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: CATHERINE MESNER 12 DATE: AUGUST 17, 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 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF TEXAS 3 SAN ANTONIO DIVISION 4 ELIZABETH T. SANCHEZ, ) INDIVIDUALLY AND AS THE ) 5 SURVIVING SPOUSE, MARGARET R. ) SANCHEZ, INDIVIDUALLY AND NEXT ) 6 OF FRIEND OF DEBRA JEAN ) SANCHEZ, VERONICA MARIE ) 7 SANCHEZ, EDWARDO ESTEBAN ) SANCHEZ, AND MICHAEL ANTHONY ) 8 SANCHEZ, CHILDREN; AND ALL ON ) BEHALF OF THE ESTATE OF ) 9 EDWARDO SANCHEZ ) ) 10 V. ) CIVIL ACTION NO. ) SA93CA367 11 ELI LILLY AND COMPANY AND ) DISTA PRODUCTS COMPANY ) 12 * * * * * * * * * * 13 IN THE UNITED STATES DISTRICT COURT 14 FOR THE SOUTHERN DISTRICT OF TEXAS HOUSTON DIVISION 15 MARIA SANCHEZ, INDIVIDUALLY ) 16 AND AS NEXT FRIEND OF DEBORAH ) SANCHEZ, VERONICA SANCHEZ, ) 17 EDDIE SANCHEZ, AND MICHAEL ) SANCHEZ, AND ON BEHALF OF THE ) 18 ESTATE OF EDUARDO SANCHEZ ) ) 19 V. ) CIVIL ACTION NO. ) H-93-1469 20 ELI LILLY AND COMPANY AND ) DISTA PRODUCTS COMPANY, A ) 21 DIVISION OF ELI LILLY AND ) COMPANY ) Page 4 1 * * * * * * * * * * 2 STATE OF NEW YORK 3 SUPREME COURT COUNTY OF JEFFERSON 4 _____________________________________________ 5 STEPHANIE CAPONE, AS EXECUTOR OF THE ESTATE OF JOSEPH J. CAPONE, JR., AND 6 STEPHANIE CAPONE, INDIVIDUALL, NOTICE TO TAKE 7 PLAINTIFF, DEPOSITION UPON ORAL EXAMINATION 8 VS. INDEX NO. 93-251 9 ELI LILLY AND COMPANY, DISTA PRODUCTS 10 COMPANY, A DIVISION OF ELI LILLY AND COMPANY, FLOYD BAJJALY, M.D, 11 DEFENDANTS. 12 _____________________________________________ 13 * * * * * * * * * * 14 SUPREME COURT OF TEH STATE OF NEW YORK COUNTY OF ORANGE 15 --------------------------------------X BRUCE R. MALEN AS EXECUTOR OF THE : INDEX NO. 16 ESTATE OF BARBARA E. MALEN, AND OF : 4119/92 BRUCE R. MALEN, INDIVIDUALLY, : 17 : HON. PETER PLAINTIFF : PATSALOS, 18 : J.S.C. -against- : 19 : ELI LILLY & COMPANY, DISTA PRODUCTS : 20 COMPANY, A DIVISION OF ELI LILLY & : COMPANY, BARRY SINGER AND UNITED : 21 HOSPITAL, : : 22 DEFENDANTS. : --------------------------------------X 23 * * * * * * * * * * Page 5 1 ---------------------------------X 2 VALARIE J. FRIEDMAN AND DAVID : SUPERIOR COURT FRIEDMAN, HER HUSBAND, : OF NEW JERSEY 3 : LAW DIVISION: PLAINTIFF, : MIDDLESEX COUNTY 4 : DOCKET NO. : L-3191-91 5 VS. : : 6 ELI LILLY & COMPANY; DISTA : PRODUCTS INC, A DIVISION OF : 7 ELI LILLY & COMPANY; LISS : PHARMACY; MADISON PHARMACY AND : 8 JOHN DOES NOS. 1-25 (UNKNOWN : ENTITIES), : 9 : DEFENDANTS. : 10 ---------------------------------X 11 * * * * * * * * * * 12 SUPREME COURT OF THE STAET OF NEW YORK COUNTY OF SUFFOLK 13 -------------------------------------x 14 RHOMDA L. HALA and JOSEPH L. HALA, : 15 Plaintiffs, : Index No. 14869/90 16 - against - : 17 ELI LILLY & COMPANY and DISTA : PRODUCTS COMPANY, a DIVISION OF 18 ELI LILLY & COMPANY : 19 Defendants. : -------------------------------------x 20 * * * * * * * * * * Page 6 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 PATRICIA BRACH, ) ) 4 Plaintiff ) ) 5 v. )No. 92 L 13369 ) 6 ELI LILLY AND COMPANY, a foreign ) corporation; ALAN N. MILLER, M.D., ) 7 WILLIAM BRUINSMA, Psy.D., and ) CONDELL MEMORIAL HOSPITAL, ) 8 ) Defendants. ) 9 * * * * * * * * * * 10 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 11 COUNTY DEPARTMENT - LAW DIVISION 12 RENATO DI SILVESTRO, Individually ) and as Special Administrator of ) 13 the Estate of JOHN DI SILVESTRO, ) Deceased, ) 14 ) Plaintiff, ) 15 ) v. ) No. 91 L 7881 16 ) ROBERT L. NELSON, et al., ) 17 ) Defendants, ) 18 ) GEORGE MELNICK, M.D. and PETER ) 19 FINK, M.D. ) ) 20 Respondents in Discovery.) * * * * * * * * * * Page 7 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 JOAN M. GRYER, ) ) 4 Plaintiff, ) ) 5 v. ) No. 92 L 7387 ) 6 ELI LILLY AND COMPANY, et al., ) ) 7 Defendants. ) 8 * * * * * * * * * * 9 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 10 COUNTY DEPARTMENT, LAW DIVISION 11 JENNIFER HAMMERLI, as Plenary ) Guardian of the Estate of RAY B. ) 12 HAMMERLI, a disabled person, ) ) 13 Plaintiff, ) ) 14 v. ) No. 92 L 2365 ) 15 ELI LILLY AND COMPANY, THE ) UPJOHN COMPANY, DICKIE KAY, M.D., ) 16 (former Respondent in Discovery), ) and RICHARD CZECHOWICZ (former ) 17 Respondent in Discovery), ) ) 18 Defendants. ) 19 * * * * * * * * * * Page 8 1 IN THE CIRCUIT COURT OF THE SIXTH JUDICIAL CIRCUIT 2 CHAMPAIGN COUNTY, ILLINOIS 3 LINDA GARDNER, Individually and ) as Special Administrator of ) 4 the Estate of SHANE GARDNER, ) deceased, ) 5 ) Plaintiff, ) 6 ) v. ) No. 91 L 1066 7 ) ELI LILLY AND COMPANY, a foreign ) 8 corporation, ) ) 9 Defendant. ) 10 * * * * * * * * * * 11 IN THE NINETEENTH JUDICIAL CIRCUIT COURT 12 LAKE COUNTY, ILLINOIS 13 JAMES E. SHEPPARD, Special ) Administrator of the Estate of ) 14 KENNETH K. SHEPPARD, Deceased, ) ) 15 Plaintiff ) ) 16 v. ) No. 93 L 124 ) 17 GOOD SHEPHERD HOSPITAL, a ) corporation, DR. STEWART SEGAL, ) 18 DR. SANFORD SHERMAN, DR. BRUCE ) CARLSON, DR. R. BERGLUND, and ELI ) 19 LILLY & COMPANY, a corporation, ) ) 20 Defendants. ) 21 * * * * * * * * * * Page 9 1 SUPERIOR COURT OF THE STATE OF CALIFORNIA 2 FOR THE COUNTY OF LOS ANGELES 3 DR. MARIUS SAINES, etc., et al., ) Case No: 4 ) SC 008331 Plaintiffs, ) 5 ) vs. ) 6 ) ELI LILLY & COMPANY, a corporation; ) 7 DISTA PRODUCTS COMPANY, a division ) of Eli Lilly & Company; and DOBS 1- ) 8 100, inclusive, ) ) 9 Defendants. ) ____________________________________) 10 11 * * * * * * * * * * Page 10 1 I N D E X 2 DEPOSITION OF CATHERINE MESNER 3 4 DIRECT EXAMINATION BY MS. ZETTLER 14 5 CERTIFICATE OF SERVICE 277 6 ERRATA 278 7 8 CERTIFIED QUESTIONS 9 QUESTION CERTIFIED 50 QUESTION CERTIFIED 166 10 QUESTION CERTIFIED 251 11 EXHIBITS 12 PLAINTIFF'S EXHIBIT NO. 1 237 13 PLAINTIFF'S EXHIBIT NO. 2 255 PLAINTIFF'S EXHIBIT NO. 3 257 14 PLAINTIFF'S EXHIBIT NO. 4 260 PLAINTIFF'S EXHIBIT NO. 5 261 15 PLAINTIFF'S EXHIBIT NO. 6 262 PLAINTIFF'S EXHIBIT NO. 7 265 16 PLAINTIFF'S EXHIBIT NO. 8 267 PLAINTIFF'S EXHIBIT NO. 9 271 17 Page 11 1 THE DEPOSITION OF CATHERINE MESNER TAKEN AT 2 THE OFFICE OF BAKER & DANIELS, 300 NORTH MERIDIAN 3 STREET, SUITE 2700, INDIANAPOLIS, INDIANA 46204, 4 ON AUGUST 17, 1993, SAID DEPOSITION TAKEN 5 PURSUANT TO NOTICE IN ACCORDANCE WITH THE RULES 6 OF CIVIL PROCEDURE. 7 * * * * * * * * * * 8 A P P E A R A N C E S 9 10 NANCY ZETTLER COUNSEL FOR GROUP A PLAINTIFFS 11 LEONARD M. RING AND ASSOCIATES, P.C. 111 WEST WASHINGTON AVENUE, SUITE 1333 12 CHICAGO, ILLINOIS 60602 13 LAWRENCE J. MYERS COUNSEL FOR ELI LILLY AND COMPANY 14 FREEMAN & HAWKINS 4000 ONE PEACHTREE CENTER 15 303 PEACHTREE STREET, NE ATLANTA, GA 30308-3243 16 MARGARET ME. HUFF 17 ELI LILLY AND COMPANY LILLY CORPORATE CENTER 18 INDIANAPOLIS, INDIANA 46285 19 DENISE BRODSKY COUNSEL FOR GOOD SHEPHERD HOSPITAL 20 415 WASHINGTON STREET, SUITE 214 WAUKEGAN, ILLINOIS 21 MIGUEL A. RUIZ 22 COUNSEL FOR DEFENDANTS CZECHOWICZ, FINK, BRUINSMA CLAUSEN MILLER GORMAN CAFFREY & WITOUS 23 10 SOUTH LASALLE CHICAGO, ILLINOIS 60603 Page 12 1 PAUL J. CLEMENTI COUNSEL FOR DR. DICKIE KAY 2 HINSHAW & CULBERTSON 222 NORTH LA SALLE STREET, SUITE 300 3 CHICAGO, ILLINOIS 60601-1081 4 KATHERINE L. LAWS COUNSEL FOR DRS. WITSCHY AND KANNEGANTI 5 BAILEY AND WILLIAMS 3500 NCNB PLAZA 6 901 MAIN STREET DALLAS, TEXAS 75202-3714 7 PAUL SMITH 8 745 CAMPBELL CENTER 2 8115 NORTH CENTRAL EXPRESSWAY 9 DALLAS, TEXAS 75206 Page 13 1 2 COMES CATHERINE MESNER, CALLED BY THE 3 PLAINTIFFS, AND AFTER FIRST BEING DULY SWORN, WAS 4 DEPOSED AND TESTIFIED AS FOLLOWS: 5 DIRECT EXAMINATION 6 BY MS. ZETTLER: 7 MS. LAWS: Larry, do we have the same 8 agreements as yesterday? 9 MS. ZETTLER: Sure, same agreements. 10 Same objections, same agreements, Larry? 11 MR. MYERS: Yes. 12 Q. Ms. Mesner, have you ever given 13 a deposition before? 14 A. No. 15 Q. State your full name for the 16 record, please. 17 A. Catherine Helen Mesner. 18 MS. ZETTLER: Let the record reflect 19 that this is the discovery deposition of 20 Catherine Mesner taken pursuant to notice and the 21 state and local rules in the State of Kentucky. 22 MR. MYERS: Before you go ahead, it has 23 been -- since you made that point, it has been 24 cross-noticed noticed in the MDL and in related Page 14 1 state court cases and I understand you have 2 objections and those will be ruled on by somebody 3 at some point in time. 4 MS. ZETTLER: And we reserve the same 5 objections as on the previous depositions. 6 Q. Do you prefer Miss or Mrs. or -- 7 A. Catherine would be fine. 8 Q. Lots of times people in a 9 situation don't like it when a lawyer calls them 10 by their first name. Catherine, have you given a 11 deposition before? You said no, right? 12 A. No. 13 Q. I represent a group of 14 plaintiffs in the Wesbecker litigation formally 15 called Fentress versus Shea Communications. But 16 that is a litigation stemming from a number of 17 deaths and injuries down in Louisville, Kentucky, 18 as a result of Joseph Wesbecker going into his 19 former place of employment and shooting a bunch 20 of people. 21 Let me tell you about some 22 ground rules in the deposition just to make sure 23 that we're both in sync on what's going on, okay. 24 First of all, you have to answer out loud. You Page 15 1 can't shake your head or go uh-huh because she 2 can't take that down. Is that okay? 3 A. Yes. 4 Q. If you don't understand my 5 question for any reason or you don't hear me or I 6 get confused, which happens a lot, let me know, 7 and I will rephrase the question until you 8 understand it. Okay? 9 A. Okay. 10 Q. If you answer the question, 11 we're going to assume you answered it as it was 12 asked. Is that fair enough? 13 A. Yes. 14 Q. Anytime you need a break, just 15 let us know and we'll take a break for any reason 16 whatsoever. Okay? 17 A. Yes. 18 Q. What's your date of birth? 19 A. 8-5-58. 20 Q. And your social security 21 number? 22 A. XXXXXXXXXXX. 23 Q. And your current address? 24 A. XXXXXXXXXXXXXXXXXXXXX, Page 16 1 XXXXXXXXXXXXXXXXXXX. 2 Q. Can you give me an idea of what 3 your educational history is beyond high school? 4 A. Yes, I attended Boston 5 University. 6 MR. SMITH: Could you speak up a little 7 bit please, ma'am. I'm the oldest one in this 8 room and I have difficulty hearing, among other 9 difficulties that I have. 10 THE WITNESS: I attended Boston 11 University. 12 Q. Did you receive a degree from 13 Boston University? 14 A. Yes, I graduated in 1985 with a 15 Bachelors Degree. 16 Q. What was your area of study? 17 A. Interdisciplinary studies. 18 Q. Okay, and what is that? 19 A. It's a degree program which you 20 design yourself, it was based on the health 21 sciences. 22 Q. So you can pick various areas 23 that you want to stress within your studies? 24 A. Yes. Page 17 1 Q. Can you tell me what some of 2 these areas were? 3 A. Anatomy, physiology, social 4 sciences. 5 Q. Any others? 6 A. There was some technical 7 studies and cardiovascular stress testing, et 8 cetera. 9 Q. Do you have any chemistry? 10 A. Yes. 11 Q. Was that one of your areas of 12 stressed or areas of study or is that just 13 chemistry classes as part of the normal 14 curriculum? 15 A. It was part of the normal 16 curriculum. 17 Q. Do you have any psychology or 18 psychiatry courses? 19 A. Yes. 20 Q. Can you tell me about those 21 courses generally? 22 A. Psych 101, abnormal psych, 23 typical liberal arts. 24 Q. Did you have any degrees past Page 18 1 your bachelors? 2 A. I took additional classes. 3 Q. Okay. What additional classes 4 did you take? 5 A. Environmental health studies. 6 Q. Is that one class or a group of 7 classes? 8 A. A cluster of classes. 9 Q. Were you working towards any 10 particular degree when you took those courses? 11 A. No. 12 Q. Have you earned a degree past 13 your bachelors? 14 A. No. 15 Q. Tell me a little bit about your 16 environmental health studies, what kinds of 17 classes did you take? 18 A. Environmental law, 19 environmental health and sciences, toxicology 20 based classes, statistics. 21 Q. Any psychiatry or psychology 22 class within that course of study? 23 A. No. 24 Q. Any other classes? Page 19 1 A. Emergency medical technician. 2 Q. Are you certified as an EMT? 3 A. I was. 4 Q. When were you certified? 5 A. I don't remember. 6 Q. Okay. That certification has 7 lapsed? 8 A. Yes. 9 Q. Did you work as an EMT? 10 A. Not on a paid basis. 11 Q. Tell me a little bit about your 12 work as an EMT. 13 A. I occasionally volunteered for 14 a local ambulance service as a rider. 15 Q. Okay. 16 A. Never as a participant. 17 Q. What would you do as a rider? 18 A. Just observe. 19 Q. Any other courses of study or 20 certifications, besides the EMT? 21 A. Current, at the current time? 22 Q. Anything. 23 A. I was a CPR instructor. 24 Q. Okay. Have you taken any Page 20 1 seminars or attended any symposiums or anything 2 of that nature? 3 A. Yes, I have. 4 Q. Can you give me an idea of some 5 of those? 6 A. Courses offered by the APA. 7 Q. Is that the American 8 Psychiatric Association? 9 A. Yes. 10 Q. What kind of courses did you 11 take through the APA? 12 A. Adverse event reporting. 13 Q. Any others? 14 A. I don't recall. 15 Q. Did you take any seminars or 16 symposiums related to clinical trials, in 17 general? 18 A. No. 19 Q. Did you take any other courses 20 related to adverse event reporting? 21 A. No. 22 Q. Did you attend that adverse 23 event reporting, was that a seminar or was that 24 like a week long course? Page 21 1 A. It was like a lecture. 2 Q. How long did the lecture last? 3 A. Half a day. 4 Q. Did you take that through your 5 employment at Lilly? 6 A. Yes. 7 Q. What kinds of topics did they 8 cover at the lecture? 9 A. Adverse events with CNS 10 compounds. 11 Q. CNS is central nervous system? 12 A. Yes. 13 Q. And the course was specific to 14 central nervous system compounds? 15 A. Yes. 16 Q. Is that a Lilly sponsored 17 course? 18 A. No. 19 Q. Were there Lilly employees that 20 participated in that course as far as teaching 21 it? 22 A. No. 23 Q. When did you take that course? 24 A. I don't remember. Page 22 1 Q. Can you give me a year? 2 A. I could tell you a month, but I 3 can't tell you a year. 4 Q. Okay, what month? 5 A. May. 6 Q. May of sometime? 7 MR. SMITH: Probably May of '91. 8 Q. When did you start working for 9 Lilly? 10 A. 1985. 11 Q. Have you worked for them 12 continuously since then? 13 A. Yes. 14 Q. Was that your first job after 15 graduating from Boston University? 16 A. No, I was employed while I was 17 in college. 18 Q. Okay, but after you received 19 your degree, was that the first job that you had, 20 the job at Lilly? 21 A. Yes. 22 Q. Well, get to employment, trust 23 me. 24 Could you tell me a little bit Page 23 1 more about the adverse event reporting lecture, 2 specifics, more specifics? 3 A. I don't remember. 4 Q. How about, did they talk about 5 COSTART or any -- 6 A. No. 7 Q. Did it talk about the 8 regulatory requirements for adverse event 9 reporting? 10 A. No. 11 Q. Did it talk about any of the 12 regulatory definitions of categories, events like 13 serious and unexpected and things of that nature? 14 A. No. 15 Q. Did you have any previous 16 experience with adverse event reporting prior to 17 taking the seminar? 18 A. Yes. 19 Q. Any other seminars that you 20 attended through your employment at Lilly? 21 A. No. 22 Q. Earlier you said that you 23 worked while you were in college, correct? 24 A. Yes. Page 24 1 Q. Where did you work while you 2 were in college? 3 A. I worked at the University of 4 Rochester Medical School. 5 Q. What did you do there? 6 A. I was a research technician. 7 Q. What were your responsibilities 8 as a research technician? 9 A. I was responsible for basic 10 research in a cardiovascular laboratory, which I 11 supervised. 12 Q. When you say basic research, 13 what do you mean? 14 A. Clinical pharmacology. 15 Q. Did you participate in clinical 16 trials? 17 A. Yes, I did. 18 Q. Were the clinical trials being 19 done on drugs that were -- were the trials being 20 performed in an attempt to gain approval by the 21 FDA for marketing of the drug, in other words was 22 it done through a manufacturer? 23 A. Some. 24 Q. Did you work on any drugs that Page 25 1 were being developed or tested by Lilly? 2 A. Yes. 3 Q. Did any of those drugs include 4 Fluoxetine? 5 A. No. 6 Q. How long did you work at 7 Rochester Medical School? 8 A. Three years. 9 Q. Was that continuous throughout 10 your time at the university? 11 A. I was a part-time student at 12 various times. 13 Q. So you worked at the hospital 14 full-time? 15 A. Yes. 16 Q. Any other employment during 17 college? 18 A. I worked at Boston University 19 Medical School. 20 Q. Okay. 21 Q. When did you work there? 22 A. From 1979 to 1982. 23 Q. Did you work at the University 24 of Rochester from '82 to '85? Page 26 1 A. Yes. 2 Q. What did you do at Boston 3 University Medical School? 4 A. I had the same assignment as I 5 did in Rochester. 6 Q. Same types of medications? 7 A. Yes. 8 Q. Did you work on any Lilly drugs 9 while you were there? 10 A. Yes. 11 Q. How about prior to Boston 12 University, where did you work -- Boston 13 University Medical School, I'm sorry. 14 A. University Hospital. 15 Q. Where is that? 16 A. Boston. 17 Q. What did you do there? 18 A. I was a research technician. 19 Q. Same as the other two 20 hospitals? 21 A. Yes. 22 Q. What types of drugs did you 23 work on at University Hospital? 24 A. Cardiovascular compounds. Page 27 1 Q. Did you work on any Lilly drugs 2 while you were there? 3 A. No. 4 Q. You graduated high school in 5 '76? 6 A. Yes. 7 Q. How long did you work at 8 University Hospital? 9 A. Approximately eighteen months. 10 Q. So about 1977 to 1979? 11 A. I overlapped many jobs at one 12 time, I had many jobs. 13 Q. When you say you had many jobs, 14 did some of these hospital jobs overlap? 15 A. Uh-huh. 16 Q. When did you start at 17 University Hospital? 18 A. I don't remember. 19 Q. Was it right out of high 20 school? 21 A. No. 22 Q. Where did you work right out of 23 high school? 24 A. I didn't, I was a full-time Page 28 1 student. 2 Q. After high school? 3 A. Yes. 4 Q. So you went to Boston 5 University full-time for how long? 6 A. Two and a half years. 7 Q. Did you work at all during that 8 period of time? 9 A. Yes, I did. 10 Q. Where did you work? 11 A. Tufts New England Medical 12 Center. 13 Q. Do you remember when you 14 started at Tufts? 15 A. No. 16 Q. That was a part-time position? 17 A. Yes, it was. 18 Q. What did you do at Tufts? 19 A. I was a phlebotomist. 20 Q. What's a phlebotomist? 21 A. A person who draws blood. 22 Q. How long -- was that a 23 part-time position? 24 A. Yes. Page 29 1 Q. How long were you at Tufts? 2 A. Two years. 3 Q. Did you work at any of these 4 other hospitals during that period of time? 5 A. Yes. 6 Q. Which ones? 7 A. University Hospital. 8 Q. Did you work there part-time 9 also? 10 A. No, I was full-time there. 11 Q. I'm talking the two and a half 12 years that you were a full-time student. 13 A. I was full-time. 14 Q. I just wanted to make sure I 15 wasn't getting it confused, sorry. So you went 16 to school full-time and you worked part-time at 17 Tufts and full-time at University Hospital? 18 A. Yes. 19 Q. Do you remember when you 20 started at University Hospital? 21 A. No. 22 Q. It was in that two and a half 23 year period of time when you were in school 24 full-time? Page 30 1 A. Sometime, yes. 2 Q. Any other employment that we 3 haven't covered yet? 4 A. Yes. 5 Q. Okay, where else? 6 A. Massachusetts General Hospital. 7 Q. With regards to your position 8 as a phlebotomist at Tufts, did you have to take 9 any courses or become certified in any way to do 10 that? 11 A. No. 12 Q. How is it that you got that 13 job? 14 A. I applied for it. 15 Q. Did they give you training? 16 A. Yes. 17 Q. And your job was strictly 18 drawing blood samples? 19 A. Yes. 20 Q. How about for your positions at 21 the other hospitals as research technicians? 22 A. All on the job. 23 Q. What did you do at 24 Massachusetts General? Page 31 1 A. I was a phlebotomist. 2 Q. Is that a full-time or 3 part-time position? 4 A. Part-time. 5 Q. Were you doing that while you 6 were at Tufts also or was that after Tufts? 7 A. I can't remember. 8 Q. Any other jobs that we haven't 9 covered? 10 A. New England Memorial Hospital. 11 Q. Did you ever sleep? 12 A. No. 13 Q. What did you do at New England 14 Memorial? 15 A. I worked in the pharmacy as a 16 pharmacy technician. 17 MR. RUIZ: I'm sorry, what was that, as 18 what? 19 THE WITNESS: A pharmacy technician. 20 Q. Was that while you were also 21 working at Massachusetts General? 22 A. Probably. 23 Q. Do you remember how long you 24 were at New England Memorial? Page 32 1 A. Less than one year. 2 Q. Was that a part-time position 3 also? 4 A. No. 5 Q. It was full-time? 6 A. Yes. 7 Q. What does a pharmacy 8 technologist do? 9 MR. MYERS: Technician. 10 Q. I'm sorry, technician. 11 A. Assist the pharmacist in 12 preparation of medications. 13 Q. Would you actually fill 14 prescriptions? 15 A. Yes. 16 Q. Would you consult with patients 17 on medication? 18 A. No. 19 Q. Do you remember what year you 20 worked at New England Memorial? 21 A. Sometime in the late '70s. 22 Q. To your recollection, did you 23 dispense any medications as part of a clinical 24 trial on any drugs that were being done in the Page 33 1 hospital? 2 A. No. 3 Q. I forgot to tell you, we can't 4 talk over each other because she can't take it 5 down, so I'll try and let you finish your answers 6 as best I can and then you should try to let me 7 finish my question. 8 A. Okay. 9 Q. I'm sorry, so the answer was 10 no, right? 11 A. No. 12 Q. Any other jobs? 13 A. Some part-time restaurant 14 experience. 15 Q. Any other medical-related jobs? 16 A. Not that I recall. 17 Q. If you think of anything else 18 go ahead and let me know. 19 A. Okay. 20 Q. Let's talk about your 21 employment at Lilly. How is it that you became 22 employed by Lilly, was it a matter of did 23 somebody contact you or did you contact Lilly? 24 A. Lilly contacted me. Page 34 1 Q. Who from Lilly contacted you? 2 A. The clinical research 3 coordinator. 4 Q. Do you remember that person's 5 name? 6 A. Chuck Capriello. 7 Q. How is it that you knew Mr. 8 Capriello? 9 A. From clinical trials in 10 Rochester. 11 Q. Is that the University of 12 Rochester Medical School? 13 A. Yes. 14 Q. What did Mr. Capriello say to 15 you when he approached you about a position at 16 Lilly? 17 A. Would you be more specific? 18 Q. Sure. Was the conversation 19 about possible employment at Lilly, was that 20 brought up by him or by you? 21 A. By him. 22 Q. What position did he talk to 23 you about? 24 A. Clinical investigation Page 35 1 representative. 2 Q. What's the difference between a 3 CRC and a CIR? 4 A. A CRC? 5 Q. Clinical research coordinator. 6 A. They have different, separate 7 job functions. 8 Q. Right, and what I want to know 9 is what the difference is between the two 10 positions. 11 A. How specific? 12 Q. As specific as you can get. 13 A. One deals with the 14 investigators and one deals with the data. 15 Q. CRCs deal with the 16 investigators, right? 17 A. Yes. 18 Q. What do they do with regards to 19 the investigators? 20 A. Initiation of studies, interest 21 in studies. 22 Q. Do they recruit investigators? 23 A. Yes. 24 Q. How about a CIR, what does a Page 36 1 CIR do? 2 A. Monitors the studies. 3 Q. Do they do site audits? 4 A. Yes. 5 Q. Other than doing a site audit, 6 what do you mean when you say monitor the 7 studies? 8 A. Enrollment status. 9 Q. Enrollment of patients? 10 A. Yes. 11 Q. Do they have any responsibility 12 for directly enrolling the patients? 13 A. No. 14 Q. The investigators have that 15 responsibility, right? 16 A. Yes. 17 Q. And the CIRs check with the 18 investigators to see how many patients are 19 enrolled at any given time? 20 A. Yes. 21 Q. What did Mr. Capriello say 22 about the CIR position when he approached you 23 about taking the job? 24 A. He asked me if I would be Page 37 1 interested in interviewing for such a position. 2 Q. Were you? 3 A. Yes. 4 Q. Who did you interview with? 5 A. Mr. Capriello initially. 6 Q. Okay. Anybody else? 7 A. On an in-house interview, yes. 8 Q. Who in-house? 9 A. I don't recall. 10 Q. Do you remember how many people 11 you interviewed with in-house? 12 A. About twelve. 13 Q. Do you remember any of their 14 names? 15 A. Gary Lightfoot. 16 Q. This was back in '85? 17 A. Yes. 18 Q. What was Mr. Lightfoot's 19 position at that time? 20 A. He was a manager. 21 Q. Manager of what? 22 A. Clinical coordination. 23 Q. Is clinical coordination 24 different than quality assurance? Page 38 1 A. Yes. 2 Q. Is Mr. Lightfoot involved in 3 the quality assurance area at all? 4 A. No. 5 Q. Tell me about the quality 6 assurance area. 7 A. Separate component. 8 Q. Is it a separate department? 9 A. Yes. 10 Q. What's the formal name of it? 11 A. Medical quality assurance. 12 Q. What's medical quality 13 assurance's function? 14 A. They audit the clinical trials. 15 Q. When you say audit the clinical 16 trials, they go to the sites and double check 17 information against the CRF? 18 A. Yes. 19 Q. The raw data, they double check 20 to make sure the raw data is memorialized 21 appropriately on the CRF? 22 A. Yes. 23 Q. How does that differ from a CRA 24 function? Page 39 1 A. It's an additional quality 2 check. 3 Q. Do either of these two groups, 4 either clinical coordination or medical quality 5 assurance make unannounced visits to the sites? 6 A. Yes. 7 Q. Which department, or both? 8 A. Medical quality assurance. 9 Q. Are their visits always 10 unannounced? 11 A. No. 12 Q. Does the clinical coordination 13 department ever make any unannounced visits to 14 the sites? 15 A. Not that I'm aware of. 16 Q. Under what circumstances would, 17 can we call it MQA instead of saying medical 18 quality assurance? 19 A. Yes. 20 Q. Under what circumstances does 21 MQA make unannounced visits at the sites? 22 A. I don't know. 23 Q. Is this done as a routine to 24 your knowledge or is there a specific reason that Page 40 1 they may do that? 2 A. I don't know. 3 Q. Who would know that? 4 A. I don't know. 5 Q. Do you know who the manager of 6 MQA is at this time? 7 A. Jim Eggerts. 8 Q. Can you spell the last name, 9 please? 10 A. E-G-G-E-R-T-S. 11 Q. How long has Mr. Eggerts been 12 manager of that position? 13 A. I don't know. 14 Q. Is Gary Lightfoot still with 15 Lilly? 