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: MERLE AMUNDSON 11 DATE: AUGUST 10, 1993 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 ) 16 * * * * * * * * * * Page 3 1 IN THE UNITED STATES DISTRICT COURT 2 FOR THE WESTERN DISTRICT OF TEXAS SAN ANTONIO DIVISION 3 ELIZABETH T. SANCHEZ, ) 4 INDIVIDUALLY AND AS THE ) SURVIVING SPOUSE, MARGARET R. ) 5 SANCHEZ, INDIVIDUALLY AND NEXT ) OF FRIEND OF DEBRA JEAN ) 6 SANCHEZ, VERONICA MARIE ) SANCHEZ, EDWARDO ESTEBAN ) 7 SANCHEZ, AND MICHAEL ANTHONY ) SANCHEZ, CHILDREN; AND ALL ON ) 8 BEHALF OF THE ESTATE OF ) EDWARDO SANCHEZ ) 9 ) V. ) CIVIL ACTION NO. 10 ) SA93CA367 ELI LILLY AND COMPANY AND ) 11 DISTA PRODUCTS COMPANY ) 12 * * * * * * * * * * 13 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS 14 HOUSTON DIVISION 15 MARIA SANCHEZ, INDIVIDUALLY ) AND AS NEXT FRIEND OF DEBORAH ) 16 SANCHEZ, VERONICA SANCHEZ, ) EDDIE SANCHEZ, AND MICHAEL ) 17 SANCHEZ, AND ON BEHALF OF THE ) ESTATE OF EDUARDO SANCHEZ ) 18 ) V. ) CIVIL ACTION NO. 19 ) H-93-1469 ELI LILLY AND COMPANY AND ) 20 DISTA PRODUCTS COMPANY, A ) DIVISION OF ELI LILLY AND ) 21 COMPANY ) Page 4 1 * * * * * * * * * * 2 STATE OF NEW YORK 3 SUPREME COURT COUNTY OF JEFFERSON 4 _____________________________________________ 5 STEPHANIE CAPONE, AS EXECUTOR OF THE ESTATE OF JOSEPH J. CAPONE, JR., AND 6 STEPHANIE CAPONE, INDIVIDUALL, NOTICE TO TAKE 7 PLAINTIFF, DEPOSITION UPON ORAL EXAMINATION 8 VS. INDEX NO. 93-251 9 ELI LILLY AND COMPANY, DISTA PRODUCTS 10 COMPANY, A DIVISION OF ELI LILLY AND COMPANY, FLOYD BAJJALY, M.D, 11 DEFENDANTS. 12 _____________________________________________ 13 * * * * * * * * * * 14 SUPREME COURT OF TEH STATE OF NEW YORK COUNTY OF ORANGE 15 --------------------------------------X BRUCE R. MALEN AS EXECUTOR OF THE : INDEX NO. 16 ESTATE OF BARBARA E. MALEN, AND OF : 4119/92 BRUCE R. MALEN, INDIVIDUALLY, : 17 : HON. PETER PLAINTIFF : PATSALOS, 18 : J.S.C. -against- : 19 : ELI LILLY & COMPANY, DISTA PRODUCTS : 20 COMPANY, A DIVISION OF ELI LILLY & : COMPANY, BARRY SINGER AND UNITED : 21 HOSPITAL, : : 22 DEFENDANTS. : --------------------------------------X 23 * * * * * * * * * * Page 5 1 ---------------------------------X 2 VALARIE J. FRIEDMAN AND DAVID : SUPERIOR COURT FRIEDMAN, HER HUSBAND, : OF NEW JERSEY 3 : LAW DIVISION: PLAINTIFF, : MIDDLESEX COUNTY 4 : DOCKET NO. : L-3191-91 5 VS. : : 6 ELI LILLY & COMPANY; DISTA : PRODUCTS INC, A DIVISION OF : 7 ELI LILLY & COMPANY; LISS : PHARMACY; MADISON PHARMACY AND : 8 JOHN DOES NOS. 1-25 (UNKNOWN : ENTITIES), : 9 : DEFENDANTS. : 10 ---------------------------------X 11 * * * * * * * * * * 12 SUPREME COURT OF THE STAET OF NEW YORK COUNTY OF SUFFOLK 13 -------------------------------------x 14 RHOMDA L. HALA and JOSEPH L. HALA, : 15 Plaintiffs, : Index No. 14869/90 16 - against - : 17 ELI LILLY & COMPANY and DISTA : PRODUCTS COMPANY, a DIVISION OF 18 ELI LILLY & COMPANY : 19 Defendants. : -------------------------------------x 20 21 * * * * * * * * * * Page 6 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 PATRICIA BRACH, ) ) 4 Plaintiff ) ) 5 v. )No. 92 L 13369 ) 6 ELI LILLY AND COMPANY, a foreign ) corporation; ALAN N. MILLER, M.D., ) 7 WILLIAM BRUINSMA, Psy.D., and ) CONDELL MEMORIAL HOSPITAL, ) 8 ) Defendants. ) 9 * * * * * * * * * * 10 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 11 COUNTY DEPARTMENT - LAW DIVISION 12 RENATO DI SILVESTRO, Individually ) and as Special Administrator of ) 13 the Estate of JOHN DI SILVESTRO, ) Deceased, ) 14 ) Plaintiff, ) 15 ) v. ) No. 91 L 7881 16 ) ROBERT L. NELSON, et al., ) 17 ) Defendants, ) 18 ) GEORGE MELNICK, M.D. and PETER ) 19 FINK, M.D. ) ) 20 Respondents in Discovery.) 21 * * * * * * * * * * Page 7 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 JOAN M. GRYER, ) ) 4 Plaintiff, ) ) 5 v. ) No. 92 L 7387 ) 6 ELI LILLY AND COMPANY, et al., ) ) 7 Defendants. ) 8 * * * * * * * * * * 9 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 10 COUNTY DEPARTMENT, LAW DIVISION 11 JENNIFER HAMMERLI, as Plenary ) Guardian of the Estate of RAY B. ) 12 HAMMERLI, a disabled person, ) ) 13 Plaintiff, ) ) 14 v. ) No. 92 L 2365 ) 15 ELI LILLY AND COMPANY, THE ) UPJOHN COMPANY, DICKIE KAY, M.D., ) 16 (former Respondent in Discovery), ) and RICHARD CZECHOWICZ (former ) 17 Respondent in Discovery), ) ) 18 Defendants. ) 19 * * * * * * * * * * Page 8 1 IN THE CIRCUIT COURT OF THE SIXTH JUDICIAL CIRCUIT 2 CHAMPAIGN COUNTY, ILLINOIS 3 LINDA GARDNER, Individually and ) as Special Administrator of ) 4 the Estate of SHANE GARDNER, ) deceased, ) 5 ) Plaintiff, ) 6 ) v. ) No. 91 L 1066 7 ) ELI LILLY AND COMPANY, a foreign ) 8 corporation, ) ) 9 Defendant. ) 10 * * * * * * * * * * 11 IN THE NINETEENTH JUDICIAL CIRCUIT COURT 12 LAKE COUNTY, ILLINOIS 13 JAMES E. SHEPPARD, Special ) Administrator of the Estate of ) 14 KENNETH K. SHEPPARD, Deceased, ) ) 15 Plaintiff ) ) 16 v. ) No. 93 L 124 ) 17 GOOD SHEPHERD HOSPITAL, a ) corporation, DR. STEWART SEGAL, ) 18 DR. SANFORD SHERMAN, DR. BRUCE ) CARLSON, DR. R. BERGLUND, and ELI ) 19 LILLY & COMPANY, a corporation, ) ) 20 Defendants. ) 21 * * * * * * * * * * Page 9 1 SUPERIOR COURT OF THE STATE OF CALIFORNIA 2 FOR THE COUNTY OF LOS ANGELES 3 DR. MARIUS SAINES, etc., et al., ) Case No: 4 ) SC 008331 Plaintiffs, ) 5 ) vs. ) 6 ) ELI LILLY & COMPANY, a corporation; ) 7 DISTA PRODUCTS COMPANY, a division ) of Eli Lilly & Company; and DOBS 1- ) 8 100, inclusive, ) ) 9 Defendants. ) ____________________________________) 10 11 * * * * * * * * * * Page 10 1 THE DEPOSITION OF MERLE AMUNDSON, TAKEN AT 2 THE OFFICE OF BAKER & DANIELS, 300 NORTH MERIDIAN 3 STREET, SUITE 2700, INDIANAPOLIS, INDIANA 46204, 4 ON AUGUST 10, 1993; SAID DEPOSITION TAKEN 5 PURSUANT TO NOTICE IN ACCORDANCE WITH THE RULES 6 OF CIVIL PROCEDURE. 7 * * * * * * * * * * 8 A P P E A R A N C E S 9 10 NANCY ZETTLER COUNSEL FOR GROUP A PLAINTIFFS 11 LEONARD M. RING AND ASSOCIATES, P.C. 111 WEST WASHINGTON AVENUE, SUITE 1333 12 CHICAGO, ILLINOIS 60602 13 GREGORY GREEN COUNSEL FOR PLAINTIFFS 14 LEONARD L. FINZ, P.C. 222 BROADWAY, 27TH FLOOR 15 NEW YORK, NEW YORK 10038 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 MARGARET M. HUFF 20 ELI LILLY AND COMPANY LILLY CORPORATE CENTER 21 INDIANAPOLIS, INDIANA 46285 22 MICHAEL D. KRAUSE COUNSEL FOR GOOD SHEPHERD HOSPITAL 23 415 WASHINGTON STREET, SUITE 214 WAUKEGAN, ILLINOIS Page 11 1 MIGUEL A. RUIZ COUNSEL FOR DEFENDANTS CZECHOWICZ, FINK, BRUINSMA 2 CLAUSEN MILLER GORMAN CAFFREY & WITOUS 10 SOUTH LASALLE 3 CHICAGO, ILLINOIS 60603 4 PAUL J. CLEMENTI COUNSEL FOR DR. DICKIE KAY 5 HINSHAW & CULBERTSON 222 NORTH LA SALLE STREET, SUITE 300 6 CHICAGO, ILLINOIS 60601-1081 7 KATHERINE L. LAWS COUNSEL FOR DRS. WITSCHY AND KANNEGANTI 8 BAILEY AND WILLIAMS 3500 NCNB PLAZA 9 901 MAIN STREET DALLAS, TEXAS 75202-3714 Page 12 1 I N D E X 2 3 DEPOSITION OF MERLE AMUNDSON 4 5 DIRECT EXAMINATION BY MS. ZETTLER 14 6 CROSS EXAMINATION BY MR. GREEN 224 7 REDIRECT EXAMINATION BY MS. ZETTLER 251 8 9 CERTIFICATE 257 10 ERRATA 258 11 12 EXHIBITS 13 PLAINTIFFS' EXHIBIT NO. 1 73 PLAINTIFFS' EXHIBIT NO. 2 105 14 PLAINTIFFS' EXHIBIT NO. 3 129 PLAINTIFFS' EXHIBIT NO. 4 140 15 PLAINTIFFS' EXHIBIT NO. 5 142 PLAINTIFFS' EXHIBIT NO. 6 172 16 PLAINTIFFS' EXHIBIT NO. 7 177 PLAINTIFFS' EXHIBIT NO. 8 188 17 PLAINTIFFS' EXHIBITS NO. 9 AND 10 197 PLAINTIFFS' EXHIBIT NO. 11 209 18 PLAINTIFFS' EXHIBIT NO. 12 212 PLAINTIFFS' EXHIBIT NO. 13 215 19 20 Page 13 1 COMES MERLE AMUNDSON, PH.D., 2 CALLED BY THE PLAINTIFFS, AND AFTER FIRST BEING 3 DULY SWORN, WAS DEPOSED AND TESTIFIED AS FOLLOWS: 4 DIRECT EXAMINATION 5 BY MS. ZETTLER: 6 Q. Doctor Amundson, state your 7 full name for the record and spell it. 8 A. Merle Edward Amundson, 9 A-M-U-N-D-S-O-N. 10 MS. ZETTLER: Let the record reflect 11 that this is a discovery deposition of Doctor 12 Merle Amundson, taken pursuant to notice and the 13 applicable rules of the state and local courts in 14 Kentucky. 15 Q. Mister Amundson -- Doctor 16 Amundson, I'm sorry. 17 A. Mister is fine. 18 Q. Have you given a deposition 19 before? 20 A. I have not. 21 MR. MYERS: Before you get going, just 22 so the record's clear, the deposition has also 23 been cross noticed in the MDL proceedings and a 24 number of related state court actions as Page 14 1 evidenced by the presence of a number of our 2 friends down here at the end of the table. 3 MS. LAWS: And I assume we're under the 4 same agreements as we were for Jeff Powell's 5 deposition, today. 6 MR. MYERS: Form of the question and 7 responsiveness of the answer for objections, 8 that's fine. 9 MS. ZETTLER: And all of the objections 10 to cross noticing are the same. 11 MR. MYERS: Right. 12 Q. (BY MS. ZETTLER) So you have 13 not given a deposition before, Doctor? 14 A. I have not. 15 Q. Have you ever testified in any 16 capacity? 17 A. No, ma'am. 18 Q. Let me give you some of the 19 ground rules before we get started so I can make 20 sure we're on same wave length. 21 The first thing, you have to 22 answer everything out loud, you can't shake your 23 head or go uh-huh because she can't take that 24 down, the court reporter can't take that down. Page 15 1 Is that okay? 2 A. Yes. 3 Q. I'm asking if it's okay so 4 we'll make a record that you understand it. If 5 you need a break at any time, we'll usually take 6 one break in the morning and one in the afternoon 7 and a break for lunch, but if you need a break 8 for any reason at any time, let Larry or I know, 9 okay? 10 A. All right. 11 Q. If you don't understand my 12 question or don't hear my question, and trust me, 13 that'll happen, let me know and I'll rephrase it, 14 okay? 15 A. Okay. 16 Q. If you answer a question, we'll 17 assume you understood it as it was asked, is that 18 fair enough? 19 A. Yes. 20 Q. Would you give us your date of 21 birth? 22 A. August 21, 1936. 23 Q. And what is your social 24 security number? Page 16 1 A. XXXXXXXXXXX. 2 Q. What is your current address? 3 A. XXXXXXXXXXXXXXXXXXX, 4 XXXXXXXXXXXXXXXXXXXXXXXXX. 5 Q. Okay. And you're an M.D., 6 right? 7 A. No, I'm a Ph.D. 8 Q. Okay. 9 Q. Could you give me a description 10 of your educational history after high school? 11 A. I graduated from South Dakota 12 State University with a bachelors degree in 13 pharmacy and then attended Massachusetts College 14 Of Pharmacy and received a masters degree and a 15 Ph.D degree in pharmacy, respectively. 16 Q. And you received both your 17 masters and your Ph.D from Massachusetts? 18 A. Correct, yes, ma'am. 19 Q. When did you receive your Ph.D? 20 A. 1961. 21 Q. And how about your masters? 22 A. 1959. 23 Q. Did you go straight through 24 from undergrad through to your Ph.D? Page 17 1 A. Yes. 2 Q. What kind of jobs did you have 3 during the time were you in college, generally? 4 A. Generally, I worked in the 5 summer at general labor, then in graduate school, 6 I became a registered pharmacist in the state of 7 Massachusetts and worked as a pharmacist. 8 Q. Where did you work as a 9 pharmacist? 10 A. In a drugstore on the north end 11 of Boston. 12 Q. Purely retail? 13 A. Yes, ma'am. 14 Q. Then after you got your Ph.D, 15 what did you do? 16 A. I came directly to Eli Lilly 17 and Company. 18 Q. So you began working for Lilly 19 in 1961? 20 A. Correct. 21 Q. You worked there continuously 22 since then? 23 A. Yes. 24 Q. How is it that you became Page 18 1 employed at Lilly? 2 A. There was a Lilly detail man 3 that frequented the college in Boston, became 4 acquainted with him and it was through him that I 5 was introduced to some of the people here and in 6 the normal application review, interview and so 7 forth. 8 Q. Do you remember that man's 9 name? 10 A. I do not. 11 Q. When you said he frequented the 12 college, was he there on a recruiting basis? 13 A. It was a friend -- I think he 14 was a graduate of the Massachusetts College of 15 Pharmacy and came back and was a friend of some 16 of the professors and made social visits. 17 Q. Did he at some point say Merle, 18 there's a job opening at Lilly I want you to 19 interview for, or how is it that you ended up 20 being hooked up with people here? 21 A. He knew I was interested, as I 22 was approaching the end of my doctorate program, 23 and knew I was interested in industry, and I had 24 some brief conversations with him as I recall and Page 19 1 he said why don't you consider Lilly and I had 2 visited Lilly as an undergraduate, in pharmacy 3 school, so I was familiar, somewhat familiar with 4 Lilly. 5 Q. Come down here and take a tour? 6 A. Yes. 7 Q. Prior to interviewing, as part -- 8 A. Yes, I was an undergraduate at 9 that time. 10 Q. What position did you initially 11 interview for? 12 A. I was interviewed for the 13 position of senior analytical chemist. 14 Q. Is that the position that you 15 eventually hired on with? 16 A. Yes. 17 Q. Who did you interview with for 18 that position at Lilly? 19 A. For that position? 20 Q. Right, your initial position. 21 A. The head or manager of that 22 area at that time was a gentleman by the name of 23 Doctor Jack Comer. 24 Q. Could you spell that please? Page 20 1 A. C-O-M-E-R. 2 Q. Is Mister Comer -- I'm sorry, 3 Doctor Comer still with Lilly? 4 A. No. 5 Q. Do you know where he is today? 6 A. Happily retired in Florida, I 7 understand. 8 Q. Did you interview with anybody 9 else? 10 A. There were other people that 11 were in supervisory positions, but I don't 12 remember exactly who they were. 13 Q. Okay. And do you know if 14 Doctor Comer ever worked on Fluoxetine? 15 A. No. 16 Q. No, you don't know, or no, he 17 didn't? 18 A. I don't know. 19 Q. Do you remember when in 1961 20 you started working at Lilly? 21 A. The 17th of July. 22 Q. When you first started at 23 Lilly, were you aware of Fluoxetine? 24 A. I was not. Page 21 1 Q. When did you first become aware 2 of Fluoxetine? 3 A. When I was a part of the 4 toxicology component of the company. 5 Q. Do you remember when, can you 6 give me a year or date when you first became 7 aware of Fluoxetine? 8 A. I can't give you an 9 approximate, you know, exact time, I was there 10 for twelve years sometime in that time frame. 11 Q. You were in toxicology for 12 twelve years? 13 A. Yes. 14 Q. Why don't you give me a run 15 down of the different positions that you held at 16 Lilly. We know that you started as a senior 17 analytical chemist, right? 18 A. Yes. I left the analytical 19 position and went to the Greenfield laboratories 20 and took a position in agricultural product 21 development. I worked at that for about two 22 years and then became the manager of that group 23 and continued in the agricultural part of the 24 company until 1978 at which time I moved over to Page 22 1 toxicology and remained there until 1990, and 2 then joined the medical component for two years 3 and the last position was that of, in the 4 quality, quality department of the organization. 5 Q. When you said medical 6 component, do you mean the medical division? 7 A. Yes. 8 Q. All right, you were a senior 9 analytical chemist for how long? 10 A. A little over five years. 11 Q. When you went -- then you said 12 you went to the Greenfield labs? 13 A. Yes. 14 Q. Where are those located? 15 A. Greenfield, Indiana. 16 Q. Those are Lilly labs? 17 A. Correct. 18 Q. They're Lilly labs that deal 19 mostly with agricultural products? 20 A. Greenfield was the center or is 21 the center of the agricultural research and 22 development activities and the toxicology 23 laboratories and there's a small production unit 24 out there as well. Page 23 1 Q. So when you said you went to 2 toxicology in 1978, you were still working out of 3 the Greenfield labs? 4 A. Correct. 5 Q. And when you said after -- you 6 were at Greenfield labs for about two years 7 before you became a manager? 8 A. Yes. 9 Q. Would that be the manager of 10 the agricultural development? 11 A. Yes. 12 Q. Okay. In your position as 13 senior analytical chemist, did you do any work at 14 all on Fluoxetine? 15 A. I did not. 16 Q. How about in your initial job 17 at the Greenfield labs? 18 A. No. 19 Q. How about as manager of the 20 Greenfield labs -- I'm sorry, manager of the 21 agricultural product development? 22 A. No. 23 Q. Okay. That cuts out a lot of 24 years. I believe you said earlier that sometime Page 24 1 after you went to the toxicology department -- 2 was that the toxicology division? 3 A. Toxicology division. 4 Q. You became aware of Fluoxetine, 5 right? 6 A. Became aware of it, that's 7 correct. 8 Q. Do you remember when you 9 started working on Fluoxetine? 10 A. I do not recall exactly. 11 Q. Would that be about the same 12 time? 13 A. I do not recall exactly when 14 the toxicology studies started on Fluoxetine. 15 Q. Okay. So it was in this 16 position in toxicology that you first began 17 working on Fluoxetine? 18 A. Yes. 19 Q. Would you tell us what a 20 toxicology study is? 21 A. Well, a toxicology study is a 22 laboratory animal study conducted to assess the 23 toxicity of whatever chemical is being tested in 24 that animal species. Page 25 1 Q. Okay. So in other words you 2 would use animals to try to determine what levels 3 of the drug or dosage of the drug people could 4 take before it became toxic? 5 A. During the course of a 6 toxicology valuation, you know what doses of the 7 drug are -- can be tolerated by whatever animal 8 species is being investigated. It doesn't 9 necessarily relate directly to man but it gives 10 one a range of doses or levels or whatever that -- 11 and look at the effects on the animals. 12 Q. So in other words a dog may be 13 able to tolerate eighty milligrams but that 14 doesn't mean a human would be able to tolerate 15 that? 16 A. Correct. 17 Q. Would those toxicology studies 18 include the effects of a drug on various bodily 19 systems? 20 A. Yes. 21 Q. While you were in the 22 toxicology division, was there ever a time that 23 you worked exclusively on Fluoxetine? 24 A. Me, personally? Page 26 1 Q. Yes. 2 A. No. 3 Q. In how many Fluoxetine 4 toxicology studies did you participate to the 5 best of your recollection? 6 A. I can't recall. 7 Q. Do you recall whether or not 8 you participated in studies done on various 9 species, dogs, rats, mice? 10 A. Yes. 11 Q. Did you participate in doing 12 studies, dog studies? 13 A. My participation was I was the 14 administrator of the toxicology division, I did 15 no hands on animal work. 16 Q. Why don't you give me an idea 17 of what your responsibilities as administrator in 18 the toxicology division entailed? 19 A. It entailed staffing, it 20 entailed budgets, it entailed new and remodeled 21 facilities, performance reviews and other 22 personnel related activities. 23 Q. Were you involved in any way 24 with deciding what studies would be performed? Page 27 1 A. Yes. 2 Q. Were you involved in any way 3 with deciding how the results of the studies 4 would be reported, either internally or to 5 regulatory safety agencies like the FDA? 6 A. In certain instances, I was 7 involved in that, not with the specific studies 8 but -- 9 Q. Right now let's concentrate on 10 your work at toxicology. 11 A. Okay. 12 Q. Has that changed your answer at 13 all as far as reporting the results of studies? 14 A. No, it doesn't. 15 Q. Okay. In the course of your 16 work in the toxicology division, did you work 17 with any statisticians? 18 A. Yes. 19 Q. In what capacity? 20 A. We had let me say from one to 21 three statisticians that were assigned to 22 toxicology, to work with the scientific group in 23 toxicology, the design of their studies and 24 evaluation of results. They were not part of the Page 28 1 toxicology structure, they were -- reported 2 elsewhere in the organization. 3 Q. Who was your immediate 4 supervisor while you were in the toxicology 5 division? 6 A. Doctor Doug Morton, Douglas 7 Morton. 8 Q. Does Doctor Morton still work 9 for Lilly? 10 A. Yes. 11 Q. Do you know where he is right 12 now within the structure? 13 A. Yes. 14 Q. Where is he? 15 A. He is at the Greenfield 16 laboratories and he is vice-president. 17 Q. Vice-president of the 18 laboratories? 19 A. Vice-president of -- his 20 primary responsibility is toxicology. 21 Q. Do you know if they're 22 currently doing any studies at Greenfield labs on 23 Fluoxetine? 24 A. I don't know, I do not know. Page 29 1 Q. What was your title, did your 2 title change throughout the time that you worked 3 in the toxicology division or did it remain the 4 same? 5 A. I started as director of 6 toxicology and sometime in the -- during the 7 twelve years I was there, I became executive 8 director and that would have been of Lilly 9 research laboratories. 10 Q. Is Lilly research labs a part 11 of the toxicology division? 12 A. The other way around, 13 toxicology is a part of Lilly research 14 laboratories. 15 Q. So you became executive 16 director of Lilly research labs? 17 A. Correct. 18 Q. Under which toxicology exists, 19 right? 20 A. Yes. 21 Q. When you became executive 22 director of Lilly research labs, did your 23 responsibilities change at all? 24 A. No. Page 30 1 Q. Basically the same type of 2 administrative? 3 A. Yes. 4 Q. Did the area that you manage 5 change at all or is it still the toxicology 6 division? 7 A. Still the toxicology division. 8 Q. And this remained the same 9 until 1990 when you moved over to the medical 10 division? 11 A. Yes. 12 Q. In your position in the 13 toxicology division itself, before you became 14 executive director of Lilly labs, did you have 15 any responsibilities with regards to marketing? 16 A. No. 17 Q. Did you have any interaction 18 with the marketing department or Dista Company? 19 A. I don't recall any interaction 20 with the marketing group. 21 Q. Let's talk about the 22 statisticians that worked with toxicology, I 23 believe you said that they worked on developing 24 or designing the studies, correct? Page 31 1 A. Correct. 2 Q. What kinds of input would they 3 have with regards to the design of a study? 4 A. Well, I think it depended on 5 what was being measured or what was to be 6 measured, but basically they would, they helped 7 with the numbers of animals to be used and 8 knowing what the effect to be measured and how -- 9 what level of confidence you were trying to 10 achieve in that study. The pharmacological 11 aspects of the study were not their 12 responsibilities, it was the numbers business. 13 Q. Would a statistical analysis be 14 decided upon before the trial was run? In other 15 words would they sit down and say okay, we're 16 going to use this statistical analysis on the 17 numbers that we get or the information we get 18 from this trial? 19 A. That is correct. 20 Q. And was that -- do you know if 21 that was true with the clinical trials as well? 22 A. Yes. 23 Q. Yes, it was true? 24 A. Yes, it was true. Page 32 1 Q. So as part of their 2 responsibilities in helping to design the trials, 3 they would discuss with the medical personnel the 4 types of information that you might have analyzed 5 and not the results as meaning the numbers that 6 actually came out, but kind of like you said, the 7 confidence that you were looking for, things of 8 that nature? 9 A. Their responsibility was to 10 help establish what types of analysis, 11 statistical analyses were going to be run at the 12 end of the study, before the study started. 13 Q. Okay. Did the way the study 14 was designed depend upon the types of statistical 15 analysis that was going to be run? 16 MR. MYERS: Are we asking -- are you 17 talking about toxicology now or pharmacology? 18 MS. ZETTLER: Toxicology. 19 A. Would you repeat that? 20 Q. Would the way that the trial 21 itself was designed depend at least in part on 22 what, the type of statistical analysis that was 23 to be run? 24 A. I would say no. Page 33 1 Q. Isn't certain things in the 2 trial affected depending on the type of 3 statistical analysis to be used at the end of the 4 trial such as numbers of patients -- 5 A. Numbers of animals? 6 Q. Yes, numbers of animals, dosage 7 schedules, things of that nature? 8 A. Yes, but I don't think that, 9 you know, that the front end of the study -- yes, 10 numbers of animals, you know, is built upon what 11 kind of analysis you're going to do with the end 12 with what level of confidence, but I don't think 13 it's the driver for the study. 14 Q. Okay. Was it more of an 15 interaction like the medical people would say we 16 want to see for instance how the drug will affect 17 cardiac rates in dogs, the cardiac system in 18 dogs, and then they would work with the 19 statisticians to determine what the best way to 20 analyze that type of data would be? I guess I'm 21 trying just to get an idea of what the 22 interaction would be between the two. 23 A. Studies were set up in animals, 24 or are set up in animals to take a look at the Page 34 1 whole body. 2 Q. Okay. 3 A. So with a large animal, like a 4 dog, one would routinely run heart rates and 5 respirations during the course of the study. If 6 an affect were seen, you know, then you would 7 zero in with a special study. But these studies 8 are very general and look at the whole, all the 9 body systems of the animal. 10 Q. Okay. Is that generally true 11 for all drug trials, would it be start out with 12 the general affect on the total body system and 13 then if something comes up within one of those 14 general tests, you do a special study on it? 15 MR. MYERS: Are we taking about humans 16 or animals? 17 MS. ZETTLER: Animals. 18 A. That is correct. 19 Q. Were you involved in any of the 20 general body system studies, toxicology studies 21 on animals? 22 A. I was not directly involved. 23 Q. Were you aware of the results 24 of any of those studies? Page 35 1 A. I can't recall any specific 2 studies that were done on any specific body 3 systems for Fluoxetine. 4 Q. Do you remember any unusual 5 occurrences during any of the animal studies, as 6 far as when I said that, I mean like abnormally 7 high heart rates in dogs or anything of that 8 nature? 9 A. I do not recall. 10 Q. Do you remember whether or not 11 there were any specific animal studies done, not 12 the general body system studies but anything on 13 any specific area of the body or any specific -- 14 A. I don't recall any special 15 toxicology studies that were run with Fluoxetine, 16 other than the normal studies that would be done 17 for any compound. 18 Q. Just to make sure I'm clear or 19 my question was clear, I mean do you recall there 20 being any studies zeroing in on unusual 21 occurrences during the animal trials? 22 A. I don't recall any specific 23 studies. 24 Q. Okay. Do you recall generally Page 36 1 if there were any specific or any -- not specific 2 studies but any zeroing in studies done on 3 animals? 4 A. I don't recall any. 5 Q. Okay. Who paid for the studies 6 that were run, the toxicology studies that were 7 run on Fluoxetine, if you know? 8 A. Who paid for them? 9 Q. Right. 10 A. Eli Lilly and Company. 11 Q. Okay. Which department? 12 A. There were no cross charges for 13 those studies. Toxicology was part of Lilly 14 research laboratories, charges went as part of 15 Lilly research laboratories. 16 Q. Do you know if the marketing 17 department ever paid for toxicology studies on 18 any drug at Lilly? 