UNITED STATES DISTRICT COURT

DISTRICT OF NEW HAMPSHIRE

Karen L. Bartlett

v. Civil No. 08-cv-00358-JL

Mutual Pharmaceutical

Company, Inc.

SUMMARY ORDER

Attached are the court’s rulings on Mutual’s objections to

the deposition testimony of one of Bartlett’s potential

witnesses, Robert Dettery, who has been deemed unavailable to

testify at trial under Rule 32(a)(4) of the Federal Rules of

Civil Procedure (see doc. 275).

SO ORDERED.

____________________________

Joseph N. Laplante

United States District Judge

Dated: August 17, 2010

cc: Bryan Ballew, Esq.

Keith M. Jensen, Esq.

Patrick J. O’Neal, Esq.

Eric Roberson, Esq.

Christine M. Craig, Esq.

Timothy P. Beaupre, Esq.

Jeffrey D. Geoppinger, Esq.

Joseph P. Thomas, Esq.

Paul J. Cosgrove, Esq.

Linda E. Maichl, Esq.

Stephen J. Judge, Esq.

Pierre A. Chabot, Esq.

Case 1:08-cv-00358-JL Document 352 Filed 08/17/10 Page 1 of 92
Bartlett v Mutual

Page 1

Witness_ Robert Dettery - Vol. 1.txt: 1:1 - 1:22

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW HAMPSHIRE

2 

3 

4 

5 KAREN L. BARTLETT and

GREGORY S. BARTLETT,

6 Plaintiffs,

Case No.: 08-cv-358-JL

7 Judge Joseph N. Laplante

V

8 

9 MUTUAL PHARMACEUTICAL

COMPANY, INC. and UNITED

10 RESEARCH LABORATORIES, INC,

Defendants.

11 

12 

13 Videotaped deposition of

14 ROBERT DETTERY, taken at the law offices

15 of Segal, McCambridge, Singer & Mahoney,

16 Ltd., United Plaza, 30 South 17th

17 Street, Suite 1700, Philadelphia,

18 Pennsylvania, on Friday, August 28,

19 2009, at 9:10 a.m., before Jennifer L.

20 Bermudez, a Registered Professional

21 Reporter, and Notary Public, pursuant to

22 notice.

Witness_ Robert Dettery - Vol. 1.txt: 5:18 - 6:9

Q. What do you do for a living,

19 Mr. Dettery?

20 A. I am a vice president of

21 regulatory affairs.

22 Q. For...?

23 A. Mutual Pharmaceutical Company.

24 Q. And you have held that position

25 for how long? 

00006

1 A. Since 1993.

2 Q. And what was your position before

3 that?

4 A. I was director of regulatory

5 affairs at Mutual Pharmaceutical

6 Company.

7 Q. And you held that position since

8 when?

9 A. Since 1989.

Witness_ Robert Dettery - Vol. 1.txt: 6:12 - 6:19

Q. You joined Mutual in '89, 20 years

13 ago?

14 A. Yes.

15 Q. And so in that 20 years, you have

16 either been the director of regulatory

17 affairs or now you are the vice

18 president of regulatory affairs?

19 A. Correct.

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Witness_ Robert Dettery - Vol. 1.txt: 7:5 - 8:11

Q. And when was Mutual established?

6 A. Mutual was established in 1984.

7 Q. And Mutual is owned by who?

8 A. Presently, it's privately owned by

9 an investment group and by our

10 president/CEO.

11 Q. And who is that?

12 A. The president and CEO, his name is

13 Dr. Richard Roberts.

14 Q. What is the relationship between

15 Mutual Pharmaceutical Company and URL

16 Pharma, Inc., formerly known as

17 Pharmaceutical Holding or URL Pharma?

18 A. Mutual and URL are separate, but

19 related business entities, under a

20 common ownership and common management.

21 And the common ownership is the -- was

22 previously known as Pharmaceutical

23 Holdings, it's now known as URL Pharma.

24 Q. What are the other separate

25 business entities owned by URL Pharma, 

00008

1 other than Mutual?

2 A. There's AR Scientific,

3 Incorporated, and AR Holding.

4 Q. So there are basically three legs,

5 as you understand it, to URL, AR

6 Scientific, AR Holding, and Mutual

7 Pharmaceutical?

8 A. I would say AR Scientific, Mutual

9 Pharmaceutical, and URL, which has

10 recently now been changed to URL

11 Distributing.

Witness_ Robert Dettery - Vol. 1.txt: 9:9 - 9:23

Q. How many ANDAs does Mutual

10 presently have? A best estimate is

11 fine.

12 A. An estimate, around 250.

13 Q. And about four NDAs?

14 A. Yes.

15 Q. And what are those four NDAs?

16 A. An NDA for Bactrim tablets and an

17 NDA for Qualaquin capsules. We have an

18 NDA for Colcrys tablets.

19 Q. Can you spell that, please.

20 A. C-O-L-C-R-Y-S.

21 Q. Okay.

22 A. And we have an NDA for Fibricor

23 tablets.

Witness_ Robert Dettery - Vol. 1.txt: 10:22 - 11:3

Q. And how long has Mutual held the

23 NDA for Bactrim?

24 A. I believe we purchased it around

25 2004. 

00011

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1 Q. When in 2004?

2 A. It was late in the year, November

3 or December, something like that.

Witness_ Robert Dettery - Vol. 1.txt: 11:4 - 11:7

Q. And when did Mutual start its

5 analysis, due diligence investigation of

6 whether or not it might want to purchase

7 Bactrim tablet's NDA?

Witness_ Robert Dettery - Vol. 1.txt: Page 11, Line 10

THE WITNESS: I don't know.

Witness_ Robert Dettery - Vol. 1.txt: 15:3 - 15:6

Q. So since you began at Mutual in

4 1989, Mutual was an ANDA holder for the

5 generic Bactrim, correct?

6 A. Correct.

Witness_ Robert Dettery - Vol. 1.txt: Page 15, Line 9

THE WITNESS: Correct.

Witness_ Robert Dettery - Vol. 1.txt: 15:23 - 17:24

Has Mutual manufactured generic

24 Bactrim and then an RLD Bactrim in only

25 one place since you have been with 

00016

1 Mutual or many places?

2 A. One place.

3 Q. Where is that place?

4 A. At our main facility, 1100

5 Orthodox Street, Philadelphia.

6 Q. And what company or companies'

7 names appear on that main facility?

8 A. I don't understand your question.

9 Q. Sure.

10 If we looked on your Web page,

11 would it say URL Pharma on the marquee

12 before you walked into that location?

13 A. I believe it does say URL Pharma.

14 Q. Is there a place where you

15 would -- headquarters where you would

16 see Mutual Pharmaceutical on any marquee

17 or is Mutual contained within URL Pharma

18 at that location at that address?

19 A. Mutual is contained within URL

20 Pharma.

21 Q. And these separate businesses with

22 a common ownership by URL Mutual, AR

23 Scientific, AR Holding, and URL

24 Distributing, is it also true for those

25 three entities that they have no 

00017

1 headquarters, but they all do business

2 out of that same address under the

3 marquee URL Pharma?

4 A. That's correct.

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5 Q. And approximately how many

6 employees are there now of URL Pharma

7 and its various subsidiaries?

8 A. Approximately 700.

9 Q. And '07 sales were greater than

10 $480 million?

11 A. I'm not sure.

12 Q. And if it says $480 million on the

13 URL Pharma website, is that something

14 that you would dispute or does it sound

15 familiar to you?

16 A. I have no reason to dispute it.

17 If it's truly on the website, then I

18 would have to accept that it would be

19 correct.

20 Q. And if I just used the number,

21 does it sound correct to you that '07

22 sales were greater than $450 million?

23 Does that sound correct or outlandish to

24 you?

Witness_ Robert Dettery - Vol. 1.txt: 18:2 - 18:3

THE WITNESS: It sounds like

3 it would likely be correct.

Witness_ Robert Dettery - Vol. 1.txt: 19:14 - 20:8

Q. Is it correct to state,

15 Mr. Dettery, that you are the top

16 regulatory affairs person within URL for

17 all its ANDAs and NDAs?

18 A. Within URL Pharma, yes.

19 Q. And if I ask you the same question

20 for Mutual, would the answer be the same

21 for Mutual?

22 A. Yes.

23 Q. Of the 250 approximate ANDAs, I

24 think I asked if they -- how many there

25 were for URL, how many approximate ANDAs 

00020

1 are under Mutual's name?

2 A. All of the ANDAs are under

3 Mutual's name.

4 Q. Okay. How many of the four NDAs

5 are under Mutual's name?

6 A. None.

7 Q. What name are they under?

8 A. AR Holdings.

Witness_ Robert Dettery - Vol. 1.txt: 21:13 - 21:16

Q. Does Mutual still have a generic

14 allopurinol on the market?

15 A. I think we are selling one

16 strength of it currently.

Witness_ Robert Dettery - Vol. 1.txt: 24:9 - 24:20

Q. Is tolmetin the only other NSAID

10 that Mutual has ever sold other than

11 sulindac?

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12 A. No.

13 Q. What are the other ones?

14 A. Indomethacin. At one time we sold

15 ibuprofen. That's all I remember at the

16 moment.

17 Q. Okay. So the only four you

18 remember are tolmetin, indomethacin, the

19 formerly sold ibuprofen, and sulindac?

20 A. That's all I remember now, yes.

Witness_ Robert Dettery - Vol. 1.txt: 26:4 - 26:22

Q. Do you understand, Mr. Dettery,

5 that you have been designated by

6 attorneys for Mutual to provide

7 testimony on behalf of the corporation

8 for a number of topics pursuant to a

9 deposition notice?

10 A. Yes.

11 Q. Please tell the ladies and

12 gentlemen of the jury what regulatory

13 affairs is.

14 A. Well, regulatory affairs is the

15 department within the company that deals

16 with the regulatory agencies,

17 particularly FDA and DEA, and we are

18 responsible for the submissions of

19 applications to FDA.

20 In our company, we are also

21 responsible for basically any

22 interaction between FDA and DEA.

Witness_ Robert Dettery - Vol. 1.txt: 27:8 - 27:14

Q. What is the Physicians' Desk

9 Reference?

10 A. It's a book of -- a published

11 document, also now available online, in

12 which brand companies will pay to have

13 their product inserts published so that

14 physicians have a reference source.

Witness_ Robert Dettery - Vol. 1.txt: 29:2 - 29:4

To your knowledge, is there a

3 Bactrim label in the PDR?

4 A. To my knowledge, it's not.

Witness_ Robert Dettery - Vol. 1.txt: 29:13 - 29:20

Is that the 2000 Bactrim label

14 that's published in the PDR?

15 A. Well, it's the Bactrim insert, and

16 the bottom of the page does indicate

17 it's the 2000 PDR, so it appears to be.

18 Q. So this is a place where a doctor

19 can go look for the risk benefit profile

20 of Bactrim, correct?

Witness_ Robert Dettery - Vol. 1.txt: 29:23 - 30:12

THE WITNESS: Yes, this would

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24 be available to a doctor. He could

25 refer to it. 

00030

1 BY MR. JENSEN:

2 Q. What are the purpose of labels

3 like the one we are looking at for

4 Bactrim?

5 A. To instruct the health care

6 professional in the safe and effective

7 way of using the product.

8 Q. And you are a regulatory affairs

9 expert, which means you know a lot about

10 the regulations which govern what needs

11 to be in a label and what shouldn't be

12 in a label, correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 30, Line 15

THE WITNESS: Yes.

Witness_ Robert Dettery - Vol. 1.txt: 31:2 - 31:4

You know that the regulations in

3 part say that a label for a drug cannot

4 be false in any particular, correct?

Witness_ Robert Dettery - Vol. 1.txt: 31:7 - 31:19

THE WITNESS: Well, yes. The

8 labeling is part of an application and

9 the application cannot contain false

10 information. So I would say then the

11 answer to your question is that's

12 correct.

13 BY MR. JENSEN:

14 Q. Okay. And let's separate it. If

15 a doctor is seeking out information

16 about a label, he doesn't have access to

17 the drug company's application you are

18 referring to, he or she just has access

19 to the label, correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 31, Line 22

THE WITNESS: Correct.

Witness_ Robert Dettery - Vol. 1.txt: 33:6 - 33:8

Isn't it

7 true the regulations state that labels

8 cannot be misleading in any particular?

Witness_ Robert Dettery - Vol. 1.txt: 33:11 - 33:18

THE WITNESS: Yes.

12 BY MR. JENSEN:

13 Q. Isn't it true that the -- you

14 agree that the purpose of the

15 regulations is that labels can neither

16 overstate the benefits associated with a

17 drug nor can they understate the risks

18 associated with a drug?

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Witness_ Robert Dettery - Vol. 1.txt: 33:21 - 34:1

THE WITNESS: That's correct.

22 BY MR. JENSEN:

23 Q. Why is it important that labels

24 neither overstate the benefits nor

25 understate the risks associated with a 

00034

1 drug?

Witness_ Robert Dettery - Vol. 1.txt: 34:4 - 34:16

THE WITNESS: So the doctor

5 has a clear understanding of the usage

6 of the product.

7 BY MR. JENSEN:

8 Q. Do you agree that when a doctor

9 lacks a clear understanding of the

10 product, if, hypothetically, a label

11 overstated benefits or understated

12 risks, it might, might, lead to the use

13 of the product when that doctor might

14 not have otherwise done it had they

15 known the accurate benefit and risk

16 profile?

Witness_ Robert Dettery - Vol. 1.txt: 34:19 - 35:2

THE WITNESS: That's

20 possible, yes.

21 BY MR. JENSEN:

22 Q. And that's the obvious purpose of

23 making sure the labels doesn't overstate

24 risks -- excuse me -- that's the obvious

25 purpose of having a label that does not 

00035

1 overstate benefits nor understate

2 risks. Fair?

Witness_ Robert Dettery - Vol. 1.txt: Page 35, Line 5

THE WITNESS: Yes.

Witness_ Robert Dettery - Vol. 1.txt: 35:12 - 35:15

Q. There's also regulations that very

13 much in detail state what information

14 needs to be in what specific section of

15 a label, correct, Mr. Dettery?

Witness_ Robert Dettery - Vol. 1.txt: 35:18 - 35:24

THE WITNESS: Yes.

19 BY MR. JENSEN:

20 Q. And those sections include the

21 Warnings section, the Indications and

22 Usage section, the Precaution section,

23 and the Adverse Reaction section,

24 correct?

Witness_ Robert Dettery - Vol. 1.txt: 36:2 - 36:6

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THE WITNESS: Yes.

3 BY MR. JENSEN:

4 Q. And tell us, Mr. Dettery, what the

5 purpose of the Warnings section of the

6 label is.

Witness_ Robert Dettery - Vol. 1.txt: 36:9 - 36:12

THE WITNESS: To provide the

10 health care professional with the

11 significant warnings pertaining to the

12 use of the product.

Witness_ Robert Dettery - Vol. 1.txt: 37:5 - 37:12

My question is, don't you agree

6 that the regulations require that when a

7 serious adverse reaction is associated

8 with a drug, and serious, as you know,

9 is defined as one that can lead to death

10 or require hospitalization, that such an

11 adverse reaction needs to be put in the

12 Warnings section of the label?

Witness_ Robert Dettery - Vol. 1.txt: 37:16 - 37:17

THE WITNESS: No, I don't

17 understand the regulations to say that.

Witness_ Robert Dettery - Vol. 1.txt: 38:5 - 38:14

Q. Is it your testimony that you

6 don't know whether or not the

7 regulations say that when a reaction is

8 serious, which they define as one that

9 can lead to death or require

10 hospitalization, that such an adverse

11 reaction needs to be put in the Warnings

12 section, is it your testimony you don't

13 know one way or the other or you are

14 disagreeing with that proposition?

Witness_ Robert Dettery - Vol. 1.txt: 38:17 - 38:19

THE WITNESS: I'm saying I

18 can't answer without referring to the

19 regulations.

Witness_ Robert Dettery - Vol. 1.txt: 40:14 - 40:22

Do you agree that the definition

15 of a serious adverse reaction is one

16 that can lead to death or require

17 hospitalization?

18 A. Yes.

19 Q. And that understanding that you

20 have comes from the regulations,

21 correct?

22 A. Yes.

Witness_ Robert Dettery - Vol. 1.txt: Page 41, Line 7

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A. Yes.

Witness_ Robert Dettery - Vol. 1.txt: 41:19 - 41:24

When an adverse event that's

20 associated with a drug is serious, as we

21 both agree is one that can lead to death

22 or require hospitalization, it has legal

23 ramifications as to where it needs to be

24 put in the label, right?

Witness_ Robert Dettery - Vol. 1.txt: 42:3 - 42:5

THE WITNESS: Again, I would

4 need to refer to the regulations in

5 order to answer that.

Witness_ Robert Dettery - Vol. 1.txt: 42:7 - 42:16

Q. How many annual reports have been

8 filed in relation to sulindac since its

9 market approval?

10 A. Well, if it was approved in 1991,

11 there would be approximately 17 annual

12 reports.

13 Q. Are they all still in the custody

14 and possession of Mutual, those 17

15 annual reports?

16 A. Probably not.

Witness_ Robert Dettery - Vol. 1.txt: 42:25 - 43:3

Where are 

00043

1 the annual reports that you are telling

2 me were likely filed with the FDA that

3 have not been produced in this lawsuit?

Witness_ Robert Dettery - Vol. 1.txt: 43:7 - 43:12

THE WITNESS: Well, I would

8 assume that they have been destroyed.

9 BY MR. JENSEN:

10 Q. And how many of the 17 annual

11 reports have been destroyed?

12 A. I don't know.

Witness_ Robert Dettery - Vol. 1.txt: 43:17 - 43:19

Q. What's your best estimate of how

18 many of the 17 annual reports for

19 sulindac have been destroyed?

Witness_ Robert Dettery - Vol. 1.txt: 43:22 - 43:24

THE WITNESS: Well, if I had

23 to estimate, I would say maybe about ten

24 or 12.

Witness_ Robert Dettery - Vol. 1.txt: 44:1 - 44:5

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Q. And in relation to the 17 that you

2 say were filed, the estimation that ten

3 or 12 have been destroyed would have

4 been in which year, starting from 1991,

5 obviously, through the present?

Witness_ Robert Dettery - Vol. 1.txt: 44:8 - 44:15

THE WITNESS: They would be

9 the oldest ones.

10 BY MR. JENSEN:

11 Q. What is your understanding, if you

12 have one, as to when and whether a drug

13 company is ever permitted by regulation

14 or otherwise to destroy annual reports

15 that it's filed?

Witness_ Robert Dettery - Vol. 1.txt: 44:19 - 44:22

THE WITNESS: Documents may

20 be destroyed a year after the last

21 expiration date of the products produced

22 during that period.

Witness_ Robert Dettery - Vol. 1.txt: 45:9 - 45:15

Q. So it's your testimony that it's

10 your understanding that, for example, if

11 an annual report's filing covering April

12 of 1995 through March of 1996, that in

13 March of 1997 the company would be free

14 to destroy that report for that annual

15 period I just mentioned?

Witness_ Robert Dettery - Vol. 1.txt: Page 45, Line 20

THE WITNESS: No.

Witness_ Robert Dettery - Vol. 1.txt: 46:8 - 46:23

Q. What is your understanding in that

9 regard, sir?

10 A. It is one year after the

11 expiration of the -- the last expiration

12 of the products manufactured during the

13 reporting period.

14 Q. And what regulation says that?

15 A. I believe it might be in the GMP

16 regulations.

17 Q. And GMP stands for what, please?

18 A. Good manufacturing practices.

19 Q. So that wouldn't be a regulation,

20 that would be a document produced, as

21 you understand it, by the FDA talking

22 about what you can do or not do in

23 relation to the regulations?

Witness_ Robert Dettery - Vol. 1.txt: 46:25 - 47:3

THE WITNESS: No. 

00047

1 BY MR. JENSEN:

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2 Q. Okay. What is it, then?

3 A. It's a regulation.

Witness_ Robert Dettery - Vol. 1.txt: 47:5 - 47:10

so listen to my example.

6 An annual report that covers March

7 1995 -- excuse me -- April 1995 through

8 March 1996, when, to your understanding,

9 could that annual report for that period

10 be destroyed?

Witness_ Robert Dettery - Vol. 1.txt: 47:12 - 47:21

THE WITNESS: It depends on

13 the expiration of the product. So, say,

14 during that 12-month period, the

15 product -- say, it had a 36-month

16 expiration period. Okay?

17 So if a product was

18 manufactured March 1996, it has a three19 year expiration period, it would take it

20 to March 1999, the annual report could

21 be destroyed after March 2000.

Witness_ Robert Dettery - Vol. 1.txt: 54:12 - 54:14

Q. You have seen Regulation 20157

13 before, correct, that I just handed you?

14 A. Yes.

Witness_ Robert Dettery - Vol. 1.txt: 54:18 - 54:20

Q. And you read that all before you

19 ever heard about this lawsuit, right?

20 That entire regulation, correct?

Witness_ Robert Dettery - Vol. 1.txt: 54:23 - 55:5

THE WITNESS: Most likely,

24 yes.

25 BY MR. JENSEN: 

00055

1 Q. And you know that to be the

2 regulation that governs what information

3 needs to be in what section of the

4 package insert that might go into the

5 Physicians' Desk Reference, correct?

Witness_ Robert Dettery - Vol. 1.txt: 55:7 - 55:13

THE WITNESS: Yes.

