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: RICHARD WOOD 11 DATE: MAY 12, 1994 12 13 * * * * * * * * * * 14 15 16 REPORTER: KATHY NOLD 17 18 KENTUCKIANA REPORTERS SUITE 260 19 730 WEST MAIN STREET LOUISVILLE, KENTUCKY 40202 20 (502) 589-2273 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 * * * * * * * * * * 13 NO. 92-14775-E 14 RICHARD HAROLD CROSSETT, JR., ) IN THE 15 CHAD H. CROSSETT, AMY MICHELLE ) DISTRICT CROSSETT AND KRISTEN ANN CROSSETT, ) COURT OF 16 INDIVIDUALLY AND AS SURVIVORS OF ) AND ON BEHALF OF THE ESTATE OF ) 17 JOCQUETTA ANN CROSSETT, DECEASED ) ) 18 V. ) DALLAS COUNTY, ) TEXAS 19 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, TEXAS ) 20 PSYCHIATRIC COMPANY, INC. ) D/B/A/ HCA WILLOW PARK ) 101ST JUDICIAL 21 HOSPITAL, JAMES K. WITSCHY, M.D., ) DISTRICT AND DOUG BELLAMY, ED.D. ) Page 2 1 * * * * * * * * * * 2 NO. A-921,405-C 3 MARIA GUADALUPE REVES ) IN THE 4 INDIVIDUALLY AND AS NEXT ) DISTRICT COURT FRIEND OF GRANT JULIAN REVES ) OF 5 A MINOR CHILD, AND ON BEHALF ) OF THE ESTATE OF CHRISTIAN ) 6 MARIE REVES, DECEASED ) ) ORANGE COUNTY, 7 V. ) TEXAS ) 8 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, RAVIKUMAR ) 9 KANNEGANTI, M.D., HOSPITAL ) CORPORATION OF AMERICA, A ) 10 TENNESSEE CORPORATION, HEALTH ) SERVICES ACQUISITION CORP., ) 11 A DELAWARE CORPORATION, ) HCA PSYCHIATRIC COMPANY, A ) 12 DELAWARE CORPORATION, TEXAS ) PSYCHIATRIC CO., INC.. A/K/A ) 13 AND/OR D/B/A HCA BEAUMONT ) NEUROLOGICAL HOSPITAL, AND HCA ) 14 HEALTH SERVICES OF TEXAS, INC. ) 128TH JUDICIAL A/K/A AND/OR BEAUMONT ) DISTRICT 15 NEUROLOGICAL HOSPITAL ) Page 3 1 * * * * * * * * * * 2 3 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS COUNTY DEPARTMENT - LAW DIVISION 4 RENATO DI SILVESTRO, Individually ) 5 and as Special Administrator of ) the Estate of JOHN DI SILVESTRO, ) 6 Deceased, ) ) 7 Plaintiff, ) ) 8 v. ) No. 91 L 7881 ) 9 ROBERT L. NELSON, et al., ) ) 10 Defendants, ) ) 11 GEORGE MELNICK, M.D. and PETER ) FINK, M.D. ) 12 ) Respondents in Discovery.) 13 * * * * * * * * * * Page 4 1 2 SUPERIOR COURT OF THE STATE OF CALIFORNIA 3 FOR THE COUNTY OF LOS ANGELES 4 DR. MARIUS SAINES, etc., et al., ) Case No: ) SC 008331 5 Plaintiffs, ) ) 6 vs. ) ) 7 ELI LILLY & COMPANY, a corporation; ) DISTA PRODUCTS COMPANY, a division ) 8 of Eli Lilly & Company; and DOBS 1- ) 100, inclusive, ) 9 ) Defendants. ) 10 ____________________________________) 11 * * * * * * * * * * 12 NO. 93-8792-D 13 DAVID KUNG, DALE KUNG COHEN ) IN THE DISTRICT 14 ROBERT KUNG, AND TIMOTHY KUNG, ) COURT OF INDIVIDUALLY AND AS SURVIVORS ) 15 AND STATUTORY BENEFICIARIES ) OF MAY YUN KUNG, DECEASED ) 16 ) VS. ) DALLAS, COUNTY 17 ) T E X A S ELI LILLY AND COMPANY, DISTA ) 18 PRODUCTS COMPANY, AND MONIQUE ) KUNKLE, PH.D. ) Page 5 1 * * * * * * * * * * 2 IN THE DISTRICT COURT OF JOHNSON COUNTY, KANSAS 3 CIVIL COURT DEPARTMENT 4 EUGENE HUSLIG, AS ADMINISTRATOR ) 5 AND EXECUTOR AND ON BEHALF OF ) THE ESTATE OF DEBORAH G. WEATHERS ) 6 HUSLIG, DECEASED, AND AS SURVIVING ) HUSBAND AND HEIR AT LAW OF DEBORAH ) 7 G. WEATHERS HUSLIG, DECEASED, ) AND IN HIS INDIVIDUAL CAPACITY AS ) 8 HUSBAND OF DEBORAH G. WEATHERS ) HUSLIG, DECEASED, AND RONALD C. ) 9 WEATHERS, SON OF DEBORAH G. ) WEATHERS HUSLIG, DECEASED, ) CASE NO.: 10 ) 94 C 192 PLAINTIFFS, ) 11 VS. ) COURT NO. 7 ) CHAPTER 60 12 MARY L. BILLINGSLEY, EXECUTOR OF ) THE ESTATE OF THAD BILLINGSLEY, ) 13 M.D., DECEASED D/B/A THE BENESSERE ) CENTER, SUSAN C. JOHNSON, PH.D., ) 14 BILLINGSLEY ENTERPRISES, INC., ) F/K/A THAD H. BILLINGSLEY, M.D. ) 15 CHARTERED, D/B/A THE BENESSERE ) CENTER, ELI LILLY AND COMPANY, ) 16 AND DISTA PRODUCTS COMPANY, ) ) 17 DEFENDANTS. ) 18 * * * * * * * * * * Page 6 1 * * * * * * * * * * 2 CAUSE NO. 93-04911-A 3 LINDA JILL WELCH, CARLINDA 4 WELCH REX, CONNAN ROSS WELCH AND CHAD MICHAEL WELCH, 5 INDIVIDUALLY AND AS SURVIVORS AND STATUTORY BENEFICIARIES 6 OF CARL EUGENE WELCH, DECEASED PLAINTIFFS 7 V. 8 ELI LILLY AND COMPANY, DISTA PRODUCTS COMPANY, NOE NEAVES, 9 M.D., AND MINITH-MEIER CLINIC, P.A. DEFENDANTS Page 7 1 THE DEPOSITION OF RICHARD WOOD TAKEN AT THE 2 OFFICE OF BAKER & DANIELS, 300 NORTH MERIDIAN 3 STREET, SUITE 2700, INDIANAPOLIS, INDIANA 46204, 4 ON MAY 12, 1994; SAID DEPOSITION TAKEN PURSUANT 5 TO NOTICE IN ACCORDANCE WITH THE RULES OF CIVIL 6 PROCEDURE. 7 * * * * * * * * * * 8 A P P E A R A N C E S 9 10 NANCY ZETTLER COUNSEL FOR PLAINTIFFS 11 1405 WEST NORWELL LANE SCHAUMBURG, ILLINOIS 60193 12 PAUL SMITH 13 COUNSEL FOR PLAINTIFFS 745 CAMPBELL CENTER 2 14 8115 NORTH CENTRAL EXPRESSWAY DALLAS, TEXAS 75206 15 JOE FREEMAN 16 LAWRENCE J. MYERS COUNSEL FOR ELI LILLY AND COMPANY 17 FREEMAN & HAWKINS 4000 ONE PEACHTREE CENTER 18 303 PEACHTREE STREET, N.E. ATLANTA, GEORGIA 30308-3243 19 Page 8 1 BEATRICE M. SMITH COUNSEL FOR BEAUMONT NEUROLOGICAL HOSPITAL 2 FRIEND & ASSOCIATES LLP 1301 MCKINNEY #2900 3 HOUSTON, TEXAS 77010 4 BARTON BROWN COUNSEL FOR DR. BILLINGSLEY 5 WALLACE, SAUNDERS, AUSTIN, BROWN & ENOCHS 10111 W. 87TH ST. 6 P.O. BOX 12290 OVERLAND PARK, KANSAS 66282 7 ROBERT L. HARRIS 8 COUNSEL FOR NOE NEAVES, M.D. SIFFOLD & ANDERSON, LLP 9 6300 NATIONS BANK PLAZA 901 MAIN STREET 10 DALLAS, TEXAS 75202 11 KATHERINE L. LAWS COUNSEL FOR DRS. WITSCHY AND KANNEGANTI 12 BAILEY & WILLIAMS 3500 NCNB PLAZA 13 901 MAIN STREET DALLAS, TEXAS 75202-3714 Page 9 1 I N D E X 2 3 DEPOSITION OF RICHARD WOOD 4 DIRECT EXAMINATION BY MR. SMITH 13 5 CERTIFICATE 279 6 ERRATA 280 7 EXHIBITS 8 PLAINTIFFS' EXHIBIT NO. 1 71 PLAINTIFFS' EXHIBIT NO. 2 81 9 PLAINTIFFS' EXHIBIT NO. 3 90 PLAINTIFFS' EXHIBIT NO. 4 109 10 PLAINTIFFS' EXHIBIT NO. 5 118 PLAINTIFFS' EXHIBIT NO. 6 127 11 PLAINTIFFS' EXHIBIT NO. 7 132 PLAINTIFFS' EXHIBIT NO. 8 143 12 PLAINTIFFS' EXHIBIT NO. 9 158 PLAINTIFFS' EXHIBIT NO. 10 168 13 PLAINTIFFS' EXHIBIT NO. 11 185 PLAINTIFFS' EXHIBIT NO. 12 188 14 PLAINTIFFS' EXHIBIT NO. 13 192 PLAINTIFFS' EXHIBIT NO. 14 194 15 PLAINTIFFS' EXHIBIT NO. 15 200 PLAINTIFFS' EXHIBIT NO. 16 209 16 PLAINTIFFS' EXHIBIT NO. 17 216 PLAINTIFFS' EXHIBIT NO. 18 218 17 PLAINTIFFS' EXHIBIT NO. 19 224 PLAINTIFFS' EXHIBIT NO. 20 231 18 PLAINTIFFS' EXHIBIT NO. 21 232 PLAINTIFFS' EXHIBIT NO. 22 236 19 PLAINTIFFS' EXHIBIT NO. 23 238 PLAINTIFFS' EXHIBIT NO. 24 248 20 PLAINTIFFS' EXHIBIT NO. 25 262 PLAINTIFFS' EXHIBIT NO. 26 265 21 PLAINTIFFS' EXHIBIT NO. 27 267 PLAINTIFFS' EXHIBIT NO. 28 273 Page 10 1 MR. MYERS: The deposition of Mister 2 Wood today, as I understand it, there are notices 3 which have been issued for his deposition in the 4 Fentress cases and in the multi-district 5 proceedings. Additionally, I have seen notices 6 from Mister Paul Smith's office in connection 7 with the Kung, Crossett, Reves, Biffle and Welch 8 cases and understand that a notice was issued in 9 the Huslig case, those are the only notices that 10 I'm aware of and as I understand it and 11 consistent with our prior agreements as relates 12 to the state court cases that I have just 13 recited, we have agreed that the confidentiality 14 order from the MDL court of May of 1992 will 15 govern this proceeding and any documents used in 16 this proceeding. Correct? 17 MR. SMITH: Correct. 18 MR. MYERS: And are there any other 19 notices? 20 MS. ZETTLER: I know of the Di 21 Silvestro case and I believe Gardner, but if 22 there isn't a notice we can stipulate to that 23 before that we will follow the protective order 24 in that instance, if that's okay. Page 11 1 MR. FREEMAN: That's fine. 2 MR. FREEMAN: And Boling, if you want, 3 if you're going to handle that case. 4 MR. SMITH: Yes. I have the Boling 5 and Raymire case. 6 MR. MYERS: I have seen some papers, 7 but not any orders. 8 9 MR. SMITH: There's not been an order 10 entered at this time, but obviously we're going 11 to want to use them for all purposes. 12 MR. MYERS: As long as we have same 13 agreement. 14 MR. SMITH: Correct. 15 MR. FREEMAN: I wish the witness to 16 read and sign the deposition upon it's 17 completion. 18 MS. LAWS: Are there any other 19 agreements under which we are taking this 20 deposition pursuant to the rules? 21 MR. FREEMAN: Let me just state at 22 this time a little brief stipulation. This is 23 the deposition of Richard Wood taken on behalf of 24 the plaintiffs for purposes of discovery and use Page 12 1 at the trial on any of the cases heretofore 2 recited. The deposition of Mister Wood is taken 3 by agreement of counsel and by notice in the 4 offices of Baker and Daniel in Indianapolis. 5 Objection will be made at this time as 6 to any leading questions that Mister Wood's own 7 counsel may put to him or any objection that any 8 lawyer may have to the witness's response to the 9 questions propounded. All other objections will 10 be reserved until the time of court hearing. 11 MS. LAWS: Do we have the agreement 12 where the objection of one defense counsel is 13 good as to all? 14 MR. MYERS: Yes. 15 MS. ZETTLER: He talks even faster 16 than me. 17 MR. FREEMAN: Would you swear the 18 witness, please? 19 * * * * * * * * * * 20 COMES RICHARD WOOD, CALLED BY THE 21 PLAINTIFFS, AND AFTER FIRST BEING DULY SWORN, WAS 22 DEPOSED AND TESTIFIED AS FOLLOWS: 23 DIRECT EXAMINATION 24 BY MR. SMITH: Page 13 1 Q. Would you state your name, 2 please, sir? 3 A. Richard D. Wood. 4 Q. That is Wood without an S, is 5 that correct? 6 A. Yes, uh-huh. 7 Q. Mister Wood, my name is Paul 8 Smith. I represent a number of individuals and 9 families of individuals who have had adverse 10 experiences and side effects in connection with 11 the drug Prozac, manufactured by Eli Lilly. We 12 are here today to take your deposition in 13 connection with those suits. If I ask you any 14 questions that you don't understand, would you 15 please let me know? 16 A. (Witness moves head up and 17 down.). 18 Q. You'll need to give an audible 19 answer, we're going to be using a written 20 transcipt as well as a video transcript so you'll 21 need to say yes or no as opposed to nodding your 22 head, Mister Wood. 23 A. Thank you. 24 Q. We are here in the offices of Page 14 1 Baker and Daniel and your deposition is being 2 videotaped. If at any time you need a break or 3 need to confer with your attorneys in any 4 respect, please feel free to do so. This is not 5 an endurance contest and we're here to accomodate 6 you with respect to any items in connection with 7 your personal comfort. All right? 8 A. Thank you, very much. 9 Q. Would you give the jury 10 basically a brief run down of your educational 11 background? 12 A. I grew up in Indianapolis, 13 went to DePaul University, Purdue University and 14 the University of Pennsylvania. I have also done 15 other postgraduate work at Indiana University. 16 Q. Did you receive a degree from 17 any of those institutions? 18 A. Yes. I have a Bachelors 19 degree from Purdue, an MBA Degree from University 20 of Pennsylvania. 21 Q. What was your Bachelors degree 22 in? 23 A. In engineering. 24 Q. And when did you receive that Page 15 1 degree, sir? 2 A. 1948. 3 Q. And your MBA from the 4 University of Pennsylvania, I assume that's a 5 Masters of Business Administration? 6 A. Yes. 7 Q. When did you receive that 8 degree? 9 A. 1950. 10 Q. Have you had any other degrees 11 or any other academic credentials conferred upon 12 you, sir? 13 A. I have honorary degrees. 14 Q. All right. Where do you have 15 honorary degrees from? 16 A. Indiana University, Purdue 17 University, Butler University, DePaul University 18 and the Philadelphia College of Pharmacy. 19 Q. Why were you conferred an 20 honorary degree from the Philadelphia College of 21 Pharmacy? 22 A. Obviously, that particular 23 institution has an interest in our industry and 24 I'm sure that over the years they have attempted Page 16 1 to recognize people from the industry for that 2 purpose. 3 Q. Are you a pharmacist, sir? 4 A. No, I'm not. 5 Q. Are you a Pharm D or do you 6 have any training in pharmacy? 7 A. No, I do not. 8 Q. Are you a medical doctor? 9 A. No. 10 Q. Are you a psychologist or 11 therapist or have any training in those 12 disciplines? 13 A. No. 14 Q. What was your honorary degree 15 from DePaul University in, sir, or why was it 16 conferred? 17 A. I can't answer that question, 18 I think you would have to ask the university. 19 Q. Did you do anything in 20 particular in connection with DePaul University, 21 did -- 22 A. I was a student there. 23 Q. And they were recognizing your 24 accomplishments after you became -- after you Page 17 1 left DePaul University? 2 A. I would assume so. Not 3 because of my academic accomplishments. 4 Q. And Indiana University? 5 A. The same. 6 Q. When was that conferred? 7 A. I don't recall the exact date. 8 Q. And Butler University? 9 A. I don't remember, I think it 10 was in the '70's. 11 Q. Does Eli Lilly Company 12 contribute or scholarship or provide any 13 financial support to DePaul University, 14 endowments, grants? 15 A. I think they have in the past, 16 as they have many universities throughout the 17 country. 18 Q. How about Indiana University, 19 does Eli Lilly or has Eli Lilly contributed 20 financially to that institution by way of 21 scholarship, grants? 22 A. I'm sure they have. 23 Q. How about Butler University? 24 A. Sure. Page 18 1 Q. And the Philadelphia College 2 of Pharmacy? 3 A. Yes. 4 Q. After you -- did you say you 5 were a native of Indianapolis? 6 A. Yes. 7 Q. After you received your 8 Bachelors degree from Purdue University, did you 9 begin work or did you go directly to the 10 University of Pennsylvania to work on your 11 Masters? 12 A. Let's see. I graduated from 13 Purdue in February, as I remember it, of 1948. I 14 started to work -- at school at the University of 15 Pennsylvania in the summer of 1948. So there 16 were a few months between my Purdue and the 17 University of Pennsylvania. 18 Q. Were you employed during that 19 time? 20 A. Yes. 21 Q. In what capacity? 22 A. I did part-time work. 23 Q. For? 24 A. It was for a private Page 19 1 individual who was in the business of printing 2 repair booklets for the television industry. 3 Q. Your Bachelors degree was in 4 engineering as I understand it. What particular 5 specialty of engineering? 6 A. It was general engineering. 7 It was a combination of the various disciplines. 8 Q. No particular specialty like 9 electrical engineering, mechanical engineering? 10 A. No. 11 Q. All right. While you were at 12 the University of Pennsylvania, Wharton Business 13 School, were you employed on a part-time basis? 14 A. No. 15 Q. After you received your 16 Masters degree in 1950 at the University of 17 Pennsylvania, what was your first employment? 18 A. Eli Lilly and Company. 19 Q. And your employment has 20 continued since that time up to the present at 21 Eli Lilly and Company, is that correct? 22 A. I retired in 1991, from Eli 23 Lilly and Company. 24 Q. Well, you still maintain an Page 20 1 office at the facility at Eli Lilly and Company? 2 A. Yes, uh-huh. 3 Q. Do you still go in to that 4 office on a regular basis? 5 A. Periodically. 6 Q. When you say periodically, 7 give me some idea how often that is, sir. 8 A. Once or twice a week. 9 Q. And how much time do you 10 spend? 11 A. Oh, three or four hours. 12 Q. Is it correct that you 13 physically occupy the same office at this time 14 that you occupied when you retired from Lilly as 15 the Chairman of the Board? 16 A. Yes. 17 Q. What was your first job with 18 Lilly? 19 A. I was asked to become a member 20 of the financial studies department. 21 Q. Give me a little more detail 22 on that. Was this in planning for future 23 financial expenditures, was it in accounting? 24 A. It was looking at management Page 21 1 projects or issues from a financial standpoint, 2 and it could touch any aspect of finance, whether 3 it was cost or expenditures of various kinds. 4 Q. You were not hired as a 5 manager? 6 A. No. 7 Q. What was your first management 8 position with Eli Lilly and Company? 9 A. My first management position 10 was manager of what they call the export market 11 research department. 12 Q. And when did you begin that 13 position, do you recall? 14 A. I believe about 1958. 15 Q. Then what was your next 16 position with Lilly? 17 A. I was general manager of the 18 operations of the company in Argentina. 19 Q. And when did you begin that 20 job? 21 A. I believe it was 1960. 22 Q. Did you physically go to 23 Argentina and live there for a while? 24 A. Yes. Page 22 1 Q. How long did you live in 2 Argentina? 3 A. Approximately two years. 4 Q. Did the Argentina branch of 5 Eli Lilly have a separate affiliate name? 6 A. Yes. 7 Q. And what was the name of it? 8 A. Eli Lilly and Company of 9 Argentina. 10 Q. Is it still known as that? 11 A. No. 12 Q. What's its name now? 13 A. I'm not sure, we pulled out of 14 Argentina several years ago. I think the company 15 does still maintain an office there, but I'm not 16 sure of the corporate name. 17 Q. But in general the corporate 18 operations have ceased in Argentina? 19 A. Yes, except for some marketing 20 types of operations. 21 Q. What was the reason for 22 ceasing operations in Argentina? 23 A. The company was under very 24 strict price controls in Argentina. The rate of Page 23 1 inflation was very, very high and the company was 2 losing money and the government would not provide 3 any price relief. 4 Q. What was your next job with 5 Lilly after you left the Argentina branch? 6 A. I became general manager of 7 the company operations in Mexico. 8 Q. Did you physically move to 9 Mexico for that job? 10 A. Yes. 11 Q. And how long were you in 12 Mexico? 13 A. About two years. 14 Q. What was Lilly's affiliate 15 name in Mexico? 16 A. Eli Lilly y Compania of 17 Mexico. 18 Q. Is that company still in 19 existence in Mexico? 20 A. Yes. 21 Q. Does it still do business in 22 Mexico? 23 A. Yes. 24 Q. What was your next job with Page 24 1 Lilly. 2 A. Director of market research 3 for the parent company. 4 Q. When you say the parent 5 company, are you talking Eli Lilly and Company? 6 A. Yes. 7 Q. How long -- when did you begin 8 that job duty and when did you end that duty? 9 A. 1962 until 1964 -- no, I'm 10 sorry, that's incorrect. I started in '64 and I 11 don't recall how long I was in that job, it was 12 for several years. 13 Q. And I assume you moved back to 14 Indianapolis for that? 15 A. Yes. 16 Q. Then what was your next job 17 duty after you left the capacity as director of 18 market research? 19 A. I believe it was executive 20 director of market development. 21 Q. And for what years did you 22 occupy that position? 23 A. Well, approximately, that 24 would be '66 to '69, something of that order. Page 25 1 Q. All right. And your next job 2 duty? 3 A. I think I was executive 4 director of sales -- pharmaceutical sales for the 5 eastern half of the United States. 6 Q. When did you leave that job? 7 A. I don't remember, it was 8 several years later. 9 Q. Then what was your next job? 10 A. I was president of the 11 international corporation. 12 Q. What was the international 13 corporation known as? 14 A. Eli Lilly International 15 Corporation. 16 Q. When did you begin in that 17 capacity? 18 A. I don't remember exactly. 19 Q. Would it have been the early 20 '70's? 21 A. It was all in a sequence, I 22 was in most of these assignments for a year or 23 two. 24 Q. Looks like around two years. Page 26 1 A. Uh-huh. 2 Q. When you became the president 3 of the international Eli Lilly Corporation, was 4 that the first time that you occupied a position 5 of an officer with Lilly in any capacity? 6 A. I believe so. 7 Q. Then what was your next job 8 duty? 9 A. I became executive 10 vice-president of the corporation, the parent 11 company. 12 Q. Do you recall when that was? 13 A. No, not exactly. 14 Q. Then were you an officer of 15 the parent company at that time? 16 A. Yes. 17 Q. And did you remain an officer 18 of the company from that time up until your 19 retirement in 1991? 20 A. Yes. 21 Q. Were you a member of the Board 22 of Directors of Eli Lilly and Company, the parent 23 company, when you became executive 24 vice-president? Page 27 1 A. I was on the board, yes, at 2 that time. 3 Q. Was that the first time that 4 you were named to the board? 5 A. I would have to check that, I 6 don't remember exactly. I think I became a board 7 member in 1970. 8 Q. So at that time you would have 9 either have been the president of the 10 international Lilly corporation or executive 11 vice-president of the corporation itself? 12 A. Yes. 13 Q. And after your job as 14 executive vice-president what title did you have 15 next? 16 A. President of the company. 17 Q. For what years were you the 18 president of the company, Mister Wood? 19 A. I have been president twice. 20 Q. Tell me about the first time. 21 A. 1971, I believe. 22 Q. All right. How long did you 23 hold that title? 24 A. Until the retirement -- well, Page 28 1 in 1973, I became chairman and Mister Thomas Lake 2 became president. He then subsequently retired, 3 I think it was about 1977, and when he retired, I 4 also reassumed the title of the president. 5 Q. Did you continue as the 6 chairman of the board of directors of the 7 corporation? 8 A. Yes. 9 Q. At that time also? 10 A. Yes, that's right. 11 Q. So you have been chairman of 12 the board of directors -- 13 A. Since 1973. 14 Q. When did you become the chief 15 executive officer? 16 A. 1973. 17 Q. And you have continued -- you 18 continued as the chairman and chief executive 19 officer of Eli Lilly and Company from 1973 until 20 your retirement in 1991? 21 A. That's correct. 22 Q. And that was October of '91? 23 A. The end of October. 24 Q. So you were the chairman and Page 29 1 chief executive officer of Eli Lilly and Company, 2 for it looks like eighteen years? 3 A. That's correct. 4 Q. Since you resigned as chairman 5 and chief executive officer, have you 6 continued -- I know you've continued to office at 7 Lilly, have you continued to participate in the 8 management decisions at Lilly? 9 A. No, not except at the board 10 level, not in the day-to-day operations. 11 Q. You are still a member of the 12 board of directors of Eli Lilly and Company? 13 A. Yes. 14 Q. I believe I've read that you 15 are the single largest stockholder of any 16 individual in Eli Lilly and Company, is that 17 correct? 18 A. Employee or -- 19 MR. FREEMAN: Excuse me, Paul, what 20 does that have to do with anything? 21 MR. SMITH: What his capacity now is 22 in connection with decisions being made and his 23 capacity then. I'm trying to develop whether 24 it's changed in any respect. Page 30 1 MR. FREEMAN: He's described how it's 2 changed. I'll let him answer this question, but 3 not after that anything else about his financial 4 interest. 5 A. I'm not the largest single 6 shareholder of Eli Lilly and Company. 7 Q. You still maintain shares of 8 stock in Eli Lilly and Company? 9 A. Yes. 10 Q. You're still on the board of 11 directors of Eli Lilly and Company? 12 A. That's correct. 13 Q. You're still interested in the 14 well-being of Eli Lilly and Company, are you not? 15 A. Yes. 16 Q. You still derive income, 17 either directly or indirectly, as a shareholder 18 and member of the board of directors of Eli Lilly 19 and Company, do you not? 20 A. Yes. 21 Q. Have you ever had any 22 management responsibilities or any job duties in 23 connection with Lilly Research Labs, which as I 24 understand it is a separate wholly owned Page 31 1 subsidiary of Eli Lilly and Company? 2 A. It's a division of Eli Lilly 3 and Company. 4 Q. All right. 5 A. I have never had direct 6 responsibility. The people who have been in 7 charge of the research operations have reported 8 to me. 9 Q. But in your various job titles 10 that you were engaged in prior to you becoming 11 chairman and chief executive officer of the 12 corporation, you never were within the Lilly 13 Research Labs -- 14 A. No. 15 Q. -- corporate structure, is 16 that correct? 17 A. That's correct. 18 Q. We have taken, Mister Wood, 19 many depositions in connection with these cases 20 and have heard the term medical division or the 21 medical group at Eli Lilly mentioned several 22 times. Up until the time that you assumed 23 indirect oversight of that division by virtue of 24 your title as chairman and chief executive Page 32 1 officer, did you ever work within the medical 2 division -- 3 A. No. 4 Q. -- of the corporation? 5 A. No. 6 Q. When you became chairman of 7 the Board of the corporation in 1973, how did you 8 oversee the direction of the Lilly Research Lab 9 on an indirect basis? 10 A. Well, in the normal course of 11 the board level activities, the research people 12 would review their progress on various projects. 13 Also, once a year we would establish our budgets 14 for the entire corporation of which the research 15 budget was a major part. Those were the 16 principle methods of the overview of the research 17 operations. 18 Q. Was there any particular -- 19 did you have a staff that assisted you in your 20 duties? 21 A. No -- well, I mean, you have, 22 I would say, corporate staff. I didn't have a, 23 quote, staff assistant at all. There's a legal 24 staff and a financial staff and so on. Page 33 1 Q. Well, was there someone that 2 you looked to directly to advise you in matters 3 of research and development at the Lilly Research 4 Labs? 5 A. Yes, the head of the research 6 and development operation. 7 Q. I would assume then that would 8 have been the president of Lilly Research Labs? 9 A. Yes. 10 Q. And who was the president of 11 Lilly Research Labs when you began as chairman of 12 the board? 13 A. I think it was Doctor Brooks 14 Fortune or Doctor Pettinga, I think, I can't 15 remember which. 16 Q. Did you say Doctor Pettey? 17 A. Pettinga, P-E-T-T-I-N-G-A. 18 Q. Then Doctor Mel Perelman 19 became president of Lilly Research Labs? 20 A. Well, there was Doctor Herr, I 21 think, and then Doctor Perelman. 22 Q. Doctor Herr and Doctor 23 Perelman have both been mentioned in connection 24 with this litigation, so I need to ask you if you Page 34 1 can recall when Doctor Herr was the president of 2 Lilly Research Labs? 3 A. Well, it would be a guess, it 4 would be in the 1980's. 5 Q. And Doctor Perelman? 6 A. Following that, mid-80's. 7 Q. So from the 1980's up until 8 you retired in October 1991, you looked to either 9 Doctor Herr or Doctor Perelman to give you direct 10 reports in connection with the activities of 11 Lilly Research Labs? 12 A. Yes. 13 Q. And Lilly Research Labs had a 14 medical division, did they not? 15 A. Yes. 16 Q. And I would assume that those 17 would have been -- if you had questions 18 concerning the medical division of Lilly Research 19 Labs, you would have looked to either Doctor Herr 20 or Doctor Perelman? 21 A. Yes. 22 Q. To advise you in that 23 connection? 24 A. That's correct. Page 35 1 Q. Then you would look to 2 different individuals in questions of sales and 3 marketing I would assume? 4 A. Uh-huh. 5 Q. Different individuals in 6 connection with manufacturing, correct? 7 A. That's correct. 8 Q. Did you have regular meetings 9 with Doctor Herr and Doctor Perelman in 10 connection with the activities of Lilly Research 11 Labs? 12 A. The executive committee of the 13 company normally met once a week in which we 14 reviewed the activities and all the key 15 components of the corporation. That doesn't mean 16 we reviewed research every week, but periodically 17 as it seemed appropriate. 18 Q. Have there been weekly 19 executive committee meetings that have been 20 conducted in connection with the corporate 21 activities ever since you've been chairman of the 22 board of the corporation or chief executive 23 officer? 24 A. You mean while I was -- Page 36 1 Q. Yes. 2 A. Yes. 3 Q. The entire time? 4 A. Yes. 5 Q. Was there anyone else that you 6 looked to in Lilly Research Labs or in the 7 medical division of Lilly Research Labs in 8 connection with the activities of that division 9 of the company? 10 A. I don't understand the 11 question. 12 Q. Well, I understand that Doctor 13 Perelman was president of Lilly Research Labs at 14 one time? 15 A. Yes. 16 Q. Is that correct? 17 A. Yes. 18 Q. So he would have been the 19 person that you would have looked to primarily, I 20 would assume? 21 A. Uh-huh. 22 Q. Is that right? 23 A. Yes. 24 Q. But would there also be people Page 37 1 at Lilly Research Labs who you would converse 2 with on a, maybe not infrequent, but some basis? 3 A. Well, in -- on the occasions 4 when research was being discussed, a particular 5 project, it was not unusual for some of the key 6 scientists to participate in those presentations. 7 Q. We have seen that Doctor Leigh 8 Thompson, for instance, has made presentations to 9 the board and has met with you and your staff in 10 connection with Prozac, is that right? 11 A. I would guess that was 12 probable, yes. 13 Q. And Doctor Leigh Thompson is 14 now in what capacity with Eli Lilly and Company? 