16 A. Yes. 17 Q. Is he in the same position? 18 A. No. 19 Q. Where is he now? 20 A. I don't know his assignment. 21 Q. Do you know when he was 22 reassigned? 23 A. No. 24 Q. Do you know what department he Page 41 1 was in? 2 A. Medical. 3 Q. You mean the medical division? 4 A. Yes. 5 Q. That's a pretty large division, 6 isn't it, encompasses a lot of different areas? 7 A. Yes. 8 Q. Do you know if he's still in 9 quality assurance or clinical coordination in any 10 capacity? 11 A. No. 12 Q. Is he in the regulatory area to 13 your knowledge? 14 A. No. 15 Q. I'm sorry, no? 16 A. No. 17 Q. Do you know if he's a manager 18 or director? 19 A. He's a manager. 20 Q. But as far as you know, he's 21 not manager of clinical coordination anymore, 22 right? 23 A. To my knowledge. 24 Q. So I take it you were hired as Page 42 1 a CIR at Lilly, right? 2 A. Yes. 3 Q. How long were you a CIR? 4 A. Approximately sixteen months. 5 Q. Did you work out of 6 Indianapolis or were you stationed out on the 7 east coast? 8 A. East coast. 9 Q. What office did you work out 10 of? 11 A. My home. 12 Q. Where were you living at the 13 time? 14 A. Needham, Massachusetts. 15 Q. Would you spell that? 16 A. N-E-E-D-H-A-M. 17 Q. Thanks. Was that pretty 18 routine that a CIR could work out of their home? 19 A. Yes. 20 Q. Was there a Lilly office 21 anywhere in the area? 22 A. Yes. 23 Q. Where? 24 A. Raintree, Massachusetts. Page 43 1 Q. Who was your immediate 2 supervisor during the sixteen months that you 3 were a CIR? 4 A. Chuck Capriello. 5 Q. Is Mr. Capriello still with 6 Lilly? 7 A. No. 8 Q. Do you know where he is now? 9 A. No. 10 Q. When did he leave Lilly? 11 A. Sometime after 1987. 12 Q. Was that after you switched to 13 a position other than a CIR? 14 A. Yes. 15 Q. Were you in charge of a 16 specific territory? 17 A. Yes. 18 Q. What territory was that? 19 A. I had New England. 20 Q. What states did that include? 21 A. Connecticut, Rhode Island, 22 Massachusetts. 23 Q. Any others? 24 A. New Hampshire, Vermont, parts Page 44 1 of New York, and Montreal, Quebec. 2 Q. Do you remember what month you 3 graduated from Boston University? 4 A. My degree says September, I was 5 a summertime graduate. 6 Q. And you started at Lilly 7 sometime after that? 8 A. Yes. 9 Q. Do you remember what month you 10 started at Lilly? 11 A. October. 12 Q. So from October of '85, for 13 approximately sixteen months, you worked as a 14 CIR? 15 A. Yes. 16 Q. So that would be until 17 approximately the beginning of '87? 18 A. Yes. 19 Q. During that sixteen month 20 period of time, did you do any work on Fluoxetine 21 clinical trials? 22 A. Yes. 23 Q. Do you recall how many trials 24 you worked on? Page 45 1 A. No, I don't. 2 Q. Was it more than five? 3 A. You will have to clarify that. 4 Q. Sure. In a CIR position you 5 would visit various sites that would be involved 6 in clinical trials on Fluoxetine, right? 7 A. Yes. 8 Q. And what I'm trying to find out 9 is how many clinical trials, beginning with 10 clinical trials, you would work on, you had 11 worked on during that sixteen month period of 12 time? 13 MR. MYERS: Fluoxetine? 14 MS. ZETTLER: Right, Fluoxetine 15 clinical trials. 16 A. Sites or trials? 17 Q. Trials. 18 A. I don't remember. 19 Q. Do you know if it was more than 20 five? 21 A. No. 22 Q. Do you remember how many 23 specific sites were involved with clinical trials 24 on Fluoxetine during that period of time that you Page 46 1 were responsible for? 2 A. No, I don't recall. 3 Q. You said you worked in Quebec 4 as part of your territory? 5 A. Yes. 6 Q. Did you work with Guy Shinard? 7 A. Not as a CIR. 8 Q. Okay. Did you work on any 9 Fluoxetine trials in Montreal during that sixteen 10 month period? 11 A. No . 12 Q. How about Connecticut? 13 A. No. 14 Q. Rhode Island? 15 A. No. 16 Q. Massachusetts? 17 A. Yes. 18 Q. New Hampshire? 19 A. No. 20 Q. Vermont? 21 A. No. 22 Q. How about New York? 23 A. Yes. 24 Q. Who did you work with in Page 47 1 Massachusetts? 2 MR. MYERS: Don't answer that, that's 3 proprietary. You know our position on that, 4 there is no reason to get in a quarrel about it. 5 Q. What was the clinical trial 6 regarding, it involved Fluoxetine, right? 7 A. Yes. 8 MR. SMITH: Maybe I'm not familiar with -- 9 MR. MYERS: Our position is that our 10 list of clinical investigators, other than our 11 pivotal investigators which have been disclosed 12 to you for example in one of your cases, are 13 proprietary and confidential business information 14 and are the subject of certain court orders and 15 the subject of ongoing litigation in other 16 states. 17 MS. ZETTLER: Basically what their 18 position is, Paul, is that they -- anybody who's 19 been disclosed by the FDA, he's been generous 20 enough to disclose to us, and if they haven't 21 been disclosed by the FDA, then they're 22 considered not pivotal, that's their position. 23 MR. SMITH: I guess I'll have to write 24 me up an affidavit or something, Larry. Page 48 1 MR. MYERS: That's all right. 2 Q. The clinical trial -- was there 3 more than one clinical trial that you worked on 4 in Massachusetts during that sixteen month 5 period? 6 MR. MYERS: Fluoxetine? 7 MS. ZETTLER: What did I say? 8 MR. MYERS: You said clinical trial is 9 all you said. 10 MS. ZETTLER: Fluoxetine, I'm sorry. 11 A. Yes. 12 Q. How many? 13 A. I don't remember. 14 MR. SMITH: Wait a minute, that was a 15 pivotal trial in Boston, can't she tell us who 16 she worked for? 17 MR. MYERS: She may or may not know 18 what the FDA has disclosed. 19 MS. ZETTLER: So you are instructing 20 her not to answer. Why don't you confer with her 21 and find out who these people are? 22 MR. MYERS: I'm not going to confer 23 with her. You have the list of who the pivotal 24 investigators are, you do for sure, and we are Page 49 1 not going to go through this exercise and have 2 her sort that out. 3 MS. ZETTLER: So in other words, we get 4 to bring her back later on if it turns out that 5 there were pivotal trials that she -- 6 MR. MYERS: No, no, just go ahead and 7 ask her another question. 8 Q. Are you going to follow your 9 attorney's advice and not answer my questions 10 regarding who you worked with in Massachusetts? 11 A. Yes. 12 MS. ZETTLER: Certify the question. 13 (QUESTION CERTIFIED.) 14 Q. The clinical trials you worked 15 on in Massachusetts, were they involved in the 16 study of Fluoxetine in the use of depression or 17 the treatment of depression? 18 A. Yes. 19 Q. Do you know what a pivotal 20 trial is? 21 A. Yes. 22 Q. What's a pivotal trial? Give 23 us your definition of a pivotal trial or what 24 your understanding of a pivotal trial is. Page 50 1 A. One used for registration of a 2 compound. 3 Q. To your knowledge, were the 4 clinical trials that you worked on in 5 Massachusetts ever considered to be pivotal? 6 A. I don't know. 7 Q. Who would know that? 8 A. The FDA. 9 Q. So the determination of what a 10 pivotal trial is is made by the FDA? 11 A. No. 12 Q. Who makes the determination? 13 A. Perhaps somebody in the medical 14 division. 15 Q. At Lilly? 16 MR. RUIZ: What was her answer? 17 MS. ZETTLER: Somebody in the medical 18 division. 19 Q. Somebody in the medical 20 division at Lilly? 21 A. Yes. 22 Q. In the incidence of Fluoxetine 23 obviously? 24 A. Yes. Page 51 1 Q. How many depression trials did 2 you work on in Massachusetts, if you know? 3 A. Less than five. 4 Q. Were there other trials that 5 you worked on in Massachusetts that involved 6 Fluoxetine and the treatment of other conditions 7 or conditions other than depression? 8 A. Yes. 9 Q. What other conditions, 10 generally? 11 MR. MYERS: You can tell her generally. 12 A. Eating disorders. 13 Q. Obesity? 14 A. No. 15 Q. Bulimia? 16 A. Yes. 17 Q. Any others? 18 A. No. 19 Q. Any other illnesses or 20 disorders? 21 MR. MYERS: That she worked on in 22 Massachusetts? 23 MS. ZETTLER: Right. 24 A. No. Page 52 1 Q. Smoking cessation? 2 A. No. 3 Q. OCD? 4 A. No. 5 Q. Alcoholism? 6 A. No. 7 Q. How many bulimia trials did you 8 work on? 9 MR. MYERS: In Massachusetts? 10 MS. ZETTLER: In Massachusetts. 11 A. One. 12 Q. So in that sixteen month period 13 you worked on approximately six trials in 14 Massachusetts on Fluoxetine? 15 A. No. 16 Q. Okay. Earlier you testified 17 that you worked on less than five depression 18 studies and one bulimia study. Were there any 19 other studies that you worked on regarding 20 Fluoxetine in Massachusetts during this sixteen 21 month period of time? 22 A. Please repeat the question. 23 Q. Sure. I just want to know, 24 earlier you testified that you worked on less Page 53 1 than five depression studies while you were a CIR 2 up in New England, okay, depression studies in 3 Massachusetts. 4 A. Uh-huh. 5 Q. And to your knowledge, there 6 was one bulimia study you worked on? 7 A. Yes. 8 Q. Were there any other studies 9 you worked on in Massachusetts regarding 10 Fluoxetine during that sixteen month period of 11 time? 12 A. No. 13 Q. So approximately six studies 14 you worked on in Massachusetts during that 15 sixteen month period? 16 A. No, less than five and one. 17 Q. Well, then can you give me -- 18 A. Approximately five. 19 Q. Approximately five, okay. So 20 approximately six total? 21 A. Yes. 22 Q. How about New York, how many 23 depression studies did you work on in New York 24 during that sixteen month period of time? Page 54 1 A. Two. 2 Q. Let me back up for a second. 3 Do you remember the protocol numbers of any of 4 the trials you worked on in Massachusetts during 5 that sixteen month period of time, Fluoxetine 6 protocols? 7 MR. MYERS: You can tell her the 8 numbers of depression trials, don't tell her the 9 number of the bulimia trials, that's proprietary. 10 MS. ZETTLER: You've been ordered in 11 the MDL and you probably will be ordered in 12 Potter's court to give us the adverse event 13 information which I've said you have offered to 14 give us. 15 MR. MYERS: We have, that's right. 16 MS. ZETTLER: So how are we going to 17 know what we are talking about if we don't know 18 the numbers of studies? 19 MR. MYERS: It doesn't make any 20 difference. 21 MS. ZETTLER: She can't tell us the 22 number of the study? 23 MR. MYERS: No, it's proprietary. 24 MS. ZETTLER: Based on what, Larry? Page 55 1 MR. MYERS: Because it's proprietary. 2 MS. ZETTLER: Based on what? 3 MR. MYERS: Based on the fact that it 4 is a trade secret. Tell her the depression ones 5 if you remember the numbers in Massachusetts, 6 protocol numbers. 7 A. HCDL. 8 Q. Any others? 9 A. HCDH. 10 Q. Any others? 11 A. No. 12 Q. Do you remember the numbers or 13 the number of the bulimia study? 14 A. No. 15 Q. Is there a listing somewhere of 16 the protocols and their numbers and initials, to 17 your knowledge? 18 A. Not to my knowledge. 19 Q. You said you worked on two 20 depression studies in New York and that's during 21 that sixteen month period of time? 22 A. Yes. 23 Q. Do you remember the numbers of 24 those studies? Page 56 1 A. HCDL, I don't remember the 2 other one. 3 Q. HCDL, was that -- you said that 4 you worked on a trial that was conducted under 5 that protocol in Massachusetts and one in New 6 York, correct? 7 A. Yes. 8 Q. So there were two different 9 site studies related to the same protocol? 10 A. Yes. 11 Q. Was Doctor Kline one of the 12 investigators on the New York depression study? 13 A. No. 14 Q. Any studies other than 15 depression studies that you worked on in New York 16 during that sixteen month period of time? 17 A. No. 18 Q. Two total for New York then? 19 A. Yes. 20 Q. Tell us about what your 21 responsibilities as a CIR on those approximately 22 eight studies were for the sixteen months that 23 you worked as a CIR. 24 A. Monitored enrollment. Page 57 1 Q. What does that entail? 2 A. Asking the sites how often I 3 need to visit, how much paper they had for me to 4 review. 5 Q. So the sites determined then 6 how often you would visit the site? 7 A. It was one parameter to follow. 8 Q. Give me some other parameters? 9 A. I don't understand your 10 question. 11 Q. Sure. Under the purview of 12 monitoring enrollment, you said you would ask the 13 sites -- one of the parameters was that you would 14 ask the sites on how many times you would have to 15 visit, and I'm assuming that's during the 16 enrollment period? 17 A. Throughout the course of the 18 trial. 19 Q. What are the other 20 determinations or other factors that are taken 21 into consideration on determining how often you 22 had to visit a particular site? 23 A. How fast they enrolled. 24 Q. Was there a deadline for Page 58 1 enrollment for that in the protocol? 2 A. I don't recall. 3 Q. Do you recall whether or not a 4 deadline for enrollment was set with regards to 5 any particular trial or in general? 6 A. No. 7 Q. No, you don't recall or no, 8 there were no deadlines? 9 A. No, I don't recall. 10 Q. What else did you do in 11 monitoring enrollment? 12 A. That was it. 13 Q. Would you have any 14 responsibility for double checking whether or not 15 a particular patient fit the inclusion or 16 exclusion criteria set out in the protocol? 17 A. Yes. 18 Q. How would you do that? 19 A. Checking the medical record. 20 Q. When you say medical record, 21 what do you mean? 22 A. Clinician notes. 23 Q. Clinician notes taken prior to 24 the persons becoming involved in the clinical Page 59 1 trial? 2 A. No. 3 Q. Okay. Clinician notes that you 4 would review would be the investigator's notes 5 regarding the initial examination and interview? 6 A. Yes. 7 Q. Is this something that's 8 outside the CRF? 9 A. Yes. 10 Q. Is there a form that was 11 provided by Lilly for the investigator to record 12 these notes? 13 A. No. 14 Q. Was it a requirement that they 15 provide these notes to you when you reviewed 16 exclusion-inclusion criteria? 17 A. Within the extent of their law. 18 Q. To the extent of their law? 19 A. Uh-huh. 20 Q. What does that mean? 21 A. If they were required by law to 22 provide them to me. I don't understand the law, 23 so -- 24 Q. Neither do I. Page 60 1 MR. SMITH: Neither do several other 2 people. 3 (A SHORT RECESS WAS TAKEN.) 4 Q. Let me ask you this, was it a 5 requirement of Lilly that the investigators keep 6 clinician notes on patients that were 7 participating in the trials? 8 A. We requested they keep notes. 9 Q. Okay. And what generally would 10 those notes entail, would it -- generally what 11 would those notes entail? 12 A. Any outcomes of a patient 13 visit. 14 Q. Okay. 15 A. Medication. 16 Q. Is this something that is 17 separate and apart from the clinical report 18 forms? 19 A. Yes. 20 Q. And as part of your job as a 21 CIR, you would go and double check the clinical 22 report forms against the clinician's notes? 23 A. Yes. 24 Q. In any of the studies that you Page 61 1 worked on on Fluoxetine during your sixteen month 2 stint as a CIR, were drug diary pamphlets 3 provided to the patients? 4 A. Could you repeat the question? 5 Q. Do you know what a drug diary 6 pamphlets is? 7 A. Yes. 8 Q. What is it? 9 A. It's a tool that some study 10 coordinators use to have the patients keep track 11 of information. 12 Q. What are study coordinators, is 13 that the same as a clinical investigator? 14 A. They may be the same or it may 15 be a person employed by the clinical 16 investigator. 17 Q. So a study coordinator is 18 somebody at the site? 19 A. Yes. 20 Q. Were the drug diary pamphlets 21 used in the Fluoxetine study provided by Lilly? 22 A. Yes. 23 Q. On any of those Fluoxetine 24 studies that you worked on as a CIR, did they use Page 62 1 drug diary pamphlets? 2 A. Yes. 3 Q. How many of those studies? 4 A. Only bulimia. 5 Q. As part of your job as a CIR, 6 did you review the drug diary pamphlets? 7 A. Yes. 8 Q. Were those pamphlets turned in 9 by the patient on a weekly basis or were they 10 turned in at the end of the study? 11 A. I don't recall. 12 Q. What kind of information would 13 the patient be asked to record on the drug diary 14 pamphlets? 15 A. Medication taken, food eaten. 16 Q. Anything else? 17 A. Episodes of bulimia. 18 Q. Anything else? 19 A. I don't recall. 20 Q. Adverse event information? 21 A. I don't recall. 22 Q. Would you visit these sites as 23 a CIR on a regular basis -- on a regular basis or 24 was it something that was done as a need arose? Page 63 1 A. Excuse me? 2 Q. When you were a CIR, did you 3 visit the sites on a regular basis, was it a 4 regular type of thing like go in every other week 5 or things like that? 6 A. Yes. 7 Q. How often would you look at the 8 sites? 9 A. It was dependent upon 10 enrollment. 11 Q. When you say dependent upon 12 enrollment, do you mean the number of patients 13 that were enrolled? 14 A. Yes. 15 Q. The more patients enrolled, the 16 more often you would have to visit the site? 17 A. Perhaps. 18 Q. Explain to me what you mean by 19 it was dependent on enrollment then, what do you 20 mean? 21 A. If there was one patient, you 22 maybe had to go once. If that patient 23 discontinued, maybe you didn't go back. Maybe if 24 there were ten patients and they were coming in Page 64 1 on a regular basis, then you would go in on a 2 regular basis. 3 Q. On these approximately six, I'm 4 sorry, approximately eight trials you worked on 5 regarding Fluoxetine while you were a CIR, what 6 was the largest number of patients enrolled with 7 any of the given studies? 8 A. Approximately two hundred. 9 Q. Do you remember what state that 10 study was in? 11 A. New York. 12 Q. What was the lowest number of 13 patients enrolled in any of the studies? 14 A. I don't recall. 15 Q. Was there a situation where 16 there was only seventeen patients enrolled in a 17 study in any of those eight studies? 18 MR. MYERS: Let me object to the form 19 and ask at a given point in time or for the 20 entire duration of the study because if one 21 patient enrolled at one point there would be one 22 patient in the study. 23 Q. Sure. I mean was there ever an 24 occasion within that sixteen month period within Page 65 1 these approximately eight studies when there was 2 only one patient enrolled at any time during the 3 study, in other words a study was done on one 4 patient? 5 MR. MYERS: A one patient study. 6 A. No, I don't recall. 7 Q. Did any of those studies 8 include only ten patients? 9 A. I don't remember the patient 10 enrollment status. 11 Q. Were there any other studies 12 included in that group of eight that had two 13 hundred patients or around that number? 14 A. Could you repeat the question? 15 Q. Out of those eight studies, 16 were there any other studies that had as many as 17 two hundred patient in it like the one you told 18 me about earlier? 19 A. No. 20 Q. Can you give me an average of 21 how many patients were in those studies besides 22 the one with two hundred? 23 A. No. 24 MR. MYERS: An average of the remaining Page 66 1 six or seven or however many? 2 MS. ZETTLER: Right. 3 A. No. 4 Q. How often did you visit the 5 site with two hundred patients in that sixteen 6 month period of time? 7 A. At the most, three times a 8 week. 9 Q. Was that study in progress when 10 you became a CIR? 11 A. No. 12 Q. Was that study in progress when 13 you left the position of CIR? 14 A. I don't remember. 15 Q. Was it a double blind placebo 16 controlled study? 17 A. I don't remember. 18 Q. Were any of these studies 19 double blind placebo controlled studies, any of 20 the eight that you worked on as a CIR? 21 A. I don't remember. 22 Q. Besides double blind placebo 23 controlled depression studies, what other kind of 24 depression studies were performed on Fluoxetine Page 67 1 to your knowledge? 2 A. Comparative trials. 3 Q. Any others? 4 A. No. 5 Q. Were any of these eight studies 6 comparative trials? 7 A. Yes. 8 Q. How many of them? 9 A. At least two. 10 Q. Was the two hundred patient 11 study a comparative trial? 12 A. No. 13 Q. Was it a fixed dose study? 14 A. No. 15 Q. Was it a study looking at the 16 incidence of suicidality and the use of 17 Fluoxetine? 18 A. No. 19 Q. Were any of those eight studies 20 that you worked on studies looking at the 21 incidence of suicidality and the use of 22 Fluoxetine? 23 A. No. 24 Q. Were any of those studies Page 68 1 looking at the use of Fluoxetine and 2 violent-aggressive behavior? 3 A. No. 4 Q. What were the suicide rating 5 scales that were used in those studies, to your 6 knowledge? 7 A. Could you expand on the 8 question? 9 Q. Sure. Was the Hamilton 10 depression rating scale used in all of those 11 studies, to your knowledge? 12 A. Yes. 13 Q. Were there any other 14 psychiatric tests or rating scales used that 15 measured suicidality in any of those eight 16 studies? 17 A. I don't recall. 18 Q. What other rating scales were 19 used in those studies? 20 A. I don't remember specific ones 21 to specific studies. 22 Q. Okay, just generally. 23 A. Co-V anxiety. 24 Q. Okay. Any others? Page 69 1 A. Clinical global impressions. 2 Q. Any others? 3 A. A memory testing scale. 4 Q. Any others? 5 A. I don't remember. 6 Q. How about the Rafson, was that 7 used? 8 A. I don't remember specifically. 9 I know it's been used, I don't know if it's been 10 used in trials. 11 Q. Were the investigators 12 conducting these trials asked to record adverse 13 event information? 14 A. Yes. 15 Q. Were they given a specific form 16 to use to record that information? 17 A. Yes. 18 Q. What was that form? 19 A. Clinical case report form. 20 Q. So there was a portion in the 21 CRF that was used to record adverse events? 22 A. Yes. 23 Q. Would they also record adverse 24 event information in their clinician notes? Page 70 1 A. Yes. 2 Q. Tell me a little bit about how 3 this worked with clinician notes, would the 4 investigators record information on the clinician 5 notes and then complete CRFs according to that 6 information? 7 A. Yes. 8 Q. With regards to some of these 9 tests we talked about earlier like the Co-V and 10 Clinical Global Impression or the Hamilton 11 Depression Rating Scale, was that something that 12 was recorded directly on the CRF or were they 13 asked to record their findings on those tests 14 separately and then transfer that to the CRF? 15 A. I have seen it done both ways. 16 Q. Okay. Was there a specific 17 form separate and apart from the CRF that was 18 provided to the investigators to record answers 19 to those various tests, questions to those 20 various tests? 21 A. No. 22 Q. As part of your job as a CIR, 23 were you responsible for going to the sites and 24 double checking the clinical notes taken by the Page 71 1 investigators with regards to these various tests 2 as opposed to and compared to what they recorded 3 on the CRF? 4 A. Yes. 5 Q. Was there ever a time that you 6 found that the information on the clinical notes 7 or clinician notes were different than what was 8 actually recorded on the CRF? 9 A. Yes. 10 Q. What were you to do in a 11 situation like that? 12 A. Question it. 13 Q. Question it with who, the 14 investigator? 15 A. Or study personnel. 16 Q. If you found that there was a 17 conflict between what was recorded in the 18 clinician notes and what was reported on the CRF, 19 were you asked to report that to Lilly? 20 A. Yes. 21 Q. Was there a form that you used 22 to report that? 23 A. Yes. 24 Q. What was that form called? Page 72 1 A. I don't know the specific name. 2 Q. Your visits to the various 3 sites are called audits, correct? 4 A. No. 5 Q. What are they called? 6 A. CIR visit. 7 Q. Have you heard the term audit, 8 site audit used throughout your employment at Eli 9 Lilly? 10 A. Yes. 11 Q. What is a site audit? 12 A. Visit specifically to the site 13 for the purpose of auditing. 14 Q. What is auditing? 15 A. Validating the data from the 16 various source documents. 17 Q. How does that differ from what 18 you did on your visits? 19 A. My visits incorporated 20 auditing. 21 Q. Besides auditing, what else did 22 you do on your visits to the site? 23 A. Monitored enrollment. 24 Q. Besides monitoring enrollment Page 73 1 and auditing, what else did you do? 2 A. Teaching. 3 Q. Who would you teach? 4 A. Study personnel. 5 Q. What would you teach them? 6 A. Case report form completion. 7 Q. Would this be at the start up 8 meetings? 9 A. Yes. 10 Q. Would you teach them case 11 report form completion any other time throughout 12 the trials? 13 A. Yes. 14 Q. On what occasion? 15 A. When there was a new employee 16 or if they just needed a refresher. 17 Q. Did you give the sites 18 refresher courses on filling out the CRF on a 19 regular basis or was that something that happened 20 as a need arose? 21 A. On a fairly regular basis. 22 Q. Would you give them a refresher 23 course on filling out the CRF if it appeared that 24 there was a problem with the way they filled out Page 74 1 the CRF? 2 A. Yes. 3 Q. Were there any other situations 4 where you would give them those refresher 5 courses? 6 A. If they had numerous errors. 7 Q. You wouldn't go in like every 8 six months just as a matter of course and say 9 okay, here's our time for a refresher course, if 10 there wasn't a problem with the way the CRFs were 11 being filled out, would you? 12 MR. MYERS: Well -- okay. 13 Q. You can answer. 14 A. No. 15 Q. And you testified earlier that 16 you gave these refresher courses on a fairly 17 regular basis? 18 A. Yes? 19 Q. Is this true for all of the 20 sites? 21 A. Yes. 22 Q. Would the decision to give a 23 particular site a refresher course on filling out 24 the CRF be a decision that you would make or was Page 75 1 that made by somebody else at Lilly? 2 A. I would make. 3 Q. What was your criteria for 4 determining whether or not a site needed a 5 refresher course on filling out CRFs? 6 A. The number of errors. 7 Q. What types of errors generally 8 would you see on filling out case report forms? 9 A. Transcription errors. 10 Q. What's transcription errors? 11 A. Copying from one source 12 document to a case report form. 13 Q. In other words copying from the 14 clinician notes to the CRF? 15 A. Yes. 16 Q. Any other sources of 17 information that they would have that they would 18 transcribe to the CRF? 19 A. Yes. 20 Q. What other sources of 21 information? 22 A. Medical records. 23 Q. How are medical records 24 different than the clinician notes? Page 76 1 A. Sometimes medical records are 2 kept in a hospital by the medical records 3 department, clinician notes are typically kept in 4 the clinician's office. 5 Q. So the inpatient studies, there 6 may be additional medical records? 