate to severe pain
22
23
23
money to date has been generated by the sale of
24
OxyContin?
requiring opioids.
24
25
MR. THOMPSON: Let's mark this as
Exhibit 4.
25
Q.
I don't understand the question, money
A.
Page 40
Page 38
Q.
2
3
1
(DEPOSITION EXHIBIT NO. 4 MARKED)
1
And here is PDD9524706426, OxyContin
2
3
launch team memo dated 3-31-95.
And OxyContin was actually launched in
4
5 January of '96; is that correct?
generated.
How much money has Purdue Frederick or
Q.
Purdue Pharma made off the sale of OxyContin?
4
A.
I don't know.
5
Q.
There was an article last month in
6
A.
That sounds correct.
6
7
Q.
And what this says -- if you will turn
7 to Forbes 2015 List of the Richest U.S. Families."
8 to page -- first of all, let me ask you this.
Have you seen that?
8
Do you recall having any significant
9
Forbes. "The OxyContin Clan. The 14 Billion Newcomer
9
A.
I have seen it once.
Q.
Do you know what percentage of Purdue
1 o problem with MS Cantin with respect to addiction,
10
11 abuse, diversion or any of the problems that you
11 Pharma sales is made up of OxyContin?
12
12
A.
Presently?
13
Q.
Yes.
14
A.
Approximately two-thirds.
15
Q.
I've looked at the --
16 the last paragraph. It says, "Our meeting ended with
16
A.
That's Purdue Pharma's sales.
1 7 a question and comment period. Michael Friedman
17
Q.
Sales. Purdue Frederick does not sell
18 emphasized the threat that AB-rated generics posed to
18 anymore, correct?
19
experienced with OxyContin CR?
A.
13
I -- I recall never hearing about
14 that.
15
Q.
All right. So let's look at page 2,
19
A.
No.
2 o be launched, but we don't think it will be until 1996.
MS Cantin. We're not sure when AB-rated generics will
20
Q.
You've got another -- a number of
21
Inevitably, AB-rated generics will arrive, and this is
21
22
why it is of extreme timely importance that we must
2 2 OxyContin, correct?
other entities that generate income from the sale of
23
establish OxyContin. qxyContin can cure the
23
A.
Overseas .
24
vulnerability of the AB-rated generic threat, and that
24
Q.
Yes. And do approximately 90 percent
25
is why it is so crucial that we devote our fullest
25
Coulter Reporting, LLC
of the profits of the company come from OxyContin?
www.coulterreporting.com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page: 11
Richard Sackler, M.D.
Page 41
2
A.
4
Q.
7
9
3
I don't believe it would be 90
4
5
Do you currently make over a billion
9
MR. THOMPSON: Yes.
10
11
A.
No, I don't.
11
12
Q.
All right. Does Purdue Pharma make
12
13 over a billion dollars a year?
14
be that much.
16
Q.
17
6, I'm sorry.
Exhibit 6, PKY1738172006, appears to
be a profit calculation for a Purdue entity.
Can you tell me which entity that is?
If it's not on the document, I
A.
couldn't possibly tell you.
Did Purdue Frederick still exist in
Q.
13
I'm not sure. I don't think it would
15
MR. ELLIS: 6 .
Q.
8
By "you," now you're talking about Dr. Sackler?
A.
This appears to me - - what's been
marked as Exhibit 5, it's PKY --
7
MR. STRAUSER: Objection to the form.
10
(Passing document.)
Q.
6
dollars a year selling OxyContin?
8
(DEPOSITION EXHIBIT NO. 6 MARKED)
2
MR. THOMPSON: Purdue Pharma.
percent, but it is certainly a majority.
6
I don't know.
A.
1
company"? You're referring to now Purdue Pharma?
3
5
Page 43
MR. STRAUSER: Question. "The
1
14 2006?
Let's talk about gross sales.
Are gross sales over 3 billion dollars
15
A.
I'm not clear. I think it did.
16
Q.
This appears to be a profit
17
18 a year?
calculation for OxyContin Tablets only. Do you see
18 that?
19
A.
No, they're not.
19
A.
I do.
20
Q.
What are the gross sales?
20
Q.
And it appears that at least by 2006
21
A.
Well, I think what you're looking for
21
profit contribution was 4 million -- 4,718,767,000.
Is that correct?
22
is net sales. Because in the industry a lot of money
22
23
is inherently rebated back to purchasers, insurance
23
24
companies, hospitals, et cetera, through wholesalers
24
25
in rebate agreements, which are negotiated . So I
25
Q.
And what would you subtract from that?
A.
All of the money that was invested in
You've read the number correctly, but
A.
profit contribution is not profit.
Page 42
Page 44
1
believe the net sales are in the range of, this year,
1
2
a billion dollars.
2
the business to develop new products. That would be a
3
major deduction from that.
MR. STRAUSER: Your question was
3
4
directed to Purdue Pharma?
5
4
MR. THOMPSON: Purdue Pharma.
5
6
A.
Right.
6
7
Q.
Are there any other Purdue entities
7
8 that make money that would not be included in that one
8
9
9
10
billion dollar sales?
A.
Not -MR. STRAUSER: Objection to the form
11
12 of the question.
You can answer.
13
14
A.
Not in the United States.
15
Q.
Do you know how much the Sackler
16 family has made off the sale of OxyContin?
Let's mark this -- well, let's --
Q.
you're right, I think it is.
Look up at the top where it says,
"Gross profit 7,502,367,000."
Just a second. Small type. Just a
A.
second. "Gross Profit." I see "Gross Sales." I see
10 "Rebates," and then "Net Sales." Okay, I'm with you
11 on "Gross Profit."
12
Okay. So deducted from that is
Q.
13 shipping, warehousing. You have 536 million paid to
14 Abbott for co-promotion commission?
That's correct.
15
A.
16
Q.
You have an S&P expense. What's that?
17
A.
I don't know.
17
A.
Sales and promotion.
18
Q.
But fair to say it's over a billion
18
Q.
All right. That was 141 million on
19 dollars?
19 sales and promotion; is that correct?
20
A.
It would be fair to say that, yes.
20
A.
21
Q.
Do you know if it's over 10 billion
21
Q.
R&D expense, 308 million?
22
A.
Right. And I'm looking for the
22
dollars?
That's correct.
23
A.
I don't think so.
23
24
Q.
Do you know if it's over 5 billion
24
Q.
Sales force.
25
A.
Yes, I see that. But can I explain?
25
dollars?
Coulter Reporting, LLC
number. I'm sorry.
www.coulterreporting .com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page: 12
Richard Sackler, M.D.
Page 45
Page 47
1 That's the R&D associated with the product.
Right.
Q.
2
1
approximately 95 percent of the patients out there
2
could be treated with MS Cantin?
3
A.
Not the R&D for other products .
3
A.
No.
4
Q.
Right. And then sales force is 960 --
4
Q.
Do you disagree with that statement
5
that --
5 or 87,222,000 that they've been paid?
A.
That's what it says.
6
A.
I do. I disagree.
7
Q.
And then it's got a G&A expense. What
7
Q.
What percentage do you think of
8
is that?
6
8 patients could be adequately treated with MS Contin?
9
A.
General and administrative.
9
A.
Between 50 and 75 percent.
10
Q.
All right. 492 million?
10
Q.
And what studies are you basing that
11
A.
Yes. Over how many years? '96 to
11 on?
A.
I'm basing it on general experience of
12
2005. So it's nine years. Am I counting correctly?
Q.
13
12
You are.
Then there is product liability and
14
13
being involved with MS Cantin and OxyContin since
14
1980.
15 patent litigation expense. You had OxyContin
15
16 litigation expenses. Then you have profit after all
16 determine what percentage of patients could be
1 7 those are subtracted on OxyContin of 4,718,000,000.
1 7 adequately treated with MS Cantin?
18 Is that correct?
18
A.
I don't remember any.
19
Q.
Okay. Did you ever do any studies on
A.
19
That's what it says. I can't testify
2 o that that's correct, but that's what it says.
Did you ever do any studies to
Q.
20 abuse liability for OxyContin before you-all put it on
MR. THOMPSON: Let's mark this as
21
the market?
22
Plaintiff's Exhibit 6. I think we've already marked
22
A.
I'm not aware of any.
23
it.
23
Q.
Let me show you what's been identified
21
24 by Bates stamp PDD8801123847. We'll mark this
MR. DANFORD: We've been going about
24
25 Plaintiff's Exhibit 7.
25 an hour.
Page 48
Page 46
MR. THOMPSON: I try to go a little
1
2 bit longer. I mean, if you all need a break, we can
3
THE WITNESS: I need to take a break.
at 10:06 a.m.
7
(RECESS)
8
VIDEOGRAPHER: We are back on the
9
record at 10:18 a.m.
12
Q.
(Passing document.)
5
MR. STRAUBER: May I have a copy?
6
MR. ELLIS: I'm getting one.
7
(Passing document.)
8
MR. STRAUBER: Thank you.
And does this appear to be a memo to
Q.
9
10 BY MR. THOMPSON:
11
this?
4
VIDEOGRAPHER: We are off the record
5
6
3
And I'll ask you if you can identify
Q.
2
take a break, but ...
4
(DEPOSITION EXHIBIT NO. 7 MARKED)
1
10 you from Paul Goldenheim?
All right. Dr. Sackler, I want to ask
you about one more thing in Exhibit 4.
11
A.
It is.
12
Q.
And who is Paul Goldenheim?
A.
At the time he was head of Research
13
(Passing document.)
13
14
And if you look at the second
14
15 paragraph, there's a comment that says, when
and Development.
Okay. And just to kind of walk
Q.
15
16 discussing Oxycodone AcroContin, which is
16 through this memo. From the bottom down there, it
17
1 7 looks like you had sent a memo on March 14th of '97 to
controlled-release Oxycodone --
18
A.
I'm sorry. Just -- page what?
18 a number of individuals at --
19
Q.
The first page, second paragraph.
19
A.
I'm looking for that. I'm looking for
20
A.
Okay.
2 o my -- oh, from me. Okay. I see that. Okay. I'm
21
Q.
It says, "The molecule lacks the
21
sorry. I see now. It's two e-mails. Okay. Thank
22 stigma of morphine and may be of particular advantage
22
you.
23 in the five percent, approximately, of patients who
23
24 cannot be adequately treated with morphine."
25
Was it your understanding that
Coulter Reporting, LLC
Q.
And the paragraph at the bottom says,
24 "The BfArM," what is that?
25
A.
That was the German regulatory agency
www.coulterreporting.com
502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 51
Page 49
1
at that time.
It says, "Were asked whether OxyContin
Q.
2
3
to be classified as a controlled drug or whether it
2
the subject of "Is this an opening to descheduling the
3
agent?"
4
would be possible to obtain a relaxed status because
4
5
of the difficulty in extracting Oxycodone from the
5
6
matrix and the fact it was less liable to abuse
6
7
because it was unknown."
7
So just dialing down on that first
8
9
1 o be Jess regulated in Germany; is that correct?
A.
11
And descheduling means make it less
restrictive, correct?
11
That -- that's how I would understand
Q.
And if it's less restricted, would you
think that you could sell it to more people?
It would be easier for physicians to
A.
10
I believe that I was reporting
A.
it.
8
9
sentence, you were wondering whether Oxycodone could
And then Dr. Goldenheim writes back on
Q.
1
prescribe it.
12
something to Paul that I must have heard, but I was
12
Q.
It's going to increase sales?
13
not involved in making any discussions or meetings
13
A.
That is reasonable because they could
14
with BfArM.
14
15
16
17
Okay.
15 Schedule II, as are some drugs, physicians could
A.
Can I -- may I just read the rest of
16
it if we're going to continue on this?
And his response is, "We do not have
Q.
18 any abuse liability studies."
19 it to you.
And this is as of 1997, correct?
19
The next sentence says, "The BfArM" --
20
prescribe by telephone.
17
Sure. I'll tell you what, I'll read
Q.
18
prescribe it -- if it were Schedule III instead of
Q.
21
B-f-A-r-M -- which I understand is the German
22
regulatory authority?
20
A.
That's correct.
21
Q.
To date have you done abuse liability
22
studies?
23
A.
That's correct.
23
A.
24
Q.
-- "answered that unfortunately
24
Q.
When were they done?
25
A.
I don't know when the first ones were
25 OxyContin would definitely be classified as a
Yes; many.
Page 52
Page 50
1 controlled drug for all strengths as is morphine.
1
done, but they were done repeatedly for many
2
2
formulations subsequently of both Oxycodone and of
There could be no exception because of the
3
controlled-release protection because there had been a
3
other abusable opioids, both in controlled - release
4
few reports of abuse and there were limited data on
4
form and in immediate-release form.
5
long-term use."
6
6
7
A.
You did.
7
8
Q.
Okay. And then you have here in caps,
8
9
"We have a lot of use data in the U.S. with very,
1 o very, very few ADEs."
for OxyContin Controlled-Release?
I don't -- yes, the new -- the new
A.
formulations definitely.
9
Q.
And when were those done?
10
A.
I don't know exactly. But before the
11
What are ADEs?
11
Have you done abuse liability studies
Q.
5
Did I read that correctly?
products were submitted to the agency.
12
Q.
You're saying the new formulations?
13
A.
The new formulation.
14 All adverse drug experiences are reportable to the
14
Q.
When were the new formulations
15 submitted?
A.
12
13
Those are reports to the agency, to
the FDA. And ADE stands for adverse drug experience.
15
agency. Anything we are aware of we must report
16
periodically. Anybody else, however, can also report
16
17
ADEs to the agency. And so the agency maintains a
17 2008 .
18
catalog for every drug of ADEs .
18
Q.
Okay.
19
A.
But I could be in error by a year or
Q.
So by 1997, two years after this
Q.
19
And then you have in caps, continuing,
A.
2 o "We can run another long-term trial to get more data,
20 two .
21
and if the abuse potential is equal or lower than with
21
22
another nonscheduled drugs, would BfArM unschedule
22
23
it?"
product was on the market, he says, "We do not have
23 any abuse liability studies. I think this is a dead
That's your question, correct?
24
25
I'm doing this from memory now. About
A.
That was a question.
Coulter Reporting, LLC
24
end. Adding naloxone, I think, is the only
25
possibility, but this is a difficult project from the
www.coulterreporting.com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
Page: 14
Richard Sackler, M.D.
8/28/2015
Page 53
1
Page 55
clinical perspective. We are investigating for
1
2 Oxycodone."
Was that his response?
3
2
THE WITNESS: Pardon?
3
MR. ELLIS: I've highlighted your
4
A.
That is what he wrote.
4
5
Q.
He's basically saying they're not
5
6
going to deschedule this?
6
Unless -- perhaps they might if it
A.
7
Q.
And naloxone is an additive?
10
A.
It is - - it is a reversal agent. It
MR. ELLIS: These are the -- this is
the way this document was produced to us. The reason
13 two pages is because Purdue produced a totally random
14 document in between it. But if you look at the Bates
We subsequently did in some markets.
A.
MR. STRAUSER: Yeah, I'm not sure that
all the pages have been assembled properly.
12 that there's a skip in the Bates range from the last
13 naloxone, correct?
14
MR. DANFORD: Can we organize those?
10
11
And you-all did not incorporate
Q.
2-27 . It's not -- oh, it's the middle
A.
page for me, not the last. Okay. Yep.
8
9
11 blocks the effect of opioids.
12
e-mail.
7
8 incorporated naloxone.
9
you, Dr. Sackler.
15 In Europe in particular and to some extent elsewhere.
15 numbers of the original Bates stamp on this document,
16
Q.
Did they require you to do that?
16 they're consecutive among those pages in a consecutive
17
A.
No. We did it for another reason.
17
18
Q.
What was the reason?
18
19
A.
We discovered that it did not block
19 removing the completely erroneous page that has
e-mail chain.
So I have taken the liberty of
2 o the effect of the opioid apparently at all, but it did
2 o nothing to do with this e-mail chain and produced it
21 reduce the gastrointestinal side effects dramatically,
21
22 including constipation, which is the most common side
22
23
23
that. The question is if he has a different
24
formulation.
effect for any opioid.
I could add that by the time we had a
24
25
full press to develop an abuse-resistant form of
to the witness.
MR. DANFORD: My question is not about
MR. ELLIS: No. He's got the same
25
Page 54
1
Page 56
OxyContin we did do extensive work with another
1 document.
2
antagonist called naltrexone, and naltrexone did, when
2
3
it got released, block the effect of the opioid. But,
3
trying to make sure that we're all working from the
4
unfortunately, after a huge investment, we could never
4
same document here.
5
be certain that it wouldn't be released when it was
6
7 perfect because the agency said that if it released
7
and blocked the effect of the opioid in patients, they
9
would not approve it and we could not reach
8
11
Q.
MR. STRAUSER: That's it (indicating).
I had to look for it. I expected it
A.
at the end, but it wasn't. Okay. Yes.
It says -- this is from Walter Wimmer
Q.
9
1 o perfection.
So if you'll go to the 2-27-97 e-mail.
Q.
5
6 taken orally. It was almost perfect, but it had to be
8
MR. STRAUSER: Exactly. We're just
1 o at Mundipharma-Germany.
Let me show you an e-mail chain that's
And that's a company that's owned by
11
12 been produced. I'll mark this.
12 the Sackler family, correct?
(DEPOSITION EXHIBIT NO. 8 MARKED)
13
A.
14
Q.
And who is Walter Wimmer?
15 at the back, I believe, this e-mail chain begins at
15
A.
He was the general manager at that
16 the back. And this is an e-mail from you dated -- the
16
Q.
And he says, "Dear Bob." First
13
14
Q.
It's PDD29520806439. And if you start
It is.
time.
1 7 last e-mail is the first e-mail, and it's dated
17
18 3-2-97.
18 paragraph. "In the course of this conversation he
19
A.
Wait_. I'm seeing 3-11-97. It's sort
2 o of a little out of order, isn 't it?
21
Q.
I'm sorry, yeah. There is -- mine
22 tore off.
19 explained to you that due to his discussions with
2 o BfArM he does see a 50 percent chance to get OxyContin
21
off the narcotic drug status provided you could give
22
some information on the very low abuse potential of
our CR formulation."
23
A.
Oh, no, 3-12-97.
23
24
Q.
2-12-97 is the first.
24
25
MR. ELLIS: I've highlighted it for
Coulter Reporting, LLC
25
Did I read that correctly?
A.
You did.
www.coulterreporting .com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page: 15
Richard Sackler, M.D.
Page 57
Q,
1
Page 59
And then in response to that, if you
Were you aware at that time that
1
2
go up to the top, Dr. Robert Kaiko has an e-mail dated
3
2-27-97.
2
OxyContin -- there was a concern that Oxycodone
3
opioids could be injected or abused?
4
A.
He does.
4
5
Q.
And he says, "While my thinking is
5
remember whether I had read the whole chain carefully
or not or even saw it.
I don't remember this memo and I don't
A.
6
still developing, frankly, I'm very concerned, and I
6
7
would have to recommend against the uncontrolled but
7
8
monitored proposal at this time. (Perhaps if only to
8
acknowledges" -- by "dossier," I assume he means the
9
make sure the risks are appreciated and accepted
9
documents --
1 O before we proceed as proposed)."
11
Do you know what risk he was
Then he says, "Our dossier
Q.
10
A.
Yes.
11
Q.
-- Purdue has?
12
discussing?
12
A.
Yes.
13
A.
I have no idea.
13
Q.
"Our dossier acknowledges a small
14
Q.
Did you ever discuss with him why he
14
15 was recommending against going uncontrolled but
16
handful of patients in our research program" -- and
15 that means studies you-all were doing; is that
monitored with respect to OxyContin?
16
17
A.
I don't even know what it means.
17
18
Q.
All right.
18
19
A.
If I read the rest of it, do you think
19
2 o it would give me a clue or -- I infer that because you
correct?
That's -- that's what I would
A.
understand it would mean.
-- "who were suspect in terms of their
Q.
2 o drug accountability."
21
didn't highlight it, you don't think it would shed any
21
22
light on what was meant above?
22
anyone, that your-all's dossier had a handful of
23
patients who were suspect in terms of their drug
accountability?
23
Q.
Well, let's read the rest of it. It
24
might help. He says under paragraph B, "I don't
24
25
believe we have a sufficiently strong case to argue
25
Do you know if that was reported to
I don't know if it was reported, but
A.
Page 58
1
Page 60
that OxyContin has minimal or no abuse liability."
1 I'm confident it was . If it was an FDA-submitted
This is dated 1997, correct?
2
3
A.
Yes.
4
Q.
He says, "In the U.S.
2 trial, it would have been in either the safety summary
·3
4
or the -- or the efficacy summary, or both.
Do you remember the issues with the
Q.
5
Oxycodone-containing products were once less
5
Roth reprint where there were patients who they
6
controlled than now. Abuse resulted in greater
6
determined had withdrawal symptoms and that was not
7
controls."
7
reported?
Is that accurate?
8
9
A.
I believe it is.
10
Q.
And what he's saying there is, these
MR. STRAUBER: Objection to form.
8
9
A.
No. I'm sorry.
10
Q.
Are you familiar with the Roth
11 weren't as controlled at one time and they got abused,
11
12
12
and that's why we have controls now, correct?
reprint?
A.
No.
Q.
Do you know whether that was part of
13
A.
I believe that is the case.
13
14
Q.
He says, "Oxycodone-containing
14
the plea agreement that Purdue Frederick had when they
15
pied guilty to a felony?
15
products are still among the most abused opioids in
16 the U.S. This information is available to BfArM, the
16
A.
I don't -- I don't recall.
17
17
Q,
And it says under paragraph C,
18
19
German regulators."
A.
I -- that's certainly true that the
18 continuing on, "We do not" -- "We do not have a
information would be available to them.
19
post-marketing abuse monitoring system and database
And he says, "The local tissue
20
from which we could conclude that diversion abuse is
21
necrosis that can result from injection of OxyContin
21
not occurring."
22
'fixed' for such abuse is not likely to be a deterrent
22
23
to abuse. Let us not forget that in New Zealand MST
23
20
Q.
Were you aware that you-all put this
on the market, OxyContin CR, and did not have a
24
is the most common sources of parenterally abused
24
post-marketing abuse monitoring system or database
25
morphine/heroin."
25
from which you could tell whether abuse or diversion
Coulter Reporting, LLC
www.coulterreporting.com
502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 63
Page 61
1 was occurring?
I was not aware of that. I don't
A.
Q.
1
And this is your response to Robert
2
Kaiko saying this is a bad idea for all these reasons.
3
believe it was a requirement at the time. I'm sure we
3
And you say, "This is the first time I've heard of
4
would have fulfilled all the FDA requirements that
4
this idea. What makes us believe that we can
5
they asked us.
2
7
Do you think it would have been a good
Q.
6
5
accomplish it, Walter? How substantially would it
6
improve your sales?"
And what you're talking about there is
idea before putting OxyContin Controlled-Release on
7
8 the market to have an abuse monitoring system and
8
9
if we can get it uncontrolled in Germany, how
9 substantially will it improve sales, correct?
database from which to tell if it was being diverted
10 or abused?
Yeah. Yes, that was -- it would
A.
10
11
A.
Absolutely, yes.
11 appear that that's what my question was.
12
Q.
And then under paragraph C it says,
12
"Please give a five-year projection
Q.
13
"If OxyContin is uncontrolled in Germany, it is highly
13
with control and without. Does each member of the
14
likely that it will eventually be abused there and
14
EU" -- is that the European Union?
15 then controlled. This may be more damaging to
15
A.
Yes.
16
Q.
-- "decide this for themselves or
16 OxyContin internationally than any temporarily higher
1 7 sales that could be gleaned from an uncontrolled
1 7 would one lead? If one would lead, then is Denmark or
18 status. Let us not forget the experience with
18 Germany more likely to agree?"
19 buprenorphine, which was initially uncontrolled.
19
2 o Reports of abuse in Germany in part eventually led to
20
writes you back on March 7th and says, "Dear
Dr. Richard" --
21
lots of bad press and controlled status. Worldwide
21
22
sales suffered even where buprenorphine had already
22
23
been controlled. So, given the above, what do others
23
24
have to offer that should prompt us to pursue the
25
proposal for uncontrolled status for OxyContin
And then Harry Kletzko of Mundipharma
A.
Just a second. Now we're on page 1 or
24
Q.
That's the same page. The one right
25
above.
1
A.
Okay.
Q.
"Please find stated below our
27
Page 62
Page 64
1 anywhere?"
And was that the response of Robert
2
3
Kaiko?
2
3
five-year projection of OxyContin without and with
controls as requested."
4
A.
It appears to be so.
4
5
Q.
And who was Robert Kaiko?
5
A.
He was in charge of the development
6
7
program of OxyContin.
6
7
A.
Uh-huh.
Q.
And it was projected that with first
year non-narcotic -- narcotic drug with control would
8
Q.
Was he the chief medical officer?
8 be 3.000 TDM. Do you know what that is?
9
A.
No. But he was -- he was respected.
9
10
His opinions were respected and were heeded.
Q.
11
12
from you, is Dr. Richard Sackler at Norwalk.
A.
13
14
And then the next e-mail, which comes
Give me just a little time to find it
since they're not in order. Okay, Norwalk. And could
15 you read the date, please?
I assume total or something
A.
1 o Deutsch marks. Something Deutsch marks.
11
Q.
And that would be 3 million?
12
A.
That would be my understanding.
13
Q.
And then turnover non-narcotic drug
14 without control is 10 million?
15
A.
The first year.
Q.
The first year. And on the fifth year
16
Q.
It looks like it's 3-2-1997.
16
17
A.
3-12. 3-12-97?
17
18
Q.
I'm looking at 3-2. It says 02-03-97,
it was projected to be 18 million with control but 30
18 million without control, correct?
19 but I think the way it's computed, it's really March
19
A.
That's what it says.
20
20
Q.
And then you wrote back on 3-8-97,
21
22
3rd.
A.
Okay. I see something from 3-12. I
see something from 11- 3- 97.
23
Q.
It's page 5, Maybe that will help.
24
A.
Oh, I don't think I have page -- oh,
25
page 5. Okay. Thank you.
Coulter Reporting, LLC
21
right above that one, and it says, "BK advised that
22
the regulatory authorities did say" --
23
A.
RK. BK. I'm sorry. I heard DK.
24
Q.
-- "advised the regulatory authorities
25
said that Oxy would be scheduled and so it would be
"'(WW.coulterreporting.com
502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma LP., et al.
8/28/2015
Page 67
Page 65
1
under narcotic control. Does this correspond to your
1
2
info? If so, is this matter now closed or is there
2 back, "Yes, Richard, this does correspond to the
Let's go to the next one, which is page 4. He writes
3
some appeal or other procedure you would want to
3
information given by Mr. Goerich, our registration
4
consider?"
4
officer. We also attended the meeting with the BGA.
5
This matter is now closed. There is no way of
6
getting OxyContin CR uncontrolled and were wondering
6
appeal."
7
if there was some way you might appeal the German
7
So you still saw the advantage of
5
8 decision?
MR. STRAUBER: Objection to form .
9
1 o That's not what the statement says that you just read.
Q.
11
Is that what he told you?
8
A.
That seems to be what he told me .
9
Q.
And then you wrote back and said,
10
"When we are next together we should talk about how
11 this idea was raised and why it failed to be realized.
Well, correct me if I'm wrong there.
12
Why did you say is there some appeal or other
12
I thought that it was a good idea if it could be
13
procedure you want to consider?
13
done."
A.
14
Okay. This whole experience is
15
actually like reliving a third of my life, and I had
Was that your response to --
14
15
That's what it said, but I didn't mean
A.
16
completely forgotten, until I saw this document, that
16
it. I just wanted to be encouraging. I was very glad
17
Walter had been very hesitant to pursue the
17
it was closed.
18
development or the marketing of OxyContin because he
18
Q.
didn't believe it would sell very well. He turned out
19 there's another response from Walter Wimmer who says,
19
Up at the top there's a note --
2 o to be completely wrong and when it was introduced it
2 Q "To get the product off narcotic drug status, it would
21
21
did extremely well.
22
23
be possible to combine Oxycodone with naloxone
22 provided the development costs weren't too high."
We were of the contrary opinion, but
he said -- he came back and he did quite a bit of work
23
That was sent on 3-12.
24
without any reference to anybody else on determining
24
A.
Okay. Let me --
25
or trying to get the BfArM to consider not scheduling
25
Q.
And then the top one is cut off, but
Page 68
Page 66
1
1 it says, "Paul, Michael. Would this be a feasible
it. And this whole stream was occasioned by that.
2
We -- many of us in the U.S. were not enthusiastic
2
approach here in the U.S.? I don't know of any C-II
3
about not scheduling it.
3
narcotic that is de-scheduled when naloxone is added,
4
do you?"
In Germany there is no equivalent, at
4
Was that a question you were raising?
5
least at that time that I recall, of anything like
5
6
Schedule III. You are either an abusable drug and,
6
7
thus, you had all the abusable drug controls or you
7
matter of information. As I said, they eventually did
8
were not. And we were not in favor of this, but we
8
develop that product and it was extremely successful.
9
were trying to be polite and solicitous rather than
9
At the time they researched it, they quickly
It looks like I raised it just as a
A.
1 o saying, this is a terrible idea, forget it, don't do
1 o discovered that naloxone didn't achieve the desired
11
11
blocking effect, but they made another discovery that
12 which we thought would be appropriate and were
12
was even more valuable .
13
13
it. Because we still felt that with the controls,
appropriate obviously, it would still be very welcome,
Would I be correct that Purdue Pharma
Q.
14
never conducted or retained anyone to conduct studies
15
regarding addiction and physical dependency rates of
16 trail really was occasioned by that. But I don't
16
Oxycodone products at least as of March 4th, 2002?
17
remember anymore. So if we go on, I'm going to relive
17
A.
I don't know the answer.
18
another few days of my life.
18
Q.
Are you aware that counsel for Purdue
14 very useful to patients in the German market.
So this whole stream -- this whole
15
19
Q.
19
Sure. Let me ask you. If you thought
Pharma's answer to interrogatories that requested the
2 o controls were appropriate, why were you asking here or
2 o names of all individuals retained by Purdue Pharma to
21
raising the issue if there was some appeal that could
21
22
be taken with regard to the --
22 rates of OxyContin products and copies of all studies,
23
24
25
A.
Just to be polite, not to just shut
23
and he answered, "We never conducted or retained
24
anyone to conduct studies regarding addiction and
Okay. Well, let me ask you this.
25 physical dependency rates of Oxycodone products."
him down.
Q.
do studies regarding addiction and physical dependency
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www.coulterreporting.com
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Richard Sackler, M.D.
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8/28/2015
Page 71
Page 69
MR. STRAUSER: Mr. Thompson, if you're
1
Do you have a knowledge of what
Q.
1
2
reading from a document, could you show it to the
2 Percocet and Duragesic was used mostly to treat?
3
witness?
3
Percocet and -- Percocet was an
A.
4
extremely widely used product used to treat both short
5
he's aware of it because I'm trying to move the
5
and long-term pain conditions, both non-malignant and
6
deposition along.
6
malignant.
MR. THOMPSON: No. I'm just asking if
4
7
Q.
So are you aware of that?
8
A.
No, I'm not aware of his -- his
8 paragraph 2.3. And this says 1993. It says, "Abuse
9 Toxicity Bench-Top Study - The results of a spoon" --
9 statement.
Are you aware of any studies conducted
Q.
10
And then, if you'll turn over to
Q.
7
11 or retained -- or anyone being retained to conduct
10
A.
Okay. I see. 2.3 you said?
11
Q.
Yes.
12 studies regarding addiction and physical dependency
12
A.
Thank you.
13
13
Q.
-- "The results of a 'spoon & shoot'
14
rates of Oxycodone products prior to 2002?
I'm not aware of any or don't remember
A.
14 study have been sent to the FDA."
15 any. In 2002 I was the president of Purdue Pharma,
What was a 'spoon & shoot' study?
15
16 and this would not have necessarily -- this wouldn't
16
17
17
have required my approval or knowledge unless it
I don't know. I could guess, but I
A.
don't know.
Was that a study done to determine if
18 was -- it led to something that was surprising or
18
19 important and unexpected .
19 the drug could be abused by extracting Oxycodone from
2 O the tablet?
MR. STRAUSER: Mr. Thompson, did you
20
Q.
21
put an -- give an exhibit number to the last document
21
22
that we were discussing, which was a series of
22
23
e-mails?
23
It's a reasonable guess, but I don't
A.
know the details of what that study was.
And then under 3.2, the last sentence
Q.
24
MR. THOMPSON: It was 8.
24
25
MR. STRAUSER: 8. Okay. Thank you.
2 5 decide such a study is needed."
says, "A crushed tablet study may be conducted if we
Page 72
Page 70
(Passing document.)
1
2
All right. I'm going to switch and
Q.
Do you know if you ever decided such a
1
2 study was needed?
3
ask you a little bit about the OxyContin Project Team.
3
A.
4
And this is a memo dated December 14th, 1993,
4
like to read it.
What's the number on that? I'd just
5
PDD9520509356. There's a few paragraphs I want to try
5
Q.
3.2, the last sentence.
6
to cover here.
6
A.
I'm sorry. Thank you. 3.27
7
Q.
Uh-huh.
8
points on the front page, the second one from the
8
A.
Yes. Okay, I've read that.
9
bottom says "Marketing: OxyContin Tablets will be
9
If you will look at the bulletin
7
I don't know if such a study was done.
1 o marketed against Percocet and Duragesic. The
10
11 OxyContin line may replace our MS Cantin line if
11 sentence says, "Mike Innaurato." Was he a guy in
12
12 charge of marketing? '
MSC generics are competing." Is that correct?
13
A.
That's correct.
13
14
Q.
And that's not the -- is that the
14
And then on 5.4, the very last
Q.
No. He was -- he worked in the
A.
marketing department, but he was not -- at this time
15 malignant cancer group of patients, or is that the
15 he was not in charge. He was a middle manager of
16 non-malignant cancer group of patients?
16
marketing.
17
Q.
17
A.
I'm sorry?
MR. STRAUSER: Objection to the form.
18
19 I don't understand the question.
20
21
Q,
Go ahead, you may answer.
A.
MS Cantin, as I said before, was used
19 ongoing studies. Robert Reder stated that we did not,
2 o but that we could include quality of life questions in
21 future studies."
22
in treating both cancer patients and non-cancer
22
23
patients and there was no focus, I don't believe, or
23
24
consideration in this statement of whether it would be
24
25
both, I think.
25
Coulter Reporting, LLC
All right. It says, "Mike Innaurato
18 asked if we had any quality of life questions in our
Do you know if quality of life
questions were included?
A.
I believe there were studies later
that included quality of life measures, but I am not
www.coulterreporting.com
502-582-1627
Page: 19
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 75
Page 73
1
certain of that. I am certain it would have been
Correct. And if you'll look at this,
Q.
1
2
favorable, but I'm not certain just what studies were
2
it says, "A literature search" -- the second
3
or were not done.
3
paragraph. "A literature search on oxycodone and
4
oxymorphone is being conducted" --
MR. THOMPSON: Let's mark that as --
4
5
has it been marked yet?
I'm sorry. It's just not very clear.
A.
5
6
COURT REPORTER: No. 9.
6
Give me a second. "A literature search" -- are we
7
MR. THOMPSON: -- Exhibit 9.
7
looking at the same page?
(DEPOSITION EXHIBIT NO. 9 MARKED)
8
9
8
9
With respect to Oxycodone and
Q.
1 o morphine, do you know whether OxyContin is more
10
11 powerful or less powerful a drug than morphine?
11
13
It depends what you mean by
A.
12
12
"powerful."
No, we're not. You're on page 2, I'm
Q.
on page 1, second paragraph.
I'm sorry. I thought you said August
A.
10th. This one is August 4th. Okay. I'm sorry.
Second paragraph. "A literature
Q.
13
search on oxycodone and oxymorphone is being conducted
by one of the summer employees."
14
Q.
I think Dr. -- is it Goldenheim?
14
15
A.
Yes .
15
16
Q.
Was he an~employee of --
16
17
A.
Yes.
17
Q.
I think he testified that -- that
18
daughter of one of the people who worked for Purdue
19
Frederick or Purdue Pharma.
18
19
Oxycodone was twice as strong as morphine. Is that
2 O your understanding?
21
22
A.
20
21
If the question -- if powerful means
Do you know who was doing the
literature search initially?
No. It would have been a son or
A.
Fifth paragraph down, second sentence
Q.
says, "The current consideration is to develop 20, 40,
potency, absolutely, it is twice as potent as
22 80 and 160 milligram tablets in addition to the 10
23
morphine. And we were very proud that we discovered
23
24
this, first in animal studies and then in human
24
25
studies, and we made it widely known perhaps even
25
milligram tablets now in the clinic."
And whose idea was it to develop 20,
40, 80 and 160 milligram tablets?
Page 74
Page 76
1
before the drug was introduced, but certainly in the
1
2
package insert and all the promotional material.
2
3
Q.
Do you know how many doctors or what
percentage of doctors thought that it was equal to or
4
5
less strong than morphine?
5
6
I would assume very few if they -- if
are you reading from, Mr. Thompson?
MR. THOMPSON: The first page, just
3
4
A.
MR. STRAUBER: I'm sorry. Which page
6
what I called out, fourth paragraph, second sentence.
MR. STRAUBER: Okay. Thank you.
This was a team decision. It was
A.
7
they were promoted to. I can't believe that they
7
8
wouldn't have understood that. That formed the basis
8
discussed extensively.
9
of our recommendations of dosing of the strength of
9 first paragraph, it says, "With regard to the package
10
the tablets that were developed. And, in fact, it was
10
Then if you'll go to the second page,
Q.
insert and the first year advertising claims, it was
consistent with physicians' own experience with
11 discussed that Mr. Segar should meet with others and
12
Percocet where they would administer a 5-milligram
12
rework the 'draft' package insert. The purpose would
13
dose and they -- if they used morphine, they knew that
13
be to idealize the insert and coordinate the contents
14
5 milligrams of morphine would achieve very little
14 with the advertising claims and clinical trials
11
15
pain relief if given orally, perhaps somewhat more if
15
program. The package insert should include
16
given by injection.
16
comparative claims. It must be kept in mind this is a
MR. THOMPSON: Let's mark this as
17
18
Plaintiff's Exhibit 10.
1 7 working document."
19
(DEPOSITION EXHIBIT NO. 10 MARKED)
19
20
(Passing document.)
20
21
22
Q.
This is the memo dated 1992, August
10th, Oxycodone Project Team Meeting Minutes.
Why did you want to coordinate the
18
package insert with your advertising claims?
A.
The package insert is the Bible for
21
the product. It is the core document from which all
22
promotion or communication with physicians is to be
23
A.
I'm sorry, August 10th.
23
based. It is typical in the industry that a lot of
24
Q.
And it is PDD9521410329.
24
work is expended to make the package insert as
25
A.
39? I have 30. The first page is 39.
25
comprehensive and complete as possible.
Coulter Reporting, LLC
www.coulterreporting.com
502-582-1627
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8/28/2015
Page:20
Richard Sackler, M.D.
Page 77
Q,
1
Page 79
Then this is a -- you talked about
1
market."
2
physicians being aware of OxyContin being twice as
2
3
strong as morphine a second ago. Let me hand you --
3
product was geared toward the non-malignant market.
4
let's mark this as Exhibit 11.
4
We knew if we priced low per milligram for the higher
(Passing document.)
6
Q.
7
8
5 dosed cancer patient we would be priced way too low
{DEPOSITION EXHIBIT NO. 11 MARKED)
5
This is an e-mail. It says the author
is Dr. -MR. STRAUBER: May I have a copy?
9
And it says, "Our pricing of the
6
per milligram for the standard non-malignant pain
7
patient, where we really wanted to make a market. We
8
feared that the 'cancer pain experts' would object to
9
the two-to-one ratio" -- and that two-to-one ratio is
10
MR. THOMPSON: Right in front of you.
1 o the ratio of oxycodone -- OxyContin to morphine; is
11
MR. STRAUBER: I'm sorry.
11 that correct?
Q.
12
13
It says the author is Dr. Richard
Are you familiar with this e-mail to
14
15 Michael Friedman?
understand the ratio, the two-to-one would refer to
14
the ratio of morphine to oxycodone.
Okay.
16
A.
Not the other way around.
17
Q.
All right.
He was head of marketing and sales.
18
A.
That's what you -- I know that's what
Okay. And let's drop down and see
19 you meant to say.
16
Yes.
17
Q.
Who is Michael Friedman?
18
A.
Q.
20
13
Q.
A.
19
Actually, if you want to strictly
A.
12
Sackler at Norwalk dated 5-28-97.
15
what Michael Friedman has written.
20
Yes. Yes.
Q.
21
The first paragraph he says, "My
21
22
purpose in writing this memorandum is to clarify our
22
23
position on the very complex issues raised by Mike
23
our position for OxyContin. In any case, we're
24
Cullen during the Phase IV team meeting and which were
24
developing hydromorphone codeine" --
25
the subject of Dr. Richard's inquiry."
25
-- "and resulting cost of therapy for
high-dose patients. However, we had no choice given
I've lost you here. "In any case" --
A.
Page 78
2
1
A.
4
Q.
That was me.
All right.
2
Q.
-- "for the high-dose patient."
A.
Okay. I'm at the end of paragraph 4.
Q.
And then it says, "Despite our initial
4
First paragraph. "We are well aware
what paragraph are you in now?
3
that?
3
5
Page 80
When they say "Dr. Richards," who's
1
5
uncertainty, we've been successful beyond our
expectations in the non-malignant pain market."
6
of the view held by many physicians that oxycodone is
6
7
weaker than morphine. We all know that this is the
7
A.
Yes.
8
result of their association of oxycodone with less
8
Q.
And non-malignant pain market is sort
9
serious pain syndromes. This association arises from
9
of the chronic arthritis, back pain, those types of
10 their extensive experience with and use of oxycodone
1 o patients?
11 combinations to treat pain arising from a diverse set
11
12
of causes, some serious, but most less serious. This
12
moderate pain patients, some of them may be severe.
13
'personality' of oxycodone is an integral part of the
13
But there are many less common conditions that produce
14
'personality"' -- "this 'personality' of oxycodone is
15 an integral part of the 'personality' of OxyContin.
Well, those are most typically
A.
14
severe, crippling, life-destroying pain. And we had
15
an indication, and still have, for all pain states
16
"When we launched OxyContin, we
17
intentionally avoided a promotional theme that would
17
18
link OxyContin to cancer pain. We specifically linked
18
16 that are appropriately treatable with opioids for an
extended period of time.
We wanted -- so non-malignant really
19 OxyContin to the oxycodone combinations with our
19
2 o directly caused by the encroachment and destruction of
20
'old way, new way' campaign. We made sure our initial
21
detail piece provided reps with the opportunity to
21
22
sell the product for a number of different pain
22
23
states. With all of this, we were still concerned
23
is a distinction. All pain other than the pain
tumor tissue in the patient.
Q.
And then he says here, "Doctors use
the drug in non-malignant pain because it is effective
24
that the drug would be slotted for cancer pain and we
24
and the personality of OxyContin is less threatening
25
would encounter resistance in the non-malignant pain
25
to them and their patients than that of the morphine
Coulter Reporting, LLC
www. cou lterreporting. com
502-582-1627
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Page:21
Richard Sackler, M.D.
Page 81
Page 83
1
alternatives. I apologize for this unspecific term,
1
2
but I feel it captures the notion that there are
2 less likely to write prescriptions and sales of
less twice as strong as morphine, that they would be
3
image-related attributes that influence drug
3
4
acceptance. While we might wish to see more of this
4
5
product sold for cancer pain, it would be extremely
5
6
dangerous at this early stage in the life of the
6 limit its usefulness. The term "stronger" here meant
7
product to tamper with this 'personality' to make
7
8
physicians think the drug is stronger or equal to
8 that this intended or had the effect of causing
9 morphine. We are better off expanding use of
9
1 o OxyContin in the non-malignant pain states and waiting
11 for hydromorphone, in 1999, to relaunch into cancer
11
12
13
14
No. If its personality was changed,
A.
if it was stigmatized as an end-of-life drug, it could
more threatening, more frightening. There is no way
physicians to overlook the fact that it was twice as
10 potent.
12
pain."
OxyContin would go down?
It was called out in virtually every
promotional piece of literature, it was reflected in a
13 conversion chart which we had developed for the few
Why was it felt that there would be a
danger -- it would be extremely dangerous at the early
14
patients who were being treated with morphine where we
15 stage in the life of this product to tamper with this
15
made it very clear if they're on any dose -- daily
16
16
dose of morphine, you cut that dose in half for
"personality" to make physicians think the drug is
1 7 stronger or equal to morphine?
18
1 7 OxyContin.
The context of this was, as you know,
A.
And every action we took before the
18
19
a thread of e-mails that actually, he alludes to, I
19
20
started.
2 o insert and promotion and in all detailing emphasized
The whole context and the whole
product was launched with the FDA in the package
21
that it was twice as strong. Some physicians had
2 2 discussion of Mr. Friedman here and in other -- I'll
22
formed their own impression that it wasn't twice as
23
23
strong, it was less strong, and we insisted that they
21
pause here.
24
Q.
No, go ahead.
24
observe -- we said, "With this drug, Doctor, it is
25
A.
Because I think it's really important
25
twice as strong." Even when they said, "No, I think
Page 82
Page 84
1
1 for you to understand this.
The whole context was not to -- the
2
3
context was not to stigmatize oxycodone in a way that
it's one and a half times as strong." And some
2
physicians even said, "I think it's about the same
3
potency as morphine." We would insist, "No. Please
use it the way we have researched it and the way the
4
morphine was stigmatized. Morphine was seen as an
4
5
end-of-life extreme duress -- patient in extreme
5 FDA has approved it."
6
Q.
Okay. Now --
7
A.
And I think we were effective in
6
duress, often dying of cancer, but not only cancer.
7
It was reserved by most physicians, if it was used at
8
all, even when patients were in serious severe or even
8 getting that message across in time to most and
9
crippling pain, because telling a patient "I'm going
9
eventually almost all physicians.
10 to put you on morphine," "I'm going to prescribe
10
11 morphine for you," "Now we've got to use morphine,"
11 the launch of OxyContin Controlled-Release, correct?
Okay. This is 1997, two years after
Q.
12
A.
Yes.
13 associated with a death sentence. Oh, thinks the
13
Q.
So it's been on the market now over --
14
14 well, you launched it January '96. We're now in May
12
however the physician told the patient, it often was
patient, he's telling me I'm going to die. Even
15 worse, my doctor's putting me on morphine, he's giving
16
up on me.