19 A. I don't think that they did. 20 Q. Earlier you stated that part of 21 your responsibilities were to decide which 22 studies would be performed, or at least in part 23 help with deciding what studies would be 24 performed. Did you do that with Fluoxetine, were Page 37 1 you involved in the decision on what toxicology 2 studies were to be performed on Fluoxetine? 3 A. I would say that I was, I don't 4 recall specific studies, but there was a study 5 design review group that reviewed all studies 6 that started. 7 Q. How would it be that a study 8 would come before the study design review group, 9 or a proposed study? 10 A. The design would be brought to 11 the study design group by the project leader for 12 the specific compound that was being discussed. 13 Q. Do you recall who the project 14 leader was for Fluoxetine? 15 A. I do not. 16 Q. Would that, to your knowledge, 17 project leader stay the same throughout all 18 phases of the trials, toxicology, clinical, 19 post-marketing? 20 A. No, there would be a project 21 leader specifically for the toxicology studies. 22 Q. As project leader, would the 23 project leader decide which studies to propose to 24 the design group? Page 38 1 A. The project leader was 2 responsible for, you know, the whole of the 3 toxicology that's run on any specific compound. 4 So in consort with their fellow scientists, they 5 would decide on what studies needed to be done in 6 what sequence and then these were brought to the 7 study design review group for approval. 8 Q. So it would be a matter of at 9 least initially coming in and saying we would 10 like to do a dog study? 11 A. No. 12 Q. They would come in and say 13 we're trying to develop this compound, these are 14 the studies we would like to run in toxicology on 15 these various animals and this is where we may go 16 from there or whatever? 17 A. Yes, yes. 18 Q. Do you recognize the name 19 Doctor David Wong? 20 A. Yes. 21 Q. How about Ray Fuller? 22 A. Yes. 23 Q. How about Robert Zerbe? 24 A. Yes. Page 39 1 Q. Brian Molloy? 2 A. Yes. 3 Q. Who is Doctor Wong? 4 A. Doctor Wong is a scientist 5 within the discovery group of Lilly research 6 laboratories. 7 Q. Are you aware of what his role 8 is with regards to the development of Fluoxetine? 9 A. He was a pharmacologist. 10 Q. How about directly with the 11 development of Fluoxetine, were you aware of what 12 his role is? 13 A. I am not aware. 14 Q. How about Ray Fuller, Ray 15 Fuller is a doctor, right? 16 A. Yes. 17 Q. How about Doctor Fuller, who is 18 he? 19 A. Doctor Ray Fuller is a senior 20 scientist within Lilly research laboratories, 21 discovery. 22 Q. Are you aware of what his 23 direct role with regards to the development of 24 Fluoxetine was? Page 40 1 A. Doctor Fuller is also a 2 pharmacologist. 3 Q. How about specifically, are you 4 aware of what Doctor Fuller's role in the 5 development of Fluoxetine was? 6 A. The role of the scientist in 7 discovery is to look at mechanism of action of 8 compounds or to screen compounds for some 9 specific behavior. Doctors Wong and Fuller are 10 involved in doing that. 11 Q. Okay. Would that be the same 12 with Doctor Zerbe? 13 A. Doctor Zerbe is a physician. 14 Q. He's not in the discovery area, 15 is he? 16 A. No. 17 Q. He's in the medical division, I 18 believe, or was? 19 A. Was a member of the medical 20 division. 21 Q. And how about Brian Molloy? 22 A. Brian Molloy is a Doctor, Brian 23 Molloy is a senior scientist type within the 24 discovery portion of Lilly research laboratories. Page 41 1 Q. Are you aware of what Doctor 2 Molloy's direct involvement with the development 3 of Fluoxetine was? 4 A. I believe that he was part of a 5 group that was responsible for synthesizing the 6 compounds. 7 Q. To your knowledge was Doctor 8 Wong and Doctor Fuller also part of that group? 9 A. Yes. 10 Q. Fluoxetine is a man made 11 compound, correct? 12 A. Yes. 13 Q. And this group basically set 14 out to create a compound that would have an 15 affect on serotonin levels, didn't they? 16 A. Yes. 17 Q. When did you become aware of 18 that history? 19 A. I have known those gentlemen 20 for many years. 21 Q. Okay. When is it that the 22 group decided that the compound Fluoxetine was 23 ready to be tested on animals, if you know? 24 MR. MYERS: What group? Page 42 1 MS. ZETTLER: I'm sorry, the 2 development group, I believe Doctors Wong, Fuller 3 and Molloy. 4 A. I do not know. 5 Q. Were you in toxicology when 6 they did the initial animal toxicology studies on 7 Fluoxetine? 8 A. I think I was not, I was not 9 there yet. 10 Q. So that may have been sometime 11 before 1961? 12 A. No, wrong, 1960 -- 1978. 13 MR. MYERS: He started at Lilly in '61. 14 MS. ZETTLER: I'm sorry, you're right. 15 A. I'm reasonably confident that 16 the studies started prior to my arrival in 17 toxicology. 18 Q. Do you know how long the animal 19 toxicology studies on Fluoxetine lasted? 20 A. As a group of studies or 21 individual studies? 22 Q. As a group, let's start as a 23 group. 24 A. I don't know how -- over what Page 43 1 period of time they were conducted. 2 Q. Are additional animal 3 toxicology studies run on a compound when it is 4 going to be tested for various indicated uses? 5 In other words like for instance in depression, 6 with Fluoxetine, animal toxicology studies were 7 run prior to its approval for use with 8 depression, correct? 9 A. Generally toxicology studies 10 are generic in nature, irrespective of what the 11 indication is. 12 Q. But do you know if in the case 13 of Fluoxetine, if additional toxicology studies 14 were run for any reason in anticipation of 15 Fluoxetine being approved for uses in addition to 16 depression? 17 A. I don't know the answer to that 18 question, I previously answered that I couldn't 19 recall any, you know, specific studies that were 20 done to follow-up on any findings in animal 21 studies. 22 Q. Okay. Generally what were the 23 results of the animal toxicology studies on 24 Fluoxetine, did it show that it would be safe for Page 44 1 use in humans? 2 A. I think any toxicology study 3 indicates what levels of compounds will have 4 dilatorious effects on the animals that are being 5 tested, it doesn't -- and then based upon that, 6 the clinician, the physician group is responsible 7 for deciding at what levels the compound will be 8 first tested in humans, Phase 1 test. 9 Q. So it's not a matter of 10 deciding at least at the animal toxicology level 11 if the drug would be safe for use with humans, 12 it's more of a matter of trying to figure out a 13 toxicology level or toxic level of the compound? 14 A. Toxicology studies define the 15 maximum dose that can be tolerated by an animal 16 and a minimum is -- there isn't any minimum dose, 17 but it's a maximum dose determination. 18 Q. Then the next step would be to 19 recruit healthy volunteers and give them the drug 20 and see what kind of effect it had on them, not 21 from an in this case antidepressent point of view 22 but on the various body systems? 23 A. Safety, systems. 24 Q. Then in 1990, you moved to the Page 45 1 medical division? 2 A. That's correct. 3 Q. What position did you hold in 4 the medical division? 5 A. I was an executive director of 6 Lilly research laboratories. 7 Q. And what were your 8 responsibilities in that position? 9 A. My responsibilities were as an 10 administrator for the clinical investigation 11 regulatory affairs area and this had to do with 12 regulatory affairs, medical information systems, 13 medical plans, planning and training, were the 14 parts of the group that I was responsible for. 15 Q. And you worked as an executive 16 director at Lilly research labs until 1992? 17 A. Correct. 18 Q. At any time during that period 19 were your sole -- was your sole concentration on 20 Fluoxetine? 21 A. No. 22 Q. Did you work in a -- did you 23 work with a specific division under Lilly -- 24 under the medical division such as like Page 46 1 neuropsychopharmacology or pharmacology? 2 A. There were a number of 3 divisions within the medical area, based upon 4 therapeutic classes. 5 Q. Did you work over all of those 6 divisions as a whole? 7 A. The people I was responsible 8 for worked with all of the groups. 9 Q. Which division did Prozac fall 10 under? 11 A. Neuro. 12 Q. Neuro? 13 A. (Witness moves head up and 14 down.). 15 Q. During the two year period that 16 you were in the medical division, were you 17 executive director of Lilly research labs that 18 whole time? 19 A. Yes. 20 Q. At that time Fluoxetine had 21 been approved by the FDA for use with depression? 22 A. Yes. 23 Q. Another ground rule we have is 24 to try to not talk over each other so she can Page 47 1 take down everything. 2 Would it be fair to say that 3 the majority of the work that you did in your 4 position as executive director of Lilly research 5 labs on Fluoxetine was related to post-marketing 6 studies? 7 A. Post-marketing and other 8 indications. 9 Q. Okay. Did you have any 10 responsibility with regards to the issue of 11 Fluoxetine and suicidality? 12 A. I was part of the group that 13 discussed this periodically. 14 Q. Did you have any responsibility 15 with either directly or indirectly reporting to 16 the FDA safety updates on Fluoxetine? 17 A. That was the responsibility of 18 the regulatory affairs area. The director of 19 that area reported to me, during my tenure in 20 medical. 21 Q. Who was the director of that 22 area while you were executive director? 23 A. Doctor Max Talbott. 24 Q. Was it -- Doctor Talbott, Page 48 1 right? 2 A. Yes. 3 Q. He is a Ph.D? 4 A. Yes. 5 Q. Was Doctor Talbott director of 6 regulatory affairs the whole time that you were 7 executive director? 8 A. Yes. 9 Q. Did you have any responsibility 10 with regards to the reporting of adverse events 11 to the FDA? When I say adverse events, I mean 12 for Fluoxetine. 13 A. Specifically, I did not, it was 14 the responsibility within the regulatory affairs 15 and within the clinical area. 16 Q. Did you have any administrative 17 responsibility related to the reporting of an 18 adverse event on Fluoxetine? 19 A. I had administrative 20 responsibility for people that were responsible 21 for reporting those events. 22 Q. Were you involved in making any 23 policy decisions on the reporting of adverse 24 events to the FDA? Page 49 1 A. No, I was not. 2 Q. Who would decide how various 3 adverse events would be reported, and I don't 4 mean whether or not they needed to be reported in 5 regulations but in what form they would be 6 reported to the FDA? 7 A. I think Doctor Talbott in 8 conjunction with other members in medical 9 management. 10 Q. Okay. And people in management 11 would be above you? 12 A. Yes. 13 Q. Why is it that you weren't 14 involved in those decisions? 15 A. Those decisions were already 16 made before I got there. 17 Q. Okay. Who in medical 18 management would Doctor Talbott have worked with 19 to make the policy decisions on the form of 20 reporting of adverse events? 21 A. There were a lot of people. 22 Q. Okay. I know this is tiresome 23 but please give me some of the names if you can 24 recall. Page 50 1 A. Doctor Zerbe, Robert Zerbe. 2 Q. Okay. 3 A. Doctor Allan Weinstein, and as 4 I mentioned before, each of the therapeutic areas 5 had a medical, a physician, director, and Doctor 6 Talbott would have worked with those people 7 directly. 8 Q. Who would be -- and you said 9 that at the time you were -- that you were in the 10 medical division that Prozac would have been 11 under the neuropsychopharmacology division? 12 A. Yes. 13 Q. Who was the physician -- let me 14 ask you this: Was the physician and director two 15 different people or the same person? 16 A. I guess you would have to zero 17 in on a period of time. Doctor Dan Masica was in 18 charge of that area at the time I joined. 19 Q. He was the director of the area 20 when you joined? 21 A. I'm not confident that his 22 title was director, okay. 23 Q. But he was in charge of the 24 area? Page 51 1 A. Correct. 2 Q. And he was underneath you? 3 A. He was not, I had no 4 responsibility for the physician group of people. 5 Q. How about on the hierarchy 6 though as far as reporting goes, he's a director 7 and you're an executive director, on a hierarchy -- 8 are you higher on the corporate food chain, let's 9 put it that way? 10 A. Yes. 11 Q. Who would Doctor Masica report 12 to? 13 A. Doctor who? 14 Q. I'm sorry, is Dan Masica a 15 doctor? 16 MR. MYERS: Masica. 17 A. He is a physician, that's 18 correct. 19 Q. Who would he report to if he 20 didn't report to you? 21 A. Doctor Robert Zerbe. 22 Q. I just want to make sure that 23 we're not talking about two different people 24 here, a doctor and a head of the department, or Page 52 1 is that just the same person? In other words 2 would there be somebody else besides Doctor 3 Masica that would be in charge of that area, the 4 neuropsychopharmacology area? 5 A. At the time that Doctor Masica 6 was in charge, he was in charge, there would have 7 been other physicians working with him and then 8 he reported to Doctor Zerbe in that 9 responsibility. 10 Q. So when you say department head 11 and physician, you mean one and the same? 12 A. Yes. 13 Q. That's what I was getting 14 confused on, I wasn't sure. 15 A. Yes. 16 Q. And Doctor Masica was in charge 17 of the department when you first came on board as 18 executive director? 19 A. Yes. 20 Q. Was there a time when Doctor 21 Masica was replaced as head of the department? 22 A. He relinquished that 23 responsibility. 24 Q. Who became head of the Page 53 1 department then? 2 A. Doctor Gary Tollefson. 3 Q. Was that the same situation as 4 far as hierarchy, Doctor Tollefson would report 5 directly to Doctor Zerbe or somebody in Doctor 6 Zerbe's position? 7 A. Doctor Tollefson reported to 8 Doctor Zerbe. 9 Q. Anybody else that was in -- 10 that were in Doctor Masica's position while you 11 were executive director? 12 A. In that specific position, is 13 that your question? 14 Q. Right, as head of that 15 department. 16 A. No. 17 Q. Who is Doctor Charles Beasley? 18 A. Doctor Charles Beasley is a 19 physician in the medical division at Eli Lilly 20 and Company and was part of the neuropharm group. 21 Q. To your knowledge, would Doctor 22 Beasley have been involved in the policy 23 decisions related to the way that adverse events 24 would be reported to the FDA? Page 54 1 A. Yes. 2 Q. How about Doctor John 3 Heiligenstein? 4 A. Doctor Heiligenstein had a 5 similar position to Doctor Beasley. 6 Q. Do you know if he would have 7 been involved in that policy decision on how to 8 report adverse events? 9 A. I don't know specifically that 10 he would have been, okay. He was in a little 11 different position, different responsibilities. 12 Q. What is the difference between 13 his responsibility as opposed to say Doctor 14 Beasley's responsibility? 15 A. My understanding was that 16 Doctor Beasley was the lead physician, okay, on 17 Fluoxetine. 18 Q. So he was higher on the food 19 chain? 20 A. I think that he was not 21 necessarily higher on the food chain, he had more 22 experience, been there longer. 23 Q. Okay. And then Doctor 24 Heiligenstein would work -- how would his Page 55 1 responsibilities be different than Doctor 2 Beasley's, would he work under Doctor Beasley? 3 A. I don't think Doctor 4 Heiligenstein did work under Doctor Beasley, I 5 think Doctor Heiligenstein had responsibilities 6 for other potentially new drugs and Doctor 7 Beasley was responsible for Fluoxetine. 8 Q. To your knowledge, did Doctor 9 Heiligenstein ever work on Fluoxetine? 10 A. Yes, yes. 11 Q. And what period of time, if you 12 know, was it? 13 A. I only have knowledge of the 14 two years that I was there, '90 to '92. 15 Q. That was while you were in that 16 tenure that he worked? 17 A. Yes. 18 Q. What did he do with regards to 19 Fluoxetine during that period of time? 20 A. I don't know what he did, I 21 don't know. 22 MS. ZETTLER: Do you want to take a 23 quick break, Larry? 24 MR. MYERS: Sure, that's fine. Page 56 1 (A SHORT RECESS WAS TAKEN.) 2 Q. (BY MS. ZETTLER) Did Prozac 3 have its own department within the 4 neuropsychopharmacology division while you were 5 executive director? 6 A. No, it didn't. 7 Q. Have you ever heard the word 8 cluster? 9 A. Yes. 10 Q. What is a cluster? 11 A. A cluster is a group of people 12 who, you know, various disciplines that have the 13 responsibility for a compound or a series of 14 clinical studies. 15 Q. Was there a Prozac cluster? 16 A. There was a Prozac cluster, 17 yes. 18 Q. So the cluster would be made up 19 of people from regulatory, epidemiology, various 20 groups, but all these people would be people with 21 responsibilities with regards to Fluoxetine, 22 right? 23 A. Yes. Some of them would be 24 specific, okay, or exclusive to Fluoxetine and Page 57 1 some would have other responsibilities. 2 Q. Okay. What was Doctor 3 Heiligenstein's responsibilities with regards to 4 Fluoxetine while you were executive director? 5 A. I'm really not certain what his 6 specific responsibilities were since he was not 7 part of my organization, he was part of the 8 clinical group, I don't really know what it was. 9 Q. How does the clinical group 10 differ from the medical division? 11 A. Well, the medical division is 12 comprised of a number of other activities other 13 than within the physician group, okay. There are 14 systems, information systems, that is, 15 statistical group, medical plans, planning and 16 training, and then there was the clinical group 17 and I mentioned before that they were split by 18 therapeutic area, the CNS group and antibiotics 19 and endocrine and so forth, okay. 20 Q. But is that separate and apart 21 from the medical division? 22 A. No, that's all a part of 23 medical. 24 Q. Okay. Page 58 1 A. Embraces all of these 2 professional groups. 3 Q. Was there more than one 4 executive director of the medical division when 5 you were an executive director? 6 A. I was an executive director 7 within the medical group with responsibility for 8 the -- certain of the nonclinical, nonphysician 9 groups, okay. 10 Q. Okay. 11 A. I think I've previously defined 12 what those were. 13 Q. You were talking systems, 14 statistics, medical plans, planning and training, 15 you mentioned regulatory earlier, I think? 16 A. Yes. 17 Q. Is that one of the groups that 18 you had responsibility over? 19 A. Yes. 20 Q. Now, people in your various 21 subgroups, for lack of a better phrase -- 22 A. Yes. 23 Q. Would interact with people in 24 clinical, wouldn't they? Page 59 1 A. Yes, they would. 2 Q. Was there a medical director of 3 the clinical area -- I'm sorry, executive 4 director of the clinical area while you were the 5 executive director? 6 A. At the time I was there, there 7 was one other executive director. 8 Q. Okay. Who was that? 9 A. That was Doctor Gary Tollefson 10 who came during my tenure, okay. 11 Q. Okay. And is that the position 12 that we were talking about earlier with Doctor 13 Masica and Doctor Tollefson? 14 A. Yes. 15 Q. Would they have similar 16 responsibilities over these other groups, 17 systems, statistics, medical plans, regulatory, 18 et cetera. 19 MR. MYERS: When you say they, you mean 20 the physician executive director? 21 MS. ZETTLER: Right, Masica or 22 Tollefson. 23 A. I had administrative 24 responsibility for these paraphysician people, Page 60 1 okay. 2 Q. Okay. 3 A. And they had responsibility, 4 they being the director or executive director who 5 was a clinician, a physician, had responsibility 6 for the physicians within that discipline and the 7 people I had responsibility for interacted with 8 and provided them support in the design of 9 clinical trials and statistics. I did not have 10 responsibility for the statistical group, but the 11 systems people setting up the systems, reporting 12 systems and so forth, so they got support from my 13 group, okay. 14 Q. So the physicians would run the 15 clinical trials and your group would help them 16 out in any way they could depending on what their 17 various responsibilities were? 18 A. Physicians were primarily 19 responsible for the conduct, design conduct of 20 the clinical trial. 21 Q. Is there anybody else that you 22 can think of that would have been involved in 23 this policy decision on how to report adverse 24 events to the FDA with regards to Prozac or Page 61 1 Fluoxetine? 2 A. I think I previously identified 3 Doctor Zerbe and Doctor Weinstein -- 4 Q. Right. 5 A. -- as part of that group. 6 Doctor Talbott -- I think that was the line of 7 questioning at the time was Doctor Talbott. 8 Q. Right, possibly Doctor Beasley. 9 A. Possibly Doctor Beasley but not 10 necessarily at the policy level, as I think I 11 also mentioned that the policies and procedures 12 had been established before I got there. I did 13 not necessarily participate in establishing the 14 policies or how they were then reported. 15 Q. Were you ever made aware of 16 what those policies were with regards to 17 reporting? 18 A. Yes. 19 Q. Can you tell me what Lilly's 20 policies were with regards to reporting adverse 21 events to the FDA on Prozac adverse events, 22 Fluoxetine adverse events? 23 A. The policy was that all adverse 24 events were reported. Page 62 1 Q. Were you ever made aware of 2 when this policy was actually put in place? 3 A. I was not made aware of when it 4 was put in place, no. 5 Q. Are you familiar with the FDA 6 regulations with regards to determining whether 7 or not an adverse event is serious? 8 A. I was at the time, you know, 9 but I really couldn't recount what those 10 regulations are. 11 Q. Did Lilly have a policy with 12 regards to reporting adverse events to various 13 foreign regulatory agencies? 14 A. Yes. 15 Q. What was their policy on that? 16 A. They were reported, to the 17 regulatory bodies if such existed. If there was 18 a regulatory process in place in the country in 19 which the adverse events occurred, it was 20 reported. 21 Q. To your knowledge, was there a 22 policy similar with regards to foreign regulatory 23 agencies as it was to the FDA, in other words 24 report everything? Page 63 1 A. To my knowledge, the policy was 2 no different internationally than it was 3 domestically. 4 Q. Were you aware of a group 5 called CIOMS? 6 A. CIOMS? I've heard the acronym, 7 yes. 8 Q. What is CIOMS? 9 A. I've heard the acronym, I can't 10 tell you what the CIOMS stands for. 11 Q. Without telling me what each 12 individual letter stands, for do you know what 13 CIOMS is? 14 A. I can't describe specifically. 15 Q. Can you tell me generally? 16 A. I can't. 17 Q. CIOMS, to your knowledge, did 18 they have any regulations with regards to 19 reporting of adverse events? 20 A. I can't tell you, I don't know. 21 I could tell you if I knew but I don't know. 22 Q. I think earlier you said that 23 the issue of suicidality in Fluoxetine had 24 already come up prior to your becoming executive Page 64 1 director, right? 2 A. Yes, yes. 3 Q. To your knowledge, what was 4 Lilly doing in response to that, the issue of 5 suicidality and Fluoxetine while you were 6 executive director? 7 A. That's a rather broad question. 8 If you want to approach it in steps or -- 9 Q. Can you give me a general idea 10 of what they were doing and maybe we can narrow 11 it down, I'm at a disadvantage because I don't 12 know what they were doing so I can't ask you a 13 more specific question. 14 A. Well, they were following the 15 issue as they were, you know, any adverse event 16 that occurred in the course of a clinical trial. 17 Q. How about in spontaneous 18 adverse events reports? 19 A. Would you define spontaneous? 20 Q. Sure. My understanding from 21 other depositions, other people we talked to from 22 Lilly, is a spontaneous adverse event is one that 23 occurs in a person who's prescribed Prozac after 24 it's been approved and put on the market and the Page 65 1 report is then spontaneously reported, in other 2 words the report is made by say a physician 3 without being interrogated so to speak by a 4 regulatory person or a Lilly employee or -- does 5 that sound fair enough? 6 A. That sounds fair. Now would 7 you rephrase the original question? 8 Q. Sure. What was Lilly doing 9 with regards to spontaneous adverse events on the 10 issue of suicidality and Fluoxetine? 11 A. My understanding that they were 12 recorded and tracked as in the similar manner to 13 all the other adverse events, however they came 14 in, through clinical trials or post use of the 15 drug. 16 Q. Okay. When you say that they 17 were recorded, how were they recorded? 18 A. I'm not absolutely certain how 19 they were recorded but the adverse events 20 information came through the drug epidemiology 21 unit of the DEU, drug experience records, and so 22 forth. 23 Q. Do you know what the -- can we 24 call the drug epidemiology unit the DEU? Page 66 1 A. Yes, you may. 2 Q. Do you know what the DEU did 3 with the information once it was collected? 4 A. Specifically, I don't. 5 Information circulated, you know, for information 6 purposes. 7 Q. Are you familiar with the Drug 8 Experience Network? 9 A. DEN. 10 Q. Yes, we'll call it DEN. DEN 11 also because there was a DEN and a DEN 2, right? 12 A. Yes. 13 Q. When did DEN 2 come into 14 existence, do you remember? 15 A. DEN 2 was I believe in 16 existence prior to my arrival. 17 Q. Okay. Do you know what the 18 difference is between the DEN and DEN 2? 19 A. I do not. 20 Q. Do you know why Den 2 was 21 created? 22 A. I could surmise but I don't 23 know specifically why. 24 Q. Do you have an idea generally Page 67 1 why it was created? 2 A. As an improvement, upgrade over 3 DEN, as any one to two upgrade is. 4 Q. Just because you create a new 5 system doesn't necessarily mean it's an upgrade 6 or a better system, does it? 7 A. I suspect there are exceptions 8 to that but generally you go from one to two, 9 it's an improvement, it's an upgrade. 10 Q. Okay. What upgrades did the 11 DEN 2 provide to DEN? 12 A. I think I stated that it was in 13 existence before I came so I had no experience 14 with DEN, okay, so I don't know what the older 15 system's attributes were compared to what DEN 2 16 may be. 17 Q. Are you familiar with the words 18 ELECT? 19 A. ELECT, well, I know what the 20 word ELECT means, but -- 21 Q. Are you familiar with the ELECT 22 dictionary? 23 A. I'm not familiar with it. I've 24 heard the, you know, the phrase, the ELECT Page 68 1 dictionary. I cannot define it for you what it 2 is. 3 Q. Have you heard the term COSTART 4 dictionary? 5 A. COSTART? 6 Q. Yes. 7 A. Yes. 8 Q. Do you know what the COSTART 9 dictionary is? 10 A. No. 11 Q. Is there, to your knowledge, a 12 relationship between the ELECT dictionary and the 13 COSTART dictionary? 14 A. I cannot describe what that 15 relationship might be. 16 Q. You can't describe it because 17 you don't know? 18 A. I can't describe it because I 19 don't know. 20 Q. In your position as executive 21 director of the medical division, did you have 22 any interaction with the marketing department at 23 Lilly? 24 A. I had some interaction with Page 69 1 them in general meetings. 2 Q. Can you describe that 3 interaction? 