7 A. Yes. 8 Q. Is that true for the outpatient 9 studies also? 10 A. Yes. 11 Q. Would the medical records be 12 kept by somebody other than the investigator? 13 A. Yes. 14 Q. Who would be keeping those 15 records? 16 A. Multiple clinicians, the 17 medical records department. 18 Q. Who would be recording 19 information on the medical records other than the 20 investigators? 21 A. Other physicians, social 22 workers, psychologists, lab technicians, nurses, 23 hospital quality assurance. 24 Q. In these medical records, are Page 77 1 these records that were kept as a part of the 2 clinical trial or were these records that were 3 generated outside the clinical trial process? 4 A. Outside. 5 Q. These medical records that 6 you're talking about, are they related to adverse 7 events? 8 A. Yes. 9 Q. Related to anything other than 10 adverse events? 11 A. Yes. 12 Q. I guess I'm a little bit 13 confused. It's my understanding that people were 14 recruited and screened by the investigators 15 specifically for participation in clinical 16 trials, is that correct? 17 A. Yes. 18 Q. Why would medical records 19 generated outside the clinical trial process be 20 included in the information that was recorded in 21 the clinical trial? 22 A. Past history. 23 Q. Anything else, any other 24 reason? Page 78 1 A. Previous therapy. 2 Q. Anything else? 3 A. Disease documentation. 4 Q. Anything else? 5 A. I think that covers it. 6 Q. Now all this information 7 regarding past history, previous therapy, disease 8 documentation, is this information that would be 9 taken into consideration during the screening 10 process before the patient was officially 11 enrolled in the trial? 12 A. Yes. 13 Q. Would this information be used 14 after the patient was enrolled in the trial? 15 A. Yes. 16 Q. In what context? 17 A. To validate that the 18 information in the source was correct. 19 A. Other than within your position 20 as a CIR and validating that information was 21 reported correctly, how would this type of 22 information be used within the clinical trials? 23 A. To assure that 24 exclusion-inclusion criteria were met. Page 79 1 Q. So if it appeared that somebody 2 was included in the study who may have fallen 3 under one of the exclusion criteria, you would 4 relate back to this information to see what their 5 previous history was? 6 A. You may need to. 7 Q. Is this something that is kept 8 in the patient's file after the study is over 9 with? 10 A. Yes. 11 Q. Who keeps that information, is 12 that sent to Lilly? 13 A. No. 14 Q. It's kept at the site? 15 A. Yes. 16 Q. How long is it kept at the 17 site, do you know? 18 A. No. 19 Q. Do you know if it was a 20 requirement of Lilly that the information be kept 21 indefinitely? 22 A. No. 23 Q. No, you don't know or no, it 24 wasn't? Page 80 1 A. No, I don't know. 2 Q. Do you know if there was a 3 policy at Lilly that information could be -- this 4 kind of information could be discarded or 5 destroyed after a certain period of time? 6 MR. MYERS: Before she answers that, 7 let me object to the form to the extent that your 8 question assumes that there was such a policy. 9 MS. ZETTLER: I'm asking her if there 10 was. 11 MR. MYERS: I think the form is 12 defective, but if you can answer that, go ahead. 13 A. I think that -- in my opinion, 14 medical records are kept by an institution 15 indefinitely. 16 Q. But the question is, to your 17 knowledge, was there a requirement by Lilly that 18 this information be kept like for a certain 19 period of time, in other words after five years 20 you can do whatever you want with the information 21 but it must be kept for five years? 22 A. There are federal regulations. 23 Q. What do the regulations 24 require, to your knowledge? Page 81 1 A. I don't know the specific time 2 frame but it's based on when drugs are approved. 3 Q. So the regulation requires that 4 for a certain period of time after the drug is 5 approved this information must be maintained? 6 A. Could you state that again? 7 Q. Sure. I'm just trying to 8 understand -- you stated that federal regulations 9 require that documents and information be kept 10 for a certain period of time after the drug is 11 approved, correct? 12 A. Yes. 13 Q. Do you know what that period of 14 time is? 15 A. No. 16 Q. Besides site audits, monitoring 17 enrollment, what else did you do as a CIR? 18 MR. MYERS: She said she did teaching, 19 too. 20 Q. That's right, and teaching, I'm 21 sorry. 22 A. Drug accountability. 23 Q. What's drug accountability? 24 A. Assessing the number of pills Page 82 1 in a bottle, match the number on the case report 2 form, on the accountability forms, on the source 3 document, on the pharmacy dispensing records. 4 Q. You say source documents, again 5 you mean like the clinician notes and medical 6 records? 7 A. Records, yes. 8 Q. Did you have any 9 responsibilities as a CIR to oversee 10 randomization, in other words keep track of who 11 is assigned what medication during a trial? 12 A. No. 13 Q. Who would have that 14 responsibility? 15 A. Investigator or pharmacist. 16 Q. In a double blind study, who 17 would have responsibility to keep track of who 18 was getting which medication? And when I say who 19 was getting which medication, what person was 20 getting a placebo as opposed to what person was 21 getting the Fluoxetine? 22 A. It was random. 23 MR. MYERS: Is your question who knew? 24 MS. ZETTLER: Right. Page 83 1 A. A systems analyst at Lilly 2 perhaps. 3 Q. Were you ever privy to that 4 information during a double blind study that you 5 worked on? 6 A. No. 7 Q. Other than the responsibilities 8 we've already talked about, are there any other 9 responsibilities that you had as a clinical -- as 10 a CIR? 11 A. Performing start-ups. 12 Q. Start-ups are meetings held at 13 the beginning of the clinical trial? 14 A. Yes, or if new personnel come 15 onboard. 16 Q. That would be part of your 17 teaching responsibilities that you talked about 18 earlier? 19 A. Yes. 20 Q. Other than teaching on how to 21 fill out the CRF -- did I get that right? 22 A. Right, CRF. 23 Q. What other responsibilities did 24 you have with regards to the start-ups? Page 84 1 A. Reviewing regulations. 2 Q. Reviewing them with the site 3 personnel? 4 A. Yes. 5 Q. What regulations? 6 A. If the study was conducted 7 under the U.S. IND-IND regulations. 8 Q. FDA regulations? 9 A. Yes. 10 Q. Any other responsibilities 11 besides instructing and completion of CRFs and 12 reviewing regulations? 13 A. Review of the protocol. 14 Q. Did you have any 15 responsibilities as a CIR in writing the 16 protocols? 17 A. No. 18 Q. What would you review on the 19 protocol? 20 A. Inclusion-exclusion criteria. 21 Q. Anything else? 22 A. Visit intervals. 23 Q. In other words, patients have 24 to come back once a week, things of that nature? Page 85 1 A. Yes. 2 Q. Anything else? 3 A. Drug dispensing. 4 Q. Anything else? 5 A. Use of patient numbers. 6 Q. What would you tell them about 7 the use of patient numbers? 8 A. Start with the lowest number. 9 Q. In other words, the first 10 patient that came in assign them with number one? 11 A. If number one was their lowest 12 number. 13 Q. In what situation would number 14 one not be their lowest number? 15 A. If that was not the design of 16 the study. 17 Q. In other words, if there was a 18 multi-center study, a patient at another study 19 may already have number one? 20 A. Yes. 21 MR. MYERS: You really mean another 22 site, right, if it was a multi-center study, then 23 you said a patient in another study. 24 MS. ZETTLER: I guess, my understanding Page 86 1 was there were numerous trials that were done at 2 multi-center studies. So maybe I'm using study 3 wrong, maybe I mean trial instead. 4 MR. MYERS: I think you meant to say 5 site. 6 MS. ZETTLER: She seemed to understand 7 it. 8 MR. MYERS: I guess so. 9 Q. Anything else about the 10 protocol that you would review besides the 11 inclusion-exclusion criteria, visit intervals and 12 you said drug dispensing and patient numbers? 13 A. What parameters needed to be 14 tested at what points in time. 15 Q. Let me back up a little bit. 16 What else did you tell them about the use of 17 patient numbers? 18 A. Just to use them sequentially. 19 Q. How about the use of patient 20 numbers in the CRF? 21 A. The same, start with their 22 lowest number. 23 Q. Okay. Were you ever privy to 24 the names of the people that were involved in the Page 87 1 studies? 2 A. Yes. 3 Q. Patients? 4 A. Yes. 5 Q. Under what circumstances, 6 generally? 7 A. Reviewing their medical 8 records. 9 Q. Were you provided with a list 10 by the investigator of what patient number was 11 assigned to what patient? 12 A. Could you repeat that? 13 Q. Were you given a list of the 14 patients' names with their assigned patient 15 numbers? 16 A. No. 17 Q. How would you know which 18 patient's clinical report form you were reviewing 19 from comparing it against source information? 20 A. Patient initials. 21 Q. What if a patient, two patients 22 had similar initials? 23 A. Date of birth. 24 Q. Was the patient's initials Page 88 1 recorded routinely in the CRFs? 2 A. Yes. 3 Q. If the patient's initials were 4 used, why were numbers assigned? 5 A. In case two patients had the 6 same initials. 7 Q. But more often than not, 8 patients don't have the same initials, do they? 9 A. I don't know the answer to 10 that. 11 Q. Any other reason patient 12 numbers were assigned to patients other than 13 possibly having similar initials? 14 A. Not to my knowledge. 15 Q. Is it your understanding that 16 the information from the CRFs was entered into a 17 data base at some point in time at Eli Lilly? 18 A. Yes. 19 Q. When the information was 20 entered into that data base, were the patient's 21 initials used? 22 A. Yes. 23 Q. Was their patient number also 24 used? Page 89 1 A. Yes. 2 Q. Why were both used? 3 A. I don't know the answer to 4 that. 5 Q. When a final report was 6 generated as a result of a study, were the -- was 7 the information reported in the study reported 8 under the patient initials or the number? 9 A. Most likely the number. 10 Q. You said that you would review 11 the parameters that needed to be tested at 12 different intervals during the study, is that 13 correct? 14 A. Yes. 15 Q. What do you mean when you say 16 the different parameters? 17 A. Vital signs. 18 Q. Anything else? 19 A. Weighting scales, laboratory 20 tests, if there were x-rays or ECGs. 21 MR. CLEMENTS: Did you say EEG or ECG? 22 THE WITNESS: ECG. 23 Q. Would this be a matter of 24 saying, just as an example, on the fourth visit Page 90 1 we want you to take blood tests, on the sixth 2 visit we want you to do an ECG? 3 A. Yes. 4 Q. Generally on these studies that 5 you participated in as a CIR, the Fluoxetine 6 studies that you worked on, were the rating 7 scales given at every visit? 8 A. Generally, yes. 9 Q. Let's go back to what you did 10 if you found an error in the reporting 11 information on the CRF, okay. Were you required 12 to fill out a report on every error that you 13 found? 14 A. I don't remember what the 15 criteria for filling out the report was. 16 Q. Okay. Were there some errors 17 that were excluded from the reporting 18 requirement? 19 A. No. 20 Q. Is it your memory that you 21 filled out a report on every error that you 22 found? 23 A. I don't remember. 24 Q. What types of errors would you Page 91 1 generally find on clinical report forms? 2 A. Transcription errors. 3 Q. Transcription of what kinds of 4 information? 5 A. Information from the medical 6 record to the case report form. 7 Q. Medical records? 8 A. Or source document. 9 Q. Can you give me an idea of what 10 we're talking about lab data information, adverse 11 event information, what types of information 12 would you find errors on? 13 A. Different studies had different 14 errors. 15 Q. If you had to pick one error 16 that you thought was most commonly made in 17 filling out the CRF, what would that error be? I 18 mean specific type of information that's 19 misrecorded on the CRF. 20 A. Patient initials. 21 Q. What about patient numbers, 22 were there errors on recording the patient 23 numbers? 24 A. No. Page 92 1 Q. How about adverse event 2 reporting, what kind of errors did you find in 3 regards to adverse event reporting? 4 A. Errors that would not fit into 5 a computer, such as dashes or blanks. 6 Q. What do you mean they would not 7 fit into a computer? 8 A. Computer systems have 9 typically, in my knowledge, is that they have 10 specific parameters that you can enter in either 11 alphas or numerics within certain guidelines. 12 They would not maybe accept blanks or dashes. 13 Q. To your knowledge, did Lilly 14 require that an adverse event term be assigned to 15 various adverse events that were reported by the 16 investigators? 17 A. Yes. 18 Q. So in the context of what you 19 just testified to regarding parameters, would it 20 be a case of they may have reported an adverse 21 event as a injury dash accidental as opposed to 22 injury comma accidental and that wouldn't go into 23 the computer? 24 A. Yes. Page 93 1 Q. How about any substantive 2 errors? 3 A. Could you define that? 4 Q. Sure. Did you ever find a case 5 where -- well, first of all, an adverse event 6 wasn't recorded on a CFR that was evident in the 7 clinician notes? 8 A. Yes. 9 Q. Did you ever find a case where 10 an adverse event was misrecorded by an 11 investigator, in other words they assigned a term 12 or described an event differently than was 13 accurate with regards to the event, in other 14 words say somebody broke a leg and they called it 15 like a nosebleed? 16 A. Yes. 17 Q. How about that first situation 18 where somebody -- where they forgot to or 19 somebody did not record the adverse event on the 20 CRF, on how many occasions would you say that 21 happened? 22 A. I don't recall. 23 Q. Can you give me a general idea? 24 A. Not that often. Page 94 1 Q. Okay. Was there any particular 2 study that you worked on during -- out of those 3 eight studies that we talked about earlier where 4 that happened more often than the other studies? 5 A. No. 6 Q. How about the situation where 7 adverse events were misrecorded, on how many 8 occasions did that happen? 9 A. Would you repeat the question? 10 Q. Sure. The second example I 11 gave you was a situation where somebody 12 misreported on the CRF what adverse event was, in 13 other words in a situation where say a broken leg 14 and they reported it as a nosebleed, how often 15 did you find that happening throughout the trials 16 that you worked on? 17 A. Infrequently. 18 Q. Were there any occasions where 19 any of -- that happened in any of the given 20 studies more often than the others? 21 A. No. 22 Q. Was it pretty consistent 23 throughout all the studies? 24 A. Yes. Page 95 1 Q. The same with the first 2 category of not reporting adverse events that 3 were memorialized in the clinician notes or the 4 medical records? 5 A. Yes. 6 Q. How about the drug diary 7 pamphlets, was there ever an occasion where an 8 adverse event was reported by the patient in the 9 drug diary but was not reported on the CRF? 10 A. I don't remember specifically. 11 Q. How about generally, do you 12 remember it happening? 13 A. I don't recall. 14 Q. How about misreporting of 15 adverse events in the CRFs as opposed to what was 16 recorded in the drug diary pamphlets, do you 17 recall that happening? 18 A. I don't understand the 19 question. 20 Q. Say that the patient said I 21 fell and broke my leg on this date and the 22 investigator or somebody at the site records it 23 as a nosebleed, did you ever see an occasion 24 where that happened, not that specific scenario Page 96 1 but that type of thing? 2 A. I don't recall. 3 Q. I might have asked you this 4 earlier and if I did I apologize, but the drug 5 diary pamphlets, were they maintained -- at the 6 close of study were they maintained at the site 7 or were they maintained at Lilly? 8 A. The site. For that, for the 9 specific bulimia study. 10 Q. Okay. To your knowledge were 11 drug diary pamphlets ever used on depression 12 studies? And I'm not talking just those eight 13 trials that we talked about earlier. 14 A. I don't recall. 15 Q. How about are you aware of what 16 an adverse event checklist is? 17 A. Yes. 18 Q. What is it? 19 A. It's where there's a preprinted 20 checklist of adverse events or clinical symptoms 21 and a physician or investigator or study 22 personnel is to check off if a patient said that 23 they had that or they noticed it. 24 Q. Was that a list that was Page 97 1 printed by Lilly? 2 A. Yes. 3 Q. Was it a list developed by 4 Lilly? 5 A. I don't know. 6 Q. Was that type of a list used in 7 any of the eight studies you worked on as a CIR? 8 A. Not to my recollection. 9 Q. To your knowledge, was that 10 type of a list used on any of the Fluoxetine 11 clinical trials performed in the United States? 12 A. Not to my knowledge. 13 Q. Was the adverse event list 14 something that was used exclusively in 15 international trials? 16 A. Could you qualify that? 17 Q. In what way? 18 A. Be more specific. 19 Q. Okay. 20 Q. You just testified that to your 21 knowledge the adverse event checklist was not 22 used in the U.S. clinical trials, right? 23 A. To my knowledge, yes. 24 Q. Was such a list used in any of Page 98 1 the international clinical trials? 2 A. Are you referring specifically 3 to Fluoxetine trials or other trials -- 4 depression trials? 5 Q. Let's start with Fluoxetine 6 trials, to your knowledge were the adverse event 7 checklists used in international Fluoxetine 8 trials? 9 A. I know of a situation where 10 they were. 11 Q. Okay. What situation? 12 A. In an international trial. 13 Q. Which international trial? 14 A. I don't remember the number. 15 Q. Okay. Where was it performed? 16 A. I don't know. I'm sorry, I 17 just remember it being an international trial. 18 Q. You don't remember what country 19 it was performed in? 20 A. No, but the form was in 21 English. 22 Q. So it could have been in the 23 United Kingdom? 24 A. Yes. Page 99 1 Q. Would they typically send forms 2 to the international trials in the language of 3 the country that was performing the studies, in 4 other words, would the French study documents be 5 in French? 6 A. Could you explain documents? 7 Q. Sure. Did you use CRFs or some 8 form of a CRF in the international studies? 9 A. Yes. 10 Q. If you had a study that was 11 going on in France, would the CRF be provided to 12 the investigators in France in French as opposed 13 to English? 14 A. I don't know. 15 Q. What type of study was the 16 study that you were aware that was used in 17 adverse event checklists, Fluoxetine study and 18 what? 19 A. I don't remember the 20 indication. 21 Q. Do you remember when the study 22 was performed? 23 A. No. 24 Q. Do you remember who the Page 100 1 investigators were that performed the study? 2 A. No. 3 Q. Do you remember who the CRA was 4 that worked on the study? 5 A. No. 6 Q. Earlier you asked me to 7 differentiate or be more specific of what I meant 8 by the study, was it a Fluoxetine study or 9 depression study. Are you aware of any studies 10 that were done generally on depression? 11 MR. MYERS: Well, wait a minute, let me 12 object. What do you mean generally on 13 depression? 14 MS. ZETTLER: That's what I'm trying to 15 find out. 16 Q. You said earlier that you asked 17 me to differentiate or be more specific as to 18 what I meant by the studies that were performed 19 using the adverse event checklist, right? 20 A. Yes. 21 Q. When you were asking me to do 22 that, you said do you mean a Fluoxetine study or 23 depression study, right? 24 A. Yes. Page 101 1 Q. What's the difference between a 2 Fluoxetine study and a depression study? 3 A. There may be depression studies 4 on other compounds. 5 Q. Okay. Are you aware of any 6 depression studies that were being done on other 7 compounds? 8 MR. MYERS: You can tell her yes or no. 9 A. Yes. 10 Q. Were these compounds that were 11 compounds produced by Lilly? 12 A. I think you would have to be 13 more specific on produced by Lilly. 14 Q. Was this a Lilly product, were 15 those Lilly products? 16 A. Yes. 17 Q. Were these anti-depressant 18 compounds? 19 A. Yes. 20 Q. Are they compounds that are now 21 on the market? 22 A. No. 23 Q. Are they Seratonin reuptake 24 inhibitors? Page 102 1 MR. MYERS: Don't answer that, that's a 2 privileged trade secret. I've given you enough 3 latitude to inquire generally as to non- 4 Fluoxetine compounds. I think to go any further 5 would be an infringement upon trade secrets and 6 proprietary commercial information. 7 Q. Are you going to follow your 8 lawyer's advice? 9 A. Yes. 10 MS. ZETTLER: Certify the question. 11 (QUESTION CERTIFIED.) 12 Q. Were any of these studies that 13 involved other compounds, studies where 14 Fluoxetine was used as a comparator drug? 15 A. I don't know the answer to that 16 one. 17 Q. You don't know or you don't 18 remember? 19 A. I don't remember. 20 Q. To your knowledge, did Lilly 21 conduct any studies on the incidence of 22 suicidality and the disease of depression 23 generally? When I say conducted a study, I mean 24 conducted their own clinical trial where they Page 103 1 recruit patients, et cetera. 2 A. Could you explain further? 3 Q. Sure. To your knowledge, did 4 Lilly ever conduct a study that just measured 5 generally the rate of suicide experienced by 6 people with depression? 7 A. No. 8 MR. MYERS: When you say that -- you 9 know we you use this term study a lot. When you 10 say study, are we talking about clinical trial? 11 MS. ZETTLER: Right. 12 Q. Okay. And your answer was no? 13 A. Yes, my answer was no. 14 Q. Okay. To your knowledge, did 15 Lilly conduct any trials comparing the rate or 16 incidence of suicide in Fluoxetine as opposed to 17 other anti-depressants? 18 A. Not to my knowledge. 19 Q. To your knowledge, did Lilly 20 conduct any trials specifically with the 21 objective to measure the incidence of suicidality 22 of people on Prozac or Fluoxetine? 23 A. Could you repeat that? 24 Q. Sure. Did Lilly -- to your Page 104 1 knowledge, did Lilly ever perform a trial that -- 2 in which the specific objective of the trial was 3 to measure the incidence of suicidality on people 4 on Fluoxetine? 5 A. Not to my knowledge. 6 Q. Other than the non-Fluoxetine 7 anti-depressant that you talked about earlier, 8 were there any other studies to your knowledge 9 that -- in which Lilly used the adverse event 10 checklist? 11 MR. MYERS: Any compound? 12 MS. ZETTLER: No, Fluoxetine. 13 A. Not to my knowledge. 14 Q. How many other compounds have 15 you worked on at Lilly other than Fluoxetine, 16 throughout your entire history with Lilly? 17 A. Perhaps more than forty. 18 Q. Okay. And on clinical trials 19 on those forty various compounds, how often would 20 an event -- adverse event checklist be used? 21 A. I don't know. 22 Q. Were they used on more than one 23 occasion with regards to any particular 24 compounds? Page 105 1 A. I don't know. 2 Q. You worked on the trials, 3 correct, in some form or another? 4 A. On development, yes. 5 Q. Would the use of an adverse 6 event checklist be involved or be something that 7 was covered under the protocol? 8 A. Yes. 9 Q. You worked on developing 10 protocols for these various compounds, trials of 11 these various compounds? 12 A. Yes. 13 Q. Do you recall in any of those 14 situations whether or not an adverse event 15 checklist was included as a requirement of the 16 protocol? 17 A. No. 18 Q. Do you know why an adverse 19 event checklist was used in the clinical trial, 20 the Prozac clinical trial that you told us about 21 earlier? 22 A. No. 23 Q. Do you know why it was used in 24 the clinical trials with regards to the other Page 106 1 anti-depressant compounds that you told us about 2 earlier? 3 A. No. 4 Q. Who would make the decision 5 whether or not to use an adverse event checklist 6 with regards to any given trial? 7 A. Research physician. 8 Q. Do you recall who the research 9 physician was on the Fluoxetine study, 10 international Fluoxetine study, where they used 11 the adverse event checklist? 12 A. No, I don't know the person, I 13 don't know who worked on it. 14 Q. Other than bringing up the 15 subject with the investigation site, what else 16 would you do when you found an error on a 17 clinical report form? 18 A. I'm sorry, you're going to have 19 to ask again. 20 Q. Sure. You testified earlier 21 that there was a -- if you found an error in the 22 clinical report form, you would discuss it with 23 the clinical investigation site personnel there, 24 right? Page 107 1 A. Uh-huh, yes. 2 Q. And you also testified that you 3 would fill out an audit report -- or I'm sorry, a 4 site report on some if not all of the errors that 5 you found, right? 6 A. Yes. 7 Q. What else would you do as far 8 as either recording or reporting an error? 9 A. I would perhaps flag an error 10 and ask them to find out the answer. 11 Q. When you say them, you mean 12 people? 13 A. The site personnel. 14 Q. Okay. In what situations would 15 you flag an error? 16 A. In a case where I was working 17 alone during part of the time and then meeting 18 with site personnel later, that we weren't 19 working one-on-one next to each other. 20 Q. So in other words, if you 21 couldn't find the answer in the clinician's notes 22 or medical records, you would flag the error and 23 talk to the personnel later? 24 A. Yes. Page 108 1 Q. Did you fill out a correction 2 form or anything of that nature? 3 A. No. 4 Q. How would the information on 5 the CRF be manually corrected, just be corrected 6 on the CRF itself? 7 A. The study personnel would 8 correct it. 9 Q. Would there be an indication on 10 the CRF anywhere that there was a correction that 11 had been made? 12 A. Study personnel was instructed 13 to date and initial it and put one line through 14 it. 15 Q. How about the situation where 16 they forgot to record an adverse event that was 17 reported either in the drug diary pamphlets or 18 clinician notes or medical records? 19 A. They were asked to add it to 20 the case report form. 21 Q. And then anything else that 22 they would do to indicate that it was an addition 23 or a correction? 