17
We didn't want oxycodone to -- to
15 of '97. And it says, "We are well aware of the view
16
held by many physicians that oxycodone is weaker than
17
morphine."
18
change the, as he says, personality of oxycodone, but
18
19
you could say all the associated feelings of
19
And the conclusion of this was, "I do
not plan to do anything about that."
2 o oxycodone, which were generally appropriate to a
20
21
narcotic. We didn't want that to be polluted by all
21
22
of the bad associations that patients and healthcare
22 some holdouts?"
23
givers had with morphine.
23
24
Q.
Did you think that if physicians
2 5 thought it was stronger or equal to morphine, much
Coulter Reporting, LLC
And you wrote back and said, "I agree
with you. Is there a general agreement, or are there
Is that what you wrote at the top of
24
the e-mail?
25
A.
I did. And I agreed with him then and
www.coulterreporting.com
502-582-1627
Page:22
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 87
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1
1 being as strong as MS Contin; is that correct?
I agree with him now because I knew what he meant, and
2 so did everybody else know -- knew what he meant.
3
And, more important, our actions in promoting the
4
"twice as potent as morphine" never wavered . We never
5 disguised it or hid it; we emphasized it.
2
A.
That's what the words say.
3
Q.
And he says, "Although this perception
4
has had some effect with physicians switching to
5
MS Contin with more severe cancer pain patients, it
6
has actually had a positive effect with physicians'
7
pain market for non-malignant pain was a much greater
7
use in non-cancer pain."
8
market share; is that your testimony?
8
And there he's saying non-cancer
9
physicians that don't think it's as strong as
Q.
6
A.
9
So you weren't doing this because the
No. No, that isn't. We wanted to
1 o address both markets. The e-mail -- which perhaps you
1 o MS Contin were having a positive effect from that.
11 want to explore or not. What started this was, as he
11
And I assume it's talking about sales,
12 says in the first paragraph, something that I had
12 wouldn't you?
13 inquired about. And what I had inquired about was an
13
A.
Yes.
14 error on my part.
14
Q.
He says, "Since oxycodone is perceived
15 as being a weaker opioid than morphine, it has
When we -- before we launched
15
16 OxyContin, we thought that our sales would be about
17
16 resulted in OxyContin being used much earlier for
17 non-cancer pain. Physicians are positioning this
equally divided between cancer pain and non-malignant
18 pain. We knew that the market for non-malignant pain
18 product where Percocet, hydrocodone and Tylenol with
19 was much larger, of course. Fortunately for all of
19 codeine have been traditionally used."
2 o us, cancer is not -- is much less common than other
20
So he's saying here physicians are
using it because they think it's weaker than morphine,
21
pain states. But we had expected it would be about
21
22
50/50.
22 correct?
I had seen some report or had attended
23
23
He's using the word "weaker," but not
A.
24
a meeting where I learned it was about 20 percent of
24
meaning less potent than morphine. Within this time
25
our sales, and, thus, I wrote to Michael and said,
25
it appears that people had fallen into a habit of
Page 86
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1 why -- what's going on here? Why aren't we getting
2
1 signifying less frightening, less threatening, more
more cancer sales?
Q.
3
Let's -- let's look at the e-mail you
2
patient acceptable as under the rubric of weaker or
3
more frightening, more -- less acceptable and less
4
wrote to Michael Cullen at Norwalk. Let's mark this
4
desirable under the rubric or word "stronger." But we
5
Plaintiff's Exhibit 12.
5
knew that the word "weaker" did not mean less potent.
6 We knew that the word "stronger" did not mean more
(DEPOSITION EXHIBIT NO. 12 MARKED}
6
Q.
7
7
And Michael Cullen writes on June 2nd
potent. And we knew that because, by this time
8
of '97 -- that was after the e-mail we were just
8 surely, anybody who was using this product recognized
9
looking at -- and says, "In recent team meetings we've
9
it was more potent, they knew it was more potent.
So it's very unfortunate for your
10 discussed the issue that OxyContin is perceived by
10
11
some physicians, particularly oncologists, as not
11 understanding as well as anybody else's understanding
12
being as strong as MS Cantin."
12 that all those issues of the stigma of morphine, of
13 the frightening nature of morphine, of morphine being
Now, oncologists are cancer --
13
14
A.
Yes.
14 a cancer drug, end-of-life drug, it's very unfortunate
15
Q.
-- doctors, correct?
15 for your understanding and for most people's
16 understanding that the word "weaker" and "stronger"
So even the cancer doctors don't think
16
1 7 that OxyContin is as strong as MS Contin according to
18 this, correct?
18
MR. STRAUBER: Objection to the form.
19
20
MR. THOMPSON: Well, let me rephrase
21
22
22 it.
23
24
Q,
Coulter Reporting, LLC
Q.
We're not done reading it yet, but let
A.
Okay.
Q.
You were advised by your senior
employees that physicians perceived OxyContin
23 Controlled-Release as less strong than morphine? Many
You were aware -- or at least Michael
Cullen was advising you that OxyContin is perceived by
2 5 some physicians, particularly oncologists, as not
was used, but we understood what it meant.
19 me ask you this.
2 o That's not what it says.
21
17
24
25
physicians perceived it that way, correct?
A.
Words used, but didn't mean that they
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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
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Page:23
Richard Sackler, M.D.
Page 89
1
Page 91
1 smaller cancer pain market but hurt us in the
believed it was less potent, because I knew they
2
believed it was more potent. Their own practice
2 larger -- larger potential non-cancer pain market.
3
proved they recognized it was more potent. As I said
3
Some physicians may start positioning this product
4
before, Percocet was 5 milligrams.
4
where morphine is used and wait until the pain is
5
severe before using it.
Q,
5
Did you do any studies yourself or
6 conduct any investigation to determine what percentage
6
"Marketing has decided that" -- and by
7
of physicians believed that OxyContin
7
that, they're talking about the marketing group,
8
Controlled-Release was less powerful than morphine and
8
correct?
9
were not aware it was twice as strong as morphine?
9
A.
Q,
10
A.
You're talking about less potent?
10
11
Q.
Yes.
11
12
A.
I don't know of such studies. But in
The marketing department, yes.
Yeah, marketing department.
So it says, "Marketing has decided
12 that the effects of the Phase IV team should be
13 common parlance in discussions with physicians, if
13 predominantly focussed on expanding OxyContin use for
14
really a substantial -- if any substantial number of
14
15
them believed -- believed in the -- believed - - had an
15
16
erroneous belief -- excuse me. If any had an
16
non-cancer pain."
And then if you look at the last
paragraph, it says, "It is important that we be
1 7 erroneous belief and said to a representative, "Oh,
1 7 careful not to change the perception of physicians
18 this is -- this stuff is less potent than morphine,"
18 toward oxycodone when developing promotional pieces,
19 the salesman had ample materials to demonstrate to the
19 symposia, review articles, studies, et cetera."
2 o physician that he was in error and was instructed to
20
21
21
use those and did use it.
22 physicians have that OxyContin is not as strong as
And I wish we had a survey - - had done
22
And what they're talking about there
is, let's not clear up this misconception that
23
a survey to demonstrate it in retrospect, but it was
23
24
so generally accepted that it was at least one and a
24
25
half times more potent by even the skeptics -- most
25
NS Cantin, correct?
MR. STRAUBER: I object to the form of
the question, Mr. Thompson. You, in reading this,
Page 90
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1
skeptics -- and there weren't many -- but generally
1
skipped over two sentences. I 'd ask that you go back
2
recommended to be twice as potent as morphine, it just
2
and read this with the two sentences that you omitted.
3
never occurred to us.
4
Q,
3 The one beginning with "The sales force can teach the
Sure. And it's your belief that your
4
5 sales force was telling these physicians that it's
oncologists ... "
MR. THOMPSON: Oh, sure.
5
6 actually twice as strong as morphine and correcting
6
7
7 to get physicians to use it earlier instead of
8
that misperception that they had?
A.
8
Absolutely. It was in the package
9 insert, the promotion, in the conversion tables, and
11
12
1 o and titrate OxyContin to ensure that they stay with it
So promotional pieces, your
11 as the pain increases."
symposiums, your review articles, your studies would
13 all point that out?
14
Now, oncologists are the cancer pain
12
13 doctors, correct?
I can't say that every one would point
A.
products such as Percocet, Vicodin or Tylenol 3. The
9 sales force can teach the oncologists the proper dose
10 in the recommended dosing, which -Q.
"Our approach to cancer pain will be
Q.
14
A.
Yes.
Q.
That doesn't say anything about all
15
it out in every page, but it should have been an
15
16
important part of most promotional materials.
16 the non-malignant doctors -- all the doctors that
17
1 7 treat non-malignant pain, correct?
Let's read the rest of Michael
Q.
18 Cullen's e-mail dated 6-2-97, well after the launch of
19
20
OxyContin.
18
A.
19 thing, how to titrate. Because that was the -- that
2 o was, in a sense, the fundamental doctrine of treating
Paragraph 3 says, "Since the
21
non-cancer pain market is much greater than the cancer
21
22
pain market, it is important that we allow this
22
pain with opioids; start low and titrate.
Q.
And -- well, the whole -Adjust the dose, in other words,
23
product to be positioned where it currently is in the
23
A.
24
physician's mind. If we stress the 'power of
24
upward.
25
OxyContin' versus morphine, it may help us in the
25
Q.
Coulter Reporting, LLC
But they would be taught the same
Well, the whole purpose of this e-mail
www.coulterreporting.com
502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 93
Page 95
is that you not teach the non-malignant pain
1
develop. And that was understood and contained within
2 physicians that OxyContin is twice as strong as
2
this dialogue, not all of it documented here.
3
morphine and let them continue with their perception
3
4
that it's not, correct?
4
1
about it a little bit more, then.
5
A.
No, not correct.
5
6
Q.
Well, let's -- let's continue reading
6
In the first paragraph he says, "We've
discussed the issue that OxyContin is perceived by
7 some physicians, particularly oncologists, as not
7 the rest of it, then.
8
The last paragraph. "It is important
8
Yeah. Sure. Let's go back and talk
Q.
9 that we be careful not to change the perception of
9
being as strong as MS Contin. Although this
perception has had some effect with physicians
10
switching to MS Contin with the more severe cancer
11 promotional pieces, symposia, review articles,
11
pain, it has actually had a positive effect with
12 studies, et cetera."
12
physicians' use in non-cancer pain."
10
physicians toward oxycodone when developing
Now, am I correct that what he's
13
So what he's saying there, if I'm
13
14 saying in here is, let's not clear up the
14
reading this correctly, is that because they think it
15
15
is not as strong as MS Contin, when they need a strong
misperception in any of our promotional pieces,
16 symposia, review articles or studies?
17
Don't change the personality. Don't
A.
16
drug for cancer pain patients, some of the physicians
17
aren't switching to it because they don't think it's
18 change this to an end-of-life cancer drug to a drug
18 as strong, and that may hurt sales a little bit there.
19 that shouldn't be used except at the end of life when
19
But with the non-cancer pain, where you don't want as
20
everything else has been exhausted. That was the
2 o strong a drug as an end-of-life malignant cancer pain
21
thrust.
21
patient might need, it's actually helping our sales
22
that they have this misperception because they are
23
going ahead and prescribing it because they don't
think it's as strong as MS Contin.
22
23
I may just add something here.
There's a conflation within this which you wouldn't
24
understand, and that was in the first paragraph which
24
25
you read where he said that oncologists think it isn't
25
Is that what that first paragraph is
Page 96
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1
1
as strong as MS Cantin. Here the meaning that we
saying?
You're -- that's what the words say.
2
understood -- certainly I understood and anybody who
2
3
was involved - - was the cancer doctors who were using
3
But the meaning of "strong" here would be effective.
4
the drug were stopping at -- they had established a
4
It is not as effective. And the reason they thought
A.
5
notional idea based on their past habit of using
5
it was not as effective is, they had a mental notion
6
Percocet that they shouldn't go above 40 to 60
6
of a limit and they didn't follow the doctrine of
7
milligrams a day of oxycodone. And the reason they
7
titrating -- increasing the dose when the pain is
8
developed that habit, that practice limit, was not
8
getting worse.
9
because of the oxycodone, it was because of the
10 Tylenol, which was the more toxic agent in that
11 combination.
12
13
You're probably aware that recently
the FDA has recommended lowering the maximum daily
14 Tylenol dose from 4 grams a day to 3. But even then
And all of this was greatly known. I
9
10 mean, by 1997 most of the people who disagreed and
11
thought that OxyContin was not two-to-one, they
12
thought it was one-and-a-half-to-one, that was by far
13
the most common objection. Still stronger than
14
morphine, but not quite as much stronger as we said it
15 4 grams a day was recognized as being the then
15
was. They had been persuaded if they used the drug,
16
16
oh, yes, particularly those oncologists who switched
17
from MS Cantin to OxyContin.
17
practical limit.
So oncologists who were using
Q.
So then he says, "Since oxycodone is
18 oxycodone as Percocet were just in the habit, well,
18
19 you're getting 40 milligrams a day of Oxycodone, your
19
2 o pain is coming back. Rather than titrate those
2 o has resulted in OxyContin being used much earlier for
21
patients to a higher OxyContin level, they said, Well,
21
22
we've got to switch to something else.
22
23
And that was really what was going on
non-cancer pain." Correct?
So he's saying more people are using
23
it earlier for non-cancer pain because they think it's
weaker?
24
and in part why oncologists' use of a product had not
24
25
developed as well as we had wished that it would
25
Coulter Reporting, LLC
perceived as being a weaker opioid than morphine, it
A.
Not -- not less potent. More
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502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page:25
Richard Sackler, M.D.
Page 97
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1
acceptable to the patient, not frightening, not
1
2
stigmatized as morphine unfairly was by history. That
2 'power of OxyContin' versus morphine, it may help us
3
was the meaning.
3
And I've lost my thought here. Could
4
Sure. He says, "If we stress the
Q.
in the smaller cancer pain market ... "
That means let them know that it is
4
5
you just repeat your question so I can finish my
5
more powerful than morphine; that will help in the
6
answer?
6
smaller cancer pain market, correct?
7
Q.
Sure. And what he's saying here is,
7
A.
That's what he says.
8
the non-cancer pain doctors -- which is the much
8
Q.
Yeah. " ... but hurt us in the larger
9
bigger market share when you're trying to sell
9
potential non-cancer pain market. Some physicians --
1 o physicians may start positioning this product where
10 OxyContin, is the non-malignant pain market -- it's
11 actually helping sales there because they don't think
11 morphine is used and wait until pain is severe before
12 it's as strong as morphine?
12
Again, as I've testified before, the
A.
13
13
14 term "stronger" and "weaker" was a very unfortunate
17
18
He's coming back probably to the
A.
14 cancer market. I'm not sure. But we always said it
15 term.
16
using it."
15 was a powerful drug. We implied that. We didn't use
Q.
Do you want to use "effective"?
16 the words. Because words can elicit a whole variety
A.
In the case of here, "effective," yes,
17
in the case of cancer. Because they were using it.
18
Let me explain one other thing. At
19
19
of responses.
And then, "The marketing department
Q.
has decided that the efforts of the Phase IV team
2 o the time that this product was introduced, the World
2 o should be predominantly focused on expanding OxyContin
21
Health Organization had promulgated a stepladder
21
22
approach to cancer pain. And when OxyContin was
22
23
introduced, we properly, with the agreement of the
23
24
FDA, said that MS -- that OxyContin was appropriate
24
you clear up the misperception may be less likely to
25
for the second step and the third step. That's where
25
prescribe according to what he's written here,
use for non-cancer pain."
A.
Right.
Q.
That's the -- that's the group that if
Page 98
1
1
So I know that this could cause real
2
3
Page 100
the start with and stay with theme came from .
2
confusion reading these documents if you're not
3
correct?
If you change the -- if you change the
A.
character of the drug in their mind. If you tell them
4
involved day to day, but there is no way that any of
4
it's a cancer drug, it's for end-of-life care, yes,
5
the people on these documents understood "stronger" to
5
you might change their perception. We didn't believe
6
mean more potent, "weaker" to mean less potent. We
6
that that was appropriate, nor did the FDA, nor did
7
had never departed from a strong promotional theme,
7
the opinion leaders believe it was appropriate. It
8
that it was twice as strong as morphine.
8
truly was a drug that, in appropriate doses, could
9
manage moderate and severe and extremely severe pain
9
And then down at the bottom he says --
Q.
1 o or let's take the middle paragraph. "Since the
10 where patients needed an opioid to manage their pain.
11 non-cancer pain market is much greater than the cancer
11
It's important, also, that you
12
pain market, it is important we allow this product to
12
understand that for a hundred years, and even today,
13
be positioned where it currently is in the physicians'
13
there is no drug that is more effective or safer than
14
mind."
And that means let them believe that
15
14
opioids for treating pain over a long term. And it
15
was a shame that when -- that for decades no opioid
16 OxyContin Controlled-Release is not as effective as
16
was used in many -- most, perhaps overwhelming
1 7 morphine?
17
majority of patients who had severe pain.
18
A.
No. I said the effectiveness really
19 applied to the oncologists who were saying, This isn't
18
Q.
Do you think it might compromise
19 patient care if Purdue Pharma allowed patients'
2 o as effective, or, you know, I have to -- when the pain
2 o physicians to believe that the drug they are
21
gets really bad, I switch them to something else. And
21
22
that was the one place or the one circumstance in
22
A.
Could you just repeat the question?
23
which we understood it as effective. And I've
23
Q.
Yes.
24
explained that we believe that that was a consequence
24
A.
I just want to get the question
25
of them just having a mental limit.
25
straight.
Coulter Reporting, LLC
prescribing them is weaker than morphine?
www.coulterreporting.com
502-582-1627
Page:26
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 101
Q.
1
Page 103
Do you think it might compromise
1
promotional pieces, symposia, review articles or
studies."
2
patient care if Purdue Pharma was aware that many
2
3
physicians felt like OxyContin was weaker than
3
4
morphine and did nothing to clear up that
4
character of the drug, not change -- not change it
5
misconception?
5
into a frightening, scary, end-of-life drug.
No. If they believed it was less
A.
6
7
7
All right. Let me hand you -- let's
Q.
6
potent than morphine, we clearly cleared up that
That's correct. Not change the
A.
mark this as Plaintiff's Exhibit 13.
8
misconception. We told them it was twice as potent.
8
(DEPOSITION EXHIBIT NO. 13 MARKED)
9
We told them to use doses that were considerably lower
9
(Passing document.)
10 than the morphine doses that they might have been
10
11 accustomed to. What we didn 't want to do is to turn
11
12 this into a cancer drug.
12
Q.
This is an interoffice memo dated
1994.
MR. STRAUBER: You gave me two copies.
13
Q.
Right. And this is 1997.
13
14
A.
That's correct.
14
15
Q.
Well after the launch, well after your
15
A.
16
Q.
And it's to?
17
A.
To the three people he reported to.
Q.
And that's Mortimer Sackler, Raymond
16
17
18
19
package insert has been put out and all that, correct?
A.
Yes.
Q.
And Michael Cullen says, "It is
18
important that we be careful not to change the
19
And this is from Michael Friedman.
Q.
What was his role in 1994?
He was head of marketing and sales.
Sackler, and Dr. Richard Sackler, which would be you?
2 o perception of physicians toward oxycodone when
20
A.
That's correct. Yes.
21
developing promotional pieces, symposia, review
21
Q.
And under "Discussion," if you go to
22
articles, studies, et cetera," correct? Is that what
22
page 4, it says, "We believe that the FDA will
23
he wrote?
23
restrict our initial launch of OxyContin to the cancer
24
A.
It looks like that's what he wrote.
24
pain market."
25
Q.
And you replied to him and did not
25
Did you believe that at the time?
Page 104
Page 102
1
say, no, we need to clear up this misconception
1
2
immediately. What you said is, "I think that you have
2
3
this issue well in hand."
3
He may have believed it; I didn't
A.
believe it.
Q,
Okay. "However, we also believe that
4
A.
That's correct.
4
5
Q.
"If there are developments, please let
5
That's what I said. But the
7
Q.
Next sentence, 1.3.
1.3. Thank you.
"However, we also believe that
6
me know."
7
A.
6
physicians will perceive OxyContin" --
Where are you reading from, which
A.
number?
8
misconception that you're referring to didn't exist.
8
A.
9
The misconception that this was a benign, harmless,
9
Q.
1 o weak drug for treating pain was not the perception
1 o physicians will perceive OxyContin as
11 that existed. So that was not the error that he -- I
11
controlled-release Percocet without acetaminophen and
12
don't know quite what he -- let me just read what he
12
expand its use."
13
said here.
13
14
What are we reading from, please?
14
15
We've gone through this a number of times, so where
15
16 were you reading from here?
17
A.
You just read me something from --
18
19
Q.
From your top where you said "I think
19
21
A.
But where you said I was responding,
where was that?
Q.
Where he says, " It is important that
Without acetaminophen that would be
active ingredients, acetaminophen and oxycodone.
We were reading from --
18
22
A.
one way of describing it, because there are only two
Q,
that you have this issue well in hand."
Percocet?
16
17
20
Now, is OxyContin Controlled-Release
20
Q.
Is -- is OxyContin Controlled-Release
more powerful than Percocet?
A.
It depends on the dose. The initial
21
dose at 10 milligrams twice a day would be equivalent
22
to the standard introductory dose of Percocet four
23
tablets -- one tablet four times a day; in other
24
we be careful not to change the perception of
24
words, four. So it would be the same dose.
25
physicians toward oxycodone when developing
25
23
Coulter Reporting, LLC
Q.
When you-all did studies, did you find
www.cou lterreporting .com
502-582-1627
Page:27
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 107
Page 105
1
1 "There will always be misconceptions about drug
out that 10 milligrams of OxyContin had the same
2 effect as a placebo and it was really only the 20
3
I don't recall that, but it's
A.
3
these misconceptions are the result of residual
attitudes associated with the immediate-release
5
forms."
possible.
Q.
6
substances. For controlled-release drugs, many of
4
milligram that was effective?
4
5
2
"We do not want to position OxyContin
6
I'll just read the whole thing.
"For example, morphine has a
7
in a way that will discourage physicians from using
7
8
OxyContin for the chronic non-malignant pain,
8 'personality' that was shaped when it was an IV drug.
9
especially" --
9
Oxycodone has a 'personality' that was influenced by
Where are you reading from again?
10
many years of Oxycodone use in Percocet. We built a
11 large part of our platform on this personality and it
10
A.
11
Q.
Next paragraph.
12
A.
Okay.
12
is to differentiate OxyContin from MS Cantin and
13
Q.
I mean next sentence.
13
Duragesic. This differentiation has led to much
14
non-malignant business.
-- "especially when we have studies
14
15 available that demonstrate efficacy and safety for
15
16 this indication."
16
"Marketing" -- this is the next
paragraph.
"Marketing is not only about what you
17
A.
Okay.
17
18
Q.
Do you know what your studies showed
18
are, but it's about what you are not. We have had
19
success beyond our expectations that is in part due to
19
about non-malignant chronic pain patients developing
2 o tolerance or dependency or withdrawal from OxyContin?
A.
21
21 to increase the use of the drug in higher doses, we
I don't have them immediately in my
22
22 mind.
23
24
MR. THOMPSON: Let's mark -- that's
been marked, correct?
MR. DANFORD: Just off the record.
25
2 o the unique personality of OxyContin. Even as we seek
should be very careful. As you know, the strength of
23
the drug is principally a barrier in malignant pain.
24
If we do not want to change the image in a way" -- I'm
25
sorry. "We do not want to change the image in a way
Page 108
Page 106
2
(RECESS)
record at 11:57 a.m.
6
Q.
And you wrote back, "Excellent points.
4
What about rifle shots?"
Is that correct?
5
I'm going to hand you a document that
is dated April 23, 1997.
(Passing document.)
9
would be ill advised."
3
VIDEOGRAPHER: We are back on the
4
5
8
2
at 11:45 a.m.
3
7
1 that will discourage non-malignant use. A barrage
VIDEOGRAPHER: We are off the record
1
6
A.
That's correct, that's what I wrote.
7
Q.
And over here before that, there's a
8
letter to you from James Lang, and he's pointing out
9
that he sat in some oncology focus groups and --
10
A.
What page is that?
11 e-mail you sent regarding San Antonio, and it says --
11
Q.
It's page 2.
12
it's 4-22-97. This is PDD1701801141. And it's to, it
12
A.
The second page of what you handed me?
13
looks like, Michael Friedman.
13
And on the bottom of page 1 is an
10
"Michael, I am somewhat surprised that
14
15
14
15
18 months into marketing significant groups of
Oh, Jim. Yes. Okay.
It says, "Issues affecting the
Q.
oncologists' utilization of OxyContin are: M.D.s feel
16 experts, oncologists, for example, believe that
16 the product dosing has a ceiling; don't feel it is as
17
17
OxyContin has a ceiling effect."
19
A.
Has a dose above which it would not be
19
2 o effective. That was what I meant, not be effective.
21
Q.
strong as MS Contin; like and are very comfortable
18 with MS Contin and don't see a need for another
What did you mean by "ceiling effect"?
18
20
Okay. "What materials could we pull
21
product except where MS Cantin fails.
"Interestingly, when asked to describe
what they like about OxyContin, they for the most part
22
together that would smash this critical misconception?
22
cited all the key points our reps are or should be
23
Can we put together some approaches and test whether
23
stating in their sales presentation.
24
they would be potent weapons in this effort?"
24
"The anesthesiology focus group
25
And he writes back and says to you,
25
Saturday evening was of less value however. Their
Coulter Reporting, LLC
www.coulterreporting.com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page:28
Richard Sackler, M.D.
Page 109
Page 111
1
primary concerns were the Medtronic pump being used by
1
A.
That's what it says .
2
the orthopods and the need for Purdue to educate
2
Q.
And the part I wanted to ask you
3
surgeons on proper post surgery pain management and
3 about, if you go back to page 10 -- and you were in
4
fears with opioid prescribing."
4
Is that the e-mail that prompted you
5
attendance at this meeting, correct?
6
I don't -- let me check that. I
A.
5
6 to write the letter?
certainly don't recollect by date.
7
A.
It might be; I don't recall.
7
Q.
R.S. Sackler attended.
8
Q.
I'm sorry, prompted you to write your
8
A.
Yes, that was me.
9
e-mail.
9
Q.
All right. So on page 10, it looks
10
A.
10 like you're discussing an osteoarthritis study that
It could be.
MR. THOMPSON: Why don't we mark that
11
11 was being done.
12 as Exhibit 14.
(DEPOSITION EXHIBIT NO. 14 MARKED)
13
But I'm not sure. It could have been
A.
Okay. Where on page 10?
12
A.
13
Q,
I am on the third paragraph.
Okay. I'm sorry.
14
A.
15 there could be another e-mail in which I pointed out
15
Q.
Fourth paragraph.
16 the lack of sales development with oncologists as
16
A.
It says page 10, but it doesn't look
17
compared to our plan . So I'm not sure that this is --
17 like what you have here.
18
but it would have been around the same time perhaps.
18
14
Q.
That's it.
Is it?
19 Maybe I looked at the results with oncologists after I
19
A.
2 o read this.
20
Q.
Yeah.
21
A.
Okay. Pardon my eyesight.
22
Q,
So read along with me the section over
MR. ELLIS: That's already in
21
22
evidence. It's either Exhibit 2 or 3. It's the May
23
1993 memorandum. Here we go.
24
25
A.
23
here "RR." Do you know who "RR" is?
MR. THOMPSON: All right.
24
A.
Robert Reder.
Are we finished with this
25
Q.
What was his job at that time?
1
A.
He was senior medical researcher.
Q.
And he says here in this paragraph,
Page 110
1
(indicating)?
2
Q.
2
3
memorandum.
5
6
7
Yes, sir.
I wanted to go back to the May 1993
3
4
A.
4
two dose levels in patients with osteoarthritis was
5
discussed with C. Wright."
And this is the --
6
July '92?
Q.
Would that be Curtis Wright?
8
understand it to be.
And at that time he was the person who
Q.
9
1 o was reviewing your-all's OxyContin submission to the
Wait a minute. Let me -- can I see
11 what you have here?
11
FDA?
12
(Passing document.)
12
A.
13
Let me just clear this up. It's not
13
correct.
14
Q.
14 in evidence yet. April 2nd, 1993.
Let's -- I'm sorry. I misspoke.
15
That's -- that's what I would
A.
7
MR. STRAUSER: What exhibit number are
8
"The protocol for the placebo- controlled study versus
(Passing document.)
9 we talking about?
10
Page 112
He was the medical reviewer, that's
And he's the guy that actually
15 approved it to be sold, you know, allowed you-all to
16
Let's -- let's jump to the April 2nd, 1993 memorandum.
16 sell it from the FDA?
17
Let's mark this as Sackler 15.
17
A.
That's my recollection.
Q.
You-all ultimately hired him a few
18
(DEPOSITION EXHIBIT NO. 15 MARKED)
18
19
(Passing document.)
19 years later, didn't you?
20
Q.
What is "PFRC" at the top of this?
20
21
A.
Purdue Frederick Research Center.
21
22
Q.
And it's the R&D meeting?
22
Purdue when he was planning on leaving the FDA, and
23
A.
R&D meeting.
23
Paul and I discussed it and agreed that we should not
Q.
And it is dated April 2nd, 1993,
24
25
correct?
Coulter Reporting, LLC
A.
We did hire him, but not after his
tenure at the FDA. We - - he spoke to somebody at
24
hire somebody who had -- who had reviewed our product
25
and had left. And so he went to another company,
www.cou lterreporti ng. com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
Page: 29
Richard Sackler, M.D.
8/28/2015
Page 113
1
regrettably for us, because he was very, very
2
knowledgeable --
Page 115
And then down below that it says,
1
2
"Dr. Richard Sackler asked if there was consensus
3
within the pain group about the appropriate use of
Q.
Sure. He went there --
4
A.
-- and very smart.
4
opiates for certain patient groups. B. Kaiko stated
5
Q.
He went there for a short period of
5
this is very -- a very controversial area, and most
3
6
time and then came to work for you-all?
A.
7
I don't remember. It was certainly --
6
people in the pain group say that well-controlled
7
studies are necessary to investigate the questions."
8
it was certainly -- my recollection is a couple of
8
9
years, two or three years, but I don't recall exactly.
9
1 o in-house to clarify the politica I issues."
1 o The record, I'm certain, could be produced.
Q.
11
"Dr. Sackler" -- next paragraph says,
"Dr. Sackler has suggested a smaller group meet
All right. Well, let's -- let's take
What were the political issues?
11
12 a look at page 10. "The protocol for the
12
13
placebo-control study versus two dose levels in
13
referred to the preferences and the sometimes
14
patients with osteoarthritis was discussed with
14
prejudices of physicians and other experts.
15 C. Wright. He stated there were very strong opinions
The political issues would have
A.
Over whether you should prescribe
Q.
15
16 of members at the FDA that opiates should not be used
16 opioids for non-malignant pain at all?
1 7 for non-malignant pain. And this study" --
17
A.
18
Let me just follow you, if I may. I'm
19 a slow reader, I'm sorry, but I just do want to follow
20
And for what conditions in
A.
18 non-malignant pain . I don't think there were very
19 many people, or any people really, of any reputation
2 o who would have proscribed, that is prohibited, the use
you.
21
Q.
Great. Well, I'll read it again.
21
of opioids for non-malignant pain, but there were a
22
A.
Okay .
22
lot of opinions when it came to listing one condition
23
Q.
"He stated there were very strong
23
or another or another or another.
24 opinions of members at the FDA that opiates should not
24
Pain is the most common symptom that
25
25
patients have and present to doctors, and so every
be used for non-malignant pain and this study would
Page 114
1
Page 116
1
not be greatly accepted by the FDA as it is written
doctor has his own opin ion as to what is -- what is
2
now for that reason. C. Wright has suggested
2
best and what is appropriate for treating pain, or in
3
rewriting the protocol in order to make it clear
3
some cases what pains are not appropriate to be
4
osteoarthritis is being used as a convenient pain
4
treated at all. And this is a highly -- is a highly
5
model. He would also like the open label extension to
5
personal and contentious issue in the medical world
6
be eliminated from the protocol."
6
and has been so for a hundred years.
Now, what do you refer to as the open
7
8
A.
9
And that's the reason that morphine
Q.
7
8 was stigmatized and not prescribed generally for
label extension?
In many trials of chronic-use drugs,
9
non-malignant pain, it was more reserved by physicians
10 after the trial period, which might have been 12
10 for end-of-life Hospice care and cancer pain in the
11
weeks, was completed, the subjects in the trial were
11 medical community?
12
given an option to continue being treated and
12
I don't understand the connection
A.
13
monitored by their physician. It's completely at
13
14
their election or choice. They -- they -- some decide
14
is unique and it doesn't relate to what we're talking
15
that they want to, some decide that they don't. And
15
about here.
16 we continue them on medication for an extended period
17
of time . This is extremely common in all kinds of
Q.
Q.
16
What about heroin, was it prescribed
1 7 for --
18 trials.
19
you're drawing. I think the situation with morphine
"P. Goldenheim stated the open label
2 o extension could be done as a post-marketing study.
18
A.
For pain?
19
Q.
-- pain?
20
A.
It is prescribed for pain in many
21
B. Kaiko and R. Reder will meet with P. Lacouture to
21
countries and is part of the pharmaco -- the
22
communicate what is necessary to revise the protocol.
22
pharmacopeia. For example, it is very popular in the
23
The protocol must be clear that we are not going for a
23
UK.
24 general indication for the treatment of osteoarthritis
24
Q.
Is it controlled?
2 5 with osteo -- with oxycodone."
25
A.
It is, just like morphine.
Coulter Reporting, LLC
www.coulterreporting.com
502-582-1627
Page: 30
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma LP., et al.
8/28/2015
Page 117
2
1
I can't tell you that because I don't
3
the principal agents of getting the word out, to use
know . But it is -- it's -- I don't believe that it
4
your expression.
mostly?
to write prescriptions?
Not directly. The salespeople were
A.
2
A.
3
4
Page 119
Is it used for end-of-life pain
Q.
1
5
established itself as an analgesic in the United
5
Q.
All right.
6
States at any time even when it was -- was an
6
A.
Of putting the materials in the hands
7
analgesic and was available.
7
of doctors, et cetera. I don't recollect that
8
advertising ever played much of a role in the
9
promotion of OxyContin.
8
9
Q.
I'm going to hand you a memo --
A.
Are we finished with this
10
(indicating)?
11
Q.
11 4.3, "Potential Studies." "Mike" -- I'm going to read
Yes, we are.
12
I'm going to hand you a memo dated --
12
Let's talk about -- if you'll look at
Q.
10
that paragraph. "Mike Innaurato said that an
13 Project Team Meeting Minutes of Tuesday, August 17,
13 OxyContin versus Percocet comparative study" --
14
14
A.
15
Q.
From "Potential Studies."
16
A.
Okay. I'm sorry, this is so small,
1993.
15
(DEPOSITION EXHIBIT NO. 16 MARKED)
16
(Passing document.)
17
18
1 7 it's not too easy.
It says here under "Marketing,"
Q.
Oh, you weren't reading -- I see.
"There's some initial interest in having a 5 milligram
"Mike Innaurato" -- and,
Q.
18
19 and 10 milligram immediate release Oxycodone capsule
19
20
2 O we're stuck with it, too.
produced."
Do you know why marketing wanted those
21
22
23
24
25
I -- I could -- I could guess, but I
don't know specifically why they wanted it.
Q.
"Potential Studies: Mike Innaurato
21
produced?
A.
unfortunately, that's the way Purdue gave it to us, so
22
said that an OxyContin versus Percocet comparative
23
study would be useful for marketing purposes."
Now, in trying to decide whether the
24
Well, if you don't mind, turn back to
25
drug is safe, is it normal to have the marketing
Page 120
Page 118
1
1 page 4. And on page 4 what I really want to ask you
2 about is potential studies.
3
4
5
A.
Okay.
Q.
And Mike Innaurato is the guy we
3
on it or suggesting things, but normally it's the
4
medical department that has the primary responsibility
5
both for the medical research strategy and the -- and
certainly the implementation.
6
A.
Innaurato, yes.
6
7
Q.
-- in the marketing department,
7
8 correct?
A.
Yes. Yes.
10
Q.
And he's the guy in charge of perhaps
A.
read the next sentence. "Through such a study
9
(OCSB-1105) has previously been conducted and
10
12
No. He would be in charge of the
published in abstract form, it was a single-dose study
stated that a multiple-dose study would be best to
13 support claims relating to relief of post-surgical
13 marketing execution of the strategy. So he would be
14
"Through such a study" -- I'm going to
Q.
8
11 using non-GMP released material. Mike Innaurato
11 the sales force that goes out and tries to sell?
12
They might be involved in commenting
A.
2
mentioned earlier who was in --
9
people decide what studies will be done?
14
intimately involved with the promotional materials,
pain, low back pain and herpetic neuralgia pain."
15 secondarily involved with training, and would be the
15
16 person who would set the direction and themes that
16
17
1 7 design studies to support them.
would be used. But he wouldn't be a person who would
From my review of that, it looks like
he's got claims he wants to make and is trying to
Is that what that appears to you?
18
be responsible for sales, although he might go out in
18
19
the field, and he should, to determine what is
19
20
happening.
2 o think he is doing here in the general is he is, in a
21
Q.
Let me rephrase it then.
21
A.
No. He -- half yes, half no. What I
group meeting, presenting ideas for consideration by
22
A.
Sure.
22
the group. Certainly this was not directed and he was
23
Q.
As part of marketing, he's the guy who
23
not in a position to direct any studies be done or not
is supposed to get the word out and hopefully increase
24
done.
25 sales by advertising the product and convincing people
25
24
Coulter Reporting, LLC
Q.
Then the next sentence says, "Mike
www.coulterreporting.com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page: 31
Richard Sackler, M.D.
Page 121
Page 123
1
Innaurato stated marketing would like to position
1
-- halfway down it says, "The
2
differently than MS Contin. Robert Reder" --
2
development and launching of OxyContin Tablets is the
first time that we have chosen to obsolete our own
Q.
3
A.
Just a second.
3
4
Q.
Who is Robert Reder?
4
product, and we have done it before the competition
5
A.
He was the senior medical officer in
5
has slowed our growth of sales."
6
this -- in this minute of the meeting.
Let me just read -- catch up to you.
7
Q.
8
9
And you were referring to MS Cantin
6
7
"Robert Reder stated that the FDA has
suggested that we do not issue claims supporting the
that you obsoleted; is that correct?
8
A.
That's correct.
9
Q.
And then at the bottom it says, "We
1 o have the most powerful selling package insert in the
10 general use of a Schedule II opiate in patients with
11 non-malignant pain. Robert Reder indicated that
11
12 decisions to make additional claims could be developed
12
13
after the product is marketed. Jim Conover agreed
13
14 with Robert Reder, but added that any study conducted
14
15
in a patient with non-malignant pain could be included
15
Q.
The very last paragraph.
16
in the clinical studies section of a package insert.
16
A.
Yes, that is correct.
17
"Robert Reder added that any proposed
17
Q.
And if you'll turn to page 8. It says
18 marketing claims and their supported studies should be
category and in the industry."
And is that accurate?
I'm trying to see where it is. "We
A.
have" -- which paragraph in that column?"
18
"Speech" at the top, "continued from page 2." So I'm
19 first reviewed with our legal and regulatory
19
assuming this is a speech you gave?
2 o departments; perhaps the marketing concepts could be
20
A.
Maybe, but I don't know. We'll see.
21
reviewed now. Robert Reder stated that the marketing
21
Q.
"OxyContin was brought to NDA" --
22
could start thinking of a five-year plan on potential
22
What's NDA?
23
marketing studies and strategies."
23
Did I read that correctly?
24
24
" ... to NDA filing." That's the filing
A.
of the new drug application.
25
A.
You did .
1
Q.
I'm going hand you -- let's mark
1
2
and in an incredibly compressed period of two years'
3
A.
Are we finished with this?
3
time."
4
Q.
-- Exhibit 17.
4
25
Right.
Q.
Page 122
2
Page 124
this --
-- "from early Phase I work on time
That's because an NDA usually takes
5
(DEPOSITION EXHIBIT NO. 17 MARKED)
5
6
(Passing document.)
6
A.
Well --
7
MR. THOMPSON: If I haven't done it,
7
Q.
And let me just preface it with, the
longer, correct?
8
I'm going to move to admit all these into evidence as
8
reason that it takes longer is because there's a
9
Exhibits 1 through 16 and 17.
9
number of studies that have to be done, both animal
10
Q.
And this is a -- appears to be a
11 speech you gave, is that what this is, or a
12
13
publication you made?
A.
This looks like it was a newspaper or
10 and human, to determine if a drug is safe and
11
efficacious, correct?
12
A.
Right. In general, that's correct.
13
Q.
But in this case you-all got it done
14
magazine-like internal document for the field force
14
in an incredibly compressed period of time of two
15
principally. I think it was basically the field
15
years.
16 force. And -- and in-house marketing and salespeople
16
17
would like to see their picture there or be quoted or
17
18
whatever.
19
20
Q.
"Robert Reder set the goal in November
of '93 to file by December 31st, '95, and we submitted
18
on December 28th, '95, three days ahead of schedule.
And it's the winter of 1996; is that
19
This didn't 'just happen.' It was a deftly
2 o coordinated planned event that took dozens of workers
right?
21
A.
That's correct.
21
22
Q.
And if you'll turn to page 8 for me,
22
A.
True.
23
Q.
"The most demanding NDA package for
23
please. I'm sorry, I misspoke. Turn to page 2,
24
please. Over on the third column --
25
A.
Yes.
Coulter Reporting, LLC
years of effort to succeed."
24
any analgesic product ever submitted didn't languish
25
at the agency. Unlike the years that other filings
www.coulterreporting.com
502-582-1627
Page: 32
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 125
Page 127
1
linger at FDA, this product was approved in 11 months,
1
2
14 days. Our previous best approval time for other
2 subsequently, correct?
3
products was measured in years, not months.
"Much can be attributed to the
4
3
A.
He was hired by Purdue Pharma --
4
Q.
In his last --
A.
-- maybe three years after this . I
5
unparalleled teamwork of the product team and the
5
6
FDA's approval team which came into being as a result
6
7
of our joint desires to operate within the context of
7
8 a new time frame. Both we and the Pilot Drug Division
8
9 of the FDA were motivated by the same goal to set the
9
10 high standard NDA with the broadest indications
about that?
Q.
15
No. I just wanted to know if that was
A.
His overall conclusion on the last
13
A.
Yes .
14
Q.
-- "appears to be a b.i.d. alternative
15 to conventional q.i.d. Oxycodone. Approval is
16 the statement you got and is it accurate?
17
(DEPOSITION EXHIBIT NO. 18 MARKED)
Q.
12 correct?
You did. Did you have any questions
A.
Why don't we go ahead and mark this as
Q.
Exhibit 18.
11 page is, "CR Oxycodone" -- that's controlled-release,
Did I read that correctly?
13
14
don't recall ex actly.
10
11 approved in the shortest possible time frame."
12
He was hired by Purdue Pharma
Q.
This was a -- I believe it is
18 accurate. I'm certa in that the facts in there were
16
recommended. Care should be taken to limit
17
competitive promotion."
What is "competitive promotion"?
18
I'm not sure what he meant. I could
19 accurate . The tone was very upbeat, almost a team
19
2 o enthusiasm building expression. I believe the facts
2 o guess that he means promotion comparing this to other
21
are correct. And I perhaps -- I don 't regret trying
21 agents that are used in various pain conditions, but
22
to energize our sales force, I think that was my
22 that's a guess on my part.
A.
And, then, I think the next sentence
23
mission. But this isn't what I would have written if
23
24
a board had been -- or said if the board had been
24
explains it. He says, "The product has been shown to
25
there . I wouldn 't have been -- the tone would have
25
be as good as current therapy, but has not been shown
Q.
Page 126
1
Page 128
1 to have a significant advantage beyond reduction in
been more restrained . I'm not embarrassed by the
2 tone. In the context, I think it was very reasonable .
3
4
5
2 frequency of dosing."
Do you have any questions about the
reason it was so quick or anything else?
Q.
So other than you don't have to take
3
4
No. We've got a lot of documents to
it as much, the FDA has concluded that there's no
5
benefit other than -- "it has not been shown to have a
6
get through, so I'm trying to hit the high points and
6
significant advantage beyond reduction in frequency of
7
ask you about those.
7
dosing "?
8
A.
Okay.
8
A.
Not been shown in the NDA, yes.
9
Q.
One of the things that they wrote
9
Q.
All right. Let's --
10 you -MR. THOMPSON: Do you have the other
11
12 pages of this (indicating)?
10
(Knock at the door.)
11
THE WITNESS: Probably announcing
12
13
MR. ELLIS: Yeah. Here. Right here.
13
14
(Passing document.)
14
15
Q.
-- when you got your approval .
lunch.
MR. THOMPSON: Probably so. Let's go
off the record .
VIDEOGRAPHER: We are off the record
15
16
(Passing document.)
16
17
If you'll look at the last page on
17
(RECESS)
VIDEOGRAPHER: We are back on the
18
overall conclusion. And this is a document from the
18
19
Medical Officer Review, Curtis Wright.
19
20
A.
This is part of the approval -- part
21 of the FDA approval process.
22
23
24
25
Q.
He's the guy that now works for Purdue
Pharma, correct?
A.
No. No, he hasn't worked for Purdue
Pharma for a long time, regrettably.
Coulter Reporting, LLC
at 12:32 p.m.
record at 12:32 p.m.
(Passing document.)
20
21
22
Q.
This is the OxyContin Project Team
Memo.
Do you know if you ever reviewed this
23
24
memo?
25
A.
I wasn't on the project team. I don't
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Richard Sackler, M.D.
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1
know if I reviewed it. I'm curious. I could read
2
through this. Was it sent to me or not?
3
4
5
Page 131
2
regulatory department, were the principal owners of
Q.
I don't know if it was or not.
3
the document in the company. And the owner of the
A.
It looks like I was not on the
4
document for the government was the Food and Drug
5
Administration, and, of course, they had determinative
6
power as to what it -- what it ultimately ended up as.
circulation list.
Q.
6
But the medical department was, and
1
Well, this list down here is -- yeah,
7
there's a circulation list. It appears that it was
7
8
not.
8
And, if you would, go over to page 4.
Sure. If you'll turn to page 5 under
Q.
7.0, "Marketing."
9
A.
Yes.
1 o The last paragraph down at the bottom, 6.2, "Mike
10
Q.
It says, "Post-Marketing Studies (QQL,
11 Innaurato asked if marketing would be able to review
11
12
12 discussed some of the planned post-marketing studies.
