1 NO. 90-CI-6033 JEFFERSON CIRCUIT COURT
DIVISION ONE (1)
2
3
JOYCE FENTRESS, ET AL. PLAINTIFFS
4
5 VS.
DEPOSITION FOR PLAINTIFFS
6
7 SHEA COMMUNICATIONS, ET AL. DEFENDANTS
8 * * * * * * * * * *
9
10 DEPONENT: AL WEBBER
11
DATE: DECEMBER 16 AND 17, 1993
12
13
* * * * * * * * * *
14
15
16 REPORTER: KATHY NOLD
17
18 KENTUCKIANA REPORTERS
SUITE 260
19 730 WEST MAIN STREET
LOUISVILLE, KENTUCKY 40202
Page 1
1
* * * * * * * * * *
2
3 UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
4 INDIANAPOLIS DIVISION
5 IN RE ELI LILLY AND COMPANY )
Prozac Products Liability ) MDL Docket No. 907
6 Litigation )
7 * * * * * * * * * *
8 NO. 91-02496-A
9 JACKIE LYNN BIFFLE, ET AL ) IN THE DISTRICT
) COURT OF
10 V. ) DALLAS COUNTY, TEXAS
)
11 ELI LILLY & COMPANY AND ) 14TH JUDICIAL
DISTA PRODUCTS COMPANY ) DISTRICT
12
* * * * * * * * * *
Page 2
1
SUPERIOR COURT OF THE STATE OF CALIFORNIA
2
FOR THE COUNTY OF LOS ANGELES
3
DR. MARIUS SAINES, etc., et al., ) Case No:
4 ) SC 008331
Plaintiffs, )
5 )
vs. )
6 )
ELI LILLY & COMPANY, a corporation; )
7 DISTA PRODUCTS COMPANY, a division )
of Eli Lilly & Company; and DOBS 1- )
8 100, inclusive, )
)
9 Defendants. )
____________________________________)
10
11 * * * * * * * * * *
Page 3
1
2 THE DEPOSITION OF AL WEBBER TAKEN AT THE
3 OFFICE OF BAKER & DANIELS, 300 NORTH MERIDIAN
4 STREET, SUITE 2700, INDIANAPOLIS, INDIANA 46204,
5 ON DECEMBER 16 AND 17, 1993; SAID DEPOSITION
6 TAKEN PURSUANT TO NOTICE IN ACCORDANCE WITH THE
7 RULES OF CIVIL PROCEDURE.
8 * * * * * * * * * *
9 A P P E A R A N C E S
10
NANCY ZETTLER
11 COUNSEL FOR PLAINTIFFS
LEONARD M. RING AND ASSOCIATES, P.C.
12 111 WEST WASHINGTON AVENUE, SUITE 1333
CHICAGO, ILLINOIS 60602
13
LAWRENCE J. MYERS
14 COUNSEL FOR ELI LILLY AND COMPANY
FREEMAN & HAWKINS
15 4000 ONE PEACHTREE CENTER
303 PEACHTREE STREET, N.E.
16 ATLANTA, GEORGIA 30308-3243
17 MARGARET M. HUFF
ELI LILLY AND COMPANY
18 LILLY CORPORATE CENTER
INDIANAPOLIS, INDIANA 46285
19
BENJAMIN E. PATTERSON
20 COUNSEL FOR DEFENDANTS CZECHOWICZ, FINK, BRUINSMA
CLAUSEN MILLER GORMAN CAFFREY & WITOUS
21 10 SOUTH LASALLE
CHICAGO, ILLINOIS 60603
Page 4
1
PAUL SMITH
2 COUNSEL FOR PLAINTIFFS
745 CAMPBELL CENTER 2
3 8115 NORTH CENTRAL EXPRESSWAY
DALLAS, TEXAS 75206
4
Page 5
1 I N D E X
2
3 DEPOSITION OF AL WEBBER
4
5 DIRECT EXAMINATION BY MR. SMITH 7
6 EXAMINATION BY MS. ZETTLER 263
7
8 CERTIFICATE 474
9 ERRATA 475
10
11 CERTIFIED QUESTIONS
12 QUESTIONS CERTIFIED 93
QUESTION CERTIFIED 187
13
EXHIBITS
14
PLAINTIFFS' EXHIBIT NO. 1 111
15 PLAINTIFFS' EXHIBIT NO. 2 141
PLAINTIFFS' EXHIBIT NO. 3 217
16 PLAINTIFFS' EXHIBIT NO. 4 304
PLAINTIFFS' EXHIBIT NO. 5 311
17 PLAINTIFFS' EXHIBIT NO. 6 316
PLAINTIFFS' EXHIBIT NO. 7 354
18 PLAINTIFFS' EXHIBIT NO. 8 366
PLAINTIFFS' EXHIBIT NO. 9 374
19 PLAINTIFFS' EXHIBIT NO. 10 378
PLAINTIFFS' EXHIBIT NO. 11 389
20 PLAINTIFFS' EXHIBIT NO. 12 397
PLAINTIFFS' EXHIBIT NO. 13 409
21 PLAINTIFFS' EXHIBIT NO. 14 422
PLAINTIFFS' EXHIBIT NO. 15 447
22 PLAINTIFFS' EXHIBIT NO. 16 456
PLAINTIFFS' EXHIBIT NO. 17 461
23
Page 6
1
2 COMES AL WEBBER, CALLED BY THE
3 PLAINTIFFS, AND AFTER FIRST BEING DULY SWORN, WAS
4 DEPOSED AND TESTIFIED AS FOLLOWS:
5 DIRECT EXAMINATION
6 BY MR. SMITH:
7 Q. Would you state your name,
8 please, sir.
9 A. Al Webber.
10 Q. I've heard you referred to as
11 Doctor Al Webber. Are you a physician?
12 A. No.
13 Q. Ph.D?
14 A. Yes.
15 Q. What did you receive your Ph.D
16 in, Doctor Webber?
17 A. Organic chemistry.
18 Q. Where did you receive your
19 Ph.D?
20 A. Stanford University.
21 Q. In what year?
22 A. 1966.
23 Q. Where did you get -- well,
24 where did you get your Bachelor's degree?
Page 7
1 A. University of Colorado.
2 Q. In what year?
3 A. 1962.
4 Q. And your Bachelor's degree?
5 A. It was in chemistry.
6 Q. From what institution?
7 A. University of Colorado.
8 Q. When did you get your
9 Bachelor's degree?
10 A. 1962. Didn't you ask me --
11 Q. I thought you got your
12 Master's in '62.
13 A. I didn't hear you say
14 Master's.
15 MR. MYERS: It sort of got garbled.
16 A. I don't have a Master's
17 degree.
18 Q. You don't have a Master's
19 degree. You got your BS from the University of
20 Colorado in 1962, and then you got your Ph.D in
21 chemistry from Stanford in 1966; is that correct,
22 Doctor Webber?
23 A. That's correct.
24 Q. You don't have to have a
Page 8
1 Master's degree to get a Ph.D?
2 A. No.
3 Q. Where did you grow up, Doctor
4 Webber?
5 A. Chicago.
6 Q. Do you know Ms. Zettler here?
7 She grew up in Chicago.
8 A. I never met her before.
9 MS. ZETTLER: I thought everybody in
10 the city knew me.
11 Q. How come you chose University
12 of Colorado to go to do your undergraduate work,
13 Doctor Webber?
14 A. My parents and I had gone on
15 vacation in Colorado, and I had a lot of sinus
16 trouble in Chicago, and I thought it was a
17 healthy place to go.
18 Q. What high school did you
19 graduate from in Chicago?
20 A. Oak Park River Forrest High
21 School.
22 Q. In what year?
23 A. 1958.
24 Q. So you are fifty --
Page 9
1 A. Three.
2 Q. Are you married, Doctor
3 Webber?
4 A. No.
5 Q. Have you ever been married?
6 A. Yes.
7 Q. Did that marriage end in
8 divorce or --
9 A. Yes, it did.
10 Q. When was the divorce?
11 A. 1981.
12 Q. Have you been married on more
13 than one occasion?
14 A. No.
15 Q. Do you have any children?
16 A. Yes.
17 Q. Age and sex, please.
18 A. One male, sixteen.
19 Q. Did you say sixteen?
20 A. Yes.
21 Q. So you have had that child
22 since your divorce -- no, that's right, I'm
23 thinking '71. Does that child live with you or
24 his mom?
Page 10
1 A. His mom.
2 Q. Where do you live, Doctor
3 Webber?
4 A. I live in xxxxxxxxxxxxx.
5 Q. And your street address,
6 please?
7 A. xxxxxxxxxxxxxxxxxxxx.
8 Q. What is your current
9 employment, sir?
10 A. I beg your pardon?
11 Q. What is your current
12 employment?
13 A. Eli Lilly.
14 Q. And what is your job capacity?
15 A. Regulatory scientist.
16 Q. Is that your job title now,
17 regulatory scientist?
18 A. Yes.
19 Q. How long have you had that
20 position?
21 A. In February, it will be six
22 years.
23 Q. So you started in February,
24 1988?
Page 11
1 A. Yes, I did.
2 Q. Who is your immediate
3 supervisor at this time?
4 A. Max Talbott.
5 Q. And has he been your immediate
6 supervisor throughout your tenure as a regulatory
7 scientist at Eli Lilly and Company?
8 A. Yes.
9 Q. Before you began as a
10 regulatory scientist, what was your occupation?
11 A. I was a chemist.
12 Q. With Eli Lilly?
13 A. Yes.
14 Q. For what period of time,
15 dates, please, were you a chemist at Eli Lilly
16 and Company?
17 A. From July, 1966 until February
18 of '88.
19 Q. So you went directly from
20 Stanford to Eli Lilly and Company, it looks like?
21 A. Yes.
22 Q. Did you work while you were in
23 college, either working on your undergraduate
24 degree or your Ph.D?
Page 12
1 A. Not in graduate school, I had
2 summer jobs in college.
3 Q. Any of those involve
4 pharmaceuticals?
5 A. No.
6 Q. What did your job entail as a
7 chemist for the twenty-two years that you were a
8 chemist for Lilly?
9 A. I worked on antibiotic
10 research.
11 Q. What particular medications
12 were you involved in in connection with a
13 medicine that was approved for sale and sold by
14 Lilly? I don't want any research compounds that
15 you might have been involved in.
16 A. I've worked on Cephalosporin
17 antibiotics.
18 Q. Keflex?
19 A. And if you want examples of
20 those, Keflex is an example of a Cephalosporin
21 antibiotic.
22 Q. Did you work on antibiotic
23 research the entire twenty-two years that you
24 were a chemist?
Page 13
1 A. Yes.
2 Q. Was there a classification of
3 chemist within that particular area, did you move
4 from assistant research chemist to chemist to
5 senior chemist? Tell me how that was -- tell me
6 how you progressed within that department,
7 please.
8 A. I began as a senior organic
9 chemist.
10 Q. Senior organic chemist?
11 A. Yes.
12 Q. And how long did you --
13 A. About four years.
14 Q. All right.
15 A. And then I became a -- it's
16 been a long time, research scientist.
17 Q. And how long did you have that
18 position?
19 A. Approximately four years.
20 Q. What's the difference in a
21 senior organic chemist and a research scientist
22 at Lilly?
23 A. There isn't a great deal of
24 difference, other than it's a promotion or
Page 14
1 recognized as having accomplished certain things.
2 Q. You were doing the same thing
3 in essence during that tenure as a senior organic
4 chemist and a research scientist?
5 A. In essence.
6 Q. Is the term scientist at Eli
7 Lilly given some particular meaning?
8 A. I don't think so.
9 Q. I've heard Doctor Leigh
10 Thompson referred to either in the press or in
11 some Lilly documents as Lilly's chief scientific
12 officer. What would that be?
13 A. In my opinion, it would be the
14 person with the highest rank at Lilly who was a
15 scientist.
16 Q. And being a scientist at
17 Lilly, does that require that you have achieved
18 some particular distinction within the Lilly
19 organization?
20 A. No.
21 Q. After you were research
22 scientist at Lilly, what was your next position?
23 A. Research associate.
24 Q. And how long did you hold that
Page 15
1 position?
2 A. I held that position until I
3 moved to regulatory.
4 Q. Until 1988?
5 A. Yes.
6 Q. What's the difference in a
7 research scientist and a research associate?
8 A. Again, it's a recognition of
9 having accomplished certain things, it's a
10 promotion.
11 Q. But the title research
12 associate is higher up on the level than research
13 scientist?
14 A. That's correct.
15 Q. It sounds like it would be the
16 opposite way, I guess that's maybe because we
17 lawyers in law firms have associates and then
18 partners. But that's not correct in your
19 instance, is that right?
20 A. You are correct.
21 MR. MYERS: It's sort of like being a
22 Supreme Court Justice in New York.
23 Q. And it's your testimony that
24 during the entire period of time that you were an
Page 16
1 organic chemist, research scientist and research
2 associate with Lilly, that your work was devoted
3 primarily to antibiotic research?
4 A. That's correct.
5 Q. Or antibiotic products?
6 A. Yes.
7 Q. Did you have anything to do
8 with manufacturing while you were in the
9 chemistry area at Lilly?
10 A. No.
11 Q. Would you consider yourself as
12 being in research and development the entire time
13 that you were in the chemistry area?
14 A. I'm not sure I understand your
15 question.
16 Q. Would you consider your
17 position as a R and D, research and development,
18 position for those twenty-two years that you were
19 in the chemistry area?
20 A. Yes.
21 Q. Did any of your work during
22 this period of time have anything to do with the
23 regulatory matters?
24 A. No.
Page 17
1 Q. In the chemistry department,
2 in the chemistry area, where you had been
3 working, what was the next position that you
4 would have obtained had you remained in the
5 chemistry department?
6 A. If I had gotten another
7 promotion, it was called research advisor.
8 Q. But you would have had to have
9 been promoted to become a research advisor, is
10 that right?
11 A. Yes.
12 Q. Did you fail to obtain that
13 promotion?
14 A. I did not obtain it.
15 Q. Were you striving to attain
16 it?
17 A. Yes.
18 Q. Did you ask to be transferred
19 from the chemistry area when you didn't obtain
20 that promotion?
21 A. Would you rephrase that
22 question, please?
23 Q. Well, once you saw that you
24 were not going to be promoted to research
Page 18
1 advisor, did you request that you be moved into
2 some other area of the Lilly organization?
3 A. Those two events were only
4 very loosely associated.
5 Q. Tell me how loosely they were
6 associated then.
7 A. It's possible that if I had
8 stayed as a chemist longer, I would have gotten
9 promoted. I had been a chemist for quite a
10 while, I was interested in trying something
11 different in the corporation.
12 Q. Were you passed over for that
13 promotion as research advisor?
14 A. Passed over is not the right
15 word for scientist.
16 Q. Were you not selected --
17 A. That's correct.
18 Q. -- to become a research
19 advisor?
20 A. That's correct.
21 Q. And was someone else selected
22 in your place to become a research advisor?
23 A. That is not the way it works.
24 Q. They just didn't promote
Page 19
1 anybody?
2 A. They didn't promote me. If
3 they promoted other people, it was just
4 coincidence.
5 Q. So did you put in for a
6 change?
7 A. Yes.
8 Q. What did you have to do to put
9 in for a change to a different area?
10 A. My bosses knew that I was
11 interested in trying something new.
12 Q. Who was your boss at the time?
13 A. At that time it was Lowell
14 Hatfield.
15 Q. So what happened?
16 A. I was given the opportunity to
17 talk to a few different people.
18 Q. Who?
19 A. Doctor Max Talbott.
20 Q. Who else?
21 A. I talked to Wally Lange.
22 Q. We know who Doctor Talbott is,
23 who is Wally Lange?
24 A. He was vice-president of
Page 20
1 marketing.
2 Q. Was he interviewing you for a
3 regulatory position or was he interviewing you
4 for a marketing position?
5 A. He wasn't really interviewing
6 with me, I think they were humoring me by letting
7 me talk to some other people. But he was not
8 interviewing me for a regulatory position.
9 Q. Why were they humoring you,
10 Doctor Webber?
11 A. I think they respected me.
12 Q. Did they have the perception
13 that you were disappointed or that you needed
14 some special treatment, so they in fact humored
15 you?
16 A. I don't know what their
17 perceptions were.
18 Q. I'm just wondering what you
19 meant when you referred to you talked to Wally
20 Lange because they were just kind of humoring
21 you, to use your term.
22 A. I don't believe I fit to be in
23 a marketing job.
24 Q. Who else did you talk with?
Page 21
1 A. I do not recall any others.
2 Q. Did you look into any other
3 areas besides regulatory and marketing?
4 A. No.
5 Q. Did you interview with anyone
6 else in the regulatory area other than Doctor
7 Talbott?
8 A. Yes.
9 Q. Who?
10 A. Chuck Matsumoto.
11 Q. Matsumoto?
12 A. Matsumoto, M-A-T-S-U-M-O-T-O,
13 I believe.
14 Q. What was his position at the
15 time?
16 A. He was a regulatory scientist.
17 Q. All right. Anybody else?
18 A. Don Robinson.
19 Q. What was his position at the
20 time?
21 A. He was also a regulatory
22 scientist.
23 Q. Were they interviewing you,
24 Mister Matsumoto, and Mister Robinson or were
Page 22
1 they simply giving you some insight as to what a
2 regulatory scientist did?
3 A. I felt it was more the latter.
4 Q. All right. Anybody else?
5 A. No.
6 Q. During the time that you were
7 a chemist, from 1966 until February of 1988, were
8 you employed by Lilly Research Laboratories?
9 A. Yes.
10 Q. Which was at that time or is a
11 division of Eli Lilly and Company; correct?
12 A. Yes.
13 Q. When you went to regulatory,
14 were you still an employee of Lilly Research Labs
15 or were you an Eli Lilly and Company employee at
16 that time?
17 A. I believe I was still in Lilly
18 Research Laboratories.
19 Q. Did your checks have Lilly
20 Research Labs on it?
21 A. We have direct deposit.
22 Q. They don't let you see them.
23 But your understanding that the entire time that
24 you've been an employee of Eli Lilly and Company,
Page 23
1 you were technically in the Lilly Research Labs
2 area?
3 A. Yes.
4 Q. Before February of 1988, had
5 you done any work in connection with Fluoxetine
6 Hydrochloride, brand name Prozac?
7 A. No.
8 Q. All right. Tell me what the
9 differences are in the regulatory area and in the
10 chemistry area?
11 A. Well, in the chemistry area, I
12 was working in the lab making compounds.
13 Q. The entire time?
14 A. Yes.
15 Q. All right.
16 A. And in the regulatory, you're
17 not in the lab, you're in an office.
18 Q. Pushing paper, right?
19 A. You're in an office. I guess
20 I have a lot of papers on my desk.
21 Q. Would it be accurate to say
22 that once you went into the regulatory area of
23 Lilly, that you were no longer using your
24 chemistry experience on a day-to-day basis?
Page 24
1 A. Not on a day-to-day basis.
2 Q. Would there be occasions that
3 your chemistry area would be used?
4 A. Yes.
5 Q. What would those occasions be?
6 A. For instance, someone might
7 want me to look at the structure that was on some
8 document.
9 Q. You mean one of those stick
10 chemical figures?
11 A. Uh-huh.
12 MR. MYERS: You need to say yes so she
13 can take it down.
14 A. I'm sorry, yes.
15 Q. Did you ever look at any
16 chemical compound, what are they called,
17 formulas?
18 A. Is that a question?
19 Q. Well, I started a question,
20 and then I asked another question within that.
21 What are those things called where they've got
22 the stick figures?
23 A. Formula.
24 Q. Formula. Did you ever look at
Page 25
1 any formulas in connection with Fluoxetine once
2 you went into regulatory?
3 A. Yes.
4 Q. In what instances?
5 A. In one instance, I thought it
6 could be depicted better from a chemistry
7 standpoint.
8 Q. And when was that?
9 A. I don't recall the exact time.
10 Q. In other words, when you say
11 depicted better, you thought it could be drawn in
12 a more descriptive way to describe what the
13 chemical formula was, a chemical composition?
14 A. From a chemist's viewpoint, I
15 thought it could communicate better.
16 Q. And was it changed in
17 connection with your suggestion?
18 A. Yes.
19 Q. When was that?
20 A. I do not recall the month and
21 year.
22 Q. I can pick up a Physician's
23 Desk Reference. You know what that is, don't
24 you?
Page 26
1 A. Yes.
2 Q. I can turn to page ten
3 something now in the PDR and see Prozac listed,
4 and there will be a picture of a chemical formula
5 there. Is that your work?
6 A. It reflects the suggestion I
7 made.
8 Q. Has your suggestion always
9 been the formula that is depicted in the PDR?
10 A. No.
11 Q. Do you remember when that PDR
12 change was made?
13 A. No.
14 Q. Has it been since 1990?
15 A. I just do not recall the exact
16 month.
17 Q. Were you asked to prepare a
18 better depiction of the formula or was this
19 something that came up on your own as a result of
20 your own initiative?
21 A. Own initiative.
22 Q. Was it to solve a problem or
23 were there particular issues raised that caused
24 you to make this suggestion?
Page 27
1 A. No.
2 Q. Any other instances in which
3 you've used your chemistry background in
4 connection with Fluoxetine Hydrochloride?
5 A. No.
6 Q. Why don't you give us a little
7 lesson on Fluoxetine Hydrochloride since you're a
8 chemist and you worked on describing that
9 chemical formula. If I took a pill -- I mean a
10 capsule, a pulvule of Prozac, it would be a small
11 pulvule, and it could be opened and there would
12 be a powder that would come out of that; is that
13 correct?
14 A. Yes.
15 Q. The powder is white, as I
16 recall, is that right?
17 A. I do not know the color.
18 Q. Have you ever seen a Prozac
19 pulvule?
20 A. I'm sure I've seen a picture
21 of one, I can't tell you that I've actually seen
22 one.
23 Q. You don't take Prozac?
24 A. No, I do not.
Page 28
1 Q. Never have?
2 A. Never have.
3 Q. Fluoxetine, what's Fluoxetine?
4 A. Fluoxetine is the generic
5 name.
6 Q. And what is, chemically,
7 Fluoxetine?
8 A. I cannot tell you the name of
9 that, I don't know.
10 Q. It's got some atoms, and
11 you've drawn up those atom pictures, haven't you?
12 A. No.
13 Q. I thought --
14 A. I have not drawn them out with
15 my own hand.
16 Q. You made suggestion as to how
17 they should be drawn to better describe the
18 chemical, haven't you?
19 A. That's correct.
20 Q. All I'm trying to get is an
21 idea of what the chemicals are that are being
22 drawn.
23 A. Those aren't chemicals.
24 Q. What are they?
Page 29
1 A. They're atoms.
2 Q. All right. What comprises
3 those -- what different atoms are used to
4 comprise Fluoxetine?
5 A. I would do a better job if you
6 showed me a picture, and I would be able to
7 remember every one.
8 Q. I don't think I've got one
9 right off the top of my stack of documents. And
10 I'm not going to hold you to this, Doctor Webber,
11 I'm just trying to get an idea of what you recall
12 as being the particular elements that make up
13 Fluoxetine, and if you miss one or include one
14 that's not really involved, I'm not going to come
15 back and jump on you on that.
16 MR. MYERS: As best you recall, Al,
17 without reference to it, you can tell him. If
18 you're unable, you can tell him that. But tell
19 Mister Smith as best you recall.
20 A. All right. The best I recall,
21 there's carbon, hydrogen, nitrogen, oxygen, and
22 chlorine.
23 Q. Chlorine. What's chlorine?
24 I'm familiar with all those other elements.
Page 30
1 A. It's an element, also.
2 Q. What are the properties of
3 chlorine as a chemist?
4 A. Elemental chlorine?
5 Q. Yes.
6 A. It's a gas.
7 Q. Is it combustible?
8 A. Yes.
9 Q. Approximately what temperature
10 would it liquify?
11 A. I don't know.
12 Q. Or will it liquify?
13 A. I suspect it will.
14 Q. But chlorine is an essential
15 element like carbon, hydrogen?
16 A. It's an element.
17 Q. Is it an element that occurs
18 naturally or is it an element that is
19 synthetically made, or is there such a thing as
20 an element that's synthetically made?
21 A. It does not occur naturally.
22 Q. What is combined to produce
23 chlorine?
24 A. That's not how you make
Page 31
1 chlorine, by combining things.
2 Q. Tell me how it comes about?
3 A. I believe it exists in mineral
4 form combined with a metal.
5 Q. It's a gas and a metal?
6 A. No.
7 Q. All right.
8 MR. SMITH: You see, now, we've got
9 computers, statistics, and now we're into
10 chemistry.
11 Q. But in the state of chlorine,
12 it would normally be a gas, is that right?
13 A. Chlorine is a gas.
14 Q. Any other elements in
15 Fluoxetine?
16 A. Not that I can recall.
17 Q. And Hydrochloride is what?
18 A. Hydrochloric Acid.
19 Q. Hydrochloric Acid?
20 A. Yes.
21 Q. When they call it Fluoxetine
22 Hydrochloride, does that mean you combine these
23 two compounds?
24 A. You combine Fluoxetine and
Page 32
1 Hydrochloric Acid.
2 Q. And then you achieve the
3 substance that is manufactured as Prozac?
4 A. You achieve Fluoxetine
5 Hydrochloride.
6 Q. Which is manufactured as
7 Prozac?
8 A. That's the generic name for
9 Prozac.
10 Q. And Lilly or Lilly employees
11 hold the patent on Fluoxetine Hydrochloride;
12 correct?
13 A. I believe they do.
14 Q. The job as a regulatory
15 scientist that you had, did that entail any
16 training in how to do that job?
17 A. Yes.
18 Q. All right. Tell me about how
19 you were trained to do your function as a
20 regulatory scientist.
21 A. I mainly just listened to and
22 watched what was going on in the department.
23 Q. Who did you listen to and who
24 did you watch?
Page 33
1 A. The three gentlemen that I
2 referred to earlier, Talbott, Matsumoto and
3 Robinson.
4 Q. Was there any formal training
5 period for this position?
6 A. No.
7 Q. Did you go to any formal
8 training school for this position?
9 A. No.
10 Q. When you began as a regulatory
11 scientist, what generally were your duties as a
12 regulatory scientist?
13 A. I had partial responsibility
14 for the anti-infective agencies.
15 Q. Explain to me about that,
16 partial responsibility?
17 A. Don Robinson also had
18 responsibility for the anti-infective agencies.
19 Q. So what was your
20 responsibility in connection with the
21 anti-infection agencies as a regulatory
22 scientist?
23 A. Well, at the beginning, very
24 little. As I was learning -- it was mainly just
Page 34
1 a learning phase, I really didn't do anything.
2 Q. What did you do in connection
3 with your learning, then?
4 A. Just listened and watched, go
5 to some meetings.
6 Q. What were they doing, what
7 were the people that you were watching doing?
8 A. Well, they were facilitating
9 communication between the FDA and Lilly.
10 Q. The term regulatory scientist
11 at Lilly denotes an individual who interfaces
12 between Lilly or on behalf of Lilly with the
13 appropriate regulatory bodies, is that right?
14 A. That's correct.
15 Q. And were there any other
16 regulatory bodies that you were dealing with
17 other than the U.S. Food and Drug Administration?
18 A. No.
19 Q. Were there any state
20 regulatory bodies that you dealt with?
21 A. No.
22 Q. How long were you in the
23 responsibility for anti-infective agencies?
24 A. Only in 1988.
Page 35
1 Q. You started early '88,
2 February '88; correct?
3 A. That's correct.
4 Q. And continued until when?
5 A. The end of '88.
6 Q. Exactly December 31st?
7 A. I believe so.
8 Q. All right. What was your next
9 responsibility?
10 A. In 1989, I had responsibility
11 for endocrine and central nervous system.
12 Q. Did that include any work with
13 Prozac or Fluoxetine Hydrochloride?
14 A. Yes.
15 Q. Did any of your work from
16 February, 1988 until December 31st, 1988, in
17 connection with the anti-infection medications,
18 have to do with Fluoxetine Hydrochloride?
19 A. I didn't -- the anti-infective
20 responsibility did not involve Prozac.
21 Q. Right. Did you have any
22 responsibility for Prozac?
23 A. Yes.
24 Q. All right. In 1988?
Page 36
1 A. Yes.
2 Q. Tell me what responsibility
3 you had in 1988?
4 A. I was the regulatory scientist
5 for CNS agencies from the Summer of '88 to the
6 end.
7 Q. Were there any other
8 regulatory scientists within the regulatory group
9 that had responsibilities in connection with
10 Prozac during that period of time?
11 A. What period?
12 Q. Summer of 1988 until January
13 1, 1989?
14 A. No.
15 Q. Who had responsibility for
16 Prozac before you?
17 A. Don Robinson.
18 Q. But he completely discontinued
19 his work on Prozac in the Summer of 1988 and
20 turned it over to you, is that right?
21 A. Yes.
22 Q. All right. What did you do to
23 make yourself familiar with Prozac, Fluoxetine
24 Hydrochloride, and your duties in connection with
Page 37
1 that from a regulatory responsibility?
2 A. I just listened and talked to
3 people.
4 Q. Who did you listen to?
5 A. Well, I listened to anyone
6 that I came in contact with during the day, going
7 to meetings.
8 Q. Well, I'm interested in
9 knowing how you made yourself familiar with
10 Prozac, familiar with the status of where it was,
11 familiar with what work you were going to need to
12 do, where you were going to go, in connection
13 with the drug?
14 A. It was really learning by
15 doing. When somebody wanted something from
16 regulatory, they would come to me.
17 Q. The drug Prozac had been
18 approved for sale to the public in the Summer of
19 1988, had it not?
20 MR. MYERS: I object to the form, sale
21 to the public. Answer if you know, not when it
22 had been approved, I think --
23 A. It was approved at the end of
24 December, 1987.
Page 38
1 Q. So there wasn't any work in
2 connection with getting the drug approved for
3 marketing by Lilly, was there?
4 A. I was not involved in that.
5 Q. That had already been done?
6 A. Yes.
7 Q. What was your understanding
8 with respect to who had done that from a
9 regulatory standpoint?
10 A. I do not know.
11 Q. Well, I understand you don't
12 personally know, but do you have any knowledge in
13 your work that would have indicated to you as to
14 who had regulatory responsibility for Prozac
15 during its approval stage?
16 A. I have reason to think that
17 Max Talbott was involved.
18 Q. Well, Max Talbott was still
19 involved because in the Summer of 1988 he was
20 your supervisor, was he not?
21 A. That's correct.
22 Q. Anybody else that you recall
23 that was involved in the approval stage?
24 A. No.
Page 39
1 Q. Do you remember what the first
2 general area of work, what the first projects
3 were that you did in the Summer of 1988 in
4 connection with Prozac?
5 A. No.
6 Q. What's the first recollection
7 you have of specific work you did on Prozac?
8 A. I believe the first
9 recollection is package insert change.
10 Q. All right. When was that?
11 A. Sometime subsequent to the
12 Summer, I don't recall the exact date.
13 Q. You think it would have still
14 been in 1988?
15 A. I believe so.
16 Q. What specifically were you
17 doing in connection with changing the package
18 insert?
19 A. It was just my job to be sure
20 that the submission of that change went to the
21 FDA.
22 Q. Did you have to do a lot of
23 reading and research on the various federal
24 regulations involved in connection with
Page 40
1 pharmaceutical products in order to do your job?
2 A. No.
3 Q. Did you have, as a regulatory
4 scientist, a set of manuals or rules or
5 guidelines that gave you instruction in
6 connection with how you were to do your job and
7 the manner in which you were to perform your
8 function as a regulatory scientist?
9 A. No.
10 Q. There wasn't any policies and
11 procedures manuals that covered that particular
12 aspect?
13 A. Not to my knowledge.
14 Q. Are there any policy and
15 procedure manuals that describe or define a
16 regulatory scientist at Lilly?
17 A. I don't believe so.
18 Q. As a regulatory scientist
19 under Doctor Talbott, were you in the medical
20 division or were you in the regulatory division,
21 or is regulatory a part of medical, I guess, is
22 maybe the better way to ask it.
23 A. Regulatory is a part of
24 medical.
Page 41
1 Q. And medical is a part of Lilly
2 Research Labs; correct?
3 A. Yes.
4 Q. Who was the head of medical in
5 the Summer of 1988 when you first began your work
6 as a regulatory scientist on Prozac?
7 A. I believe it was Leigh
8 Thompson.
9 Q. And how long did he continue
10 in that position?
11 A. I don't recall the exact
12 duration.
13 Q. But he no longer holds that
14 position, does he?
15 A. That's correct.
16 Q. That first work you did in
17 connection with the package insert changes, did
18 it have anything to do with suicide?
19 A. No.
20 Q. Did it have anything to do
21 with adverse events?
22 A. I believe it did.
23 Q. What did it have to do in
24 connection with adverse events?
Page 42
1 A. I do not recall.
2 Q. Do you recall suicide as being
3 a consideration as an adverse event at that time?
4 A. No.
5 Q. Do you remember whether or not
6 the word suicide was mentioned in the package
7 insert at all when you first did work in
8 connection with getting package insert changes
9 made?
10 A. I do not recall.
11 Q. You couldn't tell me as we sit
12 here today whether or not the word suicide was
13 mentioned in the package insert when you first
14 worked on it?
15 A. No, I could not.
16 Q. Can you tell me today?
17 A. Would you rephrase the
18 question?
19 Q. Do you know today whether or
20 not the package insert today contains any mention
21 of suicide?
22 A. It does mention the word
23 suicide.
24 Q. Do you remember basically, I'm
Page 43
1 not going to hold you to verbatim, as to what
2 that insert says in connection with suicide
3 today?
4 A. No.
5 Q. Do you remember anything about
6 what it says?
7 A. I just remember that there is
8 a subsection of one of the sections that's titled
9 that.
10 Q. Do you remember when that
11 section came into the package insert material?
12 A. No.
13 Q. It's been, though, since
14 you've been a regulatory scientist at Lilly,
15 hasn't it?
16 A. I'm not sure I understand your
17 question.
18 Q. Well, that section on suicide
19 wasn't in the original package insert with
20 Prozac, was it?
21 A. I do not believe that's
22 correct.
23 Q. You think it was?
24 A. Yes.
Page 44
1 Q. The reason I ask is, I asked
2 you earlier if the word suicide was mentioned in
3 that first package insert, and it's my
4 recollection that you said you didn't think it
5 was.
6 MR. MYERS: I object to the form only
7 because I think the first insert that you all
8 talked about was when he came into the job, which
9 was not the first insert.
10 MR. SMITH: Right.
11 MR. MYERS: Or it wasn't at the time
12 of approval. You're talking about two different
13 things, Paul.
14 MR. SMITH: Maybe we are.
15 Q. Has there been something, in
16 your opinion, and based on your recollection,
17 some section on suicide in the package insert
18 since Prozac was approved for marketing by Lilly?
19 A. I think we're having trouble
20 when you use the word section, it doesn't
21 communicate to me what you really mean.
22 Q. I was using section in
23 connection -- in that sense that you used
24 section, Doctor, where you said I know now there
Page 45
1 is a section on suicide, that's listed suicide,
2 all right. Are we communicating now?
3 A. I don't think so.
4 Q. All right. Well, is there
5 today a section in the package insert that begins
6 with the word suicide?
7 A. No.
8 Q. There's not?
9 A. The term section refers to a
10 major part of the package insert.
11 Q. Is there a paragraph in the
12 package insert that mentions suicide?
13 A. Yes.
14 Q. Is there a paragraph in the
15 package insert that has suicide as the first word
16 in the paragraph?
17 A. I believe so.
18 Q. With a period by it?
19 A. I do not know.
20 Q. Has that paragraph, that
21 begins with suicide, always been in the package
22 insert?
23 A. I believe so.
24 Q. As far as you know?
Page 46
1 A. I believe so.
2 Q. That section or that area of
3 the package insert that has to do with adverse
4 events, are you with me now?
5 A. Yes.
6 Q. Did it have suicide mentioned
7 in the original package insert?
8 A. I do not know.
9 Q. Did it have suicide mentioned
10 in the first package insert that you worked on?
11 A. I do not know.
12 Q. Does it have suicide mentioned
13 in it now?
14 A. It doesn't have the word
15 suicide.
16 Q. What does it have?
17 A. I believe the expression is
18 suicidal ideation.
19 Q. And what's your recollection
20 as to the first time that suicidal ideation was
21 mentioned in the adverse event portion of the
22 package insert?
23 A. I do not remember the exact
24 timing.
Page 47
1 Q. It has been, though, since
2 you've been a regulatory scientist at Lilly,
3 hasn't it?
4 A. Yes.
5 Q. And you did work in connection
6 with the label change that included suicidal
7 ideation as an adverse event that had not had
8 that term prior to that?
9 A. I sent that label change to
10 the FDA.
11 Q. Can you give me any idea as to
12 when that was?
13 A. No.
14 Q. It hasn't been this year, has
15 it?
16 A. No.
17 Q. It wasn't in 1992 either, was
18 it?
19 A. I don't think so.
20 Q. Was it in 1991?
21 A. I do not remember.
22 Q. Do you think it would have
23 been 1991?
24 A. I do not remember.
Page 48
1 Q. Can you give me any idea at
2 all, Doctor Webber, on when you made that label
3 change as a regulatory scientist at the request
4 of the FDA?
5 MR. MYERS: I object to the form. The
6 assumption -- I don't know that there's been any
7 testimony of a request or not, just that it was
8 made.
9 Q. Well, the label was changed at
10 the request of the Food and Drug Administration,
11 wasn't it?
12 A. No.
13 Q. Did Lilly request that they
14 include suicidal ideation in the package insert?
15 A. We put it in a submission to
16 the FDA.
17 Q. Did Lilly institute the change
18 of the package insert to include suicidal
19 ideation?
20 A. Yes.
21 Q. Do you remember when that was?
22 A. No.
23 Q. But it's your testimony here
24 today, as the regulatory scientist involved,
Page 49
1 Doctor Webber, that Lilly did not move for a
2 change in the package insert to include suicidal
3 ideation as an adverse event. Is that your
4 testimony?
5 A. No.
6 Q. What is your testimony then?
7 A. Would you ask me a question,
8 please?
9 Q. Is it your testimony here
10 today that Lilly was the institution that was
11 requesting that suicidal ideation be included in
12 the package insert as opposed to a request from
13 the Food and Drug Administration that suicidal
14 ideation be included in the package insert?
15 A. That's correct.
16 Q. Did Lilly make the request
17 that suicidal ideation be included as an adverse
18 event in the package insert as a result of
19 existing federal regulations in connection with
20 what adverse events should or had to be included
21 in the package insert?
22 A. That's kind of a long
23 question, could you rephrase it?
24 MR. SMITH: Could you read that back?
Page 50
1 (THE COURT REPORTER READ BACK THE
2 REQUESTED TESTIMONY.)
3 A. No.
4 Q. Why did Lilly then make the
5 request that suicidal ideation be included as an
6 adverse event in the package insert?
7 A. I believe it came from
8 post-marketing surveillance.
9 Q. Was there post-marketing
10 surveillance picked up by Lilly that indicated
11 that suicidal ideation was an adverse event being
12 reported in connection with Prozac?
13 A. Well, I don't know.
14 Q. Well, I thought you said it
15 was post-marketing surveillance?
16 A. I said I thought that was the
17 basis for it, but the physicians come to me and
18 say we want to make a change.
19 Q. And I assume, based on your
20 earlier answer, it's your assumption that those
21 physicians came to you and said we want to make a
22 label change because their post-marketing
23 surveillance had indicated that there was
24 suicidal ideation being reported to them in
Page 51
1 connection with Prozac.
2 A. Yes.
3 Q. Do you remember when it was
4 that the physicians first began reporting to you
5 that they wanted changes in the labeling of
6 Prozac to include the adverse event being
7 reported to them of suicidal ideation?
8 A. No.
9 Q. Do you remember which
10 physicians it was that were reporting to you that
11 suicidal ideation was being reported in the
12 post-marketing surveillance as an adverse event?
13 A. I don't remember.
14 Q. Would it have been a group of
15 a number of physicians?
16 A. Yes.
17 Q. And would it have been those
18 physicians that had been doing work in connection
19 with collecting adverse events with respect to
20 Fluoxetine?
21 A. Yes.
22 Q. Who were those physicians?
23 A. It included Charles Beasley,
24 and John Heiligenstein, and David Wheadon, and
Page 52
1 Dan Masica.
2 Q. Any other physicians actually
3 doing work in collecting post-marketing
4 surveillance in connection with suicidal ideation
5 adverse events being reported to them?
6 A. No.
7 MR. MYERS: Paul --
8 Q. Do you specifically recall
9 Doctor Beasley as being a physician who had
10 reported this to you?
11 MR. MYERS: Go ahead.
12 A. No, but it would be logical.
13 Q. Why?
14 A. Because of what you just said,
15 he was one of the group.
16 MR. MYERS: Can we take a break at a
17 convenient point for you?
18 MR. SMITH: Sure.
19 Q. Do you have a specific
20 recollection of Doctor Beasley coming to you and
21 suggesting labeling changes in connection with
22 suicidal ideation because of post-marketing
23 surveillance?
24 A. No.
Page 53
1 Q. Do you have a specific
2 recollection of Doctor John Heiligenstein -- do
3 you suppose in time I will be able to say his
4 name before we depose him?
5 MS. ZETTLER: There's no hope for you,
6 Paul.
7 Q. Do you have a specific
8 recollection of Doctor Heiligenstein reporting to
9 you a request for labeling changes to include
10 suicidal ideation as an adverse event being
11 reported to them?
12 A. No.
13 Q. Same question in connection
14 with Doctor Wheadon?
15 A. No.
16 Q. Same question with respect to
17 Doctor Masica?
18 A. No.
19 Q. But it would have been one of
20 those or maybe all of those physicians that
21 reported that to you?
22 A. It might have been.
23 MR. SMITH: Let's take a break.
24 (A SHORT RECESS WAS TAKEN.)
Page 54
1 Q. Did you have any discussions
2 with this label change and the number of adverse
3 events reported on suicidal ideation with either
4 Doctor Talbott or Doctor Leigh Thompson?
5 A. I don't think so, I don't
6 recall.
7 Q. Do you recall any with Ms.
8 Earlene Ashbrook?
9 A. I did not.
10 Q. You recall that you did not
11 have any discussions with her?
12 A. (Witness moves head up and
13 down.).
14 MR. MYERS: Yes.
15 A. Yes, that's correct.
16 Q. Did you work with Ms. Ashbrook
17 on a regular basis?
18 A. No.
19 Q. Were you a member of the
20 Prozac project team at any time?
21 A. Yes.
22 Q. When was that?
23 A. Not before the Summer of '88,
24 not before the Summer of '88, probably
Page 55
1 thereafter.
2 Q. Until when?
3 A. Until it no longer existed.
4 Q. When did it go out of
5 existence?
6 A. I do not recall that.
7 Q. Approximately?
8 A. I do not recall.
9 Q. Has it been in existence this
10 year?
11 A. No.
12 Q. Was it in existence last year?
13 A. No.
14 Q. Was it in existence in 1991?
15 A. I don't recall that.
16 Q. Do you recall what other
17 changes were made in the labeling changes, that
18 first package insert change, that you worked on
19 in probably 1988 in connection with other adverse
20 events that were being reported?
21 A. I do not recall.
22 Q. Do you recall any other
23 changes made in the package insert at that time
24 other than this change to reflect suicidal
Page 56
1 ideation as being a reported adverse event?
2 MR. MYERS: Let me object to the form,
3 Paul, only because I don't know that you've
4 established, and I don't know that it's the case
5 that the change that you've just been discussing
6 is the same change as the first one he
7 remembered, I just don't know that.
8 Q. All right. Was the change in
9 connection with suicidal ideation the first label
10 change that you remember?
11 A. No.
12 Q. So there were other labeling
13 changes before there was a change in the label to
14 reflect this post-marketing surveillance which
15 indicated suicidal ideation as an adverse event
16 being reported?
17 A. Yes.
18 Q. But you can't pin it down as
19 to any year or any particular period of time as
20 to when that suicidal ideation change was made?
21 A. No.
22 Q. Do you recall any other
23 changes made in the package insert at the time
24 the suicidal ideation was included?
Page 57
1 A. Yes.
2 Q. All right, what?
3 A. I remember violent behaviors.
4 Q. And was this violent behavior
5 something that was also added --
6 A. Yes.
7 Q. -- to the package insert?
8 A. In the post-introduction parts
9 section -- subsection, excuse me.
10 Q. Was that added as a result of --
11 in the same manner that the suicidal ideation was
12 picked up as a result of post-marketing
13 surveillance by the physicians there at Lilly?
14 A. That's my recollection.
15 Q. Before that labeling change in
16 connection with suicidal ideation, do you recall
17 any discussions or any issue being present in
18 connection with whether or not Prozac was in any
19 way related to suicidal ideation or suicide?
20 A. I'm not sure what you mean by
21 discussion.
22 Q. Where it came up as a topic
23 that was being discussed within the Lilly group.
24 A. Yes.
Page 58
1 Q. All right. When was that?
2 A. Probably Spring of 1990.
3 Q. All right. How did that come
4 up?
5 A. In response to awareness of
6 the Teicher paper.
7 Q. If we can pinpoint Spring of
8 1990 as when you first recall there being
9 discussions of suicide and its relationship to
10 Prozac, as being Spring of 1990, then would the
11 package insert change to reflect suicidal
12 ideation have occurred after the Spring of 1990?
13 A. I do not remember the month
14 that it occurred.
15 Q. I understand that, but now
16 it's my understanding that your first
17 recollection of any mention of suicide, suicidal
18 ideation, was in the Spring of 1990, is that
19 right?
20 A. Yes.
21 Q. Based on that, can you
22 conclude that the package insert post-marketing
23 surveillance change was after that?
24 A. That would be logical.
Page 59
1 Q. Did you do anything at any
2 time to determine as a regulatory scientist the
3 number of reports of suicide that had been
4 reported as an adverse event in connection with
5 Prozac?
6 A. No.
7 Q. Same question with respect to
8 suicidal ideation?
9 A. No.
10 Q. Same question with respect to
11 suicide attempts?
12 A. No.
13 Q. Same question in connection
14 with overdose?
15 A. No.
16 Q. Same question with respect to
17 aggression or violence?
18 A. No.
19 Q. Do you recall there being any
20 instances in which the Food and Drug
21 Administration requested from the regulatory
22 scientist department there at Lilly, after the
23 Spring of 1990, numbers in connection with the
24 amount of reports of suicidal ideation?
Page 60
1 A. I don't recall.
2 Q. Have you reviewed any
3 documents, Doctor Webber, in connection with
4 giving your deposition here today?
5 A. No.
6 Q. Does your work still include
7 regulatory matters?
8 A. Yes.
9 Q. Does it still include areas in
10 which Prozac is involved?
11 A. Yes.
12 Q. So your work on Prozac since
13 the Summer of 1988 has been an ongoing activity?
14 A. Yes.
15 Q. Do you maintain a particular
16 file on Prozac or Fluoxetine Hydrochloride?
17 A. Yes.
18 Q. And do you maintain a separate
19 file on your work in connection with Prozac from
20 the other regulatory scientists at Lilly?
21 A. Well, there are no other
22 regulatory scientists at Lilly working on Prozac.
23 Q. All right. You're the only
24 one?
Page 61
1 A. Yes.
2 Q. And have been the only one
3 since 1988?
4 A. That's correct.
5 Q. Doctor Talbott, I would
6 assume, is considered a regulatory scientist?
7 A. No.
8 Q. What is he considered?
9 A. He's the director.
10 Q. Of?
11 A. The medical regulatory affairs
12 division.
13 Q. What is Doctor Talbott's
14 degree in, I've forgotten, do you know?
15 A. I think it's immunology.
16 Q. Is he a medical doctor?
17 A. No.
18 Q. A Ph.D?
19 A. Yes.
20 Q. Currently are there
21 individuals within your department that you
22 supervise?
