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 11 DEPONENT: JAMIE STREET, M.D. 12 DATE: JUNE 24, 1993 13 14 * * * * * * * * * * 15 16 17 REPORTER: KATHY NOLD 18 19 KENTUCKIANA REPORTERS SUITE 260 20 730 WEST MAIN STREET LOUISVILLE, KENTUCKY 40202 21 (502) 589-2273 Page 1 1 * * * * * * * * * * 2 3 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA 4 INDIANAPOLIS DIVISION 5 IN RE ELI LILLY AND COMPANY ) Prozac Products Liability ) MDL Docket No. 907 6 Litigation ) 7 * * * * * * * * * * 8 NO. 91-02496-A 9 JACKIE LYNN BIFFLE, ET AL ) IN THE DISTRICT ) COURT OF 10 V. ) DALLAS COUNTY, TEXAS ) 11 ELI LILLY & COMPANY AND ) 14TH JUDICIAL DISTA PRODUCTS COMPANY ) DISTRICT 12 * * * * * * * * * * 13 NO. 92-14775-E 14 RICHARD HAROLD CROSSETT, JR., ) IN THE 15 CHAD H. CROSSETT, AMY MICHELLE ) DISTRICT CROSSETT AND KRISTEN ANN CROSSETT, ) COURT OF 16 INDIVIDUALLY AND AS SURVIVORS OF ) AND ON BEHALF OF THE ESTATE OF ) 17 JOCQUETTA ANN CROSSETT, DECEASED ) ) 18 V. ) DALLAS COUNTY, ) TEXAS 19 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, TEXAS ) 20 PSYCHIATRIC COMPANY, INC. ) D/B/A/ HCA WILLOW PARK ) 101ST JUDICIAL 21 HOSPITAL, JAMES K. WITSCHY, M.D., ) DISTRICT AND DOUG BELLAMY, ED.D. ) Page 2 1 * * * * * * * * * * 2 NO. A-921,405-C 3 MARIA GUADALUPE REVES ) IN THE 4 INDIVIDUALLY AND AS NEXT ) DISTRICT COURT FRIEND OF GRANT JULIAN REVES ) OF 5 A MINOR CHILD, AND ON BEHALF ) OF THE ESTATE OF CHRISTIAN ) 6 MARIE REVES, DECEASED ) ) ORANGE COUNTY, 7 V. ) TEXAS ) 8 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, RAVIKUMAR ) 9 KANNEGANTI, M.D., HOSPITAL ) CORPORATION OF AMERICA, A ) 10 TENNESSEE CORPORATION, HEALTH ) SERVICES ACQUISITION CORP., ) 11 A DELAWARE CORPORATION, ) HCA PSYCHIATRIC COMPANY, A ) 12 DELAWARE CORPORATION, TEXAS ) PSYCHIATRIC CO., INC.. A/K/A ) 13 AND/OR D/B/A HCA BEAUMONT ) NEUROLOGICAL HOSPITAL, AND HCA ) 14 HEALTH SERVICES OF TEXAS, INC. ) 128TH JUDICIAL A/K/A AND/OR BEAUMONT ) DISTRICT 15 NEUROLOGICAL HOSPITAL ) Page 3 1 2 * * * * * * * * * * 3 IN THE UNITED STATES DISTRICT COURT 4 FOR THE WESTERN DISTRICT OF TEXAS SAN ANTONIO DIVISION 5 ELIZABETH T. SANCHEZ, ) 6 INDIVIDUALLY AND AS THE ) SURVIVING SPOUSE, MARGARET R. ) 7 SANCHEZ, INDIVIDUALLY AND NEXT ) OF FRIEND OF DEBRA JEAN ) 8 SANCHEZ, VERONICA MARIE ) SANCHEZ, EDWARDO ESTEBAN ) 9 SANCHEZ, AND MICHAEL ANTHONY ) SANCHEZ, CHILDREN; AND ALL ON ) 10 BEHALF OF THE ESTATE OF ) EDWARDO SANCHEZ ) 11 ) V. ) CIVIL ACTION NO. 12 ) SA93CA367 ELI LILLY AND COMPANY AND ) 13 DISTA PRODUCTS COMPANY ) 14 * * * * * * * * * * 15 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS 16 HOUSTON DIVISION 17 MARIA SANCHEZ, INDIVIDUALLY ) AND AS NEXT FRIEND OF DEBORAH ) 18 SANCHEZ, VERONICA SANCHEZ, ) EDDIE SANCHEZ, AND MICHAEL ) 19 SANCHEZ, AND ON BEHALF OF THE ) ESTATE OF EDUARDO SANCHEZ ) 20 ) V. ) CIVIL ACTION NO. 21 ) H-93-1469 ELI LILLY AND COMPANY AND ) 22 DISTA PRODUCTS COMPANY, A ) DIVISION OF ELI LILLY AND ) 23 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 Page 5 1 2 * * * * * * * * * * 3 ---------------------------------X 4 VALARIE J. FRIEDMAN AND DAVID : SUPERIOR COURT FRIEDMAN, HER HUSBAND, : OF NEW JERSEY 5 : LAW DIVISION: PLAINTIFF, : MIDDLESEX COUNTY 6 : DOCKET NO. : L-3191-91 7 VS. : : 8 ELI LILLY & COMPANY; DISTA : PRODUCTS INC, A DIVISION OF : 9 ELI LILLY & COMPANY; LISS : PHARMACY; MADISON PHARMACY AND : 10 JOHN DOES NOS. 1-25 (UNKNOWN : ENTITIES), : 11 : DEFENDANTS. : 12 ---------------------------------X 13 * * * * * * * * * * 14 SUPREME COURT OF THE STAET OF NEW YORK COUNTY OF SUFFOLK 15 -------------------------------------x 16 RHOMDA L. HALA and JOSEPH L. HALA, : 17 Plaintiffs, : Index No. 14869/90 18 - against - : 19 ELI LILLY & COMPANY and DISTA : PRODUCTS COMPANY, a DIVISION OF 20 ELI LILLY & COMPANY : 21 Defendants. : -------------------------------------x Page 6 1 2 3 * * * * * * * * * * 4 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 5 COUNTY DEPARTMENT, LAW DIVISION 6 PATRICIA BRACH, ) ) 7 Plaintiff ) ) 8 v. )No. 92 L 13369 ) 9 ELI LILLY AND COMPANY, a foreign ) corporation; ALAN N. MILLER, M.D., ) 10 WILLIAM BRUINSMA, Psy.D., and ) CONDELL MEMORIAL HOSPITAL, ) 11 ) Defendants. ) 12 * * * * * * * * * * 13 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 14 COUNTY DEPARTMENT - LAW DIVISION 15 RENATO DI SILVESTRO, Individually ) and as Special Administrator of ) 16 the Estate of JOHN DI SILVESTRO, ) Deceased, ) 17 ) Plaintiff, ) 18 ) v. ) No. 91 L 7881 19 ) ROBERT L. NELSON, et al., ) 20 ) Defendants, ) 21 ) GEORGE MELNICK, M.D. and PETER ) 22 FINK, M.D. ) ) 23 Respondents in Discovery.) Page 7 1 2 * * * * * * * * * * 3 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 4 COUNTY DEPARTMENT, LAW DIVISION 5 JOAN M. GRYER, ) ) 6 Plaintiff, ) ) 7 v. ) No. 92 L 7387 ) 8 ELI LILLY AND COMPANY, et al., ) ) 9 Defendants. ) 10 * * * * * * * * * * 11 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 12 COUNTY DEPARTMENT, LAW DIVISION 13 JENNIFER HAMMERLI, as Plenary ) Guardian of the Estate of RAY B. ) 14 HAMMERLI, a disabled person, ) ) 15 Plaintiff, ) ) 16 v. ) No. 92 L 2365 ) 17 ELI LILLY AND COMPANY, THE ) UPJOHN COMPANY, DICKIE KAY, M.D., ) 18 (former Respondent in Discovery), ) and RICHARD CZECHOWICZ (former ) 19 Respondent in Discovery), ) ) 20 Defendants. ) 21 * * * * * * * * * * 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. ) Page 9 1 2 * * * * * * * * * * 3 SUPERIOR COURT OF THE STATE OF CALIFORNIA 4 FOR THE COUNTY OF LOS ANGELES 5 DR. MARIUS SAINES, etc., et al., ) Case No: 6 ) SC 008331 Plaintiffs, ) 7 ) vs. ) 8 ) ELI LILLY & COMPANY, a corporation; ) 9 DISTA PRODUCTS COMPANY, a division ) of Eli Lilly & Company; and DOBS 1- ) 10 100, inclusive, ) ) 11 Defendants. ) ____________________________________) 12 13 * * * * * * * * * * 14 15 16 17 18 19 Page 10 1 I N D E X 2 DEPOSITION OF JAMIE STREET, M.D. 3 4 DIRECT EXAMINATION BY MR. GREEN 15 CROSS EXAMINATION BY MS. ZETTLER 172 5 CROSS EXAMINATION BY MR. CLEMENTI 192 RECROSS EXAMINATION BY MS. ZETTLER 193 6 CROSS EXAMINATION BY MS. WILKINS 297 RECROSS EXAMINATION BY MS. ZETTLER 298 7 8 CERTIFICATION 302 9 ERRATA 303 10 CERTIFIED QUESTION 133 CERTIFIED QUESTION 193 11 CERTIFIED QUESTION 272 12 EXHIBITS 13 PLAINTIFFS' EXHIBIT NO. 1 79 PLAINTIFFS' EXHIBIT NO. 2 88 14 PLAINTIFFS' EXHIBIT NO. 3 97 PLAINTIFFS' EXHIBIT NO. 4 103 15 PLAINTIFFS' EXHIBIT NO. 5 108 PLAINTIFFS' EXHIBIT NO. 6 113 16 PLAINTIFFS' EXHIBIT NO. 7 128 PLAINTIFFS' EXHIBIT NO. 8 133 17 PLAINTIFFS' EXHIBIT NO. 9 141 PLAINTIFFS' EXHIBIT NO. 10 143 18 PLAINTIFFS' EXHIBIT NO. 11 167 PLAINTIFFS' EXHIBITS 12 AND 13 168 19 Page 11 1 THE DEPOSITION OF JAMIE STREET, M.D. TAKEN 2 AT THE OFFICE OF BAKER & DANIELS, 300 NORTH 3 MERIDIAN STREET, SUITE 2700, INDIANAPOLIS, 4 INDIANA 46204, ON JUNE 24, 1993, SAID DEPOSITION 5 TAKEN PURSUANT TO NOTICE IN ACCORDANCE WITH THE 6 RULES OF CIVIL PROCEDURE. 7 * * * * * * * * * * 8 A P P E A R A N C E S 9 10 GREGORY GREEN COUNSEL FOR GROUP B PLAINTIFFS 11 LAW OFFICES OF LEONARD L. FINZ, P.C. 222 BROADWAY, 27TH FLOOR 12 NEW YORK, NEW YORK 10038 13 NANCY ZETTLER COUNSEL FOR GROUP A PLAINTIFFS 14 LEONARD M. RING AND ASSOCIATES, P.C. 111 WEST WASHINGTON AVENUE, SUITE 1333 15 CHICAGO, ILLINOIS 60602 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 LISA M. GOLDMAN 20 COUNSEL FOR ELI LILLY AND COMPANY MCCARTER & ENGLISH 21 FOUR GATEWAY CENTER 100 MULBERRY STREET 22 NEWARK, NEW JERSEY 07101-0652 23 MARGARET M. HUFF ELI LILLY AND COMPANY 24 LILLY CORPORATE CENTER INDIANAPOLIS, INDIANA 46285 Page 12 1 DENISE BRODSKY 2 COUNSEL FOR GOOD SHEPHERD HOSPITAL 415 WASHINGTON STREET, SUITE 214 3 WAUKEGAN, ILLINOIS 4 KIMBERLY A. WILKINS COUNSEL FOR DEFENDANTS CZECHOWICZ, FINK, BRUINSMA 5 CLAUSEN MILLER GORMAN CAFFREY & WITOUS 10 SOUTH LASALLE 6 CHICAGO, ILLINOIS 60603 7 PAUL J. CLEMENTI COUNSEL FOR DR. DICKIE KAY 8 HINSHAW & CULBERTSON 222 NORTH LA SALLE STREET, SUITE 300 9 CHICAGO, ILLINOIS 60601-1081 10 KATHERINE L. LAWS COUNSEL FOR DRS. WITSCHY AND KANNEGANTI 11 BAILEY AND WILLIAMS 3500 NCNB PLAZA 12 901 MAIN STREET DALLAS, TEXAS 75202-3714 13 CHRISTINA B. SAILER 14 COUNSEL FOR DR. LEE COLEMAN OGDEN NEWELL & WELCH 15 1200 ONE RIVERFRONT PLAZA LOUISVILLE, KENTUCKY 40202 16 BEATRICE M. SMITH 17 COUNSEL FOR BEAUMONT NEUROLOGICAL HOSPITAL BARTLETT & FRIEND, L.L.P. 18 1301 MCKINNEY, SUITE 2900 HOUSTON, TEXAS 77010 Page 13 1 2 3 4 5 MS. LAWS: We just agreed, for those 6 new here today, that the objection of one 7 defendant was good as to all, and since we're all 8 working under different state rules, at least for 9 purposes of the Texas cases, we'll be reserving 10 objections. 11 MR. GREEN: We also agreed prior to 12 going on the record that today some documents may 13 be put into exhibit form and that they are 14 technically MDL documents, but Mr. Myers has 15 agreed that it is acceptable to use these 16 documents in this deposition. 17 MR. MYERS: Absolutely. 18 MS. ZETTLER: That's without waiving 19 our objection to the cross notice. 20 MR. GREEN: That's right, no objections 21 were waived. 22 * * * * * * * * * * 23 COMES JAMIE STREET, M.D., CALLED BY THE 24 PLAINTIFF, AND AFTER FIRST BEING DULY SWORN, WAS Page 14 1 DEPOSED AND TESTIFIED AS FOLLOWS: 2 DIRECT EXAMINATION 3 BY MR. GREEN: 4 Q. Good morning, Dr. Street. My 5 first question is, are you a medical doctor? 6 A. Yes. 7 Q. And what is your address? 8 A. Personal or professional? 9 Q. Personal. 10 A. xxxxxxxxxxxxxxxxxxxxxxxxxxx 11 xxxxxxxxxxxxxxxxxxxxx. 12 Q. And the Zip Code there? 13 A. xxxxx. 14 Q. And where and when did you 15 receive your medical degree? 16 A. Indiana University, 1973. 17 Q. And did you attend graduate 18 school prior to receiving your M.D.? 19 A. Medical degree is a graduate 20 school program. 21 Q. Any other graduate schools, 22 other than the medical school? 23 A. No. 24 Q. Did you take any public health Page 15 1 courses when you were in medical school? 2 A. No. 3 Q. And where did you attend 4 undergraduate school? 5 A. Purdue University. 6 Q. When did you graduate from 7 Purdue? 8 A. '68. 9 Q. Did there come a time when you 10 were hired by Eli Lilly and Company? 11 A. Yes. 12 Q. When was that? 13 A. August 1, 1989. 14 Q. And are you presently employed 15 by Eli Lilly and Company? 16 A. Yes. 17 Q. And could you give me a brief 18 description of your work history from the point 19 in time when you graduated with your M.D. up 20 until the point in time when you were hired by 21 Eli Lilly? 22 A. I did an internal medicine 23 internship at Indiana University Medical Center 24 from 1973 to 1974. I did a neurology residency Page 16 1 at the Indiana University Medical Center from 2 1974 through 1977, and I spent six months doing a 3 pediatric neurology fellowship in the mid '77 4 through early '78. 5 MR. CLEMENTI: Is that pediatric 6 urology or neurology? 7 THE WITNESS: Top end, neurology. 8 A. In February 1978, I went into 9 private practice here in Indianapolis and was in 10 private practice until I joined Lilly in August 11 1st of 1989. 12 Q. Is Indiana University in 13 Indianapolis? 14 A. The Medical Center is, yes. 15 Q. And where did you do your 16 pediatric fellowship? 17 A. Indiana University Medical 18 Center. 19 Q. Have you received any medical 20 training from the point in time when you 21 graduated medical school to the point in time 22 when you were hired by Eli Lilly and Company, any 23 courses you may have taken or seminars you may 24 have attended? Page 17 1 A. Yes. 2 Q. Could you describe those or 3 name those? 4 A. Over the last twenty years? 5 Q. Yes, just what you -- well, let 6 me ask you this: Do you do several a year? 7 A. Frequently. 8 Q. Okay. Did you ever get any 9 training or attend any seminars which discussed 10 epidemiology as a topic? 11 A. Probably, yes. 12 Q. And are you an M.D., a medical 13 doctor, and as a medical doctor, what is your 14 understanding as to what epidemiology is? 15 A. It's the incidence of a disease 16 process. 17 Q. Can you recall when and where 18 you may have received training in epidemiology 19 after medical school and prior to being hired by 20 Lilly? 21 A. I never took an epidemiology 22 course. In various seminars a discussion of 23 disease epidemiology may be pertinent to a 24 disease topic and a disease discussion that would Page 18 1 be included. 2 Q. When you were hired by Eli 3 Lilly and Company, did you feel you had a clear 4 understanding of the science of epidemiology? 5 A. I'm not an epidemiologist, I 6 was not hired as an epidemiologist either. 7 Q. As a medical doctor, do you 8 feel you had a clear understanding of 9 epidemiology when you were hired by Eli Lilly? 10 A. As I said, I'm not an 11 epidemiologist. I'm not sure what you mean by a 12 clear understanding of epidemiology. That was 13 not a focus of mine, no. 14 Q. Okay, I'll ask the question in 15 a different way. Was epidemiology a subject that 16 was foreign to you when you were hired by Eli 17 Lilly and Company? 18 MR. MYERS: I object to the term 19 foreign as being vague and otherwise ambiguous, 20 but if the doctor can answer, please go ahead. 21 Q. I'll just rephrase the 22 question. When you were hired by Eli Lilly and 23 Company, do you feel that you understood the 24 basic principles of epidemiology? Page 19 1 A. Such as? 2 Q. Such as what the science was, 3 such as what certain terms and phrases meant 4 within the epidemiology context, such as 5 epidemiology and its relation to statistics? 6 A. Since I never really formally 7 studied that, I probably would say that I'm 8 certainly not an expert on it and I would have to 9 say that if you're basing it on that, no, I 10 certainly don't feel that I'm a qualified 11 epidemiologist. 12 Q. Why don't you describe to me 13 what your standing was in the epidemiology field, 14 if any, at the point in time when you were hired 15 by Eli Lilly and Company? 16 A. I had no standing in the 17 epidemiology field. 18 Q. Did you study epidemiology in 19 med school? 20 A. As a distinct course, no, there 21 was no epidemiology given. 22 Q. When you were hired by Eli 23 Lilly on August 1, 1989, what was your title at 24 that point? Page 20 1 A. Associate clinical research 2 physician. 3 Q. What is your title today? 4 A. Clinical research physician. 5 Q. And during the course of your 6 employment with Lilly, has that -- has your title 7 changed more than once? 8 A. No. 9 Q. And when did you go from being 10 an associate clinical research physician to 11 clinical research physician? 12 A. 1991. 13 Q. Do you recall about what month 14 that was? 15 A. Probably in August. 16 Q. Are those the only two titles 17 that you have had since you've been employed by 18 Lilly? 19 A. That's correct. 20 Q. What's the reason you left 21 private practice to work for Eli Lilly? 22 A. My associate went back to the 23 V.A. system to work, I took a look at a number of 24 different opportunities, continue in private Page 21 1 practice, continue in the public health arena, 2 and I also looked at Eli Lilly. I thought it 3 probably offered the most intellectual challenge, 4 interest. 5 Q. What was your -- did you have a 6 major area of practice, a focus? 7 A. I did general neurology with an 8 emphasis sometimes on headaches, we had a fairly 9 large headache practice. 10 Q. You should open your office in 11 my building. You said you were considering the 12 public health arena, were you in the public 13 health arena at that point? 14 A. No. 15 Q. What do you mean by that? 16 A. The Department of Mental 17 Health, the State Department of Mental Health. 18 Q. Were you qualified to get a job 19 in the public health arena? 20 A. As a neurologist, I would have 21 been. 22 Q. And what qualifications did you 23 have that made you so qualified? 24 A. As a neurologist? Page 22 1 Q. Yes. 2 A. I completed a neurology 3 residency, I'm boarded by the American Board of 4 Psychiatry and Neurology. 5 Q. Did you ever hear of the 6 Fentress litigation in Kentucky? 7 A. Only in reference to this 8 deposition. 9 Q. Did you ever -- do you know 10 what happened to Fentress? 11 A. No. 12 Q. Did you ever hear of the 13 Wesbecker litigation in Kentucky? 14 A. Yes. 15 Q. And when did you first hear of 16 Joseph Wesbecker? 17 A. Fall of '89, maybe. 18 Q. And how did you hear about it? 19 A. The adverse event report that 20 came into Lilly. 21 Q. Was that the first time you 22 heard about it? 23 A. Yes. 24 Q. When you received that adverse Page 23 1 event report, did you pass on the information? 2 A. I did not take the adverse 3 event report. 4 Q. Right, but you did receive it 5 while you were employed by Eli Lilly, is that 6 right, you received the adverse event report? 7 A. Let me make this clear, I was 8 aware of it because the company had received it. 9 I personally did not take the adverse event 10 report. 11 Q. Who in the company received it? 12 A. I don't know. 13 Q. Who in the company gave it to 14 you? 15 A. I did not take the adverse 16 event report. I never, as far as I know, 17 distinctly remember receiving it from anybody. 18 When I say we received it, it's a generic term of 19 reporting to the company. 20 Q. Do you recall having the 21 adverse event report, a copy of it given to you 22 at any point in time? 23 A. At any point in time? 24 Q. Yes, the first time, I mean, in Page 24 1 the Fall of '89. 2 A. Not distinctly, no, I don't 3 remember that, not clearly, no. 4 Q. Did you ever discuss the Joseph 5 Wesbecker situation with anybody at Eli Lilly? 6 A. Yes. 7 Q. And who did you discuss it 8 with? 9 A. The people in the area working 10 on that, that would have been Dr. Dan Masica, Dr. 11 John Heiligenstein, Dr. Charles Beasley, Dr. 12 David Wheadon. 13 MR. GREEN: Would you read those names 14 back, please? 15 (THE COURT REPORTER READ BACK THE 16 REQUESTED TESTIMONY.) 17 Q. Now, you said that these people 18 were working in the area, what do you mean the 19 area? 20 A. They were in the division. 21 Q. Is that the division that was 22 dealing with Wesbecker or is that some other 23 division? 24 A. It was the generic division, Page 25 1 the psychopharmacology division, neuropsyche 2 division. I don't even remember what it was 3 called then. 4 Q. It has changed its name since 5 then? 6 A. We've divided the division in 7 which it's now the neuropharmacology and 8 psychopharmacology area. At that time, all of it 9 was together. 10 Q. Which division do you work in 11 now? 12 A. Neuropharmacology. 13 Q. Does neuropharmacology deal 14 with Prozac? 15 A. No. 16 Q. Have you dealt with Prozac 17 since you became clinical research physician? 18 A. Probably, but I don't 19 distinctly remember when I stopped dealing with 20 Prozac, I don't remember a particular date. 21 Q. Do you remember if it was in 22 1991 or 1992? 23 A. I don't remember specifically. 24 Q. Do you recall approximately how Page 26 1 long your experience working with Prozac was 2 while you were employed with Eli Lilly? 3 A. My experience in working with 4 Prozac? 5 Q. Right. 6 A. One probably would take 7 specifics up until May of 1992, but that was a 8 very focused experience up to that time. 9 Q. From the point in time you were 10 hired until May of 1992, are you saying it was 11 focused on Prozac? 12 A. It was focused in one area of 13 Prozac. 14 Q. What was that area? 15 A. I was the clinical monitor for 16 a post-stroke depression trial involving Prozac. 17 Q. How long did that position 18 last? 19 A. That position -- it was part of 20 my general position. 21 Q. How long did that 22 responsibility last? 23 A. We had a start-up in May of 24 1991 and closed the study in May or June of '92. Page 27 1 Q. And after that you didn't -- 2 you stopped working with Prozac? 3 A. Completely, and I really had 4 had no other dealings with Prozac for some time 5 other than that study alone. 6 Q. When you were in private 7 practice, did you ever prescribe Prozac? 8 A. Rarely. 9 Q. Could you try to enumerate what 10 you mean by rarely? 11 A. It had just come out by the 12 time I left practice. I don't remember when the 13 launch date of Prozac was, but I closed my 14 practice in June of 1989 and I had had an 15 occasion to use Prozac, perhaps, with five 16 patients or less. 17 Q. Now, you said that from May of 18 '91 to May of '92, thereabouts, your 19 responsibility was to be the clinical monitor for 20 a post-stroke depression trial. What was your 21 responsibility when you were first hired? 22 A. I worked in the division and 23 worked in the general area of Prozac, primarily 24 learning about the drug, learning about the Page 28 1 company, learning about the various regulatory 2 requirements and monitoring. 3 Q. And was that up until May of 4 1991 or was there something in between your 5 general work and the area of Prozac? 6 A. No. No, if I understand your 7 question. Was there anything else, I'm not sure 8 what you mean. 9 Q. I mean when you first were 10 hired, you were doing this general type work with 11 Prozac, how long did that last? 12 A. That's what I don't distinctly 13 remember, sometime maybe in '91, late '90, '91, 14 something like that. 15 Q. Okay. And if it ended in late 16 '90, '91, did you do anything after that but 17 before you were the clinical monitor for the 18 post-stroke depression trial? 19 A. I also, at that point, had also -- 20 was part-time in the psychopharm division and 21 part-time in the neuropharm division, so I had 22 other neurological monitoring duties for our 23 products. 24 Q. Would that be for Prozac? Page 29 1 A. No. 2 Q. Have you mentioned your 3 responsibilities regarding Prozac, from the point 4 in time you were hired at Eli Lilly until the 5 present, in total, or is there something else we 6 have not discussed? 7 A. I'm not clear I understand what 8 you're asking. 9 Q. You've described two 10 responsibilities which you have had with Prozac 11 within Eli Lilly since you were hired. 12 A. I think one cannot distinctly 13 say that this is a responsibility and this is 14 another responsibility, oftentimes they meshed. 15 My responsibility with the clinical trial was 16 also concurrently with my neuropharmacology 17 responsibilities. 18 Q. What else did you do with 19 Prozac that we haven't mentioned, if anything, 20 since the point in time you were hired by Eli 21 Lilly? 22 A. What else did I do with Prozac? 23 Q. Yes. 24 A. I'm not sure if you're looking Page 30 1 for something in specific, an adverse event 2 monitoring -- did any pertinent regulatory 3 records that were required by FDA, for monitoring 4 of a new drug, reporting, monitoring, I think 5 those are the predominant ones. 6 Q. Is there anything that's not 7 predominant that you're not mentioning? 8 A. I think predominant is 9 inclusive. 10 Q. When you were first hired by 11 Eli Lilly and you were learning about Prozac, did 12 there come a time when you learned that Prozac 13 alleviated the symptoms of depression? 14 MR. MYERS: I'm going to object to the 15 form of using the term alleviate the symptoms of 16 depression, but if you can answer it go ahead. 17 A. I would like the question 18 repeated, I'm not sure if I remember the first 19 part of it. 20 Q. I might rephrase the question a 21 bit. 22 A. Okay. 23 Q. After you were hired by Eli 24 Lilly and you were going through the period where Page 31 1 one of the things you were doing was learning 2 about Prozac, did there ever come a time during 3 that period where you learned the effects of 4 Prozac on depression? 5 A. I believe I recognized it as 6 being an anti-depressant before I even worked for 7 Eli Lilly. 8 Q. When did you learn that it was 9 an anti-depressant? 10 A. An exact date, I don't know. 11 Q. Was it prior to the FDA 12 approval of the drug? 13 A. It may have been, but probably 14 after the FDA approval of it. 15 Q. Was it while you were 16 prescribing the drug to one of the five patients 17 that you prescribed it to? 18 A. I knew that before I prescribed 19 it to the five patients. 20 Q. How did you find that out? 21 A. Probably through literature, 22 articles on the subject. It may or may not have 23 been mentioned at a meeting, I don't remember. 24 Q. Where did you get the Page 32 1 literature from? 2 A. General literature. 3 Q. Did any representative of Lilly 4 visit you? 5 A. I never had an Eli Lilly 6 representative visit me during my eleven and a 7 half years of private practice. 8 Q. As far as the Wesbecker case 9 goes, were you assigned any duties or 10 responsibilities which related to the Wesbecker 11 occurrence? 12 A. Specific responsibilities, no, 13 I think we all shared any duties as a part of 14 that division. 15 Q. What were those duties? 16 A. As I've stated, adverse event 17 monitoring, regulatory duties and meeting 18 regulatory requirements. 19 Q. Was there anything special 20 about the Wesbecker homicides which required more 21 attention on the part of your division? 22 MR. MYERS: What do you mean by 23 special? 24 MR. GREEN: I mean was there anything Page 33 1 remarkable about it or was it just another 2 adverse event, was it equal to all the other 3 adverse events or was it prioritized in any way? 4 A. I believe when the initial 5 report came in to the company, it came in as a 6 question by the coroner, medical examiner, in 7 Louisville, who had questions regarding it. So 8 in that sense, no, it did not come in as a ho hum 9 report, it came in with specific questions for 10 the medical examiner, coroner, that certainly one 11 attempted to answer accurately. 12 Q. So the coroner, medical 13 examiner, contacted Eli Lilly and Company? 14 A. I believe so. 15 Q. Who responded, if anyone, to 16 the coroner? 17 A. I believe that he had questions 18 that when they were originally asked, I don't 19 know what his specific questions were, but I 20 believe that the division got back with him about 21 that. 22 Q. Okay. So when I say who 23 contacted him and you say the division got back 24 to him, do you mean it wasn't an individual, the Page 34 1 whole division contacted him as one unit and you 2 all just somehow got on the phone together, you 3 all signed a letter or -- 4 A. I don't know who signed the 5 letter. 6 Q. Did you ever sign a letter that 7 went out to the coroner? 8 A. No. 9 Q. Did you ever hear of an a 10 company called the Dista Products Company? 11 A. Yes. 12 Q. And what is Dista Products 13 Company? 14 A. It's a division of Eli Lilly 15 and Company. 16 Q. Now in your role as a clinical 17 monitor and doing work on adverse events, et 18 cetera, did you ever work for Dista Products 19 Company? 20 A. No. 21 Q. Did you ever receive any 22 payments from Dista Products Company for work 23 performed through a contract? 24 A. No. Page 35 1 Q. Did you ever do any 2 investigations for Dista Products Company? 3 A. No. 4 Q. Did you ever write a letter for 5 Dista Products Company? 6 A. All my letters that were ever 7 written were for Lilly Research Laboratories. 8 Q. What is the function of Dista 9 Products Company? 10 A. What is the function? 11 Q. I mean what -- it's a division 12 of Eli Lilly, what is the division designed to 13 do? 14 A. I believe it has a certain set 15 of products that it is responsible for. 16 Q. And what products are those? 17 A. Prozac, others, I don't know, 18 it does not pertain to me who -- which division -- 19 there's a hospital division, I think there's an 20 anti-infected division, but they also have other 21 products they are responsible for. There's a 22 Dista -- I'm not sure how it all breaks down. 23 Q. Okay. Are you just -- I don't 24 want you to guess, okay, and I just -- I wasn't Page 36 1 sure if you were speculating when you answered 2 before. My question is: Does Dista Products 3 Company deal with other products other than 4 Prozac? 5 MR. MYERS: Let me object. I think 6 she's answered, she said they did and Prozac was 7 one, and she doesn't know the other ones. I 8 think she's answered that. 9 Q. Are you saying you don't know 10 what the other ones were, but yes, there were -- 11 MR. GREEN: See, my confusion is I'm 12 not sure if she's saying yes, there were other 13 products but I don't know what they were or 14 whether she's saying I don't know if there were 15 other products, and I'm just trying to clear that 16 up. 17 A. I would think there would be 18 other products, I don't know what they were. 19 Q. You think there would be other 20 products. Do you know for sure whether or not 21 there were other products? 22 A. I believe my product of 23 Percolite is a Dista product, but I would have to 24 check to be sure. It's never been important to Page 37 1 me to know that. 2 Q. What kind of drug is Percolite? 3 A. It's an anti-Parkinson drug. 4 Q. Are you familiar with the term, 5 within your Eli Lilly experience, the term, 6 quote, Prozac spontaneous report data, end quote? 7 A. I assume you are talking about 8 the drug epidemiology network, yes. 9 Q. And what do you take that term 10 to mean? 11 A. Which term? 12 Q. The Prozac spontaneous report 13 data. 14 A. Those were reports that come 15 from anything other than clinical trial 16 information. 17 Q. Where did these reports come 18 from? 19 A. They can come from any health 20 care professional, consumer, anyone other than a 21 clinical trial investigator. 22 Q. Are the reports sought out by 23 Eli Lilly and Company? 24 MR. MYERS: What do you mean by sought Page 38 1 out? 2 Q. Well, you said that they can 3 come from various origins. My question is: Does 4 Eli Lilly attempt to seek out these spontaneous 5 events or does Eli Lilly have the events reported 6 to them? 7 A. Eli Lilly will report any event 8 that is reported, mentioned, sent, or just 9 discussed, not even, quote, reported, end quote. 10 If a sales representative is visiting a 11 physicians office, and the physician, just in 12 discussion, mentions a report, then the sales 13 representative will forward that to us. 14 Q. Okay. And then you enter the 15 information into the Drug Experience Network? 16 A. Yes. 17 Q. Now that information is used 18 for epidemiological studies, isn't it? 19 A. It's -- true epidemiological 20 studies -- since I'm not an epidemiologist, I 21 can't say that that's quite accurate since there 22 is no basis on what number of patients have been 23 exposed. That does not become a true 24 epidemiological incident formation data base, no. Page 39 1 Q. Well, what's the purpose for 2 entering spontaneous reports into the Drug 3 Experience Network? 4 A. A number of things. Number 5 one, it's a regulatory requirement in which 6 companies must, I believe, accept and report on 7 to the FDA any events. It also helps us to 8 identify and monitor safety after a drug is on 9 the market. 10 Q. But if it's not a basis for 11 true epidemiological reports, as you stated, how 12 does that help you to monitor its safety? 13 A. True epidemiology may have an 14 incidence requirement, an incidence in which one 15 needs to know a certain denominator of patients 16 exposed. There is no easy and clear-cut way of 17 determining patient exposures after a drug 18 reaches the market. One takes a look at trends, 19 gives us an idea, once a drug reaches the market, 20 if there are specifics that need to be monitored, 21 it allows us to look at the population, also, 22 that may be using the drug. 23 Q. But it's not based on true 24 epidemiology? Page 40 1 MR. MYERS: What do you mean by true 2 epidemiology? 3 Q. I mean it's not really 4 epidemiologic -- the results that you get when 5 you do a study on DEN are not based on 6 epidemiology? 7 A. One doesn't do studies on DEN. 8 Q. You don't. Well, do you know 9 why the DEN was created? 10 A. For just this purpose of 11 monitoring, and also to have some sort of 12 organization for monitoring and reporting adverse 13 events to the FDA. 14 Q. For monitoring and reporting 15 adverse events. 