1 NO. 90-CI-6033 JEFFERSON CIRCUIT COURT DIVISION ONE (1) 2 3 JOYCE FENTRESS, ET AL. PLAINTIFFS 4 5 VS. DEPOSITION FOR PLAINTIFFS 6 7 SHEA COMMUNICATIONS, ET AL. DEFENDANTS 8 * * * * * * * * * * 9 10 DEPONENT: MELISSA HUMBERT 11 DATE: JUNE 23, 1993 12 13 * * * * * * * * * * 14 15 16 REPORTER: KATHY NOLD 17 18 KENTUCKIANA REPORTERS SUITE 260 19 730 WEST MAIN STREET LOUISVILLE, KENTUCKY 40202 20 (502) 589-2273 Page 1 1 * * * * * * * * * * 2 3 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA 4 INDIANAPOLIS DIVISION 5 IN RE ELI LILLY AND COMPANY ) Prozac Products Liability ) MDL Docket No. 907 6 Litigation ) 7 * * * * * * * * * * 8 NO. 91-02496-A 9 JACKIE LYNN BIFFLE, ET AL ) IN THE DISTRICT ) COURT OF 10 V. ) DALLAS COUNTY, TEXAS ) 11 ELI LILLY & COMPANY AND ) 14TH JUDICIAL DISTA PRODUCTS COMPANY ) DISTRICT 12 * * * * * * * * * * 13 NO. 92-14775-E 14 RICHARD HAROLD CROSSETT, JR., ) IN THE 15 CHAD H. CROSSETT, AMY MICHELLE ) DISTRICT CROSSETT AND KRISTEN ANN CROSSETT, ) COURT OF 16 INDIVIDUALLY AND AS SURVIVORS OF ) AND ON BEHALF OF THE ESTATE OF ) 17 JOCQUETTA ANN CROSSETT, DECEASED ) ) 18 V. ) DALLAS COUNTY, ) TEXAS 19 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, TEXAS ) 20 PSYCHIATRIC COMPANY, INC. ) D/B/A/ HCA WILLOW PARK ) 101ST JUDICIAL 21 HOSPITAL, JAMES K. WITSCHY, M.D., ) DISTRICT AND DOUG BELLAMY, ED.D. ) 22 * * * * * * * * * * Page 2 1 NO. A-921,405-C 2 MARIA GUADALUPE REVES ) IN THE 3 INDIVIDUALLY AND AS NEXT ) DISTRICT COURT FRIEND OF GRANT JULIAN REVES ) OF 4 A MINOR CHILD, AND ON BEHALF ) OF THE ESTATE OF CHRISTIAN ) 5 MARIE REVES, DECEASED ) ) ORANGE COUNTY, 6 V. ) TEXAS ) 7 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, RAVIKUMAR ) 8 KANNEGANTI, M.D., HOSPITAL ) CORPORATION OF AMERICA, A ) 9 TENNESSEE CORPORATION, HEALTH ) SERVICES ACQUISITION CORP., ) 10 A DELAWARE CORPORATION, ) HCA PSYCHIATRIC COMPANY, A ) 11 DELAWARE CORPORATION, TEXAS ) PSYCHIATRIC CO., INC.. A/K/A ) 12 AND/OR D/B/A HCA BEAUMONT ) NEUROLOGICAL HOSPITAL, AND HCA ) 13 HEALTH SERVICES OF TEXAS, INC. ) 128TH JUDICIAL A/K/A AND/OR BEAUMONT ) DISTRICT 14 NEUROLOGICAL HOSPITAL ) 15 * * * * * * * * * * Page 3 1 IN THE UNITED STATES DISTRICT COURT 2 FOR THE WESTERN DISTRICT OF TEXAS SAN ANTONIO DIVISION 3 ELIZABETH T. SANCHEZ, ) 4 INDIVIDUALLY AND AS THE ) SURVIVING SPOUSE, MARGARET R. ) 5 SANCHEZ, INDIVIDUALLY AND NEXT ) OF FRIEND OF DEBRA JEAN ) 6 SANCHEZ, VERONICA MARIE ) SANCHEZ, EDWARDO ESTEBAN ) 7 SANCHEZ, AND MICHAEL ANTHONY ) SANCHEZ, CHILDREN; AND ALL ON ) 8 BEHALF OF THE ESTATE OF ) EDWARDO SANCHEZ ) 9 ) V. ) CIVIL ACTION NO. 10 ) SA93CA367 ELI LILLY AND COMPANY AND ) 11 DISTA PRODUCTS COMPANY ) 12 * * * * * * * * * * 13 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS 14 HOUSTON DIVISION 15 MARIA SANCHEZ, INDIVIDUALLY ) AND AS NEXT FRIEND OF DEBORAH ) 16 SANCHEZ, VERONICA SANCHEZ, ) EDDIE SANCHEZ, AND MICHAEL ) 17 SANCHEZ, AND ON BEHALF OF THE ) ESTATE OF EDUARDO SANCHEZ ) 18 ) V. ) CIVIL ACTION NO. 19 ) H-93-1469 ELI LILLY AND COMPANY AND ) 20 DISTA PRODUCTS COMPANY, A ) DIVISION OF ELI LILLY AND ) 21 COMPANY ) 22 * * * * * * * * * * Page 4 1 STATE OF NEW YORK 2 SUPREME COURT COUNTY OF JEFFERSON 3 _____________________________________________ 4 STEPHANIE CAPONE, AS EXECUTOR OF THE ESTATE OF JOSEPH J. CAPONE, JR., AND 5 STEPHANIE CAPONE, INDIVIDUALL, NOTICE TO TAKE 6 PLAINTIFF, DEPOSITION UPON ORAL EXAMINATION 7 VS. INDEX NO. 93-251 8 ELI LILLY AND COMPANY, DISTA PRODUCTS 9 COMPANY, A DIVISION OF ELI LILLY AND COMPANY, FLOYD BAJJALY, M.D, 10 DEFENDANTS. 11 _____________________________________________ 12 * * * * * * * * * * 13 SUPREME COURT OF TEH STATE OF NEW YORK COUNTY OF ORANGE 14 --------------------------------------X BRUCE R. MALEN AS EXECUTOR OF THE : INDEX NO. 15 ESTATE OF BARBARA E. MALEN, AND OF : 4119/92 BRUCE R. MALEN, INDIVIDUALLY, : 16 : HON. PETER PLAINTIFF : PATSALOS, 17 : J.S.C. -against- : 18 : ELI LILLY & COMPANY, DISTA PRODUCTS : 19 COMPANY, A DIVISION OF ELI LILLY & : COMPANY, BARRY SINGER AND UNITED : 20 HOSPITAL, : : 21 DEFENDANTS. : --------------------------------------X 22 * * * * * * * * * * 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 COUNTY DEPARTMENT, LAW DIVISION 2 PATRICIA BRACH, ) 3 ) Plaintiff ) 4 ) v. )No. 92 L 13369 5 ) ELI LILLY AND COMPANY, a foreign ) 6 corporation; ALAN N. MILLER, M.D., ) WILLIAM BRUINSMA, Psy.D., and ) 7 CONDELL MEMORIAL HOSPITAL, ) ) 8 Defendants. ) 9 * * * * * * * * * * 10 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS COUNTY DEPARTMENT - LAW DIVISION 11 RENATO DI SILVESTRO, Individually ) 12 and as Special Administrator of ) the Estate of JOHN DI SILVESTRO, ) 13 Deceased, ) ) 14 Plaintiff, ) ) 15 v. ) No. 91 L 7881 ) 16 ROBERT L. NELSON, et al., ) ) 17 Defendants, ) ) 18 GEORGE MELNICK, M.D. and PETER ) FINK, M.D. ) 19 ) Respondents in Discovery.) 20 * * * * * * * * * * 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 CHAMPAIGN COUNTY, ILLINOIS 2 LINDA GARDNER, Individually and ) 3 as Special Administrator of ) the Estate of SHANE GARDNER, ) 4 deceased, ) ) 5 Plaintiff, ) ) 6 v. ) No. 91 L 1066 ) 7 ELI LILLY AND COMPANY, a foreign ) corporation, ) 8 ) Defendant. ) 9 10 * * * * * * * * * * 11 IN THE NINETEENTH JUDICIAL CIRCUIT COURT LAKE COUNTY, ILLINOIS 12 JAMES E. SHEPPARD, Special ) 13 Administrator of the Estate of ) KENNETH K. SHEPPARD, Deceased, ) 14 ) Plaintiff ) 15 ) v. ) No. 93 L 124 16 ) GOOD SHEPHERD HOSPITAL, a ) 17 corporation, DR. STEWART SEGAL, ) DR. SANFORD SHERMAN, DR. BRUCE ) 18 CARLSON, DR. R. BERGLUND, and ELI ) LILLY & COMPANY, a corporation, ) 19 ) Defendants. ) 20 * * * * * * * * * * 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: ) SC 008331 4 Plaintiffs, ) ) 5 vs. ) ) 6 ELI LILLY & COMPANY, a corporation; ) DISTA PRODUCTS COMPANY, a division ) 7 of Eli Lilly & Company; and DOBS 1- ) 100, inclusive, ) 8 ) Defendants. ) 9 ____________________________________) 10 * * * * * * * * * * Page 10 1 I N D E X 2 DEPOSITION OF MELISSA HUMBERT 3 4 DIRECT EXAMINATION BY MR. GREEN 15 CROSS EXAMINATION BY MR. CLEMENTI 192 5 CERTIFICATION 193 6 ERRATA 194 7 8 EXHIBITS 9 PLAINTIFFS' EXHIBIT NO. 1 30 PLAINTIFFS' EXHIBIT NO. 2 91 10 PLAINTIFFS' EXHIBIT NO. 3 109 PLAINTIFFS' EXHIBIT NO. 4 116 11 PLAINTIFFS' EXHIBIT NO. 5 120 PLAINTIFFS' EXHIBIT NO. 6 125 12 PLAINTIFFS' EXHIBIT NO. 7 133 PLAINTIFFS' EXHIBIT NO. 8 148 13 PLAINTIFFS' EXHIBIT NO. 9 161 PLAINTIFFS' EXHIBIT NO. 10 179 14 PLAINTIFFS' EXHIBIT NO. 11 182 PLAINTIFFS' EXHIBIT NO. 12 185 15 Page 11 1 THE DEPOSITION OF MELISSA HUMBERT, TAKEN AT 2 THE OFFICE OF BAKER & DANIELS, 300 NORTH MERIDIAN 3 STREET, SUITE 2700, INDIANAPOLIS, INDIANA 46204, 4 ON JUNE 23, 1993, SAID DEPOSITION TAKEN PURSUANT 5 TO NOTICE IN ACCORDANCE WITH THE RULES OF CIVIL 6 PROCEDURE. 7 * * * * * * * * * * 8 A P P E A R A N C E S 9 10 GREGORY GREEN COUNSEL FOR GROUP B PLAINTIFFS 11 LAW OFFICES OF LEONARD L. FINZ, P.C. 222 BROADWAY, 27TH FLOOR 12 NEW YORK, NEW YORK 10038 13 LAWRENCE J. MYERS COUNSEL FOR ELI LILLY AND COMPANY 14 FREEMAN & HAWKINS 4000 ONE PEACHTREE CENTER 15 303 PEACHTREE STREET, N.E. ATLANTA, GEORGIA 30308-3243 16 LISA M. GOLDMAN 17 COUNSEL FOR ELI LILLY AND COMPANY MCCARTER & ENGLISH 18 FOUR GATEWAY CENTER 100 MULBERRY STREET 19 NEWARK, NEW JERSEY 07101-0652 20 MARGARET M. HUFF ELI LILLY AND COMPANY 21 LILLY CORPORATE CENTER INDIANAPOLIS, INDIANA 46285 22 23 DENISE BRODSKY COUNSEL FOR GOOD SHEPHERD HOSPITAL 24 415 WASHINGTON STREET, SUITE 214 WAUKEGAN, ILLINOIS Page 12 1 2 KIMBERLY A. WILKINS 3 COUNSEL FOR DEFENDANTS CZECHOWICZ, FINK, BRUINSMA 4 CLAUSEN MILLER GORMAN CAFFREY & WITOUS 5 10 SOUTH LASALLE 6 CHICAGO, ILLINOIS 60603 7 8 PAUL J. CLEMENTI 9 COUNSEL FOR DR. DICKIE KAY 10 HINSHAW & CULBERTSON 11 222 NORTH LA SALLE STREET, SUITE 300 12 CHICAGO, ILLINOIS 60601-1081 13 14 KATHERINE L. LAWS 15 COUNSEL FOR DRS. WITSCHY AND KANNEGANTI 16 BAILEY AND WILLIAMS 17 3500 NCNB PLAZA 18 901 MAIN STREET 19 DALLAS, TEXAS 75202-3714 20 21 DOUGLAS C. BALLANTINE 22 COUNSEL FOR DR. LEE COLEMAN 23 OGDEN NEWELL & WELCH 24 1200 ONE RIVERFRONT PLAZA Page 13 1 LOUISVILLE, KENTUCKY 40202 2 3 BEATRICE M. SMITH 4 COUNSEL FOR BEAUMONT NEUROLOGICAL HOSPITAL 5 BARTLETT & FRIEND, L.L.P. 6 1301 MCKINNEY, SUITE 2900 7 HOUSTON, TEXAS 77010 Page 14 1 COMES MELISSA HUMBERT, CALLED BY THE 2 PLAINTIFFS, AND AFTER FIRST BEING DULY SWORN, WAS 3 DEPOSED AND TESTIFIED AS FOLLOWS: 4 DIRECT EXAMINATION 5 BY MR. GREEN: 6 Q. Good morning, Ms. Humbert, can 7 you state your name? 8 A. Melissa Humbert. 9 Q. Did you also go by the name 10 Melissa Au? 11 A. Yes. 12 Q. But Humbert is your present 13 name? 14 A. Yes. 15 Q. And what years did you go by 16 Melissa Au? 17 A. 1959 to 1984. 18 Q. My name is Gregory Green and I 19 represent plaintiffs in Kentucky who have brought 20 suit against your employer, Eli Lilly and 21 Company. Today I will be asking you some 22 questions and if anything I ask is unclear to 23 you, please tell me and I will attempt to 24 rephrase my question, okay? Page 15 1 A. Okay. 2 Q. I would ask that you answer 3 verbally so that the court reporter can take 4 everything that you say down. 5 A. Okay. 6 Q. Can you tell us what your 7 highest level of education is? 8 A. I have a bachelors degree. 9 Q. Where did you get that? 10 A. Miami University. 11 Q. Is that in Ohio or Florida? 12 A. Ohio. 13 Q. And is that a BA or BS? 14 A. BA. 15 Q. What did you major in? 16 A. A double major in chemistry and 17 microbiology. 18 Q. And when did you graduate? 19 A. 1981. 20 Q. And what is your address? 21 A. My present address? 22 Q. Yes. 23 A. XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 24 XXXXXXXXXXXX. Page 16 1 Q. And the zip code there? 2 A. XXXXX. 3 Q. Are you presently married? 4 A. Yes. 5 Q. Does your husband work for 6 Lilly? 7 A. No. 8 Q. When did you begin working for 9 Eli Lilly and Company? 10 A. 1981. 11 Q. Right out of college? 12 A. Right. 13 Q. And you're presently employed 14 by Lilly? 15 A. Yes. 16 Q. Have you worked for Lilly 17 continuously from 1981 to present? 18 A. Yes. 19 Q. And could you give me a list of 20 your job titles from 1981 to present, and when 21 you got a new title, the date of the new title if 22 you did get a new title. 23 A. Okay. 24 I was an associate in the Page 17 1 laboratories from 1981 to 1983. I joined medical 2 in '83, as a clinical research administrator 3 until 1988, when I joined medical regulatory and 4 regulatory services as a supervisor of regulatory 5 services and that was 1988 to 1990. In 1990, I 6 became department head of the drug epidemiology 7 unit and that was until 1992. In 1992, I became 8 manager of natural products research and 9 biochemical pharmacology research. 10 Q. Was your move from medical as a 11 CRA to medical regulatory a promotion? 12 A. No, lateral. 13 Q. Did your rate of pay increase? 14 A. No. 15 Q. At the time that Prozac was 16 approved by the FDA, did you receive any bonus, 17 monetary bonus? 18 A. No. 19 Q. Since 1981, what years did you 20 work with Prozac? 21 A. 1983 through 1992. 22 Q. Is that the period of time from 23 which you became a CRA until you moved to manager 24 of natural products? Page 18 1 A. Yes. 2 Q. Did you work with any other 3 drugs during that time? 4 A. Yes. 5 Q. Could you give me some idea of 6 the proportion of time you spent on Prozac from 7 1983 through 1990? 8 A. From 1983 through 1988, all of 9 my time was working with Prozac, and then from 10 '88 to '90, it's very difficult to say, I worked 11 with all drugs in that capacity. 12 Q. When you say with all drugs, is 13 that all drugs that Lilly was investigating 14 clinically at that time or was it a group of 15 drugs? 16 A. All drugs, we had our 17 regulatory documents and that's what regulatory 18 services is, all drugs. 19 Q. When you were with the 20 department of -- or the drug epidemiology unit, 21 from '88 to '90, were you considered the Prozac 22 expert in the unit? 23 MR. MYERS: Excuse me, didn't you say 24 you were with DU from '90 to '92? Page 19 1 THE WITNESS: Yes. 2 Q. I'm sorry. So when you were in 3 medical regulatory, were you considered the 4 Prozac expert? 5 MR. MYERS: Well, let me object to the 6 question, the form of the question. What does, 7 quote, the Prozac expert mean? That's undefined. 8 MR. GREEN: That means somebody who had 9 spent five years working exclusively on Prozac 10 throughout its clinical investigation and its 11 approval by the FDA. 12 MR. MYERS: I still object to the form. 13 She can answer as to what expertise she did or 14 didn't have during that period of time with 15 respect to the drug. 16 A. The move that I made into 17 regulatory services, it was an administrative 18 move and I worked more on the administrative 19 people side of things than with the particular 20 drugs. 21 Q. When you began working with the 22 drug epidemiology unit, did you work at all with 23 Prozac? 24 A. That was part of the drugs that Page 20 1 we tracked in the drug epidemiology unit. 2 Q. What about when you became 3 manager of natural products? 4 A. No. 5 Q. When you came on board with 6 Lilly in 1981, did you receive any special 7 training regarding the clinical investigation of 8 psychotropic drugs? 9 MR. MYERS: Let me object to the form 10 only to the extent that her testimony is that 11 when she came on board she worked in the labs as 12 an associate and was not involved in the clinical 13 investigation of psychotropic drugs. 14 MR. GREEN: That's a yes or no 15 question. 16 MR. MYERS: You answer the question as 17 best you can, you're not limited to a yes or no. 18 A. I worked in the laboratories, 19 not with Prozac, in 1981. 20 Q. Did you meet with your 21 attorneys prior to this deposition to discuss 22 this deposition? 23 A. We met. 24 Q. When did you meet? Page 21 1 A. About an hour ago. 2 Q. Did you meet at any other point 3 in time other than an hour ago? 4 A. A couple of weeks ago. 5 Q. How long did you meet a couple 6 of weeks ago? 7 A. For a little more than an hour. 8 Q. Did your attorney tell you to 9 listen to the objections and pick up a cue from 10 the objections? 11 MR. MYERS: She's not required to 12 answer any questions about what she did or did 13 not discuss with her lawyers, that's privileged 14 and I direct her not to answer that. 15 Q. Did you receive training from 16 Eli Lilly regarding your job of clinical research 17 associate? 18 MR. MYERS: Administrator. 19 Q. I'm sorry, clinical research 20 administrator. 21 A. Yes. 22 Q. When did you receive that 23 training? 24 A. When I joined medical in 1983. Page 22 1 Q. And could you describe that 2 training to me, please? 3 A. It was a formal training period 4 was two weeks, two weeks, and then it was, I was -- 5 I had a mentoring system. 6 Q. I'm sorry? 7 A. A mentor in the cluster that I 8 worked in. 9 Q. Was that the Prozac cluster? 10 A. Yes. 11 Q. What departments were 12 represented within the Prozac cluster? 13 A. Department number -- I don't 14 understand your question. 15 Q. I mean were different 16 departments other than medical represented within 17 the Prozac cluster or was the Prozac cluster made 18 up entirely of medical personnel? 19 A. They were all medical, they 20 were diverse backgrounds. 21 Q. Was there anybody from 22 marketing within the Prozac cluster? 23 A. No. 24 Q. What was the subject matter of Page 23 1 that formal training you received? 2 A. As best that I recall, it went 3 into the specifics of the variety of tasks that 4 CRAs have. 5 Q. Now, when you first became a 6 CRA in 1983, who was your immediate supervisor? 7 A. Earleen Ashbrook. 8 Q. Was your training session, the 9 two week training session, was that directed 10 toward being a CRA for Prozac? 11 A. No. 12 Q. At that time during that two 13 week training period, were there any other new 14 CRAs who also went on to work on Prozac? 15 A. Not immediately. 16 Q. Over the course of those five 17 years, what other CRAs worked on Prozac? 18 MR. MYERS: '83 to '88? 19 MR. GREEN: Yes. 20 MR. MYERS: Thank you. 21 A. Okay, you're looking for that 22 time period, Roberta Smithy, Dan Russell, Gisele 23 Soyez. The only other name is Katherine Messner. 24 Q. Okay. Page 24 1 A. That I recall. 2 Q. And over the course of those 3 five years, did your -- the person who was your 4 immediate supervisor, did that person ever 5 change? 6 A. No. 7 Q. It was Earleen Ashbrook 8 throughout the five years? 9 A. Right. 10 Q. What was her title exactly? 11 A. She was a department head. 12 Q. What department was that? 13 A. I'm trying to remember the 14 specific title of it -- I don't recall the 15 specific title when I first joined of that 16 particular department, it was MC 661. 17 Q. Do you recall the title when 18 you left that department or when you stopped 19 being a CRA in 1988? 20 A. Not in 1988. 21 Q. Must be kind of hard not to 22 know what department you worked for. 23 MR. MYERS: Is that a question? 24 Q. Do you know Earleen Ashbrook's Page 25 1 title now? 2 A. She is the manager. 3 Q. Manager of what? 4 A. In medical regulatory affairs. 5 Q. Did she become the manager in 6 1988? 7 A. I don't know. 8 Q. Did she make the move about the 9 same time you did? 10 A. I'm not really sure when she 11 moved. 12 Q. Was that a promotion for her to 13 go from being a department head to manager? 14 A. She had some other assignments 15 in between, so -- but I'm not sure what the 16 timing of those are. 17 Q. During that timeframe, from 18 1983 to 1988, do you recall whether or not the 19 drug Prozac was approved for use in Belgium 20 during that time? 21 A. I don't recall when it was 22 approved in Belgium. 