24 A. It would be dated and initialed Page 109 1 so you would be able to go by the date. 2 Q. Other than the dates and 3 initials, is there any other indication on the 4 clinical report form itself that a correction had 5 been made to the report, to the form? 6 A. No. 7 Q. Have you ever seen clinical 8 report forms that were stamped corrected copy? 9 A. Yes. 10 Q. What does that mean when you 11 stamp a clinical report form corrected copy? 12 A. My interpretation is that after 13 a correction was entered into the computer, after 14 the paper left the site, a corrected copy was 15 then sent back to the site to place in front of 16 their page, this was made after it was removed. 17 Q. Okay. So once the CRF left the 18 site and an error was found off site, so to 19 speak, in other words somebody who wasn't 20 on-site, such as yourself or personnel, then a 21 new copy was generated and sent back to the site 22 that was corrected? 23 A. Yes. 24 Q. What kind of corrections would Page 110 1 be made at Lilly on the CRF? 2 A. Information if it was needed, a 3 dash for computer purposes. 4 Q. Anything substantive? 5 A. All corrections were made in 6 coordination with the study personnel, if it was 7 beyond a computer generated correction. 8 Q. In what circumstances would 9 that happen, what would be beyond a computer 10 generated correction? 11 MR. MYERS: You want an example? 12 MS. ZETTLER: Yes. 13 A. An adverse event or perhaps a 14 concomitant medication was not carried forward to 15 a next visit or did not have a stop date or a 16 continuation date. 17 Q. Okay. Were the investigators 18 charged with assigning event terms to various 19 adverse events? 20 A. Yes. 21 Q. Did you do any instructing on 22 how to assign event terms? 23 A. Yes. 24 Q. When did you -- what kinds of Page 111 1 things did you tell the site event about 2 assigning event terms? 3 A. They were to look up the 4 synonym term which best described medically the 5 situation which they saw on the patient and pick 6 either the ELECT or the COSTART or whatever 7 dictionary term was provided to them and that 8 described the situation the best. 9 Q. Okay. The ELECT is a 10 dictionary created by Eli Lilly, correct? 11 A. Yes. 12 Q. The COSTART is a dictionary 13 that's created by the FDA? 14 A. To my knowledge, yes. 15 Q. To your knowledge are both of 16 those dictionaries available in hard copy, hard 17 form? 18 A. Yes. 19 Q. And have you ever seen a 20 COSTART dictionary? 21 A. Yes. 22 Q. Have you seen an ELECT 23 dictionary? 24 A. Yes. Page 112 1 Q. Two separate books, correct? 2 A. Yes. 3 Q. Okay. Was there ever a 4 situation where you would provide a site with 5 copies of both the COSTART and the ELECT 6 dictionary? 7 A. No. 8 Q. Which one were they provided 9 with? 10 A. One or the other. 11 Q. Okay. Was this something that 12 was interchangeable throughout your career with 13 Lilly or was there a point when only the ELECT 14 dictionary was provided and then you switched to 15 the COSTART dictionary? 16 A. Yes. 17 Q. Which one? 18 A. ELECT and switch. 19 Q. So while you were still using 20 the ELECT dictionary at Lilly, they would only be 21 provided with a copy of the ELECT dictionary, 22 correct? 23 A. Ask that again. 24 Q. There was a certain point in Page 113 1 time where you switched from using the ELECT 2 dictionary to the COSTART dictionary, right? 3 A. Yes. 4 Q. So until you switched from 5 using the ELECT dictionary to the COSTART 6 dictionary, the sites would only be provided with 7 the ELECT dictionary? 8 A. Yes. 9 Q. And then after you switched 10 they would be provided with the COSTART 11 dictionary and not the ELECT dictionary, right? 12 A. Yes. 13 Q. Do you have an understanding of 14 what differences between the ELECT dictionary and 15 the COSTART dictionary are or were? 16 A. I have a recollection of one 17 and that's the injury comma accident. 18 Q. What do you mean when you have 19 one recollection? 20 A. I think that that's included in 21 the ELECT and not in the COSTART. 22 Q. Okay. Do you know why they 23 switched from the ELECT dictionary to the COSTART 24 dictionary? Page 114 1 A. No. 2 Q. Do you remember when that 3 occurred? 4 A. No. 5 Q. Do you have a recollection of 6 any other event terms that were changed in the 7 ELECT dictionary prior to switching to the 8 COSTART dictionary? 9 MR. MYERS: Other than? 10 MS. ZETTLER: Other than injury 11 accidental. 12 A. No. 13 Q. Do you have any knowledge as 14 to, not specific event terms but that in fact 15 event terms were changed prior to the injury 16 accidental change? 17 MR. MYERS: Changed where? 18 MS. ZETTLER: In the ELECT dictionary. 19 A. No. 20 Q. I may have asked you this, why 21 did they change the injury accidental term in the 22 ELECT dictionary? 23 A. To my knowledge, that injury 24 comma accident is not included in the COSTART Page 115 1 dictionary. 2 Q. And they changed it to what? 3 A. Accidental injury. 4 Q. Accidental injury is how it's 5 termed in COSTART? 6 A. To my knowledge. 7 Q. Okay. Why was the decision 8 made to change to the COSTART term from the ELECT 9 term? 10 A. I don't know. 11 MR. MYERS: Are you still talking about 12 injury accident, accidental injury? 13 A. Yes. 14 Q. Any other responsibilities in 15 your position as a CIR that we haven't already 16 talked about? 17 A. No. 18 Q. What was the next position that 19 you had with Lilly? 20 A. I was a clinical research 21 administrator. 22 Q. And you became a CRA 23 approximately in 19 -- sometime in early 1987? 24 A. Yes. Page 116 1 Q. Before we move on, in your 2 position as a CIR, how many other compounds did 3 you work on other than Fluoxetine? 4 A. Between ten and fifteen. 5 Q. Any other anti-depressants? 6 A. Yes. 7 Q. Are those anti-depressants now 8 on the market? 9 A. No. 10 Q. Were any of those eight studies 11 that you worked on a comparison of the efficacy 12 and safety of Fluoxetine as opposed to any of 13 other anti-depressants? 14 A. No. 15 Q. Why did you switch from being a 16 CIR to a CRA? 17 A. I was asked to have a different 18 assignment. 19 Q. Who asked you to change 20 assignments? 21 A. Mario Savalone. 22 Q. Who is Mario Savalone. 23 A. He was my CRC at the time of my 24 switch. Page 117 1 Q. Clinical research coordinator? 2 A. Yes. 3 Q. Did Mr. Savalone say why he 4 wanted you or they wanted you to switch from 5 being a CIR to CRA? 6 A. Increased responsibility. 7 Q. So it was a promotion of sorts? 8 A. No, it was a lateral move. 9 MR. SMITH: It was what? 10 THE WITNESS: A lateral move. 11 Q. Did you accept the offer? 12 A. Yes. 13 Q. Did that entail a move to 14 Indianapolis? 15 A. Yes. 16 Q. What division were you working 17 in when you became a CRA? 18 A. Medical division. 19 Q. What compounds were you working 20 on as a CRA? 21 A. Fluoxetine. 22 Q. Exclusively? 23 A. For a period of time, yes. 24 Q. What period of time? Page 118 1 A. 1987 until 1989. 2 MS. ZETTLER: Let's take a quick break. 3 MR. MYERS: Sure. 4 (A SHORT RECESS WAS TAKEN.) 5 Q. What position do you presently 6 hold at Lilly? 7 A. I'm an associate in the 8 international R and D department responsible for 9 Japan. 10 Q. Do you have any current 11 responsibilities with regards to Fluoxetine? 12 A. No. 13 Q. When did you become an 14 associate in R and D? 15 A. My current assignment? 16 Q. Yes. 17 A. September, 1992. 18 Q. Okay. How long were you in the 19 position of a CRA in the medical division? 20 A. From 1987 until 1992. 21 Q. Until you changed to your 22 present position? 23 A. Yes. 24 Q. Did you work continuously in Page 119 1 the medical division during that period of time 2 from '87 to September of '92? 3 A. Yes, I had a four month 4 developmental assignment but I was still under 5 the same division. 6 Q. When you say you had a four 7 month developmental assignment, what do you mean? 8 A. I went to a relief sales 9 assignment. 10 Q. What's a relief sales? 11 A. It's part of a development 12 program, you participate in sales school and go 13 out on a detail assignment. 14 Q. Was that four month 15 developmental assignment in preparation for your 16 current position? 17 A. No, it was to broaden my cross 18 functional knowledge. 19 Q. Okay. When did you participate 20 in that four month assignment? 21 A. September of 1989 until January 22 of 1990 -- February of 1990. 23 Q. When you were in that four 24 month developmental assignment, did you have any Page 120 1 responsibilities with regards to Fluoxetine? 2 A. No. 3 Q. Did you detail Fluoxetine to 4 any potential customers? 5 A. No. 6 Q. So when you said from 1987 7 through 1989 you were working exclusively on 8 Fluoxetine, were you working exclusively on 9 Fluoxetine until you went on this four month 10 assignment? 11 A. No. 12 Q. When did you stop working 13 exclusively on Fluoxetine? 14 A. February of '89, approximately. 15 Q. Did you continue to work on 16 Fluoxetine after February of '89 through 17 September of '89 but worked on other drugs as 18 well? 19 A. Yes. 20 Q. How many other drugs did you 21 work on during that period of time between 22 February of '89 and September of '89? 23 A. One. 24 Q. During that period of time from Page 121 1 February of '89 to September of '89, what 2 percentage of your time was devoted to 3 Fluoxetine? 4 A. I'm sorry, can you ask the 5 question again? 6 Q. From that period, from February 7 of '89 through September of '89 when you went on 8 the four month developmental assignment, what 9 percentage of your time was devoted to working on 10 Fluoxetine as opposed to this other drug you 11 worked on? 12 A. Approximately thirty percent. 13 Q. Was this other drug an 14 anti-depressant? 15 A. Yes. 16 Q. Is the anti-depressant on the 17 market now? 18 A. No. 19 Q. Have you heard of a drug, I 20 believe it's called Amitril? 21 A. No. 22 Q. After you returned from your 23 four month developmental assignment, did you work 24 on Fluoxetine? Page 122 1 A. Yes. 2 Q. Did you work on Fluoxetine then 3 continuously until you were changed to your 4 present assignment? 5 A. No. 6 Q. When you were finished with 7 your four month developmental assignment, did you 8 return to being a CRA in the medical division? 9 A. Yes. 10 Q. At that time you resumed 11 working on Fluoxetine? 12 A. Yes. 13 Q. When did you stop working on 14 Fluoxetine after you resumed working on it in 15 February of '90? 16 A. I had some responsibilities up 17 until September of last year, 1990. 18 Q. September of 1990? 19 A. 1992, I'm sorry. 20 Q. During that period of time from 21 February of 1990 through September of 1992, was 22 there a period where you worked exclusively on 23 Fluoxetine again? 24 A. No. Page 123 1 Q. Was there a period of time 2 between February of 1990 through September of 3 1992 when the percentage of time that you devoted 4 to Fluoxetine increased from the thirty percent 5 you talked about earlier? 6 A. Yes. 7 Q. What period of time was that? 8 A. I probably spent approximately 9 fifty percent of my time. 10 Q. Okay. When you came back from 11 the four month developmental assignment in 12 February of 1990, did you spend approximately 13 fifty percent of your time on Fluoxetine? 14 A. At the most, yes. It varied. 15 Q. Was there ever a time that you 16 spent more than fifty percent of your time on 17 Fluoxetine between February of '90 and September 18 of 1992? 19 A. No. 20 Q. During that period from 21 February of 1990 to September of 1992, how many 22 other drugs did you work on in addition to 23 Fluoxetine? 24 A. None. Page 124 1 Q. What did you do in the other 2 fifty percent of your time during that period of 3 time? 4 A. I had non-compound related 5 assignments. 6 Q. Did you work on any other Lilly 7 products during that period of time? 8 A. No. 9 Q. When you say you had 10 non-compound related assignments, what do you 11 mean? 12 A. Committee responsibilities. 13 Q. Such as? 14 A. Case report forms. 15 Q. Developing case report forms? 16 A. Yes. 17 Q. Were you responsible for 18 developing case report forms for use with 19 Fluoxetine trials? 20 A. Yes. 21 MR. MYERS: When, during that same 22 period of time? 23 MS. ZETTLER: Yes. 24 Q. Right now, I'm just Page 125 1 concentrating on the period of time when you 2 returned from the four month developmental 3 assignment in February of 1990 until you ceased 4 work on Fluoxetine in February of 1992. So your 5 answer was yes, you did have responsibilities for 6 developing the Prozac or Fluoxetine CRF? 7 A. After you clarified that, no. 8 Q. Did you at any time have the 9 responsibility for developing a CRF for use in 10 Fluoxetine trials? 11 A. Ask that again. 12 Q. Sure. At any time, did you 13 have responsibility for developing clinical 14 report forms to be used in Fluoxetine clinical 15 trials? 16 A. Yes. 17 Q. During what period of time? 18 A. From February of '87 until 19 September of '89. 20 Q. What other committees -- what 21 other committee responsibilities did you have 22 from February of 1990 to September of 1992? 23 A. I don't remember. 24 Q. Have you ever heard the term Page 126 1 mini CRF? 2 A. No. 3 Q. Is this the acronym CTE? 4 MR. MYERS: Excuse me? 5 MS. ZETTLER: CTE. 6 A. No. 7 Q. Were the CRFs that you were 8 developing in the committee work you did from 9 February of 1990 through September of 1992 used 10 exclusively for clinical trials on specific 11 compounds? 12 A. Let me qualify, I didn't 13 develop them, we would review the pages or 14 perhaps think of better ways of collecting them, 15 better design mechanisms. 16 Q. Any of that responsibility in 17 the CRF committee related to Fluoxetine? 18 A. I don't recall. 19 Q. On the fifty percent of the 20 time that you worked on Fluoxetine from February 21 of 1990 through September of 1992, what did you 22 do with regards to Fluoxetine? 23 MR. MYERS: What were her 24 responsibilities? Page 127 1 MS. ZETTLER: Yes. 2 A. What was that time period? 3 Q. February of '90 to September of 4 '92. 5 A. I worked on another indication 6 for Fluoxetine. 7 Q. What indication? 8 A. Maybe it wasn't qualified as -- 9 not another indication, cardiac study. 10 MR. SMITH: I'm sorry? 11 THE WITNESS: Cardiac study. 12 Q. Any other responsibilities? 13 A. Validating data. We worked on 14 a team concept, we pitched in and helped where 15 things were -- when people got busy, we helped. 16 I helped out a lot. 17 Q. Helped out in what way? 18 A. Validating case report forms. 19 Q. Was this for indications or 20 studies other than the cardiac study? 21 A. Yes. 22 Q. Were these for international 23 studies? 24 A. Yes. Page 128 1 Q. When you say validating 2 information, what do you mean? 3 A. Running edit checks on the 4 information. 5 Q. What information? 6 A. Contained on the case report 7 forms. 8 Q. What are edit checks? 9 A. The computer generates edits, 10 highlighting either errors or non-computer fits, 11 and sometimes you would have to call the site or 12 sometimes your job was just to highlight that 13 information so the CRA responsible could contact 14 the site. 15 Q. What kinds of errors would the 16 computer pick up on? 17 A. Dates that weren't consistent, 18 initials that didn't match, visits occurring 19 outside the time frame, spelling errors. 20 Q. Was there a computer edit 21 developed to flag adverse event terms that 22 weren't contained in the ELECT dictionary? 23 A. Yes. 24 Q. How did that work, do you know? Page 129 1 MR. MYERS: Let me -- when you say how 2 did that work, how did that work, how did the 3 computer do it? 4 Q. I mean if the computer found an 5 adverse event that wasn't listed -- that was 6 listed on the CRF but wasn't listed in the ELECT 7 dictionary, would it somehow bring that fact to 8 your attention? 9 A. Yes. 10 Q. How would it do that? 11 A. The edit would state event term 12 not found in ELECT dictionary. 13 Q. What did you do in response to 14 something like that? 15 A. You would look at what was 16 written on the page to see what kind of error it 17 was, if it was a spelling mistake or a space 18 would even prompt an error message. 19 Q. Okay. What if it was there, it 20 was an error like a space or a misspelling and it 21 was a term that just was not included in the 22 ELECT dictionary, what would you do? 23 A. Call the site or flag it so 24 somebody responsible for the site could call the Page 130 1 site and question the site. 2 Q. Okay. Did you in your position 3 as a CRA have responsibilities for assigning 4 event terms to adverse events? 5 MR. MYERS: When? 6 MS. ZETTLER: At any time. 7 A. Not to my knowledge. 8 Q. Who would do that to your 9 knowledge? 10 A. To my knowledge, the only 11 people that could assign a term would be site 12 personnel, investigator personnel. 13 Q. And was there anybody at Lilly 14 who would review the terms assigned by the site 15 personnel? 16 A. Yes. 17 Q. Who would that be? 18 A. Research physicians. 19 Q. Did you ever have any 20 responsibility to review the terms assigned 21 adverse events by the site personnel? 22 A. I'm sorry, say that again. 23 Q. Did you have responsibility to 24 review the terms assigned by the site personnel, Page 131 1 the adverse event terms? 2 A. Yes. 3 Q. In what context? 4 A. A report that's generated 5 called morning report. 6 Q. Morning report, what's a 7 morning report? 8 A. All adverse events that were 9 entered into the computer the night before. 10 Q. Is this done with every study, 11 clinical trial performed on Fluoxetine by Lilly? 12 A. Every study I've ever worked on 13 as a CRA. 14 Q. To your knowledge, was there an 15 occasion where this was not done with a study 16 performed by Lilly on Fluoxetine? 17 MR. MYERS: This what? 18 MS. ZETTLER: The morning reports. 19 A. No. 20 Q. Was this -- to your knowledge, 21 were the morning reports run on spontaneous 22 adverse events reported to Lilly? 23 A. No. 24 Q. Why not? Page 132 1 A. Not to my knowledge. I was 2 only responsible for clinical trial data. 3 Q. Do you know what an EW study 4 is? 5 A. Yes. 6 Q. What's an EW study? 7 A. EW is an acronym for Earlwood. 8 MR. SMITH: For what? 9 THE WITNESS: Earlwood, it's an 10 affiliate office. 11 Q. To your knowledge, were 12 Fluoxetine clinical trials performed at Earlwood? 13 A. Yes, they were. Excuse me, 14 they were monitored from Earlwood, they weren't 15 performed. The study was performed at an 16 investigator site. 17 Q. Okay. To your knowledge, 18 during the period of time that you worked on 19 Fluoxetine, were there clinical trials performed 20 out of Earlwood other than Fluoxetine trials? 21 A. Yes. 22 Q. Were these exclusively trials 23 on other Lilly compounds? 24 A. Yes. Page 133 1 Q. Who is Lisa DeVault? 2 D-E-V-A-U-L-T. 3 A. Project leader in systems, at 4 least that's how I knew her. 5 Q. Was she stationed here at 6 Indianapolis? 7 A. Yes. 8 Q. Is she still working for Lilly? 9 A. To my knowledge, yes. 10 Q. Do you know what department she 11 works in? 12 A. No, I don't. 13 Q. To your knowledge, is she still 14 working here in Indianapolis? 15 A. Yes. 16 Q. What are batch edits? 17 A. Edits that are run after all 18 the information is in a particular data base and 19 it's batched and run as it's named in batch. 20 Q. So after all of the information 21 from the CRFs are entered into a data base, then 22 batch edits are run on the information? 23 A. You can identify your 24 parameters, yes. Page 134 1 Q. To your knowledge, was that 2 done on information collected through Fluoxetine 3 clinical trials? 4 A. Yes. 5 Q. What kind of batch edits were 6 performed on Fluoxetine clinical trial 7 information? 8 A. Can you be more specific? 9 Q. No, because I don't know what 10 you mean by batch edits. 11 MR. MYERS: Are you asking what the 12 edit looks for? 13 MS. ZETTLER: No. 14 Q. Let me ask this: When you're 15 talking a batch, you mean a batch of information 16 that's entered into a data base? 17 A. It's searching that batch. 18 Q. Okay. So it's specific 19 information that you want to search, a specific 20 group of information? 21 A. No, it's already probably 22 defined. Rather than -- let me clarify. Rather 23 than running something on one particular thing, 24 as it's being entered, this is done after the Page 135 1 fact that it's already in a computer system. 2 Q. So, for example, let's say you 3 have a particular clinical trial and say it has 4 two hundred people -- two hundred patients 5 involved, you can enter all the information from 6 all of their CRFs and then do a batch edit on all 7 of that information at one time as opposed to 8 doing an edit for each individual CRF that is 9 entered? 10 A. Yes. 11 Q. What kinds of edits could you 12 do to a batch edit? 13 A. You could define your 14 parameters as tight or as wide as you wish. 15 Q. Could you change adverse event 16 terms? 17 MR. MYERS: Through a batch edit? 18 MS. ZETTLER: Through a batch edit. 19 A. No, you cannot. 20 Q. Okay. Give me an idea of some 21 types of things that you can do with a batch 22 edit. 23 A. A batch -- it would just -- 24 it's no different than running an edit on one Page 136 1 thing, it's just a term used for running it on a 2 group of things. 3 Q. Okay. So what you're doing is 4 instead of looking for errors in a particular 5 CRF, you're looking for errors in a number of 6 CRFs at one time? 7 A. Yes. 8 Q. And then the computer would 9 call up or mark somehow the individual errors in 10 the CRF as they came up? 11 A. Yes. 12 MS. ZETTLER: Do you want to take a 13 lunch break, this is a good place to stop for 14 lunch. 15 MR. MYERS: Sure, if that's a good 16 place, that's fine. 17 (A LUNCH BREAK WAS TAKEN, WHEREUPON 18 THE PROCEEDINGS CONTINUED AS 19 FOLLOWS:) 20 21 Q. (BY MS. ZETTLER) Catherine, do 22 you know a David Dunner, M.D.? 23 A. Yes. 24 Q. Who is David Dunner? Page 137 1 A. He is a psychiatrist in 2 Seattle. 3 Q. Has he performed a clinical 4 trial on Fluoxetine? 5 A. Yes. 6 Q. Are you familiar with a man 7 named Frederique Dunner? 8 A. Yes. 9 Q. Who is Frederique Dunner. 10 A. I think it's his brother. 11 Q. Did he perform clinical trials 12 on Fluoxetine? 13 A. I think he was associated with 14 an investigational site. 15 Q. Same site as David Dunner? 16 A. No. 17 Q. Where is his investigational 18 site located, if you know? 19 A. I don't remember. 20 Q. Did he work on the same 21 protocol as David Dunner? 22 A. I don't remember. 23 Q. When you say he's associated 24 with an investigational site, is he a medical Page 138 1 doctor, to your knowledge? 2 A. I don't know. 3 Q. What do you mean when you say 4 associated with an investigational site? 5 A. I somehow recall that he was 6 affiliated with somebody that was participating 7 in it, maybe he was a subinvestigator or part of 8 the study personnel. 9 Q. Okay. To your knowledge, were 10 there any -- had there been or are there any 11 ongoing clinical trials comparing Fluoxetine to 12 any anti-depressants that Lilly is currently 13 developing for market? 14 A. Could you ask that again, I'm 15 trying to get focused again. 16 Q. Sure. Earlier you testified 17 that some of the work you've done has been on 18 other anti-depressants in development by Lilly; 19 correct? 20 A. Uh-huh. 21 MR. MYERS: Yes. 22 A. Yes. 23 Q. Don't worry about it, that's 24 human nature. To your knowledge, is Lilly Page 139 1 conducting or have they ever conducted a clinical 2 trial comparing the safety and efficacy of 3 Fluoxetine against any other anti-depressant that 4 they are developing or have developed? 5 A. Yes. 6 Q. Is the anti-depressant that 7 they're comparing Fluoxetine on the market? 8 A. Yes. 9 Q. What anti-depressant is that? 10 A. I recall a trial of Fluoxetine 11 and Nortriptyline. 12 Q. Okay. Any others? 13 A. No. 14 MR. SMITH: What's the brand name of 15 Nortriptyline? 16 MR. MYERS: Which one? I think there's 17 more than one. 18 MR. SMITH: The one manufactured by 19 Lilly. 20 MR. MYERS: Do you know? 21 THE WITNESS: Aventyl. 22 MS. ZETTLER: I think that's the one I 23 was trying to remember earlier when I said 24 Amitryl. Page 140 1 Q. What are you currently doing in 2 your position right now? I know you said you 3 were working with a Japanese affiliate, I 4 believe. 5 A. Yes, I work on the research and 6 development of compounds for Eli Lilly in Japan. 7 Q. Generally what does that 8 position entail? 9 MR. MYERS: Give her a very, very 10 general description. We're not going to go into 11 depth on research and development of other 12 compounds, but generally tell her what you're 13 doing. 14 A. I'm the liaison and facilitate 15 the communications between project teams and the 16 affiliate office. 17 Q. And I think earlier you 18 testified that the work you're doing now in 19 research and development is not related in any 20 way to Fluoxetine? 21 A. It is not. 22 Q. Have you ever heard of the 23 phrase OUS analysis? 24 A. Yes. Page 141 1 Q. What is an OUS analysis? 2 A. My definition of OUS analysis 3 is a term that was used when we at Lilly analyzed 4 the international data base. 5 Q. What is the international data 6 base? 7 A. A data base that was developed 8 by centralizing all Prozac -- excuse me, all 9 Fluoxetine double-blind clinical trials performed 10 outside the United States. 11 Q. What do you mean by 12 centralizing? 13 A. Not all of the data for 14 Fluoxetine outside the United States resided in 15 one central location. 16 Q. Okay. And when you say data, 17 what do you mean? 18 A. Information collected from 19 clinical trials. 20 Q. Information that would be 21 reported on the clinical report forms? 22 A. Yes. 23 Q. Were there other trials that 24 were conducted on Fluoxetine outside the U.S. Page 142 1 besides double blind clinical trials? 2 A. Yes. 3 Q. Give me an example of what 4 other kind of studies were performed? 5 A. Open label trials. 6 Q. Any others? 7 A. Fluoxetine only trials. 8 Q. Any others? 9 A. Single blind trials. 10 Q. Any others? 11 A. Perhaps there were some 12 clinical pharmacology, but that's probably all 13 covered under single blind. 14 Q. Why was the OUS analysis done? 15 A. So we would be able to have 16 more information on our trials world wide. 17 Q. I think you've broken it down 18 into two things, that the information was 19 centralized and then there was analysis, an 20 analysis of the information done? 21 A. Yes. 22 Q. When you say that, so you would 23 have more information on your clinical trials 24 world wide, are you talking about the actual Page 143 1 analysis or are you talking about the 2 centralizing of the information? 3 A. Both. 4 Q. Okay. Was the information ever 5 analyzed for a specific purpose? 6 A. It was analyzed to look at the 7 incidence of suicidality. 