16 A. Right. 17 Q. Does it have -- well, I thought 18 before, maybe you want to clear this up, I 19 thought before you said the purpose for 20 monitoring the events was to determine the 21 safety. 22 A. It's not do determine safety, 23 but to monitor safety. 24 Q. To monitor safety. Page 41 1 A. To continue to monitor safety. 2 Q. So you're going to monitor 3 safety based on adverse events that are entered 4 into the DEN? 5 A. Right, yes. 6 Q. And those adverse events, many 7 of them are collected through spontaneous 8 reports; is that correct? 9 A. Yes. 10 Q. And the spontaneous reports do 11 not reflect the total population exposed to 12 Prozac, do they? 13 A. No. 14 Q. And the spontaneous reports are 15 not a complete listing of all the adverse events 16 which occur, are they? 17 MR. MYERS: When you say all the 18 adverse events that occur, what do you mean? 19 MR. GREEN: I mean there are adverse 20 events which occur that Lilly does not hear about 21 and does not enter into the DEN. 22 MR. MYERS: Is that a question or 23 statement? 24 MR. GREEN: Yes, that's a question. Page 42 1 MS. ZETTLER: I object to your 2 constantly asking for definitions when I think 3 the doctor is obviously capable of understanding 4 and answering the questions. 5 MR. MYERS: Well, I'm entitled to 6 understand it, I'm her lawyer. 7 MS. ZETTLER: If you have an objection, 8 I think you should make it, and if -- if she can 9 understand it, that's what counts here, not 10 whether you understand it. 11 MR. MYERS: My comments are as to the 12 form. 13 Q. Do you want the question again? 14 A. Yes. 15 MR. GREEN: Can you read back the 16 question? 17 (THE COURT REPORTER READ BACK THE 18 REQUESTED TESTIMONY.) 19 A. We enter all events that are 20 reported to us. 21 Q. Let me ask my question again. 22 All events that are reported to Lilly are entered 23 into the DEN; is that correct? 24 A. That is correct. Page 43 1 Q. Are all events which occur in 2 the population reported to Eli Lilly? 3 A. They may be reported to Eli 4 Lilly, they may be reported directly to the FDA 5 or they may not be reported. 6 Q. Do you know what percent of 7 adverse events which occur are reported to Eli 8 Lilly? 9 A. No. 10 Q. Do you know what percent of 11 adverse events which occur are reported to the 12 FDA? 13 A. No. 14 Q. Does anybody at Eli Lilly know 15 what event -- know what -- I'm sorry. Does 16 anybody at Eli Lilly know what percent of adverse 17 events are actually reported to Eli Lilly? 18 A. I don't know. 19 Q. Has anybody at Eli Lilly ever 20 studied that question? 21 A. I don't know. 22 Q. Are you familiar with the 23 phrase statistically insignificant? 24 A. Statistically insignificant? Page 44 1 Q. Yes. 2 A. Not specifically, no, I'm not 3 sure -- one usually talks about things being 4 statistically significant, and I guess the 5 converse of that would be true of statistically 6 not significant, I guess, is more of a term it 7 might be typically phrased. 8 Q. So let's switch it around a 9 little bit and talk about statistically 10 significant. What is your understanding as to 11 what that phrase means? 12 A. It's simply a statistical 13 meaning based upon a P value, what's called a P 14 value in which the P value is equal to less than 15 point zero zero one, as a general rule. 16 Q. Are the adverse events which 17 are entered into the DEN statistically 18 significant? 19 MR. MYERS: Let me object to the form 20 because you have not given her anything to 21 compare it with. Statistically significant in 22 relationship to what? 23 Q. In relationship to using the 24 DEN information. Page 45 1 A. You always have to have a 2 comparator for statistical significance. 3 Q. So there's no comparator in the 4 DEN? 5 A. There's no comparator in the 6 DEN. 7 Q. Now, in your 8 neuropsychopharmacology division, and any 9 formations thereof over the years, was it ever 10 important for that division to consider the 11 marketing perspective? 12 MR. MYERS: Object to the form. You 13 used the term marketing perspective, it's awfully 14 vague. 15 Q. The marketing perspective of 16 the drug Prozac. There is a marketing division 17 in Lilly, isn't there? 18 A. There is. 19 Q. And they would have a 20 perspective on a certain issue, can we assume 21 that to be true? 22 A. Yes. 23 Q. And can we assume that the 24 neuropsychopharmacology division would have a Page 46 1 perspective on a certain issue as well, can we 2 assume that to be true? 3 A. Yes. 4 Q. Was it important for the 5 neuropsychopharmacology division to consider 6 marketing perspective, especially with regard to 7 Prozac? 8 A. One would always consider it, 9 one did not have to agree with it. 10 Q. Well, did your division ever 11 give advice to salesmen? 12 A. Salesmen? We never did any -- 13 when you say advice to salesmen, I mean if they 14 called on the phone and asked a question did we 15 talk with them? 16 Q. Yes. 17 A. Yes. 18 Q. Are you aware of any marketing 19 which Eli Lilly had for Prozac? 20 A. Strategy per se, no. 21 Q. But marketing results, in other 22 words a successful marketing strategy, was that 23 important to your division? 24 A. An important marketing strategy Page 47 1 important to the division, there is a separation 2 of those two areas, in which we were primarily 3 interested in the product. And we would 4 certainly give our input into marketing and we 5 would certainly work with them on their concept, 6 but as I say, it was not a -- it was a 7 relationship in which one listened and one 8 listened to both sides, one did not always have 9 to agree. 10 Q. Do you remember any 11 disagreements between your division and marketing 12 in the context of Prozac? 13 A. Do I remember any 14 disagreements? I'm sure we never agreed all the 15 time. 16 Q. Do you remember any 17 disagreements? 18 A. Specific ones, no, not 19 necessarily. 20 Q. Would you say that marketing 21 pays for the studies which Eli Lilly conducts? 22 A. It depends on -- in the 23 premarketing studies, no, marketing does not pay 24 for those. If it is after marketing, marketing Page 48 1 may pay for those in what is called a support 2 study in which there is an interest in a 3 particular population that may be of interest. 4 Medical pays for studies through the registration 5 phase. 6 Q. Okay. Do you know what the 7 dosage recommendation for Prozac is presently for 8 the indication of depression? 9 A. I would have to look to be 10 specific what the range is, the general dose is 11 twenty milligrams a day, but there is a range. 12 Q. Okay. At twenty milligrams a 13 day, for thirty days, is there a range of blood 14 level of Fluoxetine in the blood or is Fluoxetine 15 broken down and is that measured in the blood? 16 A. I don't know that I've ever 17 seen a Prozac blood level. 18 Q. How -- was there a way to 19 measure the blood and a certain chemical in the 20 blood in order to determine whether or not Prozac 21 had been metabolized by that patient? 22 A. I don't remember. 23 Q. Do you remember reading any 24 autopsy reports of anyone who had died as a Page 49 1 result of an adverse event, and as part of that 2 autopsy report reading the results of a blood 3 sample? 4 MR. MYERS: Before she answers, let me 5 object to the form because your question assumes 6 that the adverse event was the result of the 7 death. 8 Q. Let me start over. In the 9 course of your work with Prozac at Eli Lilly, did 10 there come a time when you reviewed an autopsy 11 report? 12 A. (No response.) 13 Q. You have to answer. 14 A. I'm sorry, I didn't realize you 15 had paused there. Yes, most probably, uh-huh. 16 Q. How many times did that happen? 17 A. I don't remember. 18 Q. Was it once a week? 19 A. I don't remember, it would not 20 have been that often, though. Specific numbers, 21 I can't give, but not once a week. 22 Q. The autopsy reports that you 23 read, were they reports of people who had taken 24 Prozac pursuant to their doctor's prescription? Page 50 1 A. Yes. 2 Q. Okay. When you read those 3 autopsy reports, did you read anything about 4 blood samples or blood tests? 5 A. In general, yes, I'm sure. 6 Oftentimes they ran various blood samples and 7 blood tests on those autopsy reports. 8 Q. Were you interested in looking 9 at the level of the Fluoxetine or the Fluoxetine 10 metabolized within the blood system? 11 A. I usually did not review 12 anything if there were blood samples. 13 Q. Who would do that? 14 A. One of the psychiatrists. 15 Q. In the course of your private 16 practice, did you ever take blood samples? 17 A. Of Prozac? 18 Q. No, of any patients. 19 A. Yes. 20 Q. And did you send those blood 21 samples to a laboratory to be analyzed? 22 A. Yes, I guess. 23 Q. And the laboratory would send 24 you back an analysis of the blood, isn't that Page 51 1 right? 2 A. Yes. 3 Q. And you would read that 4 analysis and you would understand it, wouldn't 5 you, as a medically trained professional doctor? 6 A. Yes. 7 Q. But when you were at Eli Lilly 8 and you were reading the autopsies and you saw 9 the blood level, you didn't understand that, did 10 you? 11 MR. MYERS: Object to the form, Greg, 12 becuase you're mischaracterizing testimony. She 13 said that the psychiatrist reviewed it, she's 14 answered that question. 15 Q. Why would the psychiatrist 16 review it and not you? 17 A. Prozac blood levels are not 18 common occurrences and are not available in all 19 laboratories. It was a very specific technique 20 and the psychiatrist had a specific interest in 21 those and they just did that. 22 Q. Well, the information that 23 would be listed in the analysis would be X 24 milligrams per liter. Page 52 1 A. But there was no range of 2 Prozac, there's no, quote, therapeutic range, per 3 se, as one may get with an anticonvulsant level. 4 So there may be levels, but the question is what 5 do those levels represent. 6 Q. You said there's no range. 7 A. There was not at the time, 8 there may be now. 9 Q. There might be now. At the 10 time, when there was no range, does that mean 11 that it was irrelevant? 12 A. No. 13 Q. What the measurement was? 14 A. No. 15 Q. What do you mean by that, that 16 there was no range? 17 A. One has an idea, a therapeutic 18 range, with some drugs, i.e. a range in which one 19 achieves a therapeutic response. And that is 20 determined by a number of different methods. 21 Some drugs you will not be able to get a 22 therapeutic range on simply because of a number 23 of factors, their metabolism, their excretion, 24 where they're distributed in the body, where Page 53 1 they're stored, et cetera. So therapeutic ranges 2 can be very helpful guides, but by nonetheless 3 even for those compounds and drugs that have a 4 therapeutic range, it is merely a guideline and 5 not a dictation. 6 Q. In the case of Prozac, was the 7 therapeutic range a guideline and not a 8 dictation? 9 A. There was no therapeutic range 10 ever that was established at that time. 11 Q. What psychiatrist would review 12 that blood analysis? 13 A. Possibly any of them. 14 Q. Could you give their names, 15 please? 16 A. I've already discussed that and 17 given Dr. Heiligenstein, Dr. Beasley, Dr. Wheadon 18 and Dr. Masica. Dr. Masica is the division 19 director. 20 Q. You have to forgive me because 21 I didn't realize they were psychiatrists. 22 A. Uh-huh. 23 Q. Were there any other 24 psychiatrists in the neuropsychopharmacology Page 54 1 division? 2 A. No. 3 Q. Now, did you ever hear of a 4 protocol that was called, quote, the Lilly 5 protocol, end quote? 6 A. No. 7 Q. Well, for instance, in your 8 post-drug depression study, was there a, quote, 9 Lilly protocol? 10 A. There was a clinical trial 11 protocol for that study. 12 Q. And that was not -- you never 13 heard of the Lilly protocol? 14 A. As a particular protocol? 15 Q. Right. 16 A. Well, Lilly has the protocol 17 for the study, if they are sponsoring it, if 18 that's what you mean by a generic term of Lilly 19 protocol. 20 Q. I don't mean anything, I'm 21 trying to find out if such a phrase exists, and 22 if it does exist what is your understanding of 23 what the phrase means? 24 A. My understanding of the phrase Page 55 1 would be that it is the protocol of the study 2 sponsored by and conducted by Lilly. 3 Q. So -- you have to forgive me, 4 are you changing your answer and saying now that 5 the Lilly protocol is a phrase which does exist? 6 A. No, I'm not. 7 MR. MYERS: Wait a minute, Greg, she's 8 testified -- you asked her had you ever heard of 9 this term, she said no, she then explained to you 10 the circumstances under which there is a protocol 11 and the circumstances under which Lilly might 12 sponsor a protocol, that's what she told you, she 13 hasn't changed anything. 14 MR. GREEN: Can you read back the 15 original question and answer? 16 (THE COURT REPORTER READ BACK THE 17 REQUESTED TESTIMONY.) 18 Q. Do you want to change that 19 answer? 20 A. No. My answer stands as you 21 asked it, and as I understood it, you were 22 talking about a very specific protocol, i.e., one 23 protocol that might be referred to as the Lilly 24 protocol. A protocol for measuring glass -- iced Page 56 1 tea in a glass, as far as the Lilly protocol, no. 2 Protocol for a study sponsored by Lilly might be 3 called the Lilly protocol or the protocol or the 4 study protocol. I guess, perhaps, I was assuming 5 a certain specificity that wasn't there. 6 Q. Okay. Did you ever become 7 involved with any clinical trials of Prozac for 8 the indication of depression? 9 A. No -- for the indication of 10 depression? 11 Q. Yes. 12 A. No. With the indication of 13 depression, as in a post-stroke, in patients with 14 post-stroke depression, yes, but in depression 15 per se, no. 16 Q. In the post-stroke depression 17 study, was the Ham D scale used? 18 A. Yes. 19 Q. When did you first hear of the 20 Ham D scale? 21 A. When I went to work for Lilly. 22 Q. Throughout your time with 23 Lilly, did you ever become aware of -- well, let 24 me rephrase this question. The Ham D scale, does Page 57 1 it contain a portion which deals with suicide? 2 A. I think there's a question on 3 suicide. 4 Q. Okay. And in the course of 5 your work with Lilly, did you ever become aware 6 of any other scales which could be used to 7 measure suicidalities other than that portion of 8 the Ham D scale? 9 A. In my -- 10 Q. In your work with Lilly. 11 A. Could you kind of summarize 12 that a bit, I'm not sure I understand what your 13 question is. 14 Q. I believe the testimony is that 15 you became aware of the Ham D scale when you 16 started to work with Lilly, and that a portion of 17 the Ham D scales deals with suicide, a measure of 18 suicidality. 19 A. There's a question about 20 suicide. 21 Q. Okay. There's -- is there one 22 question about suicide? 23 A. I don't know, I would have to 24 look at the Ham D, I have not looked at it for a Page 58 1 long time. 2 Q. My question is: Using that as 3 a measurement of suicidality, in the course of 4 your work with Lilly, did you ever become aware 5 of another scale or way of measuring suicidality? 6 MR. MYERS: Before she answers, let me 7 object to the form because you've referenced the 8 Ham D item as a measure of suicidality and I 9 think her answer was there was a 10 question about suicides. So to that extent, I 11 object to the form. 12 Q. The question is, boiled down, 13 did you ever become aware of alternate ways to 14 measure suicidality? 15 A. I was never into that 16 particular area of looking at suicide, so no, I 17 was not aware of anything. 18 Q. And were you ever aware of a 19 scale which was maybe consisted of a hundred 20 questions just on the one element of suicide? 21 A. Am I aware of that, no. 22 Q. Are you aware of any other 23 suicidality measuring device or scale which was 24 feasible to use instead of the Ham D question? Page 59 1 MR. MYERS: I object to the form as to 2 the word -- term feasible to use, being vague and 3 otherwise ambiguous. 4 Q. As another suicidal measurement 5 scale which was feasible other than the Ham D? 6 A. I didn't work in that area, so 7 I have no -- no real knowledge or expertise or 8 knowledge of the full psyche scales. 9 Q. Okay. So you were not involved 10 with that, is that right? 11 A. I did no specific work in the 12 area of suicide, no. 13 Q. Doctor Beasley never had a 14 discussion with you about scaling suicidality, 15 figuring the extent of suicidality in clinical 16 subjects? 17 A. No. 18 Q. Doctor Masica never had such a 19 conversation? 20 A. No. 21 Q. And Dr. Heiligenstein never had 22 such a conversation? 23 A. (Witness moves head from side 24 to side.). Page 60 1 Q. And never communicated to you 2 in any way, hey, here's an alternate suicidality 3 measuring scale? 4 A. Since I was not involved, if it 5 was, any comments, they were in the hall 6 comments. There was nothing that would have been 7 specific, et cetera, type of thing, I was not 8 involved in that. 9 Q. Okay. 10 MR. MYERS: Are you going to move to 11 something else right now or another subject 12 because I thought we might could take a short 13 break. 14 (A SHORT RECESS WAS TAKEN.) 15 Q. Now, the Drug Experience 16 Network is also called DEN, right? 17 A. Yes. 18 Q. Now, is DEN a computer data 19 base? 20 A. It's computerized. 21 Q. The information is on computer, 22 is that what you mean? 23 A. I believe so, yes. 24 Q. In order to enter information Page 61 1 into the computer, it's true, is it not, that you 2 have to use a certain type of language? 3 A. I don't know, I've never 4 entered. 5 Q. Okay. Are you familiar with 6 COSTART? 7 A. Yes. 8 Q. Okay. What is COSTART? 9 A. It's a dictionary of terms that 10 are coding terms for events. 11 Q. Coding terms for events? 12 A. Uh-huh. 13 Q. And what were you coding terms 14 for? 15 A. The adverse event reports. 16 Q. But why would they have to be 17 coded, was that because they were going into the 18 computer? 19 A. Yes, I assume. They've always 20 been coded, they were coded when I came, so that 21 is the process. 22 Q. Did you have anything to do 23 with the selection of certain terms to use to 24 describe an adverse event? Page 62 1 A. Yes. 2 Q. What was your role in that 3 regard? 4 A. I might review the terms. 5 Q. You might review the terms? 6 A. Uh-huh. 7 MR. MYERS: You need to say yes. 8 A. Yes. 9 Q. Well, what do you mean you 10 might review the terms, does that mean that under 11 certain situations you reviewed the terms? 12 A. If they were given to me as a 13 part of the adverse event report. 14 Q. So adverse event reports that 15 came to you, you reviewed the terms, is that 16 right? 17 A. Yes. 18 Q. And is that true for all the 19 adverse event reports that came to you? 20 A. Yes. 21 Q. Now when you say you reviewed 22 the terms, what exactly does that mean? 23 A. Reviewed them for specificity 24 and accuracy of the event being reported. Page 63 1 Q. Who would use the original term 2 which you were reviewing? 3 A. Who would use the original 4 term? 5 Q. Yes, who would have listed the 6 original term which you were reviewing? 7 A. Probably -- I think what you're 8 asking is who generated the term, which would be 9 one of the CRA's out of the DEU. 10 Q. Would the CRA's and the DEU get 11 the adverse event report, generate a term, and 12 then you would review the term? 13 A. I would review the entire 14 report, not just the term. 15 Q. So you would read the report 16 and make sure that the term was accurate? 17 A. Yes. 18 Q. And that term that you were 19 making sure was accurate was a term from a 20 dictionary, right? 21 A. Yes. 22 Q. And was that from the ELECT 23 dictionary? 24 A. What time period are you Page 64 1 speaking of? 2 Q. I'm speaking of the time period 3 when you were working with Prozac at Eli Lilly. 4 A. We have switched to the COSTART 5 dictionary and I don't remember when that 6 actually occurred. I believe most of the Prozac 7 was done under ELECT. 8 Q. Why -- what was the reason for 9 the switch? 10 A. I don't know. 11 Q. Now, the reason you have the 12 dictionary is to be consistent in the terms that 13 are used; is that correct? 14 A. I suppose consistent is one 15 aspect one is looking for. 16 Q. When you reviewed the terms, 17 were you also striving to be consistent over a 18 period of time in analyzing the reports and 19 giving all reports which were the same, the same 20 term? 21 A. Yes. 22 Q. And why was it important to be 23 consistent? 24 A. So that one could be identified Page 65 1 in a way of making sure that one captures all of 2 those under a specific term. 3 Q. Well, now, if it's going -- if 4 the information is going into the computer 5 network, is that information ever taken out of 6 the computer network? 7 A. Taken out? 8 Q. Yes, does information only go 9 in or does it go in for a purpose? 10 A. It goes in. 11 Q. The information definitely goes 12 in? 13 A. Yes. 14 Q. We have no problem with that. 15 A. No. 16 Q. Is the information ever 17 analyzed? 18 A. It may be reviewed. 19 Q. And it's just reviewed. Are 20 any studies done with the information that's in 21 that network? 22 A. Studies done, I have not done 23 any studies. I'm not sure what you mean by 24 studies. Page 66 1 Q. Any epidemiological studies. 2 A. I don't know, they may be, but 3 I think as we discussed before, it's not a data 4 base that lends itself to what one typically 5 thinks of epidemiological studies, per se, it can 6 certainly give one information. 7 Q. What's the purpose for creating 8 that data base? 9 MR. MYERS: Hold on, let me just 10 object, Greg, I think she answered this earlier 11 when you were talking about why there was a DEN. 12 She gave you the reason, she's answered the 13 reason there was a DEN earlier. 14 MR. GREEN: I don't think she did give 15 that reason, and I think she said it wasn't a 16 data base and now she just said it was, so her 17 answers are kind of evolving, it's a process. 18 Why don't you let her answer it again. 19 Q. What's the purpose of creating 20 that data base? 21 A. To collect safety data and for 22 reports that go to the FDA. 23 MR. MYERS: That's what she said 24 before. Page 67 1 MR. GREEN: That's right, that's what 2 she said before. 3 Q. Did you meet with your 4 attorneys prior to this deposition? 5 A. Yes. 6 Q. When did you first meet with 7 them? 8 A. First, I guess when I first -- 9 they first informed me that I would be deposed 10 for this. 11 Q. When was that? 12 A. April, May. 13 Q. How long did that particular 14 meeting last? 15 A. Maybe an hour. 16 Q. And did you meet with them 17 again this morning? 18 A. Yes. 19 Q. How long did that meeting last? 20 A. A little over an hour. 21 Q. Did you meet with them at any 22 other time? 23 A. I talked with them, of course, 24 during the break, that's it. Page 68 1 Q. Okay. When you met with them, 2 were you given instructions about how to respond 3 to questions? 4 MR. MYERS: Greg, anything she talked 5 about with her lawyers is privileged and you know 6 well enough to that, she's not required to and is 7 not going to answer any questions about what she 8 discussed, direct questions or indirect 9 questions, so please ask another question. 10 Q. Were you told to listen to what 11 your lawyer says? 12 MR. MYERS: Don't answer that question, 13 it's privileged. 14 Q. Were you told to take ques from 15 your lawyer when he objected? 16 MR. MYERS: Don't answer that question, 17 that's privileged. Anything she discussed is 18 privileged, so please move on to something else. 19 Q. Were you told to incorporate 20 your lawyer's objection into your next answer? 21 MR. MYERS: Don't answer that, it's 22 privileged. 23 Q. What is the purpose for using 24 terms which would consistently describe similar Page 69 1 events? 2 A. What's the purpose of 3 consistently? I believe that when one sends 4 reports to the FDA, they have requested, 5 required, I have no idea what it is, but they 6 asked for certain consistency in reporting. 7 Q. Does it have anything to do 8 with categorizing the event? 9 A. One may want to look at body 10 systems and categorize by body systems and body 11 system events. 12 Q. For instance, would one want to 13 look at rashes and all similar rashes and look at 14 all the adverse reports on rashes? 15 A. Yes. 16 Q. And, so, therefore, it was 17 important to use a consistent term for rash? 18 A. Yes. 19 Q. And if one wanted to look for 20 anxiety, did you have a term that you used for 21 anxiety and -- or did you have a term that you 22 used for any adverse event where anxiety was 23 obviously the adverse event, you had a consistent 24 term to use, didn't you? Page 70 1 A. The terms were defined by the 2 dictionaries. 3 A. Right. 4 Q. So those were the terms that 5 one used for consistency, and it was important to 6 use those dictionary terms to categorize the 7 events, wasn't it? 8 A. Yes. 9 Q. So an event would happen, and 10 it's categorization would depend on the term that 11 was used to describe that event, isn't that 12 correct? 13 A. Say that again, repeat the 14 question? 15 Q. An adverse event would occur 16 and its categorization would be dependent on the 17 term that was used to describe that event. 18 A. Well, the final event term was 19 dependent upon both what the dictionary term was 20 and what the event was so that the two would 21 correspond and correlate. 22 Q. Was there, within the ELECT 23 dictionary, an adverse event term, quote, 24 overdose, end quote? Page 71 1 A. Yes. 2 Q. And what events would go into 3 that category of overdose? 4 A. What event terms? Overdose. 5 Q. Would that include overdose of 6 carbon monoxide? 7 A. Yes, I think, uh-huh, that's a 8 carbon monoxide overdose, so that would overdose. 9 Q. What about if somebody 10 committed suicide by inhaling carbon monoxide, is 11 that an overdose? 12 A. Could be, in a sense, yes. 13 Q. What about if somebody took, 14 hypothetically, too much Seldane or -- because 15 they thought that they had very bad allergies, 16 they thought they were doing the right thing by 17 taking a hundred Seldane in one day, would that 18 be an overdose? 19 A. Yes. 20 Q. What about somebody who 21 couldn't read the prescription labels simply 22 because they didn't know how to read, and 23 therefore they took a dosage beyond the physician 24 prescription, and got sick, would that be an Page 72 1 overdose? 2 A. I'm given all this information 3 when I'm assessing this? 4 Q. Yes. 5 A. Yes. 6 Q. What about if somebody had just 7 been prescribed Prozac and they had the bottle, 8 the brand new bottle with Prozac, and they wanted 9 to kill themselves, and they write a suicide 10 note, and they take the whole bottle of Prozac, 11 is that an overdose? 12 A. Yes. 13 Q. So the term overdose included 14 intentional overdose of Prozac, accidental 15 overdose of other drugs, overdose of carbon 16 monoxide, it included all those events and 17 similar events; is that correct? 18 A. It may. 19 Q. Well -- 20 A. If it does, I would have to 21 look at the -- 22 Q. I just asked you if all those 23 events were overdoses and you said yes. 24 MR. MYERS: You gave her some Page 73 1 hypotheticals, you said would that be an 2 overdose, and I think she answered affirmatively 3 to those questions, under those hypotheticals. 4 Q. Do you want to change your 5 responses to any of those hypotheticals? 6 A. No. 7 Q. Why do you say it may include 8 those now instead of it definitely does include 9 those? 10 A. Because I interpreted your 11 question to mean that those are, in the DEN 12 system, to be now, in a sense. From a 13 hypothetical, yes, they are overdoses. 14 MS. ZETTLER: Could you read that back? 15 (THE COURT REPORTER READ BACK THE 16 REQUESTED TESTIMONY.) 17 Q. In your review of adverse event 18 terms, did you ever change the term intentional 19 overdose to overdose? 20 A. Yes. 21 Q. And what was -- how many times 22 did you do that? 23 A. I don't know. 24 Q. Was it twice a week during the Page 74 1 course of your experience with Prozac at Eli 2 Lilly? 3 A. I don't know. 4 Q. Do you know, throughout your 5 entire career at Lilly, was it less than ten 6 times that you did that? 7 A. I don't know. 8 Q. Did you ever change the term 9 suicide attempt to overdose? 10 A. No. 11 Q. Did anybody in your division 12 change the term suicide attempt to overdose? 13 A. I don't know. 14 Q. Did you ever read anybody 15 making -- anybody's note wherein the suggestion 16 was made to change suicide attempt to overdose? 17 A. I don't remember. 18 Q. Have you ever heard of the 19 SSAI? 20 A. SSAI? 21 Q. Science, Symptoms and Illness? 22 A. Yes. 23 Q. What is that? 24 A. I believe that's an early Page 75 1 adverse event coding dictionary. 2 Q. When you say early, what time 3 frame is that? 4 A. I don't know. 5 Q. Did you ever use it? 6 A. I've used it only in relation 7 to my product of Percolite. 8 Q. When you did your study about 9 the post-stroke depression of Prozac, did you use 10 the Ham D scale in that study? 11 A. Yes. 12 Q. And did you use the portion of 13 the Ham D scale which was directed to suicide? 14 A. I believe we used the entire 15 scale. 16 Q. Did you use any other scale to 17 measure suicidality? 18 A. Such as? 19 Q. Just any other scale. 20 A. There were probably other 21 scales in there. Whether you say they -- whether 22 you are -- there are other scales in the study. 23 Q. Were there other scales which 24 dealt specifically with suicidality? Page 76 1 A. I don't remember. 2 Q. Do you remember any other 3 scales at all that were used? 4 A. No. 5 Q. Now, I did give you a 6 hypothetical before about somebody who just came 7 home with the brand new bottle of Prozac and they 8 wrote a suicide note and took the whole bottle. 9 And I believe you said that would be considered 10 an overdose? 11 A. Yes. 12 Q. Would it be considered a 13 suicide attempt? 14 A. Yes. 15 Q. Would it be considered both? 16 A. Yes. 17 Q. Would both events be listed? 18 A. Yes. 19 Q. Has anybody, as far as you 20 know, done any epidemiological studies which 21 studied the incident rate of attempted suicide by 22 patients on Prozac? 23 A. What was the first part of the 24 question? Page 77 1 Q. Are you aware of any studies. 2 A. Yes. 3 Q. Can you name those studies 4 specifically? 5 A. I believe there was one by 6 Rosenburg, and I cannot think of the other 7 fellow's name from Massachusetts. 8 Q. Do you know where Rosenburg got 9 his data from? 10 A. I believe it was his patient 11 population file. 12 Q. Do you know where the person in 13 Massachusetts got their data from? 14 A. I believe his data file, his 15 patient data file. 16 Q. Is there anybody at Eli Lilly 17 by the name of Bob Hunt? 18 A. I think so. 19 Q. Are you aware of a special data 20 base for Prozac spontaneous suicidality reports 21 which runs through the Paradox software? 22 A. No. 23 Q. Let me show you this and see if 24 it refreshes your recollection. Page 78 1 (PLAINTIFF'S EXHIBIT NO. 1 WAS 2 MARKED FOR IDENTIFICATION AND 3 RECEIVED IN EVIDENCE.) 4 Q. I've just shown you PLAINTIFFS' 5 EXHIBIT 1. Dr. Street, does that refresh your 6 recollection? 7 A. No. 8 Q. Now does the ELECT dictionary 9 have a term, quote, life threatening, end quote? 10 A. ELECT dictionary, I don't know, 11 I don't think so. 12 Q. Was that a term -- is that 13 because it's a term that's used to describe a 14 situation as opposed to a categorization of an 15 event? 16 A. Is that a -- 17 Q. Are you not sure because that's 18 not really an event, quote, life threatening, end 19 quote? 