23 Q. Do you recall whether or not 24 the drug was approved in Germany during that Page 26 1 time? 2 A. I don't know the specific date 3 that it was approved. 4 Q. Was it within 1983 to 1988? 5 A. I don't know. 6 Q. Do you recall whether the drug 7 was approved in the United States during that 8 time? 9 A. Yes. 10 Q. Do you recall whether the drug 11 was approved in Sweden at that time? 12 A. I don't know the specific date. 13 Q. Do you know whether or not the 14 drug was approved in Norway during that time? 15 A. I don't know the specific date. 16 Q. Did you have anything to do 17 with having -- did you work on having the drug 18 approved in other countries other than the United 19 States? 20 A. Work in terms of like what? 21 Q. I mean did you do the same kind 22 of thing that you did within the United States, 23 organize clinical trials, things of that nature? 24 A. The data that we used for the Page 27 1 registration document in the United States was 2 also supplied for our international affiliates. 3 Q. You worked on Protocol 79, 4 didn't you? 5 A. Yes. 6 Q. How long did that protocol 7 last? 8 A. By last, what do you mean? 9 Q. What was the timeframe from 10 when the first patient was signed up for the 11 protocol until the summary report was completed? 12 A. For an individual patient? 13 Q. No, for the entire protocol. 14 A. The entire study? 15 Q. Yes. 16 A. I don't remember dates. 17 Q. Were there any other CRAs who 18 were involved with Protocol 79? 19 A. The best I recall, no. 20 Q. Okay. Who were the clinical 21 investigators for Protocol 79? 22 MR. MYERS: Let me object to that 23 question to the extent it calls upon the witness 24 to disclose information which Lilly considers to Page 28 1 be confidential trade secrets, other confidential 2 commercial information. Mister Green, you have 3 been supplied with a list of a number of pivotal 4 clinical investigators by us in the Biffle case, 5 also in turn in the MDL, and thus I'm going to 6 direct the witness not to give you a laundry list 7 of who the clinical investigators are. If you've 8 got some names and you want to ask her, by all 9 means go ahead, but she's not going to give a 10 laundry list. 11 Q. Okay. Was Doctor Feighner 12 involved with Protocol 79? 13 A. Doctor Feighner. 14 Q. Feighner, I'm sorry. 15 A. Yes. 16 Q. And what was the organization 17 that Doctor Feighner worked out of, he didn't 18 work out of a solo office, right, did he work out 19 of an organization? 20 A. He had his office as an 21 investigator, he also was part of a contract 22 organization. 23 Q. You mean that Lilly contracted 24 his organization to provide some service Page 29 1 regarding Protocol 79? 2 A. It was someone else who 3 initiated this organization as well. 4 Q. What was the function of the 5 organization under the contract? 6 A. They worked with Lilly in 7 setting up that study, finding the investigators 8 and then monitoring the study and then providing 9 data back to Lilly. 10 Q. Were the funds for the study 11 channeled through this organization? 12 A. Yes. 13 Q. And what was the amount of the 14 fund which Lilly spent on Protocol 79? 15 MR. MYERS: Let me object to that 16 question. The amount of money that Lilly spends 17 on any clinical trial is confidential, it's 18 business information, the specific amount. She 19 is not required to answer that question. 20 (PLAINTIFFS' EXHIBIT NO. 1 WAS 21 MARKED FOR IDENTIFICATION AND 22 RECEIVED IN EVIDENCE.) 23 Q. Miss Humbert, Exhibit 1, have 24 you had a chance to read it? Page 30 1 A. Yes. 2 Q. It consists of seven pages, 3 does it not? 4 A. Yes. 5 Q. Miss Humbert, I would like to 6 ask you, on each of those pages, there is a 7 dollar amount mentioned, and I would like to ask 8 you what that dollar amount represents? 9 A. It's an installment of their 10 grant. 11 Q. How many installments were made 12 on this grant? 13 A. I'm not sure if this represents 14 all the payments or not, I don't recall. 15 Q. Well, would the number seven, 16 since there are seven installments apparently, is 17 that usually the number of installments that were 18 made on a protocol? 19 MR. MYERS: Excuse me, she told you she 20 didn't recall how many installments there were 21 and now you've told her there were seven, so I 22 object to the form. 23 Q. I want to know if seven was the 24 total or if there were more? Page 31 1 A. I don't recall. 2 Q. Were any other funds expended 3 by Lilly through, do you mind if we call it the 4 Feighner organization, is that okay with you? 5 A. It was International Clinical 6 Research Corporation. 7 Q. Okay, were any other funds 8 expended by Lilly through the ICRC for the 9 Protocol 79? 10 MR. MYERS: Object to the form, funds 11 other than what? 12 MR. GREEN: Other than the installments 13 which are expressed within Exhibit Number 1. 14 A. I don't recall. 15 Q. Okay. Now, if we look through 16 these numbers, on the first page, it's a hundred 17 twenty-eight thousand six hundred twenty-five 18 dollars and on the second page it's again one 19 twenty-eight, six twenty-five, the third page is 20 again a hundred twenty-eight thousand six hundred 21 twenty-five dollars. Fourth page is a hundred 22 twenty-eight thousand six hundred twenty-five 23 dollars, the fifth page is a hundred twenty-eight 24 thousand six hundred twenty-five dollars, sixth Page 32 1 page is a hundred twenty-eight thousand six 2 hundred and twenty-five dollars, the seventh page 3 is two hundred and fifty-seven thousand two 4 hundred fifty dollars, correct? 5 A. Right? 6 Q. How many patients were patients 7 within Protocol 79? 8 A. I don't remember the specific 9 number. 10 Q. Does the number forty-nine 11 refresh your recollection? 12 A. Forty-nine referring to what? 13 Q. Forty-nine patients within 14 Protocol 79. 15 MR. MYERS: Are you asking her if there 16 were forty-nine patients in the study, is that 17 the question? 18 MR. GREEN: Yes. 19 A. To the best I recall it was 20 more than that. 21 Q. Was it more than a hundred? 22 A. The best I can recall it's more 23 than a hundred but I don't remember the specific 24 number. Page 33 1 Q. Well, let me ask you this: 2 What, if any, other protocols did you work on 3 during that five year time period from '83 to 4 '88? 5 A. I worked on several different 6 protocols. 7 Q. Do you recall their titles, not 8 their name titles, but just the number? 9 A. I don't remember their protocol 10 numbers. 11 Q. Was there an average amount 12 which Lilly expended on its protocols per 13 patient? 14 A. It depended on the nature of 15 the study and the complexity of the study and the 16 negotiations that went on. 17 Q. How much did it depend on the 18 negotiations? 19 A. I wasn't part of that aspect. 20 Q. But you were part of sending 21 the check to the investigators, weren't you? 22 A. I administrated it. 23 Q. Did you notice how much the 24 checks were for as you were administrating it? Page 34 1 A. I would issue the voucher to 2 initiate the check. 3 Q. Were some checks greater than 4 other checks on a per patient basis? 5 A. Oh, you mean between individual 6 patients? 7 Q. I mean between individual 8 clinical investigators. 9 MR. MYERS: For the same study or 10 different studies? 11 MR. GREEN: For different studies. 12 Q. Had some investigators 13 negotiated a higher price per patient than other 14 investigators? 15 A. Okay. For this particular 16 study, my dealing with money went through ICRC 17 and I did not get down to the individual 18 investigators and how the money was distributed 19 to individual investigators. 20 Q. So for instance another -- was 21 another investigator in this study a Doctor Fabre 22 in Houston, Texas? 23 A. Yes. 24 Q. You're not -- you don't know Page 35 1 what he was paid to conduct this study? 2 A. No. 3 Q. Does anybody at Eli Lilly know 4 what he was paid to conduct this study? 5 MR. MYERS: As far as she knows? 6 Q. As far as you know. Everything 7 is as far as you know. 8 A. I don't know. 9 Q. Did you ever have contact with 10 Doctor Fabre in the course of Protocol 79? 11 A. Not that I recall. 12 Q. Do you know if the FDA had 13 ever -- has ever reprimanded Doctor Fabre? 14 A. No, I don't know. 15 Q. Do you know if Doctor Fabre has 16 ever used subjects from an alcoholic 17 rehabilitation clinic in Houston, Texas, in the 18 course of his studies on psychotropic drugs? 19 A. I'm not aware, I don't know. 20 Q. When you were working on Prozac 21 from 1983 to 1988, were you working under any 22 kind of deadline for approval? 23 A. Deadline for approval? 24 Q. Yes, FDA approval in the United Page 36 1 States. 2 A. Uh-huh. We weren't working on 3 a deadline for approval, that's in the FDA's 4 hands. 5 Q. Did Lilly have a timeframe for 6 completing the clinical investigations in order 7 to get that information to the FDA sooner rather 8 than later? 9 A. You mean deadline then for 10 submission? 11 Q. Yes. 12 A. We had a target date for 13 submission. 14 Q. Do you recall what that target 15 date was? 16 A. The best I recall it was 17 September of '83. 18 Q. Was Mister Gary D. Tolivson 19 associated with Eli Lilly from 1983 to 1988? 20 A. Doctor Tolivson was not there 21 when I was a CRA. 22 Q. When did he get there or was he 23 there before you? 24 A. Oh, he was there after. I am Page 37 1 not sure when he joined. 2 Q. What's his present title? 3 A. To the best of my knowledge, 4 he's an executive director of psychopharmacology 5 research. 6 MR. CLEMENTI: Would you read that 7 back? 8 (THE COURT REPORTER READ BACK THE 9 REQUESTED TESTIMONY.) 10 Q. In the course of your career, 11 have you ever worked on any other antidepressant 12 drugs? 13 A. No. 14 Q. What about Mike Harrel, did you 15 ever work with him during those five years? 16 A. No. 17 Q. Do you know what his present 18 title was? 19 A. He is manager in medical plans. 20 Q. What is medical plans? 21 A. Medical plans is the piece of 22 medical that coordinates clinical trials. 23 Q. How is that different, if at 24 all, from what you do? Page 38 1 MR. MYERS: She does now? 2 Q. From what you used to do in '83 3 to '88. 4 A. It was part of that. 5 Q. What about Greg Brickler, was 6 he involved with Prozac from '83 to '88? 7 A. No. 8 Q. What about someone with the 9 last name of Zapapus? 10 A. She was not involved between 11 '83 and '88. 12 Q. What is Mister Brickler's 13 present title? 14 A. He's an executive director. 15 Q. Of what? 16 A. Medical plans. 17 Q. And what is -- is Zapapas a man 18 or a woman? 19 A. A woman. 20 Q. What is the first name? 21 A. Carol. 22 Q. And what is her present title. 23 A. She is a department head. 24 Q. Of what? Page 39 1 A. Psychopharmacology research. 2 Q. From 1983 to 1988, could you 3 please tell me what clinical research physicians, 4 if any, that you worked with? 5 A. I worked with Joe Wernicke, 6 Louise Levine. 7 MS. WILKINS: Would you repeat the last 8 name? 9 THE WITNESS: Levine. 10 A. Those were the two primary 11 physicians I worked with. 12 Q. Did you ever work with a Doctor 13 Heiligenstein? 14 A. Not directly on a project. 15 Q. During the timeframe of '83 to 16 '88, what was his title, was he a research 17 physician? 18 A. I believe that that was his 19 title. 20 Q. Do you know what his title is 21 today? 22 A. I'm not really sure. 23 Q. Did you ever work with a Doctor 24 Jamie Street? Page 40 1 A. Not directly. 2 Q. Was Doctor Street a research 3 physician for Prozac at any time from 1983 to 4 1988? 5 A. No. 6 Q. Did Doctor Street work for 7 Lilly during that timeframe? 8 A. I'm not really sure. 9 Q. Do you know when Doctor Street 10 began to work with Prozac? 11 A. I'm not really sure. 12 Q. How about a Doctor Houston, 13 Doctor John Houston? 14 A. That -- did I work with him 15 directly? 16 Q. Yes. 17 A. No. 18 Q. These clinical research 19 physicians that you've named who did work on 20 Prozac during that timeframe, from '83 to '88, 21 who was their immediate supervisor? 22 A. Doctor Dan Masica became the 23 supervisor -- the director in that area and I'm 24 not sure when. Page 41 1 Q. Do you happen to recall his 2 title when he became director, what was he 3 director of exactly? 4 A. I don't recall the specific 5 title. 6 Q. When he became the director, 7 was he working exclusively with Prozac? 8 A. No. 9 Q. Did you ever work with a Doctor 10 Beasley? 11 A. Not directly on a project. 12 Q. Did you ever read anything by 13 Doctor Beasley that was published in a medical 14 journal? 15 MR. MYERS: At any time? 16 MR. GREEN: At any time. 17 A. No. 18 Q. As a clinical research 19 administrator, was it part of your job to attend 20 start up meetings? 21 A. Yes. 22 Q. And could you describe what a 23 start up meeting is? 24 A. In general, it's a meeting Page 42 1 where we bring the appropriate people together to 2 teach investigators about our drug, our protocol, 3 the case report forms and other Lilly policies 4 related to running clinical trials. 5 Q. Do you recall having a start up 6 meeting for Protocol 79? 7 A. Yes. 8 Q. Where did that meeting take 9 place? 10 A. I don't recall the exact 11 location. 12 (A SHORT BREAK WAS TAKEN.) 13 Q. (BY MR. GREEN) We were talking 14 about the start up meeting. 15 A. Uh-huh. 16 Q. And I believe you said you 17 didn't recall where it took place? 18 A. The location. 19 Q. Do you recall if Laura 20 Fludzinski attended that meeting with you? 21 A. Boy, I don't recall. 22 Q. How about Chuck Loman? 23 A. I don't recall. 24 Q. Do you recall the general Page 43 1 procedures -- well, I think you already described 2 them to me. Let me ask you if the general 3 procedures of a start up meeting included 4 discussing how to treat side effects should they 5 arise within patients on the various forms that 6 the clinical investigators would fill out? 7 A. How to treat side effects? 8 Q. Yes. 9 A. I'm sorry, could you ask that 10 again? 11 Q. Was there a general discussion 12 about how to treat side effects or what to do 13 when a side effect was noted within a patient, 14 was there a form to fill out, was there somebody 15 that the clinical investigator should report to, 16 what was the guideline that was discussed by the 17 Lilly people at the start up meeting? 18 A. We had a form with a section 19 for adverse events and we did teach the 20 investigator sites how to complete that form. 21 Q. Is there a difference between 22 adverse events and side effect? 23 MR. MYERS: Well, let me just object to 24 the form to the extent you're asking her as a lay Page 44 1 person to distinguish that, that may well be a 2 medical issue, but if she is able to distinguish, 3 let her try, but I object to the form. 4 A. I believe the issue was 5 causality but I don't know the -- I couldn't tell 6 you the specifics of the difference. 7 Q. As far as you know, does Prozac 8 have any side effects? 9 MR. MYERS: Same objection, you're 10 asking a lay person what is a medical question, a 11 medical issue about side effects of the drug. 12 Q. Let's discuss your lawyer's 13 objections there. 14 MR. MYERS: Excuse me, Mister Green, 15 we're not going to discuss my objection. You're 16 going to ask a question and she's going to give 17 you an answer. We're not going to have a 18 discussion about any objections. 19 Q. Did you ever read anything that 20 Lilly printed or had published about Prozac in 21 the course of your work? 22 A. Yes. 23 Q. When you read these documents 24 which Lilly published, did you believe what they Page 45 1 said? 2 A. In terms of the accuracy of the 3 data that was printed? 4 Q. Yes. 5 A. Yes. 6 Q. And when you read these 7 publications, throughout your experience in 8 reading them, did you ever read anything which 9 discussed side effects? 10 A. Using the term side effects? 11 Q. Yes. 12 A. I don't recall to that specific 13 detail. 14 Q. Do you recall based on your 15 knowledge from what you read about Prozac whether 16 or not Prozac has side effects? 17 MR. MYERS: Same objection, but she can 18 give her understanding. 19 A. When we collect the data from 20 the case report forms, we collect it without 21 questioning causality and the issue of side 22 effects and inference of causality is left with 23 the research physicians. 24 Q. What do you do with that Page 46 1 information once you collect it? 2 A. From the case report form? 3 Q. Yes. 4 A. It's entered into the computer. 5 Q. So is it entered into the 6 computer as an adverse event? 7 A. From the adverse event page, 8 yes. 9 Q. And there's not a separate area 10 for side effect from that page? 11 A. Not from that page, as best I 12 recall. 13 Q. Suppose somebody intentionally 14 took an overdose of Prozac, would that be 15 considered an adverse event? 16 MR. MYERS: Your question is -- let me 17 just ask, is your question in the clinical trial 18 setting, or what's the setting on which you're 19 asking the hypothetical question? 20 MR. GREEN: Let's do it within a 21 clinical trial setting. 22 A. Overdose is an outcome. 23 Q. So it's not an adverse event? 24 A. The symptoms of it would be Page 47 1 considered an adverse event over what it resulted 2 in. 3 Q. What are the symptoms of an 4 intentional overdose? 5 MR. MYERS: Let me object to that 6 question, again that it gets into a medical area 7 and this witness is not a medical doctor. 