8 BY MR. JENSEN:

9 Q. And you know that, as we discussed

10 before, the warnings, it's under sub

11 E -- can you read me the first sentence

12 as to what needs to be in the Warnings

13 section of the label?

Witness_ Robert Dettery - Vol. 1.txt: 55:22 - 56:7

A. "Warnings: Under this section

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23 heading the labeling shall describe

24 serious adverse reactions and potential

25 safety hazards, limitations in use 

00056

1 imposed by them and steps that should be

2 taken if they occur."

3 Q. So now that I have shown you this

4 regulation, do you agree that, based on

5 our conversation, when an adverse

6 reaction is serious, it needs to be in

7 the Warnings section of the label?

Witness_ Robert Dettery - Vol. 1.txt: 56:9 - 56:16

THE WITNESS: That's what it

10 appears to say, yes.

11 BY MR. JENSEN:

12 Q. And you have known for -- is it

13 true that you have known for well over a

14 decade that Stevens-Johnson Syndrome and

15 toxic epidermal necrolysis are serious

16 adverse reactions?

Witness_ Robert Dettery - Vol. 1.txt: 56:20 - 57:2

THE WITNESS: Are you asking

21 if I personally knew that for over a

22 decade?

23 BY MR. JENSEN:

24 Q. Yes.

25 A. I don't know how long I have known 

00057

1 that.

2 Q. You knew it before 2003, correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 57, Line 5

THE WITNESS: Yes.

Witness_ Robert Dettery - Vol. 1.txt: 57:18 - 57:22

Q. Okay. Do you -- are you telling

19 the jury you don't know that SJS and TEN

20 are associated with a high mortality

21 rate, meaning the percent by which they

22 result in death?

Witness_ Robert Dettery - Vol. 1.txt: 57:25 - 58:9

THE WITNESS: I am saying I 

00058

1 don't know that it's a serious adverse

2 event because of a -- what you

3 characterize as a high mortality rate.

4 BY MR. JENSEN:

5 Q. Well, you agree that the

6 definition in the CFR is that what is a

7 serious event is an event that can

8 either result in death or require

9 hospitalization, correct?

Witness_ Robert Dettery - Vol. 1.txt: 58:11 - 58:12

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THE WITNESS: Among other

12 things, yes.

Witness_ Robert Dettery - Vol. 1.txt: 58:25 - 59:1

Q. You know that SJS and TEN can and 

00059

1 do result in death, correct?

Witness_ Robert Dettery - Vol. 1.txt: 59:4 - 59:8

THE WITNESS: Yes.

5 BY MR. JENSEN:

6 Q. Okay. And you know that SJS and

7 TEN can and do require hospitalization,

8 correct?

Witness_ Robert Dettery - Vol. 1.txt: 59:10 - 59:13

THE WITNESS: Yes.

11 BY MR. JENSEN:

12 Q. You know that SJS and TEN can and

13 do result in blindness, correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 59, Line 15

THE WITNESS: No.

Witness_ Robert Dettery - Vol. 1.txt: 60:13 - 60:20

Q. Do you have knowledge that Karen

14 Bartlett has undergone a number of eye

15 surgeries?

16 A. No.

17 Q. Do you have knowledge that Karen's

18 eye surgeons and ophthalmologists have

19 frequently described her as legally

20 blind?

Witness_ Robert Dettery - Vol. 1.txt: 60:22 - 61:5

THE WITNESS: No.

23 BY MR. JENSEN:

24 Q. So if I were to represent to you

25 that it's true, because it is, that 

00061

1 Karen Bartlett's had now over nine

2 surgeries and she's still legally blind

3 in both eyes, worse than 2200 visual

4 acuity in both eyes, that's completely

5 new information to you?

Witness_ Robert Dettery - Vol. 1.txt: 61:8 - 61:15

THE WITNESS: Yes.

9 BY MR. JENSEN:

10 Q. And if I were to represent to you

11 that everyone, "everyone" defining that

12 as her doctors who treat her, believed

13 her blindness resulted from her SJS and

14 TEN, would that be completely new

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15 information to you?

Witness_ Robert Dettery - Vol. 1.txt: 61:18 - 61:25

THE WITNESS: Yes.

19 BY MR. JENSEN:

20 Q. Has it always been true that

21 there's never been a doubt in your mind,

22 since you learned about SJS and TEN,

23 that they constituted serious adverse

24 reactions as defined by the regulations

25 that you understand? 

Witness_ Robert Dettery - Vol. 1.txt: 62:4 - 62:8

THE WITNESS: Yes.

5 BY MR. JENSEN:

6 Q. Yes, there's never been any doubt

7 in your mind, correct?

8 A. Correct.

Witness_ Robert Dettery - Vol. 1.txt: 62:18 - 62:21

Q. Nonetheless, SJS and TEN were

19 never in the Warnings section of the

20 sulindac label all the way through the

21 end of 2004, correct?

Witness_ Robert Dettery - Vol. 1.txt: 62:24 - 63:7

THE WITNESS: Correct.

25 BY MR. JENSEN: 

00063

1 Q. In 2005, after Karen Bartlett

2 spent over a hundred days in five

3 hospitals and was still on a G-tube,

4 then, for the first time, there was a

5 change to the label and sulindac got an

6 SJS/TEN warning in the Warnings section

7 of the label, correct?

Witness_ Robert Dettery - Vol. 1.txt: 63:10 - 63:19

THE WITNESS: I would need to

11 review the labeling history to confirm

12 that.

13 BY MR. JENSEN:

14 Q. You do know that in 2005, the year

15 after Karen Bartlett took sulindac, that

16 there was, for the first time, a label

17 change, which included SJS and TEN in

18 the Warnings section of the label,

19 correct?

Witness_ Robert Dettery - Vol. 1.txt: 63:22 - 63:23

THE WITNESS: That sounds

23 correct, yes.

Witness_ Robert Dettery - Vol. 1.txt: 64:13 - 64:19

In the March 2006 letter before

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14 you is Mutual telling the FDA that it is

15 now changing its label, for the first

16 time since you have been with the

17 company, to have for the first time an

18 SJS and TEN warning in the Warnings

19 section of the label, correct.

Witness_ Robert Dettery - Vol. 1.txt: Page 64, Line 22

THE WITNESS: Correct.

Witness_ Robert Dettery - Vol. 1.txt: 66:18 - 66:22

The March 2006 letter that Mutual

19 provided the FDA is the first time that

20 Mutual would ever have a medication

21 guide that would accompany their label

22 for sulindac, correct?

Witness_ Robert Dettery - Vol. 1.txt: 66:25 - 67:17

THE WITNESS: Yes. 

00067

1 BY MR. JENSEN:

2 Q. Tell the jury what a medication

3 guide is, please.

4 A. A medication guide is a document

5 that goes with the product. It's

6 written in layperson's terms and is

7 summarizing the product to the -- how to

8 take the product, the side effects and

9 precautions to take while taking the

10 product, and is intended to be

11 distributed by the pharmacist to each

12 person getting a prescription for that

13 product.

14 Q. So the medication guide is a

15 document designed for the patient, not

16 the doctor?

17 A. Correct.

Witness_ Robert Dettery - Vol. 1.txt: 68:12 - 68:17

Q. And for the first time, in March

13 of 2006, two years after Karen Bartlett

14 ingested sulindac, is the first time

15 that a patient-designed medication guide

16 ever accompanied Mutual's sulindac,

17 correct?

Witness_ Robert Dettery - Vol. 1.txt: 68:20 - 69:4

THE WITNESS: Correct.

21 BY MR. JENSEN:

22 Q. And that March 2006 medication

23 guide, for the first time, advised

24 patients that they should stop their

25 NSAID and call their health care 

00069

1 provider right away if they have any of

2 the following symptoms, and it lists,

3 under those symptoms, skin rash or

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4 blisters with fever, correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 69, Line 25

THE WITNESS: Yes. 

Witness_ Robert Dettery - Vol. 1.txt: 70:2 - 70:9

Q. And do you understand that was to

3 alert patients that if they got skin

4 rash or blisters with fever, which,

5 unfortunately, are commonly associated

6 when they progress or get worse with SJS

7 or TEN, that if they start to get a skin

8 rash, they should call their doctor

9 right away?

Witness_ Robert Dettery - Vol. 1.txt: 70:12 - 70:20

THE WITNESS: Yes.

13 BY MR. JENSEN:

14 Q. And you agree that, for the first

15 time, in March 2006, two years after

16 Karen Bartlett took sulindac, the label,

17 also for the first time, not only had a

18 warning about SJS and TEN, it actually

19 said that NSAIDs, including sulindac,

20 therefore, caused SJS and TEN, correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 70, Line 23

THE WITNESS: Yes.

Witness_ Robert Dettery - Vol. 1.txt: 74:1 - 75:8

Q. And what you are looking at is a

2 side-by-side comparison of the March '06

3 label and the RLD's label, correct?

4 A. That's correct.

5 Q. Other than the difference between

6 the words Clinoril, the brand name, and

7 sulindac, the generic name, and other

8 minor differences, do you agree,

9 Mr. Dettery, that the sulindac label was

10 always substantively the same as the

11 Clinoril branded label?

12 A. That's correct.

13 Q. I refer your attention to Exhibit

14 3, which is on here. Okay. Does that

15 appear to you to be the Clinoril branded

16 label?

17 This one is dated 2004. You can

18 see it in the bottom of the second

19 page. As published in the Physicians'

20 Desk Reference.

21 A. Yes.

22 Q. And, to your knowledge -- I'm not

23 asking you to tell me what other people

24 think or know, sir, but, to your

25 knowledge, do physicians, as you being a 

00075

1 20-year regulatory person, know that if

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2 they are looking for the risk/benefit

3 profile of a drug, they can either look

4 at the RLD drug or they can look at the

5 generic drug, because they know, but for

6 minor differences in words, like brand

7 name versus generic name, they are going

8 to be substantively the same?

Witness_ Robert Dettery - Vol. 1.txt: 75:11 - 75:23

THE WITNESS: Yes.

12 BY MR. JENSEN:

13 Q. So do you agree that if we look at

14 the 2004 brand name label for sulindac,

15 we will substantively know what was in

16 the same time in 2004 for the Mutual

17 sulindac label?

18 A. Yes, I would agree with that.

19 Q. So now let's do that.

20 And do you agree that this 2004

21 brand name label for sulindac doesn't

22 have anything in the Warnings section

23 about SJS or TEN?

Witness_ Robert Dettery - Vol. 1.txt: 76:6 - 76:11

Now that you have reviewed the

7 2004 brand name label for sulindac,

8 isn't it true that the Warnings section

9 says nothing about Stevens-Johnson

10 Syndrome, toxic epidermal necrolysis, or

11 any abbreviation of them?

Witness_ Robert Dettery - Vol. 1.txt: 76:14 - 76:22

THE WITNESS: It does refer

15 to rash, but it does not, that I can

16 see, refer to Stevens-Johnson Syndrome

17 or TEN.

18 BY MR. JENSEN:

19 Q. You would agree, sir, that there

20 is a world of difference between a rash

21 and toxic epidermal necrolysis, do you

22 not?

Witness_ Robert Dettery - Vol. 1.txt: 76:25 - 77:14

THE WITNESS: I'm not a 

00077

1 medical professional, so I don't know

2 what a world of difference would be.

3 BY MR. JENSEN:

4 Q. Well, let me define a world of

5 difference for you.

6 Do you agree that a rash, which

7 might be as minor as something that

8 might last three or four days, on your

9 arm or your leg or your scalp, is not

10 anywhere near, in your mind, in your

11 estimation, as serious as toxic

12 epidermal necrolysis, which can result

13 and often does result in half, threeCase 1:08-cv-00358-JL Document 206-4 Filed 05/24/10 Page 17 of 54 Case 1:08-cv-00358-JL Document 352 Filed 08/17/10 Page 18 of 92
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14 quarters, or all your skin burning off?

Witness_ Robert Dettery - Vol. 1.txt: Page 77, Line 18

THE WITNESS: Well, if you

Witness_ Robert Dettery - Vol. 1.txt: 77:22 - 78:2

Q. You agree, sir, do you not, that

23 telling people of a rash does not put

24 them on notice of a serious adverse

25 reaction that's supposed to be in the 

00078

1 Warnings section, like Stevens-Johnson

2 Syndrome or TEN, correct?

Witness_ Robert Dettery - Vol. 1.txt: 78:7 - 78:22

THE WITNESS: All I'm saying

8 is, it does not mention Stevens-Johnson

9 Syndrome in the Warnings section of the

10 previous labeling.

11 BY MR. JENSEN:

12 Q. Now, given that the March 2006

13 label, for the first time, had a

14 medication guide that told patients that

15 if they got a skin rash, which might,

16 heaven forbid, develop into all their

17 skin burning off, that they should call

18 their doctor, and the 2004 label in

19 existence when Karen Bartlett took the

20 drug had no such medication guide, do

21 you agree, sir, that the March 2006

22 sulindac label was better?

Witness_ Robert Dettery - Vol. 1.txt: 79:2 - 79:5

THE WITNESS: You are asking

3 me for an opinion, and I can't say

4 whether it's better or not. It's

5 different.

Witness_ Robert Dettery - Vol. 1.txt: 79:23 - 80:18

Q. Did you speak with your attorney

24 during the break?

25 A. Yes. 

00080

1 Q. Are you ready to continue now?

2 A. Yes.

3 Q. Before our break and before you

4 spoke with the attorney, I asked you

5 about the label in March 2006, which

6 first had a medication guide, which

7 first advised patients to call their

8 doctor if they got a rash or a fever.

9 And I asked you if that label was

10 better than the one that existed when

11 Karen Bartlett took the drug in 2004,

12 which had no medication guide at all for

13 a patient, and you said they are

14 different, but not better.

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15 My question, sir, is, just

16 defining better as everyone does, wasn't

17 the March 2006 label better than the

18 2004 label?

Witness_ Robert Dettery - Vol. 1.txt: 80:21 - 81:18

THE WITNESS: Well, again, I

22 don't know what you -- what the meaning

23 is as far as you are concerned of what

24 the word "better" is.

25 It is different. Labels 

00081

1 change over time and this one is

2 different. Information in them

3 changes. I don't know if you can say

4 one is better than the other.

5 BY MR. JENSEN:

6 Q. Well, if we define better as

7 putting a patient on notice through a

8 medication guide that if they get a

9 rash, they should call their doctor, and

10 their doctor hopefully will tell them to

11 stop taking the drug before it

12 progresses to all their skin burning

13 off, and the prior one had no such

14 mechanism, nothing for the patient to

15 read in that regard, if we limit our

16 definition of better to that, don't you

17 agree that the March 2006 label was

18 better than the 2004 label?

Witness_ Robert Dettery - Vol. 1.txt: 81:23 - 82:9

THE WITNESS: Well, if you

24 are defining better as whether it has a

25 med guide or not, then this one does 

00082

1 have a med guide.

2 BY MR. JENSEN:

3 Q. Specifically, this one had a

4 medication guide, the March '06 one,

5 that Karen Bartlett didn't have the

6 benefit of, that first advised patients

7 specifically that if they got a rash or

8 fever, they should call their doctor,

9 correct?

Witness_ Robert Dettery - Vol. 1.txt: 82:12 - 82:14

THE WITNESS: If her incident

13 was before -- before this insert went

14 into effect, then that's correct.

Witness_ Robert Dettery - Vol. 1.txt: 83:13 - 83:15

Do you know that rash and fever

14 are commonly associated with progressing

15 to SJS and TEN?

Witness_ Robert Dettery - Vol. 1.txt: 83:19 - 83:23

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THE WITNESS: No.

20 BY MR. JENSEN:

21 Q. Do you know that when people get

22 SJS and TEN, they invariably started out

23 with a rash and fever?

Witness_ Robert Dettery - Vol. 1.txt: 88:11 - 88:13

Q. Do you agree that the 2004 label

12 that Ms. Bartlett and her physician had

13 to rely on says nothing of blindness?

Witness_ Robert Dettery - Vol. 1.txt: 88:16 - 88:22

THE WITNESS: I do not see

17 the word "blindness" in there.

18 BY MR. JENSEN:

19 Q. Do you agree that the 2004

20 sulindac label that Ms. Bartlett and her

21 physician had to rely on says nothing of

22 a coma?

Witness_ Robert Dettery - Vol. 1.txt: 88:25 - 89:9

THE WITNESS: Again, in my 

00089

1 cursory read here, I didn't see the word

2 "coma."

3 BY MR. JENSEN:

4 Q. Do you also agree that the 2004

5 label said nothing of the potential need

6 for a hospital-induced coma, a medical

7 protective coma, or that you might need

8 to be sedated for weeks or months on end

9 after you take sulindac?

Witness_ Robert Dettery - Vol. 1.txt: 89:12 - 89:20

THE WITNESS: I did not see

13 that in that insert.

14 BY MR. JENSEN:

15 Q. Is there anything in the 2004

16 label that says that if you get SJS or

17 TEN, that as much as half or three18 quarters, or maybe even all, your skin

19 might exfoliate, slough off, peel off,

20 or, in colloquial terms, burn off?

Witness_ Robert Dettery - Vol. 1.txt: 90:4 - 90:7

A. I did not see that.

5 Q. Are blindness and comas serious

6 adverse reactions, Mr. Dettery?

7 A. Yes.

Witness_ Robert Dettery - Vol. 1.txt: 91:18 - 91:21

Isn't it true that neither

19 blindness nor coma nor SJS nor TEN are

20 anywhere in the Warnings section of the

21 2004 label?

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Witness_ Robert Dettery - Vol. 1.txt: 91:24 - 91:25

THE WITNESS: I do not see

25 it. 

Witness_ Robert Dettery - Vol. 1.txt: 92:2 - 92:12

Q. Since Mutual Pharmaceutical

3 Company learned that Karen Bartlett was

4 in a coma for weeks or months on end,

5 and since Mutual Pharmaceutical Company

6 learned that Karen Bartlett has been,

7 for the most part, legally blind in both

8 eyes after three, six, nine, and ten eye

9 surgeries, most of which have been at

10 Harvard, what has Mutual Pharmaceutical

11 Company done to put coma or blindness in

12 the label?

Witness_ Robert Dettery - Vol. 1.txt: 93:18 - 93:22

THE WITNESS: If I recall the

19 dates correctly, I believe we learned of

20 this incident in early 2008, and as far

21 as I'm aware, we have not had any

22 labeling changes required since then.

Witness_ Robert Dettery - Vol. 1.txt: 94:24 - 95:6

Isn't it true that since Mutual

25 Pharmaceutical Company has learned of 

00095

1 Karen Bartlett's blindness, isn't it

2 true that since Mutual learned of

3 Karen's coma that she was in for weeks

4 or months on end, it has done nothing

5 since it learned to try to put either

6 coma or blindness in the label?

Witness_ Robert Dettery - Vol. 1.txt: 95:9 - 95:13

THE WITNESS: Well, as I

10 answered before, there has been no

11 labeling changes, so you can interpret

12 that as there being no changes to the

13 label.

Witness_ Robert Dettery - Vol. 1.txt: 95:25 - 96:16

Q. Isn't it true that Mutual has 

00096

1 never picked up the phone through today,

2 to your knowledge, and called anyone at

3 the FDA and said, we, at Mutual, believe

4 that because blindness and coma are

5 serious adverse events, and Ms. Bartlett

6 clearly has had blindness, likely in

7 both eyes for most of the last four or

8 five years, she was in a coma for weeks

9 or months on end, and that's a serious

10 adverse reaction, we think, you guys,

11 the FDA, should allow us to, or we think

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12 you guys, the FDA, should require that

13 everyone who sells sulindac should put

14 coma and blindness in the label?

15 No such hypothetical call has ever

16 occurred, to your knowledge, correct?

Witness_ Robert Dettery - Vol. 1.txt: 96:22 - 96:23

THE WITNESS: To my

23 knowledge, no such call has made.

Witness_ Robert Dettery - Vol. 1.txt: 97:9 - 97:14

Mutual, since it learned of

10 Karen's coma, Mutual, since it learned

11 of Karen's blindness, has never filed a

12 citizen's petition to advocate for a

13 label change to put coma or blindness on

14 the sulindac label, correct?

Witness_ Robert Dettery - Vol. 1.txt: 97:16 - 97:24

THE WITNESS: Correct.

17 BY MR. JENSEN:

18 Q. Mutual, since it learned of

19 Karen's blindness and coma, has never

20 sent out a "Dear Doctor" letter to

21 advise doctors that their patients might

22 need a medically-induced coma and might

23 go blind if they take sulindac, have

24 they?

Witness_ Robert Dettery - Vol. 1.txt: Page 98, Line 1

THE WITNESS: No.

Witness_ Robert Dettery - Vol. 1.txt: 98:15 - 98:18

Mutual has never sent out a "Dear

16 Doctor" letter regarding sulindac since

17 1991 when they started selling it

18 through today in August 2009, correct?

Witness_ Robert Dettery - Vol. 1.txt: 98:22 - 99:3

Q. Mutual has never filed a citizen's

23 petition advocating enhanced or stronger

24 warnings about incidents information

25 regarding SJS and TEN, regarding any 

00099

1 complications of SJS and TEN, like

2 blindness or coma, from 1991 through

3 today, in August 2009, correct?

Witness_ Robert Dettery - Vol. 1.txt: 99:6 - 99:12

THE WITNESS: Correct.