20 A. I don't know if that's an event 21 or not, I would have to check the dictionary. I 22 don't think so, but I don't know. 23 Q. Was that term used within the 24 course of your work with Eli Lilly? Page 79 1 A. Yes. 2 Q. And what was that term taken to 3 mean? 4 A. Term which -- 5 Q. Life threatening. 6 A. Yes, a term that would mean 7 that threatened the patient's survival. 8 Q. Okay. Were there any other 9 characteristics that determined whether or not 10 the patient's survival was life threatening? 11 A. I don't know of anything that 12 was ever specifically written down. 13 Q. Well, did it matter whether or 14 not the survival of the patient and the life 15 threatening situation, did it matter not whether 16 the death of the patient was an immediate threat 17 or just a threat as to whether that situation 18 would be classified as life threatening? 19 A. It's an immediate threat, I 20 suppose it could be both. 21 Q. Okay. So immediacy is not a 22 factor in using the term life threatening then? 23 MR. MYERS: Let me object to the form, 24 she said it could be one or the other, and thus Page 80 1 your question is inaccurate. 2 MR. GREEN: Could you read back the 3 question and answer, please? 4 (THE COURT REPORTER READ BACK THE 5 REQUESTED TESTIMONY.) 6 Q. So if it could be both, that 7 would mean that it could be a situation where 8 death was not immediate; is that correct? 9 A. I think the life threatening is 10 probably related to the seriousness of the event, 11 and is it life threatening both immediate -- I'm 12 having trouble with just the vagueness and the 13 generalities, I guess, in which you're asking, 14 because usually when one does this one has 15 specific guidelines by the report you're looking 16 at. 17 Q. Let me try the question again. 18 To use the term life threatening, would you have 19 to look to whether the life threatening situation 20 was immediate or not, was that a factor in your 21 use of the term life threatening? 22 A. Immediacy, if it were 23 immediately life threatening, yes, I mean death 24 potentially. Page 81 1 Q. And what if it was not 2 immediate but was still life threatening, were 3 you permitted to use the term life threatening? 4 A. Permitted to use, I don't know 5 if I've ever seen any guidelines, that's an FDA 6 regulatory term, I believe, that you're referring 7 to, and I don't know that I've seen any specific 8 guidelines by the FDA as to whether it's -- 9 Q. Have you seen any guidelines by 10 Eli Lilly and Company? 11 A. No, that's an FDA definition of 12 term. 13 Q. Did there come a time in the 14 course of your employment where you reviewed a 15 letter intended to be signed by Dr. Beasley which 16 was addressed to physicians, and the letter 17 concerned overdose of Prozac? 18 A. I believe so, yes. 19 Q. Okay. Was this a form letter? 20 A. A form letter, I don't know 21 what you mean by a form letter. 22 Q. Was it a letter that was 23 created in order to send to physicians so that 24 when a physician would contact Lilly with a Page 82 1 question about the overdose of Prozac, all you 2 needed to do was put in the address and other 3 specific things, but the main body of the letter 4 was written? 5 A. Yes. 6 Q. So your answer is -- my 7 question is: Was it a form letter? 8 A. Yes. 9 Q. Okay. What caused the creation 10 of the form letter? 11 A. I believe some of the questions 12 that we had gotten regarding the media press on 13 Prozac and suicide. 14 Q. Did it have anything to do with 15 the number of requests from physicians which 16 Lilly received? 17 A. I don't know. 18 Q. Is there anyone who kept track 19 of the number of requests for information about 20 Prozac and overdose? 21 A. Yes. 22 Q. And who would keep such 23 information? 24 A. The medical information Page 83 1 division. 2 Q. Is there a person in the 3 medical information division that had the 4 responsibility of dealing with Prozac questions? 5 A. Yes. 6 Q. And who was that person? 7 A. I don't know. 8 Q. Now, you said that the form 9 letter was created because of the media 10 attention, okay. Was there media attention about 11 Prozac and overdose of Prozac? 12 A. Prozac and overdose? 13 Q. Of Prozac. 14 A. And overdose? 15 Q. Yes, my original question was 16 about the form letter which addressed the 17 concerns of physicians which they had regarding 18 Prozac and overdose of Prozac, okay? 19 A. Uh-huh. 20 Q. And you said that the letter 21 was created because of the media attention. And 22 I'm asking you what media attention existed about 23 Prozac and the overdose of Prozac? 24 A. I think there was a great deal Page 84 1 of media attention regarding Prozac and overdose. 2 Q. Overdose of Prozac? 3 A. Overdose. 4 Q. Oh, just overdose? 5 A. Just overdose. 6 Q. And that's -- this letter arose 7 out of the media attention of Prozac and 8 overdose? 9 A. Yes. 10 Q. What media attention, what 11 media articles, television programs, dealt with 12 Prozac and overdose? 13 A. I think it was fairly generic, 14 from my recollection, there was a great deal of 15 information or media attention on Prozac and 16 overdose. 17 Q. Do you mean the media attention 18 that came out of the Wesbecker case? 19 A. Yes. 20 Q. But the Wesbecker case was 21 about a man who took Prozac and then shot the 22 people he worked with, right? 23 A. Yes. 24 Q. I'm not sure how overdose fits Page 85 1 into that. 2 A. I think once they started 3 focusing on Prozac, they certainly focused on all 4 sorts of aspects, and overdose was one of those 5 aspects. 6 Q. So you had a letter which dealt 7 with Prozac and overdose. Did you have a letter 8 which dealt with the other aspects? 9 A. Such as? 10 Q. Well, you said that overdose 11 was just one aspect, what were the other aspects? 12 A. We did not have a letter on 13 people going in and shooting other people, no. 14 Q. You just had a letter on the 15 Prozac overdose? 16 A. Yes, there were questions. 17 Q. And that letter arose out of 18 media like the Wesbecker media? 19 A. Uh-huh. 20 MR. MYERS: Yes, you need to say yes. 21 A. Yes, yes. 22 Q. So the letter dealt with one 23 aspect of the Wesbecker media? 24 A. One aspect of media. Page 86 1 Q. What do you mean by that? 2 A. One aspect of the media 3 attention, I don't know that I want to 4 specifically say Wesbecker media. 5 Q. Okay. Now, was there an event 6 term suicide? 7 A. Suicide, yes, I think. 8 Q. Was that an event of -- was 9 that an event or was it a symptom of depression 10 when it was listed, how was it considered by 11 Lilly? 12 MR. MYERS: Let me object to the form. 13 I think the answer to the question was -- you 14 said was it an event term and she said yes, and 15 now are you asking her if it was something else? 16 Q. Now I'm asking was it also a 17 symptom of depression, suicide? 18 A. Are you asking me can it be a 19 symptom of depression? 20 Q. Yes. 21 A. Yes. 22 Q. In the course of your work with 23 Prozac, when you had an adverse report which 24 reported suicide, okay, was that suicide Page 87 1 considered a symptom of depression? 2 A. In terms of the event reporting 3 or in terms of the disease? 4 Q. In terms of the disease. 5 A. In terms of the disease, it can 6 be related to depression, yes. 7 Q. When is suicide not related to 8 depression? 9 A. I suppose if you have embezzled 10 something and you're about to be caught, you can 11 commit suicide and not certainly be depressed. 12 Q. Okay. 13 (PLAINTIFF'S EXHIBIT NO. 2 WAS 14 MARKED FOR IDENTIFICATION AND 15 RECEIVED IN EVIDENCE.) 16 Q. Dr. Street, have you had a 17 chance to review PLAINTIFFS' EXHIBIT Number 2? 18 A. Yes. 19 Q. And the first page of the 20 exhibit is Pz 884 221; is that correct? 21 A. Yes. 22 Q. Dr. Street, do you know whose 23 handwriting that is on this page? 24 A. It looks like mine. Page 88 1 Q. And does that say Dr. Zerbe? 2 A. Yes. 3 Q. The pages which follow, PZ 884 4 222 and PZ 884 223 -- 5 A. Uh-huh. 6 Q. -- were they next to PZ 884 7 221? 8 MR. MYERS: Are you asking are they or 9 were they? 10 Q. Were they, within your files. 11 A. I don't know what PZ 884 221, 12 that's not a filing system or numbering of mine. 13 Q. Okay. At least the first page 14 of this exhibit, with your handwriting and Dr. 15 Zerbe's name, does that indicate that at least 16 the first page went from you to Dr. Zerbe at some 17 point in time? 18 A. It may have, this does not ring 19 a particular bell. 20 Q. Would there be any other reason 21 that you would write Dr. Zerbe's name in the 22 middle of a blank page? 23 A. I don't know. 24 Q. Now when your lawyers gave us Page 89 1 this document, they gave us the next two 2 documents in order, 222 and 223. And my question 3 to you is: Based on your memory, were these 4 three documents attached to each other and given 5 from you to Dr. Zerbe at some point in time? 6 A. I don't know, I don't remember. 7 Q. Who has the original of these 8 pages? 9 A. I don't know. The originals 10 for the 1639 would be in the DEE. 11 Q. Okay. 12 A. The originals to the note to 13 file, the page with the handwriting that I can't 14 read, I don't know, and I assume Dr. Zerbe's 15 letter, he has. 16 Q. Regarding the note to file, do 17 you know who wrote that? 18 A. No, I don't remember. 19 Q. Now you are listed as one of 20 the conferees, are you not? 21 A. Yes. 22 Q. Do you recall who the other 23 conferees were? 24 A. Dr. Weinstein, Dr. Masica, Dr. Page 90 1 Heiligenstein, along with the medical examiner, 2 coroner, up from Louisville. 3 Q. I believe you testified that 4 the medical examiner sent you some information? 5 A. I believe he called asking for 6 information. 7 Q. If you read the second 8 paragraph, it says the coroner also very briefly 9 relayed some medical information regarding 10 belated past history to include his use of 11 multiple drugs, including other anti-depressants, 12 sedatives and Lithium, and the patient's refusal 13 of hospitalization as recommended by the 14 psychiatrist. 15 A. Approval? 16 MR. MYERS: It's in the first 17 paragraph. 18 Q. I'm sorry, it's the first 19 paragraph. So the coroner did relay some medical 20 information, do you recall that? 21 A. Not specifically, no. 22 Q. Do you recall having an 23 authorization to obtain that medical information? 24 A. Did I have the authorization? Page 91 1 Q. Did Eli Lilly have the 2 authorization? 3 A. I don't know. 4 Q. Apparently this was a phone 5 call, is that correct, because it says re 6 conference telephone call at the top, right? 7 A. Yes. 8 Q. Was this the first 9 communication Eli Lilly had with the medical 10 examiner? 11 A. No. 12 Q. Did Eli Lilly ever obtain from 13 the Wesbecker family an authorization to obtain 14 medical records prior to October 30, 1989? 15 A. I don't know. 16 Q. You don't know? 17 A. I don't know. 18 Q. Did people outside of Eli Lilly 19 review 1639 reports? 20 A. Did people outside of Lilly 21 review 1639 reports? 22 Q. Right. 23 A. The FDA. 24 Q. Prior to their submission to Page 92 1 the FDA, did people outside of Lilly review 1639 2 reports? 3 A. We might send a 1639 back to a 4 reporting physician for review, yes. 5 Q. Okay. In the Wesbecker case, 6 there was not a reporting physician, was there? 7 A. It would have been the coroner, 8 he was a health professional. 9 Q. Okay. And the second paragraph 10 from the bottom, where it says a copy of the 1639 11 report that would be sent to the FDA regarding 12 the multiple homicide, suicide, will also be sent 13 to, it's deleted, for his review of the data as 14 well as a request for any clarifications and 15 additional information that he has available. Is 16 that referring to the coroner? 17 A. Yes. 18 Q. And the next paragraph where 19 it's deleted, it says expressed his concern. Is 20 that also referring to the coroner? 21 A. I would assume so. Since the 22 name is blacked out, that would be my supposition 23 since this is a phone call to him. 24 Q. Now, PZ 884 223, which is the Page 93 1 third page of the exhibit, is that your 2 handwriting? 3 A. No. 4 Q. Can you read that? 5 A. No. 6 Q. Now, if we move to the next 7 page, PZ 884 259, and the pages which follow it, 8 260 and 261, I would like to ask you, Dr. Street, 9 do those three pages refer to the Wesbecker 10 situation? 11 A. I'm sorry, was that a question? 12 Q. Yes. 13 A. Yes, they do. 14 Q. Okay. Now, regarding page 259, 15 it is a letter from Dr. Zerbe, the executive 16 director, is it not? 17 A. Yes. 18 Q. And he is thanking somebody for 19 providing summaries and telling them that the 20 information has been sent to the FDA, follow-up 21 report is attached, right? 22 A. Yes. 23 Q. And then the last paragraph, he 24 says should you have any questions, please feel Page 94 1 free to contact me at three one seven two seven 2 six one four three eight or Dr. Jamie Street. 3 Were you the contact person handling the 4 Wesbecker matter within Lilly? 5 A. Not specifically, no. I may 6 have been a person since I had been in attendance 7 at the conference call, that Dr. Masica may have 8 suggested to Dr. Zerbe that I be listed. 9 Q. Okay. Were you listed on any 10 other occasion? 11 A. I don't know, I may well have 12 been. 13 Q. Do you recall ever being 14 contacted at that phone number regarding the 15 Wesbecker case? 16 A. From? 17 Q. From anyone. 18 A. From anybody? 19 Q. Uh-huh. 20 A. I don't distinctly remember 21 being contacted by the coroner in regards to it. 22 Q. Did anybody contact you at that 23 number as a result of the media that came out of 24 the Wesbecker case? Page 95 1 A. No. 2 Q. But that media did cause you to 3 create that form letter that we were discussing 4 earlier, right? 5 A. Yes. 6 Q. Now, on the next page, two 7 sixty, the drug experience report, did a Lilly 8 employee create the writing which is listed on 9 this form? 10 A. Did they put together the 11 report, is that what you're asking, create the 12 writing? 13 Q. Yes, did they input the 14 information that begins with patient entered as 15 former place of employment? 16 A. Yes. 17 Q. And you can see how that looks 18 like a different type face, it's computer type, I 19 believe. 20 A. Yes, I believe so. 21 Q. And my question is: Did a 22 Lilly employee create that? 23 A. Yes. 24 MR. MYERS: She said yes. Page 96 1 Q. Do you know who that Lilly 2 employee was? 3 A. No. 4 (PLAINTIFF'S EXHIBIT NO. 3 WAS 5 MARKED FOR IDENTIFICATION AND 6 RECEIVED IN EVIDENCE.) 7 Q. Dr. Street, have you a chance 8 to review PLAINTIFFS' EXHIBIT 3? 9 A. Yes. 10 Q. Do you recall before when I 11 asked you if you ever wrote a letter for Dista 12 Products Company? 13 A. Yes. 14 Q. Do you recall what you 15 testimony was to my original question? 16 A. I do. 17 Q. Do you want to change that 18 testimony now? 19 A. I did not remember writing it 20 on the Dista Product letterhead, and I still 21 don't remember writing it on the Dista Product 22 letterhead. 23 Q. Do you want to change your 24 testimony? Page 97 1 MR. MYERS: She's already answered the 2 question. 3 Q. Do you want to leave your 4 testimony at no, you never did it. 5 MR. MYERS: Greg, she's already 6 clarified what she earlier said, she said she 7 didn't recall, she doesn't recall now. Obviously 8 it's on the letterhead, ask her something else, I 9 don't care. 10 Q. Regarding this first paragraph 11 which you wrote, it says we are interested in 12 obtaining further information concerning the 13 death of, deleted, who died outside of, deleted, 14 hospital, and then some words are deleted, on a 15 Saturday in April or May, 1990. Do you know how 16 that person died? 17 A. I don't remember this case at 18 all, no. 19 Q. Do you recall getting the 20 information from the City of New York Department 21 of Health? 22 A. I don't remember the case, so I 23 don't remember if we got the information. 24 Q. If you read the second page of Page 98 1 the exhibit, perhaps that will refresh your 2 recollection as to why you did not receive the 3 information. Does that refresh your recollection 4 as to why you did not receive the information? 5 A. It certainly would be an 6 explanation for not receiving information. 7 Q. And what's the reason you did 8 not receive the information? 9 A. We did not have a signed 10 release from anyone other than a relative, it is -- 11 we did not have a signed release from a relative, 12 next of kin or heir of the decedent. 13 Q. Now that's the law in the State 14 of New York. Is that the law, as far as you 15 know, in the State of Kentucky? 16 MR. MYERS: Well, let me object to the 17 form of the question. You're asking the witness 18 to now depart from the sphere of medicine and 19 science into law and asking her what the law is 20 in the State of Kentucky, and I thus object to 21 the question. If you know what the law is, tell 22 him. If you don't know, tell him that. 23 A. I don't know the law. 24 Q. Did Lilly have a procedure for Page 99 1 obtaining medical records of people who were 2 listed -- or patients who were listed on adverse 3 event reports? 4 A. Do we have a procedure, we 5 usually request a review or requested additional 6 information from a health care professional that 7 could be the patient's treating physician, or in 8 this case, you know, we asked the medical 9 examiner if we could have that information. 10 Q. And that information was 11 usually medical records, wasn't it? 12 A. Or information. 13 Q. Did you get medical records, as 14 a practice, at Eli Lilly, without an 15 authorization for the release of those records? 16 A. Not as a practice, that I 17 recall. 18 Q. Did you ever try to get medical 19 records without an authorization? 20 A. Obviously, yes. 21 Q. Within your practice, when you 22 were in solo practice, did you ever give medical 23 records to somebody that requested them if they 24 did not have an authorization? Page 100 1 A. No. 2 Q. So why did you think that Lilly 3 could get the information without an 4 authorization, whereas you, as a doctor, would 5 not give out that information? 6 A. If they had information they 7 would share, we would be happy to take it and put 8 it in our reporting base and send it on to the 9 FDA. 10 Q. As a doctor, you're telling me 11 that a patient's medical record is something that 12 could be shared without an authorization. 13 A. If there is information that 14 the reporting person felt they could share, we 15 would be interested in having it without their 16 breaching any professional conduct. 17 Q. Correct me if I'm wrong, but 18 within the context of Exhibit 3, the New York 19 City Department of Health is not the reporting 20 person, is it? 21 A. No, probably would not be. 22 Q. So you're asking somebody who 23 was not the reporting person for medical records, 24 right? Page 101 1 A. Yes. 2 Q. Do you want to change your 3 answer? 4 A. To which question? 5 Q. I took you to say that you 6 would attempt to get medical records without an 7 authorization from the reporting person. 8 A. Yes. 9 Q. Okay. Now my question is: Was 10 there any other situation where you attempted to 11 get medical records without an authorization from 12 someone other than the reporting person? 13 MR. MYERS: Let me object to the form 14 of the question for this reason: She answered a 15 specific question and gave you specific answers. 16 You have now enlarged upon it to a person other 17 than a reporter, so I object on that basis. 18 Second, it's not a proper deposition question to 19 ask the witness do you want to change your 20 earlier answer to a question, and for that 21 reason, I object. 22 MR. GREEN: I just didn't want 23 inconsistencies to exist within the transcript. 24 MR. MYERS: The witness has responded Page 102 1 to your specific question. 2 MR. GREEN: I'm simply giving her an 3 opportunity to explain her -- 4 MR. MYERS: The witness has responded 5 to your specific question. 6 (PLAINTIFF'S EXHIBIT NO. 4 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Okay, Dr. Street, have you had 10 a chance to review PLAINTIFFS' EXHIBIT 4? 11 A. Yes. 12 Q. Now, at the top of the exhibit 13 I believe it says Jamie. And I would like to ask 14 you if you know whose handwriting that is? 15 A. I would -- it would only be a 16 guess. 17 MR. MYERS: Don't guess. 18 Q. Okay. If you look at the last 19 page, I believe it says Jamie, John H, F-Y-I, and 20 then there is an initial or it is initialed. Do 21 you know whose signature or initials that is? 22 A. Dr. Masica's. 23 Q. Who is Mr. L.C. Cimino? 24 A. I don't know. Page 103 1 Q. Do you know who Mr. J.P. 2 Northrup is? 3 A. Yes. 4 Q. Could you describe that or 5 explain who he is? 6 A. He was in an area that did 7 patient accountability. 8 Q. What do you mean by patient 9 accountability? 10 A. Patient exposures to a drug. 11 Q. What division did he work in? 12 A. I don't know. 13 Q. What was he trying to find out 14 or what information was he trying to obtain? 15 A. How many patients, 16 post-marketing, had been exposed to Prozac. 17 Q. Who was Mr. C. R. Perry, if you 18 know? 19 A. He was a marketing director. 20 Q. Was he a marketing director for 21 Prozac? 22 A. Yes. 23 Q. And what is his division? 24 A. I don't know. Page 104 1 Q. Okay. And who is Mr. 2 G. J. Clark? 3 A. A marketing division director 4 as well, marketing director, I'm not sure what 5 his title is. 6 Q. What about Dr. Thompson? 7 A. I'm not sure which Dr. Thompson 8 that is. 9 Q. Now, Dr. Dornseif was a 10 statistician, was he not? 11 A. Yes. 12 Q. And he was working with the 13 drug Prozac, was he not? 14 A. Yes. 15 Q. Was he studying adverse events 16 or was he studying different types of problems as 17 they were presented to him? 18 A. I don't know. 19 Q. Of course Dr. Masica was your 20 superior, was he not? 21 A. Yes. 22 Q. And Dr. Masica was in the 23 neuropharma -- neuropsychopharmacological 24 division, wasn't he? Page 105 1 A. Yes. 2 Q. And it appears, doesn't it, 3 that this letter is addressed to those both in 4 that division and in marketing; correct? 5 A. Yes. 6 Q. So did your division and 7 marketing have goals which they attempted to 8 achieve and which they attempted to establish as 9 being goals which were in common? 10 A. Goals in common? 11 Q. Yes. 12 A. Such as? 13 Q. Such as doing clinical trials 14 on the drug Prozac within a certain schedule so 15 that certain information could be gathered and 16 released by a certain date. 17 MR. MYERS: Your question is was that a 18 specific goal? 19 MR. GREEN: Yes. 20 A. I don't know if I can answer 21 that specifically, meaning all of the things that 22 you've mentioned. 23 Q. Well, I'm really trying to just 24 get a general idea as to why a letter or an Page 106 1 internal memo or this document from Gary L. -- 2 by the way, who is Gary L. Tauscher? 3 A. He's a marketing individual. 4 Q. When you say he's an 5 individual, do you know what his title is? 6 A. I don't know, no. 7 Q. I'm just wondering why a letter 8 would go from somebody in marketing to somebody 9 in the neuropsychopharmacological division and 10 somebody in the statistics division. 11 MR. MYERS: Let me object to the form 12 of the question insofar as the witness was not 13 the preparer of the document nor was she an 14 addressee on the document, and thus you're asking 15 her why the writer sent it to this group of 16 people who you've asked her some questions about, 17 you call upon her to speculate. 18 Q. Dr. Street, if you look on the 19 last page of the exhibit. Where that says your 20 name, does that indicate -- is that your name, 21 Jamie, does that mean Dr. Jamie Street? 22 A. Yes. 23 Q. And since your attorneys gave 24 us these four pages together, would that indicate Page 107 1 that in the course of your work, at some point in 2 time, this document came to you, did it not? 3 A. I'm not sure why the last page 4 would be connected with these pages because I 5 don't know why I. M. Brandt's name is on there or 6 E. A. West, that makes no real logic to me as it 7 goes through. It may have come to you, I can't 8 explain why it's there, logically I have no idea 9 because that doesn't seem to have any connection. 10 Q. It doesn't seem to have logic 11 or connection, does it? 12 A. Uh-uh. 13 Q. Do you know why it was 14 presented to the plaintiff's attorney in this 15 fashion if it has no logic or connection? 16 A. It may have gotten stuck on, I 17 have no idea. 18 Q. Do you recall ever receiving 19 this letter or memorandum, whatever it is? 20 A. I don't. 21 (PLAINTIFF'S EXHIBIT NO. 5 WAS 22 MARKED FOR IDENTIFICATION AND 23 RECEIVED IN EVIDENCE.) 24 Q. Dr. Street, I believe this is Page 108 1 five? 2 A. Yes. 3 Q. Have you had a chance to look 4 over PLAINTIFFS' EXHIBIT 5? 5 A. Yes. 6 Q. And can you tell me, Dr. 7 Street, exactly what is it we're looking at here? 8 A. I have not used this before, so 9 this would be a speculation, supposition, 10 commentary, on my part. 11 Q. Have you ever seen this before? 12 A. Not specifically, I've seen all 13 of this information in one form or another, but 14 to put it all down like this, I'm not sure. 15 Q. You know that when the 16 plaintiffs came to Eli Lilly to do the document 17 discovery, that this document was in a box which 18 was assigned to your name? 19 A. Uh-huh. 20 Q. And this PZ number 762 -- 21 A. Uh-huh. 22 Q. -- contained all documents that 23 were assigned to your name. 24 A. Okay. Page 109 1 Q. So can you tell me what a 2 document was doing in a box that was assigned to 3 your name that you've never seen, that you don't 4 recognize, that you know nothing about? 5 MR. MYERS: Well, before she answers, 6 Greg, let me make clear that this witness is not 7 here to testify about the form or manner of any 8 document production. If your question is was 9 this document a document that came from your 10 files, certainly she can testify yes, no, or she 11 doesn't recall or whatever the answer is. She's 12 not going to testify about the form or manner of 13 any document production, but she can certainly 14 testify whether she recognizes it or whether it 15 came from her file, if that is the question. 16 MS. ZETTLER: She can also testify as 17 to whether or not records were placed in the file 18 which were not there prior to. 19 MR. MYERS: She's not going to testify 20 about the document production. 21 MS. ZETTLER: She certainly can if she 22 has information and knowledge about what 23 documents were in the files and which were not. 24 MR. MYERS: Well that's a different Page 110 1 question. What is the question? 2 MR. GREEN: Let's ask Nancy's question. 3 Q. Was this document in your file 4 at the time you stopped working with Prozac? 5 A. It may have been. 6 Q. Okay. What is this document, 7 if you know? 8 A. It -- the DEU ask file requires 9 that sales representives report adverse events, 10 and this is an outline of how to do that. 11 Q. Okay. Now when the salesmen 12 called, would you take the calls from the 13 salesmen, you personally? 14 A. No. 15 Q. Who would take the calls from 16 the salesmen, would that be somebody in the DEU? 17 A. Yes. 18 Q. Okay. Do you happen to know 19 any of the salesmen? 20 A. No. 21 Q. Now, my question is: Why would 22 this have been in your file? 23 A. It may have been sent saying 24 this is what we have distributed, this is what Page 111 1 we're requesting, this is the form that we've 2 given to the sales representatives to follow. 3 Q. Do you know what a VMX number 4 is with regard to a sales representative? 5 A. Yes, voice mail exchange. 6 Q. Okay. And do you know what the 7 territory number for the State of New York is? 8 A. I haven't the vaguest idea. 9 Q. Do you know what the territory 10 number for the State of Texas is? 11 A. No. 12 Q. Do you know -- who would know 13 what the territory number is for those two 14 states? 15 A. I have no idea. 16 Q. Do you know who would know what 17 detail men were assigned to those geographical 18 areas? 19 A. I have no idea. 20 Q. Would Mr. Perry know that? 21 A. I don't know. 22 Q. Would Mr. Clark know that? 23 A. I don't know. 24 Q. Would anybody at Eli Lilly know Page 112 1 that? 2 A. I hope so, but I don't know who 3 specifically that is. That is not in the medical 4 division, so I don't know who keeps track -- tabs 5 on that. 6 Q. You see on the bottom of this, 7 it looks like a card, so I'll call it a card, if 8 that's okay. 9 A. A card? 10 MR. MYERS: This left-hand panel. 11 A. Oh, the panel. 12 Q. I'll withdraw that question. 13 MR. MYERS: Can we break now? 14 MR. GREEN: Let me do this one last 15 one. 16 (PLAINTIFF'S EXHIBIT NO. 6 WAS 17 MARKED FOR IDENTIFICATION AND 18 RECEIVED IN EVIDENCE.) 19 Q. Dr. Street, have you had a 20 chance to review PLAINTIFFS' EXHIBIT 6? 21 A. Yes. 22 Q. And that's number Pz 763 dash 23 39? 24 A. Yes. Page 113 1 Q. Dr. Street, who is Charles 2 Matsumoto? 3 A. Charles Matsumoto was the 4 secretary of the clinical research protocol 5 committee. 6 Q. And who was on that protocol 7 committee? 8 A. Medical directors and 9 regulatory executive directors, vice-president, 10 it varied from time to time. 11 Q. Do you know the names of 12 anybody who was on that committee since the point 13 in time you were hired by Eli Lilly? 14 A. Well, it varies from time to 15 time. 16 Q. I understand that. 17 A. Like I said, the medical 18 directors for any division -- 19 Q. Do you know the names? 20 A. Yes. 21 Q. Could I please have the names? 22 A. If I can remember. Dr. Masica 23 may have been, would have been, Dr. Draper, Dr. 24 Zerbe, Dr. Weinstein. Do you want a specific Page 114 1 time period, do you want this time period? 2 Q. No, I just want names of 3 anybody who may have served on that committee 4 since you were hired. 5 A. My present director, Dr. Dies. 6 MS. ZETTLER: What was that name? 7 THE WITNESS: Dies, D-I-E-S. 8 MS. ZETTLER: Do you know the first 9 name? 10 THE WITNESS: Frederico. 11 A. Dr. Gary Tolivson, Dr. Anders, 12 and I don't remember Dr. Anders' first name, Dr. 13 Keohane, Patrick Keohane. 14 MS. ZETTLER: How do you spell that? 15 THE WITNESS: K-E-O-H-A-N-E. 16 A. Dr. Fransin, Tim Fransin. 17 That's all that comes to mind right now. 18 Q. Now, this appears to be an 19 internal memo; is that correct? 20 A. Yes. 21 Q. Is it an E-mail? 22 A. I call it a messenger message, 23 yes. 24 Q. It showed up on your computer, Page 115 1 though? 2 A. Yes. 3 Q. Is the messenger message 4 different than E-mail? 5 A. I don't know, I'm not sure what 6 E-mail is, I assume that's electronic mail, I 7 assume they're the same thing. I'm making the 8 assumption we're talking about the same thing, 9 but I don't know. 10 Q. It says at the top Fluoxetine 11 in post-stroke depression patients. Is that 12 referring to the protocol which you worked on? 13 A. Yes. 14 Q. And we have that term again at 15 the end of that paragraph, the Lilly protocol. 16 What does that mean, the Lilly protocol? 17 A. Protocol that is specifically 18 the one being conducted and funded by Lilly in 19 this area. 20 Q. Where it says therefore, 21 deleted, requested an abbreviated version of the 22 Lilly protocol. Do you know who that person is 23 whose name was deleted? 24 A. No. Page 116 1 Q. Do you know whether they were a 2 Lilly employee? 3 A. I don't know. 4 Q. Now in the last paragraph, they 5 referred to you as the physician monitor, Jamie 6 Street. Now I thought you told me that the only 7 titles you had was clinical research physician 8 and associate clinical research physician? 9 A. That's true. 10 Q. Is this title, then, incorrect? 11 A. That is not a title. 12 Q. What is that? 13 A. I am the monitor for that 14 study, so it is not specifically an official 15 title at all. I have only had two titles. I am 16 the monitor for that study or was the monitor for 17 that study, that's not an official title. 18 Q. Were you the monitor for any 19 other Prozac studies? 