9
the package insert."
Do you have any idea why marketing
13
14
wanted to review the package insert?
Pharmacoeconomic, Percocet, Duragesic) - Robert Reder
13
These included an OxyContin versus MS Cantin
14
comparative study, the Duragesic study, which is
15
A.
Surely. They have many reasons.
15 currently on hold, and a relative potency study
16
Q.
"Robert Reder stated the package
16 comparing OxyContin to MS Cantin.
17
insert will be circulated to marketing and other
17
18
reviewers at the same time as the protocol review."
18 need additional studies to recruit several hundred
A.
19
As I said earlier, the package insert
19
"Robert Reder stated that we would
patients in order to get data to support claims for
2 o was becoming -- originally, 20 years prior to this,
2 O non-cancer pain."
21
package inserts were very, very brief and very simple.
21
22
Over time the agency wanted them to be more complete
22
This was in March of 1994. Do you
know if those studies were done?
23
documents, and then it had regulatory implications, as
23
24
well.
24
approval, but I don't know whether any were done
25
before approval.
So if you look at the history of use
25
I'm sure they were done after
A.
Page 130
Page 132
1
of package inserts, they, by this time, had become
2
fairly long and extensive documentation for the
2
3
physician. Their notion of being printed in that tiny
3
A.
4
format and stuck with every package in a sense was
4
Q.
Okay. Who is Robert Reder?
5
inconsistent, so you ended up sometimes having this
5
A.
He was the senior medical officer on
6
package insert that was as big as the bottle adhered
6
7
to every bottle. But it was available to physicians
7
8
in a variety of other forms. The Physician's Desk
8
9
Reference, I think you must be familiar with, which
9
A.
Right.
Q.
-- "stated that a Percocet comparative
1
Do you know if they were done before
Q.
the drug was put on the market?
I don't know.
this project at Purdue Frederick.
And then it says, "Mike Innaurato" --
Q.
again, he's the marketing guy, correct?
1 o was the way most physicians then would read a package
10
11
insert. It was just a compilation of all the approved
11 study would be of benefit to marketing. Mike
12
products package inserts.
13
14
15
Q.
13
First of all, they have to understand
15 claim. Mike Innaurato stated in the future Tramadol
answering that equal efficacy of OxyContin to Percocet
14 with better quality of life would be a beneficial
that?
A.
12 Innaurato replied to Bob Kaiko's question on claims by
What is marketing going to add to
16
what the package insert is going to say about the
16 would pose a threat to the OxyContin market."
17
product so that they can think of how they're going to
17
18
present promotional materials.
Secondarily, they might, if the
19
18
And then down below that it says, 7.2,
"Marketing Claims/Studies Desired - Mike Innaurato
19 gave a presentation on the results from the focus
2 o package insert is in draft form and under discussion
2 o groups. A copy of the market research results would
21
21
with the agency, turn to the responsible medical
be issued to the OxyContin team. The results of the
22
officer as an example or the regulatory people and
22
focus groups are attached. The results cover issues
23
say, you know, this could be misunderstood, this could
23
such as benefits, positioning and claims."
24
represent a problem, and so they would contribute to
24
25
the clarity .
25
Coulter Reporting, LLC
Do you know whether the studies
recommended by Robert Reder were done before it went
www.coulterreporting.com
502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma LP., et al.
8/28/2015
Page 133
1 to market or the studies requested by the marketing
1
2 guy were done before it went to market?
2
Page 135
(DEPOSITION EXHIBIT NO. 20 MARKED)
Now it's 20.
A.
THE WITNESS: Are you keeping these?
3
A.
I don't know.
3
4
Q.
Then there is a -- if you go to
4
MR. STRAUBER: Yes.
5 page -- the very last page, I guess, it is --
5
THE WITNESS: Okay. It's No. 20.
6
6
"OxyContin Tablets Project Team."
7
A.
Okay.
8
Q.
And this is June 22nd, 1994, correct?
9
A.
That's what it says.
Just a second. "OxyContin
A.
7
8
Q.
"OxyContin Presentation 3-22-94" up at the top.
Presentation." I see it.
And it says down at the bottom, it's
Q.
9
10
Q.
And on page 2, "Marketing" it says --
11 as the only opioid combining the efficacy and safety
11
A.
Wait, wait.
12 of Oxycodone with the convenience of a 12-hour
12
Q.
-- 1.0.
13
schedule, which allows for precise and accurate
13
A.
I see June 8th, not June 22nd.
14 conversion and titration, while allowing the patient
14
Q.
Oh, the date it's sent is June 22nd
15 to lead a more normal quality of life. OxyContin is
15 over on the right.
10 got all the list of -- "OxyContin will be positioned
16 the opiate to start with for patients who may be on
16
A.
Woops. Okay. My mistake. Okay.
1 7 Percocet, Lortab or Vicodin and the opiate to stay
17
Q.
But it's project team meetings from
18 with as the disease progresses."
18 June 8th, you're correct.
Now, that was a marketing campaign,
19
20
On page 2 under 1.0 "Marketing," under
19
20 the "OxyContin Tablets Project Team Meeting Minutes,"
correct, the "Start With, Stay With"?
21
A.
Yes.
21
"Mike Innaurato gave an overview of the Oxycodone
22
Q.
And the "Start With, Stay With"
22
market referring to sales and growth charts and
23
campaign, do you know who came up with the "Start
23
prescription data. Mr. Innaurato also presented our
24
With, Stay With" marketing campaign?
24 current strategy for introducing OxyContin Tablets to
25
I wish I could lay claim to it, but,
A.
25
the market. OxyContin Tablets will be targeted at the
Page 136
Page 134
1
1
no, I don't know who came up with it.
cancer pain market."
Was a decision subsequently made not
2
Q.
And then it says --
2
3
A.
That was not the launch campaign in a
3 to target specifically at the cancer pain market?
4
sense. It may have been a subtext of the launch
4
5
campaign, which was the old way and the new way.
5
6
But ...
6
7
8 abuse than other opioids."
8
9
Do you know where that claim came
9
I don't know. Looking at -- is this
A.
12
after the package insert? No. No, it's before the
13
package insert was approved. I don't know.
14
A.
I don't know what this refers to.
MR. THOMPSON: Let's mark that as 19
17
18 and move to admit it into evidence.
(DEPOSITION EXHIBIT NO. 19 MARKED)
19
20
Yes. It doesn't say, however, that
A.
we -- let me just read this again. "Will be targeted
And here is this one.
Q.
It doesn't say that it will not be
11
12
13
Do you know whether OxyContin had less
Q.
15 potential abuse than other opioids?
16
But at least by June 8th of '94 the
Q.
10 at the cancer pain market."
10 from?
11
when.
7 plan was still to target the cancer pain market?
It says at the bottom, "Less potential
Q.
I would infer that, but I don't know
A.
promoted to the non-malignant pain market.
It says, "OxyContin Tablets will be
Q.
14 targeted at the cancer pain market. Since it is
15 possible that morphine generic products may soon be in
16 competition with MS Cantin Tablets, we will target
17
patients who are currently receiving MS Cantin as well
18 as those patients thought to eventually use MS Cantin
19 Tablets (i.e., on the analgesic ladder late step one,
2 o step two and step three). The bulk of opiate business
21
(Passing document.)
21
comes from 7,500 physicians, 3,000 of whom are
22
This is PDD9520821306. This appears
22
oncologists."
23
to be the --
23
A.
That's correct.
Q.
So you-all had market share from
24
A.
Do you want to mark it?
24
25
Q.
Yes, let's do that.
25
Coulter Reporting, LLC
MS Cantin, correct?
www. cou lterreporting. com
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Richard Sackler, M.D.
Page 137
1
A.
Yes.
2
Q.
And in order to keep from losing that
Page 139
And then under "Publications," right
Q.
1
2
below that, "Manuscripts for studies C90-0708 and
3
market share to generics who are going to be priced
3
OC93-0101 have been sent to Drs. Stanski and Mandema
4
much lower than MS Contin generally, correct?
4
for review as potential authors."
5
A.
That was the trend at that time, yes.
5
6
Q.
What you did is put out OxyContin and
6
7
obsoleted MS Contin, and if you could keep the
Why was Purdue sending out manuscripts
to doctors to be potential authors?
I can't say for sure, but two
A.
7
8 MS Contin market through the use of OxyContin, you
8
9
9 that the manuscript had come to us in draft form and
wouldn't lose any market share there; and if you could
possibilities arise in my mind. One possibility is
10 expand it to non-malignant pain, you would gain all of
1 o we had helped them fill in details, such as the
11 that market share, correct?
11
MR. STRAUBER: I object to the form of
12
references and so forth. That was one of the ways
12 that companies helped authors lighten the burden, so
13
the question. At the minimum, it's compound.
13
14
MR. THOMPSON: Sure.
14
to speak, of writing a paper.
The second possibility is the first
15
Q.
Go ahead, you can answer.
15 draft might have been written in-house and sent to
16
A.
So could you just break it into two
16
them for their review and their correction and
17
additions.
1 7 questions and I'll answer them both?
MR. THOMPSON : Can you read the
18
18
19 question back?
20
THE WITNESS: And stop after one.
21
A.
22
Well, it says "as potential
Q.
19 authors" - -
20
A.
Yes.
(Record read .)
21
Q.
-- meaning it would appear that they
Okay. And that's what this seems to
22 authored the manuscript even though it really came
23
say, and certainly that was an element of
23
24
consideration and part of the strategy. What I think
24
25
might be m issing here is any discussion of the
25
from Purdue, correct?
MR. STRAUBER: Objection.
It's a collaborative effort. It's --
A.
Page 138
Page 140
1
non-malignant pain market, which you asked me a
1
we can't -- we don't impose on any author what they
2
question.
2
submit. What they submit for publication is submitted
3
from them, by them and totally in their control.
THE WITNESS: Could you read question
3
4
two?
4
5
A.
6
7
Do you know if Drs. Stanski and
Q.
(Record read.)
5
We would not -- we would not gain all
6
A.
I don't know.
7
Q,
Do you know whether these manuscripts
of the non-malignant pain market share, but we could
Mandema were paid by Purdue?
8
augment or add to the cancer pain market non-malignant
8
ultimately identified Purdue Pharma as being any part
9
pain.
9
of the author?
And I'm quite surprised, actually,
10
11
10
that this didn't discuss non-malignant pain as late as
11
I don't know. But it was not
A.
infrequent that employees of Purdue Pharma would be
12 June 8th. So for whatever reason, the -- either
12
co -authors on manuscripts. I don't know whether in
13
Mr. Innaurato or the person who was writing the
13
this case they were.
14
minutes didn't seem to include that, because I don't
14
And then if you'll turn over to page 4
Q.
15
think -- not to my recollection was there ever
15 of this document. It says, "Clinical: Status of Core
16
consideration of restricting this product to malignant
16 Clinical Program - Robert Reder" -- now, he's the
17
pain alone. It was widely used. Percodan, Percocet
17
18
were widely used in non-malignant pain .
18
A.
19
this product.
19
Q.
Down below that it says, "Marketing
2 o has been interviewing potential advertising groups and
20
21
21
is close to selecting one."
Do you know which advertising group
22
23
24
25
was ultimately selected?
A.
I don't know, but I'm sure we could
find out if that were important.
Coulter Reporting, LLC
medical --
Q.
Senior -- senior medical officer on
Okay. "Robert Reder stated that the
OC92-1102 study (OA Pain) has been completed and
22 preliminary data is currently being reviewed. It
23
appears that the 10 milligram tablet is similar to
24
placebo in efficacy, but the 20 milligram tablet was
25
significantly different compared to placebo."
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502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma LP., et al.
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Page 141
Were you aware that the 10 milligram
1
2
A.
4
Q.
2
morphine and that there is a stigma attached to
3
morphine so far as many patients and physicians are
4
concerned."
I don't recall that. That would not
be unusual in any analgesic trial, however.
5
6
I'm going to ask you about the
9
MR. THOMPSON : I'm sorry. We can go
7
principally cancer, drug associated with a whole bunch
8
of negative associations.
Were one of the negative associations
Q.
9
1 o ahead and mark it if you want.
It's an end-of-life in many hands,
A.
6
7 did we mark that? We did.
This is PDD --
And that stigma is what?
5
meetings of the international R&D meeting. This is --
8
Page 143
1 that not all patients can be successfully treated with
tablet was similar to placebo in efficacy?
3
Page: 36
Richard Sackler, M.D.
10 side effects addiction, dependency, tolerance buildup?
11
PDDl 701824723, Exhibit 21.
11
12
(DEPOSITION EXHIBIT NO. 21 MARKED)
12 not differentiate it from any other opioid. It was
13
(Passing document.)
Q.
14
Yes . But that -- the dependency did
A.
13 not more dependence causing or less.
Which appears to -- now we're in
Q.
14
And under this, "In summary, the
15 November of '94, and present was Dr. R.S. Sackler,
15 efficacy of the product has been demonstrated" -- I'm
16 correct?
16 sorry, go to page 12.
17
A.
If that's what it says, I must have
18 been present for at least part of that.
19
Q.
Then on page 13 --
20
A.
Oh, yes, I was probably present for
21 all of it.
Q.
22
17
A.
Okay. Thank you . Okay .
18
Q.
It's therapeutic --
19
A.
Okay. I'm on page --
20
Q.
Third paragraph.
21
A.
From the top or bottom?
Page 13, third paragraph.
22
Q.
Third paragraph from the top.
23
A.
Okay .
23 Actually, the fourth. Where it says, "In summary ... "
24
Q.
"Dr. Yeang asked if there were any" --
24
A.
Yes. Thank you.
25
A.
Just a second. I'm sorry. Page 13.
25
Q.
" ... the efficacy of the product has
Page 142
1
This one (indicating)? Are you reading from the top
2
here?
Q.
3
4
Page 144
1
5
A.
Okay. Thank you .
6
Q.
About the eighth line down.
"Dr. Yeang asked if there were any
7
2
involving 713 patients. Therapeutic conclusions are:
3
The equivalence of 1 milligram of Oxycodone to 2
4
milligrams of morphine sulfate."
Yes, I'm reading from the middle of
the paragraph.
5
A.
That's correct.
6
Q.
All right. No. 2 says, "Equivalence
7
8
statistically significant results. It was confirmed
9
that the 20 milligram product was significantly better
been demonstrated in six double-blind clinical trials
to IR Oxycodone."
8
A.
Immediate release.
9
Q.
Yeah. So they're saying
10 than the placebo but the 10 milligram product was
1 o controlled-release is equivalent to immediate-release
11 not."
11 Oxycodone?
Was that brought up at the meeting?
12
13
A.
It must have been. This is minutes of
12
A.
The implication here is in terms of
13 potency, I assume.
14 the meeting, so I'm sure this was -- these minutes
14
15 were generally of good quality.
15 titration."
16
17
Q.
If you'll turn over to page 11. And
this is shortly before the launch of OxyContin,
No. 3 was "The need for dose
Q.
16
A.
Yes.
17
Q.
And No. 4 says, "The need for the
18 correct? We're now into November of '90- -- no, it
18 availability of a rescue formulation." And No. 5
19 was not. This is over a year before the launch,
19 said, "The need for aggressive management of side
2 O November of '94.
2 o effects."
It says, in the third paragraph,
21
22
halfway down that paragraph --
Why would you need the availability of
21
22 a rescue formulation?
23
A.
Yes. Dr. Reder?
23
24
Q.
Dr. Reder.
24 doctrine of using opioids is to titrate to effect.
25
It says, "Advantages for OxyContin are
Coulter Reporting, LLC
25
A.
At this time, and still today, the
But in some conditions, cancer and others, the dose
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Page 147
1
that has, in general, a good effect may suddenly be
1
whether to say it was for three to four hours or for
2
insubstantial due to what's called breakthrough pain,
2
six hours, and there was a real debate at the company
3
and breakthrough pain could be occasioned by movement
3
of how we're going to market this because we're going
4
or trauma or just occasioned by the fluctuation in the
4
to hurt ourselves one way or the other depending on
5
pain state.
5
whether we say our rescue drug is three to four versus
6
six, because it's the same and you're marketing it two
Rather than maintaining a patient on
6
7 different ways?
7
the highest number of milligrams of any opioid around
8
the clock just to prevent breakthrough pain, the
8
9
normal practice -- and I think it's the prudent and
9
1 o safest practice -- is to give the patient an
MR. STRAUBER: Objection to the form
of the question. It consists of multiple questions
1 O and parts.
11
immediate-release form ideally of the same analgesic
11
12
agent that they can take when they have breakthrough
12
13
pain on an as-needed basis.
13
you could show me some documents - - if you wanted to
14
pursue this with other questions, please show me some
14
Q.
Were there studies done at Purdue that
You can answer it if you can.
I have a vague recollection of it. If
A.
15
showed that blood plasma levels that the medication,
15
documents. I have -- I do have a very hazy
16
instead of lasting for 12 hours really lasted between
16
recollection of this very minor complication, but
1 7 8 and 12 hours?
18
19
There were -- there were blood level
A.
studies that showed the profile of blood level, but
17
perhaps it was a big regulatory complication. I don't
18
remember. I couldn't explain it to you.
19
So we'll go back to that in a second.
Q.
2 o there is no prediction of what blood level you will
2 o He's going to pull something . Let me continue to read
21
need to control what pain. So when we -- what we
21
22
attended to were the clinical results of treating
22
from this document.
It says, "Dr. Kaiko reported that bio
23
patients at a 12-hour basis, and that was what we
23
24
researched.
24
A.
Right.
25
Q.
-- "undertaken to show that the 10, 20
Now, may I just go on a little bit?
25
studies" -- it's the fourth paragraph.
Page 146
1
Q.
Page 148
1
Sure. Let me ask you this though.
and 40 milligram tablets were bioequivalent and dose
2
What your research actually showed is that OxyContin
2
proportional. In normal subjects it has been
3
Controlled-Release provides pain relief somewhere
3
demonstrated that at the same total daily dose the
4
between 8 and 12 hours, correct?
4
controlled-release product given 12 hourly showed the
5
6
A.
appeared that way, but principally most were 12 hours .
Allow me to just elaborate just a bit.
7
Normally people take a Tylenol tablet
8
9
I think there were some patients who
every -- or two tablets every four hours, but they
5 same twofold fluctuation as the immediate-release
6
product given six hourly and that this held across the
7
four-fold dosage range."
Were you-all aware of that in 1994?
8
9
I'm not certain what this means. I'm
A.
1 o will get essentially the same effect if they take one
1 o sorry, but I don't know -- I don't know what "two-fold
11 tablet every two hours. What we had found was in most
11
12
patients - - this was found as the drug was marketed --
12
13
who complained that at eight or nine hours they were
13
14
back in pain, yes, they could be treated every
15 three -- three times a day. But if you took that
14
15
fluctuation" means. I'm sorry.
Did you ask anybody when you were at
Q.
the meeting?
A.
I'm sure I understood it, but I have
a - - my -- my best guess is that whoever was taking
16
dosage, daily dose, and divided it twice a day, q. 12
16 the minutes somehow perhaps even didn't understand the
17
hours, they were just as pleased with the pain relief.
17
discussion or may have understood it but wrote it up
18 It was simply that the physician, perhaps by habit or
18
in a way that doesn't make any sense to me now.
19 for other reasons, rather than increasing the
19
Q.
Going down to the fifth paragraph.
2 o twice-a-day dose increased the daily dose by telling
20 "A clinical study has been undertaken comparing
21
the patient, Well, take it every eight hours, and it
21
22
would work fine.
22 q.i.d. in patients previously stabilized to pain
23
Q.
Do you recall Purdue Pharma running
23
24
into a real problem with their rescue drug because
24
25
they were trying to decide how to market it and
25
Coulter Reporting, LLC
Oxycodone b.d. versus immediate-release Oxycodone
relief."
And then if you drop down, "the study
demonstrated that both products maintained baseline
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1
pain control and pain intensity was the same
Page 151
Do you recall that study being
Q.
1
2 throughout the day. The acceptability score was the
2
3
same throughout the study and the same for immediate-
3
4
and controlled-release products."
4
It was studied. But they must have concluded that
5
that finding is not consistent with either their
And then if you drop down to the next
5
dismissed as a failed study?
I don't know that it was dismissed.
A.
6 paragraph. "The conclusion from the study was that
6
expectation or ours, or, more importantly, other
7 the 12-hour product was equivalent in efficacy to
7
studies and experience. And clearly the product's
8 immediate-release Oxycodone."
8 success in treating patients in pain, which is
9
And is that why the FDA said other
9
indisputable, would put a lie to anybody who would
10 than how many times you take the product being the
1 o say, Oh, Oxycodone is no better than placebo. I don't
11 dosing requirements, there's really not any other
11 think any doctor would assert that. For treating
12
12
13
14
benefit?
A.
The F- -- I can't tell you whether
this was the study that convinced the FDA of that, but
pain, I should say.
13
Q.
Right.
14
A.
Maybe they -- maybe they would say in
15 it certainly -- it's not -- the finding is completely
15 terms of urinary incontinence it's not effective, but
16 consistent with that. There may have been other
16
for treating pain.
1 7 studies that led them to that conclusion with this
17
18
18 depends on other factors, such as abuse. I mean, you
19
being just supportive of that conclusion.
In pain studies, I might point out
But whether it's effective or not also
Q.
19 can kill somebody and take away their pain, but that
2 o that the biggest advance in measuring pain -- which,
20 certainly wouldn't be effective, would it?
21
of course, is a personal experience. No doctor can
21
22
look at you and say, Oh, you've got a pain level of 3
22 considered a sign of efficacy.
I don't think that death would be
A.
23
and you have a pain level of 6. There's no way of
23
Q.
Correct.
24
doing it. You have to depend on the patient's report.
24
A.
Yes -- I mean, in the extreme, yes,
25
And the huge advance that led to all the research in
25 what you said is correct.
1
analgesia and pain relief was called the McGill Visual
1
Page 150
Page 152
2
Analog Scale that was developed in the 'S0s at McGill
2
3
University in Montreal. Seventy years later we have
3
4
no advance on that.
5
And needless to say -- I suspect
4
5
So just because it takes away pain
Q.
doesn't mean it's a good drug, does it?
A.
No.
Q.
All right. Let's look at Sackler
Exhibit 13 again. I did want to c;1sk you one question
6
everybody in this room has gone to a doctor where they
6 about this.
7
say, "Do you have pain," and if you say -- or to a
7
8
nurse when they take your blood pressure -- "Yes, I
8
effectiveness -- I'm sorry. There's always a balance
9
have pain," and they ask you to rate it. That is
9
between effectiveness and safety.
1 o clearly better than just saying, patient has pain
10
11 plus, yes or no. But it's not a lot better. It's not
11
There's always a balance between
A.
If you go to page 4, 1.4. It says,
Q.
"If physicians perceive OxyContin as
12
terribly -- it's not reproducible and it is highly
12 controlled-release Percocet, it is likely that they
13
influenced by the environment and other factors that
13
14 affect the report the patient gives.
15
So very often you can compare a highly
will start to use it in place of Oxycodone
14 combinations. As physicians become more comfortable
15 with the use of the Oxycodone combination market, it
16 effective pain reliever to a placebo and you get in
16
17
the study no difference, and that is widely
1 7 of Class III hydrocodone or codeine combination
18
recognized, and that probably related to the study
18 drugs."
19
that you talked about earlier.
19
20
The FDA, however, would have required
21
studies that showed a difference, and they did, before
22
is possible they will start to use OxyContin in place
And Class III are not as regulated as
2 o Class II, correct?
21
A.
That is correct.
they would approve the product. In other words, the
22
Q.
"Therefore, it is imperative that we
23
negative didn't -- was dismissed as a failed study by
23
24
the FDA. The positive studies control, because
24
25
negative studies --
2 5 establish a literature to support a Class III use for
Coulter Reporting, LLC
establish a literature to support such use."
Who at Purdue Pharma was trying to
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1
Page 155
1
OxyContin?
MR. STRAUSER: Object to the form of
2
3
the question.
4
A.
R-E-D-E-R.
2
A.
Yes.
3
Q.
And he says, "Currently our draft
Your -- the answer to your question is
4
5
nobody. We had no plan, program or expectation
5
A.
Yes.
6
that -- or intention to change OxyContin from a
6
Q.
-- "and, therefore, our sales material
7
Class II to Class III. In fact, it is not too long
7
8
ago the FDA has reclassified Oxycodone as a Class II
8
9
drug.
Okay. So you think that -- where it
Q.
10
have the same dosing of rescue as q. 3-4h p.r.n."
And that is -- means what?
9
A.
10
needed .
11 says, "Therefore, it is imperative we establish a
11
12
12
literature to support such use" is referring to
PI" -- that's package insert, correct?
It means every three to four hours as
Okay. And do you know if the people
Q.
who were involved in the studies of OxyContin were
13 physicians believing where it says "Physicians
13 given OxyContin for rescue pain?
14 perceive OxyContin as controlled-release Percocet, it
14
A.
OxyContin?
15 is likely they will start to use it in place of
15
Q.
Yes.
16 Oxycodone combinations"? Is that what that
16
A.
Or you mean Oxycodone?
1 7 development of literature is referring to in your
17
Q.
Oxycodone. I'm sorry.
18
A.
I'm sorry. I don't know.
19
A.
Probably, yes.
19
Q.
It says, "BK brought this issue up
20
Q.
Who -- who was --
20
21
A.
I don't know.
21
the review of our sales material. OxyIR" -- and is
22
Q.
-- trying to develop that literature?
22
that Oxycodone?
A.
I don't know. That would have been a
18 opinion?
some time ago. It is now surfacing again because of
23
A.
Yes.
24
combination. That would have been the medical
24
Q.
-- "is being promoted as rescue q.
25
department to do studies and then have them published.
25
23
3-4h."
Page 154
1
Page 156
That would have been a research effort.
And that's every three to four hours,
1
2
Are we finished with this one?
2
3
MR. STRAUSER: Off the record. In
3
A.
That's correct.
Q.
He said, "While this may be consistent
right?
4
between subjects, would now be a good time to break
4
5
for lunch?
5
with the OxyContin package insert if it is approved as
stands, it will be inconsistent with the OxyIR 5
6
MR. THOMPSON: Yes.
6
7
VIDEOGRAPHER: We are off the record.
7
milligram package insert which uses q. 6h," meaning
8
you take it every six hours, correct?
8 1:11 p.m.
(RECESS)
9
VIDEOGRAPHER: We are back on the
10
13
Q.
up after our break. We've taken a number of breaks,
but I'll just remind you, any time you need to stop or
16 need a break, just let us know -17
Q.
10
Q.
He says, "Moreover, if we use the q.
What was the reason that you-all did
13
14
18
That's what it means.
12 their package insert."
All right. Dr. Sackler, picking back
15
A.
A.
11 3-4 hours, it will help to validate Roxane's change in
11 record at 2:03 p.m.
12
9
14 not want to validate Roxane's change in their package
15
16
Thank you.
-- and we'll stop again.
We were talking earlier about this
insert?
A.
I -- I would have to read this
17
completely and try to answer your question, but I'm
18
not sure this will prompt me to remember. May I?
19
Q.
Sure.
2 o issue with rescue OxyContin. And let me hand you what
20
A.
I really don't remember this well
21
21
19
we're going to mark as Exhibit 22.
22
(DEPOSITION EXHIBIT NO. 22 MARKED)
22
23
(Passing document.)
23
24
25
Q.
And if you go back to the last page,
there is a memo dated 9-21-95 from Robert Reder,
Coulter Reporting, LLC
enough to answer your question.
Q.
Well, let me continue reading here.
It says, "Finally, it creates a problem for the OxyIR
24
10 milligram and 20 milligram capsules as the package
25
insert would have two different dosing intervals
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depending upon the use, i.e., q. 4 for rescue and q. 6
Page 159
1
2 for usual pain use."
2
3
He says, "One suggestion would be to
3
Page:40
Richard Sackler, M.D.
A.
No, but it looks like I wrote it.
Q.
Okay. And then Robert Kaiko writes
back and says, "Unfortunately soon may be too late.
4
make everything consistent at q. 6 hours. Rescue
4
Robert? As previously" -- so he's saying I brought
5
would then be q. 6 p.r.n." -- as needed -- "as would
5
this up again.
6 some acute pain prescriptions. For ATC use, it would
6
7 be just q. 6 hours.
7
everything to q. 6 hours for immediate-release
8
Oxycodone products."
"Although I hate the thought of
8
9
10
recommending a PI change" -- package insert change -"I understand FDA may recommend a change or two such
"As previously, I recommend we change
9
10
And he is the head of what, Robert
Kaiko?
11 as removing the plasma curve graph. At this point we
11
12 could change the frequency of dosing in the PI. What
12
he was the project -- the research project head for
13
13
the overall OxyContin project.
do you guys think?"
So what he's saying here is, we've got
14
He was in the medical department and
A.
Okay. So he's saying, it appears to
Q.
14
15 the exact same drug, we've marketed it for two
15 me, maybe perhaps to be a little frustrated and
16 different purposes, and we've got two different dosing
16 saying --
1 7 regimens for the exact same drug, correct?
17
A.
I don't know.
18
Q.
-- "Soon may be too late. As
A.
18
It seems to suggest that, but I can't
19 confirm it.
19 previously, I recommend we change everything to q. 6
20 hours"?
And then Paul Goldenheim -- if you
Q.
20
21 turn to the next page and read the next one at the
21
22 bottom -- says -- and who is Paul Goldenheim?
A.
23
24
22
He was head of R&D, research and
development and medical.
He says, "The issue that won't go
Q.
25
I can't say why he wrote the first
A.
sentence, whether he was frustrated or whether he was
23
actually referring to some sort of deadline, maybe in
24
a clinical trial, maybe on submissions to the FDA. I
25
don't know why.
Page 158
Page 160
1 away. Robert is right, we need to discuss again.
1
2 Robert, please arrange a meeting. Round up the usual
2
But at least from the appearance of
Q.
this, you've got Friedman, the head of marketing,
3 suspects. This is too complicated for e-mail."
3
saying why don't we take the same product and just say
Then Friedman -- and what was his
4
take it every six hours, and if it's for rescue it's
5
good for three or four hours?
4
5
role?
6
A.
He was head of marketing and sales.
6
7
Q.
Right. This -- essentially to fill in
A.
The head of marketing and sales writes
7
8 back and says, "Is it unreasonable to have a q. 6h
8
was, have two indications. For regular use of
9 dose" -- meaning take it every six hours -- "for
9
immediate- release Oxycodone, administer it around the
10
1 o clock every six hours; for rescue use, administer --
normal dosing and a q. 3-4 hour for rescue?"
So the marketing guy is saying, Well,
11
the blank here, what his -- what he must have meant
11 you can administer the dose every three to four. But
12
hey, can't we just take the exact same medication and
12
that wouldn't be indefinite, this would be for rescue
13
say if it's for a normal dosing, take it every six
13
for breakthrough -- actually for breakthrough pain .
14 hours, but if it's for rescue, take it every three to
14
15 four hours?
16
A.
15 is not a physician, correct?
That's what he says. And what he
16
A.
1 7 meant was for normal around-the-clock dosing rather
1 7 suggestion.
18 than rescue, which is one or two or three doses and
18
19 that's it, as needed.
20
Q.
And Friedman, the head of marketing,
Q.
That's correct. So he's making a
Dr. Robert Kaiko, the head of the
Q.
19 project for Oxycodone, is a physician, correct?
And then up at the top you write back
20
A.
He is.
Q.
And he's saying, don't do what
21
and say, second one down, "I agree, this is too
21
22
complicated to solve through written exchange. Paul,
22 Friedman's saying, we need to make it q. 6 hours for
23
I think that you should get us together soon. Good
23
24
pickup someone."
24
25
Do you recall writing that e-mail?
Coulter Reporting, LLC
25
immediate-release Oxycodone products, correct?
A.
First of all, Friedman asks a question
here. He's not asserting a proposition, he's asking,
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Page 163
1 immediate releases? Is that what that is?
explain to me why we can't do this. And I understand
2 why he asks the question. And the only answer could
2
3
be it would -- it might be confusing to a physician,
3
I'm just reading the sentence because I'm not -- I
4
but I think the emphasis should be on "might be
4
didn't follow what it meant.
5
confusing."
5
and say, "I don't know how urgent this is. If it
He says -- the next sentence says, "In
Q.
6
essence if you can use an IR q. 6 hours at a cheap
7
price, then those doctors that use OxyContin q. 8
And then you write back the next day
Q.
6
7
Yes, IR would be immediate releases.
A.
8
can't wait until tomorrow, let us know immediately. I
8
hours (there will be some regardless of what we say or
9
don't have a problem with this change at all. Does
9
do) will not see a benefit over the immediate
1 o releases. In addition, our promotional campaign has a
1 o anyone question it?"
And who is Mr. Alfonso?
11
12
A.
He was head of marketing at the time.
13
Q.
Okay. So the head of marketing comes
11 visual, six cups representing q. 4 hours. If we go
12 q. 6 hours, we will -- might have to change the visual
13 to four cups, and this will not have as much impact.
14 back and he says, "The way these drugs are written are
14 We need to go q. 6 hours for maintenance and q. 3-4
15 q. 4-6. The rescue is for q. 3-4 hours." And he
15 hours for rescue so that we can maintain the integrity
16 explains, "The problem might be that if we go the q.
16 of our OxyContin studies."
1 7 3-4 hour route, we will validate the Roxane dosing ... "
17
Again, I'm going to ask you, do you
18
19
know what the problem was what validating the Roxane
Did I read that correctly?
18
A.
You did.
19
Q.
Do you know whether you went q. 3-4
2 o hours for rescue and 6 hours for maintenance?
2 Q dosing and why he thought it was a problem?
21
A.
I don't know.
22 think it was a problem. I can't imagine what he was
22
Q.
All right. Let's -- let me jump back.
23
23 I'm going to hand you this document.
21
24
I don't remember. I don't really
A.
thinking of.
Q.
Okay. So he writes, "The problem
25 might be that if we go the q. 4 -- q. 3-4 hour route,
24
(Passing document.)
25
MR. THOMPSON : Why don't we go ahead
Page 164
Page 162
1 we will validate the Roxane dosing and possibly
1
2
present a challenge to the OxyContin studies."
2
3
So if he's validating the Roxane with
3
4
the q. 3-4, would it appear that perhaps the Roxane
4
5
had required -- now, that's an overseas company,
5
6
correct?
7
8
9
6
and mark that as Exhibit 23.
(DEPOSITION EXHIBIT NO. 23 MARKED)
This is from you dated April 20th,
Q.
2000.
So OxyContin has been on the market
over four years at this point, correct?
No. Roxane was an American company, I
7
A.
Yes.
believe, at that time owned by Boehringer-Ingelheim.
8
Q.
And under No. 5 it says, "OxyContin
A.
Q.
Okay. Did they -- did they put a
9
1 o dosing limit on OxyContin to your knowledge?
Tablets price increase is the central decision. Every
10 0.1 percent is 1M" -- I'm assuming that's one million?
11
A.
Oxycodone you mean?
11
A.
That's correct.
12
Q.
On Oxycodone.
12
Q.
-- "one million to the bottom line.
13
A.
No, not to my knowledge. I don't
13 What would the risk of having a 4 percent
14 think it was an issue of limit.
15
Q.
14 increase instead of a" -- "what would the risk be of
15 having a 4 percent increase instead of a 3 percent
Do you know what Roxane's dosing was
16 that he's referring to?
17
18
19
A.
No.
Q.
So he says, "The problem might be that
16 increase?"
17
And you're talking about price
18 increase, correct?
if we go the q. 3-4h route, we will validate the
19
A.
That's correct.
2 o Roxane dosing and possibly present a challenge to the
20
Q.
"Our average realized price is
21
21
OxyContin studies. On the other hand, a much more
constant, suggesting that rebates and other discounts
22
dangerous scenario can occur if we go the q. 6 hour
22 are taking a larger share of our business. 3 percent
23
for maintenance and rescue. If we go this route and
23
annual notional increases seems to hold our per KG" --
24 price continues to be a major issue when we narrow the
24 is that kilogram?
2 5 value of OxyContin closer to the IRs" -- and that's
25
Coulter Reporting, LLC
A.
Kilogram.
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Richard Sackler, M.D.
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2
2
Was it true that every time you
increased the price 0.1 percent you added one million
5 to the bottom line of Purdue Pharma?
A.
6
Yes.
Q.
You-all paid him approximately 50
I don't remember. The answer is no to
3
million dollars to defend you in that case -- or paid
4
his firm approximately 50 million dollars to defend
5
Purdue in that case?
7
8 correct or not when I wrote it, but it certainly
8
9 wouldn't have been correct every time.
I'm -- I can't verify. That's the
A.
6
7 your question. I don't remember whether this is
Q.
A.
1
where many prices are going up."
3
4
-- "price constant in an environment
Q.
1
first time I've heard a number attached to that.
If he testified to that, would you
Q.
9 dispute it?
We were talking earlier about Purdue
10
A.
I would have no basis to dispute it.
11 Frederick versus Purdue Pharma. Did you ever
11
Q.
And do you know if anybody at Purdue
12 determine whether the employees -- the sales force
12
10
made an effort to determine whether the submission and
13 that engaged in improper conduct as referenced in the
13 the call notes that were pulled by the lawyer hired to
14 felony plea agreement were employees of Purdue
14 represent you were accurate or not?
15
Frederick or employees of Purdue Pharma?
MR. STRAUBER: I object to the form,
15
MR. STRAUBER: I object to the form of
16
because I don't know how anyone knows what it is
1 7 the question. I don't think it accurately reflects
17
you 're referring to .
18 the plea agreement.
18
16
19
A.
Could you just restate the question
2 o because I kind of lost the thrust?
21
Q.
Are you aware that he made a
Q.
19 submission on behalf of Purdue to the U.S. Attorney's
20
Sure. Did you ever make a -- we've
Office?
talked about Purdue Pharma and Purdue Frederick. Did
23
you ever make a determination whether the employees
22
I am not aware of anything that he
A.
21
22
submitted to the U.S. Attorney's Office.
You've not reviewed any of the
Q.
23
24 who engaged in illegal activity as referenced in the
24
materials he submitted to the U.S. Attorney's Office
25
25
when he was defending Purdue?
felony plea agreement -- or improper activity as
Page 166
1
Page 168
referenced in the felony plea agreement were employees
1
2 of Purdue Frederick or employees of Purdue Pharma?
3
A.
2
I'm not aware of whether such a study
A.
I did not.
Q.
Were you aware of the call notes that
3
he pulled and purported were evidence of improper
behavior on behalf of Purdue salespeople?
4
was done or anybody focused on that question that may
4
s
have been done. But you should be -- you should think
5
6
of this, that the felony plea agreement came years
6
7
after many remedial actions had been taken to retrain
7
A.
No.
Q.
Did anyone at Purdue, to your
knowledge -- Purdue Pharma or Purdue Frederick -- make
8
everybody, to discipline, sanction -- correct,
8 any attempt to ascertain what percentage of reps in
9
discipline, sanction or dismiss employees who had
9
10
behaved improperly, and those processes which started
Kentucky were engaging in the type of behavior that
1 o the plea agreement says was improper?
11 late in 2000 or early 2001 continued right up to the
11
A.
I'm not aware of that.
12
12
Q.
Did you ever instruct anybody to do
To do? Could you be more precise,
13
plea agreement and then after the plea agreement.
Q.
Sure. Have you looked at the call
14 notes of the reps in Kentucky?
13
it?
14
A.
15
please?
16 were showed to me during my preparation. There were
16
Q.
17
1 7 Purdue to undertake an investigation to find out what
15
18
19
A.
I have not seen any except those that
three or four that I saw.
Q.
Did you review the documents that
Mr. Shapiro, the lawyer that you-all hired, put
2 o together for the U.S. attorney in Virginia?
21
22
23
A.
I don't think so. Those don't seem
familiar to me.
Q.
And that was the attorney that you-all
24
hired to defend you in the case brought by the U.S.
25
attorney in Virginia; is that correct?
Coulter Reporting, LLC
18
Did you ever instruct anybody at
percentage of reps in Kentucky, and which ones, were
19 engaging in conduct that was referenced as improper in
2 o the felony plea agreement?
21
A.
No, I did not.
22
Q.
Have you reviewed Howard Shapiro's
23 deposition in this case?
24
A.
I have never seen it.
25
Q.
He was asked -- let me read this
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Page 169
1 question and his answer.
"Mr. Shapiro, before the break, we
2
Page 171
No. I think he would like to see it.
A.
1
MR. STRAUSER: I'd like to see it
2
3
were discussing the agreed statement of facts, and
3
also . Plus, he really can't see that distance
4
specifically paragraph 20. One of the questions that
4
physically.
5 I asked you previously about the conduct described in
5
6
the agreed statement of facts was, did you ever figure
6
7
out who the employees referenced in the agreed
7
8
statement of facts worked for, was it Purdue Frederick
8
9
Company, was it Purdue Pharma, L.L.P., or some other
10 entity?
MR. ELLIS: We'll print off some
copies .
MR. THOMPSON: Why don't we go off the
record while we get some copies of this.
VIDEOGRAPHER: We are off the record
9
10 at 2: 28 p.m.
11
(RECESS)
12
been discussing -- and those are employees whose
12
VIDEOGRAPHER: We are back on the
13
conduct is described in paragraph 20 and its various
13
"With respect to the employees we've
11
record at 2:29 p.m.
Sure. And to save time, I'll let you
14 subparts -- did you ever do a determination to
14
15 determine whether those employees were employees of
15
read it. Can you start with the next question, which
16
16
was "Uh-huh" and read the answer.
Purdue Frederick Company who signed the agreed
1 7 statement of facts or some other Purdue entity?"
18
Read the answer. The "Uh-huh" doesn't
A.
17
And his answer is, "Without going into
18
Q.
really set up the answer for me.
19 too much work product, let me state we did sufficient
19
2 o investigation once -- once it turned this direction to
2 O 27, the "Uh-huh ."
21
satisfy ourselves and our client that there were
MR. STRAUSER: That's page 214, line
THE WITNESS: 2017?
21
22 Purdue Frederick employees who engaged in the conduct
22
23
that's referenced in here and that forms the basis for
23
24
the guilty plea."
24
THE WITNESS: 214.
25
MR. STRAUSER: -- 14, line 17.
"Question: Were there any employees
25
MR. STRAUSER: Yes, I'm sorry. Page
2 --
Page 172
Page 170
1
of Purdue Pharma, LLP that are referenced here or any
2 other Purdue entity?"
MR. STRAUSER: Okay.
2
"Answer: Well, again, and I'm -- just
3
THE WITNESS: Right.
1
3
"Uh-huh" is the question.
A.
"Answer: Of people who are referenced
4
what I said before, the -- I don't know whether at --
4
5
at which point in time Michael Friedman hired Udell,
5 but not named in some of the paragraphs, I don't
6
Paul Goldenheim, whether they were Purdue Pharma or
6
believe that we made any effort to determine whether
7
Purdue Frederick or some of the -- some of them had
7
at the relevant times they were Purdue Frederick
8
been one and then the other. Beyond them there
8
Company employees or Purdue Pharma employees."
9
were -- when we looked, for instance, at the names
9
Q.
Okay. And is that testimony accurate?
A.
I can't -- I can't vouch that it's
1 o that are associated with the -- in the first
10
11 supplemental responses to whatever that was, 23, I
11 accurate. It's consistent with my knowledge.
12 think."
12
Now, did you understand that answer?
13
MR. STRAUSER: Mr. Thompson, I object
14
13
14
15
to the question. Plus, could you let the witness have
15
16
a copy to read, as it's very hard to follow when
16
17
you're reading such a lengthy - -
17
So the next question says, "So it
Q.
could have been either or one or both."
A.
Yes. The question is, "So it could
have been one or either or both; you're not sure?"
And the answer is, "Correct."
Q.
Yeah. Now, in 2001, who did Michael
18
MR. THOMPSON: Sure.
18
19
MR. STRAUSER: -- series of questions
19
A.
I don't know.
20
Q.
You don't know if he worked for Purdue
20
and answers.
MR. THOMPSON: Do we have another copy
21
22
of this, Tony?
23
Q.
21
22
Friedman work for?
Pharma in 2001?
A.
My best guess is he worked for Purdue
23
Frederick, but it's a guess, and maybe for Purdue
24 just read along with me, if you want to do that, and
24
Pharma, but I don't really know.
25
25
Here. I'll tell you what, you can
I'll hold it over here.
Coulter Reporting, LLC
Q.
How about Howard Udell, do you know
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Richard Sackler, M.D.
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Page 173
1
2
3
4
A.
No.
Q.
What about Paul Goldenheim, do you
know who he worked for?
5
A.
I don't -- I don't know that.
6
Q.
Do you know whether you worked for
7
Purdue Pharma or Purdue Frederick in 2001?
Page 175
1
interviews were conducted with more than 500
2
healthcare professionals. In our focus group findings
who he worked for?
3
we learned that MS Cantin" -- that's the drug that you
4
already sold, correct?
5
A.
I'm sorry, I didn't hear the question.
6
Q.
That's morphine sulfate, correct?
7
A.
Yes.
Q.
That's the one that you had not had
8
A.
I don't know for sure.
8
9
Q.
So going back to our OxyContin launch
9
any reports of abuse or diversion with that you could
1 O recall, correct?
10 team. I'll hand you that.
(Passing document.)
11
A.
None that I was aware of, yes.
Do you want to put a number on this?
12
Q.
And it says, "We learned that
Q.
Yes. Let's mark that as Exhibit --
13
25?
14 creative concept testing showed the likelihood of
11
12
A.
13
MS Contin is the gold standard for cancer pain. Our
14
A.
15
Q.
-- 25.
15
16
A.
No.
16 scale of 1 to 5, which is very favorable."
OxyContin usage by physicians and nurses were 4.6 on a
Were you aware of this creative
17
COURT REPORTER: 24.
17
18
(DEPOSITION EXHIBIT NO. 24 MARKED)
18 concept testing and focus groups that were being
Q.
19
And I've just got a couple of
19 conducted?
2 o paragraphs I want to ask you about.
20
A.
I don't recall .
Q.
And then if you go to the next page,
21
A.
Sure.
21
22
Q.
So on -- this is dated April 4th,
22
page 2, last paragraph. "Our meeting ended with a
23
1995, and it says at the first paragraph, second
23
question and comment period. Michael Friedman
24
sentence, "Mike Innaurato" --
24
emphasized the threat that AB-rated generics posed to
25
MS Cantin. We're not sure when AB-rated generics will
25
A.
Oops. First paragraph on which page?
1
Q.
I'm sorry. Page 1, second paragraph.
2
A.
3
Q.
Page 176
Page 174
4
be launched, but we don't think it will be until 1996.