23 A. No, except I have a secretary
24 that reports to -- does work for some other
Page 62
1 people.
2 Q. You share a secretary?
3 A. Yes.
4 Q. Who is that?
5 A. Her name is Sharay Arnold.
6 Q. Have you ever had, since
7 you've been in regulatory, individuals who were
8 subordinate to you, who reported to you?
9 A. No.
10 Q. What is the next position past
11 regulatory scientist?
12 A. There really is none.
13 Q. If you were to get a
14 promotion, could you be promoted within the
15 regulatory division?
16 A. I do not know.
17 Q. Who would know that?
18 A. Somebody higher in management,
19 I guess.
20 Q. Since you've been in
21 regulatory, have you received any promotions?
22 A. No.
23 Q. Have you applied for any
24 promotions --
Page 63
1 A. No.
2 Q. -- since you've been in
3 regulatory?
4 A. No.
5 Q. Since you've been in
6 regulatory, have you requested to be moved to any
7 other department or division?
8 A. No.
9 Q. Are you happy with your
10 current position?
11 A. Yes.
12 Q. You've been with Lilly for how
13 many years?
14 A. Twenty-seven.
15 Q. Twenty-seven. Have you been
16 offered their early retirement program?
17 A. Yes.
18 Q. Have you decided on whether or
19 not you're going to take that?
20 A. I have decided not to.
21 Q. As I understand it, it's your
22 testimony there may have been more package insert
23 changes or earlier package insert changes that
24 you worked on before the change including
Page 64
1 suicidal ideation and violent behavior --
2 A. Yes.
3 Q. -- was effectuated. Did you
4 have occasion to go to Washington, DC and meet
5 with any members of the Food and Drug
6 Administration in connection with the label
7 change that included suicidal ideation or violent
8 behavior?
9 A. Not associated with the label
10 change.
11 Q. All right. What was your
12 first occasion, then, to go to Washington and
13 meet with the FDA?
14 A. For what subject?
15 Q. Any subject in connection with
16 Prozac or Fluoxetine.
17 A. I believe I went with a group
18 that went to discuss suicidal behavior.
19 Q. Well, we know you went in May,
20 1991. You may not know that, but --
21 A. I don't remember the month,
22 but I'll believe you.
23 Q. We've got some documents and
24 some memos that you authored that will reflect a
Page 65
1 May 1991 trip.
2 A. All right.
3 Q. So we'll discuss that in
4 detail later on, but that May, 1991 -- and that
5 meeting as a --
6 MR. MYERS: Reference point.
7 Q. -- reference point -- thank
8 you, Mister Myers -- to go back further in time.
9 Had you been to Washington to discuss Prozac at
10 all on any occasion before May, 1991?
11 A. I don't recall that I did.
12 Q. You think the May, 1991
13 discussion about suicidality was probably your
14 first trip to Washington in connection with
15 Prozac?
16 A. I believe it may have been.
17 Q. Have you ever been to
18 Washington to meet with the FDA on any other
19 occasions for any other reasons before May, 1991?
20 A. Yes.
21 Q. Tell me about those occasions.
22 A. Well, there were a number of
23 them, some of them for drugs that are in IND
24 status.
Page 66
1 Q. Any other occasions?
2 A. In addition to?
3 Q. In addition to these other
4 compounds, and I don't want you to mention the
5 names.
6 A. Actually, I'm remembering
7 another meeting now.
8 Q. With Prozac?
9 A. Yes, about smoking cessation.
10 Q. All right. Was that before
11 May, 1991?
12 A. Yes, I believe it was. It was
13 a long time ago, sorry for not remembering.
14 Q. That's all right. And by the
15 way, if -- you're going to be here for a couple
16 of days, at least. If, during any of our
17 questioning of you, there comes up additional
18 information or additional things that you want to
19 amend or delete, feel free to stop us and do
20 that. And if I ask you any questions that you
21 don't understand, which more than likely I have,
22 and will, please ask me to clarify that, would
23 you?
24 A. (Witness moves head up and
Page 67
1 down.).
2 Q. You have to give an audible
3 answer, too.
4 A. Yes.
5 Q. The smoking cessation meeting
6 with the Food and Drug Administration must have
7 been from the Summer of 1988 up until May of
8 1991, within that period of time?
9 A. I believe it was.
10 Q. Can you recall any better as
11 to when that meeting was?
12 A. No, but I believe it may have
13 been in '89.
14 Q. Was the meeting in Washington?
15 A. Yes.
16 Q. Who from Lilly accompanied
17 you?
18 A. I can remember Louise Levine
19 and Dan Masica. I don't recall the others, there
20 were a few others.
21 Q. Would Doctor Talbott have been
22 with you?
23 A. I don't know.
24 Q. How about Earlene Ashbrook?
Page 68
1 A. I don't think so.
2 Q. Who is Louise Levine?
3 A. She's a physician.
4 Q. Was she working on Prozac?
5 A. I believe she was the monitor,
6 physician monitor, for smoking cessation at the
7 time.
8 Q. Is she still with Lilly?
9 A. Yes.
10 Q. What is her position now?
11 A. Well, she's still a physician,
12 but I can't tell you what she works on, I don't
13 know what she works on.
14 Q. You're still working on
15 Prozac?
16 A. Yes.
17 Q. Is she still working on
18 Prozac?
19 A. No.
20 Q. Is she working in CNS drugs?
21 A. No.
22 Q. Is she working on immunology
23 or anti-infectives?
24 A. I believe she's in the
Page 69
1 division that works on internal medicine.
2 Q. Do you know if she's doing any
3 work on the liver drug?
4 A. I don't know specifically what
5 she's doing.
6 Q. What's her specialty as a
7 physician?
8 A. I don't know.
9 Q. Is she a psychiatrist,
10 psychology type?
11 A. I do not think she's a
12 psychiatrist.
13 Q. Were there any clinical
14 research administrators that might have been with
15 you on this trip in 1989 to the Food and Drug
16 Administration on smoking cessation?
17 A. I don't recall.
18 Q. Was there an ongoing study at
19 the time in connection with smoking cessation?
20 A. I believe there was.
21 Q. What was the purpose of the
22 meeting with the FDA?
23 MR. MYERS: Before you answer, Doctor
24 Webber, let me caution you, you can tell him
Page 70
1 generally, and certainly you're able under the
2 orders of the court to answer questions
3 concerning safety, but anything related to the
4 project specifically related to efficacy, he's
5 not going to get into. But give him a general
6 description of why you went up there.
7 A. My best recollection was that
8 we wanted to learn how the FDA's expectation and
9 our plans might have meshed or we'll do what was
10 needed or demanded by them for a potential
11 approval.
12 Q. At that time, Prozac was being
13 investigated for uses as a smoking cessation aid
14 or agent, is that right?
15 A. Yes.
16 Q. And there were either ongoing
17 or planned clinical studies in connection with
18 that?
19 A. Yes.
20 Q. And the Food and Drug
21 Administration was aware of those ongoing
22 studies?
23 A. Yes.
24 Q. Who was there from the Food
Page 71
1 and Drug Administration?
2 A. I remember Paul Leber. He's
3 the only one I'm certain of.
4 Q. How about Paul David?
5 A. I don't think he was involved
6 at that point.
7 Q. How about Tom Laughren?
8 A. He might have been there.
9 Q. How about Robert Temple?
10 A. I don't believe he was at that
11 meeting.
12 Q. Who was Doctor Temple at that
13 time, what was his position?
14 A. I don't know what his exact
15 title is, but he's one of the higher up people at
16 the FDA.
17 Q. Was it your impression that
18 Doctor Temple was higher up than Doctor Leber --
19 A. Yes.
20 Q. -- within the FDA, is that
21 right?
22 A. Yes.
23 Q. And then Doctor David and
24 Doctor Laughren would have been under Doctor
Page 72
1 Leber?
2 A. Paul David is not a doctor.
3 Q. Okay. But Paul David, whoever
4 he is, and Doctor Laughren were physicians under
5 Doctor Leber?
6 A. Doctor Laughren is a physician
7 under Doctor Leber.
8 Q. Anybody else from the Food and
9 Drug Administration that might have been there?
10 A. I don't remember.
11 Q. At the time that you met with
12 those members of the Food and Drug Administration
13 in 1989, were there studies ongoing in connection
14 with smoking cessation?
15 A. Yes.
16 Q. And were patients enrolled in
17 clinical studies?
18 A. I believe they were.
19 Q. And were patients being
20 administered Fluoxetine?
21 A. In smoking trials, is that
22 what you're asking me?
23 Q. Yes.
24 A. Yes.
Page 73
1 Q. And were those patients
2 monitored by clinical investigators hired by
3 Lilly?
4 A. Yes.
5 Q. And do you recall whether or
6 not those patients were being administered any
7 type of tests?
8 MR. MYERS: Let me object to the form.
9 What do you mean by tests? That could mean a lot
10 of different things.
11 Q. Any test, such as the Hamilton
12 Depression Scale.
13 A. I'm not aware that they were.
14 Q. All right. You're not aware
15 of any tests that they might have been
16 administered?
17 A. I remember a test, it was not
18 a psychological test, a test for something called
19 Cotinine that I had never heard of before, and it
20 just caught in my mind.
21 Q. How do you spell that?
22 A. I can only guess,
23 C-O-T-I-N-I-N-E. And I believe it's a metabolite
24 of nicotine.
Page 74
1 Q. Is it something that you can
2 get blood levels on?
3 A. My recollection, from what I
4 recall, is that that probably is correct.
5 Q. So they were measuring
6 nicotine, and maybe Cotinine levels in patients'
7 blood?
8 A. I believe they were measuring
9 Cotinine levels.
10 Q. Case report forms were being
11 filled out on these patients?
12 A. I presume.
13 Q. Well, there weren't any
14 studies that you were aware of in connection with
15 Fluoxetine that there weren't case report forms
16 being used, were there?
17 A. I'm not aware of any.
18 Q. Those patients were being
19 monitored for adverse events or adverse
20 experiences or adverse drug reactions that
21 occurred in connection with those patients during
22 those smoking cessation clinical trials, were
23 they not?
24 A. Yes.
Page 75
1 Q. And those adverse events were
2 being recorded by Lilly?
3 A. I believe so.
4 Q. And reported to the Food and
5 Drug Administration?
6 A. Yes.
7 Q. Do you recall whether or not
8 those -- in that meeting with the Food and Drug
9 Administration employees, whether or not -- or
10 what adverse events were being discussed?
11 A. I do not recall.
12 Q. What was the subject of the
13 discussion?
14 A. Well, I think I already
15 answered that question.
16 Q. If you did, I forgot.
17 A. Well, I believe what I said
18 was we were learning what their expectations were
19 relative to what our plans were for doing the
20 study.
21 Q. What were their expectations
22 relative to your plans?
23 A. I don't recall.
24 Q. Do you recall that they wanted
Page 76
1 more information in connection with the clinical
2 trials?
3 A. I do not recall that.
4 Q. Did you write a memo in
5 connection --
6 A. I cannot recall.
7 Q. Was that your habit to write a
8 memo?
9 A. I wrote memos.
10 Q. Do you recall that there had
11 been suicidal ideation, suicide attempts and
12 suicide that had occurred during the smoking
13 cessation trial?
14 A. I'm not aware of that.
15 Q. Would that surprise you?
16 A. I think that's a medical
17 judgment, I don't want to make a medical
18 judgment.
19 Q. As a regulatory scientist,
20 would that surprise you?
21 A. I consider that a medical
22 judgment, not a regulatory issue.
23 Q. Is it your testimony here
24 today that there were no instances of suicide,
Page 77
1 suicide attempts or suicidal ideation that
2 occurred during the smoking trials?
3 A. I do not know that.
4 Q. Is it your testimony here
5 today that there weren't discussions there at
6 that meeting with the Food and Drug
7 Administration concerning suicide, suicide
8 attempts and suicidal ideation?
9 A. I do not recall any.
10 Q. You don't deny that that was
11 discussed, it's just your testimony here today
12 that you don't recall it?
13 A. I do not recall that that
14 occurred.
15 Q. Did you have any other
16 meetings with the Food and Drug Administration
17 before the May 15th, 1991 meeting in connection
18 with Prozac?
19 A. I don't believe so.
20 Q. There were ongoing trials at
21 that time, as I recall, in connection with weight
22 control, obsessive compulsive disorders, alcohol
23 abuse, and maybe bulimia nervosa. Would there
24 have been any meetings with the Food and Drug
Page 78
1 Administration in connection with those
2 indications?
3 A. I don't remember any meetings.
4 Q. You remember that there were
5 ongoing trials in those areas?
6 A. Yes.
7 Q. Up to May 15th --
8 A. Let me make an exception,
9 alcohol is not one I remember.
10 Q. All right. But for those
11 other indications?
12 A. Yes.
13 Q. You recall that there were
14 ongoing clinical trials?
15 A. And I'm not sure what timing
16 you put it. So for obsessive compulsive
17 disorder, I'm not sure what timing you were
18 asking me about.
19 Q. I was trying to combine my --
20 confine my question to up to May, 1991.
21 A. Then probably the answer is
22 yes.
23 Q. Do you recall as a regulatory
24 scientist responsibility for complying with the
Page 79
1 regulations of the Food and Drug Administration
2 in connection with Prozac reports of suicide,
3 suicidal ideation or suicide attempts in these
4 other clinical trials that were ongoing up to
5 May, 1991?
6 A. No.
7 Q. Were you aware of the
8 requirements of the Food and Drug Administration
9 with respect to reporting adverse events that
10 occurred during the clinical trials?
11 A. I'm fairly aware, yes.
12 Q. Were you aware that up to May,
13 1991, Prozac was being taken by individuals or
14 prescribed by physicians for indications other
15 than depression prior to May of 1991?
16 A. I may have been aware.
17 Q. In other words, there were
18 spontaneous reports of adverse experiences being
19 received at Lilly prior to May, 1991; correct?
20 A. Yes.
21 Q. And Lilly was, through their
22 detail people, monitoring the physicians involved
23 in connection with the prescribing of Prozac;
24 correct?
Page 80
1 A. Yes.
2 Q. And it was generally known by
3 May of 1991 that there were physicians who were
4 prescribing Prozac for indications other than
5 depression?
6 MR. MYERS: I object to the form.
7 Generally known by whom? Do you know, you can
8 answer.
9 A. I don't know whether that was
10 generally known.
11 Q. You generally knew it, didn't
12 you?
13 A. I generally knew it?
14 Q. You knew it generally.
15 A. I had heard hearsay of this
16 fact.
17 Q. In other words, the fact that
18 a medication is indicated for use by the Food and
19 Drug Administration for depression doesn't limit
20 what a particular physician can prescribe Prozac
21 for, does it?
22 A. You are correct.
23 Q. Whether or not a physician can
24 prescribe a medication for a particular
Page 81
1 indication is up to the physician, isn't it?
2 A. I believe that's correct.
3 Q. And you knew that as a
4 regulatory scientist for Eli Lilly and Company,
5 responsible for Prozac in May of 1991, didn't
6 you, Doctor Webber?
7 A. I believe so.
8 Q. Were you aware, Doctor Webber,
9 of an effort by the marketing arm of Lilly to
10 make general practice physicians and physicians
11 other than psychiatrists aware of the benefits of
12 treatment of Prozac for depression in May of
13 1991?
14 A. Well, I am now, but I cannot
15 be sure that I was in May of '91.
16 Q. Well, you wouldn't dispute
17 that there was an effort ongoing in May of 1991
18 to make physicians in the general practice area,
19 other than psychiatrists, aware of the benefits
20 of Prozac in treatment for depression?
21 A. I would not dispute that.
22 Q. Do you know of any publication
23 or initiative that was made by anybody at Eli
24 Lilly and Company to make physicians aware that
Page 82
1 Prozac was approved only for use in treatment of
2 depression?
3 A. I believe that some of the
4 promotion material that I have observed asserts
5 that fact.
6 Q. Are you aware of whether or
7 not that promotional material warns against using
8 Prozac for other indications?
9 A. No, I'm not aware.
10 Q. Are you aware of any material
11 that suggests by Lilly that physicians should not
12 use Prozac for other indications other than
13 treatment of depression?
14 A. I'm not aware.
15 Q. Who would know that?
16 A. Well, the people that compile
17 the promotional literature.
18 Q. It would be somebody in the
19 marketing arm?
20 A. Yes.
21 Q. How long did this meeting in
22 1989 last at the Food and Drug Administration?
23 A. I don't recall, but I can
24 guess about an hour.
Page 83
1 Q. And after that meeting, did
2 you do work in connection with the regulatory end
3 of the smoking cessation study?
4 A. Yes.
5 Q. And what did you do?
6 A. Not a great deal. I recall
7 making contact with another division at FDA to
8 which the smoking cessation responsibility had
9 been transferred.
10 Q. What division was that?
11 A. It's called the pilot
12 division.
13 Q. What was the pilot division?
14 A. Well, the pilot division was
15 set up, as I recall, it was a Summer of some
16 years, so it may have been the Summer of '89, and
17 it had a number of things in it.
18 Q. Such as?
19 A. It had analgesics,
20 anti-inflammatories, and it had the drug abuse
21 staff which was what brought smoking cessation
22 review.
23 Q. I take it the name pilot
24 division doesn't mean that there's aircraft
Page 84
1 involved, does it?
2 A. I don't think so.
3 Q. Probably has to do with the
4 fact that these are pilot projects or initial new
5 sort of experimental type projects, is that
6 right?
7 A. I don't think so.
8 Q. Then give me a better
9 description of what this division is. You and I
10 are on different --
11 A. The FDA named the division.
12 Q. All right.
13 A. That's what they called it.
14 Q. What is your understanding as
15 to why that division was named pilot?
16 A. They didn't tell me.
17 Q. Do you have an understanding
18 at all?
19 A. No, but I have a guess.
20 Q. Tell me that.
21 A. This division was set up to
22 try some new approaches to doing regulatory
23 issues, like I'm trying to think, NDA Day, that
24 was one of their ideas.
Page 85
1 Q. NDA Day?
2 A. Yes.
3 Q. What is NDA Day?
4 A. Well, I never participated in
5 one but the way it's been described is that they
6 bring the sponsor in after they've reviewed the
7 submission and the sponsor has contact with the
8 home office, can ask questions and they have a
9 dialogue back and forth to basically clarify the
10 issue of use that the FDA wants to ask about.
11 Q. What other things does the
12 pilot division of the Food and Drug
13 Administration do?
14 A. Those are the only things that
15 I'm aware of.
16 Q. But they have a drug abuse
17 staff, correct?
18 A. The drug abuse staff was in
19 the pilot division, I believe when it -- or
20 shortly after it was formed or at the time it was
21 formed.
22 Q. And the smoking cessation
23 study went from neuropsychopharmacology over to
24 the pilot division; is that right?
Page 86
1 A. Yes.
2 Q. And they took over the
3 overseeing and regulatory affairs in connection
4 with the smoking cessation study?
5 A. Yes.
6 Q. Who was head of the pilot, who
7 is head of the pilot division of the FDA?
8 A. Doctor Harter.
9 Q. What is his first name?
10 A. John.
11 Q. And who did you or do you deal
12 with in connection with your work in that
13 division?
14 A. Well, I deal with a lot of
15 different people, none of them that I can
16 remember for Fluoxetine.
17 Q. What is the status of the
18 smoking cessation indication?
19 MR. MYERS: Don't answer that, that's
20 proprietary.
21 Q. Well, are there still ongoing
22 studies in connection with that?
23 MR. MYERS: Don't even that.
24 MR. OLTMAN: Paul, I believe Bob
Page 87
1 yesterday at the hearing said they had dropped
2 that as an indication.
3 Q. Do you know whether or not
4 it's been dropped as an indication?
5 MR. MYERS: Don't answer that either.
6 MR. SMITH: If there's safety data
7 that could be obtained from that study, it's a
8 logical question to know whether or not that
9 study is ongoing or not.
10 MR. MYERS: No, it's not.
11 MR. SMITH: Yes, it is.
12 MR. MYERS: If you want the safety
13 data, that's one question. Whether it's ongoing
14 or not is another question.
15 Q. Is the study ongoing?
16 MR. MYERS: Answer that.
17 MS. ZETTLER: How are we going to ask
18 for the safety data if we can't find out if there
19 is a study?
20 MR. MYERS: He's not going to answer
21 that question so ask him another question.
22 MS. ZETTLER: For the record, for
23 Fentress, it's your position that we do not have
24 the right to find out whether or not there are
Page 88
1 studies ongoing?
2 MR. MYERS: Whether or not they're
3 continuing to study smoking cessation, that's
4 correct.
5 MS. ZETTLER: Even related to safety?
6 MR. MYERS: That's a different
7 question. Whether there's safety data or not has
8 nothing to do with whether there's a study
9 ongoing.
10 MS. ZETTLER: So you're saying that
11 any studies that are ongoing with smoking
12 cessation have nothing to do with safety
13 whatsoever?
14 MR. MYERS: He didn't ask that. I'm
15 trying to --
16 MS. ZETTLER: Are you instructing him
17 not to answer as to whether or not there are any
18 ongoing safety studies?
19 MR. MYERS: That isn't the question,
20 Ms. Zettler, that's not the question.
21 MS. ZETTLER: What is the question?
22 MR. MYERS: The question was whether
23 there were any ongoing studies.
24 THE WITNESS: Right, on smoking
Page 89
1 cessation.
2 MR. MYERS: Right, you said any
3 ongoing safety studies.
4 MS. ZETTLER: No, I said anything
5 related to safety and you know it.
6 MR. MYERS: The record will speak for
7 itself. He's not going to answer that particular
8 question.
9 Q. (BY MR. SMITH) Let me ask you
10 this, Doctor Webber: It's my understanding that
11 in each and every study that is done in
12 connection with any particular drug that's under
13 investigation by Eli Lilly and Company, that
14 safety is always analyzed as part of that study,
15 is it not?
16 A. That's correct.
17 Q. And safety data is accumulated
18 in each and every study that is done on any drug
19 manufactured under investigation by Lilly, is it
20 not?
21 A. That's correct.
22 Q. Now, with that in mind, are
23 there any ongoing studies in connection with
24 smoking cessation and Fluoxetine?
Page 90
1 MR. MYERS: He's not going to answer
2 that question, I'm directing him not to answer
3 it.
4 (DISCUSSION OFF THE RECORD.)
5 Q. Is there any safety data being
6 collected in connection with an ongoing smoking
7 cessation study on Fluoxetine?
8 MR. MYERS: You can tell him whether
9 there's any safety data being collected. Whether
10 anything is ongoing or not, don't disclose that.
11 A. You're asking me if there
12 currently -- I mean -- will you repeat the
13 question then?
14 MR. SMITH: Read it back.
15 (THE COURT REPORTER READ BACK THE
16 REQUESTED TESTIMONY.)
17 MR. MYERS: You may answer the
18 question as to whether there's any safety data
19 being collected. Don't disclose whether or not
20 there's an ongoing smoking study. But if there's
21 any safety data being collected --
22 MR. SMITH: Don't amend my question.
23 If you're going to instruct him not to answer,
24 instruct him not to answer.
Page 91
1 MR. MYERS: He won't answer the
2 question as stated.
3 MR. SMITH: I want the question
4 answered as asked.
5 MR. MYERS: He's not going to answer
6 the question as asked.
7 MS. ZETTLER: Certify it, and also
8 make a record on the other questions because we
9 have to make a record.
10 MR. SMITH: You have to actually
11 certify it?
12 MR. MYERS: I'm not going to insist
13 that you have to certify it to clutter up the
14 record.
15 MS. ZETTLER: So when you're
16 instructing him, you're disagreeing and
17 instructing him not to answer, then it's
18 automatically certifying it for the record?
19 MR. MYERS: No, I'm not going to make
20 him go back to the other questions is all I'm
21 saying.
22 MR. SMITH: In Kentucky, you have to
23 certify it?
24 MS. ZETTLER: I think you are supposed
Page 92
1 to in Kentucky.
2 MR. SMITH: But you're not going to
3 require that we actually certify these questions
4 that you're instructing him not to answer?
5 MR. MYERS: No, no. I said you don't
6 have to go back and remake the record on the
7 other questions that I directed him not to
8 answer. Prospectively, if you want to certify
9 the question, go ahead. I'm just simply not
10 going to go back and redo the record.
11 MR. SMITH: We just want to make sure
12 that it isn't violative. If we haven't certified
13 those questions --
14 MR. MYERS: You haven't waived
15 anything up until right now.
16 MR. SMITH: All right.
17 (QUESTIONS CERTIFIED.).
18 Q. Are you aware of any other
19 ongoing trials in connection with Fluoxetine in
20 which safety data is being collected for any
21 indication?
22 MR. MYERS: He can answer that.
23 A. Yes.
24 Q. List those for me, please.
Page 93
1 MR. MYERS: Tell him what the
2 indications are. That's what you want to know,
3 right?
4 MR. SMITH: Yes.
5 A. There are depression studies,
6 obesity, I believe.
7 Q. Now, obesity and --
8 A. You used the word weight
9 reduction before, and those are maybe vague
10 terms. We call it just obesity.
11 Q. Are the bulimia studies
12 different from the obesity studies?
13 A. Yes.
14 Q. So you listed obesity,
15 depression, what else?
16 A. I'm not aware of any others.
17 Q. So there are no studies
18 ongoing in connection with smoking cessation?
19 MR. MYERS: Go ahead and answer that
20 then.
21 A. I'm not aware of any.
22 MR. MYERS: Do you want to take back
23 everything you say?
24 MS. ZETTLER: No.
Page 94
1 MR. MYERS: There goes your record.
2 MS. ZETTLER: That's okay, as long as
3 the question is answered, Larry.
4 MR. MYERS: A lot to do about nothing,
5 I guess.
6 MR. SMITH: Do you want to go eat now
7 and beat the traffic?
8 MR. MYERS: That's fine.
9 (A LUNCH RECESS WAS TAKEN.)
10 Q. (BY MR. SMITH) Doctor Webber,
11 before we broke for lunch, you indicated there
12 were currently ongoing studies in connection with
13 depression and obesity with respect to
14 Fluoxetine; is that correct?
15 A. Yes.
16 Q. Are there no ongoing studies
17 with respect to obsessive compulsive disorders?
18 A. I don't think there are.
19 Q. With respect to depression,
20 are you familiar at all with the types of studies
21 that are ongoing in connection with depression?
22 A. Only very slightly.
23 Q. Tell me what your
24 understanding is in connection with the ongoing
Page 95
1 depression studies?
2 A. As a nonphysician, I feel that
3 we're studying depression and some different
4 types of sick populations.
5 Q. What's your understanding with
6 respect to the various population groups that is
7 under study in connection with depression?
8 A. Are you looking for me to name
9 them?
10 Q. Yes.
11 A. Well, I'm going to -- well, I
12 can remember we were -- and I'm not sure -- these
13 are ones I remember.
14 Q. Okay.
15 A. I can't promise you that
16 they're ongoing because they stop and start, and
17 I don't have to be aware of that.
18 Q. Okay.
19 A. I think we were interested in
20 cancer patients with depression. You already
21 know that we were interested in what we call
22 geriatric, that's a matter of record. We were
23 interested in what's called long-term depression,
24 that's vague for anybody but a psychiatrist, and
Page 96
1 that would be hard for me to explain exactly what
2 we were doing there.
3 Q. When you're talking long-term
4 depression, are you talking about individuals who
5 have been depressed for a long period of time or
6 are you talking about individuals who are on
7 Prozac for longer periods of time than the
8 initial clinical trials?
9 A. I don't know.
10 Q. Or both?
11 A. I don't know, okay. I've had --
12 but I've had a hard time understanding myself
13 what we did, because basically it's done and when
14 I've tried to understand, it's too subtle for me
15 from a psychiatric standpoint, too complicated.
16 So I do not know.
17 Q. Any others?
18 A. Let's put it this way: A
19 number of them pass by me on the way to the FDA,
20 but I don't recall any -- I mean they tend to be
21 in front of my nose for a few seconds, and then
22 they're gone, and I just don't recall any others.
23 Q. Well, you're responsible for
24 insuring that those studies are being done in
Page 97
1 accordance with federal regulations, are you not?
2 A. No, I'm not.
3 Q. Who is?
4 A. Well, really meaning good
5 clinical practices, so it's the medical people
6 that monitor that, the people in the clinical
7 area at Lilly.
8 Q. As I understand it, you're the
9 regulatory scientist in charge of Fluoxetine
10 work; correct?
11 A. Well, in charge has a certain
12 meaning, but within that meaning, yes.
13 Q. Well, you're the person who
14 has the primary responsibility to interface with
15 the Food and Drug Administration in connection
16 with regulations pertinent to development and
17 trials of Fluoxetine?
18 A. That's correct.
19 Q. And you don't act as a rubber
20 stamp by any stretch of the imagination, do you?
21 A. I act as a conduit for the
22 information.
23 Q. But isn't your job such that
24 you're there to ensure that these studies are
Page 98
1 done in accordance with the appropriate federal
2 regulations?
3 A. No, I'm not.
4 Q. Maybe I'm under a
5 misapprehension in connection with what you do.
6 Are you simply a conduit following information
7 from the doctors to the Food and Drug
8 Administration?
9 A. That's correct.
10 Q. Don't those doctors come to
11 you and ask what the Food and Drug Administration
12 requires in connection with these particular
13 studies?
14 A. No.
15 Q. Who do they go to for that
16 information?
17 A. Well, their clinical expertise
18 sources, whatever that is.
19 Q. I'm not talking about clinical
20 expertise, I'm talking about somebody conducting
21 the studies or somebody in charge of ensuring
22 that the studies are conducted in compliance with
23 federal regulations. Maybe I made a bad
24 misassumption, Doctor Webber. I thought you were
Page 99
1 the individual that was designated by Lilly to
2 ensure that Lilly's work in connection with
3 Fluoxetine with respect to the clinical studies,
4 and with respect to ongoing work in connection
5 with Fluoxetine was being done in accordance with
6 federal regulations. Am I wrong?
7 A. You're wrong.
8 Q. Who is it, then, that is
9 overseeing Eli Lilly and Company within the
10 company to ensure that their work in connection
11 with Fluoxetine complies with applicable Food and
12 Drug Administration regulations?
13 A. The key word here is ensure,
14 and that's what makes it difficult.
15 Q. The key word is what?
16 A. Ensure. I mean I advise
17 people, okay. But I think it's a collective
18 input of everyone's awareness and knowledge and
19 talents and intelligence.
20 Q. Who's responsible within the
21 company for seeing to it that Lilly's work in
22 connection with Fluoxetine and Prozac complies
23 with federal regulations?
24 A. I'm not sure.
Page 100
1 Q. You don't know?
2 A. No.
3 Q. And you are currently, today,
4 the regulatory scientist in charge of Prozac?
5 A. That's correct.
6 Q. In connection with the
7 depression studies, have you seen a study
8 regarding subsyndromal syndrome?
9 A. I'm aware of our interest in
10 that.
11 Q. What's your understanding with
12 respect to what the subsyndromal syndrome is?
13 A. It's a psychiatric issue that
14 I really do not understand.
15 Q. Do you have any belief with
16 respect to whether or not it can be
17 characterized, the subsyndromal syndrome, as
18 being a relatively milder form of depression?
19 A. I do not know.
20 Q. You just don't have any idea
21 what that is?
22 A. No.
23 Q. Are you aware that that study
24 is ongoing?
Page 101
1 A. I'm aware of our interest in
2 it, I wasn't aware it was ongoing.
3 Q. Was it your understanding that
4 that study had been concluded or had not begun?
5 A. If you asked me to guess, I
6 would say it hadn't begun.
7 Q. The long-term depression study
8 that you mentioned earlier, has that study been
9 completed, is it ongoing or has it not yet begun?
10 A. I believe it's completed.
11 Q. When do you think that was
12 completed?
13 A. Well, maybe approximately nine
14 to twelve months ago, maybe six months ago.
15 Q. Were there any -- as a
16 regulatory scientist at Eli Lilly and Company,
17 and responsible for Prozac, are you aware of any
18 suicidal ideation or suicide attempts that
19 occurred on that long-term depression study?
20 A. I'm not aware of any.
21 Q. How about violence or
22 aggression that occurred in patients
23 participating in that long-term depression study?
24 A. I don't know.
Page 102
1 Q. Do you remember whether or not
2 there was any particular adverse event reported
3 in connection with those patients participating
4 in that study?
5 A. No, I don't.
6 Q. The geriatric study, has that
7 study been completed, is it ongoing or is it yet
8 to be started?
9 A. It's completed.
10 Q. Same question with respect to
11 that study, were there any instances where there
12 were reported adverse events in that study
13 regarding suicide, suicide attempts or suicidal
14 ideation?
15 A. I don't know.
16 Q. Were there any -- in your
17 capacity, do you recall any violent -- instances
18 of violence or aggression that occurred in that
19 study which has now been completed?
20 A. I do not recall.
21 Q. The cancer study, were there
22 any adverse events in connection with that study?
23 MR. MYERS: Any?
24 MR. SMITH: Yes.
Page 103
1 A. I will be honest with you, I
2 don't know whether we did that study, all I
3 remember is seeing the title.
4 Q. Okay. Well, do you recall
5 whether or not --
6 A. So I remember nothing, no
7 facts.
8 Q. Do you recall whether or not
9 that study has even been completed?
10 A. I do not know.
11 Q. In the obesity studies that
12 are ongoing -- am I correct that those studies
13 are ongoing?
14 A. I believe that there are some
15 ongoing.
16 Q. Do you recall how many ongoing
17 obesity studies there are?
18 A. No, I do not know that.
19 Q. Are all of those studies that
20 are ongoing in connection with obesity,
21 evaluating safety aspects of Fluoxetine in those
22 patients?
23 A. Yes, I believe they are.
24 Q. And how are those studies
Page 104
1 divided in connection with are there more than
2 one, are there several, are there several?
3 A. I really don't know how many
4 there are. My feeling is there's maybe more than
5 one.
6 Q. Are these multi-center or
7 single-center studies?
8 A. I do not know that.
9 Q. Do you know who the clinical
10 research assistant is that's in charge of those
11 ongoing obesity studies?
12 MR. MYERS: Assistant?
13 MR. SMITH: Administrator, I'm sorry.
14 A. The answer to your question is
15 no, I do not.
16 Q. How about depression, those
17 ongoing depression studies, do you know who the
18 clinical research administrator is who is
19 overseeing those studies?
20 A. The three that we discussed?
21 Q. Yes.
22 A. Long-term, the CRA's name is
23 Kevin Marks.
24 Q. Kevin Marks?
Page 105
1 A. Uh-huh. And I don't associate
2 any CRA with the cancer one in my mind, and I
3 don't remember the geriatric CRA.
4 Q. Do you recall any of the CRAs
5 working on obesity?
6 A. I think Bob Hunt may currently
7 be working on obesity, he isn't necessarily
8 involved with the ongoing studies.
9 Q. How about OCD, do you know who
10 the clinical research administrator is or was in
11 connection with those studies?
12 A. Was, I do not, I don't know
13 whether there is any.
14 Q. Has Fluoxetine been approved
15 for treatment of obsessive compulsive patients in
16 the United States?
17 A. No.
18 Q. Has Lilly received an
19 approvable letter from the Food and Drug
20 Administration in connection with the OCD/NDA?
21 MR. MYERS: You can tell him.
22 A. Yes.
23 Q. And when was that?
24 MR. MYERS: You can tell him that.
Page 106
1 A. It's dated November 2, 1993.
2 Q. Is Prozac currently approved --
3 or not Prozac, but Fluoxetine Hydrochloride
4 currently approved in the treatment of obsessive
5 compulsive disorders in any other countries?
6 A. Yes.
7 Q. Which countries?
8 A. I cannot name them.
9 Q. Can you name any?
10 A. I would be guessing. I
11 believe that the number is either eight or nine.
12 Q. Are you aware of any adverse
13 events in connection with patients in other
14 countries taking Fluoxetine for obsessive
15 compulsive disorders in which it's been reported
16 that those patients have experienced suicidal
17 ideation, attempted suicide or completed suicide
18 while taking that medication?
19 A. I'm not aware of that.
20 Q. And I'm not confining my
21 question to patients who are participating in
22 studies, but any spontaneous international events
23 that might have occurred in connection with
24 patients treating for OCD with Fluoxetine?
Page 107
1 A. I understand.
2 Q. And your answer is?
3 A. I have not heard of that.
4 Q. Who currently is in charge of
5 collecting adverse events in connection with
6 Fluoxetine at this time?
7 A. You mean spontaneous?
8 Q. Yes.
9 A. The drug epidemiology unit.
10 Q. Who in the drug epidemiology
11 unit is heading up the adverse events in
12 connection with Prozac or Fluoxetine?
13 A. I'm not sure there's anyone
14 heading it up. Over time there have been
15 different individuals sharing responsibility, and
16 it changes almost faster than I can meet them.
17 The only name that I'm certain that I can recall
18 at this juncture is Phyllis Donahue.
19 Q. Is she currently in that
20 capacity in the DEU?
21 A. Yes.
22 Q. And she's working on Prozac
23 spontaneous adverse events?
24 A. Yes.
Page 108
1 Q. Prozac has currently been
2 approved for treatment in depression in the
3 United States; correct?
4 A. Yes.
5 Q. Has it been approved for
6 treatment in depression at a ten milligram
7 dosage?
8 A. Well, the reason I'm stopping
9 is because of the substance of your question.
10 There is a ten milligram dose that has been
11 approved in the package insert.
12 Q. All right.
13 A. It's there, okay. That means
14 that we can sell a ten milligram dose. We've
15 done the correct data for that, manufacturing
16 control data.
17 Q. Is Lilly currently
18 manufacturing Prozac in pulvules at ten milligram
19 dosage?
20 A. Yes.
21 Q. Where?
22 MR. MYERS: Wait a minute.
23 Q. Where is the manufacturing
24 facility located?
Page 109
1 MR. MYERS: He's not going to answer
2 that. We're not going to tell you where we
3 manufacture certain dosages. If you want to know --
4 he's told you it's manufactured. Maybe if you
5 ask a little different question, but we're not
6 going to disclose where we manufacture certain
7 dosages.
8 Q. Is the ten milligram dosage
9 that's being manufactured at the same location as
10 the twenty milligram dosage?
11 A. I do not know that.
12 Q. Is ten milligram dosage, as
13 far as you know, currently in stock in the
14 marketplace?
15 A. I do believe it is.
16 Q. In other words, the physician
17 could write me a prescription for Prozac ten
18 milligrams?
19 A. I think so.
20 Q. Are you aware that Prozac is
21 now being dispensed by physicians in this country
22 at ten milligram dosages?
23 A. I'm not aware, but I believe
24 that may be true.
Page 110
1 Q. And is that ten milligram
2 dosage being used in the treatment of depression
3 by these physicians, as far as you know?
4 A. As far as I understand.
5 (PLAINTIFFS' EXHIBIT NO. 1 WAS
6 MARKED FOR IDENTIFICATION AND
7 RECEIVED IN EVIDENCE.)
8 MR. MYERS: Is this supposed to be
9 attached?
10 (DISCUSSION OFF THE RECORD.)
11 Q. Doctor Webber, I've handed you
12 a document marked Plaintiffs' Exhibit 1, and I'll
13 ask you if you can identify that document?
14 A. I've never seen it before, but
15 by reading it, I can surmise what it may be.
16 Does it say on the outside what it is? Well,
17 then, I can guess what it is, but I don't ever
18 remember paying attention to it because I don't
19 deal with chemistry manufacture control issues, I
20 hand them over to the people that do. Now I
21 would say it may be something that a reviewing
22 chemist at the FDA named Restorsky must have
23 given to Paul David to fax to me so that we can
24 answer chemistry manufacturing control questions.
Page 111
1 So, like I said, as soon as I get these, I give
2 them to the group at Lilly who is supposed to
3 answer this.
4 Q. My question is simply -- look
5 at all pages of the document.
6 A. I have.
7 Q. Start with page one, start --
8 turn to page one.
9 A. Okay.
10 Q. Can you identify what page one
11 of Webber Exhibit 1 is?
12 A. Yes, it looks like a cover
13 memo of a fax.
14 Q. And it's from the Food and
15 Drug Administration, is it not?
16 A. Yes, it is.
17 Q. It's addressed to you?
18 A. Uh-huh.
19 MR. MYERS: Yes, you need to say yes.
20 A. Yes.
21 Q. It says Al Webber, Ph.D, Eli
22 Lilly, does it not?
23 A. Yes.
24 Q. And it says under that, drug
Page 112
1 regulatory -- what's that next word?
2 A. Probably affairs.
3 Q. All right. Could somebody
4 classify you as being in drug regulatory affairs
5 at Eli Lilly and Company?
6 A. I suppose they could.
7 Q. Have you ever heard of your
8 organization or your division being known as drug
9 regulatory affairs affiliate?
10 A. No, I have not.
11 Q. It's from Paul David, CSO?
12 A. Yes.
13 Q. Who is Paul David?
14 A. He's the civil safety officer
15 for Prozac.
16 Q. Is it his exclusive duty at
17 this time to be that individual at the Food and
18 Drug Administration who is responsible for
19 consumer safety in connection with Prozac, as far
20 as you understand?
21 A. I think that's just a title,
22 and so if you take that literally, I would say I
23 don't think that's what his responsibilities are.
24 Q. So he's not a consumer safety
Page 113
1 officer in fact?
2 A. In the literal standpoint,
3 that's his title.
4 Q. But he doesn't act as a
5 consumer safety officer?
6 A. No, I don't think so.
7 Q. Do you know of anybody that
8 does act as a consumer safety officer in
9 connection with Fluoxetine --
10 A. No.
11 Q. -- at the Food and Drug
12 Administration?
13 A. No, I do not.
14 Q. There's five pages that have
15 been faxed to you, and under that there's a
16 message; correct?
17 A. Uh-huh.
18 MR. MYERS: Yes.
19 A. Yes, sorry.
20 Q. Can you read what that message
21 says?
22 A. Yes. Has discussed earlier
23 this morning, attached is the -- it probably says
24 C and M deficiencies -- looks like it says as
Page 114
1 well, at bio -- probably means bio pharm request --
2 for -- and this is NDA, eighteen nine three six.
3 Q. Is that NDA number, eighteen
4 nine three six, is that the Prozac NDA number?
5 A. Yes.
6 Q. Is that the Prozac twenty
7 milligram or Prozac ten milligram NDA number?
8 A. Both.
9 Q. Okay. It says as discussed
10 earlier this morning. Now this is 1-15-92. Do
11 you recall that discussion that you had with
12 Mister David?
13 A. No.
14 Q. Do you have frequent
15 conversations with Mister David at the Food and
16 Drug Administration?
17 A. Yes.
18 Q. Once a day?
19 A. That's too often for the pace.
20 Q. Once every other day?
21 A. That's probably too often too.
22 Q. Twice a week?
23 A. No, that's too often.
24 Q. Once a week?
Page 115
1 A. Averaged over time, possibly.
2 Q. Since you've been working on
3 Fluoxetine?
4 A. Possibly.
5 Q. Is he the individual that if
6 you need some information from the Food and Drug
7 Administration that you normally initiated
8 contact with?
9 A. Could you rephrase that,
10 please?
11 Q. Is Mister David, Mister Paul
12 David, the individual that you usually initiate
13 contact with when you want to get some
14 information from the Food and Drug Administration
15 in connection with your work on Fluoxetine?
16 A. He's the individual that I
17 would call to ask questions of.
18 Q. In other words, you wouldn't
19 call Doctor Kesler?
20 A. No, I would not.
21 Q. You wouldn't call Doctor
22 Leber?
23 A. No.
24 Q. You wouldn't call Doctor
Page 116
1 Temple?
2 A. No.
3 Q. Probably you would be calling
4 Paul David for an ordinary regular day-to-day
5 question.
6 A. Yes.
7 Q. Would you be the individual
8 that Mister David would normally call at Lilly
9 when he needed day-to-day regulatory information
10 from Lilly?
11 A. Yes.
12 Q. All right. It says -- but you
13 don't recall that discussion that you had on
14 January 15, 1992?
15 A. No, I do not.
16 Q. It says as discussed earlier
17 this morning, attached is the C and M deficiency.
18 What is a C and M deficiency?
19 A. It probably stands for
20 chemistry and manufacturing.
21 Q. Now, is this a check, a C and
22 M analysis, is this something that the Food and
23 Drug Administration does of Lilly manufacturing
24 plants?
Page 117
1 A. Well, not of the plant
2 necessarily, but I mean -- could you ask me
3 another question so I can try to help you?
4 Q. I'm not familiar with this, I
5 don't know what a C and M deficiency is, myself.
6 I mean I can read this attachment, and it appears
7 to me that there's some problems with respect to
8 the ten milligram dosage of the capsule that's
9 being made, in some respect, or that they have
10 some questions or wanting some further analysis
11 in connection with that capsule; correct?
12 A. I don't believe this reflected
13 the manufacturing of it because I don't know
14 whether it was approved at this point.
15 Q. Well --
16 A. So I think --
17 Q. Ten milligram dosage is being
18 manufactured.
19 A. Now?
20 Q. Now. Correct?
21 A. I believe so.
22 Q. When was it approved?
23 A. I do not know the date of
24 that.
Page 118
1 Q. Was it approved before or
2 after January 15, 1992?
3 A. I do not know the date of
4 approval.
5 Q. Well, read the attachment,
6 then, and see if you can discuss with me what it
7 was that they were -- that the Food and Drug
8 Administration was complaining about in
9 connection with the ten milligram capsule.
10 A. You need to understand that I
11 don't deal with chemistry issues in communicating
12 with the FDA.
13 Q. My understanding is you deal
14 with regulatory issues.
15 A. Fair.
16 Q. You don't deal with chemistry
17 issues now, but you did for twenty-two years at
18 Lilly, didn't you?
19 A. I dealt with antibiotic
20 chemistry.
21 Q. You have a Ph.D in chemistry;
22 correct?
23 A. Yes.
24 Q. And you were a research
Page 119
1 chemist, a chemist, and a chemist associate at
2 Lilly over your twenty-two years, right?
3 A. Right.
4 Q. All right.
5 MR. MYERS: Read through the memo,
6 Doctor Webber, and see if you can answer Mister
7 Smith's questions. Take your time and read it.
8 Q. Before we get started here,
9 before you read that, you're not going to tell me
10 that you're ignorant of chemistry when you're
11 fixing to read this attachment, are you?
12 A. What I'm saying is it's not my
13 responsibility to answer these questions, I hand
14 them over to the people that were responsible.
15 Q. It's your responsibility, as I
16 understand it, to ensure that what Lilly's doing
17 complies with federal regulations, isn't it?
18 A. No, it's not.
19 Q. Or to pass on requests from
20 the Food and Drug Administration concerning
21 particular federal regulations in connection with
22 the manufacture of Prozac.
23 A. That's correct.
24 Q. Is that just a clerical job?
Page 120
1 A. In some ways, it is.
2 Q. I mean does it take a Ph.D in
3 chemistry to be able to do the job that you do,
4 Doctor Webber?
5 A. Not in chemistry.
6 Q. Does it take a Ph.D in
7 anything?
8 A. Quite possibly.
9 Q. What?
10 MR. MYERS: What, what subject matter?
11 MR. SMITH: Yes.
12 A. I don't think it makes any
13 difference what the subject matter is.
14 Q. In one way you tell me that
15 your work is a clerical job, and that you don't
16 have any responsibility for seeing that any of
17 these regulations is complied with. So it makes
18 me wonder what you're doing in the position that
19 you hold, what is it that you do that you put
20 your Ph.D in chemistry to work at?
21 A. I do not apply my Ph.D in
22 chemistry.
23 Q. What do you apply your
24 experience in?
Page 121
1 A. The scientific process.
2 Q. What scientific issues are
3 presented to you as the regulatory person or
4 regulatory scientist at Eli Lilly and Company in
5 connection with Prozac?