8 MR. GREEN: She used the phrase, not 9 me. She brought it up. 10 MR. MYERS: She said -- 11 MR. GREEN: She said it depends on the 12 symptoms and I'm just -- 13 Q. Do you know what the symptoms 14 are? 15 MR. MYERS: Same objection. If you 16 know what some of the symptoms are, tell him. 17 A. I'll give a hypothetical, an 18 overdose with some drugs nausea could be a 19 symptom, nausea would be listed as an event, the 20 outcome, it would be needed to put an overdose on 21 there as well. 22 Q. Okay, let's look at this 23 hypothetical for a second. 24 MS. LAWS: Do we have our same Page 48 1 agreement as last time that the objections of one 2 defendant are good for another and that we can 3 reserve objections except as to form and 4 responsiveness? 5 MR. GREEN: Yes, we have the same 6 objections. 7 MS. LAWS: Same agreement. 8 Q. How would the adverse event of 9 somebody intentionally taking an overdose of 10 Prozac be entered in the computer, what word or 11 language would be entered into the computer? 12 A. I don't remember how we would 13 handle that. 14 Q. What's that? 15 A. I don't remember how we handled 16 that. 17 Q. Do you remember if it was 18 entered as an overdose? 19 A. I don't recall. 20 Q. Do you have a definition for 21 overdose? 22 A. There is a definition. 23 Q. Do you know what that 24 definition is? Page 49 1 MR. MYERS: Same objection in terms of 2 the medical nature of the question, but if she 3 knows of the definition. 4 A. We had a general definition, 5 anything above what was stated as a dosage 6 regimen in the protocol. 7 Q. So it could be accidental, 8 couldn't it? 9 A. Sure. 10 Q. Now at these start up meetings, 11 did you ever discuss a clinical trial record 12 book? 13 A. Yes. 14 Q. And could you describe what 15 that is exactly? 16 A. It was a book, a binder, that 17 we supplied to the investigational sites to keep 18 important documents from their study in. 19 Q. At the end of the study, would 20 Lilly receive those clinical trial record books? 21 A. As best as I recall, no. 22 Q. Would those books remain with 23 the investigator, as best you know? 24 A. As best as I know, yes. Page 50 1 Q. Throughout the course of the 2 investigation, would any Lilly representative 3 review those books? 4 A. Yes. 5 Q. Did Doctor Jamie Street ever 6 inform the people who enter adverse events into 7 the computer to change the word intentional 8 overdose to overdose? 9 A. I am not aware. 10 Q. You don't recall that? 11 A. I don't know. 12 Q. The people who entered adverse 13 events into the computer, what was their title? 14 A. Who actually entered from the 15 case report form into the computer, is that what 16 you're asking? 17 Q. Yes. 18 A. Data entry clerk. 19 Q. What does a systems analyst do? 20 A. They create the system that 21 allows us to enter the data. 22 Q. By the way, throughout the 23 course of your employment at Lilly, do Lilly 24 employees use E-mail? Page 51 1 A. Yes. 2 Q. When did they first start using 3 E-mail? 4 A. I'm not sure when it started. 5 Q. Are those E-mails preserved on 6 hard copy? 7 A. By individuals? 8 Q. Yes. 9 A. Printing them out? 10 Q. Yes. 11 A. Sometimes. 12 Q. So it's on an individual by 13 individual basis or is there a company policy 14 regarding E-mail? 15 A. A general policy on E-mail? 16 Q. Yes. 17 A. Not that I'm aware of. 18 Q. For instance, if you received 19 an E-mail on your computer, is there a policy 20 about what you have to do as far as preserving 21 that message or is that up to you personally? 22 A. There is no general policy 23 across all E-mail. 24 Q. Did you ever hear of the Drug Page 52 1 Experience Network? 2 A. Yes. 3 Q. Could you describe what that 4 is, please? 5 A. It is the system we have to 6 collect serious adverse event information. 7 Q. How does that relate, if at 8 all, to ELECT? 9 A. ELECT? 10 Q. Yes. 11 A. ELECT is a dictionary that we 12 use to classify terms. 13 Q. And I'll just call it DEN, is 14 that more than a dictionary? 15 A. It's a system. 16 Q. Is ELECT something which Eli 17 Lilly developed or is it something which was 18 developed outside of Eli Lilly? 19 A. ELECT'S foundation is COSTART 20 plus a very few additional terms. 21 Q. Now COSTART was developed by 22 the FDA, right? 23 A. Right. 24 Q. And my question was, was ELECT Page 53 1 developed by Eli Lilly or by some entity outside 2 of Eli Lilly? 3 A. It was developed by Lilly using 4 COSTART as a foundation. 5 Q. And you said it uses some 6 additional terms? 7 A. Uh-huh. 8 Q. Did it replace COSTART terms 9 with ELECT terms? 10 A. As best I recall, no. 11 Q. As best you recall, no COSTART 12 term was replaced by an ELECT term? 13 MR. MYERS: She's answered that. 14 MR. GREEN: I'm just making the 15 question clear. 16 A. My recollection is we used 17 COSTART, and ELECT is just a few additional terms 18 to COSTART. 19 Q. How many terms? 20 A. Additional? 21 Q. Yes. 22 A. Oh, gosh, I don't know. 23 Q. Was overdose an ELECT term? 24 A. I don't remember the specifics Page 54 1 of the dictionary. 2 Q. Now, as far as the DEN and the 3 ELECT and the COSTART, how much of this was 4 discussed at the start up meetings, if anything? 5 A. DEN, ELECT and COSTART? 6 Q. Yes, did you discuss any of 7 those at the meetings? 8 A. Yes, we provided for -- we 9 provided an ELECT dictionary to investigators, 10 and part of the education that they received when 11 completing the forms was how to use that 12 particular dictionary. Now as far as educating 13 on DEN, that education was more to define for 14 them the criteria for serious adverse events as 15 laid out by the FDA and Lilly policies. 16 Q. The ELECT dictionary was in 17 hard copy? 18 A. Yes. 19 Q. That's a question, I'm sorry. 20 A. Yes. 21 Q. How many pages was there? 22 A. Oh, I don't know. 23 Q. More than a hundred? 24 MR. MYERS: She said she didn't know. Page 55 1 MR. GREEN: I have a right to refresh 2 her recollection. 3 MR. MYERS: Not when she says she 4 doesn't know, she's answered the question. 5 MR. GREEN: I have an absolute right to 6 refresh her recollection when she says she 7 doesn't know. 8 MR. MYERS: Move on to something else. 9 Q. Was it more than a hundred 10 pages? 11 A. I don't know. 12 Q. The instructions on how to use 13 the dictionary, was that printed on hard copy or 14 was that just a verbal instruction? 15 A. I don't recall the specifics of 16 what we gave them. 17 Q. Is the ELECT dictionary 18 specific to a group of drugs, or is it designed 19 for all drugs within Eli Lilly? 20 A. We used it for all. 21 Q. Is that ELECT dictionary 22 updated on a regular basis? 23 A. I'm not certain how it's 24 updated. Page 56 1 Q. The question is, is it updated? 2 A. It's reviewed. As best I know, 3 I believe it is updated. 4 Q. Do you recall if it was updated 5 during the years 1983 to 1988? 6 A. I don't recall. 7 Q. Do you recall whether or not 8 the dictionary was in use when you became a CRA 9 in 1983? 10 A. The ELECT dictionary? 11 Q. Yes. 12 A. No. 13 Q. Do you recall what edition or 14 any other designation was -- could be used to 15 describe the ELECT dictionary or editions of the 16 dictionary which were in use from 1983 to 1988? 17 A. I'm sorry, I didn't follow the 18 question. 19 Q. I'm just trying to find out how 20 to identify which ELECT dictionary was used 21 during those years. Do you recall any, maybe an 22 edition number? 23 A. I don't recall, it was just 24 called the ELECT dictionary. Page 57 1 Q. Do you have a copy of the ELECT 2 dictionary presently? 3 A. No. 4 Q. What was the purpose of using 5 the ELECT dictionary in addition to the COSTART 6 dictionary? 7 A. In addition to the COSTART 8 dictionary or instead of? 9 Q. Okay, I'm sorry, I'll say 10 instead of it. The ELECT dictionary held 11 additional terms and incorporated all the terms? 12 A. From COSTART. 13 Q. From COSTART? 14 A. Right. 15 Q. So you just used the ELECT 16 dictionary? 17 A. Right. 18 Q. You didn't use the COSTART 19 dictionary? 20 A. (Witness moves head up and 21 down.). 22 Q. So what was the purpose of 23 using the ELECT dictionary instead of the COSTART 24 dictionary? Page 58 1 A. It provided those extra terms. 2 Q. Was the COSTART dictionary 3 considered to have terms which were so general 4 that they were uninformative? 5 MR. MYERS: Let me object to the form. 6 What does so general as to be uninformative mean? 7 MR. GREEN: I think you're going to 8 have to ask your client that since the phrase was 9 lifted from one of their documents. 10 MR. MYERS: If you're reading from a 11 document, you might show it to her, maybe that 12 would help us move through this. 13 MR. GREEN: Obviously I'm not reading 14 from a document. 15 MR. MYERS: Well, if you're referencing 16 one, why don't you show it to her. 17 MR. GREEN: I'll have to perhaps ask 18 Doctor Street that question. Would you read back 19 the question and the objection? 20 (THE COURT REPORTER READ BACK THE 21 REQUESTED TESTIMONY.) 22 MR. GREEN: I'll rephrase the question 23 since it's unclear to your attorney. 24 Q. Was the ELECT dictionary used Page 59 1 because the COSTART terms were too general? 2 A. ELECT is COSTART but it has 3 those additional terms to it so I can't really 4 answer that question. 5 Q. Are the additional terms 6 actually terms which are added or are they terms 7 which break down COSTART terms more specifically? 8 A. As best I know they were added 9 terms. 10 Q. Okay. Now the data entry 11 clerks, did they do anything other than read from 12 a document and enter it into a computer? 13 A. That was their job, yes. 14 Q. If something was entered on a 15 document which was not understood or was unclear 16 to the department which would eventually enter it 17 into a computer, what was the process by which an 18 explanation would be sought for that term? 19 MR. MYERS: I'm sorry, Greg. Is the 20 question, if it was not understood, you said to 21 the department, do you mean to the data entry 22 clerk? 23 MR. GREEN: Yes. 24 A. If something was unclear to the Page 60 1 data entry clerk? 2 Q. Right. 3 A. What process did we use to 4 clarify that, is that what you mean? 5 Q. Yes. 6 A. If it was unclear to them, they 7 could not enter it and that report would then 8 come back to the cluster personnel. 9 Q. Who is Donna Pearson? 10 A. She is a CRA in the drug 11 epidemiology unit. 12 Q. Now, how does the drug 13 epidemiology unit interact with the medical unit, 14 what is their function? 15 A. Their function is to work with 16 the serious adverse events for marketing and 17 trial reports. Their interactions with the 18 medical plans area is on those trial reports. 19 MR. GREEN: Would you read that answer 20 back? 21 (THE COURT REPORTER READ BACK THE 22 REQUESTED TESTIMONY.) 23 Q. Now, you worked in DEU, right? 24 A. Uh-huh. Page 61 1 MR. MYERS: You need to say yes. 2 A. Yes. 3 Q. And how -- what does DEU do as 4 far as marketing goes? 5 A. Nothing as far as marketing 6 goes, they work with what we call marketing 7 reports or serious adverse event reports on 8 marketed products. 9 Q. What do they do with those 10 reports? 11 A. Those need to be submitted to 12 the FDA. 13 Q. Are they also somehow 14 communicated to the marketing department? 15 A. They work very closely with the 16 research physicians. 17 Q. Is there a way for the 18 marketing department to find out what the DEU is 19 learning about adverse events? 20 A. What do you mean when you say 21 marketing department? 22 Q. Well, I'm not really sure what 23 the division or department within Eli Lilly is 24 called, but obviously there are salesmen who sell Page 62 1 Prozac, right? 2 A. Yes. 3 Q. And that's a whole division, 4 isn't it? 5 A. Yes, I think of that as our 6 sales area. Marketing is separate from the sales 7 area. We work closely with the sales reps as 8 they call in adverse events. 9 Q. So when a sales rep finds out 10 about an adverse event from the physician, they 11 will call in the adverse event? 12 A. Right, they call the hotline in 13 the DEU. 14 Q. Now how is sales different than 15 marketing? 16 A. Sales are the field people that 17 detail the physicians, marketing is the corporate 18 area that provides strategic planning for 19 marketing of products. 20 Q. Is sales a part of marketing? 21 A. To the best of my knowledge, 22 it's a branch but I'm not sure of the lines. 23 Q. Did the marketing -- what is 24 it, a department or division? Marketing, is it a Page 63 1 marketing division? 2 A. Division, I guess. 3 Q. Did the marketing division have 4 anything to do with Prozac prior to 1987? 5 A. In terms of what I was involved 6 in? 7 Q. Just to your general knowledge. 8 A. Well, to my general knowledge, 9 they were pulling together a strategic plan for 10 marketing. 11 Q. Do you have any ideas as to 12 what that strategic plan was? 13 A. The most I can recollect is 14 that we wanted to target detailing psychiatrists 15 first. 16 Q. Now you told me how information 17 gets from the sales reps to the DEU through a 18 hotline. 19 A. Right. 20 Q. Is there a way that the DEU 21 gets information to the sales reps? 22 A. In general, the DEU CRAs follow 23 up with the physicians, if there are points that 24 are unclear that only the sales rep can answer, Page 64 1 then they would contact the sales rep. 2 Q. Was the term suicide attempt 3 ever used on a product insert for Prozac as far 4 as you know? 5 A. I don't recall the specific 6 words on the insert. 7 Q. Do you recall where something 8 along that subject was added to the insert around 9 May of 1990? 10 A. I don't recall. 11 Q. If I hadn't mentioned the 12 timeframe, would you have recalled whether or not 13 something around that subject area was ever added 14 to the product insert? 15 A. I don't recall specifically. 16 Q. Well, what do you recall about 17 it, if anything? 18 A. About the Prozac insert? 19 Q. Yes. 20 A. We included events, regardless 21 of causality, and we added a postmarketing 22 section to capture events on the insert related 23 to the data that we were collecting in DEN. 24 Q. Well, you included any event Page 65 1 that occurred? 2 A. It was up to the research 3 physicians to make a judgment. 4 Q. And when you say the research 5 physicians, was that a group of physicians at one 6 particular time or was it one research physician 7 and then another because the one stepped down and 8 the another took his place or what exactly do you 9 mean by that? 10 A. Are you asking about the 11 process for updating the literature? 12 Q. No, I'm just asking -- you said 13 it was the responsibility of the research 14 physicians to decide which events would be listed 15 on the product insert and I'm just trying to 16 figure out, was it a group or a single research 17 physician? 18 A. As best I know, they 19 collaborated with the director at the time and 20 they may have collaborated with each other in 21 discussing events. 22 Q. Who was the director in 1990? 23 A. I believe it was Doctor Masica. 24 Q. Do you believe when he became a Page 66 1 director -- I'm sorry. Do you know when he 2 became the director? 3 A. I'm not sure of the date. 4 Q. Who was the director prior to 5 Doctor Masica? 6 A. I'm not sure, I can't recall. 7 Q. Do you recall the last research 8 physician you worked with as a CRA? 9 A. Doctor Levine. 10 Q. And do you know how long you 11 worked with her? 12 A. About four years. 13 MR. MYERS: Greg, we've been going 14 about an hour and a half, can we take a short 15 break? 16 MR. GREEN: Sure. 17 (A SHORT RECESS WAS TAKEN.) 18 Q. (BY MR. GREEN) Ms. Humbert, 19 to get back to the start up meetings, I believe 20 you mentioned that you would discuss the 21 background of the drug at that time? 22 A. I mentioned -- I don't do that, 23 but it was discussed. 24 Q. Some other Lilly employee would Page 67 1 discuss that? 2 A. A physician. 3 Q. Do you recall which physician 4 went with you for the start up meeting for 5 Protocol 79? 6 A. Doctor Wernicke. 7 Q. Do you recall whether Doctor 8 Wernicke mentioned suicidality or 9 violent-aggressive behavior? 10 A. I don't recall. 11 Q. Do you recall any research 12 physician mentioning that at any start up 13 meeting? 14 A. I don't recall. 15 Q. Are you aware of any studies 16 regarding Prozac, and when I say studies I mean 17 clinical investigations, which are ongoing at 18 this time? 19 A. No, I'm not aware. 20 Q. At these start up meetings, was 21 a Lilly standard of clinical ethics discussed? 22 A. It wasn't called a standard of 23 clinical ethics that I recall, but we did discuss 24 standard Lilly policy for running clinical Page 68 1 trials. 2 Q. Was that separate and apart 3 from the FDA policy? 4 A. It embellished. 5 Q. And was that published in a 6 book form or hand out form or brochure form or 7 anything else? 8 A. There was a small book. 9 Q. Were you ever part of a start 10 up meeting for Prozac wherein a videotape was 11 played? 12 A. Not that I recall. 13 Q. Do you know if a videotape was 14 ever made for the purpose of showing at a Prozac 15 start up meeting? 16 A. No, I wasn't aware. 17 Q. At these start up meetings, 18 would you generally have the same function or did 19 your function change from meeting to meeting? 20 A. It was generally the same 21 function. 22 Q. And what was that function? 23 A. To coordinate the meeting and 24 lead the discussion on case report forms. Page 69 1 Q. Would there be a practice 2 session in filling out the case report forms? 3 A. There were break out sessions. 