20 A. No. 21 Q. How would you classify the 22 physician monitor, if it's not a title, is it 23 some kind of a designation as to your duties or 24 what exactly is it? Page 117 1 A. I guess a designation of 2 duties. 3 Q. What are all the designation of 4 duties that you've had at Eli Lilly since you 5 were hired until the present time? 6 A. Designation of duties. 7 MR. MYERS: Let me object to the form 8 of the question. She told you near the beginning 9 of the deposition what her general duties and 10 responsibilities had been since she had been with 11 the company, she's already answered that. 12 MR. GREEN: That's right, she did 13 answer that, but she left out physician monitor. 14 MR. MYERS: She told you she had 15 followed a study, she didn't say she was a 16 physician monitor, but she told you about the 17 study and you've talked about it two or three 18 times. 19 MR. GREEN: I just want to make sure 20 that we haven't left anything out. 21 A. I guess in your questions you 22 asked about titles, official titles. This is not 23 an official title, it's a part of the -- it's a 24 part of the position. Page 118 1 Q. Now, Gary Tolivson, is he a 2 doctor? 3 A. Yes. 4 Q. And when was he hired by Lilly, 5 if you know? 6 A. I don't remember exactly. 7 Q. Was it before you or after you? 8 A. After. 9 Q. Do you know how long after? 10 A. Two to three years, I don't 11 remember distinctly. 12 Q. And when he was hired, what was 13 his job title? 14 A. I believe executive director. 15 Q. Do you know where he came from? 16 A. Minnesota. 17 Q. What was his job in Minnesota? 18 A. I don't know. 19 Q. Do you know how Eli Lilly found 20 out about him? 21 A. I believe that he had done some 22 studies for Eli Lilly. 23 Q. So he was associated with Eli 24 Lilly before he was hired? Page 119 1 MR. MYERS: Let me object to the form. 2 What does associated mean? That's awfully vague 3 and open-ended. 4 Q. That means you worked with 5 Lilly, maybe had a -- okay, let me ask you this: 6 When you say he did some studies, what kind of 7 studies did he do with Lilly? 8 A. I believe he had done some 9 Prozac studies. 10 Q. Do you know what studies he 11 did? 12 A. No. 13 Q. Do you know what exactly he was 14 studying? 15 A. No. 16 MR. GREEN: Okay, I think that's all I 17 have for her. 18 MR. MYERS: Do you want to break until 19 quarter after 1:00, that's thirty-four minutes. 20 MR. GREEN: Sure. 21 (A SHORT RECESS WAS TAKEN.) 22 Q. Good afternoon, Dr. Street. 23 Dr. Street, based on your experience as a 24 physician, are you aware that the illness of Page 120 1 depression has certain symptoms? 2 A. Yes. 3 Q. And do you recall what any of 4 those symptoms are? 5 A. They can be manifested in a 6 number of different ways depending upon the 7 patient. They can be sleep disturbances, eating 8 disturbances, motor disturbances, i.e. changes in 9 activity and repetitively of all that, obviously 10 affective disturbances with it. So it 11 encompasses a number of physiological and 12 psychological parameters. 13 Q. Would a symptom of depression 14 such as those you just listed ever be listed by a 15 term from COSTART as an adverse event? 16 A. From COSTART? 17 Q. Yes. 18 A. I don't know that I could say 19 for COSTART specifically. 20 Q. Okay. Let me ask this 21 question: Would a symptom of depression ever be 22 categorized as an adverse event? 23 A. If it's a change from a base 24 line. Page 121 1 Q. Does suicide have a base line? 2 A. Does suicide have a base line? 3 Suicide would -- suicide would probably get 4 listed as an adverse event, period. 5 Q. Do you know that for a fact? 6 A. I can't say it as a blanket 7 fact for everyone, no. 8 Q. Do you mean as a blanket fact 9 for everyone did you say? 10 A. For anyone reviewing or doing 11 adverse events. 12 Q. So -- 13 A. Because I'm not quite sure what 14 your thinking is as to making blanket statements. 15 Q. I didn't mean to make a blanket 16 statement, all I'm asking is -- I think all I 17 asked was is suicide ever listed as an adverse 18 event? 19 A. No, I don't think you asked 20 that. 21 Q. Okay, so -- 22 MR. MYERS: I think that was the 23 answer, actually. 24 A. That was my answer, that wasn't Page 122 1 your question. 2 MR. GREEN: Why don't we read back the 3 testimony. 4 (THE COURT REPORTER READ BACK THE 5 REQUESTED TESTIMONY.). 6 Q. I'll rephrase my question. Do 7 you know that for a fact that suicide is listed 8 as an adverse event or if you answered that yes, 9 no, maybe, whatever, would that be a blanket 10 statement? 11 A. Suicide is listed, can be 12 listed, and has been listed as an adverse event. 13 Q. Are there ever times when 14 suicide is the result of an adverse event and not 15 the adverse event itself? 16 A. Off the top of my head, I can't 17 think of anything unless there is something 18 specific that you have in mind. 19 Q. Is suicide a symptom of 20 depression? 21 A. Many patients who are depressed 22 will attempt suicide and actually complete it. 23 Q. And I think I asked you before 24 is there ever a time when suicide is completed Page 123 1 where the patient is not depressed, and you gave 2 me an example. 3 A. Uh-huh. 4 Q. So my question is: If suicide 5 is listed as an adverse event, isn't that in 6 effect listing a symptom of depression as an 7 adverse event? 8 A. I'm sorry, you'll have to 9 repeat that again. 10 Q. If suicide is listed as an 11 adverse event, isn't that in effect listing a 12 symptom of depression as an adverse event? 13 A. Are you asking if a patient 14 commits suicide I am to imply he's depressed? 15 Q. No. I'm asking you if suicide 16 is listed as an adverse event, isn't that in 17 effect listing a symptom of depression as an 18 adverse event? 19 A. It may be a new symptom, at 20 which point it would be a change from the base 21 line and it would be listed as an adverse event. 22 Suicide events -- suicide as an event has been 23 recorded as an adverse event and is part of the 24 process as long as I've been with Lilly. Page 124 1 Q. And when it's listed as an 2 adverse event, it's only coincidentally listing a 3 symptom of depression when suicide is a change 4 from the base line; is that correct? 5 MR. MYERS: Let me object to the form 6 and the use of terminology only conincidentally 7 as being vague and not a specific medical term. 8 Q. When suicide is listed as an 9 adverse event, it is in effect listing a symptom 10 of depression only when there is a change in the 11 base line, only when a suicide is a change in the 12 base line; is that correct? 13 MR. MYERS: Same objection, you 14 mischaracterized her earlier testimony about 15 changing base line and suicide. 16 Q. I'm not characterizing your 17 testimony, I'm just asking you if -- 18 A. I find this a very confusing 19 question. I'm not really sure if I have a clear 20 understanding of exactly what it is and how to 21 truthfully answer this in somewhat of a blanket 22 way. 23 MR. MYERS: Let me caution you, Dr. 24 Street, to give Mr. Green an answer to his Page 125 1 question, but only at such time as you understand 2 it. 3 A. I'm sorry, I'm really vague 4 right here, I don't know. 5 Q. It is confusing and I 6 understand that, but sometimes I'm wondering 7 where the confusion came from. Perhaps, you 8 know, if people had just called suicide either an 9 adverse event or a symptom of depression, 10 consistently throughout, I wouldn't even be 11 asking you this question. But it has been called 12 both things and, so, I'm asking you basically, 13 and rephrasing my question, how did Eli Lilly 14 view suicide while a clinical investigation 15 patient was on the drug, did they view that 16 suicide as a symptom of depression or did they 17 view that suicide as an adverse event? 18 A. I don't know how the 19 investigator viewed it, I didn't have any -- I 20 don't know what the instructions were 21 specifically with a particular clinical trial. 22 Q. As a clinical research 23 physician, how did you view it? 24 A. Since there were only five Page 126 1 patients ever enrolled in the trial and the trial 2 was never completed, it was not an issue for my 3 trial. 4 Q. But you reviewed adverse event 5 reports from trials beyond the one you worked on 6 in your role as a clinical research physician, 7 did you not? 8 A. The majority of adverse events 9 I reviewed were spontaneous reports. 10 Q. When you reviewed those 11 spontaneous reports, if there was a suicide 12 included in those spontaneous reports, did you 13 view the suicide as a symptom of the depression 14 or did you view it as an adverse event? 15 A. It was listed as an adverse 16 event, by definition, by process. 17 Q. By you, everytime you saw the 18 word? 19 A. Yes, I believe so. 20 Q. Do you know for a fact? 21 A. Oh, no, I can't say that I know 22 for a fact that I do that every time, no. 23 Q. If you don't know something for 24 a fact, you should say so on the record. Page 127 1 MR. MYERS: Greg, I appreciate your 2 helping the witness, she gave an answer and said 3 she believed so and qualified it, so let's just 4 ask another question. 5 (PLAINTIFF'S EXHIBIT NO. 7 WAS 6 MARKED FOR IDENTIFICATION AND 7 RECEIVED IN EVIDENCE.) 8 Q. Okay, Doctor, do you remember 9 earlier we were talking about the term life 10 threatening? 11 A. Uh-huh, yes. 12 Q. When you read the first page of 13 Plaintiffs' Exhibit 7, that's Pz 762 page 264, 14 and it says -- and by the way, this is an 15 internal computer message addressed to you, is 16 that correct -- or CC to you, I'm sorry? 17 A. I'm on the addressee list. 18 Q. Okay. And it's from Mr. Jeff 19 Powell, the drug epidemiology unit, right? 20 A. Yes. 21 Q. And it says please clarify the 22 classification of life threatening on this 23 report, we reserve the use of life threatening 24 for situations in which the patient is in Page 128 1 immediate, not potential risk of dying. Now, 2 does that at all change your understanding of 3 what life threatening means in the context of 4 your employment with Eli Lilly and your role as a 5 clinical research physician? 6 MR. MYERS: Before she answers, let me 7 object to the form to the extent that it 8 mischaracterizes her earlier testimony and also 9 asks the witness to comment upon the intent of 10 the writer of this memo, which she is not. 11 Q. Was the content of this memo a 12 Lilly policy? 13 A. Was the content of this memo a 14 Lilly policy? It may have been. 15 Q. You don't know for sure? 16 A. I'm not sure if the definition 17 was derived from a more specific reference, it 18 certainly may have been. 19 Q. Okay and on the second page, in 20 the first paragraph, it stated, the third 21 sentence, Dr. Street said that if the patient 22 dies, then the death outcome is circled yes, but 23 the life threatening outcome is not circled yes, 24 since the patient died. Is that a Lilly policy? Page 129 1 MR. MYERS: Let me only object to the 2 form to the extent that you've read one sentence 3 of a five-paragraph memorandum that may well have 4 taken the statement out of context, but if she 5 can answer it and if you need to look at the 6 entire memo, please do so, Doctor. 7 A. By policy, oftentimes that 8 implies something that is defined in a written 9 manner in an official policy book, is that what 10 you're asking, is this a policy book? 11 Q. No, I'm asking -- I probably 12 should have used the word practice. Is it the 13 practice of Eli Lilly that when death is the 14 outcome, life threatening does not get a Y for 15 yes because the patient died? 16 A. I think so. 17 Q. Okay. So in other words, if 18 the patient dies it's not life threatening, 19 right? 20 A. They're dead and it can't be 21 life threatening anymore. 22 Q. So say for instance you were 23 doing some research on a drug and you wanted to 24 try to find out if there was an incidence of life Page 130 1 threatening adverse events as a result of taking 2 that drug, that research would omit the incidence 3 of death, wouldn't it? 4 A. You probably would look at 5 death because it is by far the more serious 6 outcome of the two, you would probably include 7 both life threatening and death. 8 Q. But in the hypothetical I gave 9 you, it would not include death, would it? 10 MR. MYERS: Before she answers, let me 11 object insofar as the hypothetical is concerned, 12 it gives her insufficient facts upon which to 13 form an opinion, and also mischaracterizes her 14 earlier testimony about what was and was not life 15 threatening and the fact that you're dealing with 16 regulatory definitions of terms. 17 MR. GREEN: Could you read two 18 questions back, please? 19 (THE COURT REPORTER READ BACK THE 20 REQUESTED TESTIMONY.). 21 Q. That's the question, your 22 attorney has objected to the form. 23 MR. MYERS: But you can answer. 24 A. In the hypothetical, I would Page 131 1 still look at both, because life threatening is 2 one and death is by far the most serious outcome 3 of a life threatening event. So in a 4 hypothetical, you're asking me what I would do, I 5 would look at both. 6 Q. I'm not asking you what you 7 would do. 8 A. I thought that was the 9 question. 10 Q. No. I'm asking you if a study 11 was done that was looking at the incidence of 12 life threatening -- 13 A. You would still -- 14 Q. -- and life threatening only -- 15 MR. MYERS: Let him finish. 16 Q. -- that would not include 17 incidence of death, would it? 18 MR. MYERS: Same objection, go ahead. 19 A. Same answer, sir. If you're 20 going to look at life threatening, you would look 21 at life threatening and you would look at the 22 more serious outcome. Life threatening and death 23 are both listed as serious outcomes by the FDA. 24 If you're going to look at life threatening, you Page 132 1 also would look at the more serious outcome of 2 death as a more inclusive and conservative look 3 than just looking at life threatening only. 4 MR. GREEN: Okay. I'm going to certify 5 that question because I don't believe that was an 6 answer to my question. 7 (QUESTION CERTIFIED.) 8 MR. MYERS: You can do whatever you 9 want. 10 MR. GREEN: I don't want to push the 11 matter further at this time. 12 (PLAINTIFF'S EXHIBIT NO. 8 WAS 13 MARKED FOR IDENTIFICATION AND 14 RECEIVED IN EVIDENCE.) 15 A. Do you have the rest of the 16 bibliography for this? 17 Q. No, I don't, Doctor, that was 18 not provided to plaintiffs. 19 A. Okay. 20 Q. Doctor, is this the letter we 21 were discussing earlier which was -- 22 A. I'm sorry, I'm not through with 23 it, may I finish it all? 24 Q. Yes. Page 133 1 A. Okay. 2 Q. Doctor, as you noted while you 3 were reading this exhibit, a portion of the 4 bibliography is not annexed to the exhibit; is 5 that correct? 6 A. Yes. 7 Q. Was anything on that 8 bibliography, as far as you know, confidential? 9 MR. MYERS: Let me object to the form 10 to the extent that the word confidential in the 11 context of this litigation is far outside of this 12 witness's area of expertise, and probably most of 13 the lawyers. 14 MS. ZETTLER: Depending on your 15 definition, I think. 16 Q. Would that bibliography contain 17 any information which would be considered a trade 18 secret to Eli Lilly? 19 MR. MYERS: Same objection. Tell them 20 if you know. 21 A. I don't think so. 22 Q. Would it contain any 23 information that is not otherwise pretty much 24 covered by the three pages of what's Exhibit 8? Page 134 1 A. I would assume it would cover 2 what was in the body. 3 Q. Now, Doctor, is Exhibit 8 a 4 letter we were discussing earlier today, which is 5 the form letter which was created to respond to 6 physicians who have contacted Lilly who were 7 concerned about overdose and Prozac? 8 A. It's a medical information 9 letter, yes. 10 Q. And is it the letter we were 11 discussing earlier today? 12 A. I believe it is. 13 Q. Now, I'm going to read from the -- 14 first of all, before we start, you'll notice that 15 each of the paragraphs is numbered, is that 16 right? 17 A. Yes. 18 Q. Do you know -- is that your 19 handwriting? 20 A. No. 21 Q. From the paragraph that's 22 numbered two, the third sentence states: During 23 Prozac worldwide pre-marketing clinical trials of 24 about five thousand six hundred patients, Page 135 1 approximately thirty-eight patients took 2 overdoses of Prozac. Of these, two patients died 3 who took overdoses of multiple medications, 4 including Prozac. Is that right, did I read that 5 right? 6 A. You read that correctly. 7 Q. Okay. Now the first half of 8 that sentence, which states during Prozac 9 worldwide pre-marketing clinical trials of about 10 five thousand six hundred patients, approximately 11 thirty-eight patients took overdoses of Prozac, 12 okay. Just talking about that one phrase, does 13 that number, thirty-eight patients took overdoses 14 of Prozac, include patients who took overdoses of 15 other drugs? 16 A. I don't know, I didn't write 17 this letter. There may be in there, I don't 18 know. 19 Q. Okay. Are you familiar with 20 any of the information that's contained in this 21 letter? 22 A. Am I familiar? 23 MR. MYERS: If you need time to 24 rereview the letter, please do so so you can give Page 136 1 him an accurate answer. 2 A. I'm familiar with information 3 on paragraph four, nine, ten and eleven, to a 4 certain extent, and twelve. Those are all 5 paragraphs that have statements to that effect 6 and reports similar information in the Prozac 7 package insert. 8 Q. Okay. 9 A. Other paragraphs do not 10 necessarily ring a bell with me nor do they 11 specifically -- 12 Q. Including paragraphs one, two 13 and three? 14 A. A major concern among health 15 care -- the sentence on major concern among 16 health care professionals who treat their 17 impressions with potential for depressed patients 18 to commit suicide, that is familiar. Compounding 19 this potential is a fact that ingesting small 20 quantities of tricyclics anti-depressants, et 21 cetera, that would be familiar. During Prozac 22 worldwide pre-marketing, I would take that at 23 face value as being accurate, I could not verify 24 that at the present time, and with the previous Page 137 1 information that I can remember, two patients 2 died who took overdoses, I can't verify that, in 3 recollection. All patients who took only Prozac -- 4 so paragraph two, I will take as being accurate 5 based upon the clinical trial data base. 6 Symptoms of overdose, there are parts of that or 7 I know paraphrased in the package insert. 8 Q. Let's look at paragraph four. 9 I'll read the first sentence from paragraph four 10 for the court reporter. Quote, since the 11 introduction of Prozac in the United States, we 12 estimate that more than one million patients have 13 been treated with Prozac. A single death 14 attributed to overdose of Prozac alone has been 15 reported. Are you familiar with those two 16 sentences? 17 A. Yes -- well, I'm not sure if -- 18 I'm sure that at one time there had been at least 19 one million patients who had been treated with 20 Prozac. 21 Q. Where it says a single death 22 attributed to overdose of Prozac alone has been 23 reported, was that overdose a suicide? 24 A. I don't remember. Page 138 1 Q. And there's no way to tell from 2 the language here; is that correct? 3 A. No. 4 Q. And there's also no way to tell 5 whether or not there were any people who 6 attempted suicide by overdose, is there? 7 MR. MYERS: Let me object to the form 8 of the question. If your question refers to the 9 letter, the letter speaks for itself. Are you 10 asking her about what the letter says or are you 11 asking her about other sources of information? 12 MR. GREEN: I'm asking her about what 13 the letter says. 14 Q. There's no information in the 15 letter, is there, to determine whether attempted 16 suicide was performed through overdose, there's 17 no way to tell that, is there? 18 MR. MYERS: Let me object to the form 19 of the question, again, for the same reason, the 20 letter speaks for itself, and on the very next 21 page addresses that subject, and you can read it 22 as well as she can. 23 MS. ZETTLER: I object to your 24 continually coaching this witness by your Page 139 1 objections. This woman has a bachelor's degree 2 and she's obviously an intelligent person and I'm 3 sure if that's the way she feels about this 4 letter, she can answer for herself. 5 MR. MYERS: And we're all aware, Nancy, 6 and we can all read and, you know, if it wasn't a 7 document, maybe your objection would have some 8 merit, but everybody here can read the letter and 9 read what it says about suicide and overdose. 10 MS. ZETTLER: Then certainly Dr. Street 11 can answer without your coaching. 12 MR. MYERS: What is the question, Mr. 13 Green? 14 Q. My question is: Does this 15 letter -- you have read this letter, haven't you? 16 A. Yes. 17 Q. And you just sat here and read 18 it and we've had no problem with you taking your 19 time to read the letter, is that right? 20 A. And I appreciate that. 21 Q. And my question is: Is there 22 information in the letter about people who 23 attempted suicide by overdose of Prozac? 24 MR. MYERS: Same objection, but go Page 140 1 ahead. 2 A. The intent of this letter, as 3 it is written, discusses outcome of overdose 4 patients. It is not a discussion of suicide or 5 suicide attempts, either by overdose or other 6 means. 7 (PLAINTIFF'S EXHIBIT NO. 9 WAS 8 MARKED FOR IDENTIFICATION AND 9 RECEIVED IN EVIDENCE.) 10 Q. Doctor, have you had a chance 11 to review PLAINTIFFS' EXHIBIT 9? 12 A. Yes. 13 Q. And in the top right-hand 14 corner it says Jamie dash FYI. Does that refer 15 to you? 16 A. Yes. 17 Q. And FYI is for your 18 information? 19 A. Yes. 20 Q. And whose signature is that? 21 A. I would read that to be Al 22 Weber. 23 Q. Okay. Is it Mr. Weber or 24 doctor? Page 141 1 A. Doctor Weber. 2 Q. Is Doctor Weber in the 3 regulatory affairs division? 4 A. He is. 5 Q. Did you interact with Doctor 6 Weber on a regular basis, professionally? 7 A. Yes. 8 Q. Now, I believe this is a letter 9 from Doctor Talbott regarding the label which 10 would be applied to the Prozac product; is that 11 correct? 12 A. Yes. 13 Q. And if you look on the second 14 page of the exhibit, underneath the heading 15 overdose section, we see that sentence again. 16 Since introduction, a single death attributed to 17 overdose of Fluoxetine has been reported. Now, 18 was that overdose a suicide? 19 A. I don't know. 20 Q. Is there any way to tell from 21 the language? 22 A. Not from the language. 23 Q. Is there any way to tell 24 whether or not that overdose was a suicide on the Page 142 1 language in any other part of the label? 2 MR. MYERS: The label or the letter? 3 MR. GREEN: No, no, the label that was 4 applied, which was -- I mean the complete label. 5 Q. This letter only addresses 6 certain portions of the label, are you familiar 7 with the entire label? 8 A. Not in complete recollection, 9 no. 10 Q. Do you recollect if there is 11 any other language on the complete label which 12 would indicate whether this overdose was a 13 suicide or not? 14 A. I don't remember, I don't know. 15 (PLAINTIFF'S EXHIBIT NO. 10 WAS 16 MARKED FOR IDENTIFICATION AND 17 RECEIVED IN EVIDENCE.) 18 Q. Dr. Street, have you had a 19 chance to review PLAINTIFFS' EXHIBIT 10? 20 A. Yes. 21 Q. And would you agree, Dr. 22 Street, that PLAINTIFFS' EXHIBIT 10 is a series 23 of computer messages printed in hard copy? 24 A. Yes. Page 143 1 Q. And the first page is dated 2 April 13, 1990, isn't it? 3 A. Yes. 4 Q. And I'm not sure I can say this 5 name correctly, but who is Leredde Frederique? 6 A. I don't know. 7 Q. Do you know who Donna Pearson 8 is? 9 A. Yes. 10 Q. What role did Miss Pearson have 11 in the reporting of adverse effects to the DEN 12 system? 13 MR. MYERS: Let me object to the form 14 to the extent you have used the word effects, you 15 probably meant to say event. 16 MR. GREEN: I'm sorry, I did mean to 17 say event. 18 A. Miss Pearson is a CRA, clinical 19 research associate, in the drug epidemiology 20 unit, and would have received reports, adverse 21 events reports, and would have taken those 22 reports, written them in a 1639 format. 23 Q. Was she working exclusively 24 with Prozac in and around the time of April of Page 144 1 1990? 2 A. I don't know. 3 Q. Were there other clinical 4 research associates in the DEU who had the same 5 responsibility that Miss Pearson had with regard 6 to Prozac? 7 A. Yes. 8 Q. And what were their names? 9 A. Jeff Powell and Leslie Chiplis, 10 who is on one of these messages. Those would 11 have been the major people I can think of that 12 might have been dealing with it. 13 Q. This first page refers to a 14 term lack of drug effect. 15 A. Yes. 16 Q. What does that mean? 17 A. It did not give the effect that 18 it was prescribed for in that particular patient 19 at that dose or -- 20 Q. Okay. Now, the adverse event 21 here is a tremor, is it not? 22 A. That's listed as the event 23 term. 24 Q. Was Prozac ever prescribed to Page 145 1 treat tremors? 2 A. Was it ever prescribed, it's 3 not indicated for such, no. 4 Q. Then what's the relationship of 5 lack of drug effect to the adverse event of 6 tremor? 7 A. I think you need the entire 8 report to make the assumptions as to what is the 9 association between lack of drug effect and 10 tremor. There may not be a specific, I think 11 there's a great deal of information missing here. 12 Q. I think I need the entire 13 report as well, and I also think there's a lot of 14 information missing here. 15 MR. MYERS: Before we go on, Mr. Green, 16 you've taken about half a dozen cheap shots at 17 this witness and I've let it go on. Now ask 18 questions, but don't make those kinds of 19 statements, just ask the questions and get some 20 answers and move on, we don't need a lot of cheap 21 shots at the witness. 22 MR. GREEN: What's a cheap shot, 23 agreeing with the witness about -- I don't need 24 you to say it was a cheap shot. Like yesterday, Page 146 1 when you said I was arguing with the witness and 2 I was sitting here speaking softly with the 3 witness and you characterized it as an argument 4 on the record, so that when somebody reads it 5 they think I'm sitting here arguing with the 6 witness. That's a cheap shot. It was not a 7 cheap shot to agree with this witness. 8 MS. GOLDMAN: At the moment, your voice 9 is the only one that's raised. Shall we 10 continue? 11 MR. GREEN: I have to fight two lawyers 12 now. What's going on here, who is representing 13 the witness, you or Ms. Goldman, who is 14 representing the witness, do you want to take his 15 chair and represent the witness? 16 MR. MYERS: Ask a question. 17 Q. On the second page -- by the 18 way, I was just agreeing with you despite what 19 your attorney says. 20 A. Okay, fine. 21 Q. There is a sentence there that 22 begins in the first paragraph, it seems that the 23 pharmacist contacted CSM for all events and 24 assumed causality. Do you know what CSM stands Page 147 1 for? 2 A. That is a UK regulatory 3 division, and no, I don't know what it stands for 4 right off the top of my head. 5 Q. Is it like the FDA, is that 6 what you mean by regulatory division? 7 A. It's a regulatory division, 8 that's about as specific as I can get for you 9 without kind of guessing, it's a regulatory area. 10 Q. And it's a government 11 regulatory -- 12 A. It is a government agency. 13 Q. Okay. On the third page, and 14 that's Pz 983 634, this says re, event term, 15 suicide attempt, paren overdose, and it says 16 please change event term suicide attempt to 17 overdose. Now, if the event term was suicide or 18 suicide attempt, a suicide attempt is an 19 intentional act, is it not? 20 A. Yes. 21 Q. And an overdose is not 22 necessarily an intentional act, is it? 23 A. It may not be. 24 Q. So when the term changed from Page 148 1 suicide attempt to overdose, is that removing the 2 intent from the term? 3 A. I don't think that one can make 4 that general assumption. Overdose is a very 5 large term and is a more conservative and more 6 inclusive term with it. The number of accidental 7 overdoses is probably much smaller than 8 intentional overdoses, so I think when one sees 9 overdose, especially from a lay, and even from a 10 professional standpoint, overdose implies a 11 certain intent there. 12 Q. But the COSTART or ELECT term 13 overdose includes accidental overdose, doesn't 14 it? 15 A. I don't know if there's a 16 specific term accidental overdose or not off the 17 top of my head. 18 Q. Now, on the next page, and this 19 particular page is dated January 27th, 1990, the 20 event term was again changed from suicide attempt 21 to overdose, was it not? 22 A. Yes. 23 MS. ZETTLER: I'm sorry, did you say 24 January or June? Page 149 1 MR. GREEN: June 27th. 2 Q. And on the next page, it's also 3 June 27th, 1990, but the time is 11:36, the time 4 of the prior page is 11:25. So this came eleven 5 minutes after; is that correct, after the prior 6 page? 7 A. No, more than eleven minutes. 8 Eleven minutes would be 11:47. 9 Q. Okay. Pz 983 434 is June 27th, 10 1990. 11 MR. MYERS: For this page. 12 A. I may not be on the correct 13 page. All right. 14 Q. June 27, 1990, 11:25, right? 15 A. Okay. 16 Q. And the next page is June 27, 17 1990, 11:36, is that right? 18 A. Yes. 19 Q. If we look at June 27, 1990, 20 11:36, that is message twenty-four, isn't it, at 21 the very top of the page? 22 A. Yes. 23 Q. And the prior page is message 24 twenty-three, isn't it? Page 150 1 A. Yes. 2 Q. So these are two different 3 messages, right? 4 A. Yes. 5 Q. And one was sent at 11:25 and 6 one was sent at 11:36, right? 7 A. Yes, sir. 8 Q. And the one that was sent at 9 11:36 also says please change event term from 10 suicide attempt to overdose, doesn't it? 11 A. Yes. 12 Q. And there's also the phrase 13 which we were discussing before, life 14 threatening. 15 A. Yes. 16 Q. And that's your name, it says 17 per J. S. Street, M.D., right? 18 A. Yes. 19 Q. And it says: Let us know if 20 the outcome, life threatening, is appropriate per 21 J. S. Street, M.D., right? 22 A. Yes. 23 Q. Does that mean -- what does 24 that mean, that you actually had to do with this Page 151 1 message? 2 A. I probably reviewed the 1639 3 for this patient. 4 Q. And when you reviewed the 1639, 5 you saw the phrase life threatening? 6 A. Yes. 7 Q. And you wanted to check to make 8 sure that life threatening was appropriate? 9 A. Yes. 10 Q. Why is that important? 11 A. Because that's a serious 12 outcome. 13 Q. And, so, if the term life 14 threatening was not used, it would not be 15 classified as a serious outcome, isn't that 16 right? 17 A. Unless there are other reasons 18 that it's also serious. 19 Q. If this were the only reason 20 that it would be serious, and life threatening 21 was changed from life threatening to something 22 else, which was not serious, then the event would 23 not be considered serious, isn't that correct? 24 A. That is correct. Page 152 1 Q. Now, on the next page, message 2 twenty-six, June 27th, 12:02, it states: Please 3 change the event term from intentional overdose 4 to suicide attempt. Can you tell me or give me 5 an example of when intentional overdose was 6 changed to suicide attempt as opposed to 7 intentional overdoes being changed to overdose? 8 MR. MYERS: Let me just ask a 9 clarification. You're not asking her what 10 happened in this report, you're asking her 11 generally the circumstances in which that report 12 occurred? 13 MR. GREEN: I asked her for an example. 14 A. If we received information 15 which this patient did not overdose, but 16 attempted a suicide attempt by shooting, then one 17 would delete the term intentional overdose and 18 certainly make sure it would be a suicide 19 attempt. 