Oh, second paragraph. Okay.
2
Inevitably the AB-rated generics will arrive and this
"Mike Innaurato" -- he's the marketing
3
is why it is extremely timely importance that we must
guy again, correct?
4
establish OxyContin. OxyContin can cure the
5
vulnerability of the AB-rated generic threat, and that
A.
Yes.
Q.
-- "discussed the marketplace that
6
is why it is so crucial that we devote our fullest
OxyContin will enter and how OxyContin will expand out
7
efforts now to a successful launch of OxyContin."
5
6
7
1
8
of the cancer pain market. OxyContin will be launched
8
9
in 10, 20, 40 milligram tablet strength, 80 and 160
9
10
milligram tablet strength to follow."
10
And if you go on down a little bit
11
Were you aware that was part of the
strategy?
I'm sorry, but what was part of the
A.
11 strategy?
That the AB-rated generics were going
Q.
12 further, he says, "OxyContin will be indicated for the
12
13
relief of pain with the convenience of q. 12 dosing.
13
to arrive and that is why it was extremely timely
14
OxyContin's primary market positioning will be for
14
importance -- that's the way it's written -- that we
15 just establish OxyContin and it was crucial to devote
15 cancer pain and the secondary market will be for
16
non-malignant pain, musculoskeletal injury and trauma.
16 the fullest efforts to a successful launch because of
17
It was reinforced that we do not want to niche
17
18 OxyContin just for cancer pain."
And was it part of your-all's
19
AB-rated generics?
MR. STRAUBER: Objection to the form.
18
19 The witness can answer.
2 o marketing strategy not to niche OxyContin for cancer
20
21
21
pain?
A.
Yes, I was aware of that. And the
reason is clear. MS Cantin was our most important
22
A.
Not to limit it, yes.
22
product at that point, and when the sales were eroded
23
Q.
Below that it says, on the last
23
by generics, we would have -- if we had not replaced
24
paragraph, "In our market research efforts, focus
24
those sales with other product sales, we would have a
25
groups, personal one-on-one interviews and telephone
25
much smaller company. That would cost many people
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Richard Sackler, M.D.
8/28/2015
Page 177
1
their jobs.
Are you familiar with the OxyContin
Q.
2
3
I've become reminded of it, yes.
A.
long-term safety study devoid of some condition, so
the long-term study would be focused on following a
4
condition, that's low back pain or osteoarthritis.
5 And at that time the studies were typically 12 weeks
MR. THOMPSON: Let's mark this as
5
6
2
3
Product Team?
4
Page 179
I don't know how you would do a
A.
1
Exhibit -- is it 257
6
and with an open extension at the end they could go on
7
COURT REPORTER: 25.
7 for a year.
8
(DEPOSITION EXHIBIT NO. 25 MARKED)
8
(Passing document.)
9
9
And this is minutes of the OxyContin
Q.
10
That is a subcategory of non-malignant
Q.
pain, correct?
These two studies, low back pain and
A.
10
11 Product Team dated -- the meeting was February 22nd,
11 osteoarthritis. Long-term safety would be a general
12 1996 up at the top.
12 concept that would apply to any kind of study that's
13
A.
Washington's birthday.
13
14
Q.
It says, first paragraph, "The
14
long enough to accumulate that data.
They've included long-term safety data
Q.
15 OxyContin Product Team met on Friday, February 22nd,
15 under their marketing wish list under non-malignant
16 1996, and topics of discussion included the
16 pain, correct?
17 following:" Number one is "Marketing's wish list for
17
A.
They did.
18
18
Q.
So it looks like they're saying we
clinical studies," and then it's got a list of
19 studies. Number one is "Postoperative pain to support
19
2 0 the Abbott agreement."
2 0 for non-malignant pain.
Why did you need studies on
21
22
need long-term safety data on prescribing OxyContin
Do you read that the same way or
21
postoperative pain to support the Abbott agreement?
22
differently?
23
A.
I don't recall.
23
24
Q.
"Pharmacoeconomic." What was the
24
than you do. Just that it wasn't that we needed it,
25
it was a wish list. But it was inherent in any
25 reason for pharmacoeconomic studies being needed, if
I -- I guess I read it differently
A.
Page 178
Page 180
1 you recall?
1
2
A.
I don't recall that circumstance .
2
3
Q.
And then it says, "Non-malignant pain
3
long-term study we did of any pain condition.
And then we talked about the FDA's
Q.
statement about comparative studies. Do you remember
4
(example, functional improvement)." And then the
4
that, where they said you should refrain from
5
subcategories are "Low back pain; osteoarthritis,
5
comparative analysis?
6
long-term safety data."
7
8
9
6
I don't remember. So if you could
A.
A.
Right.
7 just go forward with the question, that would be
Q.
Why did you think that marketing
8
needed -- was needing on March 7th, 1996, after the
9
great.
Sure. One of the things that the
Q.
1 o product had already been launched, long-term safety
1 o OxyContin marketing team's wish list has under No. 5
11 data?
11 is "Comparative studies, especially versus:
12
13
A.
12 Combination opioids such as hydrocodone combinations,
I don't remember precisely. But all
13
studies would include or would enhance the data
Duragesic, MS Contin, Kadian and Ultram NSAIDS."
14 available to support long-term safety if the studies
14
15 were long term. And the studies that were referenced
15 antiinflammatory drugs; is that right?
16 here, low back pain and osteoarthritis, would surely
16
1 7 have been long enough to add to that database.
17
Those are nonsteroidal
A.
Ultram is an opioid drug. NSAIDS are
nonsteroidal antiinflammatory drugs.
18
Q.
Right, NSAIDS.
19 the OxyContin -- or the OxyContin Product Team on
19
A.
So they're not the same. I don't know
20
2 o why they were -- the bullet put them together, but
18
Q.
Then can you explain why the head of
February 22nd, 1996, after the product launch said we
21 need long-term safety data?
22
A.
I don't think there was any question
21 they're different.
22
Q.
Right. No, no. I get it. I'm asking
23
about the safety of the drug. It was just an addition
23 you, is that what NSAID stands for, nonsteroidal?
24
that it would enhance the dossier that was available.
24
A.
Yes.
25
Q.
Has that been marked?
25
Q.
Do you --
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Richard Sackler, M.D.
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Page 183
Page 181
1
2
A.
That's been marked 25.
Q.
All right. Now, let's go to the
1
other healthcare companies weren't involved?
launch plan. And this is dated September 27th, 1995.
4
And if you 'll go to page 42 of the launch plan.
I don't know whether other healthcare
A.
2
3
3
companies were involved, but the government would not
4
have been involved in setting up this program.
5
(Passing document.)
5
6
Under 5.851 under " Public Relations"
6
reiterate the prevalence and problems uncovered in the
7
consumer survey and explain how Purdue Frederick has
7 at the top it says, "The objective of the public
And it says, "This campaign would
Q.
8
relations campaign is to create broad awareness of the
8
made a commitment to improving the level of care for
9
launch of OxyContin. This awareness will be directed
9
patients suffering in pain. In addition, the campaign
10 at the consumer and healthcare professionals through
10 would expand the recent launch of Purdue Frederick's
11 various media channels, such as print, TV and radio.
11
newest partner against pain; OxyContin."
12 In an effort to create a 'media hook' that would
12
13
coincide with the launch of OxyContin, a consumer
13 just made an error in reading . "It would explain" not
14
survey conducted by a company such as the Gallop Poll
14
15
is being proposed. This survey would focus on the
15
16
prevalence and problems of chronic pain, both
16
MR. STRAUBER: Excuse me. I think you
"would expand."
MR. THOMPSON : I thought I said
"explain."
1 7 malignant and nonmalignant. The release of the
17
18
18
addition to the above public relations campaigns, we
19
are exploring the possibility of Purdue Frederick
results of such a survey would be publicized along
19 with the recent FDA approval of the new
And then the next paragraph says, "In
Q.
2 o controlled-release Oxycodone preparation OxyContin.
20
sponsoring a pain management foundation in association
21
This is a classic problem/ solution strategy to create
21
with an organization such as Gilda's Club."
22
a need for the launch of a product such as OxyContin."
Did I read that correctly?
23
Do you know if you sponsored a pain
22
23
24
A.
You did.
24
25
Q.
Do you know if a poll was conducted by
25
management foundation?
I do not, but I -- no, I don't -- I
A.
don't know if we did that. I don't think we did, but
Page 184
Page 182
1 someone such as the Gallop Poll?
2
3
4
5
A.
1
I don't know what the poll is
2
precisely.
Q.
Then -- then the next paragraph
says -- 5.852. It says, "In an effort to continue the
that's a vague recollection.
Can we agree that the main way you
Q.
3
marketed and promoted OxyContin was with your sales
4
force?
5
A.
Yes.
Q.
And those are the people that actually
6
publicity about the launch of OxyContin, approximately
6
7
two to three months after the initial public relations
7
8
campaign, another campaign would be launched focusing
8 to the communities and sell OxyContin, correct?
9
go out to the physicians' offices and pharmacies and
They don't actually sell, but they
on the expansion of Purdue Frederick's Partners
9
1 o Against Pain Program developed to improve pain
10
11
management knowledge among healthcare professionals
11
don't actually take orders and arrange deliveries and
12
and patients' caregivers."
12
collect any money.
Partners Against Pain was a creation
13
14
13
of Purdue Frederick, correct?
most valuable resource that Purdue had to sell
OxyContin, correct?
A.
That's what it says .
15
16
Q.
And there were no partners, correct?
16
A.
No, I think there were partners, the
17
17
meaning of the campaign.
Okay. And you would consider them the
Q.
14
15
18
A.
promote OxyContin. The distinction being that they
A.
It was the most valuable resource that
we used. We thought it was the most efficient
18
resource and that's why we used them. Whether other
19
Q.
Who do you think the partners were?
19
approaches or resources would have been more valuable,
20
A.
Physicians, nurses. Other healthcare
20
Ican'tsay.
21
22
23
workers are partners.
Q.
21
24 the sales force?
government wasn 't involved in Partners Against Pain,
Coulter Reporting, LLC
At some point did you figure out that
2 3 prescribing OxyContin was through regular visits from
it up, there weren't any other partners involved in
24 setting up Partners Against Pain? I mean, the
25
Q.
2 2 the key to getting physicians to prescribe and keep
Oh, okay. So -- but as far as setting
25
A.
That would be typical of any
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Richard Sackler, M.D.
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Page 185
1
pharmaceutical sales force, yes.
Q.
2
1
And was there a realization that
Page 187
And then your top sellers were
Q.
2
rewarded with trips to Bermuda or London in what was
called the Toppers Program; is that correct?
3
developed that certain physicians, so-called core
3
4
physicians, were more likely to prescribe OxyContin?
4
A.
Yes.
5
Q.
And during the first five years of
A.
5
I'm not sure. It wasn't -- I think it
was the other way around. Our most significant
6
7
prescribers were called core, not that we identified a
7
8
core and then they became important prescribers.
8
A.
That's correct.
9
Q.
And do you know how much of the sales
6
Q.
9
And how many companies were sending
1 o sales representatives to physicians' offices to talk
OxyContin's release, Purdue more than doubled the size
of its sales force, correct?
10 force during the first five years was Purdue Frederick
11 versus Purdue Pharma employees?
11 to them about opioids during this time?
12
A.
I don't know.
part. I don't recall any survey that counted that up.
13
Q.
At some point were some people
14
But it's a guess based upon my recollection of what
14 designated -- all new hires designated Purdue Pharma
15
was being actively promoted.
A.
12
13
16
Q.
Three to five. It's a guess on my
15 as opposed to Purdue Frederick?
And you compensated your sales force
1 7 very well based predominantly on how much OxyContin
18 they sold; is that correct?
16
A.
I believe that that's the case.
17
Q.
But you're not sure what date that
18 started?
The successful -- the most successful
19
A.
No.
2 o salespeople, a majority of their income was bonus .
20
Q.
Do you know if it was after the
21 The average salesman, certainly when we launched the
21 creation of Purdue Pharma that that started?
22
22
19
A.
product the overwhelming majority of their income was
It would had to have been. If Purdue
A.
23
their salary and the benefits that they received. And
23
24
for the average sales force -- salesman, I think it
24
Pharma didn't exist, we couldn't have hired somebody.
25
would have been 50 percent of their income or 70
25
immediately after that that all -- once it was created
Right. But, I mean, was it
Q.
Page 186
Page 188
1
percent of their income salary and the balance in
1
all reps were hired by Purdue Pharma as opposed to
2
bonus.
2
Purdue Frederick?
3
Q.
Sure.
3
A.
4
A.
But I don't -- I don't remember this
4
Q.
Who would know that at Purdue?
in detail. And, of course, it changed over time.
5
A.
I don't know. At Purdue now?
6
Q.
Yes.
At Purdue Pharma you mean?
5
6
Q.
The way the sales scheme was set up,
I don't know.
7
if they sold more OxyContin, they made more money,
7
A.
8
basically?
8
Q.
Yes.
9
A.
Well, the people who were there at
9
A.
Yes. Yes. The same as almost every
1 o other company in the industry.
11
Q.
10 that time might recall it, but I don't know who today
11 would know it.
And then you-all gave your reps an
12 additional incentive because you decentivized them to
12
13
13
sell MS Cantin but you increased the incentive for
14 targeted wholesalers, correct?
14 selling OxyContin; is that true?
15
16
17
18
19
A.
Yes.
Q.
And then you had one of the highest
15
A.
Wholesalers were called upon by the
16 salesmen, yes.
paid sales forces in the country; is that accurate?
A.
And then in addition to targeting or
Q.
providing initiatives to the sales force, you also
17
Q.
And, in fact, I think if you go to
18 page 27 of the initial launch plan -- let's see if I
I've heard that said for one or two
19 can find this -- the last paragraph. It says, "All
years. It certainly wasn't the case or hasn't been
2 o promotional efforts for the retail distribution of
2 o the case during the history of OxyContin.
21
OxyContin will focus on the incredible success that
22 sold OxyContin sometimes ended up making over $250,000
22
Purdue Frederick has achieved and sustained with the
23
23
MS Cantin product line. Wholesale pharmaceutical
24
buyers and retail pharmacists should be reminded of
25
how MS Cantin created such a large market for the use
21
24
25
Q.
Do you know if reps that promoted and
a year?
A.
I've heard that that was the case.
I'm sure it was unusual.
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1
of sustained-release opioids for the treatment of
It says, "A cooperative direct mail
Q.
1
2
pain. This in turn created profits for pharmacists
2
advertising sales sheet offering a rebate on the
3
helping to grow their businesses. Promotional copies
3
initial order of OxyContin to retail pharmacists will
4
should focus on the market potential for OxyContin and
4
be mailed every month during the first three months of
5
patient populations to be targeted, including the
5
launch."
What was the rebate you-all were
6
number of prescriptions written for Class II and Class
6
7
III opioids every year.
7 offering to pharmacists?
"The executive director of national
8
9
Some discount on their early orders to
A.
8
9
accounts should work with drug wholesalers in
encourage them to stock the product in advance of
1 o developing programs to utilize the wholesaler sales
1 o seeing any prescriptions or one or two prescriptions.
11
11
And like the rest of -- there was nothing innovative
12 Consideration should be given to advertisements in
12
in this program. This is -- this was standard
13
13
programming in the pharmaceutical industry and in
14
other industries.
representatives to ensure adequate distribution.
drug wholesaler ad books and computer programs."
Were the sales force told to emphasize
14
15 with pharmacists that they could make more money with
A.
Well, some of your other literature
Q.
16 talks about you-all had an unprecedented marketing
16 OxyContin prescriptions?
17
15
I don't think that they would have
1 7 campaign.
Have you ever seen another company
18
been encouraged to say that. The objective when any
18
19
product is launched, and certainly any medicine is
19 that instituted a more broad-ranging marketing
20
launched, is to be -- is to minimize the number of
20
21
times a patient -- number of patients who get
21
22
prescriptions from their doctor and go to the pharmacy
22
Unprecedented perhaps for us, but not unprecedented in
23
and the pharmacist says "I don't have that" or, even
23
the industry. This would -- this is conventional
24
worse, "I never heard of that," for obvious reasons.
24
standard textbook. This is how you do it.
So in order to reduce that, one tries
25
25
campaign than you-all did for OxyContin?
I think this was conventional.
A.
All right. You-all also were involved
Q.
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1
1 with third-party orga·nizations, Partners in Pain.
to stock all three strengths in as many pharmacies as
2
possible. But to begin with, there's no demand. So
2
3
there's a bit of tension there. In order to supply
3
you use Partners in Pain to drum up demand for
4
the pharmacists, the wholesalers have to have enough
4
OxyContin?
5
stock on hand for the ones who buy it early and a
5
6
sufficient backup stock both to supply the early
6
7
buyers and the later adopters. And that was all that
7
the proper use of our drugs, our medicines, and to
8
we needed to accomplish and there's not much more I
8
encourage patients who may have had pain, sometimes
9
can say about it except that however we did it was
9
for years, inadequately treated or not treated at all
1 o ethical and proper.
11
Q.
They were referenced in the launch campaign. And did
1 o to present themselves to their physicians.
And let me go back to my question.
11
12
Where it says "Wholesale pharmaceutical buyers and
13
retail pharmacists should be reminded of how MS Cantin
There was also -- Purdue funded a
Q.
12
variety of so-called pain societies. The American
13
Pain Society, was that funded by Purdue Pharma?
14 created such a large market for the use of
14
15 sustained-release opioids for the treatment of pain.
15 Society.
16 This in turn created profit for pharmacists."
16
A.
Q.
We donated money to the American Pain
Did you also fund the American
1 7 Association for Pain Management?
Am I reading that incorrectly somehow
17
No. I -- I think that Partners in
A.
Pain was principally designed to inform doctors about
18 that --
18
19
A.
You're reading it correctly.
19
20
Q.
What you're telling -- what this
20
A.
If -- it wouldn't surprise me. I
don't remember.
Q.
Did you also fund the Appalachian Pain
21
launch plan, sales force -- under the title "Sales
21
22
Force Allocation and Representative Delivered
22
23
Promotional Materials" is saying, hey, remind them
23
known it. But if that's what the record shows, it
24
they're making a bunch of money selling our product?
24
wouldn't surprise me.
25
A.
As opposed to not selling any product.
Coulter Reporting, LLC
25
Society?
A.
Q.
I . don't know that, and I wouldn't have
There was a figure we looked at a
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1
1 while ago that said there was -- basically the target
Page 195
attended and spoke were trainers, and some of them
2
market for physicians was about 7,500 physicians,
2 were in-house people and some were outside physicians.
3
including the cancer, malignant pain and the
3
4
non-malignant pain across the U.S. Do you remember
4
5
seeing that?
5
A.
Certainly might have.
Q.
And would these take place at resorts,
like in Florida and Arizona, these meetings?
6
A.
No.
6
Q.
And you also --
7
Q.
Do you think the market was more than
7
A.
But - - but -- but to my knowledge, I
8
8 7,500 physicians --
don't think anybody would go more than once, and they
9 were trained in what they could say, what they
9
A.
Much larger.
10
Q.
-- for pain?
1 o couldn't say, and they were given materials to use in
11
A.
Much larger. Pain is the most common
11 the presentations, for a while slides and then I guess
12
12 eventually PowerPoint presentations. So it was to
presenting symptom for physicians in total, and very
13 few physicians would have a different experience.
13 create some control to see, hopefully, that they would
14
14
Perhaps ophthalmologists or dermatologists may, but
not go off label.
And did Purdue pay for that, or did
Q.
15 every other physician it would be the most common or
15
16
16 they pay their own way?
the second most common presenting complaint.
18
Do you recall whether Purdue Pharma
Q.
17
17
set up a speakers bureau in which it allowed
19 physicians who were recommended by salespeople to be
20
put on the so-called, quote, speakers bureau?
A.
21
18
paid for it. This was, again, customary in the
19
industry.
20
They -- yes, such a program existed.
21
22
Not everybody who was recommended was put on the
22
23
speakers bureau. They were vetted by internal experts
23
24
to determine their qualifications.
Q.
25
Do you recall that there were over
At the time it was started, Purdue
A.
Who told you that was customary in the
Q.
industry?
I don't remember who told me. But I
A.
can tell you that sometimes I'd go to hotels and I'd
24
see events sponsored by Pfizer or sponsored by J & J,
25
and they were precisely -- either they were speaking
Page 196
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1 3,000 physicians on the speakers bureau?
I don't recall it, but it wouldn't
2
A.
3
surprise me.
4
Q.
5
Do you think somebody vetted all 3,000
physicians internally that were on the speakers
6 bureau?
1
engagements in which somebody spoke, and occasionally
2
they were Train the Trainer kind of ideas where the
3
company in question -- other companies in that case --
4
trained physicians, you can say this and this and
5
this, beware you shouldn't say that and that and that.
6
Do you know whether pharmaceutical
Q.
7
companies and medical device companies have come under
8 do that and to manage the speakers bureau. So I think
8
criticism for giving incentives for doctors to write
9
9
prescriptions or use their medical devices?
7
A.
We had quite a large organization to
everyone was -- should have been vetted. There was --
1 o there was no excuse for not validating their degrees
10
11 and confirming that they were licensed to practice in
11
12
12
the place that they were practicing and so forth. I
13 don't know precisely how they were vetted, but they
14 definitely should have all been vetted.
15
Q.
A.
I'm aware of that.
Q.
And the answer is, they have come
under criticism for that?
13
A.
Yes. I...
14
Q.
Was Russell Portenoy one of the
15 speakers that spoke on behalf of Purdue Pharma at
Do you think putting these 3,000
16 doctors on your speakers bureau caused them to write
16 these meetings?
1 7 more prescriptions for OxyContin or less prescriptions
17
A.
OxyContin?
18
Q.
Yes.
18 for OxyContin?
19
20
21
22
A.
I don't think it would have had an
effect.
Q.
And there were also individuals -- you
started a program called Train the Trainers where you
19
A.
I don't know.
20
Q.
In addition to the stuff we've just
21
talked about, you also hired a number of third parties
22
to assist in the marketing of OxyContin, such as
marketing firms, correct?
23
would fly physicians around the country to speak on
23
24
behalf of Purdue. Do you recall that?
24
A.
I don't know.
25
Q.
Do you know if Purdue retained Lyons
25
A.
Actually, the -- the physicians who
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Lavey to market OxyContin?
I've heard the name, but I don't know
A.
2
2
3 that it was OxyContin.
were also hired to assist in the marketing and the
6 expansion of the market -7
A.
I don't know.
8
Q.
You've got to let me finish my
in the industry.
4
discussed would be done, these marketing efforts, to
5
sell more OxyContin, correct?
had access to OxyContin, yes.
Were you aware that there was a direct
Q.
8
9
To see to it that appropriate patients
A.
6
7
9 question.
And all of the things we've just
Q.
3
Do you know if public relation firms
Q.
4
5
I don't know, but that would be common
A.
1
link between the number of sales representatives that
10
A.
I'm sorry. Excuse me.
10 were out promoting OxyContin and how much OxyContin
11
Q.
That's okay. We've got a video, but
11 would be prescribed?
12 we also have a court reporter/stenographer taking it
12
A.
Could you just ask that again?
13
13
Q.
Yeah. Was there a link -- a direct
down.
14
A.
I'm sorry. Apologies.
14
15
Q.
She can't get it if we both talk at
15 were out promoting OxyContin and how much OxyContin
16 the same time.
16 would be prescribed?
17
So my question is, do you know --
17
18
MR. THOMPSON: Can you read my
18
19 question back?
I don't think "direct link" would
A.
capture the concept. So the answer is no.
Do you believe that the number of
Q.
19
2 o sales representatives that promoted OxyContin would
(Record read.)
20
link between the number of sales representatives that
21
Q.
-- for OxyContin?
21
22
A.
I don't know.
22 OxyContin, the more prescriptions would be written?
23
Q.
Have you heard of a company called
23
24
FleishmanHilliard?
A.
25
That's a vaguely familiar name, but I
increase; the more sales representatives that promoted
I don't think anybody thought of it
A.
24
that way. We had a product that had tremendous
25
potential and our principal means of getting it used
Page 198
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1 don't know whether they were ever hired by Purdue
2
3
4
1
Frederick or Purdue Pharma .
Q.
Do you recall at some point being
notified of a problem with abuse occurring with
was to convince physicians -- convince physicians that
2
he had in his practice appropriate patients to use it,
3
but the linkage there is very loose.
Was there also a correlation between
Q.
4
5 OxyContin and Purdue Pharma hiring a crisis management
5 the number of times a sales representative called on a
6
physician to how much OxyContin that physician would
7
A.
Yes.
7
prescribe?
8
Q.
Do you recall when that crisis
8
6 firm?
9
10
11
12
management firm was hired?
A.
I don't recall precisely, no.
Q.
Have you ever read the interview
9
Again, that would be a loose
A.
correlation, and there would be -- clearly if he
1 o called not at all, there would be nothing to
11 correlate. And I am sure there was a practical limit
Michael Friedman gave to the crisis management firm?
12
as to how many calls he could make. I don't know
whether there was any kind of specific relationship
13
A.
No.
13
14
Q.
And in addition to all that, you also
14
between calling every quarter or every month or more
15
frequently or less frequently.
15
put out videos. Are you familiar with the "I Got My
16 Life Back" video?
17
A.
I've heard the title; I'm not familiar
18 with it.
Okay. Why don't we mark the OxyContin
Q.
16
1 7 Launch Plan as 27.
18
MR. STRAUSER: It's 26.
19
(DEPOSITION EXHIBIT NO. 26 MARKED)
2 o out whether the participants in the "I Got My Life
20
MR. THOMPSON: And this is going to be
21
21
19
Q.
Did you ever do any follow-up to find
Back" video actually got their life back or wound up
22 having problems with dependency on OxyContin?
27.
22
(DEPOSITION EXHIBIT NO. 27 MARKED)
MR. STRAUSER: Mr. Thompson, I note on
23
A.
No, I did not.
23
24
Q.
Did Purdue also give away coupons so
24
Exhibit 27 there's some material that's been -- a good
25
deal of material that's been bracketed, and I've seen
25
people could get a week's free supply of OxyContin?
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1
Page 203
1
that on other documents that you've marked . My
meaningless. Was the number of increased
2
assumption throughout is that the brackets were not on
2 prescriptions commercially significant? If so, what
3
the original and this is something that you guys
3
would the cost per increased prescription be assuming
4
added.
4
that the absolute difference persisted? When will a
6
brackets were produced that way.
brackets?
MR. ELLIS: These documents that have
9
And was that your --
6
MR. STRAUBER: It came to you with the
7
8
5 more complete report be available?"
MR. ELLIS: That is incorrect. The
5
7
A.
8
Q.
You read it correctly.
-- e-mail?
Did you ever get a more complete
9
10 writing on them were produced that way. If the e-mail
10 report?
11 ends and it's only half an e-mail, that's also the way
11
A.
I don't remember.
12
12
Q.
And then above that it looks like
that they were produced to us.
13 Alfonse (sic) writes back to you. And Alfonse was --
MR. STRAUBER: And what if the
13
Alfonso.
14 document was highlighted in yellow, was it produced to
14
A.
15 you --
15
Q.
Alfonso was head of marketing?
16
A.
He was head of marketing.
17
Q.
And he says, "Interesting comments
MR. ELLIS : If it was highlighted in
16
17
the context that I just gave it to him, I would have
18 from Dr. Richard. I also wonder if there was a bias
18 added that highlighting just now; but in terms of
19 attachments that aren't connected to the e-mails,
19 in the form of representatives increasing calls to the
2 o that's because we didn't get them from Purdue.
20 selected physicians. Would we get the same ROI" -- is
MR. STRAUBER: I'm asking about the --
21
MR. ELLIS: I'm trying to explain to
22
23
you -MR. THOMPSON: Tony, it's okay.
24
25
21
Brackets were not added.
that return on investment?
22
A.
Yes.
23
Q.
-- "in prescriptions" -- "Would we get
24
the same return on investment in prescriptions as a
25
result of the representatives increasing the call rate
Page 202
2
Page 204
1 to the selected group regardless of dinners? I don 't
MR. STRAUBER: Okay. Thank you.
1
2 have the list, therefore, I don't know if there was a
3
selected preference toward this group in the part of
4
e-mail from you, "Phase IV OxyContin Team Minutes"
4
the reps. It's reasonable that these core doctors
5
dated 10-23-96, and you have a copy of it.
5
were already receiving special attention, which would
6
have generated an increase in prescriptions. If this
3
Q.
Sackler Exhibit 27. And this is an
And -- so this would have been after
6
7
is the case, the cost of the dinners would
8
A.
Yes.
8
unnecessarily increase the cost per prescription."
9
Q.
Okay. And it says here, "Michael:
9
A.
Right.
10
Q.
Did you-all ever determine whether the
7
the launch of OxyContin, correct?
10 The oxymin12 said:"
11 dinners that you were taking the doctors on were
What was the oxymin12?
11
12
A.
I don't know.
12
13
Q.
Reading from it, it says, "Results
13
helping to sell OxyContin?
A.
I don't remember.
MR. THOMPSON: Let's mark this 28 .
14 showed the following: Physicians who attended the
14
15 dinner programs or the weekend meetings wrote more
15
(DEPOSITION EXHIBIT NO. 28 MARKED)
16 than double the number of new prescriptions for
16
(Passing document.)
17
OxyContin compared to the control group, and this was
18 sustained over the three-month post-meeting evaluation
17
And this says, "6-9-99, Dr. Richard
Q.
18 Sackler. Subject: Promotion of OxyContin by Abbott."
And if you would go down to the
19 period. Weekend meetings had the greatest impact,
19
2 o increasing new prescriptions for OxyContin by a factor
2 o bottom, it says, "Enclosed for your information is a
21
between 2.16 and 2.62. These results will be
21
memorandum from Mark Alfonso that describes a
22
presented in more detail at a later date.
22
substantial increase in Abbott's field force
allocation toward OxyContin. 120 Abbott reps
23
"This is very encouraging, although I
23
24
must allow that a proportion of the percentage without
24
previously selling urokinase, which has been
25
the associated absolute numbers is inherently
25
temporarily withdrawn from the market, will be
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Richard Sackler, M.D.
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1
assigned full time to OxyContin. This will be totally
2
at Abbott's expense and should have a very positive
2
A.
You read the words .
3
effect on OxyContin sales."
3
Q.
"Words such as powerful may make some
That is from Michael Friedman,
4
5
correct?
4
people think the drug is dangerous and should be
5
reserved for the more severe pain."
6
A.
Right.
6
7
Q.
What was the agreement reached with
7
8
9
10
11
Abbott to sell OxyContin?
I don't recall the details of the
A.
agreement.
Q.
Now, did I read that correctly?
1
And then up at the top it says,
MR. STRAUBER: If I could interject
for one second . While you are reading it correctly,
8
what you haven't included is the fact that the word
9
"powerful" is in quotes.
10
MR. THOMPSON: Yes .
11
MR. STRAUBER: Okay.
12
"Sender: Dr. Richard Sackler." So this would be, I
12
13
think, your reply to that. And it says, "This sounds
13
include those.
14 very good for the brand. I just hope that we can
14
Q.
15 supply the surge that may follow this program."
15 show that we are 'effective' as morphine, but do not
And were you referring to a surge of
16
MR. THOMPSON: We'll read it again and
"We can" -- second paragraph. "We can
16 want to say OxyContin is as 'powerful' as morphine.
17 OxyContin sales?
17
Words such as 'powerful' may make some people think
18
A.
Yes.
18 the drug is dangerous and should be reserved for the
19
Q.
And was it your expectation that the
19 more severe pain. This could have a negative effect
2 o sales representatives were going to create a surge in
2 o in the much larger non-cancer pain market. Mike
21
21
22
OxyContin sales?
A.
23
24
25
Q.
reminded the team that we should keep this positioning
I didn't know. I said let's hope.
22
in mind as we develop future marketing programs,
(DEPOSITION EXHIBIT NO. 29 MARKED)
23
symposia, clinical study manuscripts and any other
(Passing document.)
24
items that discuss the use of OxyContin."
And then this is a document that I
Did I read that correctly?
25
Page 206
Page 208
1
wanted to bring to your attention, because we were
1
A.
Are you asking me?
2
talking earlier today where you said -- you know, when
2
Q.
Yes.
3
I was pointing out to you the documents from your
3
A.
I believe you did.
4
officers that said OxyContin is believed by other
4
Q.
All right. Were you aware that your
5
physicians to be not as strong as morphine.
5
marketing and sales team were being careful not to and
Remember us having that discussion?
6
did not want to say that OxyContin is as powerful as
morphine?
6
7
A.
I recall.
7
8
Q.
And this is a Phase II OxyContin
8
A.
I don't recall if I was aware of this.
9
Q.
And, in effect, it's twice as powerful
9
Tablets Team Meeting, June 13th, 1997.
1 o as morphine, correct?
So this would be well over a year
10
11 after -- a year and a half after OxyContin has been
11
12
12
13
14
15
launched and in the marketplace, correct?
Yes. About a year and a half. Maybe
A.
a little less.
Q.
And if you could go to the -- it says
No, it's not. We've gone through this
A.
quite a few times. And here "powerful" is in quotes.
13
Sometimes the words "stronger," "weaker," "powerful"
14
are not in quotes. But here it is very clear that it
15
was specifically the word "powerful" that he did
16
"Marketing and Sales Update." The first paragraph.
16
not -- he was advising people to stay away from. It
17
"Mike Cullen discussed in detail marketing's
17
had nothing to do with potency.
18 positioning of OxyContin. He explained we want to
18
Q.
When you go in and see a doctor and
19 expand extensively in the non-cancer market segment
19 you say -- if they say OxyContin is not as powerful as
2 o while promoting OxyContin as the one to start with in
2 o morphine, what do you think the doctor thinks?
21
cancer pain and the one to stay with through proper
21
22
titration."
22
23
And the next paragraph reads, "We can
A.
He was not supposed to say that, and I
don't think he did say that. That would create
23
confusion. He was warning not to use the word
24
show that we are as effective as morphine, but do not
24
"powerful" in any context. But he clearly didn't mean
25
want to say OxyContin is as powerful as morphine."
25
potency, because potency was declared as twice as
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1
potent as morphine from day one of marketing to
1
2
Page 211
having that conversation?
2
yesterday and today in every piece of material, in all
3
the conversion charts and was recognized and
3
seen a lot of documents. But I do recall having --
4
understood by physicians.
4
talking about this many times, yes.
THE WITNESS: Do you want to take a
5
6
8
MR. STRAUBER: It's almost 3:30.
7
Would this be a time to take a break?
MR. STRAUBER: I object to the form of
9
1 O that question.
10 time.
VIDEOGRAPHER: We are off the record
11
12
it's not as effective. I'm sorry. Let me rephrase
8 that.
MR. THOMPSON: This would be a great
9
Yes. And your comment was, Well,
Q.
5
6 we're not saying that it's not as strong, we're saying
break now?
7
I'm not sure which documents. I've
A.
12
13
(RECESS)
13
14
VIDEOGRAPHER: We are back on the
14
Your comment was, We're not trying to
Q.
11
at 3:27 p.m .
convey that it's not as powerful; is that correct?
No. What I thought I communicated --
A.
perhaps I didn't do it well -- was that the meaning of
15
record at 3:42 p.m.
15 that word "strong" was not that it was a weak drug,
16
16 weaker than morphine. It was not that meaning. The
Q.
17
Okay. A while ago when we were
17
18 talking about salespeople making calls, did I
meaning related to the stigma of morphine and to the
18 fear of morphine. And precisely in this case I
19
understand you to say that you did not believe the
19
believe that the efficacy of the drug -- and I really
20
number of calls made by a salesperson affected the
20
would like to see the document, if I might, if we're
21
number of prescriptions for OxyContin?
22
A.
I didn't mean to communicate that.
23
Q.
Thank you. In fact, Purdue had
21
going to talk about it, because I'd like to refresh my
22
memory not only as to the document but as to what I
23
had meant to say if I didn't say it clearly.
24
requirements on their salespeople that they had to
24
25
make a certain number of calls every day to
2 5 when we broke.
Here's the one we were talking about
Q.
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Page 212
1 physicians, correct?
A.
2
3
There was a standard number of calls,
3
Q.
MR. STRAUBER: What exhibit is that,
2
yes.
4
(Passing document.)
1
And before we broke, we were
sir? Is that 29?
THE WITNESS: 29.
4
5 discussing this Phase II OxyContin Tablets team
5
MR. THOMPSON: It's on the bottom.
6 meeting. And to kind of put this in perspective,
6
THE WITNESS: 29.
7 there was this e-mail dated 6-2-97 -- so that's June
7
MR. STRAUBER: 29. Okay.
8 2nd, '97 -- that we were discussing earlier where we
8
9
9
discussed that physicians did not think OxyContin was
And they've actually used two words
Q.
here that are in quotes, correct? One is "effective"
1 o as strong as MS Contin and that perception was out
10 and one is "power." And the sentence reads, "We can
11 there, and it noted that it was important to be
11 show that we are as effective as morphine, but we do
12
careful not to change the perception by physicians
12
13
toward Oxycodone when developing promotional pieces.
13
14
MR. STRAUBER: Mr. Thompson, if you're
14
A.
That's correct.
15
Q.
Have you reviewed the "OxyContin Abuse
15
referring to another document, could you identify it
16
and give it to the witness?
MR. THOMPSON: We've already talked
17
18
about it earlier. I'm just asking a question right
19
now.
MR. STRAUBER: Well, but you're asking
20
16
not want to say OxyContin is as powerful as morphine."
Did I read that correctly?
and Diversion and Efforts to Address the Problem" that
1 7 was put out in December of 2003 by the GAO?
18
A.
No, I did not review that.
19
Q.
I'll give you a copy of that.
20
(Passing document.)
You've never seen that document; is
21
your question based on the earlier document and
21
22
reading from the earlier document.
22 that correct?
23
24
25
MR. THOMPSON: I won't read from it
23
A.
Do you want to mark it as an exhibit?
24
Q.
I will, yes. But have you ever seen
Let me ask you. Do you recall us
2 S that document?
then.
Q.
Coulter Reporting, LLC
www.coulterreporting.com
502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 213
Page 215
I don't recollect seeing that
1
2
in 1997 through 2002. According to IMS Health data,
If you would, turn to page 9. And I'm
3
the annual number of OxyContin prescriptions for
looking at the second paragraph, last two sentences.
4
non-cancer pain increased nearly tenfold, from about
5
"In both 2001 and 2002, OxyContin's sales exceeded 1
5
670,000 in 1997 to 6.2 million in 2002."
6
billion and prescriptions were over 7 million. The
6
7
drug became Purdue's main product, accounting for 90
7
8
percent of the company's total prescription sales by
8
9
2001."
A.
1
2
document.
Q.
3
4
A.
11
10
To the best of my recollection, it's
12 correct -- very close to correct.
Q.
13
Is that information accurate?
And if you'll turn to page 17. Under
14 the heading "Purdue Focused on Promoting OxyContin for
I don't know. I just don't have these
A.
numbers in my mind.
Q.
9
Is that information correct?
10
prescriptions for non-cancer pain than for cancer pain
If you'd go to page 20, the second
paragraph. "By more than doubling its total sales
11
representatives, Purdue significantly increased the
12
number of physicians to whom it was promoting
13
OxyContin. Each Purdue sales representative had
14 specific sales territory and is responsible for
15 Treatment of Non-Cancer Pain," and if you go down to
15 developing a list of about 105 to 140 physicians to
16 the last sentence in the second paragraph, it says,
16
call on who already prescribe opioids or who are
candidates for prescribing opioids.
17
"One of Purdue's goals was to identify primary care
17
18
physicians who would expand the company's OxyContin
18
19
prescribing base. Sales representatives were also
19
2 o directed to call on oncology nurses, consultant
21
2 o 33,400 to 44,500, By 2000, the nearly 700
pharmacists, hospices, hospitals and nursing homes."
Is that information accurate?
22
"In 1996, the 300-plus Purdue sales
representatives had a total physician call list of
As a general proposition, yes. It
21
representatives had a total call list of approximately
22
70,500 to 94,000 physicians. Each Purdue sales
23
representative is expected to make 35 physician calls
24
doesn't include oncologists. I don't think -- in the
24
per week and typically calls on each physician every
25
spirit I think it's accurate.
25
three to four weeks. Each hospital sales
A.
23
Page 214
Q.
1
Page 216
And then down, the second sentence
1
representative is expected to make about 50 calls per
2
from the bottom, "Purdue has stated that by 2003
2
week and typically calls on each facility every four
3
primary care physicians had grown to constitute nearly
3
weeks,"
4
half of all OxyContin prescribers, based on data from
4
5
IMS Health, an information service providing
5
information about how Purdue was marketing OxyContin
6
pharmaceutical market research."
6
through its sales force?
Is that information accurate?
7
A.
8
9
10
7
I can't vouch for the accuracy of
8
Was that, to your knowledge, accurate
Without quibbling, it isn't really --
A.
you're asking me to vouch for the accuracy of this. I
9 just don't carry these numbers in my mind, so I can't
this .
Q.
1 o agree or dis- -- I just don't know. But this is a
The next sentence says, "DEA's
count of physicians and a description of the standards
analysis of physicians prescribing OxyContin found
11
12 that the scope of medical specialties was wider for
12
of calls, but I don't -- but that's -- that really
13
13
doesn't describe how we were marketing it, to use your
11
OxyContin than five other controlled-release,
14 schedule II narcotic analgesics. DEA" -- and is that
14
question. So I'm not trying to quibble with you, sir,
15 the Drug Enforcement Agency?
15
but I just don't know.
16
A.
I believe it would be.
16
17
Q.
"DEA expressed concern that this
17
Q,
All right. And if you'll go down to
the middle of that next paragraph. "The total amount
18
related in OxyContins being promoted to physicians who
18
of -- the amount of total bonuses that Purdue
19
were not adequately trained in pain management."
19
estimated were tied to OxyContin sales increased
2O
21
Do you recall the DEA expressing that
concern?
20
significantly from about 1 million in 1996, when
21
OxyContin was first marketed, to about 40 million in
2001."
22
A.
No.
22
23
Q.
The next two sentences. "Purdue's
23
24
promotion of OxyContin for the treatment of non-cancer
24
reason to disagree with the 40 million number for
25
pain contributed to a greater increase in
25
bonuses paid out to your marketing salesmen in 2001?
Coulter Reporting, LLC
Do you recall -- do you have any
www.coulterreporting.com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
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Richard Sackler, M.D.
8/28/2015
Page 217
A.
1
2
I don't have -- I don't know the
1
number, so I don't have any reason to disagree.
Q.
3
And then if you go to the next page,
Page 219
"What Happened to the Poster Children of OxyContin"?
2
A.
No, that doesn't sound familiar.
3
Q.
Nobody has ever provided that to you
4
the last paragraph, it says, "According to DEA's
4
5
analysis of IMS Health data, Purdue spent
5
A.
When was it published?
6
approximately 6 to 12 times more on promotional
6
Q.
September 8th, 2012.
7
efforts during OxyContin's first six years on the
7
A.
No. That wouldn't necessarily have
at Purdue Pharma?
8
market than it had spent for its older product,
8
been provided to the board. But I don't -- I
9
MS Cantin, during its first_six years or than had been
9
really -- I'm not familiar with it.
10 spent by Janssen Pharmaceutical for one of OxyContin's
10
11
11
OxyContin was considered so successful that other
12
companies were thinking about whether they could make
drug competitors, Duragesic."
Do you see that?
12
A.
13
Do you recall a time when Purdue's
Q.
13 their own version of OxyContin?
Yes. Yes, I did .
14
Q.
Is that accurate?
14
15
A.
I don't know. I have no reason to
15 so I can answer it.
16
agree with it or disagree with it at this point.
Q.
17
18 overly aggressive?
No.
20
Q.
Do you believe Purdue's marketing was
21
appropriate?
19
Sure. Do you recall a period of time
Q.
16
1 7 where OxyContin was considered so successful that
Do you believe Purdue's marketing was
A.
Just -- just -- ask the question again
A.
18 other companies were considering making their own
19 version of OxyContin?
I can 't say that they did it because
A.
20
21
it was, quote, so successful, but I do recall that I
22
A.
I believe so .
22
did hear that other companies were trying to copy
23
Q.
It says here under -- on page 30,
23
OxyContin, yes.
24
"OxyContin's Wide Availability May Have Increased
24
25
Opportunities for Illicit Use."
25
(Passing document.)
So this is an e-mail chain that was
Q.
Page 218
A.
1
2
Page 220
I'm sorry. What page are you reading
1
from?
provided . Let's go ahead and mark that as 31.
(DEPOSmON EXHIBIT NO. 31 MARKED)
2
3
Q.
Page 30.
3
4
A.
Page 30?
4
"Subject: Press release or similar promotion .
Author: Dr. Richard Sackler, 8-23-96 ."
And if you go to page 2 it says,
Q.
5
Q.
Yes.
5
6
A.
3-0. Okay. Where should I look?
6
7
Q.
Last paragraph.
7
8-23 -- oh, the bottom of the page. Okay, I'm with
8
A.
Okay. Thank you.
8
you .
9
Q.
"The large amount of OxyContin
9
1 o available in the marketplace may have increased
Just let me catch up with you.
A.
And it says, "I think it is noteworthy
Q.
1 o to release information on OxyContin Tablets, its use
11 opportunities for abuse and diversion. Both DEA and
11
and success in the market and the tremendous reception
12
12
it received in Vancouver." Basically, "The newsworthy
Purdue have stated that an increase in a drug's
13 availability in the marketplace may be a factor that
13 occasion is that this product has achieved our first
14 attracts interest by those who abuse and divert
14 year's sales projection four months early and that by
15
15 the end of the year we should have 130,000 to 150,000
drugs."
"OxyContin" -- if you go on down.
16
17
18 pain reliever seller in 2001 ... "
Is that accurate?
19
20
21
A.
MR. THOMPSON: So let's mark that as
Exhibit 30.
(DEPOSITION EXHIBIT NO. 30 MARKED)
24
25
I don't know, but -- I just don't
know.
22
23
16
"OxyContin became the top-telling name-brand narcotic
Q.
Have you ever seen an article called
Coulter Reporting, LLC
17
per salesman of sales.
"The objectives of this release would
18 be: Stimulate interest in the U.S. community -- in
19 the medical community of the U.S. to recognize the
20 tremendous success of OxyContin Tablets clinically and
21
the ratification commercially. We want many more
22
physicians than have presently used it to become aware
23
of its availability and importance in their practice.
24 It would be hoped that this would lead to greater use
25
by those currently prescribing and broaden our
www.coulterreporting .com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page: 56
Richard Sackler, M.D.
Page 221
1
Page 223
prescribing base in the U.S. and Canada."