4 Q. How long would your portion of 5 the start up meeting last? 6 A. As I recall, it was about two 7 or three hours. 8 Q. And could you give me the 9 general outline of what you would discuss during 10 your portion? 11 A. Generally discuss section by 12 section, familiarize the investigational sites 13 with the case report form and go over the written 14 instructions for it. 15 Q. Okay. When you say section by 16 section, what were the sections? 17 A. Oh, demographics would be one, 18 adverse events another, laboratory, et cetera. 19 Q. Was the case report form a form 20 that was used for each patient visit? 21 A. Yes. 22 Q. And how many pages was the case 23 report form? 24 A. It varied depending on the Page 70 1 study. 2 Q. Did the case report form 3 include gathering information regarding the 4 degree of depression which that patient was 5 suffering? 6 A. Through a Ham D, yes. 7 Q. Did you instruct at start up 8 meetings the use of the Ham D? 9 A. No. 10 Q. Who did that? 11 A. As I recall, it was the 12 research physician. 13 Q. Do you recall how much time 14 Doctor Wernicke spent on the Ham D, if any, at 15 the start up meeting for Protocol 79? 16 A. I was not involved in that 17 session, I don't recall. 18 Q. So if you weren't involved in 19 the session, would you leave? 20 A. We split the session, and yes, 21 I left. 22 Q. Do you know a Lori Sheldon? 23 A. Yes. 24 Q. Did you work with her or Page 71 1 interact with her regarding Prozac during the 2 years '83 to '88? 3 A. Yes. 4 Q. And what was her job title? 5 A. She was a systems analyst. 6 Q. And what was it that a systems 7 analyst did again? 8 A. They brought up the computer 9 system that allowed us to collect the data for 10 the studies we were running. 11 Q. That allowed you to collect the 12 data? 13 A. Uh-huh. 14 Q. How would the computer system 15 allow you to collect data? 16 A. It's the place where we input 17 the data that was collected. 18 Q. So they wrote the program that 19 allowed you to input the data? 20 A. Into the system, right. 21 Q. Were the data entry clerks 22 working with the system analyst? 23 A. They were in a different 24 department, I'm not really sure what their Page 72 1 interactions were. 2 Q. When you say that the system 3 analyst developed a system that permitted you to 4 input the data, was the form of the data 5 substantially changed as you put it -- as it was 6 entered into the computer? 7 MR. MYERS: Object to the form. What 8 do you mean by the form of the data? 9 Q. I mean was a case report form 10 on the screen in the computer or was the hard 11 copy case report form somehow changed into a 12 paragraph and then entered into the computer or 13 was it changed to numbers and then entered into 14 the computer? 15 A. I know what you mean. The 16 screen was created to be as close as possible to 17 the hard copy form. 18 Q. So would the data entry clerk 19 transmit the hard copy to the computer? 20 A. They would type it into the 21 computer, yes. 22 Q. Would the case report form go 23 directly from the clinical investigator to the 24 data entry clerk? Page 73 1 A. No. 2 Q. Who would it go through from 3 the clinical investigator to the data entry 4 clerk? 5 A. For what study? 6 Q. I'm sorry? 7 A. For what study? 8 Q. You mean what protocol? 9 A. Uh-huh. 10 Q. Well, let's start with Protocol 11 79. 12 A. It would go through ICRC. 13 Q. Okay. Would you see it before 14 the data entry clerk put it into the computer? 15 A. No. 16 Q. For other studies where ICRC 17 was not involved, would it go through some other 18 entity before the data entry clerk received it? 19 A. Yes. 20 Q. Who would that go through? 21 A. A document control area. 22 Q. Would a CRA review it at any 23 point before the data entry clerk received it? 24 A. No. Page 74 1 Q. Would the CRA look over the 2 case report form to search for glaring 3 deficiencies? 4 A. Yes. 5 Q. So exactly how did that work if 6 they didn't see it but they would look it over 7 for glaring deficiencies? 8 A. They didn't see it before data 9 entry got it, but saw it after. 10 Q. You saw it on the computer? 11 A. And we saw the hard copy form. 12 Q. So you compared the hard copy 13 form to the computer? 14 A. Right. 15 Q. But with Protocol 79, did ICRC 16 carry out that function? 17 A. They did a quality check before 18 sending it in. 19 Q. Okay. Did anybody at Lilly do 20 a quality check after the data entry clerk had 21 entered it? 22 A. Yes. 23 Q. And who at Lilly did that? 24 A. I did. Page 75 1 Q. Did you do that for all the 2 case report forms in Protocol 79? 3 A. They all came through me, yes. 4 Q. What actually would you do as 5 you carried out that function? 6 A. The quality check? 7 Q. Yes. 8 A. Ensure completeness, accuracy, 9 and that everything was recorded in the doctor 10 sections of the case report form. 11 Q. Did the case report form and 12 the computer system contain terms which were part 13 of the ELECT dictionary? 14 A. Yes, there were classification 15 terms. 16 Q. Okay. Was there concern about 17 the classification term "suicide attempt" within 18 the Lilly organization? 19 A. What do you mean concern? 20 Q. I mean were you ever given 21 instructions about how to handle that term? 22 A. In which job are we focusing? 23 Q. In your clinical research 24 administrator job. Page 76 1 A. I don't recall specifically. 2 Q. If you were checking the hard 3 copy with the computer and the term was both on 4 the hard copy and the computer, did you have any 5 instructions about what you were supposed to do? 6 MR. MYERS: Your question assumes that 7 was in fact the case? 8 MR. GREEN: Yes. 9 A. If in checking for accuracy, I 10 would be sure if that -- if it was on the hard 11 copy it must be in the computer. 12 Q. Now on protocols other than 79, 13 I believe you stated that you actually checked 14 the case report forms as they came into Lilly 15 before they went to data entry. 16 A. No, I misunderstood your 17 question, you didn't say before. 18 Q. I might be -- I don't think you 19 misunderstood my question, I think that I may 20 have stated something which perhaps you didn't 21 testify to. When ICRC was not involved -- 22 A. Uh-huh. 23 Q. Who at Lilly checked the case 24 report forms prior to data entry? Page 77 1 A. Document control. 2 Q. Okay. Now, if the term suicide 3 attempt was listed on a case report form, was 4 document control instructed to call you and tell 5 you about it or to call a CRA and tell the CRA 6 about it? 7 A. The best I recall, they were 8 instructed to inform the cluster immediately if 9 they saw a serious adverse event. 10 Q. Was suicide attempt considered 11 serious? 12 A. Serious relates to the FDA 13 defined definition. 14 Q. Do you know that definition? 15 A. I don't recall it exactly. 16 Q. Would it be if it was life 17 threatening? 18 A. Yes. 19 Q. Now, hypothetically all suicide 20 attempts are not life threatening, are they? 21 MR. MYERS: Let me object to the form 22 to the extent it would call upon her, number one, 23 to get into matters of maybe medical expertise 24 and also to speculate as to all suicide attempts Page 78 1 for any reason, way, shape or form. 2 Q. You would agree, wouldn't you, 3 that some suicide attempts are not life 4 threatening? 5 MR. MYERS: Same objection but she can 6 answer if she's able to. 7 A. Speculating hypothetically, 8 yes. 9 Q. So let's say hypothetically 10 somebody stood on the edge of a bridge and said 11 I'm going to kill myself and a policeman came and 12 rescued them, would a situation like that be 13 considered life threatening to the CRAs? 14 MR. MYERS: Let me object again to the 15 form on the same ground plus your hypothetical 16 may or may not give her sufficient information 17 from which to draw any such conclusion as to 18 whether the event you described was life 19 threatening or not. 20 Q. Do you recall any suicide 21 attempts which you saw or heard about through 22 clinical investigators in the course of their 23 trials which were not life threatening? 24 A. I don't recall specifics. Page 79 1 Q. Do you recall generally? 2 A. Generally, what? 3 Q. Whether or not there were 4 suicide attempts which were not life threatening 5 that you read about or learned of while you were 6 a CRA? 7 A. Generally in that situation we 8 worked with the research physician to make that 9 kind of a call. 10 Q. So you're saying you weren't 11 responsible? 12 A. I worked with a research 13 physician on that. 14 Q. I'm not looking for who was 15 responsible, my question was do you recall, and 16 that could include -- 17 A. I don't recall specifics. 18 Q. You don't recall a research 19 physician saying this is not life threatening, it 20 was a suicide attempt but it wasn't life 21 threatening? 22 A. I don't recall. 23 Q. It was important to Lilly, 24 wasn't it, that suicide attempts which were not Page 80 1 life threatening were indicated as such, wasn't 2 that important? 3 A. Indicated as such in term of 4 what? 5 Q. Were not indicated as life 6 threatening. 7 A. Based on the physician's 8 judgment that it wasn't? 9 Q. Yes. 10 A. Yes. They -- 11 Q. So every suicide attempt -- 12 would every suicide attempt be examined to 13 determine whether or not it was life threatening? 14 A. I don't recall specific 15 examples. 16 Q. Do you recall whether or not 17 there was a policy which required looking into 18 every suicide attempt which was listed on the 19 case report form as an adverse event to determine 20 whether that suicide attempt was life threatening 21 or not? 22 A. I don't recall a policy. 23 Q. Do you recall whether or not 24 suicide attempts were just entered without Page 81 1 consulting with the physician, if that's what was 2 on the case report form? 3 A. I don't remember. 4 Q. Do you remember anything about 5 what would happen if a suicide attempt was listed 6 on a case report form and it came back to 7 document control? 8 MR. MYERS: This is when it's at 9 document control and not with her? 10 MR. GREEN: When it's at document 11 control. 12 Q. Because after all you would 13 only be called if it was serious, right? 14 A. I don't remember any specific 15 examples of when I was involved in that. 16 Q. I'm not looking for specific 17 examples, I said do you remember anything about 18 it? 19 A. I don't remember specifics. 20 Q. So was it not an important 21 thing to consider when these case report forms 22 come back, was it not important to consider 23 whether or not suicide attempt was listed on the 24 case report form? Page 82 1 MR. MYERS: Are you still at document 2 control, now? 3 MR. GREEN: Yes, I am still at document 4 control. 5 A. You said was it not an 6 important thing. 7 Q. I'm saying was it -- let me 8 withdraw the question and I'll ask it again. 9 Are you testifying that when 10 suicide attempt was listed on a case report form 11 and it came to document control, no action was 12 taken and it was just entered into the computer? 13 MR. MYERS: Let me object to the form 14 because she has already told you that she would 15 be contacted if it met the serious criteria. So 16 your question inaccurately attempts to rephrase 17 her prior testimony. 18 MR. GREEN: Well, I'm just trying to 19 clarify because she said she would only be 20 contacted if it was serious. 21 MR. MYERS: Your question didn't 22 include that. 23 MR. GREEN: So it makes a complete 24 circle because if she's only contacting -- if Page 83 1 document control is only contacting the CRAs when 2 it's serious, but then the physician has to 3 determine whether or not it's serious, then how 4 does document control know whether or not to 5 contact the CRA, and based on the prior testimony 6 of what she said about three minutes ago, she 7 doesn't recall ever receiving any information 8 about a specific or general suicide attempt and 9 therefore I am a little bit confused and I hope 10 you can understand why. 11 MR. MYERS: And the problem with your 12 question, Greg, is that it omits the fact that 13 she testified to earlier that that would be when 14 the document or the CRF is in document control, 15 the document eventually got to her, she's already 16 testified to that two or three times, that she 17 saw all the case report forms and all the events 18 listed on the form. 19 MR. GREEN: I'm talking about prior to 20 data entry though. 21 MR. MYERS: Then what's the question? 22 MR. GREEN: The question is, when 23 document control received the document from the 24 clinical investigator and suicide attempt was Page 84 1 listed on that document, on that CRF, what would 2 happen? 3 MR. MYERS: She's already answered 4 that. 5 MR. GREEN: And my question, because I 6 think the testimony is confusing, is are you 7 testifying that nothing would happen, that it 8 would just be entered into the computer. 9 MR. MYERS: Let me object again. She 10 answered that question as to what would happen 11 when the CRF arrived at document control and it 12 carried that term or a description of any such 13 term, she answered that question at least twice. 14 Q. (BY MR. GREEN) Are you 15 testifying that a CRA would only be called if the 16 suicide attempt was serious, and if the suicide 17 attempt was not serious it would be entered into 18 the computer? 19 MR. MYERS: At the time it was at 20 document control, is that the question? 21 MR. GREEN: Yes. 22 MR. MYERS: Do you understand the 23 question? 24 THE WITNESS: I do. Page 85 1 A. As best I recall, one of the 2 reasons that document control should call a CRA 3 when they get a document is if they see a serious 4 event. Related to, I think the second part of 5 your question, I don't recall any other specific 6 policies that existed in document control that 7 relates to if they saw a suicide attempt or 8 something along that line on a case report form 9 what their steps should be, I just don't remember 10 what that is. 11 Q. But you do know that if the 12 suicide attempt was not serious, a CRA would not 13 be called, is that right? 14 A. I don't remember. 15 Q. Okay, I'm just trying 16 to clarify. If the suicide attempt was serious, 17 a CRA would definitely be called, correct? 18 A. As best as I recall. 19 Q. Was the term suicide attempt 20 ever changed to a result as opposed to being an 21 event? 22 A. I don't remember the specifics 23 of that. 24 Q. Do you remember any policy Page 86 1 along those lines? 2 A. I don't remember a specific 3 policy. 4 Q. It's true is it not that 5 everytime suicide attempt was changed from an 6 event to a result, the rate of occurrence of 7 suicide attempt in those taking Prozac would go 8 down, would it not? 9 MR. MYERS: Hold on, let me object to 10 the form of the question. She's already told you 11 that she doesn't know whether or not or does not 12 recall if there was ever a change from an event 13 to an outcome. The form of your question is 14 deficient and your hypothetical is thus deficient 15 because there are no facts to support it. 16 Q. What's the difference between 17 an event and a result or outcome? 18 A. An event is supposed -- as best 19 I recall, is supposed to be a descriptor and the 20 outcome is what happened as a result of. 21 Q. Okay. So the event would be 22 within the ELECT dictionary, would it not? 23 A. Yes. 24 Q. Would the result be within the Page 87 1 ELECT dictionary? 2 A. I don't recall. 3 Q. Okay. Did the systems analyst 4 have anything to do with the speed with which FDA 5 approval was accomplished? 6 MR. MYERS: I'm sorry, would you repeat 7 that? 8 Q. Did a systems analyst have 9 anything to do with the speed with which FDA 10 approval of Prozac was accomplished? 11 A. In terms of what? 12 Q. In terms of were they able to 13 speed the input of information based upon the 14 system they developed? 15 A. During the time that I was 16 there, speeding the input of information, that 17 doesn't relate to the FDA approval. 18 Q. That wasn't important to get 19 the information in a presentable form as quickly 20 as possible to present to the FDA? 21 A. Oh, in data sets? The systems 22 analyst, that was part of their function. 23 Q. Okay. Once they designed the 24 case report form on the computer, what was left Page 88 1 for them to do exactly as far as assisting in the 2 input of data? 3 MR. MYERS: Let me object to the form, 4 Greg. She's testified that the data people put 5 the data in and then she testified to what the 6 systems analyst did and your question assumes 7 that the systems analyst was putting the data in. 8 Q. Okay, so I'll drop the end of 9 my question and just ask, what was left for them 10 to do once they designed the system? 11 A. Another aspect of their job 12 besides input was output. 13 Q. Could you describe output, what 14 exactly is that? 15 A. They would work with other 16 groups in pulling together the data sets. 17 Q. You mean the statisticians? 18 A. Yes. 19 Q. Anyone else besides the 20 statisticians? 21 A. The research physicians, the 22 cluster personnel. 23 Q. When Prozac was approved by the 24 FDA, did anybody in the Prozac cluster or any of Page 89 1 the systems analysts or statisticians receive any 2 recognition or award? 3 A. The only thing I recall is we 4 had our picture taken. 5 Q. And what was done with that 6 picture? 7 A. Everybody got a copy. 8 Q. Was the picture taken at a 9 party or at the celebration? 10 A. I wasn't part of the picture, I 11 think it was just done on-site. 12 Q. Okay. Did you yourself ever 13 receive any recognition for the approval of 14 Prozac by the FDA? 15 A. Nothing specifically that I 16 recall. 