4 A. In committee meetings relating 5 to the various drugs as relates to the clinical 6 trials and so forth, marketing people were a part 7 of that as were medical people. 8 Q. Okay. To your knowledge was 9 Dista Products Company charged with marketing 10 Prozac at any time? 11 A. Were they charged with 12 marketing? 13 Q. Right, was it one of their 14 responsibilities, was one of the responsibilities 15 of the company to market Prozac or promote 16 Prozac? 17 A. I'm sorry, I don't know the 18 answer to your question. 19 Q. What is Dista? 20 A. Dista is a marketing division 21 through which -- of Eli Lilly and Company through 22 which certain products are marketed but it is not 23 necessarily identified as such within the 24 company. The people are not part of Dista, part Page 70 1 of Lilly, they're part of marketing. Whether 2 it's Lilly marketing whether it's Dista 3 marketing, they don't differentiate. 4 Q. So -- 5 A. That's why I can't answer your 6 question. 7 Q. Is the marketing department at 8 Lilly housed within Dista exclusively? 9 A. No. 10 Q. So there are marketing arms at 11 Lilly that are in Dista and there are some that 12 are not? 13 A. I am not totally familiar with 14 the marketing organization but there is a 15 marketing organization and some of those people 16 are associated with the products that are 17 marketed through the Dista label and some are 18 associated with the products that go through the 19 Lilly label and that's my understanding of the 20 structure. 21 Q. So it depends on the product? 22 A. Yes. 23 Q. To your knowledge, is Lovan 24 going to be marketed through Dista or Lilly? Page 71 1 A. I do not know. 2 Q. Was there ever a time when 3 Prozac or Fluoxetine was marketed through Dista 4 and then it was changed to be marketed through 5 Lilly? 6 A. I do not know. 7 Q. Are you familiar with any of 8 Dista or Lilly's outside advertising agencies or 9 marketing agencies? 10 A. I have no knowledge of their 11 interaction with outside advertising agencies, I 12 do not know their names or never had any 13 interaction with them. 14 Q. When you say general meetings 15 with marketing, what do you mean? 16 A. For example in the medical 17 area, there was a review, a group to -- that met 18 to review and approve clinical studies and 19 frequently there was a marketing representative 20 that attended those meetings. That 21 representative would depend upon what therapeutic 22 area the study was going to fall in. 23 Q. When you say therapeutic area, 24 you mean indicated use or stage of clinical Page 72 1 trial? 2 A. It could be either therapeutic -- 3 if it was the anti-infective area then you had an 4 antibiotic marketer there and if it was CNS you 5 had that. 6 Q. Do you consider Prozac a CNS 7 drug -- do you consider Fluoxetine a CNS drug? 8 A. Yes. 9 Q. CNS, central nervous system? 10 A. Correct. 11 (PLAINTIFFS' EXHIBIT NO. 1 WAS 12 MARKED FOR IDENTIFICATION AND 13 RECEIVED IN EVIDENCE.) 14 Q. Would you take a look at 15 Exhibit Number 1, please, Doctor? 16 MR. KRAUS: Could you give us a chance 17 to glance at the document before you ask 18 questions so we know what you're asking? 19 MS. ZETTLER: Sure, as long as it 20 doesn't slow things down. You can probably get 21 copies of all of this stuff. 22 MR. MYERS: He's reviewed it. 23 Q. You have had a chance to review 24 it? Page 73 1 A. Yes, quickly, yes. 2 Q. Do you recognize this document? 3 A. I do not. 4 Q. Do you have any idea why this 5 would have been produced to the plaintiffs as 6 having been in your files on Prozac? 7 A. Probably would have received a 8 copy of it as I received, you know, carbons or a 9 copy of a number of documents for my information 10 just because of the position that I had in 11 medical, but I don't recall this document 12 specifically. 13 Q. Okay. Were you aware of any of 14 the contents of this page two, the second page of 15 this exhibit prior to looking at it today? 16 A. No. 17 Q. Were you aware of any campaign 18 at Dista or Lilly under which retail or sales 19 reps would use this information with customers? 20 A. I was not part of that process. 21 Q. Okay. 22 A. If this was part of my file 23 that was submitted, I suspect that I saw this at 24 some point in time but my involvement would have Page 74 1 been For Your Information only, you know, I was 2 not involved in the construct of the document at 3 all. 4 Q. Could you look at like the 5 seventh page, it's Pz 284, page seven? 6 A. Where it says Teicher article? 7 Q. Right. 8 A. Okay. 9 Q. Were you aware of that article? 10 A. I'm aware of the issue around 11 Doctor Teicher and Prozac, yes. 12 Q. Would you agree that it was 13 Doctor Teicher's article that raised the 14 suicidality and Fluoxetine issue? 15 A. Would I do what? 16 Q. Would you agree that it was 17 Doctor Teicher's article that raised the 18 suicidality and Fluoxetine issue? 19 MR. MYERS: Before he answers let me 20 object to the question as being vague and 21 ambiguous as to the term raised the issue as 22 being undefined and I'm unclear as to raised the 23 issue with who or with what group. 24 MS. ZETTLER: He's already testified Page 75 1 for a while now that there was an issue at Lilly 2 regarding the use of Fluoxetine and suicidality 3 and I'm asking him now if this is the article 4 that raised that issue at Lilly. 5 MR. MYERS: Subject to that, see if you 6 can answer it, Doctor. 7 A. I would say that it certainly 8 brought it into sharper focus. 9 Q. Was there an issue regarding 10 suicidality and Fluoxetine at Lilly prior to 11 Doctor Teicher's article? 12 A. I think I stated before, ma'am, 13 that all adverse events, okay, were recorded and 14 followed and so I'm assuming that our people were 15 aware of suicidality, okay, relative to Prozac, 16 prior to the Teicher article. 17 Q. Okay. So there had been 18 instances where either trial subjects or patients 19 had become suicidal while using Fluoxetine, to 20 your knowledge? 21 A. I have no specific knowledge 22 about that but I would assume so, yes. 23 Q. Why would you assume so? 24 A. Because all adverse events were Page 76 1 recorded, and I also assume that, you know, the 2 first suicidality patients were not Doctor 3 Teicher's. 4 Q. Do you have any knowledge as to 5 how many events, adverse events of suicide or 6 suicidality were reported to Lilly prior to 7 Doctor Teicher's article? 8 A. I have no knowledge of that. 9 Q. On this page, it says on 10 January 30, 1990, a marketing letter was sent to 11 Dista on Lilly select products sales 12 representative addressing an article that 13 appeared in the February, 1990 issue of the 14 American Journal of Psychiatry. To your 15 knowledge, was Lilly aware of Doctor Teicher's 16 article before it was published? 17 A. I do not know. 18 Q. This letter implies that that 19 was the case, doesn't it? 20 MR. MYERS: Let me object to the form 21 of the question because he didn't write the 22 document so he doesn't know what it intends or 23 implies. It says what you read to him. 24 Q. Doctor, would you draw the Page 77 1 inference from what I just read that Lilly knew 2 of the Teicher article before it was published in 3 February of 1990? 4 A. It certainly implies that but 5 that's not unusual in the scientific community 6 that you get, you know, precopied, prepublication 7 copy of articles that -- so, you know, the dates 8 could be in error but if they're correct then the 9 implications are -- 10 Q. So when you say it's not 11 unusual, is it unusual for a company such as 12 Lilly to get free publication copies of articles -- 13 for articles that were written by people not 14 affiliated in some way with Lilly? 15 A. As a professional courtesy, it 16 frequently happens, yes. 17 Q. To your knowledge, did Doctor 18 Teicher send Lilly a copy of his article prior to 19 publishing? 20 A. I cannot -- I don't know, I 21 don't know that. 22 Q. Who at Lilly would know that, 23 if you know? 24 A. The dates that are here Page 78 1 preceded my presence in medical, okay, and the 2 year is right but I think the months are wrong, 3 but I would assume that somebody like Doctor 4 Zerbe or Doctor Masica would know that 5 information. 6 Q. And at the bottom of the page 7 it sets out, looks like four points regarding 8 various issues or facts that were set out in 9 Doctor Teicher's article, correct? 10 A. Rephrase your question. 11 Q. Sure. At the bottom it's got 12 four, looks like subparagraphs, marked with dots? 13 A. Yes. 14 Q. And those appear to be 15 discussions of points raised in Doctor Teicher's 16 article, correct? 17 A. Yes. 18 Q. Okay. And the third point 19 down, it says all six patients had a history of 20 suicidal ideation including suicidal gestures in 21 three and then in parentheses it says although 22 the discussion indicates that only five patients 23 had experienced such ideation and that case two 24 did not, the history for case two indicates that Page 79 1 suicidal ideation was present prior to Prozac 2 treatment, close paren. 3 A. Yes. 4 Q. Do you know where they got that 5 information regarding case two? 6 A. I do not know that. 7 Q. Who would have put together 8 this suicide, depression and antidepressant 9 therapy paper attached to the letter in Exhibit 10 1? 11 A. I don't know who specifically 12 put together this. 13 Q. Do you know what department 14 that may have come out of? 15 A. I would suspect that it's a 16 combined effort between clinical group and the 17 discovery group if there are discovery issues in 18 this. 19 Q. Would marketing be involved in 20 this effort? 21 A. Most certainly, yes. 22 Q. Are you familiar with the 23 Citizens' Commission on Human Rights? 24 A. Yes, somewhat, okay. Page 80 1 Q. What is your knowledge of that 2 commission? 3 A. Well, it's associated with or 4 affiliated with the Church of Scientology. 5 Q. Okay. 6 A. I've read a few articles about 7 them. I have no specific information about the 8 group. 9 Q. Did you read the Time article 10 about the Church of Scientology that came out 11 after the Prozac issue came out? 12 A. Yes, I did. 13 Q. Do you know if Lilly had 14 anything to do with that article in Time 15 Magazine? 16 A. I do not know if they had 17 anything to do with it or not. 18 Q. Who at Lilly would have been 19 responsible for that article if anybody at Lilly 20 was, if you can give me a department? 21 A. I don't know who would have 22 been. I don't know who gets involved with lay 23 articles. 24 Q. To your knowledge has Lilly Page 81 1 ever been involved with lay articles in various 2 publications? 3 MR. MYERS: Ever? 4 MS. ZETTLER: Ever. 5 Q. Ever in the entire history of 6 the world, Doctor Amundson? 7 A. I suspect that they have been 8 contacted by the authors for bits of information. 9 I can't say that specifically, one would just 10 assume in the editorial process that this would 11 happen. 12 Q. Was one of your 13 responsibilities as executive director in the 14 medical division related to quality assurance? 15 A. There was a quality assurance 16 group responsible for medical, that was not a 17 part of my organization. 18 Q. Okay. 19 A. But the quality assurance 20 people worked with my people, okay, in performing 21 their functions. I had frequent interactions 22 with them and so forth. 23 Q. Were you ever charged with any 24 responsibility to respond to any quality Page 82 1 assurance audits that were done on clinical 2 trials and Fluoxetine? 3 A. I don't know that I was 4 specifically for Fluoxetine since most of those 5 clinical studies were conducted prior to my being 6 in medical, okay, so I -- but generically for 7 other compounds, yes, I was. 8 Q. To your knowledge, were there 9 any Fluoxetine studies going on in the clinical 10 division or department of the medical division 11 while you were executive director? 12 A. Yes. 13 Q. What types of studies were 14 going on? 15 A. There were other indications 16 being pursued. 17 Q. Okay. Were there any 18 post-marketing depression studies that were being 19 conducted? 20 A. Yes, there were. Specifically 21 I can't tell you which ones but there were 22 studies going on, yes. 23 Q. During the time that you were 24 executive director were you aware of any Page 83 1 rechallenging studies being performed on 2 Fluoxetine or suicidality or homicidality? 3 A. No, I'm not aware of that. 4 Q. Are you aware at any time of a 5 rechallenging study being conducted on 6 Fluoxetine? 7 A. No. 8 Q. Are you familiar with the word 9 corhort or the term corhort study, C-O-R-H-O-R-T? 10 A. I understand the word but I 11 don't know what a corhort study is specifically. 12 Q. What is your understanding of 13 the words? 14 A. A corhort study, my 15 understanding of the word corhort is that there 16 is an association between things that are 17 corhorts, okay. 18 Q. Okay. You have never heard the 19 term corhort study in your position at Lilly? 20 A. It's vaguely familiar but I 21 can't tell you what a corhort study is. 22 Q. Do you have any responsibility 23 over European affiliates in your position as 24 executive director? Page 84 1 A. I have no responsibility of 2 European affiliates. 3 Q. Was there somebody in a similar 4 position as you in the medical division who would 5 have had responsibility over European or 6 international studies? 7 A. The group that I worked with 8 the primary responsibility was domestic, was 9 U.S., and there was an international medical 10 organization as well. 11 Q. Was that also under the 12 umbrella of the medical division? 13 A. Well, that's -- Lilly's 14 organization is, you know, the affiliate 15 countries had medical directors who had 16 responsibility for the medical activities, 17 clinical trials, et cetera, going on within those 18 affiliated countries. Yes, there was a tie in 19 back to the U.S. 20 Q. What entity within Lilly would 21 have had responsibility over the affiliates? 22 A. Lilly International had 23 responsibility for affiliates. 24 Q. And Lilly International is a Page 85 1 department at Lilly here in Indianapolis? 2 A. Lilly International is one of 3 the components of Eli Lilly and Company, okay. 4 Q. But they do office here in 5 Indianapolis? 6 A. Uh-huh, I think so. I think 7 the most senior person would office -- would 8 probably be here but I can't give you a name, I 9 don't know. 10 Q. Do you know if Lilly 11 International would work with Doctor Tollefson's 12 group with regards to international studies at 13 all? 14 A. I think Doctor Tollefson would 15 be aware of what studies globally are being 16 conducted or were being conducted with 17 Fluoxetine. It's his responsibility to know that 18 information. 19 Q. Earlier we talked about a group 20 of people who would have had responsibility for 21 creating Lilly policy with regards to reporting 22 of adverse events, I believe Doctor Zerbe, 23 Weinstein, Masica, and Tollefson, that group? 24 A. Yes. Page 86 1 Q. Do you know if that group would 2 have had responsibility for deciding what 3 clinical trials would have been conducted? 4 A. That group plus others. Are 5 you talking domestic within the U.S. studies? 6 Q. Sure, we'll start with 7 domestic, we'll start with domestic, that group 8 and other people that would have had 9 responsibility for deciding which clinical trial? 10 A. The primary responsibility as I 11 said earlier resided with the physician in charge 12 of that particular drug or that particular 13 indication for that drug, if it had multiple 14 indications. 15 Q. And I believe you said the term 16 was project leader? 17 A. Project leader was in 18 toxicology, okay, we're talking about two 19 different things. 20 Q. To your knowledge, were there 21 project leaders throughout the various other 22 phases of the clinical trials? 23 A. In the medical arena, okay, in 24 the medical division, the physician was in charge Page 87 1 of the product or of the indication if the 2 product had multiple indications. And the 3 toxicology project later could be any number of 4 people, okay. 5 Q. When you say the physician, 6 there obviously are a lot of physicians who are 7 working in the clinical trial area, right? 8 A. That's correct. 9 Q. What do you mean when you say 10 the physician would have responsibility, what is 11 the physician? 12 A. Well, as I stated, a product or 13 an indication for a product has a physician that 14 is responsible for following that product, for 15 initiating or designing additional clinical 16 trials to be conducted on that product. If there 17 are packaging changes, or whatever, they were 18 from a medical standpoint, they are responsible 19 for that product. 20 Q. Okay. So in this case would it 21 be the same person who is a physician you talked 22 about earlier who would have recommended the 23 toxicology studies to be done on the compound? 24 A. Yes. The physician doesn't Page 88 1 recommend toxicology studies, we're starting to 2 mix. 3 Q. That's where I was getting 4 confused. 5 A. Apples and oranges. The 6 physicians are involved in the human aspects, 7 okay, and other people are involved in the animal 8 aspects of the business. 9 Q. Okay. Who is the physician 10 involved in the human aspects on Fluoxetine? 11 A. The leader of that group was 12 Doctor Masica. 13 Q. Do you know if Doctor Masica 14 was always a leader of that group? 15 A. He was a leader of that group 16 when I came into medical and Doctor Tollefson was 17 when I left. 18 Q. So Doctor Masica when you came 19 into medical would have been the person charged 20 with suggesting what clinical studies should have 21 been run on Fluoxetine during that period of 22 time? 23 A. He or one of the physicians 24 that were responsible to him working with Page 89 1 Fluoxetine would have brought those studies 2 forward for review and approval, yes. 3 Q. So it was either Masica or 4 Tollefson when he was in Masica's position -- or 5 Masica, I'm sorry, or somebody working, people 6 below them? 7 A. Yes. 8 Q. It wouldn't have been anybody 9 else like on the Zerbe level? 10 A. No. 11 Q. Who would they bring the 12 proposed trials to for approval? 13 A. They brought them to clinical 14 review committee, I forget specifically what the 15 name of that was but -- and there are multiple 16 people, medical people, okay, represented on that 17 group and they brought in the design and so 18 forth. 19 Q. Okay. Clinical trial review 20 committee, does that sound familiar, protocol 21 maybe? 22 A. CPRC sounds more familiar than 23 CTRC. How about clinical projects review 24 committee. Page 90 1 Q. Okay. You said medical people, 2 would there been anybody from any other 3 department on that committee, such as marketing? 4 A. Marketing, I think I identified 5 that earlier, would be present, and most of the 6 other people in there were medical, part of 7 medical, you know, the physician groups and 8 myself, I sat in on that most of the time. 9 Q. Anybody from regulatory? 10 A. Yes, Doctor Talbott. 11 Q. Okay. 12 Q. Would Doctor Zerbe be involved 13 in these meetings? 14 A. Yes. 15 Q. Did Doctor Zerbe have 16 responsibility at Lilly other than Fluoxetine? 17 A. Most certainly he did, yes. 18 Q. How about Doctors Fuller, Wong 19 and Molloy, would they be involved in that 20 committee? 21 A. I recall Doctor Molloy being 22 present at some of the meetings, but not the 23 other two, and the ones that Doctor Molloy was 24 present at, I don't know if they were specific to Page 91 1 Fluoxetine or if he was there in general 2 representing discovery research. He had rather 3 high broad ranging responsibilities within the 4 discovery research area at Lilly so he couldn't, 5 but I remember seeing him there. 6 Q. Would you attend these meetings 7 on a regular basis or was this a project specific 8 type of thing? 9 A. I attended them on a regular 10 basis. 11 Q. Would you review post trials on 12 drugs other than Fluoxetine? 13 A. Yes. 14 Q. What kinds of things would you 15 look at when you reviewed the trials? 16 A. Looked at the indication, what 17 was being pursued, parameters to be measured, how 18 many patients, the design of study, how many 19 patients were being proposed to be involved and 20 some target estimate of what the cost of the 21 study might be. 22 Q. How much input would marketing 23 have in these meetings? 24 A. Little, unless it was a Phase 4 Page 92 1 study or something. They had as I recollect 2 little to no input. 3 Q. Phase 4 study -- 4 A. For them to know what was going 5 on, in the case of Fluoxetine or any other post 6 marketing, it was their responsibility is to know 7 what's going on. 8 Q. Phase 4 studies are 9 post-marketing studies? 10 A. Yes. 11 Q. And they would have more 12 involvement in those studies than they would in 13 like say a Phase 2 study or a Phase 3 study? 14 A. Yes. 15 Q. Do you recall reviewing any 16 post trials on Fluoxetine as a member of this 17 committee while you were an executive director in 18 the medical division? 19 A. I'm confident that I did. The 20 specific ones, you know, I can't recall. There 21 are a lot of studies that come through there on a 22 lot of drugs and I cannot recall specifically any 23 single clinical trial on Fluoxetine that came 24 through during my tenure there. Page 93 1 Q. Do you remember generally if 2 during your tenure there were proposed 3 retrospective studies of Fluoxetine and 4 suicidality that may or may not have occurred 5 during clinical trials? 6 A. Proposed retrospective studies? 7 Q. Right. 8 A. I don't know what a 9 retrospective study might be. 10 Q. Okay. Retrospective meaning a 11 reanalysis of data that was collected in other 12 clinical trials that were performed? 13 A. A retrospective analysis of an 14 existing study? 15 Q. Right. 16 A. Yes. 17 Q. There were post studies then on 18 Fluoxetine and suicidality while you were there? 19 A. Yes. 20 Q. How many, to your knowledge? 21 A. How many such of those? 22 Q. Right. 23 A. I can't give you a number, I 24 don't know a number, okay. Page 94 1 Q. Was it more than one, to your 2 knowledge? 3 A. Yes. 4 Q. Were there -- was there more 5 than one reanalyzing data on depression trials? 6 A. What kind of data on depression 7 trials? 8 Q. You tell me, I don't know. I 9 guess what I'm trying to ask is was there more 10 than one of these retrospective analyses done on 11 depression trials as opposed to OCD trials or 12 obesity trials? 13 MR. MYERS: Are you asking whether they 14 were done or considered? 15 MS. ZETTLER: Considered, I'm sorry, 16 let's start with considered. 17 A. I think with any drug, clinical 18 trials on any drug, there are retrospective 19 analyses performed. 20 Q. Okay. Let me ask it this way: 21 Prozac was approved for the use of depression in 22 late 1987, correct? 23 A. (Witness moves head up and 24 down.). Page 95 1 Q. You have to say yes or no. 2 A. Yes. 3 Q. Sometime after that, the 4 approval and the marketing of Prozac, the issue 5 of Fluoxetine related suicidality came up; 6 correct? 7 A. Yes. 8 Q. And at some point at Lilly, a 9 retrospective analysis or analyses were done with 10 regards to the data that was collected during 11 clinical trials performed on Fluoxetine and then 12 submitted in the IND NDA to the FDA for approval, 13 right? 14 A. You were doing good up until 15 that last statement. 16 Q. Okay, that's fine. 17 A. That was a little confusing to 18 me what your last part of this discourse. 19 Q. By the time you became 20 executive director in the medical division, a 21 number of clinical trials had been performed on 22 human beings regarding Fluoxetine? 23 A. Correct. 24 Q. And as part of those clinical Page 96 1 trials, data was collected and stored in some 2 manner by Lilly regarding those trials? 3 A. Yes. 4 Q. Lilly had in effect a data base 5 of information on what occurred with these 6 patients throughout the various trials, correct? 7 A. Yes. 8 Q. At some point in your 9 experience as an executive director within the 10 medical division and as a member of this 11 committee that reviewed possible studies, was the 12 committee approached with regards to a 13 retrospective analysis of all of this data that 14 had been collected throughout the clinical trials 15 up to that point for determination on the rate of 16 suicidality in people on Prozac? 17 A. I would say that the answer to 18 that is no. 19 Q. Okay. Then earlier when you 20 said they came -- that the committee was 21 approached on retrospective analyses of -- 22 A. Different group, okay, a 23 different group of individuals. That is not -- 24 retrospective analysis studies were not the Page 97 1 purview of that particular group. 2 Q. Okay. 3 A. New trials, okay. 4 Q. New trials, okay. What group 5 would have been approached with regards to doing 6 a retrospective analysis of data collected during 7 clinical trials? 8 A. The group was a group of the 9 management people within medical, the CNS 10 psychopharm group, neuropharm group, and the 11 cluster. Those were the people that were 12 involved in approving and conducting any 13 reanalysis. 14 Q. Okay. You say the management 15 within the medical division? 16 A. Yes. 17 Q. Were you part of that group? 18 A. I sat in on those studies 19 because some of my people were part of the 20 cluster, okay. 21 Q. You sat in on studies or on the 22 meetings? 23 A. On the meetings. 24 Q. Okay. Who else was at those Page 98 1 meetings? 2 A. Doctor Masica, Doctor Zerbe and 3 Weinstein, Talbott, you know, and other members 4 of the various disciplines within medical that 5 were involved or would be involved in the 6 analysis. 7 Q. Okay. Anybody from marketing 8 there? 9 A. I do not recall that marketing 10 had a visible presence at those meetings. 11 Q. Did they have a tangential 12 presence? 13 MR. MYERS: What does that mean? 14 Q. Was the marketing perspective 15 taken into consideration at the meetings? 16 A. I don't know what the marketing 17 perspective might have been, I'm sure they had an 18 interest. 19 Q. The issue of suicidality and 20 Fluoxetine was critical to Lilly during this time 21 period, wasn't it? 22 A. It was a very important issue 23 during part of the time that I was part of the 24 medical group. Page 99 1 Q. How about regulatory, was there 2 somebody from regulatory that would have been -- 3 is that Doctor Talbott, is he regulatory? 4 A. Doctor Talbott or one of his 5 more senior people would have been part of that 6 group. 7 Q. Okay. Could you tell us what 8 the role of the FDA is with regards to approval 9 of a new drug, generally what's the role of the 10 FDA? 11 MR. MYERS: Generally. 12 A. In general, I just say that the 13 FDA controls both the testing and the approval of 14 new drug substances in human beings through first 15 the IND process and then the new drug application 16 process. 17 Q. When you say they control the 18 testing, you mean through regulations or they 19 don't actually perform the testing, correct? 20 A. There are very explicit 21 regulations governing the testing process in 22 humans promulgated by the FDA, yes. 23 Q. What kind of a relationship 24 would you say that the FDA had with the drug Page 100 1 manufacturers, was it an advisory capacity, was 2 it a regulatory capacity? 