7 BY MR. JENSEN:

8 Q. Mutual has always had the ability

9 to file a citizen's petition to advocate

10 for enhanced SJS/TEN warnings or for

11 warnings like blindness and coma for the

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12 sulindac label, correct?

Witness_ Robert Dettery - Vol. 1.txt: 99:15 - 99:20

THE WITNESS: Anyone has that

16 ability to file a citizen's petition.

17 BY MR. JENSEN:

18 Q. And anyone includes you and it

19 includes everyone with whom you work at

20 Mutual, correct?

Witness_ Robert Dettery - Vol. 1.txt: 99:23 - 99:24

THE WITNESS: Yes, it

24 includes Mutual.

Witness_ Robert Dettery - Vol. 1.txt: 101:18 - 101:21

You understand, Mr. Dettery, that

19 drug companies retain and maintain

20 ultimate responsibility for the content

21 of their label, correct?

Witness_ Robert Dettery - Vol. 1.txt: 101:23 - 102:5

THE WITNESS: No.

24 BY MR. JENSEN:

25 Q. Okay. So it's your understanding 

00102

1 that the FDA has ultimate responsibility

2 for the content and accuracy of a label,

3 not the drug companies who sell the

4 drug? Is that your understanding and

5 claim?

Witness_ Robert Dettery - Vol. 1.txt: 102:7 - 102:16

THE WITNESS: My

8 understanding is that the brand company,

9 along with FDA, determines what is to be

10 included in the labeling.

11 BY MR. JENSEN:

12 Q. Do you understand that in this

13 case the presiding judge has ruled

14 against Mutual's claim that they cannot

15 change the label to strengthen or add

16 warnings?

Witness_ Robert Dettery - Vol. 1.txt: 103:7 - 103:14

THE WITNESS: Yes, I was

8 informed of that.

9 BY MR. JENSEN:

10 Q. Do you understand that it was the

11 fourth time this year that a federal

12 judge has ruled that ANDA holders have

13 the unilateral ability to change their

14 labels to add or strengthen warnings?

Witness_ Robert Dettery - Vol. 1.txt: 103:20 - 103:22

THE WITNESS: I was aware

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21 there have been one or two previous

22 cases.

Witness_ Robert Dettery - Vol. 1.txt: 109:18 - 109:24

Q. Excluding post-marketing

19 surveillance, excluding keeping your

20 label the same, isn't it true that

21 Mutual never took any affirmative

22 action, from 1991 to 2004, to advocate

23 any enhanced or strengthened warning to

24 the sulindac label?

Witness_ Robert Dettery - Vol. 1.txt: 110:2 - 110:7

THE WITNESS: Strengthened

3 warning regarding SJS?

4 BY MR. JENSEN:

5 Q. Or any adverse reaction, including

6 SJS, TEN, blindness, or coma.

7 A. No. 

Witness_ Robert Dettery - Vol. 1.txt: 110:12 - 110:13

Q. No, you never did so, correct?

13 A. Correct.

Witness_ Robert Dettery - Vol. 1.txt: 110:17 - 110:20

Q. You see the fax from the FDA,

18 dated September 2000, advising

19 sulindac -- Mutual of its need to change

20 the sulindac label?

Witness_ Robert Dettery - Vol. 1.txt: 110:22 - 111:3

THE WITNESS: Yes.

23 BY MR. JENSEN:

24 Q. And they are telling Mutual, the

25 FDA, that they need to change the label 

00111

1 that was changed more than five years

2 before that to so-called match or be the

3 same as the branded label, correct?

Witness_ Robert Dettery - Vol. 1.txt: 111:12 - 111:25

THE WITNESS: It says that

13 the most recently approved labeling for

14 Clinoril tablets is attached, the

15 reference listed drug for sulindac, it

16 was approved July 10th, 1995. And then

17 this fax was dated in 2000.

18 BY MR. JENSEN:

19 Q. So we know from this, that more

20 than five years have gone by since the

21 branded label was updated, and Mutual,

22 according to the FDA, still has not

23 updated its label to match the branded

24 label, correct?

25 A. Yes. 

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Witness_ Robert Dettery - Vol. 1.txt: 112:3 - 112:10

Q. And we know from 318 that, seven

4 months later Mutual finally did what the

5 FDA requested it to do more than five

6 years after the Clinoril label was

7 changed, and Mutual then in April 2001

8 submitted a label to have it match or be

9 consistent with the brand name label,

10 correct?

Witness_ Robert Dettery - Vol. 1.txt: 112:12 - 112:18

THE WITNESS: Yes.

13 BY MR. JENSEN:

14 Q. So why did it take Mutual nearly

15 six years, from July '95 to April 2001,

16 that's three months short of six years,

17 to get the label the same if it's so

18 important that the labels be the same?

Witness_ Robert Dettery - Vol. 1.txt: 112:20 - 113:5

THE WITNESS: Because we

21 changed our inserts when FDA tells us to

22 change the inserts, and they notified us

23 in 2000 to do so for sulindac.

24 BY MR. JENSEN:

25 Q. Okay. So, let's go with that for 

00113

1 a second.

2 Why did it take Mutual seven

3 months, from September 2000 to April

4 2001, if it's so important that labels

5 be the same, to do it?

Witness_ Robert Dettery - Vol. 1.txt: 113:7 - 113:21

THE WITNESS: Well, I don't

8 know why it took seven months to change

9 in this particular case.

10 BY MR. JENSEN:

11 Q. And now let's go back to the first

12 five years.

13 What was Mutual doing in these

14 five years, if it's so important for

15 labels to be the same, and their labels

16 were different in '95 and '96 and '97

17 and '98 and '99, and then in 2000 the

18 FDA has got to tell you your labels are

19 not the same?

20 What happened in those five

21 years?

Witness_ Robert Dettery - Vol. 1.txt: 113:25 - 114:10

THE WITNESS: Well, you are 

00114

1 making -- you are assuming every label

2 change is a label change that

3 requires -- or is one that is conveying

4 new significant information.

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5 The labeling changes

6 frequently for reference listed drugs,

7 and I can only assume that it took the

8 FDA five years to notify us because it

9 was not -- there were not significant

10 changes in this insert.

Witness_ Robert Dettery - Vol. 1.txt: 126:7 - 126:10

I already marked the PDR

8 label for Bactrim.

9 Can you reference that again,

10 please, sir, if you have it handy there.

Witness_ Robert Dettery - Vol. 1.txt: 126:17 - 126:20

And Page 2, just to refresh your

18 recollection, does, in fact, have a

19 bolded, capitalized warning in the

20 Bactrim label for SJS and TEN, correct?

Witness_ Robert Dettery - Vol. 1.txt: 126:23 - 127:4

THE WITNESS: Yes.

24 BY MR. JENSEN:

25 Q. And it also has a bolded, 

00127

1 capitalized warning that says, Bactrim

2 should be discontinued at the first

3 appearance of skin rash or any sign of

4 adverse reaction?

Witness_ Robert Dettery - Vol. 1.txt: 127:6 - 127:12

THE WITNESS: Yes.

7 BY MR. JENSEN:

8 Q. All the way up through 2004, there

9 is nothing ever bolded and capitalized

10 in the warning or contraindication that

11 said either of those two things in the

12 sulindac label, correct?

Witness_ Robert Dettery - Vol. 1.txt: 127:14 - 127:21

THE WITNESS: Well, I think

15 we already established that, yes.

16 BY MR. JENSEN:

17 Q. Exhibit 301, sir, in the stack,

18 that's the August 1987 letter from the

19 FDA stating -- advising of receipt of

20 the sulindac application from Mutual,

21 correct?

Witness_ Robert Dettery - Vol. 1.txt: 127:24 - 128:4

THE WITNESS: Well, it

25 acknowledges the receipt. 

00128

1 BY MR. JENSEN:

2 Q. And sulindac's application was

3 filed in 1987 and approved in 1981, why

4 did it take about four years?

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Witness_ Robert Dettery - Vol. 1.txt: 128:7 - 128:9

THE WITNESS: Why did it take

8 four years to get approval? You have to

9 ask FDA. I don't know.

Witness_ Robert Dettery - Vol. 1.txt: 129:25 - 130:16

Q. Is that is an FDA label 

00130

1 acknowledging approval of a waiver that

2 was sought by Mutual for certain

3 reporting, correct?

4 A. That's correct.

5 Q. And the waiver that was sought was

6 what?

7 A. To report the adverse events in

8 the periodic reports in just a summary

9 form, rather than submitting the Med --

10 what's called a MedWatch form for the

11 adverse events.

12 Q. Is that the first waiver of

13 reporting requirements of the Food and

14 Drug Administration that Mutual ever

15 sought in relation to sulindac?

16 A. Yes.

Witness_ Robert Dettery - Vol. 1.txt: 130:24 - 131:3

Before this waiver was sought,

25 FDA, without any exceptions granted by a 

00131

1 waiver, had to comply with all the FDA

2 reporting requirements?

3 A. Yes.

Witness_ Robert Dettery - Vol. 1.txt: 131:17 - 131:21

And Mutual's reporting

18 requirements included providing medical

19 literature of certain types to the FDA,

20 correct?

21 A. No.

Witness_ Robert Dettery - Vol. 1.txt: 131:24 - 132:8

Q. So it's your belief that Mutual

25 never had to give any medical literature 

00132

1 of any type to the FDA for sulindac?

2 A. No. Generic companies do not have

3 to do that.

4 Q. Is there any regulation that says

5 generic companies don't have to do that?

6 A. I don't see any regulation that

7 says generic companies do have to do

8 that.

Witness_ Robert Dettery - Vol. 1.txt: 132:12 - 132:15

Q. Is there any regulation that says

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13 generic companies do not have to provide

14 certain types of medical literature or

15 any medical literature to the FDA?

Witness_ Robert Dettery - Vol. 1.txt: 132:20 - 132:21

but I don't recall any

21 regulation to that effect.

Witness_ Robert Dettery - Vol. 1.txt: 133:17 - 133:20

Q. How many NSAIDs have been pulled

18 off the market, in whole or in part, due

19 to the risks of Stevens-Johnson Syndrome

20 or TEN?

Witness_ Robert Dettery - Vol. 1.txt: 133:23 - 134:3

THE WITNESS: I don't know.

24 BY MR. JENSEN:

25 Q. Well, you know Bextra was an NSAID 

00134

1 and you know it was withdrawn from the

2 market, in whole or in part, due to SJS

3 or TEN, correct?

Witness_ Robert Dettery - Vol. 1.txt: 134:7 - 134:15

THE WITNESS: No.

8 BY MR. JENSEN:

9 Q. You don't know any of that?

10 A. I didn't know that Bextra was an

11 NSAID.

12 Q. Did you know that Bextra, the

13 drug, was pulled from the market due, in

14 part or in whole, to SJS or TEN?

15 A. No.

Witness_ Robert Dettery - Vol. 1.txt: 135:18 - 136:1

THE WITNESS: Yes.

19 BY MR. JENSEN:

20 Q. And 314.81 is another regulation

21 that you have read before you learned of

22 this lawsuit, correct, sir?

23 A. Yes.

24 Q. And you read it in conjunction

25 with needing to comply with it for ANDA 

00136

1 and NDA drugs, correct?

Witness_ Robert Dettery - Vol. 1.txt: 136:3 - 136:15

THE WITNESS: That's correct.

4 BY MR. JENSEN:

5 Q. And under 6(a) there, on Page 3,

6 that defines what clinical data needs to

7 be reported to the FDA, correct?

8 A. I have to find my way here.

9 Oh, you are talking about little

10 Roman numeral vi?

11 Q. Yes, sir.

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Witness_ Robert Dettery - Vol. 1.txt: 134:16 - 135:15

Q. Did you know that isoxicam was

17 withdrawn from the market due, in whole

18 or in part, because of its risks of SJS

19 and TEN?

20 A. Did I know that?

21 Q. Yes.

22 A. No, I did not.

23 Q. You have seen 314.80, have you

24 not, sir?

25 A. Yes. 

00135

1 MR. JENSEN: I don't have a

2 copy. Yes, I do.

3 BY MR. JENSEN:

4 Q. And you have read this regulation

5 a number of times before you learned

6 about this lawsuit, right?

7 A. I have read it a few times.

8 Q. And it pertains to the reporting

9 requirements, in part, for drug

10 companies, correct?

11 A. Yes.

12 Q. And, in part, it tells us that

13 when an event is both serious and

14 unlabeled, it has got to be reported on

15 a 15-day basis, correct?

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12 A. Okay.

13 Q. And 6(a) of that statute defines

14 what needs to be reported as defined as

15 clinical data, correct?

Witness_ Robert Dettery - Vol. 1.txt: 136:19 - 136:25

THE WITNESS: Yes.

20 BY MR. JENSEN:

21 Q. And it includes, as you can see

22 the second parenthetical,

23 epidemiological studies or analyses of

24 experience in a monitored series of

25 patients, correct? 

Witness_ Robert Dettery - Vol. 1.txt: 137:2 - 137:9

THE WITNESS: That's what it

3 says.

4 BY MR. JENSEN:

5 Q. And you agree that if such a study

6 or analysis of experience occurs in

7 relation to an ANDA drug, the ANDA

8 holder needs to provide that clinical

9 data publication to the FDA, correct?

Witness_ Robert Dettery - Vol. 1.txt: 137:13 - 137:24

THE WITNESS: No.

14 BY MR. JENSEN:

15 Q. And what is the regulation upon

16 which you rely on in disagreeing with

17 that?

18 A. The 314.97, I believe, addresses

19 that to some extent, and also the FDA

20 policy.

21 Q. How do you think 314.97 in any

22 manner allows an ANDA holder to not

23 comply with what we just reviewed of

24 314.81?

Witness_ Robert Dettery - Vol. 1.txt: 138:1 - 138:8

THE WITNESS: Well, I would

2 need to see 314.97 to refresh my memory.

3 BY MR. JENSEN:

4 Q. Other than 314.97, is there any

5 other regulation that you know of that

6 you believe supports the proposition

7 that an ANDA holder need not supply such

8 clinical data to the FDA?

Witness_ Robert Dettery - Vol. 1.txt: 138:10 - 138:11

THE WITNESS: Again, only

11 that section

Witness_ Robert Dettery - Vol. 1.txt: 138:16 - 138:21

Q. Here is 314.97. And don't you

17 agree that it says nothing that any

18 plain read of that one English sentence

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19 can be interpreted to mean that an ANDA

20 holder need not comply with the clinical

21 data production requirements of 314.81?

Witness_ Robert Dettery - Vol. 1.txt: 138:23 - 139:9

THE WITNESS: Well, I don't

24 know if this is the complete citation

25 for 314.97. 

00139

1 BY MR. JENSEN:

2 Q. I represent to you it is, and I

3 ask you to assume for the purposes of my

4 question that it is.

5 Isn't it true that nothing in it

6 provides support for the proposition

7 that an ANDA holder need not supply

8 clinical data, as we just defined it, to

9 the FDA?

Witness_ Robert Dettery - Vol. 1.txt: 139:13 - 139:15

THE WITNESS: It says, the

14 applicant shall comply with requirements

15 of 314.70 and 314.71.

Witness_ Robert Dettery - Vol. 1.txt: 139:21 - 140:5

Q. You just told me that the

22 regulation you relied on to not have to

23 provide clinical data to the FDA was

24 314.97. Now I have shown it to you,

25 it's one sentence long. 

00140

1 Isn't it true, sir, that there is

2 nothing in that sentence from which one

3 might conclude that an ANDA holder need

4 not provide such clinical data to the

5 FDA?

Witness_ Robert Dettery - Vol. 1.txt: 140:8 - 140:20

THE WITNESS: I can't

9 conclude that because this sentence

10 refers to other sections of 314.

11 BY MR. JENSEN:

12 Q. The bottom line is, you can't

13 identify any regulation upon which you

14 have ever concluded that an ANDA holder

15 need not supply clinical data as we just

16 defined it to the FDA, as we sit here

17 now, correct?

18 MR. COSGROVE: The same

19 objection.

20 THE WITNESS: No.

Witness_ Robert Dettery - Vol. 1.txt: 141:13 - 141:15

Q. Has Mutual ever done any post14 marketing surveillance of the medical

15 literature for sulindac?

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Witness_ Robert Dettery - Vol. 1.txt: 141:19 - 142:17

THE WITNESS: I believe so.

20 BY MR. JENSEN:

21 Q. When did Mutual first do post22 marketing surveillance of the medical

23 literature for sulindac?

24 A. I believe it was about maybe two

25 years ago. 

00142

1 Q. So why, in 2007, which is two

2 years ago, did Mutual first decide to do

3 its first surveillance of the medical

4 literature regarding sulindac?

5 A. It was not surveillance of medical

6 literature just for sulindac. As the

7 company transitioned from a generic

8 company to a branded company, we began

9 to follow the expectations and

10 obligations of a branded company and do

11 the survey of the medical literature for

12 all of our products.

13 Q. Starting in 2007, when Mutual's

14 related company first got NDA products,

15 did Mutual start surveying the medical

16 literature regarding its ANDA products

17 also?

Witness_ Robert Dettery - Vol. 1.txt: 142:20 - 142:22

THE WITNESS: We began doing

21 medical literature searches for all of

22 our products.

Witness_ Robert Dettery - Vol. 1.txt: 143:21 - 143:25

Q. Okay. So starting in 2007, when

22 Mutual's related company got NDAs,

23 Mutual started doing surveillance of the

24 medical literature regarding about 50 or

25 60 of its ANDA drugs also, correct? 

Witness_ Robert Dettery - Vol. 1.txt: 144:4 - 144:9

THE WITNESS: It was around

5 2006, 2007, sometime around there.

6 BY MR. JENSEN:

7 Q. Definitely not before 2006,

8 though, correct?

9 A. Correct.

Witness_ Robert Dettery - Vol. 1.txt: 146:2 - 146:10

Do you think it's better for the

3 health of the patients who take their

4 drugs and do you think it's better for

5 the information that's potentially

6 provided to the physicians who prescribe

7 drugs, that companies survey the medical

8 literature to find out new information

9 that effects the benefit and risk

10 profile of their drugs?

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Witness_ Robert Dettery - Vol. 1.txt: 146:13 - 147:15

THE WITNESS: I really have

14 no opinion on that.

15 BY MR. JENSEN:

16 Q. Why did Mutual start surveying the

17 medical literature for its ANDA drugs in

18 2006 and 2007 just because its related

19 company was looking into or then got

20 some NDA drugs?

21 A. Well, as I said, we transitioned

22 from a generic company to a branded

23 company, and as a branded company, even

24 though we may be marketing generic

25 products, it's expected of a branded 

00147

1 company to do that surveillance of the

2 literature.

3 Q. For both its NDA and ANDA drugs,

4 correct?

5 A. It's --

6 MR. COSGROVE: Objection.

7 THE WITNESS: It's expected

8 for the branded drugs, but we went over

9 above and included the generic drugs.

10 BY MR. JENSEN:

11 Q. Okay. And Mutual had never gone

12 over and above and ever surveyed the

13 medical literature for any of its ANDA

14 drugs, including sulindac, before 2006,

15 correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 148, Line 13

Before 2006

Witness_ Robert Dettery - Vol. 1.txt: Page 148, Line 14

we

Witness_ Robert Dettery - Vol. 1.txt: 148:15 - 148:16

did not

16 perform literature surveillance.

Witness_ Robert Dettery - Vol. 1.txt: 148:21 - 149:3

Q. You agree that for the 13 years,

22 between 1991 and 2004, that the

23 regulations did not prohibit you,

24 meaning Mutual, from doing what it now

25 you say chooses to do for its ANDA 

00149

1 drugs, which is survey the medical

2 literature?

3 Nothing prohibited that, correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 149, Line 16

THE WITNESS: I don't know.

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Witness_ Robert Dettery - Vol. 1.txt: 150:5 - 150:13

As a regulatory professional, who

6 knows the regulations or should know the

7 regulations, isn't it correct that you

8 can't identify any regulation which

9 prohibited Mutual, in those 13 years,

10 from doing what it now chooses to do as

11 it says for some of its ANDA drugs and

12 survey the medical literature?

13 Isn't that true?

Witness_ Robert Dettery - Vol. 1.txt: 150:16 - 150:23

THE WITNESS: Correct.

17 BY MR. JENSEN:

18 Q. Does Mutual, after 2006 or '07,

19 now provide the FDA for the 50 or 60 of

20 its ANDA drugs that it surveys the

21 medical literature for some of that

22 medical literature when it deems it

23 reportable?

Witness_ Robert Dettery - Vol. 1.txt: 150:25 - 151:9

THE WITNESS: Yes. 

00151

1 BY MR. JENSEN:

2 Q. And when I just referenced the

3 clinical studies section there in the

4 parenthetical about epidemiological

5 studies or following a monitored series

6 of patients, is that exactly the type of

7 medical literature that Mutual would now

8 provide the FDA for 50 or 60 of its ANDA

9 drugs?

Witness_ Robert Dettery - Vol. 1.txt: 151:14 - 151:22

THE WITNESS: Yes, I really

15 don't know.

16 BY MR. JENSEN:

17 Q. Well, aren't you the one at Mutual

18 who makes the call of what's

19 reportable? Ultimately, you are where

20 the buck stops?

21 A. I'm the head of the department

22 that makes that decision.