17 Q. So Eli Lilly and Company never 18 really made a big deal about the approval of 19 Prozac? 20 MR. MYERS: Let me object to the form. 21 You asked her whether she or anybody else got any 22 recognition, she's answered that question. Now 23 you've asked this open ended vague question about 24 whether anybody made a big deal about it, that's Page 90 1 absolutely undefined and vague as it can be. 2 Q. Big deal, I mean celebration or 3 party or dinner or recognition, plaques, awards, 4 nothing like that? 5 A. Nothing that I participated in. 6 (PLAINTIFFS' EXHIBIT NO. 2 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Okay. Have you had a chance to 10 read Exhibit 2? 11 A. Uh-huh. 12 MR. GREEN: Just for the court 13 reporter, Exhibit 2 is Pz 1225 283. 14 Q. Now, Lori Sheldon was a systems 15 analyst, right? 16 A. Uh-huh. 17 MR. MYERS: Yes. 18 A. Yes. 19 Q. Did you ever receive a first 20 out the chute award? 21 A. Not that I recall. 22 Q. What does that exactly mean, if 23 you know, first out the chute award? 24 A. I don't know. Page 91 1 Q. Did you ever receive any 2 recognition for your intensive efforts in the 3 clinical investigation studies leading to the 4 approval of Prozac? 5 A. A piece of paper like this? 6 Q. A piece of paper like this or 7 anything else. 8 A. I don't remember. 9 Q. Did you ever receive any 10 recognition for your imagination and 11 perserverance in the conduct of clinical 12 investigation studies leading to the approval of 13 Prozac? 14 MR. MYERS: Greg, she's answered that 15 question a couple of times. You're reading from 16 the document, you read from the document the 17 earlier question. She said she didn't or didn't 18 recall. 19 Q. Did you say yes or no? 20 A. I said I don't recall. I 21 don't. 22 Q. I thought you said you didn't 23 receive it before. Are you changing that to you 24 don't recall now? Page 92 1 MR. MYERS: No, sir, hold on for a 2 second. You asked her a series of questions 3 before you showed her this document, about any 4 recognition she or anybody else received. She 5 answered those questions. Now you've shown her 6 this piece of paper, you read from the piece of 7 paper and asked her whether or not she received 8 any such recognition. She then said, you mean 9 this award and you said this or anything else. 10 And she's answered that two or three times, now 11 she's going to answer it now and that's going to 12 be the question you ask on this subject. 13 MR. GREEN: Okay. I didn't read from 14 the document, just so you know. 15 MR. MYERS: Did you invent those words? 16 MR. GREEN: They're in the English 17 language, they're in the dictionary. Am I 18 permitted to use words in the dictionary? 19 MR. MYERS: Go ahead and ask her a 20 question, let's see what she can do. 21 Q. What is the division of 22 clinical neurosciences? 23 A. The name of the division that 24 Prozac is in. Page 93 1 Q. So your department was within 2 that division? 3 A. Yes. 4 Q. And anybody who worked on 5 Prozac as far as clinical investigation goes was 6 within that division? 7 A. No. 8 Q. Okay. Could you tell me who 9 would be working on Prozac as far as clinical 10 investigation goes who would not be within the 11 division of clinical neurosciences? 12 A. The systems analyst and the 13 statisticians. 14 Q. Okay. And what does a CIRA 15 stand for? 16 A. A clinical investigation and 17 regulatory affairs. 18 Q. And LRL, is that Lilly research 19 laboratories? 20 A. Yes. 21 MR. GREEN: It's 12:15. 22 MR. MYERS: We're going to take a lunch 23 break until one o'clock. 24 (A LUNCH BREAK WAS TAKEN.) Page 94 1 MR. MYERS: As I was saying, Ms. 2 Humbert indicated to us at the break that she 3 needed to clarify a couple of things that were 4 said during that long series of questions about 5 serious events, document control and a bunch of 6 hypotheticals associated with that, and I'm 7 concerned that you may be misinformed in terms of 8 what she said. So why don't you clarify what was 9 said. 10 THE WITNESS: The process, document 11 control specifically doesn't make any judgment on 12 serious or not serious, that's just based on 13 whether a box is checked on the case report form, 14 and whatever they get goes -- whatever they get 15 goes to data entry and is entered into the 16 computer and then all of that then goes to the 17 CRAs. 18 MR. GREEN: All right, thank you for 19 the clarification. 20 Q. Ms. Humbert, I would like to 21 ask you in your -- as far as you know, why was 22 Lilly studying Prozac during the years 1983 to 23 1988? 24 A. Why were we further studying Page 95 1 Prozac, was that your question? 2 Q. Yes. 3 A. We wanted to complete the study 4 that we already talked about, Protocol 79, the 5 fixed dose study, and then we wanted to further 6 investigate potentially for other indications. 7 Q. For other indications, do you 8 mean indications in addition to depression? 9 A. Yes. 10 Q. When did this studying for the 11 indication of depression become complete? 12 A. It's not complete. 13 Q. It's not complete today? 14 A. As of the time when I left. In 15 1988, as far as I know, it's not complete. 16 Q. Was Lilly studying Prozac for 17 the indication of depression during your time 18 period as a CRA from 1983 to 1988? 19 A. As far as I can recall, yes. 20 Q. Now, the drug was not approved 21 by the FDA for the indication of depression in 22 1983, was it? 23 A. No. 24 Q. And it was not approved by the Page 96 1 FDA in 1984 for that indication, was it? 2 A. No. 3 Q. Nor in '85 or '86, correct? 4 A. Correct. 5 Q. Was it approved in 1987 for 6 that indication? 7 A. As I recall, it was approved in 8 December of '87. 9 Q. Around Christmastime? 10 A. I believe that's right. 11 Q. Now, why was Lilly studying 12 Prozac for the indication of depression from 1983 13 to December of 1987? 14 A. To collect further information. 15 Q. Why would they need that 16 information, were they just collecting the 17 information to file it or were they collecting it 18 for a purpose? 19 A. Well, the one study that I was 20 involved in was a fixed dose study. 21 Q. Was Lilly studying Prozac for 22 that indication just to study it or was there a 23 purpose for their studies? 24 A. The purpose of that particular Page 97 1 study was to establish a optimal dosage regimen. 2 Q. An optimal dosage regimen for 3 the indication of depression? 4 A. Right. 5 Q. Now, did the study have 6 anything at all to do with Prozac being approved 7 by the FDA? 8 A. Did that particular study? 9 Q. Yes. 10 A. Not that I'm aware of. 11 Q. So as far as you know as a 12 clinical research administrator for the years '83 13 to '88, the study of Prozac for the indication of 14 depression by Eli Lilly was done not for FDA 15 approval? 16 MR. MYERS: Well, let me object to the 17 form of the question. You've now jumped from 18 what -- she has been testifying as to what she 19 was doing with respect to a trial, a protocol 20 that she's identified by number. You've now 21 jumped to the entire universe of Eli Lilly and 22 what Lilly was or was not doing at any given 23 time. 24 Q. Was there a goal, a result goal Page 98 1 of these clinical trials? In other words, once 2 you assembled the information and put it into a 3 computer and paid a million dollars to the 4 Feighner Institute in this CRIC, or maybe it's 5 the other way around, was there a goal to that or 6 was it simply to input data and then it stops? 7 MR. MYERS: Let me object to the form 8 for among other reasons is that you are 9 beginning, Mister Green, to argue with the 10 witness and we're not going to argue with the 11 witness, she'll be here to answer your questions, 12 but do not start to argue with her. 13 Q. Do you think I'm arguing with 14 you? 15 MR. MYERS: That's not a question, you 16 don't have to answer that. 17 MR. GREEN: That's a question. I don't 18 want you to represent on the record that I'm 19 arguing with the witness. 20 MR. MYERS: I object to the form of 21 your question. 22 MR. GREEN: I believe that that's a 23 completely misleading description of what was 24 going on at this deposition. In fact, my Page 99 1 question was fine and you interrupted and that 2 has done more to upset the flow of this 3 deposition than anything that I have done. 4 MR. MYERS: The form of your question, 5 sir, was argumentative and thus I object to the 6 form. The witness may certainly answer the 7 question, if she can. 8 MR. GREEN: Would you read the question 9 back, the one before do you think I'm arguing 10 with you. 11 (THE COURT REPORTER READ BACK THE 12 REQUESTED TESTIMONY.) 13 A. There are objectives for every 14 study that we run. 15 Q. Okay, I'm not talking about the 16 objective of individual studies, I'm talking 17 about all the studies together, was there a 18 reason and a goal why Lilly was conducting all of 19 these studies? 20 A. To learn as much as we can. 21 Q. After Lilly learned as much as 22 they could about Prozac, was there a goal beyond 23 that or was the goal of all these studies simply 24 to learn? Page 100 1 A. All the data was the data 2 submitted to the FDA. 3 Q. And why was the data submitted 4 to the FDA? 5 A. Because it's data that was 6 collected for a product that's being reviewed by 7 the FDA. 8 Q. Okay. And why would Lilly want 9 the data reviewed by the FDA? 10 A. Because the data as studied 11 provides information about the drug. 12 Q. Does it have anything to do 13 with the fact that Lilly wanted to sell Prozac, 14 is that why they wanted the FDA to review the 15 data? 16 A. That's why we submit for 17 approval. 18 Q. Okay. Was the submittal for 19 approval the goal of all of these studies which 20 Lilly was conducting? 21 A. The new drug application that's 22 submitted is an application that is submitted to 23 the FDA to request permission to market a drug. 24 Q. Okay. Now, in December of 1987 Page 101 1 and prior to 1987, are you aware of other -- any 2 other antidepressants which were on the market 3 during that timeframe? 4 A. Imipramine is the primary one 5 that I'm aware of. 6 Q. Were there, as far as you know, 7 were there other antidepressants on the market 8 other than the one you just mentioned during that 9 timeframe, '83 to December '87? 10 MR. MYERS: Whether she knows them by 11 name or not? 12 Q. Whether you know them by name 13 or not. 14 A. Oh, yes, there were other 15 antidepressants. 16 Q. Were they available to the 17 public through their psychiatrists or doctors who 18 would prescribe them, as far as you know were 19 these antidepressants available to the public? 20 A. There were other marketed 21 anti-depressants available. 22 Q. What was it that Lilly found 23 out about Prozac that made it marketable as 24 against these other antidepressants? Page 102 1 MR. MYERS: Let me object to the form 2 to the extent it could possibly call upon her to 3 give testimony of a medical and scientific nature 4 which she's not specifically qualified to do. 5 But to the extent she has some knowledge, she can 6 certainly attempt to answer your question. 7 A. My understanding is that 8 Fluoxetine has a different mode of action than 9 the other classic antidepressants that were on 10 the market. 11 Q. Is your understanding that 12 Prozac has the same effect as the other 13 antidepressants but has a different mode of 14 action? 15 MR. MYERS: Same objection as to form, 16 but if she can answer. 17 A. Same effect referring to 18 efficacy? 19 Q. Yes. 20 A. My understanding, yes. 21 Q. Was there anything else about 22 Prozac, other than that it in effect did the same 23 job but in a different way, that made it 24 marketable as against the other antidepressants Page 103 1 on the market? 2 MR. MYERS: Same objection as to form. 3 Go ahead. 4 A. From what I'm aware of and my 5 understanding is that we did not see cholinergic 6 adverse events with Prozac as one would see with 7 the Imipramine type of antidepressant. 8 Q. You're going to have to tell me 9 what cholinergic? 10 A. Side effects like dry mouth. 11 Q. What other -- anything else 12 come under that term cholinergic? 13 A. Yes, it's a clumping of events. 14 I don't recall, I don't recall the others. 15 Q. Could we -- would you say 16 generally that Prozac was more marketable as 17 against the other antidepressants because it did 18 not lead to certain side effects? 19 MR. MYERS: Let me object to the form 20 there on the basis not only that it may again 21 call for medical and scientific testimony, but 22 now you've gotten into the issue of whether a 23 given agent is quote, more marketable, unquote, 24 than another, and into a field of expertise that Page 104 1 she may not have. But subject to that, if she's 2 able to answer, let her try. 3 A. Could you repeat the question? 4 Q. Let me rephrase it. Was Prozac 5 marketable as against other antidepressants 6 because there were no side effects? 7 MR. MYERS: Same objection and it 8 assumes certain facts that probably would not be 9 in evidence, it's hypothetical in nature. 10 A. The approach as far as 11 marketability of Prozac based on my understanding 12 is that it had a different mode of action and it 13 had fewer cholinergic side effects, you did not 14 see those classic side effects and beyond that, 15 I'm really not aware. 16 Q. Where did you learn that from? 17 A. I'm not sure where, just 18 working in the cluster, I'm not sure where. 19 Q. So it was generally known in 20 the cluster? 21 A. I can't address whether it was 22 generally known, I knew it from being in the 23 cluster. 24 Q. Did you know that in 1984? Page 105 1 A. That was -- yes, that was the 2 general -- 3 Q. So if you knew it in 1984, did 4 you know it while Protocol 79 was being 5 conducted? 6 A. Yes. 7 Q. Did that knowledge in any way 8 affect the reporting of side effects of Prozac? 9 A. My personal -- 10 MR. MYERS: Her knowledge? 11 MR. GREEN: The knowledge of the 12 cluster. 13 A. The investigators were the ones 14 that recorded adverse events on the case report 15 forms and classified the terms and those events 16 and terms were entered into the computer. 17 Q. The clinical investigator 18 classified terms? 19 A. Yes. 20 Q. And that was the end of the 21 process of classifying terms? 22 A. The investigator had 23 responsibility to do that. 24 Q. So once the investigator Page 106 1 classified that term, it was not changed? 2 MR. MYERS: When, at what point in 3 time? 4 MR. GREEN: After the case report form 5 was received by Eli Lilly and Company. 6 A. It was reviewed by the CRA, if 7 there were questions the CRA could discuss with 8 the research physician whether that 9 classification made sense. If there was a 10 question then the CRA got back with the 11 investigator and said did you mean this term for 12 this particular event that you recorded, and 13 discuss it. 14 Q. And some of those events were 15 side effects, right? 16 MR. MYERS: Let me object to the form 17 to the extent that the term side effects as the 18 witness has testified a couple of times already 19 implies causality, so I object to the form of the 20 question. 21 A. We listed them as adverse 22 events. 23 MR. GREEN: Could you read back my 24 question, please? Page 107 1 (THE COURT REPORTER READ BACK THE 2 REQUESTED TESTIMONY.) 3 Q. Do you remember the context? 4 A. That information or the 5 assessment of side effects, was not done on a 6 patient by patient, visit by visit basis. 7 Q. Do you mean that you never 8 discussed an adverse event on a patient by 9 patient basis with the clinical physician, or am 10 I misunderstanding? 11 A. No, I do not mean that. 12 Q. What do you mean? 13 A. To assess side effects, you 14 need to collect enough data to really assess 15 whether you're seeing a trend with a drug or not, 16 and just to look at a single visit of a single 17 patient and see an adverse event recorded, you 18 can't just take that data and say side effect. 19 Q. Now to some extent, you had 20 some control over what adverse event was 21 recorded, is that correct? 22 MR. MYERS: Object to the form and the 23 vagueness of the word control over, the term 24 control over. Page 108 1 A. No, we had no control over how 2 the investigator recorded the terms on the case 3 report form. How they were classified could be 4 reviewed. 5 (PLAINTIFFS' EXHIBIT NO. 3 WAS 6 MARKED FOR IDENTIFICATION AND 7 RECEIVED IN EVIDENCE.) 8 Q. Ms. Humbert, have you had a 9 chance to read Plaintiffs' Exhibit 3? 10 A. Yes. 11 Q. If you look at the first page, 12 it states, does it not -- and by the way for the 13 record, this is Pz 985 340. 14 As discussed in the DEN 15 training, please mark overdose as an outcome for 16 each event term of overdose. Could you describe 17 what that means? 18 MR. MYERS: Let me object to the form 19 to the extent that she's not the author of the 20 document and thus you may well be calling upon 21 her to explain what the author, a person other 22 than her, meant when they wrote it. But if she 23 knows or can shed some light on it, by all means 24 see what she can do. Page 109 1 A. This is not a question about 2 clinical trial report forms. This document 3 relates to the FDA 1639 form for collecting the 4 serious adverse event information. And the 5 serious 1639's are completed for serious events 6 and trial reports, but for marketed reports can 7 be serious or nonserious, I wanted to clarify 8 that point too from earlier. The outcome box, 9 there's a section called outcome on the FDA 1639 10 form, and in speculating on -- 11 MR. MYERS: Don't speculate on what she 12 meant. 