15 A. My understanding is he's the 16 scientific advisor to the chairman. 17 Q. I've heard the term chief 18 scientific offficer? 19 A. Uh-huh. 20 Q. Would that be appropriate in 21 connection with Doctor Thompson? 22 A. I'm not sure. 23 Q. What was his position when you 24 retired in -- Page 38 1 A. I believe he was head of the 2 medical division. 3 Q. Was that a corporate office 4 holder position at that time? 5 A. No. It's part of the Lilly 6 Research Laboratory. 7 Q. Is he a corporate officer at 8 this time as far as you know? 9 A. I don't know. 10 Q. Is he a member of the board of 11 directors? 12 A. No, he is not. 13 Q. Doctor Perelman was a member 14 of the board of directors when you retired as 15 chief executive officer in October of 1991, was 16 he not? 17 A. Yes. 18 Q. And do you recall how long 19 Doctor Perelman was a member of the board of 20 directors at Eli Lilly and Company? 21 A. Not precisely, I would say 22 maybe ten. It was a number of years. 23 Q. Would it have been his last 24 ten years with Lilly? Page 39 1 A. Yes. 2 Q. He has retired also, has he 3 not? 4 A. Yes. 5 Q. When did he retire? 6 A. I believe he retired last 7 December, 1993. 8 Q. Was there anyone else within 9 Lilly Research Labs or the medical division that 10 you recall consulting with or in any way seeking 11 their opinion in connection with the activities 12 of research and development, other than Doctor 13 Perelman and Doctor Leigh Thompson? 14 A. No. 15 Q. In connection with the 16 research and development of Prozac, fluoxetine 17 hydrochloride, would it be accurate to state that 18 you looked to Doctor Herr and Doctor Perelman as 19 being directly responsible for that function? 20 A. Yes. 21 Q. And would it be accurate to 22 state that on some occasions, you, as chief 23 executive officer of the corporation, looked to 24 Doctor Leigh Thompson for details and advice in Page 40 1 connection with Prozac? 2 A. Well, as I said earlier, on 3 occasion members of the Lilly research group 4 would participate in discussions and also 5 participate in the presentations. 6 Q. My question is do you recall 7 the names of any of those other gentlemen that 8 might have been involved in those discussions? 9 A. Well, if the question were 10 antibiotics, it would have been -- or infectious 11 disease groups, if it were cardiovascular drugs 12 or cancer drugs, the staff responsible for those 13 products would participate. 14 Q. I'm interested only in Prozac. 15 Do you recall looking to anybody else other than 16 Doctor Herr or Doctor Perelman and Doctor Leigh 17 Thompson? 18 A. Doctor Thompson would have 19 been involved since he was head of the medical 20 group. 21 Q. Anybody under him that you 22 recall -- 23 A. No. 24 Q. -- having discussions with? Page 41 1 A. Not precisely, no. 2 Q. And I'm not holding you to 3 that, I'm just trying to get an idea, Mister 4 Wood, with respect to how you were dealing with 5 individuals who were directly responsible for the 6 research and development and marketing experience 7 of Prozac -- 8 A. I understand. 9 Q. -- from the medical aspect at 10 this time. Does that cover that then that it 11 would be Herr, Perelman and Leigh Thompson 12 primarily? 13 A. There may have been others, 14 but I don't recall their names. 15 Q. The development of Prozac, 16 fluoxetine hydrochloride, the clinical trial 17 experience and the marketing of Prozac all 18 occurred while you were chief executive officer 19 and chairman of the board of the company, is that 20 correct? 21 A. Yes. I have to qualify that, 22 I'm not sure when the clinical trials started. 23 It goes way on back into history and I don't 24 remember the precise date. But certainly the Page 42 1 bulk of the trials occurred during the time I was 2 CEO. 3 Q. Do you recall that at the time 4 you assumed the position of chairman of the board 5 and chief executive officer of the company that 6 in connection with a report to you of activities 7 of the company, research on Prozac was already 8 underway or was this something that occurred 9 after you had become chairman of the board? 10 A. I would think the latter. The 11 development of Prozac went on for many, many 12 years and I don't recall the precise date when 13 they were initiated. 14 Q. Well, maybe we can get at it 15 this way. The process in order to secure 16 approval from the Food and Drug Administration of 17 the research and marketing of Prozac, all 18 occurred while you were chief executive officer? 19 A. I think that would be a 20 correct statement, yes. 21 Q. During your tenure as chairman 22 of the board and chief executive officer of Eli 23 Lilly and Company, was there any policy in place 24 in connection with the safety of drugs produced Page 43 1 by Eli Lilly and Company? 2 A. I don't understand that 3 question. 4 Q. Well, was it Lilly's intent to 5 develop and market drugs during that time that 6 were safe for human beings? 7 A. Yes. 8 Q. And to achieve that intent was 9 there any policy in place that would direct that 10 the products of Eli Lilly and Company were safe 11 for humans? 12 MR. FREEMAN: Other than clinical 13 trials and things of that kind? 14 Q. We'll get to clinical trials 15 specifically, I wanted to know generally what the 16 safety policies were of Eli Lilly and Company in 17 connection with development and marketing of the 18 products for human consumption. 19 A. Well, generally speaking, I 20 think it was well understood that the company was 21 to develop products which were effective for the 22 indications prescribed and generally safe when 23 used as prescribed according to the label, and is 24 approved by the Food and Drug Administration. Page 44 1 Q. You used the term generally 2 safe for use by the public. 3 A. Uh-huh. 4 Q. What do you mean by the term 5 generally safe? 6 A. Well, in the medical world, it 7 is also understood that pharmaceutical products 8 do have side effects and these are described on 9 the label. 10 Q. All right. Then could it be 11 said that obviously most drugs that human beings 12 consume have side effects? 13 A. With some people. 14 Q. In some percentage of the 15 patients -- 16 A. Yes. 17 Q. -- who are going to be 18 consuming that drug? 19 A. Yes. And that is described 20 fully in the package insert. 21 Q. Is it Lilly's policy to 22 describe fully the risk to patients consuming 23 their products in the package insert? 24 MR. FREEMAN: Now, you said risk to Page 45 1 patients, to describe to patients. 2 MR. SMITH: Yes. 3 MR. FREEMAN: Lilly is not describing 4 to patients, the package insert goes to doctors. 5 Q. Well, did you understand my 6 question, Mister Wood? 7 A. Well, the answer is that we 8 don't promote the product to patients. Our 9 efforts are totally to the medical profession. 10 Q. But you understand, do you 11 not, sir, that the medical profession is going to 12 give those products to patients? 13 A. Yes, that's the idea. 14 Q. This is what we call ethical 15 drugs that you know when you manufacture and 16 develop these drugs that they're going to be 17 prescribed via prescription from a doctor, but 18 they're going to be given to patients for various 19 indications, is that correct? 20 A. Yes. 21 Q. And if one of those drugs 22 manufactured by Lilly has a particular side 23 effect then it's Lilly's safety policy to advise 24 the -- Page 46 1 A. Physicians. 2 Q. -- physicians who are going to 3 prescribe the medicine to the public concerning 4 the side effects of that medication, is that 5 right? 6 A. Yes, that's correct. 7 Q. Now, would it be true, Mister 8 Wood, that some medications manufactured by Lilly 9 have side effects that present some risk to 10 patients? 11 A. Some products may have side 12 effects that could be -- could present a risk to 13 patients, as described in the label. 14 Q. You're jumping ahead of me. 15 What is the policy of Lilly in connection with 16 what to do about those products in connection 17 with those side effects that may present some 18 risk to the patient? 19 A. Those risks are described in 20 detail in the package insert. 21 Q. Who decides what risks 22 generally are described in detail in the package 23 insert? 24 A. The -- ultimately the Food and Page 47 1 Drug Administration, of course participating with 2 the medical group. But ultimately the Food and 3 Drug Administration approves the package insert. 4 Q. I understand that the Food and 5 Drug Administration approves the package inserts, 6 but isn't the proposal for the package insert 7 submitted by Eli Lilly and Company? 8 A. Yes. But all side effects are 9 reported to the Food and Drug Administration. 10 Q. I'm talking about the package 11 insert, the labeling that goes with the product, 12 all right? 13 A. Yes. Well, on occasion, my 14 point is, the Food and Drug Administration may 15 propose labeling changes, it's not totally up to 16 the company. 17 Q. I understand that, I 18 understand that. But when you've got a new 19 product that you're seeking FDA approval, isn't 20 it correct that Lilly submits to the Food and 21 Drug Administration proposed package labeling 22 instructions? 23 A. That's an over-simplification. 24 All of the clinical data, including all of the Page 48 1 side effects, plus all of the efficacy issues, 2 everything we know about the product is presented 3 to the Food and Drug Administration. They see 4 the same data as the company. It's not -- what 5 you're proposing is that we write the label. 6 That's not the way it's done, that's an 7 over-simplification. 8 Q. All right. Well, are you 9 saying that the Food and Drug Administration 10 writes the labeling instructions? 11 A. Well, they have a labeling 12 conference in which the representatives of the 13 company and the the Food and Drug Administration 14 sit down and jointly agree what the scientific 15 data indicates and that's what goes in the label. 16 Q. You say that Lilly and the FDA 17 jointly agree on what goes in the label? 18 A. Yes. 19 Q. Now -- 20 A. That doesn't mean the company 21 has an equal vote, that's a misnomer. 22 Q. Well, from that standpoint -- 23 A. But it's a conference, that's 24 when they develop the label. Page 49 1 Q. But the Food and Drug 2 Administration doesn't conduct the testing on a 3 particular drug during the approval process, does 4 it? 5 A. No. 6 Q. That's done by Eli Lilly and 7 Company or the manufacturer of the particular 8 drug in question, isn't it? 9 A. That's correct. 10 Q. And the Food and Drug 11 Administration gets information concerning the 12 product based on the research that's done by Eli 13 Lilly and Company, correct? 14 A. Correct. 15 Q. And this is submitted to the 16 FDA, correct? 17 A. Yes. 18 Q. So when we see a product that 19 is an FDA approved product, that doesn't mean 20 that that product is a FDA tested product, does 21 it? 22 A. I think maybe it's not clear, 23 but what I mean to indicate is that all of the 24 data that we collect goes to the FDA, we don't Page 50 1 selectively present data, they see everything. 2 Q. Is that the policy of Eli 3 Lilly and Company -- 4 A. Yes. 5 Q. -- Mister Wood -- 6 A. Yes. 7 Q. -- to submit all data in 8 connection with a product -- 9 A. Yes. 10 Q. -- to the Food and Drug 11 Administration? 12 A. That can be presented in 13 summary tables and that sort of thing. But they 14 see all the results of every single study, the 15 data we present is not selectively presented. 16 Q. All right. Are you sure of 17 that, sir? 18 A. That's the company policy. 19 Q. Do you know of any instance at 20 any time where the Food and Drug Administration 21 did not see data in connection with Prozac that 22 Lilly had? 23 A. Not to my knowledge. 24 Q. Would this be something that Page 51 1 would be contrary to Lilly policy if there was 2 some data in connection with Prozac that was not 3 submitted to the Food and Drug Administration? 4 A. I couldn't have answered that. 5 Q. I understand that. But if 6 that occurred would that be something that would 7 be contrary to the policy of Eli Lilly and 8 Company? 9 A. Yes. 10 Q. What if there was some data 11 about the safety of Prozac, would that be 12 required to be submitted to the Food and Drug 13 Administration -- 14 A. Yes. 15 Q. -- as far as a policy of Eli 16 Lilly and Company, is that right? 17 A. Yes. 18 Q. And would that be true whether 19 that data was harmful or helpful to the product? 20 A. It's a company policy that all 21 reports of, say, adverse reactions, go to the 22 Food and Drug Administration regardless of the 23 cause and regardless of the merits of the 24 situation. Page 52 1 Q. How about any reports of Lilly 2 experts who have reviewed data in connection with 3 adverse experiences with Prozac? 4 A. You mean their own evaluation? 5 Q. Yes. 6 A. I don't know, I can't answer 7 that. 8 Q. Well, would that be something 9 that you would have required during your period 10 as chief executive officer of the corporation 11 that it be submitted to the Food and Drug 12 Administration? 13 A. There own evaluation? 14 Q. Lilly's own evaluation. 15 A. They send in all of the 16 reports of side effects, that's the company 17 policy. Now, obviously they have to try to sort 18 out what is scientifically important and what 19 isn't, but the FDA is looking at the same data. 20 They make their own judgements and we make our 21 own. 22 Q. Wouldn't Lilly consider data 23 that is developed in connection with the safety 24 of the product as important and therefore Page 53 1 necessary to be sent to the Food and Drug 2 Administration? 3 A. The FDA sees all adverse drug 4 reaction reports. 5 Q. I understand that, that's 6 required by law, isn't it? 7 A. I'm not sure, I don't think 8 that's required by law. 9 Q. You don't know of any Food and 10 Drug Administration regulations that require a 11 manufacturer of a product to submit -- 12 A. Well -- 13 Q. Let me finish my question, 14 Mister Wood. I'm from Texas and I talk slow and 15 probably telegraph the answer to my questions. 16 But are you familiar with any data that is not 17 submitted to the Food and Drug Administration in 18 connection with safety of the product? 19 A. It's the company policy to 20 submit all data regarding safety. But that 21 wasn't your first question. 22 Q. I know, my first question was 23 are you -- is this something that you think is 24 required by FDA regulation? Page 54 1 A. Well, I don't know what it is 2 today, I've been retired since 1991. For many 3 years, the requirement, generally speaking, was 4 that only medically significant data had to be 5 reported to the Food and Drug Administration. It 6 was up to the company's medical and scientific 7 groups to decide what was important and what 8 isn't. But that was not Lilly policy, we sent 9 everything, regardless. 10 Q. So it was your understanding 11 that there was a period of time that the Food and 12 Drug Administration required only medically 13 significant data, is that right? 14 A. Well, if it were medically 15 significant they were required to report it. If 16 it was not a cause and effect relationship, for 17 example, then the data was not required to be 18 reported, but Lilly did report such data. 19 Q. Because that was Lilly's 20 policy? 21 A. Yes. 22 Q. To go beyond -- 23 A. Food and Drug Administration. 24 Q. -- federal guidelines? Page 55 1 A. That's correct. 2 Q. And those guidelines, during 3 your tenure as chairman of the board and chief 4 executive officer of Lilly, those guidelines of 5 the Food and Drug Administration were minimum 6 standards in connection with the safety of a 7 product, is that right? 8 A. Oh, I would not classify it as 9 minimal. 10 Q. Well, I thought you were 11 telling me that Lilly sought to provide more 12 information and go beyond those requirements of 13 the Food and Drug Administration. 14 A. Yes, that's correct. 15 Q. So from your standpoint you 16 were looking to the Food and Drug Administration 17 as the minimum that Lilly would do in connection 18 with the safety of a particular product? 19 A. That's a fair statement. 20 Q. And that's what I meant by 21 Food and Drug Administration regulations being 22 minimum standards as far as Lilly was concerned. 23 A. Yes. 24 Q. So I understand it, is it your Page 56 1 testimony that all data that impacts the safety 2 of a product manufactured by Eli Lilly and 3 Company should be submitted to the Food and Drug 4 Administration? 5 A. Yes. 6 Q. All data reflective of adverse 7 events then in connection with Prozac should have 8 been submitted to the Food and Drug 9 Administration -- 10 A. That's correct. 11 Q. -- by Eli Lilly and Company, 12 is that right? 13 A. You're right. 14 Q. Who is the individual that you 15 looked to in connection with Prozac to insure 16 that all safety data was being submitted to the 17 Food and Drug Administration? 18 A. I, as chairman, relied on the 19 supervision of the research activities to carry 20 that out. 21 Q. Who was supervising the 22 research activities? 23 A. Well, in this period of time 24 that you're focusing on, it would be Doctor Herr, Page 57 1 Doctor Perelman. 2 Q. Anybody else? 3 A. Well, they in turn would look 4 to the people in the research organization to 5 physically carry that out. 6 Q. Are there any safeguards in 7 place at Lilly to insure the safety data 8 concerning a Lilly product and Prozac in 9 particular is submitted to the Food and Drug 10 Administration? 11 A. Yes. There are reports of a 12 regular nature that are published by the people 13 responsible for reporting those. There is an 14 auditing activity, I believe administered by our 15 control division, who actually audit the files 16 and records of the research organization to make 17 sure that that policy is being carried out. 18 Q. Have there been any instances, 19 which you are aware, in which audits on the 20 control division has found that data that was 21 supposed to be submitted on Prozac to the Food 22 and Drug Administration was not submitted? 23 A. None to my knowledge. 24 Q. At any point is there any risk Page 58 1 benefit analysis made in connection with a 2 product under consideration by Eli Lilly and 3 Company? 4 A. Yes. That's the whole point 5 of the clinical trial process is to evaluate the 6 risk versus the benefits. 7 Q. Now, when you say evaluate the 8 risk versus the benefits, identify for me what is 9 meant by the risk of a particular product. 10 A. Well, in a clinical trial 11 setting, you have two areas of interest. One, 12 what has been the efficacy of the product for 13 various indications, as well as what is the 14 scientific profile of the side effect situation. 15 And then the scientist must make a judgment as to 16 whether the benefits outweigh the risk. 17 Q. Now you're talking about the 18 benefits of the product as far as efficacy -- 19 A. Yes. 20 Q. -- to cure or to treat the 21 particular condition for which the product is 22 being marketed or researched for, correct? 23 A. That's correct. 24 Q. And the risk that you're Page 59 1 talking about then would be any safety problems 2 in connection with the product? 3 A. That's correct. 4 Q. Who makes the final 5 determination or the final decision in connection 6 with the risk benefit analysis? 7 A. The scientific division. But 8 this is also reviewed by the board of directors 9 prior to marketing. 10 Q. I would assume that the 11 scientific division are those individuals such as 12 Doctor Herr, Perelman, and Leigh Thompson in 13 connection with Prozac, is that right? 14 A. They would certainly be 15 involved, yes. 16 Q. They are all medical doctors? 17 A. No. 18 Q. Is Doctor Thompson a medical 19 doctor? 20 A. Yes. 21 Q. Is Doctor Perelman? 22 A. No. 23 Q. He's not a medical doctor? 24 A. No. Page 60 1 Q. What is his -- 2 A. He's a Ph.D. 3 Q. Ph.D in what? 4 A. I don't recall, chemistry. 5 Q. How about Doctor Herr? 6 A. Same. 7 Q. Ph.D in chemistry? 8 A. Ph.D in chemistry. 9 Q. All right. So those 10 individuals are going to be making the initial 11 scientific determination to clinical trial 12 experience, is that right? 13 A. Well, the initial evaluation 14 is done by those who are responsible for the 15 product within Lilly Research Laboratories. 16 Ultimately it would rise up the ladder to the 17 head of the research organization. 18 Q. I understand that. But that's 19 going to be done in a clinical trial setting, is 20 it not? 21 A. Yes, as a result of the 22 clinical trial. 23 Q. Well, as I understand it, you 24 can't make a risk benefit analysis of any Page 61 1 particular pharmaceutical products until you've 2 conducted clinical trials to identify what those 3 risks and benefits are. 4 A. Well, you have indications all 5 the way along, but you do need the broad scale 6 clinical trial to confirm the laboratory 7 indications and animal studies. 8 Q. Well, be they Phase 1, 2, 3, 9 a, b, c, there is a trial phase in examining the 10 risk benefits of a product -- 11 A. Correct. 12 Q. -- in human beings, is there 13 not? 14 A. Yes. 15 Q. And that's done by the 16 scientific division -- 17 A. That's correct. 18 Q. -- in medical at Lilly 19 Research Labs, is that right? 20 A. Correct. 21 Q. And then the heads of those -- 22 that organization report to you directly in 23 connection with the risk and benefit presented? 24 A. Ultimately, yes. Page 62 1 Q. All right. Is there somebody 2 in between you and Doctor Perelman, for instance, 3 that would receive -- 4 A. No. 5 Q. -- this information? 6 A. No. 7 Q. Does Doctor Perelman have a 8 staff or do you have a staff of independent 9 individuals that meets to determine agendas and 10 to assist each of you in determining risks and 11 benefits? 12 A. Well, the research 13 organization has staff, I mean they have advisors 14 of national known experts from around the world 15 of any particular therapeutic field. They 16 participate in the evaluation, but the ultimate 17 decision is that of the research organization. 18 Q. All right. And then they 19 present the risk and the benefits of a product to 20 you as chief executive officer and chairman of 21 the board? 22 A. And to the board of directors. 23 Q. Now does the board of 24 directors have a particular committee within the Page 63 1 board that is charged with the responsibility of 2 recommending to the board or making this 3 risk/benefit analysis? 4 A. No. 5 Q. You follow what I'm saying? 6 A. Yes. 7 Q. In other words, the board of 8 directors probably has a financial committee and 9 various committees to help the board in general 10 do its functions, correct? 11 A. That's correct. 12 Q. And my question to you then to 13 be clear is is there any committee within the 14 board of directors at Eli Lilly and Company that 15 is charged with the particular responsibility of 16 making the risk/benefit analysis? 17 A. No. 18 Q. Then is that risk/benefit 19 analysis approved by the board in general? 20 A. Yes. 21 Q. How is that done, 22 specifically? 23 A. The scientific component makes 24 a presentation which summarizes everything they Page 64 1 know of material importance about a particular 2 compound and this includes inside as well as 3 outside advice. 4 Q. All right. Then did the board 5 make a decision based on those recommendations? 6 A. Yes. 7 Q. Do you recall of any instances 8 when the board of directors has disagreed with 9 the recommendation presented by the scientific 10 end? 11 A. No. 12 Q. Are you saying that the board 13 of directors acts as a rubber stamp? 14 A. No. 15 Q. As recommendations -- to 16 recommendations that are made by the scientific 17 end? 18 A. No. 19 Q. Then how is there an 20 independent analysis made by the board of 21 directors? 22 A. Well, these are very 23 outstanding people from all walks of life, and I 24 don't think you could ever claim that they would Page 65 1 just automatically rubber stamp something that 2 didn't make any sense whether they disagreed with 3 it. 4 Q. But you say they're from all 5 walks of life? 6 A. Yes. 7 Q. They're not all scientists? 8 A. Some are and some aren't. 9 Q. So they're not all scientists? 10 A. No. 11 Q. They're not all involved in 12 the pharmaceutical industry, are they? 13 A. No. 14 Q. Some are heads of other 15 corporations, correct? 16 A. Correct. 17 Q. Some have been vice-presidents 18 of the United States, in fact, have they not? 19 A. One. 20 Q. Later to become president of 21 the United States? 22 A. Yes. 23 Q. And I'm speaking of George 24 Bush. He's a former member of the board of Page 66 1 directors of Eli Lilly and Company? 2 A. Yes. 3 Q. Has he rejoined the board 4 since his retirement as president of the United 5 States? 6 A. No. 7 Q. Has he been active? 8 A. No, he's above the age limit. 9 Q. But he wasn't fired or retired 10 by the board of directors, was he? 11 A. No. 12 Q. My point is that the board of 13 directors are gentlemen that are charged with 14 various responsibilities and they don't meet on a 15 day to day basis in connection with the running 16 of Eli Lilly and Company, do they, Mister Wood? 17 A. No. 18 Q. That was while you were the 19 chief executive officer your function, was it 20 not? 21 A. That's correct. 22 Q. And did you make an 23 independent analysis of the risk and benefit that 24 a particular product presented? Page 67 1 A. I always did, yes. 2 Q. And did you do that in 3 connection with Prozac, fluoxetine hydrochloride? 4 A. I'm sure I did. 5 Q. When did you do that, sir? 6 A. Prior to the first marketing 7 of the compound in the '80's, whenever that was. 8 Q. The product was first 9 marketed, I believe, in December of 1987. 10 A. '87. 11 MR. FREEMAN: That's when it was 12 approved. 13 MR. SMITH: It wasn't marketed before 14 it was approved, was it? 15 MR. FREEMAN: But that doesn't mean it 16 was marketed in December of 1987 either. 17 A. It was approved in other 18 countries first. 19 Q. Okay. 20 A. So the review would have been 21 done before that date. 22 Q. Would you have made this 23 risk/benefit analysis yourself then before the 24 drug was approved for consumption by the Food and Page 68 1 Drug Administration in the United States? 2 A. I probably was, yes. 3 Q. How did you go about making 4 that decision or that analysis in connection with 5 Prozac, Mister Wood? 6 A. The scientific component would 7 present all summary data concerning the efficacy 8 and safety of the compound. 9 Q. All right. 10 A. And then it's a judgment call 11 based on those facts. 12 Q. All right. So summary data 13 was presented to you concerning the safety and 14 efficacy of Prozac? 15 A. Yes. 16 Q. And then you made a 17 risk/benefit analysis, is that correct? 18 A. Yes. 19 Q. And approved as chairman of 20 the board and chief executive officer the 21 marketing of Prozac by Eli Lilly and Company? 22 A. Yes. 23 Q. And so you made a decision 24 that any risk inherent in Prozac was outweighed Page 69 1 by the benefits of Prozac, is that right? 2 A. That's correct. 3 Q. When you first -- well, let me 4 back-up. When did you first learn, as chairman 5 of the board and chief executive officer of Eli 6 Lilly and Company, that there might be some 7 concern by any group or individual that Prozac 8 might be causing suicidality or violent 9 aggressive behavior in human beings? 10 A. Well, I think the first event 11 was the report by Doctor Teicher. 12 Q. All right. Is it your 13 testimony that up until the report by Doctor 14 Teicher, you were not aware of any other 15 individual or group or entity that might have 16 raised some concerns or some questions whether or 17 not Prozac could cause suicidal or violent 18 aggressive behavior in human beings? 19 A. Not that I remember. 20 Q. Well, do you think you would 21 have remembered had that issue come up? 22 A. I'm sure I would have, yes. 23 MR. SMITH: Shall we take a quick 24 break? Page 70 1 (A SHORT RECESS WAS TAKEN.) 2 Q. (BY MR. SMITH) I'm going to 3 hand you some documents, Mister Wood, that 4 apparently you must not have ever seen before. 5 And I want to give you some time to look at these 6 documents. I guess we better do this like 7 lawyers do it and have the reporter mark it 8 before I give it to you. 9 (PLAINTIFFS' EXHIBIT NO. 1 WAS 10 MARKED FOR IDENTIFICATION AND 11 RECEIVED IN EVIDENCE.) 12 Q. Have you had an opportunity to 13 review Exhibit 1, Mister Wood? 14 A. Yes. 15 Q. And this -- I will tell you 16 this document has been provided to us by virtue 17 of the stamp on it by your company, Eli Lilly and 18 Company. Does it appear to you to be an E-mail 19 from your German affiliate to Indianapolis? 20 A. E-mail? 21 Q. Yes. 22 A. I don't know. 23 Q. Or telex of some sort? 24 A. Well, it's a standard looking Page 71 1 communication. 