6 A. Relatively few with Prozac.
7 Q. Which ones?
8 A. Any document that might need
9 to go to the FDA, a scientist will say to me here
10 is what you should say to the FDA. If, as a
11 scientist, I don't understand what they've told
12 me, then I'm not going to do as good a job of
13 passing it on.
14 Q. But you said all you're doing
15 is passing something on that's handed to you from
16 the scientists that needs to be sent to the Food
17 and Drug Administration, is that right?
18 A. Uh-huh.
19 Q. That's just a clerical job,
20 isn't it?
21 A. Yes.
22 Q. You're not doing -- from what
23 I understand, you're not doing anything to ensure
24 that what you're passing on to the Food and Drug
Page 122
1 Administration is accurate; correct?
2 A. That's correct.
3 Q. You're not doing anything, as
4 far as I can tell from what you're telling me,
5 that what you're passing on to the Food and Drug
6 Administration is based on good science even.
7 A. That's correct.
8 Q. You're not using your
9 chemistry background at all in connection with
10 Prozac.
11 A. That's correct.
12 Q. In dealing with the Food and
13 Drug Administration.
14 A. That's correct.
15 Q. So is there anything that
16 you're doing as the regulatory scientist at Eli
17 Lilly and Company in connection with Prozac that
18 is anything other than work of a clerical nature?
19 A. No.
20 Q. Now, can you give us some help
21 in your education as a chemist, and your
22 experience as a chemist as to what the deficiency
23 is as it appears to you in connection with this
24 analysis that we've made -- well, it looks like
Page 123
1 the analysis we've made back in July, 1991.
2 A. You need to understand that
3 there are people who are experts in all of these
4 issues, and I'm not. And generally this is not
5 the kind of chemistry that's my training, this is
6 formulation chemistry, and I'm an organic
7 chemist.
8 MR. MYERS: Go ahead and read the
9 document, Doctor Webber, and give Mister Smith
10 your best appreciation. And while he's reading
11 the document, let me say this: I've looked at
12 that, and I simply cannot tell from a quick
13 review, but that may have to do and may summarize
14 some materials that have to do with the subject
15 of the manufacture of the product which has been
16 exempted from discovery, that may be an
17 inadvertent disclosure of a manufacturing
18 process, notwithstanding the communication from
19 the FDA in summary form, and I'm not waiving any
20 provisions under the protective order with
21 respect to manufacturing.
22 MR. SMITH: That's fine. I don't see
23 an FD number, I don't know whether it came from
24 the FDA or --
Page 124
1 MR. MYERS: And I'm saying from a
2 quick review, and the words manufacturing
3 appearing in some review that I quickly made of
4 the document, it may have to do, at least in
5 part, with the manufacturing process which has
6 been exempted from discovery. It may thus
7 constitute some limited inadvertent disclosure.
8 I'm simply not waiving anything.
9 MR. SMITH: That's fine. I'm not
10 claiming that you're waiving anything.
11 MR. MYERS: All right. And to the
12 extent that the -- well, I'll let the witness
13 tell you what his appreciation is of what they're
14 trying to communicate to him. To the extent the
15 document discloses, for example, how the product
16 may be made, I'm not going to let him testify
17 about that. But let's just see how we go.
18 A. I have looked at it again.
19 Would you, within this context, care to ask me a
20 specific question?
21 Q. Sure. Can you tell from your
22 reading of that document whether or not there is
23 Prozac at the time either the document was sent
24 or at the time the document was dated? I believe
Page 125
1 it's dated July 30, '91, and it was sent to you
2 January of '92, approximately six months later.
3 Can you tell whether or not Prozac at ten
4 milligrams is being manufactured at a plant?
5 A. I don't believe it had been
6 approved as of this faxing.
7 Q. I understand it hadn't been
8 approved, but obviously Prozac at ten milligram
9 prior to approval has got to be made up
10 somewhere, doesn't it?
11 A. Yes.
12 Q. Does it appear to you from
13 reading this that they were making up ten
14 milligram dosages?
15 A. Yes, because I think you have
16 to. I can see represented -- it mentions
17 representative lots here, I believe, yes, the
18 first three production lots manufactured. It
19 says right there.
20 Q. If you look down at the bottom
21 of the page -- well, it's under paragraph three,
22 specifications and methods for drug product. Do
23 you see that?
24 A. Yes.
Page 126
1 Q. It's talking about a dosage
2 unit test that has to do -- has to do with
3 capsules that contain fifty milligrams or more of
4 active ingredients. Does that mean that there
5 was some manufacturer or that there was some
6 capsules or tablets or pulvules being made up of
7 Prozac that contained more than fifty milligrams
8 of active ingredients?
9 A. Not that I'm aware.
10 Q. I know you may not be aware of
11 it, but would that be the inference from looking
12 at this, that they were --
13 A. No.
14 MR. MYERS: Wait a minute. Let me
15 object to the form of the question. You asked
16 him to draw an inference from a document that he
17 didn't write, and you're asking him to interpret
18 what the author meant, and that would be
19 speculatory and I object to the form.
20 MS. ZETTLER: I don't think he
21 finished the question when you interrupted him,
22 Larry.
23 MR. MYERS: He either finished the
24 question or took another bite of his cookie. He
Page 127
1 stopped talking and I interpreted that to mean
2 the question was over with.
3 Q. Can you tell from your reading
4 and your experience as a chemist for twenty-two
5 years at Eli Lilly and Company, and being the
6 regulatory scientist responsible for Prozac since
7 1988, whether or not that document indicates that
8 Prozac may have been made up in fifty milligram
9 dosages?
10 A. I cannot tell that from this.
11 Q. You see, though, where my
12 question arises is talking about the revised
13 section for UNIFORMITY OF DOSAGE UNITS, USP XXII,
14 Supplement 5 Section 905, Page 2721, provides
15 instructions for this determination by the Weight
16 Variation Test for capsules that contain 50
17 milligram or more active ingredients, and also by
18 averaging the Content Uniformity results of 10
19 capsules. Why would they be talking about
20 determining weight of fifty milligrams of
21 capsules that contain fifty milligrams or more
22 unless there was being some Prozac being made up
23 in excess of fifty milligrams or in excess
24 thereof?
Page 128
1 MR. MYERS: Same objection. If you
2 know, tell him.
3 A. I have no idea.
4 Q. Are you aware of any instance
5 in which Prozac was manufactured in a dosage ever
6 in excess of twenty milligrams?
7 A. Fluoxetine Hydrochloride has
8 been put into capsules, clinical trial capsules
9 of sixty milligrams.
10 Q. Has it been made up in higher
11 dosages that you're aware than sixty milligrams?
12 A. I do not believe it has been.
13 Q. Did you say it was November of
14 '93 -- no, it was November of '93 when you got
15 the approvable letter on OCD, is that right?
16 A. That's correct.
17 Q. And you think it's been this
18 year since Prozac at ten milligrams has been
19 available for the general physician to, say,
20 prescribe it?
21 A. I don't remember you asking me
22 that question.
23 Q. Okay. How long has Prozac
24 been available for physicians prescribing ten
Page 129
1 milligram dosages in the ten milligram form?
2 A. Approximately since approval,
3 whenever that was.
4 Q. When was it approved?
5 A. I do not know.
6 Q. Has it been -- was it in 1993,
7 1992, 1991, when?
8 A. I don't think it was before
9 '91, I do not remember the exact month.
10 Q. Was it approved in the ten
11 milligram dosage when you were the regulatory
12 scientist in charge of it?
13 A. Yes.
14 Q. Do you have any work to do in
15 connection with securing that approval?
16 A. Yes.
17 Q. But it's your testimony that
18 you don't know when the approval was granted?
19 A. I do not recall the exact
20 month.
21 Q. I'm not talking about the
22 exact month, I want a year, even, can give me
23 that?
24 A. I cannot give you the year for
Page 130
1 sure.
2 Q. Can you give me the year
3 approximately?
4 A. It was probably '92 or '93.
5 Q. Did you have anything to do
6 with submitting the application to manufacture
7 Prozac in a ten milligram form?
8 A. Yes.
9 Q. When was the application sent
10 to the Food and Drug Administration?
11 A. I believe -- well, can I see
12 that?
13 Q. Sure.
14 A. I believe that's the date,
15 right there, July 30th, 1991, but I don't recall
16 it. I think that's --
17 Q. Look at Exhibit 1 again. On
18 page two there's the number S dash oh two six,
19 semicolon, dated July 30th, '91, is that right?
20 A. Yes.
21 Q. Is S dash oh two six the
22 application number for Prozac in ten milligrams?
23 A. It's the supplement number.
24 Q. S, then, stands for
Page 131
1 supplement?
2 A. Yes.
3 Q. And it's a supplement NDA to
4 the original NDA on Prozac?
5 A. Yes.
6 Q. What were the reasons that
7 Lilly began manufacturing Prozac in a ten
8 milligram form?
9 A. I don't know.
10 Q. Who would know that?
11 A. I'm not sure.
12 Q. Do you have any idea?
13 A. No.
14 Q. As chief regulatory scientist
15 at Lilly in connection with Fluoxetine --
16 MR. MYERS: I object to the form.
17 MR. SMITH: Let me finish my question.
18 MR. MYERS: All right, go ahead.
19 Q. Who would have been the
20 individual to make that decision?
21 MR. MYERS: I object to the form only
22 to the extent you have changed his title, and
23 maybe elevated him, I don't know.
24 Q. The regulatory scientist in
Page 132
1 charge of Fluoxetine.
2 A. I don't know.
3 Q. Who signed the supplemental
4 NDA?
5 A. To the extent that it has a
6 signature, Doctor Talbott.
7 Q. Were there any studies done to
8 support this supplemental NDA on Prozac in ten
9 milligrams?
10 MR. MYERS: When you say studies, you
11 mean clinical studies?
12 MR. SMITH: Clinical trials.
13 MR. MYERS: Trials.
14 A. There was a bioequivalent
15 study.
16 Q. Bioequivalent study. When was
17 that study begun and completed?
18 A. I do not know.
19 Q. Did that bioequivalent study
20 involve human beings?
21 A. Yes.
22 Q. How many?
23 A. I do not know.
24 Q. Who was the clinical research
Page 133
1 administrator in charge of that bioequivalent
2 study?
3 A. I do not know.
4 Q. This information would have
5 all been contained in the application, would it
6 not?
7 A. Which information?
8 Q. The last five or six questions
9 I asked you about, particulars on the study,
10 number of patients involved --
11 A. Yes.
12 Q. -- name of the CRA involved.
13 A. I don't think so.
14 Q. Okay. Do you remember having
15 any -- doing any work in connection with the
16 application to market Prozac in ten milligrams?
17 A. Yes.
18 Q. What is your first
19 recollection of the first work you did in that
20 connection as a regulatory scientist in charge of
21 Fluoxetine?
22 A. I guess the first thing I
23 remember was thinking about what pieces there
24 would be to put together for that submission,
Page 134
1 pieces of information.
2 Q. Well, had the Food and Drug
3 Administration requested that Lilly do this?
4 A. Not that I recall.
5 Q. And when I say do this, I mean
6 manufacture Prozac at a ten milligram dose.
7 A. I don't recall.
8 Q. Who would recall that
9 information?
10 A. I have no idea who would
11 recall it.
12 Q. Well, then, whose idea at
13 Lilly was it that this drug be manufactured in a
14 ten milligram dosage?
15 A. I don't know whose idea it
16 was.
17 Q. Who would know?
18 A. I don't know who would know.
19 Q. As the regulatory scientist
20 involved in the submission of the ten milligram
21 NDA, did you do anything other than clerical
22 work?
23 A. No.
24 Q. Were you ever asked as a
Page 135
1 regulatory scientist in charge of Fluoxetine and
2 Prozac as to whether or not it would be
3 advantageous from a public safety standpoint that
4 Lilly manufacture Prozac at a ten milligram
5 dosage?
6 A. No.
7 Q. Anything else submitted other
8 than the bioequivalent study?
9 A. Could you ask it more
10 specific?
11 Q. Submitted with the application
12 S dash oh two six for Prozac in ten milligram
13 half strength form?
14 A. Yes.
15 Q. What else?
16 A. There was a draft labeling,
17 and the manufacturing and control information,
18 that's chemistry.
19 Q. Would the manufacturing and
20 control information be information concerning how
21 the product is manufactured, where it's
22 manufactured, the exact chemical mix of the ten
23 milligram form?
24 A. Yes.
Page 136
1 Q. Is the package insert at ten
2 milligram Prozac any different than the package
3 insert for twenty milligram Prozac?
4 A. Essentially, no.
5 Q. Anything else done in
6 connection with application S dash oh two six,
7 the supplementary NDA on Prozac at ten
8 milligrams?
9 A. I don't recall it containing
10 any other pieces of information.
11 Q. Is it called Prozac, this ten
12 milligram version, is it called Prozac --
13 A. I think so.
14 Q. -- or is it called something
15 else?
16 A. I think it's called Prozac.
17 Q. Any of the approved usage for
18 indication depression?
19 A. Could you ask that question
20 again?
21 Q. Has the Food and Drug
22 Administration approved Prozac at ten milligrams
23 for depression?
24 A. Yes.
Page 137
1 Q. Have they approved it for any
2 other indications, like obsessive compulsive
3 disorder, bulimia, obesity?
4 A. No.
5 Q. Okay. So Eli Lilly and
6 Company then is now manufacturing Prozac at half
7 the strength they were originally manufacturing
8 it; correct?
9 A. They're manufacturing it at
10 ten milligrams.
11 Q. Which is half the strength
12 that they were originally manufacturing it,
13 aren't they?
14 A. Yes.
15 Q. Isn't it, is the better
16 question, right?
17 A. Yes.
18 Q. And Prozac at ten milligrams,
19 like Prozac at twenty milligrams, is approved for
20 use in treatment of depression; correct?
21 A. I believe that's correct.
22 Q. What does the dosage section
23 say of the product information literature in
24 connection with the dosage to be used with
Page 138
1 respect to Prozac twenty versus Prozac ten?
2 A. I can't recite that to you.
3 Q. Essentially the same?
4 A. I can't tell you what it says.
5 Q. Are you aware -- are you a
6 biochemist?
7 A. No, I'm not.
8 Q. You're a chemist?
9 A. I'm an organic chemist.
10 Q. Are you aware, as an organic
11 chemist, of the term nonlinear as it's applied to
12 organic chemistry?
13 A. No.
14 Q. You've never heard of it?
15 A. It's not something that's used
16 in organic chemistry.
17 Q. Are you aware, as a person
18 schooled in chemistry, in any degree, concerning
19 nonlinear increases in propensities of compounds?
20 A. I do believe I can comprehend
21 the word.
22 Q. What is your understanding of
23 what that is, the meaning of nonlinear?
24 A. It's nonlinear, I mean it's
Page 139
1 kind of intuitive from a scientific standpoint.
2 Q. Linear means what?
3 A. Straight line.
4 Q. So it doesn't increase on a
5 regular basis?
6 A. I would just say it's not a
7 straight line.
8 Q. All right. Do you know
9 whether or not the package labeling information
10 in connection with Fluoxetine ten milligrams
11 contains the same language with respect to
12 suicide as the Fluoxetine, Prozac labeling at
13 Prozac twenty milligrams?
14 A. You're asking me about the
15 label?
16 Q. Yes.
17 A. I believe it's the same, it
18 does say the same thing.
19 Q. Anything else submitted in
20 connection with S dash oh two six, the ten
21 milligram NDA?
22 A. Not that I can recall.
23 Q. And that's a supplementary
24 NDA?
Page 140
1 A. It's a supplement to the NDA.
2 Q. But you're not aware of any
3 new clinical trials that were done specifically
4 to examine the efficacy and safety of Prozac at
5 ten milligrams other than those that were done in
6 connection with the original NDA for Prozac at
7 twenty milligrams?
8 A. I'm not aware of any.
9 Q. Do you know why Prozac is
10 manufactured half strength, ten milligrams, now?
11 A. No.
12 Q. Who would know?
13 A. I don't know.
14 Q. Do you have any opinion in
15 connection with why it's now being manufactured
16 and marketed at half strength levels?
17 A. No.
18 (DISCUSSION OFF THE RECORD.)
19 (PLAINTIFFS' EXHIBIT NO. 2 WAS
20 MARKED FOR IDENTIFICATION AND
21 RECEIVED IN EVIDENCE.).
22 Q. Doctor Webber, have you had an
23 opportunity to review the document marked Webber
24 Exhibit 2 in front of you?
Page 141
1 A. Yes.
2 Q. And is that a two-page
3 memorandum that is dictated under your name in
4 connection with this May, 1991 meeting with the
5 Food and Drug Administration that we discussed
6 very briefly earlier?
7 A. Yes.
8 Q. And you were present for the
9 Monday, May 13, 1991 meeting with the Food and
10 Drug Administration to discuss studying
11 suicidality?
12 A. Yes.
13 Q. Is that right?
14 A. Yes.
15 Q. It says that the -- that you
16 met with the FDA to discuss draft protocols for
17 studying suicidality, does it not?
18 A. It says that.
19 Q. And then you list the
20 attendees, is that right?
21 A. Yes.
22 Q. Let's identify who the
23 attendees are that you mentioned in your memo.
24 Doctor Beasley, is that right, Charles Beasley?
Page 142
1 A. Yes.
2 Q. Charles Beasley's position at
3 that time was what?
4 A. Psychiatrist.
5 Q. What was his function and what
6 was his title in connection with Prozac?
7 A. I don't know what his title
8 was. He was -- at one time he was a physician
9 monitor for Prozac, I believe.
10 Q. Greg Enas, E-N-A-S?
11 A. He's a statistician.
12 Q. Ph.D?
13 A. Yes.
14 Q. James Kotsanos?
15 A. He's a physician.
16 Q. What was his capacity in
17 connection with Prozac?
18 A. He's -- I think he was
19 operating as a pharmacoepidemiologist.
20 Q. Was he in the drug
21 epidemiology unit at the time?
22 A. No.
23 Q. What was he doing at the time?
24 A. He was in the same division
Page 143
1 that Doctor Beasley was in.
2 Q. Which was?
3 A. I don't know what the name of
4 it was, it was a division that studied
5 psychopharmacology drugs.
6 Q. Ivan Miller, and it's got a
7 paren out there, Brown University, close paren;
8 correct?
9 A. That's what it says.
10 Q. Who is Ivan Miller?
11 A. He's a professor at Brown
12 University, I think.
13 Q. What, did Doctor Miller go out
14 there with you?
15 A. Either that or he met us
16 there.
17 Q. Which was it?
18 A. I don't remember.
19 Q. Where is Brown University?
20 MR. MYERS: Providence.
21 MR. SMITH: Providence, Rhode Island.
22 Q. Do you remember swinging by
23 Providence and picking him up or do you remember
24 him being at the airport here when you left?
Page 144
1 A. I don't remember, but I
2 suspect he met us there.
3 Q. You list him as a
4 representative of Eli Lilly and Company, though,
5 don't you, under -- in your memo?
6 A. And I point out that he's at
7 Brown University also.
8 Q. But he's listed under there
9 for Eli Lilly and Company, isn't he?
10 A. Yes.
11 Q. And Gary Tollefson, who is
12 Gary Tollefson?
13 A. Gary Tollefson is a
14 psychiatrist.
15 Q. Al Webber is you.
16 A. Yes.
17 Q. What is your full name?
18 A. John Allen Webber.
19 Q. David Wheadon, who is David
20 Wheadon?
21 A. He's a psychiatrist.
22 Q. With Lilly?
23 A. He does not work for Lilly
24 now.
Page 145
1 Q. He did then?
2 A. Yes.
3 Q. Where is Doctor Wheadon now?
4 A. Smith-Kline Beacham.
5 Q. And where are they?
6 A. Beacham.
7 Q. That's another drug company,
8 isn't it?
9 A. Yes, it is.
10 Q. And they're where, outside of
11 Boston?
12 A. No.
13 Q. Where?
14 A. I think they're near
15 Philadelphia.
16 Q. And Bob Zerbe?
17 A. He's a physician.
18 Q. What was Bob Zerbe's position
19 in connection with Prozac or in Lilly Research
20 Labs?
21 A. In this meeting, he was the
22 highest ranking physician in that group.
23 Q. Beg your pardon?
24 A. He was the highest ranking
Page 146
1 physician in this group that attended this
2 meeting.
3 Q. So this group from Lilly is
4 listed in alphabetical order, not in order of
5 seniority?
6 A. Yes.
7 Q. What was Doctor Zerbe's title
8 at the time?
9 A. I'm not certain what his title
10 is, was.
11 Q. The individuals from the Food
12 and Drug Administration were listed, Charles -- I
13 can't read that --
14 A. Annello.
15 Q. Annello, A-N-N-E-L-L-O, right?
16 A. Yes.
17 Q. What was his position with the
18 FDA?
19 A. I'm not certain what his
20 position is. He's a physician, I believe, but
21 I'm not certain what his position is.
22 Q. Martin Brecher?
23 A. Brecher.
24 Q. Brecher?
Page 147
1 A. He was the medical reviewing
2 officer for Prozac.
3 Q. Medical reviewing officer.
4 Now what's that, as far as you know?
5 A. Essentially a physician in
6 charge of Prozac in Doctor Leber's division.
7 Q. Was he senior or junior to
8 Doctor Leber?
9 A. Junior.
10 Q. Paul David?
11 A. He was a CSO.
12 Q. Is Paul David a medical
13 doctor?
14 A. No.
15 Q. I believe you said he was a
16 Ph.D?
17 A. No, I did not.
18 Q. You don't know or do you know?
19 A. I don't believe he's a doctor
20 of any kind.
21 Q. David Graham?
22 A. I don't know who David Graham
23 is.
24 Q. Do you remember him being
Page 148
1 there?
2 A. No, I don't.
3 Q. We've already discussed Tom
4 Laughren and Paul Leber. Who is Jay Levine?
5 A. He's a statistician.
6 Q. Who is Bruce Stadel,
7 S-T-A-D-E-L?
8 A. I believe he's a physician.
9 Q. In neuropsychopharmacology?
10 A. No.
11 Q. In what?
12 A. Some other part of the FDA.
13 It may be a group that collects the first events,
14 adverse events, adverse event reporting.
15 Q. He might be a group -- from
16 that group reporting -- collecting 1639s?
17 A. That's one way of saying it.
18 Q. 1639s are reports of adverse
19 events, are they not?
20 A. Uh-huh.
21 Q. That are generated
22 spontaneously. Is that a yes?
23 A. Yes.
24 Q. Do you remember what input
Page 149
1 Doctor Stadel had in connection with this
2 meeting?
3 A. No, I don't, but it quotes him
4 over on the second page, I did notice that.
5 Q. But Stadel was the individual
6 at the FDA who was most particularly involved
7 with the adverse reaction end of Prozac, is that
8 right?
9 A. Well, you said most, and I
10 couldn't agree with that. He was involved in
11 that department that would be receiving those
12 reports.
13 Q. He was represented -- the
14 representative from that department?
15 A. That's fair, yes.
16 Q. And the adverse events were
17 more in his bailiwick than, say, Doctor Leber or
18 Tom Laughren?
19 A. Well, I wouldn't want to
20 comment on relative importance to these
21 individuals.
22 Q. I understand that, and I'm not
23 asking you to do that. I'm asking you to give us
24 your impression, since you were the regulatory
Page 150
1 scientist from Lilly that was there, as to what
2 your recollection was of Mister Stadel's, Doctor
3 Stadel's function was at that meeting.
4 A. I do not recall his function
5 at the meeting.
6 Q. You recall him saying
7 something at the meeting?
8 A. I cannot remember him saying
9 anything.
10 Q. Well, you recorded something
11 he said?
12 A. That's what I remember at that
13 time, but I don't remember today.
14 Q. All right. What you
15 remembered at that time would be more accurate
16 than what you remember now, wouldn't it?
17 A. Probably.
18 Q. That's why, fortunately, you
19 wrote the memo; correct?
20 A. That's correct.
21 Q. And Bob Temple?
22 A. We've discussed -- I don't
23 know his exact title, but he is Doctor Leber's
24 boss.
Page 151
1 Q. Do you know who Bob Temple was
2 reporting to?
3 A. No.
4 Q. Would the next level of
5 authority within the Food and Drug
6 Administration, as far as you know, have been the
7 assistant or associate deputy secretary of the
8 Food and Drug Administration?
9 A. I don't know the titles, I
10 know some names, but I don't know the titles.
11 Q. Who would be next up?
12 A. Again, I said I wasn't sure,
13 but it might be Carl Peck.
14 Q. And Carl Peck at that time was
15 what?
16 A. I don't know his title.
17 Q. Did you all fly out there that
18 morning, that Monday morning, or did you go down
19 the night before?
20 A. I believe we went down that
21 morning.
22 Q. Did you take Air Lilly?
23 A. We may have.
24 Q. Don't you remember when you
Page 152
1 get to fly on the company plane?
2 A. No.
3 Q. Doesn't make any difference to
4 you?
5 A. No, I prefer to fly on the
6 company plane.
7 Q. Do you recall flying on the
8 company plane on that occasion?
9 A. No, I do not.
10 Q. Did all of the Lilly people go
11 down there together as a group, other than the
12 possible exception of Doctor Ivan Miller?
13 A. No, I don't think so.
14 Q. Tell me how you happen to --
15 where everybody came from.
16 A. Well, we may have gone down as
17 a group, other than Tollefson.
18 Q. All right.
19 A. Because at that time Tollefson
20 didn't work for Eli Lilly.
21 Q. Where was Tollefson at that
22 time?
23 A. Minnesota.
24 Q. But you remember being on a
Page 153
1 plane with Doctor Zerbe, Doctor Wheadon, Doctor
2 Beasley, and --
3 A. I don't remember that.
4 Q. How come?
5 A. How come, did you say?
6 Q. Yes.
7 A. I don't remember.
8 Q. Have you made numerous trips
9 from Indianapolis to Washington, DC?
10 A. Yes.
11 Q. Approximately how many trips
12 have you made to Washington, DC since May, 1991?
13 A. In the vicinity of two dozen.
14 Q. Twenty-four?
15 A. Maybe more.
16 Q. All in connection with Prozac?
17 A. No.
18 Q. What other reasons have you
19 gone to Washington, DC? I'm talking about
20 company business, I'm not talking about anything
21 personal.
22 A. Other --
23 MR. MYERS: Other compounds?
24 A. Other drugs.
Page 154
1 Q. I thought you hadn't worked on
2 any other compounds since May, 1991?
3 A. That's not correct.
4 Q. That's not correct. Of the
5 twenty-four times since May, 1991, how many times
6 have you been down on Prozac to Washington versus
7 other compounds? I don't need to know the names
8 of any of the compounds, I just want Prozac
9 versus others.
10 A. I would just be guessing the
11 number.
12 Q. Give me a reasonable estimate.
13 A. It would be extremely
14 arbitrary.
15 Q. Would it be more for Prozac or
16 more for other compounds?
17 A. More for other compounds.
18 Q. Would it be one third for
19 Prozac?
20 A. That comparison number is just
21 a guess, not necessarily one third.
22 Q. All right. Maybe we can help
23 you this way: As I understand it, you went to
24 Washington in connection with the smoking
Page 155
1 cessation Prozac trip or Prozac studies on
2 smoking cessation before you went in May of 1991;
3 correct?
4 A. Yes.
5 Q. Then you went in May, 1991.
6 Was there any time in between there that you went
7 down on Prozac?
8 A. I don't remember it, but this
9 memo prompted me to think there may have been
10 one.
11 Q. What memo is that, what thing
12 in the memo?
13 MR. MYERS: Tell him.
14 A. Point A there is a typo, I
15 think.
16 Q. Two objectives apparently from
17 the September 25th, 1991 meeting?
18 A. It's not unlikely that the May
19 meeting talked about a September meeting that was
20 three months later.
21 Q. That's what was going to be my
22 next question. Has there been any indication
23 that Prozac is useful in predicting the future?
24 A. I don't think so.
Page 156
1 MS. ZETTLER: Only for a profit point
2 of view.
3 Q. You think that your reference
4 there to September 25, 1991, in seriousness, was
5 a simple typographical error, it should have been
6 September 25, 1990?
7 A. That's the way I feel.
8 Q. So we had the smoking
9 cessation trip, that's one, we had the September
10 1990 trip, that's two, we had the May, 1991 trip,
11 that's three. What was the next trip, what other
12 trips did you have in '91 in connection with
13 Prozac?
14 A. I went to the advisory
15 committee meeting.
16 Q. That was in September, 1991,
17 right?
18 A. Yes.
19 Q. Then what was the next trip
20 that you had?
21 A. The next one I remember was
22 the OCD advisory committee meeting.
23 Q. And help me, I have forgotten
24 when you said that was.
Page 157
1 A. I didn't say. I believe it
2 was in July of this year.
3 Q. Have you been, between
4 September, 1991 and July, 1993, to Washington on
5 Prozac?
6 A. I don't remember that I have.
7 Q. Well, that would indicate that
8 you'd been five times on Prozac?
9 A. I believe that's the way it
10 adds up.
11 Q. All right. The middle
12 paragraph there says at our opening introduction,
13 Charles Beasley showed several slides which
14 discussed the following points: A, two
15 objectives apparent from the September 25th --
16 and it says here 1991, but should mean 1990
17 meeting; correct?
18 A. That's what it says.
19 Q. What does that refer to?
20 A. I do not know.
21 Q. Why?
22 A. I don't remember.
23 Q. Why don't you know?
24 A. I don't remember.
Page 158
1 Q. Why don't you remember?
2 A. It's been a long time.
3 Q. Have you been to the FDA in
4 connection with Prozac and suicide on any other
5 occasions other than May, 1991 and September,
6 1991?
7 A. You mean in addition to the
8 advisory committee meeting?
9 Q. Yes, that's why I said
10 September, 1991.
11 A. Well, would you rephrase your
12 question because I'm not sure how many meetings
13 you mentioned.
14 Q. I'm just, frankly, a little
15 bit amazed, Doctor, that you would forget the
16 objectives apparent from the September 25, 1990
17 meeting, and I'm trying to search for a reason
18 that you would not have any recollection from
19 what the objectives were from the September, 1990
20 meeting. Can you give me any reasons?
21 A. No.
22 Q. You were there?
23 A. Yes.
24 Q. In September, 1990?
Page 159
1 A. Yes.
2 Q. Was the subject of that
3 meeting suicide and Prozac?
4 A. It may have been.
5 Q. Probably was, wasn't it?
6 A. Probably was, yes.
7 Q. You remember Doctor Beasley
8 showing slides in the May, 1991 meeting?
9 A. No.
10 Q. You don't remember anything
11 about him showing some slides?
12 A. No.
13 Q. Do you remember who was
14 present at the September, 1990 meeting?
15 A. I remember some people.
16 Q. Okay. Tell me who you
17 remember that was present in the September, 1990
18 meeting?
19 A. I remember Leigh Thompson.
20 Q. All right. Why wasn't Leigh
21 Thompson there at this May, 1991 meeting?
22 A. I don't know.
23 Q. Who else besides Leigh
24 Thompson was there from Lilly?
Page 160
1 A. Other than myself, I do not
2 remember.
3 Q. Would Beasley have been there?
4 A. I do not know whether he was
5 there.
6 Q. You don't remember him being
7 there?
8 A. I do not remember whether he
9 was there or not.
10 Q. So you can't help us at all in
11 point A of your May 15, 1991 memo in connection
12 with what the two objectives apparent from the
13 September 25, 1990 meeting were?
14 A. That's correct.
15 Q. Maybe only Leigh Thompson
16 could remember that.
17 A. I don't know.
18 Q. Who was present from the FDA
19 in September, 1990?
20 A. I remember Doctor Leber and
21 Doctor Temple being there.
22 Q. Do you remember -- look at
23 that list of the people that were there in May,
24 1991, and see if any of the members of that list
Page 161
1 were there in September of 1990.
2 A. I don't remember for sure who
3 was there.
4 Q. But you know Leber and Temple?
5 A. I remember them.
6 Q. Can you tell me one thing that
7 was discussed in that September, 1990 meeting
8 between Doctor Leber and Doctor Temple of the
9 Food and Drug Administration, and you and Doctor
10 Leigh Thompson from Lilly, do you remember one
11 thing that was said in that September, 1990
12 meeting?
13 A. No, I don't.
14 Q. Have you had a problem with
15 your memory, Doctor Webber?
16 A. No.
17 Q. Have you sought medical
18 attention for memory problems?
19 MR. MYERS: Paul, don't start to argue
20 with him.
21 MR. SMITH: I'm not.
22 Q. Please, I'm not trying to be
23 facetious in this line of questioning, it's a
24 legitimate line of questioning in my mind in
Page 162
1 connection with your recollection of these
2 events. Because you can't remember this, in
3 order to represent my client, I'm forced to ask
4 you, Doctor Webber, have you had treatment for --
5 medical treatment for memory problems?
6 A. No.
7 Q. Do you believe that your
8 memory is as good as it should be?
9 A. I don't know.
10 Q. Have you had other people
11 criticize your memory?
12 A. I'm sure the answer to that
13 must be yes.
14 Q. Have you felt that you've
15 forgotten things that you should have remembered
16 in the past?
17 A. Yes.
18 Q. Has this become worse in your
19 mind?
20 A. As I get older you mean?
21 Q. For any reason.
22 A. I'm sure it must have.
23 Q. Have your superiors at Lilly
24 ever complained to you concerning the quality of
Page 163
1 your memory, Doctor Webber?
2 A. No.
3 Q. Have you taken any medication
4 in connection with any physical ailment that
5 could affect your memory?
6 A. No.
7 Q. Have you had problems with
8 memory unrelated to work?
9 A. No.
10 Q. Let's look at point two -- or
11 point B, under that paragraph that says after
12 opening introductions Charles Beasley showed
13 several slides which discussed the following
14 point: Point B, measurement and definition,
15 questionnaires, paren, modified scale for
16 suicidal ideation revisited, paren, MSSI dash R,
17 close paren. Do you recall that point being
18 discussed at that meeting?
19 A. No.
20 Q. Not at all?
21 A. No.
22 Q. Point C, four possible study
23 approaches. There was considerable discussion
24 with the protocol designed to characterize the
Page 164
1 phenomenon. Do you recall any of the study
2 approaches?
3 A. No, I don't.
4 Q. Do you recall anything about
5 this?
6 A. No, I don't.
7 Q. Point C?
8 A. No.
9 Q. Do you recall any of the
10 considerable discussions of the protocol designed
11 to characterize a phenomenon?
12 A. No.
13 Q. You recall nothing, then,
14 about point C?
15 A. I recall nothing.
16 Q. Point D is the essentials of
17 rechallenge protocol. Do you see that?
18 A. Yes.
19 Q. Do you recall discussion of
20 the rechallenge protocol?
21 A. I don't recall it.
22 Q. I'm not asking you whether you
23 recall the protocol, do you recall discussions of
24 the rechallenge protocol?
Page 165
1 A. I do not recall discussions.
2 Q. Do you recall discussions of
3 the essentials of the rechallenge protocol?
4 A. No.
5 Q. You don't recall anything as
6 we sit here today concerning point D in your May
7 15, 1991 memo, essentials of rechallenge
8 protocol?
9 A. I do not recall any.
10 Q. The next sentence says a
11 collegial -- is that how you say that?
12 MS. ZETTLER: Collegial.
13 Q. Collegial debate and
14 discussion ensued. The meeting began at 1:45
15 p.m. and ended at 3:10 p.m. Do you recall that a
16 collegial debate and discussion occurred?
17 A. I don't recall, but I must
18 have thought that that was true at that time.
19 Q. I assume that at the time you
20 wrote these items in May, 1991, you had a
21 recollection of what had occurred two days
22 before, didn't you?
23 A. I hope so.
24 Q. I want to question you now
Page 166
1 about what happened then. Do you understand
2 that, Doctor Webber?
3 A. Yes.
4 Q. Again, it's my understanding,
5 up to this point you remember nothing concerning
6 that meeting up to the last sentence of that
7 page, is that right?
8 A. That's correct.
9 Q. Now, do you remember, as we
10 sit here today, that a collegial debate and
11 discussion occurred at the meeting in May, 1991?
12 A. No, I don't remember that.
13 Q. Do you recall anything, then,
14 about the debate?
15 A. No, no.
16 Q. Do you recall anything
17 discussed?
18 A. Discussed?
19 Q. Yes.
20 A. At this meeting at all?
21 Q. Yes.
22 A. Yes.
23 Q. What?
24 A. I recall the very last point.
Page 167
1 Q. Okay, we'll get to that. But
2 we're going to take this item by item to make
3 sure we know what you know and what you don't
4 know, and what you remember and what you don't
5 remember.
6 A. Okay.
7 Q. Do you remember that the
8 meeting began at 1:45 and ended at 3:10 p.m.?
9 A. No.
10 Q. Do you remember that the
11 meeting occurred in the afternoon?
12 A. No.
13 Q. Let's go to page two. Summary
14 points were: Number one, FDA -- quote, FDA had
15 internal disagreement, paren, the epidemiologist
16 liked it, close paren, over the value of the
17 proposed characterization descriptive study, but
18 did not object to our doing it. Do you remember
19 the FDA having an internal disagreement?
20 A. No.
21 Q. Do you remember the
22 characterization descriptive study?
23 A. No.
24 Q. Do you have any idea what
Page 168
1 that's talking about?
2 A. No.
3 Q. Do you remember even the
4 epidemiologist liking this particular proposed
5 characterization study?
6 A. No, I do not remember that.
7 Q. Do you remember any discussion
8 concerning summary point one on page two of
9 Webber Exhibit 2?
10 A. No.
11 Q. Let's look at point two. FDA
12 is supportive of our rechallenge protocol,
13 period; correct, that's what it says there?
14 A. It says that.
15 Q. Do you recall the FDA being
16 supportive of the rechallenge protocol?
17 A. No.
18 Q. Do you recall discussions of a
19 rechallenge protocol at that meeting?
20 A. I vaguely remember that there
21 might have been discussion.
22 Q. Tell me what you remember
23 about the rechallenge.
24 A. I don't remember the details,
Page 169
1 they were very medical and psychiatric oriented
2 and over my head.
3 Q. Why were you there?
4 A. More or less to --
5 Q. Take notes?
6 A. No, not take notes, I mean --
7 Q. You obviously weren't there to
8 remember, were you?
9 A. That's correct.
10 Q. So why were you there?
11 A. I was there to make sure that
12 the -- our Lilly individuals got to the right
13 place at the right time.
14 Q. You were a tour guide then?
15 A. There were elements of that.
16 Q. Were some of them under some
17 infirmity that they couldn't get to an office
18 building at the Food and Drug Administration?
19 A. No.
20 Q. Then why did they need your
21 direction in getting them there to the right
22 place and at the right time?
23 A. It was my responsibility to
24 make sure that they were there, and the only way
Page 170
1 I could make sure that they were there would be
2 to do that.
3 Q. Had one of them demonstrated
4 some irresponsibility in making meetings prior to
5 this?
6 A. No.
7 Q. Who delegated this
8 responsibility to you to get them there at the
9 right place and at the right time?
10 A. I pretty much take it upon
11 myself as my responsibility.
12 Q. You took it upon yourself as
13 that responsibility, why, why did you consider
14 that your responsibility?
15 A. Because I was responsible for
16 seeing that the meeting took place.
17 Q. Had you called the meeting to
18 order or had you arranged the meeting?
19 A. I arranged it from the
20 standpoint of negotiating the time, the date of
21 mutual availability.
22 Q. So you kind of worked as a
23 secretary --
24 MR. MYERS: Wait a minute.
Page 171
1 Q. -- to get a hold of everybody
2 and to make the telephone arrangements.
3 MR. MYERS: Don't answer that, Doctor
4 Webber. Paul, you're starting to demean him and
5 argue with him, and I'm not going to let him
6 answer that.
7 MS. ZETTLER: What's demeaning about
8 being a secretary?
9 MR. MYERS: Because the entire course
10 of this discussion has degenerated. He's not
11 going to answer that question so ask him another
12 question.
13 MS. ZETTLER: Can I send that portion
14 of the transcript to your secretary?
15 MR. MYERS: That's an assinine
16 question, Nancy, on the record. Yes, just ask
17 another question.
18 Q. In all seriousness, Doctor
19 Webber, this is not an exercise to demean you in
20 any, any at all manner or means. Do you
21 understand that?
22 A. Yes.
23 Q. Let me make myself clear. I'm
24 here representing about thirty or forty people
Page 172
1 who have lost their loved ones as a result of
2 what I think was an ingestion of a dangerous drug
3 manufactured by the company for whom you are
4 employed. Do you understand that?
5 A. I understand.
6 Q. You have had an opportunity to
7 talk with the legal people at Lilly, and talk
8 with Mister Myers concerning what we're doing
9 here today, haven't you?
10 A. Yes.
11 Q. They didn't tell you this was
12 not a serious matter, did they?
13 A. They did not say that.
14 Q. In fact they instructed you
15 that this was a serious matter, didn't they?
16 A. Yes.
17 Q. Now, you've told me that you
18 remembered nothing concerning the first page of
19 this document in all candor, haven't you?
20 A. That's correct.
21 Q. And you've told me that you
22 were there for Lilly at the meeting, weren't you?
23 A. Yes.
24 Q. My purpose in asking these
Page 173
1 questions, and my purpose in asking even if you
2 were acting as a secretary in arranging the
3 meeting was to try to get some idea of what your
4 function was, all right, and it's not intended to
5 be demeaning, it's intended to do what I'm here
6 at Indianapolis to do, and that's get some facts
7 about this lawsuit, okay. Are we straight?
8 A. Yes.
9 Q. Do you understand?
10 A. Yes.
11 Q. Don't ever think anything I
12 say to you is intended to be demeaning, all
13 right?
14 A. Yes.
15 Q. Now, were you acting in a
16 secretarial capacity in arranging this meeting?
17 A. Yes.
18 Q. Were you acting in a
19 secretarial capacity in taking notes with respect
20 to this meeting?
21 A. No.
22 Q. Were you acting in your
23 capacity as a regulatory scientist in taking
24 notes at this meeting?
Page 174
1 A. Yes.
2 Q. Was it part of your duties as
3 the regulatory scientist in connection with
4 Prozac to get the Prozac medical personnel from
5 one place to the other?
6 A. Yes.
7 Q. Was there some difficulty that
8 these people were having in getting to a time --
9 getting to a particular place at a particular
10 time?
11 A. No.
12 Q. Then I'm still at a loss to
13 understand what your function was at this
14 meeting.
15 A. I needed to ensure that they
16 got to a particular place at a particular time.
17 Q. Was there some problem in the
18 past with any members of Eli Lilly people that
19 were there at the meeting where they could be
20 relied on to get to a particular place at a
21 particular time?
22 A. Not that I'm aware of.
23 Q. Did you say a word at this
24 meeting?
Page 175
1 A. I don't recall.
2 Q. What was your understanding,
3 based on your presence at this meeting, of what
4 the rechallenge protocol was?
5 A. Well, it was heavily
6 psychiatric in nature, and I really do not
7 understand it.
8 Q. Well, do you not consider
9 yourself conversed in connection with psychiatric
10 matters?
11 A. I do not consider myself
12 conversed.
13 Q. Even though you're the
14 regulatory scientist in connection with Prozac,
15 which is a psychiatric medication?
16 A. That's correct.
17 Q. Can you tell me anything about
18 what your understanding is or was of the
19 rechallenge protocol?
20 A. No.
21 Q. The next sentence in point two
22 says: In response to their urging, we agree to
23 try to get started by September 1, 1991, and get
24 back to them with the progress on the crude
Page 176
1 enrollment, not necessarily outcome, report after
2 the first quarter of 1992. Did I read that
3 right?
4 A. It sounded like you did.
5 Q. Do you recall the Food and
6 Drug Administration urging that you get back or
7 that you get started by September 1, 1991 and get
8 back with them on the progress?
9 A. I don't remember those words.
10 Q. Do you recall there being
11 something said to that effect?
12 A. I don't remember that.
13 Q. Do you recall that you would
14 report after the first quarter of 1992 with
15 respect to the progress on the rechallenge
16 protocol?
17 A. No, I don't remember that.
18 Q. Do you remember that being
19 discussed?
20 A. No, I don't.
21 Q. Do you know whether or not a
22 study was ever done in connection with a
23 rechallenge protocol?
24 A. I don't believe it was.
Page 177
1 Q. All right. Did you report, in
2 your capacity as the regulatory scientist in
3 connection with Fluoxetine, in the first quarter
4 of 1992, concerning your progress on the
5 rechallenge protocol?
6 A. I did not report.
7 Q. Was that because there wasn't
8 anything to report?
9 A. I believe that's correct.
10 Q. Were the plans for the
11 rechallenge protocol discontinued?
12 A. I'm not sure what you mean by
13 discontinued.
14 Q. Was it scrapped?
15 A. I know it never happened.
16 What the right verb is, I'm not sure.
17 Q. Do you know why it never
18 happened?
19 A. No, I don't.
20 Q. Do you recall at any time
21 anybody from the Food and Drug Administration
22 asking you why you hadn't done the rechallenge
23 study?
24 A. I don't remember necessarily
Page 178
1 the word rechallenge, but I do remember once,
2 possibly twice, Paul David, while we were
3 chatting, asked me if we were going to submit the
4 protocol.
5 Q. And what was your response?
6 A. I told him I would ask the
7 physicians.
8 Q. Did you ask the physicians?
9 A. Probably.
10 Q. And what did they say?
11 A. I don't remember what they
12 said, but we certainly didn't have it at that
13 time.
14 Q. Has any work been done that
15 you're aware of on a rechallenge study in
16 connection with Prozac?
17 A. What do you mean by work, any
18 clinical work?
19 Q. Yes.
20 A. No, not that I'm aware of.
21 Q. We know a protocol was
22 drafted, don't we -- or you may not know it, I
23 know that a protocol was drafted through previous
24 discovery in this case, all right. Do you
Page 179
1 remember that there was a protocol drafted?
2 A. Yes, I do.
3 Q. Do you remember that there was
4 a protocol approved by the Food and Drug
5 Administration?
6 A. No.
7 Q. All right. Do you have any
8 explanation, as the regulatory scientist in
9 connection with Prozac, as to why a rechallenge
10 protocol was never done by Lilly?
11 A. No, I do not.
12 Q. Did you -- well, you say Paul
13 David, the FDA consumer safety officer, asked you
14 about it on a couple of occasions, didn't he?
15 A. Yes.
16 Q. And is it your testimony that
17 your recollection is that you asked some of the
18 doctors involved about it, is that right?
19 A. Uh-huh.
20 MR. MYERS: You need to say yes.
21 A. Yes, sorry.
22 Q. And what did the doctors
23 report back to you?
24 A. Well, I don't remember the
Page 180
1 exact words.
2 Q. Generally, what did they say?
3 A. My feeling was that it was not
4 ready to be sent.
5 Q. Not ready to be sent, is that
6 right?
7 A. At that time.
8 Q. Well, that tells me the study
9 was started, but not completed. Is that not
10 true?
11 A. That's not true.
12 Q. What is true in connection
13 with whether or not the rechallenge protocol was
14 ever -- rechallenge study was ever done?
15 A. In my opinion, it was never
16 done.
17 Q. Was it ever started?
18 A. I don't believe so.
19 Q. Do you know why it wasn't
20 started?
21 A. No, I do not.
22 Q. Do you have any idea why you
23 would, in May of 1991, be writing a memo as the
24 regulatory scientist involved and responsible for
Page 181
1 Prozac that the FDA was supportive of the
2 protocol?
3 MR. MYERS: You want to know why he
4 wrote it then?
5 MR. SMITH: Yes.
6 A. Apparently that was my
7 impression then.
8 Q. And you say in response to
9 their urging, that is the FDA's urging; correct?
10 A. Yes.
11 Q. That you had agreed to get
12 back to them by September 1, 1991, right?
13 A. That's what it says.
14 Q. And that's been over two years
15 now, as we sit here today, hasn't it?
16 A. Yes.
17 Q. And nothing was ever done, was
18 it --
19 MR. MYERS: Let me object to the form.
20 Q. -- in connection with the
21 rechallenge study?