3 A. They're a regulatory group, you 4 know, I think by definition. I don't know 5 that -- they have advisory groups in various 6 therapeutic areas that are there to review 7 certain new drugs prior to approval, to that 8 extent they're advisory. 9 Q. When you say advisory, what 10 kind of a role would the FDA take an advisory on 11 various issues? 12 A. If your new drug application 13 was incomplete, they would advise you that it's 14 not approvable and they certainly are available 15 too for consultation on, you know, studies 16 intended to be conducted or so forth. It's 17 primarily a regulatory function. 18 Q. They're charged with basically 19 passing judgment on the testing that was done on 20 the product, correct? 21 A. Correct. 22 Q. Did you have any contact with 23 FDA personnel with regards to Fluoxetine when you 24 were executive director? Page 101 1 A. While I was executive director 2 of medical? 3 Q. Right. 4 A. I had no personal contact with 5 the Food and Drug Administration. 6 Q. Are you aware of anybody within 7 the Lilly organization who had any direct contact 8 with FDA personnel after the approval of Prozac 9 for use in depression? 10 A. I'm confident there are a 11 number of Lilly people who would have had such 12 information, additional studies constantly being 13 submitted to Food and Drug Administration, 14 questions come back, telephone calls, as well as 15 visits, you know, to Washington for consulting. 16 Q. Are you familiar with a 17 gentleman named Tom Laughren, L-A-U-G-H-R-E-N? 18 A. I am not. 19 Q. How about a gentleman named 20 Paul Leber, L-E-B-E-R? 21 A. I've heard Paul Leber's name, 22 yes. 23 Q. Who is Paul Leber, do you know? 24 A. Who is it, I've never met the Page 102 1 man, and I think that he is a director of the 2 neuropharm division or something at the FDA, I 3 think, I'm not absolutely confident of that. 4 Q. At the FDA? 5 A. At the FDA. 6 Q. To your knowledge, does the 7 director of the neuropharmacology division at the 8 FDA have primary responsibility over a drug such 9 as Prozac? 10 A. He would have primary 11 responsibility over all the drugs that fall into 12 that therapeutic class for which he's 13 responsible. 14 Q. And Prozac falls into the 15 therapeutic class, correct? 16 A. Yes. 17 Q. Have you ever heard of a Prozac 18 project team? 19 A. Prozac project team, I suspect 20 that there are a number of those that may exist 21 within the different functional areas and I don't 22 know what the nature of your -- or from where 23 you're coming from with that, Prozac project 24 team. Page 103 1 Q. That's what it says. How about 2 a Prozac safety team, have you ever heard that 3 term? 4 A. I have not heard that team -- 5 that term, excuse me. 6 Q. Have you ever heard of Plan D 7 studies? 8 A. Yes, I have. 9 Q. What are Plan D studies? 10 A. Well, post-marketing studies 11 usually that are conducted, you know, to expand 12 the patient population and -- 13 Q. Would they be the same as a 14 Phase 4 study? 15 A. Yes, in my opinion they are the 16 same, yes. 17 Q. What do you mean when you say 18 expand the patient population? 19 A. Get more experience with the 20 drug in the patient population. 21 Q. To your knowledge, has a liquid 22 form of Prozac been approved by the FDA? 23 A. Yes, it has. 24 Q. When was that approved? Page 104 1 A. I can't give you the specific 2 date. 3 Q. Do you remember what year it 4 was approved? 5 A. I would say 1992. 6 (PLAINTIFFS' EXHIBIT NO. 2 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 A. I have looked at it. 10 Q. Okay. You have had a chance to 11 take a look at Exhibit 2? 12 A. Yes. 13 Q. Who is K. Z. Farid, F-A-R-I-D? 14 A. K. Z. Farid, I'm assuming that 15 this is the person that I know as DeeDee Farid. 16 Q. Okay. 17 A. She's listed here as project 18 manager for Fluoxetine project and she -- I'm not 19 confident what she's doing today, she's no longer 20 in that position, so -- 21 Q. Okay. What position was she in 22 at this time in April of '90? 23 A. From information that's given 24 here, I assume that she was project manager of a Page 105 1 Fluoxetine project team that existed within the 2 project management group. Each drug had a 3 project team and I think in the second page, the 4 members of that team are listed and they were 5 responsible for various aspects of the 6 development of the compound or new indications 7 for the compound. She was one of several 8 managers that existed within that group. 9 Q. Okay. Correct me if I'm wrong, 10 but would the project possibly be one of these 11 Plan D studies or both of these Plan D studies 12 that they're talking about, long-term depression 13 and geriatric depression? Would she be a manager -- 14 would those two things be considered projects? 15 A. Those would be projects 16 occurring within the whole of the Fluoxetine team 17 and would have been brought to the attention of 18 the team by the physician responsible for the 19 studies. The project team is responsible for 20 being aware of everything that was going on with 21 the drug that they were responsible for. 22 Q. Do you know what consumatory 23 behavior disorders are? 24 A. I could hazard a guess, but I -- Page 106 1 MR. MYERS: Don't guess. 2 A. Don't guess. No, I don't know 3 what they are. 4 Q. Have you heard that term used 5 before with regard to Fluoxetine? 6 A. I don't recall those specific 7 two words together, okay, consumatory behavior. 8 Q. At any time were violence 9 aggression studies done on Fluoxetine considered 10 consumatory behavior? 11 A. What kinds of studies, ma'am? 12 Q. Violence aggression studies. 13 A. Violent aggression studies? 14 Q. Violence aggression. 15 A. I don't know. 16 Q. Okay. How about suicidal 17 ideation or suicidal behavior studies, were they 18 ever called consumatory behavior disorders? 19 A. Not to my knowledge. 20 Q. Could you look at the second 21 page of that exhibit. In the upper right-hand 22 corner of the page it says LY110140. Is that the -- 23 Lilly's number for Fluoxetine in general? 24 A. That's the number of -- yes, Page 107 1 that's the number of Fluoxetine. 2 Q. For any indication? 3 A. For any indication. 4 Q. In the upper left-hand corner, 5 it says Status Report No. 90-02, does that 6 indicate that's the second status report in 1990? 7 A. Yes. 8 Q. On the first page, I'm sorry to 9 make you jump back and forth, on the first page, 10 it says up at the top, it say LY110140 Fluoxetine 11 dash B1Y. What does B1Y stand for? 12 A. That is an accounting code 13 that's used, okay, to track project expenses and 14 so forth. 15 Q. Do you know what these specific 16 letters and numbers stand for, like B? 17 A. I don't think they stand for 18 anything, okay. Each compound or indication has 19 a three letter designation and you track expense 20 to that project by use of that code. 21 Q. Any expenses for Fluoxetine 22 would have this code then? 23 A. Yes. 24 Q. Did you have any responsibility Page 108 1 over any of these team members listed at the top 2 of the second page of Exhibit 2? 3 A. In April of 1990? 4 Q. Right. 5 A. Laura Fludzinski, and the third 6 from the bottom name, Doctor J. A. Webber, okay. 7 Those two people were part of the groups that 8 were responsible to me at this time. 9 Q. Okay. Doctor Webber was in 10 regulatory, wasn't he? 11 A. He reported to Max Talbott in 12 regulatory. 13 Q. That's Al Webber? 14 A. Al Webber, correct. 15 Q. Underneath that group of team 16 members, it says index on the left? 17 A. Uh-huh. 18 Q. What's an RMS minutes? 19 A. RMS stands for research 20 management staff. 21 Q. On the right it says ADME under 22 department status report, what's an ADME? 23 A. A is absorption with a B, D is 24 distribution, M is metabolism and E is excretion. Page 109 1 Q. Would those be toxicology 2 studies? 3 A. They can be either toxicology 4 or human studies depending upon which species the 5 compound is given, you can do them on humans and 6 you can do them on animals, usually done in both. 7 Q. These types of studies in 8 humams would generally be a Phase 1 studies? 9 A. Some would be Phase 1, yes. 10 Q. Others could fall in the other 11 phases? 12 A. Yes. 13 Q. What position did Laura 14 Fludzinski hold in April of '90, if you remember? 15 A. In April of '90, to the best of 16 my knowledge, she was a department head within 17 clinical plans and clinical plans previously 18 identified as one of the areas that reported to 19 me. 20 Q. What's the difference between 21 Doctor Masica's area and clinical plans? 22 A. Doctor Masica had 23 responsibility for the physician group and I had 24 responsibility for the nonphysician group and Page 110 1 Laura was in the nonphysician group, okay, 2 supporting, you know, people in Doctor -- 3 physicians in Doctor Masica's group. She had a 4 group of CRAs, okay, responsible to her. 5 Q. Okay. So let me make sure I 6 understand this, under Doctor Masica's group you 7 could have the same subdivision set up, but the 8 people that would have been working in those 9 divisions in Doctor Masica's group would have 10 been physicians? 11 A. Correct. 12 Q. So you could have a regulatory 13 person under Doctor Masica's purview but he would 14 have been a physician as opposed to, for lack of 15 a better phrase, lay person? 16 A. No, that's not correct. Let me 17 try and get this straight. Medical, during my 18 tenure there was a matrix organization, okay, and 19 it had basically physicians responsible for 20 physicians. And while I was there, obviously not 21 being a physician, they had a nonphysician 22 responsible for nonphysician people. I had no 23 physicians on my staff. 24 Q. Okay. Page 111 1 A. And so -- but the physicians 2 needed the help of these nonphysician people to 3 get the job done. Even though they reported to 4 me, you know, I had people that did work to 5 support Fluoxetine, to support other therapeutic. 6 Q. That part I understand. What 7 I'm getting confused about is Doctor Masica's 8 portion of the medical division. 9 A. Yes. 10 Q. Could he have some subdivisions 11 or departments within his portion in regulatory, 12 in medical plans, you know, similar to the ones 13 that you had containing lay people, systems, 14 statistics, I mean did he have a breakdown within 15 his area that was similar to that but contained 16 physicians as opposed to the nonphysicians? 17 A. I think we briefly earlier 18 talked about clusters. 19 Q. Okay. 20 A. Doctor Masica was supported by 21 a group of people called a cluster. 22 Q. Okay. 23 A. Other than the physician 24 members of that cluster, those people were Page 112 1 responsible to me administratively, okay. They 2 may have taken direction, you know, on the 3 clinical trials and whether a statisticians, 4 systems, you know, pharmacist or whatever they 5 were, you know, they're taking their scientific 6 direction from him, but administratively they 7 reported to me. 8 Q. Okay. 9 A. Through me, okay. 10 Q. Okay. 11 A. Okay. 12 Q. Now I get it. Where is Laura 13 Fludzinski now, if you know? 14 A. She is now at our Erl Wood 15 Laboratories. To the best of my knowledge, she's 16 at our Erl Wood laboratories in London, outside 17 of London. 18 Q. What is she doing there, if you 19 know? 20 A. She is a manager of within the 21 clinical plans area there, my last contact with 22 her that was her position. 23 Q. Okay. Do you know if that's a 24 promotion from what she was doing when you worked Page 113 1 there as executive director? 2 A. She went to the Erl Wood 3 laboratories as a part of a husband-wife 4 transfer, okay, and at the time she went, she was 5 department head over here and when she went over 6 there, they didn't have department head people so 7 she became a manager within the clinical trials 8 planning area and -- similar position to what she 9 had here with a different title. Whether she was 10 promoted at the time, she went from my group so I 11 don't know how they administer their salaries, et 12 cetera, over there, so -- 13 Q. What is her husband's name? 14 A. Fludzinski. 15 Q. Don't be so sure. 16 A. No, I know that in this case, 17 it is. 18 Q. Do you know his first name? 19 A. His name is Pawel, Doctor 20 P-A-W-E-L. 21 Q. Is Doctor Fludzinski an M.D.? 22 A. He's a Ph.D. 23 Q. What area did he work in, if 24 you know? Page 114 1 A. I think he's -- I don't think, 2 I'm reasonably confident that he is the managing 3 director of Erl Wood laboratories. 4 Q. Do you know how long he's been 5 in that position? 6 A. I don't know for certain how 7 long that's been, it's fairly recent. 8 Q. Okay. Did he go over to Erl 9 Wood at the same time his wife did or did they go 10 at different times? 11 A. To the best of my knowledge, 12 they went about the same time. 13 Q. Okay. Do you know what he did 14 when he was here in Indianapolis? 15 A. His career started as an 16 organic chemist and multiple, you know, positions 17 throughout Lilly research and maybe even had some 18 in other components of the company. 19 Q. Do you know if he ever worked 20 on Fluoxetine? 21 A. I don't know that, I don't know 22 that. 23 Q. Do you know if he works on 24 Fluoxetine now at the Erl Wood facility? Page 115 1 A. Indirectly I suspect that he 2 does. 3 Q. What capacity would he work on 4 it indirectly? 5 A. I said he was managing director 6 so he is the top level administrator of the 7 laboratories over there. If there is work going 8 on over there on Fluoxetine, it's under his 9 umbrella. That's why I say indirectly. 10 Q. Who is G. D. Lightfoot? 11 A. What is it? 12 Q. Who is it, G period, D period, 13 Lightfoot? 14 A. His name is Gary Lightfoot. 15 Q. Okay. What does Mister 16 Lightfoot do at Lilly to your knowledge, if 17 anything? 18 A. He's currently, to the best of 19 my knowledge, he's currently employed. He has a 20 job different than he had when I was there, he 21 was a manager reporting to me at the time I was 22 in medical, okay. 23 Q. Manager of what department? 24 A. He had -- he was a manager and Page 116 1 then he and another gentleman shared managership, 2 okay, of a group of field people that we had 3 residing outside, most of them resided outside of 4 Indianapolis, who were part of the clinical trial 5 planning group and so forth and Gary was the 6 manager of that. 7 Q. Okay. Would the field people 8 you're talking about include quality assurance 9 people? 10 A. The quality assurance group was 11 Indianapolis based. 12 Q. Okay. 13 A. And were not part of Gary 14 Lightfoot's operation. 15 Q. Okay. How about CRAs, would 16 they be under him? 17 A. The CRA, he had no CRA, there 18 was a group called CIR, clinical investigation 19 representatives. 20 Q. How about CRCs? 21 A. CRC and CIR were the letter 22 designations for the people that were part of his 23 group. 24 Q. Okay. Were either the CIR or Page 117 1 the CRC charged with any sort of site auditing 2 responsibility? 3 A. They were -- they had a 4 responsibility to periodically visit the sites or 5 a selected number of the sites and, you know, 6 look over the data, if that was an auditing 7 function, you can call it auditing function, but 8 they worked with the people at physician sites, 9 okay, that was their job. 10 Q. What would they do in 11 conjunction with the people at the sites? 12 A. Review case report forms. 13 Q. For what purpose? 14 A. For any obvious discrepancies, 15 obvious being age, weight, time of visit, number 16 of, which visit, et cetera. 17 Q. Did they then report back to 18 Mister Lightfoot? 19 A. The CIR was basically 20 responsible to one of the CRCs. 21 Q. Okay. 22 A. And then that information, you 23 know, would come -- it would go to the CIR, CRC, 24 to Mister Lightfoot. Page 118 1 Q. And Mister Lightfoot reported 2 to you? 3 A. He reported directly to me, 4 that's right. 5 Q. Did you have any authority over 6 the quality assurance people or department? 7 A. I had no administrative 8 authority over those people. 9 Q. Okay. Did you have any other 10 authority over those people? 11 A. I had no authority over the 12 quality assurance people. 13 MS. ZETTLER: Okay. Let's take a lunch 14 break. 15 (A LUNCH BREAK WAS TAKEN.) 16 17 Q. (BY MS. ZETTLER) You did have 18 authority over Mr. Lightfoot though, didn't you? 19 A. Yes, I did. 20 Q. What kind of authority would 21 that have been, is that just a reporting, did he 22 just report to you? 23 A. He reported to me 24 administratively. Page 119 1 Q. Were you charged with giving 2 Mister Lightfoot any direction with regards to 3 quality assurance? 4 A. Quality assurance visited his 5 sites and when there were issues, they would have 6 been brought to my attention. 7 Q. Would you have to make 8 decisions on various issues or would it be more 9 of a funneling questions to somebody else? 10 A. I think funneling decisions 11 down to the CRCs who were basically responsible 12 for the activities at the sites, from Lilly 13 perspectively. 14 Q. Were you aware of any 15 complaints by anyone in Mister Lightfoot's 16 department regarding the quality of the 17 performance of any clinical investigators on 18 Prozac trials? 19 A. No, I'm not. 20 Q. Are you aware of any of the 21 Fluoxetine trial sites being audited by the FDA? 22 A. I'm not specifically aware but 23 I assume they were, some of them. 24 Q. Do you have any understanding Page 120 1 that the FDA would routinely investigate sites, 2 not just Prozac sites but various clinical trial 3 sites as part of their procedure? 4 A. They made a number of visits to 5 sites, various therapeutic areas, I was aware of 6 those. I'm not aware of all of them that 7 occurred but when there were findings or 8 whatever, I was. 9 Q. Are you aware of what the FDA 10 criteria for making site visits was? 11 A. I'm not aware of all of the 12 criteria that they have. 13 Q. Can you tell me which ones 14 you're aware of? 15 A. Pending approval or prior to 16 approval, they seem to have increased their 17 visits within the sites related to the drug that 18 they were about to approve. 19 Q. Are there any other reasons why 20 the FDA would make a visit to a particular site? 21 A. If they had any specific 22 information, you know, about the investigator or 23 the site from other trials that might have been 24 conducted there and they have any suspicion that Page 121 1 things were not all what they should be. 2 Q. Have you heard of a four-cause 3 audit? 4 A. A four-cause inspection, yes. 5 Q. And those are inspections that 6 would be conducted for a particular reason? 7 A. Yes, something has come up and 8 it gives them reason to visit the site. 9 Q. Okay. Do the manufacturers 10 generally have any responsibility to report 11 certain deviations on the part of these sites to 12 the FDA? 13 A. The manufacturers, like Lilly? 14 Q. Right. 15 A. In deviations relative to what? 16 Q. Clinical trials. 17 A. Not the clinical trial. 18 Q. Okay. 19 A. A clinical trial is handled by 20 a different division of the FDA, they have their 21 own deviation issues that might have to be 22 reported. 23 Q. But say Lilly became aware of -- 24 and I'm not -- this is just a hypothetical and Page 122 1 I'm not putting it on Fluoxetine or any 2 particular drug. 3 MR. MYERS: A general hypothetical. 4 MS. ZETTLER: A general hypothetical, 5 and I'm not going to try to tie this to any 6 particular drug, yet. 7 Q. Say somebody within Mister 8 Lightfoot's department became aware of a clinical 9 investigator falsifying clinical report forms, 10 would in that situation Lilly have an obligation 11 to report that clinical investigator to the FDA? 12 A. Absolutely. 13 Q. Are you aware of any situations -- 14 and I'm not saying just falsifying information, 15 but any situations whatsoever where Lilly 16 reported any of the Fluoxetine clinical 17 investigators to the FDA as a result of their 18 work on a clinical trial? 19 A. I'm not aware of any specific 20 to Fluoxetine. 21 Q. Are you aware of any clinical 22 investigators that were reported to the FDA by 23 Lilly in general? 24 A. Yes. Page 123 1 Q. On how many occasions was that 2 done, to your knowledge? 3 A. Two or three. 4 Q. And on those two or three 5 occasions were any of those clinical 6 investigators involved with clinical trials on 7 Fluoxetine for any indicated use? 8 A. To the best of my recollection, 9 no. 10 Q. Were any of those clinical 11 investigators that Lilly reported to the FDA ever 12 investigators on clinical trials for Fluoxetine? 13 In other words, the deviation may not have 14 occurred during a Fluoxetine clinical trial but 15 did any of those investigators either previously 16 or subsequently work on Fluoxetine trials? 17 A. I am not aware of any, no, 18 ma'am. 19 Q. Lilly has used investigators on 20 more than one occasion for different drugs, 21 correct? 22 A. Same investigator? 23 Q. Right. Investigator A may have 24 been used for Fluoxetine but he also may have Page 124 1 been used later on for another drug? 2 A. I think within a therapeutic 3 class, you may. An antibiotic, you may -- Ceclor 4 may go back with Keflex or Product X, if they're 5 in the anti-infective business, maybe a 6 psychiatrist might be investigating Fluoxetine 7 unless you had other psychoactive drugs, he 8 wouldn't be used for an antibiotic, for example, 9 okay. 10 Q. Right. But you may use the 11 same investigator within the -- 12 A. Within the therapeutic class, 13 that's correct. 14 Q. To your knowledge, were any of 15 these investigators that were reported to the FDA 16 by Lilly sanctioned by the FDA as a result of 17 what was reported to the FDA by Lilly? 18 A. By sanctioned, you mean? 19 Q. Either told they couldn't run 20 any more clinical trials or punished in any way? 21 A. The FDA does maintain such a 22 listing. 23 Q. Right. 24 A. Whether any individual Page 125 1 physician got on that list as a result of Lilly's 2 activity or not, I'm not certain. But they do 3 maintain such a list. 4 Q. Okay. Any of these two or 5 three investigators that were reported to the FDA 6 by Lilly, did any of them work on psychotropic 7 drugs? 8 MR. MYERS: For Lilly? 9 MS. ZETTLER: Right. 10 A. To the best of my knowledge, 11 no. I don't recall that that was ever an issue. 12 Q. You're presently working in the 13 quality assurance area at Lilly, correct? 14 A. I am presently approaching 15 retirement and I am no longer an active employee 16 of Eli Lilly. 17 MR. KRAUS: Congratulations. 18 Q. When did you become inactive? 19 A. Middle of May of this year. 20 Q. And I believe you testified 21 earlier that you left the medical division 22 sometime in 1992? 23 A. Correct. 24 Q. Do you remember when in 1992? Page 126 1 A. I think about April. 2 Q. And after you left the medical 3 division, you went to quality assurance? 4 A. I went to the -- let me say the 5 quality component which included quality control, 6 quality assurance, and environmental affairs. 7 Q. What did you do within that 8 department? 9 A. What did I do in that position? 10 Q. Correct, did you have a title? 11 A. Executive director. 12 Q. Executive director of? 13 A. It was really called special 14 projects, and I had responsibility for two or 15 three special projects within the quality arena 16 relating to the laboratories, quality control 17 laboratories. 18 Q. Okay. And you say quality 19 control laboratories, that goes to quality 20 control as far as the manufacturing perspective 21 is concerned or is that in a clinical trial 22 testing -- 23 A. This related to the quality 24 control laboratories, the analytical work, really Page 127 1 came back to where I started. 2 Q. Okay. Full circle? 3 A. Full circle. 4 Q. In your position as executive 5 director of special projects, did you do any 6 Fluoxetine related work? 7 A. I did none. 8 Q. You had no responsibilities 9 whatsoever with regards to Fluoxetine? 10 A. Correct. 11 Q. So again, we can go back and 12 concentrate on your two year period as executive 13 director of the medical division instead of 14 worrying about quality assurance? 15 A. Whatever, wherever. 16 Q. Have you ever heard of the U.S. 17 SWAT team? 18 A. U.S. SWAT? 19 Q. S-W-A-T. 20 A. As relates to what? 21 Q. Fluoxetine. 22 A. No, I have never heard that. 23 Q. Have you ever heard that term 24 used in relation to Eli Lilly in general, your Page 128 1 work there? 2 A. No . 3 (PLAINTIFFS' EXHIBIT NO. 3 WAS 4 MARKED FOR IDENTIFICATION AND 5 RECEIVED IN EVIDENCE.) 6 7 Q. Have you had a chance to take a 8 look at Exhibit 3? 9 A. Yes. 10 Q. Do you recognize this document, 11 Mister Admundson? 12 A. I don't specifically recognize 13 the document. 14 Q. Okay. Are you familiar with 15 the subject matter discussed in the document? 16 A. Yes. 17 Q. Now does this refresh your 18 recollection as to what the U.S. SWAT team is? 19 A. I think the SWAT as used here 20 is somebody's personal slang, that is not an 21 official -- even though it's capitalized in one 22 instance, there was no such thing as a -- had no 23 official designation as a SWAT team, okay. 24 Q. It appears that these first two Page 129 1 messages were written by RLZ. Would that be 2 Robert Zerbe to the best of your knowledge? 3 A. Well, there are a number of 4 Bobs, okay, and I assume that the one that's 5 addressed to me and to Nancy Langwith is probably 6 from Doctor Zerbe. But, you know, the sequence 7 in which they're given, that Bob could have been 8 Robert Thompson, Bob Thompson as well, so I 9 really don't recall. 10 Q. Okay. The second one looks 11 like the first forwarded message signed RLZ, 12 Would that indicate that that was Doctor Zerbe? 13 A. RLZ is Doctor Zerbe. 14 Q. Who is Nancy Langwith? 15 A. At the time I was in my 16 position, she was director of medical information 17 systems and reported to me. 18 Q. Medical information systems, 19 would that be the systems analysts? 20 A. That was a group of systems 21 analysts, supporting the medical function. 22 Q. Then this large message that's 23 underneath the RLZ message appears to be written 24 by Bob Thompson, correct? Page 130 1 A. Correct. 2 Q. Earlier you testified that you 3 were familiar with the subject matter of this 4 memorandum, could you explain to us what they 5 mean by translating CRFs? 6 MR. MYERS: Before he answers, let me 7 object to the form as to what somebody who wrote 8 it meant. If he has an independent 9 understanding, he can give it. 10 Q. That's all I'm asking for, 11 Doctor Amundson, is your independent 12 understanding on any of the questions about these 13 documents that you have not authored. 14 A. A translated CRF would be a 15 language translation of a CRF that was probably 16 in German, for example, and being translated to 17 English. 18 Q. Okay. 19 A. Or French to English or 20 whatever the situation might be. 21 Q. Would these be computerized 22 CRFs or hard copy CRFs? 23 A. These would be hard copy CRFs, 24 at this time frame. Page 131 1 Q. Were you aware that at a 2 certain point, some of the affiliate's CRFs were 3 being transferred to Lilly via computer? 4 A. Transferred to Lilly, now 5 what's -- affiliate is Lilly, you mean 6 transferred to the U.S.? 7 Q. I'm sorry, Indianapolis, right. 8 A. Some of the information came 9 here electronically, yes. 10 Q. Now the information that would 11 come in electronically, would that be sent in 12 English or would that be sent in the originator 13 language? 