20 Q. Okay. On the next page -- 21 actually go two pages, to June 28th, 1990. 22 A. Yes. 23 Q. Who is Leandro Herrero? 24 A. I don't know. Page 153 1 Q. Now, this says please change 2 event term from suicide attempt to overdose. 3 A. Uh-huh. 4 Q. Now, if you look two pages 5 back, it says please change event term from 6 intentional overdose to suicide attempt. Were 7 those changes made on the same patient on the 8 same adverse event form? 9 A. Those are not the same patient, 10 no. 11 Q. Based on your recollection, was 12 the change from intentional overdose to overdose 13 made more often than the change from suicide 14 attempt to overdose? 15 A. I don't know. 16 Q. Do you know about how many of 17 these types of messages you would receive from 18 Donna Pearson or somebody who was performing a 19 job similar to Donna Pearson, how many of those 20 messages would you receive on a daily basis? 21 MR. MYERS: Let me object to the form 22 to the extent that you refer to these types of 23 messages, and I don't know whether you're asking 24 her about the specific ones you just discussed or Page 154 1 messages where there was some question or change 2 about an event term. 3 Q. I'm talking about messages that 4 said -- began with please change event term from 5 whatever to this or that. 6 A. I don't know. 7 Q. Do you have any idea whether 8 you received five or six a day? 9 A. No. Anything I remember, any 10 answer I gave you was a guess, my honest answer 11 is I don't know, I don't remember. 12 Q. Do you recall if it were a 13 daily occurrence? 14 A. My guess would be no, my honest 15 answer is I don't remember. 16 Q. Now, on the next page, June 28, 17 1990. 18 A. Can you give me the Pz number, 19 there are a couple of June 28ths here and I may 20 have gone through a couple of pages. 21 Q. Pz 981 1968. 22 A. Yes. 23 Q. The event term is overdose, 24 suicide attempt, coma, urine abnormality and skin Page 155 1 discoloration. Based on the information that we 2 have on this message, and this message alone, is 3 there any way to determine what chemical the 4 patient overdosed on? 5 A. My assumption in looking at 6 this is that they overdosed on carbon monoxide. 7 Q. Okay. Is a coma considered 8 life threatening? 9 A. Not necessarily, no. 10 Q. That would depend on the type 11 of coma and the degree of the coma? 12 A. It would depend upon a number 13 of issues. 14 Q. Do you know who on the next 15 page H.W. Otten is, O-T-T-E-N? 16 A. No. 17 Q. And on the next page, July 13, 18 1990, the very bottom entry, it says please 19 change event term depression to lack of drug 20 effect since patient had no benefit from the 21 drug. 22 A. Yes. 23 Q. Depression, that term, is there 24 an indication of a change in base line there? Page 156 1 A. That's probably why they have 2 included the lack of drug effect. There may have 3 been, and my guess is there may have been an 4 event report saying patient received no 5 improvement in depression. 6 Q. Okay. If we wanted to find out 7 whether or not there was a change in base line 8 there, how could we go about doing that? 9 A. If it's in the report. 10 Q. Which report? 11 A. The 1639. 12 Q. The 1639 would be the document 13 which would describe the actual event, would it 14 not? 15 A. It would describe the 16 information that was reported about that event. 17 Q. So it would not describe the 18 actual event, it would just contain the 19 information reported that was submitted regarding 20 the actual event? 21 A. I'm not sure I appreciate the 22 distinction you're making. 23 Q. Why don't we read back my 24 original question and her answer about the 1639. Page 157 1 (THE COURT REPORTER READ BACK THE 2 REQUESTED TESTIMONY.) 3 Q. Now, unless I'm wrong, the 4 distinction was made when you said it would 5 contain the information reported. 6 A. Uh-huh, to us, yes. 7 Q. Is that different from the 8 actual event? 9 A. There may be other information 10 in the medical record of the physician that is 11 not included in our report. 12 Q. On the next page, I believe 13 that's July 13, 1990 at fifteen fifty-five. 14 A. Yes. 15 Q. Pz 983 385, three entries down, 16 it says please change event term from drug 17 dependence to lack of drug effect. Now, the 18 letters FR in front of the DEN number -- 19 A. Yes. 20 Q. -- what does that mean? 21 A. It's a French report from 22 France. 23 Q. Do you know what the indication 24 for the use of Prozac was in that DEN report? Page 158 1 A. No. 2 Q. There's no way of telling 3 whether it was for depression, obesity? 4 A. It would be listed on the 5 report if it's available, I have no recollection 6 of that report. 7 Q. And the next entry says please 8 delete life threatening as an outcome since the 9 outcome of death is already listed. That goes to 10 what we talked about before, right? 11 A. Yes. 12 Q. It can't be life threatening if 13 the person is dead, right? 14 A. True. 15 Q. And the next entry says almost 16 the same thing about life threatening and death, 17 right? 18 A. Yes. 19 Q. Okay. Now if we go two pages 20 over, August 9, 1990. 21 A. Yes. 22 Q. By the way, who is Anita 23 Fletcher? 24 A. She also worked in the DEU. Page 159 1 Q. Do you know what her title was 2 there? 3 A. No. 4 Q. Do you know if Jeff Powell had 5 any training in epidemiology? 6 A. I don't know. 7 Q. Now, this entry says please 8 change this event term death to suicide attempt 9 with the serious outcome of death. 10 A. Yes. 11 Q. Now that would be entered into 12 the DEN system as a suicide attempt, right? 13 A. Yes. 14 Q. That would not be entered into 15 the DEN system as death, would it? 16 A. No. 17 Q. Now, could you -- if you know, 18 could you explain what that means, suicide 19 attempt with a serious outcome of death, can you 20 give me an example of that? 21 A. Well, this is an example of 22 this, you have events and you have outcomes, 23 death is an outcome. If you have information as 24 to the cause of death, or events causing the Page 160 1 death, then you list those events with outcomes 2 of death. Death is listed only as an event if 3 there is no other information available. 4 Q. Okay. Now where did the policy 5 to follow that practice come from? 6 A. I don't know. 7 Q. Now, if that policy were 8 followed, if somebody wanted to do a study 9 whereby they wanted to determine the incidence of 10 death by suicide, from the data within the DEN 11 system, would that in fact be possible? 12 A. Say that again. If you wanted 13 to take a look at death by suicide? 14 Q. Yes. 15 A. Yes, because you would pull up 16 a number of event terms as well as the outcome. 17 Q. Okay. The outcome is listed on 18 the 1639? 19 A. Yes. 20 Q. When -- by the way, these 21 studies that I'm saying that would be performed, 22 would those studies be performed by an 23 epidemiologist? 24 MR. MYERS: Let me object to the form Page 161 1 to the extent that I don't know that an 2 epidemiologist could take your proposed study and 3 turn it into a study, I think you're assuming 4 that it could be done from an epidemiological 5 standpoint, and thus I object to the form. 6 Q. Could the study that I just 7 mentioned be done from an epidemiological 8 standpoint? 9 MR. MYERS: Same objection. 10 A. I don't know, I think there are 11 a number of questions that would have to be 12 answered, and I don't know. 13 Q. Do you know what an 14 epidemiologist could do with the information that 15 was in the DEN system? 16 A. And be definitive, no. 17 Q. On the next page, September 24, 18 1990, the first entry is please change event term 19 from intentional overdose to overdose, is that 20 right? 21 A. Yes. 22 Q. And the third entry is please 23 change event term from suicide attempt to 24 overdose, is that right? Page 162 1 A. Yes. 2 Q. On the next page, September 24, 3 1990. 4 A. Yes. 5 Q. Three entries down it states 6 please change the event term intentional overdose 7 to overdose and add depression as the first 8 event, also add overdose, since overdose appeared 9 twice. 10 A. Yes. 11 Q. Do you recall that particular 12 case? 13 A. No. 14 Q. That would be another French 15 report? 16 A. It's another French report. 17 Q. Did all the French reports come 18 from the same origin? 19 A. The same origin. 20 Q. I mean the same clinical 21 investigator or same reporter? 22 A. No -- well, I don't know. If 23 you're talking about all the French reports in 24 the DEN data base, the answer is no. If you're Page 163 1 talking about all of these reports, I don't know. 2 Q. On September 24, 1990, we again 3 see change suicide attempt to overdose. 4 MR. MYERS: Wait a minute, which one 5 are you referring to? 6 MR. GREEN: The first entry, September 7 24, 1990, 9:04, Pz 985 269. 8 MR. MYERS: Is there a question? 9 MR. GREEN: I'm going to ask a question 10 after I briefly view this document and Pz 984 11 847, where the first entry also changes suicide 12 attempt to overdose. 13 A. Yes. 14 Q. Now you can see, Dr. Street, 15 that we've looked at a number of these computer 16 messages which requested that the term suicide 17 attempt be changed to overdose, and I'm just 18 wondering if, since I asked you the question the 19 first time, whether or not your recollection has 20 been refreshed as to how often, in the course of 21 your employment while you were working with 22 Prozac, you would receive this type of request? 23 MR. MYERS: Before she answers, let me 24 object to the form only to the extent that the Page 164 1 specific two entries that you've referenced, you 2 did not read the entire entry. But subject to 3 that, go ahead and answer. 4 A. No, I don't remember. 5 Q. And I want to move to the last 6 page now, November 1, 1990. 7 A. Yes. 8 Q. There's an entry after it says 9 Hi Marie, please provide us, it begins 10 clarifications of event terms for this report. 11 If this patient experienced suicidal thoughts, 12 the event term depression needs to be added, 13 right? 14 A. Yes. 15 Q. Was there an event term for 16 suicidal thoughts? 17 A. I don't remember. 18 Q. Would the -- do you remember 19 whether or not the event of suicidal thoughts was 20 changed to depression as a practice of Eli Lilly? 21 A. I don't remember, I don't 22 remember what the ELECT term coding was. 23 Q. Now on the study that you did 24 with the post-depression. Page 165 1 A. Post-stroke depression. 2 Q. Post-stroke depression. Was 3 there any exclusion criteria for that study? 4 A. Yes. 5 Q. And was serious suicidal risks 6 an exclusion criteria? 7 A. I don't know, I don't remember. 8 Q. Do you remember what any of the 9 exclusion criteria was? 10 A. No. 11 Q. And correct me if I'm wrong, 12 but did you say that study consisted of five 13 patients? 14 A. The study was to have enrolled 15 forty patients, if my memory is correct. We only 16 enrolled five, so the study was terminated. 17 Q. And that's the study -- what 18 was the time frame that that study took place? 19 A. We started up in May of 1991, 20 and I believe we terminated in May or June of 21 '92. 22 Q. Now, had other patients been 23 enrolled but then been dropped? 24 A. No, that's the total Page 166 1 enrollment, five or less. 2 Q. Okay. Was there difficulty in 3 getting subjects for that study? 4 A. Yes. 5 Q. Why is that? 6 A. The site where it was done also 7 had a concurrent stroke trial competing for the 8 very same patients of stroke, and since the 9 neurologist was running the stroke trial and 10 since stroke patients come from the neurology 11 division, the neurologist did not pass them on 12 for the depression trial. 13 MR. GREEN: Do you want to take a 14 little break? 15 THE WITNESS: Sure, that would be fine. 16 (A SHORT BREAK WAS TAKEN.) 17 (PLAINTIFF'S EXHIBIT NO. 11 WAS 18 MARKED FOR IDENTIFICATION AND 19 RECEIVED IN EVIDENCE.). 20 Q. (BY MR. GREEN) Dr. Street, 21 have you had a chance to review PLAINTIFFS' 22 EXHIBIT 11? 23 A. Yes. 24 Q. Doctor, this note on the first Page 167 1 page of PLAINTIFFS' EXHIBIT 11, is that an 2 indication that Dr. Heiligenstein, annexed to the 3 note, the questionnaires which are part of 4 Exhibit 11, and that you received the 5 questionnaires from Dr. Heiligenstein? 6 A. Yes. 7 Q. Once you received those 8 questionnaires, did you have a conversation with 9 Dr. Heiligenstein regarding the questionnaires? 10 A. I don't ever remember looking 11 at this questionnaire. 12 Q. Does it refresh your 13 recollection at all as to whether or not other 14 forms of measuring suicidality in the subjects of 15 the clinical investigations was ever considered 16 in addition to the Ham D scale? 17 A. Still does not -- that still 18 does not prompt any recall, at all. 19 (PLAINTIFFS' EXHIBITS 12 AND 13 20 WERE MARKED FOR IDENTIFICATION AND 21 RECEIVED IN EVIDENCE.) 22 Q. Okay, Doctor, regarding 23 Plaintiffs' Exhibit Number 12, which is Pz 762 24 322 and 323, and regarding the first paragraph, Page 168 1 after the dots there in the middle of the 2 paragraph, it says I would honestly prefer that 3 we not have CRAs in the clusters following up on 4 reports because the applied consistency that is 5 needed in fulfilling our regulatory and medical 6 obligations. Before I ask you specifically about 7 that quote, I would ask you, is the Mike from 8 which this message apparently originated, Michael 9 S. Noon? 10 A. Yes. 11 Q. And who is Michael S. Noon? 12 A. He was a manager in the DEU. 13 Q. And when he uses the term 14 applied consistency, what exactly does he mean by 15 applied consistency? 16 MR. MYERS: Well, before she answers -- 17 Q. If you know. 18 MR. MYERS: -- I object to the form of 19 the question as stated, maybe even as modified. 20 It calls upon her to speculate as to what the 21 writer of this intended by usage of those words, 22 so I object to the form. 23 A. All I can do is take it at face 24 value, consistently applied across all areas. Page 169 1 Q. Does that mean consistently 2 used the same terms to describe adverse events? 3 MR. MYERS: Same objection. 4 A. It may. 5 Q. Would you say that it was 6 important to have applied consistency in 7 fulfilling regulatory and medical obligations? 8 A. Yes. 9 Q. When the message says that they 10 are adding five people to the DEU, two are 11 replacements and three are additions, were those 12 additions working on Prozac? 13 A. I have no idea. 14 Q. Dr. Street, in reviewing 15 Plaintiffs' Exhibit 13, do you recognize what 16 this piece of literature is? 17 A. It appears to be an abbreviated 18 package insert. 19 Q. And for what purposes would a 20 package insert be abbreviated and apparently 21 published? 22 A. I'm not sure what all the 23 regulatory requirements are for complete 24 disclosure. Page 170 1 Q. I'm sorry, I may have 2 misunderstand you. Do you mean that you are not 3 sure if your -- about whether or not you have to 4 completely disclose the information? 5 A. This is a brief summary, it 6 says consult the package insert for complete 7 prescribing information. There are regulatory 8 requirements in which -- it may be summarized in 9 regulatory requirements in which the entire 10 package insert must be produced. 11 Q. Let me ask you if you look in 12 the last column, on the very bottom of that 13 column, even below the very last paragraph, below 14 the word residual, I don't think -- the L might 15 have not come out on the copy, but below the word 16 residual, there are the letters and numbers PV 17 two one five zero DPP. Do you know what those 18 numbers refer to? 19 A. No. 20 Q. Do you know who within Eli 21 Lilly would know that? 22 A. Someone in the regulatory 23 division that deals with package inserts. 24 Q. Who did that for Prozac? Page 171 1 A. I don't know. 2 Q. Would anybody on the medical 3 writing staff know that? 4 A. No, probably not. 5 Q. Did you ever see a draft for 6 this which was used in creating this document? 7 A. No. 8 Q. Did you have anything to do 9 with creating this document? 10 A. No. 11 MR. GREEN: I have no further 12 questions. 13 * * * * * * * * * * 14 CROSS EXAMINATION 15 BY MS. ZETTLER: 16 Q. My name is Nancy Zettler, and I 17 represent another group of plaintiffs in the 18 Fentress case down in Kentucky that is related to 19 the Wesbecker murder. I've got some follow-up 20 questions on some of the things that Greg covered 21 and some questions on things he didn't cover. 22 First of all, I'm a little bit confused in the 23 review process on the 1639s when they come in. I 24 think earlier you testified that your involvement Page 172 1 with the 1639s were basically from outside 2 reporting sources, not from clinical trial 3 evidence; is that correct? 4 A. The majority of the spontaneous 5 reports. 6 Q. And were 1639s filled out for 7 adverse events that occurred within a trial, do 8 you know? 9 A. Yes. 10 Q. They were. What percentage of 11 the 1639s that you dealt with would you say were 12 the spontaneous events as opposed to clinical 13 trial events? 14 A. The majority. 15 Q. More than ninety percent? 16 A. I don't know, I don't want to 17 give a figure on it, I don't truly know. The 18 majority were spontaneous. 19 Q. More than seventy-five percent? 20 A. Perhaps. 21 Q. And my understanding of how a 22 spontaneous act can be reported would be through 23 a doctor or hospital or some other health care 24 provider; is that correct? Page 173 1 A. Health care provider, we do 2 take information from patients. 3 Q. So if the patient wrote to you 4 and said this is the experience I had with your 5 drug, I believe it was with the drug Prozac or 6 while I was on Prozac, do you fill out a 1639 on 7 that person? 8 A. Yes. 9 Q. Do you know what would happen 10 with the complaint letters from patients? 11 A. I believe they got forwarded. 12 There were specific questions about issues and 13 questions the patient had, those would be 14 directed to whomever with -- 15 Q. They would be directed to 16 whomever within -- 17 A. If there was a question on, I 18 believe that I'm having a rash with Prozac, does 19 it contain peanut oil, that went to a particular 20 area that dealt with the technical technicalities 21 of is or is there not peanut oil in some part of 22 the process. 23 Q. And would there be one person 24 who that question would be forwarded to who would Page 174 1 most likely know the answer to that question? 2 A. I'm not sure if there's one 3 person or one area, I don't know. I did not take -- 4 I did not usually -- I did not have complaints 5 forwarded to me all that often to take care of 6 and then forward to someplace else. 7 Q. What types of complaints were 8 forwarded to you? 9 A. They were very rare, I'm trying 10 to think. I remember of only -- well, let's see. 11 Oftentimes there were complaints associated with 12 questions in which it was felt that there was 13 need of a medical background -- a physician whose 14 daughter was on Prozac asked about complaints of 15 during airplane flights, that type of thing, that 16 I tried to answer, that sort of question. 17 Q. So it wouldn't be a scenario 18 where all the people who complained of agitation 19 would be directed towards you or anything like 20 that? 21 A. No. 22 Q. So once a complaint -- let's 23 take this situation of a phone call from a doctor 24 reporting -- Page 175 1 A. Can I ask you for your 2 definition of complaint? 3 Q. Okay. Report, let's use the 4 word report instead, record of an adverse event. 5 A. Okay. 6 Q. Let's take a situation where a 7 doctor calls in to report an adverse event that 8 he's perceived that one of his patients has 9 suffered while on Prozac. 10 A. Okay. 11 Q. Is that okay? You have to say 12 yes or no. 13 A. Yes. 14 MR. MYERS: You're assuming this, a 15 hypothetical? 16 Q. Right, I just want to use that 17 word. I mean, that's a situation, right, doctors 18 would call and say patient acts on Prozac, while 19 on Prozac suffered from B, right? 20 A. Yes. 21 Q. So that's not necessarily a 22 hypothetical, that situation actually did happen 23 occasionally; correct? 24 A. That is probably the majority Page 176 1 of times in which a physician is the major 2 reporter. 3 Q. Also, let me ask you this: 4 Adverse event doesn't necessarily mean a causal 5 relationship between the use of Prozac and the 6 event that occurred during the use of Prozac; 7 correct? 8 A. That's true. 9 Q. Were there situations where a 10 determination was made or where you tried to make 11 a determination of whether an adverse event was 12 actually related to the use of Prozac? 13 A. Yes. 14 Q. What situations would those be? 15 A. If the event is unexpected, 16 that is a regulatory definition in which the 17 event is not listed in the package insert, if it 18 is unexpected and serious, then one is asked to 19 assess a possible causality to it. 20 Q. Who would ask you to assess the 21 causality? 22 A. The FDA. 23 Q. It would have to be a specific 24 request by the FDA? Page 177 1 A. It's a blanket request, I 2 believe. If it's a serious unexpected event, 3 then one automatically assesses causality. 4 Q. So this is -- 5 A. This is process. As far as I 6 know, this is process. 7 Q. Was suicidality ever considered 8 an unexpected event from Prozac? 9 A. Suicidality? 10 Q. Yes. 11 A. You mean suicide? 12 Q. Right. 13 A. I don't remember, I don't know. 14 Q. It's obviously considered a 15 serious event; correct? 16 A. If it met the serious 17 regulatory outcome definitions of death, 18 hospitalization, overdose, life threatening or 19 congenital anomaly. 20 Q. When somebody commits suicide, 21 that usually means they take their life, doesn't 22 it? 23 A. There can be suicide attempts. 24 Q. Okay, let's stick with suicide Page 178 1 for now. Suicide, again, usually connotes that 2 somebody succeeded in taking their life, right? 3 A. Correct. 4 Q. And that's an intentional act 5 on their part, right? 6 A. Yes. 7 Q. And that would be considered 8 serious under the regulations that you're talking 9 about? 10 A. Yes. 11 Q. And you stated earlier that 12 you're not sure whether or not or you don't 13 recall whether or not suicide was considered an 14 unexpected event for purposes of regulations, 15 right? 16 A. I don't remember. 17 Q. Is that something that would be 18 specifically listed in the regulation? 19 A. In the regulation? 20 Q. Yes. 21 A. No. The question is, is it -- 22 you base expectancy upon package insert, suicide 23 was discussed in the package insert. 24 Q. But it wasn't always discussed Page 179 1 in the package insert, was it? 2 A. It was in the 1987 version that 3 Mr. Green just showed me. 4 Q. So assuming that it was 5 discussed in the package insert, then that, per 6 your definition, it means that it wasn't an 7 unexpected event, right? 8 A. It might not be. 9 Q. How about suicide attempt? 10 A. I don't know what was done with 11 suicide attempt, I don't know how it was tracked. 12 Q. Serious -- as far as the 13 serious portion of the regulations, suicide 14 attempt would be serious or not depending on the 15 attempt itself? 16 A. No, depending upon the outcome. 17 Suicide attempt if it resulted in death. 18 Q. What if it resulted in coma? 19 A. One assumes that it also 20 results in a hospitalization then. 21 Q. Okay. So as long as it's a 22 hospitalization and/or death -- 23 A. Death, hospitalization, 24 overdose, life threatening or congenital anomaly. Page 180 1 Q. When you say overdose, you mean 2 overdose of the subject's drug, in this case 3 Prozac? 4 A. Overdose of anything, overdose, 5 period. 6 Q. What was the other something? 7 A. Death. 8 Q. Congenital anomaly? 9 A. Congenital anomaly. 10 Q. What does that mean? 11 A. A fetus that is deformed during 12 pregnancy and there are deformities and deficits 13 present at birth. 14 Q. While on the drug, while the 15 mother was on the drug? 16 A. Not necessarily. It may or may 17 not occur while on drug. We track clinical trial 18 patients after they have been on drug and we may 19 have a report of a patient who delivered a child 20 with a congenital deformity and they have been 21 off drug and off trial for three years, but that 22 still can be reported and we still report that. 23 Q. Okay. Then what was the other 24 one that was -- the fifth one, I believe, or Page 181 1 fourth one? 2 A. Life threatening. 3 Q. Life threatening, okay. Is a 4 suicide attempt generally life threatening? 5 A. Not necessarily, no, it may not 6 be. 7 Q. Can you give me an example 8 where a suicide attempt would not be life 9 threatening? 10 A. If I took twenty aspirin 11 tablets, probably not life threatening. It may 12 be an overdose. 13 Q. Well, if it were an overdose? 14 A. It would still be serious. 15 Q. Can you give me an example of a 16 suicide attempt that would not be considered 17 serious? 18 A. There are a number of suicidal 19 gestures that can be made. 20 Q. Such as? 21 A. Patient may make scratches on 22 the wrists, no evidence of significant bleeding 23 or involvement below, you know, just superficial 24 skin lacerations. Page 182 1 Q. Okay. Is whether or not a 2 suicide attempt is life threatening is subjective 3 or objective determination? 4 A. I'm sorry, would you say that 5 again? 6 Q. Sure. Is the determination -- 7 first of all, who decides whether or not a 8 suicide attempt is life threatening? 9 A. It can be the reporting 10 physician. 11 Q. Okay. 12 A. It may also be the clinical 13 physician reviewing the 1639. 14 Q. Okay. Assuming that it's the 15 clinical physician, is that the clinical research 16 physician? 17 A. Yes. 18 Q. Assuming that the clinical 19 research physician is making the determination, 20 would that be a subjective or objective decision 21 on his part? 22 A. Could have implications for 23 both. 24 Q. What I'm trying to get at is Page 183 1 that earlier you said that taking an overdose of 2 aspirin wouldn't necessarily be life threatening, 3 right? 4 A. Yes. 5 Q. But the patient or person 6 taking those aspirin doesn't necessarily know 7 that, do they? 8 A. I can't -- 9 MR. MYERS: Let me object to the form 10 to the extent that's a hypothetical, it may not 11 include enough facts. 12 Q. Okay. Let's say somebody takes 13 fifty aspirin in a suicide attempt. The person 14 taking the aspirin is, assuming that they're a 15 lay person, not a doctor or pharmacist or 16 chemist, wouldn't necessarily know that these 17 fifty aspirins were not going to kill them 18 necessarily, right? 19 A. I don't know. 20 Q. Do you think the average person 21 on the street knows that taking fifty aspirins 22 are not going to kill them? 23 A. Many patients are quite 24 sophisticated. Page 184 1 Q. Is that a determination made by 2 somebody in your department or at Lilly whether 3 or not a person is sophisticated enough to know 4 that, in that situation? 5 A. I don't know, it depends upon 6 the amount of information that's related. 7 Oftentimes there may be information on the 1639 8 that would lead one to believe that it was not a 9 life threatening event. 10 Q. And again that would be the 11 determination of the person who is interpreting 12 the 1639, right? 13 A. It may be, it may also be by 14 comments from the health care provider who has 15 given the report. 16 Q. Is any effort ever made to 17 attempt to talk to these people who attempt to 18 kill themselves while on the drug? 19 A. No. We would attempt to talk, 20 for any further information or clarification, 21 with the reporter, the physician reporter or 22 provider, the pharmacist, not -- we, as a general 23 rule, do not call patients. 24 Q. Okay. Now, can the doctors Page 185 1 fill out 1639s themselves and send in the actual 2 form or is that something you guys do once they 3 make a phone call? 4 MR. MYERS: When you say the doctors -- 5 MS. ZETTLER: The reporting doctors, 6 the guys from outside. 7 A. They may call and report to us. 8 There are, however, forms that can be obtained 9 that are very similar to our 1639s, which are 10 provided by the FDA if a physician would prefer 11 to do that and send it directly to the FDA or 12 send it to us. 13 Q. And assume that it's a form 14 that's filled out by the outside doctor and sent 15 to Lilly, then it would be reviewed by somebody 16 within your department? 17 A. Yes. 18 Q. Who would be the first person 19 that would be most likely to see that form? 20 A. The DEU. 21 Q. And what would they do with the 22 form once they obtained it? 23 A. They would probably assess it. 24 If there were any further questions, they might Page 186 1 contact the physician filling it out. They would 2 assign the proper coding event, coding terms, and 3 then forward it to the physician for review, to 4 the clinical physician for review. 5 Q. So they would take whatever the 6 doctor wrote and assign a coding term to what the 7 doctor wrote? 8 A. Yes. 9 Q. Earlier you testified that 10 Lilly was using the ELECT dictionary during the 11 time that you worked with Prozac? 12 A. Yes. 13 Q. Do you know what -- can you 14 tell me what the difference between COSTART and 15 the ELECT dictionaries are? 16 A. Specifics, no. 17 Q. Can you tell me generally what 18 they are? 19 A. No. 20 Q. ELECT is a dictionary designed 21 by Eli Lilly; correct? 22 A. I believe so, yes. 23 Q. Is it basically something that 24 was designed on the same theory as COSTART? Page 187 1 A. I believe so. 2 Q. Do you know why they stopped 3 using the ELECT system and went back to COSTART? 4 A. No. 5 Q. Do you know if the FDA ever 6 complained about the use of ELECT as opposed to 7 COSTART? 8 A. No. 9 Q. No, you don't know or no, they 10 never have? 11 A. No, I don't know. 12 Q. Your drug trial that you worked 13 on, the drug depression trial, was that an 14 on-site or off-site trial at Lilly? 15 A. An on-site. 16 Q. Was that done at the Lilly 17 clinic or was that done -- 18 A. If was off-site. 19 Q. Where was that done at? 20 A. University of Iowa. 21 Q. Why did that take two years to 22 enroll five people in that study? 23 A. It's only one year. 24 Q. Why did it take one year to Page 188 1 enroll five people in the study? 2 A. As I explained, the stroke 3 patients that one hoped to get in that study were 4 also -- were enrolled first and primarily into a 5 stroke treatment study that was going on 6 concurrently at the University of Iowa. 7 Q. Was that the stroke treatment 8 study that was done with Prozac? 9 A. No. 10 Q. How long did it take before you 11 realized you weren't going to get the patients 12 you needed for the study? 13 A. One always has concerns at 14 certain points that one is not going to be able 15 to do that, so we were well aware of it for 16 several months. The site made various attempts 17 to identify other hospitals within the vicinity 18 of the University of Iowa in which we might be 19 able to obtain stroke patients that were not also 20 in the concurrent stroke treatment study going 21 on. 22 Q. Were you living in Iowa at the 23 time this study was going on? 24 A. No. Page 189 1 Q. But you were -- the clinical 2 monitor is the same thing as clinical 3 investigator, isn't it? 4 A. It is not, no. 5 Q. It is not? 6 A. It is not. 7 Q. What is the difference? 8 A. The clinical investigator is 9 the actual person conducting the study at the 10 site, monitoring the study at the site. The 11 clinical monitor is the person employed by the 12 sponsor of the study to oversee the general 13 workings of the study. 14 Q. Is that anything like the 15 clinical research administrator? 16 A. No. 17 Q. CRA? 18 A. No. They deal with 19 administrative issues, the clinical monitor will 20 deal with administrative issues, efficacy issues, 21 enrollment issues, inclusion-exclusion criteria 22 issues. 23 Q. So that's closer to a clinical 24 research physician? Page 190 1 A. Yes. 2 Q. Is that basically another term 3 for clinical research physician? 