22 MR. MYERS: Let me object to the form
23 because that's not what he said. That's not what
24 you said, either.
Page 182
1 Q. You can go ahead and answer
2 the question.
3 MR. MYERS: Yes, if you know, tell
4 him.
5 A. I'm sorry, I guess you need to
6 repeat the question.
7 MR. SMITH: Can you read it back?
8 (THE COURT REPORTER READ BACK THE
9 REQUESTED TESTIMONY.)
10 A. So the question is did we
11 start that study?
12 Q. Yes.
13 A. I don't believe we started
14 that study.
15 Q. Do you know why you didn't
16 start the study?
17 A. No, I don't.
18 Q. Did you ever ask the doctors
19 why they didn't start the study?
20 A. No.
21 Q. From what you told me earlier,
22 you did ask the doctors about it in response to
23 the FDA consumer safety officer's questioning,
24 and they told you it wasn't ready. Is that what
Page 183
1 you said?
2 A. That's what I said.
3 Q. Is that true?
4 A. Yes.
5 Q. Did you report that to Mister
6 Paul David, the consumer safety officer at the
7 FDA, that you had asked the doctors about this
8 and they were telling you that the study wasn't
9 ready?
10 A. I don't remember what I said
11 to him.
12 Q. Would you have lied to him?
13 A. No.
14 Q. Would you have probably told
15 him exactly what the doctors told you?
16 A. I don't remember what I said
17 to him.
18 Q. That the study wasn't ready?
19 A. I don't remember what I said.
20 Q. Would you have told him
21 something differently than what the doctors told
22 you?
23 A. No.
24 Q. All right. So, then, you
Page 184
1 probably did report to Paul David, consumer
2 safety officer at the Food and Drug
3 Administration, that the studies weren't ready,
4 didn't you?
5 A. I don't know that I did that.
6 Q. But that's what you said you
7 probably said, didn't you?
8 A. No, I didn't say that.
9 Q. What did you say?
10 A. I said I do not remember what
11 I told Paul David.
12 Q. Would you have lied to Paul
13 David about it?
14 MR. MYERS: Paul, he answered that.
15 Q. All right. Didn't you tell me --
16 I'm trying to get this straight because I think
17 it's extremely important. Didn't you tell me
18 that you did recall that Paul David called you on
19 a couple of occasions subsequent to May 15, 1991
20 and asked you about the rechallenge study?
21 A. What I said was during
22 telephone conversations, he asked me.
23 Q. Asked about the status of it;
24 correct?
Page 185
1 A. Yes.
2 Q. And did you not testify
3 earlier that you went to the physicians involved
4 and asked them about it?
5 A. Yes.
6 Q. And is it not your testimony
7 or didn't you testify earlier that those
8 physicians told you it wasn't ready yet?
9 A. Yes.
10 Q. But in fact the rechallenge
11 study was never started, was it?
12 A. That's my understanding.
13 Q. So you reported back to Paul
14 David that the rechallenge study wasn't ready
15 yet, didn't you?
16 A. I don't remember that.
17 Q. But you wouldn't have reported
18 anything to him anything differently than what
19 the physicians were telling you, would you?
20 A. That's correct.
21 Q. So is it reasonable to assume
22 that you reported to Mister David that the
23 rechallenge study wasn't ready yet?
24 A. I don't remember telling him
Page 186
1 that.
2 Q. Is that a reasonable
3 assumption based on what your testimony had just
4 been?
5 MR. MYERS: He's answered that three
6 times. Answer it one more time.
7 A. I don't recall.
8 Q. I'm not asking you whether you
9 recall, I'm asking you whether or not it's a
10 reasonable assumption that that's what you would
11 have told him?
12 MR. MYERS: Don't answer that, you've
13 answered it four times. He's not going to answer
14 it again. Take it up with the judge.
15 MR. SMITH: Are you instructing him
16 not to answer?
17 MR. MYERS: You bet I am.
18 MS. ZETTLER: Certify it.
19 (QUESTION CERTIFIED.).
20 Q. If you had reported to Paul
21 David that the rechallenge study had not been
22 completed when in fact as you now testify, it's
23 your understanding the rechallenge study was
24 never started, then you would have been giving
Page 187
1 Paul David misinformation, would you not?
2 MR. MYERS: Before he answers, let me
3 object to the form. There's been no testimony
4 that he testified that he told the man that it
5 was not completed. The original testimony,
6 Mister Smith, if you recall, was the inquiry was
7 about the protocol.
8 MR. SMITH: Can he answer the
9 question?
10 A. You'll have to tell me what
11 the question is.
12 (THE COURT REPORTER READ BACK THE
13 REQUESTED TESTIMONY.)
14 MR. MYERS: Same objection. If you
15 can answer it, answer it.
16 A. I never said the first thing
17 you said.
18 Q. Which was?
19 A. Well, it was kind of
20 convoluted, and it didn't happen.
21 Q. What didn't happen?
22 A. What you said. I never told
23 him that we had begun the study.
24 Q. I understand that. It's my
Page 188
1 understanding that you inquired of the doctors,
2 in response to questions he had asked about the
3 status of the study, as to what the status of the
4 study was, and the doctors at Lilly told you that
5 the study had not been completed.
6 A. No.
7 Q. What did they tell you?
8 A. Paul David asked me about the
9 protocol, I asked our physicians about the status
10 of the protocol, they said the protocol had not
11 been completed.
12 Q. Well, the protocol was
13 completed on May 15, 1991, wasn't it?
14 A. Not that I'm aware.
15 Q. It had been approved, hadn't
16 it?
17 A. Not that I'm aware.
18 Q. Do you remember that the
19 rechallenge protocol was approved?
20 A. No, I do not.
21 Q. Do you deny that the
22 rechallenge protocol was ever approved by the
23 Food and Drug Administration?
24 A. I don't recall that it ever
Page 189
1 was.
2 Q. Do you recall submitting it
3 for approval --
4 A. No, I do not.
5 Q. -- as the regulatory scientist
6 responsible for Prozac?
7 A. No, I do not.
8 Q. All right. The last -- let's
9 go back to Exhibit 2. The last sentence of point
10 two says Doctor Stadel was most enthusiastic
11 about a progress report; correct?
12 A. That's what it says.
13 Q. That's something you do
14 remember in this memo, is that right?
15 A. No, I do not.
16 Q. You don't recall. What is it
17 about Doctor Stadel that you do recall?
18 A. Vaguely what he looked like.
19 Q. What did he look like?
20 A. Kind of tall, gangly.
21 Q. Do you recall Doctor Stadel
22 being enthusiastic about a progress report in
23 connection with a rechallenge study on Prozac?
24 A. No.
Page 190
1 Q. You just don't recall that at
2 all?
3 A. No, I do not.
4 Q. This is written there, is it
5 not?
6 A. Yes, it is.
7 Q. And it's intended to reflect
8 accurately what was said there at the time on May
9 15, 1991, wasn't it?
10 A. Yes.
11 Q. And Doctor Stadel was the
12 representative from that portion of the Food and
13 Drug Administration that had to do with
14 collection of adverse event reports; correct?
15 A. That's my understanding.
16 MS. ZETTLER: Paul, I'm sorry, I don't
17 mean to interrupt, but it's about twenty minutes
18 after 3:00 right now, and we still need to see
19 Lilly's changes to our letter we submit to the
20 Judge tomorrow morning, and I'd like to receive
21 it.
22 MR. SMITH: Let's take a break now and
23 call Mister Stanley.
24 MR. MYERS: I'll call him.
Page 191
1 (A SHORT RECESS WAS TAKEN.)
2 Q. (BY MR. SMITH) Let's go to
3 point three in Webber Exhibit 2, which is your
4 memo of May 15th concerning the May 13, 1991
5 meeting between Eli Lilly and the FDA concerning
6 suicide, all right?
7 A. Yes.
8 Q. Point three says an additional
9 categorical outcome variable to be analyzed in
10 the rechallenge protocol is hospitalization. Do
11 you recall that discussion?
12 A. No.
13 Q. Do you recall anything about
14 the hospitalization aspect of the rechallenge
15 protocol?
16 A. No, I don't.
17 Q. Do you remember anything
18 anybody said about point three?
19 A. No.
20 Q. You have no recollection as we
21 sit here what you could mean at all about what's
22 written in point three?
23 A. I do not.
24 Q. Point four is Doctor Jonathan
Page 192
1 Cole, prominant co-author with Doctor Teicher,
2 will be asked to comment on the suicidal ideation
3 questionnaire and definition of substantially
4 increased ideation. Do you recall that point
5 being discussed?
6 A. No.
7 Q. Do you recall who Doctor
8 Jonathan Cole was?
9 A. Yes.
10 Q. Who was he?
11 A. I remember him being a
12 co-author with Doctor Teicher.
13 Q. Do you recall, as we sit here
14 today, discussions concerning submitting or
15 asking Doctor Cole to comment on the suicidal
16 ideation questionnaire that was being developed?
17 A. No.
18 Q. You don't recall anything, you
19 just can tell me from reading what is written
20 there that Doctor Cole was a prominent co-author
21 with Doctor Teicher?
22 A. That's correct.
23 Q. Do you know where Doctor Cole
24 is, where he works?
Page 193
1 A. No, I don't.
2 Q. Where he lives?
3 A. No.
4 Q. Do you recall what his
5 specialty is?
6 A. I think he's a psychiatrist.
7 Q. Point five is the MSSIR
8 questionnaire and supporting system will be
9 examined to further validate it, and also to
10 characterize patients in the context of
11 evaluating the course of depression in
12 in-patients, presumably patients with more severe
13 depression. Do you recall those discussions?
14 A. No.
15 Q. Do you recall anything at all
16 said about the MSSIR questionnaire and
17 in-patients who are more depressed?
18 A. No.
19 Q. Do you recall anything anybody
20 said about that?
21 A. No.
22 Q. Point six says we'll
23 incorporate the MSSIR questionnaire in our
24 ongoing and new depression trials, U.S. and OUS.
Page 194
1 Do you recall that?
2 A. I remember that better, yes.
3 Q. Tell me what you remember
4 about that.
5 A. I remember more that we did
6 that. My opinion is that we did that.
7 Q. You did incorporate the MSSIR
8 questionnaire in the ongoing and new depression
9 trials?
10 A. Let me clarify. We
11 incorporated some kind of suicidality
12 questionnaire. I will be honest with you, I
13 don't know the name of one from another.
14 Q. All right. Point seven -- do
15 you remember anything else about point six?
16 A. No.
17 Q. Other than you know from your
18 past experience as the regulatory scientist
19 involved with Prozac or responsible for Prozac,
20 that after that there was additional
21 questionnaires submitted in the clinical trials?
22 A. They were incorporated in the
23 protocol, some protocols.
24 Q. But you don't recall who was
Page 195
1 urging that, and why, and what the discussion was
2 concerning the reasoning for incorporating the
3 MSSIR questionnaire into the ongoing and new
4 trials?
5 A. I don't remember that from
6 that meeting, no.
7 Q. Point seven is we will
8 investigate the possibility of making the new
9 questionnaire available to other sponsors. Do
10 you recall that?
11 A. No, I don't.
12 Q. By other sponsors, are you
13 talking about other drug manufacturers?
14 A. That's what I think that
15 means.
16 Q. And by other sponsors, you're
17 talking about competitors?
18 A. Correct.
19 Q. Do you recall who urged that
20 you make that questionnaire responsible to other
21 sponsors or competitors?
22 MR. MYERS: You mean available to
23 other sponsors.
24 MR. SMITH: Yes.
Page 196
1 MR. MYERS: You said responsible to
2 other sponsors.
3 MR. SMITH: Okay. Available.
4 A. I don't recall.
5 Q. Do you recall what other
6 sponsors were working on issues in connection
7 with suicide?
8 A. No.
9 Q. Do you recall what other
10 sponsors were working on drugs that had
11 psychiatric potentials with respect to suicidal
12 ideation that would make the availability of
13 those questionnaires useful?
14 MR. MYERS: Before he answers, let me
15 object to the form to the extent it assumes that
16 the product in question has psychiatric potential
17 related to suicide or whatever you said. But if
18 you know, tell him.
19 A. I don't know.
20 Q. Do you recall anything about
21 point seven?
22 A. No, I don't.
23 Q. The last paragraph says Doctor
24 Temple, right?
Page 197
1 A. Yes.
2 Q. Begins Doctor Temple. And
3 Doctor Temple is the head honcho from the FDA
4 there; correct?
5 A. He was the ranking personnel.
6 Q. The big cheese?
7 A. Yes.
8 Q. Numero uno.
9 A. Yes.
10 Q. Doctor Temple asked if he
11 could bring up an additional issue, right?
12 A. Yes.
13 Q. And then inquired, that is
14 Doctor Temple inquired, as to our intention of
15 providing a more convenient way of delivering
16 less than twenty milligrams of Prozac, right?
17 A. Yes.
18 Q. Do you remember that
19 discussion?
20 A. Yes.
21 Q. And what was said in
22 connection with that discussion?
23 A. Basically just what I've said
24 here.
Page 198
1 Q. Doctor Temple wanted a more
2 convenient way to deliver less than 20 milligrams
3 of Prozac, right?
4 A. He brought it up as an issue
5 of interest to him.
6 Q. It was an issue of interest in
7 connection with your suicide meeting, wasn't it?
8 A. I don't believe that that had
9 anything to do with the suicide meeting.
10 Q. The whole meeting had to do
11 with --
12 MR. MYERS: Wait a minute, let him
13 finish.
14 A. I remember him saying let me
15 change gears.
16 Q. Wasn't the meeting in
17 connection with suicide?
18 A. The rest of the meeting was.
19 Q. All right. It says -- the
20 first paragraph with respect to the memo says on
21 Monday May 13th, a group of Eli Lilly and Company
22 met with FDA representatives to discuss draft
23 protocols for studying suicidality, right?
24 A. That's what I said.
Page 199
1 Q. The purpose of the meeting was
2 to discuss suicidality, right?
3 A. Yes.
4 Q. Everything there, every point
5 made in this two-page memorandum is discussing
6 Prozac and suicidality; correct?
7 A. No.
8 Q. Except for -- now it's your
9 testimony except for this last comment made by
10 Doctor Temple.
11 A. That's correct.
12 Q. Now, you can't remember, can
13 you, Doctor Webber, anything in connection with
14 all of these points that we've just discussed
15 other than this last subject, is that right?
16 A. That's correct.
17 Q. And now your recollection is
18 that when Doctor Temple was talking about
19 delivering less than twenty milligrams of Prozac,
20 he was talking about something else other than
21 suicide?
22 A. It says right there.
23 Q. No, it doesn't.
24 A. An additional issue.
Page 200
1 Q. All right, an additional issue
2 to all of these other issues that had been
3 listed, right?
4 A. No.
5 Q. Now you have some recollection
6 of this meeting, is that right?
7 MR. MYERS: Hold on just a second.
8 Mister Smith, lower your tone of voice.
9 Q. Now you have some recollection
10 of this meeting.
11 MR. MYERS: Go ahead and answer.
12 A. I do recollect this
13 discussion.
14 Q. And things are coming into
15 focus now, is that right?
16 A. I remember this discussion at
17 the end here.
18 Q. You don't remember any other
19 discussion, right, other than this one?
20 MR. MYERS: I object to the form only
21 because there were some matters of which he had
22 recollection that he told you about.
23 MR. SMITH: The record will reflect
24 what he recalled and what he didn't recall.
Page 201
1 Q. You recall now that part,
2 right?
3 A. I recall this part.
4 Q. Did he say let's change gears?
5 A. Yes, he did.
6 Q. Did he say let's talk about
7 something other than suicide?
8 A. The implication was that, I
9 don't know whether those were his exact words.
10 Q. Is it your testimony that you
11 can't recall anything concerning any detail of
12 any of this, and now you're testifying you recall
13 what Doctor Temple's implication is in connection
14 with twenty milligrams of Prozac being delivered
15 at a less strength form?
16 A. Yes.
17 Q. And he wasn't talking at all
18 about suicide when he talked about delivering
19 less than twenty milligrams.
20 A. I don't believe he was.
21 Q. Do you recall that
22 specifically?
23 A. I do not believe he was.
24 Q. That's the truth, what you're
Page 202
1 saying here now?
2 A. That's the truth.
3 Q. All right. Do you recall
4 anything else about this meeting that's not
5 written down in this paper?
6 A. No.
7 MS. ZETTLER: Paul, see if he
8 remembers who was present during the meeting
9 during that portion of the conversation since he
10 remembers that conversation.
11 Q. Did anybody come or leave this
12 meeting?
13 A. Not that I recall.
14 Q. Who was present when Doctor
15 Temple said that?
16 A. I believe the same people.
17 Q. Did Doctor Temple ask anything
18 else, do you have a more convenient way of
19 delivering less than twenty milligrams of Prozac?
20 A. That was the gist of what he
21 said.
22 Q. Why was he wanting -- since
23 you have a recollection of this, why was he
24 wanting to deliver less than ten milligrams --
Page 203
1 less than twenty milligrams of Prozac?
2 A. I do not know.
3 Q. Didn't he say?
4 A. He may or may not have said, I
5 don't remember.
6 Q. Oh, you don't remember that
7 part of it, is that right?
8 A. I don't know whether he said
9 anything about it or not.
10 Q. Well, you said you had a
11 recollection of this discussion.
12 A. No, you just asked me whether
13 I remember why he brought it up.
14 Q. Are you saying you don't
15 remember the discussion, but you remember why the
16 discussion was occurring?
17 A. No.
18 Q. All right. Is it your
19 testimony that you don't remember why Doctor
20 Temple wanted to know whether or not there was a
21 more convenient way of delivering less than
22 twenty milligrams of Prozac?
23 A. That's correct.
24 Q. But it's your testimony, and
Page 204
1 it's the truth, that Doctor Temple wasn't talking
2 about suicide when he brought up the issue of
3 delivering less than twenty milligrams of Prozac?
4 A. I did not feel that he had
5 that in mind.
6 Q. I'm not asking you what you
7 feel, I'm asking you what you recall.
8 A. I do not recall that he had
9 that in mind.
10 Q. What did he say that made you
11 think that he didn't have suicide in mind when he
12 brought up that issue?
13 A. Because he said can we change
14 gears and talk about additional issues.
15 Q. Did he actually say can we
16 change gears?
17 A. I told you before, he gave the
18 impression he wanted to add a new subject to the
19 meeting.
20 Q. What did he say to give you
21 the impression that he wanted to change subjects?
22 A. I can't remember the exact
23 words, he may have actually said what I just
24 said.
Page 205
1 Q. Do you know why you can
2 remember this about what Doctor Temple said, and
3 you have such a difficult time in remembering
4 anything else about any of the other points that
5 are written here?
6 A. Yes.
7 Q. Tell me why?
8 A. Because the other is all
9 psychiatric stuff that's over my head, and this
10 is a regulatory issue.
11 Q. This is a regulatory issue on
12 delivering less than -- a more convenient way of
13 delivering less than twenty milligrams of Prozac?
14 A. It requires the assembly of a
15 regulatory document that we talked about earlier.
16 Q. What you say here is that
17 Doctor Temple inquired as to our intention of
18 providing a more convenient way of delivering
19 less than twenty milligrams of Prozac.
20 A. Yes.
21 Q. Well, isn't how to deliver
22 less than twenty milligrams of Prozac a
23 psychiatric and scientific issue as opposed to a
24 regulatory issue?
Page 206
1 A. The implications are assembly
2 of a regulatory document to do that.
3 Q. I thought that had already
4 been submitted, the ten milligram application?
5 A. July 30th, 1991.
6 Q. Okay. Well, then, that was
7 already in the process, then, in May, wasn't it?
8 A. Yes, it was.
9 Q. You don't mention that we have
10 this in progress, do you?
11 A. I do not mention that.
12 Q. You don't mention that you
13 reported to Doctor Temple we have the material
14 that we're compiling to submit to you a more
15 convenient way, that is ten milligrams, of
16 delivering less than twenty milligrams of Prozac;
17 correct?
18 A. That's correct.
19 Q. But you don't write that down
20 there, do you?
21 A. I didn't write it down.
22 Q. Did you say it?
23 A. No.
24 Q. Did you have any response to
Page 207
1 what --
2 A. What Doctor Zerbe said there
3 is what I recalled at the time.
4 Q. You say that Doctor Zerbe
5 responded that we were seriously considering
6 alternatives, don't you?
7 A. Yes, I do.
8 Q. That's a quote, Doctor Zerbe
9 responded that we were seriously considering
10 alternatives, end quote; correct?
11 A. Yes.
12 Q. Well, there weren't any
13 alternatives at all, you already had the plan
14 under way to submit the supplemental NDA, and it
15 was done in July of '91, two and a half months
16 later, wasn't it?
17 A. That's correct.
18 Q. And work was already under way
19 on it.
20 A. That's correct.
21 Q. The -- probably, I bet you,
22 the bioequivalent study was complete.
23 A. Yes.
24 Q. By May 15, 1991, wasn't it?
Page 208
1 A. Yes.
2 Q. You don't mention to him that
3 the bioequivalent study had been done, and that
4 the bioequivalent study was completed in May of
5 1991, do you?
6 A. That's correct.
7 Q. In fact, what you record
8 sounds contrary to me, doesn't it, Doctor Zerbe
9 responded that we were seriously considering
10 alternatives; correct?
11 A. I don't agree with the first
12 part of your sentence.
13 Q. I just read what you said. Is
14 there something that's incorrect about it?
15 A. No, something I heard you
16 saying.
17 Q. What?
18 A. Well, you know, I shouldn't be
19 the one asking her to repeat what you said.
20 Q. I mean don't you say --
21 A. You said it was contradictory,
22 and you asked me to agree to that.
23 Q. It sounds contradictory to me.
24 You tell me if it sounds contradictory to you.
Page 209
1 A. It does not.
2 Q. If there is a bioequivalent
3 study already complete, and if the supplementary
4 submission is already underway, were draft
5 labeling materials already prepared?
6 A. I don't know about the timing
7 of that.
8 Q. Why?
9 A. Because I don't know what date
10 they were begun.
11 Q. Weren't you doing it?
12 A. I was involved with it.
13 Q. All right. But you don't
14 remember it?
15 A. I don't remember the date.
16 Q. Do you recall Doctor Zerbe
17 responding that we were seriously considering
18 alternatives?
19 A. I don't recall.
20 Q. What Doctor Zerbe said?
21 A. Not exactly. I know he
22 responded, and this is what I said at the time
23 that he responded.
24 Q. Do you specifically recall
Page 210
1 anything he said as we sit here today?
2 A. Nothing better than what's
3 here.
4 Q. Do you recall what's here?
5 A. I'm reading it and looking at
6 it.
7 Q. I know, but you've been
8 reading and looking at all these other points
9 that you don't have any recollection at all of.
10 I'm trying to see if there's any distinction here
11 between those points that you don't have any
12 recollection of --
13 A. I recall Doctor Zerbe
14 responding to Doctor Leber.
15 Q. Do you recall what he said?
16 A. No.
17 Q. All right. What's that number
18 under your name there on Exhibit 2?
19 A. My phone number.
20 Q. And what are those numbers
21 under --
22 A. You mean the letters?
23 Q. Uh-huh.
24 A. That's my secretary's
Page 211
1 initials.
2 Q. Did you all spend the night
3 there in Washington that night?
4 A. I don't think so.
5 Q. Do you recall?
6 A. I don't think we did, no.
7 Q. Did you get on a plane
8 together after this meeting?
9 A. I think we may have.
10 Q. Do you recall who you sat by
11 on the plane after this meeting?
12 A. No.
13 Q. Do you recall any discussions
14 between those of you at Eli Lilly that had been
15 at that meeting on the way to the airport,
16 sitting at the airport in the Admiral's Club, on
17 the plane back, in connection with the contents
18 of this meeting?
19 A. I don't recall any of that.
20 Q. Do you know what day of the
21 week this meeting was?
22 A. No, I don't know.
23 Q. Do you know why it took you
24 two days or why this memo was dated two days
Page 212
1 after the meeting?
2 A. I don't know why, but my
3 conjecture is that was the time that my secretary
4 typed it.
5 Q. Did you take written notes
6 during this meeting?
7 A. I don't know for sure, but I
8 may have written down some things like who was
9 there from the FDA.
10 Q. Where would those written
11 notes be?
12 A. In my files.
13 Q. Would they still be in your
14 files?
15 A. Oh, yes.
16 Q. Do you have any idea why
17 they've not been produced to us?
18 A. If they exist, they have been
19 produced.
20 Q. How do you know?
21 A. Because I surrendered
22 everything.
23 Q. When?
24 A. In several periods, several
Page 213
1 times.
2 Q. To legal?
3 A. Yes.
4 Q. What if I told you we don't
5 have any written notes?
6 A. I would be surprised.
7 Q. You think you did make written
8 notes?
9 A. I don't know that I did, but I
10 would think I would have written down something.
11 Q. Do you think those notes would
12 be more or less in detail than what you've
13 written in this formal memo to the file?
14 A. There might be more details.
15 Q. In connection with any of the
16 points, is that right?
17 A. (Witness moves head up and
18 down.).
19 Q. Is that a yes?
20 A. Yes, sorry.
21 Q. Could you go back and look at
22 your file, I mean did you keep copies of your
23 file when you surrendered to legal on a periodic
24 basis?
Page 214
1 A. Yes.
2 Q. I'll tell you, Doctor Webber,
3 we've not seen those notes. There may not be any
4 notes or there may be some mistake in connection
5 with legal at Lilly in getting us those notes or
6 maybe we've overlooked those notes, all right,
7 several possibilities. Would you, with your
8 attorney's permission, go back and see if you can
9 find those notes and submit those to Ms. Huff or
10 Mister Myers?
11 MR. MYERS: We will look and see if
12 there are any notes of this meeting.
13 MR. SMITH: Because we've carefully
14 gone over the documents and we have not seen
15 those notes.
16 MS. ZETTLER: To my knowledge, there
17 are no notes, handwritten notes in the file that
18 was produced.
19 MR. MYERS: I will inquire about these
20 notes, if there are any.
21 MS. ZETTLER: We want all handwritten
22 notes of his related to Fluoxetine.
23 MR. MYERS: I understand what you
24 want, and it's specific to notes about this
Page 215
1 meeting.
2 MS. ZETTLER: I know. Just reflect
3 that it's almost 4:00 o'clock and we still have
4 not seen Lilly's revisions to the letter that we
5 submitted to them, just about twenty-four hours
6 ago now, in final form.
7 MR. MYERS: And?
8 MS. ZETTLER: And we would like to see
9 it. It's supposed to be a draft -- final draft
10 that's supposed to be submitted to Judge Godish
11 tomorrow, and we would like to see it sometime
12 before the end of the day tomorrow so we can
13 submit it to him.
14 MR. MYERS: And as I've told you
15 before, Mister Stanley and Mister McLaughlen are
16 dealing with it, and Mister McLaughlen, as I
17 understand it, was on the phone about the subject
18 and I had a message to Mister McLaughlen to come
19 up here when he got off the phone and tell us
20 what the status was.
21 MS. ZETTLER: I find it hard to
22 believe it takes a day and a half to revise a one
23 and a half page letter.
24 MR. MYERS: But you find it hard to
Page 216
1 believe a lot of things.
2 MS. ZETTLER: In this litigation, I
3 do.
4 MR. SMITH: I have a multi-page
5 document that I'm fixing to hand to the witness.
6 I'm sure it would take him a few minutes to
7 review, I want to give him the opportunity to
8 review it. Why don't we mark this, and let me
9 hand it to him, and then we can take a break and
10 the witness can review this document and, if you
11 would be so kind, Mister Myers, to check again
12 with counsel to see what the status of our letter
13 to Judge Godish.
14 MR. MYERS: I will be glad to inquire
15 of Mister McLaughlen.
16 MR. SMITH: Thank you so very much.
17 (A SHORT RECESS WAS TAKEN.)
18 (PLAINTIFFS' EXHIBIT NO. 3 WAS
19 MARKED FOR IDENTIFICATION AND
20 RECEIVED IN EVIDENCE.)
21 Q. Doctor Webber, have you had an
22 opportunity to review Exhibit 3?
23 A. The answer to your question is
24 yes.
Page 217
1 Q. Have you ever seen this
2 exhibit before?
3 A. I believe that I have.
4 Q. All right. When did you first
5 see it?
6 A. I have no idea when I first
7 saw it.
8 Q. Would you have seen it shortly
9 or at or about the time it was authored on July
10 18th, 1990?
11 A. I don't know when I saw it.
12 Q. Did you see it in the Summer
13 of 1990?
14 A. Probably.
15 Q. Okay. Let's look on the first
16 page, and I think actually the part that we're
17 interested in starts about a third of the way
18 down from the top of the page, is that right?
19 A. I don't know what you're
20 interested in.
21 Q. I'm interested in the date,
22 July 18, 1990, 6:48 a.m.
23 A. Okay, fine.
24 Q. You're familiar with how the
Page 218
1 Lilly E-mail works.
2 A. I thought you meant the text.
3 Q. Yes, we're going to talk about
4 the text in a minute, but I just want to make
5 sure that that portion of the document, first
6 page of this document, that is dated July 18,
7 1990, 9:52, probably doesn't go with what is
8 below it dated 6:48 a.m., or does it?
9 A. Yes, it goes with it from the
10 standpoint that that was the time it was
11 forwarded, in my opinion.
12 Q. All right. Then who are these
13 individuals listed on the top under 9:52 a.m.?
14 A. These are the people it was
15 forwarded to.
16 Q. All right. Who is Winston
17 Satterlee?
18 A. He's a physician.
19 Q. Where?
20 A. At Eli Lilly.
21 Q. I know that, but in what
22 department?
23 A. Right now he's in the
24 psychopharmacology division.
Page 219
1 Q. What did he have to do with
2 Prozac back in July, 1990?
3 A. I have no idea.
4 Q. Who is Timothy Krupa?
5 A. Tim Krupa, he was a department
6 head in medical plans.
7 Q. Medical plans?
8 A. Uh-huh. Essentially the CRAs.
9 Q. Not an M.D.?
10 A. No.
11 Q. Who is David Goldstein?
12 A. He's a physician.
13 Q. In what capacity?
14 A. He's the obesity monitor.
15 Q. Now?
16 A. Yes.
17 Q. Was he then?
18 A. Probably. It's a matter of
19 timing, but I think he was.
20 Q. Amy S. Chappell?
21 A. She's a physician.
22 Q. What was her function then?
23 A. She's a neurologist, and I
24 don't know why she was on this addressee list.
Page 220
1 Q. There were some studies or
2 some research being done, I think, at Lilly or
3 within the area in connection with Fluoxetine and
4 movement disorders. Would she have been involved
5 in that, does that help you any?
6 A. She might have been aware of
7 it, but the more I think about this, this is Dan
8 Masica's staff, probably, and that's why -- these
9 are the people that reported to him.
10 Q. What was Dan Masica's
11 position?
12 A. He was the director.
13 Q. Director of what?
14 A. Probably psychopharmacology
15 wasn't the real name of them, but it was more
16 probably CNS clinical research.
17 Q. All right. Well, who was
18 senior, Dan Masica or Charles Beasley?
19 A. Dan Masica was the director,
20 and Charles Beasley reported to him.
21 Q. Now, let's go down from that
22 top third of the page, and at the top third
23 apparently is individuals who received copies of
24 the document, is that right, from Masica?
Page 221
1 A. That's what it looks like to
2 me.
3 Q. And you go down to the middle
4 of the page and there's some individuals listed;
5 correct?
6 A. Yes.
7 Q. Now these are people that
8 Doctor Leber is directing -- I mean Doctor
9 Thompson is directing the memo to; correct?
10 A. Yes.
11 Q. The first name on the list is
12 Mel Perelman. Who is Mel Perelman?
13 A. He's president of Lilly
14 Research Laboratories.
15 Q. He was president of Lilly
16 Research Laboratories at the time?
17 A. Yes.
18 Q. He was a vice-president of Eli
19 Lilly and Company at the time?
20 A. I'm more familiar with the
21 other title, but he may have been.
22 Q. All right. He was on the
23 board of directors of Eli Lilly and Company at
24 the time also?
Page 222
1 A. I believe that's correct.
2 Q. Robert L. Zerbe -- here it
3 looks like we do have people listed in order of
4 importance, doesn't it?
5 A. No.
6 Q. All right. Zerbe, we know who
7 Zerbe is, and we know who Doctor Talbott is;
8 correct?
9 A. Yes.
10 Q. We know who Doctor Masica is;
11 correct?
12 A. Yes.
13 Q. And then we do have somebody
14 out of order, don't we. Who was Merle E.
15 Amundson?
16 A. Merle Amundson was the
17 executive director that the nonphysicians in
18 medical reported to. I believe Talbott reported
19 to him.
20 Q. He was Talbott's boss?
21 A. I believe so.
22 Q. And he was a corporate officer
23 with Lilly Research Labs also at the time?
24 A. He was executive director, I'm
Page 223
1 not sure I would define it the way you said.
2 Q. Was he on the board of Eli
3 Lilly and Company at the time?
4 A. I don't think so.
5 Q. Is he now?
6 A. No.
7 Q. Who is Philip R. Reid?
8 A. He's a physician.
9 Q. What's his specialty?
10 A. His specialty is cardiology.
11 Q. Why is he listed here?
12 A. I believe at that time he was
13 one of the vice-presidents in medical.
14 Q. He was a vice-president of
15 Lilly Research Labs?
16 A. Well, there's a vice-president
17 of medical, I'm not sure his title was
18 vice-president of Lilly Research Labs, but it may
19 have been.
20 Q. He was vice-president -- so he
21 was a corporate officer of Lilly Research Labs in
22 some capacity?
23 A. I don't -- I'm not sure how to
24 define corporate officer, but he was a
Page 224
1 vice-president, I believe.
2 Q. Rebecca O. Goss?
3 A. She's an attorney.
4 Q. With who?
5 A. Eli Lilly.
6 Q. All right. In what section of
7 corporate attorneys?
8 A. Of regulatory, legal.
9 Q. Regulatory legal, all right.
10 And then it says CC, Leigh Thompson; correct?
11 A. Yes.
12 Q. But if you look at the second
13 page, we see that Doctor Thompson authored this
14 document, and apparently just wanted a copy to go
15 to his file. Is that the practice?
16 A. That's how I would interpret
17 that.
18 Q. So you've read this memo
19 shortly after it was authored?
20 A. I believe I have seen it.
21 Q. How did you come into
22 possession of this memo since you're not listed
23 on any of these?
24 A. I would have to conjecture
Page 225
1 that Doctor Talbott showed it to me.
2 Q. Because Talbott was your boss?
3 A. Yes.
4 Q. What discussions did you and
5 Doctor Talbott have concerning this initial Leigh
6 Thompson memo?
7 A. I do not recall those
8 discussions, if they had occurred at all.
9 Q. Do you recall that Doctor
10 Thompson was talking with Doctor Leber, and
11 Doctor Laughren, and Doctor Temple about Prozac
12 and suicide in the July, 1990 time period?
13 A. I don't recall that he was.
14 Q. When had been the last time
15 that you talked to Doctor Thompson before the
16 date of this memo?
17 A. I don't feel I talked to him
18 very often, so I have no idea when I talked to
19 him before this.
20 Q. Where was Doctor Thompson's
21 office in relation to where your office was?
22 A. It was in a different
23 building.
24 Q. All right. Was he the chief
Page 226
1 scientific officer of Eli Lilly and Company at
2 that time?
3 A. I don't believe he had that
4 title at that time.
5 Q. He does now?
6 A. I believe he does.
7 Q. Doctor Thompson reported in
8 this memo that Doctor Leber had suggested several
9 study designs to explore the issue of Prozac and
10 suicide. Do you see that?
11 A. I can see that.
12 Q. Where it says Paul suggested
13 several designs; correct?
14 A. I see that.
15 Q. It talked about a case control
16 retrospective study. Do you see that?
17 A. I see that.
18 Q. Were you aware of any case
19 control retrospective study as the regulatory
20 scientist in charge of Prozac at the time?
21 A. I'm not aware.
22 Q. You see where they're talking
23 about a cohort study?
24 A. I see that.
Page 227
1 Q. Were you aware of any cohort
2 study that was underway or had been done in
3 connection with Prozac and suicidality before the
4 date of this memo?
5 A. I'm not aware.
6 Q. Are you aware of any cohort
7 study in your capacity as regulatory scientist in
8 charge of Prozac that's been done since?
9 A. I'm not aware of that.
10 Q. Are you aware of any
11 retrospective study that has been done since the
12 date of this memo?
13 A. No, I'm not.
14 Q. Are you aware of any -- the
15 item three there on page one, a larger blind
16 prospective study that had been done or was
17 ongoing at the time this memo was made?
18 A. I'm not aware of that.
19 Q. Are you aware of any large
20 blind prospective study that's been designed,
21 since the date of this memo, to analyze Prozac
22 and suicidality in your capacity as the chief or
23 as the regulatory scientist in charge of Prozac?
24 A. No, I'm not aware.
Page 228
1 Q. The next paragraph says he's
2 been awaiting the package of material from us,
3 which I promised he would have in his hands this
4 afternoon, exclamation point. Do you know what
5 package of materials he refers to?
6 A. I believe I do.
7 Q. What is it?
8 A. It's a document that I believe
9 is dated July 17th, possibly because it was dated
10 the day before, that I'm putting together because
11 I remember flying down, as the third page says --
12 Q. We're going to get to that.
13 A. And it was essentially data on
14 eight different issues, and they were reverse
15 event issues.
16 Q. Date on what?
17 A. Data on eight different
18 adverse event issues.
19 Q. All right. So the package of
20 material that apparently is referred to on page
21 one of Webber 3 that you in fact took to the Food
22 and Drug Administration?
23 A. Yes, I believe I did.
24 Q. Was the package of material
Page 229
1 dated July 17, 1990, and it was data on eight
2 different adverse event issues; correct?
3 A. Correct.
4 Q. Now was that package of
5 material a thick package or just a small package?
6 Since you carried it, I guess you remember.
7 A. I mean, I carried it, so --
8 I've seen some huge ones and I've seen some small
9 ones. Can you ask me more specifically?
10 Q. Would it fit in that briefcase
11 right there?
12 A. No.
13 Q. Larger?
14 A. Maybe two.
15 Q. Would it fit in this kind of
16 briefcase that we lawyers and airline pilots use?
17 A. You need to understand that I
18 was carrying two copies of it, so that's what you
19 have to do. So my perception is two copies would
20 not have fit in there.
21 Q. Would two copies have fit in
22 two of these type of briefcases that we lawyers
23 lug around in airports?
24 A. I think it might have.
Page 230
1 Q. Do you recall having two big
2 briefcases with you or did you carry it in a box?
3 A. A box or two, one or two
4 boxes.
5 Q. Did you check that box?
6 A. No, I was on the Lilly
7 aircraft.
8 Q. What kind of aircraft was
9 that?
10 A. I'm not into aircraft, I can't
11 tell you what kind. It was a small one.
12 Q. Was it a jet or is it a turbo
13 prop?
14 A. I think it was a jet.
15 Q. How many airplanes did Lilly
16 have at that time?
17 A. I do not know.
18 Q. How many different ones had
19 you flown on up to that time?
20 A. Two or three.
21 Q. Was this the smallest or the
22 largest of the jets that you had -- that you flew
23 on in July of 1990?
24 A. It was not the largest.
Page 231
1 Q. All right. How many
2 passengers would that jet that you flew on in
3 July of 1990 hold, approximately?
4 A. Either twelve or fourteen.
5 Q. And it's your testimony that
6 Lilly had at that time a larger jet?
7 A. I remember at some time they
8 had a larger jet.
9 Q. Okay. That package of
10 material that you took to Doctor Leber at the
11 Food and Drug Administration on the Lilly
12 corporate jet aircraft that was two boxes of
13 material, was that all you took?
14 A. Yes.
15 Q. The reason I ask is on page
16 two of the memo, and page two of the exhibit,
17 paragraph three says Paul also asked for a
18 chronology of all label changes on Prozac, right?
19 A. I can read that, yes.
20 Q. Was what you were carrying a
21 chronology of label changes or was the data on
22 eight different adverse event issues?
23 A. It was the latter.
24 Q. So you didn't take to
Page 232
1 Washington on the corporate jet the chronology of
2 label changes?
3 A. I don't recall a chronology.
4 Q. This data on eight different
5 adverse event issues, did you compile that data?
6 A. No.
7 Q. Who compiled that data?
8 A. The clinical medical group.
9 Q. But was this a part of the
10 regulatory process that would have been funneled
11 through you?
12 A. The end of it. I would have
13 been the end of the conduit just before it went
14 to the FDA.
15 Q. And your work would have
16 probably been in either under your name or Doctor
17 Talbott's name of preparing a transmittal letter
18 identifying the data, is that right?
19 A. Yes.
20 Q. Did you do that in connection
21 with this data on eight different adverse events?
22 A. Yes.
23 Q. You prepared a transmittal
24 letter?
Page 233
1 A. Yes.
2 Q. And is that transmittal letter
3 what's dated July 17, 1990?
4 A. Yes, I believe it is.
5 Q. All right. And what is your
6 recollection of what that transmittal letter
7 said?
8 A. I remember that the eight
9 issues are in the letter.
10 Q. Were set out?
11 A. Yes. You know, they're not in
12 line, they're like indented one through eight.
13 Q. Was that under your signature
14 or Doctor Talbott's signature?
15 A. Doctor Talbott's.
16 Q. Did you sign it or did Doctor
17 Talbott sign it?
18 A. Doctor Talbott signed it.
19 Q. We'll get to the details on
20 your trip to Washington in just a second. Look
21 at paragraph one, two, three, four. There,
22 Doctor Leber, in paragraph four -- I mean Doctor
23 Thompson, in paragraph four, states that Doctor
24 Leber says, quote, he asked that we fax nothing
Page 234
1 to him unless he had agreed to it beforehand. He
2 said that, quote within a quote, someone had
3 found that mailbox, either makes a second route
4 of information, end quote. Continuing what he
5 said in the paragraph, so he said he was warning
6 people like us not to use fax unless we had
7 specifically agreed with him to do so, period,
8 end quote. Do you know anything about the fax
9 situation at the FDA?
10 A. I have faxed documents to the
11 FDA.
12 Q. Have you ever had any problem
13 with items being lifted, for want of a better
14 word, from the FDA fax machine?
15 A. I have never been told that
16 that happened.
17 Q. Did you ever have a problem
18 getting material to the Food and Drug
19 Administration via fax?
20 A. No.
21 Q. Was faxing data to the Food
22 and Drug Administration something that you did
23 regularly?
24 A. Not as often as regularly,
Page 235
1 occasionally.
2 Q. What percentage of the data
3 that you transmitted to the Food and Drug
4 Administration would you use an initial
5 transmission by facsimile transmission?
6 A. A very small percentage.
7 Q. After this -- after you read
8 this memo, did you quit faxing information to the
9 Food and Drug Administration?
10 A. I believe that I always asked
11 permission first.
12 Q. Do you know anything about
13 what they're saying there about the problems with
14 the fax at Washington?
15 A. Well, you'll notice later they
16 talk about Paul Leber's computer, and there was a
17 story about it, its integrity, the security being
18 compromised.
19 Q. Tell me that story.
20 A. Well, I read it in a gossip
21 sheet about regulatory issues that's distributed
22 all around the world, and I don't know how it
23 happened, but somehow someone got in and read
24 some memos he had made for himself.
Page 236
1 Q. Somebody had gotten into
2 Doctor Leber's personal computer --
3 A. At the FDA.
4 Q. -- at the Food and Drug
5 Administration, and read memos that he had
6 authored on that computer that were stored in the
7 computer?
8 A. Yes.
9 Q. And then you read something
10 about this in some gossip page that was sent all
11 over the world?
12 A. It's like a newsletter,
13 regulatory newsletter. I don't remember which
14 one it was, I could see it in my mind's eye, but
15 since there are two or three of them, I don't
16 remember which one it was.
17 Q. Was this a newsletter that was
18 sent out by the Food and Drug Administration or
19 was this a newsletter that was sent out by some
20 other?
21 A. The latter. It's someone who
22 just does this to make money on a subscription.
23 Q. What was said in that gossip
24 column about somebody breaking into his computer,
Page 237
1 Doctor Leber's computer?
2 A. Well, they just said that it
3 happened. As I recall they gave a couple of
4 examples of things that were mentioned there.
5 Q. Like what?
6 A. Like he said something
7 derogatory about someone else at the FDA in a
8 memo.
9 Q. What else?
10 A. I don't remember anything, it
11 was a lot of hearsay, and it was -- this
12 newsletter is mainly meant to just be
13 provocative, and I don't know what else it said
14 that was of any interest, nor do I remember it.
15 Q. You don't -- certainly are not
16 speaking for the factual authenticity of this
17 newsletter?
18 A. No, but I think people did
19 believe this break-in happened.
20 Q. Beg your pardon?
21 A. People do believe that this
22 happened.
23 Q. Who was the other FDA official
24 that it was attributed to Doctor Leber was
Page 238
1 critical of?
2 A. I no longer recall that.
3 Q. Beg your pardon?
4 A. I don't recall.
5 Q. When did this occur in
6 connection with the date of this memo of July 18,
7 1990?
8 A. I don't recall the date.
9 Q. Did you know about that
10 computer break-in yourself when you read this
11 memo for the first time?
12 A. I don't know, but there's a
13 good chance that I did.
14 Q. And, so, it's your testimony
15 that after you saw this memo, that you quit using
16 the fax unless you called somebody at the Food
17 and Drug Administration and got permission to fax
18 something to them?
19 A. Yes.
20 Q. Who were you calling?
21 A. Paul David.
22 Q. The memo goes on to say in
23 that same paragraph, I think we better start
24 using the Washington office more aggressively to
Page 239
1 transmit stuff, as this link to the break-in into
2 Paul's computer, et cetera. I also want to
3 reenergize our periodic discussions about opening
4 an office adjacent to the Parklawn Building,
5 specifically for the purposes of expediting
6 submissions, dialogue, and meetings; correct?
7 A. That's what it says.
8 Q. Was there a Washington office
9 of Eli Lilly and Company in existence?
10 A. Yes.
11 Q. Where was it located?
12 A. Someplace downtown in
13 Washington, I don't know the address.
14 Q. When he's talking about an
15 office adjacent to the Parklawn Building -- the
16 Parklawn Building is where the Food and Drug
17 Administration was, right?
18 A. Yes.
19 Q. And Doctor Thompson was
20 wanting either in lieu of or in addition to the
21 Washington office, a new office next to the
22 Parklawn Building; correct?
23 A. Yes.
24 Q. Was that ever done?
Page 240
1 A. No.
2 Q. Doctor Webber, if you go down
3 to the next to the last paragraph, there's a
4 sentence there that says Paul is taking a
5 position -- Paul being Doctor Leber. Paul is
6 taking a position in talking with outside folks
7 today that Lilly and FDA are working together on
8 the suicide issue, and following closely the
9 post-marketing events. But there are no
10 denominators, and the best that can be done is to
11 put a cap on the number of events. Do you see
12 that?
13 A. I see it.
14 Q. Did you have any discussions
15 with Doctor Talbott about that?
16 A. Not that I can recall, I don't
17 think so.
18 Q. Did you have any discussions
19 with Doctor Talbott about putting any kind of cap
20 on the number of post-marketing adverse events?
21 A. No.
22 Q. Did you have a discussion with
23 anybody at Eli Lilly about putting a cap on the
24 number of post-marketing adverse events?
Page 241
1 A. No.
2 Q. Did you ever do anything,
3 design or calculate it to put a cap on the number
4 of post-marketing events in connection with
5 Fluoxetine and suicide?
6 A. No.
7 Q. Do you know of anybody that
8 did?
9 A. No.
10 Q. Do you have any explanation as
11 to why Doctor Leber would suggest that some
12 individual or Lilly, as an entity, would or
13 should put a cap on the number of post-marketing
14 adverse events?