1
Do you know whether that press release
2
3
took place?
4
A.
I don't know.
5
Q.
And then above that it looks like
A.
Yes.
8
Q.
"Given the diverse in both short- and
9
2
Kentucky. And he points out that none of the federal
3
courts in Kentucky has found any misconduct on the
4
part of Purdue. Correct?
6
mid-term goals, I would recommend a full-fledged PR
I'm not sure just where you 're reading
A.
5
6 there's a response to your e-mail from Robert Reder.
7
17th, 2005 to Greg Stumbo, the Attorney General of
from.
7
Q.
Oh, I'm sorry. I'm on page 5.
8
A.
Oh, page 5. I'm sorry . I was on the
9
wrong page . And where are you reading from?
1 o firm with a one- to three-year contract. That way
10
Q.
The third paragraph down.
11 this can be coordinated actively to achieve all goals
11
A.
It begins, "I believe that even this
12
rather than a one-shot flash. Is this a departure
12
13
from traditional PF/PPLP?"
14
15
14
Pharma, LP. strategy; is that correct?
16
Correct.
17
Q.
And you wrote back and said, "I don't
15
courts has found any misconduct on the part of
16
Purdue."
Please bear with me while I try to
A.
18 find this.
And then it looks like -- and perhaps
19
paragraph. "Significantly, however, not one of these
17
18 see this as a 'departure' from policy."
No. I'm reading in the middle of the
Q.
13
And that's Purdue Frederick/Purdue
A.
brief... "?
20
21
you want to use PR to signal our market as to our
21
22
development pipeline, I have no problem. I do not
22
Do you see that? Right above the case
Q.
19
2 o this is Friedman who says, "My view is different. If
cites.
I'm sorry. In the paragraph that has
A.
a list of cases?
23
want to spend money on PR to increase sales. We do
23
Q.
Yes. The paragraph right above it.
24
not need to have an agency in our pockets. I have
24
A.
"Significantly, however... " Thank
25
learned my lessons."
25
Q.
Yeah. Purdue answered -- filed an
you.
Page 222
Page 224
And then you write back on page 1 and
1
1
2
say, "I agree about the agency. I want to signal the
2
answer in all of these cases and claimed they had
3
licensing in market for the product around the world,
3
never done anything improper or wrong; isn't that
true?
4
get an audience for our patent infringement suits so
4
5
that we are feared as a tiger with claws, teeth and
5
A.
6
balls and build some excitement with prescribers that
6
Q.
Are you aware prior to the --
7
OxyContin Tablets is the way to go."
7
A.
That is, I don't know whether we filed
And what was your concern there about
8
9
10
licensing and patent infringement?
A.
Well, licensing in market meant the --
11
get the attention of companies that had products that
12
might be attractive for us to license.
13
Q.
8
in all these cases or whatever. That's what I mean
9
when I say "I don't know."
10
Do you recall Howard Udell making a
12
where the company pied guilty to a felony of
13
misbranding a drug with the intent to defraud or
mislead?
trip down to Kentucky to meet with Attorney General
14
15
Greg Stumbo and other members of the -- of his staff?
15
16
A.
I don't recall it, no.
16
17
Q.
This is a letter dated May 17th, 2005.
17
And that would be prior to the felony plea agreement
19 that Purdue Frederick entered into, correct?
20
A.
I'm not -- I think I'm clear on the
21
dates and that that would be correct. Please
22
correct -- somebody here correct me if I'm wrong.
(Pass ing document.)
23
24
25
Are you aware of Purdue ever admitting
Q.
11 to doing anything improper prior to the plea agreement
14
18
I don't know.
Okay. Just ask the question. Before
A.
the plea am I what? Aware?
Q.
Are you aware of anyone at Purdue ever
18 admitting they did anything improper prior to entering
19
into the plea agreement where the company pied guilty
2 o to misbranding a drug with the intent to defraud or
21
mislead?
22
A.
I am not aware of anybody.
23
Q.
And then if you go to page 6, the
If you'll turn to page 6. This
24
middle of the second paragraph from the bottom, it
appears to be a letter from Howard Udell dated May
25
says, "First, any suit brought under the Act requires
Q.
Coulter Reporting, LLC
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502-582-1627
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Richard Sackler, M.D.
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Page 227
Page 225
1
1
proof that a defendant engaged in a practice of
agreement?
2
violation of KRS 367.170, an unsurmountable obstacle
2
A.
Yes.
3
since Purdue has committed no unlawful act."
3
Q.
Do you recall whether Purdue had
Did I read that correctly?
4
4
received warning letters about its marketing of
MS Cantin?
5
A.
You did .
5
6
Q.
And were you aware that Howard Udell
6
A.
I don't recall.
7 had communicated with Greg Stumbo that Purdue had
7
Q.
You don't recall six warning letters
8
8 coming in from MS Cantin?
committed no unlawful act on May 17th, 2005?
A.
9
I think he was writing for Purdue
1 o Pharma, just for clarity, but I was not aware of this.
Q.
11
12
No, I don't - - I don't recall the
A.
9
1 o instances.
And May 17th of 2005, did Purdue
12
Frederick exist?
Do you recall Purdue getting warning
Q.
11
letters with respect to the way it was marketing
13
A.
I don't know.
13 MS -- marketing OxyContin?
14
Q.
Do you know if the companies were
14
A.
I don't recall.
15
Q.
Do you know if Purdue consistently
15 merged at some point?
16
A.
I don't believe they were.
17
Q.
Let's talk about the Agreed Statement
16 denied it was doing anything wrong with respect to
17
18 of Facts.
marketing OxyContin?
I'm not sure. I would think that we
A.
18
19
denied doing anything wrong, but that's a guess on my
2 o the letter and the Agreed Statement of Facts.
20
part. I don't really know.
21
MR. THOMPSON: Yeah, that's a good
21
MR. ELLIS: The letter is going to be
MR. ELLIS: Might as well mark both
19
22
idea, T.
23
24
The guilty --
22
A.
I don't recollect.
23
Q.
Were you involved in approving the
24
Exhibit -MR. THOMPSON: 32 .
25
Q.
25
Agreed Statement of Facts for the guilty plea?
The board voted in favor of
A.
Page 228
Page 226
2
1
MR. ELLIS: -- 32, and the Agreed
1
2
plead guilty under a plea agreement with the
3
U.S. Attorney.
Q.
Statement of Facts is going to be Exhibit 33.
(DEPOSITION EXHIBIT NOS. 32 AND 33
3
management's recommendation that we have -- that we
And just so there's no confusion, the
4
MARKED)
4
5
MR. STRAUBER: By "the letter," you 're
5 board voted to adopt the Agreed Statement of Facts; is
6
8
9
6 that correct?
talking about the Udell letter?
7
Q.
MR. ELLIS: Yeah, May 2005.
7
A.
I don't know. I don't remember.
Who was in charge of preparing and
8
Q.
Is the Agreed Statement of Facts
9
approving the sales and marketing materials at the
1 o time of OxyContin's release?
I'm sorry. At the time of
11
A.
12
OxyContin's --
13
Q.
Release?
accurate?
10
A.
I believe it is.
11
Q.
And in addition to the guilty plea of
12
a felony for misbranding a drug with the intent to
13 defraud or mislead -- and that drug is OxyContin,
14
A.
Release, meaning launch?
14 correct?
15
Q.
Launch.
15
A.
I believe it is.
16
A.
Michael Friedman, I believe.
16
Q.
-- these three individuals, Howard
17
Q.
And at that time -- at the time of the
1 7 Udell, Michael Friedman and Paul Goldenheim, also pied
18 launch, who was in charge of the marketing department?
19
A.
20
Alfonso.
21
Q.
To the best of my recollection, Mark
18 guilty to misdemeanors, correct?
19
A.
Yes.
20
Q.
And Howard Udell was Purdue's
21
And Michael Friedman, was he the
22 person who ultimately was appointed CEO of Purdue?
executive vice president and chief legal officer?
22
A.
He was.
23
A.
He was. Purdue Pharma .
23
Q.
Michael Friedman was the president and
24
Q.
Is he one of the individuals who pied
24
25
guilty to the misdemeanor at the time of the plea
Coulter Reporting, LLC
25
CEO of Purdue at the time of the guilty plea?
A.
I believe he was.
www.coulterreporting .com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page:58
Richard Sackler, M.D.
Page 229
Page 231
1
And Paul Goldenheim was the former
Q.
1
investigating OxyContin abuse and diversion and that
2 executive vice president for worldwide research and
2
the law department in general and Howard Udell in
3
3
particular were providing any documents he wished
development and chief scientific officer, correct?
4
A.
I believe so .
4
voluntarily to help his investigation. That the
5
Q.
By 2006 Dr. Goldenheim had already
5
investigation turned on Purdue was a surprise, but I
6
6 don't remember when that happened.
left Purdue, correct?
7
A.
Yes.
7
Q.
Was it before you left as CEO?
8
Q.
Did he leave voluntarily?
8
A.
I don't recall.
9
A.
He did.
9
Q.
Do you recall there being issues about
10
Q.
What reason did he provide you
10 addiction, dependency, tolerance buildup, abuse and
11 regarding why he was leaving Purdue?
He was leaving Purdue in order to be
A.
12
11 diversion prior to your leaving as CEO?
13 diversion, yes.
Have you seen this Agreed Statement of
Q.
14
14
15 Facts before?
16
A.
Before today? Yes.
16
Q.
Did you provide comments on this
17
18 document?
19
20
21
Q.
Were you surprised by any of the
18
20
21
I don't -- I didn't read the whole
A.
Yes. Same time as I was informed
A.
about possible abuse and diversion.
Q.
And when were you first informed about
19 possible abuse and diversion?
allegations in the document?
22
23
No, I did not.
Do you recall there being issues with
Q.
15 addiction?
17
A.
Yes. Not all of those, but abuse and
A.
12
13 CEO of another company.
document, so I can't say if there are allegations that
Sometime in 2000 an article was
A.
published in a newspaper in Maine that very
22
graphically described the impact of abuse and
23
diversion of individuals who were using OxyContin .
24
would surprise me. I had understood that this was a
24
That was the first -- the first time I became aware of
25
settlement document and that people in the company who
25
that possibility.
Page 230
1
investigated thoroughly said to the board that the
2
statements in the document were true.
3
4
And when you say "I didn't read the
Q.
document," as we sit here today, have you ever read
5 the entire document?
6
Page 232
1
A.
No.
Q.
Do you recall receiving a letter or
Q.
2
being notified about a letter from a hospital in
3
Pikeville or Hazard concerning problems with patients
4
who were on OxyContin?
5
I don't recall a letter. Was it
A.
6 directed to me?
At the time this was signed, May 7th
7
8
and 8th of 2007, what was your position in the
8
to Purdue, and I'm wondering if you saw it.
9
company?
9
All right. Let's go back to the plea
7
10
11
12
13
A.
I was a director of the company.
Q.
Did you have any other role at that
A.
1 o agreement and we'll try to get through this.
Not to my recollection. For a period
Are you aware that we've requested
11
12
time?
I don't believe so. I think it came
Q.
Purdue to identify the names of documents referenced
13 in the Agreed Statement of Facts?
14 of time after I ceased to be CEO in early 2003, I was
14
A.
I'm not aware of that.
15 co-nonexecutive chairman of the board . But that came
15
Q.
Are you aware we've asked them to
16 to an end more or less around this time, but I don't
16
identify the individuals who are referenced in the
17
Agreed Statement of Facts?
17
18
remember whether it was before the plea or after.
Q.
You ceased to be CEO in 2003; is that
19 correct?
20
21
A.
That's correct.
Q.
When were you first notified that the
22
U.S. attorneys for the Western District of Virginia
23
were investigating Purdue?
24
25
A.
I can't recall precisely. We were, as
a board, notified that the U.S. attorney was
Coulter Reporting, LLC
18
A.
No.
19
Q.
Paragraph -- if we can go to paragraph
2 o 13 of the Agreed Statement of Facts. Paragraph 13
21
says that on December 28th, 2004 "Purdue submitted an
22
OxyContin NDA to the FDA. The NDA included clinical
23
trials showing that OxyContin, when dosed every 12
24
hour, was as safe and as effective as
25
Immediate-Release Oxycodone dosed every 12 hours."
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Every six hours.
A.
They might.
Q.
Paragraph 16 says, "The Medical
1
A.
2
Q.
I'm sorry, every six hours, yes.
2
3
A.
Yes, that's what it says.
3
Officer Review of the ISS included these statements:
Q.
And then paragraph 14 says, "The NDA
1
4
The blood level data in clinical use suggests the
5
did not claim that OxyContin was safer or more
5
opioid effects of OxyContin and Immediate-Release
6
effective than Immediate-Release Oxycodone or other
6 Oxycodone would be similar."
7
pain medications, and Purdue did not have and did not
7
4
8
provide the FDA with any clinical studies
8
9
demonstrating that OxyContin was less addictive, less
9
To your knowledge, is that clinically
correct?
Well, it's an inference, and I
A.
10 subject to abuse and diversion or less likely to cause
1 o certainly can't differ with the inference. But it may
11 tolerance and withdrawal than other pain medications."
11
Is that paragraph correct?
12
A.
13
14
15
And then there are some medical
A.
18
Q.
possible in patients who have their dosage abruptly
14
reduced or discontinued."
16
Yes. I believe those are within the
FDA.
19
13
Is that your understanding of the
15
16 officer reviews, correct?
17
Under "d" it said, "Withdrawal is
Q.
12
That's what it says. I don't know if
it's correct, but I wouldn't differ with it.
Q.
not be correct.
Right. And those also did not state
characteristic of the drug?
17
A.
Absolutely.
18
Q.
Then it said, "Care should be taken to
19 limit competitive promotion. OxyContin has been shown
20 that OxyContin was more effective than or superior to,
2 o to be as good as current therapy, but has not been
21
21
shown to have a significant advantage beyond reduction
22
in frequency of dosing."
safer, had less opioid effects or caused fewer adverse
22 events than any other marketed product, correct?
23
A.
24
Q.
I believe that's true.
And let me back up a minute.
24
Do you know what-- when salespeople
25
Is that your understanding of the
23
25
characteristic of the drug?
No. It is my understanding that that
A.
Page 234
Page 236
1 go call on physicians what type of information the
2
physician usually asks the salesperson?
A.
3
4
5
6
1
I would not be able to comment on
that.
Q.
You don't know whether they want to
know if there's any studies, if there's any
statement is correct. But the reason I said that that
2
may not be the case was the very surprisingly large
3
number of reports from the field that I heard second
4
and third hand, that early in the life of the product
5
doctors spontaneously volunteered that the drug was
6
better than we said it was. And this was so frequent
7 contraindications to the medicine, any problems
7
and so unusual that it raised in my mind, and
8
8
continues to raise, the question maybe it is actually
9
superior, but we were never able to demonstrate using
9
10
reported? Have you ever heard that sort of thing?
A.
That makes sense. I thought you meant
in more -- that's a very general thing. They want to
1 o the methods that would be generally accepted that this
11 understand what is the medicine for, what kind of
11
was the case. It was an impression that doctors
12
condition, who are the patients, what is the -- what
12
developed on their own.
13
is the effectiveness. They might ask for comparative
13
14
effectiveness if it exists; and if it doesn't exist,
14
anything of that nature that would support that
15
the answer is we can't give you any. They might ask
15
statement?
16
about safety. They might ask about anything related
16
A.
No. I said we could never prove it.
17
to what they feel they should know when they -- were
17
Q.
So if you go on here under the heading
18
they to use the medicine.
18
19
Q.
One of the things they might ask is
20 why is it better than what I'm already using, why
21
should I switch. Is that reasonable?
Any studies -- retrospective studies,
Q.
"Misbranding of OxyContin" and -- and when we talk
19 about misbranding, that's just really making claims
2 o and statements that aren't true about a drug. That's
21
called misbranding the drug. Is that correct?
22
A.
Perfectly reasonable.
22
23
Q.
One of the things they might ask is,
23
say it's got a different meaning in the regulatory
24
world. It's stating things that are not strictly in
25
the package insert.
24
you know, you got any studies that show it's better.
25 Is that another thing that comes up?
Coulter Reporting, LLC
A.
No, I wouldn't say it's that. I would
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1
2
3
Q.
Okay.
A.
They may be true, but if they're not
1 representatives they could tell healthcare providers
2 that there was less chance for addiction with
in the package insert, they're misbranding.
Do you know if Purdue had information
Q.
4
3
5 that physicians were concerned about the abuse
6
4
A.
No, I was not aware of that.
5
Q.
And under "c" it says, "Sponsored
potential for OxyContin?
I did not have that. It wouldn't
A.
7
OxyContin than with immediate-release opioids?
6
training that taught Purdue's sales supervisors that
7
OxyContin had fewer 'peak and trough' blood level
8
surprise me that physicians would be concerned about
8
effects than immediate-release opioids resulting in
9
that as with any other strong opioid or, in fact, any
9
less euphoria and less potential for abuse than
1 O short-acting opioids."
10 other opioid.
Let me refer you to paragraph 20. It
Q.
11
Were you aware that they were teaching
11
12
says here, "Beginning on or about December 12, 1995
12
13
and continuing on or about June 30th, 2001. .. "
13
A.
14
Q.
And that is the time frame that the
14
15
U.S. Attorney's Office looked into the conduct at
16
Purdue, correct?
17
18
19
A.
I don't know.
Q.
" ••. certain Purdue supervisors and
sales supervisors to make that misleading -Absolutely not.
-- statement?
Under "d" it says, "Told healthcare
15
16
providers that patients could stop therapy abruptly
1 7 without experiencing withdrawal symptoms and that
18
employees, with the intent to defraud or mislead,
patients who took OxyContin would not develop
19 tolerance to the drug."
2 o marketed and promoted OxyContin as less addictive,
20
MR. STRAUBER: I object to the form of
21
21
the question. In reading "d," you omitted the word
22 to cause tolerance and withdrawal than other pain
22
"certain" which appears before " healthcare providers."
23
23
less subject to abuse and diversion, and less likely
medications as follows:"
Oh . Well, let me read it again.
Q.
24
Under "a" it says that you "Trained
24
Under "d," "Purdue told certain
25
Purdue sales representatives" -- meaning -- when I say
25
healthcare providers that patients could stop therapy
Page 238
Page 240
1
"you," I mean Purdue, the company -- "Trained Purdue
1
abruptly without experiencing withdrawal symptoms and
2
sales representatives and told some healthcare
2
that patients who took OxyContin would not develop
3 providers that it was more difficult to extract the
3 tolerance to the drug ."
4
Oxycodone from an OxyContin tablet for the purpose of
4
5
intravenous abuse, although Purdue's own study showed
5
providers were being told that they could stop therapy
6
that a drug abuser could extract approximately 68
6
abruptly without experiencing withdrawal symptoms and
Were you aware that certain healthcare
7
percent of the Oxycodone from a single 10 milligram
7 that patients who took OxyContin would not develop
8
OxyContin tablet by crushing the tablet, stirring it
8
9
in water and drawing the solution through cotton into
9
A.
No.
10
Q.
Okay. And that statement is false,
1 o a syringe."
Were you aware that Purdue trained
11
12
tolerance to the drug?
11 correct?
sales representatives to make that misrepresentation?
12
It -- no. It's -- it's not clear to
A.
13
A.
No.
13
me it's false, but I am eager not to contend with it.
14
Q.
Is that a misrepresentation that would
14
It says "certain healthcare providers" and it -- the
rest of it is conditioned really, in large measure,
15
cause a physician to be more likely to use -- to write
15
16
prescriptions for OxyContin or less likely to write
16 on, in the first case, the dose that the patient is
1 7 prescriptions for OxyContin?
18
19
I would -- I couldn't guess. The
A.
implication is that it would be more likely, but I
17
on, and the second case in the duration that the
18
patient is on. But reading between the lines, as I
19 suspect those who shaped this did and understood the
2 o government, I can accept it as being a reasonable
2 O don't know.
21
ex pression of improper conduct. That is, certain
22
healthcare providers might have been told regardless
providers that OxyContin potentially creates less
23
of dose or regardless of duration.
24 chance for addiction than immediate-release opioids."
24
21
Q.
And then number "b" says, "Told Purdue
22 sales representatives they could tell healthcare
23
25
Were you aware that Purdue told sales
Coulter Reporting, LLC
25
But had I known about this, I would
have alerted our attorneys when negotiating this that
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Richard Sackler, M.D .
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1
Page 243
th is ought to be a little bit more specific because
1
showing Oxycodone plasma concentration provided by
2 it's going to be difficult to agree with it the way
2
OxyContin on a logarithmic scale along with a
3
3
statement that OxyContin's Oxycodone blood plasma
it's written . But I'm -- I won't quibble with it.
Q.
4
5
A.
6
7
8
9
Well, there was actually a whole lot
of back and forth on this document.
There may have been, but it wasn't
And a lot of the things brought up the
U.S. Attorney's Office said, no, we've reviewed the
12
7
8
Q.
Oxycodone.
Oxycodone. I'm sorry.
Paragraph 23 says, On December 20th of
1 o '95, after - -
Is that what happened?
A.
MR. STRAUSER: Oxycodone.
A.
9
10 documents and we're not changing this stuff.
11
levels provided fewer 'peaks and valleys' than
Immediate-Release OxyContin."
6
with me.
Q.
4
5
I don't know.
12
MR. STRAUSER: Just to be clear, in
We're going -- I'm sorry. Turn the
A.
11
page?
Q.
Yes.
14
the document we're reading, the Agreed Statement of
14
A.
Thank you.
15
Facts, "Purdue" refers to the Purdue Frederick
15
Q.
On December 20th, '95, "After
16
Company, which is the practice we've had in this
16
reviewing the proposed OxyContin launch materials,
1 7 deposition from the outset that you've used "Purdue"
17
DDMAC" -- what is DDMAC?
13
18
19
to refer to Purdue Frederick.
Q.
13
DDMAC. It's the division of the
A.
18
Yes. And because nobody at Purdue is
19 FDA -- I don't know what the letters stand for, but it
2 o able to say which employees were Purdue Frederick and
2 o is the division of the FDA that reviews promotional
21
21
materials and comments on their agreement that they
22 able to ascertain in any of the depositions I've read
22
are reasonably reasonable and accurate and consistent
23
so far, and including ones taken in the past, but
23
with the package insert or they differ with them and
24
we'll cover that later.
24
recommend changes or elimination of things.
which employees were Purdue Pharma as far as I've been
Under "e" here it says that Purdue --
25
25
And to sort of cut through it, what
Q.
Page 242
1
Page 244
1
"Certain Purdue supervisors and employees, with the
they did is they said, if you wish to compare blood
2
intent to defraud or mislead, told certain healthcare
2
levels in this text, we suggest that the blood levels
3
providers that OxyContin did not cause a 'buzz' or
3
for both dosage forms be presented in the graphic so
4
euphoria, caused less euphoria, had less addiction
4
that the reader can accurately interpret this claim.
5
potential, had less abuse potential, was less likely
5
6
to be diverted than immediate-release opioids, and
6
7
could not be -- and could be used to 'weed out'
7
8 addicts and drug seekers."
9
1 o were being made to healthcare providers?
11
A.
No.
12
Q.
And then the next section is
No, I don't -- I don't think so. I
A.
8 think they had a suggestion that we should add that.
Were you aware that those statements
9
They thought it was misleading the way
it was, correct?
And I don't know why it wasn't there. We certainly
1 o had the data as is shown above.
11
Q.
Okay.
12
A.
So I assume we added the data.
Q.
And then it says, paragraph 24, "On or
13
"Misbranding of OxyContin: Use of Graphical
13
14
Depictions by Sales Representatives." And it says,
14
about January 11, 1996, Purdue told DDMAC that it had
15
"Data from Purdue's clinical studies was used to
15
'deleted' the statement 'fewer peaks and valleys than
16
create the following graphical demonstration of the
16
with Immediate-Release Oxycodone."'
17
difference in the plasma levels at steady state
17
18
between patients who took OxyContin every 12 hours and
18
19
patients who took Immediate-Release OxyContin every 6
19
20
hours."
2 o dialogue between them or why they took it out.
21
22
And it says that "On October 12th,
21
They took the statement out, correct?
A.
That's what it says. I don't know
why. It was true. But I have no knowledge of the
Q.
Did you review any of the studies that
1995, Purdue requested comments from the FDA's
22
were done -- I mean actually get down and look at the
23
Division of Drug Marketing, Advertising and
23
data in the studies that were done prior to the
24
Communication about its proposed launch marketing
24
launch?
25
materials, which included the following graph and text
25
Coulter Reporting, LLC
A.
I looked at the analysis of studies,
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Richard Sackler, M.D.
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1
but I didn 't look at the data, that is, the individual
2
case report forms.
ever seen the data of the studies themselves?
No. That would be voluminous, and I
A.
5
6
And as we sit here today, have you
Q.
3
4
1
4
label when we said it was a Class II narcotic, and
every doctor knows that Class II narcotics are among
6
the most abusable products.
A Class II narcotic that your own
Q.
_8 records show there was a belief among physicians that
database with the paper record, the paper record that
9
1 o exists with the doctor's own records.
it wasn't as strong as morphine, correct?
No. That it wasn't stigmatized as
A.
10
And so this approach, which has been
11
denied that, in fact, has called it out explicitly in
several places, including right in the front of the
7
8 subject to extremely rigorous validation of the
9
2
3
5
don't -- I don't think it would be necessary for a
7 senior executive to do that because every study is
package insert then and through many changes has not
11
morphine was . They knew it was -- if you would ask
them, Is it more potent than morphine, many physicians
12
standard in the industry and, I believe, part of good
12
13
laboratory practices or one of the other standards
13
knew it was more potent. If they used both drugs,
14
that the FDA has promulgated, is extremely exhaustive,
14
they knew that they would always start with a much
15
lower dose of Oxycodone than they would with morphine.
15 which is one of the reasons the studies take so long,
16
because the validation of the data can take anything
16
17
from a month to a year.
17
18
Are you saying that your studies that
Q.
20
21
19
extremely exhaustive?
it in.
20
They were certainly appropriate for a
A.
Yes. They also knew what doses to use
A.
18
19 you did before putting Purdue on the market were
So you think physicians -- most
Q.
physicians knew it was more potent than morphine?
21
MR. THOMPSON: Let's mark this as
Exhibit --
22
molecule that had been in use, at that point, 80 years
22
MR. STRAUBER: It's 34.
23
or more, that was believed then to be safe and
23
(DEPOSITION EXHIBIT NO . 34 MARKED)
24
effective as a molecule, and that had no -- at that
24
25
time no long-term toxicities that hadn't been
25
(Passing document.)
Let me refer you to the first
Q.
Page 248
Page 246
1
well-developed, and so a lot of that information was
1
2
brought into the package insert whether we observed
2
3
them in the trials or not.
3
So the standards for this kind of an
4
paragraph of this document dated January 26th, 2001.
We're now five years after OxyContin
has been on the market, correct?
Which part of this should I read from?
A.
4
5
approval, which has its own designation, are easier to
5
6
meet. They're called 505(b)(2) NDA, and draw upon, in
6
7
this case, a vast publ ic literature, as I said
7
8
extended back 80-plus years. So for that it was very
8 will. In the mind of the physicians, hydrocodone
9
extensive in those kind of applications.
10
Q.
9
Yes, the date is around five years from marketing.
And it says up here -- this is from
Q.
Mark Alfonso. The first paragraph says, "I think it
gives them a great degree of comfort. Physicians rank
1 o the drugs based on the position that they have created
But when you took a controversial
11 opioid and expanded it to non-malignant pain at pills
11 in their mind as a result of prescription" --
12 that contained high dosages of opiate, you didn't do
12
A.
13 any addiction studies before putting it on the market,
13
Q.
14 correct?
14
MR. STRAUBER: I object to the form of
15
16 the question .
17
A.
First of all, the compound Oxycodone
18 was mostly used in non-malignant pain before we
15
Prescribing .
-- "prescribing habit and promotion."
And promotion would be, what,
marketing from Purdue Pharma?
16
A.
No.
17
Q.
What do you think it means when it
18 says --
19 entered the market. That was where the market -- the
19
2 o great bulk of the market existed. So there was no
2 o everybody in the industry from going back years and
21
innovation or change in our bringing it to the
21
22
non-malignant pain market.
22
23
The second thing was that we didn't - -
Promotion is the promotion of
years.
Q.
Okay. It says, "For them morphine and
23
hydromorphone are the most potent, followed by
Oxycodone and then hydrocodone."
24
we assumed that it was potentially addictive, that it
24
25
could be subject to abuse and diversion, and the
25
Coulter Reporting, LLC
A.
A.
I see it.
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Richard Sackler, M.D.
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Yeah. Were you aware that on January
Q.
1
1
Page 251
Oxycodone are close to equal potent. But he didn 't
2 25th of 2001 Mark Alfonso -- and what was his role at
2 say "potent," he said "powerful," and "powerful" in
3
3
this case has to do with the hierarchy that they place
Purdue?
4
A.
He was head of marketing .
4
drugs. Morphine was the last because it was the most
5
Q.
-- the head of marketing, felt like
5
stigmatized.
6
physicians did not feel like Oxycodone was as potent
6
7
as morphine?
7
we tried to reposition OxyContin as powerful as
8
morphine and we could not, finally we decided not to
9
mess with this perception since it was helping us in
We've gone through this before . It
A.
8
9
was -- that was a term that didn't refer to relative
So when he says here, "Remember that
Q.
1 o potency, it just didn't. He didn't include Fentanyl
1 O the non-cancer market."
11 in this, which is the most potent, but is often used
11
12
12
A.
I see where he wrote it.
13
Q.
All right. Let's go back to the plea
before hydrocodone or morphine.
13
Q.
Well, let me ask you this --
14
A.
So -- well, I'm just saying, it
14 agreement.
15 just -- I realize that you've changed the meaning that
15
16 was intended and understood by the recipients.
16
17
No. That's his word, "potent," not
Q.
MR. THOMPSON: It's marked.
MR. STRAUSER: It's No. 34.
18
No, no, no. You've changed the
A.
MR. ELLIS: Tyler, we need to mark
that document.
17
18 mine, correct?
19
Did you see where he wrote that?
Paragraph 25 of the Agreed Statement
Q.
19
2 o meaning of the word "potent." Not the word, the
2 o of Facts says, "On or about December 1998, Purdue
21
21
22
meaning of the word.
Well, I didn't change it. It's --
Q.
22 managers."
23 it's his word.
24
25
Now, it wasn't some of them, it's all
23
No. You've changed it when you've
A.
sponsored training for all its district sales
24
tried to use it as though it means relative potency.
of them, correct?
25
A.
It says "all."
1
Q.
"During this meeting, a pharmacist
Page 250
1
Q.
Page 252
All right. When we first discussed
2
the first group of documents, you said, no, they're
2
retained by Purdue" -- do you know who that pharmacist
was?
3
just talking about effectiveness, not strength. The
3
4
second group of documents where they said it's
4
A.
No.
5
stronger than morphine, you said, no, they just mean
5
Q.
-- a pharmacist retained by Purdue to
6
strong in a general sense, they don't mean potent.
6
7
Here they .use the word "potent."
7 graphical demonstration (instead of the graphical
9
8 demonstration of the actual clinical data described in
Do you just not think physicians don't
8
think it's as strong as morphine? Because that's what
10 they keep saying they don't want to clear up in the
11 physicians' mind, that it's as strong as morphine.
It -- this is a hierarchy here.
conduct a portion of the training used the following
9
paragraph 21 of this Agreed Statement of Facts) and
1 o falsely stated that OxyContin had significantly fewer
11
'peak and trough' blood level effects than
12
immediate-release opioids resulting in less euphoria
12
A.
13
Q.
Okay.
13 and less potential for abuse than short-acting
14
A.
Okay?
14 opioids." And they've got a graph that was used at
15
Q.
Well, we'll just have to disagree
16 about that.
17
A.
Here Mark Alfonso said here that -- if
18
following your reasoning, if your reasoning were
19
correct -- the physicians would see morphine as the
15 the training for the Purdue employees.
16
17
18
19
A.
I would call that a cartoon, not a
graph .
Q.
And it says on paragraph 26,
"Beginning in or around 1999, some of Purdue's new
2 o most potent of all these drugs. It was the for them
2 o sales representatives" -- those would be Purdue Pharma
21
morphine, and then hydrocodone, and in most places
21
22
Oxycodone, and then hydrocodone.
22
23
The facts are that hydromorphone is
sales representatives in 1999, correct?
A.
I can't say.
MR. STRAUBER: Object to the question.
23
24
three to eight times more potent than morphine, but
24
Purdue is defined in this document as Purdue
25
that isn't how he listed it. And hydrocodone and
25
Frederick.
Coulter Reporting, LLC
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2
So are we talking about Purdue Pharma
Q.
or Purdue Frederick?
I just don't know.
A.
5
10
12
4
May I read it? If you don't want to
8
helped put the document together, the lawyer, we took
read it into the record, can I just read it and then
Sure. I'll tell you what, it will
Q.
save time, I'll read it into the record.
A.
Okay.
Q.
"On or about January 16, 1997, certain
9
his deposition. Have you seen his deposition?
10
MR. STRAUBER: I've seen his
11
12
results of a clinical study pertaining to the use of
MR. THOMPSON: Yeah. And he says he
13
low doses of OxyContin by osteoarthritis patients."
deposition.
13
Yeah. Are you familiar with that?
A.
7
MR. THOMPSON: Yeah. The guy that
11
A.
Q.
6 respond?
face is talking only about Purdue Frederick.
8
9
That's okay, you don't have to rush.
2
3
5
MR. STRAUBER: The document on its
6
7
Purdue had an osteoarthritis study --
1
sales representatives."
3
4
Page 255
MR. THOMPSON: Yeah, but it says "new
1
Purdue supervisors and employees sent to the FDA the
14
doesn't know if they're Purdue Frederick or Purdue
14 They call it the "Osteoarthritis Study." "And a final
15
when he refers to this.
15
MR. STRAUBER: I'm telling you, I'm
16
1 7 taking this document on its face defines Purdue as
1 7 reported 'withdrawal syndrome' as an adverse
18 Purdue Frederick. I don't care what anyone else said.
18 experience during the respite periods.'
MR. THOMPSON: Sure. And I'm asking
19
22
23
24
25
Q.
You don't know, correct?
A.
That's -- go -- I said I don't know
20
Experiences by Body System During Respite Periods,'
21 the report summary of the major results listed the
who employed these new representatives.
Q.
"In a section entitled 'Adverse
19
2 o him if it's correct, and he's saying -21
report that included, in a section pertaining to
16 respite periods, the statement 'No investigator
Okay. It says, "Some of Purdue's new
sales representatives were permitted, during training
22
most frequently reported adverse experiences in
23
respite periods to be nervousness, insomnia, nausea,
24
pain, anxiety, depression and diarrhea followed by the
25
statement: '28 patients {26 percent) had symptoms
Page 254
Page 256
1
at Purdue's training headquarters, to draw their own
1
2
blood level graphs to falsely represent that
2
recorded during one or more respite periods."'
Did I read that correctly?
3
OxyContin, unlike immediate-release or short-acting
3
A.
4
opioids, did not swing up and down between euphoria
4
ahead of you.
5
and pain and resulted in less abuse potential.
5
6
Were you aware that the sales reps
6
about May 1997, certain Purdue supervisors and
7
employees stated that while they were well aware of
7
8
9
10
were doing that?
A.
No.
Q.
And then it says, "During the period
I think so. I was kind of reading
And then it says, paragraph 29, "On or
Q.
8 the incorrect view held by many physicians that
9 Oxycodone was weaker than morphine, they did not want
1999 through June 30th, 2001 Purdue reps used
10 to do anything 'to make physicians think that
11
graphical depictions similar to the one described in
11 Oxycodone was stronger or equal to morphine' or to
12
paragraph 25 of this Agreed Statement of Facts and
12
'take any steps in the form of promotional material,
13
falsely stated to some healthcare providers that
13
symposia, clinical publications, conventions or
14
OxyContin had less euphoric effect and less abuse
14
communications with the field force that would affect
15
potential than short-acting opioids."
15 the unique position that OxyContin had in many
16 physicians' minds."'
Were you aware that they had --
16
17
A.
No.
18
Q.
-- engaged in that conduct?
And did I read that correctly?
17
18
A.
You read the words correctly.
Q.
And was that part of the Agreed
19
A.
No. I'm sorry.
19
20
Q.
And then to go on with the conduct,
2 o Statement of Facts?
21
paragraph 28 says, "Misbranding of OxyContin:
22
Misleading Use of Article to Claim No Withdrawal or
21
A.
It is.
22
Q.
And then it goes on to say, "On or
23
Tolerance," and it proceeds to discuss how Purdue --
23
about February 12th, 1997, certain supervisors and
24
well, let's go ahead and read it. I'll try to shorten
24
employees of a United Kingdom company affiliated with
25
Purdue provided certain Purdue supervisors and
2 5 this a little bit.
Coulter Reporting, LLC
www.coulterreporting .com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P ., et al.
8/28/2015
Page 257
1
employees with an analysis of the osteoarthritis study
1
2
together with another clinical study. This analysis
2
Page: 65
Richard Sackler, M.D.
Page 259
-- "included the following three
Q.
statements pertaining to the incidence of withdrawal
3
included a list of eight patients in the
3
syndrome and withdrawal symptoms experienced by study
4
osteoarthritis study and eleven patients in the other
4
patients: One patient was hospitalized for withdrawal
5
study who had symptoms recorded that may possibly have
5
symptoms. The patient who was hospitalized with
6
been related to opioid withdrawal, including one
6
withdrawal symptoms had completed the study on the
7
patient in the other study who required treatment for
7
previous day and had been receiving CR Oxycodone, 70
8
withdrawal syndrome."
8
milligrams. Symptoms resolved after three days.
9
"A second patient received 60
Did you ever review that study?
9
10
A.
No.
1 o milligrams CR Oxycodone, experienced withdrawal
Q.
"The 'Discussion' section of this
11
symptoms after running out of study medication. The
analysis included the following: 'It's not surprising
12
patient had not reported withdrawal symptoms during
13
that some patients in the clinical trials developed
13
scheduled respites from doses of 30 or 40.
14
some degree of physical dependence and consequently
14
11
12
"Withdrawal symptom was not reported
15 experienced withdrawal symptoms as a result of abrupt
15
as an adverse event for any patient during scheduled
16
discontinuation of OxyContin Tablets. All patients
16
respites. Adverse experiences reported by more than
17
who were suspected to have withdrawal symptoms have
17
10 percent of patients during scheduled respites were
18
been reported, but this may have resulted in a falsely
18
nervousness (nine patients) and insomnia (eight
19
high incidence.
19
patients)."
"Of the patients who participated in
20
Paragraph 32 says the article included
20
21
the osteoarthritis study (in which patients entered
21
a "Comment" section, summarized the three statements
22
respite periods without OxyContin Tablets) many
22
and the "Results" and "further suggested that patients
23
symptoms suspected to be due to opioid withdrawal may
23
taking low doses could have their OxyContin treatment
24
simply have resulted from the return of pain. After
24
abruptly discontinued without experiencing withdrawal
25
withdrawal of OxyContin Tablets, patient 6007
25
if their condition so warranted."
Page 258
1
Page 260
Were you aware they were making that
complained of nervousness, patient 2004 complained of
1
2
insomnia and felt restless, patients 2020 and 2028
2
claim?
3
were restless and anxious.
3
A.
No.
Q.
If you go over to paragraph 34, it
"Since these are symptoms which often
4
4
5
says, "On or about June 26, 2000, certain Purdue
5
accompany the return of significant pain, it may be
6
wrong to label these as withdrawal symptoms.
6
supervisors and employees sent the full text of this
7
Nonetheless, the incidence of withdrawal symptoms in
7
osteoarthritis study article ... "
Do you know which supervisors and
8
patients treated with OxyContin Tablets is a concern,
8
9
and it is safer to over report than under report this
9 employees sent the full text of this article?
1 o problem.'
10
A.
No.
Do you know if it was the marketing
11
Q.
12 the statement: 'As expected, some patients did become
12
group?
13
physically dependent on OxyContin Tablets, but this is
13
A.
I don't know.
14
not expected to be a clinical problem so long as
14
Q.
And it says, " ... together with a
15
abrupt withdrawal of the drug is avoided."'
15
11
"This analysis' conclusions included
Were you aware that certain Purdue
16
17
employees participating in the final draft of the
'marketing tip' to Purdue's entire sales force. The
16
marketing tip stated that a reprint of the
17
osteoarthritis study article was available for use in
18
article regarding the osteoarthritis study that was
18
achieving sales success. The marketing tip also
19
published in a medical journal on or about March 27th,
19
included as one of the articles 12 key points: There
20
2000, were you aware they participated in the
2 o were two reports of withdrawal symptoms after patients
21
publishing of that study?
21
22
A.
No.
22
70. Withdrawal syndrome was not reported as an
23
Q.
"The 'Results' section of the
23
adverse event during scheduled respites, indicating
24
25
article" -- I'm reading from paragraph 31.
A.
Right.
Coulter Reporting, LLC
abruptly stopped taking CR Oxycodone at doses of 60 or
24
that CR Oxycodone at doses below 60 milligrams can be
25
discontinued without tapering the dose if the patient
www.coulterreporting.com
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page: 66
Richard Sackler, M.D.
Page 261
1
Page 263
condition so warrants."
1
It says, "On or about February 13th,
it and asked should we write it up or is this going to
2
add to the current negative press and should be
2001, certain Purdue supervisors and employees
3
deferred, the person's supervisor said, "I would not
4
received a review of the accuracy of the withdrawal
4
write it up at this point." Correct?
5
data in the osteoarthritis study and stated" --
5
A.
That's what it says.
6
Q.
Do you know if it ever got written up?
2
3
Now, this is Purdue's own people
6
7
reviewing this data, correct?
7
A.
I don't know.
8
A.
That's how I would read it.
8
Q.
Do you know if any of these doctors
9
Q.
And it says, "Upon a review of all
9
1 o comments for the enrolled patients, it was noted that
10
that were shown this were ever told that it actually
wasn 't correct?
11
multiple had comments which directly stated or implied
11
A.
I don't know.
12
that an adverse experience was due to possible
12
Q.
Do you know if anybody at Purdue made
13
withdrawal symptoms. This was followed by a list of
13
an effort to go tell these doctors that all of these
14
11 study patients who reported adverse experience due
14
marketing things that have been brought up in the
15 to possible withdrawal symptoms during these periods.
15 Agreed Statement of Facts were not correct?
16
106 patients initially participated in the
16
A.
I don't know.
17
osteoarthritis study. 32 of them withdrew because of
17
Q.
Did you yourself ever tell anybody to
18 severe" -- I'm sorry - - "because of adverse (not
19
18 go inform doctors that these marketing statements that
necessarily related to withdrawal) and 38 patients
19
2 o remained in the study at 12 months."
And then the next paragraph reads, "On
21
22
had been used by Purdue's employees that were not
2 o accurate were -- were, in fact, not accurate?
21
or about March 28th, 2001" -- so this was a month and
22
23
a half later -- "a Purdue employee e-mailed a Purdue
23
24
supervisor regarding the review of the withdrawal data
24
25
described in paragraph 35 of the Agreed Statement of
25
1
Facts asking: 'Do you think the withdrawal data from
1
2
the osteoarthritis study is worth writing up (an
2
3
abstract)? Or would this add to the current negative
I was not aware of this story or the
A.
study or the marketing materials or statements.
And as the director of Purdue Pharma,
Q.
you were not made aware of any of this?
MR. STRAUBER: I object to the form of
Page 264
Page 262
3
the question.
You can answer.
I do not recall whether we were --
A.
4
press that should be deferred? ' The supervisor
4
you're talking about at the time of this document
5
responded: 'I would not write it up at this point.'
5
being written?
6
And no abstract was prepared."
6
Q.
Yes.
7
A.
I don't recall.
Q.
And at the time that this conduct went
Do you see that?
7
8
A.
I see it.
8
9
Q.
So am I correct that Purdue was using
9
on, from '96 to 2001, the time period investigated by
10 the marketing material from this article improperly
1 o at least this U.S. attorney under this Agreed
11
and not reporting the adverse effects and was allowing
11
Statement of Facts, you were, in fact, the CEO of
12
their sales force to use it?
12
Purdue Pharma, correct?
MR. STRAUBER: I object to the form of
13
14
the question.
15
A.
16
17
18
19
20
21
13
14
Let's break that into one question at
15
a time, please.
Q.
Sure. Was Purdue's marketing
department using this article?
A.
That's what it says here.
Q.
And were they using it
22
That's what it says here.
23
Q.
And when somebody pointed out that the
16
18th, 2000, June 22nd, 2000, February 13th, 2000 and
17
on March 18th, 2001, this employee was told not to
18 write up the withdrawal data because of negative press
2 o the CEO during this time period, correct?
Yes.
21
A.
22
Q.
What was Robert -From '99 until this.
Yeah. What was Robert Reder's role at
23
A.
24
withdrawal data from the osteoarthritis study was
24
Q.
25
actually different than how the sales force was using
25 Purdue?
Coulter Reporting, LLC
So if this conduct occurred on May
Q.
19 and that it should be deferred, you would have been
inappropriately?
A.
During 2000, very, very late '99 until
A.
early 2003 I was the CEO, yes.
www.coulterreporting.com
502-582-1627
Page: 67
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 267
Page 265
1
A.
He was a senior medical officer.
1
Purdue sales representatives distributed the reprint
2
Q.
The next paragraph says, "Between June
2
of the osteoarthritis article to some healthcare
3
26, 2000 and June 30th, 2001, Certain Purdue
3
providers and falsely or misleadingly stated that
4
supervisors and employees distributed copies of the
4
patients taking OxyContin at doses below 60 milligrams
5
reprint of the osteoarthritis study article to all of
5
per day can always be discontinued abruptly without
6
Purdue's sales representatives for use in the
6
withdrawal symptoms and that patients on such doses
7
would not develop tolerance."
promotion and marketing of OxyContin to healthcare
7
8 providers, including the distribution of 10,615 copies
8
9
9
to certain Purdue sales representatives between
And that's not an accurate statement,
is it?
1 o February 13th, 2001 and June 30th, 2001."
10
So it looks like on March 28th the
11
11
12
supervisor tells the employee, Don't write up the
13
withdrawal data from the osteoarthritis study, it
12
14 would add to the current negative press and should be
A.
I don't believe so.
Q.
And then with regard to "Misbranding
of OxyContin: Use of Reduced Abuse Liability Claims
13
in Marketing," it says, paragraph -- "OxyContin
14
package insert approved by the FDA stated: 'Delayed
15
deferred, and between February 13th, 2001 and June
15
absorption, as provided by OxyContin Tablets, is
16
30th, 2001, 10,615 copies of the osteoarthritis study
16
believed to reduce the abuse liability of the drug."'