Witness_ Robert Dettery - Vol. 1.txt: 152:17 - 153:4

Q. Isn't it true that the ultimate

18 decision as to whether something gets

19 reported or not, in an annual report or

20 a periodic report, there's an issue at

21 Mutual, you are the final word on that

22 because you are the head of regulatory

23 affairs, correct?

24 A. Yes.

25 Q. And you agree, as the head of 

00153

1 regulatory affairs, that epidemiological

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2 studies or monitored series of patients

3 must be reported pursuant to the

4 literature we just looked at, right?

Witness_ Robert Dettery - Vol. 1.txt: 153:7 - 153:9

THE WITNESS: If it provides

8 new information on serious and

9 unexpected events, then yes.

Witness_ Robert Dettery - Vol. 1.txt: 153:20 - 153:23

Q. Isn't it true that Mutual provides

21 such information now to the FDA on its

22 ANDA products that it markets and

23 distributes like sulindac?

Witness_ Robert Dettery - Vol. 1.txt: 153:25 - 154:7

THE WITNESS: Well, like I 

00154

1 said, we do the literature searches in

2 the medical literature, and if something

3 needs to be reported, we will report it.

4 BY MR. JENSEN:

5 Q. Including that example, right, an

6 epidemiological study that monitored a

7 series of patients, correct?

Witness_ Robert Dettery - Vol. 1.txt: 154:9 - 154:10

THE WITNESS: If it results

10 in a serious and unexpected event.

Witness_ Robert Dettery - Vol. 1.txt: 154:20 - 154:24

Q. Is Mutual now a more responsible

21 company as pertains to its 50 or 60 ANDA

22 drugs now that it surveys the medical

23 literature and reports it when

24 appropriate to the FDA?

Witness_ Robert Dettery - Vol. 1.txt: 155:4 - 155:6

THE WITNESS: Well, you are

5 asking me for an opinion. I can't -- I

6 have no opinion on that.

Witness_ Robert Dettery - Vol. 1.txt: 157:23 - 158:5

Q. Don't you agree, Mr. Dettery, that

24 it is more responsible for drug

25 companies and in the best and better 

00158

1 interest of patients and their

2 physicians when they survey the medical

3 literature and report it as appropriate

4 as Mutual has chosen to do since about

5 '06 or '07 and did not do before that?

Witness_ Robert Dettery - Vol. 1.txt: 158:8 - 158:18

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THE WITNESS: Again, I can't

9 answer that. That calls for an

10 opinion. I really have no opinion on

11 that.

12 BY MR. JENSEN:

13 Q. Well, if you don't have an opinion

14 on that and you are the top regulatory

15 person at Mutual, please tell the jury

16 why in '06 or '07 Mutual decided to

17 start doing this for their ANDA drugs

18 that it distributes?

Witness_ Robert Dettery - Vol. 1.txt: 158:24 - 159:18

THE WITNESS: I think I

25 already told you that we became a 

00159

1 branded company, and we -- as branded

2 companies are obligated to do, then we

3 began to do the literature searches.

4 BY MR. JENSEN:

5 Q. But that's really a distinction

6 that makes no difference as it pertains

7 to the ANDA drugs.

8 Just, if there is a reason, please

9 tell this jury why it was a good reason

10 for Mutual to start on its ANDA drugs

11 surveying the medical literature and

12 reporting that it was appropriate,

13 forgetting about the fact that you

14 became a branded company. I'm

15 suggesting, so what?

16 I'm suggesting please tell the

17 jury why it's better that you do that

18 now for your generic drugs.

Witness_ Robert Dettery - Vol. 1.txt: 159:20 - 159:24

THE WITNESS: I'm saying the

21 reason we began doing it for generic

22 drugs is because we began doing it for

23 all of our products once we became a

24 branded company.

Witness_ Robert Dettery - Vol. 1.txt: 160:1 - 160:13

Q. If you would flip to Exhibit 13 in

2 here, sir. In there.

3 And that's a publication in the

4 Journal of Rheumatology in 2003, as you

5 can see from the bottom, correct?

6 A. Yes.

7 Q. And it's a publication entitled

8 "The Risk of" -- I will abbreviate --

9 "SJS and TEN from NSAIDs, a

10 Multinational Perspective." Correct?

11 A. That's what it says.

12 Q. And sulindac is an NSAID, right?

13 A. Yes.

Witness_ Robert Dettery - Vol. 1.txt: 160:15 - 160:19

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At least we know from the title that

16 this article is about the relationship

17 or not between these deadly skin

18 diseases and NSAIDs, and sulindac is an

19 NSAID. Fair?

Witness_ Robert Dettery - Vol. 1.txt: 160:22 - 161:3

THE WITNESS: What you asked

23 is correct, yes.

24 BY MR. JENSEN:

25 Q. Okay. And this was published the 

00161

1 year before Karen Bartlett was

2 prescribed sulindac, she was prescribed

3 it at the end of 2004, correct?

Witness_ Robert Dettery - Vol. 1.txt: 161:6 - 161:7

THE WITNESS: I don't know

7 when she was prescribed sulindac.

Witness_ Robert Dettery - Vol. 1.txt: 161:10 - 161:19

I'm asking you to assume she was

11 prescribed it December 30, 2004, which

12 was the year after this was published,

13 correct?

14 A. This was published 2003, so...

15 Q. Okay. And if we flip to Page 3 of

16 the medical publication, it has a table

17 there and it lists many NSAIDs and some

18 other drugs and their multivariate

19 relative risks, correct?

Witness_ Robert Dettery - Vol. 1.txt: 161:22 - 162:6

THE WITNESS: I can only read

23 from the page, and that's what it says.

24 BY MR. JENSEN:

25 Q. Thank you, sir. 

00162

1 And the other NSAID category,

2 if you follow across, has a cross there,

3 and that cross is a footnote, and that

4 footnote defines the other NSAID group

5 as a number of NSAIDs, which includes

6 sulindac, correct?

Witness_ Robert Dettery - Vol. 1.txt: 162:9 - 162:17

THE WITNESS: That's what it

10 says.

11 BY MR. JENSEN:

12 Q. And in the next table down, under

13 the Other NSAIDs, when taken for less

14 than or equal to eight weeks, it reports

15 a relative risk of 4.5 to a

16 statistically significant degree,

17 correct?

Witness_ Robert Dettery - Vol. 1.txt: 162:20 - 163:4

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THE WITNESS: That's what it

21 says.

22 BY MR. JENSEN:

23 Q. And you understand, do you not,

24 that this publication the year before

25 Karen was prescribed this drug was 

00163

1 reporting that this group of other

2 NSAIDs has a 450 percent greater

3 likelihood of resulting in SJS and TEN

4 than the background rate, correct?

Witness_ Robert Dettery - Vol. 1.txt: 163:9 - 163:16

THE WITNESS: I can't agree

10 to that.

11 BY MR. JENSEN:

12 Q. Is the reason you can't agree to

13 that is because you don't have an

14 understanding of the relationship

15 between a relative risk of 4.5 and a 400

16 percent greater risk? Is that fair?

Witness_ Robert Dettery - Vol. 1.txt: 163:18 - 163:24

THE WITNESS: Yes.

19 BY MR. JENSEN:

20 Q. So the reason you can't say that

21 is because you are not clear whether

22 that is true or not from a statistic

23 standpoint, not that you are denying

24 it's true. Fair?

Witness_ Robert Dettery - Vol. 1.txt: 164:1 - 164:3

THE WITNESS: I'm not denying

2 it is written on this piece of paper.

3 That's all I can testify to.

Witness_ Robert Dettery - Vol. 1.txt: 164:6 - 164:12

And this multinational study of

7 NSAIDs, which include two reports of

8 sulindac, is the precise type of

9 clinical data that starting in '06 or

10 '07 that Mutual would have provided to

11 the FDA for its ANDA drugs, including

12 sulindac, correct?

Witness_ Robert Dettery - Vol. 1.txt: 164:15 - 164:16

THE WITNESS: Not

16 necessarily.

Witness_ Robert Dettery - Vol. 1.txt: 164:24 - 165:2

Q. Your interpretation of 314.81 is

25 that epidemiological studies only need 

00165

1 be reported when they have -- relate to

2 unexpected, unlabeled events?

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Witness_ Robert Dettery - Vol. 1.txt: 165:6 - 165:7

Q. That's what you have twice said,

7 right?

Witness_ Robert Dettery - Vol. 1.txt: 165:10 - 165:13

THE WITNESS: Yes. My

11 understanding is the literature to be

12 reported is for serious and unexpected

13 events.

Witness_ Robert Dettery - Vol. 1.txt: 167:11 - 167:16

There is

12 nothing in the text of 314.81 that

13 limits the need to report clinical data,

14 such as epidemiological studies, to ones

15 that are not in the label or not

16 expected. Isn't that true?

Witness_ Robert Dettery - Vol. 1.txt: Page 168, Line 11

THE WITNESS: That's correct.

Witness_ Robert Dettery - Vol. 1.txt: 169:12 - 169:23

Isn't it true the only effect of

13 the distinction that you were talking

14 about, which has nothing to do with

15 whether you provide clinical data or

16 not, whether an event is expected or

17 unexpected, meaning labeled or

18 unlabeled, the only effect of that is

19 that you don't need to give adverse

20 events on a 15-day basis to the FDA, if

21 they are in the label, then they don't

22 need to be provided on a 15-day basis?

23 Isn't that true?

Witness_ Robert Dettery - Vol. 1.txt: 170:1 - 170:2

THE WITNESS: That part is

2 true about it being a 15-day report.

Witness_ Robert Dettery - Vol. 1.txt: 170:5 - 170:24

Back to Exhibit 362, which is

6 314.80. Tell me when you are there.

7 A. Okay.

8 Q. Page 5, the letter I. Can you

9 read me where it says Recordkeeping,

10 please.

11 A. Yes. You want me to read it?

12 Q. Please.

13 A. "Recordkeeping: The applicant

14 shall maintain for a period of ten years

15 records of all adverse drug experiences

16 known to the applicant, including raw

17 data and any correspondence relating to

18 adverse drug experiences."

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19 Q. And, first, for the words used, a

20 drug company remains an applicant after

21 they are selling their product, for ten

22 or 20 or 30 years they are still

23 considered an applicant in these

24 regulations, correct?

Witness_ Robert Dettery - Vol. 1.txt: 171:1 - 171:7

THE WITNESS: Yes.

2 BY MR. JENSEN:

3 Q. Right. Because an NDA or an ANDA

4 is a living document, even after

5 approval occurs, you still file stuff

6 with the application, whether it be an

7 abbreviated one or a new one, correct?

Witness_ Robert Dettery - Vol. 1.txt: 171:9 - 171:14

THE WITNESS: That's correct.

10 BY MR. JENSEN:

11 Q. So when they are talking about

12 applicant here, you understand that's

13 talking about drug companies whether

14 pre-approval or post-approval. Fair?

Witness_ Robert Dettery - Vol. 1.txt: 171:16 - 171:17

THE WITNESS: Yes. That's my

17 definition of an applicant, yes.

Witness_ Robert Dettery - Vol. 1.txt: 176:2 - 176:11

Q. And what is Exhibit 365,

3 Mr. Dettery?

4 A. It is the -- our complaint file

5 for medical complaint No. 08035.

6 Q. And who is the patient for that

7 complaint?

8 A. Karen Bartlett.

9 Q. Does all of 365 pertain to Karen

10 Bartlett's adverse reactions, SJS, TEN,

11 blindness, coma, to sulindac?

Witness_ Robert Dettery - Vol. 1.txt: 176:14 - 177:3

THE WITNESS: Well, the file

15 is our investigation into the reported

16 side effects that were provided to us in

17 the notification of this lawsuit.

18 BY MR. JENSEN:

19 Q. Okay. But, obviously, you have

20 all Karen's medical records, and so you

21 know that she has generally been blind

22 in both eyes for the last four years,

23 she was in a medically protective coma

24 for weeks on end, she has had esophageal

25 dilatation because she had an esophageal 

00177

1 stricture.

2 Have all those records been

3 provided to the FDA?

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Witness_ Robert Dettery - Vol. 1.txt: 177:11 - 177:13

A. I don't know specifically. I

12 wasn't directly involved in what was

13 submitted to FDA.

Witness_ Robert Dettery - Vol. 1.txt: 180:14 - 180:22

Q. And how long has Mutual been

15 utilizing Prosar to analyze adverse

16 reactions reported to it?

17 A. Since about 2005.

18 Q. Definitely not in 2004?

19 A. No.

20 Q. Does Prosar also survey the

21 medical literature on Mutual's behalf

22 since 2006 or 2007?

Witness_ Robert Dettery - Vol. 1.txt: 180:25 - 181:5

THE WITNESS: Yes. 

00181

1 BY MR. JENSEN:

2 Q. It's still Mutual's

3 responsibility, but Prosar is Mutual's

4 agent which does that, provides those

5 services for it, correct?

Witness_ Robert Dettery - Vol. 1.txt: 181:9 - 181:10

THE WITNESS: Well, Prosar is

10 our agent. When

Witness_ Robert Dettery - Vol. 1.txt: 184:1 - 184:14

Q. Exhibit 303, sir. Tell me when

2 you are there.

3 A. 303?

4 Q. Yes, sir.

5 Is that the document that

6 authorized Mutual to start manufacturing

7 and distributing sulindac?

8 A. Yes.

9 Q. And Mutual is reminded to comply

10 with 314.80 and 314.81 of the

11 regulations, which are the very

12 regulations that you and I have spoken

13 about today, correct?

14 A. Yes.

Witness_ Robert Dettery - Vol. 1.txt: 188:1 - 188:3

Q. And did you review 367, these

2 Answers to Interrogatories, before they

3 were produced, sir?

Witness_ Robert Dettery - Vol. 1.txt: 188:9 - 188:10

THE WITNESS: I don't recall

10 if I saw this before or not.

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Witness_ Robert Dettery - Vol. 1.txt: 188:15 - 189:2

And do you see

16 Interrogatory No. 6.

17 A. Yes.

18 Q. And it says, "Do you contend,"

19 and, of course, you is not a reference

20 to Robert Dettery, it's a reference to

21 Mutual, because that's who it is served

22 to.

23 It says, "Do you contend that

24 sulindac cannot cause SJS or TEN?" And

25 the answer is "No." 

00189

1 Do you see that?

2 A. That's what it says, yes.

Witness_ Robert Dettery - Vol. 1.txt: 190:12 - 190:15

Q. Mutual has a label for its

13 sulindac product that says SJS and TEN

14 are caused by sulindac. Does Mutual

15 agree that label is true and accurate?

Witness_ Robert Dettery - Vol. 1.txt: 190:18 - 190:20

THE WITNESS: As far as I

19 know, our labeling is as true and as

20 accurate as we can make it.

Witness_ Robert Dettery - Vol. 1.txt: 192:13 - 192:20

You see that Interrogatory 13 asks

14 whether or not Mutual had ever done any

15 safety analyses or reviews or safety

16 signal or pharmacovigilance analyses or

17 reviews for serious skin reactions

18 relating to sulindac, and it says none.

19 Do you understand that to be

20 true?

Witness_ Robert Dettery - Vol. 1.txt: 192:23 - 193:12

THE WITNESS: Yes.

24 BY MR. JENSEN:

25 Q. And now go to Page 12. Tell me 

00193

1 when you are there.

2 A. Page 12?

3 Q. Yes, sir.

4 And does the answer -- just the

5 answer reads, "Mutual responds that it

6 did not conduct routine scientific

7 literature searches for sulindac

8 products between 1990 and the date of

9 plaintiff's prescription."

10 Representing to you that was 2004,

11 you know that to be true as well,

12 correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 193, Line 14

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THE WITNESS: Correct.

Witness_ Robert Dettery - Vol. 1.txt: 194:10 - 194:15

Q. You know that Mutual never

11 distributed or made any advocacy to

12 distribute a medication guide or a

13 patient insertion leaflet or a document

14 designed for the patient to read before

15 2004, correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 194, Line 18

THE WITNESS: That's correct.

Witness_ Robert Dettery - Vol. 1.txt: 200:5 - 200:8

Do you agree that Mutual has

6 always had the ability since the day

7 after sulindac was approved to suspend

8 sales or take sulindac off the market?

Witness_ Robert Dettery - Vol. 1.txt: Page 200, Line 10

THE WITNESS: Yes.

Witness_ Robert Dettery - Vol. 1.txt: 200:12 - 200:14

Q. Do you agree that Mutual has

13 always had the ability to do CBE label

14 changes?

Witness_ Robert Dettery - Vol. 1.txt: 200:16 - 201:9

THE WITNESS: No.

17 BY MR. JENSEN:

18 Q. Is a CBE label change something

19 that stands for changes being effected?

20 A. That's correct.

21 Q. And a changes being effected label

22 changes can be for minor things, like

23 dosage or administration, or they can be

24 for major things, like enhancing or

25 strengthening warnings, correct? 

00201

1 A. No.

2 Q. Okay. What is your definition of

3 changes being effected label changes?

4 A. The regulations permit the brand

5 companies to change their labeling to

6 include newly acquired information that

7 shows a causal relationship between

8 their product and whatever information

9 they have.

Witness_ Robert Dettery - Vol. 1.txt: 203:23 - 203:25

Q. 314.97, as you understand it,

24 applies to ANDA products whether they

25 are RLDs or not, correct? 

Witness_ Robert Dettery - Vol. 1.txt: 204:2 - 204:14

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THE WITNESS: It says,

3 changes for approved abbreviated

4 applications, so I would agree with

5 that.

6 BY MR. JENSEN:

7 Q. And an RLD is the referenced

8 listed drug, correct?

9 A. Right.

10 Q. Are any of the Mutual's ANDAs

11 designated RLDs?

12 A. Yes.

13 Q. Which drugs, please, in which

14 form?

Witness_ Robert Dettery - Vol. 1.txt: 204:17 - 205:14

THE WITNESS: Quinidine

18 gluconate extended-release tablets.

19 BY MR. JENSEN:

20 Q. When did Mutual become the RLD for

21 that extended-release drug?

22 A. Are you asking me like what year?

23 Q. Best approximation.

24 A. Approximately seven, eight years

25 ago. 

00205

1 Q. Okay. When did Mutual first start

2 doing surveying of the medical

3 literature and potentially reporting

4 what it found and deemed appropriately

5 reportable for that drug in that

6 extended-release form?

7 A. About two years ago.

8 Q. So, hence, is it correct to state

9 that even after Mutual became the

10 reference listed drug for quinidine, it

11 did not start surveying the literature

12 until approximately three or four years

13 after it became the reference listed

14 drug?

Witness_ Robert Dettery - Vol. 1.txt: 205:17 - 205:23

THE WITNESS: That's correct.

18 BY MR. JENSEN:

19 Q. So, I take it, you did not see a

20 cause-and-effect relationship between

21 being designated the RLD and having to

22 start surveying the literature

23 immediately. Fair?

Witness_ Robert Dettery - Vol. 1.txt: 206:2 - 206:6

THE WITNESS: Yes.

3 BY MR. JENSEN:

4 Q. Yes, that's true, you didn't think

5 one related to the other?

6 A. Yes.

Witness_ Robert Dettery - Vol. 1.txt: 208:25 - 209:25

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Q. Approximately how many times has 

00209

1 Mutual suspended the sales of or

2 withdrawn an application to stop selling

3 an ANDA drug?

4 A. Well, suspended sales happened

5 several times, and withdrawing an

6 application happened once, that I

7 remember.

8 Q. And for the benefit of the jury,

9 is withdrawing an application the same

10 thing as telling the FDA you are no

11 longer going to distribute or market

12 this drug?

13 Does it have that effect?

14 A. No.

15 Q. Okay. Tell us what withdrawing an

16 application means, then, to you.

17 A. Withdrawing an application means

18 that you are basically doing away with

19 your application and you will not market

20 that product in the future because your

21 application no longer exists.

22 Q. Is what I said right, then, that

23 when you withdraw an application, you

24 can no longer sell the drug, right?

25 A. Yes. 

Witness_ Robert Dettery - Vol. 1.txt: 212:17 - 212:22

Q. Has Mutual ever advocated to the

18 FDA, between, let's pick years, 1991 and

19 2004, that it be permitted to make a

20 change as being effected label change to

21 add to or increase risk information or

22 warning information?

Witness_ Robert Dettery - Vol. 1.txt: 213:1 - 213:7

THE WITNESS: Between 1991

2 and 2004?

3 BY MR. JENSEN:

4 Q. Yes, sir.

5 A. No.

6 Q. Has Mutual at any time before 1991

7 ever so advocated?

Witness_ Robert Dettery - Vol. 1.txt: 213:10 - 213:16

THE WITNESS: Not to my

11 knowledge.

12 BY MR. JENSEN:

13 Q. Has Mutual ever advocated to the

14 FDA that all of the labels be changed

15 for a given drug, such as sulindac, at

16 any time between 1991 and 2004?

Witness_ Robert Dettery - Vol. 1.txt: 213:19 - 213:22

BY MR. JENSEN:

20 Q. To add to or strengthen warning or

21 risk information?

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22 A. No.

Witness_ Robert Dettery - Vol. 1.txt: 214:16 - 215:6

Q. Okay. And which drug did Mutual

17 advocate for a label change to add to or

18 strengthen warnings?

19 A. Our product Qualaquin.

20 Q. And what additional or enhanced

21 risk information did Mutual advocate for

22 Qualaquin?

23 A. We submitted a CBE to strengthen

24 the warnings for thrombocytopenia.