4 A. Well, that is a job, one of the 5 jobs of a clinical research physician, as a 6 clinical monitor. 7 Q. Okay. Who was the clinical 8 investigator on the stroke study? 9 MR. MYERS: You don't have to tell her 10 that, that's proprietary. 11 MS. ZETTLER: Absolutely not, it's a 12 depression study, she said that at the beginning 13 and you know it. 14 MR. MYERS: If it's not a pivotal 15 study, she's not required to disclose it. 16 MS. ZETTLER: Let's hear your 17 definition of pivotal study. 18 MR. MYERS: Who, mine? 19 MS. ZETTLER: Yes, yours. 20 MR. MYERS: I'm not under examination. 21 MS. ZETTLER: Well, either she's going 22 to respond to that question or we're going to 23 call Judge Potter right now. 24 MR. MYERS: Go ahead. Page 191 1 (A SHORT RECESS W0AS TAKEN.) 2 * * * * * * * * * * 3 CROSS EXAMINATION 4 BY MR. CLEMENTI: 5 Q. Doctor, my name is Paul 6 Clementi, and I have a real short question. I 7 represent a number of doctors, including a Dr. 8 Kay, K-A-Y, and a Dr. Miller, who are both from 9 the Chicago area. Do you know if you've ever 10 spoken with or communicated with Dr. Kay or Dr. 11 Miller? 12 A. I don't know, I don't remember, 13 there's nothing that spurs those two names into 14 recall. 15 Q. You don't recognize those two 16 names? 17 A. No. 18 MR. CLEMENTI: Thank you. 19 MS. ZETTLER: Would you read back my 20 last question? 21 (THE COURT REPORTER READ BACK THE 22 REQUESTED TESTIMONY.) 23 * * * * * * * * * * 24 RECROSS EXAMINATION Page 192 1 BY MS. ZETTLER: 2 Q. Are you going to follow your 3 counsel's advice regarding that question? 4 A. Yes. 5 MS. ZETTLER: Certify that. 6 (QUESTION CERTIFIED.). 7 Q. Who decided that a study on 8 post-stroke depression should be done? 9 A. It was in the workings when I 10 arrived at Lilly. 11 Q. Do you know who decided that it 12 should be conducted? 13 A. No. I believe, though, that 14 the medical department had looked at it. 15 Q. When you say the medical 16 department, what do you mean? 17 A. Our group, our division. 18 Q. Is there a Prozac group within 19 the medical division? 20 A. Now? 21 Q. Back when you worked on the 22 stroke study. 23 A. The neuropsyche essentially 24 included the Prozac group as well as any other Page 193 1 neuropsychological drugs that we had at the time. 2 Q. Okay. I think back then you 3 said there was also a psychopharmacology group; 4 is that correct, or am I mistaken on that? 5 A. You're mistaken. 6 Q. So there was just one group. 7 A. Yes. 8 Q. One Prozac group and it was 9 under the neuropsyche group? 10 A. We were everything. 11 Q. Okay. Go back to the 1639s. I 12 believe you said that the -- if the doctor sent 13 in the 1639 and somebody within the department 14 would review it and code it, assign code words to 15 the adverse event; correct? 16 A. Yes. The number of 1639s that 17 we received from a doctor is probably very, very 18 few. Most of these are taken via phone. 19 Q. So let's use that example, 20 then. A doctor calls in with the report of an 21 adverse event, and the person within your 22 department would fill out the form? 23 A. No. 24 Q. Who would fill out the form? Page 194 1 A. The DEU would fill out the 2 form. 3 Q. Okay. And they would assign a 4 term to the adverse event? 5 A. Yes. 6 Q. Would what the doctor told them 7 be recorded word for word? 8 A. Yes, that makes up the 9 narrative text of the 1639. 10 Q. Whatever term was assigned by 11 the DEU person to the narrative that was reported 12 by the doctor, would that also be indicated on 13 the 1639? 14 A. Yes. 15 Q. Where would that be indicated, 16 is there a space for it? 17 A. There is a follow-up on event 18 term listings that one is asked to review, one 19 reviews those, makes any additions or 20 corrections, signs that sheet, sends it back, and 21 then a formal sixteen -- printed 1639 is done. 22 Q. Could you look at Exhibit 23 Number 2 again? 24 A. (Witness complies.) Page 195 1 Q. It's the second to the last 2 page, Pz 884 260. 3 A. Yes. 4 Q. Is that the official 1639 5 that's filled out after the report is taken? 6 A. That's the final one. 7 Q. Is the person within the DEU 8 who takes this information, do you know do they 9 have a specific title? 10 A. I don't know. 11 Q. Okay. Is this form that's 12 connected to Exhibit Number 2 which you said is 13 the final form, is that similar to what the DEU 14 person fills out when they take the information 15 from the doctor over the phone? 16 A. Yes. 17 Q. Is there a place on this form 18 that's contained in Exhibit 2 to indicate what 19 terms is assigned to the narrative report of the 20 adverse event by the doctor? 21 A. I'm sorry, I didn't catch the 22 first part. 23 Q. On this form that's connected 24 and made a part of Exhibit Number 2, is there a Page 196 1 space in here, this form, the final form, to 2 indicate what term has been assigned to the 3 narrative that the doctor gives you over the 4 phone as to what the adverse event is? 5 A. On the working drafts in which 6 one takes down the information at the time, there 7 is a specific sheet in which one lists the event 8 term. 9 Q. So my question is: On the 10 final report -- I'm assuming this is the report 11 that's submitted to the FDA; correct? 12 A. Yes. 13 Q. Now the report I'm referring to 14 is part of Exhibit Number 2, Pz 884 260. 15 A. Yes. 16 Q. On this form, is there a space 17 to indicate whatever term has been assigned to 18 this adverse event by somebody within the DEU? 19 A. Yes. 20 Q. Where? 21 A. It's listed on the event terms 22 section, top of the second page. 23 Q. Okay. So this second page is 24 also sent to the FDA? Page 197 1 A. Yes, that's a whole report. 2 Q. Okay. So on the second page of 3 the final report, which is Pz 884 261, the event 4 terms that are listed is death, hostility, 5 suicide attempt, comma, no drug used, agitation, 6 thinking abnormal and ischemia? 7 A. Yes. 8 Q. Now is this considered one 9 single adverse event or are these considered all 10 adverse events? 11 A. Those are all considered 12 adverse events. 13 Q. So this person suffered from 14 six different adverse events? 15 A. Yes. 16 Q. After the person from the DEU 17 assigns a term or terms to an adverse event or 18 adverse events, what happens to the report? 19 A. It goes to the clinical 20 physician for review and sign-off. 21 Q. Do you know which clinical 22 physician reviewed the report that's made a part 23 of Exhibit Number 2? 24 A. No, not right offhand. Page 198 1 Q. Is there any way of telling 2 from this report? 3 A. No. 4 Q. Do you know if a determination 5 of causality was ever made on this report in 6 regards to Prozac? 7 A. I don't know. 8 Q. How would somebody go about 9 making that determination? 10 A. How would somebody go about 11 making that determination? 12 Q. Right, whether or not these 13 adverse events listed in this report were related 14 to this person's use of Prozac. 15 A. Whether it met the unexpected 16 serious criteria. 17 Q. Looking at this final report 18 that's contained in Exhibit Number 2, would you 19 say that this met that criteria? 20 A. There are also caveats 21 regarding litigation that may preclude the 22 signing of causality as well. 23 Q. What caveats are those? 24 A. If there is some litigation Page 199 1 involved, causality is not assigned. 2 Q. How is it determined whether or 3 not litigation is involved? 4 A. It may be said. 5 Q. Okay. Do you know whether or 6 not, then, at the time that this drug form was 7 filled out whether or not litigation was 8 involved? 9 A. I don't know. 10 Q. Let's go back to my original 11 question. Is this considered, knowing what we 12 know about this report, and what's been listed in 13 here, would this be considered serious under the 14 regulations we talked about earlier? 15 A. Yes. 16 Q. Is there some place on here 17 where they make a determination whether or not 18 Prozac was causally related to this man's 19 actions? 20 A. No. 21 Q. In a situation like this, is a 22 causal relationship usually determined or 23 dismissed on this form somewhere? 24 MR. MYERS: Let me object to the form Page 200 1 only to the extent that you're mischaracterizing 2 her prior testimony, if the only criteria you're 3 using is serious. 4 MS. ZETTLER: My original question was 5 whether or not a determination of causality or 6 some sort of causal relationship would be made as 7 to a given adverse event, and she said only the 8 cases where it would fit under that serious part. 9 THE WITNESS: Serious and unexpected. 10 Q. Okay. Would this be 11 unexpected? 12 A. You take each term 13 individually. 14 Q. Okay, let's do that. In this 15 situation, would death be unexpected? 16 A. Yes. 17 Q. In this situation, would 18 hostility be unexpected? 19 A. I don't know, I would have to 20 look up what's in the package insert. 21 Q. How about suicide attempt? 22 A. Might have to look up and see 23 how the package insert at the time read, suicide 24 would have been included in the package insert. Page 201 1 Q. How about agitation? 2 A. I'd have to look in the package 3 insert. 4 Q. How about abnormal thinking? 5 A. Same. 6 Q. Same what? 7 A. The same thing, I would have to 8 look in the package insert as well as for 9 ischemia. 10 Q. What is ischemia? 11 A. Weakness, generalized weakness, 12 malaise. 13 Q. If I understand your testimony 14 correctly, if I don't, please let me know, but in 15 this case death would fit both the categories of 16 unexpected and serious; correct? 17 A. Yes. 18 Q. So in that situation, it's 19 normal practice, outside these litigation 20 caveats, to try to make some sort of 21 determination of causal relationship between the 22 event and the use of Prozac, is that right? 23 A. Yes. 24 Q. In that situation, would that Page 202 1 causal determination be listed somewhere on this 2 form? 3 A. No. 4 Q. Where would it be listed? 5 A. It would be listed on the 6 working 1639. 7 Q. Why would it not be listed on 8 this form? 9 A. I'm not sure that -- where that 10 is required, I don't know. I don't know what the 11 requirements are for reporting causality. 12 Q. After it was listed on the 13 working 1639, what would happen with that 14 information? 15 A. It goes back to the DEU and 16 they generate a final draft, which is what this 17 is. 18 Q. Talking about the causal 19 relationship information, what happened with 20 that? 21 A. I don't know. 22 Q. Do you know if that's entered 23 into the DEU at all? 24 A. I don't know. Page 203 1 Q. Who would know that? 2 A. The regulatory division. 3 Q. So unless there was a 4 regulation that required that causal relationship 5 be recorded, it would not normally be reported? 6 A. I don't know. 7 Q. Have you ever seen a file 1639 8 where a causal relationship was discussed? 9 A. No. 10 Q. To your knowledge, has anybody 11 ever tried to make a determination at Eli Lilly 12 as to whether or not a certain adverse event was 13 causally related to the use of Prozac? 14 A. Say that again, please? 15 Q. Sure. To your knowledge, has 16 there ever been anybody at Lilly or connected 17 with Lilly in any way, such as clinical 18 investigator, et cetera, who has attempted to 19 make the determination as to whether any given 20 adverse event was causally related to the use of 21 Prozac? 22 MR. MYERS: Object to the form of the 23 question to the extent that the clinical 24 investigators, it may assume -- it assumes that Page 204 1 they may be agents of Lilly, which they're not, 2 and it's also quite overbroad if it addresses all 3 events. We've gotten off this form now, haven't 4 we? 5 MS. ZETTLER: Right, I'm saying any 6 given event. 7 Q. To your knowledge, for any 8 given event or event, has anybody -- let's start 9 at Lilly, who works for Lilly, is employed by 10 Lilly, has ever tried to make a determination as 11 to whether or not any given adverse event was 12 causally related to the use of Prozac? 13 MR. MYERS: Same objection as to form. 14 You can answer. 15 A. Yes. 16 Q. Which adverse events? 17 A. Any that are serious and 18 unexpected. 19 Q. How would that determination be 20 made? 21 A. The serious would be the 22 outcome criteria as defined, death, 23 hospitalization, overdose, life threatening or 24 congenital anomaly, expectancy as determined by Page 205 1 listings in the package insert. 2 Q. Is there a division or 3 department at Lilly that is in charge of trying 4 to make that causal -- definition of a causal 5 relationship? 6 A. A division, no. 7 Q. Is there any certain individual 8 or individuals that you know of that would try to 9 do that? 10 A. The reviewing physician makes 11 that determination. 12 Q. Do you know if the reviewing 13 physician, is that a title? 14 A. The person that reviewed the 15 1639. 16 Q. Okay. And that would be 17 somebody such as yourself, the clinical research 18 physician? 19 A. Yes. 20 Q. Did you ever try to make a 21 determination of causal relationship between a 22 given adverse event and the use of Prozac? 23 A. Yes. 24 Q. Which adverse events? Page 206 1 A. I don't know, could have been 2 any of them. 3 Q. How would you go about trying 4 to make that determination? 5 A. From a medical judgment. 6 Q. Your own personal medical 7 judgment? 8 A. Yes. 9 Q. What would you take into 10 consideration when forming that judgment or 11 opinion? 12 A. Information that was obtained 13 on the 1639, past medical experience, and 14 information regarding the mechanism and action of 15 the drug. 16 Q. Have you formed opinions as to 17 whether or not suicidality is causally related to 18 the use of Prozac? 19 A. Yes. 20 Q. What is your opinion? 21 A. It is not. 22 Q. Based on what? 23 A. My past experience as a 24 physician. Page 207 1 Q. You said earlier, you testified 2 earlier that you're a board certified 3 neurologist/psychiatrist; correct? 4 A. Neurologist. 5 Q. Have you ever practiced 6 psychiatry? 7 A. No, not as a psychiatrist, no. 8 Q. What about your background in 9 neurology did you believe that Prozac is not 10 causally related to suicidality or suicide 11 attempts? 12 A. One does also receive training 13 in psychiatry in the area of neurology, and vice 14 versa. 15 Q. Okay. What about that 16 training, does it lead you to believe that Prozac 17 is not causally related to? 18 A. I believe that patients who are 19 depressed have suicidal tendencies based upon the 20 illness itself. 21 Q. How about homicidal tendencies, 22 do you have an opinion an as to whether or not 23 there is a causal relationship between the use of 24 Prozac and homicidal tendencies? Page 208 1 A. I do. 2 Q. What is your opinion? 3 A. I do not believe there is an 4 association between Prozac and homicidal 5 tendencies. 6 Q. Based on what? 7 A. My past experience and my 8 knowledge as a physician, and the underlying 9 illnesses that may occur, and the underlying 10 mental and neurotransmitter abnormalities that 11 may occur in patients with depression. 12 Q. Do you believe in such a thing 13 as chemical depression? 14 MR. MYERS: Excuse me, I didn't hear 15 you. 16 Q. Do you believe in such a thing 17 as chemical depression? 18 A. Comical? 19 Q. Chemical. 20 A. Oh, chemical depression. I 21 believe that depression has a chemical background 22 or basis. 23 Q. Has anybody ever proven that in 24 fact there is a chemical background and basis in Page 209 1 depression? 2 A. I think there's scientific 3 evidence that there are a number of 4 neurotransmitters that are altered in depression. 5 Q. Has anybody ever proven that 6 suicide is related to a chemical imbalance of 7 some sort in the brain? 8 A. Suicide is related to a 9 chemical imbalance in the brain, I don't know. 10 Q. How about homicide? 11 A. I don't know. 12 Q. Earlier you said that you 13 believe that there were -- you said defects in 14 the neurotransmission related to homicidal 15 behavior; is that correct? 16 A. Yes. 17 Q. What type of defects are you 18 talking about? 19 A. Could be any number of 20 abnormalities of neurotransmission, could be 21 abnormalities of function, could be deficit 22 states, longlasting from previous years. 23 Q. Do you have an opinion within a 24 reasonable degree of medical and psychiatric Page 210 1 certainty as to whether or not depression can be 2 caused by a chemical imbalance in the brain? 3 MR. MYERS: I think she's already 4 answered that. 5 Q. This is slightly different. 6 A. I would answer it the same way. 7 I believe depression is related to and has a 8 chemical basis. 9 Q. Do you have an opinion within a 10 reasonable degree of medical and psychiatric 11 certainty as to whether or not Prozac or 12 Fluoxetine hydrochloride actually alters a 13 chemical balance within the brain -- do you have 14 an opinion within a reasonable degree of medical 15 and psychiatric certainty as to whether or not 16 Fluoxetine hydrochloride, otherwise known as 17 Prozac, in psychiatric cases, can alter the 18 chemical balance or imbalance in the brain? 19 A. It works upon the serotonin 20 system, so one assumes there is a certain 21 alteration of the serotonin system. 22 Q. Medicine is an inexact science, 23 isn't it, Doctor? 24 A. It is. Page 211 1 Q. And nobody really knows exactly 2 how chemical imbalance in the brain operates to 3 cause depression, do they? 4 A. Not exactly. 5 Q. And nobody knows exactly how 6 Fluoxetine or any other anti-depressant works on 7 the brain, do they? 8 A. We have good ideas and we have 9 evidence of certain functions. 10 Q. It's really just an educated 11 guess, isn't it? 12 A. I don't think so. 13 MR. MYERS: Hold on. Let me object to 14 the form before you answer that. I think you are 15 starting to argue with the witness when she's 16 answered your question once, Nancy. 17 MS. ZETTLER: She just answered it. 18 MR. MYERS: Right, she's trying to help 19 you. 20 MS. ZETTLER: I know. 21 Q. After the clinical research 22 physician reviews, and I think you said signs off 23 on the working 1639, what happens to the terms 24 that are assigned to the various adverse events, Page 212 1 are they entered into some sort of a computer 2 data base? 3 A. I assume. Since I don't work 4 in the DEU, I'm not sure what happens 5 specifically. 6 Q. But you have signed off on 7 1639s, working 1639s, haven't you? 8 A. Yes. 9 Q. Would all of those terms that 10 were assigned to the adverse events, would they 11 be entered into the DEN? 12 A. Yes. To the best of my 13 knowledge, yes. 14 Q. Could you look at Exhibit 15 Number 12 again? 16 A. (Witness complies.) 17 Q. About that first message that 18 starts with Jamie, thanks for the input, what is 19 that ADE, adverse drug event? 20 A. Adverse experience, adverse 21 drug experience, adverse event. 22 Q. Why is it that -- I believe you 23 said earlier it was Mike Noon who wrote this 24 E-mail. Why is it that he did not want CRAs Page 213 1 working in the clusters to follow up on the 2 reports? 3 MR. MYERS: Before she answers, let me 4 object to the extent you've asked the witness to 5 speculate since she was not the writer of this 6 message, as she's testified previously, and thus 7 would call upon her to speculate. But if she can 8 answer or if she knows, certainly go ahead. 9 A. I can only reiterate what he 10 says in his comments here. He would prefer to 11 have CRAs in clusters -- would not have CRAs in 12 the clusters following up on the reports because 13 it would imply consistency needed in fulfilling 14 the medical regulations. 15 Q. Do you know who he would prefer 16 having do the follow-up on the report? 17 A. His own CRAs. 18 Q. His own? 19 A. His own CRAs in the DEU. 20 Q. Cluster or group are 21 essentially the same thing, right, if you're 22 talking about Prozac cluster or Prozac group, is 23 that basically the same thing? 24 A. I'm not sure how you're Page 214 1 interpreting that, I don't want to equate them 2 yet. 3 Q. Okay. Let me ask you this, 4 what is a cluster? 5 A. A cluster is a specific working 6 group around a drug or a study or a compound. 7 Q. Okay. So in here he's speaking 8 about the Prozac cluster or is he speaking about 9 the CRAs in the clusters generally? 10 A. I think he's -- well, I don't 11 know what he's talking about. He may be talking 12 about the Prozac cluster, he may be talking about 13 he does not wish to set a precedent for CRAs in 14 any of the other clusters, whether we're talking 15 about diabetes or infections or diabetes to do 16 this type of work either. 17 Q. To your knowledge, were the 18 CRAs in the Prozac cluster as experienced with 19 working with the ELECT dictionary as the CRAs in 20 the DEU? 21 A. They would have some 22 experience. 23 Q. Would the CRAs in the DEU have 24 more experience than the CRAs in the cluster? Page 215 1 A. I believe any 1639 that was 2 done by a cluster CRA would always be reviewed by 3 a DEU CRA. 4 Q. Do you know any times when a 5 DEU CRA would change a term that was assigned to 6 the adverse event by a CRA in a cluster? 7 A. Possibly. 8 Q. Do you have any specific 9 knowledge of any particular case where that 10 happened? 11 A. No. 12 Q. Do you know of any times when a 13 clinical research physician would change the term 14 that was assigned to an adverse event by somebody 15 in the DEU? 16 A. Yes. 17 Q. And you cited some examples of 18 that earlier in one of the exhibits that Greg 19 showed you, right? 20 A. Yes. 21 MS. ZETTLER: Let's look at that 22 exhibit again, is that Exhibit 10? 23 MR. GREEN: Ten. 24 Q. Go back to 12. The last Page 216 1 paragraph on the first page, it says with a large 2 number of Pz event. What does Pz event mean? 3 A. Prozac. 4 Q. The sentence goes on to say 5 they are presently being handled by the DEU on 6 initial reports, follow-up can be lost in the 7 mountain of blue and green forms. What are blue 8 and green forms? 9 A. Those are the working forms, 10 those are the colors of working forms. 11 Q. What are initial reports? 12 A. Those are those first reports 13 that come in from the physician or the sales 14 representative. 15 Q. The paragraph above that, it 16 says with our present understanding of FDA 17 assessment of the SRS. What is SRS? 18 A. I don't know, I don't remember 19 that. 20 Q. What did he mean by the fourth 21 line, starting with the third line, with 22 reporting regulations yet provide ourselves with 23 adequate data for assessment of our own signals. 24 What does he mean by our own signals? Page 217 1 A. Things that we can pick up as 2 we take a look at all this, are we identify 3 patients who are exhibiting perhaps more nausea, 4 patients who an exhibiting alterations in any 5 kind of white cell counts. 6 Q. Okay. Now Exhibit 10, Doctor. 7 Would a hard copy of these E-mails that are 8 represented in Exhibit 10 always be printed out? 9 A. Not necessarily, no. 10 Q. Do you know why these were 11 printed out as opposed to being stored on the 12 computer somewhere? 13 A. I have no idea, I don't know 14 whose they were. 15 Q. Did you keep copies of these 16 types of E-mails, hard copies of E-mails in your 17 files? 18 A. Maybe yes, maybe no. 19 Q. Would you normally keep a copy 20 of a 1639 with the E-mail? 21 A. No. 22 Q. But to be able to make sense 23 out of what was done, at least reported to be 24 done, in these E-mails, you would have to look at Page 218 1 1639s; correct? 2 A. Correct. 3 Q. This -- at the top, after it 4 says regarding international report. 5 MR. MYERS: On the first page? 6 MS. ZETTLER: Yes. 7 Q. Where it says international 8 report, and underneath there's something blacked 9 out and underneath it says DES slash DEN. What 10 does DES stand for? 11 A. I don't know, drug epidemiology 12 system, I don't know. 13 Q. Can you turn to the third page? 14 A. (Witness complies.) 15 Q. Doctor, I believe you testified 16 earlier that the term overdose implies to some 17 extent an intentional act; correct? 18 A. Yes. 19 Q. Would you agree that suicide 20 attempt has a much more stronger implication of 21 an intentional act than the word overdose? 22 A. No, I would not necessarily 23 agree with that. 24 Q. Can you give me an example Page 219 1 where a suicide attempt may be unintentional? 2 MR. MYERS: Object to the form. Your 3 previous question was whether or not the suicide 4 attempt, I think in your words, had a much more 5 stronger implication of intent than overdose. 6 Now you're backtracking where a suicide attempt 7 would be unintentional. 8 MS. ZETTLER: Very good, Larry, that's 9 exactly what I mean. 10 MR. MYERS: It's a different question. 11 MS. ZETTLER: I'm asking her and she 12 gave me an answer to my first question. 13 A. I think suicide attempt implies 14 intention, overdose frequently implies intention. 15 Q. Suicide attempt across the 16 board implies intention? 17 A. Yes. 18 Q. Correct. So would you agree 19 with me that suicide attempt at some level 20 implies in a stronger manner intent than just the 21 word overdose? 22 A. No. I would have to take it as 23 seriously. I would -- 24 Q. I'm not talking about Page 220 1 seriousness, Doctor, I'm talking about the 2 element of intent. 3 A. I understand that, I understand 4 that. Overdose usually, in the mind of either a 5 health professional or even a lay person, until 6 proven otherwise, overdose implies a form of 7 suicide attempt, it is a specific form of suicide 8 attempt. 9 Q. Is there ever a time when it's 10 specifically listed as unintentional or 11 accidental overdose? 12 A. It can be and has been at 13 times. 14 Q. At what times? 15 A. I think early on, some patients 16 were captured as accidental overdose if there was 17 evidence of some form of an accidental overdose. 18 Q. Is a suicide attempt and an 19 overdose ever listed within the same terminology? 20 A. They might be. 21 Q. Why, in page Pz 983 634, why 22 would the term suicide attempt be changed to 23 overdose? 24 MR. MYERS: Before you answer, let me Page 221 1 object to the form to the extent that she's not 2 the writer of this message. Unless you're asking 3 her to comment on a specific case where she's not 4 even the writer of the message, and thus I object 5 to the form of the question. 6 MS. ZETTLER: You can answer it, 7 Doctor. 8 A. Overdose is actually a more 9 specific term than suicide attempt, it implies 10 both the intent and it informs you of a method. 11 So from a specificity, it is more specific and 12 one always goes to the more specific term on the 13 adverse event. 14 Q. Why are they both listed? 15 A. That results in a double count, 16 potentially. 17 Q. If we go back to the 1639 18 that's made a part of Exhibit Number 2, there are 19 six events listed; correct? 20 MR. MYERS: Let her get a hold of them. 21 A. All right. 22 Q. And you have there, listed 23 death, hostility, suicide attempt, comma, no drug 24 use. Page 222 1 A. Yes. 2 Q. -- agitation, thinking 3 abnormally, ischemia. 4 A. Yes. 5 Q. Isn't this suicide attempt, 6 comma, no drug use, essentially the same thing as 7 saying suicide attempt, non-overdose? 8 MR. MYERS: Let me object to the form 9 of the question. She doesn't have, just looking 10 at this report, have sufficient facts upon which 11 to make that determination. You're asking her to 12 equate suicide attempt, no drug used, to suicide 13 attempt, no overdose, just based on looking at 14 this form, without the benefit of any additional 15 information. What are you trying to get her to 16 do or say? 17 MS. ZETTLER: Let me just ask another 18 question. 19 MR. MYERS: Or just rephrase it. 20 Q. Let's go back to Exhibit 10, 21 page 983 634, okay. Now, am I correct that your 22 testimony up to now is that the word, changing 23 the term suicide attempt to the word overdose 24 implies a suicide attempt with an overdose? Page 223 1 A. Yes. 2 MR. MYERS: Did you say applies or 3 implies? 4 MS. ZETTLER: Implies. 5 A. Yes. It also adds a 6 seriousness to the outcome because overdose 7 automatically makes it a serious outcome. 8 Q. Where suicide attempt wouldn't 9 necessarily be a serious outcome? 10 A. That's correct. 11 Q. In this case -- in the case of 12 a suicide attempt being changed to overdose, you 13 wouldn't have to put an outcome on there? 14 A. You do have to put an outcome. 15 By changing to overdose, that automatically makes 16 it an overdose outcome, and a serious outcome. 17 You've changed actually -- you potentially 18 changed the seriousness by making it overdose 19 because you guarantee that it is a serious 20 outcome now. 21 Q. But the word overdose, then, 22 implies both the event and the outcome in one 23 word? 24 A. Yes -- no, no, there are two. Page 224 1 Overdose is an event and overdose is an outcome. 2 Q. Okay. So it's listed as both. 3 A. It's listed as both. 4 Q. So in other words, originally 5 on this form, suicide attempt would have been the 6 event; correct? 7 A. Yes. 8 Q. That suicide attempt is changed 9 to -- it's changed to overdose? 10 A. Yes. 11 Q. So it went from suicide 12 attempt, overdose, overdose, overdose. 13 A. No. Suicide attempt is the 14 event. 15 Q. Right. 16 A. If may or may not have a 17 seriousness assigned to it if it does not result 18 in death, if it does not result in 19 hospitalization, if for some reason there is not 20 an assumption of life threatening event to it, it 21 may not be a serious event. By changing it to 22 overdose, as the event, you must also then 23 upgrade it to a serious event, to a serious 24 outcome, because of overdose. Page 225 1 Q. Is this all based on the ELECT 2 system, the ELECT dictionary? 3 A. The serious outcome is an FDA 4 regulation and definition. 5 Q. But the term overdose, as used 6 in the context of these records, is something 7 that was determined under the ELECT dictionary? 8 A. Yes. 9 Q. And that is a dictionary that 10 was created by Eli Lilly; correct? 11 A. Yes. 12 Q. And again, the FDA, to your 13 knowledge, doesn't have a list included in 14 regulations somewhere as to specific events, such 15 as overdose, suicide attempt, things of that 16 nature, that should be considered serious and 17 unexpected, right, that is something that is a 18 judgment made on the criteria that you set out 19 earlier? 20 MR. MYERS: I think you've asked her 21 about three questions in that question. One part 22 was does the FDA have a written criteria for 23 what's serious? 24 Q. No, what I want to know is, and Page 226 1 I think I asked you this earlier, and if I did, I 2 apologize, but there is no list, as far as you 3 know, contained in the FDA regulations that say 4 this -- a suicide attempt in general has to be 5 considered serious for reasons of causing -- 6 determining causality. 7 A. If you really consider that 8 across all drugs, that becomes a major 9 undertaking. So my guess is I would doubt that 10 the FDA has a listing for every marketed drug of 11 adverse events, serious and unexpected. 12 Q. Okay. So it's a criteria, like 13 you say, the serious and unexpected criteria that 14 you use, your judgment to determine whether or 15 not this is something that falls under the 16 requirement of the FDA, right? 17 MR. MYERS: Let me object to the form 18 because when you talk about the serious criteria, 19 I object to the form because some of it is not 20 judgmental, it's objective, i.e. if the patient 21 died. So I object to the form. 22 MS. ZETTLER: Except if it's 23 unexpected. She already testified that if it's 24 unexpected, it's not necessarily something that Page 227 1 should be followed up in a causal relationship 2 aspect. 3 MR. MYERS: Are we talking about -- 4 A. Those are two different things. 5 Q. Right. 6 A. They're two different things in 7 my mind. They may or may not be two different 8 things in your mind the way you are addressing 9 the question. 