2 Q. If you will look down in the 3 lower right-hand corner of each page, printed on 4 the side is the particular Pz number and I will 5 tell you that that was an internal number 6 assigned to these documents by the Legal 7 Department at Eli Lilly and Company. Will you 8 accept for me that this is a Lilly document? 9 A. I assume so. 10 MR. FREEMAN: We'll stipulate. 11 MR. SMITH: Does anybody have any 12 problem with any of these documents with Pz 13 numbers are Lilly documents? 14 MR. FREEMAN: They may not be created 15 by Lilly, maybe they've come from some outside 16 source, but we will stipulate it's something that 17 we produced. 18 Q. But this document is signed by -- 19 or not signed, but appears to be authored by a 20 Schenk -- an individual by the name of Schenk and 21 Weber. Testimony has been developed up to this 22 point that Mister Hans Weber -- or Doctor Hans 23 Weber was the medical director of your German 24 affiliate in Germany, were you aware of that? Page 72 1 A. That's my understanding. 2 Q. All right. And did you know 3 that there was a Mister Hans or Doctor Hans Weber 4 working for the Lilly German affiliate in 1984? 5 A. I've heard the name, yes. 6 Q. Have you ever seen this 7 document before? 8 A. No, not to my knowledge. 9 Q. Go with me. It appears -- the 10 first page indicates that it's dated Bad Homburg, 11 June 26th, 1984, does it not? 12 A. Yes. 13 Q. And Bad Homburg was where your 14 German affiliate was located, was it not? 15 A. Correct. 16 Q. In 1984, correct? 17 A. Yes. 18 Q. And the subject appears to be 19 Fluoxetine - Registration Germany, does it not? 20 A. Yes. 21 Q. And Fluoxetine is Prozac, is 22 it not? 23 A. Yes. 24 Q. Anytime we see the word Page 73 1 Fluoxetine, we know it's Prozac, correct? 2 A. Right. 3 Q. Anytime we see the word 4 Prozac, we see -- we know it's Fluoxetine, 5 correct? 6 A. Yes. 7 Q. In fact, in Germany, the drug 8 was known as Fluctin, was it not? 9 A. I don't remember. 10 Q. But it was known by a 11 different trade name other than Fluoxetine or 12 Prozac in Germany, correct? 13 A. I don't know. 14 Q. Would you have any reason to 15 disagree with me if I told you that that would 16 have been developed so far? 17 A. No. I know around the world 18 we use different names. 19 Q. It appears that this is being 20 sent back to some individuals in Indianapolis, 21 does it not? 22 A. Yes. 23 Q. All right. And it says, this 24 is the first page, first paragraph, this is to Page 74 1 confirm which additional data have been 2 identified to be essential during our discussions 3 at the BGA, June 15th, 1984, correct? 4 A. Yes. 5 Q. Now the BGA is the German 6 equivalent to the United States Food and Drug 7 Administration, is it not? 8 A. Yes. 9 Q. The BGA is that entity in 10 Germany required to make determinations of safety 11 and efficacy of that product in Germany, correct? 12 A. That's correct. 13 Q. And it's necessary in order 14 for Eli Lilly and Company to market any of their 15 products in Germany that they secure approval of 16 an entity known as the BGA, correct? 17 A. Yes. 18 Q. Can you tell me what the 19 initials BGA stand for? 20 A. No. 21 Q. But it's like FDA in the 22 United States? 23 A. That's my understanding. 24 Q. Would you turn with me to item Page 75 1 ten. It says comparative use of concomitantly 2 taken hypnotics and benzodiazepines in agitated 3 retarded Fluoxetine patients versus agitated 4 retarded patients on comparators. Reason: The 5 BGA suspects Fluoxetine to be a stimulating 6 activating drug, paren, side-effect profile, 7 suicides, suicide attempts, close paren. Is that 8 what it says there? 9 A. Yes. 10 Q. That says to me that in 1984, 11 the German regulatory authorities were concerned 12 about whether or not Prozac caused suicide and 13 agitation in patients, correct? 14 A. Well, apparently was an area 15 that they were interested in. 16 Q. All right. And that they were 17 were concerned about it, otherwise they wouldn't 18 be interested in it, right, Mister Wood? 19 A. That's right. 20 Q. Is that correct? 21 A. I assume so. 22 Q. I believe -- 23 A. I don't know what they were 24 worried about. Page 76 1 Q. I believe it's your testimony 2 that you, as chairman of the board of the 3 company, didn't know of any question from any 4 source concerning whether or not Prozac could 5 cause suicidal or agitated violent aggressive 6 behavior prior to the Teicher article in 1990, is 7 that correct? 8 A. Correct. 9 MR. FREEMAN: And this paragraph does 10 not indicate what you're saying it indicates. 11 You have to understand what the German system is 12 with respect to these drugs. 13 MR. SMITH: We object to the side bar 14 remarks and ask that it be stricken. 15 Q. Turn with me, Mister Wood, to 16 paragraph 14 on page 3. Paragraph 14 reads, and 17 read it with me please, sir, quote, as we already 18 explained by our telex to Doctor Zerbe of June 19 8th, 1984, we need a careful analysis of suicides 20 and suicide attempts, patient by patient, 21 symptomatology /severity upon entry into the 22 study and week by week until the event occurred, 23 dose of Fluoxetine, side-effects, et cetera. It 24 might well be that we will have to recommend Page 77 1 concomitant tranquilizer intake for the first two 2 or three weeks in the package literature. Did I 3 read that correct? 4 A. Yes. 5 Q. It says -- I didn't read it 6 correctly. 7 A. You didn't. 8 Q. I missed something. It says, 9 this is a very serious issue in the opinion of 10 the BGA. Correct? 11 A. Yes. 12 Q. Then they say, it might well 13 be that we will have to recommend concomitant 14 tranquilizer intake for the first two or three 15 weeks in the package literature. Correct? 16 A. Yes. 17 Q. So as I read that as a lay 18 person, it would appear to me that the German 19 government is concerned about suicide and suicide 20 attempts and that this was a serious issue in the 21 opinion of the BGA, and it looked like there was 22 going to have to be recommended concomitant 23 tranquilizers in connection with the use of 24 Prozac in Germany, doesn't it? Page 78 1 A. I have no idea. This is a 2 typical list of questions on a government 3 regulatory agency on a drug like Prozac. 4 Q. All right. 5 A. You don't know or I don't know 6 what they finally concluded based on the data. 7 Q. You don't? 8 A. No, I don't know. 9 Q. You will agree with me that 10 the German government is raising the issue in 11 1984, won't you? 12 A. Apparently, yes. 13 Q. And that you didn't know the 14 German government was raising this issue? 15 A. There would be no reason for 16 me know. 17 Q. Why? 18 A. This is a typical list of 19 questions that most regulatory agencies might 20 follow through on a product like an 21 antidepressant. 22 Q. But the question they're 23 raising is whether or not Prozac causes suicide, 24 isn't it? Page 79 1 A. Well, just because they asked 2 the question, you shouldn't assume that it's a 3 fact. They asked lots of questions. 4 Q. I understand that. 5 A. Then it's up to the company to 6 go forward with the facts. 7 Q. All right. You would expect 8 Lilly to go forward and make another analysis of 9 this based on the issue being raised by the 10 German government, correct? 11 A. I don't know whether they made 12 another analysis or not, they obviously had to 13 respond. 14 Q. Well, but you were not made 15 aware that the German government was concerned 16 about this issue back in 1984? 17 A. No. 18 Q. You didn't know that anybody 19 was concerned about suicide until the Teicher 20 article in 1990, is that correct? 21 A. Well, my answer to that is 22 just because a regulatory agency asks a question, 23 doesn't mean that it's a fact. It's their 24 responsibility to ask questions. Page 80 1 Q. I didn't ask you whether or 2 not you ever learned that it was a fact that 3 Prozac caused suicide or that Prozac caused 4 aggressive violent behavior. My question to you 5 was was there ever any concern raised or question 6 ever posed to you -- 7 A. To me? 8 Q. -- or by anybody at the board 9 of directors or anybody at Eli Lilly of which 10 you're aware before the Teicher article in 1990? 11 A. I answered that earlier. 12 Q. And it was you didn't know 13 anything about it -- 14 A. That's correct. 15 Q. -- until 1990? 16 MR. FREEMAN: And we object to this 17 line of questioning on the grounds that the 18 document speaks for itself and it does not say 19 what you said it says there. 20 (PLAINTIFFS' EXHIBIT NO. 2 WAS 21 MARKED FOR IDENTIFICATION AND 22 RECEIVED IN EVIDENCE.) 23 Q. Before we go to Exhibit 2, 24 Mister Wood, would you agree that Exhibit 1, the Page 81 1 June, 1984 document concerning Fluoxetine and its 2 registration in Germany has to do with the 3 product safety? 4 A. Yes. 5 Q. Would you agree that it has to 6 do with risks inherent in the product Prozac? 7 A. Yes. 8 Q. And then would you agree that 9 this is a document that should be submitted to 10 the Food and Drug Administration? 11 A. No. 12 Q. All right. Why? 13 A. It's not a report of 14 side-effects, it's not a clinical trial, this is 15 a typical type of regulatory agency review of a 16 new compound, in my judgment. 17 Q. And you wouldn't submit this 18 to the Food and Drug Administration? 19 A. I don't know what the law 20 requires. If you are asking me personally -- 21 Q. Yes. 22 A. -- my judgment is no. I would 23 not. 24 Q. Would that judgement be -- Page 82 1 your judgment if you were asked in 1984 when you 2 were chairman of the board of the corporation not 3 to send it to the Food and Drug Administration? 4 A. That letter? 5 Q. Yes. 6 A. No. 7 Q. Well, let's look at Exhibit 2. 8 Have you had a chance to review that? 9 A. Yes. 10 Q. That appears to be another 11 document authored by Doctor Weber and others in 12 Germany, does it not? 13 A. Yes. 14 Q. And that's dated January 29th, 15 1985, is it not? 16 A. Yes. 17 Q. And it also contains -- is the 18 subject of Fluoxetine registration in Germany, is 19 it not? 20 A. Yes. 21 Q. And again, Fluoxetine is 22 Prozac, is it not? 23 A. Yes. 24 Q. All right. The first Page 83 1 paragraph of that document says, we unofficially 2 received and confirmed that Fluoxetine was 3 discussed by the commission at the BGA on January 4 21st. Two major concerns seem to be the reason 5 that the registration was not accepted. Did I 6 read that correct, Mister Wood? 7 A. Yes. 8 Q. Then the two concerns that 9 caused the registration not to be accepted was: 10 One, that efficacy questioned. This may be due 11 to the experiences in study design and 12 classifications used in the United States versus 13 Germany. Correct? 14 A. Yes. 15 Q. And the second reason that 16 registration was not accepted in Germany was 17 suicidal risk, is that correct? 18 A. That's what it says. 19 Q. Have you ever seen this 20 document before -- 21 A. No. 22 Q. -- Mister Wood? 23 A. No. 24 Q. Do you agree that this Page 84 1 document has to do with risk associated with 2 Prozac? 3 A. Yes. 4 Q. Do you agree that this 5 document has to do with the safety of Prozac? 6 A. It has to do with efficacy and 7 safety. 8 Q. And do you agree that this 9 document identifies a serious risk in connection 10 with Prozac? 11 A. It states that the BGA was 12 concerned about efficacy as well as suicidal 13 risk. 14 Q. And do you agree that suicidal 15 risk is a serious risk? 16 A. Yes. 17 Q. Would you have submitted, had 18 you been asked as chairman of the board in 19 January, 1985, would you have submitted this to 20 the United States Food and Drug Administration? 21 A. In my opinion, no. 22 Q. Why? 23 A. It is not a clinical trial 24 report. Page 85 1 Q. Did you know, Mister Wood, 2 that the application for Fluoxetine was not 3 accepted in Germany? 4 A. There were a number of 5 countries where it was not accepted initially. 6 MR. FREEMAN: But you're stating that 7 as a fact. Now it has been accepted and approved 8 a long time in Germany. 9 MR. SMITH: All right, we'll talk 10 about that, we'll get to that. 11 Q. But did you know that the 12 registration as originally submitted was not 13 accepted? 14 A. No, not specifically. But I 15 would answer that by saying this is not atypical 16 in the new drug approval process. 17 Q. Is it your testimony that 18 you're not concerned and wouldn't have been 19 concerned in January of 1985 about the fact that 20 the German government was concerned that Prozac 21 might cause or might be a suicidal risk? 22 A. Not necessarily. 23 Q. Does it concern you now? 24 A. No. Page 86 1 Q. Would you need more 2 information concerning that before it became a 3 concern to you? 4 A. Well, the German BGA and the 5 U.S. FDA were all looking at the same data. 6 Q. All right. 7 A. And this is true throughout 8 the world, all the countries reviewed the same 9 information. They sometimes come to different 10 conclusions at different times. 11 Q. All right. 12 A. In the new drug approval 13 process, this goes on for years. 14 Q. Do you have an opinion, Mister 15 Wood, that the Food and Drug Administration is 16 better able to examine the risks in connection 17 with Prozac than is the Food and Drug 18 Administration -- the German government? Let me 19 ask that for you again. Do you have an opinion 20 concerning whether or not the Food and Drug 21 Administration does a better job or worse job of 22 examining the risk to patients than that of the 23 German BGA? 24 A. No. Nor by the contrary, I Page 87 1 don't think the BGA necessarily is better than 2 the FDA. 3 Q. All right. You think they're 4 both equally equipped to examine the risk -- 5 A. Oh, I can't answer that 6 question. 7 Q. Let me finish my question. 8 Q. Do you have any opinion then 9 whether or not they're both equally equipped to 10 examine the risk presented by a particular 11 product? 12 A. I haven't the foggiest idea. 13 Q. Well, would this be something, 14 had this been brought -- as I understand it, this 15 was not brought to your attention? 16 A. I don't recall this, no. 17 Q. Don't you think you would have 18 recalled it? 19 A. Yes. 20 Q. If something this serious had 21 been brought to your attention? 22 A. I don't think it is 23 necessarily that serious. 24 Q. Okay. You'd want more Page 88 1 information, wouldn't you? 2 A. My question would be what are 3 the facts? 4 Q. Would you have requested some 5 scientific dialogue on this? 6 A. I may have -- well, had this 7 appeared to be a serious issue, it would have 8 come to my attention at that time. 9 Q. All right. Who would have 10 made the determination at that time as to whether 11 or not this was a serious issue that should have 12 come to your attention? 13 A. The scientific component. 14 Q. Who, in the scientific 15 component? 16 A. The people responsible first 17 for the compound as well as their supervision. 18 Q. Give me a name in January, 19 1985 that you would have looked to? 20 A. Doctor Herr and Doctor 21 Perelman. 22 Q. Would you have had any 23 objection to a scientific inquiry concerning this 24 issue raised by the German government? Page 89 1 MR. FREEMAN: Could you restate that 2 question? 3 Q. Would you have had any 4 objection, as chairman of the board then, to a 5 scientific inquiry -- 6 A. I'm sure -- 7 Q. -- if this issue was raised by 8 the -- 9 A. As I said earlier, our 10 scientific component, I'm sure it went back and 11 reviewed all of the data and responded in the 12 normal course of procedure. 13 Q. All right. I think Exhibit 3 14 will demonstrate that they did. After the court 15 reporter marks Exhibit 3, would you review it, 16 please, sir? 17 (PLAINTIFFS' EXHIBIT NO. 3 WAS 18 MARKED FOR IDENTIFICATION AND 19 RECEIVED IN EVIDENCE.) 20 Q. Mister Wood, it appears that 21 Exhibit 3 is dated in the upper left-hand corner, 22 April 3rd, 1985, and is being received or sent 23 from Lilly Bad Homburg, correct? 24 A. Yes. Page 90 1 Q. And it's dated April 2nd, 2 1985, correct? 3 A. Yes. 4 Q. And it is addressed to a 5 number of individuals with Eli Lilly and Company, 6 is it not? 7 A. Yes. 8 Q. Some of those individuals are 9 in London, correct? 10 A. Yes. 11 Q. Some are in England. Isn't 12 Erl Wood in England? 13 A. Yes. 14 Q. Some are in Germany, correct? 15 A. Yes. 16 Q. But there is a lot of 17 scientists listed here in Indianapolis, aren't 18 there? 19 A. Yes, some. 20 Q. Doctor D. E. Thompson, do you 21 know him as a scientist here in Indianapolis? 22 A. D. E., he's not a scientist. 23 Q. What was his capacity? 24 A. I have no idea. Page 91 1 Q. All right. Doctor Weinstein 2 is a scientist, is he not, with Lilly? 3 A. Yes. 4 Q. Here in Indianapolis? 5 A. Yes. 6 Q. Doctor Wernicke was the 7 clinical monitor for the Prozac clinical trials, 8 was he not? 9 A. I don't know. 10 Q. Beg pardon? 11 A. I do not know. 12 Q. You know he's a scientist? 13 A. Well, it says doctor. Doctor, 14 doctor, it says. 15 Q. Did you know Doctor Wernicke? 16 A. No. 17 Q. Did you know whether he had 18 anything to do with Prozac? 19 A. I haven't the foggiest idea. 20 Q. You know Doctor Zerbe, don't 21 you? 22 A. Yes. 23 Q. And you know he was extremely 24 responsible in the scientific issues here in Page 92 1 Indianapolis in connection with Prozac, don't 2 you, Mister Wood? 3 A. Yes. 4 Q. Now, this document appears to 5 be headed a Report Of fluoxetine Working Session, 6 does it not? 7 A. Yes. 8 Q. And it states that the 9 objective of the meeting is to make a professor 10 and his co-worker familiar with Fluoxetine data 11 so that he is in a better position to give the 12 best advice as a consultant to the company on the 13 registration process of Fluoxetine. Isn't that 14 what it states the purpose of the -- 15 A. Yes. 16 Q. -- of the objective of the 17 meeting is? Then it appears those scientists 18 reviewed some data, doesn't it? 19 A. Yes. 20 Q. And it appears that they 21 reviewed what's called an original documentation 22 submitted March 1st, 1994, correct? 23 A. Yes. 24 Q. And an analysis of pooled Page 93 1 studies, Fluoxetine versus Imipramine versus 2 placebo? 3 A. Yes. 4 Q. Protocol Number 27, correct? 5 A. Yes. 6 Q. Now, Protocol Number 27, do 7 you know, Mister Wood, is a multi-centered study 8 done by Lilly on Prozac? 9 A. Oh, I would have no idea what 10 pool Protocol Number 27 is. 11 Q. Well, you have heard of 12 clinical studies being conducted by Lilly under 13 protocols, have you not? 14 A. Oh, yes. 15 Q. And you know Lilly gives those 16 protocols numbers, don't you? 17 A. No, not necessarily. 18 Q. Well, do you know that 19 Protocol Number 27 was a protocol that the Food 20 and Drug Administration and Eli Lilly 21 characterized as a pivotal study in connection 22 with a determination of the safety and efficacy 23 of Prozac? 24 A. I didn't know that, no. Page 94 1 Q. Would that surprise you? 2 A. No. 3 Q. All right. Under Outcome, it 4 says that this professor left an opinion of 5 twenty-one typewritten pages, does it not? 6 A. Yes. 7 Q. And then it goes on -- this 8 document goes on to summarize that opinion, does 9 it not? 10 A. Yes. 11 Q. Again, you've never seen this 12 document, have you? 13 A. No. 14 Q. Never heard of this document? 15 A. No. 16 Q. Nobody ever brought this to 17 your attention during your tenure as chairman of 18 the board -- 19 A. No. 20 Q. -- of Eli Lilly and Company, 21 did they? 22 A. No. 23 Q. That opinion has an entire 24 section on safety, doesn't it? Page 95 1 A. Yes. 2 Q. It says, under the third 3 bullet point there, does it not, that initial 4 sedation more pronounced under imipramine, 5 correct? 6 A. That's what it says, yes. 7 Q. Then if you go down to the 8 next to the last bullet point under the safety 9 section, does it not say, Mister Wood, still not 10 resolved is the fact that suicide attempts have 11 been observed more frequently on Fluoxetine as 12 compared to Imipramine, only epidemiologic data 13 or literature or other antidepressants may help 14 to identify whether it happened by chance that 15 incidents of suicide attempts was abnormally high 16 on Fluoxetine or abnormally low under 17 comparitors. Isn't that what it says? 18 A. Yes. 19 Q. Did you know in 1985, Mister 20 Wood, that suicide attempts were being observed 21 more frequently on Fluoxetine as compared to 22 Imipramine? 23 A. No. 24 Q. Anybody ever bring that to Page 96 1 your attention? 2 A. No. 3 Q. Does that surprise you -- 4 A. No. 5 Q. -- Mister Wood? 6 A. Not necessarily. 7 Q. Does that concern you? 8 A. No. 9 Q. Why doesn't it concern you, 10 sir? 11 A. Because the bulk of all the 12 scientific data on Prozac, both in the clinical 13 trials as well as marketing experience since that 14 time have shown that, if anything, Prozac reduces 15 the incidence of suicide. 16 Q. That's the opinion that you 17 formed as a result of that input you received 18 from your scientific advisors at Lilly, isn't it? 19 A. Of course, and it may be in 20 the label, I'm not sure of that. But that is a 21 fact. 22 Q. Well, is there anything in the 23 label that you know about that suggests even that 24 suicide attempts were found in Protocol Number 27 Page 97 1 to be more frequent on Prozac than Imipramine? 2 A. It does not indicate cause and 3 effect, there is no suggestion of cause and 4 effect. In fact, they're asking for it to be 5 analyzed to determine cause and effect. That's 6 the way I read it. 7 Q. It says that the benefit risk 8 ratio is affected negatively by the increased 9 suicidal risk, doesn't it? 10 A. It depends on the cause and 11 effect. This does not address that issue. 12 Q. But this is an analysis done 13 of the protocol after it was done, correct? 14 A. Well, I'm reading this for the 15 first time, you're asking my opinion. 16 Q. I understand that. 17 A. What I read into this is that 18 in this particular Protocol 27, as analyzed by 19 the professor, whoever he is in Berlin -- 20 Q. It says down in the bottom of 21 the third page his name is Doctor Herrmann. 22 A. Well, whatever it is. That he 23 says that there are more suicides on those on 24 Fluoxetine than the comparitor group. It doesn't Page 98 1 indicate cause and effect. 2 Q. All right. 3 A. One way or the other. 4 Q. It indicates greater frequency 5 on Prozac than it does on the comparitor drug, 6 doesn't it? 7 A. Yes, in this particular trial, 8 that's correct. 9 Q. And that doesn't concern you? 10 A. Not by itself, no. 11 Q. You would want some cause and 12 effect analysis made? 13 A. Absolutely. 14 Q. Is that what you're saying? 15 A. Yes. 16 Q. Don't you think that's strange 17 that there would be more suicide attempts 18 observed on Prozac than Imipramine if Prozac 19 theoretically reduces suicidal ideation? 20 A. No. Because I'm sure there 21 are studies that show just the opposite. That's 22 the nature of the clinical trials. 23 Q. All right. Are you saying 24 that there's no conclusive proof, whatsoever, as Page 99 1 to whether or not Prozac causes suicidality? 2 MR. FREEMAN: He hasn't testified to 3 that in any way. 4 A. No. 5 Q. Do you know of any conclusive 6 proof or any proof that Prozac causes or does not 7 cause suicidality? 8 A. I answered that earlier, I 9 thought. 10 Q. Then help us, what was your 11 answer? 12 A. The body of everything that we 13 know about Prozac in terms of scientific data as 14 well as marketing experience with millions of 15 patients around the world indicates that Prozac, 16 if anything, reduces the incidence of suicide 17 among those with depression. 18 Q. All right. That's not 19 supported by this review of Protocol Number 27, 20 is it? 21 A. I have no idea whether it is 22 or isn't. You'd have to know the cause and 23 effect. 24 Q. This expert is concerned about Page 100 1 it, is he not? 2 A. He's raising the issue, sure. 3 This is not unusual. 4 Q. But it wasn't raised to you, 5 was it? 6 A. I beg your pardon? 7 Q. It wasn't raised to you? 8 A. No. 9 Q. The document goes on to say 10 that the benefit risk ratio of this expert was 11 that it was not unequivocally positive, doesn't 12 it? 13 A. That's what it says, yes. 14 Q. The document goes on to say it 15 is of great importance to determine certain type 16 of patients who will better respond to Fluoxetine 17 than to Imipramine so that higher risk may be 18 acceptable, doesn't it? 19 A. That's what it says. 20 Q. Do you have any idea what the 21 author of this is meaning by that? 22 A. Well, my first reaction is he 23 must be very lonesome. 24 Q. Who's that? Page 101 1 A. Doctor Herrmann. Because the 2 scientific community around the world would never 3 agree that the benefit/risk ratio is not positive 4 on Prozac. 5 Q. Well, but Doctor Herrmann is 6 somebody that was hired by Lilly, Mister Wood? 7 A. That's not unusual for them to 8 come to a different opinion. 9 Q. Well, it would appear that you 10 have discounted his opinion. 11 A. No, I didn't say that at all. 12 Q. All right. Then tell me, what 13 else would you want? 14 A. Well, how many physicians did 15 we have looking and doing clinical trials on 16 Prozac around the world? That's what you look 17 at, you look at the total body of facts, 18 including that of Doctor Herrmann. Then you put 19 it all together and make your judgment, which is 20 what the Food and Drug Administration does. 21 Q. I'm not talking about the Food 22 and Drug Administration, I'm talking about what 23 you're doing as chairman of the board of Eli 24 Lilly and Company. Page 102 1 A. I look at the total, I don't 2 look at individual reports. 3 Q. Why, couldn't there be 4 somebody that's right and somebody that's wrong? 5 A. Of course. 6 Q. And couldn't somebody that is 7 right happen to be in the minority? 8 A. No, I don't agree with that at 9 all. If you've done a broad clinical study with 10 thousands of patients, you look at the body of 11 evidence and make your judgment. You put them 12 all together. You don't single out one study by 13 itself and say this is right and the others are 14 wrong. 15 Q. Well, do you know of any 16 reason why this expert wouldn't be qualified to 17 render such an opinion? 18 A. I have no knowledge of Doctor 19 Herrmann. 20 Q. Well, you have knowledge by 21 reading the document that he was hired by Lilly, 22 don't you? 23 A. You asked me to evaluate his 24 scientific credentials, I cannot do that. Page 103 1 Q. Somebody at Lilly must have 2 evaluated his credentials. They hired him, 3 didn't they? 4 A. That doesn't mean he's good or 5 bad, based on my opinion, I don't know. 6 Q. If you look at the first page, 7 Mister Wood, it says that he was hired as a 8 consultant to the company in the registration 9 process of Fluoxetine in that he wanted to give 10 his best advice as a consultant. 11 A. Yes. 12 Q. He wrote a twenty-one page 13 typewritten document, did he not? 14 A. That's what it says, yes. 15 Q. And came to the conclusion 16 that the benefit/risk ratio in connection with 17 Prozac in Germany was not unequivocally positive, 18 didn't he? 19 A. That's what the document says. 20 Q. Do you know how many patients 21 were covered by Protocol Number 27? 22 A. I haven't the foggiest idea. 23 Q. Do you have any reason to 24 suspect that Protocol Number 27 was not done in a Page 104 1 good and scientific manner? 2 A. I haven't the foggiest idea. 3 Q. Do you know if it was done by 4 Lilly? 5 A. I never heard of Protocol 27. 6 Q. The third page of the document 7 says, in connection with the probability of 8 success of the registration, quote, that today's 9 knowledge of data does not justify the judgment 10 that there is a high probability of getting 11 Fluoxetine registered in Germany, doesn't it? 12 A. That's what it says. 13 Q. Then it gives a reason, 14 correct? 15 A. Yes. 16 Q. Because of benefit/risk ratio 17 as discussed above, correct? 18 A. Yes. 19 Q. Then it says, in their 20 opinion, in this expert's opinion, that a 21 prerequisite for successful outcome would be a 22 limited indication, that is for mild to moderate 23 endogenous depression plus precautionary 24 statements concerning suicidal risk, correct? Page 105 1 A. That's what it says. 2 Q. Do you disagree with this 3 expert in connection with the necessity of a 4 precautionary statement concerning suicidal risk? 5 A. Well, this is 1994. Yes, by 6 benefit of everything we know about Prozac, I 7 would say I would violently disagree with him. 8 Q. You don't think it's necessary 9 that any company -- that any country require a 10 precautionary statement about suicidal risk in 11 connection with Prozac? 12 A. In my non-scientific opinion 13 and based on what I know about the product, no. 14 Q. I'm asking your opinion as 15 chairman of the board -- 16 A. As chairman of the board, yes. 17 Q. -- of Eli Lilly and Company? 18 A. Yes. 19 Q. Well, would you have, had it 20 been brought to your attention in 1985, would you 21 have recommended that Lilly market Prozac in 22 Germany with a precautionary statement concerning 23 suicidal risk? 24 A. I have no idea what my Page 106 1 reaction to this would have been in 1984, 2 whatever it is -- 3 Q. '85, April 8th. 4 A. '85, what are the facts. 