8 Q. When was that done? 9 A. In 19 -- excuse me, '91. 10 Q. Do you remember what part of 11 1991? 12 A. The analysis occurred? 13 Q. Right, the suicidality 14 analysis. 15 A. I think in the Spring. 16 Q. Do you know why an analysis of 17 suicidality was done on the OUS data in the 18 Spring of 1991, is there a specific project or 19 purpose in mind when it was done? 20 A. It was to answer questions for 21 the FDA. 22 Q. What kind of questions? 23 A. That our data base from the 24 U.S. was comparable to that outside the United Page 144 1 States. 2 Q. Do you know why the analysis 3 was limited to an analysis of data from double 4 blind clinical trials done outside the U.S.? 5 A. Because that would make it 6 comparable data to that of the United States 7 data. 8 Q. Was a similar analysis done on 9 double blind clinical trials performed in the 10 United States? 11 A. Yes. 12 Q. Are there other trials besides 13 double blind clinical trials performed in the 14 United States on Fluoxetine? 15 A. Yes. 16 Q. What kind of trials were 17 performed on Fluoxetine in the United States 18 besides double blind clinical trials? 19 A. Single blind clinical trials. 20 Q. Any others? 21 A. Open label. 22 Q. Any others? 23 A. None that I'm aware of. 24 Q. Any Fluoxetine only trials? Page 145 1 A. No, none that I'm aware of. 2 Q. Any clinical pharmacology 3 trials? 4 A. Yes. I'm sorry, that's the 5 same -- to me, that's the same as a single blind. 6 Q. Okay. And when you say single 7 blind, you mean the patients are blinded; 8 correct? 9 A. The patients are blinded. 10 Q. And generally for what purpose 11 are clinical pharmacology trials run? 12 A. Safety information. 13 Q. Do you know if there was any 14 single blind clinical pharmacology studies or 15 trials run either in the United States or 16 internationally done regarding the specific issue 17 of Fluoxetine and suicidality? 18 A. Not that I'm aware of. 19 Q. Have you ever heard of 20 rechallenging? 21 A. Yes. 22 Q. What is rechallenging? 23 A. To see if you can duplicate, 24 scientifically duplicate, something, an event or Page 146 1 parameter. 2 Q. When you say an event, you mean 3 like an adverse event? 4 A. Yes. 5 Q. To your knowledge has Lilly or 6 anybody on behalf of Lilly ever performed a 7 rechallenging study on the issue of Fluoxetine 8 use in suicidality? 9 A. No. 10 Q. No, you don't know or no, they 11 didn't? 12 A. To my knowledge, they did not. 13 Q. Have you ever heard the phrase 14 pilot study? 15 A. Yes. 16 Q. What is a pilot study? 17 A. To perform something on a 18 smaller scale. 19 Q. Perform a study on a smaller 20 scale? 21 A. The term pilot could mean a 22 study, yes, or it could mean a variety of things, 23 just doing something on a smaller scale. 24 Q. Okay. When -- what is your Page 147 1 understanding of the term pilot study, though? 2 A. To perform it on a smaller 3 group rather than a larger group. 4 Q. What is the purpose of 5 performing a pilot study, if you know? 6 A. To my knowledge, it's a test, a 7 theory. 8 Q. I'm sorry, to test a theory? 9 A. Uh-huh. 10 MR. MYERS: Yes. 11 A. Yes, I'm sorry. 12 Q. So in other words, if you had 13 considered running a particular trial to study, 14 say, the efficacy on five milligrams of Prozac 15 and you weren't sure if it was feasible or if it 16 would produce any usable information, you might 17 run a pilot study on it to see if -- it's sort of 18 a test run? 19 A. Yes. 20 Q. To your knowledge, were any 21 pilot studies done on the issue of Fluoxetine and 22 suicidality? 23 A. No. 24 Q. How about Fluoxetine and Page 148 1 violent-aggressive behavior? 2 A. Not to my knowledge. 3 Q. To your knowledge, were any 4 pilot studies run regarding Fluoxetine 5 whatsoever? 6 A. I'm not sure I understand that 7 question. 8 Q. Were any pilot studies run 9 where Fluoxetine was involved? 10 A. Not to my knowledge. 11 Q. To your knowledge, did Lilly 12 ever consider running a rechallenge study on the 13 use of Fluoxetine and suicidality? 14 A. Yes, they did. 15 Q. When did they consider that? 16 MR. MYERS: What or when? 17 MS. ZETTLER: When. 18 A. 1991. 19 Q. Why did they consider running 20 the rechallenge study? 21 A. To address the issue of 22 suicidality. 23 Q. To your knowledge, did the FDA 24 ever request that they run a rechallenge study on Page 149 1 the issue of Fluoxetine and suicidality? 2 A. Not to my knowledge. 3 Q. To your knowledge, was a 4 protocol ever written for a rechallenge study of 5 Fluoxetine and suicidality? 6 A. Yes. 7 Q. Who wrote the protocol? 8 A. I wrote the draft protocol. 9 MR. SMITH: Was that produced with 10 those documents that you requested be produced in 11 connection with this witness? 12 MS. ZETTLER: Absolutely not. 13 MR. SMITH: We would, at this time, 14 request that those documents be produced. 15 MR. MYERS: Well, among other things, 16 one place to look might be in the IND or NDA, 17 which has been made available to you on a prior 18 occasion. 19 MS. ZETTLER: Well, it's real funny, 20 Larry, but lots of people have looked at those 21 documents and nobody has ever seen a rechallenge 22 protocol, ever. In fact, nobody's even known 23 about a rechallenge study until I got the 24 documents on the witness from yesterday. Page 150 1 MR. MYERS: Well, I suggest you look at 2 the documents in more detail, then. 3 MS. ZETTLER: Why don't you call over 4 there and have somebody find if for us and pull 5 it. 6 MR. MYERS: I'm not having anybody pull 7 any documents for you right now. 8 MR. SMITH: Well, why were they not 9 produced? As I understand it, there was a 10 subpoena duces tecum issued for this witness to 11 produce certain documents. Why were they not 12 produced in connection with the production of 13 this witness, regardless of whether or not they 14 happen to be in the IND or NDA? 15 MR. MYERS: The documents produced for 16 this deposition, Mr. Smith, were the documents of 17 this witness that had been gathered. If the 18 document were in the file of the witness, the 19 document would have been produced. 20 MR. SMITH: She drafted the document. 21 MR. MYERS: Well, I've answered the 22 question, I'm not under examination, so let's 23 either continue with the deposition or not. 24 MR. SMITH: Are you refusing to produce Page 151 1 that document? 2 MR. MYERS: I'm not under examination 3 by you. 4 MR. SMITH: Are you refusing to produce 5 that document? 6 MR. MYERS: No, I do not refuse to 7 produce that document, but am I going to go have 8 somebody retrieve any such document now in the 9 middle of the deposition, the answer to that 10 question is no. 11 MS. ZETTLER: Larry, as you know, 12 that's an extremely important document to us, and 13 since this witness testified that she drafted the 14 first draft of the protocol, I don't know how we 15 can conclude this deposition today. 16 MR. MYERS: Well, I suggest you 17 continue with whatever examination you have 18 planned to continue. 19 MR. SMITH: We had planned to question 20 her concerning the documents that were produced. 21 Now we find that there's a vital document which 22 has not been produced. Certainly we cannot -- 23 you can understand that we would want to question 24 this lady concerning that document. Page 152 1 MR. MYERS: Just so that you 2 understand, the document has been produced to the 3 extent that it's been made available within the 4 body of FDA documents that have been produced to 5 both you and Ms. Zettler on more than one 6 occasion. If the document is not in the 7 documents that have been produced for this 8 deposition, then it's not in there. But it's 9 incorrect that the document has not been either 10 made available for production or either produced. 11 MR. SMITH: Whether you produced it on 12 another occuasion under a different format is not 13 relevant to whether or not you should produce it 14 in response to a notice and subpoena duces tecum 15 in this deposition. We are entitled under the 16 rules to request specific documents of a 17 particular witness at the time a deposition is 18 given. 19 MR. MYERS: And if -- 20 MR. SMITH: And that's what we want to 21 do, we want to question this witness concerning 22 documents she's authored, this is a document that 23 is relevant to the inquiry, we need to talk to 24 this lady about this protocol. Page 153 1 MR. MYERS: Are you through, or are you 2 going to keep talking? 3 MR. SMITH: Am I going to convince you 4 to do anything if I continue to talk? 5 MR. MYERS: You're not going to 6 convince me to do anything other than proceed 7 with the deposition. 8 MR. SMITH: We're taking the 9 deposition, our point is we can't effectively 10 take this lady's deposition when you haven't 11 produced the document. 12 MR. MYERS: That's your position and 13 I've made our position clear. 14 MR. SMITH: Are you in a position to be 15 able to produce this document for us this 16 afternoon? 17 MR. MYERS: I don't believe that I am. 18 MS. ZETTLER: Is it -- 19 MR. MYERS: No, Ms. Huff is not here to 20 answer any questions, she's not under examination 21 and neither am I, and we can proceed with the 22 deposition or not proceed with the deposition. 23 MS. ZETTLER: Larry, there's no reason 24 to get so upset about this whole thing, we're Page 154 1 just trying to find out what the heck is going on 2 here. 3 MR. MYERS: And I have made our 4 position clear. I am not under examination and 5 Ms. Huff is not under examination, we are not 6 going to turn the deposition into a document 7 production session. So if you want to proceed 8 with the examination, that's fine, if you don't, 9 then that's fine as well. 10 MS. ZETTLER: It's our deposition and 11 we'll do anything we want with it. If we want to 12 ask her about documents, then we're going to ask 13 her about documents -- 14 MR. MYERS: Absolutely. 15 MS. ZETTLER: -- and their existence. 16 And if they are not in the file, we've going to 17 reserve the right to bring her back when the 18 documents requested are produced. 19 MR. MYERS: You can reserve whatever 20 you like, I've made our position clear and I 21 think that you and Paul, between the two of you, 22 have made your position clear, so let's either 23 proceed or not. 24 MS. ZETTLER: I think the history of Page 155 1 these depositions has been we have requested, 2 made proper requests for a variety of documents 3 and it has been obvious throughout these 4 depositions that the majority of the documents 5 related to these people have not been produced, 6 especially as evidenced by the delivery of 7 thirteen additional documents for the depositions 8 of Jan Potvin and Dan Russell, which were not 9 produced prior to their depositions. 10 MR. MYERS: A fact which was made known 11 to you before the deposition took place. 12 MS. ZETTLER: That there were thirteen -- 13 MR. MYERS: That there would be a 14 supplemental production. 15 MS. ZETTLER: Absolutely not. 16 MR. MYERS: We can debate that from now 17 until forever. 18 MS. ZETTLER: Now it's obvious that 19 there's been a select production of documents, 20 and frankly I wasn't even considering asking her 21 this question, and I just happened to ask it, and 22 if I hadn't asked her that question, we probably 23 never would have known that this woman was in any 24 way related to that protocol. Page 156 1 MR. MYERS: Your interpretation of what 2 the production is or isn't is your interpretation 3 of it, and you're not adding anything to the 4 proceedings by carrying on. I suggest you either 5 continue the examination or not. 6 MS. ZETTLER: Larry, I want to know why 7 it wasn't produced. You have represented to us 8 before that you have gone to various locations 9 and collected documents related to each of these 10 individuals, that this is part of the reason why 11 you need at least thirty days notice to produce 12 these people for their depositions. Obviously if 13 the document exists in the IND/NDA documents, you 14 did not search those documents for any documents 15 related to this witness. 16 MR. MYERS: I can't answer your 17 questions. What I can tell you is my 18 understanding is that the protocol reference that 19 was prepared was submitted to the Food and Drug 20 Administration. Now whether it was submitted to 21 the Food and Drug Administration, for example, 22 with this witness as the author, I don't know the 23 answer to that, but I am generally aware that it 24 was submitted to the FDA and hence it is in those Page 157 1 documents. As to why it is not in her files that 2 are here for this deposition today, I can't 3 answer that question for you, but it is not a 4 function of somebody not producing a document 5 that's available. I'm generally aware of such a 6 protocol, that's what I'm telling you. 7 Q. (BY MS. ZETTLER) Catherine, if 8 you had drafted the first draft of the protocol, 9 would you have had a copy of that in your file at 10 some period of time? 11 A. I may not have kept a file. 12 Q. In what situation would you not 13 have kept it? 14 A. If I was to draft it, I would 15 pass it on to the next person. 16 Q. Were you involved in the 17 development of the protocol after writing the 18 first draft? 19 A. Yes. 20 Q. Okay. Were you involved with 21 any subsequent drafts of the protocol? 22 A. Yes. 23 Q. So at some point in time you 24 would have had another draft with either Page 158 1 corrections, additions or whatever anybody else 2 had done to the protocol, right? 3 A. Yes. 4 Q. To your knowledge, were you 5 involved in more than two drafts of the protocol? 6 A. Yes. 7 Q. What would you do with the 8 previous drafts once you worked on a subsequent 9 draft? 10 A. Throw it out. 11 Q. To your knowledge, did you have 12 any other documents -- did you generate any other 13 documents related to the rechallenging protocol? 14 A. Yes. 15 Q. What documents? 16 A. Budget documents. 17 Q. Any others? 18 MR. SMITH: I'm sorry, I didn't hear 19 that. 20 THE WITNESS: Budget documents. 21 A. I would have needed to request 22 a study drug number. 23 Q. Would an investigator have been 24 recruited for that study? Page 159 1 A. Not to my knowledge. 2 Q. Had any investigators been 3 contacted with a proposal they work on that 4 study? 5 A. Some investigators were, I 6 think, involved in the discussion of the 7 development of that protocol. 8 Q. Do you remember any of their 9 names? 10 MR. MYERS: If you do, don't tell her. 11 MS. ZETTLER: Based on what? 12 MR. MYERS: That it's proprietary. 13 MS. ZETTLER: In what way? 14 MR. MYERS: It's confidential and 15 commercial information. 16 MS. ZETTLER: In what way? 17 MR. MYERS: I'm not under examination. 18 That's the objection and that's the instruction 19 so don't waste your time. 20 MS. ZETTLER: Larry, you're not going 21 to get along here by just pulling out the old 22 trade secret proprietary information garbage. 23 Why don't you tell us specifically in what way a 24 rechallenge study on Fluoxetine and suicidality Page 160 1 is proprietary information other than the fact 2 that you didn't like what the results might have 3 been. That is completely and directly relevant 4 and you know it. 5 MR. MYERS: I'm not under examination 6 here, so ask her another question. 7 MS. ZETTLER: Either you let her answer 8 that question or I'm going to quit this 9 deposition right now and we're going to come in 10 on sanctions for today and for bringing her back. 11 You know that that's an improper objection. 12 MR. MYERS: She's not going to answer 13 that question. 14 MR. SMITH: Let's go. 15 MS. ZETTLER: Obviously this is a sore 16 subject for you and we're not going to pursue 17 this anymore until we get a ruling from the court 18 as to whether or not information on a rechallenge 19 study of Fluoxetine and suicidality is relevant 20 and discoverable in this case. 21 MR. MYERS: Before you recess the 22 deposition, let's just be clear that you've 23 recessed it because I would not allow her to 24 identify the investigators. She's been sitting Page 161 1 here to the extent you've asked her questions 2 giving you information about the rechallenge 3 protocol. So to the extent that we refused -- 4 that you contend we refused to give you 5 information about the protocol, that's simply 6 erroneous since you examined Dr. Katsanos about 7 it for a couple of hours yesterday. 8 MS. ZETTLER: Who just happened to have 9 a very vague memory of it. 10 MR. MYERS: That's your opinion. But 11 the reality is that you examined him and have 12 examined this witness on the subject. The 13 position about the investigators is the position 14 about the investigators that we've urged 15 throughout this litigation, it's not peculiar to 16 this protocol or any other protocol. So before 17 you recess the deposition, let's be absolutely 18 clear that we've not refused to give you 19 information about this protocol. 20 MS. ZETTLER: No, just the critical 21 information. 22 MR. MYERS: Well, you interpret it 23 however you want, the position on the 24 investigators is the position we've urged all Page 162 1 along. 2 MS. ZETTLER: I think it's a better 3 statement to say that you've either refused or 4 failed to give us information on this. 5 MR. MYERS: Well, that's your opinion. 6 MS. ZETTLER: You have not produced 7 completely relevant admissible and crucial 8 documents to this witness and you know it. 9 MR. MYERS: That's your opinion. 10 MS. ZETTLER: And it's your opinion 11 that this is irrelevant to this litigation, and I 12 think you're completely and wholly wrong, and I 13 think you know it. And also, there is no such 14 order in the Fentress litigation, the litigation 15 in which this deposition has been noticed, that 16 determines whether or not any particular protocol 17 or study is relevant to this action and you know 18 it. 19 MR. MYERS: There is an order in place 20 that addresses the subject of the discoverability 21 of the identity of investigators in this case, 22 there is an order in place in the MDL proceeding, 23 and the matter is the subject of litigation in 24 other courts. Page 163 1 MS. ZETTLER: You chose to cross-notice 2 this deposition in the MDL, and we're not going 3 to be fired to preview any discovery that's 4 completely proper in the Fentress case not 5 representing that this discovery would not be 6 proper from the MDL case, but there is absolutely 7 no order in the Fentress case that bars me from 8 asking her these questions and protects you from 9 having her answer them, and you know it. 10 MR. MYERS: The subject isn't your 11 questions generally. If you want to ask her 12 about the protocol, go ahead. 13 MS. ZETTLER: There's nothing in the 14 Fentress order that says that you are preventing 15 us from asking you who the investigators on the 16 various studies are and you know it. 17 MR. MYERS: There is an order in place, 18 in fact it addresses which investigators' 19 identities are to be disclosed. 20 MS. ZETTLER: Which order is that? 21 MR. MYERS: The order from the April 12 22 hearing, I believe. 23 MS. ZETTLER: Absolutely not. All that 24 order says is that with regards to those limited Page 164 1 pivotal, non-pivotal, studies, you were to put 2 back the investigators on those, it doesn't 3 address generally, and you know that the purpose 4 of Judge Potter doing that was for us to be able 5 to demonstrate to him why all that information 6 should be put back. Just because you've 7 improperly removed that information from the 8 beginning doesn't mean that it's not properly 9 discoverable and that there's an order in place 10 in Fentress that prevents us from obtaining that 11 information from you and any of your witnesses. 12 MR. MYERS: The information from the 13 documents has been redacted pursuant to the order 14 and it's been redacted pursuant to the 15 confidentiality order entered early on in the 16 case, and it's been redacted and our objections 17 have been urged otherwise pursuant to the more 18 recent order of the court. Now we can either sit 19 here and have this debate on the record or you 20 can continue to ask the witness questions, I 21 don't have a preference one way or another. If 22 you want to proceed, proceed, if you want to 23 adjourn the deposition, that's your decision. 24 But the witness is here and we're here and we're Page 165 1 ready to proceed. 2 MR. SMITH: What was the original 3 question, who were the investigators that she 4 worked with in connection with the development of 5 that protocol? 6 MS. ZETTLER: The investigators who 7 were involved in the development of the protocol. 8 MR. SMITH: And you refused to let her 9 answer that? 10 MR. MYERS: That's right. 11 Q. (BY MS. ZETTLER) Are you 12 following your lawyer's instructions? 13 A. Yes. 14 MS. ZETTLER: Certify the question. 15 (QUESTION CERTIFIED.) 16 Q. From time to time when you 17 worked as a CRA, were you asked to turn over any 18 Fluoxetine related documents that you had in your 19 files to the legal department at Lilly? 20 A. Yes. 21 Q. When did they start asking you 22 that? 23 A. I don't remember the date. 24 Q. Was it before or after you went Page 166 1 on the four-month developmental assignment? 2 A. After. 3 Q. Did they ask you periodically 4 to turn over any new documents that you had 5 either gathered or generated regarding 6 Fluoxetine? 7 A. Yes. 8 Q. How often did they ask you to 9 do that? 10 A. I think I was asked quarterly. 11 Q. Four times a year you were 12 asked to turn over documents related to 13 Fluoxetine to the legal department? 14 A. I think it was quarterly. 15 Q. Was there a limitation on the 16 documents that you had to turn over? 17 MR. MYERS: What do you mean by 18 limitation? 19 Q. Did they ask you for every 20 single document that you had in your files 21 related to Fluoxetine or did they ask you for 22 certain documents? 23 A. They asked for everything. 24 Q. Are you aware of what an Page 167 1 investigator file is? 2 A. Yes. 3 Q. Did you have an investigator 4 file or start an investigator file with regards 5 to the rechallenge protocol? 6 A. No. 7 Q. Besides the budget documents 8 that you created on the rechallenge protocol, 9 what other documents would you have created? 10 MR. MYERS: What other documents that 11 she would have ever created on that subject? 12 MS. ZETTLER: On that subject. 13 A. A request for medical study 14 number. 15 Q. When you say medical study 16 number, would that have been a protocol number? 17 A. Yes. 18 Q. Were you given a medical study 19 number for that protocol? 20 A. Yes. 21 Q. What was that number? 22 A. It was S zero zero, and I don't 23 know what the third number was. 24 Q. S as in Sam, zero zero? Page 168 1 A. Yes. 2 Q. Any other documents related to 3 the rechallenging protocol that you would have 4 authored? 5 A. None that I'm aware of. 6 Q. Would you have written any 7 correspondence related to the rechallenge 8 protocol or study? 9 A. Probably. 10 Q. Who would you have written to 11 to the best of your recollection? 12 A. Outside or inside? 13 Q. Let's start with inside. 14 A. Probably within the research 15 physicians or my management. 16 Q. Who was the research physician 17 assigned to this study? 18 A. Charles Beasley. 19 Q. Anyone else, any other research 20 physicians who would have been involved? 21 A. Gary Tollefson. 22 Q. Anyone else? 23 A. None that I'm aware of. 24 Q. How about John Heiligenstein, Page 169 1 was he involved in any way with this project? 2 A. Not that I'm aware of. 3 Q. To your knowledge was there 4 ever a rechallenge study that was planned or 5 discussed related to the use of Fluoxetine and 6 violent-aggressive behavior? 7 A. Not to my knowledge. 8 Q. Was violent-aggressive behavior 9 to be studied as part of the rechallenge protocol 10 we've been talking about? 11 A. Not that I'm aware of. 12 Q. How many patients were going to 13 be enrolled in that study? 14 A. I don't recall. 15 Q. Do you know if it was going to 16 be an inpatient or outpatient study? 17 A. I don't recall. 18 Q. You drafted -- you wrote the 19 original draft of the protocol; correct? 20 A. Yes. 21 Q. That kind of information would 22 have been contained in the protocol, wouldn't it? 23 A. Not necessarily in the first 24 draft or subsequent drafts. Page 170 1 Q. When would that information 2 have been decided? 3 A. The research physician would 4 fill that part in. 5 Q. Typically is that the kind of 6 information that's filled in towards the end of 7 the development of the protocol? 8 A. My role was perhaps to first 9 get the outline, the draft outline, and some of 10 the key points to lead the physicians to fill in 11 their pieces, statistics, et cetera. My idea of 12 providing them a template to follow. 13 Q. When you say a template, you 14 mean a paragraph or a portion? 15 A. Yes. 16 Q. Related to a specific part of 17 the protocol? 18 A. Yes. 19 Q. Did you work on the objectives 20 template? 21 A. Dr. Beasley worked along with 22 me. 23 Q. Okay. What was the specific 24 objection that was -- objective that was going to Page 171 1 be studied on the rechallenge protocol? 2 A. I don't remember. 3 Q. Do you remember what any of the 4 inclusion-exclusion criteria were on that 5 protocol? 6 A. No, I do not. 7 Q. Do you recall if a serious 8 suicidal risk was an exclusion criteria? 9 A. No, I do not. 10 Q. Do you recall whether or not 11 any specific mental illness was included as an 12 exclusion criteria or inclusion criteria? 13 A. No, I do not. 14 Q. Were these people that 15 supposedly were suffering from a major depressive 16 disorder? 17 A. I don't remember. 18 Q. How long did you work on the 19 protocol, over what period of time? 20 A. Probably a couple of months. 21 Q. When did you work on the 22 protocol, what year? 23 A. I believe it's 1991. 24 Q. Do you remember what time of Page 172 1 year, Spring, Fall, Summer? 2 A. I think it was the Spring. 3 Q. Around the same time that the 4 analysis of the OUS data was done? 5 A. Within that same time frame, 6 yes. 7 MR. SMITH: You okay, do you need to 8 take a break? 9 THE WITNESS: In a couple of minutes. 10 Q. Other than Dr. Beasley and Dr. 11 Tollefson, who else would you have communicated 12 in-house at Lilly with regard to the rechallenge 13 protocol? 14 A. My management. 15 Q. Who was your management? 16 A. Carol Zapapas. 17 Q. Anyone else? 18 A. Mike Harrell. 19 Q. Anyone else? 20 A. No, I don't think. 21 Q. Was this going to be a 22 multi-center study or was it going to be a 23 single-center study? 24 A. I believe it was going to be a Page 173 1 multi-center study. 