25 Q. And tell us what thrombocytopenia 

00215

1 is, please.

2 A. My understanding, and, again, I'm

3 not a physician, my understanding is a

4 hematological disorder, meaning the

5 blood, where the person tends to bleed

6 under the skin I think.

Witness_ Robert Dettery - Vol. 1.txt: 216:1 - 216:4

Did Mutual do a CBE

2 label change before the FDA approved the

3 label change for thrombocytopenia?

4 A. Yes.

Witness_ Robert Dettery - Vol. 1.txt: 216:21 - 217:21

Q. Chronologically speaking, tell us

22 what happened.

23 A. Okay. Going how far back?

24 Q. From Mutual's determination that

25 new risk or enhanced risk information 

00217

1 needed to be in the Qualaquin label.

2 A. Okay. We determined that the

3 warnings -- or the information about

4 thrombocytopenia needed to be

5 strengthened in the insert, so we

6 submitted that in June 2009 as a CBE

7 supplement.

8 And at the same time, we submitted

9 a prior approval supplement to do

10 additional labeling changes, such as

11 adding a med guide to the labeling that

12 cannot be submitted as a CBE, so we

13 submitted that as a prior approval

14 supplement.

15 So the changes that were submitted

16 under the CBE, since it went into June,

17 30 days went by, FDA did not tell us not

18 to make it effective, so it became

19 effective. It has not yet officially

20 been approved by FDA, but it is

21 effective.

Witness_ Robert Dettery - Vol. 1.txt: 217:23 - 217:24

A. And the prior approval supplement

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24 has not yet been approved.

Witness_ Robert Dettery - Vol. 1.txt: 218:21 - 219:3

Q. And is it correct to state that

22 you understand what happens is, when

23 Mutual took it upon itself to make the

24 label change to enhance the risk

25 information for this drug, is that if 

00219

1 the FDA did not do anything within 30

2 days, like reject the proposed change,

3 it became effective at that time?

Witness_ Robert Dettery - Vol. 1.txt: 219:7 - 219:13

THE WITNESS: Yes.

8 BY MR. JENSEN:

9 Q. Hence, because we are in August

10 2009, Mutual's unilateral -- defining

11 unilateral as before it was approved by

12 the FDA -- Mutual's unilateral label

13 change is now effective, correct?

Witness_ Robert Dettery - Vol. 1.txt: 219:17 - 219:22

THE WITNESS: Correct.

18 BY MR. JENSEN:

19 Q. What was the increased or enhanced

20 safety information Mutual found it

21 appropriate to make this label change

22 for? Tell us, please.

Witness_ Robert Dettery - Vol. 1.txt: 219:24 - 221:4

THE WITNESS: We became aware

25 of a number of adverse events in which 

00220

1 the patient reported -- or the

2 information that was reported to us

3 claim that the patient suffered

4 thrombocytopenia or some type of a

5 relate blood disorder.

6 BY MR. JENSEN:

7 Q. How many parts of thrombocytopenia

8 or a related blood disorder did Mutual

9 receive before it determined that a

10 label needed to be changed by its own

11 action?

12 A. I don't recall the exact number.

13 Q. What's your best estimate?

14 A. There may have been about -- there

15 may have been about 30.

16 Q. And in how many years were these

17 30 received, approximately? The

18 approximate 30.

19 A. Well, they covered a time span

20 going back into the 1990s.

21 Q. Okay. So in the 1990s, we are

22 talking 15 or so years that 30

23 thrombocytopenia or related blood

24 disorder reports had been received?

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25 A. Well, we received them all at the 

00221

1 same time, but the reports were from --

2 covering a period back into 1990, which,

3 of course, predates our approval of our

4 NDA.

Witness_ Robert Dettery - Vol. 1.txt: 221:10 - 221:19

Q. Tell me then why approximately 30

11 were received by Mutual at the same

12 time, even though they dated for many

13 years back, 15 or so?

14 A. It was a lawsuit. We were

15 informed of a lawsuit.

16 Q. And the adverse reaction

17 information came from information

18 learned as a result of this lawsuit?

19 MR. COSGROVE: Objection.

Witness_ Robert Dettery - Vol. 1.txt: 221:20 - 222:2

THE WITNESS: Yes.

21 BY MR. JENSEN:

22 Q. Was the lawsuit on behalf of the

23 approximate 30 or so persons?

24 A. The lawsuit was on behalf of a

25 number of people. I don't remember the 

00222

1 exact number. I think there were more

2 than 30.

Witness_ Robert Dettery - Vol. 1.txt: 222:24 - 223:3

Q. Is Mutual presently waiting for

25 its prior approval supplement of the 

00223

1 medication guide for Qualaquin to be

2 approved?

3 A. Yes.

Witness_ Robert Dettery - Vol. 1.txt: 223:12 - 224:1

Q. Was thrombocytopenia mentioned

13 anywhere in the Qualaquin label before

14 Mutual learned of these cases through

15 this lawsuit?

16 A. Yes.

17 Q. Was it in the adverse reaction

18 section?

19 A. If I remember correctly, it was in

20 more than one section.

21 Q. Was thrombocytopenia or related

22 blood disorders in the Warnings section

23 of the Qualaquin label before Mutual

24 learned of this lawsuit and these

25 approximate 30 cases? 

00224

1 A. If I remember correctly, it was.

Witness_ Robert Dettery - Vol. 1.txt: 224:14 - 225:5

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Tell me what Mutual put in the

15 label through its unilateral action

16 before getting FDA approval that wasn't

17 in there.

18 A. We moved it -- we expanded on the

19 statement about the warning -- warning

20 regarding the possibility of

21 thrombocytopenia, and we also moved it

22 to the top or the beginning of the

23 Warnings section, rather than it was

24 about halfway in the Warnings section

25 previously. 

00225

1 Q. Is the reason Mutual moved the

2 location within the Warnings section

3 about the possibility of

4 thrombocytopenia so it would be more

5 obvious and more striking to the reader?

Witness_ Robert Dettery - Vol. 1.txt: 225:9 - 226:1

THE WITNESS: Well, we moved

10 it to the beginning just to make it more

11 prominent.

12 BY MR. JENSEN:

13 Q. And when you make things more

14 prominent, that is an attempt to get

15 people to take notice more easily and

16 readily. Fair?

17 That's why you move it, right?

18 A. Yes.

19 Q. Is that fair?

20 A. Yes.

21 MR. COSGROVE: Objection.

22 BY MR. JENSEN:

23 Q. So, you agree, based upon that

24 action you just took two months ago,

25 that where things are in a label are 

00226

1 important? Fair?

Witness_ Robert Dettery - Vol. 1.txt: Page 226, Line 5

THE WITNESS: Yes.

Witness_ Robert Dettery - Vol. 1.txt: 228:21 - 229:5

Is Mutual's Qualaquin changes

22 being effected to enhance or add to

23 warning information for a serious

24 adverse reaction the first time, to your

25 knowledge, when they did it in June 

00229

1 2009, that the company had ever done it

2 for any drug, NDA or ANDA?

3 MR. COSGROVE: Objection.

4 Form.

5 THE WITNESS: Yes.

Witness_ Robert Dettery - Vol. 1.txt: 229:11 - 230:8

Q. Before Mutual decides to initially

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12 file and initially become an applicant,

13 pre-approval obviously, for an ANDA

14 product, does it assess the risk and

15 benefit profile of the product in

16 relation to the product's label?

17 A. What do you mean by assess?

18 Q. I mean make an assessment of

19 whether they believe that the product

20 label as it presently exists for other

21 participants in the market of that drug

22 is a proper reflection of the risk and

23 benefit profile.

24 Obviously, I know they don't have

25 access to the data, the clinical or 

00230

1 preclinical trials of the RLD.

2 Obviously, what that assess would entail

3 is a review of the medical literature

4 and an assessment in that regard.

5 So, does Mutual do an assessment

6 of the accuracy of the label for an ANDA

7 drug before it decides to file an ANDA

8 application for a drug?

Witness_ Robert Dettery - Vol. 1.txt: 230:12 - 231:6

THE WITNESS: No.

13 BY MR. JENSEN:

14 Q. To your knowledge, Mr. Dettery,

15 did anyone at Mutual ever do an

16 assessment of serious skin reactions,

17 including, of course, SJS and TEN, in

18 relation to sulindac before learning of

19 Karen Bartlett?

20 A. Not to my knowledge.

21 Q. Let me expand my question.

22 To your knowledge, did Mutual ever

23 do an assessment of severe skin

24 reactions, including, of course, SJS and

25 TEN, in relation to any NSAID or Bactrim 

00231

1 before learning of Karen Bartlett --

2 MR. COSGROVE: Objection.

3 BY MR. JENSEN:

4 Q. -- i.e., the association of such

5 reactions, obviously, in any of its

6 drugs?

Witness_ Robert Dettery - Vol. 1.txt: 231:8 - 231:23

THE WITNESS: To my

9 knowledge, we haven't done any

10 assessment of the type that you are

11 describing.

12 BY MR. JENSEN:

13 Q. After Mutual learned of Karen

14 Bartlett's SJS and TEN and over a

15 hundred days hospitalization, weeks,

16 perhaps months, of being in a medically

17 protective coma, doctors' conclusions

18 that for most of the last five years she

19 has been legally blind in both eyes,

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20 after nine or ten surgeries now, what

21 has Mutual done to assess the

22 relationship between sulindac and SJS

23 and TEN?

Witness_ Robert Dettery - Vol. 1.txt: 232:2 - 232:5

THE WITNESS: Well, as I

3 stated previously, we now do literature

4 searches, and anything that would show

5 up there would be assessed.

Witness_ Robert Dettery - Vol. 1.txt: 241:4 - 241:13

And is that a changes being

5 effected for number of tablets in a

6 bottle?

7 A. Yes.

8 Q. And that's pursuant to the same

9 general provisions as was utilized on

10 behalf of the NDA drug Qualaquin to make

11 CBE label changes. They are, obviously,

12 different sections, but it's part of the

13 same 314.70, correct?

Witness_ Robert Dettery - Vol. 1.txt: 241:16 - 241:20

BY MR. JENSEN:

17 Q. They are both changes being

18 effected, and changes being effected

19 both emanate from the same regulation,

20 which is 314.70, correct?

Witness_ Robert Dettery - Vol. 1.txt: 241:23 - 243:3

THE WITNESS: They are both,

24 yes, special supplements changes being

25 effected. 

00242

1 BY MR. JENSEN:

2 Q. Please refer to Exhibit 317. Tell

3 me when you are there.

4 That also is a special supplement

5 changes being effected by Mutual,

6 correct?

7 A. Yes.

8 Q. And that is for moisture

9 specifications, correct?

10 A. Yes, it is.

11 Q. And Exhibit 320 is the FDA's

12 response letter telling you that that

13 changes being effected proposal was

14 deficient, correct?

15 A. Yes.

16 Q. What is Exhibit 321, please?

17 A. 321 is the summary report of the

18 stability data for several different

19 lots of sulindac.

20 Q. Okay. And, again, does this

21 pertain to the 24 versus 36 months, how

22 long you can keep it issue?

23 A. Yes, it pertains to it. Sure.

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24 Q. Was this an analysis to see

25 whether or how or on what basis Mutual 

00243

1 might again try to increase how long it

2 can keep the drug before it had to

3 dispose of it up to three years?

Witness_ Robert Dettery - Vol. 1.txt: 243:6 - 244:1

THE WITNESS: Well, I don't

7 know if you would call this an

8 analysis. This is a summary of the

9 results.

10 BY MR. JENSEN:

11 Q. And this is dated July of '01,

12 correct? I see by a signature down

13 there, the first page.

14 A. Yes.

15 Q. And is there any way to tell from

16 this document where any of these batch

17 shipments went? For example, were

18 they -- strike that.

19 Does Mutual have a way of going

20 back and determining, from any

21 information, what batches shipped what

22 sulindac product where, or what batches

23 went to where?

24 A. We have distribution records that

25 would show where specific lots were 

00244

1 sent.

Witness_ Robert Dettery - Vol. 1.txt: 246:6 - 246:11

BY MR. JENSEN:

7 Q. So far we have reviewed changes

8 being effected submissions by Mutual for

9 how many tablets could go in a bottle

10 and the moisture of the product and

11 where the supplier might be, correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 246, Line 15

THE WITNESS: Yes.

Witness_ Robert Dettery - Vol. 1.txt: 247:6 - 247:14

Q. Do you agree that it is more

7 important to patients and physicians

8 that they have the most current risk

9 information regarding risks, such as SJS

10 and TEN and coma and blindness, as

11 opposed to these supplemental changes

12 being effected, which address matters of

13 where the product is produced or

14 moisture specifications?

Witness_ Robert Dettery - Vol. 1.txt: 247:18 - 247:25

THE WITNESS: No, I don't

19 necessarily agree with that.

20 BY MR. JENSEN:

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21 Q. Obviously, physicians want to make

22 sure the product is produced properly.

23 That's your point, correct?

24 A. Yes. They want to make sure the

25 product is not adulterated in any way. 

Witness_ Robert Dettery - Vol. 1.txt: 248:19 - 249:3

What's more important to

20 physicians and patients, in your view,

21 having done this for over two decades

22 like you have, to have updated risk

23 information regarding deadly diseases,

24 like SJS and TEN, and risks, like coma

25 and blindness, or where the product 

00249

1 might be produced, presuming it is going

2 to be just as well produced in either of

3 two places?

Witness_ Robert Dettery - Vol. 1.txt: 249:6 - 250:2

THE WITNESS: Well, you are

7 asking me what's important to

8 physicians. I don't -- I'm not a

9 physician. I don't know how to answer

10 that.

11 BY MR. JENSEN:

12 Q. Exhibit 328 is a fourth example of

13 a special supplement label change under

14 314.70 that Mutual sought, correct?

15 A. Yes.

16 Q. Exhibit 330 is a fifth example of

17 a special supplement label change that

18 Mutual sought, this time for thickness

19 of the tablets, right, in August 2002?

20 A. Yes.

21 Q. Exhibit 331 is a sixth example of

22 a special supplement label change --

23 strike that.

24 Exhibit 331, in September 2002, is

25 a sixth example of a special supplement 

00250

1 that Mutual sought this time regarding

2 raw material method testing, correct?

Witness_ Robert Dettery - Vol. 1.txt: 250:5 - 250:8

THE WITNESS: This is a --

6 such a supplement. I have lost track of

7 how many now we have looked at, so I

8 don't know if this is the sixth or not.

Witness_ Robert Dettery - Vol. 1.txt: 251:11 - 251:16

Q. And I did not ask you, regarding

12 this risk of SJS and TEN from NSAID 2003

13 publication, is it correct that in 2003

14 Mutual never provided that publication

15 regarding NSAIDs, and specifically

16 sulindac and SJS and TEN, to the FDA?

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Witness_ Robert Dettery - Vol. 1.txt: 251:21 - 251:22

THE WITNESS: To my

22 knowledge, we haven't submitted it.

Witness_ Robert Dettery - Vol. 1.txt: 252:1 - 252:5

Is it correct to

2 state that, to your knowledge, Mutual

3 has never submitted a 2003 publication

4 regarding NSAIDs, SJS, TEN, and sulindac

5 to the FDA?

Witness_ Robert Dettery - Vol. 1.txt: Page 252, Line 8

THE WITNESS: That's correct.

Witness_ Robert Dettery - Vol. 1.txt: 253:18 - 253:23

Q. You have already reviewed the

19 brand insert for 2004 today, and you

20 know that none of the information from

21 this 2003 publication was in the brand

22 insert or Mutual's insert a year later

23 in 2004, correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 254, Line 1

THE WITNESS: Yes.

Witness_ Robert Dettery - Vol. 1.txt: 254:5 - 254:8

Q. Yes, it's correct that none of

6 that information from the 2003

7 publication was in the 2004 Mutual

8 label, correct?

Witness_ Robert Dettery - Vol. 1.txt: Page 254, Line 16

A. That's correct.

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Witness_ Robert Dettery - Vol. 2.txt: 261:1 - 261:22

VOLUME II,

IN THE UNITED STATES DISTRICT COURT

2 FOR THE DISTRICT OF NEW HAMPSHIRE

3 

4 

KAREN L. BARTLETT and

5 GREGORY S. BARTLETT,

Plaintiffs,

6 Case No.: 08-cv-358-JL

Judge Joseph N. Laplante

7 V

8 

MUTUAL PHARMACEUTICAL

9 COMPANY, INC. and UNITED

RESEARCH LABORATORIES, INC,

10 Defendants.

11 

12 

13 SuperDeposition of ROBERT

14 DETTERY, taken at the law offices of

15 Segal, McCambridge, Singer & Mahoney,

16 Ltd., United Plaza, 30 South 17th

17 Street, Suite 1700, Philadelphia,

18 Pennsylvania, on Tuesday, September 1,

19 2009, at 11:32 a.m., before Jennifer L.

20 Bermudez, a Registered Professional

21 Reporter, and Notary Public, pursuant to

22 notice.

Witness_ Robert Dettery - Vol. 2.txt: 273:13 - 273:19

Q. Mr. Dettery, the benefit/risk

14 profile of a drug can change and often

15 does change over time, correct?

16 A. I don't know.

17 Q. Why do you not know?

18 A. Well, I'm not an expert in the

19 benefit/risk ratio of a product.

Witness_ Robert Dettery - Vol. 2.txt: 274:24 - 275:1

Do you agree, Mr. Dettery, that

25 the benefit/risk ratio of a product can 

00275

1 change over the life of the product?

Witness_ Robert Dettery - Vol. 2.txt: 275:7 - 275:10

THE WITNESS: Well, to answer

8 your question, since FDA acknowledges

9 it, then I would have to say that that

10 must be the case.

Witness_ Robert Dettery - Vol. 2.txt: 276:2 - 276:6

Q. Do you agree that a new medical

3 report or study can identify a new use

4 for a drug which is beneficial, and when

5 that happens, the benefits of a drug can

6 improve or increase?

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Witness_ Robert Dettery - Vol. 2.txt: 276:13 - 277:5

THE WITNESS: Well, if a

14 new -- I am aware that with new evidence

15 of safety and effectiveness, that a

16 product may get a new indication, but I

17 can't say if that relates to a better

18 benefit for the product.

19 BY MR. JENSEN:

20 Q. Can you state on the other side of

21 the coin, that an example of such as a

22 medical report or study can provide

23 information about how a labeled event,

24 like SJS and TEN, might occur or it can

25 provide information about serious 

00277

1 complications of a labeled event, like

2 blindness or coma, and that would be

3 providing additional risk information

4 that has been learned of through medical

5 reports or studies?

Witness_ Robert Dettery - Vol. 2.txt: 277:12 - 278:1

THE WITNESS: Again, I would

13 have to give you the same answer.

14 It's -- I don't necessarily conclude

15 that reports -- new -- new reports of

16 adverse events may relate to a change in

17 the risk profile of a product.

18 BY MR. JENSEN:

19 Q. Do you recall we had a discussion

20 about the relationship between the

21 Mutual entities, related entities, first

22 acquiring NDAs and the first time

23 Mutual, through Prosar, started doing

24 medical literature surveillance?

25 Do you recall that discussion we 

00278

1 had?

Witness_ Robert Dettery - Vol. 2.txt: 278:5 - 278:18

THE WITNESS: I remember a

6 general discussion about that.

7 BY MR. JENSEN:

8 Q. Okay. Let me ask you

9 specifically.

10 Other than the reason you cited,

11 which was the fact that Mutual entities

12 started marketing NDA, also known as

13 brand name drugs, in 2006 or 2007, which

14 led to Mutual, through Prosar, starting

15 to do medical literature surveillance

16 for its ANDA, also known as generic

17 drugs, can you cite any other reason why

18 that occurred?

Witness_ Robert Dettery - Vol. 2.txt: 278:22 - 279:11

THE WITNESS: I'm not aware

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23 of any other reason.

24 BY MR. JENSEN:

25 Q. Okay. Numerous times when I asked 

00279

1 questions of you last week about whether

2 or not Mutual should be or should have

3 been surveying the medical literature or

4 assessing the adequacy of its label as

5 it pertained to sulindac before Karen

6 was prescribed it at the end of 2004,

7 you said Mutual was relying on the FDA

8 to ensure the sulindac label fully and

9 accurately set forth the risks and

10 benefits of their drugs in conjunction

11 with the brand name label. Correct?

Witness_ Robert Dettery - Vol. 2.txt: 279:16 - 279:22

THE WITNESS: That's correct.

17 BY MR. JENSEN:

18 Q. And today, at least three times in

19 response to questions, I asked you about

20 whether you knew things and you talked

21 about your reliance on what the FDA told

22 you, right?

Witness_ Robert Dettery - Vol. 2.txt: 279:25 - 280:5

THE WITNESS: Yes. 

00280

1 BY MR. JENSEN:

2 Q. And you agree that a central

3 mission of the FDA is to ensure the

4 health and safety of the U.S. populous,

5 right?

Witness_ Robert Dettery - Vol. 2.txt: 280:9 - 280:18

THE WITNESS: Yes. My

10 understanding of the mission of FDA is

11 consumer protection.

12 BY MR. JENSEN:

13 Q. And that mission of consumer

14 protection of the FDA includes drug

15 labels that do not overstate the

16 benefits nor understate the risks

17 associated with drugs in package

18 inserts, also known as labels, right?