13 Q. The adverse event forms are the 14 1639's, is that correct? 15 MR. MYERS: In the clinical trial 16 setting generally or what setting? 17 Q. You mentioned the form 1639, 18 what is that? 19 A. That is the form that's 20 submitted to the FDA for FDA defined serious 21 events. 22 Q. Now the 1639's, the information 23 on the 1639 is gathered from the clinical report 24 forms, is that correct? Page 110 1 MR. MYERS: I object to the form in 2 that your question assumes that that's the 3 exclusive source of information. 4 Q. Okay, let me rephrase the 5 question. 6 Where does the information on 7 the 1639's come from? 8 A. It can come from clinical trial 9 report forms as one source. 10 Q. And does it also come from 11 events which occurred outside of the clinical 12 trial setting? 13 A. Yes. 14 Q. Such as if somebody read about 15 it in a newspaper article? 16 A. Such as if a salesman is 17 detailing in a doctor's office and learns of 18 something, they can call that in. 19 Q. Who is a Anita Fletcher? 20 A. She is a drug epidemiology 21 assistant. 22 Q. On the second page of 23 Plaintiffs' Exhibit 3, it's Pz 984 858, did Ms. 24 Fletcher also write this note that begins with, Page 111 1 please provide details regarding where this event 2 was classified? 3 A. She sent it. 4 Q. She sent it? 5 A. It wasn't necessarily the 6 author, it looks to me that Donna Pearson. 7 Q. Okay. Is this the form that an 8 E-mail comes in on your computer? 9 A. Yes. 10 Q. And this particular note was 11 addressed to the three people listed at the top, 12 is that correct? 13 A. Yes. 14 Q. What does IVM1 mean? 15 A. I am not sure. 16 Q. Okay. Do you know if that 17 means a particular department or anything like 18 that? 19 A. No, it's something with this 20 particular system, I don't know what it means. 21 Q. 22 Okay. Can you determine from 23 this exhibit what department was either Ms. 24 Pearson or Ms. Fletcher addressing this note to? Page 112 1 MR. MYERS: As opposed to the 2 individuals that are on there? 3 MR. GREEN: Yes. 4 A. It went to our German 5 affiliate. 6 Q. Now, correct me if I'm wrong, 7 let me read the note to you, please provide 8 details regarding why this event was classified 9 as life threatening, if the patient was not in 10 immediate danger of death please delete it as a 11 serious outcome. Unless once again I missed 12 something you said, does that go to what we were 13 discussing earlier about suicide attempts and 14 serious suicide attempts? 15 A. Could you describe the question 16 of earlier, the relationship that you're asking 17 about? 18 Q. I'm trying to find out, are 19 they saying that if this suicide attempt was not 20 life threatening then it is not a serious 21 outcome? 22 MR. MYERS: Well, before she answers, 23 the document speaks for itself, it says whatever 24 it says. She's not the author of the document. Page 113 1 Q. Does that appear to you to be 2 what it says? 3 MR. MYERS: Same objection, it speaks 4 for itself, it says what it says. 5 MR. GREEN: She's testifying based on 6 her knowledge and experience with Eli Lilly and 7 Company, that's eleven years of experience, and I 8 think with that knowledge and with that 9 experience she can relay the information to 10 someone who is just trying to find out about this 11 situation and how events were classified, whether 12 or not what I stated before is what is meant by 13 this note. 14 MR. MYERS: Once again -- 15 MR. GREEN: Or if I am misreading it, 16 based on your experience and knowledge, perhaps 17 you could lead me in the direct path. 18 MR. MYERS: I'll object again then 19 because your question earlier was limited at that 20 time to the clinical trial setting to what 21 happened at a certain stage of the receipt of a 22 report, and thus it's not clear from the face of 23 this document whether it's the same or not. Thus 24 I object to the form, you may be trying to mix Page 114 1 apples and oranges. 2 A. This document is a DEN 3 document, not a clinical trial report document 4 and it would be difficult for me to really answer 5 the question without seeing the specifics of the 6 information of this particular case. 7 Q. So you can't tell me if what I 8 assumed this note to mean is correct or not, and 9 I assume that this is saying if the suicide 10 attempt was not life threatening, then don't 11 classify it as a serious outcome? 12 MR. MYERS: Same objection. You're 13 asking her to speculate, number one, as to 14 whether your assumption is correct. 15 MR. GREEN: I'm not asking her to 16 speculate, I'm saying you can't tell me anything 17 about my assumption, is that correct. 18 MR. MYERS: You're calling upon her to 19 speculate as to the accuracy or the correctness 20 of your assumption, Greg, and additionally as to 21 what the writer of this meant or did not mean. 22 The document, as I said earlier, it speaks for 23 itself. 24 Q. Okay, I'll tell you what, let's Page 115 1 look at page three. 2 MR. CLEMENTI: Would you read the last 3 question, please? 4 (THE COURT REPORTER READ BACK THE 5 REQUESTED TESTIMONY.). 6 Q. Your attorney objected to the 7 form so you can answer. 8 A. I believe I did answer already. 9 I said without the specifics of this particular 10 case, it would be difficult for me to put this 11 into context of her assumption. 12 Q. Okay, moving on to page 3, do 13 you know whose handwriting that is? 14 A. No, no. 15 (PLAINTIFFS' EXHIBIT NO. 4 WAS 16 MARKED FOR IDENTIFICATION AND 17 RECEIVED IN EVIDENCE.) 18 Q. Ms. Humbert, this is 19 Plaintiffs' Exhibit 4, that's Pz 984 413, and I 20 would ask you to look at the, I believe it's the 21 third entry down. I understand this is a DEN 22 report, is that correct, or it's discussing a DEN 23 report? 24 A. Yes. Page 116 1 Q. Okay. When it says event 2 terms, is that referring to the ELECT dictionary 3 term? 4 A. Yes. 5 Q. And it says ELECT -- well it 6 says event terms colon intentional overdose, and 7 then it says please change the event term 8 intentional overdose to overdose and add 9 depression as the first event, also add overdose 10 since overdose appeared twice, quote anorexia, 11 vomiting and nervousness, end quote, per Doctor 12 J. Street. Now, I think you stated before and I 13 wanted to know if it applies to the DEN report, 14 DEN report as well as the case report form that 15 the term overdose could include accidental 16 overdose, is that right? 17 MR. MYERS: Are you asking her if she 18 testified to that before, is that what she said? 19 MR. GREEN: Yes. 20 A. I don't recall what I -- I 21 don't recall that question before. As best I 22 recall, yes. 23 Q. Okay. Now, the way this is 24 written, event terms colon intentional overdose, Page 117 1 does that mean that intentional overdose is a 2 term within the ELECT dictionary? 3 A. I'm not sure. 4 Q. Did anyone in your experience 5 at Eli Lilly ever tell you to change an event 6 term either on a DEN report or on a CRF from 7 intentional overdose to overdose? 8 MR. MYERS: Did anybody tell her? 9 MR. GREEN: Yes. 10 A. No. 11 Q. Did anybody tell that to the 12 cluster? 13 A. When I was in the cluster, not 14 that I'm aware. 15 Q. Do you know what epidemiology 16 is? 17 A. The definition of epidemiology? 18 Q. Not the exact definition but do 19 you know generally what it is? 20 A. Generally. 21 Q. What's your understanding of 22 what it is? 23 MR. MYERS: As a non-epidemiologist 24 physician. Page 118 1 A. Right. 2 Q. I think we're all grateful that 3 you're not right now. 4 A. In my mind, it's to better 5 study trends. 6 Q. Now, wouldn't the trend be 7 somewhat confusing or misunderstood if the term -- 8 event term intentional overdose was changed to 9 overdose, on a regular basis? 10 MR. MYERS: Let me object to the form, 11 number one, on the basis that it assumes that 12 there was a regular changing of an event term, 13 and second, on the basis that you're asking this 14 witness to comment on matters of epidemiology 15 with a very limited set of assumed facts, in 16 terms of epidemiological trends. We've already 17 established she's not an epidemiologist. 18 Q. You understand what statistics 19 are, don't you? 20 A. Yes. 21 Q. If I wanted to figure out how 22 many intentional overdoses occurred within the 23 population of people who took Prozac, you 24 understand that I would add up all the people who Page 119 1 took Prozac and add up all the people who 2 intentionally overdosed and I would get some 3 fraction, do you understand that? 4 MR. MYERS: Well, to the extent you're 5 posing some sort of an abbreviated 6 epidemiological or statistical study, I object to 7 it. 8 Q. I'm not posing abbreviated 9 epidemiological study, I'm completely away from 10 epidemiology right now, all I'm asking you is 11 percentages. You understand how to get 12 percentages, don't you? 13 A. Yes. 14 Q. And you understand, don't you, 15 that if I was trying to find out how many 16 intentional overdoses occur within the population 17 of people who are taking Prozac, that my 18 percentage would somehow be affected if the event 19 term was changed from intentional overdose to 20 overdose? 21 A. If that's how you were going to 22 look at the data. 23 Q. Right. 24 (PLAINTIFFS' EXHIBIT NO. 5 WAS Page 120 1 MARKED FOR IDENTIFICATION AND 2 RECEIVED IN EVIDENCE.) 3 Q. Ms. Humbert, Plaintiffs' 4 Exhibit 5, marked Pz 1848 559, is entitled 5 Fluoxetine cluster meeting, is that correct? I 6 think you've got the wrong page. 7 MR. MYERS: Let's go off the record. 8 (OFF THE RECORD DISCUSSION.) 9 Q. Now, as I stated before, 10 Plaintiffs' Exhibit 5 is entitled Fluoxetine 11 cluster meeting? 12 A. Yes. 13 Q. If we read down the list of 14 names, from Fludzinski down to Wright, are those 15 CRAs all of them? And perhaps you want to read 16 the names. 17 A. Yes. 18 Q. And does that include the 19 people to the right, Velva Brewer through Dawn 20 Taylor? 21 A. Those four ladies were CIAs, 22 clinical investigation assistant. 23 Q. What does a CIA do? Not the 24 CIA, a CIA. Page 121 1 A. Assist the CRA. 2 Q. So they weren't the people that 3 went out to the sites? 4 A. No. 5 Q. Okay. Did they assist the CRA 6 with clerical work? 7 A. Right. 8 Q. Secretarial? 9 A. Right. 10 Q. Now the next group of people 11 from Beasley down to Wheadon, are those clinical 12 research physicians? 13 A. Right. 14 Q. And the next group of people 15 from Bosomworth down to Enas, are those 16 statisticians? 17 A. Right. 18 Q. And the people to the right, 19 are they also statisticians? 20 A. No, those are the systems -- or 21 were the systems analysts at that time. 22 Q. Now the CC, who are those 23 people? 24 A. Louise Henry was the manager. Page 122 1 Q. Now when you say manager, I 2 have to ask you to be a little more specific, if 3 you would just say manager of what. 4 A. A part of her -- she was 5 manager of the Fluoxetine cluster. Do you want 6 me to go on? 7 Q. Yes. 8 A. Okay, Peggy Kunkel was our 9 medical quality assurance representative. Bob 10 Sieck was a project manager, and Leslie Daugherty 11 was an associate assisting Bob Sieck, and I'm 12 unsure what Tim Krupe or Dave Johnson's roles 13 were. 14 Q. Do you know them? 15 A. Yes. 16 Q. Did they work in the same area 17 as you? 18 A. No. 19 Q. Were they from -- 20 A. Tim Krupe was in systems, he 21 was the department head in systems. And I'm not 22 sure about Dave. 23 Q. Is Dave a scientist? 24 A. Yes, he has a Ph.D as I recall. Page 123 1 Q. Now, was Miss Henry the manager 2 for about how long prior to the date on this 3 accident, April 14, 1988 -- accident -- the date 4 on this exhibit, April 14, 1988? 5 A. I don't remember the date that 6 she started. 7 Q. Well, was it a two year period? 8 A. No, less than two years. 9 Q. Who was the manager prior to 10 Ms. Henry? 11 A. Gene Crum, Eugene Crum. 12 Q. And what about prior to Gene 13 Crum? 14 A. I don't know. 15 Q. Was Mister Crum the manager 16 when you began as a CRA? 17 A. Yes. 18 Q. Is Mister Crum still with Lilly 19 as far as you know? 20 A. He's retired. 21 Q. When you went to these start up 22 meetings, did you hand out a guideline or manual 23 which describe the way to set up the clinical 24 investigation? When I say you, I mean the group Page 124 1 of Lilly people who were there, not you 2 personally. 3 A. The protocol defines the way to 4 set up that particular investigation. 5 Q. Was the protocol written by the 6 investigator or someone at Lilly or both? 7 A. It was written by Lilly. 8 Q. Prior to the start up meeting, 9 had the investigator reviewed the protocol? 10 A. As I recall, yes. 11 Q. Did you get the sense that 12 there was some urgency prior to December of 1987 13 to get Fluoxetine approved by the FDA? 14 A. Some urgency, what do you mean 15 by urgency? 16 Q. I mean did you get the sense 17 that there was a deadline or a timeframe within 18 which you were working? 19 A. Well, we, as I mentioned 20 before, we had a target date for the initial 21 submission in '83. After that point, it was 22 really in the FDA's hands. 23 (PLAINTIFFS' EXHIBIT NO. 6 WAS 24 MARKED FOR IDENTIFICATION AND Page 125 1 RECEIVED IN EVIDENCE.) 2 Q. Now, this is Plaintiffs' 3 Exhibit 6, Pz 355 3067 and 3068. Ms. Humbert, 4 I'd like to direct your attention to the second 5 paragraph where it states, now for your other 6 question, you keep asking about the deadline and 7 I have to keep shifting it because as you know we 8 do not have approval yet. What do you mean by 9 the deadline in that sentence? 10 A. For the submission date of our 11 bulimia and obesity submissions. 12 Q. Okay. So you did have company 13 imposed deadlines? 14 A. Not for depression approval, 15 that really resides with the FDA. But as we were 16 carrying on the studies for bulimia and obesity, 17 yes, we established targets for completion of 18 those documents. 19 Q. And further on down in that 20 paragraph, it says as far as priorities within 21 this company, Fluoxetine, bulimia and obesity, 22 are one and two. What do you mean by that? 23 A. At the time that this was 24 written, the Fluoxetine obesity and Fluoxetine Page 126 1 bulimia supplements were the top two priorities 2 for the medical components as I knew it. 3 Q. Now sensing that you had two 4 priorities here, one for bulimia and one for 5 obesity, did that cause you to prioritize your 6 work with regard to these studies? 7 A. I don't understand your 8 question, I always prioritize my work. 9 Q. Do you prioritize everything 10 you do? 11 A. I try to be organized, I don't 12 understand what your question is. 13 Q. I mean it appears that you 14 considered the Fluoxetine bulimia and obesity as 15 priorities, is that correct? 16 A. That was my understanding. 17 Q. Your understanding from who? 18 A. That those were the priorities 19 that had been set at this point in time. 20 Q. Okay. And the priorty, correct 21 me if I'm wrong, was to get the data on bulimia 22 and obesity to the FDA? 23 A. To pull together the submission 24 for these two indications, for these two Page 127 1 supplements. 2 A. 3 Q. After 1983, were you still 4 studying depression as an indication? 5 A. We still had depression studies 6 ongoing, yes. 7 Q. Were the depression studies not 8 priorities? 9 MR. MYERS: Let me object to the form 10 only because she's told you on two or three 11 earlier occasions that the priorities and the 12 deadlines had to do with submitting the 13 applications and if at the time this document was 14 written, the depression application was submitted 15 and this document has to do with the submission 16 of applications, it misconstrues what her earlier 17 testimony was. 18 Q. The applications for bulimia 19 and obesity were priorities, is that correct? 20 A. Yes. 21 Q. At the point in time that this 22 note was written, June 24, 1987, was the ongoing 23 study of the indication of depression also a 24 priorty? Page 128 1 A. I can't recall specifically 2 what ongoing depression studies we had at this 3 point in time. 4 Q. But you know they were in fact 5 happening or do you not know that? 6 A. In general, we continued to 7 study the depression indication after the 1983 8 submission. In fact, I think that's what we had 9 discussed before. 10 Q. Right. So between 1983 and the 11 date of this note, 1987, depression studies had 12 occurred and may have been ongoing at the time of 13 this note? 14 A. Yes. 15 Q. Were those depression studies 16 priorities as well? 17 A. They were resourced. 18 Q. What does that mean? 19 A. That means that they were 20 ongoing and resourced, there were people working 21 on depression, even though we were also working 22 on the obesity and bulimia as new supplements. 23 Q. Were those depression studies 24 priorities? Page 129 1 MR. MYERS: Let me object again. 2 You've asked her the question about six times, 3 she's tried to answer it. The only testimony 4 about priorities have been about the applications 5 for bulimia and obesity and the testimony as you 6 know is that the depression applications had been 7 in for four years by that time. 8 MR. GREEN: With all due respect, 9 Larry, and to the witness, but she didn't answer 10 my question. I said were they priorities and she 11 said they were resourced. 