14 A. Primarily it would be data, it 15 would come -- data is kind of universal but it 16 would come in English, it would come through a 17 point where it would get translated and then get 18 sent. 19 Q. What kind of data would be sent 20 electronically? 21 A. Lab data, you know, any data on 22 the case report form would come electronically. 23 Q. How about psychiatric testing 24 results? Page 132 1 A. I am not -- efficacy results 2 are you talking? 3 Q. Or safety? 4 A. I assume that they would also 5 come. 6 Q. Electronically? 7 A. Yes. 8 Q. Do you have an understanding of 9 what Doctor Zerbe meant as the U.S. SWAT Team? 10 A. I think I have an understanding 11 of what he's referring to here. 12 Q. What is he referring to? 13 A. He's referring to a group of 14 people. 15 Q. What group? 16 A. Well, a group of people that 17 was as described in Doctor Thompson's more 18 lengthy message here, that was being -- a group 19 that was being put together to, you know, to 20 accomplish a specific purpose which is described 21 here, I think. 22 Q. What purpose is that? 23 A. The purpose was to look, to 24 visit certain affiliates and to help the Page 133 1 affiliate personnel review their case report 2 forms and get, you know, and so forth to speed 3 the process. 4 Q. Was there a problem with what 5 was being reported on the case report form to 6 certain affiliates that you needed a SWAT team to 7 work with? 8 A. There was not a problem with 9 the information, there might have been a problem 10 with the speed with which we were getting the 11 data in the U.S., okay. 12 Q. What kind of timetable did 13 Lilly have for reporting CRF information on the 14 international affiliate trials? 15 MR. MYERS: To who? 16 Q. To Lilly, here in Indianapolis, 17 if any. 18 A. Well, you know, they processed 19 the data as quickly as they could with the number 20 of personnel that they had. 21 Q. Okay. 22 A. I'd say a reasonable time, the 23 information was expected, adverse events came 24 pronto. Page 134 1 Q. The second full paragraph of 2 Bob Thompson's memo says Mini CRF, what is a Mini 3 CRF? 4 A. I don't know specifically what 5 is being referred to here, I suspect it's a 6 document that was going to be used for the 7 translation business to get the information here 8 more quickly. 9 Q. Would it have been a shortened 10 form -- could it have been a shortened clinical 11 report form including only certain information? 12 A. Correct, could have been, could 13 have been, yes. 14 Q. Above that paragraph, it says 15 that this project is now making more progress as 16 translated CRFs are arriving daily, more than 17 fifty percent of potential patients will provide 18 useful data greater than seventeen hundred total 19 and plus or minus four hundred and fifty with 20 suicide not excluded. Do you understand what he 21 means by that greater than seventeen hundred 22 total and plus or minus four hundred fifty with 23 suicide not excluded? 24 MR. MYERS: Let me object again, you've Page 135 1 asked him what he meant, as to what the writer 2 meant. 3 MS. ZETTLER: I asked him if he had an 4 understanding. 5 A. I don't have, no, I don't 6 recall specifically what that statement refers 7 to. 8 Q. Okay. Why would a study be 9 excluded because of inadequate data? 10 A. A case report form has to be 11 complete to be acceptable and if it's only 12 partially complete, I think a judgment has to be 13 made as to whether the patient visit is a valid 14 visit. 15 Q. But here it says only one of 16 thirty studies reviewed to date will be excluded 17 because of inadequate data, could that be a 18 decision made based on only one case report form? 19 A. It says one of thirty studies, 20 I think. 21 Q. Right. 22 A. I don't think one -- that one 23 case report form which represents one patient 24 making one visit during the study would Page 136 1 invalidate a study. 2 Q. So you're saying that you're 3 interpreting studies to mean particular patient 4 studies as opposed to a trial? 5 A. Thirty studies, my 6 interpretation of thirty studies is thirty 7 different clinical trials. 8 Q. Okay. So my question is if 9 this one study they're referring to that was 10 going to be excluded because of inadequate data 11 is a clinical trial -- 12 A. Yes. 13 Q. Why would a clinical trial -- 14 total clinical trial have inadequate data? 15 A. Could have enrolled 16 inappropriate patients, for example, okay. Or 17 the drugs they were taking before they entered 18 the trial were to be excluded, the patients were 19 not to be enrolled, something like that, for 20 example, that is an example, inappropriate 21 patient population. 22 Q. So the entire patient 23 population would have to be inappropriate? 24 A. I don't know if it would have Page 137 1 to be entire but a large proportion would have to 2 be, I would think. 3 Q. Is there any way of telling 4 from this, it says International Depression Trial 5 Data Update, is there any way to tell from this 6 what the purpose of the study that was excluded 7 was? 8 A. I don't think that you -- from 9 the title you could -- would lead you to why that 10 study was invalidated. I certainly couldn't do 11 it. 12 Q. To your knowledge, as of 13 September 20, 1990, had only thirty clinical 14 trials been run in the international affiliates 15 total? 16 A. I assume by the way that 17 sentence is worded, that it says reviewed to 18 date, thirty have been reviewed. I'm confident 19 that more than thirty were run, okay. 20 Q. Okay. Were you part of the 21 SWAT team? 22 A. People that reported to me were 23 part of this group that you are referring to as 24 the SWAT team, okay. Page 138 1 Q. Doctor Amundson, did you have 2 any responsibility with regards to randomization 3 of patients to drugs and double blind placebo 4 controlled studies? 5 A. I had no personal involvement 6 in that, no. 7 Q. Did you have any supervisory 8 responsibilities over randomization? 9 A. I think the randomization is 10 done through the use of randomization tables, 11 statistical group and so forth, and the 12 statistical group was not part of my area of 13 responsibility. 14 Q. Okay. Do you have an 15 understanding of how the various blind studies 16 were randomized? In other words like -- 17 A. What do you mean how they were 18 randomized, how the patients were assigned or -- 19 Q. Right, how drugs were prepared, 20 how randomization tables were set up, how the 21 patients were assigned to various groups of drugs 22 or placebo. 23 A. I have no knowledge at any 24 level of detail about how this was done. Page 139 1 (PLAINTIFFS' EXHIBIT NO. 4 WAS 2 MARKED FOR IDENTIFICATION AND 3 RECEIVED IN EVIDENCE.) 4 Q. Have you had a chance to look 5 at Exhibit 4? 6 A. Yes. 7 Q. Who is Greg Enas, E-N-A-S? 8 A. Greg Enas, during the time I 9 was there, was a manager within the statistical 10 group, okay. 11 Q. How about Catherine Mesner? 12 A. Catherine Mesner was a CRA 13 within the neuro -- CNS group, okay. 14 Q. Okay. Do you recognize this 15 document? 16 A. I do not. 17 Q. Are you familiar with the 18 subject matter of the memorandum? 19 A. I am not familiar with the 20 subject matter. I think it was addressed to 21 Mister Enas, Doctor Enas, and not to me. 22 Q. But your name is listed above 23 Doctor Enas's, aren't they? 24 A. Catherine Mesner was part of my Page 140 1 group so I was copied I am confident. 2 Q. But you're not listed under the 3 carbon copy, you're listed above Doctor Enas on 4 the salutation, aren't you? 5 A. Yes, I noticed that, I noticed 6 that. 7 Q. You have no idea why she did 8 that that way? 9 A. No, I don't. I have no -- I 10 don't know why she did it. 11 Q. Earlier we talked about this 12 B1Y number and that's the accounting number. 13 A. Same number, right. 14 Q. And EW, does that represent Erl 15 Wood? 16 A. Correct. 17 Q. And HCCQ would be the study 18 initials for a particular study? 19 A. Yes, I think that HCCQ would 20 identify the specific study. 21 Q. Okay. Do you have any idea 22 what word is after were in that first sentence? 23 A. It's blacked out on my copy, I 24 don't know. Page 141 1 Q. Do you have any idea if that is 2 a name or -- 3 A. I don't know. 4 Q. Do you know what Ms. Mesner 5 means at the bottom of the first paragraph where 6 she says the four digit patient number was 7 matched up with the original patient number? 8 MR. MYERS: I object to the form, it 9 calls upon him to speculate what she meant when 10 she wrote it. If you know tell her. 11 A. I don't know. 12 Q. Do you know what a PIPV number 13 is? 14 A. I do not. 15 (PLAINTIFFS' EXHIBIT NO. 5 WAS 16 MARKED FOR IDENTIFICATION AND 17 RECEIVED IN EVIDENCE.) 18 Q. Have you had a chance to look 19 at Exhibit Number 5? 20 A. Yes. 21 Q. Okay. Have you seen this 22 document before? 23 A. I assume that I have but I 24 don't recollect. My name is on it. Page 142 1 Q. And Allan Weinstein, is that 2 the Doctor Weinstein you talked about earlier? 3 A. Correct, yes. 4 Q. At the top of page one of 5 Exhibit 5, it lists it looks like almost twenty 6 people from various countries, I'm assuming? 7 A. Yes. 8 Q. Would these represent the Lilly 9 affiliates? 10 A. Yes, they do. The countries 11 are Lilly affiliate countries. 12 Q. To your knowledge, is this a 13 complete list of the affiliates that were running 14 clinical trials on Fluoxetine? 15 MR. MYERS: At this point in time -- 16 A. I can't say that, I assume that 17 it is, but I can't -- 18 Q. Okay. We have Spain, Mexico, 19 Canada, Italy, Phillippines, Netherlands, 20 Basingstoke is in the U.K., right? 21 A. Basingstoke, yes. 22 Q. Belgium, Austria, Mexico, South 23 Africa, and Sweden. And then the Erl Wood office 24 too. Page 143 1 A. I'm confident there were 2 studies done in other countries besides these. 3 Q. The subject matter of this 4 memorandum appears to be suicide and suicidal 5 ideation in Fluoxetine use, is that correct? 6 A. Yes. 7 Q. And here Doctor Weinstein talks 8 about a detailed global review of clinical trial 9 data has been initiated? 10 A. Uh-huh. 11 Q. Do you take this to mean global 12 review of clinical trial data with regards to 13 suicidal ideation or suicide? 14 A. Correct. 15 Q. Then on page two, it appears 16 that he attached a number of pages talking about 17 the various Fluoxetine studies known to either 18 him or his department, I'm assuming to date. 19 Does that seem correct? 20 A. Yes. 21 Q. What is GPT, is that global 22 tracking? 23 A. Global project tracking. 24 Q. Towards the bottom of the Page 144 1 second page, it says also confirm that all 2 suicides, deaths, and overdoses have been 3 reported to DEN. Is there a situation where 4 suicides, deaths or overdoses from the affiliates 5 would not have been reported to the DEN? 6 A. I am not aware that there were. 7 Q. Do you know why Doctor 8 Weinstein wanted to detail global review of 9 clinical trial data bases with regards to suicide 10 and suicide ideation on July 27, 1990? 11 A. I have an idea why it was being 12 done. 13 Q. Okay. What? 14 A. It was to collect data, 15 numbers, suicidal ideation, how many patients 16 within a study might have had such ideas. It was 17 just, you know, a survey of the global data base, 18 to have a firm fix on this in the U.S. and this 19 was an attempt to get it globally. 20 Q. For what purpose? 21 A. To understand the information 22 in the data base relative to suicide and suicide 23 ideation. 24 Q. Okay. Any other purpose other Page 145 1 than to get an understanding relative to the data 2 base? 3 A. To my knowledge, no. 4 Q. Did any regulatory agency ever 5 ask you to do such a review, a global review of 6 clinical trial data? 7 MR. MYERS: Are you asking as relates 8 to this? 9 A. Specifically to this? 10 Q. I'm asking if any regulatory 11 agency, governmental regulatory agency, be it in 12 the U.S. or outside of the U.S., did they ever 13 ask Lilly to give them a global review of the 14 clinical trial data that they had regarding 15 suicide and suicidal ideation and the use of 16 Prozac? 17 A. I'm not aware that the question 18 came from a regulatory agency. 19 Q. Did Lilly intend on submitting 20 this data to any regulatory agencies? 21 A. I'm confident it has been 22 submitted. 23 Q. At the time that Lilly 24 undertook this review of the clinical trial data, Page 146 1 was it their intention to submit that information 2 to a regulatory agency? 3 A. Yes. 4 Q. What agency? 5 A. The U.S. FDA and any other 6 agency that had requirement for post-marketing 7 reporting of such data. 8 Q. Did Lilly do a specific global 9 review of clinical trial data with regards to 10 each and every adverse event that was reported to 11 it? 12 A. I would assume that they did 13 for any serious adverse event, a serious, 14 unexpected, whatever the term, they would have 15 done it for all. 16 Q. When you say serious and 17 unexpected, what do you mean? 18 A. I think I stated before that I 19 wasn't entirely confident that I remember all of 20 these classifications, but I understand what the 21 word serious means and I understand what the word 22 unexpected means and something that's unexpected 23 and would not be on the label for example as an 24 expected adverse reaction or side effect. Page 147 1 Q. Okay. What about serious, what 2 constitutes a serious adverse event? 3 A. Life threatening. 4 Q. Anything else? 5 A. To me, it means life 6 threatening. 7 Q. Okay. Would a suicide attempt 8 be life threatening? 9 A. I would think so. 10 Q. Would suicidal ideation be life 11 threatening? 12 A. My interpretation is yes, it 13 could be. 14 Q. What is your interpretation of 15 suicidal ideation? 16 A. People that have thoughts of 17 taking their own life. 18 Q. Okay. How about depression, is 19 that life threatening? 20 MR. MYERS: Before he answers, I think 21 you've now crossed the line into the sphere of 22 medical expertise and I thus object because he's 23 not a medical doctor, but he can certainly give 24 his understanding. Page 148 1 MS. LAWS: I join in that objection. 2 MR. MYERS: Do you want the question 3 back? 4 Q. No. Let me can ask you this, 5 do you have an understanding of what depression 6 is? 7 A. Yes. 8 Q. What's your understanding of 9 what depression is? 10 MR. MYERS: Same objection. Go ahead 11 and answer as you understand. 12 MS. ZETTLER: I'm not asking him as a 13 doctor, I'm asking him to answer as a layman. 14 A. Depression is a person that is 15 depressed, okay. 16 Q. Okay. Do you consider 17 depression life threatening? 18 MR. MYERS: Same objection. 19 A. My personal opinion is it could 20 be in certain cases with certain individuals. 21 Q. But not necessarily life 22 threatening? 23 A. Correct. 24 Q. To your knowledge, did Lilly do Page 149 1 a detailed global review of clinical trial data 2 with regards to myocardial infarcts people 3 suffered while on Fluoxetine? 4 A. I'm not -- I don't know if they 5 did or if they didn't. 6 Q. How about whether or not they 7 did a detailed global review of clinical trial 8 data with regards to interactions with MAO 9 inhibitors? 10 A. I'm not -- on a global basis, 11 I'm not sure that they did this, I'm not 12 confident that they did this, I have no 13 knowledge. 14 Q. Okay. Have you ever seen a 15 memo such as Exhibit 5 where a global review of 16 clinical trial data was marked urgent like this 17 one is? 18 A. No, no. 19 Q. It looks like the third through 20 twelfth pages of Exhibit 5 are listing the 21 various clinical trial numbers? 22 A. What's the number, please? 23 Q. I'm sorry, Pz 284 114 through 24 Pz 284 123. Those appear to be lists of clinical Page 150 1 trials that were conducted on Fluoxetine, 2 correct? 3 A. Correct. 4 Q. And the first -- or the third 5 page of the exhibit, Pz 284 114, it lists about 6 four or five down Edwards, Roy and Haslam. Do 7 you know what Edwards is? 8 A. Where are you? I don't know 9 what those refer to. 10 Q. Underneath Haslam, it has the 11 number B1Y31-UK. Would that indicate it's a 12 Fluoxetine trial 31 done in the United Kingdom? 13 A. I'm not sure that those are 14 sequential numbers, the two, the last two digits 15 are. 16 Q. 31? 17 A. 31 follows 30 or I'm not sure. 18 Q. So it may be 31 but it may be 19 3, 1? 20 A. Maybe the 31st study conducted 21 in the U.K. or maybe something else. I don't 22 know that they went by a sequential numbering 23 basis, those were assigned in the U.K. and not in 24 the U.S. Page 151 1 Q. Okay. Then on page Pz 284 116 2 which is two pages back, it has it looks like 3 different indicated uses after the trial numbers? 4 A. Uh-huh, yes. 5 Q. Are you aware of any other 6 trials done on Prozac for uses other than OCD, 7 alcohol or it looks like glucose something or 8 other, for bulimia at the European international 9 affiliates? 10 A. I'm not specifically aware of 11 any others. 12 Q. Would you turn to the next 13 page. On the next page again it lists a number 14 of clinical trials, about halfway down the page, 15 it says B1Y Korea, were you aware of any other 16 studies that were done in Korea? 17 A. I'm not aware of any other 18 studies. 19 Q. How about towards the bottom 20 where it says B1Y Taiwan, were you aware of any 21 studies that were done in Taiwan other than this 22 one? 23 A. No. 24 Q. How about Thailand? Page 152 1 A. No. 2 Q. Was there anybody at Lilly that 3 was charged with keeping track of all the 4 clinical studies that were done or are being done 5 on Fluoxetine? 6 A. One person? 7 Q. Or a department. 8 A. I think what we're looking at 9 are the international studies outside the U.S. 10 Q. Okay. My question is, if I 11 wanted to find a list of every study that was 12 ever done on Fluoxetine through Eli Lilly, where 13 would I go to within the hierarchy at Lilly? 14 A. Go to someone in the medical 15 division. 16 Q. Do you know who in the medical 17 division? 18 A. One of the physicians that's 19 responsible. 20 Q. Would I go to Doctor Zerbe and 21 ask him for a listing? 22 A. He couldn't provide it to you 23 now, but he could. 24 Q. He would know who to go to to Page 153 1 get it? 2 A. Yes. 3 Q. How about Doctor Talbott, would 4 he know? 5 A. I would think that he would, 6 yes. 7 Q. If I came to you and said -- if 8 I asked you -- if I came to you and said, Doctor 9 Amundson, I'd like a listing of every single 10 trial that was ever performed on Fluoxetine 11 throughout the world by Eli Lilly or anybody 12 associated with Eli Lilly, would you be able to 13 get that information for me? 14 A. Within a reasonable period of 15 time, I could get that information specific to 16 those conducted by Eli Lilly and Company, okay. 17 Q. Right. 18 A. You had a second part to your 19 question. 20 Q. Okay. 21 A. Or anybody else or something 22 like that. 23 Q. Anybody affiliated with Eli 24 Lilly, in other words if an outside clinical Page 154 1 investigator conducted a study on behalf of 2 Lilly. 3 A. That would be considered a 4 Lilly study, so that should be in the list. 5 Q. Okay. So you would be able to 6 get me a list of those types of studies, correct? 7 A. Yes. 8 Q. What would be the first thing 9 you would do to try to attempt to get that 10 information for me? 11 A. I would place a couple of phone 12 calls. 13 Q. To who? 14 A. Doctor Zerbe or Doctor Talbott, 15 and find out who's the best source of that kind 16 of information. 17 Q. Okay. To your knowledge, was 18 any of the information from the international 19 studies provided to the FDA as part of the 20 approval process for Prozac and depression? 21 A. I'm not certain since that 22 information was submitted prior to me being in 23 the medical, I can't say one way or the other. 24 Q. How about other drugs at Lilly, Page 155 1 have you had any experience with the submissions 2 prior to approval of a drug for use of marketing? 3 A. Are you referring to the use of 4 outside the United States clinical trial data? 5 Q. No, let me rephrase it. Other 6 than Fluoxetine -- 7 A. Yes. 8 Q. Have you ever been involved 9 with a drug at Lilly where you were actually 10 involved with the approval process with the FDA? 11 A. I have never personally been 12 involved with the approval process. 13 Q. To your knowledge, is it a 14 requirement of the FDA that the results of any 15 studies performed outside the U.S. be submitted 16 to the FDA as part of the approval process? 17 A. To the best of my knowledge, 18 that is not a requirement. 19 Q. Okay. To the best of your 20 knowledge, is it a Lilly policy to provide the 21 FDA with the results of clinical trials conducted 22 outside the United States? 23 A. Results from all studies that 24 are completed at the time of submission would be Page 156 1 submitted. 2 Q. Including international 3 studies? 4 A. Correct. 5 Q. And if clinical -- you're using 6 study and trial synonymously? 7 A. Correct. 8 Q. And if a study was completed 9 after the submission process was completed and 10 after the drug was approved by the FDA, any 11 studies that were completed after that, would 12 those results be submitted to the FDA? 13 A. There are interim reporting 14 requirements following approval. I assume they 15 get submitted at those times. 16 Q. Do you know for a fact that the 17 FDA requires that any clinical studies conducted 18 outside the United States and completed after 19 approval be submitted to the FDA? 20 MR. MYERS: Are you asking him if he's 21 aware that that is a requirement or are you 22 asking him is it a requirement, are you stating 23 that as a fact? 24 MS. ZETTLER: I asked him if he is Page 157 1 aware. 2 MR. MYERS: Of the FDA requirement is 3 what you said. 4 MS. ZETTLER: Is he aware if there is a 5 requirement. 6 MR. MYERS: Now you're saying if there 7 is one. You're asking him -- 8 MS. ZETTLER: I think that's what I 9 said before but I'll rephrase it. 10 MR. MYERS: I thought you stated it as 11 a fact, that's why. 12 MS. ZETTLER: I may have asked is it a 13 fact or something along those lines but I didn't 14 state it as a fact. 15 Q. Is it a requirement, to your 16 knowledge, of the FDA that any completed trials -- 17 any trials that are completed after approval be 18 submitted to the FDA? 19 A. I'm not certain of 20 post-approval studies. 21 Q. To your knowledge, did the FDA 22 ever request that Lilly provide it with a 23 reanalysis of data collected through the clinical 24 trials on the issue of suicidality or suicide? Page 158 1 A. I'm not aware of any specific 2 request from the FDA in that regard. 3 Q. Are you aware as to whether or 4 not the FDA ever suggested that Lilly do an 5 analysis of all of the data collected by it 6 during clinical trials in relation to the issue 7 of suicidality? 8 A. I'm not aware that they might 9 have suggested such a retrospective analysis. 10 Q. To your knowledge, did the FDA 11 ever -- did the FDA ever suggest that Lilly do a 12 rechallenge study on Fluoxetine with relation to 13 suicidality? 14 A. I have no knowledge in that 15 area. 16 Q. Who is Mel Perelman? 17 A. President of Lilly Research 18 Laboratories. 19 Q. In your opinion, would it have 20 been proper for the FDA to suggest that Lilly do 21 a study, a rechallenge study on Fluoxetine and 22 suicidality? 23 MR. MYERS: Before he answers, let me 24 object to the form to the extent that whether or Page 159 1 not any clinical trial to include the one in your 2 question would call for an opinion of a medical 3 doctor, which he is not, so I object to the form. 4 But you can answer it if you -- 5 MS. ZETTLER: It takes a medical doctor 6 to decide whether or not it's appropriate for the 7 FDA to instruct a drug company on whether or not 8 to do something? 9 MR. MYERS: I object to the form. 10 Answer the question if you can. 11 A. I think I stated earlier that 12 I'm not aware that the FDA ever made such a 13 suggestion to Lilly. Would it be appropriate, 14 perhaps, certain circumstances for them to make 15 such -- 16 Q. What circumstances? 17 A. If they suspected or had some 18 information or needed some particular information 19 to respond to something, that they make such a 20 request from a, you know, from a manufacturer. 21 Q. Would it be appropriate for the 22 FDA to advise a manufacturer to put a cap on the 23 number of adverse events it reported with regards 24 to a certain drug? Page 160 1 A. In my opinion that would not be 2 appropriate. 3 Q. Are you aware that at certain 4 times, the FDA re-evaluated the safety and 5 efficacy of Prozac in response to the suicidality 6 issue? 7 A. Would you repeat that? 8 Q. Sure. Were you aware that at a 9 certain point, I believe it was September of 10 1991, an advisory committee, FDA advisory 11 committee, was empaneled to rereview the safety 12 and efficacy of Fluoxetine? 13 A. Yes. 14 Q. Were you involved in the 15 presentation to that committee? 16 A. I was not. 17 Q. Were you involved in any way 18 with that advisory committee presentation or 19 meeting? 20 A. I was not directly involved in 21 the presentation. 22 Q. Were you indirectly involved? 23 A. I sat through some of the 24 planning sessions. Page 161 1 Q. Are you familiar with a man 2 named Jan Fawcett M.D., F-A-W-C-E-T-T? 3 A. No. 4 Q. Have you ever heard that name 5 before? 6 A. I've heard the name. 7 Q. In what context have you heard 8 the name? 9 A. One of the many meetings I 10 attended at Lilly, I heard the name. But I 11 can't, I don't know who he is or with whom he's 12 affiliated. 13 Q. Okay. Are you aware of whether 14 or not Doctor Fawcett was on the advisory 15 committee panel that was convened to reevaluate 16 Fluoxetine? 17 A. I do not know if he was or was 18 not. 19 Q. In your opinion, would it be 20 appropriate for somebody at the FDA to advise a 21 drug manufacturer that the quality of their 22 experts that were to present testimony at such an 23 advisory committee meeting was good? 24 A. I have no opinion on that. Page 162 1 Q. You have no opinion as to 2 whether or not preapproval of a drug company's 3 medical experts prior to an advisory committee 4 meeting was appropriate or inappropriate? 5 A. I would think it would be 6 something that a company could do if they wanted 7 to, but would not -- 8 Q. I'm talking the FDA preapproval 9 of a manufacturer's experts who are going to 10 testify. 11 A. And my reply is if a 12 manufacturer so chose to seek FDA review of that 13 list, they could do that. 14 Q. Do you think it's appropriate 15 for the FDA to give them an opinion prior to an 16 advisory committee meeting as to whether or not 17 their experts are appropriate? 18 MR. MYERS: I think he answered that. 19 He said he didn't have an opinion. 20 A. I don't have an opinion. 21 MS. ZETTLER: Okay. Do you want to 22 take a quick break? 23 MR. MYERS: That's fine. 24 (A SHORT RECESS WAS TAKEN.) Page 163 1 Q. (BY MS. ZETTLER) Okay. Doctor 2 Amundson, what is a behavioral territology study? 3 A. Behavioral territology has to 4 do with an animal study that's conducted to look 5 at mating behaviors, does a compound interfere 6 with the mating behavior of either a male or a 7 female animal. 8 Q. Okay. 9 A. A rat or a rabbit for example. 10 Q. Okay. Were such studies 11 performed with Fluoxetine, to your knowledge? 12 A. Yes. 13 Q. What were the results of those 14 studies, if you know. 15 A. I don't recall what they might 16 have been. 17 Q. Were you ever involved in any 18 meetings between Lilly employees and FDA 19 personnel? 