Witness_ Robert Dettery - Vol. 2.txt: Page 280, Line 21

THE WITNESS: Yes.

Witness_ Robert Dettery - Vol. 2.txt: 281:23 - 282:2

Q. But you agree that the FDA, to

24 assess medical literature, either needs

25 to go and survey literature themselves 

00282

1 or they need to get it from some source

2 so they can assess it, right?

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Witness_ Robert Dettery - Vol. 2.txt: 282:7 - 282:21

THE WITNESS: Well, yes. My

8 understanding of FDA is that they are

9 relying on scientific information that

10 they either search themselves or receive

11 from the brand -- the NDA holder of the

12 brand product.

13 BY MR. JENSEN:

14 Q. Hence, part of the FDA's mission

15 for consumer protection, which was your

16 words, was when medical literature is

17 obtained, it needs to be assessed by

18 somebody to determine whether or not

19 that medical information requires or

20 warrants additional risk or additional

21 benefit information in a label, right?

Witness_ Robert Dettery - Vol. 2.txt: 283:15 - 283:20

THE WITNESS: Yes. I think

16 when FDA receives that information, they

17 assess it for the need to address if any

18 labeling changes are required.

19 BY MR. JENSEN:

20 Q. Or warranted, right?

Witness_ Robert Dettery - Vol. 2.txt: 283:25 - 284:1

THE WITNESS: Well, warranted 

00284

1 or necessary, I consider it the same.

Witness_ Robert Dettery - Vol. 2.txt: 284:19 - 285:1

Q. Before Karen Bartlett ingested

20 sulindac in 2004, Mutual relied on the

21 FDA to have enough medical experts and

22 enough resources to monitor and assess

23 the relevant medical literature and the

24 accuracy and adequacy of drug labels in

25 conjunction with the brand name 

00285

1 manufacturers, right?

Witness_ Robert Dettery - Vol. 2.txt: 285:4 - 285:10

THE WITNESS: Yes.

5 BY MR. JENSEN:

6 Q. Now, a generic maker, like Mutual,

7 does not know whether or not the brand

8 name maker is accurately or adequately

9 reporting the medical literature to the

10 FDA, right?

Witness_ Robert Dettery - Vol. 2.txt: 285:13 - 285:20

THE WITNESS: No, we would

14 not know that.

15 BY MR. JENSEN:

16 Q. A generic maker, like Mutual, does

17 not know whether or not the brand name

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18 manufacturer is assessing the medical

19 literature and/or reporting it to the

20 FDA, right?

Witness_ Robert Dettery - Vol. 2.txt: 285:23 - 285:24

THE WITNESS: No, I would not

24 agree with that.

Witness_ Robert Dettery - Vol. 2.txt: 286:16 - 286:22

A generic maker, A, doesn't know

17 whether the brand name manufacturer is

18 submitting medical literature to the

19 FDA, and a generic maker also does not

20 know, B, whether the brand name

21 manufacturer is assessing the medical

22 literature, correct?

Witness_ Robert Dettery - Vol. 2.txt: 286:25 - 287:15

THE WITNESS: Well, A, it's 

00287

1 the brand company's obligation to report

2 it, so I have to assume that they are.

3 Although, I don't have direct knowledge

4 that they do.

5 And, B, I have to assume that

6 if FDA is receiving it, they are

7 assessing it.

8 BY MR. JENSEN:

9 Q. And as you pointed out, all a

10 generic company has is the assumptions

11 that the medical literature surveillance

12 and the assumption that medical

13 literature assessment is going on, and

14 it has no knowledge one way or the

15 other, correct?

Witness_ Robert Dettery - Vol. 2.txt: 287:19 - 288:5

THE WITNESS: I have the

20 assumption that the brand companies are

21 fulfilling their obligation to report

22 medical literature, and I'm assuming

23 that FDA is fulfilling its mission in

24 assessing such literature.

25 BY MR. JENSEN: 

00288

1 Q. In short, a generic maker has to

2 assume that those things are happening

3 to conclude that the drug label is a

4 full and accurate statement of the risks

5 and benefits, right?

Witness_ Robert Dettery - Vol. 2.txt: 288:8 - 288:15

THE WITNESS: Yes.

9 BY MR. JENSEN:

10 Q. Now, if it were the case that the

11 FDA has more than enough qualified

12 experts and more than enough resources

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13 to achieve its mission before 2004, then

14 Mutual's reliance would have been well15 placed, right?

Witness_ Robert Dettery - Vol. 2.txt: 288:18 - 289:4

THE WITNESS: I have to

19 assume that FDA has such resources

20 available to them.

21 BY MR. JENSEN:

22 Q. How many times before 2004 did

23 Mutual ever investigate or assess

24 whether or not that was true, whether or

25 not the FDA had sufficient resources to 

00289

1 keep up with whether or not drug labels

2 provide full and accurate assessments of

3 the risks and benefits of the thousands

4 of market drugs?

Witness_ Robert Dettery - Vol. 2.txt: 289:8 - 289:20

THE WITNESS: That is

9 something that the company just -- we

10 don't question FDA on whether or not

11 they are capable of doing their jobs.

12 BY MR. JENSEN:

13 Q. Okay. How many times before 2004,

14 a different question, did a Mutual

15 investigator assess whether or not the

16 FDA had sufficient resources and

17 expertise to keep up with, let alone

18 assess, the new medical literature

19 pertaining to thousands of marketed

20 drugs?

Witness_ Robert Dettery - Vol. 2.txt: 289:23 - 290:7

THE WITNESS: Same question,

24 it is not a company's -- or same answer,

25 it is not a company's duty to -- or 

00290

1 obligation to question FDA if they have

2 the resources or expertise to properly

3 do their job.

4 BY MR. JENSEN:

5 Q. Don't you agree that Mutual's

6 reliance on the adequacy of the FDA's

7 resources, then, was blind reliance?

Witness_ Robert Dettery - Vol. 2.txt: 290:11 - 290:14

THE WITNESS: My experience

12 with FDA and working in the industry is

13 such that FDA is quite capable of doing

14 their job and fulfilling their mission.

Witness_ Robert Dettery - Vol. 2.txt: 290:17 - 291:1

Q. You told me what you think you

18 know about the FDA. You told me that

19 Mutual never has investigated or

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20 assessed whether or not the FDA has had

21 sufficient resources.

22 So in terms of the assuming that

23 the FDA had sufficient resources to

24 fulfill its mission regarding drug

25 labels, Mutual's reliance was a blind 

00291

1 reliance, was it not?

Witness_ Robert Dettery - Vol. 2.txt: 291:8 - 291:10

THE WITNESS: Well, again,

9 we -- I have no reason to believe that

10 FDA is incapable of doing their job.

Witness_ Robert Dettery - Vol. 2.txt: 291:14 - 292:8

First, I'm going to show you who

15 cites these studies. In 2009, the U.S.

16 Supreme Court ruled in a case called

17 Wyeth vs. Levine, and I'm going to flip

18 back here and show you what they cited

19 about the FDA.

20 They first said, in 1955, the year

21 the agency approved a particular drug,

22 an FDA advisory committee issued a

23 report finding conclusively that the

24 budget and staff of the Food and Drug

25 Administration are inadequate to permit 

00292

1 the discharge of its existing

2 responsibilities for the protection of

3 the American public.

4 Do you see that, sir?

5 A. Yes.

6 Q. Were you aware of that -- I know

7 it's a long time ago, but you might have

8 been aware.

Witness_ Robert Dettery - Vol. 2.txt: 292:15 - 293:3

But were you aware of that finding

16 a long time ago in 1955?

17 A. No, I was not aware of that.

18 Q. Thank you, sir.

19 Well, let's step up then to a more

20 recent finding.

21 The U.S. Supreme Court also found

22 it appropriate to tell in this opinion

23 about a report called FDA Science Board

24 Report of the Subcommittee on Science

25 and Technology, "FDA Science and Mission 

00293

1 at Risk," and it was a 2007 report.

2 Are you aware of anything to do --

3 or any of the findings of that report?

Witness_ Robert Dettery - Vol. 2.txt: 293:19 - 294:12

A. I'm not aware of the content of

20 that report.

21 Q. And here is one thing that the

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22 U.S. Supreme Court told us that this

23 2007 report said, they quoted them as

24 saying, "The agency suffers from serious

25 scientific deficiency and is not 

00294

1 positioned to meet current or emerging

2 regulatory responsibilities."

3 Did I read that right?

4 A. That's what it says.

5 Q. And we are going to get to that

6 very report in a second. Here it is.

7 It is the "FDA Science and Mission at

8 Risk," published in November 2000.

9 But before we do, sir, I'm going

10 to show you some testimony from one of

11 the main authors of that report, and his

12 name is Dr. Cassell.

Witness_ Robert Dettery - Vol. 2.txt: 295:4 - 297:1

Q. I'm going to represent to you,

5 Mr. Dettery, that Dr. Cassell was one of

6 the authors of this 2007 report, "FDA

7 Science and Mission at Risk" and show

8 you some of his testimony to the U.S.

9 Congress.

10 And then I'm going to ask you

11 whether or not the findings or his

12 testimony have any influence upon your

13 long-term reliance on the sufficiency of

14 the FDA's resources.

15 Do you understand what I'm going

16 to ask you to do, sir?

17 A. I believe so, yes.

18 Q. Dr. Cassell -- first of all, let's

19 show you who he is.

20 Dr. Cassell says, he is the VP of

21 scientific affairs and a distinguished

22 research scholar of infectious diseases

23 at a drug company called Eli Lilly.

24 Ever heard of that drug company,

25 sir? 

00296

1 A. Yes.

2 Q. He says -- he testifies to the

3 U.S. Congress, he is a professor and

4 chairman, and I am going to abbreviate,

5 the Department of Microbiology at the

6 Alabama Medical School, he is a member

7 of the Institute of Medicine, the

8 National Academy of Sciences, and is

9 currently serving a second term on the

10 Board of the Institute of Medicine.

11 Do you see that, sir?

12 A. Yes.

13 Q. He swears that he appears before

14 the U.S. Congress as a member of the FDA

15 Science Board Advisory Committee to the

16 FDA Commissioner, and he served as the

17 chair of the subcommittee on this.

18 He says, I served on the science

19 and technology, the Science Board, which

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20 authored the report "FDA Science and

21 Mission at Risk."

22 Do you see that?

23 A. Yes.

24 Q. So we understand, if his testimony

25 was honest, that he's a drug industry 

00297

1 person. Fair?

Witness_ Robert Dettery - Vol. 2.txt: 297:5 - 297:6

Q. He's from Eli Lilly company. He's

6 a drug industry person, correct?

Witness_ Robert Dettery - Vol. 2.txt: 297:8 - 297:9

THE WITNESS: Well, he works

9 for Eli Lilly, yes.

Witness_ Robert Dettery - Vol. 2.txt: 297:23 - 299:16

He says the record -- he swears,

24 the record of the proceedings of that

25 meeting will show that due to the 

00298

1 seriousness of the deficiencies found

2 and the urgency of the situation, the

3 Science Board was adamant that the

4 report be broadly disseminated among the

5 public and policy makers, including the

6 posting of it in the Federal Register.

7 Do you see that?

8 A. Yes.

9 Q. And he describes this report, "FDA

10 Science and Mission at Risk," as only

11 the second time in over a century, long

12 before we were born, that the agency,

13 the FDA, has been reviewed by an

14 external committee as a whole entity.

15 Do you see that?

16 A. Yes.

17 Q. And he says, "The expertise and

18 level of accomplishments of the members

19 are almost unprecedented in a single

20 committee."

21 That's what this gentleman swears

22 to, fair?

23 A. That's what it says.

24 Q. And he says -- he tells us who

25 this committee comprises. 

00299

1 He swears it included a Nobel

2 laureate in pharmacology, 14 members of

3 the National Academy of Sciences, a

4 renowned economist, a leader in

5 healthcare policy, a former CEO of a

6 large pharmaceutical company, a former

7 Assistant Secretary of Health and Human

8 Services, who also headed global

9 regulatory affairs with a large company

10 for over 24 years -- excuse me -- 20

11 years, a former chief counsel for the

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12 FDA, and the first Under Secretary For

13 Food Safety at the U.S. Department of

14 Agriculture.

15 That's who he says was on his

16 team, if you will. Fair?

Witness_ Robert Dettery - Vol. 2.txt: Page 299, Line 25

A. That's what it says, yes. 

Witness_ Robert Dettery - Vol. 2.txt: 300:18 - 301:5

Because the question I asked you,

19 sir, is, if you know of a better, bigger

20 analysis of whether or not the FDA can

21 meet its proclaimed mission of consumer

22 protection and public health, whether or

23 not it has sufficient resources.

24 You might know that two years

25 before this there was a bigger or better 

00301

1 analysis done. So you either know that

2 or you don't, sir.

3 Do you know of a better or bigger

4 analysis than what this one appears to

5 be?

Witness_ Robert Dettery - Vol. 2.txt: 301:11 - 301:13

THE WITNESS: I am not aware

12 of any other assessment, other than this

13 one that you are presenting here now.

Witness_ Robert Dettery - Vol. 2.txt: 301:16 - 302:7

Dr. Cassell went on to testify, he

17 says, "It became readily apparent that

18 the FDA suffers from serious scientific

19 deficiencies and is not positioned to

20 meet current or emerging regulatory

21 responsibilities."

22 Did I read that right?

23 A. That's what it says, yes.

24 Q. He goes on to swear to the

25 Congress, "Since every regulatory 

00302

1 decision must be based upon the best

2 available scientific evidence in order

3 to protect the public's health, we

4 conclude that American lives are at risk

5 and there's an urgent need to address

6 deficiencies."

7 Is that what it says?

Witness_ Robert Dettery - Vol. 2.txt: 302:13 - 302:20

THE WITNESS: That's what it

14 says.

15 BY MR. JENSEN:

16 Q. Okay. He goes on to testify to

17 the Congress, "What we found is quite

18 simply demands of FDA have soared over

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19 the past two decades," and he emphasizes

20 resources have not. Right?

Witness_ Robert Dettery - Vol. 2.txt: 303:1 - 303:17

THE WITNESS: Again, that's

2 what the report says -- or this

3 document.

4 BY MR. JENSEN:

5 Q. And he says his subcommittee found

6 that -- and he has a number of bullet

7 points. Let me go to the third one

8 here.

9 He says, "FDA cannot adequately

10 monitor development of new medical

11 products and adequately evaluate the

12 safety of existing products because it

13 is unable to keep up with scientific

14 advances," and then there's a

15 parenthetical.

16 That's what he swore to that his

17 subcommittee found, correct?

Witness_ Robert Dettery - Vol. 2.txt: Page 304, Line 1

That's what it says,

Witness_ Robert Dettery - Vol. 2.txt: 304:6 - 304:10

Q. The last bullet point reads, "The

7 FDA cannot fulfill its mission because

8 its scientific workforce does not have

9 sufficient capacity or capability.

10 Correct?

Witness_ Robert Dettery - Vol. 2.txt: 304:15 - 304:23

THE WITNESS: That's what it

16 says.

17 BY MR. JENSEN:

18 Q. His next bullet point says, "The

19 FDA cannot fulfill its mission because

20 its information technology

21 infrastructure is sorely inadequate. It

22 is problematic at best and at worst it

23 is dangerous." Correct?

Witness_ Robert Dettery - Vol. 2.txt: 305:5 - 305:6

THE WITNESS: That's what it

6 says.

Witness_ Robert Dettery - Vol. 2.txt: 305:13 - 305:21

He testified at Page 6 here,

14 "Specifically we found that the FDA's

15 shortfalls have resulted in a plethora

16 of inadequacies that threaten our

17 society, including, but not limited to,"

18 and then his second bullet point under

19 that is, "a dearth of scientists who

20 understand emerging new technologies."

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21 Is that what he swore to?

Witness_ Robert Dettery - Vol. 2.txt: 305:25 - 306:7

THE WITNESS: That's what the 

00306

1 document says.

2 BY MR. JENSEN:

3 Q. His last bullet point on that page

4 reads, "An information technology

5 infrastructure that was identified as a

6 source of risk in every center and

7 program reviewed by the subcommittee."

Witness_ Robert Dettery - Vol. 2.txt: 306:11 - 306:23

THE WITNESS: That's what's

12 written.

13 BY MR. JENSEN:

14 Q. Dr. Cassell, this Eli Lilly drug

15 company senior vice president, also

16 swore to the U.S. Congress that,

17 "Without immediate action, injuries and

18 death from an overwhelmed regulatory

19 system are certain and the cost to our

20 society will be far greater than any

21 dollar figure upon which we can arrive

22 at."

23 That's what he said, right?

Witness_ Robert Dettery - Vol. 2.txt: 307:6 - 307:13

THE WITNESS: Again, that's

7 what it says in the document.

8 BY MR. JENSEN:

9 Q. Do you agree that the portions of

10 the testimony I just read to you of

11 Dr. Cassell, from the Eli Lilly drug

12 company, that he gave last year in 2008,

13 are alarming?

Witness_ Robert Dettery - Vol. 2.txt: 307:20 - 308:12

THE WITNESS: You are asking

21 for my opinion, and I don't have an

22 opinion formed at this moment.

23 BY MR. JENSEN:

24 Q. Okay. Well, just as a human

25 being, sir, when Dr. Cassell, this, I 

00308

1 represent, distinguished drug company

2 representative, is on a subcommittee

3 that does an obviously intensive,

4 detailed evaluation of whether the FDA

5 can live up to its mission of consumer

6 protection and protection of the public

7 health, and he testifies, this drug

8 company vice president, that without

9 immediate action, injuries and deaths

10 from an overwhelmed regulatory system

11 are certain, don't you find that

12 alarming?

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Witness_ Robert Dettery - Vol. 2.txt: 308:21 - 308:25

THE WITNESS: I don't -- I

22 can't answer your question because,

23 again, I don't have an opinion.

24 BY MR. JENSEN:

25 Q. That's not alarming to you? 

Witness_ Robert Dettery - Vol. 2.txt: 309:3 - 309:13

THE WITNESS: No.

4 BY MR. JENSEN:

5 Q. Okay. Is it concerning to you

6 that this FDA that you have been putting

7 so much reliance on over the years has

8 been found very recently to be in such a

9 bad situation that unless immediate

10 action is taken, injuries and deaths

11 from an overwhelmed regulatory system

12 are certain?

13 Is that concerning to you, sir?

Witness_ Robert Dettery - Vol. 2.txt: 309:20 - 310:13

THE WITNESS: I have no

21 opinion whether that is concerning or

22 not.

23 BY MR. JENSEN:

24 Q. I'm not asking for an opinion.

25 I'm just asking for -- as a person 

00310

1 who works in regulatory affairs, who

2 works on and has relied on the FDA, as

3 you testified many times last week and

4 today, you rely on the FDA to have

5 enough resources, you rely on them to

6 assess medical literature.

7 And now I'm showing you evidence

8 that this review has found that the FDA

9 has insufficient resources and that

10 deaths and injuries are certain from an

11 overwhelmed regulatory system.

12 I'm just asking, as a person,

13 doesn't that concern you?

Witness_ Robert Dettery - Vol. 2.txt: 310:21 - 310:22

THE WITNESS: I don't have

22 enough evidence to form an opinion.

Witness_ Robert Dettery - Vol. 2.txt: 312:8 - 312:17

Q. Isn't it true, to your knowledge,

9 Mutual has done nothing to look into

10 whether the conclusions of this November

11 2007 report, "FDA Science and Mission at

12 Risk," were correct, and has done

13 nothing to determine whether or not its

14 chairman from the drug industry's

15 conclusion was correct that because of

16 an overwhelmed regulatory system

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17 injuries and deaths are certain?

Witness_ Robert Dettery - Vol. 2.txt: 312:21 - 312:22

Q. To your knowledge, Mutual has done

22 nothing in that regard; isn't that true?

Witness_ Robert Dettery - Vol. 2.txt: 313:9 - 313:16

THE WITNESS: Again, I can't

10 speak on behalf of others in the company

11 if they did anything in regards to this

12 report.

13 BY MR. JENSEN:

14 Q. To your knowledge, no one at

15 Mutual did anything in regard to these

16 reports and findings, correct?

Witness_ Robert Dettery - Vol. 2.txt: 313:21 - 314:5

THE WITNESS: Like I said

22 before, I have no knowledge of what

23 others in the company may have done.

24 BY MR. JENSEN:

25 Q. And you don't know that they did 

00314

1 anything regarding this, right?

2 You don't have any affirmative

3 knowledge that anyone at Mutual ever did

4 anything to look into the reports,

5 right?

Witness_ Robert Dettery - Vol. 2.txt: 314:12 - 314:15

THE WITNESS: Again, I don't

13 know what others in the company may have

14 done, if anything, possible, as follow15 up to this report.

Witness_ Robert Dettery - Vol. 2.txt: 316:1 - 316:25

And let's start with the

2 first page. Exhibit 419 is what we have

3 just been speaking about, the "FDA

4 Science and Mission at Risk" report,

5 published under two years ago, authored

6 in part by its chair, that we just read

7 his testimony, Dr. Cassell.

8 Starting with the first

9 page. Have you ever seen the first page

10 of this report before, sir?

11 A. Are you calling the title page the

12 first page?

13 Q. Yes, sir.

14 A. No.

15 Q. Okay. I'm going to, again, go

16 through some of its findings with you

17 and ask you whether or not these

18 findings affect the propriety or whether

19 it was a good idea to be relying on the

20 FDA to have sufficient resources to

21 carry out its mission of protecting the

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22 public and consumer protection.