17
were distributed to sales representatives, correct?
A.
18
18
MR. STRAUSER: It says "certain Purdue
19
21
Q.
23
physicians that they called on?
"Certain Purdue supervisors and
2 o employees instructed Purdue's sales representatives to
Was the purpose of submitting it to
the sales representatives so they could show it to the
Statement.
19
2 o sales representatives."
22
That's called the Reduced Liability
17
That's what it says.
21
use this statement to market and promote OxyContin."
22
Paragraph 40 says, "Certain Purdue
23
sales reps, while promoting and marketing OxyContin,
24
A.
I don't know.
24
falsely told some healthcare providers that the
25
Q.
There was only 800 sales reps at
25
Reduced Abuse Liability Statement meant that OxyContin
Page 268
Page 266
1
Purdue's highest volume of sales reps during this
2
period of time, correct?
3
4
5
A.
To the best of my recollection, that's
approximately true.
Q.
So if you wanted to give a copy to
1
did not cause a 'buzz' or euphoria, caused less
2
euphoria, had less addiction potential, had less abuse
3
potential, was less likely to be diverted than
4
immediate-release opioids, and could be used to 'weed
5
out' addicts and drug seekers."
6
each sales rep for their own use, you'd probably only
6
7
need 800; but they printed off 10,615 copies, correct?
7
It says, "By March 2000, various
Purdue supervisors and employees in different parts of
8
A.
Distributed, yes.
8
the company had received reports of OxyContin abuse
9
Q.
Is it reasonable to conclude that the
9
and diversion occurring in different communities."
10 And that "On or about November 27, 2000, certain
10 sales reps were showing these to the doctors?
11
A.
11
It's reasonable to conclude that some
Purdue supervisors and employees amended the Reduced
12
sales reps may have shown them to doctors, yes. To
12 Abuse Liability Statement to say that 'delayed
13
some doctors.
13
absorption, as provided by OxyContin Tablets, when
14
Q.
14
used properly for the management of pain, is believed
15
to reduce the abuse liability of the drug,' and
Do you know if Purdue ever got any of
15 this 10,615 copies of the osteoarthritis article back?
16
A.
I don't know . If this -- when this
17
was found -- and I don't know when this was found - -
18
by sales or marketing management or the medical
instructed Purdue sales reps to use the amended
statement to promote and market OxyContin."
Do you know why that statement was
18
19 department, it would have been the practice to recover
19 changed?
2 o them, yes. But I don't know if it was found and I
21
16
17
20
21
don't know if it was done. This all came to light in
A.
I'm not sure -- no, I don't, and I'm
not certain where it was changed. In the package
22
2006 or '7, so I don't know. It could have been long
22
insert? I don't know. If it was in the package
23
past, but I don't know.
23
insert, then that had to be submitted to the FDA to
24
25
Q.
It says in paragraph 38, "During the
period June 26, 2000 through June 30th, 2001, certain
Coulter Reporting, LLC
24
get approval in advance of using it, but I just don't
25
know what this refers to.
www.coulterreporting .com
502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page 271
Page 269
1
Well, when Purdue found out that
Q.
1
understand the complex processes of treating pain?
2
OxyContin was being abused and diverted, they changed
2
3
their packet insert, kind of cleverly really, if you
3
4
read it right, "When used properly for the management
4
5 of pain."
Do you know what they meant by that?
6
I don't know what the people who wrote
A.
7
8
it meant by that or what the FDA understood, because I
9
was not involved in rewriting it.
the question. It's argumentative.
5
A.
6
Q.
Should I answer it?
Sure.
MR. STRAUBER: You can answer it.
8
A.
I don't think so.
9
Q.
Did Purdue's own focus group show that
1 o doctors didn't understand whether OxyContin was
11 stronger than morphine?
March 2000 through June 30th, 2001, certain Purdue
12 sales representatives, while promoting and marketing
13
MR. STRAUBER: I object to the form of
7
Okay. The next paragraph says, "From
Q.
10
11
I don't think so.
A.
OxyContin, falsely told some healthcare providers that
12
A.
I don't know.
13
Q.
What about the treatment of pain, did
14 the Reduced Abuse Liability Statement and the amended
14 you feel like doctors understood or physicians
15 statement meant that OxyContin did not cause a 'buzz'
15
16 or euphoria, caused less euphoria, had less addiction
16 utilized for the treatment of pain?
understood prescribing practices that should be
You'd have to put a time frame to that
1 7 potential, had less abuse potential, was less likely
17
18 to be diverted than immediate-release opioids, and can
18 or ask the question with more color and more details.
19 be used to 'weed out' addicts and drug seekers."
Isn't that the reason you-all were
Q.
19
2 o claiming that you needed to spend so much money
And those statements are not correct?
20
A.
21
A.
No, they're not correct.
21 educating physicians is because they didn't understand
22
Q.
All right.
22
"Introduction of Misbranded OxyContin
23
24
And that is actually the guilty plea.
Some physicians learned how to
A.
23
Into Interstate Commerce."
25
pain prescribing?
24
prescribe for pain from materials that we produced or
25
information that sales reps gave them; others knew how
Page 272
Page 270
A.
Pardon?
Q.
It points out that Purdue manufactured
1
2
1
3
and sold OxyContin in interstate commerce from various
4
locations --
5
A.
6
7
2
trying this agent in comparison to how they were
3
treating pain before.
6
in a sense, not ignorance so much as ignoring pain of
should be following.
7
patients. Doctors just didn't want to deal with it
and left patients inadequately treated.
Q.
It's the very next paragraph.
8
A.
Which is 44?
9
10
Q.
Yes. And that's just pointing out
A.
Let me read it and I'll tell you if I
agree.
MR. STRAUBER: That's not what it
14
15 says, if you're reading from 44.
18
A.
13
Q.
Mr. Shapiro has testified --
14
A.
Oh, okay.
15
Q.
I want you to assume he's testified
18
Did Purdue Pharma sell OxyContin all
19 over the U.S.?
20
A.
During what time period?
20
Q.
1996 to 2001.
21
22
A.
Yes.
22
23
Q.
Now, is part of the reason Purdue was
23
able to get away with making these misrepresentations
25 is because Purdue was aware that physicians did not
Coulter Reporting, LLC
unmistakably to do so.
Would you agree with that?
19
21
24
I don't understand the question.
12
1 7 marketing message is to instruct them explicitly and
withdraw the question.
Q.
11 to instruct them explicitly and unmistakably to do so?
16 that the only way to get a large sales force to use a
MR. THOMPSON: You're right. I'll
16
Would you agree that the only way to
Q.
1 o get a large sales force to use a marketing message is
11 that Purdue sold OxyContin all over the U.S., correct?
17
1985 in the U.S., there was almost -- it was abysmal
interrupt you, sir. Just tell me which number I
9
12
When we entered the pain market in
4
5
Are you reading -- I'm sorry to
8
13
to treat pain and they would be more interested in
24
25
A.
I really don't understand it.
MR. STRAUBER: Once again, if you're
reading from a transcript, please share it with him.
Q.
I want you to assume he's testified to
A.
But I don't --
that.
www.coulterreporting.com
502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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Page 273
MR. STRAUSER: Why should he assume it
1
1
three-quarters of them would have been gone. But I
2
when you have a transcript in front of you?
2
don't -- I can't answer that I know of any attempt to
3
MR. THOMPSON: I don't have a
3
assess blame in that sense or to count.
Yeah. And that's not really my
4
transcript in front of me. I'm asking from my own
4
5
memory.
5 question. My question is, did anybody at Purdue
don't understand that statement, so I really can't
8
agree or disagree with it.
Pharma attempt to go back and find out which reps
7 specifically had made comments to physicians that were
8 improper or misleading about the attributes of
9
Do you believe there's evidence of
Q.
9
6
Oh, okay. I don't understand . I
A.
6
7
Q.
OxyContin?
10 improper training that has occurred at Purdue based
10
A.
The answer is, I don't know.
11
11
Q.
Would you agree that giving -- making
upon the Agreed Statement of Facts?
12
12 the statements -- the improper statements that are
I would have to review it. My
A.
13
recollection as you read -- as we read through it was
14
that one or two things involved improper training, but
13
14 compromise patient care?
15 I can't affirm that until I reread it.
16
17
here today what percentage of your sales force was
Some of them, yes. In some patients.
A.
15
Did you ever -- do you know as we sit
Q.
referred to in the Agreed Statement of Facts could
16
Obviously not all patients, but in some patients some
17
of the statements could compromise care. I would like
18 using these improper statements to educate physicians
18 to say suboptimize care, but ...
19 about prescribing OxyContin?
19
And if I understand correctly, you
Q.
20
A.
No, I don't know.
2 o have not reviewed any of the call notes that were
21
Q.
Okay. Whether it was a hundred
21
pulled by Mr. Shapiro when he was doing his
investigation?
22
percent, 50 percent, 10 percent; you don't have any
22
23
idea?
23
That's correct. As far as I know. I
A.
24
A.
I have no idea.
24
didn't -- I was shown a few call notes. I didn't ask
25
Q.
Do you know if anybody at Purdue tried
25
were these shown to Mr. Shapiro.
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1 to find out how many of their sales force had given
1
2
2
somebody right about that same time that the call note
system be changed?
physicians improper and incorrect information?
Was there a recommendation made by
Q.
I know, as I said before, that from
3
4
2000 -- sometime in 2000, as we became convinced that
4
A.
At about what time?
5
there was a problem, many efforts were launched to
5
Q.
About the same time he was doing his
6
train, retrain and to determine whether sales reps
6
7
were following company policy, and that effort goes on
7
A.
I believe it was.
8
to this day.
8
Q.
Yeah. And do the call notes not
3
9
A.
We put in place, for example, a whole
9
investigation and reviewing the call notes.
contain as much information as they used to back in
1 o compliance department in 2003 or 2004 with many
1 O two thousand --
11 employees who reported independently to the board and
11
12
have continued to report independently to the board
12
change was to make the first and second-line
13
to, in a sense, back up the sales department and
13
supervisors audit a substantial percentage of the call
14
marketing department's own efforts to assure proper
14
notes in their span of control.
15
training and compliance with training. But I don't
15
16
know of any attempt to measure who said what and how
16
17
many times. When people were properly trained and
17 them?
1 s they deviated from that or went beyond that, they were
19
20
21
sanctioned, and many of them were dismissed.
We also had a whole downsizing in the
field force from about 2003 or '4 until about 2007 or
18
That, I don't know. But the biggest
A.
If the call notes have less
Q.
information in them, is it more difficult to audit
A.
I would have -- I couldn't possibly
19 guess. I don't know what they were before or after.
2 o They were very sketchy notes, the ones I saw. I must
21
say, they were selected and shown to me, but the ones
22
'8 in which the 800 eventually went down to something
22
I saw were, in some cases, almost indeterminant. You
23
like 200. So I don't think there are too many
23
could not know what was happening.
24
survivors from this period because they were
24
Q.
How many did you see?
25
selectively weeded out and because, on average,
25
A.
Six, eight. No more. I think
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probably fewer than six or eight, but I'll say six.
2
Q.
3
to you?
And who were those -- who showed those
I was shown them during the
A.
4
5
preparation for the deposition. I had never seen them
6
before.
10
11
Were the call notes you were shown
the tablet and are using a cotton ball to filter the
talc as they draw it up in a syringe for 'main
4
lining.'"
My recollection is some were .
Q.
Did you hire anybody or ask anybody to
be audited for accuracy. There were many people in
A.
No.
8
Q.
When did you first become aware that
OxyContin was being diverted or being abused?
recollection, winter of 2000. That is early in the
12
year 2000.
13
14 the law department and then the compliance department
14
15
who may well have done so, but I don 't know.
And would you expect if we did our own
In the winter -- to the best of my
A.
11
15
Q.
in November of 1999?
10
I did not ask would his investigation
A.
Were you aware that that was a concern
7
9
A.
review Mr. Shapiro's investigation for accuracy?
12
13
2
5
8 call notes from Kentucky reps, or do you know?
9
people are finding ways to extract the Oxycodone from
3
6
Q.
7
1
Q.
Who is Dr. J. David Haddox?
A.
Dr. Haddox is both a dentist and an
M.D. He's an expert in both analgesic pain -- the use
16
of analgesics and pain management in general, and
1 7 investigation we would have essentially about the same
17
also, I think, is a recognized expert on addiction and
18
18
treatment of addiction.
16
19
number of improper call notes that he found?
A.
MR. THOMPSON: Do you want to take a
20
21
little break?
MR. STRAUBER: Let's take a short
22
23
That would be my expectation.
19
Q.
Did he work for Purdue Pharma?
20
A.
He did .
21
Q.
And what about Rena Golden and Windell
22
break.
23
Fisher, what were their jobs?
Rena Golden, I don't know; and Windell
A.
24
MR. THOMPSON: That's fine.
24
Fisher was a sales manager, but I don't recall how
25
VIDEOGRAPHER : We are off the record
25
high up he was in sales management. He was a -- I
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1
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at 5:26 p.m.
1
(RECESS)
2
2
VIDEOGRAPHER: We are back on the
3
3
think he was a regional manager at that point.
Q.
And what about Jim Speed?
A.
I recognize the name, but I don 't - - I
4
record at 5: 55 p.m.
4
5
5
salesperson. I don't know whether he was a manager or
6
not, if he was a district manager or sales manager.
6
7
Q.
So let me show you an e-mail. If
you'll go to page 2 of this e-mail.
7
can't tell you what his position was. He was a field
Is it true that Windell Fisher was a
Q.
8
(Passing document.)
8
9
This is from Jim Speed dated Tuesday,
9 territories located in Kentucky?
1 o November 30th. Let's mark this as Exhibit 35.
(DEPOSITION EXHIBIT NO. 35 MARKED)
11
12
Q.
Dated November 30th, 1999. Second
regional manager with oversights for the districts and
10
A.
I don't know.
11
Q.
Is it true that OxyContin does produce
12 a buzz or euphoria just like -- the controlled-release
13
paragraph, "During physician calls, this issue is a
13 just like the immediate-release?
14
topic of hot discussion between me and the physician.
14
A.
15
While many salespeople have sold controlled-release
When used in pain patients --
15
Q.
Yes.
16 opioids as having less abuse potential, the current
16
A.
-- or when abused?
17
17
Q.
When used in pain patients.
18 feel like we have a credibility issue with our
18
A.
I don't -- I can't tell you the
19
19
20
21
situation has placed us in an awkward situation. I
product.
"Many physicians now think OxyContin
is obviously the street drug all the drug addicts are
22 seeking. Issues like purposely crushing the 40
percentages. I'm sure there are some people who might
2 o say that they feel a sense of euphoria . I really
21
don't know what "buzz" means when people say they have
22
a buzz; I'm not familiar. But there may be a brief
23
milligram and 80 milligrams tabs to 'get high' have
23
period of t ime in which they feel some euphoria or
24
been expressed. I have heard from physicians that
24
sensation.
25
pharmacists -- and pharmacists that on the streets
25
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Q.
And whether you feel a buzz or
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1
euphoria, does that have to do with how quickly the
1
2 drug works?
could be done?
Dependency, that is, physiologic
A.
2
Not so -- well, that's an element, but
3
4
it has to do also with the dose, and also with the
4
could be done. Addiction remains to be seen. A lot
5
patient's familiarity. If they've been on the same
5
of people would say it's almost impossible to do that.
A.
3
dependence I think would be an achievable study that
6
dose for a while, I would think it's far less likely.
6
But Purdue and other industry partners are just on
7
And then there's ind ividual patient variation finally .
7
the -- on the cusp of trying to do that with a number
8
of studies.
Q.
8
And with respect to peaks and valleys,
9 do the peaks and valleys that are referred to in all
Q.
9
Could you do a retrospective study, or
1 o the marketing materials, or a number of the marketing
1 o could you have done a retrospective study if you had
11 materials, does that have to do with whether somebody
11 wanted to look at patients?
12 experiences a euphoria from taking OxyContin?
A.
13
I would have to think about whether I
A.
12
If they have any psyche --
13
could figure out a retrospective study. It would be
an interesting - - it's an interesting question, but I
14
psychological experience, like euphoria, it's most
14
15
likely to be at the peak blood level. So the fewer
15 don't know the answer to it.
16
the peaks, the fewer the periods of euphoria . But I'm
16
Q.
And what was Robert Reder's role?
1 7 just generalizing. I'm not telling you that we've
17
A.
Robert was a senior medical scientist
18 ever measured that.
18
19
Q.
When did you first become aware that
in the medical department.
And I want you to assume he's
Q.
19
2 o Purdue had marketed and promoted OxyContin as having
2 o testified that Purdue lacked any evidence that
21
21
22
less abuse potential?
A.
Not until the investigations were
OxyContin had a lower abuse potential.
If that's true -- if he testified to
22
done. And I can't tell you which investigation or
23
that -- assume he testified to that -- would you agree
24
when, but I certainly didn't know that people were
24
with that statement or disagree?
25
saying that until I was told by management that they
25
23
If you could just repeat the statement
A.
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1
had done investigation and found that some people had
1
2
said that.
2
3
Q.
so that I can concentrate on it.
That he testified Purdue lacked any
Q.
3 evidence that OxyContin had a lower abuse potential.
Let me -- let me ask you about
MR. STRAUSER: Yeah, I object to the
4
patients who have not had a prior incidence of
4
5
addiction or abuse, but just someone who's put on
5
6
OxyContin and has never had an opioid in the past. Do
6
7
you know if they're put on a 20 milligram dose of
7
done, but I don't know that no study was done. I just
8
OxyContin twice a day how long they would have to take
8
can't - - I can't tell you for sure.
9 it before developing dependency?
10
A.
question. It's a very odd hypothetical question.
I don't know of any study that was
A.
You're referring to Purdue Frederick
9
1 o and you're referring to the time frame up to 2007 or
I can give you a guess, but I don't
11
know. It would -- there's enormous individual
11 2010?
12
variation he.re. So you can't say with any one person
12
Q.
Yes.
13
or predict that this person will develop dependency or
13
A.
Okay. I just wanted to -- I don't
14
that this person won't at 40 milligrams a day. I
14
know. My answer is the same, but I just wanted to be
15
assume that's the presumptive daily dose you're asking
15 clear that my answer conformed.
16
me about?
16
17
Q.
18 conducted any studies to determine how long a
19
18
non-malignant pain patient who's never had an opioid
22
23
24
25
19 many formulations, and we did them in the course of
21
formulations. These were studies that were pioneered
22
by Purdue with outside investigators, and they
23
attempted to and, I think, quite -- would be
Is it fair to say that if Purdue
24
considered today state-of-the art, to discern how
25
easily practiced drug abusers might be able to defeat
conducted.
Q.
We've done studies on abusability of
I'm not aware of those studies being
developed dependency or addiction?
A.
A.
2 o trying to develop and then select amongst several
2 o before would have to be on the drug before they
21
Has Purdue Pharma done a study since
Q.
17 then?
Yes. Do you know if Purdue ever
wanted to do a study to make that determination that
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1
the delivery system and abuse it.
Have you ever seen the deposition of
Q.
2
3
Curtis Wright in the Poston case?
He was a doctor who a friend in Utah
A.
1
2
was using . And he must -- it looks like he may have
3
asked through his friend for me to send him some
Betadine. He was a DPM, Doctor of Podiatric Medicine,
4
A.
In the?
4
5
Q.
Poston. P-O-S-T-O-N.
5 and they do a lot of surgery, and Betadine is a
6
A.
No, I have not.
6
necessary part of any surgical procedure. At least
7
Q.
Did you ever discuss with Curtis
7
it's an antiseptic, and antiseptics are a necessary
8
Wright whether studies could have been done on the
8
part.
9
abuse potential of OxyContin prior to the release of
9
1 o OxyContin?
Let me give you a copy of this. And
Q.
10 this is -- if we can mark this as Exhibit 37.
11
A.
No.
11
{DEPOSITION EXHIBIT NO. 37 MARKED)
12
Q.
If he testified those studies were
12
(Passing document.)
13 possible and could have been performed prior to the
14 release of OxyContin, would it surprise you?
A.
15
This is an e-mail dated May 15th,
Q.
13
14 1996. It looks like it was received by P. Goldenheim,
15 M.D.
I would have to know more before I'd
16
registered surprise or not. I'd have to know what he
16
17
meant, what kind of studies and -- and so on. Perhaps
1 7 correct?
He does work at Purdue Pharma,
18
he said we could have attempted to do it. That would
18
A.
Yes. He was --
19 surprise me less than if he said absolutely it could
19
Q.
And it looks like you were also
2 o have been done. So I just have to know what he's
2 o included by fax, Dr. Richard Sackler?
21
21
22
23
talking about.
Q.
This -- let me hand you this e-mail.
22
Sorry about the delay there.
23
A.
That's what it says.
Q.
And if you go to the third page, it
says, "Professor Dayer did not see any major problems
24
(Passing document.)
24
regarding registration of OxyContin in Switzerland.
25
This is an e-mail from -- appears to
25
Some specific points need to be clarified (monitored
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1
be Richard Sackler on 8-27-97 to Craig A. McManama in
1
release approval as for DHC may be a possibility). He
2
Utah. That's a doctor; is that right?
2
considers the following subjects as important and
would need further investigations:"
3
A.
The name is not familiar.
3
4
Q.
If you will go to the -- why don't we
4
5
5
mark this 36.
6 opioids because of the rapid onset of action of
(DEPOSITION EXHIBIT NO. 36 MARKED)
6
The first paragraph says, "Information
about the abuse/addiction potential versus other
If you'll go to the bottom of the
7
8 second paragraph, you write to him, "I am drawing your
8
9
9
A.
You did .
10
Q.
Did -- do you know if you obtained
7
1o
Q.
attention to our newest product, OxyContin Tablets
(controlled-release Oxycodone HCI)
and have included
OxyContin."
Did I read that correctly?
11 some literature. Most important to your practice,
11 approval to sell OxyContin in Switzerland?
12 time of onset of OxyContin is as rapid as
12
A.
I believe we did.
13 Immediate-Release Oxycodone, but duration is a full 12
13
Q.
And did you provide him with the
14 hours and the patient reaches full blood levels in
14 information about the abuse/addiction potential versus
15 other opioids because of the rapid onset of action of
15 just two doses (one day),"
Was it your belief that the time of
16
16
1 7 onset of OxyContin was as rapid as Immediate-Release
17
18
18
19
20
Oxycodone?
A.
That is what our data showed more or
less. Almost as immediate. I believe in the study
OxyContin that he requested?
A.
I'm not clear that he was actually
requesting it, just saying that it was his opinion it
19 was necessary for registration, but I don't know
2 o whether anything was produced . I doubt anything was
21
that I was referencing, but didn't reference in the
21
produced here that was not produced for the FDA or the
22
note, I think it was 41 minutes for immediate-release
22
other European agencies who approved OxyContin. If
23
and 45 minutes or something like that for OxyContin.
24
25
Q.
23
anyth ing was produced that was different, that is,
Now I recognize who he is.
24
additional studies, they would have also gone to the
And who is he?
25
FDA.
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Do you know why he was concerned about
1
many valleys, does that cause -- is that more likely
2 the rapid onset of action of OxyContin with respect to
2
to make them become addicted or less likely, do you
3
know?
Q.
1
3
abuse and addiction?
4
A.
I don't know.
4
5
Q.
With respect to the claims about peaks
5
I don't think the -- the valleys were
A.
about the same, too. So I don't think that the
6 and valleys, did you ever review the information to
6 valleys or the height of the peak would have been any
7 see what peaks and valleys were present in the plasma
7 different. The principal difference, I think, would
8 blood levels with respect to OxyContin?
9
A.
In the five months did you say?
10
Q.
No. Did you ever review --
8 have been -- and you're saying "addictive" -- would
9 have been fewer peaks. And all of this presumes that
10 they were abusing the drugs as they were made and
11
A.
I'm sorry. My hearing is not perfect.
11 presented.
12
Q.
That's okay.
12
And if they use it as made and
Q.
13 presented, they would also be taking drugs for
I said, with respect to peaks and
13
14 valleys, the claim that peaks and valleys are
14 breakthrough pain potentially, correct?
15 different, did you ever review the literature
15
16 regarding that?
16 prescriptions from a physician.
A.
17
I was familiar with some studies that
17
18 demonstrated that. It was, to some extent, an obvious
They might well be -- have gotten two
A.
Right. If they -- you know, the
Q.
18 studies show that it lasts from 8 to 12 hours, and if
19 characteristic. Since the drug was taken twice a day,
19 it lasts 8 or 9 hours in a patient and doesn't last
2 o you'd have two peaks; whereas, the immediate release
2 o until 12, he may need an additional prescription --
21
was taken four to six times a day and so you'd have
21
22
four to six peaks.
22
23
24
25
Q,
Do you know if the level of peaks and
troughs are similar or different?
A.
My recollection is that they are about
rescue prescription for that also, correct?
Possibly. I would have told the
A.
23
physician, use the rescue, compute the daily dose and
24
try giving that dose as OxyContin twice a day; that
25
is, half of that dose twice a day.
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1
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the same. But that's a fuzzy recollection and I would
1
Do you know, was there any study done
Q.
2
need to see the data to refresh myself and be sure. I
2
to determine whether patients who were given
3
think you -- my recollection is they were close.
3
Controlled-Release OxyContin and then had to take
4
another one, because it didn't last 12 hours, were
controlled-release, because it maintained a higher
5
more likely to develop addiction or less likely to
6
level and didn't have as much trough during the day,
6
develop addiction?
7
would be more likely to cause addiction or less likely
7
4
s
Q.
Do you know whether the
8 to cause addiction?
9
A.
I -- my impression is that the average
I know of no such study, and I don't
A.
8
recollect that anybody ever suggested such a study or
9
such a hypothesis. I would have had -- I would have
1 o blood level was the same, and I'm not certain -- so
1 o asked them why do you think that they are more prone
11 your question is, given that the average blood level
11
12
or less prone to addiction. I wouldn't think it would
is the same -- if I'm correct. And that's a
12
make a difference. Again, not based on a study but
13 recollection . I haven't seen that data for a very
13
based on a conjecture. So I really would have to
14 long time. The only difference -- the difference in
14 understand what is the reasoning why -- why taking the
15 the blood level, the remarkable difference, would be
15 drug three times a day would be more likely to cause
16 half as many or a third as many peaks and valleys.
16 addiction or less likely.
And to the extent that somebody was
17
MR. THOMPSON: Could we go off the
17
18 seeking the drug or enjoying that element of the drug,
18 record one second?
19 the peak effect, I would think that the drug would be
19
VIDEOGRAPHER: We are off the record
2 o less attractive. But it's a conjecture, it's not
20
21
knowledge, because I don't think we ever did a study
21
(RECESS)
22
that I'm aware of.
22
VIDEOGRAPHER: We are back on the
23
24
Q.
My question is, if somebody has a
controlled-release and maintains a higher level during
25 the day with respect to valleys, they don't have as
Coulter Reporting, LLC
at 6:20 p.m.
23
record at 6:33 p.m .
24
25
Q.
What I'd like to do is have you sift
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1 through these documents, and with the exception of the
1
conduct has led to an increase in people being
2
GAO report, are all of these documents that are kept
2
addicted in the Commonwealth of Kentucky?
3
in the ordinary course of business at Purdue?
3
A.
No.
No, they would not all have been kept,
4
Q.
Do you agree that education
A.
4
5
5 information presented by a drug company to physicians
to my knowledge, in the ordinary course of business.
6 We would have had some sort of destruction policy.
7
6
But we have been engaged in litigation for so long and
needs to be fair and balanced?
7
A.
Yes.
8 so many different matters that basically, at least my
8
Q.
And do you agree if a company learns a
9 documents I have, I don't think anything has been
9
1 o sold by the company that they have a responsibility to
1 o thrown away.
Q.
11
12
11 educate them properly about the drug?
Are these all documents that are
generated in the ordinary course of business at
13 Purdue?
A.
14
15
physician does not understand a drug that is being
Or at -- at Purdue Frederick or in
12
A.
Yes.
13
Q.
Do you think Purdue has an obligation
14 to provide physicians with truthful information?
other companies or some of the overseas companies,
16 yes.
15
A.
Yes.
16
Q.
Do you believe Purdue provided any of
17
Q.
Sure. Purdue Pharma and Mundipharma?
1 7 the physicians in Kentucky with information that was
18
A.
Purdue Pharma, Mundipharma, Purdue
18
19
Frederick, whatever.
Q.
And are all of these business records?
21
A.
I don't know. You know, I'm not a
22
lawyer.
20
24
A.
No, I don't believe that.
Q.
And is that because you don't believe
21
for a legal conclusion .
MR. THOMPSON: I'm not sure it is.
25
19
20
any of the sales reps engaged in the conduct that
22 is -- any of the sales reps in Kentucky engaged in the
MR. STRAUBER: I think that's asking
23
not truthful?
23
conduct that is described in the felony plea
24
agreement?
25
A.
That's my belief. I don't have any
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1
Q.
Can you answer the question?
1 facts to inform me otherwise.
A.
Okay. Are they business records? I
2
Q.
And you never checked, did you?
3
really don't understand what that term means. It's
3
A.
I don't know how I would have checked
4
not a term I've ever used, so -- they are what they
4
5
are.
5
Q.
Could you have looked at the call
2
6
Q.
I asked you about the OxyContin 20
6
that.
notes from your salespeople in Kentucky to see what
7
milligram prescription. To your knowledge, was
7 they were telling physicians and whether it was the
8
anything done to determine how many people put on 40
8
same information referenced in the felony plea
9
milligram, 80 milligram or 160 milligram prescriptions
9
agreement?
1 o would become addicted or dependent if they took it for
10
11 a certain period of time?
11 but I believe that all the call notes were reviewed at
12
A.
No.
13
Q.
Sitting here today, after all you've
12
I could have looked at the call notes,
A.
least once and probably multiple times by many people.
13
Q.
And why do you have that belief?
14 come to learn as a witness, do you believe Purdue's
14
A.
Because I know of the number of
15
15
conduct in marketing and promoting OxyContin in
investigations and the extensive training and
16
Kentucky caused any of the prescription drug addiction
16
retraining that was done, and I believe it would have
17
problems now plaguing the Commonwealth?
17
surfaced, any evidence of wrongdoing and been
18
A.
I don't believe so.
18 actionable.
19
Q.
Sitting here today, after all you've
19
But as I've said, I've only seen a few
2 o come to learn as a witness, do you believe that
2 o call notes, and the ones I've seen are so cryptic and
21
Purdue's conduct in Kentucky has led to an excessive
21
imprecise and unclear in their references. Often you
22
or unnecessary amount of opioids being located
22
don't even know who's saying what. These were memory
23
throughout the Commonwealth of Kentucky?
23
joggers that I've seen. They were written by a person
24
A.
I don't believe so .
24
who had a conversation who wanted to recall that
25
Q.
Do you believe that any of Purdue's
25
conversation two, four, six weeks later.
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And when the call notes say "I told
Q.
1
2 the doctor about less abuse" or "I told the doctor the
2
3
drug had less euphoria" or emphasized that, that would
3
4
be improper, correct?
5
6
7
If such call notes existed and they
A.
were that explicit, yes. I didn't see any like that.
Lexington, Kentucky from a K. Boyles.
Do you know who that is?
4
A.
I don't know either of those people.
5
Q.
Under "Notes Memo" it says, "Got to
6 convince him to counsel patients that they won't get
7 buzzed as they will with short-acting."
Did it ever occur to you to check and
Q.
So here's a call on a Marc Dubick in
Q.
1
8 see whether the people you hired and paid SO million
8
9 dollars for to do a presentation and defend Purdue in
9 thing to do, counsel the doctor that the patients --
Now, would that be an appropriate
1 o the U.S. Attorney's Office in the Western District of
1 o tell the doctor -- convince the doctor to counsel
11 Virginia gave accurate and truthful information to the
11 patients that they won't get buzzed as they will with
12
U.S. attorneys regarding the call notes?
14
16
14
You can answer.
reading from a document, please show the witness.
(Passing document.) .
15
It wouldn't occur to me that any
A.
MR. STRAUBER: Again, if you're
13
the question.
15
17
12 short-acting?
MR. STRAUBER: I object to the form of
13
attorney that we hired would give false information to
16
MR. STRAUBER: May I have a copy?
17
MR. THOMPSON: This is the only copy
18 any other attorney, and much less so to the U.S.
18 we have. You'll have to look at it together.
19 attorney and his deputies.
19
20
21
When doing a call note search, did you
Q.
This is pretty easy to read. So could
A.
2 0 you repeat the question?
ever find out how they went about it?
Yes. Would it be appropriate to
Q.
21
22
A.
I'm sorry?
22 counsel the doctor -- to convince the doctor to
23
Q.
When -- when the people you hired did
23 counsel his patients that they would get less buzz
2 4 their call note search, did you ever find out how they
24
25
25
went about it?
with OxyContin versus --
Well, what it says here is that they
A.
Page 298
1
Page 300
At the time it was described fairly
A.
1
won't get a buzz. And I don't think that telling a
patient "I don't think you'll get a buzz" is harmful,
2
explicitly, but that was years and years ago. That
2
3
was almost 15 years ago.
3
because if they do, I would think that the patient
4
would report it and he would know, oh -- I don't know
MR. STRAUBER: I think any further
4
5
questions along this line will really impinge on
5
why he would have told this to a patient. But I think
6
attorney-client privilege, so I object.
6
that it actually could be helpful, because many
7
8
Q.
Was a breakdown of the results ever
provided to you?
9
A.
In a way, yes.
10
Q.
When you say "in a way," how was it
11 provided?
12
A.
patients won't get a buzz, and if he would like to
8
know if they do, he might have had a good medical
9
reason for wanting to know that.
10
Well, I was told that --
12 buzz was one of the things prohibited by the -- in the
13 statement -- Agreed Statement of Facts in the felony
14
think your questions are really leading the witness
15
into attorney-client communications, and I would
15
16
direct him not to -- not to respond to those
16
17
questions.
18
Do you know whether telling patients
Q.
11 they won't-- telling doctors patients won't get a
MR. STRAUBER: Let me interrupt. I
13
7
MR. THOMPSON: Well, certify the
14
plea?
A.
Yes. But that isn't what it says. He
said -- we don't know what the conversation was
17
between the doctor and the rep. But, as I've
18
testified just a minute ago, I could see that this
19 question and we'll talk to the judge about it. I
19 could have been not only -- not harmless, but helpful.
2 o think I'm entitled to go into it. If the judge says
20
21
no, then of course we can't.
22
23
(Whereupon, the pending question
23
24
was certified to the Court for
24
25
ruling.)
25
Coulter Reporting, LLC
Here's one --
MR. STRAUBER: Are you going to mark
21
MR. STRAUBER: That's fine.
22
Q.
that as an exhibit?
MR. THOMPSON: No, I'm just going to
ask him about these.
Q.
Here is one --
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Richard Sackler, M. D.
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1 time period, correct?
MR. STRAUBER: The only difficulty I
1
2
have with that is, you're asking him questions about
2
A.
Yes.
3
them and then we, going forward from here, have no
3
Q.
So by what kind of twisted logic are
4
record of what it is he was looking at.
4
MR. THOMPSON : Well, this is my only
5
6
copy. That's why I don't want to --
you saying that saying this in 1998 wouldn't be
5
improper because the -- because the Agreed Statement
6
of Facts is in 2007?
7
THE WITNESS: You can keep it.
7
8
MR. STRAUBER: Why don't you mark it
8
the question. It isn't a question; it's
9
argumentative, and it's really uncalled for.
9
as an exhibit, don't give me a copy -MR. THOMPSON: If you want to mark it
MR. STRAUBER: I object to the form of
10
Q.
If you can answer, go ahead.
11 later, you can, but I 'm going to ask him my questions
11
A.
I think I should stand on what I said.
12 right now so I can get out of here.
12
Q.
Well, let me ask you this. Tell me
10
13 all the bases you have for believing that saying this
MR. STRAUBER: I object to this line
13
14 in 1998, to talk of less euphoria with Oxy, would
14 of questions.
15 somehow not be a problem because the agreed statement
MR. THOMPSON: You can object. I
15
16 don't have to mark it if I don't want.
Q.
17
16 was in 2007?
Here is Ellen Ballard in Louisville,
20
21
22
19 don't have a dialogue. I wasn't present. I don't
Do you know who that is?
19
A.
Yes.
Q.
And in here it says, "Talked of less
2 o know what he said. And I don't even know whether this
21 was a document upon which the Agreed Statement of
euphoria and more convoluta with Oxy."
22
Facts was constructed. For all I know, this document
was tossed away as inexact or inexplicit.
23
Would it be inappropriate to tell
23
24
patients they get less euphoria with Oxy?
24
25
A.
I don't know what he said in 1998. I
A.
17
18 know what he wrote, but I don't have quotes on it, I
18 Kentucky, sales rep Mark Curran.
25
We really don't know what was said.
Let me ask you about this document.
Q.
James Donley is the doctor at the Trover Clinic in
Page 304
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1
1 Madisonville, Kentucky who was called on by Holly
As I said, this is a memory jogger. He might have
2
said, "There may be less euphoria," or, "Some people
2
Will. The note's memo says, "Quick, reminded him that
3
have less euphoria," or -- we just don't know what was
3
Oxy gives flat blood levels, so less buzz than
4
said here.
4
Lortab."
5
Q.
Okay.
A.
5
Is that the type of statement that's
prohibited by the Agreed Statement of Facts?
If all he said was "There may be less
6
7
euphoria," that could be true, and I don't see the
7
8
harm. If he promised less euphoria, it shouldn't have
8 said. If you're asking me a hypothetical, I would say
9
been said .
9
6
10
Q.
I don 't know that that's what she
A.
that this is not -- neither accurate nor appropriate.
10 It doesn't actually give flat blood levels as you
An Agreed Statement of Facts doesn't
11 say you have to promise less euphoria, it says if you
11 know, and as our rep knew and as any doctor who had
12 mention to a doctor or infer that it causes less
12 been properly presented the product would know. But,
13 euphoria, that's improper, correct?
13 nevertheless, even though it is demonstrably wrong, it
14
A.
14 would be still inappropriate to say on two bases; on
That was what we agreed to, yes. But
15 this was 1998, long before there was an Agreed
15 the basis of the Agreed Statement of Facts and also on
16 Statement of Facts .
16 the basis it's untrue.
17
Q.
What difference does that make? If
But, again, I have to emphasize, these
17
18 it's improper in 2007, wouldn't it be improper in
18 are not transcripts. These are about as distant from
19 1998?
19 transcripts as anybody can get. This is a memory
20
A.
Not necessarily.
2 o jogger, and I don't know what she said, and I find it
21
Q.
Well, the improper conduct that the
21 hard to believe that she said anything like this.
22 Agreed Statement of Facts -- the time period was 1996
22 This was to remind her of a discussion.
23
23
Q.
Have you ever spoken to her?
No.
Okay. This is Dr. David Parks in
to 2001, correct?
24
A.
Yes.
24
A.
25
Q.
And if this is 1998, it's within that
25
Q.
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1
Bowling Green, Kentucky, who was called on by Philip
1
at the package insert and could see was that in the
2
Gross. "Love the idea of getting effective pain
2
package insert or was it reasonably the same as what
3
relief, but not euphoria to get rid of druggies."
4
3
was in the package insert. I'd have to do a textual
(Passing document.)
4
analysis. It's close to what was in the package
If it was discussed with him that it
5
insert, very close, but it might have drifted away
gives effective pain relief but not euphoria and he
6
from the package insert so that at that time it was
7
loved the idea, would that be inappropriate comments
7
inappropriate. But I'm not sure because I have to
8
to make?
8
read the two -- the hypothetical statement you put
9
forward and the package insert to give you an opinion
5
6
Yes. If our rep made it. If the
A.
9
1 o doctor made it, I don't think that it's -- it may be
1 o as to whether it has drifted away from the package
11 erroneous, but it isn't improper. And I don't know
11
12
12
who made the statement.
insert.
It would be pretty easy to tell if we
Q.
13
Q.
If the rep made it --
13 looked at the Agreed Statement of Facts because they
14
A.
Or, in fact, even what statement was
14 outlined the comments they felt were improper between
15
made. I have not -- I don't remember seeing any of
15
16 these notes, by the way. But these are typical. They
16
17
17
are fragments of fragments of fragments of a
18 conversation that are designed to remind the rep of a
19
1996 and 2001, correct?
I didn't memorize the Agreed Statement
A.
of Facts either. But, yes, if that statement was an
18 example of an inappropriate statement, obviously it
conversation that he or she had two, three, four,
19 would -- we agreed it was inappropriate.
2 o five, six weeks prior. So they mean a lot, but
20
21
without asking the person who wrote them what it
21
required your -- your representatives or salespeople
22
meant, we don't, sitting here, have any idea what it
22
to do call notes and instructed them to do them within
23
means.
23
minutes of completion of the call, correct?
24
Q.
If the -- if the Purdue sales rep
25 calls on a doctor in Kentucky and explains to him that
And these call notes, you-all actually
Q.
24
A.
That's correct.
25
Q.
And that's because the information
Page 306
1
Page 308
1 recorded is generally more accurate when it's recorded
Oxy has less potential for abuse due to its sustained
2
release, would that be improper and the type of
2
immediately after the sales call while the events of
3
statement that was agreed was improper in the Agreed
3
the call are fresh in the representatives' minds,
correct?
4
Statement of Facts when Purdue pied guilty to a
4
5
felony?
5
6
A.
THE WITNESS: Could he just restate
7
8
9
Okay. State the hypo --
the hypothetical question?
Q.
Sure. If Purdue called -- I want you
I don't think that that would be true
A.
6
in the way these call notes were used -- written or
7
used when reviewed. I don't think it would have
8
mattered if they had done it that evening.
But when the system was -- or when
9
1 o to assume a hypothetical. If Purdue called on a
10 that policy was established, whoever established it
11 doctor and said that OxyContin has less potential for
11
12
abuse due to its sustained release, would that be the
13 type of statement that would be inappropriate?
14
A.
And when was that said? You're going
15
to set a time limit to it or a time period to that
16
hypothetical?
17
Q.
No. I'm just trying to get an idea of
probably had a different use in mind and expected them
12
to be much, much more -- much closer to a "he said, I
13
said," "he said, I said," "he's interested in this, I
14
have to get him an answer for that."
And the notes I've seen so far depart
15
16 so far from that that I don't think it mattered
17
whether they did it in a minute, an hour or a day. So
18
what statements you consider inappropriate versus
18
long as the conversation was fresh in their mind, they
19
appropriate.
19
sketched some notes to remind them of the conversation
Would that be an inappropriate
20
21
statement for a rep to tell a doctor?
2 o a few weeks later, two to six weeks later.
21
Q.
When you disciplined people, how did
22
A.
Today, yes.
22
you make a determination which ones needed to be
23
Q.
Would it have been inappropriate from
23
disciplined -- sales reps needed to be disciplined?
24
25
1996 to 2001?
A.
I'm not sure, because I'd have to look
Coulter Reporting, LLC
24
25
A.
I didn't discipline anybody and so I
was not asked to make a determination.
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Richard Sackler, M.D.
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Do you know if the people who did make
Q.
1
2
that determination relied on the call notes in
2
3
determining whether discipline should take place?
3
4
A.
I don't know.
4
5
Q.
Do you know if the reps in Kentucky
5
I would have to study the package
A.
1
insert.
Let me -- let me go back and talk
Q.
about what -- maybe this will help us here.
Under "Misbranding of OxyContin" there
6 were disciplined for having inappropriate call notes
6 were several things that were brought up that were --
7 that reflected their conversations with physicians?
7
were inappropriate'-. And it says, "With the intent to
defraud or mislead" --
8
A.
I don't know.
8
9
Q.
If a sales rep went to a doctor and
9
MR. STRAUBER: Are you reading from
1 o said "Discussed lack of buzz and, thus, won't be drug
1 o the Agreed Statement of Facts?
11 seeking," would that be an inappropriate comment to
11
12 make?
12
Could you form the comment for me,
A.
13
MR. THOMPSON: I'm reading from page 5
of the Agreed Statement of Facts .
14 since it's a hypothetical, as a sentence and then I'll
14
15 respond to it?
15
A.
If a sales rep went to a physician and
Q.
What number is that?
A.
13
MR. STRAUBER: It's Exhibit 33.
I'll have to find it now. Is this it?
16
Q.
Yes.
1 7 said, "You don't get a buzz with OxyContin," would
17
A.
And where are you reading from,
18 that be an inappropriate comment?
18
please?
19
Q.
16
19
A.
Yes.
20
Q.
If a sales rep went to a physician --
2 o intent to defraud or mislead" -- I'm sorry. Let's
MR. STRAUBER: I have to -- you're
21
Page 5, paragraph 20. "With the
21 back up.
22
going through a whole line of questioning where you
22
23
have documents, you purport to be reading from them,
23
24 you're not showing them to me, you're not showing them
24
25
25
to the witness. I don't think it's a fair line of
"Purdue's supervisors and employees,
between December 12th, 1995" --
MR. STRAUBER: Again, you lelt out the
word "certain."
Page 310
1
Page 312
inquiry.
MR. THOMPSON: I'm asking him what
2
2
3
types of questions a sales rep says. Whether I've got
4
notes or documents or I've got them in my head doesn't
4
5
matter. I get to ask my questions. You can follow up
5
6
if you want.
8
9
documents in front of you that you're reading from.
Q.
read it in its entirety, then .
MR. STRAUBER: Okay.
3
MR. STRAUBER: You appear to have
7
MR. THOMPSON: Sorry. Well, I 'll just
1
If a salesman went in and discussed
"Beginning on or about December 12th,
Q.
1995 and continuing on or about June 30th, 2001,
6
certain Purdue supervisors and employees, with the
7
intent to defraud or mislead, marketed and promoted
8
OxyContin as less addictive, less subject to abuse and
9
diversion, less likely to cause tolerance and
1 o abuse potential and benefits of Oxycodone --
10 withdrawal than other pain medications."
11 OxyContin -- I'm sorry -- and it not giving a
11
12 euphoria, would that be inappropriate?
13
12
MR. STRAUBER: Objection.
13
Did I read that correctly?
I think so. It's getting late, so I
A.
might have missed, too.
14
A.
I believe that would be inappropriate.
14
15
Q.
If he tells them that there's less
15 by the U.S. Attorney's Office that formed the basis of
Q.
And it was a review of the call notes
16 euphoria with OxyContin, he or she, the sales rep,
16 this plea agreement, correct?
1 7 says there's less euphoria with OxyContin, would that
17
A.