5 Q. Would you agree that this 6 document concerns safety of Prozac? 7 A. Safety and efficacy. 8 Q. So you would agree it concerns 9 safety of Prozac? 10 A. Yes. 11 Q. And would you agree that this 12 document concerns a potential risk presented by 13 Prozac? 14 A. Yes. 15 Q. And would you have submitted 16 this document or the twenty-one page typewritten 17 report of your expert, Doctor Herrmann, to the 18 Food and Drug Administration? 19 A. You're asking me a moral as 20 well as a legal kind of question in dealing with 21 the FDA, and my opinion is no. I think our 22 obligation to the FDA is to present all the 23 scientific facts that we know of. And I'm sure 24 that if they, as you suggest, helped formulate Page 107 1 Protocol Number 27, they saw the same data as 2 Doctor Herrmann. 3 Q. Well, this document is an 4 analysis of a Protocol Number 27, isn't it? 5 A. Yes. 6 Q. And Lilly has hired an expert 7 who has rendered a twenty-one page analysis of 8 the data in Protocol Number 27, correct? 9 MR. FREEMAN: That's been asked and 10 answered about six times. We agree that that's 11 what it says. 12 Q. Is that correct, last time? 13 A. Yes. 14 Q. From a, I think that you said 15 a legal and moral standpoint, shouldn't the Food 16 and Drug Administration in accordance with 17 Lilly's policy have the benefit of Doctor 18 Herrmann's twenty-one page opinion? 19 A. In my view, no. That doesn't 20 mean they didn't get Doctor Herrmann's opinion, I 21 don't have the foggiest idea. They certainly saw 22 the same data. 23 Q. Would you have instructed, had 24 you been asked -- Page 108 1 A. No. 2 Q. -- in 1985, that this opinion 3 be sent to the FDA? 4 A. No. 5 (PLAINTIFFS' EXHIBIT NO. 4 WAS 6 MARKED FOR IDENTIFICATION AND 7 RECEIVED IN EVIDENCE.) 8 Q. Have you had an opportunity to 9 review Exhibit Number 4, Mister Woods? 10 A. Yes. 11 Q. And that appears to be a telex 12 sent from Lilly Germany to Lilly Indianapolis, 13 does it not? 14 A. Yes. 15 Q. It appears to be sent from Bad 16 Homburg on September 19th, 1985, does it not? 17 A. Yes. 18 Q. The author of that document 19 has been redacted. 20 MR. FREEMAN: We'll supply -- I will 21 try to find out who it is. 22 Q. Can we agree that by virtue of 23 the nature of this document that it was authored 24 by a Lilly employee, either in Germany or Page 109 1 Indianapolis? 2 A. I think so. 3 MR. FREEMAN: I'll find out and 4 confirm it later. 5 Q. Whoever it was that wrote that 6 document wrote it to Doctor Weinstein and Doctor 7 Wernicke, did he not? 8 A. Yes. 9 Q. And copied in Doctor Zerbe? 10 A. Yes. 11 Q. And the second paragraph of 12 that document -- it's concerning again, Prozac 13 registration in Germany, isn't it? 14 A. Yes. 15 Q. And it says -- the second 16 paragraph says, what seems of great importance to 17 us is that we perform studies with regard to the 18 concerns of, blank and blank. Otherwise, we will 19 get a registration with warnings, precautions and 20 contraindications, which we do not want. Is that 21 correct? 22 A. Yes. 23 Q. Do you have any idea, Mister 24 Wood, why an employee of Eli Lilly would not want Page 110 1 a registration that concerned -- that contained 2 warnings, precautions and contraindications for 3 the product use? 4 A. Yes. 5 Q. Why? 6 A. Because they didn't agree that 7 the warnings were warranted. 8 Q. What difference would that 9 make whether or not the warnings were warranted? 10 A. Well, it would be an unfair 11 description of the efficacy and safety of the 12 product. 13 Q. What if the government 14 authority had come to the determination that it 15 was a fair description of a risk presented by the 16 drug? 17 A. If they came to that 18 conclusion, that's what would happen. 19 Q. I understand that. My 20 question is why would somebody at Lilly have a 21 problem with the foreign government that 22 identified a particular risk in connection with 23 the product and was requiring warnings, 24 precautions and contraindications? Page 111 1 MR. FREEMAN: He's already answered 2 that question. 3 A. The reason is that based on 4 the scientific data, they did not agree with the 5 statements or the proposed or the potential 6 warnings and precautions and contraindications 7 that the German government was leading up to. 8 Q. Why would it make any 9 difference whether they agreed or disagreed? 10 A. Oh, for heaven sakes. Let's 11 assume we had a compound and we submitted it to 12 registration in Germany and they on their own 13 claimed that it caused cancer. Should we just 14 accept that when we knew it did not? 15 Q. Well, let's say there was a 16 valid scientific concern whether or not it caused 17 cancer, there wasn't any conclusive proof one way 18 or the other. What would be the problem with 19 that foreign country at least advising the 20 doctors in that country that this particular 21 product might present a risk to a particular 22 group of people? 23 A. There would be nothing wrong 24 with that if it were a scientific fact. Page 112 1 Q. Does it have to be something -- 2 does an adverse event or risk have to constitute 3 an absolute scientific fact in Lilly's opinion in 4 order to be contained as a warning or a 5 precaution or contraindication? 6 A. It would have to be the 7 preponderance of scientific opinion in this 8 country and abroad for us to conclude that it was 9 a scientific fact or in a situation that maybe 10 should be mentioned. 11 Q. What if it's a valid 12 scientific controversy? 13 A. What's a valid controversy? 14 Q. Well, you've been in the 15 pharmaceutical industry since 1950, forty years, 16 in excess of forty years, and you've seen a lot 17 of valid scientific controversies, have you not? 18 A. I don't know what a valid 19 controversy is. 20 Q. Let's talk about Oraflex, a 21 product made by Eli Lilly and Company, which was 22 later required to be taken off the market, wasn't 23 it? 24 A. We took it off the market. Page 113 1 Q. You took it off the market 2 voluntarily, didn't you? 3 A. Yes. 4 Q. Because there was a 5 controversy concerning whether or not that 6 product constituted a risk to particular 7 patients, wasn't there? 8 A. It was a controversy. 9 Q. All right. And in that 10 controversy, there wasn't any warning about the 11 particular risk that was involved, was there? 12 A. I don't believe so. 13 Q. You took it off the market 14 because there was a controversy about whether or 15 not this risk presented such a risk that it 16 should be marketed to the public? 17 A. That's correct. 18 Q. And you voluntarily took it 19 off the market? 20 A. That's right. 21 Q. And it wasn't established from 22 a conclusive scientific standpoint that Oraflex 23 caused this problem, was it? 24 A. No. Page 114 1 Q. It was a matter of 2 controversy, wasn't it 3 A. It was a controversy. 4 Q. And Lilly in response to that 5 controversy took it off the market? 6 A. Yes. 7 Q. There is now a controversy, 8 Mister Wood, concerning whether or not Prozac 9 causes suicidality or violent aggressive 10 behavior, isn't there? 11 A. No. 12 Q. Not a controversy in your 13 mind? 14 A. Today, no. 15 Q. Conclusively proved that it 16 doesn't cause -- 17 A. I think the body of all the 18 evidence and marketing experience after all these 19 years with millions of patients show, that if 20 anything, Prozac reduces the incidence of 21 suicidality. And that is the body of the 22 majority of the scientific community concerned 23 with depression and treatment of depression. 24 Q. You don't think there should Page 115 1 be some warning in connection with Prozac, that 2 Prozac may cause in some individuals suicidal 3 ideation which was not present prior to the 4 person taking Prozac? 5 A. I know of no reason to do that 6 personally. 7 Q. You don't see any reason as 8 formerly the chairman of the board of Eli Lilly 9 and Company, of warning of the nature that a 10 scientific controversy exists concerning whether 11 or not in a small number of individuals Prozac 12 causes de novo suicidal ideation? 13 A. No. 14 Q. You don't see any reason, 15 formerly as chairman of the board of Eli Lilly 16 and Company, that there should be a warning that 17 there is a scientific controversy that Prozac may 18 cause violent aggressive behavior in some 19 individuals? 20 A. No. 21 Q. Because you don't think a 22 scientific controversy exists? 23 A. Not in the context that you 24 put it forward, no. Page 116 1 Q. Well -- 2 A. I think that's been answered. 3 Q. Do you know whether or not, 4 Mister Wood, if Germany is in fact allowing 5 Prozac to be marketed to German citizens? 6 A. I assume it is on the market. 7 Q. Do you know that the brand 8 name of that product of Prozac in Germany is 9 Fluctin? 10 A. No. 11 Q. Will you take my word for it, 12 for purposes of this inquiry? 13 A. Fine. 14 Q. Do you know whether or not 15 Prozac in Germany has a different package 16 labeling information than Prozac in the United 17 States? 18 A. I wouldn't be surprised. That 19 is part of our business. Governments come to the 20 writing of labels from different points of view 21 and there could be variations. 22 Q. Well, if a government is 23 coming to a label recommendation, don't you 24 believe that government is coming to a label Page 117 1 recommendation based on a recognition of a 2 scientific issue? 3 A. In their opinion, yes. 4 Q. And they have made a 5 scientific determination concerning a particular 6 issue? 7 A. I assume so. 8 (PLAINTIFFS' EXHIBIT NO. 5 WAS 9 MARKED FOR IDENTIFICATION AND 10 RECEIVED IN EVIDENCE.) 11 Q. Mister Wood, let me tell you 12 while you are reviewing this document, that this 13 document is a translation of the German package 14 insert for Prozac, that it was done by an 15 independent translation service and the 16 certificate of which is attached as the first 17 page of Exhibit 5. And does it look to you, sir, 18 like a package insert -- 19 A. Yes. 20 Q. -- document? Turn with me to 21 page two. 22 A. Uh-huh. 23 Q. Do you see where it says risk 24 patients there in the middle? Page 118 1 A. Yes. 2 Q. Will you go down with me to 3 that section under risk patients, it says risk of 4 suicide? 5 A. Yes. 6 Q. Do you see that, sir? 7 A. Yes. 8 Q. And it says Fluctin, and again 9 Fluctin is Prozac. 10 A. That's a horrible name. 11 Q. Fluctin does not have a 12 general sedative effect on the central nervous 13 system; therefore, for his or her own safety, the 14 patient must be sufficiently observed until the 15 antidepressant effect of Fluctin sets in. Taking 16 an additional sedative may be necessary. This 17 also applies in cases of extreme sleep 18 disturbance or excitability. Did I read that 19 correctly, Mister Wood? 20 A. Yes, uh-huh. 21 Q. Did you have any problems with 22 that warning -- 23 A. No. 24 Q. -- in the German insert? Page 119 1 A. No. 2 Q. It seems appropriate to you? 3 A. Yes, it could be, yes. 4 Q. Would you have any problem 5 with this warning being contained in the United 6 States prescribing information? 7 A. Not necessarily, no. 8 Q. If it was submitted to you for 9 your approval, as chairman of the board of Eli 10 Lilly and Company, you would say this is okay 11 with me? 12 A. Based on what I know, yes. 13 Q. Do you know why language like 14 this is not contained in -- 15 A. I haven't the foggiest idea. 16 Q. -- the United States 17 prescribing information? 18 A. I haven't the foggiest idea. 19 Q. Turn with me to page four. 20 Look at me -- look with me at the next to the 21 last paragraph of this document. It says in 22 addition, there are reports of the following 23 health problems which have occurred during 24 treatment with Fluctin, although Fluctin may not Page 120 1 have been the cause, correct? 2 A. Yes. 3 Q. Then the last sentence in the 4 last phrase in the last paragraph says suicidal 5 thoughts and aggressive behavior, doesn't it? 6 A. Yes. 7 Q. The German package insert then 8 includes reports of individuals being treated 9 with Prozac, whether or not they be the cause of 10 suicidal thoughts and aggressive behavior, 11 doesn't it? 12 A. Yes. 13 Q. Do you have any problem with 14 that, Mister Wood? 15 A. No. 16 Q. Would you have had any problem 17 with that when you were chairman of the board of 18 the company? 19 A. No. 20 Q. If somebody come to you and 21 said can we put something like this in the United 22 States package insert, would you have had any 23 objection? 24 A. Based on what I know, no. Page 121 1 Q. Do you know why this is not 2 contained in the United States package? 3 A. You asked me that earlier. 4 Q. Did I? I apologize. Can you 5 give me the answer one more time? 6 A. No. 7 Q. Well you, as I understand it, 8 were not made aware of any controversy raised by 9 any foreign regulatory body concerning whether or 10 not Prozac might cause suicidal behavior? 11 A. No. 12 Q. Prior to the Teicher article? 13 A. No. 14 Q. When did you first learn of 15 the Teicher article? 16 A. When? 17 Q. How? 18 A. Oh, I don't recall exactly 19 how. It was brought to my attention. 20 Q. By whom? 21 A. I don't know, I don't 22 remember. 23 Q. Do you remember what context 24 it was brought to your attention in, where you Page 122 1 were, what you were doing, was it in a safety 2 review or -- 3 A. I don't think it was any kind 4 of a formal presentation or anything like that. 5 I was made aware that it was going to be 6 published, and when it was published, I read the 7 article. 8 Q. Did you agree or disagree with 9 the article as you read it? From a layperson -- 10 I guess you and I would be reading that 11 scientific article with the same degree of 12 expertise, no medical training, correct? 13 A. My reaction to those things, 14 Paul, is just ask the question, what are the 15 facts. 16 Q. All right. Did you ask your 17 scientific people what are the facts? 18 A. Yes. 19 Q. Did they tell you anything 20 about the fact that they had come across this 21 issue back in 1984 and 1985 with Germany? 22 A. I don't recall Germany coming 23 up. 24 Q. Did they tell you that they Page 123 1 had retained an expert back in 1984 and 1985 to 2 examine this issue? 3 A. No. 4 Q. Did they tell you that they 5 had an expert in '84 and 1985 that had identified 6 a higher incidence of suicides on people with 7 Prozac than imipramine? 8 A. No. 9 Q. Then what did they tell you 10 when you asked them what were the facts? 11 A. The question I asked was, 12 let's assemble all the facts on this particular 13 issue and judge the merits of the Teicher 14 article. 15 Q. Assemble all the facts? 16 A. Uh-huh. 17 Q. All right. Who did you give 18 that direction to? 19 A. I don't recall. 20 Q. Give me a group of who you 21 would have given that direction to. 22 A. It would be the people in 23 charge of the scientific organization. 24 Q. Doctor Perelman? Page 124 1 A. He was probably in the group, 2 Doctor Herr. 3 Q. Doctor Thompson? 4 A. Maybe. 5 Q. I think Doctor Herr had 6 retired by 1990 when the Teicher article came in. 7 A. No, no, no. 8 Q. He was still there? 9 A. Oh, yes. He retired in '92 or 10 '93. 11 Q. All right. And were the facts 12 assembled? 13 A. Yes. 14 Q. What facts were assembled? 15 A. Well, the general conclusion 16 is the one I stated a number of times. 17 Q. I'm not asking you what the 18 conclusion was. My question was, you said 19 assemble the facts? 20 A. Yes. 21 Q. And my question was what facts 22 were assembled? 23 A. What do all the clinical 24 trials suggest about the cause and effect of Page 125 1 Prozac on suicidality. 2 Q. Would you have requested in 3 addition to that cause and effect of Prozac on 4 violent aggressive behavior or -- 5 A. I don't remember that coming 6 up. 7 Q. All right. So you asked the 8 question, what do the clinical trials suggest 9 about the cause and effect relationship of Prozac 10 on suicidality? 11 A. Yes. 12 Q. And what was the response? 13 A. The response is that which I 14 have given several times. 15 Q. Is that the clinical trials 16 demonstrated -- 17 A. If anything -- 18 Q. -- what? 19 A. -- Prozac reduced the 20 incidence of suicidality, suicidality being a 21 natural income among some depressed patients. 22 Q. Would that have been a report 23 that was made to you by Doctor Leigh Thompson? 24 A. He was probably involved, I Page 126 1 don't recall who specifically made the 2 presentation. It may have been one of the 3 physicians in charge of -- more directly in 4 charge of Prozac. 5 (PLAINTIFFS' EXHIBIT NO. 6 WAS 6 MARKED FOR IDENTIFICATION AND 7 RECEIVED IN EVIDENCE.) 8 Q. In order to help you, Mister 9 Wood, we have provided various minutes of Board 10 of Directors meetings and some data in connection 11 with discussions at Board of Directors meetings 12 of Prozac. Why don't you read that, I think it 13 may refresh your recollection. 14 A. Yes. 15 Q. All right. You were at the 16 point when you saw the Teicher article, you said 17 let's assemble the facts, and what you meant by 18 assemble the facts was what do the clinical 19 trials suggest about cause and effect of Prozac 20 on suicidality, correct? 21 A. Uh-huh. 22 MS. ZETTLER: You have to say yes or 23 no. 24 A. I'm sorry, yes. Page 127 1 MR. FREEMAN: And this says and 2 marketing experience, the document that you gave 3 him. 4 A. Right. 5 Q. In Exhibit 6 indicates that 6 Doctor Thompson did make a presentation to the 7 Board? 8 A. Yes. 9 Q. Would that presentation be the 10 result of your instructions that the facts be 11 assembled? 12 A. I have no idea what prompted 13 this review. When did the Teicher article 14 appear? 15 Q. The Teicher article came out, 16 I believe, in the February, 1990 issue. 17 A. 1990? 18 Q. Yes. But it may have been 19 later on before there was sufficient attention to 20 require you to examine the facts. 21 A. I don't know, I don't 22 remember. 23 Q. You will agree with me that 24 Exhibit 6 does reflect a report by Doctor Page 128 1 Thompson -- 2 A. Yes. 3 Q. -- concerning the issue, and 4 it the says that Doctor W. L. Thompson entered 5 the meeting to discuss statistics regarding the 6 occurrence of suicide and suicidal ideation, 7 correct? 8 A. Yes. 9 Q. In the United States and data 10 on those phenomena as reported from Prozac 11 clinical trials and the marketing experience, 12 correct? 13 A. Yes. 14 Q. And it was reported to you by 15 Doctor Thompson that epidemiology studies 16 demonstrate that suicide, attempted suicide and 17 suicidal thoughts are common in depressed 18 patients. Correct? 19 A. Yes. 20 Q. He indicated that suicides and 21 suicidal acts were reported infrequently in the 22 extensive controlled clinical trials on Prozac 23 and that the emergence of suicidal thinking 24 occurred less often than in patients treated with Page 129 1 Prozac than with comparable drugs. Correct? 2 A. Yes. 3 Q. Did he tell you anything about 4 this review of Protocol Number 27 that indicated 5 that suicide attempts was occurring more often on 6 Prozac than on suicidal drugs -- than on 7 comparator drug? 8 A. I've answered that before. 9 Q. No, in connection with this 10 meeting, did he mention this? 11 A. I would doubt it. I assume 12 that Protocol 27 was a part of the analysis. 13 He's summarizing all the data that we have in 14 hand at this particular moment about the product. 15 If this was finished before 1990 in September, it 16 would have been part of his statistical analysis, 17 I'm sure. 18 Q. And again, my question is, do 19 you have any recollection of him presenting the 20 fact that in connection with Protocol Number 27 21 suicide was being reported more often? 22 A. I have never heard of Protocol 23 27 until this morning. 24 Q. So the answer to my question Page 130 1 would be no? 2 A. Again, no. 3 Q. It says Doctor Thompson also 4 indicated that a view of the epidemiology 5 studies, the number of post-marketing spontaneous 6 adverse event reports of suicide and suicidal 7 acts have not been of unusual frequency in 8 relation to the large number of patients who have 9 been treated with Prozac, correct? 10 A. Yes. 11 Q. Doctor Thompson concluded by 12 stating that suicide, suicidal acts and suicidal 13 thoughts, therefore more probably reflect the 14 patient's underlying disorder and not a causal 15 relation to Prozac, correct? 16 A. Correct. 17 Q. Do you have a recollection of 18 Doctor Thompson being at that meeting and making 19 that presentation? 20 A. Well, as I said, this is my 21 conclusion as I have stated several times and I 22 got that from the scientific component. 23 Q. Do you recall anything being 24 presented to you other than this presentation by Page 131 1 Doctor Thompson? 2 A. Not specifically. 3 (PLAINTIFFS' EXHIBIT NO. 7 WAS 4 MARKED FOR IDENTIFICATION AND 5 RECEIVED IN EVIDENCE.) 6 Q. Mister Wood, you are certainly 7 free to read page one of Exhibit 7, but I think 8 page one is there solely for the date that is 9 connected to page two. 10 MR. FREEMAN: We'll just take a minute 11 and look it over. 12 A. What country are we in here? 13 Q. Well, we're back in the United 14 States and we're up to September, 1990. And 15 we're -- you're going to see your name in 16 connection with these documents, Mister Wood. 17 A. Oh, okay. 18 Q. So this may be more 19 interesting to you, sir. 20 (DISCUSSION OFF THE RECORD.) 21 A. Should we go on here? 22 MR. FREEMAN: How many pages are you 23 going to ask him about? 24 MR. SMITH: All of them. Page 132 1 MR. FREEMAN: All of them. 2 MR. SMITH: I may not ask him about 3 all of them, but I wanted him to read all of them 4 so it would be fair to him and get in context. 5 Q. Does Doctor Leigh Thompson 6 office on the same floor that you do now? 7 A. At the moment, yes. 8 Q. Did he in 1990? 9 A. I don't believe. 10 Q. Did he office in the same 11 building where you officed in? 12 A. No, I don't believe so. 13 Q. Exhibit Number 7 has been 14 identified in previous depositions as documents 15 going back and forth within the scientific group 16 at Lilly, from Doctor -- to Doctor Leigh Thompson 17 and from Doctor Leigh Thompson to several of the 18 physicians at clinical research -- well, several 19 clinical research physicians, as well as Doctor 20 Zerbe, those individuals being Doctor Charles 21 Beasley, do you know Doctor Beasley? 22 A. Yes. 23 Q. Doctor Gordon Gilad, do you 24 know Doctor Gilad? Page 133 1 A. No, I don't believe so. 2 Q. How about Doctor John 3 Heiligenstein, do you know Doctor Heiligenstein? 4 A. Yes. 5 Q. Do you believe Doctor 6 Heiligenstein to be a competent physician? 7 A. As far as I know. 8 Q. Do you believe Doctor 9 Heiligenstein to be scientific in his approach to 10 issues? 11 A. Generally, yes, I would assume 12 he is. 13 Q. How did Doctor Dan Masica, do 14 you know Doctor Dan Masica? 15 A. Yes. 16 Q. Do you have respect for his 17 judgment? 18 A. As far as I know, yes. 19 Q. How about Doctor David 20 Wheadon? 21 A. I have respect for all of our 22 employees. 23 Q. As scientists, correct? 24 A. As far as I know, yes. Page 134 1 Q. What was Robert Zerbe's job 2 title at the time this document -- 3 A. I don't remember. 4 Q. -- was written? 5 A. I don't know. 6 Q. If you go to page two, it 7 appears that there was a -- the first page 8 indicates that Doctor Thompson is saying that the 9 text of his memo Monday was only for you, Mister 10 Wood, and the attorneys, correct? 11 A. That's what it says. 12 Q. Do you recall receiving a memo 13 from Doctor Thompson? 14 A. No. 15 Q. So you probably wouldn't 16 recall anything about what the memo would have 17 said? 18 A. No. 19 Q. Do you recall Doctor Thompson 20 making a presentation, other than this 21 presentation at the board? 22 A. It may have been made to the 23 executive committee which might have been before 24 the board meeting. Page 135 1 Q. All right. Do you see on page 2 3 of this document where Doctor Heiligenstein is 3 reporting his review of the proposed proposal to 4 you? 5 MR. FREEMAN: Where is that? 6 A. Where? 7 Q. Well, it begins -- it's dated 8 September 14th, 1990. 9 A. Oh, yes. 10 Q. And goes? 11 A. Heiligenstein. 12 Q. And it's signed by Doctor 13 Heiligenstein, but apparently it's all of the 14 doctors making comments on the presentation of 15 what's going to be made to you, correct? 16 A. Yes. 17 Q. Do you recall Doctor Thompson 18 giving or making verbatims to you? 19 A. No. 20 Q. What is a verbatim or 21 verbatim, how do you call it, verbatim up here in 22 Indiana or do you call it verbatim? 23 A. I would assume it's a 24 statement of some kind, I don't know. Page 136 1 Q. All right, okay. Read with me 2 verbatim four. This is Doctor Heiligenstein 3 talking to Doctor Thompson. He says, we feel 4 that caution should be exercised in a statement 5 that suicidality and hostile acts in patients 6 taking Prozac reflect the patient's disorder and 7 not a causal relationship to Prozac. 8 Post-marketing reports are increasingly fuzzy and 9 we have assigned yes, reasonably related, on 10 several reports. Correct? 11 A. That's what it says. 12 Q. Did Doctor Thompson tell you, 13 Mister Wood, that post-marketing reports were 14 becoming increasingly fuzzy? 15 A. No. 16 Q. Did Doctor Thompson tell you, 17 Mister Wood, that the clinical research 18 physicians had assigned yes, reasonably related, 19 on several reports in connection with reports of 20 Prozac and suicide and hostile acts? 21 A. No. 22 Q. Is this news to you? 23 A. It is the first I have seen 24 it. Page 137 1 Q. Have you ever heard that any 2 physician at Eli Lilly and Company has found that 3 post-marketing reports were being reviewed and 4 that those reports have found yes, reasonably 5 related, in connection with the issue of Prozac 6 and suicidal and hostile acts, have you ever 7 heard that? 8 A. No. 9 Q. Is this something that you 10 think should be reported to the Food and Drug 11 Administration? 12 A. Oh, I think it was. Whatever 13 they decided, those were reported. All reports 14 go to the Food and Drug Administration. 15 Q. Well, was the fact that the 16 clinical research physicians were assigning 17 reasonably related between the complaint of 18 suicidal ideation and suicide and aggressive 19 hostile acts, to Prozac? 20 A. What is the question? I'm 21 sorry. 22 MS. ZETTLER: You left out that was 23 reported to the FDA. 24 Q. Was that reported to the FDA? Page 138 1 A. According to company policy, 2 it was. What actually happened, you will have to -- 3 Q. So if they put yes, reasonably 4 related -- 5 A. That would go to the FDA. 6 Q. -- it should have been 7 reported to the FDA? 8 A. All reports go to the Food and 9 Drug Administration. 10 Q. But Doctor Thompson didn't 11 tell you this, correct? 12 MR. FREEMAN: He's already answered 13 that. 14 A. No. 15 Q. Is that correct? 16 A. No. 17 Q. Now, you were asking for when 18 this Teicher article came out and you said we 19 want to assemble the facts and we want to know 20 what the clinical trials suggest about whether or 21 not there is any relationship to Prozac and 22 suicidal behavior, correct? 23 A. Yes. 24 Q. You weren't concerned at that Page 139 1 time, as I understand from your earlier 2 testimony, about whether or not Prozac could be 3 related to aggressive violent hostile acts? 4 A. I don't remember that 5 specifically. 6 Q. Look with me on the next page 7 of this document where Doctor Heiligenstein is 8 continuing to review the presentation that's 9 going to be made to you and the board, where it 10 says page 5? 11 A. Yes. 12 Q. Under suicidal thinking and 13 clinical trials, you may want to note that trials 14 were not intended to address the issue of 15 suicidality. Also, in paragraph 2, patients were 16 excluded who were serious suicidal risk. Do you 17 see that there, did I read that correctly? 18 A. Yes. 19 Q. Did Doctor Thompson tell you 20 that the clinical trials were not intended to 21 address the issue of suicidality? 22 A. I think that was understood, 23 yes. 24 Q. Then why would you be wanting Page 140 1 to know what the clinical trial results were? 2 A. They can go back and do a 3 retroactive analysis of the data and come up with 4 the conclusions that they came up with. Studies 5 really were not focused on the issue of 6 suicidality, they were looking at other 7 fundamental issues. 8 Q. Do you know why there wasn't 9 any focus on the issue of suicidality in the 10 clinical trials, Mister Wood? 11 A. No, I don't have the foggiest 12 idea. 13 Q. Don't you think that would 14 have been a valid inquiry? 15 A. In hindsight, yes. But at the 16 time, you can't presume that. 17 Q. All right. So you think you 18 understood at the time Doctor Thompson made his 19 presentation that the clinical trials never were 20 intended to address the issue of suicidality? 