15 A. No.
16 Q. Did you ever talk to Doctor
17 Leber about that?
18 A. No.
19 Q. Did you ever talk to Paul
20 David about that?
21 A. No.
22 Q. Did you ever talk to Robert
23 Temple about that?
24 A. No.
Page 242
1 Q. Did you ever talk to Tom
2 Laughren about that?
3 A. No.
4 Q. Did you ever talk to anybody
5 at the Food and Drug Administration about that?
6 A. No.
7 Q. Would this be something that
8 you, as a regulatory scientist in charge of
9 Fluoxetine, would know would be illegal in
10 connection with the reporting of adverse events
11 in connection with the medication?
12 MR. MYERS: Before he answers, let me
13 just object to the form in that you're asking him
14 to comment on the contents of a memo that he
15 didn't write, some terms of which may not be
16 defined. But if you know, tell him.
17 A. I think you have misunderstood
18 this memo, okay. I'm going to have to have you
19 repeat the question that's been -- it was long,
20 and he objected, and I want to have it repeated,
21 please.
22 (THE COURT REPORTER READ BACK THE
23 REQUESTED TESTIMONY.)
24 A. You mean -- that's all it
Page 243
1 says, is this?
2 MR. MYERS: What's the question
3 before, would that be helpful?
4 MR. SMITH: Yes.
5 (THE COURT REPORTER READ BACK THE
6 REQUESTED TESTIMONY.)
7 A. You mean literally what this
8 says?
9 Q. Yes.
10 A. I've never talked to anyone at
11 the FDA about this.
12 Q. Would putting a cap on a
13 number of adverse events in connection with a
14 drug be illegal in your capacity as a regulatory
15 scientist?
16 A. I'm not a lawyer, but it
17 doesn't sound like it's something that should be
18 done.
19 Q. You say, and I maybe
20 misunderstood this memo, is that what you said?
21 A. Yes.
22 Q. I didn't author the memo.
23 A. Neither did I.
24 Q. Neither did you.
Page 244
1 A. Yes, but I interpreted it
2 differently.
3 Q. All I can do is read what
4 words are written here. Have you got some
5 different interpretation of this memo based on
6 some additional investigation you made or some
7 facts that you know about?
8 A. No.
9 Q. What is your interpretation?
10 A. Well, my interpretation is
11 that you can determine the number, but you can't
12 determine the rate. And that word cap is just an
13 unfortunate use of that word.
14 Q. What do you mean you can
15 determine the number, but --
16 A. You can count them, but you
17 can't tell how often they happen.
18 Q. Count what?
19 A. The post-marketing event.
20 Q. Adverse events?
21 A. Uh-huh.
22 MR. MYERS: Yes.
23 A. Yes, sorry.
24 Q. You can count them, but you
Page 245
1 can't put -- I don't understand, you've lost me,
2 but you can't put a rate?
3 A. You can't determine the rate
4 because you don't have a denominator, as he says
5 here.
6 Q. What do you mean by rate?
7 MS. ZETTLER: They keep talking about
8 percentage of incidents, Paul.
9 A. Yes.
10 Q. So since you can't determine
11 the denominator, then what you should do is
12 reduce the numerator?
13 A. No, I don't think that's what
14 that says.
15 Q. It says what it says, don't
16 it?
17 A. I said what I thought it said.
18 Q. Have you talked to anybody at
19 Eli Lilly and Company about what this is saying?
20 A. No.
21 Q. Did you question anybody at
22 Eli Lilly and Company concerning what Doctor
23 Thompson meant when he characterized what Doctor
24 Leber was saying?
Page 246
1 A. No.
2 Q. The word cap is put in quotes,
3 is it not?
4 A. I see it.
5 Q. It is put in quotes, is it
6 not?
7 A. Yes.
8 Q. Does that denote to you, in
9 your reading, that Doctor Thompson is -- or the
10 author of this memo is intending to quote actual
11 wording made by the person who made the
12 statement?
13 MR. MYERS: I object to the form, that
14 would be speculative. If you know, tell him.
15 A. I don't know.
16 Q. Is that what you do when
17 you're trying to quote what somebody else has
18 said, do you put it in quotes?
19 A. Yes.
20 Q. And if you're trying to
21 capture exactly a term that somebody else is
22 using, don't you put it in quotes?
23 A. Yes.
24 Q. So I'm still not certain what
Page 247
1 your interpretation -- and I'm interested. I'm
2 still not certain about what your interpretation
3 is, as the regulatory scientist in charge of
4 Fluoxetine, what this means.
5 A. Well, I can only repeat
6 myself.
7 Q. Okay. Then do because I'm a
8 little slow.
9 A. That you can know the number
10 of events, but you can't know in what population
11 it occurred in, so you can't come up with
12 incidence.
13 Q. All right. So he's saying put
14 a cap on the number of events, adverse events;
15 correct?
16 MR. MYERS: Let me object to the form.
17 That would be speculation as to what he's saying,
18 Doctor Thompson is saying.
19 Q. What the memo says is the best
20 thing that can be done is put a cap on the number
21 of events, isn't it, that's what the memo says.
22 A. That's what it says.
23 Q. And so I take it that we're
24 both communicating here, that they're wanting to
Page 248
1 reduce -- cap to reduce the number of events; is
2 that correct?
3 A. No, that's not.
4 MR. MYERS: Same objection.
5 Q. Why is it not correct?
6 A. You asked me if that's how I
7 understood it, and I said that's not how I
8 understood it.
9 Q. How do you understand it?
10 A. Do you want me to repeat it
11 for a third time?
12 Q. I guess so, you know, I'm not
13 a mathematician and I'm not a chemist, and I'm
14 not a regulatory scientist.
15 A. You can determine the number
16 of events.
17 Q. The number of adverse events.
18 A. Yes.
19 Q. Okay. Let's use, for example,
20 you can determine the number of suicide attempts
21 reported; correct?
22 A. Correct.
23 Q. But you can't determine what?
24 A. The patient population.
Page 249
1 Q. So you don't know how many
2 people are taking Fluoxetine versus how many
3 people are reporting suicide attempts on
4 Fluoxetine, is that right?
5 A. I think that's what is implied
6 here.
7 Q. So what does the cap apply to
8 under your interpretation of what he means?
9 A. The cap is -- I don't have the
10 same interpretation as you do of the word cap.
11 Q. How do you interpret that?
12 A. You collect that number.
13 Q. Okay. So instead of -- your
14 reading of it is what Doctor Thompson intended to
15 say when he quoted cap was collect.
16 MR. MYERS: I object to the form,
17 that's speculation of what Thompson meant. He
18 told you what he believed it to mean.
19 MR. SMITH: I understand that that's
20 what he believes.
21 A. That's what I think it meant.
22 Q. Have you ever looked in a
23 syllabus, thesaurus, dictionary, or anything, to
24 see that the definition of cap and collect is in
Page 250
1 any way similar?
2 A. No, I have not.
3 Q. Have you ever used the term
4 cap when you mean collect?
5 A. No.
6 Q. Have you ever heard anybody
7 else use the term cap when they mean collect?
8 A. I don't think so.
9 Q. This would then be the only
10 instance in which throughout your entire lifetime
11 that you've heard the word cap used when the
12 meaning was collect, is that right?
13 A. That's right.
14 Q. Okay. Let's go to page three
15 of the document -- wait a second.
16 (DISCUSSION OFF THE RECORD.)
17 Q. So I can be clear, Doctor
18 Webber, you're not a statistician?
19 A. No, I'm not.
20 Q. You're not an epidemiologist?
21 A. No, I'm not.
22 Q. And you don't use statistical
23 or epidemiological terms?
24 A. That's correct.
Page 251
1 Q. Okay. On page three, your
2 name is mentioned; correct?
3 A. Correct.
4 Q. It looks like Doctor Talbott
5 is authoring a reply to Doctor Amundson in
6 connection with Doctor Thompson's messages, is
7 that right, is that what this first line is or
8 first section is here?
9 A. That's what it looks like to
10 me.
11 Q. All right. It says there that
12 Dan and his guys are still wrestling with the
13 wording of one section, and we have Al booked on
14 a series of a.m. flights to DC to hand-deliver
15 the document today; correct?
16 A. That's what it says.
17 Q. Were you in fact booked on
18 some commercial flights, and then had to take an
19 Air Lilly flight?
20 A. I did take an Air Lilly plane,
21 I don't know how far the booking actually got on
22 commercial, I can't remember that.
23 Q. But they were standing by to
24 book you on some flights, and if you could make
Page 252
1 it, you were going to, if not, you were going to
2 get on the corporate jet; correct?
3 A. Yes.
4 Q. The next sentence there says
5 Doctor Talbott talking to Doctor Amundson, right?
6 A. Yes.
7 Q. We have to do this, that is
8 book you on a series of a.m. flights, and have
9 you hand-deliver the document, we have to do this
10 since we do not have faith in the FDA document
11 control room to move any critical documents
12 through correctly in a fast manner. Okay. Did
13 you and Doctor Talbott discuss this that morning?
14 A. I don't recall that we
15 discussed it.
16 Q. Were you aware of a problem
17 with the FDA document control room at that time?
18 A. Yes.
19 Q. Tell me about that problem?
20 A. This was the neuropharm
21 division's document control room, not the FDA's,
22 although neuropharm is part of the FDA.
23 Q. What is the difference?
24 A. Each different division at the
Page 253
1 FDA has a document control room.
2 Q. What is a document control
3 room?
4 A. It's a room that receives
5 them, stores them and distributes them according
6 to what they're told to do.
7 Q. What is them?
8 A. Them is the submissions.
9 Q. Submissions?
10 A. Yes, documents that a sponsor
11 sent.
12 Q. You mean like any documents?
13 A. Yes.
14 Q. Not a formal like NDA
15 submission.
16 A. That, too.
17 Q. But not limited to a formal
18 NDA submission?
19 A. That's right.
20 Q. Any document?
21 A. Any document.
22 Q. That Lilly would be submitting
23 to the Food and Drug Administration in connection
24 with Prozac or Fluoxetine Hydrochloride would go
Page 254
1 through the neuropharm FDA document control room?
2 A. Correct.
3 Q. And there was a problem there?
4 A. Yes.
5 Q. And the problem was what?
6 A. Sometimes they couldn't find
7 the documents, sometimes they didn't get
8 forwarded to the right people in a timely
9 fashion. Just what Doctor Talbott says.
10 Q. How many people worked in the
11 FDA document control room in neuropharm?
12 A. I don't know.
13 Q. Well, you've been there,
14 haven't you?
15 A. I have walked by.
16 Q. Didn't you go there that day?
17 A. Yes.
18 Q. So how many people were in
19 there?
20 A. Are you asking me how many
21 people I saw at that moment?
22 Q. Yes.
23 A. One, two, three, I don't
24 recall.
Page 255
1 Q. Did that person seem
2 particularly inefficient to you?
3 A. No.
4 Q. Had you had, you personally,
5 had any experience of submissions getting lost or
6 being delayed or not being able to be found?
7 A. Yes.
8 Q. What kind of problems had you
9 had in that connection?
10 A. What I just said, they would
11 lose them, they would be slow to get moved on to
12 the reviewers.
13 Q. What was the rush in getting
14 this document over?
15 A. I don't know what it was other
16 than the quotes here that we had promised them it
17 at a certain time.
18 Q. Was this something that they
19 had requested earlier?
20 A. No.
21 Q. How do you know that?
22 A. Because I know we did it
23 voluntarily.
24 Q. No, but is this something that
Page 256
1 you had -- well, had they requested it earlier or
2 had you promised it earlier, or do you know?
3 A. You asked me two questions.
4 Q. Well, go back to page one so
5 we can identify this. The first sentence of the
6 last paragraph there says he, meaning Doctor
7 Leber, has been awaiting the package of material,
8 meaning this two boxes of compilation and data on
9 eight different adverse event issues, from us,
10 which I promised he would have in his hand this
11 afternoon, all right?
12 A. That's what it says.
13 Q. Okay. Had you and Doctor
14 Thompson talked about this document?
15 A. I don't recall that we had
16 talked about it.
17 Q. How did Doctor Thompson know
18 about its existence?
19 A. He must have been aware of
20 what was going on in medical.
21 Q. What was going on in medical?
22 A. Preparation of this document.
23 Q. But it's your testimony that
24 it's your recollection this wasn't something that
Page 257
1 the FDA was pressing Lilly for.
2 A. That's correct.
3 Q. But it was something that
4 Doctor Leigh Thompson promised to get in Doctor
5 Leber's hand?
6 A. I did not know that until I
7 read this here.
8 Q. But you were doing everything
9 you could to get yourself to Washington, DC and
10 walk this thing through and get it in Doctor
11 Leber's hands, weren't you?
12 A. That's correct.
13 Q. Did you actually see Doctor
14 Leber --
15 A. No.
16 Q. -- when you took the document
17 through?
18 A. No.
19 Q. Who did you give the document
20 to?
21 A. I'm not sure I remember. It
22 was either to Paul David or to the document
23 control room.
24 Q. I thought you were trying to
Page 258
1 get past the document control room.
2 A. When we send things, we send
3 them Federal Express, and I could say that I
4 handed it, whereas if we use Federal Express, you
5 could only know that the Federal Express handed
6 it. But I may have handed it to the CSO.
7 Q. Doctor Talbott is not
8 expressing a problem with Federal Express.
9 A. I don't think so.
10 Q. He's expressing a problem with
11 the FDA document control room.
12 A. Yes.
13 Q. And you had experienced a
14 problem with the FDA document control room,
15 hadn't you?
16 A. Yes.
17 Q. So I would assume -- or is it
18 your testimony that you may have, even in light
19 of this memo, and even in light of the problems
20 that you and Doctor Talbott had both had, that
21 you might have submitted this document to the
22 document control room?
23 A. I don't recall who I handed it
24 to.
Page 259
1 Q. Does the document control room
2 or does somebody there at the FDA have to do like
3 clerks in a court and stamp a file marked or
4 receive marked or an official insignia of the FDA
5 on a document once it's received by them?
6 A. As a matter of fact, I believe
7 they do.
8 Q. Is that something that has to
9 be affixed in the document control room?
10 A. For example, it may be that I
11 stopped, got that stamped, then took it to Paul
12 David.
13 Q. Exactly, we lawyers do that on
14 occasion, we get the clerk to stamp something,
15 and then go back and have a whoopy ex parte
16 hearing with the judge or something.
17 MR. SMITH: Take that out.
18 MR. MYERS: Leave it right where it
19 is, Exhibit A.
20 Q. Do you remember any comment
21 that Paul David might have had when you got the
22 document there?
23 A. I don't remember any.
24 Q. It says here, I think the big
Page 260
1 rub is Dan is getting --
2 MR. MYERS: Where are you, Paul, did
3 you move back to the third page?
4 MR. SMITH: Yes, I'm sorry.
5 Q. I'm back to the third page,
6 middle of that first paragraph. I think the big
7 rub is Dan, et al, getting the document done.
8 Which Dan are they talking about?
9 A. Dan Masica, I believe.
10 Q. I may have asked you this,
11 Doctor Webber, but at any time either when you
12 began as the regulatory scientist in charge of
13 Prozac, Fluoxetine Hydrochloride, at Eli Lilly
14 and Company, did you ever make any determination
15 concerning the number of total adverse events
16 that had been experienced in connection with
17 Prozac for any reason?
18 A. No.
19 Q. Or Fluoxetine Hydrochloride?
20 A. No.
21 Q. Did you, as chief regulatory
22 scientist, ever make any effort to count the
23 number of adverse events with respect to suicidal
24 ideation, suicide attempts or suicide in
Page 261
1 connection with Fluoxetine Hydrochloride?
2 A. No.
3 Q. Would you be able to do that
4 were you asked to do that?
5 A. I could not do it by myself,
6 no.
7 Q. You would have -- you would
8 have the availability to secure that data,
9 though, do you not?
10 A. I could ask for it, I believe,
11 and get it.
12 Q. With assistance from
13 individuals and systems analysts, and things of
14 that nature; correct?
15 A. Yes.
16 MR. SMITH: That's all I've got for
17 today. I've got a plane to catch.
18 MR. MYERS: Do you want to start
19 asking questions or do you want to resume
20 tomorrow?
21 MS. ZETTLER: Let's resume tomorrow.
22 * * * * * * * * * *
23 (THE DEPOSITION WAS ADJOURNED
24 UNTIL 9:00 A.M., DECEMBER 17,
Page 262
1 1993, WHEREUPON THE DEPOSITION
2 WAS CONTINUED AS FOLLOWS:)
3 * * * * * * * * * *
4 CROSS-EXAMINATION
5 BY MS. ZETTLER:
6 Q. Doctor, welcome back.
7 A. Good morning.
8 Q. I introduced myself briefly
9 yesterday. My name is Nancy Zettler, and I
10 represent the plaintiffs in the Fentress versus
11 Shea Communications case. That's a case that's
12 pending in Louisville resulting from the events
13 in September, 1989 related to Joseph Wesbecker.
14 Do you know anything about that case?
15 A. I'm aware of it.
16 Q. Can you tell me what you know
17 about the incidents of Joseph Wesbecker?
18 A. The only thing I'm really
19 aware of is what was in the news media, I
20 remember the Standard Gravure Company's name,
21 because I've heard it over and over. I'm aware
22 that he shot some people. I guess he killed
23 himself, but I'm not sure.
24 Q. In your capacity as -- and I
Page 263
1 was listening down there, but I didn't take very
2 good notes, but I believe you were the regulatory
3 scientist in charge of Fluoxetine; correct, since
4 1988?
5 A. Yes.
6 Q. Are you still regulatory
7 scientist in charge of Fluoxetine?
8 A. Yes.
9 Q. In that capacity, have you
10 received any interoffice memorandums regarding
11 the Wesbecker case?
12 A. Not that I can recall.
13 Q. Have you attended any meetings
14 revolving around or related to that case?
15 A. No.
16 Q. A couple of Lilly clean-up
17 items from yesterday. Can you tell me what your
18 date of birth is?
19 A. Yes, August 14th, 1940.
20 Q. And your Social Security
21 number?
22 THE WITNESS: Should I give her that?
23 MR. MYERS: Yes, sure.
24 A. xxxxxxxxxxx.
Page 264
1 Q. Doctor, just to relieve your
2 concern, the only reason we want that is if for
3 some reason you leave Lilly and you move or
4 something and we need to find you, that's all.
5 MR. MYERS: They haven't been too
6 nosey so far.
7 Q. Do you have plans to move in
8 the near future?
9 A. No.
10 Q. Do you have any plans to leave
11 Lilly in the near future?
12 A. No.
13 Q. Yesterday you talked to Paul a
14 little bit about your training at Lilly when you
15 took over the position as regulatory scientist on
16 Fluoxetine. Do you recall that?
17 A. Yes.
18 Q. Did you receive any formal
19 training in FDA regulations?
20 A. I'm not sure how you define
21 formal. My definition of formal is no.
22 Q. What type of training -- did
23 you receive any training with regards to FDA
24 regulations?
Page 265
1 A. Yes.
2 Q. What type of training did you
3 receive?
4 A. Well, they were on-the-job,
5 day-to-day, hour-to-hour exposure to mentoring by
6 the people at Lilly who did know, someone with
7 more experience, someone I could ask questions
8 to. When a need came up, I would read documents
9 available, for example the Code of Federal
10 Regulations.
11 Q. In the course of your
12 employment at Lilly as a regulatory scientist on
13 Fluoxetine, did you attend any seminars related
14 either to the FDA regulations or Fluoxetine?
15 A. Not on Fluoxetine. I did
16 attend a course at Lilly given by a gentleman who
17 I believe works in Washington. I don't recall
18 his name, but I think he was on food and drug
19 law. And it was right at the beginning of my
20 time in regulatory, probably a lot of it probably
21 didn't sink in because I had no practical use for
22 it.
23 Q. You say a gentleman from
24 Washington, was he with a governmental agency as
Page 266
1 far as you know?
2 A. I don't think so, I think he
3 was doing this for pay.
4 Q. As if governmental agencies
5 don't do anything for pay. Okay. Did you
6 receive any documents, manuals, guides, things
7 like that, during the seminar?
8 A. I recall that I did.
9 Q. Did you save that or keep
10 those documents?
11 A. I don't recall, possibly.
12 Q. Was there a manual at Lilly
13 that you could refer to with regards to federal
14 regulations?
15 A. Only the Code of Federal
16 Regulations, which I don't consider what you mean
17 by manual.
18 Q. I mean a company created
19 manual or book of some sort.
20 A. That's what I thought you
21 meant, no.
22 Q. So you actually had a copy of
23 the Code of Federal Regulations available to you?
24 A. Yes.
Page 267
1 Q. Prior to becoming a regulatory
2 scientist on Fluoxetine, had you had any
3 experience in reading and/or interpreting federal
4 regulations?
5 A. From February of '88 to the
6 Summer?
7 Q. Right, prior to that.
8 A. Well, you said --
9 Q. I'm sorry, go ahead.
10 A. You said when I started on
11 Fluoxetine. That was the Summer of '88. I
12 started in regulatory in February of '88. So
13 during -- between February and the Summer of '88,
14 I did.
15 Q. Prior to starting in
16 regulatory, let's do it that way, had you had any
17 experience in reading or interpreting or using
18 the federal regulations?
19 A. No.
20 Q. This seminar that you took
21 where the guy from Washington came in and talked
22 about the regulations, was this before or after
23 you started with Fluoxetine?
24 A. I don't recall.
Page 268
1 Q. Yesterday you talked with Paul
2 briefly about having asked that the depiction of
3 the formula for Fluoxetine or for Prozac be
4 altered or changed in the package insert. Do you
5 recall that?
6 A. Yes.
7 Q. Why is it that you felt that
8 the depiction needed to be changed?
9 A. I felt as a chemist it lacked
10 elegance.
11 Q. When you say elegance, what do
12 you mean?
13 A. It was a more complicated
14 depiction of what it looked like than what a
15 chemist would write, and since that was my area
16 of expertise -- and the structure that we put in
17 was the exact same structure that appears in the
18 USAN book, which I was happy with.
19 Q. So you say the structure that
20 you put in, you mean the structure --
21 A. The appearance of it, the way
22 it represented at some positions.
23 Q. When you say the structure
24 that you put in, you mean after you made your
Page 269
1 recommendations to change the depiction?
2 A. Yes.
3 Q. I'm trying to find out --
4 A. Yes.
5 Q. What is USAN?
6 A. It stands for United States
7 Approved Names.
8 Q. And there's a depiction of the
9 chemical structure of Fluoxetine in the USAN
10 book?
11 A. Yes.
12 Q. Is it anything like the PDR,
13 does it have an entire copy of the package
14 inserts?
15 A. No, it has very limited
16 information, possibly none.
17 Q. So it's basically setting
18 forth that the brand name has been approved and
19 showing the chemical structure of the drug?
20 A. No, it's just a compilation of
21 names of drugs, generic trade, a picture of their
22 structure, some simple chemical facts about them.
23 There may be some other information.
24 Q. Manufacturer name?
Page 270
1 A. I'm not sure.
2 Q. Does it have indicated uses in
3 there?
4 A. I don't think so.
5 Q. Okay. Just so I'm not
6 confused, okay, you felt that when you first
7 started working on Fluoxetine that the depiction
8 of the chemical formulation was too complicated?
9 A. Yes, and lacked the organic
10 chemical elegance that someone with my background
11 would have liked.
12 Q. So the reason that you wanted
13 to change it was to simplify the depiction and
14 make it look better?
15 A. Yes.
16 Q. When you change the chemical
17 depiction of a drug in the package insert, do you
18 have to get FDA approval to do that?
19 A. We did not in this particular
20 case.
21 Q. Why not?
22 A. We submitted it under three
23 fourteen seventy C.
24 Q. When you say fourteen seventy
Page 271
1 C, what do you mean?
2 A. It's that part of the Code of
3 Federal Regulations.
4 Q. And what is that --
5 A. That --
6 MR. MYERS: Let her finish.
7 Q. Doctor, you have to let me
8 finish my question, only because it's very hard
9 for Kathy to take it down, plus it's not going to
10 make it go any quicker because we're going to
11 have to keep repeating. What is it about
12 fourteen seventy C that allows you to make a
13 change such as changing the depiction of the
14 chemical formula without FDA approval?
15 A. That regulation states that --
16 that's a regulation under which you can submit
17 things without prior approval.
18 Q. What do you mean when you say
19 submit things without prior --
20 A. I'm sorry, submit labeling
21 revisions.
22 Q. Is there anything else that
23 can be submitted as a label revision under
24 fourteen seventy C without prior approval?
Page 272
1 A. Anything else?
2 Q. Any of the elements of the
3 package insert that can be changed without prior
4 approval under fourteen seventy C?
5 A. Yes.
6 Q. What?
7 A. Safety changes.
8 Q. Anything else?
9 A. I believe you may be able to
10 change like manufacturing sites, but I have never
11 had that experience. When I want to use that
12 regulation, I look it up, if it's not something
13 I've had experience with.
14 Q. When you say safety changes --
15 for instance, if through experience after the
16 drug is on the market, a new adverse event
17 appears, can the company go in and add that
18 adverse event under post-marketing experience
19 without approval from the FDA?
20 A. Yes.
21 Q. Can they delete any adverse
22 experiences under that section of the code
23 without the prior approval of the FDA?
24 A. I don't believe so.
Page 273
1 Q. So it's really just a matter
2 of adding and refining as opposed to deleting
3 information?
4 A. Yes.
5 Q. Any other changes to the
6 Fluoxetine or Prozac package insert that you
7 recall that were made under fourteen seventy C?
8 A. Yes.
9 Q. What changes?
10 A. We had -- we changed the site,
11 the amount, the soluability information, as I
12 recall.
13 Q. Anything else?
14 A. I don't remember anything
15 else.
16 Q. Could Lilly have added
17 information indicating that post-marketing
18 experience raised the issue of suicidality and
19 the use of Fluoxetine under fourteen seventy C?
20 MR. MYERS: Before he answers, let me
21 object to the form only because the form of the
22 question is --
23 MS. ZETTLER: It's a bad question, let
24 me ask it again, I agree that it's a bad
Page 274
1 question.
2 MR. MYERS: I think I know what you're
3 trying to ask.
4 Q. I'm trying to look for the
5 right word here. If, in post-marketing
6 experience, Lilly had received adverse event
7 reports of suicides and suicide attempts with the
8 use of Fluoxetine, could they have added
9 suicidality as an adverse event under
10 post-marketing experience without approval by the
11 FDA under fourteen seventy C?
12 A. I feel that they could.
13 Q. Do you know if they attempted
14 to do that?
15 A. You need to repeat the exact
16 term that you used.
17 Q. Okay. Let me -- to your
18 knowledge did Lilly at any time seek to amend the
19 package insert to include suicidality as a
20 post-marketing adverse event under fourteen
21 seventy C?
22 A. No.
23 Q. How about incidents of
24 violent/aggressive behavior, to your knowledge
Page 275
1 did Lilly ever attempt to amend the package
2 insert to include violent/aggressive behavior as
3 a post-marketing adverse event under fourteen
4 seventy C?
5 A. No.
6 Q. Did they apply or ask the FDA
7 for permission to add either one of those adverse
8 events to the package insert?
9 A. No.
10 Q. How is it they ended up in the
11 package insert?
12 A. Well, the words that are there
13 are close to what you said, but they're not
14 literally what you said.
15 Q. Okay. What words are there?
16 A. Words there are final
17 behaviors, I believe, and suicidal ideation.
18 Q. Okay. Did Lilly add the term
19 suicidal ideation to the package insert as a
20 post-marketing adverse event under fourteen
21 seventy C?
22 A. Yes.
23 Q. When did they do that?
24 A. I don't recall a year and
Page 276
1 month.
2 Q. How about violent behavior,
3 did they add that adverse event term to the
4 package insert under fourteen seventy C?
5 A. Yes.
6 Q. So it's your testimony that
7 Lilly voluntarily added those two adverse events
8 to the package insert?
9 A. Yes.
10 Q. To your knowledge did they
11 receive any resistance from the FDA on adding
12 either one of those terms?
13 A. Not to my knowledge.
14 Q. How about interaction with MAO
15 inhibitors, it's my understanding that it was
16 changed from the warning section to the
17 contraindication section at some point in time.
18 Do you recall that?
19 A. Yes.
20 Q. Was that done under fourteen
21 seventy C?
22 A. I believe it was.
23 Q. Did you have any
24 responsibility with regards to amending the
Page 277
1 package insert on these three occasions, adding
2 violent behavior, adding suicidality or making
3 the change from MAO inhibitors from warnings to
4 contraindications?
5 A. Yes.
6 Q. Why don't we start with
7 suicidal ideation, what was your responsibility
8 with regards to that?
9 A. My responsibility was to send
10 the package insert change to the FDA.
11 Q. How about with violent
12 behaviors, what was your responsibility with
13 regards to that?
14 A. The same as what I said.
15 Q. The same with MAO inhibitor
16 change?
17 A. Yes.
18 Q. Besides the addition of
19 suicidal ideation and violent behaviors to the
20 package insert, and the change of MAO inhibitor
21 information from warnings to contraindications,
22 do you recall -- and I believe the soluability
23 information that you talked about, do you recall
24 any other changes that were made to the package
Page 278
1 insert since you've been involved with Fluoxetine
2 that have been made under fourteen seventy C?
3 MR. MYERS: And the depiction?
4 MS. ZETTLER: Right.
5 A. Yes.
6 Q. What other changes?
7 A. I remember one regarding
8 hyponatremia.
9 Q. Anything else?
10 A. I don't remember. There were
11 others, but I don't remember the details of them.
12 Q. Anything related to agitation?
13 A. I don't remember that.
14 Q. Anything related to anxiety as
15 an adverse event?
16 A. I don't remember that either.
17 Q. Anything related to hostility?
18 A. No.
19 Q. What's hyponatremia, if you
20 know? Generally, I mean I know you're not a
21 doctor.
22 A. Well, hypo means low, and
23 natrime is related to sodium, so I believe it's
24 low sodium levels.
Page 279
1 Q. Besides the seminar that you
2 attended at Lilly related to federal regulations,
3 have you attended any other seminars at Lilly
4 directly or indirectly related to your job in
5 regulatory?
6 A. Well, I couldn't say no, there
7 must have been something. I don't recall
8 anything that sticks in my mind other than that
9 one.
10 Q. Any seminars that you attended
11 outside of Lilly that related to your job in
12 regulatory at Lilly?
13 A. I went to one seminar in
14 Washington.
15 Q. Okay. What was the subject of
16 that?
17 A. I do not recall the subject.
18 Q. Was it something that was put
19 on from a regulatory standpoint or was it from a
20 medical standpoint?
21 A. It probably was regulatory
22 information.
23 Q. Where was the seminar held?
24 A. I can picture the hotel, but I
Page 280
1 don't remember which one it was.
2 Q. Do you remember how long the
3 seminar lasted?
4 A. I think it was only one day.
5 Q. Anybody else from Lilly attend
6 the seminar with you?
7 A. I don't remember anyone being
8 with me.
9 Q. Do you remember when the
10 seminar was held?
11 A. No.
12 Q. Do you remember what year?
13 A. No.
14 Q. Do you recall if it was before
15 or after you started working on Fluoxetine?
16 A. I believe it may have been
17 after.
18 Q. Any other seminars that you
19 attended outside of Lilly that relates to your
20 job?
21 A. I don't recall any others.
22 Q. How about relating to
23 Fluoxetine, have you taken any seminars outside
24 of Lilly that directly relate to Fluoxetine?
Page 281
1 A. No.
2 Q. How about training inside at
3 Lilly, other than the mentoring program that you
4 talked about yesterday, did you receive any other
5 training at Lilly with regards to Fluoxetine?
6 A. Well, I'm sure I have gone to
7 seminars on it that were just of a scientific
8 nature.
9 Q. At Lilly?
10 A. Yes.
11 Q. Do you recall any of those
12 seminars?
13 A. No.
14 Q. Does Lilly hold seminars
15 on-site on a regular basis regarding the
16 compounds that they manufacture?
17 A. Yes.
18 Q. Is that part of a program, a
19 formal program, or is that just an educational
20 thing as subjects come up relating to a given
21 compound?
22 A. I believe it's part of
23 scientific communication.
24 Q. What is scientific
Page 282
1 communication?
2 A. Just one scientist talking
3 about their work with two other groups of
4 scientists, we call them seminars.
5 Q. So in other words, a scientist
6 from, say, toxicology would meet with scientist
7 from regulatory and medical and tell them what
8 they have been finding with regards to a subject
9 on a certain drug?
10 A. Yes.
11 Q. Scientific communication is
12 not a department at Lilly, is it?
13 A. No.
14 Q. So when you say scientific
15 communication, you're using it as a verb
16 basically, right?
17 A. Yes.
18 Q. Do you recall any of these
19 scientific communications on Fluoxetine?
20 A. No.
21 Q. How about on depression, have
22 you taken any seminars outside of -- or any other
23 kind of class outside of Lilly regarding the
24 disease depression?
Page 283
1 A. No.
2 Q. How about at Lilly, have you
3 received any classroom type or seminar type
4 education at Lilly regarding the disease of
5 depression?
6 A. No classroom, but I probably
7 have gone to a seminar.
8 Q. Do you recall any seminars
9 being held at Lilly regarding depression?
10 A. I don't recall specifically
11 that there were any.
12 Q. Have you received any
13 documents, pamphlets, manuals, books, texts or
14 anything from Lilly regarding depression?
15 A. I've seen those kinds of
16 things.
17 Q. Okay. When did you first see
18 those kinds of things?
19 A. I don't recall the exact date.
20 Q. Was it before or after you
21 started on Fluoxetine?
22 A. After.
23 Q. What types of documents have
24 you seen related to depression?
Page 284
1 A. I remember seeing patient
2 education information.
3 Q. Anything else?
4 A. Occasionally I'll see
5 promotional material.
6 Q. Anything else?
7 A. Occasionally I'll see a
8 publication -- I'm sorry, a journal publication
9 on something related to that.
10 Q. Like an industry journal, a
11 medical journal, psychiatric journal?
12 A. Yes.
13 Q. Anything else?
14 A. No.
15 Q. As part of your job in
16 regulatory, were you responsible for submitting
17 promotional material to the FDA for approval when
18 it was required?
19 A. No.
20 Q. Who would do that?
21 A. I think Doctor Talbott did
22 that.
23 Q. What department is Doctor
24 Talbott in?
Page 285
1 A. He's in medical regulatory
2 affairs.
3 Q. How does that differ from the
4 department that you're in?
5 A. That's the department I am in.
6 Q. He's your boss, right?
7 A. Yes, he is.
8 Q. Why would Doctor Talbott have
9 responsibility over submitting proposed
10 promotional material to the FDA for approval?
11 A. I don't know.
12 Q. He just kind of took that
13 responsibility on himself?
14 A. He did it.
15 Q. Why would you see this various
16 material that you just told me about, the patient
17 education information and promotional material
18 and occasional journal publications?
19 A. Do you want me to answer for
20 each of those?
21 Q. If there's a difference -- we
22 can take it -- if there's a difference, I'll take
23 it one at a time. Why would you see patient
24 education information?
Page 286
1 A. All I can recall is it just
2 kind of appeared. I don't have a particular
3 explanation how it happened, I would just be
4 aware of it.
5 Q. Was it a matter of having to
6 review the information to pass judgment on it
7 from a regulatory standpoint or anything like
8 that?
9 A. No.
10 Q. Did you have responsibility
11 acting as a conduit, either between departments
12 at Lilly or Lilly and the FDA, with regards to
13 the patient education information?
14 A. No.
15 Q. Did you have responsibilities
16 acting as a conduit or liaison between Lilly and
17 the National Institute of Mental Health or
18 another outside entity such as the National
19 Institute of Mental Health?
20 A. No.
21 Q. How about the National Mental
22 Health Association?
23 A. No.
24 Q. Have you ever dealt with
Page 287
1 anybody from the National Mental Health
2 Association?
3 A. No.
4 Q. How about any other
5 governmental entity such as the National
6 Institute of Health or National Institute of
7 Mental Health, have you ever dealt with employees
8 of either of those agencies?
9 A. Not that I can recall.
10 Q. How about any outside
11 not-for-profit agencies similar to the National
12 Mental Health Association?
13 A. No.
14 Q. Any psychiatric entities
15 outside of Lilly?
16 A. No.
17 Q. Any health entities outside of
18 Lilly?
19 A. I'm not sure what you mean by
20 health entities.
21 Q. Like, you know, associations
22 like the mental -- or the American Medical
23 Association or any associations on obesity or
24 bulimia or things of that nature?
Page 288
1 A. No.
2 Q. Other than the FDA, what
3 entities outside of Lilly have you dealt with?
4 A. I don't recall any others.
5 Q. Do you have any regulatory
6 responsibilities with regards to registering of
7 Fluoxetine in countries outside the United
8 States?
9 A. No.
10 Q. Have you been aware throughout
11 your job at Lilly in regulatory of efforts by
12 Lilly to register Fluoxetine in other countries?
13 A. I have been aware.
14 Q. What countries are you aware
15 of?
16 A. Germany, France, Sweden, all
17 the others -- I just don't recall any others
18 specifically.
19 Q. In your capacity as regulatory
20 scientist at Lilly on Fluoxetine, do you or did
21 you have any responsibilities with regards to
22 informing the FDA of registration efforts by
23 Lilly in other countries?
24 A. Yes.
Page 289
1 Q. What were your
2 responsibilities in that regard?
3 A. Basically to tell them what we
4 knew about that at the appropriate time.
5 Q. When you say what we knew
6 about that, you mean what Lilly knew about
7 registration efforts?
8 A. Where it was approved.
9 Q. Okay. Just where it was
10 approved?
11 A. Some regulations asked for
12 additional information, like other indications,
13 and foreign regulatory activity, really is the
14 way, I think, it may read in the regulations.
15 Q. What is your understanding
16 about the way the regulations mean about foreign
17 regulatory activity?
18 A. Basically any response, any
19 comments that foreign regulatory bodies have
20 made.
21 Q. If a foreign regulatory body
22 had questions related to a compound that was
23 pending approval in that country, would those
24 questions be transmitted to the FDA?
Page 290
1 A. No.
2 Q. Why not?
3 A. I don't believe the way you
4 worded that, that that falls within what the
5 regulations ask for.
6 Q. Would anything related to
7 those questions be transferred to the FDA or made
8 known to the FDA?
9 A. Possibly.
10 Q. If you had a country who had
11 questions regarding a compound's safety, what
12 type of information regarding those questions
13 would be made known to the FDA?
14 A. Could you repeat that?
15 Q. Sure. I'm just trying to find
16 out how much information is required to be given
17 to the FDA on registration efforts in other
18 countries. So I'm trying to get an idea from you
19 what, you know -- first of all what types of
20 information would be transferred to the FDA
21 related to registration in other countries.
22 A. I think that serious safety
23 concerns, and I believe that the regulations say
24 if a drug was taken off the market or if your
Page 291
1 application was rejected.
2 Q. Okay. So status of the
3 application?
4 A. I think that's a fair blanket
5 expression.
6 Q. Were there periodic updates to
7 the FDA as to the status of applications in other
8 countries?
9 A. I do not know that.
10 Q. Do you know if the regulations
11 require a periodic update on the status of
12 applications in other countries?
13 A. I believe the annual report
14 may.
15 Q. When you say the annual
16 report, you mean the general annual report or the
17 safety report?
18 A. The general annual report.
19 Q. Other than the general annual
20 report, are there situations under which the
21 regulations require that Lilly report activity
22 regarding registration of a drug in another
23 country?
24 A. The guidelines say at the time
Page 292
1 of an NDA submission.
2 Q. You mean actual submission of
3 the NDA?
4 A. Yes.
5 Q. Do you recall when the actual
6 submission of the NDA on Fluoxetine was made to
7 the FDA?
8 A. I was not in regulatory at
9 that time, I believe I know the year.
10 Q. What year?
11 A. I believe it was '83.
12 Q. So at the time that the NDA on
13 Fluoxetine was submitted to the FDA in 1983,
14 Lilly would have had to have informed the FDA of
15 any regulatory activities that were going on in
16 other countries?
17 A. I can't be certain that was
18 the regulation at that time.
19 Q. Is that the regulation now, as
20 you understand it?
21 A. Yes.
22 Q. Do you know what regulation
23 that falls under?
24 A. As I said, I remember it being
Page 293
1 in the guidelines for NDA submissions.
2 Q. Guidelines that you're talking
3 about, are those FDA guidelines or Lilly
4 guidelines?
5 A. FDA guidelines.
6 Q. In your capacity as regulatory
7 scientist, have you ever informed the FDA that
8 Fluoxetine has been taken off the market in any
9 country?
10 A. No.
11 Q. Has anybody at Lilly to your
12 knowledge during the time that you have been a
13 regulatory scientist informed the FDA that
14 Fluoxetine has been taken off the market in any
15 country?
16 A. No.
17 Q. How about Pakistan?
18 A. No, I know nothing about
19 Pakistan.
20 Q. How about suspension of
21 Fluoxetine, suspension of the sale of Fluoxetine?
22 A. I'm not aware of that.
23 Q. Are you aware from your
24 position as regulatory scientist of any
Page 294
1 applications that have been rejected on
2 Fluoxetine by any other country?
3 A. I'm aware of one or two where
4 there's been resistance, I'm not sure the word
5 rejected actually applies.
6 Q. Where has there been
7 resistant?
8 A. In Sweden.
9 Q. Any others?
10 A. There's another country and
11 I'm not sure which one it is in Europe. I don't
12 think --
13 Q. Are you aware that in 1985 the
14 German government rejected Lilly's application to
15 market Fluoxetine in Germany?
16 A. No.
17 MR. MYERS: I don't know if that's the
18 precise regulatory terms that was used.
19 MS. ZETTLER: That's a term used in
20 documents provided to us by Lilly.
21 Q. Are you aware of any instance
22 where the use of Fluoxetine has been suspended or
23 the sale of Fluoxetine has been suspended in any
24 other country?
Page 295
1 A. No.
2 Q. Was the resistance by the
3 Swedish government reported to the FDA?
4 A. Yes.
5 Q. In what form, how was it
6 reported?
7 A. It was reported basically in
8 an inventory of country status.
9 Q. Okay. When you say inventory
10 of country status, what do you mean?
11 A. Where we say where it was
12 approved, and the places where we had applied,
13 and we didn't have approval yet.
14 Q. Is this like an actual list of
15 a country?
16 A. As I recall, it was a list.
17 Q. And it lists the countries and
18 the status of approval at the time the report was
19 made?
20 A. Yes.
21 Q. Would it say that on that list
22 that the Swedish government was resistant to
23 approving the drug in that country?
24 A. I don't remember the exact
Page 296
1 wording.
2 Q. Would it say something like
3 registration pending or application pending?
4 A. I don't remember the wording.
5 Q. Other than this list, was
6 there any other way that the Swedish government
7 resistance to marketing of Fluoxetine was
8 conveyed to the FDA?
9 A. I don't know.
10 Q. What were the issues revolving
11 around the resistance by the Swedish government,
12 why were they resisting approval there?
13 A. I have been told that they
14 wanted a lower dose.
15 Q. Lower than twenty milligrams?
16 A. I believe that's correct.
17 Q. Yesterday, you and Paul talked
18 quite extensively about the efforts to get
19 approval for a ten milligram dosage here in the
20 United States. Do you recall that?
21 A. Yes.
22 Q. To your knowledge were the
23 efforts to get a ten milligram dosage form
24 approved here in the United States related to the
Page 297
1 Swedish government's resistance to approval?
2 A. I don't feel that they were.
3 Q. Why not?
4 A. I have no reason to think that
5 they were.
6 Q. Would the FDA have to approve
7 a dosage form here in the United States before it
8 could be used in another country?
9 A. No.
10 Q. Okay. You also said that you
11 had seen promotional material on Fluoxetine. In
12 what situations have you seen that type of
13 material?
14 A. Well, for a period of time, my
15 signature was required for approval of
16 promotional materials.
17 Q. From a regulatory standpoint?
18 A. I guess you could say that.
19 Q. Do you know specifically why
20 your signature was required?
21 A. No.
22 Q. Was it your responsibility to
23 review the promotional material?
24 A. I looked over it for what I
Page 298
1 could understand.
2 Q. What parts of the promotional
3 material could you understand?
4 A. Very little.
5 Q. Who else's signature was
6 required on that promotional material?
7 A. I know an attorney, a
8 regulatory attorney's was. I don't recall who
9 else.
10 Q. Was that responsibility at
11 some point taken away from you?
12 A. I no longer have that
13 responsibility.
14 Q. When did you stop?
15 A. I don't recall the exact year.
16 Q. Do you know why you no longer
17 have that responsibility?
18 A. No.
19 Q. Do you know who has that
20 responsibility in regulatory now?
21 A. I don't believe there is.
22 Q. Did you have any
23 responsibility to submit promotional material to
24 the FDA for approval?
Page 299
1 A. No.
2 Q. Do you know who did within
3 regulatory, if anybody?
4 MR. MYERS: He already told you that.
5 MS. ZETTLER: We're on promotional
6 material, before it was patient education
7 material.
8 A. I feel you asked the question
9 already also, and it was Doctor Talbott.
10 Q. Doctor Talbott was the person
11 with responsibility for submitting both the
12 patient education information and the promotional
13 material?
14 A. I don't remember you asking
15 about patient.
16 MR. MYERS: I wrote down promotional
17 material. I don't think you even asked that
18 other question about who submitted the patient
19 information letter.
20 MS. ZETTLER: Okay.
21 Q. Who submitted the patient
22 information, if anybody, to the FDA for approval?
23 A. I'm not sure it was submitted.
24 Q. Are you aware of the D/ART or
Page 300
1 D/ART campaign, depression awareness campaign?
2 A. I didn't know those letters,
3 but when you said the words, I'm aware.
4 Q. What is your knowledge of that
5 campaign?
6 A. It's more from the media than
7 anything else.
8 Q. What is your knowledge of the
9 campaign?
10 A. That mental health groups are
11 attempting to make citizens aware that they might
12 have depression.
13 Q. Are you aware that Lilly is
14 involved in -- whether or not Lilly is involved
15 in that program?
16 A. You changed your question in
17 mid-stream.
18 Q. Are you aware of whether or
19 not Lilly is involved in that program?
20 A. Yes.
21 Q. Is it?
22 A. I believe they were.
23 Q. What is your understanding of
24 what their involvement is in that program?
Page 301
1 A. Well, I believe we're
2 encouraging this process of awareness.
3 Q. Do you know why Lilly's
4 encouraging the process of awareness?
5 A. No.
6 Q. Would it have anything to do
7 with selling Prozac?
8 A. I don't know.
9 Q. Are you aware of any other
10 health related campaigns, awareness campaigns,
11 that Lilly is involved with other than the
12 depression awareness campaign?
13 A. I believe we have some related
14 to diabetes.
15 Q. Any others?
16 A. I'm not aware.
17 Q. Lilly sells drugs that treat
18 diabetes; correct?
19 A. That's correct.
20 Q. Are you aware of any public
21 education campaigns that Lilly is involved in
22 that don't involve somehow a compound or product
23 that they sell?
24 A. I'm not aware.
Page 302
1 Q. Are you aware of -- other than
2 the D/ART or DART campaign, are you aware of any
3 other public education campaigns that Lilly is
4 involved with regarding depression?
5 A. No.
6 Q. How about OCD, are you aware
7 of any public education campaigns that Lilly is
8 involved with on OCD?
9 A. No.
10 Q. How about panic attacks?
11 A. No.
12 Q. Any other mental health
13 related syndrome or disease that Lilly is
14 involved with in a public education program?
15 A. No.
16 Q. Have you heard of the National
17 Depression Screening Day?
18 A. No.
19 Q. Were you aware of any other
20 educational campaigns that Lilly is involved with
21 with regards to mental health, and I mean other
22 than public education campaigns?