I don't know that.
18
Q.
Did you ever review any of the
18 be inappropriate?
19
A.
Less amount of euphoria or less likely
2 o to be euphoria or something else?
19 documents filed by the U.S. Attorney's Office in the
2 o case where Purdue pied guilty to the felony?
21
Q.
Either of those.
21
A.
No, I didn't.
22
A.
I believe that today that would
22
Q.
All right. And it says here --
A.
They didn't footnote these documents,
23
24
25
definitely be inappropriate.
Q.
Would it have been inappropriate
between 1996 and 2006?
Coulter Reporting, LLC
23
24
so I don't even know if they -- the documents -- they
25
reviewed millions of documents. I don't know whether
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502-582-1627
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Page 313
1
they referenced any of the documents to this. I
2
certainly couldn't have reviewed millions of
2
3
documents. No one person could have done that.
3
Q.
4
Page 315
MR. THOMPSON: I wasn 't going to.
1
Under number -- subparagraph "e" it
MR. STRAUBER: Could you identify it
so we'll know what it is?
MR. THOMPSON: I thought I did. It's
4
5 says, "Told certain healthcare providers that
5
6
6 to Blue Cross/Blue Shield.
OxyContin did not cause a 'buzz' or euphoria."
And that would be improper, correct?
7
A.
8
It depends on -- oh, did not cause.
8
Q.
I'm looking at the third paragraph.
Q.
7
9 Yes, that would be inappropriate.
10
the reply of the United States to Defendant's response
"Purdue states an analysis of the notes that Purdue's
9 sales representatives kept from their visits to
"Caused less euphoria, had less
10 physicians revealed that less than .2 percent
11 addiction potential, had less abuse potential, was
11 contained any evidence of statements that were
12
less likely to be diverted than immediate-release
12 arguably improper."
13
opioids, and could be used to 'weed out' addicts and
13
14 drug seekers."
15
A.
In its totality, it's inappropriate.
16
Q.
And one of the things that it points
17
15 arguably improper?
16
out in here, when we went on, was the osteoarthritis
17
18 study.
19
As they say, actually, here in their
A.
response, "were even arguably improper."
18
Do you remember us talking about that?
19
Were you aware that they had claimed
14 that two-tenths of one percent of the sales notes were
But the U.S. attorney says, "This bare
Q.
statistical reference does not provide a complete
20
A.
I do.
2 o picture of the magnitude of the unlawful activity
21
Q.
Here's Carol Neilheisel, sales rep.
21
described in the information in the Agreed Statement
22 This is William Yates, doctor, Florence, Kentucky.
22 of Facts. In fact, these very same notes show the
23
And the note's memo says, "Brought osteoarthritis
23
pervasive nature of the false and misleading
24
studies that show non-addiction. Discussed how he
24
statements.
25 could use Oxy to deter addictive behavior. Less
"For example, according to the notes,
25
Page 314
Page 316
1 pills, less potential for abuse."
1
in at least 41 states physicians were informed that
2
(Passing document.)
2
addicts would not like OxyContin or that OxyContin
3
Would you agree that those comments
3
could be used to weed out drug seekers because addicts
4
would not like it. In at least 49 states physicians
4
would be improper and inappropriate?
A.
5
6
If they were quotes of the transcript
or of what he said, yes, this is inappropriate.
5
were informed that OxyContin produces no 'buzz' or
6
euphoria, and in 50 states physicians were informed
that OxyContin had less abuse potential than other
7
Q.
And --
7
8
A.
In its totality it's inappropriate.
8 opioids."
MR. STRAUBER: Are you planning to
9
1 o mark this as an exhibit?
MR. THOMPSON : I was not going to mark
11
12
13
it, no.
Q.
And it says here, "Purdue states
14 that" -- I'm reading from the reply of the United
Would all of those comments be
9
1 o improper?
11
A.
Those comments would be improper, yes.
12
Q.
This says, "In addition, once Purdue
13 learned of the investigation, it conducted training
14 that cautioned sales representatives to avoid
15 States to Defendant's response to Blue Cross/Blue
15 including references to the false and misleading
16 Shield of Tennessee, another private third-party's
16 statements in their call notes. Eventually Purdue
1 7 request for restitution.
(Passing document.)
18
1 7 changed the call notes system altogether to preclude
18 such references by allowing sales representatives to
19
A.
This is a new document, right?
19 choose only from preselected menu items that, not
20
Q.
Uh-huh.
2 o surprisingly, omitted the false and misleading
21
A.
Is this an exhibit or not?
21
statements that the employees had previously -- that
22
Q.
I just want to ask you about some of
22
the employees previously -- had previously
23
spontaneously recorded in the notes."
23
24
25
the information in here.
MR. STRAUBER: You're not going to
mark this as an exhibit either?
Coulter Reporting, LLC
24
Were you aware of that?
25
MR. STRAUBER: I object to the form of
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that question. You're showing the witness an argument
MR. STRAUBER: Can I hear the question
1
2
written by the government and submitted to the Court
2
3
in a brief that this witness has never seen. There
3
4
are government arguments and you're asking if he was
4
20, are those the improper and misleading statements
5
aware of it.
5
that were made with intent to defraud by Purdue's
The statements outlined in paragraph
Q.
6 sales force? Does that set them forth?
MR. THOMPSON: I'm asking if he was
6
7
again? I just missed it.
aware of that activity.
I don't know. To me this is almost a
A.
7
8
A.
What activity?
8
legal question, and I'd like to know whether our
9
Q.
That "Once Purdue learned of the
9
attorneys would agree with this or not. These are
1 o investigation, it conducted training that cautioned
1 o some of the statements that are in here. I think
11
sales representatives to avoid including references to
11 there are others. So I'm not sure that you mean is
12
the false and misleading statements in their call
12
13
notes." That's number one.
13
Were you aware they did that?
14
this all and nothing else.
I don't mean -- I just mean under
Q.
14 paragraph 20 --
15
A.
I don't think they did that.
15
A.
16
Q.
And it says, "Eventually Purdue
16
Q.
Okay.
-- would that constitute --
1 7 changed the call notes system altogether to preclude
17
A.
Examples of?
18 such references by allowing sales representatives to
18
Q.
-- examples of inappropriate and --
19 choose from preselected menu items that, not
19
A.
That's what --
2 o surprisingly, omitted the false and misleading
20
Q.
-- misleading statements?
MR. STRAUBER: I object to the
21
statements that the employees had previously
21
22
spontaneously recorded in their notes."
22
question. It's been a long exam, we're late in the
23
day, and now you seem to be going over the Agreed
Were you aware that that had occurred?
23
24
MR. STRAUBER: Well, I object. You're
24
Statement of Facts again and asking the witness what
25
assuming that something occurred based upon an
25
the Agreed Statement of Facts says. What it says is
Page 318
1
A.
3
5
1
MR. THOMPSON: All right.
2
4
Page 320
argument of one party to a litigation in a brief.
MR. THOMPSON: Yes.
2
Can I verify that this occurred? I
MR. STRAUBER: I don't know where this
3
4
is getting us. At this late hour I think it's
5
starting to border on harassment.
can't.
Q.
written in the Agreed Statement of Facts.
The statements referenced in the
6 Agreed Statement of Facts under "Misbranding of
6
7
7
OxyContin" --
MR. THOMPSON: Can you read my
question back?
8
A.
I don't even see a date on this.
8
(Record read.)
9
Q.
The statements --
9
THE WITNESS: Should I answer?
10
A.
I'm sorry. Can we -- are we on the
11
12
same document, or not?
Q.
No. I'm asking about the Agreed
13 Statement of Facts now.
14
A.
Oh, okay, we're back on that. Okay.
15
Q.
The statement under "Misbranding of
16 OxyContin" --
MR. STRAUBER: I object, but you can
10
11 answer, yes.
12
A.
Yes.
13
Q.
If a sales rep told a doctor that
14 using OxyContin would provide smoother blood levels,
15 would that be an appropriate statement?
16
A.
I don't know -- if smoother blood
17
A.
What page or what number?
17
18
Q.
Page 5. You've read paragraph 20 in
18 might be an inappropriate statement, but I'm not sure
19
20
21
22
23
its entirety, correct?
A.
I had read it, but it might help me to
read it again. But why don't you pose your question?
Q.
Are those the statements that were
levels was not in the package insert, it may not -- it
19 that it wasn't in the - - in the package insert.
2 o Although it might be inappropriate, I don't know.
21
22
It would have been true depending upon
what was meant by "smoother." "Smoother" is not a
23
medical term or a pharmacokinetic term. It's an
24
A.
Of Purdue Frederick?
24
opinion of -- it's a term that somebody might apply to
25
Q.
Yes.
25
a graph. It's a smoother line; it's not a smoother
improper and constituted the guilty plea?
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line. But it's not really a clear statement and,
1
A.
2 thus, I can't say it's clearly right or clearly wrong.
I did.
2
Q.
What was that title?
3
It would have been fine if that terminology was in the
3
A.
I was a senior vice president.
4
package insert. I don't know whether it was.
4
Q.
And do you know when you relinquished
6
All right. What information did you
Q.
5
5
review to prepare for your deposition today?
that title?
I don't recall, but it probably was
A.
6
7
A.
Documents.
7
8
Q.
Which documents?
8 Purdue Pharma or before.
A.
Not too many of the ones you've shown
9
10
10 corporations. There are not-for-profit corporations
11 and there are for-profit corporations.
Am I supposed to answer this? I mean,
12
13
Yes. Any other documents that you
Q.
Would I be correct that Purdue
12
I don't --
14
15
There are different types of
Q.
9
me. This Agreed Statement of Facts we reviewed in
11 part.
13
either simultaneous with ending my presidency at
Frederick and Purdue Pharma are for-profit
14 corporations?
reviewed?
They're for-profit businesses, but not
A.
15
16
A.
That I recall and can describe to you?
16 all of the companies that you've named are
17
Q.
Yes.
1 7 corporations.
18
A.
No.
18
19
Q.
You did say you reviewed six -- less
2 o Frederick or Purdue Pharma are for-profit not
21
A.
Yes.
21
22
Q.
And that was the first time you'd seen
22
call notes?
A.
24
25
Would I be correct that Purdue
19
2 o than eight call notes; is that right?
23
All right. That's a good distinction.
Q.
not-for-profit?
They're for-profit.
A.
MR. THOMPSON: Can we go off the
23
Yes . This was the second time. And
24
as I said, they are both -- both experiences are the
record a minute?
VIDEOGRAPHER: We are off the record
25
Page 322
Page 324
1 same. They are so fragmentary that they can mean --
1 at 7 : 18 p.m.
2
it's impossible to know really what was said. That's
2
(RECESS)
3
why you had to pose hypothetical statements .
3
VIDEOGRAPHER: We are back on the
Q.
4
5
Yes. Purdue Pharma, LP., Purdue
Pharma, Inc., The Purdue Frederick Company, Purdue
4
record at 7:39 p.m .
5
6
Pharmaceuticals, LP., P.F. Laboratories, Inc., do you
6
7
know if they have the same directors or are there
7
I'm going to hand you a document that is at the top --
8
different directors for those entities?
8
let's mark this as Exhibit 38.
All right. Let's go back through --
Q.
9
A.
I don't know.
10
Q.
Do you currently practice medicine?
10
11
A.
No. Not practice in the sense that I
11 recognize that?
12
have an office or see patients by appointment, no, I
13
don't.
14
15
Q.
When is the last time that you
practiced medicine?
A.
I recognize the name. Okay.
13
Q.
All right. Was this an e-mail that
14 you sent to Michael Friedman?
15
16
In 1974 during my residency.
16
17
Q.
From 1999 to 2002 you were the
17
19
A.
From the very last days of '99 until
2 O March of 2003 .
21
22
23
24
25
Q.
Were you also at some point the
president of Purdue Frederick?
A.
I don't think so, no.
Q.
Did you have any office title at
Purdue Frederick?
Coulter Reporting, LLC
It's from Richard Sackler. Do you
Q.
12
A.
18 president of Purdue Pharma, LP.?
(DEPOSITION EXHIBIT NO. 38 MARKED)
9
A.
Yep.
Q.
And it says here under "importance"
down below, "Importance: Low." But down below it
18
says, "Why don't you guys plan a presentation about
19
addiction that could be given first by RR or BK ... "
Now, who are those individuals?
20
21
A.
Robert Reder or Bob Kaiko.
22
Q.
" ... and eventually by our senior
23
24
25
managed healthcare people."
Next paragraph, "I think that Paul has
a good point, but we should consider that 'addiction'
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Richard Sackler, M.D.
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may be a convenient way to 'just say no,' and when
1
Q.
And is that a Purdue Pharma affiliate?
It's an affiliated company, yes.
2
this objection is obliterated, they will fall back on
2
A.
3
the question of cost. Unless we can give a convincing
3
Q.
Does the Sackler family own PF Canada?
4
presentation that CR products" -- that's
4
A.
Yes. Yes, we do.
5
controlled-release products, is that what that is?
5
Q.
He says under the first paragraph, "In
A.
Yes.
6 my opinion, the action that will produce the greatest
Q.
-- "are less prone to addiction
7 sales gains are the acquisition of IMS's practice
6
7
8
potential, abuse or diversion than IR products" -- is
8 quartile data and the resulting improvement in
9
that immediate release?
9
10
A.
Yes.
10
11
Q.
-- "I think that this can be done, but
11
12
I defer to BK and RR and other experts."
targeting of our sales and marketing activities."
What does that mean?
In the United States from the
A.
12
inception of the launch of OxyContin, we focused our
13
salesmen's attention to physicians who were, based on
13
A.
Yes.
14
Q.
What were you trying to accomplish
14
their history, physicians whose practice and their
15 there by trying to show that controlled-release
15
practice was to use -- write a lot of prescriptions
16
products are less prone to addiction, abuse or
16
for opioids. We didn't go to people who didn't write
17
diversion than immediate-release products?
17
them, we went to people who did.
Well, I wasn't trying to show
A.
18
19
And I don't recall whether this
18
anything. I was basically asking the question. And
19 practice was or was not done in PF, but I might have
2 o if the answer were yes, we can put together a good,
2 o learned in a meeting that they were not doing it and
21
21
effective and medically correct presentation, I
they could not purchase the same data source from IMS
22
thought it would be useful to do so. But I was asking
22
in Canada, but they appear to have had something that
23
them can we do that, do we have the information, do we
23
would have been similar where they divided physicians
24
have the data, and obviously if we had contrary
24
into quartiles.
25
information or data, then obviously I couldn't do
25
Q.
And if you look at your response to
Page 326
1
Page 328
that.
Are you aware of any presentation
Q.
2
1
him on 9-27-96, you say, "Your most important question
2
to me was: Have physicians been reluctant to use Oxy
p.r.n." --
3
showing that controlled-release products are less
3
4
prone to addiction, potential abuse and diversion than
4
5
immediate-release products was ever done?
6
5
No, I don't think so, but I don't
A.
6
What does Oxy p.r.n. mean?
I assume that Oxy referred to
A.
OxyContin. P.r.n. would mean as needed.
7
remember how this came to an end. I put on low in
7
8
importance to indicate it was not something that was
8 Oxycodone."
9
10
11
12
urgent, it was an idea I had, and I said, Can we do
-- "in place of IR forms of
Q.
9
And that's Immediate-Release
1 o Oxycodone, correct?
this.
Then another e-mail I'm going to hand
Q.
you, we'll mark this as Exhibit 39.
11
A.
Right.
12
Q.
"I've not asked this question, but
13
(DEPOSITION EXHIBIT NO. 39 MARKED)
13 judging from the very strong sales performance and
14
(Passing document.)
14 continuing growth, I would guess that this has not
15
Q.
And this is dated -- it looks like at
16
the bottom "Analgesic Plans, Dr. Richard Sackler at
17
Norwalk."
been a problem. I think that were this the case, it
1 7 fast as IR Oxycodone, that is, 45 minutes versus 41
And is this an e-mail that you sent?
18
15
16 would be because of the very rapid rate of onset (as
18 minutes for the IR form - not even close to a
19
A.
Yes. It's quite a dense e-mail.
19 significant clinical or statistical difference)."
20
Q.
And if you go back to page 3, the
20
21
e-mail that preceded it was from John Stewart.
And was it your understanding when you
21
wrote this that OxyContin Controlled-Release did not
22
have a significant clinical statistical difference
22
A.
23
Q.
Who is John Stewart?
23
with rate of onset when compared to Oxycodone
24
A.
He was the general manager in Canada,
24
Immediate-Release?
25
Yes.
PF Canada.
Coulter Reporting, LLC
25
A.
That's correct. This was drawn from a
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Richard Sackler, M.D.
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study that was done. "Onset" is not defined here, but
1
2
it was a medical term in the trial that, I believe,
2
A.
Yes.
3
John Stewart had either been given or was familiar
3
Q,
Did I read that correctly?
1
fondest dreams."
4
with which basically recorded the first instance where
4
A.
You did.
5
the patient said, Oh, I'm beginning to feel better, my
5
Q,
All right. And then the last one I
6
pain is less. That was meant by "onset." That was
6
7
the meaning of "onset" in that trial. And that was
7
A.
8
what I was quoting from.
8
Q.
Q,
9
And it says here, "The fast rise
want to ask you about --
There's no question?
No.
When you say it outperformed your
9
10 character (now a patent in the U.S.) of the drug
10 fondest dreams, you're talking in terms of market
11 combined with familiarity and a marketing program that
11 share and what it was earning; is that correct?
12 emphasized that IR was the old was" -- I think that's
12
A.
It's the overall sales trajectory.
13 supposed to be "way" --
13
Q.
And then I've got one more e-mail to
14
A.
Yes.
15
Q.
-- "and OxyContin Tablets are the new
14 ask you about. Who was -- I'm sorry. Let's mark this
15 as No. 40.
16 way to treat moderate to severe pain has resulted in
16
1 7 our success."
17
Did I read that correctly?
18
A.
19
22
Q.
Did you read the sales bulletins when
18 you were the -- when these were sent to you?
You read -- you read very correctly
19
2 o what is written here.
21
(DEPOSITION EXHIBIT NO. 40 MARKED)
Q.
I was senior vice president. Not
A.
2 o generally. I might have scanned this. I didn't read
When it says "the fast rise
character," you're referring to OxyContin having a
2 3 fast rise as far as when relief occurs, correct?
21
them carefully. They were very carefully crafted by
22
sales and marketing people and others and I didn't
23
usually read them.
24
A.
Yes.
24
Q.
Who is Russ Gasdia?
25
Q,
And then down below that, if you go to
25
A.
Russ was then either a district
Page 332
Page 330
1
about the fourth paragraph, "The overall schema that
2
Marketing here has worked our for three of the
1
2
3 four" -- I think that's "out of three of the four"
3
4
4
should probably be. But it's written, "The overall
manager or a regional manager.
And this is January 25th, 1999.
Q.
"Prescription Sales Force."
Does that mean it went out to
5
schema that Marketing here has worked our for three of
5 everybody?
6
the four is: Oxy - 1. IR old way, OxyContin Tablet,
6
7
new way, emphasizing the b.i.d. was q, 4h." And
7
salesmen who were doing -- who were selling the
8
prescription products.
8 that's -9
A.
Versus. Versus.
10
Q,
" ... b.i.d. versus q. 4h and
9
No. It probably means it went out to
A.
Well, would it have gone to everyone
Q.
1 o selling OxyContin?
11 underscoring the similarity of onset. Other
11
A.
I believe so, yes.
12 differential benefits are emphasized, such as range of
12
Q.
And the first paragraph says,
13 doses, the very small tablets, et cetera,"
13 "... effective with the first quarter 1999, MS Contin
14 sales volume and growth" --
And then Oxy - 2, your second point
14
15 with regard to Oxy, is, "In cancer and severe
15
First paragraph. I see "As was
A.
16 non-malignant pain, the one to start with and the one
16
1 7 to stay with. Here we are going directly after the
17
18
18 meeting ... "
MSC and Duragesic business."
What is MSC?
19
announced ... " Okay?
"As was announced at the national
Q.
19
A.
Right.
20
A.
MS Cantin.
20
Q.
I skipped that.
21
Q.
And Duragesic, who made Duragesic?
21
A.
Okay. Right.
22
A.
J & J.
22
Q.
" ... effective with the first quarter
23
Q.
And you say, "Clearly" -- this is
23
1999, MS Contin sales volume and growth as well as
24
highlighted -- or capitalized. "Clearly this strategy
24 quota will be calculated at .50 cents for every
25
has outperformed our expectations, market research and
25
Coulter Reporting, LLC
$1.00."
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A.
1
2
show me where.
MR. STRAUSER: I have the same
3
4
Page 335
I'm not following you. Can you just
1
don't recall the details of the incentive compensation
2
well enough to be sure.
problem. I don't know where you're reading from.
And then it says, "As pointed out,
Q.
3
4
your priority is to sell, sell, sell" -- and that's in
bold -- "OxyContin,"
5
Q.
The first paragraph.
5
6
A.
Okay. I'm looking for "effective."
6
A.
Right.
7
Q.
And is that what the sales force was
7
Oh, I see. Okay. Sorry. These are small and I can't
8 read them that fast. I'm now following you .
Q.
9
8 instructed to do?
Let me give you this one and we'll
That's what he said they were
A.
9
1 o instructed to do. But they were instructed to do
1 O make it the exhibit.
11
A.
Okay. I'm following you now.
11 their best to sell OxyContin, I guess. This was a
12
Q.
Sure. So let's read the first
12 sales force related kind of rah-rah piece.
13 paragraph. "As was announced at the national sales
13
14 meeting, effective with the first quarter 1999,
14 paragraph, "Remain focused on positioning OxyContin as
And it also says, in the last
Q.
15 MS Contin sales volume and growth as well as quota
15 the opioid to start with and stay with in chronic,
16 will be calculated at .50 cents for every $1.00,"
16 malignant and non-malignant pain states. In addition,
1 7 continue to aggressively position OxyContin for use in
What does that mean?
17
18
A.
18 osteoarthritis, low back pain, post-neuropathic
I - - I can't be sure, but I think that
19 we were reducing the bonus for MS Contin. I'd have to
19 neuralgia and post-surgical applications where
20 read the whole thing to be sure of that. Would you
20 appropriate. Finally, continue to highlight the
21
22
23
21 advantages of OxyContin, especially for use in the
like me to read it all?
Q.
That's all right. I'm going to read
it with you here.
22
elderly. If you have any questions regarding the
23
bonus calculations for the first quarter of '99,
please contact your district manager."
24
A.
Oh, okay.
24
25
Q.
The next sentence says, "OxyContin
25
That tells me he was a regional
A.
Page 334
Page 336
1 sales volume and growth as well as quota will be
2
3
1
calculated at $1.15 for every $1.00."
A.
3
here today do you know how many patients who took
OxyContin in Kentucky became dependent or addicted?
4
sales growth and increasing the incentive by a small
4
amount on OxyContin sales growth.
5
6
7
And then the next paragraph says,
6
"Early estimates indicate that the fourth quarter 1998
Have you made any effort, or as we sit
Q.
2
Again, it was de-emphasizing MS Contin
5
Q.
manager then.
7
A.
No.
Q.
Do you believe that an inappropriate
number of patients or an excessive number of patients
8 bonus payout will be another record payout. Remember,
8
who took OxyContin in Kentucky became addicted or
9 this record payout came at a time when we were
9
dependent?
1 o utilizing a factor of .55 cents for every MS Contin
10
A.
No.
11 dollar and $1.15 for every OxyContin dollar. As we
11
Q.
Do you know or has Purdue made any
12 continue to drive more business toward OxyContin, each
12
13 of you will benefit significantly from the factoring
13 on OxyContin wound up becoming dependent and moving on
14 of $1.15 for every $1.00 of OxyContin."
14 to heroin at some point?
Again, is that referring to
15
16 de-incentivizing MS Contin sales and incentivizing
16
1 7 OxyContin sales?
17
15
18
A.
Yes. We were moving the incentive
effort to ascertain how many people who were started
No .
A.
MR. THOMPSON: I think that's all the
questions I have, Dr. Sackler. Thank you very much .
THE WITNESS: Are we finished? Or
18
19 program to focus on OxyContin. And every time you
19 maybe not. I don't know.
2 o take an incentive program, reduce it, you have, at
20
MR. STRAUSER: No questions.
21
least in some of the people who are affected, some
21
VIDEOGRAPHER: That is the conclusion
22
strong negative feelings, and that's probably why
22 of this deposition. We are off the record at 7: 58
23
there was a small increase to OxyContin . It looks
23
24
like it was 15 percent. But I'm interpolating here.
24
25
I don't recall . I certainly didn't read this and I
25
Coulter Reporting, LLC
p.m.
(Deposition concluded at 7:58 p.m.)
www.coulterreporting.com
*** * *
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Richard Sackler, M.D.
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1
2
3
)(
)(
I, LAUREN I. GOOTEE, Notary Public, State of
4
Kentucky at Large, hereby certify that the foregoing
5
deposition was taken at the time and place stated in
6
the caption; that the appearances were as set forth in
7
the caption; that prior to giving testimony the
8
witness was first duly sworn by me; that said
9
testimony was taken down by me in stenographic notes
1 o and thereafter reduced under my supervision to the
11
foregoing typewritten pages and that said typewritten
12 transcript is a true, accurate and complete record of
13
my stenographic notes so taken.
14
I further certify that I am not related by blood or
15
marriage to any of the parties hereto and that I have
16
no interest in the outcome of captioned case.
17
My commission as Notary Public expires March 26,
18 2017.
19
Given under my hand this the _ _ _ day of
20 _ _ _ _ _ _ __, 2015, at Louisville, Kentucky.
21
22
23
24
NOTARY PUBLIC
25
Coulter Reporting , LLC
www.cou lterreporting .com
502-582-1627
Page: 1
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
WORD INDEX
<$>
$1.00 332:25
333 :16 334:2,
14
$1.15 334:2, 11,
14
$250,000 186:22
<0>
0.1 164:10
165:4
02-03-97 62:18
06901-3431 8:4
07-CI-01303
1:2 9:14
<1>
1 2:8 29:2, 4
32:21 63:22
75:9 106:10
122:9 144:3
174:1 175:16
213:5 216:20
222:1 330:6
1.0 135:12, 19
1.3 104:7, 8
1.4 152:10
1:11 154:8
10 2:1 3:3
42:21 64:14
74:18, 19 75:22
104:21 105:J
111:3,9,12,16
113:12 117:19
140:23 141 :J
142:10 147:25
156:24 174:9
238:7 259:17
273:22
10,615 265 :8,
16 266:7, 15
10:06 46:6
10:18 46:9
10019 7:16
101 1 :22
10-23-96 4:21
202:5
Coulter Reporting, LLC
105 215:15
106 261:16
10th 74:22, 23
75:11
11 3:7 6:13
28:21, 25 77:4,
5 125:J 142:16
244:14 261:14
11:45 106:2
11:57 106:5
11-2-94 4:8
11-30-93 3 :3
11-3-97 62:22
1-14-97 6:2
118 7:9
12 3 :9 86:5, 6
114:10 143:16
145:16, 17
146:4, 6, 16
148:4 174:13
179:5 217:6
232:23, 25
237:12 242:l 8
260:19 261 :20
286:13 291:18,
20 292:4
12:32 128:16, 19
120 204:23
12-14-93 3 :2
12-29-94 3:12
1-25-01 5:14
1-25-99 6:9
12-8-99 5 :16
12-hour 133:12
145:23 149:7
12th 242:21
256:23 311 :23
312:4
13 103:7, 8
141:19, 22, 25
152:5 232:20,
20
130,000 220:15
1301 7:15
13103 3:10
13800 7:5 9:3
13th 206:9
261:2 264:16
265:10, 15
14 40:6 109:12,
13 125:2
171:25 233:4
140 215:15
141 44:18
14109 3:13
14th 48:17
70:4
15 35:5 110:17,
18 298:3
334:24
150,000 220:15
15110 3:15
15th 35:17
287:13
16 30:17 35 :5,
5 117:J 5 122:9
235:2 255:10
160 75:22, 25
174:9 294:9
16117 3:17
17 117:13
122:4, 5, 9
171 :25 213:13
17122 3:21
17th 222:17
223:1 225:8, 11
18 64:17
106:15 127:8, 9
18127 3:22
18th 264:16, 17
19 24:9 134:17,
19
19134 4:2
1952 20:12
1974 322:16
1980 47:14
1985 272:5
1990 15:10
1990s 20:16
1992 35:18, 19
74:21
1993 70:4 71 :8
109:23 110:3,
14,16,24
117:14
1994 103 :11, 14
131:21 135:8
148:8
www.coulterreporting.com
1995 173:23
181:3 237:12
242:22 311 :23
312:5
1996 3:21
16:10 38:20
122:19 176:1
177:12, 16
178:9, 20
215:18 216:20
244:14 270:21
287:14 302:22
306:24 307:15
310:25
1997 51:19
52:21 58:2
84:10 96:J0
101:13 106:8
206:9 215:2, 5
255 :10 256:6,
23
1998 251:20
302:15, 19, 25
303:4, 14, 17
334:7
1999 16:21
30:J 81:11
252:19, 21
254:10 278:12
279:6 322:17
332:2, 13, 23
333:14
19th 18:3
lM 164:10
<2>
2 2:9 9:14
29:J 3, 14 32:21
33:1, 4 38:15
63:23 75:8
108:J l 109:22
122:23 123:18
135:10, 19
144:3, 6 171 :23
175:22 220:3
246:6 278:7
315:JO 330:14
2.16 202:21
2.3 71:8,10
2.62 202:21
2:03 154:1 J
2:28 171:10
2:29 171 :13
20 75:21, 24
85:24 105:2
129:20 135 :] , 2,
5 140:24 142:9
147:25 156:24
169:4, 13 174:9
215:9 237:11
282:7 294:6
311:19 318:18
319:4, 14
200 1:22
274:23
2000 34:23
164:4 166:11
215:20 231:20
258:20 260:5
264:13, 16, 16,
16 265:3
266:25 268:6,
JO 269:11
274:4, 4 279:11,
12
2001 34:23
166:11 172:17,
21 173:7 213:5,
9 216:22, 25
218:18 237:13
248:J 249:2
254:J0 261:3,
22 264:9, 17
265:3, 10, JO, 15,
16 266:25
269:11 270:21
302:23 306:24
307:15 312:5
2002 68:16
69:13, 15 213:5
215:2, 5 322:17
2003 5:5 16:3
212:17 214:2
230:14, 18
264:14 274:10,
21 322:20
2004 232:21
258:J 274:10
502-582-1627
Page:2
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P ., et al.
8/28/2015
2005 45:12
222:17 223 :1
225:8, 11 226:7
2006 43 :14, 20
229 :5 266 :22
310:25
2007 230:8
274:21 284:1 o
302:18 303 :6,
16
2008 52:17
2009 16:10
2010 284:11
2012 219:6
20135 4:3
2014 14:23
15:6
2015 1:4 9:4,
12 40:7 337:20
2017 171:21
337:18
2020 258:2
2028 258:2
20th 18:3
164:3 243:9, 15
21 141:11, 12
252:9
21141 4:7
21202 8:9
2-12-97 54:24
214 171:19, 24
22 154:21,22
22154 4:8
2-22-96 4:18
2-27 55:5
2-27-97 56:5
57:3
22nd 135 :8, 13,
14 177:11,15
178:20 264:16
23 106:8 164:1,
2 170:11 243 :9
2300 7:19
23164 4:10
24 173: 1 7, 18
244:13
24173 4:12
24th 35:18
25 173:14, 15
177:6, 7, 8
Coulter Reporting, LLC
181:1 251:19
254:12
250 7:18
25177 4:16
25th 249:2
332:2
26 200:18, 19
252:18 255:25
260:5 265:3
266:25 337:17
26200 4:19
26th 248:1
27 171:20
188:18 200:17,
21, 22, 24 202:3
268:10
27200 4:19
27th 181:3
258:19
28 1:4 204:14,
15 254:21
255:25
28204 4:21
28th 9:4, 12
124:18 232:21
261 :22 265:11
29 2:8, 9
205:23 212:3, 4,
6, 7 256:5
29205 5:2
298 6:13
29th 30:1
2nd 86:7
110:14, 16, 24
210:8
<3>
3 2:11 32:10,
11 33:1 41:17
64:11 90:20
92:8 94:14
109:22 144:14
149:22 164:15,
22 326:20
3,000 136:21
194:1,4,15
3.000 64:8
3.2 71 :23 72:5,
6
3:27 209:12
3:30 209:7
3:42 209:15
30 64:17 74:25
217:23 218:3, 4,
23, 24 259:13
3-0 218:6
300-plus 215:18
30218 5:3
308 44:21
30-day 11 :18
30th 14:23
15:6 237:13
254:J o 265:3,
10, 16 266:25
269:11 218:J o,
12 312:5
31 220:1, 2
258:24
3-11-97 54:19
3-12 62:17, 21
67:23
31220 5:6
3-12-97 54:23
62:17
3-15-97 2:21
31st 16:21
124:17
32 2:11 225:25
226:1, 3 259:20
261:17
3-2 62:18
3-2-1997 62:16
32226 5:10
3-22-93 3:17
3-22-94 4:3
133:6
3-2-97 54:18
32nd 7:22
33 226:2, 3
311:14
33,400 215 :20
3-31-95 4:15
38:3
33226 5:12
34 247:22, 23
251:18 260:4
3-4 156:11
158:10 161:15,
www.coulterreporting .com
17, 25 162:4
163:14, 19
34247 5:14
3-4h 155:7, 25
162:19
35 215:23
261:25 278:10,
11
350 7:22
35278 5:16
36 286:5, 6
36286 5:19
367.170 225:2
37 287:1 o, 11
37287 5:21
3-7-96 4:16
38 2:13 261:19
266:24 324:8, 9
38324 6:2
3-8-97 64:20
39 2:17 74:25,
25 326:12, 13
39327 6:5
3rd 62:20
<4>
4 2:13 37:25
38:1 39:18, 19
43:21 46:12
331:15, 16
40202 7:5, 23
40203 1:23
40331 6:8
40507-1758 7:19
40601 7:10
41 286:22
316:1 328:17
4-13-94 4:2
42 181:4
4-20-2000 4:12
4-22-97 106:12
4-23-97 3 :15
4-2-93 3:17
43 2:19
44 270:9, 15
44,500 215 :20
4-4-95 4:14
4-4-97 2:24
45 286:23
328:17
4-6 161 :15
4-7 4:12
48 2:21
49 316:4
492 45:10
4h 330:7, JO
4th 68:16
75:11 173:22
67:1 80:3
94:14, 15
103:22 118:1, 1
129:9 140:14
144:17 152:10
157:1 161:25
163:11 164:13,
15 274:21
4,718,000,000
45:17
4,718,767,000
43:21
4.3 119:11
4.6 175:15
40 75:21, 25
94:6, 19 148:1
174:9 216:21,
24 259:13
267:22 278:22
282:14 294:8
<5>
5 2:17 39:20,
21 42:24 43:5
62:23, 25 74:14
89:4 117:18
131 : 7 144: 18
156:6 164:8
175:16 180:10
223:7, 8 311 :11,
19 318:18
5.4 72:10
5.851 181:6
5.852 182:5
5:26 278:1
5:55 278:4
50 17:14 47:9
56:20 85:22, 22
167:2, 4 185:25
216:1 273:22
502-582-1627
Page: 3
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
297:8 316:6
332:24 333:16
500 175:1
502 1:23, 24
505 246:6
50s 150:2
5-15-96 5:21
5-17-05 5:10
5-28-97 3:7
77:13
5-31-99 2:11, 13
536 44:13
54 2:22
55 334:10
5-6-96 5:23
582-1627 1 :23
587-6299 1:24
5-milligram
74:12
<6>
6 2:19 35:24
36:10 43 :2, 6, 7,
8 45:22 149:23
157:1,4,5, 7
159:7, 19
160:22 162:22
163 :6, 12, 14, 20
217:6 222:24
224:23 242:19
6.2 129:10
215:5
6:20 292:20
6:33 292:23
60 94:6 259:9
260:21, 24
267:4
6007 257:25
6-12-97 3:9
6-13-97 5:3
6-16-97 5:2
6-22-94 4:5
6-24-92 2:16
6-2-97 90:18
210:7
670,000 215 :5
68 238:6
6-8-94 4:6
69 12:15
Coulter Reporting, LLC
6-9-99 4:23
204:17
6h 158:8
6h, 156:7
<7>
7 2:21 47:25
48:1 213:6
266:22
7,500 136:21
193:2, 8
7,502,367,000
44:7
7.0 131:8
7.2 132:17
7:18 324:1
7:39 324:4
7:58 336:22, 24
70 185:25
259:7 260:22
70,500 215:22
700 7:9 215:20
70s 24:15
713 144:2
7-15-92 2:15
7-16-90 2:8
73 3:2
74 3:3
75 47:9
750 8:8
7-5-07 2:19
77 3:7
7th 63:20
178:9 230:7
<8>
8 2:22 54:13
69:24, 25
122:22 123 :17
145:17 146:4
163:7 274:22
291:18, 19
80 75:22, 25
174:9 245:22
278:23 294:9
800 265:25
266:7 274:22
80-plus 246:8
80s 24:15
8-10-92 3:5
8-17-93 3:20
8-23 220:7
8-23-96 220:5
8-27-97 286:1
8-29-97 5 :19
8-30-93 3 :19
8-4-92 3:6
86 3:9 4:8
87,222,000 45 :5
8th 135:13, 18
136:6 138:12
219:6 230:8
<9>
9 3:2 73:6, 7, 8
213:3 291:19
9:11 9:5
9:12 9:12
90 40:24 41:4
142:18 213:7
900 8:8
90071 7:22
90s 21:8 24:10
92 110:7
9-21-95 154:25
9-25-95 4:10
9-27-96 328:1
93 124:17
9-30-96 6:5
94 136:6
141:15 142:20
94,000 215 :22
9-4-96 5:8
95 47:1 124:17,
18 243:10, 15
96 38:5 45:11
84:14 264:9
960 45:4
97 48:17 84:15
86:8 210:8
99 264:13, 23
322:19 335 :23
<A>
A.J 5:22
a.m 9:5, 12
46:6, 9 106:2, 5
AB 39:14
www.coulterreporting.com
Abbott 4:25
8:6, 6 9:25
44:14 177:20,
22 204:18, 23
205:8
Abbott's
204:22 205 :2
able 129:11
234:3 236:9
241:20, 22
270:24 284:25
AB-rated 38:18,
19,21,24
175:24, 25
176:2, 5, 12, 17
abrupt 257:15
258:15
abruptly
235:13 239:16
240:1, 6 259:24
260:21 267:5
absolute 202:25
203:4
Absolutely
61:11 73:22
90:8 235:17
239:13 285:19
absorption
267:15 268:13
abstract 120:10
262:3, 6
ab usability
284:18
abusable 52:3
66:6, 7 247:6
Abuse 5:6
34:12 38:11
47:20 49:6
50:4, 21 51 :18,
21 52:5, 23
56:22 58:1, 6,
22, 23 60:19, 20,
24, 25 61 :8, 20
71:8 134:8, 15
151:18 175:9
198:4 212:15
218:11, 14
231:1, 10, 12, 17,
19,22 233:10
237:5, 21 238:5
239:9 242:5
246:25 252:13
254:5, 14
267:12, 16, 25
268:2, 8, 12, 15
269:14, 17
278:16 281:21
282:5 283:21
284:3 285 :1, 9
288:5, 14 289:3
297:2 306:1, 12
310:10 312:8
313:11 314:1
316:7 325:8, 16
326:4
abused 58:11,
15, 24 59:3
61:10, 14 71:19
269:2 279:9
280:16
abuse-Jacksonvil
le 5:18
abuser 238:6
abuse-resistant
53:25
abusers 284:25
abusing 291:10
abysmal 272:5
accept 240 :2 0
acceptability
149:2
acceptable 88:2,
3 97:1
acceptance 81 :4
accepted 57 :9
89:24 114:1
236:10
access 199:7
accompany
258:5
accomplish
63:5 190:8
325:14
accountability
59:20, 24
accounting
213:7
accounts 189 :9
accumulate
179:13
502-582-1627
Page:4
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
accuracy 214:8
216:8 261:4
277:11, 13
accurate 16:18
17:12,18 21:16
58:8 123:12
125:16, 18, 19
133:13 167:14
172:9, 11
186:17 213:22,
25 214:7 215:6
216:4 217:14
218:19 228:9
243:22 263:20,
20 267:8
297:11 304:9
308:1 337:12
accurately
165:17 244:4
accustomed
101:11
acetaminophen
104: 11, 1 5, 17
achievable
283:3
achieve 26:10
68:10 74:14
221:11
achieved
188:22 220:13
achieving
260:18
acknowledges
59:8, 13
acquired 20:8,
12
acquisition
327:7
AcroContin
36:15, 24 37:4,
8 46:16
Act 224:25
225:3, 8
ACTION 1:2
9:14 83:18
288:6, 15 289:2
327:6
actionable
296:18
Coulter Reporting, LLC
actions 20:20
21:1 85:3
166:7
active 16:1,5
104:17
actively 185 :15
221:11
activities 3 0: 14
327:9
activity 16: 6
165:24, 25
315:20 317:7, 8
actual 252:8
acute 157:6
ad 189:13
add 53:24
93:22 130:13
138:8 178:17
244:8 262:3
263 :2 265 :14
added 68:3
121:14, 17
165:4 201:4, 18,
25 244:12
addicted 291 :2
294:10 295:2
336:4, 8
addiction 18 :2,
18 38:10 68:15,
21, 24 69:12
143:10 231 :JO,
15 238:24
239:2 242:4
246:13 268:2
269:16 279:17,
18 282:5, 21
283 :4 288:5, 14
289:3 290:7, 8
292:5, 6, 11, 16
294:16 313:11
324:19, 25
325:7, 16 326:4
addictive 233 :9
237:20 246:24
291:8 312:8
313:25
addicts 242:8
268:5 269:19
278:21 313:13
316:2,3
Adding 52:24
addition 75:22
163:10 178:23
183:9, 18
188:12 196:20
198:14 228:11
316:12 335:16
additional
121:12 131:18
186:12 288:24
291:20
additions
139:17
additive 53 :9
Address 5:6
85:10 212:16
ADE 50:13
adequate
189:11
adequately
46:24 47:8, 17
214:19
AD Es 50:10, 11,
17, 18
adhered 130:6
Adjust 92:23
administer
74:12 l 60:9, 10,
11
Administration
131:5
administrative
45:9
admit 122:8
134:18
admitting
224:10, 18
adopt 228:5
adopters 190:7
advance 149:20,
25 150:4 191:9
268:24
advantage
46:22 65:5
128:1, 6 235 :21
Advantages
142:25 335:21
adverse 50:13,
14 233:21
www.coulterreporting.com
255:17, 19, 22
259:15, 16
260:23 261 :12,
14, 18 262:11
advertisements
189:12
advertising
76:10, 14, 19
118:25 119:8
138:20, 22
191:2 242:23
advised 64:21,
24 88:21 108:2
advising 86:24
208:16
aellis@kytrial.co
m 7:6
affairs 16:17
affect 150:14
256:14
affidavit 15: 1
affiliate 327:1
affiliated
256:24 327:2
affirm 273:15
agencies 288:22
agency 48:25 .
50:12, 15, 17, 17
52:11 54:7
124:25 129:22
130:21 214:15
221 :24 222:2
agent 2:22
51 :3 53:10
94:10 145:12
272:2
agents 119:3
127:21
aggressive
144:19 217:18
aggressively
335:17
ago 29:25 35:6
77:3 153:8
155:20 193:l
209:17 298:2, 3
300:18
agree 19:8
63:18 84:20
85:1 158:21
184:2 216:10
217:16 222:2
241 :2 270:13
272:9, 19 273:8
275:11 283:23
295:4, 8 314:3
319:9
Agreed 5:12
11:19 84:25
112:23 121 :13
169:3, 6, 7, 16
225:17, 20
226:1 227:24
228:5, 8 229:14
232:13, 17, 20
241:14 251:19
252:9 254:12
256:19 261 :25
263:15 264:10
273:11 275:13
300:13 302:10,
14, 15, 22 303:5,
15, 21 304:6, 15
306:3, 3 307:13,
16, 19 311:10,
12 315:21
318:6, 12
319:23, 25
320:1 321 :] 0
agreement
60:14 84:21
97:23 165:14,
18, 25 166:1, 6,
12, 12 168:10,
20 l 77:20, 22
205:7, 10
222:18 224:11,
19 227:1 228:2
232:10 243:21
251:14 295:24
296:9 312:16
agreements
14:7 41:25
ahead 9:20, 23
15:20 70:20
81:24 95:23
124:18 127:7
137:15 141:10
163:25 220:1
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
254:24 256:4
303:10
al 1:4
Albright 4:23
alerted 240:25
Alfonse 203:13,
13
Alfonso 4:10,
12,21,24 5:8,
14 6:5 161:11
203:14, 15
204:21 226:20
248:7 249:2
250:17
allegations
229:21, 23
Allocation
190:22 204:23
allow 90:22
98:12 146:7
202:24
allowed 34:2
100:19 112:15
193:18
allowing 133:14
262:11 316:18
317:18
allows 13 3: 13
alludes 81:19
alongside 25: 1,
13
alternative 37:5
127:14
alternatives
81 :1
altogether
316:17 317:17
amend 17:21
amended 16:9
268:11, 16
269:14
America 5 :13
American
162:7 192:12,
14,16
Americas 7:15
amount 216:17,
18 218:9
294:22 310:19
Coulter Reporting, LLC
334:5
308:14 320:9,
ample 89:19
11 321 :12
analgesia 150:1
325:20
Analgesic 6:6
answered 49:24
26:13, 17 27:18
68:23 224:1
117:5, 7 124:24
answering
132:13
136:19 141:4
145:11 279:15
answers 170:20
antagonist 54:2
326:16
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Page:5
Richard Sackler, M.D.
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112:15 125:1,
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502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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132:12 324:21
Bobillier 5:21
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heim 162:8
bold 335:5
Bonus 6:9
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bonuses 216:18,
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border 320:5
bottle 130:6, 7
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157:22 164:12
165:5 204:20
212:5 214:2
220:7 224:24
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bracketed
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brackets 201 :2,
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
buprenorphine
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268:1 269:15
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183:5, 9 191:17,
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18:8 70:15, 16,
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330:24
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capsule 117:19
capsules 156:24
caption 337:6, 7
captioned
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P ., et al.