21 A. I'm saying I don't know that 22 and this does not surprise me. 23 Q. But you agree with it now that -- 24 A. Well, I don't know whether I Page 141 1 agree with it or not. 2 Q. Well, I guess my question is, 3 do you accept as a fact that of what is said here 4 that the clinical trials were not intended to 5 address the issue of suicidality? 6 A. If you were implying that they 7 could not go back and make a retroactive analysis 8 on suicidality issue, I would say no, I don't 9 agree with the approach. 10 Q. No, I'm not implying that at 11 all, Mister Wood. My question is, in connection 12 with what was intended at the clinical trial 13 level, it wasn't -- the clinical trials weren't 14 intended to address the issue of suicidality? 15 A. I haven't the foggiest idea. 16 Q. Did you know that patients in 17 the clinical trials were excluded who were 18 serious suicidal risks? 19 A. I don't remember that. 20 Q. Did Doctor Thompson report 21 that to you at the time? 22 A. I don't recall, he may have. 23 MR. FREEMAN: Do you want to break for 24 lunch at this point? Page 142 1 MR. SMITH: I think we're at an 2 appropriate point. 3 (A LUNCH BREAK WAS TAKEN.) 4 Q. (BY MR. SMITH) Mister Wood, 5 in connection with the presentation that Doctor 6 Leigh Thompson made to the Board, or to the 7 executive committee in September of 1990, do I 8 understand that he characterized the number of 9 suicides and suicide attempts up to that date on 10 Prozac as small? 11 A. Yes, that's my understanding. 12 (PLAINTIFFS' EXHIBIT NO. 8 WAS 13 MARKED FOR IDENTIFICATION AND 14 RECEIVED IN EVIDENCE.) 15 Q. Mister Wood, Exhibit Number 8 16 appears to be a memo from Doctor Leigh Thompson 17 to Doctor Robert Zerbe, does it not? 18 A. Yes. 19 Q. It appears to be dated 20 Tuesday, October 2nd, 1990, correct? 21 A. Yes. 22 Q. Which would be within a few 23 weeks of the date he made this presentation to 24 the board of directors of Eli Lilly and Company, Page 143 1 correct? 2 A. Yes. 3 Q. In which he characterized the 4 number of suicides and suicide attempts in the 5 data that he had reviewed as small, correct? 6 A. Yes. 7 Q. Turn with me to page two of 8 that memo. Apparently -- let me back up. It 9 appears that he is getting ready for a symposium 10 on Prozac in the following month, correct? 11 A. Uh-huh. 12 Q. And he's doing some slides? 13 A. Yes. 14 Q. And compiling some data, 15 correct? 16 A. Yes. 17 Q. It appears he's reviewed some 18 data? 19 A. Uh-huh. 20 Q. And has had some data he's 21 been reviewing in the past? 22 A. Uh-huh. 23 Q. Is that a yes? 24 A. Yes. Page 144 1 Q. The next to the last paragraph 2 says, where Doctor Thompson is speaking with 3 Doctor Zerbe, then the question is what to do 4 with the big numbers on suicidality. If the 5 report numbers are shown next to those for 6 nausea, they seem small. Should I get into the 7 total count at all (I'm afraid someone will ask 8 for sure) or should I leave this to David to 9 introduce. Did I read that correct? 10 A. Yes. 11 Q. It appears to me that in 12 communications with other members of the 13 scientific component there at Lilly, that Mister -- 14 or Doctor Thompson is making different 15 characterizations with respect to the numbers on 16 suicidality, doesn't it? 17 A. I have no idea. 18 Q. Well -- 19 A. Why did he put big in quotes? 20 I don't know what his intent was. 21 Q. Well, we'll ask him that. 22 A. Yes. 23 Q. It will be interesting to know 24 what he meant by that, won't it? Page 145 1 A. Well, I'm not the one to ask 2 what he meant. 3 Q. I understand that, but don't 4 you find that interesting? 5 A. Not necessarily. 6 Q. That he would be reflecting to 7 you the numbers on suicidality as small, and to 8 Doctor Zerbe, the numbers as big. 9 A. In the next sentence he says 10 they are small. 11 Q. He says if you report numbers 12 shown next to those for nausea, they're small. 13 A. Correct. 14 Q. Is what he says, isn't it? 15 A. That's right. 16 Q. We'll ask him about that. 17 A. Fine. 18 Q. You had never seen this memo, 19 had you? 20 A. No. 21 Q. And you had never heard Doctor 22 Thompson referring to you or the board of 23 directors or an executive committee at Lilly as 24 big in connection with numbers of suicide and Page 146 1 suicide attempts? 2 A. That's correct. 3 Q. You were under the impression 4 that the numbers were small by virtue of what he 5 had told you, weren't you? 6 A. I think they are small. 7 Q. And you were of that 8 impression at the time? 9 A. Yes. 10 Q. Whether they are or are not 11 small, he refers to them as big -- 12 A. In quotes. 13 Q. -- in this document, does he 14 not? 15 A. In quotes, yes. 16 Q. So is the answer to my 17 question yes? 18 A. I'm not sure what he meant, I 19 think you'll have to ask him. 20 Q. Has anybody ever shown you, 21 Mister Wood, the actual numbers or counts of 22 reports of suicide or suicidal ideation at any 23 particular period of time? 24 A. I think I have seen some of Page 147 1 the summaries of adverse reports. 2 Q. Concerning suicide? 3 A. Everything, the profile of the 4 drug. 5 Q. Including suicide? 6 A. Probably, I don't remember 7 that specifically. 8 Q. Well, was that before or after 9 1990? 10 A. Oh, I have no idea. 11 Q. Do you recall saying look, as 12 chairman of the board of this company, I want to 13 know how many reports we've had where it was 14 reported to us that suicide, suicide attempts or 15 suicidal ideation was involved with an adverse 16 event with Prozac, did you ever ask that? 17 A. Not in that context, no. 18 Q. Why didn't you ask that? 19 A. I can't remember asking any 20 question like that. I would rather reply that I 21 was more interested in the total adverse profile 22 of Prozac of which suicide may or may not have 23 been part of the picture. 24 Q. So are you saying you were Page 148 1 more interested in knowing what the numbers of 2 adverse reactions in connection with all reports 3 were? 4 A. Yes. And also some 5 interpretation of cause and effect and also in 6 relation to the usage of the product. 7 Q. Did anybody ever give you any 8 interpretation of cause and effect in connection 9 with the use of Prozac and the occurrence of 10 suicide -- 11 A. Yes. 12 Q. -- and suicidal ideation? 13 A. Yes. 14 Q. When was that given to you? 15 A. Probably after the Teicher 16 report. 17 Q. All right. That includes now 18 over four years? 19 A. Uh-huh. 20 Q. So narrow it down for us. 21 A. Well, it may have been in 22 connection with the report to the board which was 23 in the fall of that year after the Teicher report 24 came out. Other instances might have been Page 149 1 reports concerning the FDA review of Prozac and 2 the issue of suicidality specifically. 3 Q. All right. My question to you 4 is, did anybody ever give you any analysis of the 5 suicides and the Prozac and whether or not the 6 cause -- 7 A. Yes. 8 Q. When was that? 9 A. I don't know specifically. 10 Q. It was after the Teicher 11 article? 12 A. I'm sure. 13 Q. What was given to you? 14 A. That, if anything, Prozac 15 reduces the incidence of suicidality. 16 Q. Okay. Did somebody -- 17 A. Did not cause it. 18 Q. Did somebody take instance by 19 instance or report by report of what was 20 occurring in and investigate each of those 21 reports? 22 A. Yes. 23 Q. And then make some written 24 document to you? Page 150 1 A. I don't recall whether it was 2 in writing, yes. 3 Q. Who made that investigation? 4 A. The medical group. 5 Q. Who in the medical group? 6 A. Well, it might have been 7 Doctor Thompson and his staff of people concerned 8 with FDA reporting. 9 Q. Well, see this is important, 10 isn't it, Mister Wood, about whether or not there 11 is a causal relation? 12 A. Yes. 13 A. Correct. So I need to know 14 from you, who it was that told you I've 15 investigated to see whether or not there is a 16 causal relation and I've checked these reports or 17 I've done something to make a determination that 18 there is no causal relationship between the use 19 of Prozac and suicidality? 20 A. Is that a question? 21 Q. Yes. 22 A. I'm sorry, you'll have to 23 repeat it. 24 Q. Who did that? Page 151 1 A. Who did it? 2 Q. Yes. 3 A. Well, I think Doctor Thompson 4 referred to it in his report to the board. 5 Q. You're talking about this 6 September report? 7 A. Yes. 8 Q. That's reflected in one of 9 these exhibits here? 10 A. Yes. And it may have been 11 presented to me one way or another as a result of 12 the FDA reviews of Prozac, of which there were 13 several. 14 Q. Which FDA reviews of Prozac? 15 A. Well, there were several 16 reviews of Prozac. 17 Q. I understand that. I need to 18 know which one of them -- 19 A. I don't know which one. 20 Q. -- was there where there was 21 an examination of whether or not there was a 22 causal connection between the use of Prozac and 23 suicidality? 24 A. I don't remember which one. Page 152 1 Q. Well, did you get a written 2 report in connection with that? 3 A. I don't recall whether it was 4 in writing or it was a verbal report. 5 Q. Don't you think you would 6 recall if somebody said look, chairman Wood, I 7 made a careful analysis and I've looked at this 8 instance by instance and we can't determine any 9 causal relationship between the use of Prozac and 10 the suicide or suicide attempts or suicidal 11 ideation? 12 A. Do I remember the specific 13 incident -- 14 Q. Yes. 15 A. -- at which a report was made? 16 Q. Yes. 17 A. No. But I think it's referred 18 to in the minutes before the board, so that may 19 have been one of those. 20 Q. Well, look back at Exhibit 6 21 with me. There's a Prozac update there attached 22 to this minutes of the board of directors 23 meeting, isn't there? 24 MR. FREEMAN: That's what it says. Page 153 1 Q. It's called a Prozac update, 2 isn't it? 3 A. Yes, uh-huh. 4 Q. And it reports that Doctor 5 Thompson entered the meeting to discuss 6 statistics regarding the occurrence of suicide 7 and suicidal ideation in the United States and 8 data on these phenomena as reported from Prozac 9 clinical trials and the marketing experience. It 10 looks to me like he was reporting on statistics 11 and data, doesn't it, that's what's mentioned 12 there? 13 A. Yes. 14 Q. Whatever the statistics and 15 data were, did he say I've gone and I've made an 16 investigation, there's somebody from the medical 17 component has gone and made an investigation and 18 checked into each one of these reports to 19 determine whether or not the reported adverse 20 events of suicide or suicidal ideation was 21 related to Prozac? 22 A. I don't remember whether he 23 did or did not. 24 Q. That's not reflected in this, Page 154 1 is it? 2 A. No. But it is standard 3 practice in the medical group on any product to 4 investigate the adverse reactions. 5 Q. But you've never seen any 6 written report of such? 7 A. I may have seen it, I don't 8 remember. 9 Q. Where would that be if there 10 was a written report on taking each one of these 11 instances? 12 A. In the medical division. 13 Q. Who in the medical division? 14 A. I have no idea. 15 Q. We've asked for that kind of 16 material and it's never been furnished to us. 17 A. I don't know. 18 Q. He goes on to say, he reported 19 to you that suicides and suicidal acts were 20 reported infrequently in the controlled clinical 21 trials on Prozac, correct? 22 A. Yes. 23 Q. Well, but he also says there's 24 big numbers in the next exhibit, doesn't he? Page 155 1 A. Quote, big, yes. 2 Q. Yes. And you understood at 3 the time that the clinical trials excluded 4 individuals who presented as serious suicidal 5 risks, didn't you? 6 A. Yes. 7 Q. And you understood at the time 8 that the clinical trials were conducted in 9 accordance with protocols designed by Lilly, 10 didn't you? 11 A. Yes. 12 Q. And you understood at the time 13 that the clinical trials were conducted by 14 individuals who were hired by Lilly? 15 A. Yes. 16 Q. To do those clinical trials? 17 A. Yes. 18 Q. And that those individuals, 19 those investigators, weren't making any type of 20 independent interpretation of the data that was 21 designed in those clinical trials? 22 A. Oh, I don't know that. 23 Q. All right. You know that the 24 data was sent from the clinical investigators Page 156 1 back to Lilly in Indianapolis, don't you? 2 A. Yes. 3 Q. And you know that data was 4 stored into a computer? 5 A. I presume so. 6 Q. And that Lilly made all 7 compilations of that data? 8 A. Yes. 9 Q. And that any documents or any 10 interpretation of that data was submitted by the 11 statisticians and the clinical monitors at Lilly, 12 correct? 13 A. I presume so. 14 Q. And that Lilly had a control 15 over the individuals who were going to be in 16 their clinical trials, didn't they? 17 A. I presume so. 18 Q. So the data from the clinical 19 trials is a select amount of data, isn't it? 20 A. Well, clinical trials are 21 scientificly designed to be representative of 22 whatever condition they are attempting to test. 23 Q. Do you think Lilly was careful 24 to make sure that those designs were done in Page 157 1 accordance with proper scientific principles? 2 A. Yes. 3 Q. And do you think those 4 clinical trials were done properly? 5 A. Yes, I have no reason to 6 believe otherwise. 7 (PLAINTIFF'S EXHIBIT NO. 9 WAS 8 MARKED FOR IDENTIFICATION AND 9 RECEIVED IN EVIDENCE.). 10 Q. Have you ever seen Exhibit 9 11 before? 12 A. No. 13 Q. Exhibit 9 is a reflection of 14 meeting minutes within the Food and Drug 15 Administration, isn't it? 16 A. I presume so. 17 Q. It's dated November, 1989, 18 correct? 19 A. Uh-huh. 20 Q. And it concerns Fluoxetine NDA 21 18 dash 9 -- 22 MR. FREEMAN: Do you say November 23 1989? It's '84. 24 A. '84. Page 158 1 Q. I'm not trying to trick 2 anybody. If I try to trick you, it won't be with 3 a document that's right in front of you, Mister 4 Wood. 5 MR. FREEMAN: Please. 6 Q. The Fluoxetine NDA was NDA 7 18-936, was it not? 8 A. I have no idea. 9 Q. That document says that the -- 10 this was an in-house meeting on the Fluoxetine 11 NDA, wasn't it? 12 A. A meeting of some kind within 13 the FDA, yes. 14 Q. And Doctor Leber was there? 15 A. I don't know who was there. 16 Q. Well, it says who. 17 A. He's an addressee. I don't 18 know who was there, I don't know. 19 Q. Well, under who up there, it 20 does say P. Leber M. D. , doesn't it? 21 A. Yes, I said it was addressed 22 to him. 23 Q. Do you know Doctor Leber? 24 A. No. Page 159 1 Q. Ever met Doctor Leber? 2 A. No. 3 Q. Do you know Doctor Temple? 4 A. I've heard of him. 5 Q. Have you ever met Doctor 6 Temple? 7 A. No, I have not. 8 Q. Do you know Doctor Laughren? 9 A. No. 10 Q. Who was the head of the Food 11 and Drug Administration in November, 1984? 12 A. I don't remember. 13 Q. Can you give me an idea who it 14 would have been? 15 A. I could hazard a guess. There 16 was a Doctor Schmidt in there at some point. 17 Q. Did you know Doctor Smith? 18 A. No, Schmidt. 19 Q. Have you ever met Doctor 20 Schmidt? 21 A. No. 22 Q. Have you ever known any 23 director personally of the Food and Drug 24 Administration? Page 160 1 A. I may have met one or two on 2 occasion through industry meetings when he would 3 appear to make a presentation at a luncheon or 4 dinner. 5 Q. Have you ever played golf with 6 the commissioner of the Food and Drug 7 Administration? 8 A. No. 9 Q. Have you ever played tennis -- 10 A. No. 11 Q. -- with the commissioner of 12 the Food and Drug Administration? 13 A. No. 14 Q. Have you ever attended any 15 social functions -- 16 A. No. 17 Q. -- with the director or 18 commissioner of the Food and Drug Administration? 19 A. No. 20 Q. This document, Exhibit 9, 21 reflects an in-house meeting on Fluoxetine, does 22 it not? 23 A. Uh-huh, yes. 24 Q. That document, the first Page 161 1 sentence says this agency has discovered a flaw 2 in the experimental design and execution of the 3 Fluoxetine studies, doesn't it? 4 A. Yes. 5 Q. It says the main efficacy 6 trials -- in the main efficacy trials, patients 7 who were not doing well could go dropped at the 8 end of the second week and switched to Fluoxetine 9 after breaking the blind and determining if 10 patient was on imipramine or placebo. Correct? 11 A. Yes. 12 Q. The blind could also be broken 13 at trial completion (week six) in patients doing 14 well, and could be continued on fluoxetine or 15 imipramine if these were the drugs they were 16 receiving. Correct? 17 A. Yes. 18 Q. It says, this led to a 19 situation where an end point analysis would 20 compare patients' scores after two weeks on 21 placebo with Fluoxetine scores after six weeks of 22 treatment leaving no time for spontaneous 23 improvement in the placebo group and leading to a 24 bias comparison. Correct? Page 162 1 A. Yes. 2 Q. It also says then a strongly 3 positive study, (Cohn) showed an extreme degree 4 of this differential dropout rate, raising 5 questions about the results of this trial. 6 Correct? 7 A. Yes. 8 Q. Have you ever heard about this 9 flaw in the experimental design and execution of 10 the clinical trials on Prozac? 11 A. No. 12 Q. Anybody ever bring this to 13 your attention? 14 A. No. 15 Q. Would this have been something 16 that would have been of concern to you, Mister 17 Wood, as chairman of the board of Eli Lilly and 18 Company in November of 1984? 19 A. No. 20 Q. Why? 21 A. In the course of designing 22 clinical trial studies, there are differences in 23 how studies are designed in all the various 24 aspects. Some of these are very statistical in Page 163 1 nature, and conversations between the company and 2 the FDA are not unusual and they ultimately 3 result in an agreement on study design. 4 Q. But nobody ever brought to 5 your attention that the Food and Drug 6 Administration had discovered a flaw -- 7 A. No, that's not unusual. 8 Q. -- in the clinical trials? 9 A. No. 10 Q. Is that correct? 11 A. That's correct. 12 Q. All right. The memo goes on 13 to say, one other concern with this procedure of 14 breaking the blind on a patient by patient basis 15 was that it could lead to a knowledge of 16 treatment assignment during the course of the 17 trial which could bias the trial outcome. At the 18 Pre NDA meeting, Lilly wanted us to state at the 19 time that we would not object to this design 20 feature in the trials. We replied that we were 21 not in the position to give them an assurance on 22 this. Correct? 23 A. Yes. 24 Q. Did anybody ever bring it to Page 164 1 your attention that there was a problem which 2 could bias trial outcomes -- 3 A. No. 4 Q. -- by virtue of somebody at 5 Lilly breaking the blinds in these clinical 6 trials? 7 A. No. 8 Q. Don't you agree, as the chief 9 executive officer of Lilly, that it's important 10 that these trials not be biased? 11 A. Yes. 12 Q. In order to get an affective 13 result with respect to any particular scientific 14 phenomenon? 15 A. Yes. 16 Q. Don't you agree that a biased 17 clinical trial outcome can bias data that is 18 generated by that clinical trial -- 19 A. Yes. 20 Q. -- don't you? And can 21 influence the entire course of the clinical 22 trial. 23 A. Yes. 24 Q. The memo goes on to say that Page 165 1 concomitant medications -- do you know what the 2 term concomitant medications means? 3 A. I presume it means medications 4 being taken simultaneously with, in this case, 5 Prozac. 6 Q. I think that that's probably 7 what the medical component has testified to up to 8 this point. It says -- this memo goes on to say, 9 concomitant medications (allowed drugs, 10 disallowed drugs and other drugs with CNS 11 effects), have been a problem. Firm has not sent 12 a list of what other drugs with CNS effects 13 include. And by firm they're talking about Eli 14 Lilly and Company, are they not? 15 A. Yes. 16 Q. Were you aware of the use of 17 concomitant medications in the Prozac clinical 18 trials? 19 A. No. 20 Q. Do you agree that in -- from a 21 layperson's standpoint and as the chairman of the 22 board of Eli Lilly at the time, that if a patient 23 in a clinical trial is given a medication that 24 will effect their behavior concomitantly with a Page 166 1 drug under investigation, that this could bias or 2 affect the outcome? 3 A. It could affect it. 4 Q. The memo concludes by saying 5 this agency must inform Lilly early on that we 6 have problems with their analysis because of the 7 large number of dropouts. Did you ever receive 8 anything from the Food and Drug Administration 9 concerning this problem? 10 A. No. That's not unusual in a 11 clinical trial. 12 Q. Where would that have gone? 13 A. To the medical group. 14 Q. Do you know if anyone ever 15 asked this in-house auditing group at Lilly 16 whether or not they had made any investigation 17 into this flaw in the clinical trials? 18 A. This doesn't say there was a 19 flaw in the clinical trials, the way I read it. 20 Q. It says the agency has 21 discovered a flaw in the experimental design and 22 execution of the Fluoxetine studies. And the 23 studies were being done by virtue of clinical 24 trials, were they not? Page 167 1 A. But it doesn't mean that it 2 was an important piece of the ultimate clinical 3 trial. 4 Q. I don't know about that, 5 Mister Wood. The next sentence goes on to say in 6 the main efficacy trials, patients who were not 7 doing well could be dropped. 8 A. I could only point out that 9 the drug was approved by the FDA. 10 Q. That's your only response. 11 A. Yes. 12 Q. That the drug was approved by 13 the FDA. 14 A. Yes. 15 Q. Oraflex was approved by the 16 FDA also, wasn't it? 17 A. Yes. 18 Q. And then it was later taken 19 off the market, wasn't it? 20 A. Yes. 21 Q. Because of side effect 22 problems with that drug, wasn't it? 23 A. Yes. 24 (PLAINTIFFS' EXHIBIT NO. 10 WAS Page 168 1 MARKED FOR IDENTIFICATION AND 2 RECEIVED IN EVIDENCE.) 3 Q. Have you had an opportunity to 4 review Exhibit 10? 5 A. Yes. 6 Q. That's a document obviously 7 authored by Tina. I'm not going to ask you if 8 you know her, but do you know Atul Pande? 9 A. No, I do not. 10 Q. Well, I'll -- for your 11 assistance, I will advise you that he is a 12 physician in the medical component at Lilly 13 Research Labs. The exhibit is dated March 17th, 14 1993, is it not? 15 A. Yes. 16 Q. And it is a list of clinical 17 trials that used concomitant medications, is it 18 not? 19 A. I presume so. 20 Q. Evidence up to this date has 21 established that chloral hydrate is a sleeping 22 medication. Do you know chloral hydrate is a 23 sleeping medication? 24 A. Yes. Page 169 1 Q. Evidence has established that 2 benzodiazepine is an antianxiety agent. Do you 3 know benzodiazepine is an antianxiety agent? 4 A. Yes, I have heard of it. 5 Q. It appears patients were 6 getting sleeping pills and antianxiety agents on 7 the clinical trials, doesn't it? 8 A. This heading is vague. It 9 could be what you suggest, I can't tell from this 10 memo. 11 Q. Well, it says study -- the 12 heading is, Studies With Psychoactive 13 Medications, isn't it? 14 A. That's what it says. 15 Q. And do you recognize all of 16 those initials as being Prozac clinical trials? 17 A. What initials? 18 Q. The HCAC, HCCH? 19 A. I have no idea about that. 20 Q. Would you take my word for it 21 that evidence has been established in this case 22 that all of those initials pertain to Prozac 23 clinical trials? 24 A. I have no reason to disbelieve Page 170 1 it. 2 Q. All right. That's why -- what 3 I'm trying do, Mister Wood, is to tie this in 4 that this is Prozac clinical trials. That the 5 psychoactive medications were given concomitantly 6 with Prozac, correct? Do you understand that? 7 A. I assume that's what this is 8 about. 9 Q. Would you agree that that's a 10 reasonable assumption based on my representations 11 to you that these are Prozac trials? 12 A. All right. 13 MR. SMITH: Is there any contention, 14 Counsel, that these trials were not Prozac 15 clinical trials? 16 MR. FREEMAN: None that I know of. 17 Q. Do you find it unusual or 18 questionable that psychoactive medications would 19 be given with Prozac during the clinical trials 20 when Prozac itself is a psychoactive medication? 21 A. None, no. 22 Q. You don't find that unusual? 23 A. No. 24 Q. Don't you agree that if one Page 171 1 medication has a psychoactive action and you 2 combine it with another medication that has a 3 psychoactive medication -- psychoactive effect, 4 then you may get a situation where you don't know 5 whether or not the behavior that you're studying 6 is a result of or affected by the combination of 7 the two psychoactive medications? 8 A. You would have to know more 9 about the total design of the study. 10 Q. But in any event, we have 11 nineteen studies here. 12 A. Apparently, yes. 13 Q. That were involved with Prozac 14 that involved concomitant use of psychoactive -- 15 other psychoactive medications? 16 A. Yes. 17 Q. Were you aware of this during 18 the time the clinical trials were run? 19 A. There would be no reason for 20 me to be aware of it. 21 Q. Did Doctor Thompson advise you 22 that in reviewing this data that he had 23 potentially reviewed clinical trials where there 24 were concomitant psychoactive medications being Page 172 1 given along with the Prozac? 2 A. There was no reason for that. 3 MR. FREEMAN: He's already testified 4 he didn't know a thing about it. So obviously 5 Doctor Thompson didn't tell him anything of the 6 kind. 7 MS. ZETTLER: Why don't you let Mister 8 Woods testify, Joe. 9 MR. FREEMAN: You know, you've got a 10 day with Mister Wood and the questions are most 11 repetitive. He'd already said he didn't know 12 anything about this and that no one had told him 13 about it. You're taking all of your time with 14 repetitive questions. So let's keep that in mind 15 because Mister Wood's time is valuable. 16 Q. Do you agree with that that 17 your time is valuable, Mister Wood? 18 A. It is to me. 19 Q. Do you agree that this is a 20 serious issue? 21 A. No. 22 Q. You don't agree that whether 23 or not Prozac causes individuals to become 24 suicidal is a serious issue? Page 173 1 A. The charge is a serious 2 charge, yes. 3 Q. Why -- so what do you not 4 agree with me in connection with respect to 5 whether or not this is a serious issue, Mister 6 Wood? 7 A. I'm confused. Are you talking 8 about this subject or suicide? 9 Q. I'm talking about your 10 deposition and the questions that involved in 11 these lawsuits whether or not some of my clients 12 may have committed suicide as a result of 13 ingestion of Prozac. Don't you, as formerly the 14 chairman of the board of this company that 15 manufactured this product, consider this a 16 serious issue? 17 A. Certainly. 18 Q. And my question to you 19 originally was what was done to make any 20 determination concerning whether or not any 21 particular individual that was taking Prozac and 22 committed suicide did so as a result of their 23 ingestion of Prozac? 24 A. I think I've answered that Page 174 1 before. 2 Q. Well, what you answered was is 3 that you asked for some study to be made and I'm 4 trying to get the details of what study was made. 5 And you said the clinical trials were reviewed, 6 therefore, I think I need to go into the question 7 about the clinical trials to see whether or not 8 that might have any bearing on whether or not a 9 particular individual committed suicide as a 10 result of taking Prozac. Do you follow me? 11 A. Yes. 12 Q. So it's important that I know, 13 are you basing your conclusion as the chairman of 14 the board of Eli Lilly based on the clinical 15 trials, are you basing your conclusion on the 16 post-marketing data, are you basing your 17 conclusion based on some separate independent 18 expert analysis that's been made, or are you 19 basing your conclusion on a case by case review 20 of purported suicide attempts or suicidal 21 ideation? 22 A. I would say all of the above. 23 Q. All right. Then what about 24 the clinical trials led you to the conclusion Page 175 1 that Prozac didn't cause any particular 2 individuals to commit suicide, what clinical 3 trial data was there that supports that 4 conclusion? 5 A. I think when the issue was 6 raised, the process was that they would go back 7 and look at every instance of suicide on a case 8 by case and summarize the entire situation using 9 expert outside help in arriving at the overall 10 conclusion to help answer the question, does 11 Prozac cause suicide. And the conclusion was no, 12 if anything, it helps to prevent suicide. 13 Q. You say there was a case by 14 case analysis made. By whom? 15 A. The medical group. 16 Q. Who in the medical group? 17 A. I don't know, whoever the 18 physicians were at the time working as project 19 managers on Prozac. 20 Q. Well, that would be Zerbe? 21 A. Well, there are physicians 22 under them, I mean there are all kinds of staff. 23 Q. And your understanding as the 24 chairman of the board was that somebody had taken Page 176 1 and reviewed each one of these cases to determine 2 whether or not there was a causal relation 3 between the ingestion of Prozac and suicide? 