2 Q. Were these investigators that I 3 asked you about earlier, how many of them were 4 there? 5 A. I don't recall. 6 Q. More than two? 7 A. I don't remember. 8 Q. More than one? 9 A. More than one. 10 Q. More than ten? 11 A. I don't remember. 12 Q. Who were they going to draw 13 their patient population from, do you know? 14 A. No, I do not know. 15 Q. Were these investigators 16 investigators that had worked on previous 17 Fluoxetine clinical trials? 18 A. I do not know. 19 Q. Do you know if the patient 20 population that was going to be drawn from were 21 people who were previously involved in clinical 22 trials on Fluoxetine? 23 A. I don't remember. 24 MR. SMITH: Would seeing some of these Page 174 1 protocols help you remember that type of 2 information? 3 MR. MYERS: What information? 4 MR. SMITH: Like the last two questions 5 she couldn't remember. 6 THE WITNESS: I don't think so. 7 Q. Why not? 8 A. Because protocols usually do 9 not contain investigator information. 10 Q. They don't. Investigator names 11 are not listed in the protocols? 12 A. No. 13 Q. The protocols are attached to 14 the final reports, aren't they? 15 A. Yes. 16 Q. And the protocols have to be 17 approved by an investigational review board, 18 don't they? 19 A. Yes. 20 Q. And that information is not 21 listed on the protocol, who the investigator is? 22 A. No. 23 Q. You've never seen a Fluoxetine 24 protocol where the investigator name and Page 175 1 information has been listed? 2 A. No, I have seen. 3 Q. You have seen, okay. 4 A. Not always. 5 Q. Not always. Not in this 6 particular case; correct? 7 A. Not where there's a 8 multi-center study. 9 Q. Where would that information be 10 listed, the investigator information? 11 A. On the IND submission forms. 12 Q. Prior to the IND submission 13 forms, where would it be listed? 14 A. On budget information. 15 Q. Earlier you said that you had 16 written some budget information, budget 17 estimates, I believe you said it was. 18 A. Yes. 19 Q. How many investigators was the 20 study budgeted for? 21 A. I don't remember. 22 Q. Would you have kept that 23 information in your files? 24 A. Most likely. Page 176 1 Q. Were you going to be the CRA on 2 this study if it had gone on? 3 A. Probably not. 4 Q. Probably not. Were there any 5 other CRA's that worked on this study with you 6 for the development of the protocol? 7 A. No. 8 Q. Do you have any idea who would 9 have been the CRA on the study if it had gone 10 forward? 11 A. No. 12 Q. Why is it that you believe that 13 you would not have been the CRA on the study? 14 A. My expertise was to get studies 15 started. 16 Q. Do you recall where any of the 17 investigational sites were to be located? 18 A. No. 19 Q. Are you familiar with a 20 gentleman named Jan Fawcett? 21 A. Yes. 22 Q. Who is Dr. Fawcett, to your 23 knowledge? 24 A. Investigator in Chicago. Page 177 1 Q. Was he supposed to participate 2 in this rechallenge study? 3 A. I do not know. 4 Q. Did you work with Dr. Fawcett 5 at any time on clinical trials? 6 A. He was the investigator, I did 7 not work with him directly. 8 Q. How many studies or how many 9 trials did Dr. Fawcett participate in, to your 10 knowledge? 11 A. I know of two. 12 Q. What were those studies? 13 A. A double blind comparator trial 14 and an open label trial. 15 Q. Which one came first, the 16 comparator or open label? 17 A. They were run simultaneously. 18 Q. This wasn't -- the open label 19 wasn't an extension of the double blind 20 comparator, was it? 21 A. The double blind comparator 22 perhaps had an open label portion as well, but 23 they were separate trials. 24 Q. What was the comparator drug in Page 178 1 the double blind comparator study? 2 A. I don't remember. 3 Q. When were these trials run? 4 A. Starting in the mid-'80s. 5 Q. Did you work as a CIR on any of 6 those trials? 7 A. No. 8 Q. How far in the development 9 process did they get on the rechallenge study as 10 far as the protocol is concerned? 11 A. I think the protocol may have 12 been submitted to the IND. 13 Q. What does that mean, to submit 14 a protocol to the IND? 15 A. I believe the IND submission 16 form, our regulatory services area forwards that. 17 The regulatory services area forwards that 18 information to the FDA. 19 Q. Why would you submit it to the 20 FDA? 21 A. For their review. 22 Q. For what purpose? 23 A. In order to initiate a trial 24 under the IND it must be submitted. Page 179 1 Q. You said that this protocol was 2 being developed in 1991; correct? 3 A. Yes. 4 Q. Why would you need IND approval 5 for a study being done on a drug that's already 6 been approved by the FDA? 7 A. I do not know. 8 Q. Did you do that with all 9 studies that were initiated prior to -- I'm 10 sorry, subsequent to the approval of Prozac for 11 use in depression? 12 A. I did. 13 Q. What other studies did you work 14 on around that period of time? 15 A. 1991? 16 Q. When you were developing the 17 rechallenge protocol. 18 A. I did not work on any other 19 studies. 20 Q. What other studies did you work 21 on developing protocols for? 22 MR. MYERS: At what point in time? 23 A. Yes, I need the time frames 24 clarified. Before 1991 or 1990 or are we going Page 180 1 back to '87 again? 2 Q. Did you work on developing 3 protocols when you were a CIR? 4 A. No. 5 Q. And then after -- when you 6 became a CRA in, I believe you said it was, 1987; 7 correct? 8 A. Yes. 9 Q. Did you work on developing 10 protocols at that time? 11 A. Yes. 12 Q. What kind of protocols did you 13 work on during that period of time -- let's do it 14 this way: From the time you became a CRA until 15 you went on your four-month developmental 16 assignment, what kind of protocols did you work 17 on developing? 18 A. Specifics of Fluoxetine? 19 Q. Right. 20 A. Double blind comparator trial, 21 multi-center trial. 22 Q. Is that two different trials? 23 A. No, that's one trial. 24 Q. Okay. Any others? Page 181 1 A. On Fluoxetine for another 2 indication. 3 Q. What indication? 4 A. OCD. 5 Q. Any others? 6 MR. CLEMENTI: Obesity or OCD? 7 MS. ZETTLER: OCD, obsessive compulsive 8 disorder. 9 A. The initial development of the 10 cardiac protocol. 11 Q. Okay. Any others? 12 A. I believe that's it. 13 (A SHORT RECESS WAS TAKEN.) 14 MS. ZETTLER: Can you read back? 15 (THE COURT REPORTER READ BACK THE 16 REQUESTED TESTIMONY.) 17 Q. When you started working on 18 Fluoxetine, had it already been approved for use 19 in depression by the FDA? 20 A. No. 21 Q. Any of these protocols that you 22 just told me about working on, were those 23 protocols that were started before or after 24 Prozac was approved for use in depression by the Page 182 1 FDA? 2 A. After. 3 Q. Did you submit these all to the 4 IND for approval? 5 A. Yes. 6 Q. Any others, any other protocols 7 that you worked on prior to going on the 8 four-month developmental assignment other than 9 the double blind comparator multi-center study, 10 the Fluoxetine OCD study and the initial 11 development on the cardiac protocol? 12 A. Could you ask that question 13 again? 14 Q. Sure. Besides those three 15 protocols that you describe for us, did you do 16 any other work on protocols prior to going on 17 your four-month developmental assignment? 18 A. No, I did not develop any other 19 protocols. 20 Q. How about after you got back 21 from your four-month developmental assignment, 22 what protocols did you work on? 23 MR. MYERS: In terms of development? 24 MS. ZETTLER: Development. Page 183 1 A. With regards to Fluoxetine? 2 Q. Right . 3 A. I think only the rechallenge. 4 Q. Okay. I believe you said 5 earlier that you believed the number of the 6 protocol was S zero zero something? 7 A. Yes. 8 Q. To your knowledge, were any 9 other protocols numbered with an S zero zero? 10 A. Yes. 11 Q. Which protocols? 12 A. They were not Fluoxetine 13 studies. 14 Q. Are they related in any way to 15 depression? 16 A. Yes. 17 Q. How were they related to 18 depression? 19 A. They were to validate scales 20 used in depression trials, one was. I don't 21 remember the second protocol. 22 Q. Was one done to validate the 23 Hamilton Depression Rating Scale? 24 A. No. Page 184 1 Q. What scale was validated or 2 attempted to be validated by the other S zero 3 zero study? 4 A. It was a ratings scale 5 developed by Dr. Miller. 6 Q. Ivan Miller? 7 A. Yes. 8 Q. Was it a suicidality scale? 9 A. Yes. 10 Q. Was it related to the MSSIR? 11 A. That's the name of the scale, 12 sorry, I didn't remember. 13 Q. That's the scale that was 14 validated? 15 A. No, that was the study that was 16 done, that was designed to validate that. 17 Q. Okay. When you say validate a 18 study scale, what do you mean? 19 A. I don't know the scientific 20 statistical stuff behind it. 21 Q. Okay. I'm sorry, go ahead. 22 A. Enough to comment on how a 23 scale is validated. 24 Q. Okay. Do you know a man name Page 185 1 Dr. Jim Kotsanos? 2 A. Yes. 3 Q. How do you know Dr. Kotsanos? 4 A. He worked in the area. 5 Q. What area? 6 A. Medical component. 7 Q. I'm sorry, medical? 8 A. The medical component. 9 Q. Medical division? 10 A. Yes. 11 Q. What was his position within 12 the division? 13 A. He was a research physician. 14 Q. Did you work with Dr. Kotsanos 15 in development of the rechallenge protocol? 16 A. No. 17 Q. Did you work with Dr. Kotsanos 18 on the rechallenge project at all? 19 A. No. 20 Q. Do you know whether or not Dr. 21 Kotsanos was involved in that project? 22 A. Not to my knowledge. 23 Q. Did you attend any meetings at 24 the FDA regarding the rechallenge protocol? Page 186 1 A. No. 2 Q. Did you attend any meetings at 3 Lilly where the rechallenge protocol was 4 discussed? 5 A. Yes. 6 Q. On how many occasions did you 7 attend such meetings? 8 A. I do not know. 9 Q. More than once? 10 A. Yes. 11 Q. More than five times? 12 A. Most likely. 13 Q. Were these special meetings 14 that were held just on the rechallenge study 15 issue or were the rechallenge studies brought up 16 as a matter of course during other meetings? 17 A. Can you define meeting? 18 Q. Let's start with a formally 19 held meeting where people are notified that 20 you're going to get together to discuss one or 21 more topics. 22 A. So that could include the 23 division meetings, cluster meetings? 24 Q. Sure. Page 187 1 A. A meeting with a statistician? 2 Q. Let's start with a division 3 meeting, were there any division meetings held 4 regarding specifically the rechallenge protocol? 5 A. No. 6 Q. Was the rechallenge protocol or 7 anything related to the rechallenge protocol ever 8 raised during the course of the meeting? 9 A. Yes. 10 Q. Division meeting. And how many 11 occasions, do you remember that happening? 12 A. No, I don't. 13 Q. Were you involved in any 14 meetings specifically conducted to discuss issues 15 related to the rechallenge protocol? 16 A. Most likely. 17 Q. Do you remember any specific 18 meeting? 19 A. No. 20 Q. Do you remember general 21 meetings being held with regards to that one 22 subject? 23 A. No. 24 Q. Earlier you gave me an example Page 188 1 of like a meeting with the statistician. Did you 2 meet with any statisticians with regards to the 3 protocol? 4 A. Yes. 5 Q. Who did you meet with with 6 regards to the protocol, I mean the rechallenge 7 protocol? 8 A. I don't remember. 9 Q. Bruce Dornseif? 10 A. No, I believe he was not there. 11 Q. Greg Enas? 12 A. I don't remember. 13 MR. SMITH: Did you keep any notes of 14 that meeting? 15 A. No. 16 Q. Did you take notes during any 17 meetings regarding the rechallenge protocol? 18 A. Not that I remember. 19 Q. Was it your habit to take notes 20 during various meetings, like the division 21 meetings? 22 A. No. 23 Q. Was there somebody that was 24 assigned to take notes at any given meeting? Page 189 1 A. Not that I'm aware of. 2 Q. Did you ever see any meeting 3 minutes generated from any of the division 4 meetings that you attended regarding Fluoxetine? 5 A. I don't remember. 6 Q. Catherine, you understand that 7 you're under oath today, don't you? 8 A. Yes. 9 Q. You understand that you're 10 sworn to tell the truth? 11 A. Yes. 12 Q. You understand that to a 13 certain extent saying that you don't remember 14 when you do have a vague memory is not telling 15 the truth? 16 MR. MYERS: Before she answers that, 17 let me object to the form. She's answering the 18 questions that she understands, that she either 19 knows, she doesn't know, she doesn't recall. 20 She's not going to be governed by a definition 21 that you apply, Nancy. 22 Q. Would you agree with me that 23 the rechallenge protocol was an important 24 perspective study for Eli Lilly on the issue of Page 190 1 suicidality? 2 A. Yes. 3 Q. And you worked on that protocol 4 for two months; correct? 5 A. Yes, approximately. 6 Q. Did you work on any other 7 portion of that project other than developing a 8 protocol? 9 A. Budgets. 10 Q. Anything else? 11 A. I really don't remember. 12 Q. Did you ever see a final copy 13 of the protocol once it was finished and 14 submitted? 15 MR. MYERS: To the FDA? 16 MS. ZETTLER: To the FDA. 17 A. Probably. 18 Q. To your knowledge, would you 19 have had a copy of that protocol in your file? 20 A. Yes. 21 Q. Would you have had a copy of 22 the IND submission sheet in the file also with 23 your protocol? 24 A. Yes. Page 191 1 Q. Do you know what the IND number 2 was on that? 3 MR. MYERS: On that what? 4 MS. ZETTLER: Submission sheet. 5 A. I don't remember the Fluoxetine 6 IND number. 7 Q. Would you have turned over all 8 the final copy of the protocol and any other 9 documents you had in your file related to the 10 rechallenge study to the legal department in 11 Lilly in one of these quarterly document 12 collections? 13 A. Yes. 14 Q. Were those documents that were 15 returned to you either in original or in copy 16 form? 17 A. Usually I received a copy back. 18 Q. Do you have specific 19 recollection of receiving a copy of the final 20 protocol in the rechallenge study back from the 21 legal department? 22 A. No, I don't remember. 23 Q. Do you still maintain files on 24 Fluoxetine? Page 192 1 A. No. 2 Q. What did you do with your files 3 once you stopped working on Fluoxetine? 4 A. Left them within the 5 department. 6 Q. Did somebody take over your 7 files after you moved into your present position? 8 A. If I was working on something 9 that was being passed on, I passed it on to that 10 person. 11 Q. Would you have passed on 12 anything related to the rechallenge protocol when 13 you left? 14 A. I think that was all left 15 within Dr. Beasley's realm. 16 Q. When you left the medical 17 division was the rechallenge protocol still 18 pending? 19 A. Let me clarify, I'm still 20 within the medical division. 21 Q. When you moved to your present 22 position, was the rechallenge protocol still 23 pending? 24 A. Not to my knowledge. Page 193 1 Q. A decision had been made not to 2 pursue the study? 3 A. To the best of my knowledge, 4 yes. 5 Q. Who made that decision? 6 A. I don't know. 7 Q. Was it Dr. Beasley? 8 A. I don't know. 9 Q. Would he have been involved in 10 a decision such as that? 11 A. Probably. 12 Q. To your knowledge did the FDA 13 approve the rechallenge study? 14 A. I don't know. 15 Q. Was there ever an occasion 16 where the FDA, to your knowledge, rejected a 17 Prozac posed IND submission regarding a protocol? 18 MR. MYERS: Any protocol? 19 MS. ZETTLER: Any Fluoxetine protocol. 20 A. I do know an occasion that the 21 FDA had addressed a particular protocol and asked 22 for additional information. 23 Q. Do you know if that was the 24 case with regards to the rechallenge protocol? Page 194 1 A. I don't believe that was the 2 case. 3 Q. Why did they not pursue the 4 rechallenge protocol, to your knowledge? 5 MR. MYERS: They who, the FDA or Lilly? 6 MS. ZETTLER: Lilly. 7 A. I don't know. 8 Q. You weren't curious as to why 9 they wouldn't pursue it after they worked on it 10 for two months? 11 A. No. 12 Q. Why weren't you curious? 13 A. I'm just not. 14 Q. Did you ever ask anybody why 15 they didn't pursue the rechallenge protocol? 16 A. No, I moved on to the next 17 step. 18 Q. What was your next assignment 19 after the rechallenge protocol? 20 A. I would do multiple assignments 21 at one time. 22 Q. Were you given any new 23 assignments after the rechallenge protocol? 24 A. I continued to work on scale Page 195 1 validation protocol. 2 Q. What was the result of the 3 scale validation protocol on MSSIR? 4 A. I left my responsibility behind 5 on that before it was ended. 6 Q. Who took over for you? 7 A. Ellen Shantz. 8 Q. How do you spell her last name? 9 A. Best guess? 10 Q. You say -- I thought you said 11 Ellen Shot? 12 MR. MYERS: She said best guess. 13 MS. ZETTLER: Oh, best guess. 14 A. I think it's S-H-A-N-T-Z. 15 Q. To your knowledge is that 16 validation study on the MSSIR still proceeding or 17 has it been completed? 18 A. To my knowledge, I know the 19 enrollment had been completed. 20 Q. When you say you left that 21 behind, is that when you moved into your present 22 position? 23 A. No. 24 Q. Why is it that you stopped Page 196 1 working on the validation study on the MSSIR? 2 A. My responsibilities changed to 3 another compound. 4 Q. Were you working on Fluoxetine 5 at all during that period of time? 6 A. No. 7 Q. To your knowledge was the MSSIR 8 being validated specifically for use in the 9 rechallenge protocol? 10 A. I'm sorry, restate the 11 question. 12 Q. Sure. Was the MSSIR being 13 validated in the validation study so that it 14 could be used in conjunction with the rechallenge 15 protocol? 16 A. That was the beginning phase, 17 yes. 18 Q. To your knowledge was the 19 decision made not to pursue the rechallenge 20 protocol made prior to the completion of the 21 MSSIR validation study? 22 A. Please ask again. 23 Q. Sure. To your knowledge was 24 the decision made not to pursue the rechallenge Page 197 1 protocol prior to the completion of the 2 validation study on the MSSIR? 3 A. I don't know. 4 Q. When were you notified that no 5 more work would be done on the rechallenge 6 protocol? 7 A. I don't remember. 8 Q. Was it at the end of the 9 two-month period you worked on developing the 10 protocol? 11 A. Probably afterwards. 12 Q. Do you remember how long 13 afterwards? 14 A. No, I don't. 15 Q. Was it a year afterwards? 16 A. I don't know. 17 Q. When was the validation study 18 on the MSSIR started? 19 A. In August of '91. 20 Q. Did Dr. Miller develop the 21 MSSIR specifically for Eli Lilly, if you know? 22 A. I don't know. 23 Q. Do you know how many patients 24 were to be enrolled in the MSSIR validation Page 198 1 study? 2 A. Thirty. 3 Q. Was this an inpatient or 4 outpatient study? 5 A. Inpatient. 6 Q. Did you write the protocol on 7 the validation study in the MSSIR? 8 A. In conjunction with Dr. Miller 9 and Dr. Beasley. 10 Q. To your knowledge was Dr. 11 Miller to participate in the rechallenge study? 12 A. I don't remember. 13 Q. What does S stand for in S zero 14 zero? 15 A. Surveillance. 16 MR. SMITH: Surveillance? 17 THE WITNESS: Yes. 18 Q. To your knowledge were there 19 any other surveillance studies, trials, that were 20 performed with regards to Fluoxetine besides the 21 rechallenge study and the validation study of the 22 MSSIR? 23 A. Not that I'm aware of. 24 Q. Were any other studies Page 199 1 performed in conjunction with the rechallenge 2 study, such as the validation study on the MSSIR? 3 A. I'm sorry, could you ask that 4 again, please? 5 Q. Sure. Would you agree with me 6 that the validation study on the MSSIR was 7 performed in conjunction with the rechallenge 8 study? In other words, the MSSIR was to be used 9 with the rechallenge study; correct? 10 A. Yes. 11 Q. And they were validating the 12 MSSIR to make sure that it was a useful tool 13 within the rechallenge study, right? 14 A. Yes. 15 Q. Were there any other 16 surveillance studies done related in that way or 17 any way to the rechallenge protocol that was 18 being developed? 19 A. There was one other, but I 20 don't remember anything about it. 21 Q. It's another S study? 22 A. Yes. 23 Q. Was it a validation study on 24 another suicidality scale? Page 200 1 A. No. 2 Q. Would all surveillance studies 3 include a patient population? In other words, 4 have patients enrolled in it? 5 A. I believe so. 6 Q. Do you remember when the other 7 surveillance study was performed? 8 A. It was never performed. 9 Q. Do you remember when it was in 10 development? 11 A. The same time that I was 12 developing the rechallenge study and the MSSIR 13 validation study. 14 Q. Was this other surveillance 15 study meant to validate any other scales? 16 A. No. 17 Q. Did you work on the protocol 18 for the other surveillance study? 19 A. Yes. 20 Q. Do you remember anything about 21 the subject matter? 22 A. No. 23 Q. Was Fluoxetine to be used in 24 that surveillance study? Page 201 1 A. I don't remember. 2 Q. What kind of work did you do on 3 the other surveillance study, did you develop the 4 protocol? 5 A. I believe I worked on a draft, 6 but it's very -- in my mind, it's very sketchy. 7 Q. Who else worked on that other 8 protocol with you? 9 A. Nobody -- excuse me, Dr. 10 Beasley. 11 Q. Was the rechallenge protocol 12 developed before or after Dr. Beasley published 13 his study in the British Journal of Medicine? 14 A. I don't know the time frame. 15 Q. Was the OUS analysis related in 16 any way to Dr. Beasley's study published in the 17 British Journal? 18 A. I believe the British Medical 19 Journal is only U.S. results. 20 Q. At any point in time, to your 21 knowledge, did Dr. Beasley want to look at the 22 analysis of the OUS data in regards to the 23 article, prior to publishing? 24 MR. MYERS: That she's aware of? Page 202 1 MS. ZETTLER: That's what I said. 2 A. I don't know the answer to 3 that. 4 Q. I believe earlier you testified 5 that Dr. Beasley had one or two analyze the OUS 6 data with regards to suicidality; correct. 7 A. That was not only Dr. Beasley's 8 challenge, that was the department's challenge. 9 Q. What do you mean when you say 10 challenge? 11 A. Perhaps not the best choice of 12 words, it was -- that was our decision, our 13 department's decision, to analyze that data base. 14 Q. Who else was involved in that 15 decision? 16 A. Upper management, my 17 management. 18 Q. Can you give me names? 19 A. Gary Tollefson. 20 Q. Anybody else? 21 A. Carol Zapapas, Dr. Beasley, 22 probably the other research physicians within the 23 group. 24 Q. Who were the other research Page 203 1 physicians in the group at the time? 2 A. Heiligenstein, Kotsanos. 3 Q. Wheadon? 4 A. I don't believe David was 5 involved. 6 Q. Dr. Zerbe? 7 A. He was upper management. 8 Q. Dr. Leigh Thompson? 9 A. Yes, he was upper management. 10 Q. Were they involved in the 11 decision to analyze the data, to your knowledge? 12 A. I don't know. 13 Q. Earlier you said Dr. Beasley 14 and Gary Tollefson were involved with you in the 15 development of the rechallenge protocol; correct? 16 A. Yes. 17 Q. Anybody else besides -- Carol 18 Zapapas you said also. Anybody else that was 19 involved in that project? 20 A. Not that I remember. 21 Q. How about Dr. Leigh Thompson, 22 was he involved? 23 A. Not that I remember. 24 Q. Did somebody tell you to stop Page 204 1 work on the other surveillance study protocol, 2 the one that you can't remember what it was for? 3 A. I don't believe anybody told me 4 to stop working, I think I could only work on so 5 many at one time. 6 Q. So was that reassigned to 7 somebody else? 8 A. No. 9 Q. Do you know if a protocol was 10 ever written on that study? 11 A. It was not. 12 Q. Why not, if you know? 13 A. I don't know. 14 Q. What other information would 15 have been contained in the rechallenge protocol 16 other than the objectives and the patient numbers 17 or the number of patients? 18 A. Inclusion-exclusion criteria, 19 dosing schedules, visit intervals, study design, 20 what's going to be done when, statistical 21 analysis, data collection method. 22 Q. Anything else? 23 A. I believe that should cover it. 24 Q. If this was going to be an Page 205 1 inpatient study, then there wouldn't be any visit 2 intervals, would there? 3 A. Yes, there would. 4 Q. In what way? 5 A. From the time you saw the 6 patient and recorded information until the next 7 time you saw them was a visit interval. 8 Q. Next time you what? 9 A. Saw them. 10 MS. ZETTLER: I'm sorry, I didn't get 11 what you said. Could you that read back? 12 (THE COURT REPORTER READ BACK THE 13 REQUESTED TESTIMONY.) 14 Q. So say the clinical 15 investigator on the study would see a patient on 16 a Tuesday, and then wouldn't see them until the 17 next Tuesday. 18 A. Yes. 19 Q. Or it could be like every day, 20 but -- 21 A. They may see the patient in 22 between, but that's what's defined by the 23 protocol as the visit interval. 24 Q. How long was the rechallenge Page 206 1 study supposed to last? 2 A. I don't remember. 3 Q. Would that information be kept 4 in the protocol? 5 A. Yes. 6 Q. Would whether or not it was an 7 inpatient or outpatient study be listed in the 8 protocol? 9 A. Yes. 10 Q. Did anybody ever voice concerns 11 to you about doing a rechallenge study with 12 Fluoxetine on patients regarding suicidality? 13 MR. MYERS: Anybody from where? 14 MS. ZETTLER: Anywhere. 15 A. No. 16 Q. Were you ever involved in 17 ethical discussions related to such a study? 18 A. No. 19 Q. Were those considerations ever 20 brought up at any of the meetings you attended? 21 MR. MYERS: What ethical 22 considerations? 23 MS. ZETTLER: Ethical considerations in 24 performing a study rechallenging patients who had Page 207 1 been suicidal on Fluoxetine. 2 A. Not in discussions I can 3 recall. 4 Q. To your knowledge were the 5 people -- the patients that were to be involved 6 in that study, patients who had attempted suicide 7 previously while on Fluoxetine or patients who 8 had become suicidal, or both? 9 A. I don't remember the protocol 10 specifics. 11 Q. Would that be included in the 12 exclusion-inclusion criteria? 13 A. Yes. 14 Q. And the exclusion-inclusion 15 criteria is listed in the protocol? 16 A. Yes. 17 Q. Who was going to be the 18 clinical research physician on that project? 19 A. I believe Charles Beasley. 20 Q. I may have asked you this 21 before, and if I did I apologize, but do you know 22 how many patients were to be enrolled in that 23 study? 