23 A. No.
24 Q. How about medical education
Page 303
1 campaigns for primary care physicians?
2 A. No.
3 MS. ZETTLER: Why don't we take a
4 break.
5 (A SHORT RECESS WAS TAKEN.)
6 (PLAINTIFFS' EXHIBIT NO. 4 WAS
7 MARKED FOR IDENTIFICATION AND
8 RECEIVED IN EVIDENCE.)
9 Q. Have you had a chance to
10 review Exhibit 4?
11 A. Yes.
12 Q. I apologize for the quality of
13 the copy, we did the best we could with what we
14 had to work with. Earlier you testified that it
15 was your belief that the change from the
16 information on MAO inhibitors from the warning to
17 the contraindication section of the package
18 insert was done pursuant to fourteen seventy C;
19 correct?
20 A. That's correct.
21 Q. Does this refresh your
22 recollection as to whether or not that was
23 actually the case?
24 A. Yes.
Page 304
1 Q. And this is a letter that
2 appears to be -- to have been written by Paul
3 Leber of the FDA to Max Talbott at Lilly;
4 correct?
5 A. Yes.
6 Q. And it's dated approximately
7 October 4th, 1990?
8 A. Yes.
9 Q. In the letter, about on the
10 first page, fourth paragraph down, before the
11 indentation, it states: In addition we feel that
12 there have now been sufficient number of cases of
13 serious Fluoxetine MAO interactions to justify
14 moving the statement about this interaction to
15 the contraindications section of the package and
16 label. Correct?
17 A. Yes.
18 Q. Why is it that you feel that
19 the change was made under fourteen seventy C by
20 Lilly as opposed to being ordered by the FDA?
21 A. Fourteen seventy C is a
22 regulation by which you can submit labeling
23 changes. It says that they do not require prior
24 approval.
Page 305
1 Q. You mean the actual verbage
2 change itself?
3 A. The regulation reads that they
4 don't require prior approval.
5 Q. Okay. That doesn't mean that
6 it was done necessarily voluntarily, without a
7 suggestion by the FDA; correct?
8 A. That's correct.
9 Q. Is it your recollection that
10 the change of the MAO interaction information
11 from the warning section to the contraindication
12 section was done after a request by the FDA?
13 A. Yes.
14 Q. How about suicidal ideation,
15 was that done after a request by the FDA?
16 A. Not to my knowledge.
17 Q. How about violent behaviors,
18 was that event term added after a request by the
19 FDA?
20 A. Not to my knowledge.
21 Q. Any other changes to the
22 package insert that you recall that were done
23 under fourteen seventy C, but not until after a
24 request by the FDA?
Page 306
1 A. I believe so.
2 Q. Which ones?
3 A. To the best of my
4 recollection, there was one involving Lithium.
5 Q. Interaction with Lithium,
6 between Lithium and Fluoxetine?
7 A. I don't remember the exact
8 wording.
9 Q. Okay. And that change was
10 made pursuant to fourteen seventy C?
11 A. When it was finally sent, yes.
12 Q. Okay. Give me a little bit of
13 a history of that insert change regarding Lithium
14 and Fluoxetine.
15 A. It's going to have to be the
16 best of my recollection.
17 Q. That's fine, that's all I'm
18 asking.
19 A. I recall the FDA asking us to
20 either add or revise information, and I recall
21 sending a draft, and then I don't recall what
22 stood between that and then sending a fourteen
23 seventy C.
24 Q. Do you recall how long a time
Page 307
1 between the FDA raising the issue and the draft
2 was sent pursuant to fourteen seventy C?
3 A. I don't recall.
4 Q. Was it more than a year?
5 A. I don't believe so.
6 Q. To the best of your
7 recollection, were there any changes that were
8 made to the Fluoxetine package insert that were
9 ordered by the FDA?
10 A. I believe that some have been
11 made that were requested by the FDA.
12 Q. Which changes?
13 A. Other than --
14 Q. Besides what we've already
15 talked about.
16 A. I don't recall any other than
17 the ones we've talked about.
18 Q. Anything related to akathesia?
19 A. I don't recall any.
20 Q. Anything related to agitation?
21 A. I don't recall any.
22 Q. Anything related to
23 suicidality?
24 A. I don't recall any.
Page 308
1 Q. Anything related to
2 violent/aggressive behavior or violent behavior?
3 A. I don't recall any.
4 Q. Anything related to
5 intentional injury?
6 A. I don't recall any.
7 Q. Do you know who Doctor Martin
8 Teicher is?
9 A. I've heard of him.
10 Q. Who is Doctor Teicher?
11 A. He's a psychiatrist.
12 Q. How have you heard of Doctor
13 Teicher?
14 A. I've heard of him because of a
15 publication that he authored.
16 Q. He authored a publication that
17 related to intense suicidal ideation occurring
18 with the use of Fluoxetine; correct?
19 A. I don't know the title of the
20 paper.
21 Q. Do you know the subject matter
22 of the paper?
23 A. I'm aware of it as a
24 nonpsychiatrist.
Page 309
1 Q. What is your knowledge of what
2 the subject of the paper is?
3 A. That he had observed some
4 individuals who had experienced suicidal
5 ideation.
6 Q. While on Fluoxetine?
7 A. The implication was -- I don't
8 know exactly what his assertions were nor the
9 timing of when they may have had that.
10 Q. Have you ever spoken with
11 Doctor Teicher?
12 A. No, I have not.
13 Q. Have you ever communicated
14 with Doctor Teicher in any way?
15 A. No, I have not.
16 Q. Have you ever spoken with any
17 of Doctor Teicher's co-authors on that paper, for
18 instance Doctor Jonathan Cole?
19 A. No.
20 Q. Do you know a Doctor Jonathan
21 Cole?
22 A. No, I do not know him.
23 Q. How about Carol Glod?
24 A. I do not know her.
Page 310
1 Q. To your knowledge has anybody
2 at Lilly ever spoken with Doctor Teicher?
3 A. I do not know.
4 Q. To your knowledge has anybody
5 at Lilly spoken with Doctor Cole?
6 MR. MYERS: Ever?
7 MS. ZETTLER: Yes.
8 A. I do not know.
9 Q. Have you ever heard of anybody
10 speaking with either Doctor Teicher or Doctor
11 Cole from Lilly?
12 A. I do not recall if that has
13 occurred.
14 (PLAINTIFFS' EXHIBIT NO. 5 WAS
15 MARKED FOR IDENTIFICATION AND
16 RECEIVED IN EVIDENCE.)
17 Q. Have you had a chance to
18 review Exhibit 5, Doctor?
19 A. Yes.
20 Q. Exhibit 5 appears to be a
21 corporate chart on medical regulatory affairs at
22 Lilly; correct?
23 A. Yes.
24 Q. Under the left-hand side of
Page 311
1 the first page of the exhibit, it has the
2 designation regulatory affairs; correct?
3 A. Yes.
4 Q. And you're listed under that
5 designation; correct?
6 A. Yes.
7 Q. Can you tell me who the other
8 people on that list are starting with L. Day,
9 Ph.D?
10 A. Yes, I'll try. Larry Day is
11 another regulatory scientist.
12 Q. Does he work on Fluoxetine?
13 A. He works on anti-infective
14 agents.
15 Q. To your knowledge has Doctor
16 Day ever had responsibilities related to
17 Fluoxetine?
18 A. That's never been his
19 assignment. When I have been gone, he may have
20 for a day or a week covered for me.
21 Q. But nothing on a permanent
22 basis --
23 A. No.
24 Q. -- to your knowledge?
Page 312
1 A. No, not to my knowledge.
2 Q. How about the next one?
3 A. Paul Gesellchen is also a
4 regulatory scientist.
5 Q. Did you say Paula?
6 A. Paul.
7 Q. Does Doctor Gesellchen, to
8 your knowledge, have any responsibilities with
9 regards to Fluoxetine?
10 A. No, only in the context of
11 what I said about Doctor Day.
12 Q. Nothing permanent?
13 A. No.
14 Q. How about the next one?
15 A. Joanne Mueller, she's more or
16 less a CRA. She wouldn't be liked to be called
17 that, but that's essentially her role.
18 Q. Does Ms. Mueller have any
19 responsibilities or has she ever had any
20 responsibilities with regards to Fluoxetine as
21 far as you know?
22 A. I do not know.
23 Q. How about Charles Matsumoto,
24 we talked a little bit about him yesterday.
Page 313
1 A. Yes.
2 Q. To your knowledge has Doctor
3 Matsumoto ever had any direct responsibility with
4 regards to Fluoxetine?
5 A. I do not know that.
6 Q. Okay. How about J. Trout?
7 A. Jimmy Trout is essentially an
8 assistant to Joanne Mueller.
9 Q. Okay. To your knowledge has
10 Ms. Trout ever had any responsibilities directly
11 related to Fluoxetine?
12 A. I don't believe she has.
13 Q. What about R. Smithey?
14 A. Roberta Smithy has a similar
15 role as Joanne Mueller.
16 Q. She wouldn't want to be called
17 a CRA either?
18 A. That's correct.
19 Q. Do they have a title?
20 A. They may.
21 Q. Okay. How about A. Stewart?
22 A. Andy Stewart is also a
23 regulatory scientist.
24 Q. To your knowledge does -- is
Page 314
1 that Mr. Stewart?
2 A. He's a DVM.
3 Q. Is that a doctor?
4 A. Yes.
5 Q. To your knowledge has Doctor
6 Stewart had any responsibilities related to
7 Fluoxetine?
8 A. It would be the same as Doctor
9 Day and Doctor Gesellchen, only to cover when I
10 was gone.
11 Q. How about S. Worthen?
12 A. Sue Worthen.
13 Q. Who is Sue Worthen?
14 A. She wouldn't want to be called
15 a CRA either, but technically she's a nondoctoral
16 person in medical regulatory affairs.
17 Q. What responsibility did
18 Michael Noone have over regulatory affairs, if
19 any, to your knowledge?
20 A. He was a manager over
21 individuals who -- I can't say that they didn't
22 have doctoral because I see two Ph.Ds under
23 there, but in general they didn't have regulatory
24 scientist type responsibilities.
Page 315
1 (PLAINTIFFS' EXHIBIT NO. 6 WAS
2 MARKED FOR IDENTIFICATION AND
3 RECEIVED IN EVIDENCE.)
4 Q. Have you had a chance to
5 review Exhibit 6?
6 A. Yes.
7 Q. Do you recognize this exhibit,
8 Doctor?
9 A. No.
10 Q. And it appears to be at least
11 a draft of a letter dated October 9, 1991 to
12 Thomas Laughren on Gary Tollefson's letterhead;
13 correct?
14 A. Yes.
15 Q. And it's your testimony that
16 you don't recall this exhibit?
17 A. I do not recall having seen
18 this.
19 Q. You have not seen this?
20 A. I do not recall having seen
21 it.
22 Q. Do you know why this would
23 have been produced as part of your file on
24 Fluoxetine?
Page 316
1 A. If it's there, it must be
2 there.
3 Q. So it's possible that you
4 received this and you just don't recall?
5 A. It apparently is possible,
6 yes.
7 Q. Are you familiar with any of
8 the issues that are set out in the letter?
9 A. I recall the -- I remember
10 from the advisory committee meeting, the issue of --
11 under four, the first point, the common theme,
12 about physician management.
13 Q. Okay. Anything else?
14 A. No.
15 Q. The first paragraph or
16 subparagraph in the letter on the first page
17 talks about the issue of apparent suspension of
18 the registration of Prozac in Pakistan; correct?
19 A. That's what it says.
20 Q. And it's your testimony that
21 you don't recall that having happened?
22 A. I do not recall that.
23 Q. You were a regulatory
24 scientist on Fluoxetine on October 9, 1991?
Page 317
1 A. Yes.
2 Q. Was there any reason why you
3 would not have been made aware of that issue?
4 A. Not to my knowledge.
5 Q. Does it surprise you that that
6 issue existed and you didn't know about it?
7 A. Yes.
8 Q. Do you feel that you should
9 have been made aware of that issue as regulatory
10 scientist on Fluoxetine at Lilly?
11 A. It's my opinion that I -- yes.
12 Q. Who was Doctor Tollefson?
13 A. Doctor Tollefson is a
14 psychiatrist.
15 Q. Are you aware of any other
16 communications between Doctor Tollefson and the
17 FDA?
18 A. Yes.
19 Q. What types of communications
20 are you aware of?
21 A. Primarily letters that he
22 wrote to Doctor Laughren.
23 Q. On what subjects, generally?
24 A. Psychopharmacology.
Page 318
1 Q. Related to Fluoxetine?
2 A. Some may have been.
3 Q. Okay. Any regulatory issues
4 that you're aware of that were -- besides the
5 ones reflected in this draft -- that were
6 communicated to the FDA by Doctor Tollefson?
7 A. I'm not aware that there were
8 any.
9 Q. Has there ever been an issue
10 at Lilly related to your not being informed of
11 regulatory related issues that were conveyed to
12 the FDA without your input?
13 A. I'm not sure what you mean by
14 issue.
15 Q. Have you ever been upset or
16 disappointed or angry that another member of --
17 or employee of Lilly would convey information
18 related to regulatory issues to the FDA without
19 your input?
20 A. I don't think my emotion was
21 that strong, but I would wish that it didn't
22 happen.
23 Q. So have there been other
24 instances where you've been cut out of the loop,
Page 319
1 so to speak, with regards to regulatory issues
2 that were raised with the FDA?
3 A. Very few.
4 Q. Can you tell me what those
5 issues were?
6 A. I don't recall.
7 Q. Do you recall any issues
8 related to Fluoxetine?
9 A. No.
10 Q. Does that mean that some of
11 these issues could have related to Fluoxetine,
12 but you just don't recall?
13 A. I don't recall what they
14 related to.
15 Q. In these instances who would
16 cut you out of the loop, so to speak?
17 A. I can't name particular
18 people.
19 Q. How about departments?
20 A. No, I don't think it was
21 necessarily department related.
22 Q. But where did these people
23 generally come from, would they come from the
24 medical division or department?
Page 320
1 A. Well, there were relatively
2 few, so to generalize, that's possible.
3 Q. How about management?
4 A. That's possible.
5 Q. How did you become aware that
6 you had been cut out of the loop on regulatory
7 issues conveyed to the FDA?
8 A. Well, they were a one-off
9 situation, and probably some time would go by and
10 I would discover it accidentally, possibly by
11 later communication that wasn't accidental.
12 Q. Were you aware before today on
13 seeing this exhibit of the issue regarding the
14 Pakistan suspension?
15 A. No.
16 Q. What is an FDA talk paper?
17 A. It's a document that they make
18 available, and I've seen one or two, but from a
19 fundamental why they do it and what their
20 objective is, I do not know.
21 Q. When you say they, you mean
22 the FDA?
23 A. Yes.
24 Q. They make it available to who?
Page 321
1 A. I believe the public.
2 Q. For what purpose do they make
3 the papers available?
4 A. I do not know that.
5 Q. Do you have any understanding
6 as to what -- when I say the drug companies, I
7 don't mean just Lilly, but what drug companies in
8 general have as far as input into these talk
9 papers, if any?
10 A. I'm not aware of any input.
11 Q. Is it common for FDA personnel
12 to inform drug companies that they are in the
13 process of drafting a talk paper?
14 A. I do not know that.
15 Q. This draft is dated October
16 9th, 1991; correct?
17 A. Yes.
18 Q. Under number three on page two
19 of the exhibit, the draft states you had
20 requested information on our adverse event,
21 colon, suicidality analysis. Do you see that?
22 A. I see it.
23 Q. This draft is dated after the
24 advisory committee meeting in September of 1991;
Page 322
1 correct?
2 A. Yes.
3 Q. What information, if you have
4 an understanding, is being talked about in the
5 third paragraph of that letter?
6 A. I do not know.
7 Q. To your knowledge was there
8 any additional information on suicidality related
9 adverse events that was provided to the FDA after
10 the September, 1991 advisory committee meeting?
11 A. I don't recall.
12 Q. You don't recall whether there
13 was?
14 A. That's right, I don't recall
15 whether there was or wasn't.
16 Q. Can you think of any reason
17 why Lilly would be providing additional
18 information to the FDA after the drug advisory
19 committee meeting on the issue of suicidality?
20 MR. MYERS: Let me object to the form
21 because it assumes that it's additional to what
22 was provided, and I don't know if anybody knows
23 that. If you know, tell her.
24 A. I'm not aware of that.
Page 323
1 Q. You're not aware of any reason
2 why they would provide them additional
3 information?
4 A. I'm not aware of that, yes.
5 Q. Are you aware of Charles
6 Beasley's meta-analysis article that ran in the
7 British Medical Journal?
8 A. I'm aware of it.
9 Q. Do you know when that was
10 published?
11 A. No.
12 Q. Do you know when it was
13 written?
14 A. No.
15 Q. Do you know if it was written
16 before or after the September, 1991 advisory
17 committee meeting?
18 A. No, I don't.
19 Q. In your capacity as regulatory
20 scientist on Fluoxetine, did you have
21 responsibilities to convey the information set
22 out in Doctor Beasley's article to the FDA?
23 A. Possibly.
24 Q. In what instance would you
Page 324
1 convey that type of information to the FDA?
2 A. Well, I sent a number of
3 reports to the FDA, some of what was in that,
4 those reports may have been in his paper, some of
5 the information.
6 Q. Would you have submitted a
7 copy of Doctor Beasley's actual paper to the FDA?
8 A. I don't recall, I may have, I
9 just don't recall.
10 Q. To your knowledge, is there a
11 federal regulation, FDA regulation, that requires
12 that medical articles or articles published in
13 medical journals or psychiatric journals be
14 submitted to the FDA?
15 A. I believe there is.
16 Q. Do you know what section of
17 the regulation?
18 A. I believe we would do it in
19 the annual report, so it may be in the annual
20 report regulation.
21 Q. So you would submit the actual
22 copies of the articles?
23 A. Yes.
24 Q. Is that all articles that were
Page 325
1 known by Lilly, regardless of the author?
2 A. I believe so.
3 Q. Who would put together a list
4 of the articles that had become known by Lilly in
5 the year previous to the annual report?
6 A. I believe it would be someone
7 who would do a literature search.
8 Q. And that would be articles
9 that had been published regardless of whether or
10 not they were pro the compound?
11 A. That's correct.
12 Q. Do you recall whether or not
13 Doctor Teicher's article was submitted to the
14 FDA?
15 A. I do not know whether it was
16 or wasn't.
17 Q. Earlier you stated that you
18 were aware of the issue under number four, that
19 there was a problem with physician management of
20 antidepressant pharmacotherapy; correct?
21 A. Yes.
22 Q. How did you become aware of
23 that issue?
24 A. I had heard the advisory
Page 326
1 committee remark on that after the open public
2 forum.
3 Q. In what context did they
4 remark on it?
5 A. I just remember that in
6 discussion period subsequent to the open public
7 forum.
8 Q. The discussion period
9 subsequent to the open public forum, where was
10 that held?
11 A. In the FDA building in
12 Rockville.
13 Q. When was it held?
14 A. I believe it was September,
15 1991.
16 Q. Was it on the same day as the
17 open forum?
18 A. I don't remember there being
19 more than one day, but I believe it was the same
20 day, yes.
21 Q. Who was present during that
22 discussion at the open forum?
23 A. There were people from Lilly
24 and people from the FDA, and the advisory
Page 327
1 committee, and the audience.
2 Q. And the audience?
3 A. Uh-huh.
4 MR. MYERS: Yes.
5 A. Yes, I'm sorry.
6 Q. So those people who were there
7 during the open forum were all allowed to stay
8 during the discussion period?
9 A. Yes.
10 Q. To your knowledge was there a
11 meeting that was ever held outside the audience's --
12 where the audience was not involved?
13 A. On that day?
14 Q. Right.
15 A. No.
16 Q. To your knowledge was there
17 ever a meeting with the advisory committee where
18 it wasn't open to the public?
19 MR. MYERS: Associated with the
20 September meeting?
21 MS. ZETTLER: Right.
22 A. Not to my knowledge.
23 Q. To your knowledge has there
24 ever been a meeting with the drug advisory
Page 328
1 committee that was sitting in September of 1991
2 and people from Lilly, besides that meeting in
3 September of 1991?
4 A. Not to my knowledge.
5 Q. What did the advisory
6 committee say with regards to the issue of
7 physician management of antidepressant
8 pharmacotherapy?
9 A. I remember some committee
10 members saying it seems like a consistent theme
11 throughout the people talking in open public
12 forum was -- I'm going to use the word physician
13 neglect, but there may have been that connotation
14 that gave me that feel.
15 Q. So there were problems with
16 physicians prescribing and monitoring of
17 phychopharmacotherapy -- antidepressant
18 pharmacotherapy?
19 A. Well, those are your words,
20 and I wouldn't use those words.
21 Q. I'm trying to get an
22 understanding of what the context was that it
23 came up, was it a problem with prescribing
24 antidepressants?
Page 329
1 A. I can only recall my feeling
2 of what the committee said.
3 Q. That's fine, your impression
4 is fine.
5 A. And I've said everything I
6 understand.
7 Q. Well, I'm just trying to get
8 an idea of what it was about the physicians'
9 conduct or lack thereof that was negligent or
10 inappropriate.
11 A. Well, what I recall was one
12 physician's comment about another physician's
13 behavior, and I'm not a physician, so my
14 intuition would have been limited.
15 Q. What was that comment?
16 A. That there was a consistent
17 theme of my -- the message I received was
18 physician neglect. I'm not sure they said that.
19 Q. Was this directed towards one
20 physician?
21 A. I don't think so.
22 Q. Do you recall the physician
23 who said that?
24 A. No.
Page 330
1 Q. Was it a committee member?
2 A. It was someone at the table.
3 Q. Okay.
4 A. Where the committee was
5 sitting.
6 Q. Who else was sitting at the
7 table where the committee was sitting?
8 A. I believe there were some
9 invited guests.
10 Q. Doctor Teicher, was he sitting
11 at the table?
12 A. He was.
13 Q. Doctor Fawcett, was he sitting
14 at the table?
15 A. I don't believe so.
16 Q. Anybody from Lilly sitting at
17 the table?
18 A. I don't believe so.
19 Q. How about Doctor Nemeroff, was
20 he sitting at the table?
21 A. No.
22 Q. How do you know that?
23 A. Because he was sitting next to
24 me.
Page 331
1 Q. Okay. How about Doctor David
2 Dunner, was he sitting at the table?
3 A. I believe he was.
4 Q. Was it Doctor Dunner who made
5 the comment about physician neglect?
6 A. I do not know who made the
7 comment.
8 Q. Was it anybody from the FDA
9 who made the comment on physician neglect?
10 A. I don't remember the FDA
11 making that comment.
12 Q. The paragraph under number
13 four says first there appeared to be a common
14 theme through many of the patient vignettes that
15 physician management of antidepressant
16 pharmacotherapy may not have been optimal, and
17 second -- do you see that?
18 A. Yes.
19 Q. With regards to that issue
20 specifically, do you have a recollection of the
21 patients conveying stories or information related
22 to improper treatment by doctors that they were
23 seeing?
24 MR. MYERS: At the meeting?
Page 332
1 MS. ZETTLER: At the meeting.
2 A. I'm not sure they asserted
3 that.
4 Q. So this was something that the
5 doctor who made the comment picked up on while
6 they were conveying their stories?
7 MR. MYERS: Let me object to the form,
8 that would be pretty speculative as to what the
9 doctor did or didn't pick up. I think he told
10 you what he said, but what he picked up during
11 the session, that's highly speculative.
12 MS. ZETTLER: He started to answer
13 that, Larry, I think he had an answer to the
14 question.
15 MR. MYERS: If you know, tell her.
16 A. Repeat the question now
17 because I lost the exact wording of it.
18 (THE COURT REPORTER READ BACK THE
19 REQUESTED TESTIMONY.)
20 A. That was my impression.
21 Q. Anybody else besides that one
22 doctor make any comments related to that issue?
23 A. I do not recall whether there
24 was further comments.
Page 333
1 Q. Was there a discussion about
2 that issue as far as you know after the doctor
3 raised it?
4 A. There may have been, I don't
5 recall that.
6 Q. Have you seen a transcript of
7 that advisory committee meeting?
8 A. I'm in possession of a
9 transcript.
10 Q. You are in possession of a
11 transcript?
12 A. Yes.
13 Q. Is that the entire meeting,
14 the open forum and the discussion afterwards?
15 A. I believe it is.
16 Q. Was that turned over to the
17 legal department as part of your Fluoxetine file?
18 A. I'm not certain.
19 Q. Is there any reason why it
20 would not have been turned over?
21 A. No.
22 Q. So it's your testimony that
23 even after the open forum, the audience was
24 allowed to stay in the room while discussion was
Page 334
1 had between the committee; correct?
2 A. Correct.
3 Q. Was there press at that
4 meeting?
5 A. I believe there was.
6 MR. MYERS: Off the record.
7 (DISCUSSION OFF THE RECORD.)
8 Q. Doctor, have you ever given a
9 deposition before?
10 A. No.
11 Q. Have you ever testified under
12 oath before?
13 A. Not that I can recall.
14 Q. Did you participate in the
15 advisory committee meeting held in September of
16 1991?
17 A. I was present.
18 Q. Did you speak at that
19 committee meeting?
20 A. No.
21 Q. Did you do anything in
22 preparation for the committee meeting?
23 A. Yes.
24 Q. What did you do in preparation
Page 335
1 for the committee meeting?
2 A. I made arrangements for the
3 travel of the Lilly group, and food and lodging.
4 Q. Were those similar to those
5 responsibilities that you had at the meeting in
6 September of 1990?
7 A. That's correct.
8 Q. Did you do anything from a
9 regulatory standpoint in preparation for the
10 meeting, advisory committee meeting in September,
11 1991?
12 A. I thought that's what you just
13 asked me.
14 Q. From a regulatory standpoint.
15 MR. MYERS: I think that was the
16 difference in her question.
17 A. I viewed that as regulatory
18 responsibility, what I told you.
19 Q. Okay. Anything else?
20 A. Well, at the request of the
21 FDA, I transmitted a document, I'll call it a
22 briefing document, that was the official name,
23 for the advisory meeting prior to the meeting.
24 Q. Did you carry it up there
Page 336
1 again and hand-deliver it?
2 A. I may have, I don't recall.
3 Q. Other than the time that you
4 told us about yesterday where you transmitted the
5 documents on the eight adverse event issues to
6 the FDA personnel after the phone call between
7 Doctor Leber and Doctor Thompson, can you
8 remember any other times hand delivering
9 information on Fluoxetine to the FDA?
10 A. I can't remember specific, but
11 I can't say that I have not.
12 Q. That you have not?
13 A. I can't say that I have not.
14 Q. Do you know a Doctor Inman,
15 I-N-M-A-N?
16 A. I've heard of his name.
17 Q. Do you know who Doctor Inman
18 is?
19 A. I think he's in Britain, in
20 England.
21 Q. Do you know if he works for
22 Lilly?
23 A. He does not, to my
24 recollection.
Page 337
1 Q. Do you know who he works for?
2 A. No.
3 Q. Do you know what he does?
4 A. I have a little bit of
5 understanding.
6 Q. Tell me what your
7 understanding of what Doctor Inman does is?
8 A. Well, he has some role in
9 monitoring adverse events that are reported in
10 the UK.
11 Q. Is he a governmental employee?
12 A. I'm not certain.
13 Q. How about Doctor Ivan Miller?
14 A. I've heard of him.
15 Q. Who is Doctor Miller?
16 A. I'm not sure what his doctoral
17 is in.
18 Q. How is it that you've heard of
19 Doctor Miller?
20 A. I believe we had him as a
21 consultant.
22 Q. He was present at the
23 September, 1990 meeting; correct?
24 A. Well, he was present at some
Page 338
1 meeting because he was on one of the documents I
2 saw yesterday.
3 MR. MYERS: Let me object to the form,
4 I think you've got the meeting wrong.
5 MS. ZETTLER: I'm sorry, May 13th,
6 1990 meeting.
7 MR. MYERS: Yes.
8 Q. Have you heard of Doctor
9 Miller's suicidality scale validation study?
10 A. I've heard of it.
11 Q. And that's a study that he did --
12 was doing in conjunction with Lilly?
13 A. Repeat your previous question.
14 Q. Sure. Have you heard of his
15 study to validate a suicidality scale?
16 A. No.
17 Q. Have you heard of any study
18 that Doctor Miller has performed in conjunction
19 with Lilly?
20 A. I'm not aware he did perform a
21 study in conjunction with Lilly.
22 Q. Are you aware of any studies
23 that Doctor Miller has performed?
24 A. No.
Page 339
1 Q. Are you aware of any studies
2 that Doctor Miller is in the process of
3 performing?
4 A. No, I'm not aware.
5 Q. Are you aware of any work that
6 Doctor Miller has done on behalf of Lilly
7 whatsoever?
8 A. He may have done some, but I'm
9 not aware of any details.
10 Q. Have you ever heard the term
11 surveillance study?
12 A. I've heard the term
13 surveillance used in a number of contexts, I'm
14 not sure I've heard the word surveillance study.
15 Q. Have you heard the word
16 surveillance used in the context of your
17 employment at Eli Lilly?
18 A. Yes.
19 Q. Tell me the context that
20 you've heard that word used in?
21 A. Post-marketing surveillance.
22 Q. Any other context?
23 A. I don't recall any other
24 specific context.
Page 340
1 Q. So it's your testimony that
2 you are not aware of Doctor Ivan Miller's
3 suicidality scale validation study; correct?
4 A. I'm not aware of it.
5 Q. Are you aware of any work that
6 Doctor Miller has done or is doing within the
7 past three years?
8 A. I'm aware he has some interest
9 in a scale, but I'm not aware of any details
10 regarding it.
11 Q. When you say a scale, what do
12 you mean?
13 A. I mean a questionnaire. You
14 used the word scale, I think I picked up on that.
15 I would have said a questionnaire, I think, if
16 you hadn't used the word scale.
17 Q. Do you know what the subject
18 matter of the questionnaire is?
19 A. No, I don't.
20 Q. Are you aware of whether or
21 not that questionnaire has been developed by
22 Doctor Miller in conjunction with Lilly
23 employees?
24 A. I do not know whether it was
Page 341
1 or wasn't.
2 Q. Have you made any submissions
3 to the FDA related to Doctor Miller's scale?
4 A. I don't recall that I have.
5 Q. If you go back to Exhibit 6,
6 under number four on page two. The sentence that
7 we just talked about regarding the patient -- or
8 physician management of antidepressant
9 pharmacotherapy, it goes on to say, second, that
10 with the exception of the Fluoxetine data base,
11 Lilly information is available on the interface
12 of depression and suicidality relative to
13 treatment modalities; correct?
14 A. That's what it says.
15 Q. And it goes on to say I raised
16 the following points: A, Eli Lilly and Company
17 continues to move forward with the reliability
18 slash validation of a suicide rating instrument;
19 correct?
20 A. That's what it says.
21 Q. Do you have any knowledge
22 whatsoever with regards to the subject raised in
23 subsection A in that paragraph?
24 A. No.
Page 342
1 Q. It says B, Eli Lilly and
2 Company proposes to continue development of the
3 above validation scale, and apply it to all
4 prospective trials with Fluoxetine and other
5 anticipated antidepressant agents; correct?
6 A. That's what it says.
7 Q. Yesterday when you were
8 talking to Paul I believe you said it was your
9 recollection that you recall a suicidality scale
10 being used in Fluoxetine trials?
11 A. I recall some questionnaire
12 being added to some protocols that involve
13 Fluoxetine.
14 Q. Do you know if that's a scale
15 or questionnaire that was developed by Doctor
16 Miller?
17 A. I do not know which
18 questionnaire it might have been.
19 Q. It might have been developed
20 by Doctor Miller?
21 A. I guess it could have been.
22 Q. Do you know if those studies
23 were U.S. or OUS studies?
24 A. I'm not certain.
Page 343
1 Q. Do you recall any U.S.
2 Fluoxetine study that uses a suicidality
3 questionnaire?
4 A. Not specifically, but I
5 remember an obesity protocol that I believe was
6 being done in the U.S.
7 Q. Besides the obesity protocol,
8 do you recall any other studies or protocols?
9 A. No, I don't recall any other
10 specific.
11 Q. Under subparagraph C, it says
12 and as a part of our ongoing commitment, Lilly
13 would like to initiate dialogue with the
14 assistance of Doctor Judd with the National
15 Institute of Mental Health, paren, Doctor
16 Goodwin, et al, to discuss both an educational
17 campaign for primary care physicians on
18 pharmacotherapy of depression, and an RFP
19 initiative to further investigate suicidal
20 ideation slash acts emerging during the treatment
21 of depression. Do you see that?
22 A. Yes, I do.
23 Q. Who is Doctor Judd?
24 A. I believe he's a psychiatrist,
Page 344
1 but I don't know him.
2 Q. Do you know if he works for
3 the NIMH?
4 A. I'm not sure where he works.
5 Q. How about Doctor Goodwin, do
6 you know Doctor Goodwin?
7 A. I don't know him.
8 Q. Have you heard of him?
9 A. I've heard of him.
10 Q. Do you know if Doctor Goodwin
11 works at the NIMH?
12 A. I don't know for sure where he
13 works.
14 Q. To your knowledge has Lilly
15 started an educational campaign for primary care
16 physicians on pharmacotherapy of depression?
17 A. Not to my knowledge, I'm not
18 aware.
19 Q. What's an RFP initiative?
20 A. I don't know what those
21 letters stand for.
22 Q. Are you aware of any
23 connection between Eli Lilly and Company and the
24 National Institute of Mental Health?
Page 345
1 A. I'm not aware.
2 Q. Do you know -- are you aware
3 of the connection between the National Institute
4 of Mental Health and the FDA?
5 A. I'm not aware of what their
6 relationship is.
7 Q. Do you know if the National
8 Institute of Mental Health is a governmental
9 agency?
10 A. I believe it is.
11 Q. Under what department?
12 A. I would guess Health and Human
13 Services, but I don't know.
14 Q. Why is it that you believe the
15 NIMH is a governmental agency?
16 A. Because its letters are
17 similar to NIH, which I feel is.
18 Q. National Institutes of Health?
19 A. Uh-huh.
20 MR. MYERS: Yes.
21 A. Yes, sorry.
22 Q. The last paragraph of the
23 letter or the draft, Doctor Tollefson appears to
24 ask for permission from Doctor Laughren at the
Page 346
1 FDA to set up a formal meeting with
2 representatives of the National Institute of
3 Mental Health. Do you see that, the last
4 paragraph, last page?
5 A. Last page, I'm sorry, I'm
6 still on page two. I see the paragraph.
7 Q. Okay. And it appears that he
8 asks for permission to set up a formal meeting
9 with the appropriate representative of the
10 National Institute of Mental Health; correct?
11 A. It appears that way.
12 Q. To your knowledge, under the
13 regs do drug companies have to get permission
14 from the FDA to contact personnel from the
15 National Institute of Mental Health or the
16 National Institutes of Health?
17 A. I don't believe that's covered
18 in the regs.
19 Q. To your knowledge, prior to
20 October 9, 1991 had anybody from Lilly contacted
21 personnel from the National Institute of Mental
22 Health related to Fluoxetine and/or depression?
23 A. I do not know.
24 Q. Doctor, in your opinion, as a
Page 347
1 regulatory scientist in charge of Fluoxetine at
2 Eli Lilly and Company, would it be appropriate
3 for Eli Lilly or anyone on behalf of Eli Lilly to
4 consult with employees of the National Institute
5 of Mental Health or National Institutes of Health
6 to tell them what position they should take
7 related to a controversy on one of Lilly's
8 products?
9 MR. MYERS: Before he answers, let me
10 object to the form in that it's a hypothetical
11 question, it doesn't include enough facts to
12 allow him to make an informed opinion, and it
13 assumes facts not in evidence. But if you have
14 an answer, tell her.
15 A. It was a rather long question.
16 Q. Okay. I'll have her read it
17 back.
18 (THE COURT REPORTER READ BACK THE
19 REQUESTED TESTIMONY.)
20 MR. MYERS: Same objection.
21 A. I do not know what the
22 relationship between our scientists and the
23 scientists at those organizations are.
24 Q. Do you have an understanding
Page 348
1 of what the National Institute of Mental Health's
2 function is?
3 A. Not really.
4 Q. Do you have an understanding
5 of what the National Institutes of Health's
6 function is?
7 A. I've heard of them longer, but
8 I would have difficulty describing it to you.
9 Q. What is the FDA's function?
10 A. To review data on potential
11 new drugs and decide whether they're safe and
12 effective.
13 Q. Does that function end after
14 the approval of the drug that is given by the
15 FDA?
16 A. I believe it does not.
17 Q. What is the function of the
18 FDA post-marketing?
19 A. I believe they continue to
20 monitor the safety information.
21 Q. What is the relationship
22 generally between the FDA and drug manufacturers?
23 A. Two organizations that
24 communicate.
Page 349
1 Q. Anything else?
2 A. If you ask more about -- if
3 you deepen the question, maybe I could add
4 something.
5 Q. Is it the FDA's function to
6 regulate the manufacture and sale of drugs?
7 A. I believe it is.
8 Q. Okay. Is that an arms-length
9 relationship, in your opinion, between the FDA
10 and drug manufacturers?
11 A. Yes.
12 Q. Do you believe that the
13 conversation that's reflected in Exhibit No. 3 is
14 an arms-length conversation between Paul Leber,
15 Tom Laughren and Leigh Thompson from Eli Lilly?
16 MR. MYERS: Before he answers, let me
17 object to the form since he was not a participant
18 in the conversation, I don't know that he can
19 adequately draw an opinion.
20 MS. ZETTLER: Just as it's reflected
21 in the exhibit.
22 MR. MYERS: If you know.
23 A. Since I wasn't there, the
24 spirit of it would be very difficult to
Page 350
1 determine.
2 Q. To your knowledge did Doctor
3 Leber believe that somebody had broken into his
4 computer?
5 A. I feel he believes that.
6 Q. Do you know what basis he has,
7 if any, for believing that?
8 A. No.
9 Q. Have you ever had discussions
10 with Doctor Leber regarding that issue?
11 A. No.
12 Q. Have you ever had discussions
13 with Doctor Leber at all?
14 A. I've only spoken with him
15 once.
16 Q. When was that?
17 A. It was at the OCD advisory
18 committee.
19 Q. Did you have any discussions
20 with Doctor Leber on the safety of Fluoxetine for
21 use in OCD?
22 A. No.
23 Q. Why is it that you believe
24 that Doctor Leber believes that somebody broke
Page 351
1 into his computer?
2 A. There was rumors and stories
3 about this, and then as I told you, I read that.
4 It's hard to know whether to call it a magazine
5 or journal or whatever, that talked about it,
6 talked about it in particularly, I think, in a
7 way that was designed to entertain the
8 readership.
9 Q. Like whoever wrote it thought
10 it was amusing?
11 A. No, they were trying to make
12 interesting reading.
13 Q. Do you have any knowledge of
14 who is allegedly supposed to have broken into
15 Doctor Leber's computer?
16 A. No.
17 Q. Did the publication set forth
18 any possibilities?
19 A. I don't recall.
20 Q. Has anybody at Lilly ever
21 given an opinion as to who may have broken into
22 Doctor Leber's computer?
23 A. I don't recall that anyone
24 has.
Page 352
1 Q. Have you ever heard anybody
2 alleging that lawyers, on behalf of people suing
3 Eli Lilly, related to Fluoxetine, broke into
4 Doctor Leber's computer?
5 A. I don't recall ever hearing
6 that.
7 Q. Do you recall ever hearing
8 that anybody from Christian Scientists or one of
9 their related entities broke into Doctor Leber's
10 computer?
11 A. I don't recall hearing that.
12 MR. MYERS: You might have just
13 slandered the Christian Scientists. I think
14 you've got the group wrong. I know what you
15 meant to say.
16 Q. You're right, I'm sorry,
17 Church of Scientology, or the Christian
18 Scientists. How about the Church of Scientology?
19 A. Same answer.
20 Q. Were you told by anybody at
21 Lilly at any period of time not to fax
22 information to you, Doctor Leber or anybody in
23 his department?
24 A. I responded to awareness that
Page 353
1 they would prefer we didn't, I can't tell you I
2 was actually ordered not to.
3 Q. How did you become aware that
4 Doctor Leber and his department did not want
5 information faxed to them?
6 A. I do not recall the exact
7 conduit of that.
8 Q. Anything besides this exhibit,
9 Exhibit 3?
10 A. I do not remember anything
11 else.
12 Q. Do you recall having a
13 discussion with anybody at Lilly related to the
14 computer break-in issue?
15 A. No, I don't recall any
16 specific discussions.
17 (PLAINTIFFS' EXHIBIT NO. 7 WAS
18 MARKED FOR IDENTIFICATION AND
19 RECEIVED IN EVIDENCE.)
20 Q. Okay. Have you had a chance
21 to review Exhibit 7?
22 A. Yes.
23 Q. Do you recognize this exhibit,
24 I know it's got some names blacked out of it, but
Page 354
1 do you recognize the exhibit?
2 A. I don't recognize it.
3 Q. Do you recall at any time
4 Doctor Masica and Doctor Beasley traveling to
5 Boston to meet with Doctor Teicher or any of the
6 members of his group that published the article
7 on suicidality?
8 A. I don't specifically recall
9 it, but that may be what this reflects.
10 Q. This reflects a trip to Boston
11 by Doctor Masica and Doctor Beasley; correct?
12 A. That's what it says.
13 Q. It's an E-mail dated January
14 26, 1990?
15 A. Yes.
16 Q. It's authored by John
17 Heiligenstein; correct?
18 A. Yes.
19 Q. Do you recall anybody from
20 Lilly inviting Doctor Teicher or anybody who
21 worked with him on the article to forward calls
22 from doctors to Lilly?
23 A. I do not recall that.
24 Q. Are you familiar with the
Page 355
1 Prozac marketing advisory panel?
2 A. I've heard of it, I'm not
3 familiar with it.
4 Q. Is that an entity at Lilly, if
5 you know?
6 A. I don't think so.
7 Q. What is your understanding of
8 what the Prozac marketing advisory panel is?
9 A. I don't know what they do. It
10 has individuals who don't work for Lilly on it
11 that -- some of them are psychiatrists.
12 Q. So there are some people on
13 the committee that are from outside of Lilly?
14 A. Yes.
15 Q. Are you familiar with any of
16 Lilly's consultants related to Fluoxetine?
17 A. I'm not familiar, I may be
18 aware of some of them.
19 Q. Can you tell me the ones that
20 you are aware of?
21 A. Well, at one time I believe
22 Tollefson was a consultant.
23 Q. Before he became an employee?
24 A. Yes.
Page 356
1 Q. Okay. Anybody else?
2 A. Well, the individuals that
3 traveled to the FDA with us, I guess you could
4 presume that they could be called consultants.
5 Q. Doctor Fawcett?
6 A. I believe he went.
7 Q. Doctor Nemeroff?
8 A. Yes.
9 Q. Anybody else from outside of
10 Lilly that traveled with Lilly?
11 A. Well, Miller's name was on
12 that.
13 Q. Was he at the advisory
14 committee meeting, Doctor Miller?
15 A. I don't recall that he was.
16 Q. Just talking about
17 specifically the advisory committee meeting at
18 this time, the 1991 advisory committee meeting,
19 do you recall anybody else who was there on
20 behalf of Lilly who was not a Lilly employee at
21 that time?
22 A. I have this vague recollection
23 that there was a third person other than the two
24 you mentioned, but I don't recall his name.
Page 357
1 Q. Doctor Wolfson?
2 A. That doesn't sound familiar.
3 Q. Okay. Other than Doctor
4 Fawcett, Doctor Tollefson, Doctor Nemeroff and
5 Doctor Miller, do you recall anybody else who
6 acted at any time as a consultant to Lilly
7 regarding Fluoxetine?
8 A. No, I do not recall anybody
9 else.
10 Q. How about Doctor Dunner, David
11 Dunner?
12 A. I've heard of him, but I'm not
13 aware that he was a consultant.
14 Q. Do you know if Doctor Dunner
15 has done any work on behalf of Eli Lilly?
16 A. I do not know.
17 Q. How about James Kleghorn?
18 A. I have heard of his name.
19 Q. Do you know if Doctor Kleghorn
20 has done any work on behalf of Eli Lilly?
21 A. I'm not aware of any.
22 Q. How about Doctor Inman, has
23 Doctor Inman done any work on behalf of Lilly?
24 A. I wouldn't call it in behalf,
Page 358
1 but there have been some reports of his that we
2 have had.
3 Q. Reports on what subjects?
4 A. The post-marketing
5 surveillance in the UK.
6 Q. On Fluoxetine?
7 A. It included Fluoxetine.
8 Q. Other drugs as well?
9 A. As I recall, yes.
10 Q. With regards to the advisory
11 committee meeting, that was held out to be a
12 meeting related to suicidality and the use of
13 antidepressants in general; correct?
14 A. I believe that was the way it
15 was initiated.
16 Q. You sat there through the
17 entire meeting, right, you were there?
18 A. Except when I went to the
19 bathroom.
20 Q. Okay. Other than the times
21 that you were in the men's room, do you recall
22 discussion related to any antidepressants other
23 than Fluoxetine?
24 A. I don't recall any other
Page 359
1 specific mention.
2 Q. The patient vignettes that we
3 talked about a little bit earlier in relation to
4 Exhibit 4, were those all related to patient
5 experience with Fluoxetine?
6 A. I don't recall any others.
7 Q. The pilot division that you
8 talked with Paul about yesterday, that was a
9 division at the FDA as far as you know?
10 A. Yes.
11 Q. With regards to the
12 rechallenge study that you talked with Paul about
13 yesterday, was there anything that might refresh
14 your recollection as to the details of the facts
15 surrounding whether or not that study was done?
16 A. I don't know.
17 Q. Can you recall any documents
18 that might be out there that might refresh your
19 recollection?
20 A. No.
21 Q. How about with regards to
22 Doctor Miller's questionnaire, is there anything
23 out there that might refresh your recollection as
24 to the circumstances surrounding Doctor Miller's
Page 360
1 questionnaire?
2 A. I don't think I was aware of
3 the details of his work.
4 Q. Are you aware of any issue
5 arising where there was an allegation where the
6 Church of Scientology or any of its entities were
7 attempting to flood the FDA post-marketing
8 adverse event reporting system with adverse
9 events?
10 A. I'm not sure flood is the
11 right word, but I have heard of that possibility.
12 Q. What have you heard about that
13 possibility?
14 A. I really haven't heard much
15 more than that it might be happening, might have
16 happened.
17 Q. What might have happened?
18 A. That they were reporting
19 adverse events.
20 Q. To your knowledge would these
21 have been false reports of adverse events?
22 A. I do not know.
23 Q. To your knowledge has that
24 allegation ever been substantiated?
Page 361
1 A. Not to my knowledge.
2 Q. Are you familiar with the
3 Rocky Mountain Poison Control Center?
4 A. I'm not familiar with them,
5 but I've heard about them.
6 Q. What have you heard about
7 them?
8 A. Basically that they exist, and
9 they collect data. I don't know exactly what
10 that data is.
11 Q. Are you aware of a
12 collaboration of any sort between the Rocky
13 Mountain Poison Control Center and Eli Lilly?
14 A. I'm aware that that might have
15 happened.
16 Q. The collaboration?
17 A. Yes.
18 Q. Do you recall what they
19 collaborated on?
20 A. Well, I'm not sure they
21 collaborated on anything, but I remember possible
22 discussion with them related to MAOI.
23 Q. The --
24 A. Interaction.
Page 362
1 Q. The interaction issue?
2 A. That's the best of my
3 knowledge, yes.
4 Q. Are you aware of any
5 collaboration or discussions between the Rocky
6 Mountain Poison Control Center and Lilly
7 regarding an overdose study?
8 A. Yes, now that you mention it,
9 I may recall that.
10 Q. What is your knowledge on
11 that?
12 A. Very little.
13 Q. Okay. Tell me what you do
14 know.