12 MR. MYERS: And she can't answer the 13 question in the context you were asking it 14 looking at this document because the priorities 15 as she's testified have to do with the making of 16 applications. 17 MR. GREEN: So then it seems to me that 18 you're telling her the answer is no, they're not 19 priorities. 20 MR. MYERS: I am objecting to the form 21 of the question and to you repeatedly asking the 22 question. 23 MR. GREEN: If she is saying what you 24 say she is saying, the answer to the question is Page 130 1 no, it's very simple, it's not a priority because 2 the application had already been submitted. 3 Q. Is that your answer, Ms. 4 Humbert? 5 A. They're all priorities. 6 Q. What's that? 7 A. They're all priorities, it's 8 just that at this point in time -- 9 MR. GREEN: So -- 10 MR. MYERS: Wait a minute, let her 11 finish her answer. 12 MR. GREEN: Well, you tell me what's 13 wrong then, you misled me and you misled the 14 witness here, you said it was not a priority 15 because it had been admitted. 16 MR. MYERS: Let the witness finish her 17 answer. Finish your answer. 18 MR. GREEN: Stop interrupting, okay. 19 MR. MYERS: Go ahead. 20 A. All of the indications have 21 priority, it's not that one doesn't necessarily -- 22 at this particular time with the work that we 23 were doing and the work that I was involved in, 24 these two indications were my, what I was working Page 131 1 on, as priorities, priority one and priority two. 2 That doesn't mean that depression was not a 3 priority at all. 4 Q. Okay, so these priorities only 5 were your priorities, they were not the 6 priorities of the company? 7 A. They were the priorities that I 8 understood for myself and for, as in the context 9 of this, what did I say -- for this company, 10 which is rather a bold and general statement, but 11 they were the priorities that I was working on at 12 this point in time. 13 Q. So when you wrote within this 14 company, you weren't -- you didn't -- now you're 15 telling me that that wasn't true, those were only 16 the priorities as far as you were concerned, they 17 were not the priorities within the company? 18 A. They were the priorities that 19 we were working on at this point in time. 20 Q. When you say we, who do you 21 mean? 22 A. Fluoxetine cluster. 23 Q. So are you telling me, Ms. 24 Humbert, that the term priority was a term which Page 132 1 was applied as a practice within the company to 2 studies for indications which had not been 3 submitted to the FDA? 4 A. The term priorities relates to 5 how a particular project was going to be 6 resourced. 7 (PLAINTIFFS' EXHIBIT NO. 7 WAS 8 MARKED FOR IDENTIFICATION AND 9 RECEIVED IN EVIDENCE.) 10 Q. Ms. Humbert, we have now 11 Plaintiffs' Exhibit 7 and it's from Pz 1664, 12 pages 68, 82, 83 and 84. And you have to forgive 13 me if sometimes the pages appear not to be in 14 order if they're missing. But the pages, I 15 attempted to assemble them as they were presented 16 to the plaintiffs in this case. So and I'd like 17 to ask you to look at the last page here, Pz 1664 18 84. Apparently the top entry dated July 24, 19 1990? 20 A. Uh-huh. 21 Q. Appears to have been sent by 22 somebody named Laura, is that correct? 23 A. Yes. 24 Q. And it says, Max and Dan, I'm Page 133 1 sending my list of contributors for recognition, 2 I have CC'd Melissa because I do not know the 3 names of all of her folks and ask that she add 4 them in. We should recognize Jan Potvin, Jan 5 Henshew, Karen Dosch from medical writing, Bruce 6 Dornseif, Mary Sayler, and Janet Bosomworth from 7 stats, David Murphy, Alan Weiss, and Bev Fry from 8 systems; and Vicki Roberts from the cluster. In 9 addition Shirley Martin, Melissa and all of her 10 folks were a tremendous help. Now when they say, 11 in addition Shirley Martin, Melissa, is that you? 12 A. Yes. 13 Q. And it says here we should 14 recognize, doesn't it? 15 MR. MYERS: That's what it says. 16 A. Yes. 17 Q. Were you ever recognized for 18 the hard work you did? 19 A. I got a dancing elephant 20 button, that's what was the -- as a result of 21 this piece of paper. 22 Q. You got a dancing elephant 23 button? 24 A. (Witness moves head up and Page 134 1 down.). 2 Q. What is it made out of? 3 A. It's just a little button about 4 that big, get a magnet and put on a file cabinet 5 or something, it had a dancing elephant on it. 6 Q. Did you get anything else from 7 Eli Lilly in recognition for the hard work you 8 did? 9 A. For this, document, I mean 10 related to this? Not that I recall. 11 Q. What is this document relating 12 to? 13 A. A Prozac submission supplement. 14 Q. Do you know was that for a 15 particular indication? 16 A. It looks like it was a Prozac 17 safety document supplement. 18 Q. Okay. Throughout the years and 19 throughout all your experience with Prozac, 20 working on Prozac at Eli Lilly, have you ever 21 received anything else other than the dancing 22 elephant button? 23 A. I was taken to lunch at the 24 penthouse after the bulimia and obesity Page 135 1 supplements went in, but you know, other than 2 that, I really don't recall anything specific. 3 Q. Did you ever receive a bonus, a 4 monetary bonus? 5 A. Related to my work in Prozac? 6 Q. Yes. 7 A. No. 8 Q. Did you receive bonuses based 9 on the time you had worked for Eli Lilly? 10 MR. MYERS: You know, Greg, I'm going 11 to let her answer this one question, but her 12 compensation, she's already told you that it 13 didn't have anything to do with Prozac and I 14 don't think that's at all relevant for you to 15 inquire about that. 16 MR. GREEN: I think I can go into it to 17 see if I can determine for myself whether it's 18 relevant. 19 MR. MYERS: Ask her that and maybe we 20 can short circuit it, because we're not going to 21 get into her compensation generally. 22 MR. GREEN: I don't want to get into 23 her compensation generally. I just want an 24 answer to this question and then I may or may not Page 136 1 have more. 2 MR. MYERS: Your question was general, 3 I don't think it was limited. 4 MR. GREEN: What I said was your bonus 5 related to the time you put in at Eli Lilly and 6 Company? 7 MR. MYERS: And thus it's not limited 8 to Prozac. 9 MR. GREEN: That's right, it's limited 10 to the amount of time over years. 11 A. Uh-huh, yes, all Lilly 12 employees -- 13 MR. GREEN: I'll tell you, I'll 14 withdraw it. 15 Q. Did your bonus follow the same 16 schedule as other employees who were hired in 17 1983? 18 A. Yes. 19 MR. MYERS: She was hired in '81 but I 20 think the answer is still the same. 21 Q. I'll change my question to '81, 22 is your answer still the same? 23 A. (Witness moves head up and 24 down.). Page 137 1 Q. On the front page of 2 Plaintiffs' Exhibit 7, who is Shirley Martin? 3 A. Shirley Martin was at this 4 point in time an assistant in the regulatory 5 services area covering the IND files. 6 Q. Okay, and what about Jennifer 7 Robb? 8 A. She was a summer employee that 9 we had at this point in time to help Shirley. 10 Q. Okay. Now, when you went to 11 these start up meetings, were other 12 antidepressants discussed at these start up 13 meetings? 14 A. As I recall they were discussed 15 in a general concept of putting Fluoxetine in 16 context of that class of drugs, of 17 antidepressants. 18 Q. Do you recall what was 19 communicated in that regard? 20 A. No, I don't recall specifics. 21 Q. Do you recall anything 22 generally about what was communicated in that 23 regard? 24 A. Well, in general, the mode of Page 138 1 action, talking about what Fluoxetine, what 2 Fluoxetine mode of action, versus say the classic 3 Imipramine's mode of action. 4 Q. Was the mode of action in any 5 way linked during that communication to the lack 6 of side effects? 7 A. It related again to what we had 8 talked about previously about cholinergic side 9 effects and Fluoxetine's lack of exhibiting 10 cholinergic. 11 Q. As far as you know, does Prozac 12 help to cure depression? 13 MR. MYERS: Let me object to the form 14 to the extent that I believe you have gotten into 15 the area of medical expertise and thus I object 16 since the witness is obviously not a physician. 17 MS. LAWS: And has not been designated 18 to give medical testimony, in our case anyway. 19 MR. MYERS: Tell them if you have some 20 lay understanding, you may certainly tell him. 21 A. Your question was, does Prozac 22 cure depression? 23 Q. Yes. 24 A. My understanding based on the Page 139 1 data that we collected is that it can help 2 depressed people. 3 Q. At what point in time did you 4 come to that understanding? 5 A. I joined the cluster in 1983 at 6 the time that we were pulling together the 7 submission for depression and based on the 8 information that was shared with me at that point 9 in time, it was my understanding that Prozac was 10 an effective antidepressant. 11 Q. Who gave you that information? 12 A. It was working generally within 13 the cluster with the medical monitors at the 14 time. 15 Q. So correct me if I'm wrong, 16 Lilly employees gave you that information? 17 A. People that I worked with, yes. 18 Q. Was that submission actually 19 made in 1983? 20 MR. MYERS: When you say "that 21 submission," you mean the new drug application 22 for depression? 23 MR. GREEN: Yes. 24 A. As I recall, yes. Page 140 1 Q. And the approval I believe you 2 testified was in December of '87, is that right? 3 A. I believe that to be right. 4 Q. Does it usually take four years 5 or over four years between the submission and 6 approval of a drug by the FDA? 7 A. For antidepressants? 8 Q. Is that your answer? 9 A. Is that your question? 10 Q. Yes. 11 A. I'm not real sure what the 12 usual is. 13 Q. In the course of your work, did 14 you ever work with Doctor Fieve, F-I-E-V-E? 15 A. I don't remember that name. 16 Q. How about a Doctor Kieve in New 17 York, K-I-E-V-E? 18 A. I remember that name, I did not 19 work directly. 20 Q. Do you know who did? 21 A. I don't remember. 22 Q. Did you ever work with a Doctor 23 Saltzman in Massachusetts? 24 A. I don't remember. Page 141 1 Q. How about a Doctor Rothchild at 2 McClain Hospital in Massachusetts? 3 A. I don't remember. 4 Q. How about a Doctor Lapinsky in 5 Massachusetts? 6 A. I don't believe so. 7 Q. Now, somewhere along the line, 8 did Eli Lilly have clinical investigation 9 representatives, people who would go to the 10 clinical investigation site? 11 A. Yes. 12 Q. Were those appearances at the 13 clinical investigation site announced or were 14 they surprise visits or something else? 15 A. I'm not sure what their 16 procedures were. 17 Q. Okay. At the time you left 18 being a CRA, was there a map which indicated 19 which -- are they called representatives, 20 clinical investigation representatives? 21 A. Yes. 22 Q. Was there a map which indicated 23 how the country was divided geographically as to 24 clinical investigation representatives? Page 142 1 A. Yes. 2 Q. And do you recall who had 3 Massachusetts? 4 A. In 1988? 5 Q. Yes. 6 A. I believe it was Katherine 7 Messner but I'm not sure of the date. 8 Q. Do you recall who had New York? 9 A. I don't know. 10 Q. Okay. Does Ms. Messner still 11 work for Eli Lilly? 12 A. Yes. 13 Q. Does she live in Indianapolis 14 or Massachusetts or somewhere else? 15 A. She's in Indianapolis. 16 Q. Was Brooks Bradley a 17 representative? 18 A. He was a clinical research 19 coordinator. 20 Q. And what does that mean? 21 A. His role was to very generally 22 speaking to find investigators. 23 Q. Okay. 24 A. And then also as the studies Page 143 1 were ongoing to be in the field to assist as 2 needed. 3 Q. Okay, that's different than a 4 representative? 5 A. Yes. The representatives 6 reported through the coordinators. And the 7 representatives did more of the detail auditing. 8 Q. And what about Jim Hafner? 9 A. He's a coordinator. 10 Q. Do you recall, were the 11 coordinators divided geographically as well? 12 A. Yes. 13 Q. As far as you know, did Ms. 14 Messner cover all of New England or just 15 Massachusetts? 16 A. I'm not really sure. 17 Q. Do you recall who the 18 representative was for Texas at the time you 19 left? 20 A. Charles Sockler. 21 Q. How do you spell that? 22 A. S-O-C-K-L-E-R. 23 Q. I'm sorry, did you say he was a 24 representative or coordinator? Page 144 1 A. Yes, representative. 2 Q. Do you know who the coordinator 3 was for Texas at the time? 4 A. I believe it was Brooks 5 Bradley. 6 Q. Is Mister Sockler as far as you 7 know a resident of Indianapolis or Texas, or I 8 should say Indiana or Texas? 9 A. I believe he's in Texas but I'm 10 not sure. 11 Q. And is he an employee of Eli 12 Lilly still today? 13 A. I'm not sure. 14 Q. And what about Mister Bradley? 15 A. Yes. 16 Q. He is an employee today and do 17 you know if he's a resident of Indianapolis? 18 A. No. 19 Q. Indiana, I mean? 20 A. No, he's not. 21 Q. Do you know, is he a resident 22 of Texas? 23 A. I'm not really sure, I think 24 the way he was -- he had a broader geographic Page 145 1 area, I'm not sure if he was based in Texas or 2 not. 3 Q. Were you ever encouraged to 4 obtain a certain amount of subjects for the 5 clinical investigations, I guess what I'm trying 6 to say is was there a fixed number that you were 7 trying to get, were you trying to get a thousand 8 subjects to be part of clinical investigations or 9 two thousand or three thousand? 10 A. There was a fixed number for a 11 protocol and a target number for each site. I 12 don't know if that's what you're asking. 13 Q. As far as the protocols go, 14 were the subjects required to sign a consent 15 form? 16 A. Yes. 17 Q. Were there any warnings on the 18 consent form that Prozac may perhaps cause 19 certain side effects or certain adverse events 20 are more frequent with the use of Prozac than 21 without the use of Prozac? 22 MR. MYERS: Let me object only to the 23 extent, I think you asked her a couple of 24 questions, one was were there any warnings and Page 146 1 number two you've given her a laundry list were 2 these warnings included. 3 Q. Thank you, I'll just ask the 4 question were there any warnings on the consent 5 form? 6 A. I want to make sure we're 7 meaning the same thing when you say warnings. 8 What do you mean by warnings? 9 Q. I mean were there warnings of 10 side effects? 11 A. These are side effects that 12 have been seen? 13 Q. Right. 14 A. Yes, that was part of informed 15 consent for the patient. 16 Q. Right. What side effects were 17 listed on the consent form? 18 MR. MYERS: Let me object to the extent 19 are you limiting it to the study that you all 20 talked about at some length today or any study? 21 MR. GREEN: I imagine the side effects 22 would be the same no matter what the indication 23 was. 24 MR. MYERS: I don't know whether that's Page 147 1 true or not, I don't know. 2 MR. GREEN: I mean if it causes dry 3 mouth it causes dry mouth. 4 A. I don't recall specifically 5 what was in that consent form. Generally there 6 is a section to inform patients of adverse events 7 that have been seen in clinical trials in the 8 past. 9 MR. GREEN: Now, I have here an 10 abbreviated version of the, I believe it's the 11 summary, it's summary report Protocol 79, and I 12 guess I better do it this way and I'm afraid I 13 don't have copies for the other attorneys in the 14 room. I would like to mark as an exhibit table 15 50. 16 (PLAINTIFFS' EXHIBIT NO. 8 WAS 17 MARKED FOR IDENTIFICATION AND 18 RECEIVED IN EVIDENCE.) 19 MR. MYERS: Can we have the other pages 20 that you pulled this out of just to put it in 21 some context? 22 MR. GREEN: Only the table is marked as 23 an exhibit. 24 MR. MYERS: I understand, but in Page 148 1 reading the text, Greg, it appears to be some 2 carry over before the table from the earlier 3 page. 4 MR. GREEN: We'll have to take a break 5 then because I have to speak to you for a second. 6 (A SHORT BREAK WAS TAKEN.) 7 Q. (BY MR. GREEN) Ms. Humbert, 8 we marked as exhibit 8 a table from the summary 9 report of Protocol 79 and I'm just showing it to 10 you for one reason and that's to possibly help 11 you to remember whether or not the adverse events 12 which are listed there, or the events which are 13 listed there, were mentioned on the consent form 14 which clinical investigation subjects were 15 required to sign? 16 A. Do you have a -- 17 MR. MYERS: Excuse me, just as to the 18 form, the consent form for the study in which 19 they were studied in study 79? 20 MR. GREEN: No, I mean -- I think we 21 were discussing the consent form before and we 22 came to the understanding that consent forms my 23 possibly have been different for different 24 indications, although there was some question in Page 149 1 that. 2 Q. And so do you know the answer 3 to that, were the consent forms uniform across 4 the board or were they different depending on the 5 study? 6 A. It was protocol specific, a 7 consent form. 8 Q. So then my question is this, 9 were any of these adverse events listed on any 10 consent form for any study? 11 MR. MYERS: For studies including this 12 one? 13 MR. GREEN: Including this one or 14 anything else. 15 Q. All I'm asking is on the 16 consent form, did they say Prozac has sometimes 17 caused nausea, headache, dry mouth, et cetera, 18 down the line. I asked you the question once, 19 you didn't remember any of the warnings, any of 20 the events, and I'm just showing you this list of 21 things. 22 A. Right. Generally these exact -- 23 these are the events that could be listed on a 24 consent form now, if you're still asking me about Page 150 1 a specific consent form, I can't remember a page 2 in my mind that lists these particular events, I 3 just don't remember. 