24 A. No, I do not remember. Page 208 1 Q. Would that also be something 2 that would be listed in the protocol? 3 A. Yes. 4 Q. And I believe you testified 5 earlier that to the best of your knowledge you 6 did have a copy of the final protocol in your 7 file; correct? 8 A. Yes. 9 Q. And that file was turned over 10 to the legal department at Lilly; correct? 11 A. Yes. 12 Q. What kind of information is 13 included in the study design? 14 A. How long the study will last, 15 what type of study. For example blinded, double 16 blinded, how many patients. 17 Q. Anything else? 18 A. How often the visits will be. 19 Q. Do you know if the rechallenge 20 study was supposed to be a double blind placebo 21 controlled study? 22 A. I believe it was to be. 23 Q. Was there a comparator drug 24 that was going to be used in that study? Page 209 1 A. I believe. 2 Q. What was that drug? 3 A. I don't think it was 4 identified. 5 Q. Was it a Librium? 6 A. I don't believe it was 7 identified. 8 Q. Did you read a final copy of 9 that protocol that was turned into the IND? 10 A. Yes. 11 Q. Earlier Mr. Smith asked you if 12 looking at the protocol would refresh your 13 recollection on a number of different things, and 14 I think included in that was the number of 15 patients that were to be enrolled. 16 A. Yes. 17 Q. Would the protocol, looking at 18 the protocol refresh your recollection as to the 19 number of patients after what you just told me 20 about the study design information? 21 A. Yes, it was written into it. 22 Q. Okay. And a copy of that final 23 protocol would have -- would really be able to 24 refresh your recollection about a lot of this Page 210 1 stuff, including what was the inclusion-exclusion 2 criteria; correct? 3 A. Yes. 4 Q. The length of the study and 5 whether or not it was an inpatient or outpatient 6 study? 7 A. Yes. 8 Q. What statistical analysis was 9 to be used with that study, if you know? 10 A. I don't know. 11 Q. Would the protocol refresh your 12 recollection as to what the statistical analysis 13 would have been? 14 A. No. 15 Q. Why not? 16 A. Because I'm not a statistician. 17 Q. Would the specific statistical 18 analysis that was to be used be listed in the 19 protocol? 20 A. Most likely. 21 Q. What data collection method was 22 to be used during that study? 23 A. I don't understand your 24 question. Page 211 1 Q. Earlier you stated that one of 2 the things that would be included in the protocol 3 would be the data collection method. 4 A. I probably meant what types of 5 scales would be used, et cetera. 6 Q. Okay. Other than the MSSIR, 7 what kind of scales would be used in that study, 8 to your knowledge? 9 A. I don't remember. 10 Q. Was the Hamilton Depression 11 Rating Scale going to be used? 12 A. I don't remember. 13 Q. What about the CO-V? 14 A. I don't have any recollection 15 of pieces of the protocol. 16 Q. All that information would be 17 contained in the protocol; correct? 18 A. Yes. 19 Q. How about CRF's for that, did 20 anybody ever develop a CRF to be used in 21 relationship to the rechallenge study? 22 MR. MYERS: Would anybody or did 23 anybody? 24 MS. ZETTLER: Did anybody. Page 212 1 A. I don't believe. 2 Q. Was there ever any discussion 3 as to what would be contained in the clinical 4 report form for that study? 5 A. No. 6 Q. Was a consent form developed in 7 conjunction with the protocol? 8 A. Yes. 9 Q. Were you involved in writing 10 it? 11 A. Excuse me. Most likely. 12 Q. Why did you change your answer 13 from yes to most likely? 14 A. Because I don't remember. 15 Q. You seemed pretty sure when you 16 said yes, why is it that you don't remember? 17 A. Because most of the time when 18 you developed a protocol, you in turn develop a 19 draft consent form or guideline consent form, and 20 I can't remember if I did the whole thing. 21 Q. Okay. Before you could perform 22 a clinical study, the protocol and the consent 23 form as well as some other information needs to 24 be submitted to an institution or review board Page 213 1 for approval; correct? 2 A. Yes. 3 Q. Do you know if this protocol 4 and its consent form was ever submitted to an 5 institution or review board or boards for its 6 approval? 7 A. It was not. 8 Q. Why not? 9 A. I don't believe any 10 investigators were identified. 11 Q. But some were consulted during 12 the protocol development phase. 13 A. Yes. 14 Q. These investigators that were 15 consulted during the protocol development phase, 16 were they to be the -- or some of the 17 investigators that were to run the clinical 18 trials? 19 A. I don't know. 20 Q. CRC's are people who recruit 21 investigators for clinical trials; correct? 22 A. Yes. 23 Q. Who were the CRC's that were 24 working on the rechallenge protocol, if you know? Page 214 1 A. All CRC's usually recruit for 2 all studies. 3 Q. I don't understand what you 4 mean. You had CRC's all over the country looking 5 for investigators to work on the rechallenge 6 protocol? 7 A. Most likely. 8 Q. Is that a matter of collecting 9 a number of individual's names and picking the 10 investigators to work on trials for those names? 11 A. Yes. 12 Q. Were a group of names submitted 13 to anybody at Lilly from which investigators for 14 the rechallenge protocol were to be picked? 15 A. Not that I know of. 16 Q. Do you know if any of the 17 clinical investigators who had previously worked 18 on Prozac clinical trials were being considered 19 for working on the rechallenge study? 20 A. I don't remember. 21 Q. Is it your understanding that 22 the rechallenge study was to take patients who 23 had been on Fluoxetine and had experienced 24 suicidal ideation and put them back on Fluoxetine Page 215 1 to see if they became suicidal again? 2 A. Can you ask that again? 3 Q. Sure. Is it your understanding 4 that the rechallenge trial was a trial that was 5 going to take patients who had become suicidal or 6 been suicidal on Fluoxetine, put them on 7 Fluoxetine again to see whether or not they were 8 going to become suicidal while on Fluoxetine? 9 A. In a general concept, that 10 would be correct, but I don't know the specifics. 11 Q. Okay. When was the project to 12 collect the OUS data initiated? 13 A. The decision to collect the OUS 14 data was made sometime in September of 1990. 15 Q. Was there a target date for 16 completion of gathering all that information? 17 A. As soon as possible. 18 Q. To your knowledge was an 19 analysis of information to be submitted to the 20 FDA in conjunction with the advisory committee 21 meeting held in September of 1991? 22 A. The report was submitted to the 23 FDA prior to the advisory committee meeting. 24 Q. How long after the data was Page 216 1 collected was the report submitted, to your 2 knowledge? 3 A. From data collection? 4 Q. Right. 5 A. Ending? 6 Q. Right. 7 A. Approximately six months. 8 Q. When did data collection end? 9 A. Sometime approximately 10 December, 1990. 11 Q. Data was collected on 12 individual patients participating in the 13 international clinical trials that you defined 14 earlier, the double blind controlled studies; 15 correct? 16 A. Yes. 17 Q. How many studies were involved? 18 MR. MYERS: I'm sorry, was your 19 question about the U.S. or OUS? 20 MS. ZETTLER: OUS. 21 A. Approximately forty-eight 22 trials. 23 Q. How many trials were conducted 24 on Fluoxetine world wide, and I'm not limiting it Page 217 1 just to double blind controlled trials? 2 MR. MYERS: For what indication? 3 MS. ZETTLER: Well, we'll start with 4 depression. 5 A. I don't know. 6 Q. More than forty-eight, I take 7 it? 8 A. Yes. 9 Q. More than a hundred? 10 A. I don't know. 11 Q. Who would know that? 12 A. I don't know who would know. 13 Q. What department? 14 A. Medical department. 15 Q. Any subdivision within the 16 medical department, such as regulatory? 17 A. I don't know, maybe. 18 Q. Were any double blind 19 controlled studies for any other indications 20 collected for analysis? 21 MR. MYERS: As part of this project? 22 MS. ZETTLER: Yes, as part of this 23 project, the OUS analysis project. 24 A. No. Page 218 1 Q. Was that information 2 information from other indications collected and 3 studied regarding -- with regards to safety at 4 any other time? 5 A. Not that I'm aware of. 6 Q. How about the U.S., 7 nondepression indication studies, was that 8 collected and studied at any time? 9 A. Could you clarify that, please? 10 Q. Sure. You testified earlier, I 11 believe, if I'm wrong, tell me, okay, but you 12 testified earlier that a similar study was done 13 with U.S. double blind controlled trials where 14 all the information was collected and analyzed; 15 correct? 16 A. You're using study and trial 17 and I'm getting mixed up. 18 Q. Okay, trial, the United States -- 19 the information from the United States double 20 blind controlled studies was collected and 21 analyzed similar to the information that was 22 collected and analyzed in the OUS project; 23 correct? 24 A. Yes. Page 219 1 Q. At any time was the information 2 from the trials performed in the United States 3 for indications other than depression collected 4 and studied for any purpose? 5 MR. MYERS: I object to the form, when 6 you say for any purpose that's overly-broad. Are 7 you asking her if it was studied for any reason 8 whatsoever? 9 MS. ZETTLER: Let's limit it to safety. 10 MR. MYERS: I think that's even 11 overly-broad. 12 A. Yes. 13 Q. In what situations? I'm not 14 talking about an individual, I'm talking about as 15 a group, you know. I mean all various 16 indications, was that data ever accumulated into 17 one data base and studied from the perspective of 18 safety? And we can limit it to suicidality if 19 you want. 20 A. I'm unable to answer that 21 question the way it's phrased. 22 Q. Okay. Earlier you testified 23 that all double blind controlled Prozac studies 24 performed in the United States, all information Page 220 1 from those studies was pooled and analyzed with 2 regards to the issue of suicidality; correct? 3 A. On depression, yes. 4 Q. On depression. Same was done 5 for the depression double blind controlled 6 studies performed outside the United States; 7 correct? 8 A. Yes. 9 Q. Okay. My question is: At any 10 time were the double blind controlled studies -- 11 the data from the double blind controlled studies 12 performed on other indications, including OCD, 13 bulimia, obesity, smoking cessation, whatever 14 other indications are out there, ever collected 15 and studied from a safety point of view? And we 16 can limit it to suicidality. 17 A. I don't know. 18 Q. How about an indication of 19 specific suicidality safety analysis? 20 MR. MYERS: Indication other than 21 depression? 22 MS. ZETTLER: Right. 23 A. I don't know. 24 Q. Why was the suicidality Page 221 1 analysis limited to double blind controlled 2 depression studies, if you know? 3 MR. MYERS: When you say the analysis, 4 are you talking about U.S., OUS or both? 5 MS. ZETTLER: Both. 6 Q. We'll start with the U.S. Why 7 was it limited to the double blind controlled 8 studies? 9 A. I don't know. 10 Q. How about the international of 11 the OUS information, why was it limited to double 12 blind controlled studies? 13 A. For the same reason the U.S. 14 one was. 15 Q. You don't know. 16 A. I don't know. 17 Q. When was the U.S. data 18 compiled? 19 MR. MYERS: When you say compiled, what 20 do you mean? 21 MS. ZETTLER: She testified earlier 22 that the information from the double blind 23 controlled studies was gathered for the purpose 24 of analysis, I want to know when it was done. Page 222 1 A. Could you ask that question 2 again, please? 3 Q. Sure. Let me ask it this way: 4 It's my understanding that a rather concerted 5 effort was made to gather the information from 6 the international double blind placebo controlled 7 studies or controlled studies, and what I mean by 8 that is it was done on a relatively quick basis, 9 I think a six-month period, right? 10 A. Yes. 11 Q. Was something similar to that 12 done with regards to the U.S. double blind 13 controlled studies information? 14 A. No. 15 Q. That was accumulated over time? 16 A. Yes. 17 Q. When was the analysis of the 18 U.S. double blind controlled study data done? 19 A. I don't know. 20 Q. Was it done prior to the 21 initiation of the gathering of the OUS double 22 blind controlled study data? 23 A. I believe so. 24 Q. Did you go to Europe as part of Page 223 1 the gathering of the data, the OUS analysis data? 2 A. Yes, I did. 3 Q. Where did you go in Europe, 4 which countries? 5 A. Spain and Italy and the United 6 Kingdom. 7 Q. Okay. Where in the United 8 Kingdom? 9 A. To our affiliate offices. 10 Q. England? 11 A. Yes. 12 Q. Earlwood? 13 A. Yes. 14 Q. Basingstoke? 15 A. Yes. 16 Q. Did you make one trip over 17 there or multiple trips? 18 A. One. 19 Q. How long were you over there? 20 A. A total of one month. 21 Q. Why did you go over there? 22 A. To help coordinate the data 23 collection process. 24 Q. To your knowledge has that ever Page 224 1 been done on any other drug developed and 2 marketed by Lilly? 3 MR. MYERS: Has that what been done? 4 Q. Sending that -- let's start it 5 this way: Making a concerted effort to 6 accumulate data on specific trials for analysis 7 within a six-month period? 8 A. Not that I'm aware of. 9 Q. Besides yourself, did any other 10 Indianapolis based Lilly employees go over to 11 Lilly to help with the accumulation of data? 12 A. Yes. 13 Q. How many other employees? 14 A. Approximately eight. 15 Q. How many affiliates were 16 involved in the collection of the OUS analysis 17 data? 18 A. All of them. 19 Q. Do you have an affiliate in 20 Taiwan? 21 A. Yes, we do. 22 Q. Is that affiliate involved? 23 A. No. 24 Q. Why not? Page 225 1 A. It was not a double blind 2 placebo controlled trial. 3 Q. And you have affiliates in 4 Japan, I take it? 5 A. Yes. 6 Q. Was that affiliate involved? 7 A. No. 8 Q. So when you say all of them, 9 that's not correct, right? 10 A. I'm sorry, that's not correct. 11 Q. How about South Africa? 12 A. Yes. 13 Q. Germany? 14 A. Yes. 15 Q. France? 16 A. Yes. 17 Q. Italy? 18 A. Yes. 19 Q. Spain? 20 A. Yes. 21 Q. Netherlands? 22 A. Yes. 23 Q. Sweden? 24 A. Yes. Page 226 1 Q. Affiliates from all of those 2 places participated in gathering the data, right, 3 the OUS analysis data? 4 A. To some extent, yes. 5 Q. Have you ever heard the term 6 hit? 7 A. Yes. 8 Q. What's a hit? 9 A. A term that was used to 10 identify some mention in the case report form of 11 suicide, injury to self, injury to others. 12 Something -- a term that would be commonly used 13 to prompt our attention to that case. 14 Q. Why were they called hits? 15 A. It's a term that was just made 16 up. 17 MR. SMITH: Who made it up? 18 THE WITNESS: Probably me. 19 Q. Do you remember specifically 20 making it up? 21 A. No. 22 Q. Why do you say probably you? 23 A. It sounds like a term that I 24 would use. Page 227 1 Q. Okay. I think I asked you 2 earlier, but I'm not sure, do you know what a CTE 3 is? 4 MR. MYERS: You asked her. 5 Q. Do you know? 6 A. No. 7 Q. How about a two-part CRF? 8 A. Yes. 9 Q. What is a two-part CRF? 10 A. A case report form that's two 11 pages, a two-part form. 12 Q. Okay. To your knowledge the 13 case report forms that were typically used within 14 the double blind controlled studies were longer 15 than two pages, weren't they? 16 A. I'm sorry, ask that again? 17 Q. Sure. A typical case report 18 form, there's usually one filled out for each 19 patient visit; correct? 20 A. Yes. 21 Q. And typically the case report 22 forms are longer than two pages, aren't they? 23 A. Yes. 24 Q. Why was a two-part or two-page Page 228 1 case report form being used to collect data? 2 A. Two parts. 3 Q. Two parts, okay. How long were 4 the parts -- well, let me ask it this way: What 5 was included in the first part of the case report 6 form? 7 A. The same information, it's a 8 NCR form, two parts versus triplicate. 9 Q. I see, okay, so it's a typical 10 case report form, but it's only two copies 11 instead of three copies. 12 A. Yes. 13 Q. Why was a two-part form used as 14 opposed to a three-part form? 15 A. There was no need to have a 16 three-part form. 17 Q. What's a work sheet? 18 A. It was a device used to collect 19 data, not a case report form. 20 Q. And were work sheets used in 21 the process of accumulating the OUS analysis 22 data? 23 A. Yes. 24 Q. In what way was it used? Page 229 1 A. The work sheet was used to 2 transcribe -- the information from the affiliate 3 studies was transcribed onto a work sheet. 4 Q. My understanding is that the 5 information accumulated in the OUS analysis data 6 was information from clinical report forms or 7 trials that had been completed; correct? 8 A. Yes. 9 Q. So each site had its own set of 10 clinical report forms in conjunction with the 11 studies that they had performed or was this stuff 12 that was maintained at the affiliate office? 13 A. I'm sorry? 14 Q. The clinical report forms that 15 you reviewed -- 16 A. Yes. 17 Q. -- were they maintained at the 18 individual sites or were they maintained at the 19 affiliate offices? 20 A. If they had been at the sites, 21 they were brought to the affiliate office. 22 Q. So you looked at them at the 23 sites? 24 A. No, we looked at them at the Page 230 1 affiliate office. 2 Q. I'm sorry, okay. And as part 3 of the accumulation of the data for the OUS 4 analysis, you transferred some information from 5 the existing CRF onto the work sheets? 6 A. Yes. 7 Q. And that data was then 8 transferred back to Indianapolis? 9 A. Yes. 10 Q. Was it transferred in hard copy 11 form or electronically? 12 A. Hard copy. 13 Q. How long were the work sheets? 14 A. Per visit or -- 15 Q. Yes, per visit. 16 A. I don't remember. 17 Q. Were they identical to the CRF? 18 A. No. 19 Q. In what ways were they 20 different than the CRF? 21 A. They may not have collected all 22 the same information in the same format as the 23 case report forms. 24 Q. They would collect less data Page 231 1 than the case report forms? 2 A. In some cases, yes. 3 Q. Was the work sheet used 4 consistently across the board with all the 5 affiliates? 6 A. Yes. 7 Q. So in the areas where it would 8 collect less data than the case report forms, 9 those areas where less data was accumulated was 10 the same throughout the entire process? 11 A. Yes. 12 Q. What areas did the work sheet 13 collect less information than was contained on 14 the CRS? 15 A. For example, I believe that 16 laboratory data was not transcribed from the case 17 report forms to the work sheets. 18 Q. Why don't we do it this way, 19 why don't you tell me what data wasn't 20 transcribed from the case report forms to the 21 work sheets? 22 A. Demographic data. 23 Q. That would include the 24 patients' names or number and age? Page 232 1 A. Identifiers, sex, age. 2 Q. Anything else in the 3 demographic data? 4 A. No. 5 Q. What other data would be 6 collected on work sheets? 7 A. Study drug information. 8 Q. Would the blinds have been 9 broken prior to the work sheets being filled out? 10 In other words, would you know if any given 11 patient was on Fluoxetine as opposed to some 12 other drug or placebo? 13 A. Not during the transcription 14 process, no. 15 Q. When you say study drug 16 information, what are you talking about? 17 A. How many pills they took per 18 day, on what given days, for what length of time. 19 Q. What other information would be 20 collected on the work sheet? 21 A. Hamilton rating scales, if 22 available. 23 Q. Anything else? 24 A. MADRS rating scales, if Page 233 1 available. 2 Q. Anything else? 3 A. Adverse event information. 4 Q. Anything else? 5 A. I believe that's it. 6 Q. Why were the hits put aside for 7 review by the clinical research physician? 8 A. Because it was not our job to 9 review information that was, we felt, medical in 10 nature that the physicians needed to make a 11 decision on. 12 Q. Do you recall how many hits 13 were collected for review by the CRC? I'm 14 talking about the OUS data. 15 A. I don't recall a specific 16 number. 17 Q. Can you tell me generally? 18 A. A lot. 19 Q. Okay. When you say -- and you 20 say hits included information that indicated a 21 suicide, injury to self or injury to others; 22 correct? 23 A. Or death. 24 Q. Death. Regardless of cause of Page 234 1 death? 2 A. Yes. 3 Q. Anything else? 4 A. The word overdose or any 5 suspect of overdose. 6 Q. Anything else? 7 A. In general, anything that would 8 make you -- lead you to believe that maybe this 9 person did some injury to themself or had some 10 thoughts to do such. 11 Q. Okay. And when you say injury 12 to others, what do you mean? 13 A. If they were homicidal versus 14 suicidal. 15 Q. Okay. Do you recall how many 16 hits were collected on homicidals? 17 A. No, I don't remember. 18 Q. Were there as many as the 19 suicidal hits? 20 A. No. 21 Q. When you say a lot, earlier you 22 said that there were a lot of hits, what do you 23 mean by a lot? 24 A. We were not there to determine Page 235 1 the nature. If we saw that word meant those 2 words or those cluster of words mentioned 3 anywhere on a case report form, we were to 4 identify it as a hit, therefore we were not 5 making a decision, we were only the transcribers. 6 Q. And I'm asking you how many -- 7 you said earlier -- I asked you how many hits, 8 and I asked you generally how many, and you said 9 a lot. What do you mean by a lot? 10 A. More than a hundred. 11 Q. More than a thousand? 12 A. No. 13 Q. How many patients did you 14 review, patients, I'm not talking individual 15 visits? 16 A. Myself? 17 Q. If you know total? 18 MR. MYERS: The group? 19 MS. ZETTLER: Yes. 20 A. Approximately three thousand. 21 Q. When you say a hundred, do you 22 mean the hits that you yourself pulled or the 23 hits that were totally collected? 24 A. I'm basing that on visually Page 236 1 seeing piles. 2 Q. Okay. Piles that you 3 collected? 4 A. No, piles that were collected. 5 Q. So total piles that were 6 submitted to the clinical research physicians? 7 A. Yes. 8 Q. Now, would a hit constitute one 9 patient or one event? 10 A. One patient. 11 Q. Okay. So a patient could have 12 had multiple indications of adverse events 13 throughout the entire time they were on the 14 trial, right? 15 A. Yes. 16 MR. MYERS: Can we take a short break? 17 (A SHORT RECESS WAS TAKEN.) 18 (PLAINTIFF'S EXHIBIT NO. 1 WAS 19 MARKED FOR IDENTIFICATION AND 20 RECEIVED IN EVIDENCE.) 21 Q. Catherine, have you had a 22 chance to review Exhibit No. 1? 23 A. Yes. 24 Q. Is that an E-mail that you Page 237 1 wrote, you authored? 2 A. Yes. 3 Q. Does this document refresh your 4 recollection as to what a CTE is? 5 A. No, it does not. 6 Q. Is that your handwriting on the 7 side, at the end of that sentence? 8 A. No. 9 Q. Do you know whose handwriting 10 that is? 11 A. No. 12 Q. What do you mean in the 13 sentence number one when you say CRF's film, 14 CTE's and affiliates. What is film? 15 A. Possibly microfilm. 16 Q. Were any of the CRF's reported 17 on microfilm or microfiche, to your knowledge? 18 A. Yes. 19 Q. How many occasions? 20 A. I don't know. 21 Q. Was the transferring of the CRF 22 to microfilm or microfiche done before the 23 project began or was that done as part of the 24 project? Page 238 1 A. For the OUS project only? 2 Q. Right. 3 A. I believe we never ended up 4 using any of the film. 5 Q. Okay. My question is: So then 6 did you -- did people involved with the OUS 7 project put CRF on film or was that something 8 that was done prior to that time by the 9 affiliates? 10 A. Prior. 11 Q. Okay. Why is it that you 12 didn't use the film? 13 A. Because the hard copy of the 14 document was found. 15 Q. The very last paragraph above 16 the thanks for being so patient, meeting on 17 Wednesday, what's an MQA? 18 A. Medical quality assurance. 19 Q. Did medical quality assurance 20 personnel assist in gathering the OUS data? 21 A. They were present in Europe. 22 Q. What was their function? 23 A. To provide another quality 24 check. Page 239 1 Q. Who provided the funding for 2 the OUS data gathering project? 3 A. I don't know. 4 Q. Is it the marketing department 5 at Lilly? 6 A. No, I don't believe. 7 Q. How about DISTA, did any of the 8 money come from DISTA? 9 A. I don't think so. 10 Q. Do you recall who, and I know 11 you said earlier that it was the clinical 12 research physicians, but which clinical research 13 physicians reviewed the hits? 14 A. Dr. Beasley and Dr. 15 Heiligenstein reviewed them independently. 16 Q. In other words they each 17 reviewed the hits? 18 A. Yes. I believe they were the 19 only physicians. 20 Q. What was the purpose for them 21 to review the hits? 22 A. To make an independent decision 23 as to the words or phrases that we saw as data 24 collectors as to whether or not that should -- Page 240 1 the terms had anything to do with suicidality. 2 Q. Okay. To your knowledge were 3 adverse event terms assigned to the 4 suicide-homicide events that you pulled as hits? 5 In other words was it a descriptive, description 6 of an adverse event or was there an adverse event 7 specifically listed, a term pulled from, say, 8 ELECT or COSTART? 9 A. I don't understand the 10 question. 11 Q. What I'm trying to get at is if 12 on the work sheets, would you list -- when you 13 transferred the information from the CRF to the 14 work sheets, did you assign terms, event terms, 15 to the adverse events? 16 A. If a term had not been 17 assigned, yes. 18 Q. Okay. And when you say if a 19 term had not been assigned, if a specific event 20 term had not been assigned, you would assign a 21 term? 22 A. Yes. 23 Q. The clinical investigators on 24 the international studies were instructed to use Page 241 1 the ELECT or COSTART dictionary or whatever was 2 being used at the time to assign terms to various 3 adverse events; correct? 4 A. No. 5 Q. Okay. How is it that they came 6 to know how to assign various event terms? 7 A. Not all affiliates used 8 dictionary terms in their data collection. 9 A. Okay. So if that were the 10 case, you would then assign an event term to 11 whatever they listed? 12 A. Yes, they listed -- if they 13 listed an actual term. 14 Q. Okay. What about a narrative 15 description of what occurred, was that included 16 on the work sheet? 17 A. Yes. 18 Q. Where would that information be 19 obtained from? 20 A. From their adverse event pages. 21 Q. Would you put that down on the 22 work sheet verbatim? 