15 A. I feel it preceded the MAOI,
16 just in -- to the best of my memory. I feel that
17 Doctor Heiligenstein might have been the Lilly
18 contact with that.
19 Q. To your knowledge has an
20 overdose study or clinical trial been run by the
21 Rocky Mountain Poison Control Center with regards
22 to Fluoxetine?
23 A. Well, I felt it was more they
24 collected data than that they ran a protocol, so
Page 363
1 I'm not aware of a protocol.
2 Q. Are you aware that that data
3 was collected on overdoses?
4 A. I believe it was.
5 Q. Do you know what happened to
6 that data?
7 A. I couldn't hear your question.
8 Q. Do you know what happened to
9 the data that was collected with regards to
10 overdoses?
11 A. No, I do not know what
12 happened to the data.
13 Q. Have you ever conveyed
14 information to the FDA related to that data
15 gathering?
16 A. I may have, I do not recall
17 for sure.
18 Q. What situations would you
19 convey information on that type of project, data
20 gathering to the FDA?
21 A. It would be because someone
22 said we should send this to the FDA, and I would
23 send it.
24 Q. Under what circumstances would
Page 364
1 somebody want it conveyed to the FDA?
2 A. That would be someone else's
3 judgment, and I don't feel I could comment.
4 Q. For instance, I mean would
5 that information be reported as adverse events on
6 1639s, for instance?
7 A. I don't know, it's possible, I
8 guess.
9 Q. Could that information be
10 reported to the FDA in the form of a final
11 report?
12 A. It could be.
13 Q. To your knowledge was that
14 ever done?
15 A. I'm not certain.
16 Q. Do you have any idea
17 whatsoever, do you recall seeing anything related
18 to a final report on data gathered by the Rocky
19 Mountain Poison Control Center related to
20 overdose?
21 A. Possibly.
22 Q. Have you ever heard of an
23 Saskatchewan deliberate self-harm data base?
24 A. No.
Page 365
1 Q. Have you heard of any project
2 where data was collected from a source in Canada
3 related to deliberate self harm?
4 A. I don't recall that.
5 Q. Have you ever heard of a MAOI
6 book at Lilly?
7 A. Yes.
8 Q. What is a MAOI book?
9 A. It was a book that essentially
10 had 1639 reports of patients who may have had the
11 interaction.
12 Q. Between MAOI and Fluoxetine?
13 A. Fluoxetine.
14 Q. Are you aware of a suicidality
15 book similar to the MAOI book?
16 A. No.
17 Q. Are you aware of a violent
18 aggressive behavior book similar to the MAOI
19 book?
20 A. I'm not aware of that.
21 (PLAINTIFFS' EXHIBIT NO. 8 WAS
22 MARKED FOR IDENTIFICATION AND
23 RECEIVED IN EVIDENCE.)
24 Q. Have you had a chance to
Page 366
1 review Exhibit 8?
2 A. Yes.
3 Q. Are you familiar with that
4 exhibit?
5 A. I don't believe so.
6 Q. Okay. It appears to be an
7 E-Mail dated August 9, 1991 written by Jim
8 Kotsanos; correct?
9 A. Yes, it does appear that way.
10 Q. And you're listed as a CC on
11 that memo?
12 A. Yes.
13 Q. In your position as regulatory
14 scientist in charge of Fluoxetine, would you
15 normally be involved in submission of this kind
16 of data to the FDA, the data that's reflected in
17 the E-Mail?
18 A. I do not get directly involved
19 in that, no.
20 Q. Are you familiar with the
21 report that Doctor Kotsanos is talking about?
22 A. I'm not certain which report
23 that is.
24 Q. Are you familiar with the
Page 367
1 report written by Doctor Inman?
2 A. I'm aware of it, yes.
3 Q. Do you know if it -- does this
4 appear to be, at least in your understanding of
5 the memo, related to Doctor Inman's report?
6 A. I can't say for sure.
7 Q. Are you aware of any other
8 reports that would talk of three hundred
9 sixty-five patients who died in relation to
10 Fluoxetine therapy?
11 A. I'm not aware of any reports
12 like that.
13 Q. Would the information related
14 to this report or stemming from this report be
15 submitted to the FDA generally in the form of
16 1639s, if you know?
17 A. I guess I'm really not
18 certain.
19 Q. Would your department, the
20 regulatory department, submit information on
21 reports talking about three hundred and
22 sixty-five patients dying in relation to
23 Fluoxetine therapy?
24 A. They could -- did you say
Page 368
1 would they or did they?
2 Q. I mean would it be possible
3 that it would be something --
4 A. Yes, it's possible.
5 Q. What situations would that
6 information go to the FDA through you or somebody
7 in your department?
8 A. Well, it doesn't go through
9 me, but 1639s are initially filled out by people
10 in the DEU, and then a physician works with them
11 to make sure it says the right medical issues.
12 Q. If --
13 A. And then they are mailed by
14 clerks in regulatory.
15 Q. Okay. You have nothing to do
16 with that first mailing?
17 A. No.
18 Q. If someone were to write a
19 report memorializing six hundred and thirty-five
20 deaths on Fluoxetine as a single report, would
21 that be something that would be submitted through
22 you in regulatory?
23 MR. MYERS: When you say a single
24 report, are you talking about the report itself
Page 369
1 or a 1639 report?
2 MS. ZETTLER: The report itself, if
3 there were a report, actual report generated.
4 A. The number you said didn't
5 sound like the number here. Did you mean just a
6 hypothetical number?
7 Q. Three hundred and sixty-five.
8 A. I heard you say six hundred
9 and thirty-five.
10 Q. I'm slightly dyslexic, okay.
11 Assume that, for the purpose of my question, that
12 the report that's talked about in Exhibit 8 was
13 not a compilation of 1639s, but was a written
14 report either evaluating the events that are
15 discussed, you know, three hundred and sixty-five
16 deaths, things of that nature, would such a
17 report be submitted to the FDA through you or
18 somebody in your department as opposed to the
19 people that submitted the 1639?
20 A. It could be, yes.
21 Q. Are you aware of any occasions
22 where safety reports were submitted to the FDA
23 that were not either the quarterly or the annual
24 safety reports on Fluoxetine?
Page 370
1 A. Yes.
2 Q. And in what situations were
3 safety reports submitted outside the regular
4 submissions that are required?
5 A. There were a few suicidality
6 reports compiled.
7 Q. And those were done in
8 relation to the advisory committee meeting that
9 was held in 1991, September of 1991?
10 A. Well, I believe that the
11 advisory committee presentation reflected that
12 information.
13 Q. Were there actual reports
14 submitted to the FDA in advance of the advisory
15 committee meeting specifically dealing with
16 issues that were going to be raised at the
17 advisory committee meeting, in other words
18 advisory committee meeting reports?
19 A. As I mentioned to you earlier,
20 I was requested by the executive secretary to
21 provide a briefing document, and I did send that
22 document --
23 Q. You were --
24 A. -- in a timely fashion.
Page 371
1 Q. Prior to the executive
2 committee meeting?
3 A. Yes -- prior to the advisory
4 committee meeting.
5 Q. That's what I meant, I'm
6 sorry. Who was the executive director?
7 A. Mike Bernstein.
8 MR. MYERS: Executive secretary.
9 MS. ZETTLER: It's been a long two
10 weeks.
11 MR. MYERS: I understand.
12 Q. I apologize, Doctor. So the
13 executive director is Mike Bernstein?
14 MR. MYERS: Secretary.
15 MS. ZETTLER: Secretary, okay. I'm
16 going to write that down so I don't forget it.
17 Q. All right. The executive
18 secretary was Mike Bernstein, is that what you
19 said?
20 A. Yes.
21 Q. What did Mister Bernstein or
22 Doctor Bernstein say to you when he requested
23 that you write up the executive summary?
24 A. I don't remember his exact
Page 372
1 words, but the implication was a document that
2 would present the information we had as
3 background.
4 Q. What information?
5 A. On suicidality.
6 Q. How about violent/aggressive
7 behavior?
8 A. I don't recall that as being
9 part of it, but I will tell you, I'm remembering
10 a letter about the meeting that may have had that
11 expression in it, I just don't remember the
12 meeting or the document or the request from Mike
13 Bernstein mentioning that to me.
14 Q. Besides the submissions made
15 to the FDA just prior to and directly related to
16 the advisory committee meeting in September,
17 1991, what other safety submissions were made by
18 Lilly related to Fluoxetine outside those regular
19 submissions that were required like the quarterly
20 or yearly submissions?
21 MR. MYERS: Whatever may have been
22 required at any time by the regulations?
23 MS. ZETTLER: Yes.
24 A. Well, I can remember a
Page 373
1 pulmonary and hematological report.
2 Q. Any others?
3 A. There may have been others,
4 but I don't recall any at this point.
5 Q. The hand-delivered submission
6 that you made to the FDA at or about July 17th or
7 18th, 1990, was that something that was part of a
8 required periodic safety submission or was that
9 something that was separate and apart from the
10 regulations?
11 A. It was separate, we did that
12 voluntarily.
13 Q. How about after the advisory
14 committee meeting in September of 1991, did Lilly
15 make any additional voluntary submissions of data
16 related to suicidality and/or violent/aggressive
17 behavior?
18 A. I don't remember them being
19 timed afterwards, no.
20 (PLAINTIFFS' EXHIBIT NO. 9 WAS
21 MARKED FOR IDENTIFICATION AND
22 RECEIVED IN EVIDENCE.)
23 Q. Do you recognize the documents
24 making up this exhibit or any of the documents
Page 374
1 making up this exhibit?
2 A. When you say recognize, do you
3 mean do I think I've ever seen them before?
4 Q. Right.
5 A. I believe I may have seen them
6 before.
7 Q. Okay. Again, recognizing that
8 the names have been taken out of the document or
9 covered up in the documents except for some
10 people that I recognize as Lilly employees, can
11 you tell me what any of these documents are?
12 A. Well, I believe they involved
13 correspondence with Doctor Inman, Professor
14 Inman.
15 Q. Was the information reflected
16 in the reports comprising Exhibit 9 --
17 A. I'm sorry, I couldn't
18 understand you.
19 Q. The information that's
20 reflected in the reports that comprise this
21 exhibit, Exhibit 9, that you believe are reports
22 by Doctor Inman, was this information sent to the
23 FDA?
24 A. I do not know.
Page 375
1 Q. Do you notice in the upper
2 right-hand corner of the first page of the
3 document it looks like there's a stamped number
4 one?
5 A. Yes.
6 Q. And then various numbers
7 stamped on the other pages of documents?
8 A. Yes.
9 Q. Who puts those numbers up
10 there, do you know?
11 A. I can't tell you who put those
12 numbers up there.
13 Q. I mean when you make a
14 submission to the FDA, do you number the pages in
15 some order?
16 A. I don't myself, but yes, we
17 do.
18 Q. Okay. And I mean like in the
19 upper right-hand corner?
20 A. I believe it is.
21 Q. Can you tell me why that's
22 done?
23 A. I can only conjecture to make
24 sure that if a page is lost, it's clear.
Page 376
1 Q. Does that have anything to do
2 with paginating the document so that it falls in
3 line with other submissions to the FDA, the IND
4 or the NDA?
5 A. NDA individual -- to the best
6 of my understanding, individual NDA submissions
7 are numbered within themselves, IND submissions
8 are numbered consecutively.
9 Q. I'm just curious because I've
10 seen documents with numbers of up to and in
11 excess of forty-six, forty-seven thousand, and I
12 was wondering if that was something that was
13 internal record keeping for Lilly or if that was
14 something that was done to keep things in line
15 chronological, at least in the FDA submissions.
16 Have you ever seen that where there had been --
17 A. Yes, my answer should have
18 covered your question.
19 MS. ZETTLER: Can you read that back?
20 (THE COURT REPORTER READ BACK THE
21 REQUESTED TESTIMONY.)
22 Q. So when you say numbered
23 consecutively, they're numbered consecutively
24 from the last submission?
Page 377
1 A. Yes, in other words one
2 through end.
3 Q. Okay. Did you personally
4 submit the information reflected in Exhibit 9 to
5 the FDA?
6 A. I'm not sure.
7 Q. After reviewing this exhibit,
8 to the best of your recollection was a formal
9 report written that reflected the information set
10 out in these reports by Doctor Inman?
11 A. I don't recall.
12 Q. You don't know if there was
13 one either way?
14 A. I do not know either way.
15 Q. Who was the regulatory
16 scientist on Fluoxetine prior to you taking over
17 the position?
18 A. Don Robinson.
19 (PLAINTIFFS' EXHIBIT NO. 10 WAS
20 MARKED FOR IDENTIFICATION AND
21 RECEIVED IN EVIDENCE.)
22 Q. Have you had a chance to
23 review Exhibit 10?
24 A. Yes, I have.
Page 378
1 Q. Do you recognize this exhibit,
2 Doctor?
3 A. Yes.
4 Q. Can you tell me what it is?
5 A. It's a computer message I
6 sent.
7 Q. It's dated January 26, 1990;
8 correct?
9 A. Uh-huh, yes.
10 Q. Tell me what the subject
11 matter of the computer message is?
12 A. Telephone conversation I had
13 with the CSO for Prozac at that time.
14 Q. What was that conversation
15 about?
16 A. It must have been about the
17 Teicher paper.
18 Q. Okay. Why were you talking
19 about Tony Deciccoicso -- is that how you say the
20 name?
21 A. Deciccoicso.
22 Q. Why were you talking with Tony
23 Deciccoicso about the Teicher paper?
24 A. He was the person I
Page 379
1 communicated with at the FDA about Prozac.
2 Q. Who initiated this
3 conversation?
4 A. I don't recall. It looks like
5 I called him.
6 Q. Is it your recollection that
7 the names that are blacked out on this page is
8 Teicher?
9 MR. MYERS: Wait a second, hold on,
10 before you answer. Okay, go ahead, you can
11 answer if you know.
12 A. It is not my recollection -- I
13 do not know what's blacked out there, I don't
14 recall.
15 Q. What makes you think that this
16 is regarding the Teicher paper?
17 A. Because American Journal of
18 Psychiatry paper, I think that's where that
19 appeared.
20 Q. A paper on suicide?
21 A. Yes, that helps me also.
22 Q. So somebody called Tony
23 Deciccoicso at the FDA and asked them if they had
24 any information on suicidality related to
Page 380
1 Fluoxetine, as far as you reflect in this memo;
2 correct?
3 A. That looks like that's what he
4 told me.
5 Q. What do you recall about the
6 part of the memo where you wrote that Tony told
7 Doctor Leber about the request and he shrugged it
8 off?
9 A. I recall that that was
10 essentially what I heard. My impression was that
11 Doctor Leber did not think there was a problem,
12 and that that response reflected that.
13 Q. Tell me about the atmosphere
14 in your department specifically, and at Lilly in
15 general, was after Lilly became aware of Doctor
16 Teicher's paper?
17 A. You mean in regulatory or in
18 medical?
19 Q. Let's start with regulatory.
20 A. I don't think regulatory was
21 aware of it very soon because it's a medical
22 issue and not a direct regulatory issue, and I
23 don't think that people in regulatory are trained
24 psychiatrists intellectually, it's pretty much
Page 381
1 above them.
2 Q. Well, you were aware of it as
3 of January 26, 1990, at least; correct?
4 A. I was aware it existed.
5 Q. At the time you wrote this
6 memo, what was the atmosphere like regarding the
7 issue of Doctor Teicher's paper in regulatory?
8 A. I would say regulatory was
9 barely aware of it, so there was an atmosphere of
10 unawareness.
11 Q. How about once regulatory
12 became aware of it, what was the atmosphere like?
13 A. An awful lot of people that
14 worked in regulatory are either not involved with
15 Fluoxetine or they're clerical people.
16 Q. Would it be fair to say that
17 after Doctor Teicher's paper came out people at
18 Lilly were concerned about the paper's impact on
19 Prozac?
20 A. You're asking me about
21 regulatory, are you still talking about --
22 Q. Let's talk generally.
23 A. I think there was concern.
24 Q. Okay. Were there people who
Page 382
1 were angry about the paper?
2 A. I think that's probably too
3 strong an emotion.
4 Q. Were there people who were
5 upset about the paper?
6 A. I would say maybe upset could
7 be qualified as consistent.
8 Q. Who was concerned in
9 particular?
10 A. Well, I think anyone who had
11 been involved with Prozac and was aware of this
12 would have feelings because it's something
13 negative about something they had worked on.
14 Q. Okay. Do you know anybody who
15 felt personally insulted, anybody?
16 A. I don't recall anybody that
17 was personally insulted, no.
18 Q. How did you feel when you
19 learned about Doctor Teicher's paper?
20 A. I think intellectual curiosity
21 on the part of being a scientist is curiosity.
22 Q. Are you aware of any other
23 papers raising the issue of suicidality and the
24 use of Fluoxetine that have been published since
Page 383
1 Doctor Teicher's paper?
2 A. I don't know how you define
3 papers, I'm aware of some publications.
4 Q. Okay. Let's just right now
5 talk about medical publications or psychiatric
6 publications, okay?
7 A. Yes.
8 Q. You're aware of some
9 publications in that realm?
10 A. Yes.
11 Q. What publications?
12 A. I no longer recall them.
13 Q. More than one other one
14 besides Doctor Teicher's?
15 A. Yes.
16 Q. How about the lay press, are
17 you aware of any articles that came out that
18 raised the issue or discussed the issue of
19 suicidality and the use of Fluoxetine in the lay
20 press?
21 A. Well, I'm aware of a number of
22 lay press articles, but I don't think necessarily
23 they were all on that subject. So there may have
24 been one, but I don't know how many, just on that
Page 384
1 subject.
2 Q. Okay. How about the issue of
3 Fluoxetine and violent/aggressive behavior, are
4 you aware of any journal publications, medical or
5 psychiatric journal publications, related to
6 that?
7 MR. MYERS: Within what time frame?
8 MS. ZETTLER: At any time.
9 A. I'm much less aware and sure
10 that I recall any like that. I can't say there
11 weren't any, but I don't remember them.
12 Q. Do you recall any meetings
13 being called at Lilly after -- immediately or
14 within a short period of time after Doctor
15 Teicher's paper came out to discuss the issue of
16 suicidality and Fluoxetine?
17 A. I don't recall such meetings.
18 Q. Who, if anyone, at Lilly was
19 upset by Doctor Teicher's paper?
20 A. Like I said, I think anyone
21 who had worked on Prozac and became aware of it
22 had feelings because they had worked hard on it,
23 and this was something negative.
24 Q. Do you recall anybody in
Page 385
1 particular voicing any feelings with regards to
2 Doctor Teicher's paper?
3 A. No one in particular.
4 Q. Have you ever talked to Doctor
5 Nemeroff about Doctor Teicher?
6 A. I have not talked directly to
7 him about Doctor Teicher.
8 Q. Have you heard Doctor Nemeroff
9 talking about Doctor Teicher?
10 A. I've heard, overheard
11 comments.
12 Q. Okay. What were those
13 comments?
14 A. Well, I got the feeling he
15 didn't agree, as a psychiatrist, with Doctor
16 Teicher.
17 Q. Did Doctor Nemeroff voice that
18 opinion rather strongly?
19 A. I think with his style, what
20 little exposure I had to him, that he never had
21 mild feelings.
22 Q. Okay. Is he a rather emotive
23 person?
24 MR. MYERS: A what?
Page 386
1 MS. ZETTLER: Emotive. I'm using a
2 big word, Larry.
3 A. I wouldn't say so much emotive
4 as just had strong opinions.
5 Q. Were you involved in a
6 conversation where he voiced these opinions or
7 was he, like, in the proximity of voicing them?
8 A. I was in the proximity.
9 Q. Was he loud about his
10 opinions?
11 A. I would say loud was too
12 strong, he didn't maybe whisper it.
13 Q. Did he raise his voice at all?
14 A. I didn't feel that strongly
15 that he raised it, no.
16 Q. He wasn't talking in the
17 normal tone of voice, was he?
18 A. Well, he may have been.
19 Q. He may have been for him?
20 A. I don't remember just exactly
21 what the level was.
22 Q. Have you heard anybody else
23 voice an opinion that was in disagreement with
24 Doctor Teicher's paper?
Page 387
1 A. Well, I'm not sure that people
2 that I come in contact with at Lilly agreed with
3 him, so I can't say specifically who said they
4 didn't agree, but I'm not sure there was any
5 agreement.
6 Q. Okay. Have you ever talked
7 with Leigh Thompson about the issue of
8 suicidality and the use of Fluoxetine?
9 A. I don't recall a direct
10 conversation.
11 Q. Have you been in the room when
12 Doctor Thompson has been discussing the issue?
13 A. There's a possibility that
14 that's true.
15 Q. Do you recall any of Doctor
16 Thompson's opinions regarding the issue?
17 A. No, I don't.
18 Q. How about the issue of
19 Fluoxetine and violent/aggressive behavior, have
20 you ever talked to Doctor Thompson about that
21 issue?
22 A. Not that I recall.
23 Q. To your knowledge has Louis
24 Judd ever acted as a consultant or spokesperson
Page 388
1 for Lilly?
2 A. I'm not aware of that.
3 Q. Do you recall an issue being
4 raised as to whether or not Fluoxetine was
5 addictive?
6 A. I don't remember it as an
7 issue. I feel at some point I have heard someone
8 comment on that issue.
9 Q. How about the issue of abuse
10 potential with Fluoxetine?
11 A. I feel the same thing I said,
12 it may have been in the same context. To me
13 those seem related.
14 Q. Do you recall a Gretchen
15 Feussner Ph.D with the DEA?
16 A. I can remember her name.
17 Q. Do you recall speaking with
18 Doctor Feussner?
19 A. I don't recall speaking with
20 her.
21 (PLAINTIFFS' EXHIBIT NO. 11 WAS
22 MARKED FOR IDENTIFICATION AND
23 RECEIVED IN EVIDENCE.)
24 Q. Okay. Have you had a chance
Page 389
1 to review Exhibit 11?
2 A. Yes.
3 Q. Do you recognize that exhibit?
4 A. I beg your pardon?
5 Q. Do you recognize the exhibit?
6 A. Yes.
7 Q. Tell me what it is.
8 A. It's a note to file that I
9 wrote.
10 Q. What's the subject matter of
11 that note?
12 A. The telephone call that Doctor
13 Feussner made to me.
14 Q. Does this refresh your
15 recollection as to having talked to Doctor
16 Feussner?
17 A. Yes, it does.
18 Q. Can you tell me what the
19 conversation was about?
20 A. She asked me some questions
21 and requested information.
22 Q. On what?
23 A. According to this, on any
24 information we had on the abuse potential of
Page 390
1 Prozac.
2 Q. Did you provide Doctor
3 Feussner with that information?
4 A. I believe that I sent her
5 information.
6 Q. What information did you send
7 her?
8 A. I don't recall the specific
9 information.
10 Q. Did you send her all the
11 information that's reflected in this note to the
12 file?
13 A. Well, some of these things
14 apparently I said at the time, and it seems like
15 I recall sending her something, but when you --
16 yes, okay, I guess I must have sent her
17 something.
18 Q. Do you recall what you sent
19 her, though?
20 A. No, I presume that it's
21 reflected here.
22 Q. Do you recall if there was
23 anything in addition to what's reflected in
24 Exhibit 11 that you sent her?
Page 391
1 A. I don't recall that.
2 Q. Did you work with anybody else
3 on answering Doctor Feussner's questions?
4 A. I remember Jim Kotsanos. In
5 fact, actually, I think at the time I was
6 thinking that she might have called him, but
7 apparently not, so I must have remembered him
8 helping me in some way.
9 Q. After you provided Doctor
10 Feussner with the information that is reflected
11 in Exhibit 11, and possibly additional
12 information, did you have any other conversations
13 with Doctor Feussner on this issue?
14 A. Not that I can recall.
15 Q. Do you recall this issue being
16 raised at any other time by anybody else?
17 A. I don't remember it being
18 raised as an issue by anyone else.
19 Q. Did you do any other work on
20 this issue besides answering Doctor Feussner's
21 questions and providing her with information?
22 A. I don't recall any other work.
23 Q. Prior to 1990, were you aware
24 of any issues related to Fluoxetine and
Page 392
1 agitation?
2 A. No.
3 Q. Were you aware of any issues
4 related to Fluoxetine and suicidal ideation or
5 suicide?
6 A. No.
7 Q. Were you aware that there was
8 at one time a clinical trial that was run on
9 Fluoxetine in treating suicidal ideation?
10 A. No, I was not aware of that.
11 Q. Were you aware that at one
12 time there was a clinical trial run on Fluoxetine
13 and the treatment of agitation or agitation and --
14 or, I'm sorry, anxiety related to depression?
15 A. Can you repeat the question,
16 please?
17 Q. Sure. Are you aware that at
18 one time there was run -- a clinical trial was
19 run on the treatment of anxiety related to
20 depression with Fluoxetine?
21 MR. MYERS: Before he answers, let me
22 object to the form because I don't know that your
23 description is the precise description. But if
24 you know, tell her.
Page 393
1 A. I believe that we have some
2 information on that, but I'm not aware of a
3 study.
4 Q. What information?
5 A. I don't know what it is, but I
6 know that some countries, their package
7 literature covers either depression associated
8 with anxiety or anxiety associated with
9 depression. So anxiety has come up as something
10 that must have had data collected about it at
11 some point.
12 Q. So do you know what the
13 package insert in those countries reflects as far
14 as using Fluoxetine on people suffering from
15 anxiety related to depression?
16 A. No, I don't know that specific
17 information.
18 Q. Are you aware of any package
19 insert either in the United States or outside the
20 United States that talks about Fluoxetine being
21 an activating drug?
22 A. I'm sorry, I couldn't
23 understand what you just said.
24 Q. Are you aware of a package
Page 394
1 insert, either here in the United States or
2 outside the United States, that talks about
3 Fluoxetine being an activating drug?
4 A. No, I'm not aware of that.
5 Q. Are you aware of a package
6 insert, either here in the United States or
7 outside the United States, that talks about
8 Fluoxetine increasing agitation in depressed
9 patients?
10 A. I'm not aware of that.
11 Q. Do you have a personal
12 opinion, and I'm not asking you as an M.D. or
13 psychologist, but do you have a personnel opinion
14 as to whether or not Fluoxetine increases
15 suicidality in depressed patients?
16 MR. MYERS: Before he answers the
17 question, notwithstanding the caveats, that still
18 is a medical question and I object to the form.
19 Q. Do you have a personal
20 opinion, Doctor?
21 MR. MYERS: Same objection.
22 A. I'm not a physician, and
23 especially not a psychiatrist, so I don't
24 consider my opinion having any medical
Page 395
1 perspective or relevance at all. But just as a
2 lay person, I don't believe that there's any
3 evidence.
4 Q. Do you have an opinion as to
5 whether or not Fluoxetine causes
6 violent/aggressive behavior in people --
7 MR. MYERS: Same objection.
8 Q. -- who are depressed?
9 MR. MYERS: Same objection.
10 A. Within the same context, the
11 same answer.
12 Q. Okay. What do you base that
13 opinion on?
14 A. Just what I absorb by osmosis,
15 listening, talking to people with a chemist's
16 background as opposed to a psychiatrist's
17 background.
18 Q. What is there about the
19 chemical makeup of Fluoxetine that leads you to
20 the opinion that Fluoxetine causes neither
21 suicidality or violent/aggressive behavior in
22 depressed people?
23 A. There's nothing about the
24 chemical structure that would influence that.
Page 396
1 (PLAINTIFFS' EXHIBIT NO. 12 WAS
2 MARKED FOR IDENTIFICATION AND
3 RECEIVED IN EVIDENCE.)
4 Q. Have you had a chance to
5 review Exhibit 12?
6 A. Yes.
7 Q. Do you recognize this exhibit?
8 A. Yes.
9 Q. Can you tell me what it is,
10 please?
11 A. It's a copy of a computer
12 message to David Brockwell from me.
13 Q. Who is David Brockwell?
14 A. He's a regulatory individual
15 in the UK with Lilly.
16 Q. This E-Mail is dated January
17 3, 1992; correct?
18 A. Yes.
19 Q. And it talks about the
20 overdose section of the Prozac package insert in
21 the UK, I believe?
22 A. It refers to the Prozac
23 package insert, and the IFD is just an
24 international version of that.
Page 397
1 Q. The IFD is an international
2 version?
3 A. Yes, I mean that's a little
4 simplistic, but that's what I would call it.
5 Q. Are there individual package
6 inserts used in each country that Fluoxetine is
7 sold in?
8 A. Most of them. Some of the
9 very small countries I could be not so sure of.
10 Q. But to your knowledge, as far
11 as the larger European countries, for instance,
12 each country has their own package insert?
13 A. I believe so.
14 Q. So when you said the IFD, what
15 do you mean?
16 A. In my opinion, the IFD is the
17 U.S. package insert to communicate to other
18 countries what it says.
19 Q. What does IFD stand for?
20 A. International Full Disclosure.
21 Q. Is that a Lilly title?
22 A. I believe it is.
23 Q. And the data sheet is the same
24 thing as the IFD?
Page 398
1 A. Apparently. I don't use the
2 word data sheet, I think that's a country
3 specific reference to what we may call package
4 insert.
5 Q. So if I understand this
6 E-mail, you were conveying to David Brockwell the
7 changes in the overdose section that are made in
8 the U.S. package insert?
9 A. I believe that's correct.
10 Q. Are you recommending that the
11 UK package insert be changed to reflect the
12 changes in the U.S. package insert?
13 A. I'm not recommending that.
14 Q. You're just providing him with
15 information made on the change in the U.S.
16 package insert?
17 A. Yes.
18 Q. In the third paragraph you
19 state that Lilly has received reports of fatal
20 events associated with Fluoxetine. Do you see
21 that?
22 A. Yes.
23 Q. Are you talking about fatal
24 events associated with overdoses of Fluoxetine?
Page 399
1 A. It doesn't say that, so that
2 might be a leap of judgment.
3 Q. Okay. It goes on to say while
4 it's impossible to say that any of these reports
5 provide -- proves absolutely convincing
6 documentation of death from overdose of
7 Fluoxetine alone. Do you see that?
8 A. Yes.
9 Q. Okay. So is that two separate
10 things?
11 A. They probably are related.
12 Q. What did you mean when you
13 said it's impossible to say that any of these
14 reports -- I believe that's a typo, it's supposed
15 to be provide. Does that look correct to you?
16 A. Yes, it says provise, is that
17 what it says? Okay, there's a Fentress typed on
18 top of it.
19 Q. Yes. Can you -- is it fair to
20 say that you meant provides there?
21 A. I think so.
22 Q. While it's impossible to say
23 that any of these reports provides absolutely
24 convincing documentation of the death from
Page 400
1 overdose of Fluoxetine alone, including the case
2 that led to the previous wording quoted above, it
3 is also not possible to dismiss the possibility
4 from all such reports. Do you see that?
5 A. Yes, I see that.
6 Q. Okay. So in other words
7 you're saying here that from the information that
8 you had, there's no way to tell for sure either
9 way whether or not the cause of death was related
10 directly to the ingestion of Fluoxetine; correct?
11 A. That wording was given to me
12 by the physicians who I quote above, and I was
13 just transmitting what they said.
14 Q. So this does not reflect your
15 opinion?
16 A. That does not reflect my
17 medical judgment because I don't have any
18 training in medicine.
19 Q. Does it reflect, to your
20 knowledge, the opinions of Doctor Thompson and
21 Doctor Beasley?
22 A. I believe it does.
23 Q. Does this, to your knowledge,
24 convey an association between the use of
Page 401
1 Fluoxetine and the propensity for somebody to
2 take an overdose?
3 MR. MYERS: Let me object to the form,
4 that may be a medical question, medical opinion.
5 Q. In your opinion, Doctor?
6 MR. MYERS: I understand your
7 question, it's still the same problem with it.
8 A. I don't have an opinion,
9 that's a medical judgment and I'm not trained to
10 do.
11 Q. To your knowledge have there
12 been more than one death where Fluoxetine was the
13 only ingestant taken?
14 MR. MYERS: Death by overdose.
15 MS. ZETTLER: Right.
16 A. Well, could you repeat that
17 question?
18 Q. Sure. In this exhibit you
19 talk about the one case that led to the package
20 insert change in September of 1989. Do you see
21 that?
22 A. Yes.
23 Q. And that was a case where at
24 least as far as the information that Lilly had
Page 402
1 was concerned, the person only overdosed on
2 Fluoxetine, and then died; correct?
3 A. Well, I'll agree with what it
4 says here, I believe what it says here is
5 factual.
6 Q. Okay.
7 A. You didn't --
8 Q. Are you aware of more than one
9 case where somebody overdosed on Fluoxetine and
10 died, and that was the only thing that they had
11 ingested?
12 A. I'm not aware.
13 Q. Are you aware of one case
14 where that has happened?
15 A. Yes.
16 Q. And that was a woman; correct?
17 A. I have no idea of the facts,
18 all I know is that the physicians said that
19 happened and we put it in the package insert.
20 Q. So the information that you
21 get on Fluoxetine is information from other
22 people at Lilly; correct?
23 A. That's correct.
24 Q. Okay. And the information
Page 403
1 that you convey to the FDA for the most part is
2 information that you receive from other people at
3 Lilly; correct?
4 A. That's correct.
5 Q. Have you done any independent
6 research on Fluoxetine outside of Lilly?
7 A. No.
8 Q. Have you discussed Fluoxetine
9 with anybody outside of Lilly, including people
10 at the FDA where somebody else's information or
11 opinion was not involved?
12 MR. MYERS: I object to the form,
13 that's awfully vague when you say -- who is the
14 somebody else?
15 MS. ZETTLER: Somebody at Lilly. He's
16 already testified that he's gotten all his
17 information from other people at Lilly, and I'm
18 interested in knowing if he's ever had a
19 conversation with somebody, and I'm using the FDA
20 at this point, where he hasn't conveyed
21 information that was given to him by somebody
22 else at Lilly.
23 A. I'm sorry, that question -- I
24 don't understand the question, and I don't have
Page 404
1 any idea what to say because I don't understand
2 your question.
3 Q. Okay, that's fine.
4 A. It's not that I don't
5 understand your meaning, I just don't understand
6 your words.
7 Q. Okay, that's absolutely fair,
8 Doctor. If you don't understand me, tell me so I
9 can rephrase it. Do you recall any time when you
10 talked to somebody at the FDA where the
11 information that you have conveyed to that person
12 at the FDA regarding Fluoxetine did not come from
13 somebody else at Lilly?
14 A. I understand your question. I
15 don't recall any exceptions to that.
16 MS. ZETTLER: Let's take a break.
17 (A SHORT RECESS WAS TAKEN.)
18 Q. In your capacity as regulatory
19 scientist on Fluoxetine, did you have any
20 responsibilities with regards to submitting
21 protocols to the FDA for approval on clinical
22 trials?
23 A. Some protocols have passed
24 through my hands on their way to the FDA.
Page 405
1 Q. Was there a certain type of
2 protocol that would go through you to the FDA?
3 A. No certain type. Any that
4 were appropriate to submit, I would be the
5 conduit for those.
6 Q. Were there some Fluoxetine
7 protocols that were not submitted to the FDA for
8 approval?
9 A. Not that I'm aware of.
10 Q. In what situations would a
11 protocol go through you to be submitted to the
12 FDA?
13 A. When it was going to the FDA.
14 Q. Okay. See, now I'm getting
15 confused. Any protocol that would go to the FDA
16 for approval would go through you?
17 A. The key word is approval. Any
18 protocol submitted to the FDA would go through
19 regulatory, and I would be part of the conduit.
20 Q. Okay. So if the protocol
21 required approval, it would go through you?
22 A. And if it didn't require --
23 MR. MYERS: I think he said any that
24 was submitted for any purposes, I think is what
Page 406
1 he was saying.
2 MS. ZETTLER: Okay.
3 MR. MYERS: I don't want to put words
4 in anybody's mouth.
5 A. Yes, and you keep saying
6 approval, and approval isn't part of why I sent
7 it.
8 Q. Okay. That's fine. Were
9 there some protocols that were submitted to the
10 FDA for approval and some that were not submitted
11 for approval?
12 A. Yes.
13 Q. In what situations would a
14 protocol be submitted for approval?
15 A. The majority of those are at
16 the beginning of an IND.
17 Q. Preapproval, premarketing
18 approval, not approval of the protocol, approval
19 of the drug for marketing by the FDA?
20 A. That's not correct.
21 Q. Because there are IND studies
22 that go on after the drug is marketed, too?
23 A. When you submit an IND,
24 initial IND, you have a protocol in there.
Page 407
1 Q. Okay.
2 A. And essentially that protocol
3 is approved by the FDA.
4 Q. And in what other situations
5 would the protocols be approved by the FDA?
6 A. They would be unique
7 situations that I couldn't predict.
8 Q. Can you give me an example?
9 A. No.
10 Q. Can you think of any
11 Fluoxetine protocols other than the IND
12 protocols?
13 A. I cannot think of any, and of
14 course that one, that was before my time.
15 Q. Did you submit any Fluoxetine
16 protocols to the IND for approval?
17 A. Not to my recollection.
18 Q. And other than -- you know,
19 unless I specify otherwise, assume that I mean --
20 when I'm talking about the protocols, I mean
21 Fluoxetine clinical trials, okay?
22 A. Yes.
23 Q. To your knowledge did anybody
24 else at Lilly submit protocols for approval to
Page 408
1 the FDA on Fluoxetine?
2 A. I'm not aware either way on
3 that.
4 (DISCUSSION OFF THE RECORD.)
5 (PLAINTIFFS' EXHIBIT NO. 13 WAS
6 MARKED FOR IDENTIFICATION AND
7 RECEIVED IN EVIDENCE.)
8 Q. Have you had a chance to
9 review Exhibit 13?
10 A. Yes.
11 Q. Do you recognize the exhibit?
12 A. I recognize it.
13 Q. Tell me how you recognize it.
14 A. It's a note to file that I
15 wrote.
16 Q. Okay. The first page of the
17 exhibit is a note to file dated March 27, 1991
18 authored by you; correct?
19 A. Yes.
20 Q. And the note talks about a
21 phone call between you and Paul David asking
22 about what the progress on the protocol to study
23 suicidality was; correct?
24 A. Correct.
Page 409
1 Q. You also state that Mister
2 David stated that the agency was under political
3 pressure regarding the study; correct?
4 A. That's what I said here.
5 Q. Do you recall that?
6 A. No, I don't.
7 Q. Do you recall talking to
8 Mister David about the suicidality study?
9 A. Yes.
10 Q. What do you recall about that
11 conversation?
12 A. I recall that he called me and
13 asked about the progress.
14 Q. And what did you do in
15 response to his call besides writing the note to
16 the file?
17 A. I went to individuals I
18 thought could tell me about the progress and
19 asked them.
20 Q. Who did you go to?
21 A. I believe I went to Charles
22 Beasley.
23 Q. Anybody else?
24 A. Not that I recall.
Page 410
1 Q. What did Doctor Beasley tell
2 you?
3 A. He told me that it was still
4 in progress.
5 Q. Okay. Did he tell you that
6 there was a draft that had been written?
7 A. I don't recall that issue.
8 Q. Did he tell you to tell
9 anybody at the FDA that they would be submitting
10 a draft of the protocol later related to that
11 issue shortly?
12 A. I don't recall whether he
13 specifically said that.
14 Q. What do you recall
15 specifically about what he said the state of the
16 project was or where you were as far as the
17 development of the protocol?
18 MR. MYERS: He, as in Doctor Beasley?
19 MS. ZETTLER: Right, sorry.
20 A. My feeling was that it wasn't
21 complete yet. By that, I mean the protocol
22 wasn't complete.
23 Q. Attached to -- after your
24 March 27, 1991 note to the file is a letter by
Page 411
1 Doctor Zerbe to the FDA submitting the draft
2 protocol for the Fluoxetine/Desipramine placebo
3 rechallenge study regarding suicidal ideation;
4 correct?
5 A. I see that.
6 Q. Okay. That's what the letter
7 says?
8 A. Yes.
9 Q. To your knowledge is this
10 study different than the study that Mister Paul
11 called you about reflected in your March 27, 1991
12 note to the file?
13 A. I don't know whether it's the
14 same or different.
15 Q. What is your understanding of
16 the suicide -- the protocol to study suicidality?
17 A. I don't have any understanding
18 of it.
19 Q. How did you convey Mister
20 David's question to Doctor Beasley if you didn't
21 know what the study was?
22 A. I just said that they wanted
23 to know the progress with the protocol to study
24 suicidality.
Page 412
1 Q. Do you have any knowledge
2 whatsoever regarding the Fluoxetine/Desipramine
3 placebo rechallenge study in patients who
4 developed suicidal ideation while under treatment --
5 A. No.
6 Q. -- other than the March 29th
7 letter by Doctor Zerbe?
8 A. No.
9 Q. Attached to Doctor Zerbe's
10 letter is a cover sheet or sheets and a draft of
11 a protocol; correct -- or, I'm sorry, a draft of
12 alternative studies.
13 A. I'm sorry, I don't see the
14 expression alternative studies.
15 Q. Look at page 1339 1065.
16 A. Oh, I'm looking in the upper
17 right-hand corner, I'm sorry.
18 Q. That page is entitled Approach
19 to Study of Potential Association of Suicidality
20 to Antidepressant Therapy; correct?
21 A. Yes.
22 Q. And under there it says three
23 different basic approaches to the prospective
24 assessment of potential relationships.
Page 413
1 A. I see that.
2 Q. Have you ever seen this part
3 of the document before, the approach to study
4 potential association of suicidality to
5 antidepressant therapy?
6 A. It may have been in front of
7 me at some point.
8 Q. You don't recall seeing it?
9 A. I don't recall the substance
10 of it, and I can't say I actually have seen it,
11 but to the extent that I was the conduit by which
12 this went, it may have passed in front of my
13 eyes.
14 Q. Okay. If you would look at
15 the cover page attached to that.
16 MR. MYERS: What do you mean, these
17 forms?
18 Q. Right, the Department of
19 Health and Human Services IND forms. Does this
20 indicate that you had any involvement in
21 submitting this to the FDA?
22 A. These pages, by themselves, do
23 not directly indicate I had any involvement.
24 Q. Okay. When you made a
Page 414
1 submission to the FDA, did you always use a form
2 such as this as reflected in Exhibit 13?
3 A. I don't fill out these forms.
4 Q. Is a form usually attached to
5 submissions that you make to the FDA?
6 A. Yes.
7 Q. Is your name usually indicated
8 on these forms somewhere?
9 A. No.
10 Q. Are you able to tell from
11 anything about this exhibit whether or not you
12 were involved in the submission of this draft
13 protocol to the FDA?
14 A. You mean the whole packet?
15 Q. Right.
16 A. Yes.
17 Q. What are you able to tell,
18 were you involved?
19 A. The cover letter -- well, the
20 second page.
21 Q. March 29th letter by Doctor
22 Zerbe?
23 A. Yes.
24 Q. And that's because in the last
Page 415
1 paragraph, it says please call me or Al Webber if
2 there are any questions?
3 A. I believe I wrote this letter.
4 Q. Okay. What is it about the
5 letter that makes you believe you wrote it?
6 A. Because I wrote almost all of
7 them, and it kind of looks like my style of
8 writing.
9 Q. Do you recall submitting this
10 draft protocol to the FDA or playing a role in
11 submitting it to the FDA?
12 A. I do not remember it, no.
13 Q. But you believe, based on the
14 March 29, 1991 letter signed by Doctor Zerbe that
15 you did at least play a part in submitting the
16 protocol to the FDA?
17 A. I believe I did.
18 Q. Do you recall what the FDA's
19 response to the submission of this protocol to
20 them was?
21 A. I do not recall that.
22 Q. Do you know if this was
23 actually sent?
24 A. I'm not certain it was sent,
Page 416
1 it has every look as if it was sent.
2 Q. But you don't have any
3 independent recollection of having actually sent
4 it?
5 A. I don't have any proof that it
6 was sent.
7 Q. In the upper right-hand corner
8 are these numbers that I talked about earlier.
9 Does this indicate this was submitted to the NDA.
10 A. I believe that indicates it
11 was submitted to the IND.
12 Q. Did you ever see any document
13 that indicated that the FDA approved the
14 protocol?
15 A. Not to my recollection.
16 Q. Have you ever seen any
17 documentation that indicates that the FDA in fact
18 received that protocol?
19 A. I do not recall seeing that.
20 Q. If I wanted to find out if the
21 FDA first received the protocol, where would I
22 look?
23 A. Well, in their file.
24 Q. Okay. How about at Lilly,
Page 417
1 where would I go at Lilly to find out if they had
2 approved the protocol or received the protocol?
3 A. If this was sent Federal
4 Express, there might be a receipt that someone
5 signed for it at the FDA.
6 Q. Does Lilly -- somebody at
7 Lilly usually indicate on the letter if it was
8 sent Federal Express or not?
9 A. No.
10 Q. Besides checking with Federal
11 Express records, is there any other place at
12 Lilly that I could go to or any other person that
13 I could talk to to find out if this protocol was
14 actually sent?
15 A. Well, you have asked me
16 questions about received and asked me questions
17 about sent.
18 Q. Okay. How about sent?
19 A. Okay. Because I have been
20 asking questions about did they receive it.
21 Q. That's fine. But now let's
22 talk about whether or not it was actually sent.
23 Where would I go to Lilly to find out if this
24 document was actually sent to the FDA?
Page 418
1 A. I believe if it were in our
2 IND files, it was sent.
3 Q. Okay. Do you know why Doctor
4 Zerbe signed the letter dated March 29th, 1991 on
5 behalf of Doctor Talbott?
6 A. I presume because Doctor
7 Talbott was not present at this time, at this
8 point.
9 Q. Have you ever discussed this
10 protocol with Doctor Talbott?
11 A. I don't believe so.
12 Q. Was it unusual for Doctor
13 Zerbe to sign a letter written by Doctor Talbott?
14 A. It was not unusual.
15 Q. Why is it that Doctor Zerbe
16 could not sign the letter on his own behalf as
17 opposed to having to sign it on behalf of Doctor
18 Talbott?
19 A. All of the letters to the FDA
20 have Doctor Talbott's name at the bottom.
21 Q. Why is that?
22 A. That's just the way it's set
23 up.
24 Q. At Lilly?
Page 419
1 A. Yes. I can't explain to you
2 why.
3 Q. Is there a regulation or
4 requirement by the FDA, to your knowledge, that
5 one person at Lilly be designated as the person
6 who corresponds with the FDA?
7 A. I'm not aware of that.
8 Q. You've corresponded with the
9 FDA, have you not?
10 A. No -- I'm not sure what you're
11 really saying.
12 Q. Have you written letters to
13 the FDA under your own signature?
14 A. Maybe never, but hardly ever,
15 okay.
16 Q. Okay. Under what situations
17 might you do that?
18 A. For instance, there was a time
19 period at which regulatory scientists could sign
20 for Doctor Talbott if he wasn't present.
21 Q. Okay.
22 A. So you might see my signature
23 for Doctor Talbott.
24 Q. So it would be similar to this
Page 420
1 where it would say Doctor Webber on behalf of or
2 for Max W. Talbott?
3 A. Yes.
4 Q. But you had not -- there is no
5 letter, to your knowledge, that went from Lilly
6 to the FDA where it says sincerely Eli Lilly and
7 Company, J. A. Webber, M.D. -- or Ph.D, right?
8 A. I cannot promise you there was
9 none, but that goes against what I think should
10 be done, so I wouldn't do it now.
11 Q. Okay. Has anybody at Lilly
12 told you that you are not allowed to sign letters
13 or write letters on your own behalf to the FDA?
14 A. I would say no one's ordered
15 me not to.
16 Q. Where did you come to your
17 understanding that that was not to be done?
18 A. In the framework of all the
19 letters go over Doctor Talbott's name.
20 Q. Do you know why that is?
21 A. No.
22 Q. Are you aware of a clinical
23 trial on Fluoxetine being conducted in Taiwan?