8/28/2015
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clarity 130:25
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99:24 101:4
102:1 110:13
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222:20 240:12
241:13 250:10
284:15 288:17
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150:10 151:7
200:9 208:24
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330:23, 24
cleverly 269:3
client 169:21
clinic 75:23
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53:1 76:14
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233:8 235:4
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co-authors
140:12
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codeine 79:24
87:19 152:17
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139:25
collect 184:12
color 271 :18
column 122:24
123:14
combination
22:22 94:11
152:15, 17
153:24 180:12
combinations
78:11,19
152:14 153:16
180:12
combine 67:21
combined
329:11
combining
22:20 133:11
come 28:18
40:25 139:9
196:7, 11
294:14, 20
comes 62:11
136:21 161 :13
234:25
comfort 248 :9
comfortable
108:17 152:14
coming 94:20
99:13 227:8
comment 2:18
38:17 46:15
175:23 211 :5,
11 234:3
259:21 309:11,
13, 18
commenting
120:2
comments
203:17 229:17
242:22 243:21
261:10,11
275:7 305:7
307:14 314:3
316:9,11
Commerce
269:24 270:3
commercially
203:2 220:21
commission
44:14 337:17
commitment
183:8
committed 30:6
225:3, 8
committing
31:18
common 53:22
58:24 80:13
85:20 89:13
96:13 114:17
115:24 193:11,
15, 16 199:1
COMMONWEA
LTH 1:1, 4
9:13, 14 294:17,
23 295:2
communicate
114:22 209:22
communicated
211:13 225:7
communication
76:22 242:24
communications
256:14 298:15
communities
184:8 268:9
community
116:11 220:18,
19
companies
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24 14:2, 8, JO,
12 19:6, 9, 20
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222:11 225:14
293:15, 15
323:16
Company 5 :13
7:12, 13 12:21
13:15, 16 20:12,
502-582-1627
Page: 10
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
13,14 21:14,23
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34:8 36:1
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56:11 112:25
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224:12, 19
229:13, 25
230:9, 10 238:1
241:16 256:24
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76:16 119:13,
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132:10 180:3, 5,
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109:17 140:25
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272:2
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185:16
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335:1
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70:12
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24:12, 21 26:18
27:25 28:16
36:23 123:4
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127:17, 18
235:19
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37:7 217:11
compilation
130:11
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193:16
complete 76:25
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315:19 337:12
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114:11 140:21
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114:13 149:15
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147:16, 17
compound
137:13 246:17
comprehensive
76:25
compressed
124:2, 14
compromise
100:18 101 :1
275:14, 17
compute 291 :23
computed 62:19
computer
189:13
concentrate
284:1
concentration
243:1
concept l 75:14,
18 179:12
199:18
concepts 121 :20
concern 25:15
28:6 59:2
214:17, 21
222:8 258:8
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concerning
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concerns 18:18,
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conclude 60:20
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128:4 151:4
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127:10 149:6,
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condition
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180:1 234:12
259:25 261 :1
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80:13 115:17
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68:14, 24 69:11
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168:19 169:5,
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264:8, 15
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32:1
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confirm 157:19
confirmed 142:8
confirming
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conformed
284:15
confusing 21 :17
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16 98:3 208:23
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5:5
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290:20 292:13
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116:12
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230:15
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53:22
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318:23
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303:22
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contentious
116:5
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context 17 :4
18:21 30:23
36:1 81 :18, 21
82:2, 3 125:7
126:2 201:17
208:24
502-582-1627
Page: 11
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Contin 6:9
16:14 17:4
18:22 20:4
24:10, 11, 14, 21
25:1, 1, 11, 12,
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93:3, 6 114:12,
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CONTINUED
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130:24
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63:9 64:18
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96:21 99:6
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110:25 111 :4
112:13 118:8
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125:21 126:23
127:2, 12 132:8
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146:4 151:23,
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184:8, 15
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307:15, 23, 24
308:4 312:16
313:7 318:19
323:12, 19
325:21 328:10,
25 329:23
331:11
correcting 90:6
correction
139:16
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
correctly 28:4
30:10 37:11
39:2 43:23
45:12 50:6
56:24 95:14
121 :24 125:12
163:17 181:23
190:19 203:7
207:1, 7, 25
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256:2, 17, 18
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correlate 200:11
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65:1 67:2
cost 34:22
79:21 l 76:25
203 :3 204: 7, 8
325:3
costs 67:22
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279:2
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Counsel 8:3
68:18 299:6, 9,
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count 216:11
275:3
counted 12:18
14:6 185:13
counting 45:12
countries
116:21
country 186:17
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couple 113:8
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coupons 198:24
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85:19 131:5
149:21 186:5
284:19 293:3, 5,
12 298:21
COURT 1:1
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cover 70:6
132:22 241:24
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56:23 60:23
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create 181:8, 12,
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created 187:25
188:25 189:2
190:14, 16
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creates 156:23
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creative 175:14,
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credibility
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critical 106:22
criticism 196:8,
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cross-title 27:20
crucial 38:25
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crushing 238:8
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86:4, 7, 24
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Cullen's 90:18
cups 163:11, 13
cure 38:23
176:4
curious 129:1
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current 12:4
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127:25 135:24
235:20 262:3
263:2 265:14
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98:13 131:15
136:17 140:22
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126:19 285:3, 7
curve 157:11
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195:18,20
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83:16 243:25
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94:13 146:16,
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7:16 10:1, 1
11:18 28:23
45:24 55:7, 22
105:25
danger 81 :14
dangerous 81 :6,
14 162:22
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DANIEL 7:16
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data 50:4, 9, 20
131:19 135:23
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www.coulterreporting.com
Page: 12
Richard Sackler, M.D.
II, 13, 21
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DATE l:4
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177:11 181 :3
202:5 210:7
222:17, 25
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dates 222:21
daughter 75:18
David 5:17
279:13 304:25
day 9:4 94: 7,
14, 15, 19 98:4,
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146:15, 16
149:2 161:6
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292:15 308:17
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days 66:18
124:18 125:2
259:8 322:19
day-to-day 16:6,
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dead 52:23
deadline 159:23
deal 200:25
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death 82:13
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debate 14 7 :2
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December 5:5
70:4 124:17, 18
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15 251:20
311 :23 312:4
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186:12
decide 63 :16
71:25 114:14,
15 119:24
120:1 146:25
502-582-1627
Page: 13
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
decided 72:1
91:6, 11 99:19
251:8
deciding 28:17
decipherable
19:17
decision 65 :8
76:6 136:2
164:9
decisions 121:12
Declaration
15:7 16:8 29:5
declared 208:25
dedicated 30: 7,
12
deducted 44:12
deduction 44:3
de-emphasizing
334:3
deep 33:24
deeply 26:9
defeat 284:25
defend 166:24
167:3, 4 297:9
defendant 225 :1
DEFENDANTS
1:4 7:12 8:6
10:2, 4, 8 12:6
19:13
Defendant's
314:15 315:5
defending
167:25
defer 325:12
deferred 262:4
263:3 264:19
265:15
defined 252:24
329:1
defines 253:17
definitely 49:25
52:8 194:14
310:23
defraud 33 :8
224:13, 20
228:13 237:19
242:2 311 :8, 20
312:7 319:5
deftly 124:19
Coulter Reporting, LLC
degree 248 :9
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degrees 194:10
de-incentivizing
334:16
delay 285:23
Delayed 267:14
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Delivered
190:22
deliveries
184:11
delivery 285:1
demand 190:2
192:3
demanding
124:23
demonstrably
304:13
demonstrate
89:19, 23
105:15 236:9
demonstrated
143:15 144:1
148:3, 25
289:18
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233:9
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242:16 252:7, 8
DENHAM 7:6
10:13, 13 11 :13
denied 227:16,
19 247:2
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dense 326:19
dentist 279:14
depart 308:15
departed 98: 7
department
39:6, 7, 10
72:14 91:9,10
99:18 118:7
120:4 131:1, 2
153:25 159:11
226:18 231 :2
262:18 266:19
274:10, 13
277:14, 14
283:18
departments
121 :20
department's
274:14
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221:12, 18
depend 149:24
dependence
18:19 143:13
257:14 283:3
dependency
68:15, 21, 25
69:12 105:20
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147:4 157:1
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23 73:12
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Depictions
242:14 254:11
DEPONENT
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29:3, 4, 13, 14
30:18 32:11
38:1 39:21
43:2 48:1
54:13 69:6
73:8 74:19
77:5 86:6
103:8 109:13
110:18 117:15
122:5 127:9
134:19 135:1
141:12 154:22
164:2 168:23
173:18 177:8
200:19, 22
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204:15 205 :23
218:24 220:2
226:3 241:17
247:23 253:10,
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278:11 285:2
286:6 287:11
321 :6 324:9
326:13 331:16
336:22, 24
337:5
depositions
241 :22
depression
255:24
deputies 297:19
Deputy 7:8
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193:14
deschedule 53:6
de-scheduled
68:3
descheduling
2:22 51:2, 4
describe 108:20
216:13 321:16
described 169:5,
13 231:22
252:8 254:11
261:25 295:23
298:1 315:21
describes
204:21
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104:16
description
216:11
design 120:17
designate 11 :13,
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187:14, 14
designating
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246:5
designed 192:6
305:18
desirable 88:4
desired 26: 11
68:10 132:18
desires 125: 7
Desk 130:8
Despite 80:4
destruction
80:20 293:6
detail 22:2
78:21 186:5
202:22 206:17
detailing 83 :20
details 71 :22
139:10 205:9
271 :18 335:1
deter 313 :25
determination
165:23 169:14
282:25 308:22,
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131:5
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47:16 71:18
89:6 118:19
124:10 165:12
167:12 169:15
172:6 193:24
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65:24 309:3
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75:21, 24 95:1
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150:2 182:1 a
185:3 236:12
257:13 282:21
502-582-1627
Page: 14
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
developing
24:10, 22 25:8
26:8, 21 28:2
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91:18 93:10
101:21 102:25
105:19 189:10
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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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Page: 16
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
24:12, 19
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Richard Sackler, M.D.
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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
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8/28/2015
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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
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impossible
283:5 322:2
imprecise
296:21
impression
83 :22 236:11
290:9
improper
165:13, 25
168:3, 10, 19
224:3, 11, 18
240:21 273 :10,
14, 18 274:2
275:8, 12
277:18 297:4
302:13, 18, 18,
21 303:5
305:11 306:2, 3
307:14 313:7
314:4 315:12,
15, 17 316:10,
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improve 63 :6, 9
182:10
improvement
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improving
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IMS 214:5
215:2 217:5
327:21
IMS's 327:7
inadequately
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inappropriate
301 :23 304:14
305:7 306:13,
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18, 19 309:6, 11,
18 310:12, 14,
18, 23, 24 311:7
313:9, 15 314:4,
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320:18, 20
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inappropriately
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incentive
186:12, 13
334:4, 18, 20
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incentives 196:8
incentivizing
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inception
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incidence
257:19 258:7
259:2 282:4
include 72:20
76:15 138:14
178:13 207:13
213:24 249:10
included 42:8
72:23, 25
121:15 131:13
502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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193:3 241:23
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185:20, 22, 25
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incontinence
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incorporated
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256:8 274:2
incorrectly
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increase 51 :12
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164:9, 14, 15, 16,
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214:25 218:12
221:23 295:1
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increased
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216:19 217:24
218:10
increases 92:11
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increasing 96:7
146:19 202:20
203:19, 25
334:4
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incredible
188:21
incredibly
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indefinite
160:12
independently
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indeterminant
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indicate 326:8
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indicated
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indicating 15:4
56:6 110:1
117:10 126:12
142:1 260:23
indication
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114:24
indications
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indisputable
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individual
245:1 281:7
282:11
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48:18 68:20
194:21 226:24
228:16 231:23
232:16 324:20
industries
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industry 41 :22
76:23 123:11
186:10 191:13,
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315:21 321:5
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infrequent
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infringement
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ingredients
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inherent 179:25
inherently
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in-house 10:6
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initial 30:8
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103:23 104:20
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inquired 85:13,
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19, 20, 24 83:20
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insist 84:3
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insomnia
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502-582-1627
Page:24
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Interoffice 3:12
investigations
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502-582-1627
Page: 25
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
243 :4 244:2, 2
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www. cou lterreporting. com
Page: 26
Richard Sackler, M.D.
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502-582-1627
Page:27
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma LP., et al.
8/28/2015
management
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144:19 182:11
183:20, 23
192:17 198:5, 9,
12 214:19
266:18 268:14
269:4 279:16,
25 281 :25
management's
228:1
manager 17: 1
56:15 72:15
279:24 280:1, 5,
6, 6, 8 326:24
332:1, 1 335:24
336:1
managers
251:22
Mandema
139:3 140:5
Manners 5 :22
manufacture
21:24
manufactured
21:22 270:2
manufacturing
14:3 21:21
manuscript
139:9, 22
Manuscripts
139:2, 5 140:7,
12 207:23
Marc 299:1
March 48:17
62:19 63:20
68:16 131:21
178:9 258:19
261:22 264:17
265 :] 1 268:6
269:11 322:20
337:17
Mark 4:12, 24
5:14 29:13
32:9 37:24
39:17 44:4
45:21 47:24
54:12 73:4
Coulter Reporting, LLC
74:17 77:4
86:4 103:7
105 :23 109:11
110:17 122:1
127:7 134:17,
24 141:7, 10
154:21 164:1
173:13 177:5
200:16 204:14,
21 212:23
218:22 220:1
225:19 226:19
247:20 248:7
249:2 250:17
251:15 278:10
286:5 287:10
300:21 301 :8,
JO, 16, 18
314:10,11,25
324:8 326:12
331:14
MARKED 29:4,
14 32:11, 23, 25
38:1 39:21
43:2, 5 45:22
48:1 54:13
73:5, 8 74:19
77:5 86:6
103 :8 105 :24
109:13 110:18
117:15 122:5
127:9 134:19
135:1 141:12
154:22 164:2
173:l 8 177:8
180:25 181 :]
200:19, 22
201:1 204:15
205:23 218:24
220:2 226:4
247:23 251:17
278:11 286:6
287:11 324:9
326:13 331 :16
market 24:24
25:10, 12 36:23
47:21 52:22
60:23 61:8
66:14 79:1, 3, 7
80:6, 8 84:13
85:7,8,18
90:21, 22 91:1,
2 97:9, 10
98:11, 12 99:3,
6, 9, 14 103:24
132:2, 16, 20
133:1, 2 135:22,
25 136:1, 3, 7,
10,12,14,24
137:3, 8, 9, 11
138:1, 7, 8
146:25 147:3
152:15 164:5
174:8, 14, 15, 24
188:25 189:4
190:14 193:2, 7
197:1, 6 204:25
206:19 207:20
214:6 217:8
220:11 221 :21
222:3, 10
245:19 246:13,
19, 19,20,22
248:3 251:10
267:21 268:17
272:4 330:25
331:10
marketed 70:10
121 :13 146:12
157:15 184:3
216:21 233:22
237:20 281 :20
312:7
marketing
15:14 16:11, 17
21 :2, 14 29: 7
31:19 34:3
35:9 39:7, 10
65:18 70:9
72:12, 14, 16
77:18 91:6, 7, 9,
JO, 11 99:18
103:15 106:15
107:15, 17
117:21 118:7,
13, 23 119:23,
25 121:1, 18, 20,
21, 23 122:16
129:11, 13, 17
130:13 131 :8
www.coulterreporting.com
132:8, 11, 18
133:1, 19, 24
135:10 138:19
147:6 158:6, 7,
11
160:2,14
161:12, 13
174:3, 20 178:8
179:15 180:10
191:16, 19
196:22, 23
197:5 199:4
203:15, 16
206:16 207:22
208:5 209:1
216:5, 13, 25
217:17,20
226:9, 18 227:4,
12, 13, 17
242:23, 24
248:5, 15 249:4,
5 260:11,15,16,
18 262:10,17
263:14, 18, 22
265:7 266:18
267:23 269:12
272:10, 17
274:14 281 :] 0,
10 294:15
327:9 329:11
330:2, 5 331 :22
Marketing,
117:17 135:19
267:13
Marketing's
177:17 206:17
marketplace
174:6 206:12
218:10, 13
markets 53:14
85:10
marriage
337:15
material 74:2
120:11 155:6,
21 200:24, 25
209:2 256:12
262:10
materials 89:19
90:16 106:21
118:14 119:6
130:18 167:24
190:23 195:10
226:9 242:25
243:16, 21
263:22 271:24
281:10, 11
matrix 49:6
matter 9:12
65:2 67:5 68:7
310:5
mattered 308:8,
16
matters 293 :8
maximum 94:13
McGill 150:1, 2
McManama
286:1
MD 8:9
mean 46:2
59:18 67:15
73:12 88:5, 6,
25 96:10 98:6,
6 105:13
106:18 151:18,
24 152:2
155:16 162:11
182:24 187:24
188: 7 208:24
209:22 224:8
238:1 244:22
250:5, 6 305 :20
319:11, 13, 13
321:12 322:1
327:10 328:4, 6
332:4 333:17
meaning 87:24
94:1 96:3 97:3
139:21 156: 7
158:9 182:18
211:14, 16, 17
226:14 236:23
237:25 249:15,
20, 21 329:7
meaningless
203:1
means 51:4
57:17 59:8, 15
73:21 98:15
99:4 127:20
148:9, 11 155:8,
502-582-1627
Page:28
Richard Sackler, M. D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
9 156:9 199:25
248:17 249:25
280:21 294:3
305:23 332:6
meant 33:16
57:22 79:19
83:6 85:1,2
88:17 106:20
127:19 158:17
160:7 163:4
211:23 222:10
234:9 267:25
269:6, 8, 15
285 :17 305 :22
320:22 329:6
measure 240:15
274:16
measured
125 :3 281:18
measures 72:25
measuring
149:20
media 181:11,
12
Medical 3:24
62:8 112:1, 12
116:5, 11 120:4,
5 121:5 126:19
130:21 131 :1
132:5 140:17,
18 153:24
157:24 159:11
196:7, 9 214:12
220:19 233:15
235:2 258:19
265 :1 266:18
283:17, 18
300:8 320:23
329:2
medically
325:21
medication
37:4 114:16
145:15 158:12
259:11
medications
233:7, 11
237:23 312:10
medicine
189:19 234:7,
Coulter Reporting, LLC
11, 18 287:4
322:10, 15
medicines 192:7
Medtronic
109:1
meet 76:11
114:21 115:9
222:14 246:6
Meeting 2:15,
17 3:3,5,10,17,
20 4:3, 6, 8, 15,
18 5:3,23
30:25 31:6
35:18 38:16
67:4 74:22
77:24 85:24
l 10:22, 23
111:4 117:13
120:21 121 :6
135:20 141 :6
142:12, 14
148:13 158:2
l 75:22 177:11
206:9 210:6
252:1 327:20
332:18 333 :14
meetings 31 :25
32:1 49:13
86:9 135:17
141:6 195:4
196:16 202:15,
19
member 63:13
members
113:16, 24
222:15
Memo 2:8, 13,
21 3:2, 5, 9, 15,
17, 19 4:2, 5, 10,
12,14,16,21,23
5:2, 14, 16, 19,
21 6:2, 5 25:24
38:3 48:9, 16,
17 59:4 70:4
74:21 103:10
117:8,12
128:22, 24
154:25 299:5
304:2 313 :23
Memorandum
2:15 3:12
35:17 77:22
109:23 110:4,
16 204:21
memorize
307:16
memory 22:11
23:15 52:16
211 :22 273:5
296:22 302:1
304:19
mental 96:5
98:25
mention 302:12
mentioned
118:5
menu 316:19
317:19
Merck-Medco
6:4
merged 225:15
mess 251:9
message 84:8
272:10, 17
met l 77:15
methods 236:J 0
Michael 2:9, 24
3:8, JO, 13, 15
4:23 5:15, 16
6:3 35:7, 8
38:17 68:J
77:15, 17, 20
85:25 86:4, 7,
23 90:17
101:18 103:13
106:13, 14
170:5 172:17
175:23 198:12
202:9 205:4
226:16, 21
228:17, 23
324:14
middle 55:5
72:15 98:10
142:3 216:17
223:13 224:24
mid-term 221 :9
Mike 72:11, 17
77:23 118:4
www. cou lterreporting .com
119:11, 12, 18,
21 120:11, 25
129:10 132: 7,
11,15,18
135:21 l 73:24
174:3 206:17
207:20
Miller 5 :22, 23
milligram
75 :22, 23, 25
79:4, 6 105:3
117:18, 19
140:23, 24
141:J 142:9, 10
144:3 148:J
156:7, 24, 24
174:9, 10 238:7
278:23 282:7
294: 7, 9, 9, 9
milligrams
74:14 89:4
94:7, 19 104:21
105:1 144:4
145:7 259:8, 10
260:24 267:4
278:23 282:14
million 43:21
44:13, 18, 21
45:10 64:11, 14,
17, 18 164:10,
12 165:4 167:3,
4 213:6 215:5
216:20, 21, 24
297:8
millions 312:25
313:2
mind 76:16
90:24 98:14
100:3 105:22
117:25 139:8
207:22 215:8
216:9 236:7
248:8, 11
250:11 308:11,
18
minds 308:3
minds.' 256:16
Mine 27:13
54:21 249:18
minimal 58:1
minimize
189:20
minimum
137:13
minor 147:16
minute 110:10
121 :6 233:24
300:18 308:17
323:24
Minutes 2:J 5
3:3, 6, 10, 20
4:3, 6, 7, 15, 17,
21 5:23 74:22
117:13 138:J 4
142:13, 14
148:16 l 77:10
202:4 286:22,
23 307:23
328:17, 18
Minutes, 135:20
Misbranded
269:23
misbranding
33:7 224:13, 20
228:12 236:18,
19, 21 237:3
242:13 254:21
267:11 311:5
318:6, 15
misconception
91:21 101:5, 8
102:1, 8, 9
106:22
misconceptions
107:1, 3
misconduct
223:3, 15
misdemeanor
226:25
misdemeanors
228:18
misinterpret
31:9
mislead 33:8
34:18 224:14,
21 228:13
237:19 242:2
311:8, 20 312:7
misleading
239:12 244:5
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
254:22 275:8
315:23 316:15,
20 317:12, 20
319:4, 20
misleadingly
267:3
mis perception
90:7 93:15
95:22 99:24
misrepresentatio
n 238:12, 14
misrepresentatio
ns 270:24
missed 312:13
319:2
missing 137:25
mission 125:23
misspoke
110:15 122:23
mistake 135:16
misunderstood
130:23
MITCHELL
7:6 10:13
11:12
mitchell.denham
@ag.ky.gov
7:10
mitigate 34:21
model 114:5
moderate 3 7 :22
80:12 100:9
329:16
molecule 46:21
245:22, 24
moments 29:25
Monday 16:21
money 39:23,
25 40:2 41 :22
42:8 44:1
184:12 186:7
189:15 190:24
192:14 221:23
271 :20
monitored 57 :8,
16 114:13
287:25
monitoring
60:19, 24 61 :8
Coulter Reporting, LLC
month 40:5
move 69:5
narcotics 24 7 :5
191:4 200:14
122:8 134:18
narrow 162:24
245:17 261:22
movement
national 189:8
months 35:4
145:3
332:17 333 :13
106:15 125:1, 3
moving 334:18
nature 88:13
182:7 191 :4
336:13
236:14 315:23
220:14 261 :20
MSC 70:12
Natz 3:17
289:9
330:18, 19
nausea 255:23
Montreal 150:3
MST 36:19
NDA 123:21,
morphine 17:4,
58:23
22, 23 124:4, 23
16 18:7, 16, 19
multiple 34:14
125:10 128:8
28:12 37:10
147:9 261 :11
232:22, 22
46:22, 24 50:1
296:12
233:4 246:6
58:25 73:10, 11, multiple-dose
nearly 214:3
19, 23 74:5, 13,
120:12
215:4, 20
14 77:3 78:7
Mundipharma
necessarily
79:10, 14 80:25
13:5, 7, 9, 11, 12,
23:21 69:16
81:9,17 82:4,4,
16 17:1 63:19
219:7 261:19
11,15,23,25
293:17, 18
302:20
83:1, 14, 16
Mundipharma-G necessary
84:3, 17 85:4
ermany 56:10
114:22 115:7
87:15, 21, 24
m usculoskeletal
245:6 287:6, 7
88:12, 13, 13, 23
174:16
288:19
89:8, 9 90:2, 6,
necrosis 58:21
25 91 :4 93:3
<N>
need 29:15
96:14, 19 97:2,
naloxone 52:24
46:2, 4 95 :15,
12 98:8, 17
53:8, 9, 13
21 102:1
99:2, 5, 11
67:21 68:3, 10
108:18 109:2
100:21 101:4, 7,
naltrexone 54:2,
131 :18 144:14,
10 107:7 116:7,
2
17, 19, 21
13, 25 136:15
name 9:18
145:21 154:15,
143:2, 3 144:4
10:24 12:7
16 158:1
175:6 206:5, 24,
13:12 15:3
160:22 163:14
25 207:15, 16
19:8 22:20
177:21 178:21
208:7, JO, 20
197:2, 25 280:3
179:19 181:22
209:1 211 :16,
286:3 324:12
221:24 251:15
name-brand
17, 18 212:11,
266:7 287:25
12 247:9, 11, 12,
218:17
288:3 290:2
15, 17 248:22
named 21:23
291:20
249:7, 12 250:5,
172:5 323:16
needed 71:25
9,11,19,21,24
names 9:20, 23
72:2 100:10
251 :4, 8 256:9,
14:15 68:20
155:10 157:5
11 271:11
170:9 232:12
158:19 177:25
morphine,
narcotic 17:5, 6
178:9 179:24
82:10, 11 89:18
56:21 64:7
190:8 271 :20
Mortimer 3 :12
65:1 67:20
308:22, 23
103:18
68:3 82:21
328:6
motivated 125:9
214:14 218:17
needing 178:9
motivating 31 :4
247:4, 7
needless 150:5
needs 295:6
www.coulterreporting.com
Page:29
Richard Sackler, M.D.
negative 143:8,
9 150:23, 25
207:19 262:3
263 :2 264:18
265:14 334:22
negotiated
41:25
negotiating
37:17 240:25
Neilheisel
313:21
neither 304:9
nervousness
255:23 258:1
259:18
net 41 :22 42:1
44:10
neuralgia
120:14 335:19
Never 13:22
14:6 21:20
38:13 54:4
68:14, 23 85:4,
4 90:3 98:7
168:24 189:24
212:21 224:3
236:9, 16 277:5
282:6, 19 296:2
317:3
nevertheless
304:13
New 2:11, 13
7:16, 16 20:16,
17 44:2 52:7, 7,
12,13,14 58:23
78:20 123:24
125:8 134:5
181:19 187:14
202:16, 20
252:19 253:1,
23, 24 314:19
329:15 330: 7
Newcomer 40:6
newest 183:11
286:9
newsletter 35:12
newspaper
122:13 231 :21
newsworthy
502-582-1627
Page: 30
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
220:12
niche 174:17, 20
nine 45:12
146:13 259:18
no, 325:1
non-addiction
313:24
non-cancer
70:22 87:7, 8,
17 90:21 91 :2,
14 95:12, 19
96:21, 23 97:8
98:11 99:9, 21
131 :20 206:19
207:20 213:15
214:24 215:1, 4
251:10
non-GMP
120:11
nonmalignant
181 :17
non-malignant
70:16 71:5
78:25 79:3, 6
80:6, 8, 18, 23
81:10 85:7, 17,
18 92:16, 17
93:1 97:10
105:8, 19
107:14 108:1
113:17, 25
115:16, 18, 21
116:9 121 :11,
15 136:12
137:10 138:1, 7,
8, 11, 18 l 74:16
178:3 179:8, 15,
20 193:4
246:11, 18, 22
282:19 330:16
335:16
non-narcotic
64:7, 13
nonscheduled
50:22
nonsteroidal
180:14, 17, 23
normal 119:25
133:15 145:9
Coulter Reporting, LLC
148:2 158:10,
13, 17
normally 120:3
146:8
Norwalk 4:10
62:12, 14 77:13
86:4 326:17
NOS 226:3
Notary 337:3,
17, 24
note 11 :8
67:18 200:23
276:2 286:22
297:20, 24
noted 210:11
261:10
notes 166:14
167:13 168:2
275:20, 24
276:6, 8, 14, 15,
20 277:7,8,18
296:6, 10, 11, 20
297:1, 5, 12
299:5 305:16
307:20, 22
308:6, 15, 19
309:2, 6 310:4
312:14 315:8,
14,22,25
316:16, 17, 23
317:13, 17, 22
321:20, 23
337:9, 13
note's 304:2
313:23
noteworthy
220:9
not-for-profit
323:10, 21
Notice 9:6
notified 198:4
230:21, 25
232:2
notion 81 :2
96:5 130:3
notional 94:5
164:23
November
124:16 141 :15
142:18, 20
268:10 278:10,
12 279:6
NS 91:23
NSAID 180:23
NSAIDS
180:13, 16, 18
number 12:6,
12, 20 26:14
31:13 40:20
43:23 44:23
48:18 69:21
72:3 78:22
89:14 l 02:15
104:6 110:8
124:9 145:7
154:14 167:7
173:12 177:17,
19 189:6, 20, 21
196:21 199:9,
14, 19 200:5
202:16 203:1
209:20, 21, 25
210:2 215:3, 12
216:24 217:2
236:3 238:21
270:6 277:18
281:10 283:7
296:14 311 :13
313:4 317:13
318:17 336:7, 7
numbers 55:15
202:25 215:8
216:9
nurse 150:8
nurses 175:15
182:20 213:20
nursing 213:21
<O>
OA 140:21
object 15 :17
19:12 22:19
25:3 31:20
79:8 91:24
137:12 153:2
165:16 167:15
170:14 211 :9
239:20 246:15
252:23 262:13
263:25 271 :3
www.coulterreporting.com
284:4 297:13
298:6 301 :13,
15 303:7
316:25 317:24
319:21 320:10
objection 22:22,
24 34:5 41 :8
42:11 60:8
65:9 70:18
86:19 96:13
139:24 147:8
176:18 310:13
325:2
objections 11 :24
objective 181: 7
189:18
objectives
220:17
obligation
295:13
obliterated
325:2
observe 83:24
observed 246:2
obsolete 24:25
25:11 123:3
obsoleted 123: 7
137:7
obstacle 225 :2
obtain 49:4
obtained 288:10
obvious 189:24
289:18
obviously 66:13
275:16 278:21
307:18 325:24,
25
OC88-1105
120:9
OC92-1102
140:21
OC93-0101
139:3
occasion 220:13
occasionally
196:1
occasioned 66:1,
16 145:3,4
occur l 62:22
297:7, 16
occurred 33:20
90:3 264:15
273:10 317:23,
25 318:3
occurring
60:21 61 :1
198:4 268:9
occurs 329:23
October 242:21
odd 284:5
offer 61 :24
offering 191 :2, 7
Office 2: 11, 13
7:8 10:14
167:20, 22, 24
237:15 241:9
297 :] 0 312:15,
19 322:12, 24
Officer 3:24
62:8 67:4
121 :5 126:19
130:22 132:5
140:18 228:21
229:3 233:16
235:3 265:1
officers 206:4
offices 9:2
184:7 185:10
Oh 10:5 27:20
48:20 54:23
55:5 62:24, 24
82:13 89:17
92:5 96:16
108:13 119:14
135:14 141 :20
149:22 151:10
174:2 182:22
220:7 223:7, 8
239:23 272:14
273:6 300:4
313:8 318:14
329:5 333: 7, 24
Okay 15:23
19:25 21:7, 13,
24 22:9, 17
23:6, JO 24:7, 8
27:15 29:19, 24
31 :12 33 :3, 14,
15 37:13 44:10,
12 46:20 47:19
502-582-1627
Page: 31
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
48:15, 20, 20, 21
49:15 50:8
52:18 55:6
56:8 62:14, 21,
25 64:1 65:14
66:25 67:24
69:25 71 :10
72:8 75:11
76:5 77:19
79:15 80:3
84:6, 10 88:20
104:3 105:12,
17 106:21
108:13 111:12,
14, 21 113:22
118:3 119:16
126:8 132:4
135:5, 7, 16, 16
137:22 140:20
141 :23 142:5
143:17, 17, 19
153:10 155:11
159:2, 14
161:13,24
162:9 172:2, 9
174:2 182:22
184:13 197:11
200:16 201:24
202:1, 9 207:11
209:17 212:7
218:6, 8 220:7
224:15 237:1
240:10 244:11
248:22 250:13,
14 253:24
255:2, 9 269:10
272:14 273 :6,
21 284:13
289:12 294:2
302:5 304:25
306:6 312:3
318:14, 14
319:15 324:12
332:16, 21
333 :6, 7, 11, 24
old 78:20
134:5 329:12
330:6
older 217:8
Coulter Reporting, LLC
omitted 92 :2
239:21 316:20
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502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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502-582-1627
Page: 33
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma LP., et al.
8/28/2015
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502-582-1627
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Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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116:22
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Pharma's 40:16
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30:8 77:24
91:12 99:19
124:1 202:4
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32:17 171:4
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130:3 146:18
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polite 66:9, 23
political 115: 10,
11, 12
Poll 181:14, 25
182:1, 2
polluted 82:21
popular 18:14
116:22
502-582-1627
Page: 36
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
populations
189:5
Portenoy 196:14
portion 12:6
27:12, 16 30:2
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502-582-1627
Page: 37
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
22 323:3
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220:4 221:2
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6 22:4 26: 7, 7
52:25 70:3
74:22 117:13
128:21, 25
132:6 135:6, 17,
20 159:12, 12,
13 160:19
projected 64:6,
17
projection
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promise 302:11
promised 302:8
promote 37:14,
20 184:10
267:21 268:17
promoted 37:8
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130:18 163:10
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prompt 61:24
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97:21 245:14
prone 292:10,
11 325:7, 16
502-582-1627
Page: 38
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
326:4
proof 225:1
proper 92:9
109:3 190:10
192:7 206:21
274:14
properly 55:9
97:23 268:14
269:4 274:17
295 :11 304:12
proportion
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148:2
proposal 57:8
61:25
proposed 57:10
121:17 181:15
242:24 243:16
proposition
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115:20
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protection 50:3
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protocol 112:3
113:12 114:3, 6,
22, 23 129:18
proud 73:23
prove 236:16
proved 89:3
provide 229:10,
17 233:8
288:13 295:14
315:19 320:14
provided 56:21
67:22 78:21
219:3, 8 220:1
243 :1, 4 256:25
267:15 268:13
295:16 298:8,
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23 239:1, 16, 22,
25 240:5, 14, 22
242:3, 10
254:13 265 :8
267:3, 24
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269:13 313:5
provides 146:3
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188:13 214:5
231:3
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11:14
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281:14
Public 181 :6, 7
182:7 183:18
197:4 246:7
337:3, 17, 24
publication
122:12 140:2
publications
256:13
Publications,
139:1
publicity 182:6
publicized
181:18
published
120:10 153:25
219:5 231:21
258:19
publishing
258:21
pull 106:21
147:20
pulled 167:13
168:3 275:21
pump 109:1
purchase
327:21
purchasers
41:23
PURDUE 1:4
3:22 5:13 7:12,
12, 12, 13, 13
8:2 9:15 10:2,
4, 6, 8 11:2
12:4, 7, 9, 12, 13,
20,21,25 13:1,
3, 14, 18 14:7,
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15:8,9,15
16:12, 15 17:15
19:6, 6, 9, 13, 20,
22, 22, 25 20:5,
7, 9, 10, 11, 15,
21,22 21:3,5,9,
10, 13, 19, 19, 20,
21, 25, 25 22:3,
7, 7, 15, 15, 15,
20 23:7, 7, 7, 9,
9,18,19,24,24
24:5, 5, 6 29:8
33:6, 10, 12, 16,
17, 21, 22 34:1
35:11, 11, 15
36:21 40:2, 3,
10,16,17 41:2,
3, 12 42:4, 5, 7
43:9, 13 55:13
59:11 60:14
68:13, 18, 20
69:15 75:18, 19
100:19 101:2
109:2 110:21
112:22 119:19
126:22, 24
127:1, 3 132:6
139:5, 23 140:5,
8, 11 145:14
146:23 152:24
165:5, 10, 11, 14,
15, 22, 22 166:2,
2 167:5,11,19,
25 168:4, 6, 7, 7,
17 169:8,9,16,
17, 22 170:1, 2,
6, 7 172:7, 8, 20,
22, 23 173:7, 7
182:9, 14 183: 7,
10, 19 184:14
187:6, 10, 11, 14,
15,21,22 188:1,
2,4,5, 7,22
192:11, 13
193:17 194:24
195:15, 17
196:15, 25
198:1, 2, 5, 24
201:20 209:23
213:14 214:2
215:11, 13, 18,
22 216:5,18
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217:5 218:12
219:4 221:14,
14 222:19
223:4, 16 224:1,
10, 17 225:3, 7,
9, 11 226:22, 23
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228:24 229:6,
11, 12 230:23
231 :5 232:8, 12,
21 233:7 237:4,
16, 18, 25 238:1,
1,11,21,25
239:24 241:15,
15, 17, 18, 19, 20,
21, 25 242:1, 22
244:14 245:19
248:15 249:3
251 :20 252:2, 5,
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253:3, 4, 7, 14,
14,17,18
254:10, 23
255:1, 11 256:6,
25, 25 258:16
260:5 261 :3, 23,
23 262:9
263:12, 23
264:12, 25
265:3, 9, 19
266:14 267:1,
19,22 268:7,11,
16 269:1,11
270:2, 11, 18, 23,
25 273 :10, 25
275:5 279:19
281:20 282:17,
24 283:6, 20
284:2, 9, 16, 22
287:16 293:3,
13, 14, 17, 18, 18
295:13, 16
297:9 305:24
306:4, 9, 10
312:6, 20
314:13 315:8
316:12, 16
317:9, 16
318:24 322:4, 4,
5,5,18,22,25
323:8, 12, 13, 19,
20 327:1
336:11
Purdue, 19:9,
16 33:15
Purdue's 19:5
213:7, 17
214:23 217:17,
20 219:10
228:20 238:5
239:6 242:15
252:19 253 :24
254:1 260:15
261:6 262:17
263:19 265:6
266:1 267:20
271 :9 294:14,
21, 25 311:22
315:8 319:5
PurdueUS 2:11,
13
purport 309:23
purported
168:3
purpose 76:12
77:22 92:25
238:4 265:21
purposely
278:22
purposes
119:23 157:16
pursuant 9:6
11:10 33:11
pursue 61 :24
65:17 147:14
put 47:20
60:22 69:21
82:10 101:16
106:23 132:2
137:6 151:9
162:9 166:19
173:12 180:20
193:20, 22
198:15 210:6
212:17 253:9
271:17 274:9
282:5, 7 294:8
307:8 325:20
326:7
502-582-1627
Page: 39
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
putting 61 :7
82:15 119:6
194:15 245:19
246:13
<Q>
q.i.d 127:15
148:22
QQL 131:10
qualifications
193:24
quality 72:18,
20, 22, 25 ·
132:14 133:15
142:15
Quarter 6:9
200:14 332:13,
22 333:14
334:7 335:23
quartile 327:8
quartiles 327:24
question 2:18
11:25 15:18
20:24 25 :4, 5
31:21 33:24
38:17 39:25
41 :] 42:3, 12
50:24, 25 55:22,
23 63:11 68:5
70:19 73:21
91:25 97:5
100:22, 24
132:12 137:13,
19 138:2, 3
147:9 152:5
153:3, 4 156:17,
21 160:24
161:2, JO 165:7,
17, 19 166:4
169:1, 25
170:15 171:15
172:3, 12, 14
175:5, 23
178:22 180:7
190:11 196:3
197:9, 17, 19
210:18, 21
211:10 216:14
219:14 224:15
236:8 239:21
Coulter Reporting, LLC
246:16 252:23
262:14, 15
264:1 270:17
271:4, 18
272:12 275:5, 5
283 :14 284:5, 5
290:11, 23
294:1 297:14
298:19, 23
299:20 303:8, 8
306:8 317:1
318:21 319:1, 8,
22 320: 7 325 :3,
19 328:1, 12
331:7
questioning
309:22
questions 12:9
72:18, 20, 23
115:7 125:13
126:3 137:17
147:9, 14 169:4
170:19 298:5,
14, 17 301:2, 11,
14 310:3,5
335:22 336:17,
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random 55 :13
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range 42:1
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rank 248:9
rapid 286:12,
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289:2 328:16
rate 150:9
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ratio 16:14
29:9 79:9, 9, 10,
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Raymond 3:12
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reach 54:9
reached 205:7
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88:18 91:25
93:6 95:14
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105:10 119:14
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163:3 170:17
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240: 18 241 :14
256:3 258:24
270:5, 15
272:22 299:14
309:23 310:8
311:9, 11, 17
314:14 333:4
reads 206:23
212:10 261:21
real 98:2
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realization
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realized 67: 11
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66:16 79:7
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115:19 118:1
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18 55:11 94:7
96:4 114:2
116:7 124:8
126:4 138:12
156:13 176:21
177:25 216:24
217:2,15
502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
Page:40
Richard Sackler, M.D.
8/28/2015
229:10 236:1
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240 :20 243 :22
266:9, 11
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reasoning
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292:14
reasons 63 :2
129:15 146:19
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191 :2, 6
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rebates 164 :21
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recall 19:4
22:2 25:2, 15,
16 35:5 38:9,
13 60:16 66:5
105:4 109:7
113:9 127:6
141 :3 146:23
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175:10, 20
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RECESS 46:7
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154:9 171:11
209:13 278:2
292:21 324:2
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220:19 280:3
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record 9:11, 18
19:16 46:5, 9
105:25 106:1, 5
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301:4 320:8
323:24, 25
324:4 334:8, 9
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266:3 273:13
277:9 279:11
289:25 290:1, 3,
124:16 129:16
131:11, 17
132:4, 25
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237:11 241:18
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166:1 168:19
169:7, 23 170:1
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112:17 113:8
138:15 147:12,
16 184:1
185:14 213:11
227:22 292:8
267:12, 17, 25
268:11 269:14
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reducing 333:19
316:23 317:22
records 245:10
247:8 293:20
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recover 266:19
recruit 131 :18
Reder 2:25 3:5
5:17 6:3 72:19
111:24 114:21
121:2, 4, 8, 11,
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268:15 334:20
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referencing
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275:13 281 :9
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162:16 167:17
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241:15 253:15
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refrain 180:4
refresh 211 :21
290:2
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76:9 267:11
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69:12 106:11
229:11 258:18
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regional 280:1,
8 332:1 335:25
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288:19
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regrettably
113:1 126:25
regular 160:8
184:23
regulated 49:10
152:19
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regulatory
16:16 48:25
49:22 64:22, 24
121:19 129:23
130:22 131 :2
147:17 236:23
reinforced
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reiterate 183 :6
rel 1:4
relate 116:14
related 150:18
211:17 214:18
234:16 257:6
261:19 335:12
337:14
relating 120:13
relation 19:6
197:4
Relations 181 :6,
8 182:7 183:18
502-582-1627
Page: 41
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
relationship
200:13
relative 131:15
249:9, 25
relaunch 81 :11
relaxed 49:4
Release 5:9
17:7,8 117:19
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187:6 220:4, 10,
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226:10, 13, 14
285:9, 14 288:1
289:20 306:2,
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releases 163 :1,
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172:7
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relief 74:15
120:13 146:3,
17 148:23
150:1 174:13
305 :3, 6 329:23
reliever 150:16
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relinquished
323:4
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Remain 335:14
remained
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remains 283:4
remarkable
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47:18 59:4, 5
60:4 66:17
69:14 113:7
147:18 156:18,
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165:6, 7 178:12
180:3,6 186:4
192:19 193:4
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231:6 251:6
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repeat 20:23
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100:22 283:25
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repeatedly 52:1
rephrase 86:21
118:21 211:7
replace 70:11
replaced 176:23
replied 101 :25
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314:14 315:5
Report 5:5
50:15, 16 85:23
149:24 150:14
203:5, 10 245:2
255:15, 21
258:9, 9 274:12
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REPORTER
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Reporter's 2:1
Reporting 1:21
49:11 262:11
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236:3 260:20
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Rescue 4:10
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158:10, 14, 18
160:4, JO, 12
161:15 162:23
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291:21, 23
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59:14 110:21
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146:2 149:25
154:1 157:23
159:12 174:24
214:6 229:2
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researched
68:9 84:4
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researcher
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reserved 82:7
116:9 207:5, 18
residency
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residual 107:3
resistance 78:25
resolved 259:8 .
resorts 195 :3
resource
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20:21, 21 21:1
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314:15 315:5,
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responses 99:17
170:11
responsibilities
16:15
502-582-1627
Page:42
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
responsibility
21:9 120:4
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118:18 130:21
215:14
rest 49:16
57:19, 23 90:17
93:7 191:11
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314:17
restless 25 8 :2, 3
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result 58:21
78:8 107:3
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resulted 58:6
87:16 96:20
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Review 3:24
90:12 91:19
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101:21 103:l
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139:4, 16
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203:18 204:17
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pharma.com
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14:1 18:5, 23
20:3 22:13
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313:2 321:10,
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112:10 243:16
261:7 276:6
reviews 233 :16
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revise 114:22
rewarded 187 :2
rework 76:12
rewriting 114:3
269:9
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2:9, 11, 13, 22,
70:2 72:17
77:10 78:4
79:17 99:22
101:13 103:6
109:24 111 :9
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140:16, 20
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160:18 221 :6
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283:16,17
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role 12:4, 25
21:25 22:3
26:5 28:22
103:14 119:8
158:5 230:11
249:2 264:24
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room 150:6
Roth 60:5, 10
Round 158:2
route 161:17,
25 162:19, 23
Roxane 13:18,
19, 21 161:17,
19 162:1,3,4,7,
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Roxane's
156:11, 14
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324:19 325:12
rubric 88:2, 4
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Rules 9:7
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run 50:20
running 146:23
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Russ 6:9
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SACKLER 1:4
2:9, 11, 13, 22,
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13, 15 4:12, 23
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204:18 205 :12
220:5 286:1
287:20 324:10
502-582-1627
Page:43
Richard Sackler, M. D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
326:16 327:3
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safe 119:25
124:10 232:24
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safer 100:13
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20, 21 200:5
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213:5, 8, 19
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18, 22, 25 216:6,
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166:17 232:8
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SAYERS 8:6
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52:12 53:5
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66:10 87:8, 20
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96:1,22 97:7
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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
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surprise 192:18,
24 194:3
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Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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502-582-1627
Page: 53
Richard Sackler, M.D.
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
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502-582-1627
Commonwealth of KY, ex rel. v Purdue Pharma L.P., et al.
8/28/2015
Page: 54
Richard Sackler, M.D.
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www.coulterreporting.com
502-582-1627