10 Q. Well, let me go back to my 11 original question, okay. Exhibit Number 10, the 12 third page, where it says change the event term 13 to suicide -- from suicide attempt to overdose. 14 And I'm picturing it as columns in my head. 15 A. What? 16 Q. Columns. 17 A. Oh, columns. 18 Q. Columns. So you have an event 19 column and you have an -- I lost the word, 20 outcome column. And on this you originally had 21 suicide attempt and overdose, right? 22 A. No. 23 Q. Suicide as an event? 24 A. Suicide event is an event, but Page 228 1 outcome is not overdose. 2 Q. Okay. Then when does outcome 3 become, in this scenario, where you change a 4 suicide attempt to overdose? 5 A. Overdose, because overdose 6 implies an outcome of overdose. 7 Q. Okay. So before you change the 8 suicide attempt to overdose, there is no outcome 9 listed? 10 A. There may or may not be, there 11 may or may not be an outcome listed. They may 12 have been hospitalized, that is an outcome. They 13 may have died, that is an outcome. They may have 14 included overdose as an outcome. 15 Q. Okay. But once you change the 16 event term from suicide attempt to overdose, the 17 outcome automatically becomes overdose? 18 A. Yes. 19 Q. And therefore it becomes a 20 serious event? 21 A. Yes. 22 Q. Okay. Who is Robert Thompson, 23 do you know? 24 A. I think there are probably Page 229 1 several Robert Thompsons at Lilly, but I think 2 perhaps the one that this refers to is a Robert 3 Thompson who is a physician. 4 Q. Clinical research physician? 5 A. Yes. 6 Q. Was he working on Prozac? 7 A. I think he was in the 8 international division at the time. 9 Q. Could you look at Pz 982 1280 10 within the Exhibit 10? 11 A. 1280? 12 Q. Yes. 13 A. Yes. 14 Q. That's the E-mail dated July 15 13, 1990? 16 A. Yes. 17 Q. What is an EARS, E-A-R-S, 18 report? 19 A. I don't know, it may be an 20 international commentary since these are all 21 international reports, I don't know. 22 Q. And I think you testified 23 earlier that the FR designation on the DEN number 24 was for France? Page 230 1 A. Yes. 2 Q. What is UK for? 3 A. United Kingdom. 4 Q. Okay. Can you look at the last 5 line before the regards, before the enclosure, 6 please change event term depression to lack of 7 drug effect? 8 A. Yes. 9 Q. Is lack of drug effect 10 basically the same thing as lack of efficacy? 11 A. No. Marketed drug is already 12 proven to have efficacy, this is a lack of drug 13 effect for that particular patient. 14 Q. Okay. Lack of drug effect is 15 always listed as an adverse event? 16 MR. MYERS: Event or -- 17 Q. I'm sorry, is lack of drug 18 effect always listed as an adverse event? 19 A. I believe it is becoming a more 20 specific term now with designations by the FDA. 21 Whether it's always listed, I don't know. It 22 depends probably a great deal on the drug as 23 well. 24 Q. I guess I'm a little confused. Page 231 1 Lack of drug effect is a term that's used after 2 the drug is approved and marketed? 3 A. I believe it is. 4 Q. So lack of efficacy would be a 5 term used prior to marketing? 6 A. During the clinical trials. 7 Q. Do you have an understanding of 8 what a pivotal trial is? 9 A. I think so. 10 Q. Can you tell me what your 11 understanding of the word pivotal trial is? 12 A. It's one of the major studies, 13 they're typically large, double-blind, placebo 14 controlled, there may or may not be a comparative 15 depending upon the compound that's being studied 16 and the disease state, but typically placebo 17 controlled is a major study used for registration 18 purposes of a compound. 19 Q. Would these studies typically 20 demonstrate efficacy of the drug? 21 A. Yes. 22 Q. Was the depression stroke study 23 that you were involved with, was that a 24 double-blind study? Page 232 1 A. Yes. 2 Q. Who was in charge of acquiring 3 patients for that study, do you know? 4 A. The site. 5 Q. Do you have an understanding of 6 how the double-blind studies were randomized? 7 A. When, what double-blind 8 studies? 9 Q. Take your stroke study, was 10 that ever randomized? 11 A. Yes. 12 Q. Can you tell me how that was 13 randomized? 14 A. It was done by a systems 15 computerized format that's listed on -- the 16 process is listed in the protocol on how it would 17 be done. 18 Q. Who would keep track of -- who 19 eventually got the placebo and who eventually got 20 the Prozac? 21 MR. MYERS: In that study or any study? 22 MS. ZETTLER: In that study. 23 A. In that study, we were blinded 24 and the site was blinded. Page 233 1 Q. Somebody at Lilly had to know 2 who was getting what, when, right? 3 A. Only if the blind were to be 4 broken. 5 Q. Okay. But somebody had to have 6 possession of that information in case the blind 7 needed to be broken. 8 A. Yes. 9 Q. Who would that person be? 10 A. I would have to check the 11 study. 12 Q. Would there be a specific 13 department where that would usually be taken care 14 of? 15 A. Probably the systems division 16 would have that, as to what the blinding was. Or 17 it depends upon the study, depends upon how it is 18 written and where it is being conducted and who 19 keeps that, it may vary from study to study. 20 Q. Those five patients that were 21 enrolled in the -- 22 A. Five patients or less, I don't 23 remember exactly. 24 Q. Okay. Were those people Page 234 1 actually given either a placebo or Fluoxetine? 2 A. One or the other. 3 Q. Do you know if the 4 randomization with the drug was done prior or 5 after the patients were accumulated for the 6 study? 7 A. Say again? 8 Q. Were the -- was the 9 randomization with the drugs done before or after 10 the site acquired these five or less patients? 11 A. I would have to check and see 12 what the randomization procedure is listed in the 13 protocol. 14 Q. After the drugs were randomized 15 were they sent to the site? 16 A. After the drugs were 17 randomized? 18 Q. Strike that. After the drugs 19 were prepared for the study, were they then sent 20 to the site? 21 A. Yes. 22 Q. Was that an inpatient study? 23 A. No. 24 Q. Was that -- were the drugs sent Page 235 1 to the clinical investigator? 2 A. May have been sent to him, yes. 3 Q. And then he would be in charge 4 of distributing the pills to the various 5 patients, right? 6 A. He or his staff. 7 Q. Were you ever made aware of 8 whether or not any of those five or less people 9 that were on that study were actually on 10 Fluoxetine? 11 A. I would have to go back and 12 look. 13 Q. Was a report ever done on that 14 study? 15 A. A final report? A final report 16 is always done on every study. But with that 17 type of patient, since the study was not 18 completed and really there was no number for 19 enrollment, an actual final report, per se, was 20 not done, a closure report was done. 21 Q. So that report was never -- or 22 that study was never reported to the FDA, the 23 results of that study? 24 A. There were no results, the Page 236 1 results were, and yes they were reported in the 2 annual report for Prozac. 3 Q. When you say annual report, 4 what do you mean? 5 A. By regulatory requirements, 6 every drug is required to fulfill on an annual 7 basis an annual report. 8 Q. On what? 9 A. Any number of things, adverse 10 events, new mechanisms of action that may be 11 identified, any changes in chemistry, any 12 manufacturing, any labeling changes, any 13 packaging changes that may have been made. 14 Q. Were you ever involved with 15 preparing one of those annual reports? 16 A. For Prozac, no. 17 Q. If you wanted to do a study on 18 the incidence of suicide in people who use 19 Prozac, I believe earlier you stated that you 20 would pull up a term -- there were certain terms 21 you could pull up to determine how many people 22 had been given Prozac or experienced a suicide 23 attempt? 24 MR. MYERS: Let me object to the form Page 237 1 to the extent that are you talking about to 2 conduct the study or to look at data already 3 accumulated? 4 MS. ZETTLER: To conduct a study -- 5 well, strike that. 6 Q. I believe earlier you testified 7 that if you wanted to go in and conduct a study 8 on how many people who were given Prozac had 9 experienced suicide attempts, that there were 10 event terms that you could pull up? 11 A. Yes. 12 Q. Do you remember what those 13 terms were? 14 A. I'd probably take a look at the 15 package insert and go through and pick several. 16 Q. That would bring up information 17 related to somebody who had attempted suicide? 18 A. Yes. 19 Q. Would you take a look at 20 Exhibit Number 13 and give me some examples of 21 what you would use to pull up? 22 A. Look under patients with 23 depression, I would look under the event terms of 24 death, overdose, look for any events that might Page 238 1 include intentional overdose, even accidental 2 overdose, probably even consider patients and 3 look at a number of things that might have gotten 4 coded under psychosis, anti-social reaction, 5 paranoid reaction, hostility, depersonalization. 6 Those might be possibilities. And that's just 7 taking a look at terms in the DEN system. To do 8 a study out of the DEN system, one has to have a 9 comparator, as we said before, or one has to be 10 able to take that and recognize that simply 11 because you have data does not imply that you can 12 do magical things with it. It may be wonderful 13 information, but with the DEN system, one may not 14 get all the answer that you're looking for. So 15 to do a study with the DEN system, per se, may 16 not be possible. I'm not sure what you're 17 thinking of, but it may not be possible. You may 18 be able to get information, but you may not be 19 able to do a study. 20 Q. What types of information are 21 included in the DEN system? 22 MR. MYERS: Are or are not? 23 Q. Are. 24 A. Everything that is on the 1639, Page 239 1 the outcomes, the event terms. 2 Q. Everything on the final 1639? 3 A. Yes. 4 Q. Anything from the working 1639? 5 A. The working 1639 translates 6 pretty much to the final draft 1639. 7 Q. Including the narratives 8 reported by the doctors? 9 A. Yes. 10 Q. Who -- would somebody who was 11 not familiar with the DEN system be able to look 12 through a package insert like you just did in 13 Exhibit Number 13 and come up with the terms most 14 likely to pull up information regarding 15 suicidality in people who use Prozac? 16 MR. MYERS: Let me object to the form, 17 I believe it calls upon the witness to speculate 18 as to what some person without knowledge of the 19 DEN system could or could not do. It's highly 20 speculative. 21 A. I'm not sure what you're 22 looking for. I would assume that if somebody is 23 looking for, quote, information out of the DEN 24 system, they have more information than simply Page 240 1 what you said, they would have some working 2 knowledge of drug reporting, not just for Lilly 3 but across the board for the pharmaceutical 4 industry. 5 Q. So you're assuming that every 6 doctor who prescribes Prozac has some working 7 knowledge of the pharmaceutical industry? 8 MR. MYERS: Let me object to the form, 9 that's not what she said. You're 10 mischaracterizing her testimony. 11 A. Maybe I misunderstood your 12 question with it. I assumed that for somebody 13 who was going to do a study on suicide, I would 14 assume that every doctor who looks at this 15 package insert or this summary probably does have 16 an understanding of adverse event reporting, 17 which the practicing patient doctor may not 18 necessarily have. Most physicians in private 19 practice certainly may not be interested in doing 20 a study, per se, because they may not have any 21 understanding of adverse event reporting, et 22 cetera. 23 Q. Okay. So just so I get this 24 straight, the person who is more likely to want Page 241 1 to do a study of that nature, suicidality, as it 2 relates to people who use Prozac, would have a 3 better working knowledge of the pharmaceutical 4 industry and the reporting of adverse events as 5 would, say, a GP who was prescribing Prozac to 6 one of his patients? 7 A. One assumes so. One also 8 assumes that if you're going to do a study on 9 suicide, you would probably take a look at data 10 from double-blind placebo-controlled clinical 11 trials, and not from a spontaneous reporting 12 system such as DEN. 13 Q. Okay. Let me ask you this: 14 Assuming that all of these terms that you pulled 15 off of the Exhibit Number 13, the package insert, 16 did in effect have or -- strike that -- did, in 17 fact, have a relationship to information about 18 suicidality and Prozac, would that GP that 19 doesn't have as good a working knowledge of the 20 drug industry and the reporting of adverse 21 events, necessarily be able to look at this and 22 say well, they reported psychosis here, so that 23 must mean something about suicidality? 24 MR. MYERS: Before you answer, let me Page 242 1 object to the form on this basis: Number one, 2 the exhibit is not a package insert, it's called 3 a brief summary, as the witness testified 4 earlier, and number two, you again asked her to 5 comment on what a general practitioner would and 6 would not know, and thus puts the witness in a 7 position to have to speculate about what some 8 third party, unidentified, would or would not 9 know what the extent of their knowledge would be. 10 MS. ZETTLER: She already testified 11 that the average GP or average prescribing 12 physician wouldn't necessarily have the same type 13 of knowledge as somebody who would be wanting to 14 do a study on suicidality. 15 MR. MYERS: In answering your question 16 she gave an assumption in order to be able to 17 answer your question. I still object to the 18 form. If she can answer, that's fine. 19 Q. Can you answer the question? 20 A. I don't even remember the 21 question. 22 MS. ZETTLER: Can you read it back? 23 (THE COURT REPORTER READ BACK THE 24 REQUESTED TESTIMONY.) Page 243 1 Q. Let me rephrase the question. 2 Assuming you have somebody who is not interested 3 in doing a study on suicidality, somebody who is 4 just prescribing Prozac, be it a psychiatrist or 5 GP, somebody like that, would they be able to 6 look at something such as Exhibit Number 13, a 7 package insert or summary, such as Exhibit 13, 8 and be able to tell from what is reported in here 9 that some of these things may in fact relate to 10 reports of suicidalities? 11 A. It gets more specific, though, 12 in the package insert and the summary, it talks 13 about suicide, per se, first column. 14 Q. Setting aside suicidality, you 15 said earlier that there's -- 16 A. Those are two different issues. 17 You asked me about doing a study and evaluating 18 those terms. 19 Q. Okay. My question is -- 20 A. That becomes a different issue 21 of looking at studies and looking at event terms 22 and trying to be as inclusive as possible for 23 exactly that specific purpose with it. I think 24 physicians looking at the package insert come to Page 244 1 it for a different view than my going to a system 2 that says what event terms can I look at, how 3 inclusive can I be in answering this question. I 4 think the intents are entirely different for 5 those two objectives. 6 Q. Okay. So would you agree that 7 a person such as a GP or a psychiatrist, who were 8 just interested in prescribing the medication, 9 would be relying at least somewhat on what is 10 represented in the package insert? 11 MR. MYERS: Before she answers that, 12 that again calls upon her to speculate as to what 13 some third-party physician would or would not do, 14 would or would not rely on. But if you can 15 answer, please try. 16 A. I can't answer that. I guess 17 my question is, for what, relying for what? 18 Q. For information regarding 19 adverse events. 20 A. Can they come here and look at 21 this and get information regarding adverse 22 events? 23 Q. Right. 24 A. Yes. Page 245 1 Q. Okay. And wouldn't they, to a 2 certain extent, without having the knowledge that 3 somebody who may or may not want to do a study on 4 this stuff, but could look at this stuff and see -- 5 look at this information and see where they could 6 find further information, would -- wouldn't that 7 person who doesn't have that kind of experience 8 be more or less relying on the information 9 reported by the manufacturer in these types of 10 documents? 11 MR. MYERS: Same objection. 12 A. Haven't we answered this 13 question before? I feel like we've had this 14 question. 15 Q. Seems like it. 16 A. I think physicians look at 17 this, and based upon their knowledge and their 18 patients and their information on the disease 19 state that they are treating, as they look at 20 this, one can come up with a pretty good idea of 21 inferences as well as actual specific events 22 here. 23 Q. Okay. That's assuming that 24 what's being reported in these documents is Page 246 1 accurate; correct? 2 A. It is accurate. 3 Q. But whether or not they really 4 rely on it assumes -- depends on whether or not 5 the information that's being reported in these 6 documents is accurate? 7 MR. MYERS: She's answered that. 8 MS. ZETTLER: No, she didn't, she 9 answered that it is accurate -- 10 MR. MYERS: That's an answer. 11 MS. ZETTLER: That's not a response to 12 my question. 13 MR. MYERS: That's not the answer you 14 want, but that's an answer. 15 MS. ZETTLER: That's the answer you 16 guys want, it's not an answer to my question. 17 Q. My question is: Assuming that -- 18 whether or not somebody can rely on this assumes 19 that the information in this document is 20 accurate? 21 MR. MYERS: Same objection as to what 22 some third party can or can't rely upon, but go 23 ahead and see if you can help her. 24 A. I cannot say what they will Page 247 1 assume, I will say that I believe it is accurate. 2 Q. My question is very simple, and 3 it calls for a yes or no answer. Whether or not 4 somebody can rely on this information in 5 prescribing Prozac, the information that's 6 reported in either the package inserts or 7 documents such as Exhibit Number 13, really 8 depends on whether or not the information 9 contained in that document is reported 10 accurately, doesn't it? 11 MR. MYERS: Same objection, see if you 12 can conclude this by answering the question. 13 A. I believe they would assume 14 that the information that is reported here is 15 accurate, and they could make inferences from 16 those assumptions. 17 MS. ZETTLER: Okay. Let's take a 18 break. 19 (A SHORT RECESS WAS TAKEN.) 20 Q. (BY MS. ZETTLER) Let's back up 21 a little bit. I think earlier we were talking 22 about when a determination of a causal 23 relationship between an adverse event and Prozac 24 is made, it's reported as a working 1639? Page 248 1 A. Yes. 2 Q. And it is not reported as a 3 final report. 4 A. That's true. 5 Q. Now when the information is 6 entered into the DEN, is any information related 7 to a determination of a causal relationship also 8 entered into the DEN? 9 A. I don't know. 10 Q. I believe you also said that 11 the information related or determination related 12 to causal relationship is sent to regulatory? 13 A. That is DEN, DEN is in the 14 regulatory division. 15 Q. Okay. So you're not sure if 16 it's actually sent there or not? 17 A. Sent where? If it's on the 18 1639 working form. 19 Q. It's sent there, but it doesn't 20 necessarily go into the network. 21 A. I don't know because I've never 22 done those entries, I don't do those entries. 23 Q. Was there ever an occasion 24 where you attempted to retrieve information on a Page 249 1 causal relationship between an adverse event and 2 Prozac? 3 A. No. 4 Q. Did you know that if you wanted 5 to do that how you would go about doing that? 6 A. I have no idea. 7 Q. You also testified earlier that 8 in cases where a litigation is involved with an 9 adverse event, then a determination of a causal 10 relationship will not be made? 11 A. That's right. 12 Q. What's the criteria for 13 determining when is litigation related to an 14 adverse event? 15 A. If it's reported litigation as 16 pending. 17 Q. Let's take the case of 18 Wesbecker, Joseph Wesbecker -- do you know that -- 19 do you know whether or not that was a situation 20 where a determination of a causal relationship 21 between what Mr. Wesbecker did and his 22 consumption of Prozac was not made because 23 litigation was pending? 24 A. I don't know, I have no idea. Page 250 1 Q. In any situation where a causal 2 determination is not made because of litigation 3 pending, would that actually have to be a 4 litigation that has been commenced or could that 5 be something that's done in anticipation of 6 litigation? 7 A. I don't know. 8 Q. Would anybody at Lilly at any 9 time make a determination of a causal 10 relationship between an adverse event and the use 11 of Prozac in a litigation situation, to your 12 knowledge? 13 A. I don't know. 14 Q. I think you testified that in 15 your private practice you did a lot of work with 16 headaches? 17 A. Yes. 18 Q. Have you ever heard of 19 prescribing Prozac for migraine headaches? 20 A. I know it's done. 21 Q. That's not an indicated -- an 22 approved indicated use, though, is it? 23 A. That is true, it is not an 24 approved indication. Page 251 1 Q. In your opinion is that 2 appropriate to prescribe Prozac for treatment of 3 migraines? 4 MR. MYERS: Let me object to the form 5 of the question to the extent that it calls upon 6 the physician to comment on the propriety or not 7 of what some other physician would or would not 8 do, and thus calls upon her to speculate based on 9 the limited facts given in the question. 10 Q. Doctor, you're a board 11 certified neurologist, right? 12 A. Yes. 13 Q. And you have extensive 14 experience in treatment of headaches, different 15 types of headaches? 16 A. Yes. 17 Q. And you also have fairly 18 extensive experience in Prozac and its uses, 19 don't you? 20 A. Yes. 21 Q. Do you have an opinion within a 22 reasonable degree of medical certainty as to 23 whether or not it's appropriate for somebody to 24 prescribe Prozac for the treatment of migraine Page 252 1 headaches? 2 MR. MYERS: Same objection. You can 3 answer it if you can. 4 A. I think it depends upon the 5 patient, depends upon the headaches. I think 6 there are a number of issues that must be 7 addressed in prescribing any type of medication 8 for a migraine patient. 9 Q. In what situations would it be 10 appropriate to prescribe Prozac for migraine 11 headaches? 12 A. I think it varies from patient 13 to patient. 14 Q. Can you give me one example in 15 what situation it would be appropriate to 16 prescribe Prozac for somebody suffering from 17 migraine headaches? 18 A. They are depressed. 19 Q. What if they're not depressed? 20 A. Many patients are not aware of 21 the fact that chronic headaches do include 22 chronic migraines and may have an element of 23 depression with it, and oftentimes depression, 24 one of the symptoms that one may see with Page 253 1 depression is headaches. 2 Q. What if the person is not 3 suffering from depression, would it be 4 appropriate to prescribe Prozac for the treatment 5 of migraine headaches? 6 MR. MYERS: Same objection. 7 A. I think there are many issues 8 to that. It may be. 9 Q. Give me a situation where a 10 person who is not suffering from depression but 11 they are suffering from migraine headaches and it 12 would be appropriate to prescribe Prozac for 13 treatment of migraine headaches? 14 MR. MYERS: Same objection. 15 A. I'm sorry, what was the first 16 part of that? 17 Q. In a person -- please give me 18 an example of a person who is not suffering from 19 depression, but is suffering from migraine 20 headaches, a situation with that type of a 21 patient where it would be appropriate to 22 prescribe Prozac for treatment of her migraine 23 headaches. 24 MR. MYERS: Same objection. Page 254 1 A. Well, we certainly know that 2 the serotonin system is involved in headaches, 3 and Prozac does have an effect upon the serotonin 4 system. So indeed, at some point, in some 5 patients, is may be appropriate. 6 Q. Have you ever heard of the drug 7 Wigraine? 8 A. Yes. 9 Q. Is that appropriate to 10 prescribe Prozac in conjunction with that drug? 11 A. I don't know, I would have to 12 look and see. 13 Q. How about Nardil? 14 A. It would not be appropriate. 15 Q. Why not? 16 A. Nardil is a MAO inhibitor. 17 Q. Earlier you testified with 18 regards to the adverse event report on the 19 Wesbecker case that you don't recall ever seeing 20 the 1639. Do you remember how you first found 21 out about the Wesbecker case? 22 A. I don't remember that I 23 testified that I'd never seen a 1639, is that 24 what I said? Page 255 1 Q. On Wesbecker. 2 A. Yes. I don't remember 3 testifying specifically to that. I was asked, I 4 believe, if I had signed off on it, and I believe 5 my answer was I don't remember doing that, no. I 6 believe someone told me about the report of the 7 Wesbecker case at work. 8 Q. Okay. And then I believe you 9 testified, and we have an exhibit memorializing a 10 meeting between yourself and a number of other 11 clinical research physicians regarding the 12 Wesbecker events; correct? 13 A. Are you referring to the note 14 to file? 15 Q. Right, there's a meeting -- 16 there was a meeting that you participated in? 17 A. I believe that was a conference 18 call. 19 Q. You're right, I'm sorry, a 20 conference call. 21 A. Okay. 22 Q. Can you tell me what was 23 discussed in that conference call outside that 24 memorandum? Page 256 1 MR. MYERS: Other than what's in the 2 memo? 3 MS. ZETTLER: Right. 4 A. As far as I remember, that's 5 all that was discussed. I don't remember -- were 6 it not for the memo, I could not specifically 7 identify what was even discussed in the 8 conference call. 9 Q. How was the mood during that 10 conference call? 11 MR. MYERS: I object to the form, to 12 the term mood, that's awfully vague. 13 Q. Do you have an understanding of 14 what the word mood means? 15 A. I believe so. 16 Q. Do you have an understanding of 17 what the word mood may mean in the context of a 18 lot of people in a conference call? 19 A. There was not a lot of people, 20 I think there were just -- 21 Q. Five or six people on the 22 conference call? 23 A. Some of us, i.e. myself, 24 listened, we did not conference too awfully much Page 257 1 with it. I believe it was one of interest and 2 trying to identify and answer questions and gain 3 information, I believe that was the mood, was one 4 of trying to obtain information or provide, 5 either way. 6 Q. Okay. You also testified that 7 before you prescribed Prozac to five or less 8 patients in your private practice before working 9 with Lilly, that you gained your knowledge of 10 Prozac through, I believe it was, the package 11 inserts, the literature, literature that you 12 looked at, and during a meeting. What meeting 13 did you mean? 14 A. It may have been a symposium or 15 meeting or educational event. 16 Q. I think when we were talking 17 earlier about doing an epidemiological study with 18 the information that was contained in the DEN, 19 you said that you wouldn't be able to do that 20 because there was no comparatory; is that 21 correct? 22 A. Yes. 23 Q. Also you said that it would be 24 difficult to do because there's no way of knowing Page 258 1 how many people have been on the drug? 2 A. It's difficult to identify all 3 of that, yes. 4 Q. Do you know if there's -- are 5 there reporting requirements for pharmacists when 6 they fill a prescription? 7 MR. MYERS: Object to the form as 8 reporting requirements as to who? 9 Q. Do you know if there are 10 requirements by either the drug enforcement 11 administration or the FDA under which pharmacists 12 are required to keep track of drugs that they 13 prescribe and report them to various agencies? 14 A. I don't know what the 15 requirements are for pharmacists. 16 Q. And are you aware that it might 17 be possible to make a fairly reasonable estimate 18 of how many people have been prescribed Prozac by 19 looking at drug enforcement administration 20 records? 21 A. Probably, I don't know. 22 Q. Have you ever been involved in 23 any retrospective studies regarding Prozac and 24 suicidality? Page 259 1 A. No. 2 Q. Are you aware of any 3 prospective studies on Prozac and suicidality or 4 homicidality that are now being conducted at Eli 5 Lilly? 6 A. No. 7 Q. Do you know of any studies that 8 have been -- of those kinds that have been 9 conducted and are awaiting publication? 10 A. No. 11 Q. Earlier you said that you had 12 experience in reading autopsy reports about 13 people who have died while taking Prozac; 14 correct? 15 A. Yes. 16 Q. I'm not sure if Greg asked you 17 this or not, and if he did, I apologize, but do 18 you remember on how many occasions you have had 19 the opportunity to read autopsy reports on people 20 who have died while taking Prozac? 21 A. It's extremely a very few. The 22 exact number, I don't know, but we're talking a 23 very, very few. 24 Q. Less than twenty? Page 260 1 A. Probably. 2 Q. Less than ten? 3 A. I don't know, probably less 4 than ten even. 5 Q. Did the marketing department 6 pay for your study on post-stroke depression in 7 Prozac? 8 A. As part of the support phase 9 after registration, yes. 10 Q. To your knowledge, does the 11 marketing department pay for all studies that are 12 done on Prozac, post-marketing? 13 A. It depends on the indication. 14 Q. Say in depression studies? 15 A. They probably would, but I 16 don't know that that is a definite fact. I have 17 no idea what's presently going and who is paying 18 for any of those studies. 19 Q. To your knowledge, would the 20 marketing department pay for retrospective 21 studies on Prozac and suicidality? 22 A. I have no idea. 23 Q. Would that be considered a 24 support study, to your knowledge? Page 261 1 A. It might. On the other hand, 2 it might not, so I'm not sure how they would view 3 it. 4 Q. To your knowledge, are more 5 than one Hamilton depression scale ratings used 6 on various studies that are done on Prozac? 7 A. Are there more than what? 8 Q. More than one Hamilton 9 depression rating scale that could be used, 10 generally? 11 A. I think there are different 12 forms for the Hamilton, if that's what you're 13 talking about. Some are longer than others, some 14 have more questions. 15 Q. Do you know if Lilly 16 consistently used one form of the Hamilton 17 depression scale or another during the trials on 18 Prozac? 19 A. I don't know. 20 Q. Do you know which form was 21 intended on being used in your study? 22 A. I would have to look and see, I 23 don't remember. 24 Q. Do you know if drug diary Page 262 1 pamphlets were to be passed out to the people on 2 your stroke study? 3 A. Drug diary pamphlets, I don't 4 remember. 5 Q. Have you ever heard that term 6 before? 7 A. Yes. 8 Q. Can you tell us what it is? 9 A. It's a diary or small booklet 10 or pamphlet or even just a page in which patients 11 are asked to report certain things. It can be 12 anyplace from when they took the medicine to when 13 they ate to any other number of things. 14 Q. Would they, in some 15 circumstances, be asked to record how they would 16 feel on any given day or if they had any unusual 17 physical feelings, et cetera? 18 A. They might be. 19 Q. COSTART and ELECT are really 20 closer to being Thesauruses than dictionaries, 21 aren't they? 22 MR. MYERS: Is that a statement? 23 MS. ZETTLER: That's a question. 24 A. I don't know. I think that's a Page 263 1 semantic term and I'm not sure -- I'm not sure 2 that I can answer your question. 3 Q. Okay. My understanding of how 4 COSTART, at least, works is that there may be a 5 term sufficient as, let's say, overdose, okay, 6 and listed in relationship to that term are a 7 number of what are considered synonyms for 8 overdose, like intentional overdose, accidental 9 overdose, could be carbon monoxide poisoning, 10 something along those lines; is that your 11 understanding? 