23 Do you understand what I'm asking

24 you to do, sir?

25 A. Yes. 

Witness_ Robert Dettery - Vol. 2.txt: 317:4 - 317:20

In relation to the things I read

5 to you out of Dr. Cassell's testimony,

6 did some or all of those things,

7 Mr. Dettery, cause you to be concerned

8 about whether it was a good idea for

9 Mutual to be relying on the presumption

10 that the FDA had sufficient resources,

11 without ever looking into it, to protect

12 the consumers and to ensure public

13 health?

14 MR. COSGROVE: Objection.

15 Form. Foundation. Complex.

16 Confusing. Misleading.

17 THE WITNESS: I believe you

18 already did ask me that. And as I

19 replied, at this point, I have no

20 opinion.

Witness_ Robert Dettery - Vol. 2.txt: 317:24 - 319:2

Let's start on Page 5. And tell

25 me when you are there, sir. 

00318

1 A. I'm there.

2 Q. At the top, you will see this

3 actual report stated, "FDA's failure to

4 retain and motivate its workforce put

5 FDA's mission at risk.

6 "Inadequately trained scientists

7 are generally risk adverse and tend to

8 give no decision, a slow decision or

9 even worse the wrong decision on

10 regulatory approval or disapproval."

11 Is that what it says so far?

12 A. That's what it says.

13 Q. It says, "During our encounters

14 with staff and center leadership, we

15 were struck by the mere unanimity that

16 the shortage of science staff due to

17 lack of resources to hire and the

18 inability to recruit and retain needed

19 expertise are serious, long-standing

20 challenges."

21 Is that what they reported?

22 A. That's what it says.

23 Q. It says, it goes on, "The

24 subcommittee was extremely disturbed at

25 the state of the FDA, IT --" you 

00319

1 understand that stands for information

2 technology -- "infrastructure." Right?

Witness_ Robert Dettery - Vol. 2.txt: 319:6 - 319:12

THE WITNESS: That's what it

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7 says.

8 BY MR. JENSEN:

9 Q. And it goes on to say, "The FDA

10 lacks the information technology

11 infrastructure necessary to meet its

12 mandate." Correct?

Witness_ Robert Dettery - Vol. 2.txt: 319:15 - 319:25

THE WITNESS: That's what it

16 says.

17 BY MR. JENSEN:

18 Q. It says, "The IT situation at FDA

19 is problematic at best and at worse it

20 is dangerous. Systems fail" --

21 And it goes on to say, "Systems

22 fail frequently and even e-mail systems

23 are unstable most recently during an E.

24 coli food contamination investigation."

25 Is that what it says in part? 

Witness_ Robert Dettery - Vol. 2.txt: 320:4 - 320:14

THE WITNESS: That's what it

5 says in part, yes.

6 BY MR. JENSEN:

7 Q. Okay. And it goes on, on the

8 bottom of that page, to report that,

9 "Critical data reside in large

10 warehouses sequestered in piles and

11 piles of paper documents, there is no

12 backup of these records, which include

13 valuable clinical trial data."

14 Is that what it says?

Witness_ Robert Dettery - Vol. 2.txt: 320:18 - 321:1

THE WITNESS: That's what it

19 says.

20 BY MR. JENSEN:

21 Q. Let's start with this: If any of

22 these things are true that I just read

23 to you, that's not a good thing for the

24 FDA's attempt to meet its mission to

25 safeguard the public, is it, or are 

00321

1 they?

Witness_ Robert Dettery - Vol. 2.txt: Page 321, Line 8

THE WITNESS: I don't know.

Witness_ Robert Dettery - Vol. 2.txt: 322:3 - 322:10

If it's true that the FDA lacks

4 sufficient resources to hire and has an

5 inability to recruit and retain needed

6 expertise, do you agree that that is not

7 a good thing in terms of the FDA's

8 attempts to meet its mission to ensure

9 the health and safety of the American

10 populous?

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Witness_ Robert Dettery - Vol. 2.txt: 322:19 - 322:22

THE WITNESS: I don't have

20 enough information to -- to make a

21 determination whether your statement is

22 correct or not.

Witness_ Robert Dettery - Vol. 2.txt: 323:8 - 323:19

if it's true, as

9 was reported by the "FDA Science and

10 Mission at Risk" report, that as they

11 reported that there is insufficient

12 resources to hire and an inability to

13 recruit and retain needed expertise --

14 that's not what I'm saying, that's what

15 the report is saying -- if that is true,

16 do you agree, Mr. Dettery, that that is

17 not a good thing for the FDA's ability

18 to achieve its mission to protect the

19 American public?

Witness_ Robert Dettery - Vol. 2.txt: 324:1 - 324:19

THE WITNESS: I don't have

2 enough information in order to agree or

3 disagree with it.

4 BY MR. JENSEN:

5 Q. Okay. Let's go to the IT

6 infrastructure that you referenced.

7 If it's true that the FDA lacks

8 the IT infrastructure necessary to meet

9 its mandate, and if it's true, as

10 Dr. Cassell testified, that the FDA

11 cannot fulfill its mission because its

12 information technology infrastructure is

13 thoroughly inadequate, which is

14 problematic at best and at worst

15 dangerous, in his testimony, do you

16 agree that those are not good things for

17 the FDA's ability to meets its mission

18 to ensure the safety of the American

19 populous?

Witness_ Robert Dettery - Vol. 2.txt: 325:4 - 325:6

THE WITNESS: I don't have

5 sufficient information in order to agree

6 or disagree with the report.

Witness_ Robert Dettery - Vol. 2.txt: 326:4 - 327:4

Q. The U.S. Supreme Court this year

5 not only quoted a portion of the report

6 that we have been looking at, "FDA

7 Science and Mission at Risk," it also

8 reported some other recent findings.

9 A 2007 report of the National

10 Academies of the Institutes of Medicine,

11 entitled "The Future of Drug Safety,

12 Promoting and Protecting the Health of

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13 the Public."

14 Do you see that, sir?

15 A. I see where you have just

16 highlighted, yes.

17 Q. Thank you, sir.

18 And the U.S. Supreme Court quoted

19 the National Academies of Science to

20 say, in 2007, just two years ago, "The

21 FDA lacks the resources needed to

22 accomplish this large and complex

23 mission.

24 "There is widespread agreement

25 that the resources for post marketing 

00327

1 drug safety" -- let me stop there.

2 That's what we have been talking

3 about, post-marketing drug safety, today

4 and the last time, in large part, right?

Witness_ Robert Dettery - Vol. 2.txt: 327:9 - 327:11

THE WITNESS: Well, there are

10 various aspects of post-marketing drug

11 safety.

Witness_ Robert Dettery - Vol. 2.txt: 327:17 - 327:20

Q. In relation to the regulatory

18 affairs aspect of proper labeling, that,

19 of course, relates to post-marketing

20 drug safety, correct?

Witness_ Robert Dettery - Vol. 2.txt: 327:23 - 328:9

THE WITNESS: The labeling

24 could relate to post-marketing drug

25 safety when it's a branded product, 

00328

1 that's correct.

2 BY MR. JENSEN:

3 Q. The reason Mutual unilaterally,

4 prior to FDA approval, found it

5 appropriate to change the Qualaquin

6 label to add additional enhanced risk

7 information regarding the risk of

8 thrombocytopenia was to enhance post9 marketing drug safety, correct?

Witness_ Robert Dettery - Vol. 2.txt: Page 329, Line 3

yes.

Witness_ Robert Dettery - Vol. 2.txt: 329:10 - 329:23

Q. So a U.S. Supreme Court reported

11 that, in 2007, the National Academies of

12 Sciences said, "The FDA lacks the

13 resources needed to accomplish its large

14 and complex mission.

15 "There is widespread agreement

16 that resources for post marketing drug

17 safety work are especially inadequate

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18 and that resource limitations have

19 hobbled the agency's ability to improve

20 and expand this essential component of

21 its mission."

22 Is that what it was reporting

23 here?

Witness_ Robert Dettery - Vol. 2.txt: 330:5 - 330:7

THE WITNESS: Well, you

6 correctly read the part that you

7 highlighted. 

Witness_ Robert Dettery - Vol. 2.txt: 330:10 - 330:15

Q. Do you agree with the quote that

11 is in here, to the extent and to the

12 effect where it says that post-marketing

13 drug safety work is an essential

14 component of its mission, referring to

15 the FDA's mission?

Witness_ Robert Dettery - Vol. 2.txt: 330:19 - 330:22

THE WITNESS: I couldn't

20 agree or disagree with that. I don't

21 know what the basis of that comment was

22 about.

Witness_ Robert Dettery - Vol. 2.txt: 331:23 - 332:7

Do you agree that a part of -- a

24 critical part of FDA's mission of

25 protection of the American populous 

00332

1 is -- better if I pronounce the word

2 right.

3 New question: Do you agree that a

4 critical part and essential part of the

5 FDA's mission of protecting the health

6 of the U.S. populous is post-marketing

7 drug safety?

Witness_ Robert Dettery - Vol. 2.txt: 332:17 - 333:5

THE WITNESS: I don't know if

18 I would be able to answer that. I don't

19 know everything that FDA does to protect

20 the consumer health. So I don't know

21 what -- how the post-marketing safety

22 relates to the entire picture of FDA.

23 BY MR. JENSEN:

24 Q. What did Mutual do to look into

25 whether this finding was justified or 

00333

1 not justified, that the lack of

2 resources have hobbled the FDA's ability

3 to improve and expand this essential

4 component of its mission which they

5 refer to as post-marketing drug safety?

Witness_ Robert Dettery - Vol. 2.txt: 333:10 - 333:16

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And I don't know what Mutual

11 did.

12 BY MR. JENSEN:

13 Q. To your knowledge, Mutual did

14 nothing to look into that, correct?

15 A. Again, I don't know what anyone

16 else in the company may have done.

Witness_ Robert Dettery - Vol. 2.txt: 334:1 - 334:16

In

2 footnote 11, the U.S. Supreme Court also

3 cited a report by the Government

4 Accounting Office, drug safety

5 improvement needed in FDA's post6 marketing decision making, and that was

7 published in 2006.

8 Do you see that, sir?

9 A. I see where you just highlighted,

10 yes.

11 Q. And the quote that the U.S.

12 Supreme Court provided from that is,

13 "FDA lacks a clear and effective process

14 for making decisions about and providing

15 management oversight of post market

16 safety issues." Correct?

Witness_ Robert Dettery - Vol. 2.txt: 334:20 - 334:25

THE WITNESS: Again, the part

21 that you highlighted is what he said.

22 BY MR. JENSEN:

23 Q. And the part I highlighted is a

24 complete highlight of the U.S. Supreme

25 Court's quote as it appears here, right? 

Witness_ Robert Dettery - Vol. 2.txt: Page 335, Line 8

THE WITNESS: Yes. 

Witness_ Robert Dettery - Vol. 2.txt: 336:4 - 336:8

Does this finding

5 of the FDA, in the same study, concern

6 you, "FDA does not have the capacity to

7 ensure the safety of food for the

8 nation"? Yes or no?

Witness_ Robert Dettery - Vol. 2.txt: 336:12 - 336:14

THE WITNESS: I can't give

13 you a yes or no answer. I don't know.

14 I don't have an opinion on it.

Witness_ Robert Dettery - Vol. 2.txt: 338:17 - 338:25

In our discussion here, before we

18 got to these documents, you pointed out

19 that you were not only relying on the

20 FDA to do its job and have sufficient

21 resources to do its job, but you were

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22 relying on the name brand manufacturer

23 to do its job and go and get that

24 medical literature and assess it,

25 correct? 

Witness_ Robert Dettery - Vol. 2.txt: 339:6 - 339:24

THE WITNESS: I believe what

7 I said is that I have no reason to

8 believe FDA is incapable of doing their

9 job, and that it is the branded

10 company's obligation, rather than the

11 generic company's, to provide post12 marketing safety information to FDA.

13 BY MR. JENSEN:

14 Q. Let's just go to the one part of

15 your answer there.

16 If Dr. Cassell from the drug

17 industry, and all these people that he

18 coauthored this report with, got these

19 findings right, his ultimate conclusion

20 that injuries and death are certain from

21 an overwhelmed regulatory system, do you

22 now have reason to be concerned about

23 whether Mutual's reliance on the FDA's

24 adequate resources was well-placed?

Witness_ Robert Dettery - Vol. 2.txt: 340:7 - 340:11

THE WITNESS: Again, my

8 answer is the same as before. I have --

9 I don't have enough information to be --

10 to form an opinion about whether that is

11 concerning or not.

Witness_ Robert Dettery - Vol. 2.txt: 344:17 - 344:20

Is it correct

18 to state, sir, that for all matters of

19 regulatory affairs at Mutual, from 1991

20 through 2004, the buck stopped with you?

Witness_ Robert Dettery - Vol. 2.txt: 344:25 - 345:4

THE WITNESS: As I testified 

00345

1 previously, since 1993 I have been vice

2 president of the Regulatory Affairs

3 Department, and that is the top position

4 within that department.

Witness_ Robert Dettery - Vol. 2.txt: 345:15 - 345:18

There's never been a

16 regulatory affairs person above you from

17 1993 through 2004, correct?

18 A. That's correct.

Witness_ Robert Dettery - Vol. 2.txt: 346:9 - 346:12

Q. Hence, to the best of your

10 recollection, for those 13 years the

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11 regulatory affairs decisions, the buck

12 always has stopped with you. Fair?

Witness_ Robert Dettery - Vol. 2.txt: 346:17 - 346:21

THE WITNESS: Well, I don't

18 know what you mean by "the buck stops

19 here." But, as I said, I was in charge

20 of that department for that period of

21 time.

Witness_ Robert Dettery - Vol. 2.txt: 347:4 - 347:12

Q. Flip to Exhibit 11. Tell me when

5 you are there, sir.

6 A. Exhibit 11?

7 Q. Yes, sir.

8 And that is a 1987 publication

9 entitled, "A fatal case of sulindac

10 induced Lyell syndrome," which they

11 define as toxic epidermal necrolysis.

12 Correct?

Witness_ Robert Dettery - Vol. 2.txt: 347:18 - 347:19

that is what it appears

19 the title is, correct.

Witness_ Robert Dettery - Vol. 2.txt: 348:14 - 349:7

Q. And just so we have a date range,

15 so we know what the date is, does 303

16 allow you to confirm, sir, that the

17 approval date for sulindac was April 17,

18 1991?

19 A. Yes.

20 Q. And what date -- that's the

21 approval date.

22 Now, tell us what the initial

23 application date was by Mutual for

24 sulindac.

25 A. May 20th, 1987. 

00349

1 Q. Thank you, sir.

2 Understanding you were not there,

3 but understanding you can learn things

4 after you arrive, is it correct to state

5 that, to the best of your knowledge,

6 this 1987 report was never provided by

7 Mutual to the FDA?

Witness_ Robert Dettery - Vol. 2.txt: 349:13 - 349:25

THE WITNESS: I don't know if

14 this has ever been produced or not. It

15 says generic company. It's not likely

16 that we have, but I don't know for sure.

17 BY MR. JENSEN:

18 Q. And, also, you have no

19 knowledge -- we are only going to do

20 this for about three or four articles.

21 The question is, you have no

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22 knowledge and Mutual would have no

23 knowledge that the brand name holder

24 ever provided this publication to the

25 FDA, correct? 

Witness_ Robert Dettery - Vol. 2.txt: 350:4 - 350:15

THE WITNESS: I don't know if

5 anybody at Mutual is aware that this has

6 been submitted to FDA by the brand

7 company or not.

8 BY MR. JENSEN:

9 Q. Is it correct to state that

10 generic companies typically do not

11 receive the filings of brand name

12 companies when they submit medical

13 literature as post-marketing -- in post14 marketing periodic reports?

15 A. That is correct.

Witness_ Robert Dettery - Vol. 2.txt: 351:9 - 351:13

Q. Is the next publication that I'm

10 showing you, Mr. Dettery, appear to you

11 to be a 1988 publication entitled

12 "Sulindac Induced Toxic Epidermal

13 Necrolysis"?

Witness_ Robert Dettery - Vol. 2.txt: 351:17 - 352:4

THE WITNESS: It's a

18 document, I don't know of what type,

19 that has a subtitle that reads as you

20 read.

21 BY MR. JENSEN:

22 Q. Okay. And if it's true to what it

23 appears to be, which is a medical

24 publication and clinical pharmacy where

25 they say sulindac induced toxic 

00352

1 epidermal necrolysis, we know from those

2 four or five words that somebody is

3 concluding that somebody got TEN from

4 sulindac, right?

Witness_ Robert Dettery - Vol. 2.txt: 352:11 - 352:17

THE WITNESS: I don't know.

12 BY MR. JENSEN:

13 Q. Okay. And this was the year --

14 1988 was while, as we just established,

15 Mutual's application was pending before

16 it was approved to market sulindac,

17 correct?

Witness_ Robert Dettery - Vol. 2.txt: 352:21 - 353:17

THE WITNESS: Well, it has

22 the date October 1988 on there.

23 BY MR. JENSEN:

24 Q. Which is while the application was

25 pending, correct? 

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00353

1 A. I forget what the -- the

2 submission date was May 20th?

3 Q. It was 1987 --

4 A. '87.

5 Q. -- was the submission and '91 was

6 the approval.

7 So this was while the initial

8 application was pending, correct?

9 A. So October 1988 does fall between

10 those two dates, right.

11 Q. Thank you.

12 And a statement in this

13 publication is that clinicians should be

14 aware of the risk of TEN with sulindac

15 and should monitor patients

16 appropriately for dermatological

17 reactions, correct?

Witness_ Robert Dettery - Vol. 2.txt: 353:23 - 354:8

THE WITNESS: Well, the

24 portion of the entire document that you

25 highlighted reads that way. 

00354

1 BY MR. JENSEN:

2 Q. Okay. And, to your knowledge,

3 isn't it true that Mutual never did

4 anything to bring to the attention of

5 the FDA this conclusion that clinicians,

6 meaning doctors, should be aware of the

7 risk that this deadly skin disease is

8 associated with sulindac?

Witness_ Robert Dettery - Vol. 2.txt: 354:14 - 355:3

THE WITNESS: I don't know if

15 that was ever done or not.

16 BY MR. JENSEN:

17 Q. And you also don't know whether or

18 not the name brand ever provided this to

19 the FDA, correct?

20 A. Well, as I previously said, we

21 don't get copies of what the brand

22 company submits to FDA, so I would have

23 to rely that they did.

24 Q. Talking about assumptions and

25 reliances, you don't know the name brand 

00355

1 manufacturer provided this to the FDA,

2 correct?

3 A. As I --

Witness_ Robert Dettery - Vol. 2.txt: 355:6 - 355:8

THE WITNESS: As I answered,

7 I don't know what the name brand company

8 submits to FDA, 

Witness_ Robert Dettery - Vol. 2.txt: 355:13 - 355:17

Q. We discussed for a bit, in your

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14 prior day we spoke, this publication

15 which came out -- the jury won't be able

16 to see it, but do you see it says

17 February 2003 at the bottom there?

Witness_ Robert Dettery - Vol. 2.txt: 356:4 - 356:12

THE WITNESS: It says,

5 Revision Accepted February 2003. I

6 don't know when it was published.

7 BY MR. JENSEN:

8 Q. Thank you, sir.

9 And it's entitled -- and I am

10 going to abbreviate -- "The risk of SJS

11 and TEN associated with NSAIDs a

12 multinational perspective." Correct?

Witness_ Robert Dettery - Vol. 2.txt: 356:16 - 356:20

THE WITNESS: That is the

17 header on this document, yes.

18 BY MR. JENSEN:

19 Q. And as we discussed, sulindac is

20 an NSAID, right?

Witness_ Robert Dettery - Vol. 2.txt: 356:24 - 357:20

THE WITNESS: As I recall,

25 yes. 

00357

1 BY MR. JENSEN:

2 Q. And sulindac is referenced in this

3 document, as we discussed, on page 2771,

4 right where I just highlighted.

5 If you can look at the screen

6 right between the tables there.

7 A. I see ketoprofen and other NSAIDs.

8 Q. Yes, sir. And right here where my

9 thumb is, do you see sulindac?

10 A. No. There is something in the

11 way. Now, move it up a little.

12 Q. Yes, sir.

13 A. I see you highlighted the word

14 "sulindac."

15 Q. Thank you.

16 And you see from here other NSAIDs

17 has a footnote, and the footnote

18 represents a number of NSAIDs including

19 sulindac, as we just referenced,

20 correct?

Witness_ Robert Dettery - Vol. 2.txt: 357:25 - 358:6

THE WITNESS: I see a 

00358

1 footnote for Other NSAIDs, and I see

2 approximately 15 or so products included

3 under that footnote under Other NSAIDs.

4 BY MR. JENSEN:

5 Q. Including sulindac, correct?

6 A. Including sulindac.

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Witness_ Robert Dettery - Vol. 2.txt: 361:2 - 361:18

Mr. Dettery, assume for me the

3 following is true, and then I'm going to

4 ask you a question: Assume for me that

5 this 2003 study concluded that

6 ketoprofen, one NSAID, had no

7 relationship with people getting SJS or

8 TEN from that particular NSAID.

9 And, secondly, this study also

10 included that other NSAIDs did have what

11 is called a statistically significant

12 association with getting SJS or TEN.