23 A. Yes. 24 Q. And then if they hadn't already Page 242 1 assigned an event term -- 2 A. Excuse me. It may not have 3 been as it translated, verbatim as it translated. 4 Q. From like French to English? 5 A. Yes. 6 Q. Do you have translators working 7 on it? 8 A. Yes. 9 Q. So if you saw the narrative, 10 but there wasn't already an adverse event term 11 assigned to that narrative, you would assign an 12 adverse event term? 13 A. Yes. 14 Q. Did you use the COSTART or 15 ELECT dictionary at that time? 16 A. I don't remember. 17 Q. Did you bring copies of the 18 dictionaries with you to Lilly? 19 A. Yes. 20 Q. Did you bring copies of both 21 dictionaries or just one or the other? 22 A. One or the other. 23 Q. What happened to the hits that 24 Dr. Beasley and/or Dr. Heiligenstein determined Page 243 1 were not suicidal or homicidal related? 2 A. They were just put in the 3 regular files. 4 Q. Okay. Were they entered into 5 the data base? 6 A. Oh, yes, everything was entered 7 into the data base. 8 Q. To the best of your 9 recollection, how many of the hits were 10 determined not to be suicide or homicide related 11 by Dr. Heiligenstein and/or Dr. Beasley? 12 A. I don't recall the number. 13 Q. Can you give me a percentage, 14 like, say, fifty percent or seventy-five percent? 15 A. Less than fifty percent. 16 Q. Less than fifty percent were 17 pulled as not being related to homicide or 18 suicide, let me make sure I get that straight? 19 A. I believe so. 20 Q. What were done with the hits 21 that were determined to be related to homicide or 22 suicide? 23 A. If more information was needed, 24 they asked the affiliate to provide more Page 244 1 information. 2 Q. Okay. When you said that they 3 reviewed the hits, did they review them from the 4 perspective of whether or not the event was 5 caused by the use of Fluoxetine? 6 A. No, they were blinded. 7 Q. Okay. So they reviewed the 8 events from the perspective of deciding whether 9 or not it was really a suicidal gesture or 10 suicidal ideation or homicidal gesture? 11 A. Yes. 12 Q. At that point, after that 13 determination was made, were they then unblinded, 14 were they then allowed to see what drug or 15 placebo the patients were on? 16 A. I don't believe they were 17 unblinded until the complete analysis was done. 18 Q. Okay. So analysis of the 19 entire data base was done before it was 20 determined what these hit patients were on; 21 correct? 22 A. I believe so. 23 Q. Was a reanalysis done once it 24 was determined what drug or placebo that the hit Page 245 1 patients were on was done? 2 MR. MYERS: Reanalysis of what? 3 MS. ZETTLER: A reanalysis of the data. 4 A. Not that I'm aware of. 5 Q. To your knowledge was at any 6 time a determination of causal relationship 7 between the hit patients and the -- hit patient's 8 adverse event and the use of Fluoxetine ever 9 made? 10 A. Not that I'm aware of. 11 Q. Why was a work sheet used as 12 opposed to using the CRF? 13 A. A work sheet is just a term 14 that we developed to call those pages, they 15 resembled care report forms. 16 Q. Right, but you testified 17 earlier that less information was gathered on the 18 work sheets than was originally gathered on the 19 CRF's, right? 20 A. Not all the studies gathered 21 all the same information, we pulled and captured 22 the most of all the information that they had 23 that involved safety. 24 Q. Okay. Do you know what a CC Page 246 1 check is? 2 A. Yes. 3 Q. What is a CC check? 4 A. It's a contingent compensation 5 as part of my salary. 6 Q. Contingent compensation? 7 A. Yes. 8 Q. What's it contingent on? 9 A. I believe it's based on the 10 performance of the company that year. 11 Q. Did you receive a larger CC 12 check the year that you completed the analysis of 13 the OUS data than you did in other years? 14 A. I don't know the answer to 15 that. 16 Q. Did you receive any kind of 17 monetary bonus for the work you did on the OUS 18 data? 19 A. No. 20 Q. Did you receive any kind of 21 bonus whatsoever, be it monetary or recognition 22 or anything? 23 A. Yes, I received a recognition 24 award. Page 247 1 Q. Specifically for your work on 2 the OUS analysis data? 3 A. Yes. 4 Q. Was that award given at a 5 formal ceremony? 6 A. Yes. 7 Q. When was the formal ceremony 8 held? 9 A. In April of '92. 10 Q. Was there a dinner held and 11 things of that nature, was there a formal dinner 12 held? 13 A. There was a lunch. 14 Q. Were other people given 15 recognition awards also? 16 A. Yes. 17 Q. Who else? 18 A. That I knew? 19 Q. Right. 20 A. From -- 21 Q. Well, anybody that you can 22 think of. 23 MR. MYERS: In connection with the same 24 thing? Page 248 1 MS. ZETTLER: Right. 2 A. Lisa DuVault. 3 Q. Okay. 4 A. I believe her award was for -- 5 Q. Anybody else? 6 A. No. 7 Q. Were you given any gifts in 8 relationship to your work on the OUS data 9 gathering project? 10 A. A plaque. 11 Q. Anything else? 12 A. No. 13 Q. Are you aware of any studies 14 that were done on Fluoxetine as it related to 15 movement disorders? 16 A. Yes. 17 Q. What studies were those? 18 A. Dystonia. 19 Q. Was that a rechallenge study? 20 A. I don't remember. 21 Q. Was it specifically -- the 22 study specifically constructed to study the 23 incidence of dystonia and the use of Fluoxetine? 24 A. I'm sorry, can you rephrase Page 249 1 that? 2 Q. Sure. Was the objective of the 3 study to measure the incidence of the occurrence 4 of dystonia on patients who used Fluoxetine? 5 A. I don't know the objective of 6 the study. 7 Q. Did you work on that study? 8 A. I collected the case report 9 forms on that study. 10 Q. Where was the study conducted? 11 A. Los Angeles. 12 Q. Do you know the name of the 13 investigator on that study? 14 MR. MYERS: If you know, don't tell 15 her. 16 Q. Do you know the name of the 17 investigator? 18 MR. MYERS: You can tell her that, 19 whether you know or not. Tell her yes or no, 20 whether you know the name of the investigator. 21 A. Yes, I know the name of the 22 investigator. 23 Q. Are you going to follow your 24 attorney's direction and not give the name of the Page 250 1 investigator? 2 A. Yes. 3 MS. ZETTLER: Certify it. 4 (QUESTION CERTIFIED.) 5 Q. How many patients were enrolled 6 in that study? 7 A. I only remember one. 8 Q. One patient? 9 A. One I monitored. 10 Q. One patient that you monitored? 11 A. That was on the study -- 12 Q. When you monitored, okay, I 13 thought you said one that you monitored. 14 MR. MYERS: One when she monitored, I 15 think is what she said. 16 MS. ZETTLER: Right. 17 A. I only remember one. 18 Q. There may have been more? 19 A. Yes. 20 Q. Would they run a study with 21 just one patient? 22 A. Yes. 23 Q. They would? 24 A. Yes. Page 251 1 Q. To your knowledge have they 2 ever run any other studies on Fluoxetine with 3 just one patient? 4 MR. MYERS: Before she answers it, I 5 object to the form. She didn't state that in 6 that study there was just one patient in the 7 study. 8 MS. ZETTLER: Right, but I asked her -- 9 MR. MYERS: Did they ever run any other 10 studies with just one patient. 11 MS. ZETTLER: With regards to 12 Fluoxetine, I qualified it. 13 A. I don't recall. 14 Q. Have you ever participated in a 15 trial or worked in a trial where they only had 16 one patient in a study? 17 A. I don't recall. 18 Q. Why is it that you answered 19 that there were other occasions when only one 20 patient would be included in a study? 21 A. Because there may be a chance 22 that one patient gets enrolled and they 23 discontinue a trial. 24 Q. Okay. To your knowledge was Page 252 1 this tardive dyskinesia study discontinued? 2 MR. MYERS: It was dystonia. 3 Q. I'm sorry, dystonia study. Was 4 it discontinued? 5 A. Not that I'm aware of. 6 Q. Any other movement disorder 7 studies that you're aware of that were done on 8 Fluoxetine? 9 A. Not to my knowledge. 10 Q. Was there a final report 11 written up on the rechallenge study? 12 A. No. 13 Q. Was there a report written at 14 all on the rechallenge study for submission to 15 the FDA? 16 A. No. 17 Q. Was the rechallenge study to be 18 performed here or outside the U.S. or both? 19 A. I don't know the answer to 20 that. 21 Q. Would that be something that 22 would be included in the protocol? 23 A. No. 24 Q. Are you aware of any tardive Page 253 1 dyskinesia studies that were conducted at Wishard 2 Clinic? 3 A. No. 4 Q. Was the rechallenge study or 5 any portion of the rechallenge study to be 6 performed at the Wishard Clinic? 7 A. Not that I'm aware of. 8 Q. Was the surveillance study 9 performed on the MSSIR conducted at the Wishard 10 Clinic? 11 A. No. 12 Q. Were you involved in gathering 13 data related to movement disorders and 14 Fluoxetine? 15 A. Excuse me? 16 Q. Let me ask it this way: Are 17 you aware of a project in which all of the data 18 or data related to movement disorders was 19 collected and analyzed with regards to 20 Fluoxetine? 21 A. I believe there was some 22 analysis of movement disorders from an existing 23 data base. 24 Q. Were you involved in that at Page 254 1 all? 2 A. No. 3 Q. Was the analysis done on data 4 that you collected as part of the OUS analysis? 5 A. Not that I'm aware of. 6 (PLAINTIFF'S EXHIBIT NO. 2 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Have you had a chance to look 10 at Exhibit No. 2, Catherine? 11 A. Yes. 12 Q. Can you tell me what the first 13 page of Exhibit No. 2 is? 14 A. Yes, it's a cover sheet. 15 Q. Cover sheet for what? 16 A. That was used for the OUS. 17 Each patient on the OUS trial had a cover sheet. 18 Q. When you say the OUS trial -- 19 A. The OUS data collection 20 process, every patient had a cover sheet listing 21 whether it was -- how many visits were there, who 22 prepared it, the date it was prepared and whether 23 or not we listed any active ideation or noticed 24 any hit, and listed any questions we had. Page 255 1 Q. Is this -- would this sheet 2 represent a patient that would be considered a 3 hit? 4 A. Yes. 5 Q. And that's because at the 6 bottom of the summary it says suicide by hanging 7 reported on summary page, right? 8 A. Yes. 9 Q. What is a summary page? 10 A. Every patient had a reason 11 discontinued page. 12 Q. Okay. Were the hits taken from 13 patients -- only from patients who discontinued 14 the studies or were hits taken from any source 15 whatsoever? 16 A. Any source whatsoever. 17 Q. What about the second page, I'm 18 not saying that these are necessarily related, 19 what is the second page of Exhibit 2? 20 A. It looks like a screen print, 21 but I don't know. 22 Q. Do you have any idea why this 23 would have been included in your employee files? 24 A. No. Page 256 1 Q. Have you ever seen this before? 2 A. No. 3 Q. When you say a screen print, 4 you mean the screen print of DEN information? 5 A. No. 6 Q. Screen prints of what? 7 A. If we pulled up a data base and 8 asked the screen to print a particular screen, 9 that's what this might look like. 10 Q. Okay. 11 (PLAINTIFF'S EXHIBIT NO. 3 WAS 12 MARKED FOR IDENTIFICATION AND 13 RECEIVED IN EVIDENCE.) 14 Q. Have you had a chance to review 15 Exhibit No. 3? 16 A. Yes. 17 Q. Is this an example of the 18 adverse event checklist we were talking about 19 earlier? 20 A. Yes, it is. 21 Q. Does this, the first page of 22 Exhibit No. 3, refresh your recollection as to 23 what studies this checklist was used in? 24 A. No. Page 257 1 Q. Do you know what ADE two is? 2 A. Yes. 3 Q. What is ADE two? 4 A. It's a project code we gave to 5 enter this checklist into a data base. 6 Q. When you say enter the 7 checklist, what do you mean, information from the 8 checklist or the check -- I don't understand what 9 you mean by enter this checklist. 10 A. I'm trying to figure out how to 11 describe it. It was a computer term that we -- a 12 project code that we used to enter this 13 information and be able to identify it on the 14 computer. 15 Q. So it was a -- was it a data 16 base that contained only this information from 17 the adverse event checklist? 18 A. Yes. 19 Q. And that was only done with one 20 study, to your knowledge? 21 A. No. 22 Q. How many studies was this done 23 with? 24 A. Two. Page 258 1 Q. Two studies, okay. How about 2 the last page of Exhibit 3, in the upper 3 right-hand corner it says project number. It's 4 kinds of hard to read, but can you read it? 5 A. Yes. 6 Q. Does that refresh your 7 recollection which trials this was done with 8 regards to? 9 A. No. 10 Q. What does that say up there? 11 A. To me it says flu. 12 Q. F-L-U? 13 A. It's spelled F-L-O-U-X, 14 sometimes. 15 Q. And that stands for Fluoxetine? 16 A. Yes. 17 Q. To your knowledge was there 18 ever an individual project under which Lilly 19 would fill out these checklist forms with regards 20 to patient data that was accumulated previously 21 in clinical trials? 22 A. Please ask that question again. 23 Q. Sure. What I'm looking for is 24 whether or not at any point in time a project was Page 259 1 undertaken under which these checklists would be 2 filled out related to existing CRF's. In other 3 words, go through this stack of CRF's and see if 4 any of these people suffered from any of these 5 adverse events? 6 A. No. 7 Q. This was used specifically in 8 conjunction with the clinical trial? 9 A. Yes. 10 Q. As the trial was ongoing? 11 A. Yes. 12 Q. Did these two checklists 13 depicted in Exhibit 3 constitute the entire 14 adverse event form or are there additions to the 15 form? 16 MR. MYERS: When you say adverse event 17 form, are you equating that with what you call 18 the checklist? 19 MS. ZETTLER: Right. 20 A. I believe this is the entire 21 checklist. 22 (PLAINTIFF'S EXHIBIT NO. 4 WAS 23 MARKED FOR IDENTIFICATION AND 24 RECEIVED IN EVIDENCE.) Page 260 1 Q. Attached as the third page of 2 Exhibit 4 is another, looks like, related form 3 entitled Side Effects and Adverse Experiences 4 Continued; correct? 5 A. Yes. 6 Q. Is this in fact related to the 7 adverse event checklist or is this a separate 8 section? 9 A. I don't know. 10 Q. Were the checklists an integral 11 part of the CRF's that it was used on? 12 MR. MYERS: When you say integral part, 13 what do you mean? 14 MS. ZETTLER: Was it an actual part of 15 the CRF. 16 A. Yes. 17 Q. It wasn't something separate 18 that they were given in addition to the CRF? 19 A. No. 20 Q. Would you agree with me that it 21 appears that this last page of Exhibit 4 is also 22 a part of the CRF in this case? 23 A. Yes. 24 (PLAINTIFF'S EXHIBIT NO. 5 WAS Page 261 1 MARKED FOR IDENTIFICATION AND 2 RECEIVED IN EVIDENCE.) 3 Q. Have you had a chance to take a 4 look at Exhibit 5? 5 A. Yes. 6 Q. Can you tell us what that is? 7 A. It's the tracking sheet, it was 8 a tool that we used to assure that we collected 9 all the visits. 10 Q. Okay. This was used during the 11 OUS analysis data gathering project? 12 A. Yes, it was. 13 Q. Was it a similar tool used in 14 the gathering of the U.S. analysis data? 15 A. I don't know. 16 Q. Did you participate at all in 17 the gathering of the U.S. analysis data? 18 A. I don't think so. 19 (DISCUSSION OFF THE RECORD.) 20 (PLAINTIFF'S EXHIBIT NO. 6 WAS 21 MARKED FOR IDENTIFICATION AND 22 RECEIVED IN EVIDENCE.) 23 Q. Have you had a chance to review 24 Exhibit No. 6, Catherine? Page 262 1 A. Yes. 2 Q. Okay. Can you tell me what 3 that is? 4 A. It's an adverse event form. 5 Q. What does it mean at the top 6 where it says follow-up data? 7 A. My interpretation is that this 8 was for a follow-up visit, not for any beginning 9 visit. 10 Q. Okay. And did Lilly routinely 11 have follow-up data or some follow-up visit data 12 forms as part of the CRF's or as part of the CRF? 13 MR. MYERS: Is this part of a CRF. 14 MS. ZETTLER: Right. 15 A. Yes. 16 Q. And that was done routinely? 17 A. Yes. 18 Q. When you say follow-up visit, 19 is that either when somebody discontinued the 20 study or the study completed? 21 A. No. 22 Q. What do you mean by follow-up 23 visit then? 24 A. As opposed to a visit one, Page 263 1 everything else would be a follow-up. 2 Q. Okay. So if it's an eight-week 3 trial and the patients are supposed to go in once 4 a week for eight weeks, visits two through eight 5 would be follow-up visits? 6 A. Yes. 7 Q. On the left-hand side by the 8 words headache, et cetera, there are numbers 9 listed? 10 A. Yes. 11 Q. Do you know what those numbers 12 are? 13 A. Yes. 14 Q. What are they? 15 A. They're numbers that map to 16 adverse events using older dictionary types. 17 Q. Using older dictionaries? 18 A. Yes. 19 Q. You mean older than ELECT? 20 A. Yes. 21 Q. Would that be the SSAI 22 dictionary? 23 A. I believe so. 24 Q. Signs, Symptoms and Illnesses? Page 264 1 A. I believe so. 2 Q. Were numbers assigned to terms 3 using the ELECT dictionary and the COSTART 4 dictionary, to your knowledge? 5 A. Not to my knowledge. 6 (PLAINTIFF'S EXHIBIT NO. 7 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Okay. How about Exhibit 7, 10 have you had a chance to look at that? 11 A. Yes. 12 Q. Can you tell me what that is? 13 A. It's a hard copy of a global 14 project tracking sheet. 15 Q. What's a global project 16 tracking sheet, what is it for? 17 A. It's an internal document used 18 to track each protocol. 19 Q. And when you say track, what do 20 you mean? 21 A. Monitor its progress. 22 Q. Would this have been something 23 that you would have filled out as a CIR? 24 A. No. Page 265 1 Q. Are these forms filled out on a 2 regular basis throughout a trial? 3 A. No, usually only annually or at 4 the close of the study. 5 Q. Is this a complete tracking 6 sheet? 7 A. Obviously not, the physician 8 did not sign it. 9 Q. Okay. But I mean as far as 10 numbers of pages, is this a complete form or is 11 there stuff missing from this one? 12 A. I believe this is a complete 13 form. 14 Q. Is it true that in some 15 circumstances Lilly wouldn't pay the 16 investigators until the manuscript for various 17 studies were submitted? 18 A. Yes. 19 Q. In what situations did that 20 occur? 21 A. On Plan D studies. 22 Q. What are Plan D studies? 23 A. Studies developed beyond the 24 pivotal trial, used for additional information Page 266 1 such as comparator information. 2 Q. Like post-marketing studies? 3 A. Yes. 4 Q. Phase 4 studies, would that be 5 the same thing? 6 A. Yes. 7 Q. Were the post-marketing studies 8 paid for by the marketing department, to your 9 knowledge? 10 A. To my knowledge, I don't know 11 who pays for them. 12 Q. How about the surveillance 13 studies, was that the case with the surveillance 14 studies, would they not be paid until the work 15 was completed or a manuscript was provided? 16 A. I don't believe so. 17 (PLAINTIFF'S EXHIBIT NO. 8 WAS 18 MARKED FOR IDENTIFICATION AND 19 RECEIVED IN EVIDENCE.) 20 Q. Have you had a chance to review 21 Exhibit 8, Catherine? 22 A. Yes. 23 Q. Can you tell me what that is? 24 A. It's a means and attachment to Page 267 1 Fluoxetine study done in Italy. 2 Q. Okay. What is -- does this 3 indicate items that were in the Hamilton 4 depression rating scale in addition to the 5 regular twenty-one question Hamilton depression 6 rating scale? 7 MR. MYERS: Le me object to the form 8 only to the extent that I don't know if there's 9 any such thing as a regular twenty-one item 10 Hamilton depression scale, I don't know that your 11 descriptor is precise. 12 Q. Let me ask it this way: Is it 13 your understanding that in many of the Fluoxetine 14 studies, a twenty-one question Hamilton 15 depression rating scale is used as a scale in the 16 study? 17 A. Could you ask that again? 18 Q. Sure. You testified earlier 19 that to your knowledge the Hamilton depression 20 scale was used throughout some of the clinical 21 trials, right? 22 A. Yes. 23 Q. Are you familiar with the 24 makeup of the scale, the Hamilton depression Page 268 1 rating scale? 2 A. Not the study -- not question 3 as specific. 4 Q. Are you aware that at least one 5 form of the Hamilton depression rating scale has 6 twenty-one questions? 7 A. Yes. 8 Q. Are you familiar with the fact 9 that question number three of the twenty-one 10 question rating scale was related to suicide? 11 A. I know one question, I don't 12 know what question number it is. 13 Q. Okay. Is Exhibit No. 8 14 representative of questions that were being added 15 to the twenty-one question depression rating 16 scale, to your knowledge? 17 A. To my knowledge I don't know 18 the specific questions. 19 Q. Okay. Why would supplementary 20 items to the Hamilton depression rating scale be 21 developed, if you know? 22 A. To collect additional 23 information based on what they were studying. 24 Q. Do you know what the subject Page 269 1 matter of this Italian study was? 2 A. No, I do not. 3 Q. Was it a Fluoxetine study? 4 A. Yes. 5 Q. You know that because the B one 6 Y number at the beginning? 7 A. Yes. 8 Q. And IT stands for Italy? 9 A. Yes. It could be any 10 indication. 11 Q. Okay. Not necessarily 12 depression? 13 A. True. 14 Q. To your knowledge, was there 15 ever any discussion about logging data that came 16 in from outside the U.S. as part of the data, the 17 OUS data? 18 A. Yes. 19 Q. What did that mean, logging? 20 A. A term to describe that we 21 received the data. 22 Q. So just a log of data that had 23 been received at Indianapolis? 24 A. Yes. Page 270 1 Q. Was that ever done, to your 2 knowledge? 3 A. Yes. 4 Q. Is that computerized? 5 A. Yes. 6 (PLAINTIFF'S EXHIBIT NO. 9 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Have you had a chance to look 10 at Exhibit No. 9? 11 A. Yes. 12 Q. Can you tell me what that is? 13 A. It's a Fluoxetine study case 14 report form. 15 Q. This isn't a work sheet, is it? 16 A. No. From outside the United 17 States. 18 Q. Would you have kept any work 19 sheets in your files at Lilly? 20 A. Yes. 21 Q. Did you turn those work sheets 22 over to the legal department? 23 MR. MYERS: When you say work sheet, 24 are you talking about the same kind of work sheet Page 271 1 she was describing earlier for the data 2 collection project? 3 MS. ZETTLER: Right. 4 Q. Would you have kept the work 5 sheets in your file? 6 A. Yes. 7 Q. Your personal files? 8 A. They were sent to legal. 9 Q. But I mean at some point they 10 were in your personal files? 11 A. Yes. 12 Q. They were turned over to the 13 legal departments as documents from your files; 14 correct? 15 A. Yes. 16 Q. Did you ever receive copies of 17 those back after legal was through with them? 18 A. No, we chose not to copy those 19 but give them the originals. 20 Q. Why was that? 21 A. Because of the volume. 22 Q. Approximately how many of these 23 work sheets would you have had in your file? 24 A. Enough for three thousand Page 272 1 patients. 2 Q. Three thousand patients for 3 multiple visits? 4 A. Yes. 5 Q. Is there an average number of 6 visits that these people went through in the 7 studies? 8 A. I don't remember. 9 Q. Okay. Do you remember any of 10 the double blind controlled studies, not 11 extension phases but the initial studies going 12 longer than six or eight weeks? 13 MR. MYERS: For any study for any 14 indication or -- 15 MS. ZETTLER: Just the double blind 16 conrolled studies. 17 A. I don't remember. 18 MS. ZETTLER: Well, I don't have 19 anything right now until we get the documents 20 that should have been produced in conjunction 21 with this deposition, and I can assure you that I 22 will be asking Ms. Mesner back when we get the 23 protocol back in. 24 MR. MYERS: Well, not agreeing with Page 273 1 your statement, we are willing to adjourn the 2 deposition on the same basis that we adjourned 3 yesterday's deposition. That being that we will 4 endeavor to address the issues you've raised, and 5 subject to the outcome of those issues we will 6 work with you to either agree to a resumption of 7 the deposition with some reasonable limit on the 8 the scope and time, or failing that, somebody can 9 make application to a court on that subject. And 10 that's what we're willing to do. 11 MS. ZETTLER: Well, in addition to the 12 rechallenge protocol that we've been discussing 13 earlier, now it's come to light that there are 14 probably tens of thousands of documents that 15 weren't produced in regards to Ms. Mesner that 16 she's stated were in her file, and I think that 17 those are clearly documents that we want to see. 18 MR. MYERS: What documents are you 19 referring? 20 MS. ZETTLER: The work sheets that she 21 just talked about. 22 MR. MYERS: Well, I'll agree to 23 investigate the rechallenge protocol and work 24 sheet document issue. Page 274 1 MS. ZETTLER: Okay. 2 MR. MYERS: That's what we'll do with 3 respect to the adjournment of this deposition. 4 MS. ZETTLER: Okay. 5 MR. MYERS: I don't agree with a number 6 of the allegations that you've made, but there's 7 no reason to quarrel about it. I'm telling you 8 the basis upon which we'll adjourn the 9 deposition. 10 MS. ZETTLER: That's fine, I'm not 11 quarreling with you, I'm saying okay. 12 (DISCUSSION OFF THE RECORD.) 13 MR. SMITH: I don't have any questions 14 with the state of the record that I can ask at 15 this time, I'm unable to ask any questions at 16 this time. 17 MR. MYERS: I don't know what you mean 18 by the state of the record, I don't think. But I 19 think we addressed in your absence, the quote, 20 unquote, state of the record and what I'll call 21 open issues. 22 MR. SMITH: Whatever. 23 MR. MYERS: Whatever, okay. Anybody 24 else have any questions? Page 275 1 MR. RUIZ: I have no questions. 2 MR. CLEMENTI: I have no questions at 3 this time. 4 MS. LAWS: No questions. 5 (THE WITNESS WAS EXCUSED.) Page 276 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 CATHERINE MESNER 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 18TH DAY OF 19 AUGUST, 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 277 1 2 3 E R R A T A S H E E T 4 5 COMMONWEALTH OF KENTUCKY ) : SS 6 COUNTY OF JEFFERSON ) 7 8 9 I, CATHERINE MESNER, THE UNDERSIGNED 10 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 11 OF MY DEPOSITION AND WITH THE CHANGES NOTED 12 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 13 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 14 THE 17TH DAY OF AUGUST, 1993 AT THE TIME AND 15 PLACE STATED THEREIN. 16 PAGE NO. LINE NO. CHANGE REASON Page 278 1 PAGE NO. LINE NO. CHANGE REASON 2 3 4 5 6 7 8 _____________________________ 9 CATHERINE MESNER 10 SWORN TO AND SUBSCRIBED BEFORE ME THIS 11 _____ DAY OF __________, 1993. 12 _____________________________ NOTARY PUBLIC, STATE OF 13 KENTUCKY AT LARGE 14 15 16 Page 279