24 A. I'm aware.
Page 421
1 Q. What is that clinical trial?
2 A. I do not know the details of
3 it.
4 Q. Is it a Fluoxetine trial?
5 A. I believe it is.
6 Q. Is it a depression trial?
7 A. I do not know that for sure.
8 Q. Do you believe that it's a
9 depression trial?
10 A. If I had to guess, I would say
11 yes.
12 (PLAINTIFFS' EXHIBIT NO. 14 WAS
13 MARKED FOR IDENTIFICATION AND
14 RECEIVED IN EVIDENCE.)
15
16 Q. Have you had a chance to
17 review Exhibit 14, Doctor?
18 A. Yes, I have.
19 Q. Are you familiar with any part
20 of this exhibit?
21 A. Vaguely familiar with it.
22 Q. Do you have any recollection
23 of the Taiwanese trial of Fluoxetine versus
24 Maprotiline?
Page 422
1 A. I'm vaguely aware.
2 Q. What is your knowledge of that
3 issue, that situation?
4 A. It's just superficial.
5 Q. Just tell me what you know.
6 A. I don't know anything about
7 the details.
8 Q. Okay. Can you tell me what
9 you know generally?
10 A. I'm just aware that there was
11 a trial with Fluoxetine and Maprotiline, and
12 there's really more information here than I
13 recall, so I learned more from this document than
14 I did from my memory.
15 Q. Okay. Do you know if this
16 study that's referred to in this exhibit was a
17 study that was done on behalf of Lilly?
18 A. I do not know that.
19 Q. Was it common for Doctor Zerbe
20 to talk to Doctor Leber?
21 A. It wasn't common.
22 Q. In what situations would
23 Doctor Zerbe call Doctor Leber, contact Doctor
24 Leber directly?
Page 423
1 A. When it was appropriate for
2 there to be a physician-to-physician discussion.
3 Q. In what situations would that
4 be?
5 A. When medical information
6 needed to be discussed.
7 Q. What medical information is
8 discussed in this exhibit?
9 MR. MYERS: When you say this exhibit,
10 what part of it?
11 MS. ZETTLER: Any part of it.
12 A. The comment about the Taiwan
13 protocol study.
14 Q. Which comments, about the
15 Taiwanese study?
16 A. What is said that was
17 transpired between them.
18 Q. In Doctor Zerbe's note to the
19 file?
20 A. And apparently also in this
21 other one, which I guess is from Paul Leber.
22 Q. What is it about the
23 information that is reflected in the Leber memo
24 dated 3-13-92 memorializing this conversation
Page 424
1 with Doctor Zerbe and Doctor Zerbe's memo
2 regarding the same conversation that is, in your
3 opinion, something that a doctor would have to
4 convey to Doctor Leber's adverse events as
5 opposed to somebody from regulatory?
6 A. It reflects observations in a
7 clinical trial.
8 Q. How did Doctor Zerbe become
9 aware of this clinical trial?
10 A. I'm not aware of that.
11 Q. Did Doctor Zerbe report
12 information on clinical trials all the time to
13 Doctor Leber?
14 A. No.
15 Q. Which types of clinical trial
16 information would Doctor Zerbe feel compelled to
17 talk to Doctor Leber directly about?
18 A. That would have been Doctor
19 Zerbe's call.
20 Q. What are the times you're
21 aware that Doctor Zerbe was in contact with
22 Doctor Leber or what types of clinical trial
23 information would he be conveying to Doctor
24 Leber?
Page 425
1 A. Whatever he felt was
2 appropriate.
3 Q. I'm trying to find out what
4 you recall were the situations when Doctor Zerbe
5 would report directly to Doctor Leber about a
6 particular clinical trial or trials.
7 A. I recall it being his
8 decision.
9 Q. Do you recall any of the
10 factual situations regarding any of the
11 conversations that Doctor Zerbe had with Doctor
12 Leber?
13 A. There have been very few, and
14 I don't recall any others.
15 Q. Did they all relate to
16 suicidality?
17 A. I don't know.
18 Q. Did they all relate to safety
19 issues?
20 A. I don't know.
21 Q. Did they all relate to
22 Fluoxetine?
23 A. I don't think so.
24 Q. On the few instances that
Page 426
1 you're aware of that Doctor Zerbe called Doctor
2 Leber, not all of those related to Fluoxetine?
3 A. I believe that's correct.
4 Q. Doctor Leber's notes regarding
5 the conversation indicate that it was his
6 understanding that a source had learned that an
7 abstract may be published in the Taiwanese trial
8 of Fluoxetine versus Maprotiline where there was
9 a seven out of sixty versus zero out of sixty
10 incidence of suicide attempts reflecting that the
11 seven out of sixty was with Fluoxetine; correct?
12 MR. MYERS: Before he answers, let me
13 object to the form only to the extent that you've
14 asked what Doctor Leber, the writer of this memo,
15 understood. I don't know that you asked him what
16 the memo said. If you asked him what Leber
17 understood, that would be speculative.
18 Q. That's what the memo says;
19 correct, that a source has learned that an
20 abstract may be published of Taiwanese trial of
21 Fluoxetine versus Maprotiline where there was a
22 seven slash sixty versus zero slash sixty
23 incidence, respectively, of suicide attempts,
24 right?
Page 427
1 A. I can see that it says that.
2 Q. Okay. It goes on to say that
3 the potential for negative spin is obvious;
4 correct?
5 A. I can read that.
6 Q. And that they want to, quote,
7 alert us, unquote; correct?
8 A. It says that.
9 Q. It goes on to say that Doctor
10 Zerbe tried to critique the trial and undermine
11 its incriminating inferences, and that Doctor
12 Leber stated he replied that it was premature and
13 they needed to see the relevant information;
14 correct?
15 A. That's what it says here.
16 Q. He also puts in his
17 recollection that Maprotiline is the drug that
18 was reported by -- to be associated with a higher
19 incidence of suicide attempts compared to placebo
20 in a French trial last year; correct?
21 A. It doesn't say trial.
22 Q. RCT.
23 A. Whatever RCT means. But the
24 rest of what you read is what I read here also.
Page 428
1 Q. In other words it was his
2 recollection, as reflected in this memo, where he
3 says if I recall correctly, that Maprotiline was
4 associated with a higher incidence of suicide
5 attempt at least on one occasion, compared to
6 placebo?
7 A. Are you asking me to confirm
8 that those are his words in here?
9 Q. Right.
10 A. That's what I read also.
11 Q. Are you aware of any other
12 Maprotiline studies where the issue of
13 suicidality was raised?
14 A. No, I'm not.
15 Q. Doctor Zerbe's notation or
16 note to the file regarding that conversation is
17 slightly different than Doctor Leber's; correct?
18 MR. MYERS: Let me object to the form.
19 When you say it's different, I'm willing to bet
20 that they're not worded exactly the same, but
21 what do you want to know about what's different?
22 Q. Well, Doctor Zerbe doesn't
23 reflect in his memorialization of the
24 conversation that he tried to undermine the
Page 429
1 quality of the trial as reflected in Doctor
2 Leber's memo; correct?
3 A. I don't see Zerbe's words to
4 that effect, correct.
5 Q. In fact Doctor Zerbe's
6 memorialization makes it look like there was
7 going to be a report of increased -- possible
8 increased frequency related to the Taiwan study;
9 correct?
10 MR. MYERS: Before he answers, let me
11 object to the form in terms of what the memo
12 makes it look like. Since he didn't write it,
13 all he can do is confirm what it does and doesn't
14 say, maybe compared to the other one. But that
15 would call upon him to interpret and speculate as
16 to what he meant.
17 Q. Did you understand the
18 question, Doctor?
19 A. No, and I don't recall it
20 either.
21 Q. Okay, read it back -- wait a
22 minute, let me ask it again. Doctor Leber's
23 memorialization of the conversation does not talk
24 about Doctor Zerbe's submission or possible
Page 430
1 submission of a possible increased frequency
2 report describing the suicides or results of the
3 study done in Taiwan; correct?
4 A. It doesn't literally use that
5 expression, that's correct.
6 Q. Does he indicate -- does
7 Doctor Leber indicate in his memorialization
8 anywhere that Lilly intends to file a possible
9 increased frequency report as a result of the
10 study?
11 A. To the best of my ability to
12 see what the words say, I think he does not
13 mention that.
14 Q. If you could go to the third
15 page. This is another note to the file by Doctor
16 Zerbe which is dated March 17, 1992; correct?
17 A. Correct.
18 Q. And he talks about calling
19 Doctor Laughren regarding the same three issues
20 that he talked to Doctor Leber about the week
21 before, including the Taiwan study; correct?
22 A. Correct.
23 Q. Towards the second from the
24 last sentence in the note to the file, it says I
Page 431
1 also mentioned to him that we did intend to bring
2 a consultant, and he was quite open to that. Do
3 you know what he means by that?
4 MR. MYERS: I would object to the
5 form. If you know.
6 Q. If you know.
7 MR. MYERS: If you have independent
8 knowledge, tell her.
9 A. He's referring to the planned
10 Lovan conference.
11 Q. And then the last line says he
12 also requested that we provide a desk copy of the
13 possible increased frequency report that we would
14 be filing about the Taiwanese study; correct?
15 A. That's what I read.
16 Q. What is a desk copy?
17 A. When you make a submission to
18 the official NDA file at the FDA, you send two
19 copies, so you send an extra copy for an
20 individual's reference.
21 Q. So you would send a copy --
22 A. That would be referred to --
23 it's like a CC.
24 Q. So in this case it would be a
Page 432
1 desk copy to Doctor Laughren?
2 A. It says that's what he wants.
3 Q. Do you know if a desk copy of
4 possible increased frequency report regarding the
5 Taiwanese study was sent to Doctor Laughren?
6 A. I do not recall that.
7 Q. Do you recall making any
8 submission to the FDA as a result of the
9 Taiwanese study?
10 A. I don't recall.
11 Q. To your knowledge did anybody
12 at Eli Lilly talk to Doctor Lu in Taiwan about
13 this study?
14 A. Well, I'm not certain that
15 they did, they may have.
16 Q. Okay. Did you ever talk to
17 Doctor Lu regarding this study?
18 A. No.
19 Q. Did you ever talk to anybody
20 outside of Eli Lilly about the Taiwanese study?
21 A. I don't recall that I did.
22 Q. Do you recall that you didn't?
23 A. No, I don't recall it for sure
24 that I did not.
Page 433
1 Q. So you may have, but you just
2 don't remember?
3 A. I don't remember.
4 Q. The study that is going on
5 that you believe is related to depression in
6 Taiwan, is that Doctor Lu's study?
7 A. I didn't mean to imply that I
8 thought it was still going on. I believe it once
9 existed.
10 Q. Do you know if it still
11 exists?
12 A. No, I do not know.
13 Q. Do you know if it was started
14 and then canceled?
15 A. No, I do not know.
16 Q. Do you know if it was
17 completed?
18 A. I do not know.
19 Q. When was the last time you
20 were aware or think that it may have been going
21 on?
22 A. Some time ago, but I don't
23 remember the exact timing. I can get a feel from
24 these memos that it was maybe before then, but I
Page 434
1 don't have any recollection of a specific date.
2 Q. Do you recall whether or not
3 it was going on prior to the advisory committee
4 meeting in September of 1991?
5 A. I do not recall.
6 Q. In your position as regulatory
7 scientist on Fluoxetine at Eli Lilly, do you feel
8 it's appropriate for a drug company to try to
9 prevent the publishing of a study such as the
10 Fluoxetine/Maprotiline suicidality study that
11 Doctor Lu did in Taiwan?
12 MR. MYERS: Before he answers, let me
13 object to the form on the grounds, number one,
14 that it's hypothetical in nature and doesn't give
15 him sufficient facts upon which to base an
16 informed opinion, and also it assumes facts that
17 are not in the record and which will not be in
18 evidence. But if you can answer, answer.
19 Q. Can you answer the question?
20 A. I've begun to lose the key
21 words from my memory of your statement.
22 Q. Look at the last page of
23 Exhibit 14, okay?
24 A. I see it.
Page 435
1 Q. It's an E-Mail dated April 8,
2 1992 written by Allan Weinstein; correct?
3 A. Correct.
4 Q. And it's regarding Prozac
5 slash Taiwan; correct -- or dash Taiwan?
6 A. Yes.
7 Q. And the text says mission
8 successful, period. Professor Lu will not
9 present or publish his Fluoxetine versus
10 Maprotiline suicidality data, period. We will
11 work with him in the very near future to design a
12 prospective, randomized, controlled double-blind
13 study Fluoxetine versus Maprotiline. Correct?
14 A. I read that.
15 Q. What mission is he talking
16 about, do you know?
17 A. No, I don't.
18 Q. If the mission was to prevent
19 Doctor Lu from presenting or publishing his
20 Fluoxetine versus Maprotiline suicidality data,
21 in your opinion, as regulatory scientist on
22 Fluoxetine, would that have been appropriate?
23 MR. MYERS: Same objection. If you
24 can answer, answer.
Page 436
1 A. I can't answer that.
2 Q. Why not?
3 A. It's a judgment call.
4 Q. Whether or not publishing a
5 study that's critical of Fluoxetine is a judgment
6 call?
7 MR. MYERS: Hold on, let me object to
8 the form. That's a different question than your
9 original question.
10 MS. ZETTLER: No, my original question
11 was if the mission was to prevent Doctor Lu from
12 presenting or publishing his Fluoxetine versus
13 Maprotiline suicidality data, would that be
14 appropriate, and his answer was it was a judgment
15 call.
16 MR. MYERS: He said he could not
17 answer that, he felt it was a judgment call,
18 right.
19 MS. ZETTLER: Right.
20 Q. So my question is okay, at
21 this point, whose judgment?
22 A. I might have a judgment if I
23 knew and understood the facts.
24 Q. What facts would you need?
Page 437
1 A. I need to know and understand
2 the aspects of what his results were.
3 Q. His results were that, at
4 least with regards to suicidality, seven out of
5 sixty people on Fluoxetine made suicide attempts,
6 and no people on Maprotiline made suicide
7 attempts, Doctor.
8 MR. MYERS: Before he answers, let me
9 object to the form of the question in that it
10 assumes facts and characterizes the results of
11 the so-called study that I don't think are
12 accurate.
13 Q. Assume these are the results.
14 A. I can't assume that those are
15 the results.
16 Q. For the purpose of my
17 question, assume that those are the results.
18 A. That's not sufficient
19 information for me.
20 Q. What other information do you
21 need?
22 A. I need to know everything
23 that's available, and I would need to understand
24 it.
Page 438
1 Q. Don't you think the public
2 would have a right to know if another study where
3 Fluoxetine was shown to have an increased
4 incidence of suicidality as compared to a
5 comparitor drug?
6 MR. MYERS: Same objection in terms of
7 the hypothetical nature of the question and him
8 trying to form some judgment on the right of the
9 public to know.
10 MS. ZETTLER: He's a regulatory
11 scientist at Eli Lilly on this drug.
12 MR. MYERS: He is, no doubt about
13 that.
14 A. This involves a medical
15 awareness and understanding.
16 Q. Do you feel competent to do
17 your job on Fluoxetine without any ability to
18 tell whether or not, from a medical standpoint,
19 something is appropriate or not?
20 A. I feel competent.
21 Q. Why?
22 A. Because I do -- I feel like I
23 do competently what my job is.
24 Q. Do you feel like you do what
Page 439
1 you're told; correct?
2 A. Sometimes I do more than what
3 I'm told.
4 Q. On what occasion have you done
5 more than what you're told with regards to
6 Fluoxetine?
7 A. More often not with
8 Fluoxetine, with other drugs.
9 Q. Why is it that you do more
10 than you're told with other drugs than with
11 Fluoxetine?
12 A. Because they're in IND status,
13 and they're more of a scientific nature rather
14 than clinical nature.
15 Q. Do you feel you have input as
16 to what or how information is submitted to the
17 FDA on those other drugs?
18 A. The flow of information for
19 drugs in preliminary phases is different.
20 Q. What is the difference?
21 A. You're reporting new
22 scientific information because you're just
23 beginning to collect that scientific information.
24 Q. This is scientific information
Page 440
1 that's reflected in Exhibit 14, is it not?
2 A. But it's different, it's
3 clinical information.
4 Q. So you're saying that the work
5 that you do on the drugs that are still in the
6 IND phase is more in line with your expertise in
7 chemistry?
8 A. It's scientific, it's -- no,
9 there's not much chemistry involved.
10 Q. So I don't understand what the
11 difference is between what you're doing on those
12 other drugs and Fluoxetine that gives you the
13 flexibility to do more than you are told.
14 MR. MYERS: Before he answers, let me
15 object to the form. His answer doesn't require
16 you to understand. You asked him what the
17 difference was, and he told you what the
18 difference was. He's answered that question.
19 A. I can only repeat myself.
20 Q. Do you understand my question?
21 A. I think you asked it twice,
22 and I can say the same thing over again. In IND
23 status, there's a flow of scientific information.
24 Q. Clinical information isn't
Page 441
1 scientific information?
2 A. If I had meant clinical, I
3 would have said clinical.
4 Q. I think you did say clinical.
5 A. No, I said scientific
6 information.
7 Q. You also said that this is
8 clinical information.
9 A. Yes, and this is not something
10 that I understand as well.
11 Q. What is it about the other
12 information that you understand since it's not
13 chemistry related information per your own
14 testimony?
15 A. Because it's basically science
16 and not clinical science.
17 Q. So in your opinion clinical
18 trials are not scientific information?
19 MR. MYERS: I'll object to the form,
20 that's not what he said.
21 A. That's not what I said.
22 Q. What's the difference between
23 clinical science and the science in the IND
24 information?
Page 442
1 A. The scientific information in
2 the IND that I'm talking about does not involve
3 clinical trials.
4 Q. It's pharmacokinetic type?
5 A. Animal pharmacokinetics.
6 Q. Were you involved in the
7 mission regarding Doctor Lu's Fluoxetine versus
8 Maprotiline suicidality data as reflected in
9 Doctor Weinstein's E-Mail?
10 A. No.
11 Q. Were you aware of the mission?
12 A. No.
13 Q. Are you comfortable with the
14 fact that Doctor Lu was persuaded not to present
15 or publish his Fluoxetine versus Maprotiline
16 suicidality data?
17 MR. MYERS: Let me object to the form
18 in terms of what Doctor Lu was or wasn't
19 persuaded or not because there's nothing that
20 uses those words, those are your words. I object
21 to the form.
22 A. I'm not sure what it is I
23 should be comfortable with.
24 Q. Are you aware of any
Page 443
1 Fluoxetine clinical trial, regardless of whether
2 or not it involves Maprotiline, that Lilly is
3 working on right now with Doctor Lu?
4 A. I'm not aware of that.
5 Q. Have you ever met Doctor Lu?
6 A. No, I have not.
7 Q. Are you aware that Doctor Lu
8 visited Indianapolis?
9 A. I'm aware of that.
10 Q. When did Doctor Lu visit
11 Indianapolis?
12 A. I'm not sure what the date
13 was.
14 Q. Why did he visit Indianapolis?
15 A. I'm not sure why he visited.
16 Q. How is it you're aware that he
17 did visit?
18 A. My colleagues who were aware
19 that he visited mentioned it to me.
20 Q. Who was that?
21 A. I believe I remember both
22 Doctor Beasley and Doctor Satterlee mentioning
23 this to me.
24 Q. Who is Doctor Satterlee?
Page 444
1 A. He's a physician.
2 Q. In what area?
3 A. He's a physician in the
4 psychopharmacology clinical research area.
5 Q. Does he work on Fluoxetine?
6 A. Not to my recollection.
7 Q. Has he ever worked on
8 Fluoxetine?
9 A. Not that I'm aware of.
10 Q. Why would he know that Doctor
11 Lu was at Lilly?
12 MR. MYERS: Let me object to the form.
13 Why Doctor Satterlee -- he would know -- if you
14 know why he knows that he was there, tell her.
15 Q. That wasn't my question. My
16 question was: Why would he be involved or have
17 any --
18 MR. MYERS: The question was why would
19 Doctor Satterlee know is what you said. Tell her
20 if you know.
21 A. I presume Doctor Satterlee
22 knew because he saw Doctor Lu.
23 Q. Where did this conversation
24 regarding Doctor Lu take place?
Page 445
1 A. Which conversation?
2 Q. A conversation in which you
3 became aware that Doctor Beasley and Doctor
4 Satterlee knew that Doctor Lu was there and told
5 you about it.
6 A. I remember just in the hallway
7 it was more conversational than anything else.
8 Q. What was the context that it
9 was raised in?
10 A. I don't recall the context.
11 Q. Did they tell you why Doctor
12 Lu was there?
13 A. No, I don't recall why Doctor
14 Lu was there.
15 Q. Did you submit a protocol for
16 a prospective randomized controlled double-blind
17 study of Fluoxetine versus Maprotiline to the
18 FDA?
19 A. I don't recall that.
20 Q. Have you ever heard of a Dan
21 Gelberg or an Allen Gelberg?
22 A. I don't recall hearing those
23 names.
24 Q. Did you consider the acting
Page 446
1 chief of the surveillance and data processing
2 branch of the FDA a functionary?
3 A. How do you define functionary?
4 Q. I don't know. It's just a
5 word that's appeared in a document.
6 A. Since I'm not sure what you
7 mean by that, I can't answer.
8 Q. Are you familiar with the term
9 functionary?
10 A. It's a word I've heard, but I
11 would say the definition is vague.
12 (PLAINTIFFS' EXHIBIT NO. 15 WAS
13 MARKED FOR IDENTIFICATION AND
14 RECEIVED IN EVIDENCE.)
15 Q. Have you had a chance to
16 review Exhibit 15?
17 A. Yes.
18 Q. Are you familiar with this
19 exhibit?
20 A. I believe I've seen it before.
21 Q. Okay. When did you first see
22 it?
23 A. I do not recall that.
24 Q. Are you familiar with the
Page 447
1 issue that's raised in the exhibit regarding the
2 handwritten note by the FDA functionary on the
3 number of adverse events reported on Prozac since
4 it was marketed in 1988?
5 A. I am aware of these pages.
6 Q. Were you aware of what the
7 acting chief of surveillance and data processing
8 branch of the FDA said in his handwritten note
9 that since marketed in 1988 by Eli Lilly, Prozac
10 has had the highest number of adverse event
11 reports submitted to the FDA National Adverse
12 Drug Reaction Reporting System data base?
13 A. I have heard that before.
14 Q. And that in 1990 Prozac had
15 the largest number of reports?
16 A. That specific assertion about
17 1990, I'm not sure I've heard that before.
18 Q. Do you know if that's still
19 true today?
20 A. No, I don't know.
21 Q. Does that bother you?
22 MR. MYERS: What?
23 MS. ZETTLER: That since it was
24 marketed in 1988, Prozac has had the highest
Page 448
1 number of adverse event reports submitted to the
2 FDA National Adverse Drug Reaction Reporting
3 System data base?
4 MR. MYERS: Well, let me object to the
5 form of the question. Whether it bothers him or
6 not is an awfully vague question, and I don't
7 know what context you're asking it in.
8 MS. ZETTLER: In the context set up by
9 the acting chief of surveillance and data
10 processing branch of the FDA, Larry.
11 MR. MYERS: Well, then, I further
12 object to the form because all your questions
13 about this subject to include a reference to some
14 FDA functionary who was actually called an
15 unwitting functionary avoids this Church of
16 Scientology influence on all this, so --
17 Q. Do you think that what he
18 wrote in his note is untrue, Doctor?
19 MR. MYERS: This note?
20 MS. ZETTLER: Yes.
21 Q. Yes, the guy from the FDA, do
22 you think that what he wrote in his note is
23 untrue?
24 A. I do not think it is untrue,
Page 449
1 no.
2 Q. In fact you just testified a
3 couple of minutes ago that you were aware that
4 since it was marketed in 1988, at least at the
5 time that he wrote this, that Prozac had the
6 highest number of adverse event reports submitted
7 to the FDA data base; correct?
8 A. I believe I said I was aware
9 that this had been asserted.
10 Q. Okay. So you have no personal
11 knowledge of whether or not Prozac actually had
12 the highest number of adverse events reported to
13 the FDA data base?
14 A. I haven't done that analysis.
15 Q. Do you have any knowledge
16 whatsoever as to the number of adverse events
17 reported to the FDA's national data base on
18 Prozac?
19 A. From time to time these
20 numbers pass in front of me, but they change and
21 evolve.
22 Q. If this is true, what Mister
23 Gelberg asserts in his handwritten note, would
24 that bother you?
Page 450
1 MR. MYERS: Same objection. If you're
2 able to answer, answer.
3 A. Well, bother is an awful
4 subjective term.
5 Q. Would it concern you?
6 A. Well, so is concern. It
7 doesn't bother me a lot.
8 Q. It bothers you a little?
9 A. It doesn't bother me a lot.
10 Q. Okay. Is it fair to say it
11 bothers you a little?
12 A. No.
13 Q. Does it bother you at all?
14 A. It bothers me very little.
15 Q. Very little. On the first
16 page of Exhibit 15 is, looks like, a memo from
17 Mitch Daniels dated June 16, 1991; correct?
18 A. Yes.
19 Q. Who is Mitch Daniels?
20 A. He's an Eli Lilly employee.
21 Q. In what area?
22 A. He's changed jobs, I do not
23 know his official title.
24 Q. How about in June of 1991,
Page 451
1 what was his title?
2 A. I do not know his official
3 title.
4 Q. What was his unofficial title,
5 what area did he work in?
6 A. I'm not certain exactly what
7 it was.
8 Q. Is he in management?
9 A. Yes, he was -- I think that's
10 probably fair to say.
11 Q. Was he in corporate affairs?
12 A. He might have been, yes.
13 Q. Was he in damage control?
14 A. I don't think there's such a
15 thing.
16 Q. Not formally, though, right?
17 MR. MYERS: Well, I object to the form
18 of the question.
19 Q. It's a memo to various people
20 including Mister Bryson, Gary Tauscher, Leigh
21 Thompson, Ed West and Robert Zerbe. He attaches
22 a handwritten note that states sent by an
23 unwitting FDA functionary to a phone caller
24 pretending to be a clinical researcher, but who,
Page 452
1 naturally, was from the CCHR; correct?
2 A. I can read that, yes.
3 Q. Do you know for a fact that
4 the person who called for the information that
5 was subsequently provided by Mister Gelberg was
6 from the CCHR?
7 MR. MYERS: Did Doctor Webber know
8 that?
9 MS. ZETTLER: Yes.
10 A. I do not know.
11 Q. Second paragraph, second
12 sentence, it says at this point I believe the FDA
13 will repudiate the letter when queried, but not
14 send a second letter to the CCHR; correct?
15 A. I can read that.
16 Q. That's what it says; correct?
17 A. I can read that, yes.
18 Q. The last page of the exhibit
19 is a memorandum of telephone conversation dated
20 June 21, 1991; correct?
21 A. Yes.
22 Q. And it appears to be a
23 memorialization of a telephone call between a
24 couple of people from the FDA and -- between a
Page 453
1 couple of people at the FDA; correct?
2 A. That's what it looks like to
3 me.
4 Q. The second part of the
5 memorandum states it's true that Prozac has the
6 highest number of adverse drug reaction reports.
7 Do you see that?
8 A. I see that.
9 MS. ZETTLER: Let's take a break.
10 (A SHORT RECESS WAS TAKEN.)
11 Q. Doctor, in your experience as
12 a regulatory scientist for Fluoxetine, has the
13 FDA ever requested or suggested that an adverse
14 event be listed under post-marketing experience
15 on Fluoxetine?
16 A. Do you mean in the
17 post-introduction reports section?
18 Q. Right.
19 A. I believe they have.
20 Q. Okay. Which adverse events?
21 A. Well, I think there have been
22 several, and my recollection of them exactly
23 would be weak.
24 Q. Okay. What situation does the
Page 454
1 FDA ask for requests or suggests that Lilly add a
2 particular adverse event to the post-introduction
3 report section?
4 A. I do not know.
5 Q. Have they ever given a reason
6 when they requested that an adverse event be
7 added to that section, why they were asking that
8 it be done?
9 A. They may have made a comment.
10 Q. Do you recall any of those
11 comments?
12 A. No.
13 Q. How about in any of the other
14 drugs, not particular to a certain drug, but
15 drugs you worked on as a regulatory scientist at
16 Lilly, have they ever asked that adverse events
17 be added to the post-marketing experience
18 section?
19 A. Post-introduction reports?
20 Q. Right.
21 A. I think a post-introduction
22 report subsection is a fairly recent idea of
23 either the FDA or possibly just the neuropharm
24 division, and there isn't one, that subsection
Page 455
1 doesn't exist, I don't think, in any of our other
2 drugs.
3 Q. Do you work on drugs -- you
4 might have answered this yesterday, and if you
5 did, I apologize, but do you work on drugs other
6 than psychotropic drugs?
7 A. I work only on CNS drugs.
8 Q. CNS drugs, okay. So to the
9 best of your recollection, the Fluoxetine package
10 insert is the only CNS package insert on a Lilly
11 drug that requires or where there's a
12 post-introduction experience section?
13 A. To the best of my
14 recollection.
15 Q. Do you know why that is?
16 A. No.
17 (PLAINTIFFS' EXHIBIT NO. 16 WAS
18 MARKED FOR IDENTIFICATION AND
19 RECEIVED IN EVIDENCE.)
20 Q. Have you had a chance to
21 review Exhibit 16?
22 A. Yes.
23 Q. Are you familiar with this
24 exhibit?
Page 456
1 A. Yes.
2 Q. Tell me what it is, please.
3 A. It's essentially a table of
4 contents of a book I keep that has all the
5 package insert submissions that we've sent to the
6 FDA.
7 Q. On Fluoxetine?
8 A. On Fluoxetine.
9 Q. Okay. Did you submit that
10 book to the legal department at Lilly as part of
11 your file on Fluoxetine?
12 A. Yes.
13 Q. Is the table of contents
14 longer than what is reflected in Exhibit 16, to
15 your knowledge?
16 A. If there have been any
17 additional changes since the tab number nineteen,
18 it either is typed that way or is penned for my
19 secretary to type it to make it up to date.
20 Q. Do you know offhand if there
21 had been any changes in the package insert for
22 Fluoxetine since March 31st, 1992?
23 A. I don't recall.
24 Q. On the second page of the
Page 457
1 exhibit, under tab twelve, it indicates that
2 suicidal ideation and violent behaviors were
3 added to the package insert dated 5-24-90;
4 correct?
5 A. Correct.
6 Q. These were the additions of
7 suicidal ideation and violent behaviors to the
8 post-introduction experience section?
9 A. Reports.
10 Q. Reports section?
11 A. Yes.
12 Q. So at least as reflected in
13 this exhibit, those two adverse events did not
14 exist in that section of the package insert prior
15 to May 24th, 1990; correct?
16 A. Correct.
17 Q. How many instances of an
18 adverse event need to occur before it's added to
19 the package insert under post-introduction
20 reports?
21 A. I don't think there's an
22 answer to that. I certainly am not aware of it.
23 Q. Are you in charge of seeing
24 that changes are made to the package insert on
Page 458
1 Fluoxetine?
2 A. I submit the change label to
3 the FDA.
4 Q. How many instances of
5 pancreatitis are you aware of occurring with
6 people who use Fluoxetine?
7 A. I'm not aware of the number.
8 Q. You submit changes to the
9 package insert when you are directed to by
10 somebody else at Lilly; correct?
11 A. Correct.
12 Q. Do you know of any policy at
13 Lilly that determines when there are a sufficient
14 number of incidents of adverse events for a
15 submission in the change of the package insert to
16 be made?
17 A. I do not know of such a
18 policy.
19 Q. If you could go back to
20 Exhibit 15, the last page. Under number four it
21 says clinical trials for safety and effectiveness
22 are a very narrow selected group; correct?
23 A. I can read that.
24 Q. That's what it says, right?
Page 459
1 A. Uh-huh.
2 Q. You have to say yes or no, you
3 have to answer out loud.
4 A. Yes.
5 Q. It says where reactions, one
6 out of twenty-five thousand, for example, would
7 not show up on trials of ten thousand; correct?
8 A. That's what it says.
9 Q. Only until very widely
10 prescribed do things show up; correct?
11 A. I can read that, yes.
12 Q. Do you know who Suzanne O'Shea
13 is?
14 A. No, I do not.
15 Q. Do you know who Alan Gelberg
16 is?
17 A. No, I do not.
18 Q. Do you disagree with paragraph
19 four of the last page of Exhibit 15?
20 MR. MYERS: Let me object to the form.
21 That may well call for some sort of medical
22 opinion or conclusion as to that statement.
23 A. I think that as a
24 nonphysician, I don't know whether those
Page 460
1 assertions are true or not.
2 Q. Do you know who Doug Ellsworth
3 is?
4 A. I'm not familiar with him.
5 (PLAINTIFFS' EXHIBIT NO. 17 WAS
6 MARKED FOR IDENTIFICATION AND
7 RECEIVED IN EVIDENCE.)
8 Q. Have you had a chance to
9 review Exhibit 17, Doctor?
10 A. Yes.
11 Q. Are you familiar with this
12 exhibit?
13 A. I've seen it before.
14 Q. Can you tell me what it is?
15 A. Well, actually I haven't seen
16 page one before, excuse me, I've only seen page
17 two before.
18 Q. Okay. Tell me what page two
19 is.
20 A. It's a note to file I wrote.
21 Q. Regarding what?
22 A. A telephone call to me.
23 Q. From who?
24 A. From Mister Ellsworth and Ms.
Page 461
1 O'Shea.
2 Q. Where are they from?
3 A. The FDA.
4 Q. Why did they call you?
5 A. They wanted information.
6 Q. About what?
7 A. Well, I can only read from my
8 memo.
9 Q. Do you recall this
10 conversation?
11 A. Just barely.
12 Q. Okay. Does this memo refresh
13 your recollection as to what the conversation was
14 about?
15 A. A bit.
16 Q. Tell me what you recall after
17 reading the memo.
18 A. That they were working on a
19 response to the CCHR petition, and they wanted to
20 know the things that I state they wanted to know
21 about.
22 Q. Which were?
23 A. They wanted to know about the
24 March 8th, '91 obesity submission, they wanted to
Page 462
1 know about the September 13th and July 17th, 1990
2 submissions, they would like to prepare a summary
3 that would become public. They wanted to know if
4 this was acceptable. They wanted feedback on my
5 confidentiality report, of the full report.
6 Mister Ellsworth was not sure whether the fact
7 that we were pursuing obesity was public
8 knowledge.
9 Q. Okay. And you indicated to
10 him that it was public knowledge, right?
11 A. I did.
12 Q. When you say obesity was
13 public knowledge, the fact that Lilly was
14 studying the use of Fluoxetine in treating
15 obesity was public knowledge; correct?
16 A. Correct.
17 Q. To your knowledge is the fact
18 that Lilly is studying the use of Fluoxetine in
19 OCD public knowledge?
20 A. I believe it is.
21 Q. Is the fact that Lilly is
22 studying the use of Fluoxetine to treat bulimia
23 public knowledge?
24 A. I believe it is.
Page 463
1 Q. How has it become public
2 knowledge that those three indications are being
3 studied or have been studied?
4 A. I don't know all the manners
5 that it's become, but for a bulimia and obesity,
6 I remember Doctor Perelman stated that in an
7 interaction with a security analyst some time
8 ago.
9 Q. Who is Doctor Perelman?
10 A. He is, was, the president of
11 Lilly research laboratories.
12 Q. When you say security analyst,
13 you mean like stocks, public stocks?
14 A. Yes.
15 Q. Do you know any other way that
16 that information has been made public?
17 A. No, I do not.
18 Q. Are you aware that articles
19 have been published on the study of Fluoxetine in
20 treatment of those indications?
21 A. I probably am aware.
22 Q. Would that surprise you if
23 studies had been published regarding using
24 Fluoxetine for treatment of those various
Page 464
1 indications?
2 A. I'm not surprised, but I just
3 really wasn't aware that publications had
4 appeared already.
5 Q. Were the whole reports written
6 by Lilly on suicidality, hostility, aggression,
7 and the discussion of the eight different
8 categories of adverse events made public at any
9 time, formerly?
10 A. I do not know.
11 Q. Do you know if that
12 information was disseminated at the advisory
13 committee meeting to the audience?
14 A. The full eight issue report?
15 Q. Right.
16 A. Do I know if that was -- I do
17 not think it was.
18 Q. How about the March 8, 1991
19 submission regarding obesity and suicidality, was
20 that full report disseminated to the audience at
21 the advisory committee meeting?
22 A. I'm not sure what that
23 submission is from this memo.
24 Q. So you don't know whether or
Page 465
1 not it was disseminated?
2 A. I would doubt that it was.
3 Q. How about the September 13,
4 1990 U.S. suicidality report, was that full
5 report disseminated to the audience at the
6 advisory committee meeting?
7 A. By audience, I'm thinking you
8 mean the people sitting, listening. Is that what
9 you mean?
10 Q. Right.
11 A. I'm not aware of anything that
12 was disseminated to the audience.
13 Q. To your knowledge have the
14 full reports regarding obesity and suicidality,
15 the U.S. suicidality report or the hostility,
16 aggression section of the July 17, 1990 report
17 ever been disseminated to the public?
18 A. I don't believe they have
19 been.
20 Q. Why not?
21 MR. MYERS: Let me just object to the
22 form of the question because that may involve
23 some interpretation of numerous federal
24 regulations, and it may involve a legal
Page 466
1 conclusion. If you know, tell her.
2 Q. If you know.
3 A. I don't know why they would
4 be.
5 Q. Okay. But that's not my
6 question. Do you know why they were not?
7 A. No, I do not.
8 Q. Was there something about the
9 reports that Lilly did not want the public to
10 know?
11 A. Not that I am aware of.
12 Q. You said you don't know why
13 they would be disseminated. Why is that?
14 A. Because the submissions that
15 we sent to the FDA, to my knowledge, aren't
16 disseminated.
17 Q. Some of it is, isn't it?
18 A. Not that I'm aware of.
19 Q. In fact it says in Mister
20 Ellsworth's and Ms. O'Shea's memorialization of
21 your phone conversation with them that the
22 September 13, 1990 and May 4, 1991 reports were
23 submitted to the IND because Lilly believes that
24 information in the IND is less likely to be
Page 467
1 released information in the NDA; correct?
2 A. That's what it says.
3 Q. Does that mean released --
4 released to who, if you know?
5 MR. MYERS: I object to the form,
6 that's speculative.
7 MS. ZETTLER: Larry, I asked him if he
8 knew.
9 A. Released under the Freedom of
10 Information Act.
11 Q. To the public, right?
12 A. Whoever asks.
13 Q. And just about anybody can ask
14 under the Freedom of Information Act for
15 information; correct?
16 A. I believe that's correct.
17 Q. But you have no knowledge as
18 to why Lilly would not want that information
19 released under the Freedom of Information Act;
20 correct?
21 A. No, I do not have any
22 knowledge of why.
23 Q. You just know they didn't want
24 it released, right?
Page 468
1 A. This is the FDA's judgment.
2 Q. In your judgment that's
3 reflected in your memo regarding the same
4 conversation, it says after discussing all of
5 this in a prescheduled meeting with Becki Goss,
6 Bob Zerbe, Gary Tollefson, Gary Tauscher and Ed
7 West, I called Mister Ellsworth back, I told him
8 we would agree to their summaries becoming
9 public, but not our submission documents;
10 correct?
11 A. That's what it says.
12 Q. So it's your understanding
13 that Lilly did not want the full reports becoming
14 public; correct?
15 A. That's correct.
16 Q. Have you ever seen the
17 submission documents -- or, I'm sorry, the
18 summary documents created by the FDA in response
19 to the CCHR's petition?
20 A. I believe I have seen their
21 response, but I don't know whether it included
22 the summary documents.
23 Q. To your knowledge did the
24 FDA's response to the CCHR petition correctly
Page 469
1 reflect the information that was submitted in the
2 full reports by Eli Lilly on these various
3 subjects?
4 A. I do not recall.
5 (PLAINTIFFS' EXHIBIT NO. 18 WAS
6 MARKED FOR IDENTIFICATION AND
7 RECEIVED IN EVIDENCE.)
8 Q. Have you had a chance to
9 review Exhibit 18?
10 A. Yes.
11 Q. Are you familiar with the
12 exhibit?
13 A. No, I'm not.
14 Q. Do you know why it would have
15 been produced as part of your documents?
16 A. No.
17 Q. Are you familiar with the
18 subject matter of the first paragraph of the
19 document?
20 A. No, I'm not.
21 Q. It looks like a memo from Gary
22 Tauscher to E. L. Step dated July 25, 1990;
23 correct?
24 A. Correct.
Page 470
1 Q. And the first paragraph of the
2 first subject of the memo talks about deaths due
3 to Prozac; correct?
4 A. Correct.
5 Q. And it states through the
6 first of July, we've received a total of two
7 hundred and thirty-two reports of both U.S. and
8 OUS deaths of patients who were taking Prozac;
9 correct?
10 A. That's what it states.
11 Q. You are not aware of that
12 fact, that as of July -- beginning of July of
13 1990, Lilly was aware of two hundred and
14 thirty-two reports from both U.S. and OUS of
15 patients who were taking Prozac, is that what
16 your testimony is?
17 A. I wasn't aware until I just
18 read it.
19 (DISCUSSION OFF THE RECORD.)
20 MS. ZETTLER: It's about twenty
21 minutes to 5:00, and I'm not finished with Doctor
22 Webber, I've got probably three or four more
23 hours. Due to the fact that I'm not feeling
24 well, at all, and the fact that we've had some
Page 471
1 fairly substantial interruptions related to
2 getting drafts of our various letters over to
3 Judge Godish, I'm going to ask that Doctor Webber
4 be brought back probably for not more than a few
5 more hours, maybe a morning or something, in the
6 future to finish up. If I have to file the
7 appropriate motions, I will.
8 MR. MYERS: Just for the record,
9 Doctor Webber's deposition was scheduled for, and
10 has been held over for the course of these past
11 two days. The deposition yesterday, at
12 plaintiffs' counsel's request, was begun late,
13 and because of a conversation that Mister Paul
14 Smith engaged me in did not start even at the
15 time we had agreed upon. We recessed by
16 agreement last night at about ten minutes after
17 5:00 and commenced today at 9:00 o'clock again.
18 We took thirty minutes longer for
19 lunch than we normally would have, and about a
20 forty-five minute recess in connection with some
21 NDL matters, which, as I understand it, Nancy,
22 you felt the need to be involved in, and I was
23 involved in because you were there, understanding
24 that the matter was principally, as I perceived
Page 472
1 it, being handled by your lead counsel and our
2 liaison counsel, and I'm just simply not in a
3 position today to agree to bring Doctor Webber
4 back for any period of time. I won't rule out
5 any later agreement, but I'm certainly not in a
6 position to make any agreement today. If we can
7 reach an agreement, we will. If it has to be
8 submitted to the court, it may have to be
9 submitted to the court. But that's kind of our
10 view of the situation. If you want to -- given
11 your statement, if you want to adjourn now, I
12 don't see a reason not to in view of your
13 statement as to how much longer it's going to
14 take and your health.
15 MS. ZETTLER: I just don't, right now --
16 you know, we generally break around 5:00 o'clock
17 anyway, and I'm not going to be able to finish
18 today regardless. As far as the breaks that we
19 took, those were related to business that are
20 related to other Prozac cases. As far as me
21 attending the conference call on the submissions
22 to the MDL, I have a right to represent my
23 clients in an issue there, and I feel compelled
24 to represent my clients.
Page 473
1 MR. MYERS: Well, it's --
2 MS. ZETTLER: I mean, if you're going
3 to object to us bringing him back for another few
4 hours to finish up, then that's your prerogative,
5 but I'm going to have to make a motion.
6 MR. MYERS: Right, and we'll do one or
7 the other.
8 (THE WITNESS WAS EXCUSED.)
9
COMMONWEALTH OF KENTUCKY )
10 : ss
COUNTY OF JEFFERSON )
11
12 I, MARY KATHLEEN NOLD, A NOTARY PUBLIC IN
13 AND FOR THE STATE OF KENTUCKY AT LARGE, DO HEREBY
14 CERTIFY THAT THE FOREGOING TESTIMONY OF
15 AL WEBBER
16 WAS TAKEN BEFORE ME AT THE TIME AND PLACE AS
17 STATED IN THE CAPTION; THAT THE WITNESS WAS FIRST
18 DULY SWORN TO TELL THE TRUTH, THE WHOLE TRUTH,
19 AND NOTHING BUT THE TRUTH; THAT THE SAID
20 PROCEEDINGS WERE TAKEN DOWN BY ME IN STENOGRAPHIC
21 NOTES AND AFTERWARDS TRANSCRIBED UNDER MY
22 DIRECTION; THAT IT IS A TRUE, COMPLETE AND
23 CORRECT TRANSCRIPT OF THE SAID PROCEEDINGS SO
24 HAD; THAT THE APPEARANCES WERE AS STATED IN THE
Page 474
1 CAPTION.
2 WITNESS MY SIGNATURE THIS THE 29TH DAY OF
3 JANUARY, 1994.
4 MY COMMISSION EXPIRES MARCH 10, 1994.
5
6
7 _________________________
MARY KATHLEEN NOLD
8 COURT REPORTER AND NOTARY PUBLIC
STATE OF KENTUCKY AT LARGE
9
Page 475
1
2 E R R A T A S H E E T
3
4 COMMONWEALTH OF KENTUCKY )
: SS
5 COUNTY OF JEFFERSON )
6
7 I, AL WEBBER, THE UNDERSIGNED
8 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES
9 OF MY DEPOSITION AND WITH THE CHANGES NOTED
10 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND
11 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON
12 THE 16TH AND 17TH OF DECEMBER, 1993 AT THE TIME
13 AND PLACE STATED THEREIN.
14 PAGE NO. LINE NO. CHANGE REASON
Page 476
1
2 PAGE NO. LINE NO. CHANGE REASON
3
4
5
6
7
8
9
_____________________________
10 AL WEBBER
11 SWORN TO AND SUBSCRIBED BEFORE ME THIS
12 _____ DAY OF __________, 1994.
13 _____________________________
NOTARY PUBLIC, STATE OF
14 KENTUCKY AT LARGE
Page 477
1
2
3
4
Page 478
1 COMES AL WEBBER....................................7
2 DIRECT EXAMINATIONBY MR. SMITH:....................7
3 CROSS-EXAMINATIONBY MS. ZETTLER:.................263
4 COMMONWEALTH.....................................474
5 E R R A T A......................................476
6 (QUESTIONS CERTIFIED..............................93
7 (QUESTION CERTIFIED..............................187
8 PLAINTIFFS' EXHIBIT NO. 1........................111
9 PLAINTIFFS' EXHIBIT NO. 2........................141
10 PLAINTIFFS' EXHIBIT NO. 3........................217
11 PLAINTIFFS' EXHIBIT NO. 4........................304
12 PLAINTIFFS' EXHIBIT NO. 5........................311
13 PLAINTIFFS' EXHIBIT NO. 6........................316
14 PLAINTIFFS' EXHIBIT NO. 7........................354
15 PLAINTIFFS' EXHIBIT NO. 8........................366
16 PLAINTIFFS' EXHIBIT NO. 9........................374
17 PLAINTIFFS' EXHIBIT NO. 10.......................378
18 PLAINTIFFS' EXHIBIT NO. 11.......................389
19 PLAINTIFFS' EXHIBIT NO. 12.......................397
20 PLAINTIFFS' EXHIBIT NO. 13.......................409
21 PLAINTIFFS' EXHIBIT NO. 14.......................422
22 PLAINTIFFS' EXHIBIT NO. 15.......................447
23 PLAINTIFFS' EXHIBIT NO. 16.......................456
24 PLAINTIFFS' EXHIBIT NO. 17.......................461
Page 479
1 PLAINTIFFS' EXHIBIT NO. 18.......................470
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