12 A. Yes. 13 Q. Is that similar to the way 14 ELECT worked? 15 A. Yes. 16 Q. Did you ever work with COSTART? 17 A. Some. I work with it some now 18 in my Parkinson monitoring. 19 Q. The Parkinson drug that you're 20 working on isn't related in any way to 21 Fluoxetine, is it? 22 A. No. 23 Q. If somebody were to report that 24 a patient of theirs was restless, reported being Page 264 1 restless, how would that be reported on the 2 adverse drug event network? 3 A. I would check and see if 4 restlessness is an event term that's coded as 5 restless or if it maps, as we say, maps to a 6 specific term. 7 Q. Do you know offhand if 8 restlessness was coded to a specific term on the 9 ELECT system? 10 A. I don't remember. 11 Q. How about agitation? 12 A. I don't remember. 13 Q. Are you familiar with the term 14 akathisia? 15 A. Yes. 16 Q. Can you tell us what akathisia 17 is? 18 A. It's an uncontrollable feeling 19 of need to move. 20 Q. Okay. Are you aware that some 21 medical literature has related akathisia-type of 22 condition to the use of Prozac? 23 A. Yes. 24 Q. What is your understanding of Page 265 1 the relationship between that akathisia-type of 2 condition and the use of Prozac? 3 MR. MYERS: When you say that 4 akathisia-type of condition, what do you mean? 5 MS. ZETTLER: The one that she just 6 said that she's aware of, in response to my last 7 question. 8 MR. MYERS: As reported in literature 9 or akathisia generally? 10 MS. ZETTLER: Can you read back the 11 question? 12 (THE COURT REPORTER READ BACK THE 13 REQUESTED TESTIMONY.) 14 A. I would have to go back and 15 reread the literature, I don't remember it. 16 Q. To your knowledge, is there a 17 difference between akathisia as it's reported 18 with regards to the use of neurological 19 medications and the akathisia that's reported 20 with regards to the use of Prozac? 21 A. I don't know. 22 Q. Could you look at Exhibit 23 Number 10 again, please, Pz 985 687. It looks 24 like it's about seven pages from the end. Page 266 1 A. 985? 2 Q. Right, 687. 3 A. Yes. 4 Q. Do you know what drug they're 5 talking about there when they say patient's dose 6 is a hundred milligrams? 7 A. I assume we're still talking 8 Prozac. 9 Q. Is a hundred milligrams an 10 overdose of Prozac? 11 A. It is by the package 12 literature, yes. 13 Q. Could you turn to 983 202 in 14 that same exhibit? 15 A. Is that backward or forward? 16 Q. Backward, it's the third page 17 from the end. 18 A. 983 202? 19 Q. Right. First of all, that DEN 20 number, G-E-R-M, would that be germ? 21 A. Yes. 22 Q. And it says there event term, 23 nausea? 24 A. Yes. Page 267 1 Q. It says please provide us with 2 the following information regarding this patient: 3 Did suicidal thoughts occur prior to Prozac 4 therapy, does patient continue to have suicidal 5 thoughts, is patient losing weight. Why are 6 those types of questions listed under the term 7 event nausea? 8 MR. MYERS: I object to the form only 9 to the extent that you are asking this witness 10 what the writer of this message meant, and the 11 witness is not the writer and you're thus asking 12 her to speculate. 13 Q. Do you have any idea why these 14 questions are listed under an event term of 15 nausea? 16 A. No. 17 Q. Would an appropriate event term 18 in this case be suicide attempt? 19 MR. MYERS: Same objection. 20 A. I have no idea, there is not 21 enough information here to -- if anything that is 22 commented on, either from a question or an 23 answer, is all very speculative based on this 24 alone. Page 268 1 Q. What is atypical depression, to 2 your knowledge? 3 A. I'm not sure that I have a 4 definition that I can readily supply, having not 5 really dealt with that a great deal. It's my 6 understanding, at least from my standpoint, that 7 those are people who are depressed, but that may 8 not exhibit the, quote, typical symptoms of 9 depression. Some of them may not have the 10 definitive insomnia or sleep disturbances, some 11 of them may or may not have appetite alterations, 12 some may or may not have what we oftentimes think 13 of as significant mood alterations or to the 14 extent or severity of mood alterations. 15 Q. Okay. So it's not a condition 16 with something like depression plus psychotic 17 features or things of that nature? 18 A. I don't know if somebody has 19 defined it like that. 20 Q. Do you know if there's a DSM 21 3-R on atypical depression? 22 A. I don't know. 23 Q. Could you look at Exhibit 24 Number 6, please. Page 269 1 A. Yes. 2 Q. This looks like an E-mail 3 related to your post-stroke depression study. 4 A. Yes. 5 Q. What is this, it says this 6 protocol which has been approved by the CRPC. 7 What is a CRPC? 8 MR. MYERS: She answered that earlier, 9 but go ahead. 10 A. I always have trouble with the 11 acronyms. I believe, and I could very well be 12 wrong, so there's a caveat to this, clinical 13 research protocol committee. 14 Q. Okay, now I remember, I'm 15 sorry. Then later on it says National Institute 16 of Mental Health has recently approved blank 17 original protocol? 18 A. Yes. 19 Q. Do you know who blank is? 20 A. Yes. 21 Q. Who is blank? 22 A. That's the investigator. 23 Q. What's his name? 24 MR. MYERS: Come on, Nancy, that's Page 270 1 proprietary and confidential and she doesn't have 2 to answer. 3 THE WITNESS: I think we had this 4 previous discussion. 5 MS. ZETTLER: Right, I know we did, but 6 I'm trying to make a record here. 7 Q. It's my understanding that this 8 study was never completed or reported in the 9 annual report; correct? 10 A. It was reported in the annual 11 report. 12 Q. But there were no results drawn 13 or anything from it? 14 A. Not from that type of study, 15 no. No one ever completed the study. 16 MS. ZETTLER: So I don't see where it's 17 proprietary information. Even if it was, if it 18 is a depression study -- 19 MR. MYERS: I understand what you're 20 saying, there's no need to dwell about it. We 21 believe it's proprietary and confidential, and I 22 thus direct her not to disclose who the 23 investigator is. She said the blank is the 24 investigator. Page 271 1 MS. ZETTLER: Okay, certify that 2 question also. 3 (QUESTION CERTIFIED.) 4 Q. And I take it, therefore, blank 5 is also the investigator? 6 A. It may be, it may not be. 7 Q. On the third paragraph down, it 8 says treatment will now be covered under the NIMH 9 manual. Is that the National Institute of Mental 10 Health? 11 A. Yes. 12 Q. To your knowledge, does the 13 National Institute of Mental Health do a lot of 14 grants with Eli Lilly on Prozac? 15 A. This is not a grant with Eli 16 Lilly, this is a grant with the investigator. 17 Q. So this was a study that was 18 funded, in part, by the National Institute of 19 Mental Health as well as Eli Lilly? 20 A. No, there are two different 21 studies there. There are two components to this 22 study, one that looks at delayed treatment, 23 funded by NIMH, and a Lilly portion, done in a 24 particular subset of population, i.e. patients Page 272 1 with stroke. 2 Q. But both done with Prozac? 3 A. I believe so. But I can't 4 remember the NIMH protocol, it may not have 5 included Prozac, I don't know. 6 Q. Do you have any idea how much 7 involvement Eli Lilly has with the National 8 Institute of Mental Health? 9 A. No. 10 Q. Do you know if they worked with 11 the two groups that worked together on producing 12 advertisements that have been run on T.V. 13 recently? 14 A. I have no idea. 15 Q. What's dyspnea? 16 A. Shortness of breath. 17 MR. MYERS: I tend to have it some 18 during these depositions. 19 MS. ZETTLER: Me too. 20 Q. Can you turn to Exhibit Number 21 8? 22 A. Yes. 23 Q. Let's see, starting on page 24 two. Do you know if the following people are Page 273 1 Lilly employees or have done -- 2 MR. MYERS: Wait a minute, Exhibit 8? 3 MS. ZETTLER: Eight. 4 MR. MYERS: Is that that letter? 5 Q. Right, page two. Starting with 6 the first column it says in one published report 7 of Fluoxetine overdose. Do you know if Finnegan 8 is an employee of Eli Lilly's? 9 A. Not to my knowledge. 10 Q. Do you know if he's ever 11 conducted a clinical trial for Lilly? 12 A. I don't know. 13 Q. How about Riddle, in the second 14 paragraph? 15 A. He's not an employee, I don't 16 know if he's done any previous trials. 17 Q. How about Borys, B-O-R-Y-S? 18 A. He's not an employee, to my 19 knowledge, and I don't know if he's done clinical 20 trials. 21 Q. How about Spiller? 22 A. The same. To my knowledge, 23 he's not an employee, and I don't know if he's 24 ever done clinical trials. Page 274 1 Q. How about Risch, R-I-S-C-H? 2 A. Is that on the third page? 3 Q. Beginning of what's left of the 4 bibliography. 5 A. To my knowledge, he's not an 6 employee, and I don't know if he's ever done 7 clinical trials. 8 Q. How about J. M. Davis? 9 A. The same. To my knowledge, 10 he's not an employee, and I don't know if he's 11 done clinical trials. 12 Q. Do you know if this is John M. 13 Davis? 14 A. I have no idea. 15 Q. Was your stroke study a Phase 4 16 study? 17 A. Yes. 18 Q. Can you give me an idea of what 19 a Phase 1 study is? 20 A. Those are early studies usually 21 done in normal volunteers. 22 Q. How about animal studies, what 23 are those considered? 24 A. Preclinical. Page 275 1 Q. What qualifications do the 2 clinical investigators have to meet to work on 3 the Prozac trials for Lilly? 4 A. I don't know. 5 Q. Who would know that, do you 6 know? 7 A. Those people who may be running 8 a particular trial in a particular area. 9 Q. Have you ever worked with any 10 statisticians with Lilly on Prozac? 11 A. Yes -- on Prozac, no. 12 Q. Do you know if specific adverse 13 events were included in consent forms that were 14 given to the patients who were going to 15 participate in your stroke trial? 16 A. Say that again, if they were 17 given what? 18 Q. Given, like, say, in the form 19 of a consent form, were any specific adverse 20 events listed in the consent form? 21 A. I believe so. 22 Q. Do you know which ones they 23 were? 24 A. There's a whole list of them, I Page 276 1 would imagine. I would have to look at the 2 specific consent form used for that study. 3 Q. Where did they get the adverse 4 event forms from? 5 A. The package insert, package 6 literature. 7 Q. I believe you said you thought 8 that suicidality was an exclusion criteria on 9 your study or -- 10 A. I didn't know. 11 Q. Do you know who would formulate 12 the exclusion criteria for your protocol? 13 A. Clinical physician along with 14 the input from the investigator or investigators. 15 Q. Was there more than one 16 clinical investigator on your trial? 17 A. I had only one site. 18 Q. So one doctor at one site? 19 A. Yes. 20 Q. Have you ever heard of a FD 21 form fifteen seventy-three? 22 A. No. 23 Q. Have you ever had to fill one 24 of those out? Page 277 1 A. Well, if I knew what it was, 2 maybe I could answer if I've ever filled it out. 3 Q. It's a form for the FDA showing 4 the qualifications of investigators for 5 participation in clinical studies. 6 A. No, those were typically filled 7 out by CRAs. 8 Q. The form fifteen seventy-three 9 is filled out by CRAs? 10 A. Usually. 11 Q. Not by investigators? 12 A. Maybe by the investigator, I 13 don't know. 14 Q. Were clinical report forms 15 filled out for the five or less people that were 16 involved in your stroke study? 17 A. If they were entered into the 18 study and came and met visit criteria, yes. 19 Q. The visit criteria? 20 A. If they came to a visit. 21 Q. Oh. So -- and if they did, 22 what was the protocol or what was the procedure 23 for getting the information from the site to 24 Lilly, if you know? Page 278 1 A. I don't know. 2 Q. Do you know what the procedure 3 was for double-checking accuracy of the 4 information listed on the CRS? 5 A. I don't know. 6 Q. Do you know who would be in 7 charge of doing that? 8 A. The CRA would probably work 9 with whomever, and there's a format or process 10 for that. 11 Q. For double-checking the 12 accuracy of information? 13 A. I believe so, yes. 14 Q. Have you ever heard of a Dr. 15 Jan Fossettt? 16 A. I know the name. 17 Q. Have ever worked with Dr. 18 Fossett on any Prozac related stuff? 19 A. No. 20 Q. Do you know if there was a 21 definition of a suicide attempt that Lilly would 22 use to categorize it as either a serious or 23 nonserious adverse event? 24 A. Say that again? Page 279 1 Q. Sure. Do you know if -- did 2 Lilly have a definition of suicide attempt to 3 help categorize it as an adverse event? 4 MR. MYERS: Object to the form only to 5 the extent that your question is inconsistent 6 with, and contrary to earlier testimony as to the 7 five or six criteria for identifying those 8 events. 9 Q. Okay. Other than that criteria 10 that we talked about earlier, the regulatory 11 criteria, is there -- was there any definition of 12 suicide attempt that Lilly used to categorize 13 suicide attempt? 14 A. Categorize in what way? 15 Q. Various adverse event 16 categories. 17 A. I'm not sure that I understand 18 what you mean by categorize an adverse event. 19 Q. Let me ask this: Did Lilly 20 have a definition of suicide attempt? 21 A. Specific definition of suicide 22 attempt? 23 Q. Right. 24 A. I don't know that I remember a Page 280 1 specific written definition. 2 Q. Who is Von Bryson, if you know? 3 A. The president of Lilly. 4 Q. Is he still president of Lilly? 5 A. Yes. 6 Q. Was he president of Lilly when 7 you worked with Prozac? 8 A. No. 9 Q. Who was president of Lilly 10 then? 11 A. Richard Wood. 12 Q. Have you ever heard the word 13 synopsis? 14 A. Synopsis? 15 Q. As used in relation to clinical 16 trials? 17 MR. MYERS: Could you spell that? 18 MS. ZETTLER: Sure. Synopsis, 19 S-Y-N-O-P-S-I-S. 20 A. No, not specifically in 21 relation to a clinical trial. 22 Q. Have you ever heard of an 23 investigator or a doctor named Louis Fabre, 24 F-A-B-R-E? Page 281 1 A. No. 2 Q. Have you ever heard of David 3 Wong? 4 A. Yes. 5 Q. Who is Doctor Wong? 6 A. There are two Doctor Wongs. 7 Q. David? 8 A. There are two Davids. 9 Q. Do you know of a Dr. David Wong 10 who works with Prozac or has worked with Prozac? 11 A. Yes. 12 Q. Is that only one or both of 13 them? 14 A. You're in luck, only one. 15 Q. That would make life a little 16 easier. Is Doctor Wong that works on Prozac, is 17 he still with Lilly? 18 A. Yes. 19 Q. Do you know what he's working 20 on now? 21 A. No. 22 Q. Do you know if he's still 23 involved in any way with Prozac? 24 A. I don't know. Page 282 1 Q. Do you know what department he 2 works in? 3 A. He's in the discovery area. 4 Q. Do you know if he's the one who 5 discovered Prozac? 6 A. I don't believe he's a chemist, 7 no. 8 Q. Do you know who discovered 9 Prozac? 10 A. No. 11 Q. Have you ever heard the word 12 enantiofer? 13 A. Yes. 14 Q. What is antiomer? 15 A. It's a -- typically a chemical 16 entity can be divided into a positive and a 17 negative. 18 Q. Do you know if Fluoxetine is 19 such a compound that it can be divided into 20 positive and negative antiomers? 21 A. I don't know. 22 Q. Have you ever worked as a CRA? 23 A. No. 24 Q. Are you familiar with what a Page 283 1 CRA's responsibilities are? 2 A. Yes. 3 Q. What are those 4 responsibilities, briefly? 5 A. In which division? 6 Q. Related to Prozac. 7 A. There may be many, depending 8 upon if they are working with a clinical trial 9 that is pending, possibly, a clinical trial that 10 is in progress, a clinical trial that is 11 finishing, regulatory requirements on data going 12 into the FDA. It will vary depending upon what 13 project they may be working on and at what stage 14 of a project they may be working on. 15 Q. Do you have an understanding 16 what would be considered a protocol violation on 17 your stroke study? 18 A. Do I have an understanding? 19 Q. Right. 20 A. In general, yes. 21 Q. Could you give me an example of 22 what would be considered a protocol violation on 23 that study? 24 A. Anyone who did not meet Page 284 1 inclusion or exclusion criteria. 2 Q. Anything besides that? 3 A. I'm sure there are other 4 things, if they did not follow compliance of the 5 way the medication was to be given, they did not 6 come in for their visits at the specified time. 7 Q. Would a protocol violation of 8 the second type that you discussed, like not 9 coming into a visit at a specified time and 10 things like that, would that necessarily make a 11 person in a a study unevaluable for purposes of a 12 study? 13 A. Usually we do intent to treat 14 not evaluable patients, we do intent to treat 15 analyses, and not typically evaluable patient 16 analyses. So those patients who may indeed not 17 come in for a visit, a great deal of their 18 information is still used for analysis, because 19 the intent to treat that patient was there. 20 Q. So is there a form that you 21 fill out besides the CRF or something like that? 22 A. No, that's a statistical 23 assessment. 24 Q. What is your understanding as Page 285 1 to the procedure for follow-up of patients that 2 are included in Prozac studies? Or if you want 3 to do it in your stroke study, in particular, 4 that's fine. 5 A. Follow-up? 6 Q. Right. Say somebody drops out 7 of the study halfway through, what is your 8 understanding of what the procedure required by 9 Lilly is with regards to following up that 10 patient? 11 A. They're asked to come in for a 12 last visit so that information can be obtained 13 for that patient regarding the what is called a 14 termination visit. 15 Q. Okay. How about after that? 16 A. Depends upon the patient, 17 depends upon what may or may not be written into 18 the study, depends upon whether there is or is 19 not an extension of the study. 20 Q. What if the patient gets 21 halfway through the study and decides they want 22 to drop out? 23 A. They may do so, that's one of 24 the options for discontinuation is patient Page 286 1 request. 2 Q. And what is the provision for 3 follow-up after the patient drops out of the 4 study? 5 A. May depend upon what the study 6 is. 7 Q. Say a placebo Fluoxetine fixed 8 dosage study? 9 A. I don't know. 10 Q. How about in your study? 11 A. I believe for patients who 12 completed the study, there was a short extension 13 for minimal follow-up. 14 Q. Would that be something that 15 would be written into the protocol? 16 A. Those typically are written 17 into protocols or they may be written into 18 extension protocols, it may or may not be, it 19 depends upon the study, depends upon what you're 20 doing. 21 Q. I want to make sure I'm not 22 getting confused by what you mean by follow-up 23 and vice versa. When I say follow-up, I mean 24 somebody who has completed the study or dropped Page 287 1 out and some effort is made to check up on them 2 within a certain period of time after they leave 3 the study to see basically how they're doing or 4 make sure that everything is okay. Is that your 5 understanding of what that means? 6 MR. MYERS: Do you understand what she 7 means? 8 A. Yes, I understand, and that is 9 a combination of things. If a patient has any 10 type of laboratory abnormalities, those are 11 always continued to be monitored until they're 12 returned to a normal state. 13 Q. Okay. 14 A. With it -- oftentimes, since 15 many of those patients are the investigator's 16 patients, which is why they were enrolled, they 17 will continue to be followed by the investigator 18 and continued to be monitored by them even though 19 they have left. Many of those patients may be 20 enrolled still into an extension study, which may 21 or may not include the drug. So it depends, it 22 will vary from study to study, patient to 23 patient, that sort are of thing. 24 Q. How about somebody who attempts Page 288 1 suicide while they're on the drug? 2 A. I don't know if I can be 3 specific about that or not, I don't know. 4 Q. To your knowledge, was there 5 ever a comparison done with the various rating 6 scales that were administered during the Prozac 7 trials? 8 A. I don't know. 9 Q. As a psychiatrist, would you be 10 interested in a comparison between a Ham D rating 11 scale and a Co-V self-rating scale? 12 MR. MYERS: She's not a psychiatrist. 13 MS. ZETTLER: But she's taken 14 psychiatry, psychiatric courses. 15 A. But I'm not a psychiatrist. 16 Q. Say for instance a Hamilton 17 rating score says a person is in effect getting 18 better on Prozac, okay. However, the Co-V 19 self-rating scale indicates that the person 20 themself feels that they're getting worse, would 21 you be interested as a scientist and as a 22 neurologist in a comparison of those two scores? 23 MR. MYERS: Before she answers the 24 question to the extent that it's hypothetical in Page 289 1 nature, let me object to the form in that it does 2 not give the witness sufficient data from which 3 to make what I think is -- you're asking her to 4 do a clinical type of judgment, and thus it's 5 defective. But if she can answer it. 6 A. I think I would want to know 7 what's the reliability and validity of those two 8 rating scales compared to the other. That may 9 not have been done, so to compare the two just 10 directly, I may not know what to do with that 11 information and data. 12 Q. How would you determine the 13 validity of various scores? 14 A. If they had been officially 15 validated by validation means. 16 Q. What are validation means? 17 A. Having never done a validation 18 study for assessment criteria, I don't know, but 19 those are usually published on validation studies 20 or validations and comparisons of two. 21 Q. Is that anything like a 22 rechallenging? 23 A. Like a what -- no, not with 24 scales. Page 290 1 Q. Have you ever been involved or 2 aware of any studies done at Lilly rechallenging 3 patients who had adverse reactions on Prozac? 4 MR. MYERS: Object to the form to the 5 extent the use of the terminology reactions 6 assumes some causality. We've basically been 7 talking about events all day. 8 Q. Change it to adverse event. 9 A. And the question was am I aware 10 of -- 11 Q. First of all, are you aware of 12 what rechallenging is? 13 A. Yes. 14 Q. What is rechallenging? 15 A. It means that a patient may 16 have been on a drug, and for whatever reason has 17 discontinued the use of that drug and after a 18 particular period of time, which may or may not 19 be specified, the patient returns to that drug. 20 Q. Okay. Have you ever heard the 21 word rechallenging used in the sense that a 22 patient may be on a drug and experience an 23 adverse event, be taken off the drug for a period 24 of time and then put back on the drug to see if Page 291 1 they experience the same adverse event again? 2 A. Yes. 3 Q. Would that be a fairly reliable 4 determination as to whether or not there is some 5 sort of causal relationship between the use of 6 the drug and the adverse event? 7 MR. MYERS: Object to the form and use 8 of the term, quote, fairly reliable, as being 9 vague and ambiguous. 10 Q. Do you understand what the word 11 reliable means, Doctor? 12 A. Reliable can be mean many 13 things to many people. 14 Q. What is your understanding of 15 the word reliable? 16 A. What do you want it to be? 17 Q. I want to know what your 18 understanding? 19 A. Do I want it to be reliable, I 20 think in my terminology the reliability depends 21 upon a number of things. It depends upon patient 22 reliability, depends upon investigator 23 reliability, depends upon reporter reliability, 24 depends upon observational reliability. With it, Page 292 1 is it reliable, it may lend more credence to 2 possibilities than actual difinitive causality 3 statements, it may lend for -- yes, possibilities 4 or that sort of thing. 5 Q. Are you aware of any studies 6 that have been done at Lilly to rechallenge 7 patients who have experienced adverse reactions 8 on Prozac? 9 A. No, not that I'm aware of. 10 Q. Have you ever heard of any of 11 the clinical research physicians or the CRAs 12 complain about any clinical investigator that 13 have been running studies on Prozac? 14 A. No. 15 Q. Are the results of any of the 16 Prozac studies, to your knowledge, been suspect 17 in any way within the company or without? 18 MR. MYERS: Let me object to the form 19 and the use of the term suspect as being 20 undefined and otherwise very vague. 21 MS. ZETTLER: Let me get you a 22 dictionary. 23 MR. MYERS: A COSTART or ELECT. 24 MS. ZETTLER: It may be both. Page 293 1 MR. MYERS: Can you answer the 2 question? 3 MS. LAWS: Maybe get a Thesaurus for 4 him. 5 A. No, I'm not aware of any 6 suspect trials. 7 Q. Have you ever been in contact 8 with anybody from the National Institute of 9 Mental Health with regards to Prozac? 10 A. No. 11 Q. How about the National Safety 12 Association? 13 A. No. 14 Q. Do you have an opinion within a 15 reasonable degree of medical and scientific 16 certainty as to whether or not Prozac should be 17 used to treat manic depression? 18 A. No, I don't have an opinion. 19 Q. Have you had any experience 20 with the use of Prozac with manic depression? 21 A. No. 22 MS. ZETTLER: Can we take a five-minute 23 break so I can review my notes? 24 MR. MYERS: Sure. Page 294 1 (A SHORT RECESS WAS TAKEN.) 2 Q. Doctor, just a few more. 3 A. My son would say and what is 4 the definition of few. 5 Q. Well, it depends on your 6 answers. 7 A. We'll do our best. 8 Q. Did akathisia have a coded term 9 in either ELECT or COSTART, to your knowledge? 10 A. It certainly may, I have not 11 looked up that term for a long time. 12 Q. When you say -- now ELECT and 13 COSTART are computer software or computer 14 programs; correct? 15 A. I don't know. 16 Q. Have you ever seen a hard copy 17 of either of those dictionaries? 18 A. Yes. 19 Q. Both, either or both? 20 A. Both. 21 Q. So you could actually just look 22 it up? 23 A. Yes. 24 Q. How is it -- if there's no way Page 295 1 of telling how many people are on Prozac at any 2 given time or have been put on Prozac, how is it 3 that the company can make estimates on the number 4 of people they feel are prescribed Prozac? 5 A. Those are estimates, and that's 6 exactly what is done, one can only make 7 estimates. 8 Q. Based on what? 9 A. Based on number of 10 prescriptions written, prescriptions filled, how 11 many patients go on, go off, go on again, that 12 becomes an issue, how many patients remain on 13 after an initial prescription is written, that 14 becomes an issue, and how do you count those 15 patients, how are those patients monitored. So 16 even though it may -- it is possible to give an 17 estimate, exact numbers become extremely 18 difficult. 19 Q. Okay. On your trial, were the 20 patients participating in the trial assigned 21 numbers or were their initials used, or both? 22 A. I don't know. 23 Q. How about the 1639s, are 24 patients ever assigned numbers? Page 296 1 A. Yes. 2 Q. Was that done as a general 3 course on the 1639s? 4 A. Yes. 5 MS. ZETTLER: That's all I have. 6 * * * * * * * * * * 7 CROSS EXAMINATION 8 BY MS. WILKINS 9 Q. Very briefly, Doctor. You also 10 testified on two cases pending in Illinois 11 involving a Dr. Fink and a Dr. 12 Bruinsma. Are you formulating any opinions 13 regarding the care and treatment rendered by 14 either of those doctors? 15 A. I don't know that I remember 16 either case. 17 Q. Is it true that you have no 18 witnesses regarding the care by either one of 19 those doctors? 20 A. That's true. 21 MS. WILKINS That's all I have. 22 MS. ZETTLER: Just one more quick one. 23 * * * * * * * * * * 24 RECROSS EXAMINATION Page 297 1 BY MS. ZETTLER: 2 Q. Did you, at one time, know of 3 any other specific lawsuit besides the Wesbecker 4 case that's pending against Eli Lilly because of 5 Prozac? 6 A. There were a number of lawsuits 7 that were pending. 8 Q. Did anybody discuss 9 specifically the facts of any of those cases with 10 you at any time? 11 MR. MYERS: Let me just object to the 12 extent of any discussions that were among Lilly -- 13 you and Lilly's lawyers, you're not required to 14 disclose that. But if you discussed them with 15 anybody else, you can tell her. 16 A. I did not have any discussions 17 with any outside attorneys at any time on any of 18 the cases. 19 Q. How about anybody besides Lilly 20 lawyers in general? 21 A. No. 22 Q. Have you been asked to render 23 opinions in any of those cases? 24 MR. MYERS: Well, let me object to the Page 298 1 extent that -- I don't know if she has, but to 2 the extent that you've done any consulting with 3 Lilly or its lawyers, you're not required to 4 disclose that. 5 MS. ZETTLER: I think she is required 6 to disclose whether or not she's actually 7 rendered opinions, she doesn't have to tell us 8 what those opinions are. 9 MR. MYERS: I don't think that is a 10 rule, Nancy. 11 Q. Have you ever -- have you been 12 asked to render an opinion with regards to any of 13 those lawsuits that have been discussed with you 14 at any point in time? 15 MR. MYERS: Don't answer that. 16 A. I won't answer that. 17 MS. ZETTLER: Certify it. 18 (QUESTION CERTIFIED.) 19 MS. ZETTLER: That's all I have. 20 MR. GREEN: No further questions. 21 MS. WILKINS No further questions. 22 MR. CLEMENTI: No further questions. 23 MR. MYERS: No questions. 24 MR. SAILOR: No questions. Page 299 1 MS. LAWS: No questions. 2 MS. SMITH: No questions. 3 (THE WITNESS WAS EXCUSED.) Page 300 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 DR. JAMIE STREET 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 2ND DAY OF 19 JULY, 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 301 1 2 E R R A T A S H E E T 3 4 STATE OF ) : SS 5 COUNTY OF ) 6 7 I, JAMIE STREET, M.D., THE UNDERSIGNED 8 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 9 OF MY DEPOSITION AND WITH THE CHANGES NOTED 10 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 11 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 12 THE 24TH DAY OF JUNE, 1993 AT THE TIME AND PLACE 13 STATED THEREIN. 14 PAGE NO. LINE NO. CHANGE REASON Page 302 1 2 PAGE NO. LINE NO. CHANGE REASON 3 4 5 6 7 8 9 _____________________________ 10 JAMIE STREET, M.D. 11 SWORN TO AND SUBSCRIBED BEFORE ME THIS 12 _____ DAY OF __________, 1993. 13 _____________________________ NOTARY PUBLIC, STATE OF 14 AT LARGE Page 303 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Page 304 1 DIRECT EXAMINATION BY MR. GREEN:...................15 2 CROSS EXAMINATION BY MS. ZETTLER:.................172 3 CROSS EXAMINATION BY MR. CLEMENTI:................192 4 RECROSS EXAMINATION BY MS. ZETTLER:...............193 5 CROSS EXAMINATION BY MS. WILKINS..................297 6 RECROSS EXAMINATION BY MS. ZETTLER:...............298 7 COMMONWEALTH.....................................301 8 CERTIFIED QUESTION........................133 9 CERTIFIED QUESTION........................193 10 (QUESTION CERTIFIED..............................272 11 PLAINTIFFS' EXHIBIT NO. 1.........................79 12 PLAINTIFFS' EXHIBIT NO. 2.........................88 13 PLAINTIFFS' EXHIBIT NO. 3.........................97 14 PLAINTIFFS' EXHIBIT NO. 4 .......................103 15 PLAINTIFFS' EXHIBIT NO. 5........................108 16 PLAINTIFFS' EXHIBIT NO. 6........................113 17 PLAINTIFFS' EXHIBIT NO. 7........................128 18 PLAINTIFFS' EXHIBIT NO. 8........................133 19 PLAINTIFFS' EXHIBIT NO. 9........................141 20 PLAINTIFFS' EXHIBIT NO. 10.......................143 21 PLAINTIFFS' EXHIBIT NO. 11.......................167 22 PLAINTIFFS' EXHIBITS 12 AND 13...................168 Page 305