4 A. That's my impression. 5 Q. Did you ever see the 6 compilation of that report? 7 A. I saw the overall conclusions. 8 Q. Did you ever see the report 9 itself? 10 A. I don't remember. 11 Q. In what document are the 12 overall conclusions? 13 A. They were presented to the 14 board. 15 Q. All right. When? 16 A. I don't remember. 17 Q. By whom? 18 A. The medical group. 19 Q. Who in the medical group? 20 A. I don't recall specifically. 21 I could guess for you. 22 Q. All right. Could there be 23 minutes of the board of directors that would be 24 reflective of this case by case analysis? Page 177 1 A. I don't remember, I don't 2 know. 3 Q. Or reflective of this 4 conclusion that the medical component rendered? 5 A. I have no idea. 6 Q. Are there minutes taken of the 7 board of directors of Eli Lilly and Company? 8 A. Yes. 9 Q. Are the discussions that 10 transpire at these meetings transcribed? 11 A. No. 12 Q. Are there notes taken? 13 A. The secretary takes notes. 14 Q. Who was the secretary of Eli 15 Lilly and Company responsible for taking notes at 16 the board of directors meetings in 1990? 17 A. I don't know, I don't recall 18 exactly. 19 Q. Would it be the secretary of 20 the corporation? 21 A. Yes. It would be in the 22 annual report whoever the secretary was. 23 Q. Who is the secretary of the 24 corporation now? Page 178 1 A. Mister Dan Carmichael. 2 Q. How long has he been the 3 secretary of the corporation? 4 A. Oh, several years. 5 Q. Was he the secretary of the 6 corporation when you retired? 7 A. I think so. 8 Q. Was he the secretary of the 9 corporation when Mister Thompson made his 10 presentation in September of 1990? 11 A. I don't remember. 12 Q. Well, do you remember the 13 names of any other secretaries of the corporation 14 that might have some notes on this important 15 information? 16 A. Mister Stidle. 17 Q. What's his first name? 18 A. Stephen Stidle was a secretary 19 at one time. 20 Q. Where is he located? 21 A. Here in Indianapolis. 22 Q. Is he still employed by Eli 23 Lilly and Company? 24 A. Yes. Page 179 1 Q. In what capacity? 2 A. He's vice-president of 3 corporate affairs. But I'm not sure he was in 4 the secretarial position at the time you're 5 describing, but he had been a secretary. I think 6 Mister J. B. King also was a secretary at one 7 time. 8 Q. And they were charged with the 9 responsibility for taking notes reflective of 10 what transpired at the meetings of the board of 11 directors? 12 A. Yes. 13 Q. Were those meetings recorded 14 in any other way? 15 A. Board meetings? 16 Q. Yes. 17 A. No. 18 Q. Did you take notes during 19 those board meetings? 20 A. No. 21 Q. Were there agendas prepared 22 for the board meetings? 23 A. Yes, there was an agenda 24 prepared for each board meeting. Page 180 1 Q. Who would have custody of 2 those agendas? 3 A. I presume the secretary. 4 Q. Do you think that the minutes 5 of the board would reflect any and all situations 6 where this issue was discussed, that is, whether 7 or not Prozac caused suicidality or violent 8 aggressive behavior? 9 A. They may or may not, I don't 10 know. 11 Q. But is it your testimony that 12 you think there is some written case by case 13 analysis of each suicide attempt or suicide and a 14 determination made? 15 A. A written report? 16 Q. Yes. 17 A. There may be in some form, 18 yes, summary form. 19 Q. Well, do you know whether or 20 not those physicians found any situation where 21 Prozac was found to be causally related? 22 A. Not to my knowledge, I don't 23 recall that. 24 Q. Then this must have been a Page 181 1 surprise to you when Doctor Heiligenstein 2 mentioned that yes, he had marked some instances 3 of suicidal and aggressive behavior as reasonably 4 related? 5 A. That's the first I have seen 6 such a statement. 7 Q. Is that surprising to you, 8 Mister Wood? 9 A. Not necessarily. 10 Q. Why? 11 A. Well, I think in the total 12 process of analyzing adverse drug reaction 13 reports, one doctor can come to one conclusion 14 and another doctor can come to another. 15 Q. You understand that this was a 16 Lilly doctor, don't you -- Doctor Heiligenstein? 17 A. Yes. Even Lilly doctors can 18 disagree. 19 Q. Are you saying that this Lilly 20 doctor is wrong? 21 A. I don't know, I have no idea. 22 I know nothing about the circumstances. 23 Q. Let's be clear, Mister Wood, 24 is it your position that there is no instance -- Page 182 1 there is no case where the use of Prozac is 2 related to ingestion, where the use of Prozac is 3 related to a suicidal act? 4 A. I cannot answer that question. 5 Q. You don't know? 6 A. I do not know. 7 Q. Anything else done? 8 A. I beg your pardon? 9 Q. Anything else done to examine 10 this issue? 11 A. Anything else? 12 Q. Done. 13 A. Died? 14 Q. Done. 15 A. Oh, done. To examine which 16 issue? 17 Q. The issue of whether or not 18 Prozac could be causally related to an individual 19 suicide or a particular aggressive violent 20 behavior? 21 A. Well, there was an outside 22 panel of experts who reported on that issue. The 23 FDA, on several occasions analyzed the issue. 24 And I'm sure other regulatory bodies around the Page 183 1 world may have possibly done so. 2 Q. Who were the outside panel of 3 experts? 4 A. I do not know. 5 Q. When would they have convened? 6 A. In this period of time you're 7 describing. 8 Q. Who convened them? 9 A. The medical division. 10 Q. Did you know that some of the 11 clinical investigators that Lilly hired to 12 examine the safety and efficacy of this drug 13 ended up being members of the FDA advisory board 14 that determined the issue? 15 A. No. 16 Q. Do you think that's improper? 17 A. No. 18 Q. Why? 19 A. Well, if scientific people 20 have the appropriate credibility, it is not an 21 issue. 22 Q. You don't think the fact that 23 they had done clinical trials for Lilly would 24 cloud their judgment on this issue? Page 184 1 A. No. 2 Q. Is it your judgment that Lilly 3 has taken a fair and balanced approach in 4 examining the question of whether or not Prozac 5 causes suicidality and violent aggressive 6 behavior? 7 A. Yes. 8 Q. Do you know of anything that 9 Lilly has done to dissuade publication or 10 dissuade distribution of articles that come to 11 different conclusions than that of Lilly? 12 A. No. 13 Q. In connection with this issue? 14 A. No. 15 (PLAINTIFFS' EXHIBIT NO. 11 WAS 16 MARKED FOR IDENTIFICATION AND 17 RECEIVED IN EVIDENCE.) 18 Q. Obviously, I don't know if 19 we're going to have time for you to read all of 20 this paper. Let me just ask you, Doctor -- I 21 mean Mister Wood, if you have ever seen this 22 paper? 23 A. No. 24 Q. Have you ever heard of this Page 185 1 paper? 2 A. No. 3 Q. Do you have any idea what this 4 paper concludes? 5 A. No, except on the -- from the 6 summary there on the abstract page, page 1. 7 Q. Do you understand that this is 8 a paper that examines adverse events in 9 connection with Trazodone and Fluoxetine? 10 A. Yes. 11 Q. Fluoxetine being Prozac, 12 correct? 13 A. Yes. 14 Q. Trazodone being Desyrel, 15 correct? 16 A. I don't know what the trade 17 name is. 18 Q. Trazodone is not manufactured 19 by Eli Lilly and Company, is it? 20 A. No. 21 Q. Turn to page -- or turn to 22 table 4. 23 A. Page 4 or table 4? 24 MR. FREEMAN: Table 4. Page 186 1 A. Oh, table 4. 2 Q. Do you see there where the 3 author is indicating that he is examining adverse 4 events favoring trazodone? 5 A. Uh-huh. 6 Q. Is that a yes? 7 A. Yes. 8 Q. Where he is comparing adverse 9 events on trazodone versus fluoxetine, Prozac, 10 correct? 11 A. Yes. 12 Q. In connection with trouble 13 falling asleep, there were three reports from the 14 trazodone individuals that they were having 15 trouble falling asleep, whereas there were 16 thirty-four people on fluoxetine, Prozac, 17 correct? 18 A. Yes. 19 Q. Go with me down to suicidal 20 ideation. Two individuals there reported that on 21 trazodone reported suicidal ideation, whereas 22 nineteen individuals on Prozac reported suicidal 23 ideation, correct? 24 A. Yes. Page 187 1 Q. For a relative risk factor of 2 three point eleven percent, correct? 3 A. I don't know what that means. 4 Q. I'm not sure I do either, 5 Mister Wood. Look under the anxiety section. It 6 shows fourteen people showing anxiety on 7 trazodone and sixty-five or sixty-six individuals 8 showing anxiety on Prozac, correct? 9 A. Yes. 10 Q. It shows five individuals on 11 trazodone showing anger and aggression and 12 thirty-two showing anger and aggression on 13 Prozac, correct? 14 A. Yes. 15 Q. This would be a report then 16 that would not be favorable to Prozac in 17 connection with these issues, would it? 18 A. I'm not sure. 19 Q. Would that be something you 20 would leave to the medical component? 21 A. Yes. 22 (PLAINTIFFS' EXHIBIT NO. 12 WAS 23 MARKED FOR IDENTIFICATION AND 24 RECEIVED IN EVIDENCE.) Page 188 1 Q. Exhibit 12 is an E-mail 2 document, is it not, dated May 7th, 1992? 3 A. I don't know whether it's 4 E-mail or regular mail, I can't tell. 5 Q. Which -- it's one of those 6 Lilly computer documents that you see at Lilly, 7 isn't it? 8 A. It looks like it. 9 Q. Do they let you see those kind 10 of computer documents? 11 A. No. 12 Q. Have you ever seen this 13 document, Mister Wood? 14 A. No. 15 Q. The subject of this document 16 is the article by Doctor Fisher, is it not? 17 A. Yes. 18 Q. Or it appears to be? 19 A. Or Doctor somebody, it's 20 scratched out. 21 Q. Well, believe me, it's Doctor 22 Fisher. It says that this paper will cite that 23 there is a difference in suicidality between 24 Prozac and Desryl, Prozac being worse than Page 189 1 Desryl, correct? 2 A. Yes. 3 Q. Then the last paragraph says, 4 if this paper were published, even with the 5 caveats in it, it could prove difficult for us to 6 deal with and, therefore, it would be in our best 7 interest to have complete understanding of it and 8 perhaps a discussion with Doctor blank regarding 9 its content, correct? 10 A. Yes. 11 Q. It appears to me in context of 12 the entire statement there, the entire memo, that 13 people in the medical component at Lilly are 14 concerned about this publication, correct? 15 A. Well, yes. 16 Q. They're trying to do something 17 about getting the article published, correct? 18 A. I can't conclude that. 19 Q. Well, did you -- you weren't 20 made aware of this document prior to its being 21 published, were you? 22 A. I've never seen this subject. 23 Q. Well, it talks about talking 24 to the chairman of the department in which this Page 190 1 individual worked, doesn't it? 2 A. That's not unusual. 3 Q. That's what it says, isn't it? 4 A. Yes. 5 Q. Why would you go to the 6 chairman of the department, why would it not be 7 unusual to go over an author's head like this? 8 A. I can't answer that. 9 Q. Well, you said it would be not 10 unusual. 11 A. Well, over the years and in 12 the scientific community, many articles are 13 published on all kinds of drugs and it's quite 14 customary for the manufacturer to discuss with 15 the institutions who have sponsored the study in 16 order to explain or to have an understanding of 17 how the study was done and what the results were. 18 Q. Why not discuss it just 19 directly with the author? 20 A. They could, sure. 21 Q. Do you know whether or not Eli 22 Lilly endows or funds or gives any money to the 23 University of Texas? 24 A. Oh, I have no idea. Page 191 1 Q. Do you know whether or not Eli 2 Lilly and Company gives any money, endowments or 3 funds to the University of Texas Medical Branch 4 at Galveston, Texas? 5 A. I have no idea. 6 (PLAINTIFFS' EXHIBIT NO. 13 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Exhibit 13 appears to be 10 further investigation into this article and 11 individuals involved in the formulation of this 12 article, correct? 13 A. It would appear so. 14 Q. And it appears that Doctor 15 Kotsanos is getting more information concerning 16 how the study was done, does it not? 17 A. Yes. 18 Q. And he states that there is a 19 surveillance system which is a prescription based 20 patient self-monitoring systemsthrough Eckerd 21 Drug Store chain, which means that the patient 22 gets a prescription, calls an eight hundred 23 number with an ADR, that would be an adverse drug 24 report would it not? Page 192 1 A. Yes. 2 Q. And trained interviewers 3 administer a standard questionnaire for adverse 4 drug reports, correct? 5 A. Yes. 6 Q. It doesn't seem to be a 7 totally unreasonable way to conduct a study, does 8 it, Mister Wood? 9 A. It depends on the context in 10 which you're looking at the data. From a purely 11 clinical trial standpoint, it would not be 12 acceptable. 13 Q. Well, I understand that, but 14 it doesn't -- it appears to be something that 15 could give you some information? 16 A. Yes. 17 Q. Concerning -- 18 A. It's a type of study. 19 Q. -- the properties of a drug, 20 correct? 21 A. It is a type of study. It 22 would never qualify as part of a new drug 23 application. 24 Q. Well, Prozac had already been Page 193 1 approved at this time, hadn't it? 2 A. What I'm saying is, the 3 scientist would never buy this procedure for 4 determining the characteristics of one drug 5 versus another drug. 6 Q. But it might -- 7 A. That's my own personal 8 opinion. I don't know what our people have said. 9 Q. It might be informative 10 concerning a particular -- 11 A. All information is of 12 interest. 13 Q. You don't have any indication 14 that this study was flawed or that the 15 individuals that were doing this study had any 16 ill motives or anything do you? 17 A. No, the study is what it is, 18 for better or worst. 19 (PLAINTIFFS' EXHIBIT NO. 14 WAS 20 MARKED FOR IDENTIFICATION AND 21 RECEIVED IN EVIDENCE.) 22 Q. Before you look at that, would 23 you, please -- 24 A. I can't peek? Page 194 1 Q. No, you can peek, I just have 2 another question before that. Would you consider 3 this study done by Doctor Fisher a surveillance 4 study? And I know you just had an opportunity to 5 review it briefly. 6 A. Well, as an old market 7 researcher, it looks more like a casual type of 8 patient opinion survey, whatever that's worth. 9 It's not a scientifically controlled clinical 10 trial. 11 Q. Go ahead and review Exhibit 12 14. 13 (THE WITNESS COMPLIES.) 14 Q. Doctor, do you see Mister Gary 15 Tollefson? 16 A. Yes. 17 Q. Who is Mister Tollefson? 18 A. He is a psychiatrist in the 19 medical division. 20 Q. Well, it appears that Doctor 21 Tollefson is reporting to a number of individuals 22 in the medical component, does it not? 23 A. All kinds of people, some in 24 the medical group and some not. Page 195 1 Q. There is a Doctor Herr -- 2 Doctor Earl B. Herr. 3 A. Herr. 4 Q. Who was head of the medical 5 group at that time, I assume? 6 A. I'm not sure. No, he was not 7 head of the medical group, he's not a real 8 doctor. 9 Q. And then right under that 10 there is another individual that's not a real 11 doctor, Margaret M. Huff, correct? Margaret Huff 12 is one of these doctors like these other guys 13 sitting around in pinstriped suits, 14 A. I don't know. 15 Q. She's an attorney. 16 A. Oh, is she, patent attorney? 17 Q. No, product liability 18 attorney. Doctor Mel Perelman is listed there. 19 A. Ph.D. 20 Q. This also contains further 21 investigation into this paper, does it not? 22 A. Yes. 23 Q. And Doctor Tollefson says, I 24 had the opportunity to review the poster and Page 196 1 spoke with two of the authors, Seymour Fisher and 2 Steven Bryant. The former could be compared with 3 the fowl frequently found on the Thanksgiving 4 table. The latter is someone I have known and 5 was quite reasonable in discussing limitations of 6 their surveillance study. Do you approve of this 7 type of characterization of individuals? 8 A. No, I think that's not very 9 professional. 10 MR. SMITH: Let's take a quick break. 11 (A SHORT BREAK WAS TAKEN.) 12 Q. Mister Wood, was there any 13 study done at your request to examine the issue 14 of whether or not Prozac caused violent 15 aggressive behavior? 16 A. I don't remember asking for 17 data on that particular subject. 18 Q. Would it surprise you to know 19 that there was an FDA audit run on hostility in 20 June of 1989 that showed that Prozac was the 21 fifth leading drug of all drugs produced in the 22 United States and throughout the world in 23 connection with complaint of violent aggressive 24 behavior? Page 197 1 A. No. 2 Q. Why is that? 3 A. Why did I not know of such a 4 report? 5 Q. Why would it not surprise you 6 that this study indicated that Prozac was fifth 7 among all drugs world wide with reports of 8 violent aggressive behavior? 9 A. That would not surprise me in 10 terms of a patient population and characteristics 11 of people taking Prozac, as well as the volume of 12 just the sheer numbers of people taking Prozac. 13 Q. The study was done in June of 14 1989. 15 A. Uh-huh. 16 Q. Prozac had been on the market 17 for less than two years. Do you know how many 18 patients were taking Prozac in 1989? 19 A. No, but I'm confident that it 20 would be in the millions. 21 Q. Do you think it was the fifth 22 largest prescribed drug in June of 1989? 23 A. I don't recall that. 24 Q. Well, you know in fact it Page 198 1 wasn't, don't you? 2 A. Was not? 3 Q. Right. 4 A. Prozac was not the fifth? 5 Q. Most prescribed drug -- 6 A. I don't know. 7 Q. -- in June of 1989? 8 A. I have no idea. 9 Q. What is the highest ranking 10 that Prozac has ever achieved as far as total 11 number of prescriptions written? 12 A. You mean in terms of numbers 13 of prescriptions? 14 Q. Yes. 15 A. I don't know how to respond to 16 that. The total number to date is I'm sure ten 17 million or more. 18 Q. That's what you see reported 19 in the press? 20 A. Yes. 21 Q. That there is ten million 22 people now on Prozac. But that wasn't the case 23 in June, 1989, was it? 24 A. Well, I doubt it, but it was Page 199 1 still a large number. 2 Q. How large? 3 A. I don't know. 4 Q. Compared to other drugs? 5 A. Well, it would have been 6 significant in terms of other drugs. 7 Q. But you don't have any data at 8 hand -- 9 A. No, I do not. 10 Q. -- to support that? 11 A. No. 12 (PLAINTIFFS' EXHIBIT NO. 15 WAS 13 MARKED FOR IDENTIFICATION AND 14 RECEIVED IN EVIDENCE.). 15 Q. I apologize for the quality of 16 the copy, but this is as good as we got, Mister 17 Wood. 18 MR. FREEMAN: Do you know what the 19 abbreviations are after one? 20 MS. ZETTLER: AZN. 21 THE WITNESS: Oh, AZN. 22 Q. Have you had an opportunity to 23 review Exhibit 15, Mister Wood? 24 A. Yes. It is hard to read in Page 200 1 its entirety. 2 Q. Let's see if we can go through 3 it. It's dated November 30th, 1989, is it not -- 4 1990? 5 A. 1990. 6 Q. And it's from Leigh Thompson, 7 is it not? 8 A. Yes. 9 Q. And it appears to be to Bob 10 Zerbe and Dan Masica? 11 A. I can't read the first name, 12 Robert Weinstein, Alan Weinstein, Robert Zerbe 13 maybe, right here. 14 Q. Again, I apologize for the 15 quality of the copy. Obviously, it was a copy 16 made from a poor original and provided to us by 17 Lilly. 18 It says there -- let's see if 19 we can get what it says, it says in regard to the 20 approach to German affiliate from (1) AZN and (3) 21 BGA, it is my belief that Bob Thompson and Dan 22 Masica received on Monday, November 26th, the fax 23 from Hans Weber detailing not only the AZN 24 problem, but a draft reply from Hans Weber to Page 201 1 Doctor Hopf and a letter from the BGA which reads 2 in English translation, quote, whether, for 3 reasons of drug safety, patients with history of 4 suicidal ideation and suicide attempts, 5 respectively, be excluded from treatment with 6 Fluctin and this circumstance be listed 7 accordingly under contraindications, end quote. 8 Is that the way you read that first paragraph, 9 Mister Wood? 10 A. Yes, I think so. 11 Q. Apparently the BGA has at 12 least threatened to exclude individuals with 13 suicidal ideation and suicide attempts from being 14 able to be treated with Fluctin, correct? 15 A. Yes. 16 Q. And Fluctin is Prozac, 17 correct? 18 A. Yes. 19 Q. Apparently Mister -- or Doctor 20 Thompson is a little upset because he says if 21 this was known to Bob and Dan on Monday, November 22 26th, and if Bob Zerbe learned of this from Bob 23 Luedke late on November 29th and I learned from 24 Bob Zerbe very early on November 30th, do you Page 202 1 gentlemen perceive that there is here a 2 communication problem. This matter should have 3 been brought to us to the Tuesday, 6:30 a.m. 4 meeting, it being clearly a medical and science 5 issue, it should have been described and planned 6 for during the week. I find it absolutely 7 incredible that Bob, then I, then Mel, then Earl 8 find out Friday morning -- find out moments 9 before Dick Wood's staff meeting and executive 10 committee on Friday morning. Correct? 11 A. I think so. 12 MR. FREEMAN: This might be, the word 13 may be discussed and planned for rather than 14 described. 15 Q. Okay. Discussed or described, 16 it's one of the two. It goes on to say, I'm not 17 sure how you interpret your responsibilities to 18 your management, but I have always considered 19 that a primary rule in organizational behavior 20 was to make sure that your management is informed 21 of problems and not blindsided. If the rules 22 have changed, please let me know and my IRE may 23 be somewhat dissipated in time, exclamation 24 point. Correct? Page 203 1 A. Yes. 2 Q. Is Doctor Thompson an 3 excitable fellow? 4 A. Yes. 5 Q. Is he prone to losing his 6 temper? 7 A. Oh, maybe on occasion, uh-huh. 8 Q. Do you recall this issue being 9 brought up in November of 1990? 10 A. No, I never heard of the 11 issue. 12 Q. Did you have a meeting with 13 your staff or did your staff have a meeting with 14 the executive committee where this issue might 15 have been discussed? 16 A. Yes -- well, I don't know 17 whether this was discussed or not, but normally 18 the executive committee met every Friday morning. 19 Q. And that was the executive 20 committee of the board of directors? 21 A. Yes. 22 Q. Of Eli Lilly and Company? 23 A. Uh-huh. 24 MR. FREEMAN: Wait a minute, executive Page 204 1 committee of the corporation, not the board of 2 directors. 3 A. Of the corporation. 4 MR. FREEMAN: Executive committee is 5 the corporation. 6 Q. Does the board of directors 7 have an executive committee -- 8 A. This is it. 9 Q. -- of the board itself? 10 A. Yes. 11 Q. So it's not the executive 12 committee of the corporation, like the president, 13 the chairman of the board and some 14 Vice-president? 15 A. Well, I think we're dealing 16 with semantics here. There is one executive 17 committee. 18 Q. All right. Describe for us 19 what that executive committee is. 20 A. There is no such committee at 21 the moment, but in this period of time these were 22 the members of the board of directors who were 23 full-time employees of the company. In other 24 words, inside directors. Page 205 1 Q. Who would they have been in 2 November of 1990? 3 A. I can't remember the list 4 specifically, but it would have been, 1990, 5 Mister Stepp, Doctor Herr, Doctor Perelman, 6 Mister Cornealius -- who have I forgetten, that's 7 about it. 8 Q. Mister Terrel? 9 A. No, not 1990, I don't think 10 so. 11 Q. Would this executive committee 12 have kept notes? 13 A. The executive committee would 14 have kept notes on any subject requiring 15 executive committee action. 16 Q. Would executive committee 17 meetings have had an agenda? 18 A. Sometimes they did and 19 sometimes they did not. 20 Q. Would you always have chaired 21 the executive committee meetings? 22 A. Yes. Except in my absence, 23 someone else would have filled in. 24 Q. It talks about Dick Wood's Page 206 1 staff. 2 A. Uh-huh. 3 Q. What individuals comprised 4 your staff in 1990? 5 A. Well, it would have been the 6 executive committee plus certain other key 7 executives in the corporation. 8 Q. Such as? 9 A. Who were not on the board of 10 directors. Oh, head of corporate affairs, head 11 of personnel, the head of manufacturing, so on. 12 Q. But you don't have any 13 recollection of this problem being discussed -- 14 A. No. 15 Q. -- in an executive committee 16 meeting -- 17 A. No. 18 Q. -- with respect to a 19 possibility that the German government was going 20 to exclude under contraindications individuals 21 who had a history of suicidal ideation or suicide 22 attempts? 23 A. I don't recall that. 24 Q. Would you have had an Page 207 1 objection to individuals being excluded from 2 treatment with Prozac that had had a history of 3 suicide attempts and suicidal history? 4 MR. FREEMAN: The question doesn't 5 give him enough information as to whether or not 6 the patient's hospitalized or not hospitalized, 7 that's the issue. 8 A. Well, I think it totally 9 inconsistent with our scientific analysis of the 10 product and its labeling in other countries. 11 Q. So you would have objected? 12 A. I certainly would have asked 13 about it. 14 Q. But you don't have any 15 recollection of taking steps -- 16 A. No. 17 Q. -- to insure that this didn't 18 occur? 19 A. No. 20 Q. Do you know who Jan Fawcett 21 is? 22 A. No, I do not. 23 Q. Do you know that -- whether or 24 not Jan Fawcett has been retained as a consultant Page 208 1 to Eli Lilly and Company on the issue of Prozac 2 and suicidality? 3 A. I have never heard of Ms. 4 Fawcett. 5 MS. ZETTLER: It's a he. 6 THE WITNESS: Pardon me? 7 MS. ZETTLER: It's a he. 8 THE WITNESS: He? 9 Q. You just don't know anything 10 about who Jan Fawcett, M. D. is? 11 A. No. 12 Q. Or what he may have published 13 in connection with Prozac and suicidality? 14 A. No. 15 Q. But you said that there was 16 some consultation in connection with this 17 investigation that you had made with experts to 18 get their opinions and some review of the 19 scientific literature, is that correct? 20 A. Yes, uh-huh. 21 Q. Is that a yes? 22 A. I'm sorry, yes. 23 (PLAINTIFFS' EXHIBIT NO. 16 WAS 24 MARKED FOR IDENTIFICATION AND Page 209 1 RECEIVED IN EVIDENCE.) 2 Q. So that you won't have to read 3 this entire scientific article that was published 4 in the Journal of Clinical Psychiatry that is 5 marked as Exhibit 16, I believe the evidence has 6 been established that Jan Fawcett was on the 7 Lilly Psychiatric Advisory Board, and that he ran 8 clinical trials for Lilly on Prozac and that he 9 was a suicide consultant for Lilly in connection 10 with the issue of Prozac and suicidality. 11 A. Uh-huh. 12 Q. It's my understanding that 13 he's been identified in some of these lawsuits as 14 a potential expert witness on behalf of Eli Lilly 15 and Company, correct? 16 A. I have no idea. 17 Q. Turn to page forty-two of that 18 paper. Under the term -- under the heading 19 Treatment, under Combination Therapy, you see 20 that? 21 A. Yes. 22 Q. About the middle of that 23 paragraph, Doctor Fawcett writes, aggressive 24 treatment with a benzodiazepine anxiolytic is Page 210 1 indicated for immediate relief of anxiety in 2 patients with major depression if they manifest 3 risk factors for suicide, if the anxiety is 4 severe or if the antidepressant selected causes 5 jitteriness, paren, fluoxetine, or is without 6 sedative properties, desipramine, imipramine, 7 bupropion, close paren, period. In this 8 investigation that you did, did anybody make you 9 aware that Doctor Fawcett was recommending that 10 some antianxiety agent be given along with Prozac 11 to prevent suicide because Prozac caused 12 jitteriness? 13 MR. FREEMAN: That doesn't say that. 14 MR. SMITH: It says what it says. 15 MR. FREEMAN: It says what it says, 16 but it doesn't say that. 17 Q. Did anybody make you aware of 18 that? 19 A. No. 20 Q. Have you ever heard of Doctor 21 David Dunner? 22 A. Dunner? 23 Q. Yes. 24 A. No, I have not. Page 211 1 Q. Did you know that Doctor David 2 Dunner is a member of the Eli Lilly psychiatric 3 advisory panel? 4 A. No. 5 Q. Did you know that Doctor David 6 Dunner was a member of the Food and Drug 7 Administration's Advisory Committee in September 8 of 1990? 9 A. No. 10 Q. Did you know that Doctor David 11 Dunner was a practicing psychiatrist in Seattle, 12 Washington? 13 A. No. 14 Q. Did you know Doctor David 15 Dunner had done clinical trials -- 16 A. I've never heard of Doctor 17 Dunner. 18 Q. -- to determine efficacy and 19 safety of Prozac? 20 A. No. 21 Q. It doesn't sound like you ever 22 heard of Doctor Dunner? 23 A. I have not. 24 MR. FREEMAN: We've exhausted that Page 212 1 subject, ad nauseum. 2 Q. My point is, in your 3 investigation in connection with the consultants 4 and the practice of the clinical trials and what 5 psychiatrists who were respected in the field 6 were doing, was it ever reported to you that 7 Doctor David Dunner had been treating patients 8 with Prozac, but that one-third to one-half of 9 those patients he prescribed concomitant 10 antianxiety medications? 