20 A. As applies to what part of my 21 career? 22 Q. Right. 23 A. Pardon? 24 Q. As applies to your career at Page 164 1 Lilly. 2 MR. MYERS: He said what part. 3 MS. ZETTLER: Oh, what part. 4 Q. Any part, we'll start with a 5 general. 6 A. Toxicology, yes, yes. 7 Q. Toxicology in Fluoxetine? 8 A. Not specifically, as I recall. 9 Q. Okay. Were you involved in any 10 meetings with the FDA in your position as 11 executive director in the medical division? 12 A. I had no direct involvement 13 with the FDA during that period of time. 14 Q. Do you know who Doctor Temple 15 is? 16 A. Bob Temple is with the FDA. In 17 what capacity, I don't recall. 18 Q. Do you know a Margaret Huff? 19 A. I don't think that I do. 20 Q. Do you know a Mary Huff? 21 A. Yes. That's your name, 22 Margaret? I did not know that her first name was 23 Margaret. 24 Q. Is it your understanding that Page 165 1 Mary Huff works in the legal department at Lilly? 2 A. Yes, ma'am. 3 Q. Do you know if whether or not 4 she has any regulatory compliance capacity at 5 Lilly in the legal department? 6 A. I don't know that she does. 7 Q. Okay. While you were in the 8 medical division, were you required to turn over 9 any documents regarding Fluoxetine to the legal 10 department at any time? 11 A. Yes. 12 Q. Do you recall when the legal 13 department started requiring that you turn over 14 documents? 15 A. Prior to the time I was in 16 medical. 17 Q. Okay. And was that a periodic 18 thing that you had to turn over documents every 19 so often? 20 A. Yes. 21 Q. Do you remember how often you 22 would have to turn over documents? 23 A. I don't remember how often the 24 reminders came but they were periodic as I Page 166 1 recall. 2 Q. Do you remember when you got 3 the reminders, what did you do in response to any 4 given reminder? 5 A. My secretary and I got together 6 and saw that the documents were submitted, the 7 files were submitted. 8 Q. Did you personally collect 9 documents to be sent to the legal department? 10 A. Did I personally collect 11 documents? 12 Q. Right, in your area? 13 A. Not in my area. Personally I 14 did not go around and collect documents. 15 Q. With your own documents, did 16 you personally get them together to be sent to 17 legal? 18 A. If those documents were in my 19 desk drawer, I handed them to my secretary. 20 Q. Okay. 21 A. Who put them in a box and the 22 boxes were collected. 23 Q. Do you have any idea how many 24 boxes would have been turned over to the legal Page 167 1 department on any given -- 2 A. From me, personally? 3 Q. You or your secretary, being 4 your documents, your personal documents? 5 A. It would be -- if it was more 6 than one box it would be very few boxes, okay, I 7 didn't measure the length of every box. 8 Q. Did they give you a criteria of 9 which types of documents to turn over to them, 10 the ones that related to Fluoxetine? 11 A. I recall that the memorandum 12 said all documents, so the file, I never reviewed 13 the file, all documents went that were in my 14 possession. 15 Q. How many titles did you 16 personally keep on Fluoxetine documents? 17 A. I kept one, it was labeled 18 Fluoxetine. 19 Q. Okay. Did you have it broken 20 down according to the various departments that 21 were under your control in the medical division? 22 A. No. 23 Q. Just threw everything in there? 24 A. Well, hopefully it wasn't Page 168 1 thrown, it was appropriately filed by subject 2 matter. 3 Q. Okay. Did you have like little 4 manila folders per subject? 5 A. Yes. 6 Q. And then would the documents be 7 filed within those folders chronologically or 8 some other order? 9 A. They should have been filed 10 chronologically, most recent in the front, oldest 11 in the back. 12 Q. Okay. Did you periodically 13 write correspondence regarding Fluoxetine, either 14 interoffice or out of the office correspondence? 15 A. I don't recall any 16 correspondence initiated by me specifically on 17 the subject of Fluoxetine. 18 Q. How about generally, that would 19 apply to Fluoxetine? 20 A. Authored by me? 21 Q. Right. 22 A. I don't recall any documents. 23 Q. Have you ever heard the term 24 neuroleptic malignant syndrome? Page 169 1 A. Neuroleptic malignant syndrome? 2 Q. Right. 3 A. No. 4 Q. How about in your capacity as 5 pharmacist, pharmacologist? 6 A. I still don't know what it is 7 in that capacity either. So I'm not familiar 8 with the term. 9 Q. I'm sorry, I didn't mean to cut 10 you off. Have you ever heard the word akathisia? 11 A. I've heard the word. 12 Q. Do you know what akathisia is? 13 A. Not relative to, you know, in 14 the medical context, I don't. 15 Q. Are you familiar with adverse 16 reactions that have been related to neuroleptic 17 medications? 18 A. Do you have any specific 19 neuroleptic medications in mind? 20 Q. No, generally? 21 A. I think I probably know some 22 but I couldn't give you a very long list. 23 Q. Why don't you give me the ones 24 you remember? Page 170 1 A. Well, there are jerking 2 motions, extra parametal side effects, primarily 3 this kind of thing. 4 Q. Generally what are neuroleptic 5 medications, what are they used for? 6 A. Neuroleptic drugs are drugs 7 that are used to -- that will affect the mind or 8 neurotransmitters. 9 Q. Would Prozac be considered a 10 neuroleptic? 11 A. I think it could be. 12 Q. Believe it or not I'm trying to 13 shorten this thing. 14 A. Congratulations. 15 Q. Did you ever attend any medical 16 marketing meetings? 17 A. Marketing -- do you mean 18 meetings attended by both medical and marketing 19 or specifically medical marketing meetings? 20 Q. Have you ever heard the term 21 medical marketing meeting? 22 A. I heard the term, I never 23 attended such a meeting. 24 Q. Did you ever have any Page 171 1 responsibility for organizing a medical marketing 2 meeting? 3 A. I had no specific involvement 4 in a medical marketing meeting. 5 Q. What is a medical marketing 6 meeting? 7 A. I don't know what a medical 8 marketing meeting is in that context. I have 9 heard the term but I don't know what they were. 10 Q. Who is Linda Reed? 11 A. Who is Linda Reed. I don't 12 know that -- I don't recall ever knowing a Linda 13 Reed. 14 (PLAINTIFFS' EXHIBIT NO. 6 WAS 15 MARKED FOR IDENTIFICATION AND 16 RECEIVED IN EVIDENCE.) 17 Q. Have you had a chance to look 18 at Exhibit 6, Doctor Amundson? 19 A. Yes. 20 Q. Does that refresh your 21 recollection as to who Linda Reed is? 22 A. I have never met this Linda 23 Reed, I have obviously corresponded with her, she 24 was a secretary in the marketing area. Page 172 1 Q. Okay. How do you know she was 2 a secretary in the marketing area? 3 A. Because she used to send me the 4 requests for any agenda items that her boss was 5 responsible for -- relative to the setting up an 6 agenda for this meeting. 7 Q. Who was her boss, if you know? 8 A. I can see his face but I can't 9 recall his name. Why don't you go on, I can't 10 recall his name. 11 Q. Does this refresh your 12 recollection as to whether or not you attended 13 any medical marketing meetings? 14 A. In this context, yes, they were 15 held periodically. 16 Q. Can you give me an idea what 17 these meetings entailed? 18 A. She obviously corresponded with 19 me to see if we had any agenda items, okay, so I 20 would query my staff, the regulatory area of the 21 medical plans area, did you have any agenda 22 items. If there were no items, there was no 23 meeting and, you know. 24 Q. So at these meetings, if one Page 173 1 was held, various members of your staff would 2 interact with people from the marketing 3 department? 4 A. This was an opportunity for the 5 people to interact if there were issues common to 6 the two areas, here's a forum for discussion. 7 Q. Now that your recollection has 8 been refreshed by this memorandum or these 9 memoranda, do you recall the topics of any 10 specific medical marketing meetings? 11 A. I don't specifically recall. 12 The third page states something about a Turners 13 syndrome something, so this was obviously 14 discussed but I don't remember the discussion. 15 Q. What is Turners syndrome, if 16 you know? 17 A. Turners syndrome is one of 18 these extra movement kind of -- and a Turners 19 syndrome relative to HGH is human growth hormone 20 and Turners syndrome is -- well, I'm not -- it's 21 not a movement, it's a growth thing. But I 22 really, I can't define it for you in medical 23 terms. 24 Q. Have you ever heard of a Page 174 1 project management medical marketing meeting? 2 A. Yes, yes. 3 Q. What is a project management 4 medical marketing meeting? 5 A. Project management, slant, 6 medical, slant, marketing, three different 7 functions that not unlike the medical marketing, 8 you throw in the project management group that 9 these were meetings that were held periodically 10 to discuss issues that went across function, 11 medical marketing and project management. 12 Q. Okay. Would the issue of 13 suicidal ideation, suicide, and the use of 14 Fluoxetine, be an issue that would go across all 15 three of those departments? 16 A. It is my opinion that it could. 17 Project management's involvement in that, I don't 18 recollect what it was, but that could have been 19 part of that discussion. 20 Q. If Lilly wanted to do a 21 retrospective analysis of the clinical trial data 22 collected with regards to Fluoxetine and 23 suicidality, would that be something that project 24 management would be involved in? Page 175 1 A. There would -- no. I would say 2 they would not be involved in that. 3 Q. Okay, why not? 4 A. That would be a medical 5 decision. The project manager -- and we have 6 discussed that earlier, would be aware of what 7 was going on with Fluoxetine but they would not 8 be part of the decision making group as to what 9 retrospective analyses might be conducted, that 10 was a medical function. 11 Q. Okay. Would somebody from 12 project management be assigned to such a project? 13 A. I don't recall there being any 14 project management personnel assigned to any of 15 the retrospective analysis projects that we had 16 going at the time I was -- 17 Q. Were you aware of any 18 prospective studies that were done regarding 19 Fluoxetine and suicidality? 20 A. Was I involved? 21 Q. Were you aware of any 22 prospective studies that were done on Fluoxetine 23 and suicidality? 24 A. No. Page 176 1 (PLAINTIFFS' EXHIBIT NO. 7 WAS 2 MARKED FOR IDENTIFICATION AND 3 RECEIVED IN EVIDENCE.) 4 Q. Have you had a chance to review 5 Exhibit Number 7? 6 A. Yes, I have. 7 Q. Did you author this exhibit? 8 A. Yes. 9 Q. Do you recognize it? 10 A. Yes. Not specifically but I 11 recognize it generically since I was responsible 12 for setting the agenda for some of these 13 meetings. 14 Q. Can you tell us what you meant 15 by included with this brochure are the resource 16 planning documents for Medical, Erl Wood, the 17 Lilly Clinic, Systems and Regulatory? 18 A. Brochure is a compilation of 19 pages, a booklet. 20 Q. Okay. 21 A. That was put together. 22 Q. For what purpose? 23 A. By my people to look at human 24 resource allocation to various projects. Page 177 1 Q. Okay. To your knowledge, was 2 this human resource planning for Fluoxetine? 3 A. Fluoxetine was included. 4 Q. Okay. Do you recall this 5 meeting June 5, 1991? 6 A. Not specifically, no. 7 Q. Who were the people listed on 8 the left-hand side, upper left-hand side of the 9 page, starting with T. L. Emmick? 10 A. Who are they? 11 Q. Yes. 12 A. They're all part of the senior 13 management group of Eli Lilly and Company. 14 Q. Can you give me what Doctor 15 Emmick's title would be at that time? 16 A. At that time, vice-president 17 development. 18 Q. How about Mister Lange? 19 A. He was vice-president 20 marketing. 21 Q. How about Doctor Morton? 22 A. Vice-president Lilly Research 23 Laboratories. 24 Q. Doctor Roffey? Page 178 1 A. The same title as Doctor 2 Morton. 3 Q. How about Mister 4 D. E. Thompson? 5 A. Vice-president market research. 6 Q. Do we know if this 7 W. L. Thompson is Leigh Thompson? 8 A. Leigh Thompson, yes. 9 Q. And Doctor Weinstein we already 10 talked about as well as Doctor Zerbe, right? 11 A. Yes. 12 Q. Who is Mister Clark? 13 A. That's the gentleman whose name 14 I couldn't remember a few minutes ago, Linda 15 Reed's boss, Gary Clark, and he was 16 vice-president of marketing. 17 Q. Would the marketing department 18 run the medical marketing meetings that we talked 19 about earlier? 20 A. If they had the agenda, they 21 would. If it was medical's agenda then it would 22 be run by the medical personnel, depending on 23 what the topics were. 24 Q. Okay. So if Mister Clark Page 179 1 decided that the marketing department needed to 2 have a meeting for some reason, they would 3 contact medical and see if they wanted to put any 4 agenda items on that? 5 A. Correct. 6 Q. If medical said no, we don't 7 really have anything to include on the agenda, 8 would people from medical still show up at this 9 meeting? 10 A. If there was a meeting, a 11 select number of people would attend, yes. 12 Q. And the only situation where 13 there would not be a meeting is if nobody had 14 anything to go on the agenda? 15 A. Correct. 16 Q. How about Doctor Clayman, who 17 is Doctor Clayman? 18 A. I'm not sure exactly what 19 position he held June 4, 1991 but he was one of 20 the physicians within the medical component. 21 Q. Okay. Under Doctor Masica or 22 Doctor -- 23 A. Probably at that time under 24 Doctor Zerbe, okay. Page 180 1 Q. Would Doctor Clayman then be 2 above Doctor Masica and Doctor Tollefson on the 3 hierarchy? 4 A. I would say he would be a 5 lateral associate, okay, equivalent. 6 Q. Would he have responsibilities 7 for personnel different than Doctor Tollefson and 8 Masica? 9 A. Yes. 10 Q. What personnel would he have 11 responsibility over? 12 A. Because he is on this memo, 13 during this time frame, he was most probably 14 director of the Lilly Clinic. 15 Q. Okay. Did he hold any other 16 positions within the medical division other than 17 as director of the Lilly Clinic, to your 18 knowledge, at any time? 19 A. Senior physician at one time 20 before he assumed that position. 21 Q. So assuming the position as 22 director of the clinic would have been a 23 promotion? 24 A. Yes. Page 181 1 Q. Who is Mister Crum, C-R-U-M? 2 A. Mister Crum was one of the 3 managers in clinical plans that reported to me. 4 Q. What does clinical plans do? 5 A. Clinical plans are the group of 6 nonphysician CRAs, clinical, you know, research 7 assistants that helped the physician group within 8 the cluster, planned the studies and analyzed the 9 data on the back end. 10 Q. Would these be the people that 11 would help to write the protocols? 12 A. Yes. 13 Q. On the right-hand side there's 14 a bunch of CCs, who are these people? 15 A. Doctor Dies was a director 16 level physician within medical. 17 Q. What's a director level 18 physician? 19 A. Masica was a director level 20 physician when I came in. 21 Q. Okay. 22 A. And Doctor Dies was a director 23 level physician, Doctor Clayman was a director 24 level physician. They had more than one of these Page 182 1 people, okay, and they had different therapeutic 2 areas and the clinic. 3 Q. Who is Doctor Draper? 4 A. Doctor Draper, a similar 5 position. 6 Q. Director level? 7 A. Yes. Larry Ellingson was in 8 the market research or new product planning area. 9 Q. Were those the same, market 10 research? 11 A. They're allied areas. Tim 12 Franson, director level physician. 13 Q. Okay. 14 A. Mister Harrill was the 15 equivalent of Mister Crum and was the second 16 manager in medical plans reporting to me. 17 Q. Okay. Is that Mike Harrill? 18 A. Mike Harrill. 19 Q. Nancy Langwith we previously 20 identified as director of medical information 21 systems. Doctor Murphy was the director in the 22 project management group. 23 Q. Okay. 24 A. Mister Shinar would be an Page 183 1 equivalent to Mister Ellingson in this allied 2 group that I talked about. 3 Q. He would be in new products? 4 A. New product planning. Mrs. 5 Smitherman was on my staff as manager of medical 6 planning and training. 7 Q. Okay. 8 A. Doctor Talbott, we have talked 9 about a number of times. 10 Q. Yes. 11 A. Doctor Therasee was a director 12 level physician. 13 Q. Okay. Now did all of these 14 director level physicians have responsibilities 15 with regards to Fluoxetine, to your knowledge, 16 during this period of time? 17 A. No, I don't think they did. I 18 don't see any on there in the CC group, I don't 19 see anybody that had any responsibilities for 20 Fluoxetine. 21 Q. Do you know how often periodic 22 reports of nonalert status adverse events were 23 made to the FDA? 24 A. Nonalert? Page 184 1 Q. Right. 2 A. I can't answer that for 3 absolute certain, but at least annually. 4 Q. Okay. Did you ever hear of the 5 Rocky Mountain Poison Control Center? 6 A. Is your question am I aware of 7 it? 8 Q. Yes. 9 A. I am aware of what their 10 function is. 11 Q. Are you aware of it? 12 A. Yes. 13 Q. What is their function? 14 A. Poison control, that's a 15 resource that people can use if they overdose 16 with a common household chemical or a drug or 17 anything else. 18 Q. So if you accidently drank some 19 Draino or something, you could call them up and 20 say what do I do now? 21 A. If you could still talk you 22 could do that, yes. 23 Q. So it's a layman's source as 24 well as a manufacturer source? Page 185 1 A. Yes. 2 Q. Earlier you testified that 3 Lilly reported all adverse events to the FDA 4 regardless of seriousness, correct? 5 A. Yes, I did. 6 Q. Were you ever aware of a period 7 of time where Lilly considered whether or not to 8 report nonalert 1639s to the FDA? 9 A. I don't recall, you know. It's 10 my recollection that at the time I was in 11 medical, all adverse events were reported in some 12 format, okay. That's my recollection. 13 Q. Okay. Can you think of any 14 reason why the FDA would not want Lilly to report 15 adverse events to it regardless of whether or not 16 it was serious or not serious? 17 MR. MYERS: Before he answers, let me 18 object to the form to the extent you're, I think, 19 calling upon him to speculate as to what or why 20 the FDA might do something and I think that's 21 speculative. But if he can answer, please go 22 ahead. 23 A. Inundation. 24 Q. Okay. Wouldn't the large Page 186 1 numbers of adverse events related to a particular 2 product actually indicate that there was a 3 problem with the product to the FDA? 4 MR. MYERS: Hold on, let me object to 5 the form. It calls upon him to speculate as to 6 how the FDA would interpret a volume of reports 7 on anything. 8 MS. ZETTLER: I think it's a common 9 sense question, but go ahead. 10 MR. MYERS: It may be. 11 A. My opinion is it depends on 12 what the adverse event is. 13 Q. How about suicide? 14 A. I would think that would be 15 something that they would pay attention to as 16 would the manufacturer. 17 Q. Okay. How about suicidal 18 ideation, if they were inundated with reports of 19 suicidal ideation while people were on a 20 particular drug, would that indicate to them or 21 should that indicate to them that there may be a 22 problem with the drug? 23 MR. MYERS: Same objection. 24 A. They in this case being the Page 187 1 FDA? 2 Q. Right. 3 A. I would think that they would 4 pay some attention if they were paying attention 5 to the data that was being submitted to them, 6 okay. 7 (PLAINTIFFS' EXHIBIT NO. 8 WAS 8 MARKED FOR IDENTIFICATION AND 9 RECEIVED IN EVIDENCE.) 10 Q. Have you had time to look at 11 Exhibit 8? 12 A. Yes. 13 Q. I have to ask. Have you had a 14 chance to look at Exhibit Number 8, Doctor 15 Amundson? 16 A. Yes. 17 Q. To your knowledge, did Lilly 18 ever receive any reports of adverse events from 19 Rocky Mountain Poison Control Center? 20 A. Yes, it looks like according to 21 this memo, they did. 22 Q. Okay. In your opinion, would 23 at least some of those reports have consisted of 24 overdoses of various kinds? Page 188 1 MR. MYERS: Before he answers, let me 2 object to the form. You asked him an opinion 3 question without sufficient facts before him to 4 render an opinion, just this letter as to whether 5 any of those reports were overdoses or not. It 6 would be speculative at best for him to do that. 7 If you can answer it subject to that, go ahead. 8 A. I have no specific knowledge of 9 what information we received from Rocky Mountain 10 Poison Control Center. According to this memo, 11 we got some overdose information but it didn't 12 come to me so I have no personal knowledge. 13 Q. Okay. So you would infer from 14 this memo that some of the information you got 15 from Rocky Mountain Poison Control Center 16 involved anti-depressant overdoses, correct? 17 A. According to the memo, that's 18 correct. 19 Q. What context would an overdose 20 not be an alert 1639? 21 MR. MYERS: Are you asking him for an 22 example? 23 Q. Yes, if you know of one. 24 A. An accidental overdose. Page 189 1 Q. Okay. 2 A. Child, you know, access to 3 prescriptions drug, something like that. 4 Q. You were one of the recipients 5 of this memo that comprises Exhibit 8, correct? 6 A. Correct. 7 Q. Do you recall having any 8 questions as to the subject matter of this memo? 9 A. I don't recall that I had any 10 comments or questions. 11 Q. Do you know why it would be 12 that Lilly would not want to report nonalert 13 1639s to the FDA? 14 A. I thought I had answered that 15 previously perhaps. 16 Q. If you did -- 17 A. A large number of them, and FDA 18 in talking with them weren't interested in 19 receiving nonalerts, they're interested in the 20 alert, that's my opinion. 21 Q. Okay. Do you have an 22 understanding on how an advisory committee 23 meeting works with regards to post-marketing 24 advisory committee meetings? Page 190 1 A. It's my impression that they 2 are called, you know, post-marketing are called 3 specifically to address issues that have arisen 4 with post-marketing incident situations with a 5 drug or new indications of an already marketed 6 drug. 7 Q. Okay. Are they generally 8 public meetings? 9 A. Yes. 10 Q. And theoretically time 11 permitting anybody who wanted to speak to the 12 subject who had anything of value to add to the 13 subject would be allowed to speak? 14 A. I think you have to get on the 15 agenda, you have to. 16 Q. How did you get on the agenda? 17 A. Consult or contact the FDA and 18 tell them you'd like to speak. 19 Q. Do you have any idea what their 20 criteria is? 21 A. I do not, I do not. 22 Q. You've got to let me finish my 23 question, okay, and I'll try to let you finish 24 your answer, I know it's getting late. Page 191 1 Is it appropriate for the FDA 2 to submit proposed questions that they're going 3 to ask a manufacturer during an advisory 4 committee meeting to the manufacturer prior to 5 the meeting? 6 A. It's their call, in my opinion. 7 Q. What is your understanding of 8 the appropriate relationship between the FDA and 9 manufacturers? 10 MR. MYERS: Let me object to the form 11 as to appropriate, that's awfully broad and 12 somewhat vague and undefined. 13 Q. The FDA is charged with 14 regulating drug manufacturers, correct? 15 A. (Witness moves head up and 16 down.). 17 Q. You have to say yes or no. 18 A. Correct, yes. 19 Q. And as as we talked about 20 earlier, part of their job is to pass judgment, 21 so to speak, as to whether or not a drug is safe 22 and efficacious and should be marketed to the 23 public, correct? 24 A. Correct. Page 192 1 Q. And this relationship between 2 the FDA which is a regulatory entity and the drug 3 manufacturer should be an arms length 4 relationship to a certain extent, shouldn't it? 5 A. That's a fairly general 6 question. I think that the association is most 7 effective if it's done in cooperation and not as 8 an adversarial relationship, there's a lot of 9 information that goes back and forth, most 10 effective if it's a cooperative venture to keep 11 approval time short and so forth. 12 Q. Most effective from whose 13 perspective, the public or manufacturer's? 14 A. Both. 15 Q. The public's perspective as 16 well as the manufacturer? 17 A. From the standpoint that the 18 public benefits from new approved drugs that are 19 safe and efficacious, it's to their advantage. 20 Q. And that's assuming that the 21 drug that is being approved by the FDA is safe 22 and efficacious though, correct? 23 A. I think that's what I said. 24 Q. If the drug is not safe and Page 193 1 efficacious then such a relationship might not be 2 beneficial to the public although it might be 3 beneficial to the manufacturer, correct? 4 A. I think that is one of the 5 purposes of the FDA as you just defined it, to 6 keep such drugs from being approved and marketed. 7 Q. Would you agree with me that if 8 the FDA were to become far more aligned with the 9 manufacturer as opposed to looking out for the 10 public welfare, that would present a situation 11 that would not benefit the public? 12 A. That's a convoluted question. 13 Would you restate that, I think I know what the 14 question was. 15 Q. Sure. Would you agree with me 16 that it would not benefit the public if the FDA 17 allegiance was slanted more towards the 18 manufacturer as opposed to the public? 19 A. I do not agree with that 20 statement. 21 Q. Why not? 22 A. Because I have faith in the 23 honesty and integrity of the manufacturing 24 pharmacist, okay. Pharmaceutical companies, they Page 194 1 are familiar with drug regulations and they know 2 what the efficacy requirements are, safety 3 requirements and so forth and I just feel that as 4 you stated the question, I cannot agree with 5 that. 6 Q. Okay. Would you say it would 7 be honest and forthright of a manufacturer, drug 8 manufacturer to cap the number of adverse events 9 that were reported to the FDA? 10 A. To cap them? 11 Q. Yes, to put a limit on the 12 number of events that they reported to the FDA? 13 A. To do what? 14 Q. Put a limit on the number of 15 events that they reported to the FDA? 16 A. No. 17 Q. You don't think that's honest 18 and forthright? 19 A. I don't think that it is. To 20 put a cap on it, you mean limit the number that 21 they submit? 22 Q. Right. 23 A. If it gets to a hundred you 24 stop? Page 195 1 Q. Right. 2 A. I don't think that that is 3 honest and forthright. 4 Q. Do you think it's honest and 5 forthright for a drug manufacturer to assign 6 event terms to specific adverse events that are 7 vague and ambiguous? 8 MR. MYERS: Let me object to the form 9 of the question only to the extent that the 10 testimony of every witness that has testified 11 before him is that event terms are assigned based 12 on mapping criteria and thus to the extent the 13 terms -- you contend the terms are vague and 14 ambiguous, that's an FDA mapping criteria. 15 MS. ZETTLER: First of all, I object to 16 you instructing the witness on how to answer the 17 question in your objection. I didn't say 18 anything about any particular event or any drug 19 or anything, I'm giving him a very general 20 hypothetical. 