13 I'm asking you to assume that's true.

14 Do you, sir, as a regulatory

15 affairs official, agree that that would

16 have been important information for

17 doctors prescribing NSAIDs to know in

18 2003 or 2004?

Witness_ Robert Dettery - Vol. 2.txt: 362:2 - 362:5

THE WITNESS: Well, I

3 believe, as I testified last week, I'm

4 not a physician, I don't know what

5 information is important to a physician,

Witness_ Robert Dettery - Vol. 2.txt: 362:14 - 362:23

Is it correct, Mr. Dettery,

15 that, to your knowledge, no one at

16 Mutual ever assessed, analyzed,

17 investigated or questioned whether or

18 not this was important information for

19 doctors to have, specifically that one

20 NSAID had no relationship to these

21 highly deadly diseases and that other

22 NSAIDs did have strong relationships to

23 these highly deadly skin conditions?

Witness_ Robert Dettery - Vol. 2.txt: 363:7 - 363:9

I don't know if this

8 document has been assessed by anyone at

9 Mutual.

Witness_ Robert Dettery - Vol. 2.txt: 363:14 - 363:19

to the best of your

15 knowledge, no one at Mutual ever

16 assessed, questioned or investigated

17 whether or not this was important

18 information for prescribing doctors to

19 have, correct?

Witness_ Robert Dettery - Vol. 2.txt: 363:24 - 364:3

THE WITNESS: I don't know.

25 BY MR. JENSEN: 

00364

1 Q. Are adverse drug reactions a big

2 problem for the health of the American

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3 public, Mr. Dettery?

Witness_ Robert Dettery - Vol. 2.txt: 364:7 - 364:17

THE WITNESS: I really have

8 no opinion on that. I don't know.

9 BY MR. JENSEN:

10 Q. Okay. Well, you have frequently

11 given testimony that you rely on the FDA

12 to ensure the health and safety of the

13 American populous.

14 Tell us, you are a regulatory

15 affairs official for some 20 years, are

16 adverse drug reactions a significant

17 cause of death amongst Americans?

Witness_ Robert Dettery - Vol. 2.txt: 364:24 - 365:19

THE WITNESS: I don't know if

25 they are or not. 

00365

1 BY MR. JENSEN:

2 Q. 422, for the record. Here is a

3 copy for you, Mr. Dettery. Exhibit 422,

4 sir, was published in JAMA.

5 And you understand that to be the

6 Journal of the American Medical

7 Association, correct?

8 A. Yes.

9 Q. And it was published, as you can

10 see, in 2002, correct?

11 A. It was, yes, 2002.

12 Q. And the lead sentence in this

13 Journal of the American Medical

14 Association, 2002 publication, two years

15 before Karen Bartlett is prescribed

16 sulindac, says, "Adverse drug reactions

17 are believed to be a leading cause of

18 death in the United States."

19 Is that what this reports?

Witness_ Robert Dettery - Vol. 2.txt: 366:2 - 366:10

The sentence says

3 that "Adverse drug reactions are

4 believed to be a leading cause of death

5 in the United States."

6 BY MR. JENSEN:

7 Q. Do you have any idea what the

8 estimations are as to how many deaths in

9 the United States are caused yearly by

10 adverse drug reactions?

Witness_ Robert Dettery - Vol. 2.txt: 366:14 - 366:19

THE WITNESS: No.

15 BY MR. JENSEN:

16 Q. Exhibit 423 is another publication

17 in the Journal of the American Medical

18 Association. This time in 2005.

19 Correct?

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Witness_ Robert Dettery - Vol. 2.txt: 366:22 - 367:6

THE WITNESS: It says 2005 on

23 it.

24 BY MR. JENSEN:

25 Q. All right. And it's first 

00367

1 sentence tells us that the Journal of

2 the American Medical Association, it

3 says, in 2005, "Adverse drug and device

4 reactions account for as many as one

5 hundred thousand deaths annually."

6 Correct?

Witness_ Robert Dettery - Vol. 2.txt: 367:10 - 367:22

THE WITNESS: The highlighted

11 first sentence reads as you have stated.

12 BY MR. JENSEN:

13 Q. Let's go back to the prior one in

14 2002.

15 And it says its objective of this

16 study would "determine the frequency and

17 timing of new adverse drug reactions

18 described in black box warnings or

19 necessitating withdrawal of the drug

20 from the market."

21 That's the claimed objective,

22 right?

Witness_ Robert Dettery - Vol. 2.txt: 368:1 - 368:13

THE WITNESS: That's what it

2 says.

3 BY MR. JENSEN:

4 Q. And, in part, its results are,

5 that 45 drugs, 8.2 percent, acquired one

6 or more black box warnings and 16, 2.9

7 percent, were withdrawn from the market,

8 it goes on, in Kaplan & Meyer analyses,

9 "The estimated probability of acquiring

10 a new black box warning or being

11 withdrawn from the market over 25 years

12 was 20 percent."

13 Do you see that, sir?

Witness_ Robert Dettery - Vol. 2.txt: 368:23 - 368:24

what you stated is what the highlighted

24 sentence reads.

Witness_ Robert Dettery - Vol. 2.txt: 369:4 - 369:8

Q. And a black box warning is what,

5 please, Mr. Dettery?

6 A. It's a section of the labeling

7 with warnings about that particular

8 product.

Witness_ Robert Dettery - Vol. 2.txt: 369:13 - 370:17

When a black box

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14 appears on the label it's on the very

15 top, is that correct, right under the

16 drug's listing?

17 A. I believe it is typically located

18 there, but I believe I have also seen it

19 in other areas of the labeling.

20 Q. Is a black box, to your

21 estimation, in 20 years of being a

22 regulatory affairs officer, done to make

23 a warning prominent for the reader?

24 A. My understanding is that FDA

25 requires black box warnings for the sake 

00370

1 of prominence.

2 Q. What's underreporting,

3 Mr. Dettery?

4 A. In what regard?

5 Q. Adverse event regard.

6 A. I can give you my interpretation

7 of what it means.

8 Q. Okay.

9 A. That there are more adverse events

10 that occur than there are reports from

11 the patient or the doctor to the company

12 or to FDA.

13 Q. Fair to say you have seen

14 publications that estimate the amount of

15 reporting at one percent to ten percent,

16 meaning that 99 percent to 90 percent of

17 reactions are not reported?

Witness_ Robert Dettery - Vol. 2.txt: 370:23 - 371:7

THE WITNESS: I don't know

24 what the percentages are.

25 BY MR. JENSEN: 

00371

1 Q. Have you ever seen any

2 publications that attempt to estimate

3 how much underreporting occurs, whether

4 it is 90 percent or 99 percent, or any

5 other number?

6 A. I don't recall if I have seen any

7 such publications or not.

Witness_ Robert Dettery - Vol. 2.txt: 371:20 - 372:7

Looking at the adverse reports,

21 you have rash and you have TEN,

22 different ends of the spectrum, I submit

23 to you.

24 Do you have any reason to believe

25 that reports of rash versus TEN might be 

00372

1 any higher or lower than one, because

2 TEN is, obviously, a much more serious

3 event and, therefore, one might

4 conclude, hypothetically, that it is

5 reported at a higher percent rate than a

6 rash?

7 Do you know one way or the other?

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Witness_ Robert Dettery - Vol. 2.txt: 372:11 - 372:18

THE WITNESS: Are you

12 speaking specifically of sulindac or

13 anything?

14 BY MR. JENSEN:

15 Q. Let's start with anything.

16 A. I really don't know.

17 Q. Then I will speak of sulindac.

18 A. I really don't know that either.

Witness_ Robert Dettery - Vol. 2.txt: 378:12 - 378:19

Q. And does that appear to be a 2004

13 publication in drug safety, sir?

14 A. That's what it appears to be.

15 Q. And does it appear to be titled

16 "Evaluation of the extent of

17 underreporting of serious adverse drug

18 reactions the case of toxic epidermal

19 necrolysis"?

Witness_ Robert Dettery - Vol. 2.txt: 379:5 - 379:13

the

6 header states what you said.

7 BY MR. JENSEN:

8 Q. And just as a reference for CIHI,

9 it's a reference to Canadian Institute

10 for Health Information.

11 Do you see that here in this

12 paragraph, under the Patient Group

13 Studied, sir?

Witness_ Robert Dettery - Vol. 2.txt: 379:16 - 380:6

THE WITNESS: Yes.

17 BY MR. JENSEN:

18 Q. And the results of the study

19 were -- first of all, it talks about

20 objective. The objective was to examine

21 the extent of underreporting of TEN in

22 the country of Canada, correct?

23 A. That's what it says.

24 Q. Its results were 25 TEN cases, six

25 fatal, were reported to this 

00380

1 abbreviation, which stands for Canadian

2 adverse drug reaction monitoring

3 program, from January '95 to December

4 2000.

5 So for about five years,

6 correct?

Witness_ Robert Dettery - Vol. 2.txt: 380:9 - 380:24

THE WITNESS: That's what it

10 says.

11 BY MR. JENSEN:

12 Q. It goes on to report that, during

13 this period, 14, about 63 percent, burn

14 treatment sites reported an admission of

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15 250 TEN cases.

16 It goes on to say, "Using the burn

17 facility as a denominator, ten percent,

18 25 of 250, of TEN cases were reported to

19 that entity."

20 Using the other entity, the

21 Canadian Institute for Health

22 Information data as a denominator, only

23 four percent, 25 of 674 cases of TEN

24 were reported. Correct?

Witness_ Robert Dettery - Vol. 2.txt: 381:5 - 381:19

THE WITNESS: You have

6 accurately stated the highlighted

7 portion of this document that you gave

8 me to read.

9 BY MR. JENSEN:

10 Q. And the conclusion of this

11 document is, "There is a serious

12 underreporting of TEN. Lack of

13 reporting of life-threatening adverse

14 drug reactions can compromise population

15 safety.

16 "There is a need to increase

17 awareness of adverse drug reporting

18 programs," as they reported in 2004.

19 Correct?

Witness_ Robert Dettery - Vol. 2.txt: 382:11 - 382:13

A. You have accurately portrayed the

12 highlighted section of this document

13 that you gave me to read.

Witness_ Robert Dettery - Vol. 2.txt: 383:10 - 383:22

"QUESTION: Do you agree,

11 Mr. Dettery, that when one, therefore,

12 has one, two, five reports of TEN in

13 relation to any given drug, that one is

14 not justified in concluding those are

15 the only one, two or five cases that

16 have actually occurred in relation to

17 that drug?")

18 MR. COSGROVE: The same

19 objection.

20 THE WITNESS: I have no basis

21 to agree with that -- with that

22 conclusion

Witness_ Robert Dettery - Vol. 2.txt: 384:16 - 385:4

The following entities, to your

17 knowledge, all who knew Karen Bartlett

18 had TEN and all of whom knew she took

19 sulindac didn't report it; A, Harvard,

20 B, Northeast Rehab, C, Spaulding

21 Rehabilitation Institute, D, when she

22 went back Caritas Family Hospital.

23 Representing to you those were

24 four places Karen Bartlett was after

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25 they knew she took sulindac and after 

00385

1 they knew she had TEN, you know because

2 of the absence of a report from them

3 that none of those fine institutions

4 made such a report, right?

Witness_ Robert Dettery - Vol. 2.txt: 385:15 - 385:17

THE WITNESS: All I can say

16 is that until this lawsuit, we were

17 unaware of this event, we had no report.

Witness_ Robert Dettery - Vol. 2.txt: 386:9 - 386:13

Q. Exhibit 425, sir. This appears to

10 be published in the Journal of American

11 Dermatology in 1989.

12 You see the bottom of the

13 abstract, correct?

Witness_ Robert Dettery - Vol. 2.txt: 386:17 - 386:19

THE WITNESS: That's what it

18 appears to say at the bottom of the

19 abstract, correct.

Witness_ Robert Dettery - Vol. 2.txt: 386:23 - 387:3

And it goes on to state,

24 "Although rare, its germatic nature,

25 extremely high morbidity" -- and you 

00387

1 understand morbidity to mean other

2 things that might occur in relation to

3 it, right?

Witness_ Robert Dettery - Vol. 2.txt: 387:8 - 387:17

THE WITNESS: What do you

9 mean by other things in relation to it?

10 BY MR. JENSEN:

11 Q. Well, I'll give you some examples

12 for TEN. Sepsis, renal failure, liver

13 failure, all your skin falling off,

14 those are things that are morbidities

15 which happen to be associated with TEN.

16 But you understand that that's

17 what the word "morbidity" means, right?

Witness_ Robert Dettery - Vol. 2.txt: 387:21 - 387:25

THE WITNESS: My

22 understanding of the term "morbidity" is

23 that it's illness or some type of a

24 physiological problem.

25 BY MR. JENSEN: 

Witness_ Robert Dettery - Vol. 2.txt: 388:2 - 388:8

So it goes on and says, referring

3 to TEN, "And a relatively high

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4 mortality."

5 And you understand that to be the

6 relatively high rate at which people

7 succumb or die from the disease,

8 correct?

Witness_ Robert Dettery - Vol. 2.txt: 388:19 - 388:23

THE WITNESS: Well, if you

20 are asking me what the definition of

21 mortality is, I would agree that the

22 definition of mortality is the -- is a

23 death rate.

Witness_ Robert Dettery - Vol. 2.txt: 389:4 - 389:11

And this report says, "Because of

5 extremely high morbidity and a

6 relatively high mortality," referring to

7 TEN, "it perhaps" -- I'll insert the

8 word "is" -- "the most important drug

9 related cutaneous eruption with respect

10 to assessing risk and benefit of a

11 drug." Correct?

Witness_ Robert Dettery - Vol. 2.txt: 389:17 - 389:21

THE WITNESS: The -- what you

18 stated I believe is an accurate

19 portrayal of the highlighted section of

20 this entire document that you gave me to

21 look at.

Witness_ Robert Dettery - Vol. 2.txt: 390:6 - 390:10

Q. And it lists drugs that it says --

7 the title of Table 3 is, Drugs

8 considered responsible for causing, I

9 will abbreviate, TEN, in present study

10 and some other studies. Fair?

Witness_ Robert Dettery - Vol. 2.txt: 390:13 - 390:20

THE WITNESS: It says that,

14 and plus French series and Washington

15 series, whatever that means.

16 BY MR. JENSEN:

17 Q. Thank you.

18 And amongst the drugs that it

19 listed as considered responsible for

20 causing TEN is sulindac, correct?

Witness_ Robert Dettery - Vol. 2.txt: Page 391, Line 1

I see sulindac

Witness_ Robert Dettery - Vol. 2.txt: 393:21 - 393:24

Q. Do you see that this study lists

22 that there are two cases of TEN where

23 sulindac was identified as the drug

24 considered responsible for causing it?

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Witness_ Robert Dettery - Vol. 2.txt: 394:7 - 394:9

it appears

8 to show to me that there were two cases

9 reported for sulindac.

Witness_ Robert Dettery - Vol. 2.txt: 395:11 - 395:16

This 1989 publication, to your

12 knowledge, this was while Mutual's

13 initial ANDA, also known as generic

14 application, was pending, to the best of

15 your knowledge, was not provided to the

16 FDA by Mutual, correct?

Witness_ Robert Dettery - Vol. 2.txt: 395:22 - 396:7

THE WITNESS: I don't know if

23 it was provided or not.

24 BY MR. JENSEN:

25 Q. And, to your knowledge, this 1989 

00396

1 study was not provided by the FDA --

2 strike that.

3 To your knowledge, this 1989

4 publication was not provided to the FDA

5 by the branded drug company?

6 You might assume that, but you

7 don't know that, right?

Witness_ Robert Dettery - Vol. 2.txt: 396:10 - 396:11

THE WITNESS: I don't know if

11 it was or not.

Witness_ Robert Dettery - Vol. 2.txt: 396:24 - 397:17

Q. First, let's start out, the

25 branded name for sulindac is Clinoril. 

00397

1 Correct?

2 A. Yes.

3 Q. When you speak of Clinoril, you

4 are speaking of the same chemical entity

5 as sulindac, correct?

6 A. The same active moiety, correct.

7 Q. Correct.

8 Mutual's sulindac drug has been

9 shown to be bioequivalent to Clinoril's

10 sulindac, correct?

11 A. Correct.

12 Q. What that means is, to the best of

13 everyone's knowledge, there will be the

14 same risk and benefit profile associated

15 with Mutual's sulindac as you would

16 presume is associated with the brand

17 name Clinoril. Fair?

Witness_ Robert Dettery - Vol. 2.txt: Page 397, Line 18

correct.

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Witness_ Robert Dettery - Vol. 2.txt: 401:9 - 401:23

Q. And do you understand the label

10 starting on 2799 to be the label that

11 was being changed pursuant to the FDA's

12 direction?

13 A. I don't know if this was the label

14 that FDA was referring to or not.

15 Q. I'm asking you to presume it was

16 for purposes of my question.

17 Let's go ahead and flip to page

18 2805. Tell me when you are there.

19 A. I'm there.

20 Q. And we addressed this language,

21 and it says, "NSAIDs including

22 Clinoril," which we know is sulindac,

23 correct, under Skin Reactions?

Witness_ Robert Dettery - Vol. 2.txt: 402:4 - 402:12

Q. So where it says, "NSAIDs

5 including Clinoril, which is sulindac,

6 can cause serious adverse events such as

7 exfoliative dermatitis, Stevens-Johnson

8 Syndrome, SJS, and toxic epidermal

9 necrolysis, TEN, which can be fatal,"

10 that's the language that you and Mutual

11 believe and agree is true and accurate,

12 correct?

Witness_ Robert Dettery - Vol. 2.txt: 402:18 - 403:13

THE WITNESS: This is a --

19 well, you are asking me to presume that

20 this is an accurate representation of

21 the actual insert. I don't know. All I

22 can say is what you said is what is

23 written here.

24 BY MR. JENSEN:

25 Q. And without showing you the label, 

00403

1 I asked you last time we were with each

2 other whether the Mutual label that now

3 says that NSAIDs including sulindac can

4 cause SJS and TEN was true and accurate,

5 and you said, we believe our labels are

6 true and accurate, hence, yes.

7 Now I'm just showing you the very

8 language that you have already agreed

9 to.

10 Do you believe this language,

11 which I have just highlighted and read,

12 is true and accurate, and does Mutual as

13 well?

Witness_ Robert Dettery - Vol. 2.txt: 403:17 - 404:1

THE WITNESS: I stated that I

18 believed our labeling was true and

19 accurate, and I don't know if this is

20 the accurate portrayal of the true

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21 label.

22 BY MR. JENSEN:

23 Q. You do know that Mutual's label,

24 just like this sentence, does say that

25 NSAIDs including sulindac can cause SJS 

00404

1 and TEN, right?

Witness_ Robert Dettery - Vol. 2.txt: 404:6 - 405:5

THE WITNESS: I would need to

7 refer to our labeling again to answer

8 that.

9 BY MR. JENSEN:

10 Q. Well, let me read you my question

11 and your answer and see if you still

12 agree to it, Mr. Dettery.

13 I asked you, "Do you agree that

14 Mutual agrees that its label for

15 sulindac is accurate as of March 2006

16 where it states sulindac causes SJS and

17 TEN are accurate and true?"

18 And your answer was, "I would say

19 that our labeling is an accurate

20 representation of the referenced drug's

21 labeling as we can make it."

22 Then I asked, "Mutual has a label

23 for its sulindac product that says SJS

24 and TEN are caused by sulindac. Does

25 Mutual agree that label is true and 

00405

1 accurate?"

2 And you answered, "As far as I

3 know, our labeling is as true and as

4 accurate as we can make it."

5 Do you stand by that testimony?

Witness_ Robert Dettery - Vol. 2.txt: 405:9 - 405:10

THE WITNESS: I agree with

10 what you just read to me.

Witness_ Robert Dettery - Vol. 2.txt: 408:21 - 408:24

does Exhibit 353 appear to

22 you to be sulindac's label by Mutual?

23 Look on Page 22 for the answer.

24 A. It appears to be.

Witness_ Robert Dettery - Vol. 2.txt: 409:7 - 410:3

Tell me when you are

8 there.

9 A. There.

10 Q. And it reads, tell me if I have

11 read it correctly, "NSAIDs including

12 sulindac tablets can cause serious skin

13 adverse reactions such as exfoliative

14 dermatitis, Stevens-Johnson Syndrome,

15 SJS, and toxic epidermal necrolysis,

16 TEN, which can be fatal."

17 Did I read that correctly?

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18 A. Well, you used the term "skin

19 adverse reactions" and it really says

20 "events." But other than that, you

21 correctly read it.

22 Q. Thank you.

23 And this, what I just read with

24 your correction, is in the Warnings

25 section of a label, correct? 

00410

1 A. Yes.

2 Q. Okay. Let's go back to the

3 sentence that's highlighted on Page 9.

Witness_ Robert Dettery - Vol. 2.txt: 410:23 - 411:1

Q. Okay. And this is your labeling

24 and, as far as you know, it is true and

25 accurate that sulindac causes SJS and 

00411

1 TEN, correct?

Witness_ Robert Dettery - Vol. 2.txt: 411:7 - 411:8

THE WITNESS: It's as

8 accurate as we can make it.

Case 1:08-cv-00358-JL Document 206-5 Filed 05/24/10 Page 37 of 37 Case 1:08-cv-00358-JL Document 352 Filed 08/17/10 Page 92 of 92