11 A. No. 12 Q. Did you know that Doctor David 13 Dunner when asked the question, is it possible 14 that fluoxetine can cause suicidal ideation, had 15 said yes? 16 A. No. 17 Q. Did you know that Doctor David 18 Dunner in -- when asked the question, is it 19 possible that fluoxetine can cause violent 20 aggressive behavior, had said yes? 21 A. No. 22 Q. What steps were taken by you, 23 Mister Wood, to ensure that competing interests 24 in connection with Prozac didn't cloud careful Page 213 1 scientific development and production of this 2 drug? 3 A. I'm not sure what you mean by 4 competing interests. 5 Q. The competing interests that 6 I'm talking about are the competing interests 7 within the company such as research and 8 development, marketing, manufacturing, 9 accounting, things of that nature. 10 A. Uh-huh. 11 Q. You as a chief executive 12 officer of a large corporation see that problem 13 arise from time to time, do you not? 14 A. Not too often, no. 15 Q. It is a sort of an in-bred 16 problem that people are going to want to further 17 the interest of the division in which they're 18 working. 19 A. Well, I'm not sure of the 20 context in which your questions are leading. 21 Q. In a general context. 22 A. If you mean scientific 23 integrity of the company, no. The marketing 24 groups or financial groups or production groups Page 214 1 do not enter into those discussions. 2 Q. Do you know whether or not the 3 marketing end has any input into the clinical 4 trial phases or process? 5 A. They may suggest the type of 6 disease indications that would be helpful to be 7 included in the clinical trial in terms of their 8 importance in the market place, but in terms of 9 the final protocols, the marketing groups have no 10 authority. 11 Q. Well, have you ever heard of 12 the marketing group with respect to Prozac 13 developing a wish list of particular clinical 14 trials they wanted run? 15 A. Clinical trials in terms of 16 indications? 17 Q. Yes. 18 A. Oh, that's normal. 19 Q. Were you aware that marketing 20 was identifing and prioritizing a Plan D wish 21 list? 22 MR. FREEMAN: If you're reading from a 23 document, why don't you show it to him? 24 MR. SMITH: All right. I'm trying to Page 215 1 speed it up, but we'll surely accomodate you on 2 that. 3 Q. He gripes when I give him a 4 document and he gripes when I don't -- that is 5 Mr. Freeman. 6 (PLAINTIFFS' EXHIBIT NO. 17 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Exhibit 16 appears to be a 10 document authored by Doctor John Heiligenstien, 11 does it not? 12 A. Yes. 13 Q. I don't see a date on my copy, 14 do you on yours? 15 MR. FREEMAN: It's seventeen, Paul. 16 MR. SMITH: Thank you. 17 Q. Do you see a date, Mister 18 Woods? 19 A. No. 20 Q. That document says I met this 21 morning with Charlie Perry -- 22 A. Here it is. 23 Q. -- Rush Pruyn and Dennis 24 Tagazuki to develop guidelines for assessing Page 216 1 progress in Prozac Plan D studies. Correct? 2 A. Uh-huh, yes. 3 Q. And those are gentlemen in 4 marketing, correct? 5 A. Yes. I presume they are, I 6 don't know them. 7 Q. And point one under that says 8 marketing would identify -- or marketing 9 identifies and priortizes Plan D wish list. 10 Medical should participate in this process and 11 legal may need to be involved as well. Correct? 12 A. Yes. 13 Q. Why would you have clinical 14 trials in which you would have marketing involved 15 in the progress of the clinical trials as well as 16 legal? 17 A. Well, I don't know exactly, 18 but as I recall Plan D studies were not the core 19 clinical studies for the drug itself, rather they 20 were later stage follow-on studies. Marketing 21 groups would identify important medical centers 22 in their respective regions that they would 23 suggest could be helpful in developing additional 24 clinical studies. Page 217 1 Q. Okay. So it's your testimony 2 that marketing shouldn't get involved in the 3 pivotal core -- 4 A. They can recommend -- 5 Q. -- clinical trials? 6 A. -- certain things, and they 7 do, in terms of describing the market place to 8 the medical profession, what is important to the 9 practicing physician and make suggestions based 10 on that concerning the data to be collected that 11 would be helpful from a marketing standpoint. 12 The scientific component is the ultimate 13 gatekeeper, though, in terms of the clinical 14 studies and what is done and where it's done and 15 how it's done. 16 (PLAINTIFFS' EXHIBIT NO. 18 WAS 17 MARKED FOR IDENTIFICATION AND 18 RECEIVED IN EVIDENCE.) 19 Q. Exhibit 18 appears to be 20 minutes of a fluoxetine team meeting which 21 occurred on June 23rd, 1987, correct? 22 A. Yes. 23 Q. Authored by R. F. Sieck, the 24 project manager, correct? Page 218 1 A. I presume so. 2 Q. And the subject of that 3 meeting was whether or not there should be 4 clinical evaluations of higher doses of Prozac 5 than that that had been tested previously, that 6 is eighty to a hundred milligrams, correct? 7 A. Yes. 8 Q. And there is a heading called 9 Data Requirements And Scientific Considerations, 10 is there not, on the first page? 11 A. Yes. 12 Q. There is a heading of Safety 13 Considerations? 14 A. Yes. 15 Q. Of doing clinical trials, 16 correct? 17 A. Yes. 18 Q. And this was going to be 19 clinical trials whether that was studying in 20 particular bulimia and obesity, correct? 21 A. Yes. 22 Q. And then marketing had some 23 input, correct? 24 A. Yes. Page 219 1 Q. Read with me the second 2 paragraph from the bottom under Marketing. It 3 says, it was felt that if evaluations were 4 undertaken in higher doses, physicians treating 5 depression may be encouraged to attempt early 6 loading of patients. This practice could lead to 7 the possibility of an increase in side effects in 8 use of fluoxetine for depression, correct? 9 A. Yes. 10 Q. It goes on to say, development 11 of unanticipated side effects during study of one 12 hundred milligram doses of fluoxetine could 13 damage the perception of the safety of fluoxetine 14 for use in depression. A few really serious side 15 effect issues could have major consequences for 16 the use of the drug in treatment of depression. 17 Therefore, from a marketing perspective, it would 18 be prudent to move extremely cautiously relative 19 to studies with one hundred milligram doses. 20 Correct? 21 A. Yes. 22 Q. Then it goes on to say, it is 23 important not to be involved in studies which 24 could impact the approval or marketing of Page 220 1 fluoxetine for depression, correct? 2 A. Yes. 3 Q. So it appears to me at that 4 time that fluoxetine was indeed directing that 5 nothing be done which would impact the approval 6 or marketing of Prozac for depression, correct? 7 MR. FREEMAN: You misused a word. You 8 meant to say marketing and you said fluoxetine. 9 Q. Let me ask the question. 10 Marketing at that time in this memo is making the 11 recommendation that there not be any clinical 12 trials that would impact the approval or 13 marketing of fluoxetine for the indication of 14 depression, correct? 15 A. That was their recommendation 16 according to this memo. 17 Q. And so this is an instance 18 where marketing is making an input into what 19 clinical trials are done at a particular dosage, 20 isn't it? 21 A. Yes. 22 Q. And their concern there was 23 that if they did some clinical trials, that you 24 would have a likelihood that it would increase Page 221 1 side effects at higher dosage and if you had some 2 serious side effects it was going to affect the 3 approval or marketing of Prozac for depression, 4 correct? 5 A. Yes. 6 Q. And that this shouldn't be 7 done, correct? 8 A. Yes. 9 Q. Were you made aware of this 10 concept in June of 1987? 11 A. I don't see anything wrong 12 with the concept, but I was not made aware of it. 13 Q. But you approved of it then? 14 A. It makes good sense to me. 15 Q. Not to conduct any clinical 16 trials that -- 17 A. I presume the scientific 18 component agreed with the marketing proposal 19 based on the laboratory data up to that point 20 concerning the effect of increased dose on side 21 effects, both in animals as well as possibly 22 humans. 23 Q. My question is to you, as 24 chairman of the board of the company at the time, Page 222 1 did you feel it was important not to be involved 2 in clinical studies that would show high side 3 effects that would impact the marketing and 4 approval process of Prozac for treatment of 5 depression? 6 A. I think that makes good 7 practical sense. 8 Q. Because Prozac in June, 1987 9 hadn't been approved for treatment of depression 10 in the United States, had it? 11 A. I don't know, '87. 12 Q. Well, it was approved in 13 December of 1987 by the Food and Drug 14 Administration? 15 A. I would only observe that 16 Prozac has been approved for bulimia since that 17 time. I don't know what the dose is. 18 Q. Now, do you recall anything 19 that was done by the Food and Drug Administration 20 initially in connection with the issue of whether 21 or not Prozac caused suicidal or aggressive 22 behavior? 23 A. Could you repeat that, please? 24 Q. Do you know initially after Page 223 1 the Teicher article whether or not the Food and 2 Drug Administration made any request of Eli Lilly 3 in making this -- in examining the issue of 4 Prozac and suicidality? 5 A. I only recall that there were 6 conversations and I'm sure they agreed on further 7 studies. Exactly what they agreed to, I do not 8 remember. 9 Q. All right. That's what we're 10 going to talk about now. 11 (PLAINTIFFS' EXHIBIT NO. 19 WAS 12 MARKED FOR IDENTIFICATION AND 13 RECEIVED IN EVIDENCE.) 14 Q. Have you ever seen Exhibit 19 15 before, Mister Wood? 16 A. No, uh-uh. 17 Q. It appears that that is 18 minutes of the meeting that were kept by the Food 19 and Drug Administration in connection with 20 Prozac, correct? 21 A. Yes. 22 Q. It appears that there were 23 several members in attendance from the Food and 24 Drug Administration, correct? Page 224 1 A. Yes. 2 Q. Several members from Eli Lilly 3 and Company? 4 A. Yes. 5 Q. And that this meeting occurred 6 on September 25th, 1990 in Washington, D. C. and 7 apparently was a two hour conversation or 8 meeting, correct? 9 A. Yes. 10 Q. The document says that the 11 purpose of the meeting was that Eli Lilly 12 requested to meet with the division to discuss 13 post-marketing experience with Prozac -- 14 post-marketing safety experience with Prozac. It 15 says also everyone agreed that the most prominent 16 issue has been the spectrum of suicidal behavior. 17 Correct? 18 A. Yes. 19 Q. Then it goes on and talks 20 about a discussion in which Doctor Thompson 21 presented data from the pre-marketing studies 22 which did not demonstrate a correlation between 23 completed suicide and Prozac. Correct? 24 A. Yes. Page 225 1 Q. Do you know whether or not 2 Doctor Thompson told members of the Food and Drug 3 Administration at that time that Doctor 4 Heiligenstein had advised him that there were 5 indeed some post-marketing reports that they had 6 determined were yes, reasonably related to Prozac 7 and suicide? 8 A. I have no idea. 9 Q. Do you know whether or not 10 Doctor Thompson explained to the members of the 11 Food and Drug Administration that the 12 pre-marketing studies mentioned here did not 13 examine the issue of suicidality? 14 A. I don't know. 15 Q. Do you know whether or not he 16 reminded members of the Food and Drug 17 Administration that suicidal patients were 18 excluded -- or serious suicidal risk patients 19 were excluded from the pre-marketing studies? 20 A. I have no idea. 21 Q. The document goes on to say 22 that the firm contended that prospective trials 23 were hampered by their inability to reach 24 agreement with Doctor Teicher on operational Page 226 1 criteria for the phenomena refered to in his 2 article? 3 A. I remember that issue. 4 Q. All right. Tell me about what 5 you remember about that issue. 6 A. They went to Doctor Teicher to 7 get an understanding of his data. 8 Q. When you say they, can you 9 identify? 10 A. The scientific people. And I 11 think the other objective was to not only 12 understand his work, but then to suggest broader, 13 more complete studies to address the issues that 14 were of concern to him. And they had difficulty 15 coming to a conclusion that they could all agree 16 to concerning future clinical trials. 17 Q. Okay. Was this something that 18 you had asked people in your scientific division 19 to do, was to go meet with Doctor Teicher? 20 A. I don't recall asking them to 21 do that, no. 22 Q. But you recall that it was 23 done? 24 A. Yes. Page 227 1 Q. And it's your impression that 2 it was reported to you that Doctor Teicher 3 wouldn't do that or that there -- 4 A. My remembrance is that they 5 had difficulty coming to an agreement over the 6 design of future clinical trials to address the 7 issues that he raised. 8 Q. Do you recall what the 9 disagreement was in connection with the design of 10 any future trials? 11 A. No, I don't. 12 Q. Do you remember who it was 13 that reported that to you? 14 A. No. 15 Q. Would it surprise you that 16 Doctor Teicher has advised that he at all times 17 has been willing to work with Eli Lilly and 18 Company in doing anything in connection with 19 future clinical trials to determine whether or 20 not this phenomena exists? 21 MR. FREEMAN: That's not in evidence 22 anywhere. You can't ask him to assume all that, 23 he doesn't know anything about it. 24 A. I have never heard of it. Page 228 1 Q. Well, it will be in evidence 2 that he told Doctor Teicher and the other 3 gentlemen that were with him at the Harvard 4 Medical School. 5 A. Who told Doctor Teicher? 6 Q. Doctor Teicher told Doctor 7 Gary Tauscher who was there that he would 8 cooperate with them in any way in connection with 9 future clinical trials. 10 A. I can't respond to that. 11 Q. Let's go back to Exhibit 19. 12 It appears that the document says nevertheless, 13 two types of prospective trials were discussed, 14 does it not? 15 A. Yes. 16 Q. The first type would be a 17 large two arm, randomized, double blind, parallel 18 group study comparing fluoxetine and an active 19 control in patients with typical depression with 20 outcome measures of completed suicide, suicidal 21 acts and suicidal ideation. Correct? 22 A. Yes. 23 Q. Do you know if that study was 24 ever, ever done? Page 229 1 A. I don't recall. 2 Q. Do you think you would recall 3 had it been done? 4 A. Not necessarily. I assume it 5 was done, but I do not know. 6 Q. The next proposal is an 7 in-hospital rechallenge of patients who met 8 predefined criteria for suicidal acts or ideation 9 on either fluoxetine or a standard tricyclic 10 antidepressant. Do you know whether or not a 11 rechallenge study was ever done? 12 A. I do not know. 13 Q. Do either one of these studies 14 appear to you as being unreasonable requests or 15 unreasonable suggestions on behalf of either the 16 FDA or Eli Lilly and Company? 17 A. I have no reason to question 18 them. 19 Q. If the members of the 20 scientific group at Eli Lilly had come to you as 21 chairman of the board in September of 1990, would 22 you have given authorization for either one of 23 these studies? 24 A. The chairman of the board does Page 230 1 not enter into decisions about whether they do 2 clinical trials or they don't, it's up to the 3 scientific group. 4 Q. Well, as chief executive 5 officer? 6 A. They wouldn't come and ask is 7 what I'm saying. 8 Q. They have the authority to do 9 this? 10 A. Yes. 11 Q. And you would not be critical 12 of them for doing it? 13 A. I wouldn't be critical either 14 way, I rest on their advice. 15 (PLAINTIFFS' EXHIBIT NO. 20 WAS 16 MARKED FOR IDENTIFICATION AND 17 RECEIVED IN EVIDENCE.) 18 Q. Mister Wood, I have handed you 19 Exhibit 20 simply to show you that apparently the 20 issue of rechallenge was carried beyond the 21 September 1990 meeting into April of 1991 and 22 apparently there were meetings held in connection 23 with this rechallenge and there was apparently a 24 formal protocol that was drawn up which is Page 231 1 attached to Exhibit 20. Do you see that? 2 A. Yes. 3 Q. Were you aware that an actual 4 rechallenge protocol had been devised? 5 A. No. 6 (PLAINTIFFS' EXHIBIT NO. 21 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Exhibit 21 appears to be a 10 memo dated May 15th, 1991 authored by James 11 Kotsanos M. D., does it not? 12 A. Yes. 13 Q. And Doctor Kotsanos apparently 14 is a medical doctor within the medical division 15 at Eli Lilly, do you know that? 16 A. I do not know that. 17 Q. Will you accept my 18 representation that he is? 19 A. Yes. 20 Q. He is -- the subject of the 21 memo is a meeting with the Food and Drug 22 Administration to discuss Prozac rechallenge that 23 occurred on May 13th, 1991, correct? 24 A. Yes. Page 232 1 Q. And it says there, at the FDA 2 meeting, Lilly agreed to do the following 3 projects, doesn't it? 4 A. Yes. 5 Q. One, proceed with the 6 rechallenge study. Correct? 7 A. Yes. 8 Q. Did they make you aware in May 9 of 1991 that there was a rechallenge study 10 underway? 11 A. I don't recall that. 12 Q. Or that they had agreed with 13 the Food and Drug Administration to proceed with 14 the rechallenge study? 15 A. I don't recall that. 16 Q. Are you familiar with the 17 concept of rechallenge, Mister Wood? 18 A. Not totally. 19 Q. Do you understand it as being 20 a test that can be employed by a pharmaceutical 21 firm which would lead to some scientific 22 conclusions? 23 A. I don't know, I can't respond 24 to that. Page 233 1 Q. Do you recall whether or not 2 you know of any other instance where Eli Lilly 3 and Company was asked to do a rechallenge of any 4 of their other products? 5 A. Yes, uh-huh. I remember the 6 term when used with other products. 7 Q. Has rechallenge been done on 8 other products? 9 A. I don't know. 10 Q. Do you know whether or not the 11 FDA has requested a rechallenge study on other 12 Lilly products? 13 A. I don't recall that. 14 Q. Well, you're familiar with the 15 term to some extent? 16 A. To some degree. 17 Q. The document there says, we 18 have agreed to have the rechallenge protocol 19 ready to go by September 1st, 1991 and to provide 20 data after the first quarter, doesn't it? 21 A. Yes. 22 Q. It also says that Lilly agreed 23 to incorporate the modified scale for suicidal 24 ideation - revised (MSSI-R) in ongoing and Page 234 1 planned US and UK clinical trials, doesn't it? 2 A. Yes. 3 Q. Do you know if a modified 4 scale for suicidal ideation was ever employed at 5 any clinical trials done after May 15th, 1992? 6 A. I have no idea. 7 Q. Do you know what a modified 8 scale of a suicidal ideation revised is? 9 A. No. 10 Q. Have you ever seen one? 11 A. No. 12 Q. Did you know that the clinical 13 trials done prior to May 15th, 1991 by Lilly on 14 Prozac did not use any scale specifically 15 designed to measure suicidal ideations? 16 A. I don't know. 17 Q. It appears that Lilly also 18 agreed to use a modified scale for suicidal 19 ideation as requested by a questionnaire reviewed 20 by other independent investigators and experts. 21 In particular they asked if Doctor Teicher had 22 reviewed the scale or if it had been shared with 23 Doctor Cole. Do you know anything about that, 24 Mister Wood? Page 235 1 A. No. 2 Q. It indicates that Doctor Leber 3 had mentioned that it might be worthwhile to 4 determine what the risk or incidence is of the 5 development of suicidal ideation or these 6 symptoms in garden variety patients for the first 7 time. Do you know of any attempt made by Lilly 8 to do that? 9 A. No. 10 Q. Do any of these suggestions, 11 or does this agreement that Lilly made in May of 12 1991, appear to you, sir, as the chairman of the 13 board in May of 1991, as being reasonable? 14 A. Is this memo reasonable? 15 Q. Is doing the studies 16 reasonable, as far as you're concerned? 17 A. As far as I'm concerned, yes. 18 Q. You wouldn't have any problem 19 with the scientific division going on -- 20 A. If that was their 21 recommendation, no. 22 (PLAINTIFFS' EXHIBIT NO. 22 WAS 23 MARKED FOR IDENTIFICATION AND 24 RECEIVED IN EVIDENCE.) Page 236 1 Q. Have you had an opportunity to 2 read? Exhibit 22 appears to be a document dated 3 July 29th, 1991 authored by Doctor Zerbe, does it 4 not? 5 A. Yes. 6 Q. It's CCs to Doctor 7 M. E. Amundson. Who is Doctor M. E. Admundson, 8 do you know? 9 A. I've heard the name, that's 10 all I can tell you. He's in research. 11 Q. And Doctor Perelman is a 12 recipient also, is that correct? 13 A. Oh, yes, I'm sorry. 14 Q. The subject of this is a 15 telephone conversation with Tom Laughren 16 regarding characterization and the rechallenge 17 protocol, correct? 18 A. Yes. 19 Q. And there again, the Food and 20 Drug Administration is calling to determine 21 whether or not the rechallenge protocol was 22 proceeding, are they not? 23 A. Yes. 24 Q. Were you aware that there were Page 237 1 multiple meetings concerning rechallenge 2 protocol? 3 A. No. 4 (PLAINTIFFS' EXHIBIT NO. 23 WAS 5 MARKED FOR IDENTIFICATION AND 6 RECEIVED IN EVIDENCE.) 7 Q. Have you ever had seen Exhibit 8 23 before? 9 A. No. 10 Q. Have you ever heard of the 11 existence of this document before? 12 A. No. 13 Q. Did you and Mister Perelman 14 ever discuss conversations that Doctor Thompson 15 and Mister Paul Leber might be having together? 16 A. Vaguely, I remember reports on 17 their conversations, but I don't recall what the 18 substance was. 19 Q. The memo states that Paul 20 Leber called yesterday. I contacted him at 6:15 21 a.m. this morning and half hour conversation, 22 very, very pleasant with Paul and Tom Laughren, 23 correct? 24 A. Yes. Page 238 1 Q. Was it Doctor Thompson's usual 2 practice to be making long distance phone calls 3 at 6:15 in the morning to employees? 4 A. He seldom sleeps. 5 Q. Beg pardon? 6 A. My understanding is that he 7 seldom sleeps. 8 Q. My question was, do you know 9 of any other instance where he would be making a 10 phone call to members of the Food and Drug 11 Administration at 6:15 a.m. in the morning? 12 A. I don't know that 13 specifically, no. 14 Q. Does that seem a little 15 unusual to you that they would be having this 16 conversation at this hour of the morning? 17 A. No. 18 Q. Why? 19 A. I know Doctor Thompson. 20 Q. But do you know Doctor Leber 21 or Doctor Laughren? 22 A. No, I can't respond to your 23 question. 24 Q. Do you know whether he Page 239 1 contacted him at home or at his office? 2 A. Oh, I have no idea. 3 Q. The call was about suicide, 4 correct? 5 A. I have no idea. 6 Q. That's what the memo says. 7 A. Well, if that's correct, 8 that's it. 9 Q. The memo says that the call 10 was about suicide. They said this morning's Wall 11 Street Journal article in their minds was 12 "trivial" and the reporter had called them. 13 However, the issue is building and will not go 14 away. They feel some data are required and 15 wanted a study or studies of the issue. And then 16 Doctor Leber suggested several designs, correct? 17 A. Yes, apparently. 18 Q. Do you know whether or not -- 19 he suggested a case controlled retrospective 20 study, correct? 21 A. Yes. 22 Q. Do you know whether or not a 23 case controlled retrospective study was done? 24 A. I have no idea. Page 240 1 Q. Would you have any problem 2 with the scientific end at Eli Lilly doing a case 3 controlled retrospective study? 4 A. If that's what they 5 recommended I would agree with it. 6 Q. If that's what? 7 A. If that's what they 8 recommended, the scientific group, I would go 9 along with it. 10 Q. Or if it was what the Food and 11 Drug Administration recommended? 12 A. And if our scientific people 13 agreed, yes. 14 Q. What if the Food and Drug 15 Administration requested that you do that and 16 your scientific group disagreed? 17 A. I would want to know why. 18 Q. Why what? 19 A. I beg your pardon? 20 Q. Why they disagreed? 21 A. I would want to know why they 22 would disagree. 23 Q. Would you be called in if the 24 Food and Drug Administration were requesting that Page 241 1 a particular study be done and your scientists 2 were disagreeing that that study should be done? 3 A. Would I be called in by whom? 4 Q. By the appropriate authorities 5 at Eli Lilly and Company. 6 A. Would I be called in? 7 Q. To help solve this problem. 8 A. Oh. 9 Q. Let's say the Food and Drug 10 Administration is saying, Lilly -- 11 A. Uh-huh. 12 Q. -- do this study. 13 A. Uh-huh. 14 Q. And do this study in this way. 15 A. Uh-huh. 16 Q. We're the regulatory bodies, 17 we can require you to do this study, correct? 18 A. (Witness moves head up and 19 down.). 20 Q. And your scientific people are 21 saying no, we think it's a bad scientific idea -- 22 A. Uh-huh. 23 Q. -- to do this study. Now, you 24 said you would want to know why -- what reasons Page 242 1 they would have for opposing that study. 2 A. Uh-huh. 3 Q. Correct? 4 A. Uh-huh. 5 Q. Are you going to be the final 6 arbiter of that dispute between the FDA and the 7 scientists? 8 A. No. 9 Q. Who's going to be the final 10 arbiter? 11 A. The Food and Drug 12 Administration. 13 Q. If the Food and Drug 14 Administration would specifically require that 15 Lilly do a study -- 16 A. We would do it. 17 Q. As chief executive officer of 18 Eli Lilly and Company, you would direct that that 19 study would be done, would you not? 20 A. Yes. But I would also expect 21 the scientific folks if they didn't agree with it 22 to make their case before the FDA. 23 Q. What if they made a case and 24 the FDA said sorry, gentlemen, we disagree, we're Page 243 1 requiring that you do that study? 2 A. If they required us to do the 3 study? 4 Q. Yes. 5 A. Then what recourse would we 6 have? 7 Q. Well, I guess you could 8 withdraw the product -- 9 A. Go out of business. 10 Q. -- from consideration. Well, 11 my point is, it's normal for Lilly to comply with 12 Food and Drug Administration requests, is it not, 13 for particular studies, in particular situations? 14 A. I'm not sure what you are 15 suggesting. These memos are different periods of 16 time. They suggest an ongoing discourse with the 17 FDA over a period of many, many months in 18 designing the appropriate studies. 19 Q. I'll tell you what I am 20 suggesting. What we developed, Mister Wood, is 21 that a rechallenge study was requested by the 22 Food and Drug Administration, that Lilly agreed 23 to do a rechallenge study, that Lilly submitted a 24 rechallenge study to the Food and Drug Page 244 1 Administration and the Food and Drug 2 Administration approved that rechallenge study 3 for completion, okay? But the rechallenge study 4 was never, ever done. 5 A. I can't respond to that. 6 Q. All right. Take it -- take my 7 word from it that the unanimous consensus of the 8 testimony has been up to date that a rechallenge 9 study was never done. My question to you is, do 10 you have any explanation, as chief executive 11 officer and chairman of the board of the company, 12 as to why that study wasn't done? 13 A. I have no idea. 14 Q. There was a suggestion made in 15 this memo on Exhibit 23 in connection with this 16 telephone conversation between Doctor Teicher -- 17 I mean between Doctor Leber and Doctor Thompson 18 that a cohart study be done, do you see that? 19 A. Yes. 20 Q. Do you know if a cohort study 21 was ever done? 22 A. I don't know what a cohort 23 study is. 24 Q. So I guess you don't know Page 245 1 whether one was done? 2 A. No. 3 Q. It says that best would be a 4 larger blind prospective study designed with the 5 help of Teicher to detect his phenomena, correct? 6 A. Yes. 7 Q. Do you know if a larger blind 8 prospective study was ever done? 9 A. No. 10 Q. On page two of Exhibit 23 of 11 the Leber memo, Doctor Thompson says, I agreed 12 and committed that Lilly would perform a new 13 study on this issue to be designed in concert 14 with him, with no commitment to design, scope or 15 timing. Do you say that? 16 A. Where is this? 17 Q. I'm sorry, last sentence of 18 the first paragraph of page two. 19 A. Page two? 20 Q. Yes. Do you have any 21 knowledge where the Food and Drug Administration 22 ever relieved Lilly from any obligation to do any 23 particular study raised by this memo? 24 A. I don't know. Page 246 1 Q. The next to the last paragraph 2 of that memo says, Paul, speaking of Doctor 3 Leber, is taking a position in talking with 4 outside folks today that Lilly and the FDA and 5 working together on the suicide issue and 6 following closely the post-marketing events, but 7 that there are no denominaters and the best that 8 can be done is to put a cap on the number of 9 events. Correct? 10 A. Yes. 11 Q. Do you know of any efforts 12 that were done, Mister Wood, to put a cap on the 13 number of post-marketing events? 