21 MR. MYERS: I object to the form but he 22 can answer it if he can. 23 MS. ZETTLER: Sure, if Doctor Amundson 24 has picked up on your instruction, go ahead and Page 196 1 answer it. 2 A. I can't answer the question. I 3 have -- if your question was do I have an opinion 4 or do I think it's appropriate, you know, I can't 5 relate to the question so -- 6 Q. Have you ever heard of a group 7 called DART, D-A-R-T? 8 A. I don't recall what DART is. 9 (PLAINTIFFS' EXHIBITS NO. 9 AND 10 10 WERE MARKED FOR IDENTIFICATION AND 11 RECEIVED IN EVIDENCE.) 12 Q. Have you had a chance to look 13 at Exhibits 9 and 10, Doctor Amundson? 14 A. Yes. 15 Q. Could you refer to Exhibit 10, 16 please. It looks like a memorandum by Doctor 17 Zerbe dated August 28, 1991, correct? 18 A. Correct. 19 Q. Who is Doctor Stadel, 20 S-T-A-D-E-L? 21 A. I don't know, I don't know, 22 that name is not familiar to me. 23 Q. The first paragraph of Doctor 24 Zerbe's memo indicates that Doctor Laughren gave Page 197 1 him Doctor Stadel's phone number, correct? 2 A. Correct. 3 Q. Does he list the phone number 4 in that paragraph? 5 A. Yes. 6 Q. The second paragraph states 7 would it be possible to take a portion of our 8 presentation and make it part of the invited 9 presentations. I believe he's referring to the 10 1991 advisory committee meeting in this memo, is 11 that correct? 12 A. I assume that that's what the 13 memo is referring to. 14 Q. What are invited presentations, 15 if you know? 16 A. I do not know. 17 Q. Do you know who Doctor Judd is? 18 A. I do not know. 19 Q. The paragraph goes on to say, 20 specifically I was inquiring about the 21 possibility that Doctor Judd's presentation could 22 be presented independently at Lilly, he indicated 23 that in the invited presentations there would 24 really only be FDA and industry, other groups Page 198 1 such as DART, D-A-R-T, would not be suitable for 2 that part of the presentation. Does that refresh 3 your recollection as to what DART is? 4 A. I still don't know what DART 5 stands for. 6 Q. Do you have any idea why Doctor 7 Zerbe would rather have Doctor Judd testify as an 8 independent participant as opposed to a Lilly 9 participant? 10 MR. MYERS: Before he answers let me 11 object to the form on the grounds that it calls 12 upon him to speculate as to what Doctor Zerbe 13 meant when he wrote this. But if you can answer 14 it, please do so. 15 A. I have -- in answer to your 16 question, I have no idea. 17 Q. Okay. 18 A. Absolutely none. 19 Q. Take a look at Exhibit 9, 20 please, Doctor Amundson. Exhibit 9 looks like 21 another memorandum written by Doctor Zerbe, 22 correct? 23 A. Uh-huh, yes. 24 Q. This one is dated September 13, Page 199 1 1991, correct? 2 A. Correct. 3 Q. And again it's regarding a 4 phone call from Doctor Laughren, correct? 5 A. Correct. 6 Q. About five lines down, the 7 sentence that started, I followed with, do you 8 see that? 9 A. Yes. 10 Q. It states, I followed with a 11 number of questions, first requesting permission 12 to contact Dr. Bruce Stadel regarding his 13 presentation to the advisory committee. It 14 appears like the same Doctor Stadel who was 15 mentioned in the August 28, 1991 memo that's 16 Exhibit 10, correct? 17 A. Same last name, Stadel. 18 Q. Okay. And in the Exhibit 10 19 memorandum, Doctor Zerbe indicates that Doctor 20 Laughren had given him Doctor Stadel's telephone 21 number, correct? 22 A. Correct. 23 Q. Then the September 13th Exhibit 24 9 memo goes on to state, Doctor Laughren Page 200 1 consented, but emphasized that our questions 2 should not suggest any kind of collaboration. 3 What does that sentence imply to you? 4 MR. MYERS: Before he answers let me 5 object to the form, it calls upon him to 6 speculate as to what the writer of this memo, 7 apparently Doctor Zerbe, meant when he wrote it. 8 MS. ZETTLER: I'm not asking him what 9 Doctor Zerbe meant, I'm asking him what the line 10 implies to him. 11 MR. MYERS: I object to the form. He 12 can certainly answer it if he can. 13 A. I have no knowledge of the 14 subject matter of this memo. 15 Q. Okay. 16 A. It was written in response to a 17 phone call that occurred between two other 18 individuals. I don't know what they're talking 19 about, I don't know Stadel, I don't know the 20 issue other than it's the advisory committee 21 meeting agenda. But I have no knowledge of 22 what's being discussed here, I don't. 23 Q. So you have no idea what Doctor 24 Zerbe means when he says questions should not Page 201 1 suggest any kind of collaboration? 2 MR. MYERS: Same objection. 3 Q. Correct? 4 MR. MYERS: You can answer if you can. 5 A. I don't have an opinion on it 6 since I don't know what the subject matter is. 7 Q. Okay. Right above that, it 8 talks about Doctor Laughren's preparation for the 9 advisory committee meeting. 10 MR. MYERS: Where? 11 MS. ZETTLER: Three or four lines 12 above. 13 Q. He asked that we have 14 additional information on those specific cases 15 which he would be using in his preparation for 16 the advisory committee meeting. Putting it in 17 the context of the advisory committee meeting, 18 does that give you any idea of what Doctor Zerbe 19 meant when he said that Doctor Laughren didn't 20 want him to suggest any kind of collaboration in 21 his questions to Doctor Stadel? 22 MR. MYERS: Same objection. 23 A. I can't speculate on that, I 24 have no knowledge of what the issue is here. Page 202 1 Obviously it's the agenda of the advisory 2 committee meeting but I was not an active 3 participant in that, so I have no specific 4 knowledge, I really can't comment on it. 5 Q. If in fact Lilly employees and 6 FDA employees were collaborating on Lilly's 7 presentation to the advisory committee meeting 8 regarding Fluoxetine, would that have been 9 appropriate? 10 MR. MYERS: I object to the form and 11 the use of the word collaboration as being vague 12 and otherwise assuming that there was in fact a 13 collaboration. But if you can answer it, answer 14 it. 15 A. I think cooperation, as I 16 commented on before, would be appropriate for 17 such a meeting to let the FDA know what's going 18 to be presented and Lilly know what, in this case 19 what the FDA has on their agenda. 20 Q. Why is it that Doctor Laughren 21 appears hesitant about Doctor -- 22 A. I don't have any idea. 23 Q. Let me finish my question. Why 24 is it that Doctor Laughren appears hesitant to Page 203 1 allow Doctor Zerbe to contact Doctor Stadel? 2 MR. MYERS: Before he answers, let me 3 object, because he's now being called upon to 4 speculate about what Doctor Laughren does or 5 doesn't think or feel. He's not even the writer 6 of this memo, that is Doctor Laughren, and it's 7 highly speculative and thus I object to the form. 8 You can answer it if you can. 9 A. I find it difficult to answer 10 questions on subject matters that I have 11 absolutely no knowledge or recollection of, so -- 12 I choose not to answer. 13 Q. Why is it -- I'm sorry. 14 A. I can't answer the question. 15 Q. Why is it, Doctor Amundson, 16 that you are carbon copied on numerous memoranda 17 from other people regarding the advisory 18 committee and the issue of suicidality and 19 Fluoxetine and you have so little memory of 20 anything happening regarding that? 21 MR. MYERS: Which memoranda are talking 22 about in addition to this, you said numerous? 23 MS. ZETTLER: I'm talking about 24 generally throughout the documents that were Page 204 1 produced. 2 MR. MYERS: I think if you're going to 3 refer to specific documents, you should. If you 4 ask him why he was copied on this, he may or may 5 not know. We're talking about two documents and 6 you're talking about numerous, so in fairness to 7 the witness, I think he should know what the 8 documents are. 9 Q. When you're copied on a 10 memorandum, Doctor, do you generally read that 11 memorandum? 12 A. Do I generally what? 13 Q. Read it. 14 A. Yes, I do. 15 Q. Okay. And do you generally 16 make a mental note of what's contained in the 17 various memorandums that you received? 18 A. If it's important or germane, I 19 do. If not, when I was in various managerial 20 positions, you get copies of lots and lots and 21 lots of things because you're part of the, you 22 know, the group, the management group, and they 23 usually carbon copy people up and down. Some of 24 it is information that ought to be retained and Page 205 1 some of it is information that is just 2 information. 3 Q. Okay. Earlier you agreed that 4 the issue of suicide and suicidality and the use 5 of Fluoxetine was an important issue to Eli 6 Lilly, correct? 7 A. Correct. 8 Q. Would that be something that 9 you would make a mental note of if you received a 10 memorandum on it? 11 A. I would make a mental note if I 12 received a memorandum. How long I would retain 13 that information, since there are a fairly large 14 number of people in my area of responsibility 15 that had direct involvement in these issues, were 16 meeting directly with the FDA or corresponding 17 with other Lilly associates relative to this 18 issue, they would have better retention than I 19 that received lots of different information, not 20 just on Fluoxetine but all the other drugs too, 21 you know, so you sort it out as to what's germane 22 and what's not. 23 Q. And in the scope of your 24 position as executive director in the medical Page 206 1 division, the issue of suicidality was not as 2 germane as other issues that you worked on? 3 A. It was germane. 4 Q. Why is it that you were the 5 executive director of a portion of the medical 6 division for two years and you have so very 7 little memory of anything that happened with 8 regard to the suicidality and Fluoxetine issue? 9 MR. MYERS: You don't have to agree 10 with what she just said. 11 A. I think I stated earlier that I 12 was not, okay, involved in the presentation, nor 13 directly involved in the planning of the advisory 14 committee meeting, okay. 15 Q. But you were in an executive 16 level position over a number of people who were 17 directly involved, weren't you? 18 A. And I attended those sessions, 19 a number of those sessions. But it was a medical 20 problem, occurring in the medical division, okay, 21 and I think the primary players were the 22 physician people that were involved in it and in 23 attendance, and although my people played a role, 24 the regulatory people and so forth, my role, I Page 207 1 was not given a part of this to prepare for 2 presentation, that wasn't my role. 3 Q. Is Lilly's only reason for 4 developing, synthesizing, producing and marketing 5 Prozac is to help people with depression, is that 6 their sole reason? 7 A. Well, I don't know what Lilly's 8 sole reason is, they're in the business, okay. 9 Q. Would you agree that it's 10 probably very important to Lilly to market this 11 drug and make up to, according to some reports, a 12 billion dollars a year on the drug? 13 MR. MYERS: I object to the form of the 14 question, that assumes facts not in evidence and 15 never will be in evidence. Answer it if you can. 16 A. I can't. 17 Q. Lilly didn't market Prozac in a 18 purely altruistic -- for purely altruistic 19 reasons, did it, Doctor Amundson? 20 MR. MYERS: I object to the form purely 21 altruistic as being vague and ambiguous and 22 argumentative at this point. 23 Q. You can answer it. 24 A. Lilly's intent and purpose of Page 208 1 the corporation is to be in the drug business, 2 therefore we manufacture, market drugs, devices, 3 animal products, et cetera. 4 Q. Would Lilly be in the drug 5 business marketing drugs, devices, et cetera, if 6 it wasn't making money on it? 7 A. There wouldn't be a drug 8 business if the drug manufacturers weren't making 9 money on it. 10 (PLAINTIFFS' EXHIBIT NO. 11 WAS 11 MARKED FOR IDENTIFICATION AND 12 RECEIVED IN EVIDENCE.) 13 Q. Have you had a chance to look 14 at Exhibit 11? 15 A. Yes. 16 Q. Does Exhibit 11 refresh your 17 recollection as to whether or not Lilly has 18 performed any rechallenge studies on Fluoxetine? 19 A. It does not. 20 Q. Are you familiar with this 21 memorandum? 22 A. I am not. 23 Q. Are you familiar with the 24 subject matter of the memorandum? Page 209 1 A. Specifically, I'm not familiar 2 with it. 3 Q. How about generally? 4 A. Generally I'm not familiar with 5 the meeting that was held. 6 Q. What is characterization? 7 A. Characterization relative to 8 patients? 9 Q. I don't know. It says in this -- 10 it says meeting with Doctor Tom Laughren 11 regarding characterization and rechallenge 12 protocols. 13 MR. MYERS: If you're asking him about 14 characterization as it's stated here, I object to 15 the form because it calls upon him to speculate 16 as to what Doctor Zerbe meant by using that 17 reference. 18 Q. Doctor Amundson, are you 19 familiar with what a rechallenge study is? 20 A. I am not. 21 Q. You don't know what a 22 rechallenge study is? 23 A. I could surmise what it is but 24 I don't know exactly what it is. Page 210 1 Q. You testified earlier that you 2 understood what the concept of rechallenging was? 3 A. I do, I know what challenging 4 is, I know what rechallenging is, okay. 5 Q. Have you ever heard them use 6 the phrase characterization, in relation -- 7 A. No, I don't know. 8 MR. MYERS: Let her finish her question 9 before you answer. 10 Q. Okay. So you never heard the 11 word characterization used with regards to 12 rechallenging, right? 13 A. I have not. 14 Q. Have you ever heard of Lilly's 15 sales people making proactive requests of 16 customers? 17 A. Would you define proactive 18 requests? 19 Q. Soliciting from people that 20 they were detailing for Fluoxetine whether or not 21 any of their patients suffered an adverse event. 22 A. I am not, I don't know if they 23 were ever requested to do that or not. I'm not 24 familiar, you know, in any detail with the sales Page 211 1 part of the organization. 2 Q. Okay. Were you ever aware of 3 whether or not Lilly ever sent out a mass mailing 4 of letters to prescribing physicians and other 5 customers asking them for information on adverse 6 events suffered by their patients on Prozac? 7 A. Specifically, no, I can't 8 recall there being such a request. 9 Q. How about generally? 10 A. There might have been, there 11 might have been but I don't recall that. 12 Q. Do you know who Bob Petersen 13 is? 14 A. With a name like Amondson, you 15 know a lot of Petersens, okay, but I don't -- I 16 can't relate specifically to that Bob Petersen 17 without having the document in front of me and 18 being able to relate where Bob Petersen might be. 19 Q. Okay, we'll let you take a look 20 at the document then. 21 (PLAINTIFFS' EXHIBIT NO. 12 WAS 22 MARKED FOR IDENTIFICATION AND 23 RECEIVED IN EVIDENCE.) 24 Q. You have had a chance to take a Page 212 1 look at Exhibit 12? 2 A. Yes. 3 Q. Does that refresh your 4 recollection as to who Bob Petersen is? 5 A. I don't recollect who Bob 6 Petersen is. 7 Q. Are you familiar with the 8 subject matter of this memorandum, Doctor 9 Amundson? 10 A. I don't recall the issue. 11 Q. Are you familiar with the 12 select representatives? 13 A. Select representatives? 14 Q. Right. If you look at the 15 second paragraph under following up with Bob 16 Petersen, there were two issues listed, one 17 beginning August 15, two hundred fifty select 18 representatives and four hundred fifty Dista 19 representatives. 20 A. I think those are referring to 21 sales representatives from both the Dista side of 22 the business and the select products side of the 23 marketing business. 24 Q. Okay. I thought earlier that Page 213 1 you testified that Dista was the marketing 2 representative for particular products? 3 A. And so is select products, 4 okay. Whether they comarket a single product, I 5 can't answer that, but that is a possibility. 6 Q. Okay. So in this case it at 7 least appears from this memorandum that there 8 were Prozac representatives from both the select 9 area and the Dista area? 10 A. It would appear that that's 11 true. 12 Q. Who is Beth Meloy, M-E-L-O-Y? 13 A. Is she on this memo or is this -- 14 Q. Something else. 15 A. Beth Meloy. Part of the time 16 that I was in medical, Beth was one of the 17 managers in the medical information systems area. 18 While I was there, she moved on to a different 19 assignment. 20 Q. Do you remember when she moved 21 on? 22 A. I don't recall when. She was 23 probably there half the time I was there. 24 Q. Okay. How about January of Page 214 1 1991, do you think she was still a manager with 2 information systems? 3 A. I don't know, I don't know if 4 she was or wasn't. 5 MS. ZETTLER: Let's take about a ten or 6 fifteen minute break. 7 MR. MYERS: Okay. 8 (A SHORT RECESS WAS TAKEN.) 9 Q. (BY MS. ZETTLER) Okay. Can 10 you tell me what a CTE is? 11 A. A CTE? 12 Q. Yes. 13 A. Clinical trial exemption, I 14 don't know. Until I see in what context, I can't 15 respond to it. 16 Q. I'm trying to avoid marking 17 another exhibit if I don't have to. What is a 18 clinical trial exemption? 19 A. A clinical trial exemption, I 20 must have been right. I can't recall 21 specifically what they are or what it is. 22 (PLAINTIFFS' EXHIBIT NO. 13 WAS 23 MARKED FOR IDENTIFICATION AND 24 RECEIVED IN EVIDENCE.) Page 215 1 A. I have read the memo or 2 whatever it is, a piece of paper. 3 Q. Have you reviewed Exhibit 13? 4 A. Yes, I have. 5 Q. Does that refresh your 6 recollection as to what a CTE is? 7 A. I can't relate based upon this 8 document exactly what a CTE is, okay. 9 Q. Okay. 10 A. And I don't know what this is. 11 Q. Do you know what a CRF is? 12 A. Case report form. 13 Q. Do you know generally what a 14 CTE is? 15 A. I can comment generally on what 16 a clinical trial exemption is. 17 Q. Okay. What is a clinical trial 18 exemption? 19 A. It is a clinical trial, okay, 20 that is conducted outside of the usual 21 requirements for a clinical trial and I think 22 that the, as I recall, the requirements for data 23 reporting on the part of the physician during the 24 trial are much looser, okay. Page 216 1 Q. On the CTE? 2 A. On the CTE, and that's why the 3 exemption part of it. It's exempt from the usual 4 regulations that apply to clinical trials. In 5 general, that is my understanding of a clinical 6 trial exemption. 7 Q. For what purpose would you run 8 a CTE? 9 A. Patient experience. A 10 clinician -- a physician not familiar with the 11 drug, might want to run a trial on a small number 12 of patients just to gain some experience with the 13 drug. 14 Q. If in fact Exhibit 13 is 15 talking about a clinical trial exemption, why 16 would clinical research form data be transferred 17 to a CTE as listed in issues, under the first 18 issues area. 19 A. I don't understand the first 20 bullet point under issues. 21 Q. Right. 22 A. Does CTE accurately and 23 completely reflect what's on the CRF, I don't 24 understand the context there. Page 217 1 Q. If you were to do a 2 retrospective analysis of data related to -- data 3 collected in the clinical trials related to 4 suicidality and Fluoxetine, would that be 5 considered a CTE, or could it be considered a 6 CTE? 7 MR. MYERS: In the task of doing the 8 analysis? 9 MS. ZETTLER: The study itself. He's 10 testified that a CTE is a study by -- it's not a 11 study within the normal parameters of a clinical 12 trial, correct. 13 A. Yes. 14 MR. MYERS: Is your question you're 15 looking at existing data and going back and 16 looking at it, is that what you're asking? 17 MS. ZETTLER: Right. 18 Q. If you're going to do a 19 retrospective study of suicidality as it relates 20 to the use of Fluoxetine based on an analysis, 21 retrospective analysis of all the data you 22 collected in your clinical trials, would that be 23 considered a CTE? 24 A. I don't know that. Your Page 218 1 question isn't hanging together from my 2 understanding of what a CTE is, okay. 3 Q. Okay. 4 A. Do you want to try it again? 5 Q. Sure. Earlier, we talked about 6 a study, I asked you if you were aware of a study 7 in which Lilly went back and analyzed data that 8 it collected throughout its clinical trials and 9 looked at it from the issue of Fluoxetine and 10 suicidality? 11 A. Yes. 12 Q. Would such a study or could 13 such a study have been considered a clinical 14 trial exemption study? 15 A. Such data as you have referred 16 to could have been collected on a trial exempt, 17 on an exempt trial, if the data was collected, 18 it's usable, if it wasn't collected, there's no 19 data so you can't use it. 20 Q. But a reanalysis of all the 21 CRFs say that were collected throughout the 22 clinical trial itself would not be considered a 23 CTE? 24 A. No. Page 219 1 Q. Are you familiar with the 2 Fluoxetine international project, have you heard 3 that term before? 4 A. I have heard the term and I 5 understand what it is from the context of where 6 I'm coming from, I don't know which one you're 7 referring to or if there are more than one but 8 I'm familiar with the term. 9 Q. Okay. What is your 10 understanding of what that term means? 11 A. We referred to it or it was 12 referred to in an earlier exhibit. You used the 13 term SWAT, okay. 14 Q. Okay? 15 A. That was an international 16 project team that was put together to look at the 17 whole U.S. data base. 18 Q. And on just clinical trials or 19 on spontaneous adverse event reporting also? 20 A. The project I'm familiar with 21 had to do with CRF review, okay. 22 Q. Was the Fluoxetine 23 international project charged with evaluating the 24 CRFs from the international studies? Page 220 1 A. They were concerned with 2 reviewing the CRFs -- 3 Q. They were? 4 A. -- on trials conducted, yes, 5 for the U.S. 6 Q. And were those CRFs reviewed 7 within the context of Fluoxetine and suicidality 8 under this project? 9 A. Under the international project 10 that I'm thinking about, yes. 11 Q. Was it -- was this a project 12 that was to be completed in a fairly short period 13 of time? 14 A. Yes. 15 Q. What time frame did they want 16 that completed in? 17 A. My recollection it was within -- 18 well, from start to finish, I don't know what 19 your time frame is, but my recollection is it was 20 a two or three month time frame, the data was to 21 have been reviewed and submitted back to 22 Indianapolis for additional review and decision 23 making and so forth. 24 Q. Okay. Were each of the Page 221 1 affiliates charged with doing any retrospective 2 analysis of their own CRFs? 3 A. I think an earlier exhibit had 4 all the countries listed and people listed and so 5 forth. They were alerted and they were asked to 6 go back and verify certain data that had been 7 reported and so forth, so they did some, and the 8 international project group went, travelled and 9 did some. So, it was a cooperative effort in 10 certain affiliates, okay. 11 Q. To your knowledge, were all of 12 the international trials conducted on Fluoxetine 13 included as part of this Fluoxetine international 14 project or was it only certain countries? 15 A. Certain countries, I think. 16 Q. And those countries that we 17 talked about earlier that were listed on an 18 earlier exhibit, were those the countries that 19 were included on the project? 20 A. There were some countries not 21 listed, okay, that were a very major -- European 22 countries that were included in this 23 international project, and I can't -- I don't 24 understand why they weren't also listed other Page 222 1 than they -- some of those countries had medical 2 directors in them, okay, responsible for those 3 kind of activities within. The countries that 4 were on that previous exhibit could have been 5 those countries that didn't have medical 6 directors. 7 Q. Okay. Which countries, do any 8 countries come to mind that weren't listed on 9 that previous exhibit? 10 A. Germany, France. 11 Q. Okay. 12 A. Are the two that were 13 noticeable to me and I know that those two 14 countries had medical directors in them, so the 15 major affiliates have medical directors. 16 Q. And why were only certain of 17 the countries picked and other countries were not 18 included in the project? 19 A. I think they were the major, 20 the largest number of patients in trials, those 21 were the countries that were part of this 22 international project. 23 Q. Okay. Any other criteria for 24 excluding a country that you know of? Page 223 1 A. I don't know of any reason why 2 a country would be excluded. 3 Q. Did I ask you who Lisa DeVault 4 was already? 5 A. You have not asked me that. 6 Q. Who is Lisa DeVault? 7 A. Lisa DeVault was one of the 8 analysts, okay, in the information systems group 9 in medical. 10 Q. Do you know if she still works 11 for Lilly? 12 A. She still works for Lilly but I 13 don't recall whether or not she's still in the 14 medical systems group. 15 Q. To your knowledge, is she still 16 in the United States? 17 A. I think, I don't know for sure, 18 I think she is but I don't know. 19 MS. ZETTLER: That's all I have, Doctor 20 Amundson. Thank you. 21 * * * * * * * * * * 22 CROSS EXAMINATION 23 BY MR. GREEN: 24 Q. Good afternoon, Doctor. My is Page 224 1 Gregory Green. I represent the Group B 2 plaintiffs in the Joyce Fentress litigation in 3 Kentucky. I just have a few questions for you 4 today. 5 Doctor, are the detail men, the 6 Dista detail men, are they part of the marketing 7 department or are they part of a separate 8 department? 9 A. My response is that 10 generically, the sales representatives or detail 11 persons, or whatever you want to call them, are 12 considered to be part of the marketing 13 organization. 14 Q. When Doctor Tollefson replaced 15 Doctor Masica -- 16 A. Yes. 17 Q. -- had he been working at Lilly 18 prior to that, Doctor Tollefson? 19 A. It's my understanding that he 20 was a physician psychiatrist that did clinical 21 trials on Fluoxetine. 22 Q. And is that basically what got 23 him his job? 24 A. I don't know what basically got Page 225 1 him his job but he was a fairly well known 2 academic physician. 3 Q. Did he relocate in order to 4 become an employee of Lilly? 5 A. He did. 6 Q. Do you know what the 7 association Doctor Tollefson had with Eli Lilly 8 prior to his employment with Lilly was? 9 MR. MYERS: Other than what he already 10 told you? 11 12 MR. GREEN: Yes. 13 A. I do not know,. 14 Q. Doctor, who had the 15 responsibility for the statistical group? I 16 believe that's what you referred to them as. 17 A. Doctor Charles Sampson is the 18 director of the statistical and mathematical 19 services department, or he was at that time. I 20 think he has a new position at this time. 21 Q. Was he the director in 1987? 22 A. In 1987, I don't know, I don't 23 know. 24 Q. He was the director from 1990 Page 226 1 to 1992, correct? 2 A. He was. 3 Q. Do you know who within the 4 statistical group worked on the drug Prozac? 5 A. There were a number of Doctor 6 Sampson's staff members that -- 7 Q. Do you have any names? 8 A. Greg Enas, Doctor Enas, there 9 was a young lady whose last name was Sayler. 10 Those are the two names that come to my mind. 11 Q. How about Doctor Dornseif, was 12 he part of that group? 13 A. Dornseif? 14 Q. Yes. 15 A. I can't put a face on Doctor 16 Dornseif. 17 Q. What would you describe the 18 function of the statistical group as being? 19 A. I think we discussed earlier 20 today, they are involved in the design of the 21 trial and then the analysis, the statistical 22 analysis of those parameters that are being 23 evaluated in the trial is their responsibility. 24 Q. Are they -- did they come under Page 227 1 the medical wing or are they their own group, in 2 other words? 3 A. At the time -- 4 Q. Yes. 5 A. -- that I was in medical, the 6 staff and mathematical services department 7 reported to medical, although they had 8 responsibilities in addition to medical. Some of 9 their staff were out in other areas of the 10 company than medical. 11 Q. Would they report to the 12 physicians in medical or would they report to 13 somebody in your group? 14 A. They would be a part of this 15 cluster concept that we have talked about, the 16 statisticians and the systems people and the CRAs 17 and so forth. 18 Q. Did they have anything to do 19 with the DEU? 20 A. The only involvement that they 21 would have had with the DEU would have been in 22 statistical analysis of the output of the product 23 of the DEU. 24 Q. The DEU is the drug Page 228 1 epidemiology unit, right? 2 A. Yes. 3 Q. So statisticians were looking 4 at the output of the DEU? 5 A. If they were involved, that's 6 where they would have been looking is my reply to 7 that. I don't know for a fact that they were. 8 Q. Did any epidemiologist look at 9 the output of the DEU? 10 A. I am sure that they did. 11 Q. Well, could you tell me the 12 names of some of the epidemiologists that looked 13 at the output of the DEU in relation to any 14 information or statistic that came out of the DEU 15 that had to do with Prozac? 16 A. The principal in the area 17 during the time I was there was Doctor Jim 18 Kotsanos. 19 Q. Any other epidemiologists? 20 A. It was a very small group, he 21 was the principal and there may have been two or 22 three other people. There were a couple of 23 nonphysician people that were involved. 24 Q. When I say epidemiologist, I Page 229 1 mean somebody who had an M.D., a Masters or Ph.D 2 in public health. Is there anybody at Lilly who 3 had those qualifications who dealt with Prozac? 4 A. And I've given you the name. 5 Q. Is that the only person? 6 A. I think. 7 Q. So there was one 8 epidemiologist? 9 A. There may have been more than 10 one, you asked me specific to -- 11 Q. Do you know for sure? 12 MR. MYERS: Wait a minute, let him 13 finish his answer. 14 A. You asked me specific to 15 Prozac, Doctor Kotsanos dealt with Prozac and 16 other epidemiological issues, okay. 17 Q. You said that there may have 18 been more than one? 19 A. Yes. 20 Q. Do you know for sure whether 21 there were in fact more than one epidemiologists 22 who worked with Prozac or do you not know that 23 for sure? 24 A. I don't know that for sure, Page 230 1 okay. 2 Q. Why do you think there may have 3 been more than one? 4 A. The group was in the process of 5 formation, okay, at the time I was there, Doctor 6 Kotsanos was the principal in the group as it 7 were. 8 Q. Did Doctor Kotsanos ever create 9 a memo or a communication, a writing, a writing 10 of any kind that discussed Prozac which you read? 11 A. I can't recall, I can't recall. 12 Q. Did he ever publish any studies 13 that you know of? 14 A. I don't know. 15 Q. Did he ever show his work to 16 anybody within Eli Lilly? 17 A. Oh, I'm confident that he did. 18 Q. Who would he show his work to? 19 A. He was part of the physician 20 group, okay, and his primary interaction was with 21 the physicians, the other M.D.s in the group. 22 Q. Well, the presence of the 23 marketing division at the general meetings was 24 pretty much to observe and take note of what's Page 231 1 happening, is that correct? 2 MR. MYERS: Hold on, I object to the 3 form and the use of the term general meetings, 4 what are you talking about? 5 Q. You know, the so-called 6 approval group, the CPRC that you referred to, 7 marketing was there just to observe what was 8 happening, right? 9 A. They were there primarily to 10 observe, but if they had an opportunity to input 11 if they so choose. It was primarily, it was a 12 clinical project review committee so it was 13 primarily a medical group. 14 Q. By the way, during your 15 so-called Prozac tenure from 1990 to 1992, during 16 that time, there were other anti-depressants on 17 the market other than Prozac, weren't there? 18 A. Yes. 19 Q. And do you know how many were 20 on the market at that time? 21 A. I don't know how many were. 22 Q. Do you know if it was more than 23 ten? 24 A. I don't know if it was more Page 232 1 than ten. 2 Q. Would you agree that Prozac, 3 Eli Lilly -- Eli Lilly's Prozac was competing 4 with other antidepressants for the market share? 5 A. Yes. 6 Q. And do you have any idea what 7 the marketing division's beliefs or knowledge was 8 about Prozac that they thought that Prozac would 9 be able to occupy a significant portion of the 10 market share? 11 MR. MYERS: Before he answers, let me 12 object to the form to the extent you asked him to 13 speculate in terms of what some undefined persons 14 knew or thought at a given point in time and thus 15 I object to the form. 16 MR. GREEN: I withdraw the question, 17 let me ask it again. 18 Q. Did the marketing division ever 19 let it be known to you or anybody else within 20 Lilly why the marketing division thought that 21 Prozac could occupy a portion of the market 22 share, a significant portion of the market share 23 of anti-depressants? 24 A. They didn't divulge it to me, Page 233 1 that decision was made before I was in my -- what 2 you have called Prozac tenure. 3 Q. What decision is that? 4 A. I don't know, what you're 5 referring to. 6 Q. As far as you know does Prozac 7 have any quality or characteristics which make it 8 a drug which can be sold vis-a-vis other 9 antidepressants on the market? 10 MR. MYERS: Before he answers, let me 11 object to the question to the extent it calls for 12 him to render some testimony or opinion as a 13 medical doctor with respect to the qualities or 14 profile of a given drug. But if he knows he can 15 answer as a lay person and a pharmacist. 16 MS. ZETTLER: He is a pharmacist. 17 MR. MYERS: He is. 18 MS. ZETTLER: He's got a Ph.D in 19 pharmacology. 20 THE WITNESS: No, not in Pharmacology, 21 in Pharmacy. 22 MS. ZETTLER: You would probably know 23 better than most physicians what drugs are about. 24 MR. MYERS: He may answer in that Page 234 1 capacity, not as a medical doctor. Do you 2 remember the question? 3 A. Why don't you restate the 4 question and I'll -- 5 Q. Why did marketing think they 6 could sell Prozac? 7 A. It's my opinion that Prozac is 8 a highly efficacious anti-depressant, therefore 9 there ought to be a market for that compared to 10 the products that were currently being prescribed 11 for depression. 12 Q. So is Prozac, in your opinion, 13 more efficacious than other antidepressants that 14 were on the market from 1990 to 1992? 15 MR. MYERS: Same objection. Go ahead 16 and answer if you can. 17 A. I can't comment as to whether 18 it's more efficacious or not, I think my 19 statement was that it's a highly efficacious 20 antidepressant for mild depression and that was 21 my comment. 22 Q. Okay. These PMMM meetings, how 23 did they differ from the approval group, if at 24 all? Page 235 1 A. Yes, I understand the question. 2 The CPRC group was responsible for reviewing and 3 approving trial designs for new clinical trials. 4 The project management medical marketing meeting 5 was a meeting that had a fairly open agenda that 6 individuals in the various, the three disciplines 7 represented could add items to the agenda and 8 clinical trial design was not the perusal of that 9 group. 10 Q. So at the project management 11 medical marketing meetings, marketing, the 12 marketing division would be more than just an 13 observer, they would actually, could actually 14 come with an agenda, is that correct? 15 A. That's correct. 16 Q. Do you recall any of these 17 meetings wherein the marketing division had an 18 agenda regarding Prozac? 19 A. I don't recall any specific 20 Prozac agenda items. 21 Q. Is that a situation that 22 actually occurred and you have just forgotten it 23 or do you think that maybe it did occur and 24 you've just forgotten it or did they just never Page 236 1 come to those meetings with an agenda in regard 2 to Prozac? 3 A. It's incomprehensible to me 4 that there would have been no discussion of 5 Fluoxetine at either of those two -- well, you're 6 talking about the P-M-M-M-M-M-M, okay. 7 Q. Right. 8 A. But I don't recall specifically 9 any Prozac related issues that were discussed at 10 those meetings. 11 Q. And I think your answer is, and 12 please correct me if I'm wrong, that it's 13 incomprehensible that the marketing division over 14 the course of the years that you were there ever 15 arrived at such a meeting with no agenda 16 regarding Prozac? 17 A. Correct, that was the intent. 18 Q. So marketing had an agenda 19 regarding Prozac, right? 20 MR. MYERS: Let me object to the form 21 of the question. You say marketing had an 22 agenda, you've now moved from a meeting where 23 there might have been an agenda for the meeting 24 to a broader subject of an agenda, and that's Page 237 1 over broad. 2 MR. GREEN: Okay, I'll withdraw the 3 question. 4 Q. Was the marketing division 5 using as a sellable -- let me rephrase this. Is 6 the marketing -- did the marketing division ever 7 consider side effects and Prozac as a point to 8 sell Prozac? 9 A. I don't know if they did or did 10 not. 11 Q. Well, in your opinion, does 12 Prozac produce any side effects? 13 MR. MYERS: Let me object to the form 14 to the extent you're asking him for a medical 15 opinion. He can certainly tell you what he 16 knows. 17 MR. GREEN: I'm asking for a 18 pharmacist's opinion. 19 A. You can look at the product 20 literature on Prozac and there would be a number 21 of drug related things that have come up in 22 clinical trials and one has to list those things 23 that came up with certain frequency, it has side 24 effects. Page 238 1 Q. In your opinion, does it have 2 the same number of side effects, fewer side 3 effects, more side effects or anything else than 4 other antidepressants that were on the market 5 during your Prozac tenure? 6 MR. MYERS: Same objection as before, 7 also the use of the term anything else. 8 MR. GREEN: Any other anti-depressants. 9 MR. MYERS: Subject to that, answer if 10 you can. 11 A. I'm not that familiar with the 12 product literature on all the anti-depressants, 13 okay, and so I can't comment on that. 14 Q. So the issue of side effects 15 was not really an issue with marketing as far as 16 you're aware, is that true or false? 17 MR. MYERS: Let me object to the form 18 in that you've mischaracterized his prior 19 testimony where I think he said he didn't know 20 what they did or did not consider. I think he's 21 asking you to agree or not with his statement. 22 Q. No, I'll withdraw the question. 23 I think your attorney answered it for us. 24 This R. F. Shinar, S-H-I-N-A-R, Page 239 1 does he still work with Eli Lilly? 2 A. It's my understanding that he 3 does. 4 Q. And what was his function at 5 these -- from 1990 to 1992, what was his job? 6 A. Well, at least part of that 7 time he was in the -- I think I've characterized 8 it as a market research new product planning, 9 whichever, in that general area, part of the 10 marketing. 11 Q. So what would he do? 12 A. His job was to look at the 13 potential new indications, you know, for 14 Fluoxetine in the new product planning area. 15 Q. Did anybody in the marketing 16 division ever consider what the results of the 17 clinical trials said about Prozac as far as 18 comparing it with other antidepressants in a way 19 that would make it a so-called better 20 anti-depressant? 21 MR. MYERS: I object to the form, the 22 question is overly broad and it calls upon him to 23 speculate as to what a group of persons 24 considered. Page 240 1 Q. You were at these meetings 2 where there are people from the marketing 3 division, right, the PMMM meetings, right? 4 A. Yes. 5 Q. Did anybody from the marketing 6 division ever try to gather information about 7 Prozac information that was obtained through the 8 clinical trials that would help them to sell 9 Prozac? 10 A. My reply is that the new drug 11 application had been submitted and approved prior 12 to my arrival in medical and that those 13 discussions would have been held prior to my time 14 in medical, relating to the efficacy of Prozac as 15 an antidepressant. 16 Q. Let's not discuss relating to 17 efficacy and FDA approval, what I'm really trying 18 to focus on is the issue of suicidal ideation and 19 suicide and violent and aggressive acts. That 20 was still an issue while you were working with 21 Prozac at Lilly, wasn't it? 22 A. It was an issue while I was in 23 medical, correct. 24 Q. In fact Doctor Beasley wrote a Page 241 1 major article that was published in the British 2 Medical Journal that focused right in on that 3 issue, didn't he? 4 A. He did. 5 Q. And that article went back and 6 looked at all the clinical trials and all the 7 information that was gathered and he put all that 8 information together and just came up with a 9 solidified point of view based on all that data, 10 is that correct? 11 MR. MYERS: Before he answers, let me 12 object to the form in terms of characterizing the 13 conclusion of the article as a solidified point 14 of view. The article, whatever it says, it 15 speaks for itself. I mean I don't know that it 16 uses the term solidified point of view, I bet it 17 would not. 18 Q. Okay, I withdraw the question. 19 I'm just trying to make the point that even 20 though you came after FDA approval, you were 21 there when there was an issue about suicidality, 22 weren't you? 23 A. That's correct. 24 Q. Now, did that issue ever come Page 242 1 up at these PMMM meetings with the marketing 2 division there? 3 A. I don't recall that it ever 4 came up and I don't think that that is the forum 5 where it would have come up. 6 Q. What is the forum where it 7 would have come up? 8 A. I think we discussed this group 9 within medical that involved the CNS or 10 psychopharm medical people, the cluster group, 11 the statisticians, those people that were going 12 to do retrospective analysis on the studies 13 previously conducted. 14 Q. Would anybody in the marketing 15 division be concerned with the suicide issue? 16 A. I would assume that they would 17 be concerned. 18 Q. That would probably affect 19 sales, wouldn't it? 20 MR. MYERS: Object to the form, that 21 that what? 22 Q. The suicide issue. In fact it 23 did affect sales, didn't it? 24 MR. MYERS: Let me object. Page 243 1 Q. At some point, do you know 2 that? 3 MR. MYERS: Hold on, you've asked him 4 three questions: Would it affect sales, did it 5 affect sales, and then you said and you know 6 that. So what is the question? 7 Q. As far as you know, did the 8 suicide issue affect the sales of Prozac? 9 A. I personally feel that it 10 probably did. 11 Q. Probably -- 12 A. Did. 13 Q. Now, when you said that the 14 suicide issue was a medical problem and dealt 15 with in the medical division, isn't it also a 16 marketing problem? 17 A. I don't know if it's a 18 marketing problem or not but it was dealt with in 19 the medical division. Marketing was present at 20 some of those discussions but I don't recall 21 specifically what was talked about. 22 Q. Do you recall if marketing took 23 on an observer's role or did they have an agenda 24 at those meetings? Page 244 1 A. Those meetings referring to 2 whenever the medical and the marketing group got 3 together? 4 Q. Yes. 5 A. I don't know whether they had 6 that specific issue as an agenda item or not. 7 Q. But it did affect sales, the 8 suicide issue? 9 MR. MYERS: He's answered that question 10 already. 11 MS. ZETTLER: So your objection is 12 asked and answered? 13 MR. MYERS: Yes, thank you. 14 Q. Is there any way to find out 15 what dates these meetings were held, the PMMM 16 meetings -- 17 A. What dates? 18 Q. Yes, the dates they were held. 19 A. I suspect if you go through 20 documents, that they may be there. I can't 21 recall what dates they were held or how 22 frequently they were held. 23 Q. Do you recall how often they 24 were held? Page 245 1 A. Originally when I entered 2 medical, they were monthly meetings and then the 3 frequency was decreased, okay, to approximately 4 quarterly. 5 Q. Did anybody keep minutes of 6 those meetings? 7 A. Yes, I think minutes were kept. 8 Q. Who kept the minutes? 9 A. I don't recall who was 10 secretary of the group. 11 Q. That would have been your 12 secretary, wouldn't it? 13 MR. MYERS: Are you asking if it was 14 his secretary that was the secretary of the 15 committee? 16 Q. Secretary of the group? 17 A. No. 18 Q. Who was the secretary of the 19 group? 20 MR. MYERS: He said he didn't know. 21 A. I don't recall who was 22 secretary, I don't know that there was a 23 secretary for -- assigned to the group. 24 Q. Would the minutes have listed Page 246 1 the agenda for that particular meeting? 2 A. Yes. 3 Q. And what about L. K. Ellingson, 4 is that a male or female? 5 A. The first name is Larry, he is 6 a male and he has -- at the time I was there, he 7 and Shinar, you know, had comparable 8 responsibilities, different therapeutic areas. 9 Q. Okay. First of all, what were 10 the responsibilities? 11 A. I think I gave you that, in new 12 product planning, new indications. 13 Q. What were the therapeutic areas 14 as divided between the two? 15 A. I don't recall exactly but 16 antibiotics, new antibiotics was an area that 17 Ellingson was involved in. Shinar may have been 18 involved but I can't recall exactly in the new 19 indications, the additional indications for 20 Fluoxetine. 21 Q. Now, at these meetings, you 22 also had three vice-presidents of the marketing 23 division, at least three from what you can 24 remember, you had three vice-presidents -- I'm Page 247 1 sorry, you had two vice-presidents of the 2 marketing division, and then Mister G. J. Clark 3 was made aware that such a meeting was being 4 held, is that right? 5 A. Would you identify specifically -- 6 when you're talking about the PMM meeting? 7 Q. I'm talking about Mister 8 E. W. Lange, Mister D. E. Thompson, I'm looking 9 at -- 10 MR. MYERS: Seven? 11 MR. GREEN: Yes, seven. 12 Q. Mr. Thompson and then it was 13 CCd to Mister G. J. Clark. So was marketing -- 14 was the marketing division being present at these 15 meetings, did they play a large role at these 16 meetings? 17 MR. MYERS: Let me object to the form 18 of the question. You started out by asking him 19 what the titles were of the people that were at 20 the meeting or to confirm what the titles were 21 and now you're asking him what their role was. 22 Q. I'm sorry, I kind of asked you 23 two questions at once so I'll go back and just 24 confirm the titles. Were those three people Page 248 1 vice-presidents of marketing, that would be 2 Lange, Thompson and Clark? 3 A. All three were vice-presidents 4 within marketing. Only one, you know, the nature 5 of this specific group, I had spoken earlier that 6 they reviewed how the medical group, specifically 7 the people that I was responsible for, how we are 8 utilizing our people and they were spread across 9 many, many, many projects, one of which was 10 Fluoxetine and then are all the other new drugs 11 that we were pursuing, most of these people had 12 responsibility for new drugs that were yet to 13 appear on the market and they had a concern about 14 how medical was applying its resources, what's 15 the balance between existing products, new 16 products and so forth. 17 Q. Well, in the case of Prozac, 18 they were concerned about what, what was their 19 concern? 20 MR. MYERS: Object to the form, who is 21 they? 22 Q. These vice-presidents of 23 marketing. He said that they were there because 24 they were concerned about how your people were Page 249 1 being used. My question is could you narrow it 2 down to Prozac, what was their concern about how 3 the Prozac people were being used? 4 A. I don't know that they had a 5 concern about how the Prozac people were being 6 used, they had a concern about how the resources 7 overall, the nonphysician resources within 8 medical were being applied and they had a sense 9 of priorty, okay, of what were the promising new 10 drugs and where the people ought to be applied 11 and so that was their interest in attending these 12 resource allocation meetings. 13 Q. Do you have any indication of 14 what their sense of priorty was regarding Prozac? 15 A. I think it would have been at 16 the top of their priorty list for new 17 indications, okay, and then, you know, the other 18 issues. 19 Q. Would it also be at the top of 20 the list to deal with the suicide issue? 21 A. Prozac would be at the top of 22 the list, it's one of our leading products. For 23 whatever reason it would be at the top of the 24 list. Page 250 1 MR. GREEN: Okay. I have no further 2 questions. Thank you. 3 * * * * * * * * * * 4 REDIRECT EXAMINATION 5 BY MS. ZETTLER: 6 Q. Do you know what clinical 7 trials Doctor Tollefson ran on Prozac? 8 A. I do not, I do not. 9 Q. Do you know where Doctor 10 Tollefson lived prior to coming to Indianapolis? 11 A. I don't know specifically where 12 he lived, he lived in the Minneapolis, Saint Paul 13 area. 14 Q. Okay. Do you know who Robert 15 Taylor is? 16 A. Robert Taylor. 17 Q. Not the actor. 18 A. Okay. I know a Bob Taylor 19 that's a director in the engineering area, I 20 don't know which one you're referring to, okay. 21 Q. In the engineering area? 22 A. And -- 23 MR. MYERS: I think -- are you talking 24 about this week's witness? Page 251 1 MS. ZETTLER: Right. 2 MR. MYERS: That's not the same person, 3 it's probably likely there's more than one Robert 4 Taylor. 5 MS. ZETTLER: We know there's at least 6 two, there's a guy in engineering. 7 Q. How about Kevin Marks? 8 A. Kevin? 9 Q. Marks, M-A-R-K-S? 10 A. Kevin Marks, I know a gentleman 11 who's last name is Marks, I'm not so certain what 12 his first name is but that was in the medical 13 area. 14 Q. Do you know what this Mister 15 Marks did in the medical area? 16 A. My recollection is that he was 17 a CRA. 18 Q. How about Catherine Mesner? 19 A. Catherine Mesner? 20 Q. Right. 21 A. I know Catherine Mesner. 22 Q. Do you know where she works 23 now, well does she work for Lilly? 24 A. To the best of my knowledge, Page 252 1 she does. 2 Q. Do you know what area she works 3 in now? 4 A. I don't know for certain, when 5 I was there she was a CRA in medical. 6 Q. Would she have been under your 7 jurisdiction then? 8 A. She would have been part of the 9 medical plans area that was under my 10 jurisdiction, yes. 11 Q. Okay. How about Vicki 12 Thompson? 13 A. Yes, I know Vicki. 14 Q. Okay. And where did she work 15 when you were in that -- 16 A. Similar position to Catherine 17 Mesner. 18 Q. Do you know where she is now? 19 A. She's still there. 20 Q. Okay. Do you know who Vaughn 21 Bryson is? 22 A. Yes, ma'am. 23 Q. And is it your understanding 24 that Mister Bryson is no longer with Eli Lilly, Page 253 1 right? 2 A. Mister Bryson is still a member 3 of the board of directors of Eli Lilly. 4 Q. He is still a member. Is he 5 still a member because he's awaiting a severance 6 package, what position does he hold on the board 7 of directors? 8 A. I don't have any idea. 9 Q. Isn't it true that he was just 10 ousted as the chairman of the board of Eli Lilly 11 not too long ago? 12 A. No. 13 MR. MYERS: I object to the form and 14 the use of the term ousted as being awfully 15 vague. 16 MS. ZETTLER: How about deposed? 17 MR. MYERS: Same thing. 18 A. He was never chairman, okay, he 19 was president and CEO but not chairman. 20 Q. He's no longer president and 21 CEO? 22 A. That's correct. 23 Q. But he's still a member of the 24 board? Page 254 1 A. To my knowledge he's still a 2 member of the board. 3 Q. What's his title right now? 4 A. A member of the board of 5 directors of Eli Lilly. 6 Q. Do you know if he's going to 7 remain a member of the board of directors? 8 A. I don't know. 9 Q. Is it true that there was a 10 demonstration of sorts by Lilly employees when 11 Mr. Bryson was deposed as CEO and president? 12 A. I saw on the local news and I 13 read in a newspaper that there was but by that 14 time I was not there. 15 Q. Do you have any information to 16 indicate whether or not Vince Foster, the member 17 of President Clinton's administration was on 18 Prozac when he killed himself a couple of weeks 19 ago? 20 A. I don't have any idea, I have 21 no knowledge. 22 Q. When you said earlier about 23 talking to Greg earlier about the gentleman from 24 the marketing department that would be at the Page 255 1 PMMM meetings, and you were talking new drugs, 2 promising drugs, would those new and promising 3 drugs include the use of Prozac for indications 4 other than depression? 5 A. On -- as an antidepressant? 6 Q. No, indications for other than 7 depression. 8 A. Yes, yes. 9 Q. Like Lovan and things of that 10 nature? 11 A. That's correct. 12 Q. Not necessarily a new drug, 13 it's just a new use for an old drug, correct? 14 A. Correct. 15 MS. ZETTLER: That's all the questions 16 I have. 17 MR. MYERS: Thank you. No questions. 18 (THE WITNESS WAS EXCUSED.) Page 256 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 MERLE AMUNDSON, PH.D. 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 20TH DAY OF 19 SEPTEMBER, 1993. 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 257 1 2 3 E R R A T A S H E E T 4 5 COMMONWEALTH OF KENTUCKY ) : SS 6 COUNTY OF JEFFERSON ) 7 8 I, MERLE AMUNDSON, PH.D., THE 9 UNDERSIGNED DEPONENT, HAVE THIS DATE READ THE 10 FOREGOING PAGES OF MY DEPOSITION AND WITH THE 11 CHANGES NOTED BELOW, IF ANY, THESE PAGES 12 CONSTITUTE A TRUE AND ACCURATE TRANSCRIPTION OF 13 MY DEPOSITION GIVEN ON THE AUGUST 10, 1993 AT THE 14 TIME AND PLACE STATED THEREIN. 15 PAGE NO. LINE NO. CHANGE REASON Page 258 1 2 PAGE NO. LINE NO. CHANGE REASON 3 4 5 6 7 8 9 _____________________________ 10 MERLE AMUNDSON, PH.D. 11 SWORN TO AND SUBSCRIBED BEFORE ME THIS 12 _____ DAY OF __________, 1993. 13 _____________________________ NOTARY PUBLIC, STATE OF 14 KENTUCKY AT LARGE Page 259 1 COMES MERLE AMUNDSON..............................14 2 CROSS EXAMINATIONBY MR. GREEN:...................224 3 (PLAINTIFFS' EXHIBIT NO. 1........................73 4 (PLAINTIFFS' EXHIBIT NO. 2.......................105 5 (PLAINTIFFS' EXHIBIT NO. 3 ......................129 6 (PLAINTIFFS' EXHIBIT NO. 4.......................140 7 (PLAINTIFFS' EXHIBIT NO. 5.......................142 8 (PLAINTIFFS' EXHIBIT NO. 6 ......................172 9 (PLAINTIFFS' EXHIBIT NO. 7.......................177 10 (PLAINTIFFS' EXHIBIT NO. 8.......................188 11 (PLAINTIFFS' EXHIBITS NO. 9 AND 10 12 WERE ............................................197 13 (PLAINTIFFS' EXHIBIT NO. 11......................209 14 (PLAINTIFFS' EXHIBIT NO. 12......................212 15 (PLAINTIFFS' EXHIBIT NO. 13......................215 16 COMMONWEALTH.....................................257 17 E R R A T A......................................258 18 Page 262