14 A. I don't know what that phrase 15 means, I don't know of any such activity. 16 Q. Have you ever seen this phrase 17 used before? 18 A. No. 19 Q. Have you ever heard it 20 contended that there was a suggestion by the Food 21 and Drug Administration that Eli Lilly and 22 Company limit the number of adverse events 23 reported on suicide? 24 A. No. Page 247 1 Q. Never brought to your 2 attention? 3 A. No. 4 Q. Does that sentence appear to 5 be ambiguous to you in any respect? 6 A. I don't really know what it 7 means. 8 Q. Is Doctor Leigh Thompson in 9 the habit of writing ambiguous memos with respect 10 to conversations he has had with high ranking 11 members of the Food and Drug Administration? 12 A. I seldom have ever seen his 13 memos. 14 Q. You just don't have any 15 opinion concerning what that paragraph means, do 16 you? 17 A. No. 18 MR. SMITH: Let's take a break. 19 (A SHORT BREAK WAS TAKEN.) 20 (PLAINTIFFS' EXHIBIT NO. 24 WAS 21 MARKED FOR IDENTIFICATION AND 22 RECEIVED IN EVIDENCE.) 23 Q. Mister Wood, you have been 24 handed an exhibit marked as Exhibit 24. I will Page 248 1 ask you to review that document. 2 MR. FREEMAN: Do you want us to read 3 the whole exhibit? 4 MR. SMITH: Why don't you read for 5 present time the first page and the last page. 6 Q. Mister Wood, Exhibit 24 7 appears to be a message from an individual by the 8 name of Claude Bouchy in connection with Hans 9 Weber to Doctor Leigh Thompson, Doctor Allan 10 Weinstein and Doctor Robert Zerbe, members of the 11 scientific medical component here at Lilly. 12 Correct? 13 A. Yes. 14 Q. It's dated November 13th, 15 1990, and has to do with the adverse events 16 reporting in connection with suicide on Prozac, 17 does it not? 18 A. Yes. 19 Q. That document reads that, 20 quote, Hans Weber and I have a problem with the 21 directions our safety people are getting from the 22 corporate group (Drug Epidemiology Unit) and 23 requesting that we change the identification of 24 events as they are reported by physicians. Page 249 1 Correct? 2 A. Yes. 3 Q. Now, the drug epidemiology 4 unit, the DEN system, at Eli Lilly, is that group 5 that is charged with collecting and reporting 6 adverse events in connection with Prozac, is it 7 not? 8 A. Yes. 9 Q. And I believe you told us 10 earlier that it's Lilly's policy to report all 11 adverse events -- 12 A. Yes. 13 Q. -- to all regulatory bodies? 14 A. Correct. 15 Q. Food and Drug Administration? 16 A. Yes. 17 Q. The BGA and whatever 18 appropriate regulatory body would require -- that 19 require reporting, correct? 20 A. No. All -- we sent it to 21 everyone, whether they wanted it or not. 22 Q. Why is that? 23 A. We just think it's good 24 policy. Page 250 1 Q. Do you think it's good policy 2 to be ambiguous or vague or indefinite with 3 respect to reporting adverse events in connection 4 with Prozac? 5 A. I think it's difficult to be 6 specific at all times by nature of the reporting 7 of these events. 8 Q. This Exhibit 24 is a 9 discussion about the specificity needed in 10 reporting suicides, is it not? 11 A. Yes. 12 Q. And overdoses, is it not? 13 A. Yes. 14 Q. And it's -- your individuals 15 in Germany have a problem with the directions 16 they're getting from corporate in Indianapolis, 17 correct? 18 A. Yes. 19 Q. And they identify a particular 20 instance where the safety staff, I assume in 21 Germany, was requested to change the event term 22 suicide attempt, which was reported by the 23 physician, to the term overdose. Correct? 24 A. Yes. Page 251 1 Q. In other words, apparently 2 someone had attempted suicide and that had been 3 reported by the physician to Lilly in Germany, 4 correct? 5 A. Yes. 6 Q. And that had been communicated 7 to Lilly in Indianapolis, correct? 8 A. Yes. 9 Q. And Lilly in Indianapolis had 10 instructed the individuals in Germany to change 11 the event term from suicide attempt to overdose, 12 hadn't they? 13 A. Yes. 14 Q. In another instance, there had 15 been a report of suicidal ideation and the 16 instructions had been to change the term suicidal 17 ideation to depression, correct? 18 A. Yes. 19 Q. And Doctor Weber says, and 20 Doctor Bouchy says, Hans has a medical problem 21 with these directions and I have great concerns 22 about it. I do not think I could explain to the 23 BGA, to a judge, to a reporter or even to my 24 family why we would do this, especially on the Page 252 1 sensitive issue of suicide and suicide ideation. 2 Correct? 3 A. Yes. 4 Q. Do you agree with Doctor 5 Bouchy there that this would be hard to explain 6 to the BGA, to a judge, to a reporter or to your 7 family? 8 A. On the surface, yes. I would 9 have to know more about it. 10 Q. I assume you have not seen 11 this document. 12 A. Never. 13 Q. It says that -- Doctor Bouchy 14 says, this issue has been argued back and forth 15 for about a month between Bad Hamburg and Indy. 16 Therefore, I'm bringing it to your attention and 17 want your directions. Regards, Claude Bouchy. 18 Right? 19 A. Uh-huh. 20 Q. And the second page of this 21 document is Doctor Leigh Thompson's reply, 22 correct? 23 A. Yes. 24 Q. And Doctor Thompson admits Page 253 1 that this is a good and important point, doesn't 2 he? 3 A. Yes. 4 Q. And that he was asking that 5 Bob Zerbe and Allan Weinstein organize a group to 6 discuss it, doesn't he? 7 A. Yes. 8 Q. Do you know if that group was 9 ever organized? 10 A. I have no idea. 11 Q. Do you know whether there were 12 ever any further discussions? 13 A. I was never aware of this 14 entire subject. 15 Q. Did Doctor Leigh Thompson ever 16 bring this up to you in any respect? 17 A. No. 18 Q. On the third page of the 19 document, after Doctor Thompson has replied, 20 Doctor Bouchy replies again, does he not? 21 A. Yes. 22 Q. He says, thank you very much 23 for your prompt answer and your detailed 24 explanation. Hans and I rediscussed the issue in Page 254 1 depth. He says, our point is the following: 2 Physician has reported a suicide attempt. Do we 3 have a right to change it to some terminology 4 which we may consider to be more specific, that 5 is overdose, but which is not free from ambiguity 6 and could be regarded as inaccurate or 7 misleading. He goes on to say, the term overdose 8 is not free from ambiguity because there are 9 clearly forms of overdose which are not related 10 to suicide attempts, for instance wrong dose 11 prescription or dispensed error on the part of 12 the patient, et cetera. In fact, and perhaps 13 more importantly, the dictionaries we have looked 14 at, medical dictionaries and non-medical 15 dictionaries, failed to associate, not to mention 16 equal, the concept of overdose with suicide 17 attempt. Correct? 18 A. Yes. 19 Q. Do you agree with that, with 20 Doctor Bouchy's analysis? 21 A. On the surface, yes. 22 Q. He goes on to say, finally on 23 a very simple and non-scientific basis, I 24 personally wonder whether we are really helping Page 255 1 the credibility of an excellent ADE system by 2 calling overdose what a physician reports as 3 suicide attempt and by calling depression what a 4 physician is reporting as suicidal ideation. We 5 fully realize that there is no code in our DEN 6 system for suicide ideation, but it could be 7 argued by people who have little sympathy for the 8 company or by regulatory authorities that it is 9 not a responsible way to deal with an issue which 10 is getting so much attention in the scientific 11 and in the general press. Correct? 12 A. Yes. 13 Q. Do you agree with that, Mister 14 Wood? 15 A. Yes. 16 Q. Did you know that in 1977, 17 Mister Wood, the clinical trials on Prozac were 18 discontinued because they had failed to 19 demonstrate efficacy? 20 A. No. 21 Q. I take it by that answer that 22 no one made you aware that the clinical trials 23 had been discontinued in 1977? 24 A. I don't recall it. Page 256 1 Q. And you weren't involved in 2 the decision to discontinue the clinical trials? 3 A. Not that I remember, nor would 4 I ever be. 5 Q. Were you advised that in 1977 6 those clinical trials that had been run up to 7 that date had shown an increase in agitation -- 8 A. No. 9 Q. -- at larger doses? 10 A. No. 11 Q. Were you aware that when the 12 clinical trials were resumed that there were 13 additions of concomitant medications such as 14 chloral hydrate for sleep and benzodiazepine for 15 agitation? 16 A. No, I think we covered that 17 earlier. 18 Q. Well, I didn't know if we had 19 covered it in the period of 1977. 20 A. No. 21 Q. You were not advised of that? 22 A. (Witness moves head from side 23 to side.) 24 MS. ZETTLER: You have to answer Page 257 1 aloud. 2 A. The answer is no. 3 Q. Would that have been 4 significant to you in any respect? 5 A. No, not necessarily. 6 Q. Can you conceive of any 7 instance when it would have been significant to 8 you? 9 A. This is a generic question? 10 Q. Yes. 11 A. Oh, it's conceivable, but 12 that's not an abnormal event in the life of 13 research. 14 Q. The reason I ask the question 15 was, you said it wouldn't necessarily be 16 surprising to you. 17 A. No, clinical trials are 18 stopped on products occasionally, it's not an 19 unusual event. 20 Q. Do you know how much money was 21 spent by Eli Lilly in the research and 22 development of Prozac? 23 A. No, I do not. 24 Q. Do you know whether or not Page 258 1 there was a separate accounting kept that would 2 identify specific amounts of money developed -- 3 spent on the research and development of Prozac 4 by Eli Lilly and Company? 5 A. I do not know that. 6 Q. Who at Eli Lilly would have 7 that information? 8 A. The research organization has 9 their own financial operation. 10 Q. Is DISTA Products simply a 11 marketing arm? 12 A. Yes. 13 Q. There's no president of DISTA 14 Products? 15 A. There used to be, uh-huh. 16 Q. But there's not now? 17 A. I don't think. 18 Q. Was there at any time during 19 the development of Prozac that DISTA had a 20 president? 21 A. I think so. 22 Q. When would that have been and 23 who would that have been? 24 A. I don't know that it was Page 259 1 during the time of Prozac. When it was formed, 2 there was a president of DISTA, but that was way 3 back in the '70's. 4 Q. But DISTA has no function 5 other than being a marketing arm for Eli Lilly 6 and Company? 7 A. It's another group of sales 8 and marketing people. 9 Q. But all sales of Prozac were 10 made through the DISTA arm, were they not? 11 A. The promotion was made by the 12 DISTA arm. 13 Q. Well, if you were to get a 14 pulvule of Prozac now, I believe it would stay 15 DISTA on it, would it not? 16 A. Uh-huh, probably. 17 Q. And if you look in the 18 Physican's Desk Reference for a description of 19 Prozac -- 20 A. Uh-huh. 21 Q. -- it would be listed under 22 DISTA? 23 A. I don't know that. 24 Q. Do you know what the total Page 260 1 sales were for Prozac in the calendar year 1993? 2 A. No, I do not. 3 Q. Do you have an approximate 4 figure? 5 A. No. It would be large. 6 Q. Would it be contained in the 7 quarterly report of the corporation? 8 A. In the quarterly report, no. 9 Q. Or the annual report? 10 A. In the annual report would 11 have broken down a category in which Prozac would 12 be a part, called CNS, central nervous system 13 drugs. 14 Q. Do you recall the percentage 15 of sales that Prozac comprises versus the other 16 medications? 17 A. No. 18 Q. Were you aware of a study that 19 was done in Taiwan comparing Prozac with 20 Maprotiline wherein the Prozac group there were 21 seven individuals out of sixty who had attempted 22 suicide, and of the Maprotiline group, there were 23 no individuals who reported suicide attempts? 24 A. No. Page 261 1 Q. This would have been 2 information that would have been learned in May 3 of 1992, spring of '92? 4 A. Uh-huh. 5 Q. Is that a yes? 6 A. I don't know. 7 Q. And in the spring of 1992, you 8 had retired, is that correct? 9 A. Yes. 10 (PLAINTIFFS' EXHIBIT NO. 25 WAS 11 MARKED FOR IDENTIFICATION AND 12 RECEIVED IN EVIDENCE.) 13 Q. Exhibit 25 appears to be 14 another early morning memo directed by, or 15 produced by Doctor Thompson, does it not? 16 A. Yes. 17 Q. Dated October 23rd, 1989, 6:42 18 a.m. 19 A. 6:43. 20 Q. All right. That was a memo to 21 Doctor Perelman, correct? 22 A. To Allan Weinstein -- oh, I'm 23 sorry, I'm looking at the wrong one. Yes, 6:42 24 is right, yes, I was looking above. Page 262 1 Q. And that memo is directed to, 2 among others, Doctor Mel Perelman? 3 A. Yes. 4 Q. At that time in October of 5 '89, was he president of Lilly Research Labs? 6 A. I think so. 7 Q. There Doctor Thompson reports 8 that I'm not sure I want to tell you this -- to 9 tell this (don't kill the messenger) but Keith 10 Powell just called to inform me that fluoxetine 11 and something clinical trial materials may have 12 active drug contaminated placebo capsules. 13 Correct? 14 A. Yes. 15 Q. Is this a serious problem in 16 your judgment -- 17 A. I have no idea. 18 Q. -- Mister Wood? 19 A. I don't know. 20 Q. He said one trial is in 21 Denmark, a bulimia, just started and they are 22 stopping trial and impounding drug to see if it 23 is affected. Second trial is hindmarsh in UK, 24 have you ever heard of hindmarsh? Page 263 1 A. No. 2 Q. It says, which is an overage 3 trial, which I think sounds like testing if 4 additional dose is beneficial. This has been 5 ongoing and may be contaminated. Worst news, 6 though perhaps the least deadly, is the Guy's 7 blank materials may be contaminated. They are 8 rushing good stuff to Guys for "todays" doses. 9 Questions as to why, how, et cetera, aren't 10 answered too well. Theory is that the placebos 11 and actives are in the same room but separated by 12 screen and they might get mixed up at the end. I 13 explained my dismay at third event in short 14 period from one site and urged to have report -- 15 urged Keith to have report to us ASAP, Friday 16 latest, on all three events, what they thought 17 possible problems in procedures might be, and to 18 fix that will absolutely prevent number four, 19 which I suggested none of us would survive. I 20 hope to -- I mobilized him to mount a high level 21 and top effort to do this immediately (Bob is out 22 of town). Were you aware of this problem at all? 23 A. No. 24 Q. When he talks about mounting a Page 264 1 high level and top effort, he's not talking about 2 a level -- 3 A. I have know idea. 4 Q. -- such as yourself. He says, 5 don't know what else I can do, I'm darn tired of 6 hearing of travellers or passengers. Have you 7 ever heard that term, Mister Wood? 8 A. No. 9 Q. You can't give us any insight 10 as to what he's referring to? 11 A. I have no idea. 12 Q. Were you ever consulted or did 13 you ever make any inquiry, Mister Wood, 14 concerning whether or not there might be a 15 problem in connection with the dosage that Prozac 16 was being manufactured at? 17 A. No. 18 (PLAINTIFFS' EXHIBIT NO. 26 WAS 19 MARKED FOR IDENTIFICATION AND 20 RECEIVED IN EVIDENCE.) 21 Q. Exhibit 26 is a three page 22 document dated June 13th, 1988, authored by 23 Doctor Leigh Thompson addressed primarily to 24 Doctor Masica, correct? Page 265 1 A. Yes. 2 Q. In the second page of that -- 3 the second paragraph of the first page of that 4 document, Doctor Leigh Thompson advises that, 5 quote, there is tremendous pressure, from gurus 6 and practicing psychiatrists, to make 10 7 milligram (or even 5 milligram) available. They 8 are wrong that 20 milligrams is "excessive" from 9 the safety data we have, but they would not lose 10 appreciable efficacy at 10 milligrams. As they 11 will titrate (and are) between (5) 10 and 40 12 milligrams daily, no matter what we do, we should 13 make it easier for them. I'd agree with the 14 proposal to make available a 10 milligram dose 15 without changing the labeled dose guidelines as 16 soon as possible. Then it goes on to say in the 17 middle paragraph, I heard that GPs are using 80 18 milligrams and the psychiatrists and I were 19 concerned with doses this great. Correct? 20 A. That's what it says, yes. 21 Q. Were you made aware in June, 22 1988, that there was tremendous pressure from 23 gurus and practicing psychiatrists to make 10 or 24 5 milligram Prozac available? Page 266 1 A. I was aware there were 2 requests. I think to characterize it as any more 3 than that is not appropriate. 4 Q. You mean -- 5 A. There was no great big clamor 6 for other dosage. 7 Q. So you would disagree with 8 Doctor Thompson where he says there is tremendous 9 pressure? 10 A. Yes. The word tremendous 11 pressure is overstating it, in my view. There 12 were requests, but no tremendous pressure. 13 (PLAINTIFFS' EXHIBIT NO. 27 WAS 14 MARKED FOR IDENTIFICATION AND 15 RECEIVED IN EVIDENCE.) 16 Q. Exhibit 26 is a memorandum 17 issued by Doctor Gary Tauscher, dated July 7th, 18 1988 is it not? 19 A. Yes. 20 Q. And it concerns Prozac dosage 21 forms, does it not? 22 A. Yes, uh-huh. 23 Q. And apparently he was getting 24 input from the CNS medical team, correct? Page 267 1 A. Apparently. 2 Q. And all three physicians at 3 Lilly in the CNS medical team had received 4 requests for a lower dose from a broad range of 5 psychiatrists, hadn't they? 6 A. Uh-huh, that's what it says. 7 Q. Well, do you disagree with 8 that? 9 A. Well, I think the whole issue 10 was over blown. 11 Q. Why? 12 A. Well, first of all, I think 13 the reason for this, in my judgment, was that 14 psychiatrists ordinarily titrate the dosage up to 15 the desired level or the recommended level. We 16 came up with a fixed dosage regimen which was new 17 for them and they couldn't play with the dosage. 18 Q. It was supposed to be 19 therapeutic at the fixed dosage, was it not? 20 A. Yes, it is. 21 Q. I'm sorry, I didn't mean to 22 interrupt you. 23 A. Since then we have added other 24 forms which provide the psychiatrists with some Page 268 1 flexibility and they are very low sellers. By 2 all odds, the recommended dose is the one that's 3 prescribed. 4 Q. Well, that's because it's the 5 psychiatrists that like to titrate the dosage, 6 correct? 7 A. I beg your pardon? 8 Q. It's the psychiatrists that 9 like to titrate the dosage? 10 A. Yes. 11 Q. But Prozac is actually being 12 prescribed in far greater numbers by general 13 practitioners and physicians who are trained in 14 disciplines -- 15 A. That's true. 16 Q. -- other than psychiatry, 17 isn't it? 18 A. Yes. 19 Q. And twenty milligrams, saying 20 that that's an effective therapeutic dose, makes 21 it very advantageous from a marketing standpoint 22 to get GPs to prescribe it at twenty milligrams, 23 doesn't it? 24 A. Well, it makes it easier for Page 269 1 everyone to prescribe the proper dose, whether 2 he's a psychiatrist or a general practitioner. 3 Q. But the great majority of 4 Prozac, at this time, and when you retired from 5 the Board, was being prescribed by general 6 practitioners, was it not? 7 A. Yes. But if you look at how 8 psychiatrists prescribed the drug, you will find 9 very little usage of the other dosage forms. 10 Q. When was it that ten 11 milligrams -- 12 A. I don't know. 13 Q. -- began being produced? 14 A. I do not know. 15 Q. Can you give me any idea of 16 comparison in sales of ten milligrams versus 17 twenty milligrams? 18 A. Oh, it's minutia. 19 Q. Did you think it was a 20 mistake? 21 A. No. 22 Q. To manufacture Prozac at ten 23 milligrams? 24 A. No. Page 270 1 Q. Why? 2 A. If the psychiatrist wants it, 3 I think you should make it available. But I 4 think the demand -- so-called demand was far over 5 blown. It became an emotional issue with some 6 people and in reality the usage has not been that 7 great in the market place. 8 Q. You say it became an emotional 9 issue, in what respect? 10 A. Well, read Doctor Thompson's 11 memo. 12 Q. All right. 13 A. It's over blown, where he used 14 the phrase tremendous whatever it was. 15 Q. Pressure? 16 A. Pressure. 17 Q. Well, do you agree in 18 connection with Exhibit 26, Mister Wood? 19 A. That what? 20 Q. That the rationale for a lower 21 dosage falls within three patient groups. Number 22 one, side effect of patient tolerance, there are 23 patients who can't tolerate the normal dose and 24 other patients who do well but suffer a dose Page 271 1 related side effect? 2 A. Well, as I say, there could be 3 some side uses of the product at different dosage 4 levels. But it's a very minor need. 5 Q. Doctor Tauscher -- 6 A. He's not a doctor. 7 Q. All right. 8 A. He's in marketing. 9 Q. Marketing. He says based on 10 the request to date and the patient population 11 involved, a five milligram pulvule appears to be 12 the optimum preparation, doesn't he? 13 A. Yes, he does. 14 Q. And do you feel now he was 15 incorrect? 16 A. I think he -- while he's more 17 logical, I think, than Doctor Thompson's 18 memorandum, it's overstated and they didn't go 19 along with the five milligram in any case. 20 Q. Who made the decision 21 ultimately? 22 A. To do what? 23 Q. To manufacture Prozac at a 24 reduced ten milligram form? Page 272 1 A. Product strategy committee, I 2 would guess. 3 Q. Is that a division of medical, 4 or is that a division of marketing? 5 A. Well, at that time, it was a 6 corporate committee in which representatives from 7 the key components of the corporation belonged. 8 Q. All right. Did you have any 9 input on the decision -- 10 A. No. 11 Q. -- to manufacture Prozac in 12 ten milligrams? 13 A. No. 14 (PLAINTIFF'S EXHIBIT NO. 28 WAS MARKED 15 IDENTIFICATION AND RECEIVED IN EVIDENCE) 16 Q. This is a -- Exhibit 27 is a 17 document, eighteen months later than 26. 18 A. Yes. 19 Q. Let me give you time to read 20 it first. 21 (WITNESS READS DOCUMENT.) 22 Q. Have you seen Exhibit 28 23 before? 24 A. No, uh-uh. Page 273 1 Q. There Doctor Heiligenstein by 2 date of November 7th, 1990, advises Doctor Leigh 3 Thompson -- and was Doctor Leigh Thompson in 4 November, 1990 the chief scientific officer at 5 Lilly? 6 A. I don't recall what his title 7 was. 8 Q. He's talking about, that is 9 Doctor Heiligenstein, he's talking about a 10 meeting in Vienna where he says clearly, very 11 clearly there is a need for a lower dose in 12 pulvule form, 5 milligram would be the most 13 appropriate although at the child psychiatry 14 meetings in Chicago two and a half milligrams was 15 suggested. A liquid formulation will only 16 partially address this need. In point two he 17 says we have not established the lowest effective 18 dose and if we listen to the prescribers, some 19 efforts should be made to do this. If not, 20 M.D.'s will continue to dissolve pulvules and 21 will anxiously await new medications with greater 22 flexibility in dosing. Correct? 23 A. That's what it says. 24 Q. Do you agree with that point Page 274 1 two? 2 A. No. 3 Q. Disagree? 4 A. Yes. 5 Q. Based on what? 6 A. That's my opinion. I think 7 that he's suggesting there's a real need for a 8 lower dose and that's not been the case, it's not 9 been proven out. I didn't believe it in the 10 beginning. 11 Q. You didn't believe it in the 12 beginning? 13 A. No. 14 Q. And you don't believe it now? 15 A. No. But that doesn't mean we 16 shouldn't have one. 17 Q. I understand. He says that we 18 have not established the lowest effective dose. 19 A. Oh, I don't know about that. 20 Q. All right. You don't know 21 whether he's right or wrong in that? 22 A. On the lowest dose, I do not 23 know. 24 Q. I had asked you if you had Page 275 1 ever had any social engagements with members of 2 the Food and Drug Administration. Both president 3 Bush and Vice-president Quale have been with the 4 government of course and they have been 5 associated with Eli Lilly in some capacity. 6 A. The president has, Mister 7 Quale has not. 8 Q. It's my understanding, Mister 9 Quale had family members that were employees at 10 Eli Lilly. 11 A. No. He had in-laws, there was 12 one in-law, years and years ago. 13 Q. All right. Have you ever had 14 any social activities with president Bush or 15 Vice-president Quale? 16 A. Yes. 17 Q. In what connection? 18 A. Social events. 19 Q. When was the last -- 20 A. Rarely. 21 Q. When was the last time that 22 you attended a social event with either president 23 Bush or Vice-president Quale? 24 A. A social event for the Page 276 1 president was when he was in the White House. 2 With Mister Quale, when he returned from 3 Washington to Indianapolis after his election 4 defeat. 5 Q. Was that at his house, your 6 house? 7 A. No. It was at a business sort 8 of luncheon to welcome him back to the community. 9 Q. And have you had any social 10 engagement with him since he's been back? 11 A. No. 12 Q. And when you met with 13 president Bush last, did you meet with him at the 14 White House? 15 A. Yes, it was a State dinner. 16 Q. Have you discussed Prozac in 17 any way or the issue of Prozac and suicidality? 18 A. I have never discussed 19 corporate business with the president. 20 Q. Or the Vice-president? 21 A. Or the Vice-president. 22 MR. SMITH: It's 4:30 at this time. I 23 have not completed my questions of Mister Wood 24 and reserve -- would request that we adjourn this Page 277 1 deposition to reschedule -- potentially 2 reschedule at a later date convenient to Mister 3 Wood and the parties. 4 MR. FREEMAN: We will have to take 5 that up with the court. 6 MS. ZETTLER: Well, I haven't had any 7 opportunity, whatsoever, to ask any questions. 8 MR. FREEMAN: We'll take it up with 9 the court. Thank you, ladies and gentlemen. 10 MS. ZETTLER: Thank you, Mister Woods. 11 (THE WITNESS WAS EXCUSED.) Page 278 1 COMMONWEALTH OF KENTUCKY ) 2 : ss COUNTY OF JEFFERSON ) 3 4 I, MARY KATHLEEN NOLD, A NOTARY PUBLIC IN 5 AND FOR THE STATE OF KENTUCKY AT LARGE, DO HEREBY 6 CERTIFY THAT THE FOREGOING TESTIMONY OF 7 RICHARD WOOD 8 WAS TAKEN BEFORE ME AT THE TIME AND PLACE AS 9 STATED IN THE CAPTION; THAT THE WITNESS WAS FIRST 10 DULY SWORN TO TELL THE TRUTH, THE WHOLE TRUTH, 11 AND NOTHING BUT THE TRUTH; THAT THE SAID 12 PROCEEDINGS WERE TAKEN DOWN BY ME IN STENOGRAPHIC 13 NOTES AND AFTERWARDS TRANSCRIBED UNDER MY 14 DIRECTION; THAT IT IS A TRUE, COMPLETE AND 15 CORRECT TRANSCRIPT OF THE SAID PROCEEDINGS SO 16 HAD; THAT THE APPEARANCES WERE AS STATED IN THE 17 CAPTION. 18 WITNESS MY SIGNATURE THIS THE 10TH DAY OF 19 JUNE, 1994. 20 MY COMMISSION EXPIRES MARCH 10, 1994. 21 22 23 _________________________ MARY KATHLEEN NOLD 24 COURT REPORTER AND NOTARY PUBLIC STATE OF KENTUCKY AT LARGE Page 279 1 2 3 E R R A T A S H E E T 4 5 STATE OF INDIANA ) : SS 6 COUNTY OF ) 7 8 I, RICHARD WOOD, THE UNDERSIGNED 9 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 10 OF MY DEPOSITION AND WITH THE CHANGES NOTED 11 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 12 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 13 THE 12TH DAY OF MAY, 1994 AT THE TIME AND PLACE 14 STATED THEREIN. 15 PAGE NO. LINE NO. CHANGE REASON Page 280 1 PAGE NO. LINE NO. CHANGE REASON 2 3 4 5 6 7 8 _____________________________ 9 RICHARD WOOD 10 SWORN TO AND SUBSCRIBED BEFORE ME THIS 11 _____ DAY OF __________, 1994. 12 _____________________________ NOTARY PUBLIC, STATE OF 13 INDIANA AT LARGE Page 281 1 2 3 4 5 6 7 Page 282 1 COMES RICHARD WOOD,...............................13 2 (PLAINTIFFS' EXHIBIT NO. 1 .......................71 3 (PLAINTIFFS' EXHIBIT NO. 2........................81 4 (PLAINTIFFS' EXHIBIT NO. 3........................90 5 (PLAINTIFFS' EXHIBIT NO. 4.......................109 6 (PLAINTIFFS' EXHIBIT NO. 5.......................118 7 (PLAINTIFFS' EXHIBIT NO. 6.......................127 8 (PLAINTIFFS' EXHIBIT NO. 7.......................132 9 (PLAINTIFFS' EXHIBIT NO. 8.......................143 10 (PLAINTIFF'S EXHIBIT NO. 9.......................158 11 (PLAINTIFFS' EXHIBIT NO. 10......................168 12 (PLAINTIFFS' EXHIBIT NO. 11......................185 13 (PLAINTIFFS' EXHIBIT NO. 12......................188 14 (PLAINTIFFS' EXHIBIT NO. 13......................192 15 (PLAINTIFFS' EXHIBIT NO. 14......................194 16 (PLAINTIFFS' EXHIBIT NO. 15......................200 17 (PLAINTIFFS' EXHIBIT NO. 16......................209 18 (PLAINTIFFS' EXHIBIT NO. 17......................216 19 (PLAINTIFFS' EXHIBIT NO. 18......................218 20 (PLAINTIFFS' EXHIBIT NO. 19......................224 21 (PLAINTIFFS' EXHIBIT NO. 20......................231 22 (PLAINTIFFS' EXHIBIT NO. 21......................232 23 (PLAINTIFFS' EXHIBIT NO. 22......................236 24 (PLAINTIFFS' EXHIBIT NO. 23......................238 Page 283 1 (PLAINTIFFS' EXHIBIT NO. 24......................248 2 (PLAINTIFFS' EXHIBIT NO. 25......................262 3 (PLAINTIFFS' EXHIBIT NO. 26......................265 4 (PLAINTIFFS' EXHIBIT NO. 27......................267 5 (PLAINTIFF'S EXHIBIT NO. 28......................273 6 7 8 9 10 11 12 13 14 15 16 17 18 19 Page 284