4 Q. Do you recall whether suicidal 5 ideation was ever listed on any consent form? 6 A. I don't remember. 7 Q. Do you recall whether suicide 8 attempt was ever listed on any consent form? 9 A. I don't remember. 10 Q. Now as far as the protocols 11 which were performed for the indication of 12 depression, there were certain exclusion 13 criteria, were there not? 14 A. Yes. 15 Q. And do you recall whether or 16 not a serious suicidal risk was an exclusion 17 criteria? 18 MR. MYERS: As to the form in those 19 specific terms that you've just given? 20 MR. GREEN: Yes, in those specific 21 terms. 22 A. I don't remember that 23 specifically. 24 Q. Do you remember whether Page 151 1 anything about suicide was listed as an exclusion 2 criteria? 3 A. I can't remember. 4 Q. Do you recall whether exclusion 5 criteria included the degree of depression which 6 a subject was suffering at the commencement of 7 the study? 8 A. As best I can recall, we may 9 have had a statement in there about moderate 10 depression but I don't recall the specifics. 11 Q. In other words, were you 12 looking for subjects who were moderately 13 depressed? 14 A. Yes. 15 Q. Were subjects who were severely 16 depressed excluded? 17 A. I can't remember. 18 Q. Can you give me a general idea 19 of how subjects were determined to be appropriate 20 subjects for a clinical investigation for the 21 indication of depression? 22 MR. MYERS: What do you mean by quote, 23 unquote, appropriate? 24 MR. GREEN: Appropriate for that study, Page 152 1 that you had to determine -- if they weren't 2 appropriate, they wouldn't become part of the 3 study, if they were appropriate they would become 4 part of the study, and I'm just wondering what 5 the general practice was in determining who was 6 appropriate and who wasn't. 7 A. As we've been chatting about, 8 the protocol defines inclusion and exclusion 9 criteria, the practice was that the investigator 10 understanding those criteria would screen 11 patients, potential patients. 12 Q. As far as the criteria went, 13 who decided what the exclusion criteria would be? 14 A. The responsibility for that was 15 with the research physicians. 16 Q. Is severe depression as far as 17 you know an indication for Prozac? 18 A. I am not aware. 19 Q. Do you have any idea how long 20 Prozac takes to have an effect on a person? 21 MR. MYERS: Let me object to the form 22 of that question, that's clearly in the medical 23 realm and the witness is not qualified to answer 24 that type of question. Page 153 1 MS. LAWS: Also, she's not properly 2 designated as a medical expert. 3 Q. I believe you can answer the 4 question, since the objection was just to the 5 form. 6 A. And the question was how long 7 does it -- 8 Q. Take to have an effect on the 9 patient? 10 A. My understanding, of course, 11 was every patient is different, but in general my 12 understanding of the data is that it takes two to 13 three weeks. 14 Q. Did you ever hear of a patient 15 who claimed through -- and I'm just saying this 16 through case report forms you may have read or 17 through discussion with clinical investigators or 18 clinical research physicians or whatever, did you 19 ever hear of a patient who claimed to feel the 20 effects of Prozac after ten days? 21 A. No, I don't recall that 22 specifically. 23 Q. How about after five days? 24 A. I can't recall. Page 154 1 Q. Do you ever recall receiving 2 any kind of communication which stated something 3 to the effect that a patient reporting the effect 4 of Prozac after ten days was reporting an 5 impossible situation? 6 MR. MYERS: Let me object to the form 7 of the question to the extent you mentioned the 8 effect of Prozac and I don't know whether -- the 9 witness can't tell I'm sure whether you're 10 talking an antidepressant effect or adverse event 11 or side effect and the term impossible situation, 12 I think is awfully vague. 13 Q. Okay. When I say effect, I'm 14 incorporating everything which your attorney just 15 mentioned, in other words they feel the Prozac. 16 And when I said impossible situation, I meant did 17 anybody say that was medically and scientifically 18 impossible to feel the effects of Prozac after 19 only ten days on the drug? 20 MR. MYERS: Did anybody say it could 21 not happen, it's impossible? 22 MR. GREEN: Yes, that it's medically 23 impossible. 24 MR. MYERS: And if she heard that. Page 155 1 MR. GREEN: Yes. 2 A. No, I don't recall hearing 3 that. 4 Q. Would the number of times that 5 a subject would visit the clinical investigation 6 site to be examined by a clinical investigator, 7 who determined that, was that protocol specific? 8 A. Yes. 9 Q. And did Eli Lilly determine 10 that or did the clinical investigator determine 11 that? 12 A. That was part of what Lilly 13 defined as the protocol and the visit regimen. 14 Q. As far as protocols for the 15 indication of depression, was there a variance in 16 that or was it pretty much a regular throughout 17 the protocols? 18 MR. MYERS: A variance in the frequency 19 or in the number of visits from protocol to 20 protocol? 21 MR. GREEN: Frequency of visits by a 22 subject to the clinical investigator. 23 A. For the studies that I was 24 responsible for, the frequency of visits were Page 156 1 similar between protocols. 2 Q. And do you recall what that 3 frequency was? 4 A. As I recall, we had a wash out 5 period, placebo wash out period followed by six 6 weeks of double blind therapy, visits at each 7 week. 8 Q. So there were, correct me if 9 I'm wrong, were there weekly visits? 10 A. That's what I recall for those 11 studies. 12 Q. And prior to the six weeks of 13 the double blind study, there was a two week wash 14 out period, is that right? 15 A. It was one or two weeks, yes. 16 Q. So is it true that the subject 17 would visit the clinical investigator 18 approximately seven to eight times during the 19 investigation? 20 A. Yes. 21 Q. Now, were those -- did those 22 visits have a name, did they have a term? 23 A. They were numbered. 24 Q. They were numbered. They were Page 157 1 numbered by patient and visit? 2 A. Yes. 3 Q. Did any other factor go into 4 the numbering other than patient and visit? 5 A. They were designated by project 6 number as well. 7 Q. And was the patient number 8 always the first set of numbers -- or let me 9 rephrase that. 10 Was the patient number 11 consistent throughout the seven or eight visits? 12 A. Oh, yes. 13 Q. And did the numbers for the 14 patient always hold the same spot in the range or 15 in the line of numbers that were listed? 16 A. I do not follow you there. 17 Q. Like on a social security 18 number, you have nine numbers, and the middle two 19 numbers always have dashes to the left and to the 20 right, my question is were the patient numbers 21 always placed somewhere within the line of 22 numbers that was consistent? 23 A. Yes. 24 Q. And what spaces did the patient Page 158 1 numbers hold? 2 A. You're talking as far as entry 3 into the computer or on a hard copy? 4 Q. Well, wouldn't it be the same 5 on the hard copy and the entry into the computer? 6 A. As best I recall, it was 7 project, investigator, patient, visit. 8 Q. Now if the investigator did two 9 or more projects, would his or her number change? 10 A. It could. 11 Q. And the point in time of these 12 visits, was the investigator required to 13 determine the patient's diagnosis, medical 14 diagnosis? 15 A. For depression? 16 Q. Yes. 17 A. There was a Hamilton depression 18 rating scale at each visit. 19 Q. Was the investigator required 20 to determine any other type of diagnosis, 21 cardiac, skin rash, anything else? 22 MR. MYERS: At each visit? 23 MR. GREEN: At each visit. 24 A. The second part of your Page 159 1 question, the skin rash refers to an adverse 2 event collection and, yes, that was done at each 3 visit. And as far as as a small physical type of 4 exam taking blood pressure, weight, as best I 5 recall I believe that was done on every visit. 6 Q. Did the investigator have a set 7 of questions in order to extract from the patient 8 any symptoms which the patient was feeling? 9 A. For adverse events, it was to 10 be collected spontaneously. 11 Q. With nonprobing questions? 12 A. Nonprobing questions, we did 13 not want them to have a checklist. 14 Q. Why not? 15 A. It wouldn't have been reported 16 spontaneously then. 17 Q. I'm sorry, I thought you said 18 it was reported spontaneously? 19 A. That's right, and we didn't 20 want them to do a checklist because then it 21 wouldn't be a spontaneous report by the patient. 22 Q. Does that mean that you didn't 23 want them to have a checklist because if an 24 investigator read down the checklist it might put Page 160 1 the idea in the patient's mind? 2 A. It would be a solicited 3 response then and not a spontaneous response. 4 Q. And who was responsible for not 5 requiring a checklist? 6 A. The research physicians. 7 Q. Now at these visits, was 8 suicidality measured, I mean by that suicidal 9 ideation? 10 A. As best I recall, only as part 11 of the Ham D. 12 Q. Was it measured in any other 13 way other than with the Ham D? 14 A. I don't remember if there were 15 other diagnostic tools. 16 (PLAINTIFFS' EXHIBIT NO. 9 WAS 17 MARKED FOR IDENTIFICATION AND 18 RECEIVED IN EVIDENCE.) 19 Q. Ms. Humbert, is this the Ham D 20 scale you were discussing, Plaintiffs' Exhibit 9? 21 MR. MYERS: Is the question is this a 22 Ham D scale or is this the specific scale they 23 used in their study? 24 MR. GREEN: The second question. Page 161 1 Q. Is this the specific study that 2 you used in your study? 3 A. I think as best I recall, I 4 think there are a couple of versions of the Ham D 5 and I'm not sure which ones we used in the fixed 6 dose. 7 Q. Okay. Well, I think it's the 8 front page where the patient's name is on top, 9 three down, it says suicide. 10 A. Uh-huh. 11 Q. And it's numbered zero through 12 four? 13 A. Right. 14 Q. Do you recall that as being the 15 Ham D suicide scale which you used in your study? 16 A. Yes, I believe that was part of 17 the Ham D that we used. 18 Q. So you are saying that this is 19 the suicide scale that is the same as the suicide 20 scale on the Ham D scale that you used in your 21 studies, is that correct? 22 A. As best I recall, I believe 23 that's right. 24 Q. Now, I'm sorry, you have to Page 162 1 remind me, I may have asked you this question. 2 But did you measure suicidal ideation in any 3 other way other than with the Ham D scale? 4 A. I can't remember whether we 5 used another diagnostic tool. 6 Q. Now, if somebody, you can see 7 that number two says wishes he were dead or any 8 thoughts of possible death to self? 9 A. Yes. 10 Q. Now if a patient in a clinical 11 investigation came to an investigator and said I 12 wish I were dead, that number two would 13 presumably be checked off, is that how this scale 14 would work? 15 MR. MYERS: I'll object only to the 16 extent that you're asking her what a given 17 clinical investigator, thus a physician would do, 18 and that's a matter of physician judgment. If 19 you want to ask her a general understanding 20 question, I'll let her try to answer subject to 21 my objection. 22 Q. I'm just asking -- 23 MS. LAWS: We'll object to the extent 24 it calls for her to render a medical opinion Page 163 1 which she's neither designated or qualified to 2 render. 3 MR. GREEN: I'm just asking to get a 4 general understanding to make sure that we're on 5 the same wave length. 6 Q. Is that generally how you 7 perceive the scale to work with the way I just 8 described it? 9 A. I perceive the scale can't work 10 as cut and dry as you just stated, there has to 11 be more probing. Psychiatrists or psychologists 12 are the ones that complete the Ham D or that we 13 ask to complete the Ham D in our studies. I 14 can't really answer that. 15 Q. You mean the entire Ham D? 16 A. Right. 17 Q. Well, let me ask you this: If 18 you were looking at a Ham D and you saw a number 19 two checked off, okay. As a Lilly employee, 20 okay, is there any way to determine whether that 21 number two under suicide on the Ham D scale, is a 22 symptom of depression or whether it is an adverse 23 event? 24 MR. MYERS: Well, I think that the same Page 164 1 objection would pertain since she's not a 2 psychiatrist or a physician, you're asking her 3 how she in her role I assume as a CRA would make 4 that judgment, and that's a clinical medical 5 judgment and thus I object to the form. 6 A. I don't recall specifically 7 ever seeing number two marked. 8 Q. Okay. But theoretically, if 9 number one through four was marked, is there any 10 way -- first I'll ask is there any way that you 11 as a CRA could differentiate that between an 12 adverse event and symptom of depression? 13 MR. MYERS: Same objection. 14 A. I as a CRA would not make that 15 differentiation. 16 Q. Would that differentiation be 17 limited to the research physician? 18 A. Not limited to. 19 Q. Who else could make that 20 differentiation? 21 A. It would need to include the 22 investigator, the person who actually sat down 23 and delivered this. 24 Q. Okay. Do you ever recall being Page 165 1 part of a discussion or hearing about an 2 investigator who communicated with the research 3 physician and said I don't know how to classify 4 this suicidal ideation, I don't know if I should 5 classify it as a symptom of depression or as an 6 adverse event, do you ever recall anything along 7 those lines? 8 A. Personally, no. 9 MR. MYERS: Let me belatedly object to 10 the form that the term suicidal ideation is not 11 on the form. 12 MR. GREEN: Okay. 13 Q. Now was it critical to the 14 studies and to the investigations to measure 15 suicidality? 16 MR. MYERS: Object to the form as to 17 quote, critical to the studies, unquote as being 18 vague and otherwise ambiguous. 19 Q. How about the word important, 20 was it important to the studies -- 21 MR. MYERS: That's better. 22 Q. -- to measure suicidality? 23 MR. MYERS: But I'll object to the form 24 to the extent it calls upon her to render some Page 166 1 sort of a medical opinion. 2 MR. GREEN: I don't know if that's 3 medical, Larry, because she was a clinical 4 research administrator and she was apparently an 5 organizer for the clinical investigations and 6 making sure that the paper flow went smoothly and 7 as part of the paper flow was it important that 8 the suicidality had been measured in a patient by 9 the clinical investigator. 10 MR. MYERS: That's a different 11 question. 12 A. Yes. 13 MR. MYERS: That's the administrator's 14 side. 15 A. Yes, as far as the paperwork if 16 any item of the Ham D was left blank, in my 17 review, I'd get back to the investigational site. 18 Q. Was this item three, suicide, 19 on exhibit 9 ever isolated in the system, the 20 computer system? 21 A. How do you mean isolated? 22 Q. I mean you had the case report 23 form in the computer system, right? 24 A. Right. Page 167 1 Q. Did you have the Ham D scale in 2 the computer system? 3 A. Yes. 4 Q. And did you have the different 5 items of the Ham D scale separated? 6 A. Yes. 7 Q. Did each one have its own 8 screen? 9 A. As I recall each one had its 10 own field but not necessarily its own screen. 11 Q. Each one had its own field. 12 Would it be possible then to track a patient's 13 suicide rating on the Ham D scale over the course 14 of the seven or eight visits that that patient 15 would make to a clinical investigator? 16 A. Yes. 17 Q. And would it be possible to 18 gather that information across the board on the 19 thousands of subjects who took the drug in the 20 course of the clinical investigations, to find 21 out if there was a trend? 22 MR. MYERS: Object to the form to the 23 extent you asked gather across the board. 24 Q. I mean would it be possible to Page 168 1 take all of the patients and look at all of their 2 visits and to track whether there was a trend in 3 this item three on the Ham D scale as far as 4 suicide going from zero to four or zero to three 5 or three to two or whatever, would it be possible 6 to get that information from the computer? 7 MR. MYERS: Are you asking if it's 8 possible just to from a scientific standpoint to 9 value that or are you asking her from a systems 10 standpoint can you do that on a computer? 11 MR. GREEN: I'm asking can you do that. 12 A. On the computer, okay. My 13 understanding is that it is possible to colate 14 that data with the computer for the studies that 15 were run with that specific computer. The 16 studies that were run before that we would have 17 to build some bridging, programming, but I do 18 not, I'm not an analyst, I don't know about that. 19 Q. Were the physicians -- I'm 20 sorry, the investigators, required to take blood 21 samples of the patients at any time during the 22 course of their investigation? 23 A. Yes. 24 Q. How many times on an average Page 169 1 would they take such a blood sample? 2 A. On average for a study with six 3 weeks double blind, twice. 4 Q. Twice. At what point in the 5 investigation would such blood samples be taken? 6 A. As I recall generally at the 7 introductory, the initial visit and at the 8 summary visit. 9 Q. Okay. At the summary visit, 10 was there an average amount or a range -- let me 11 ask the question, was there a range amount of the 12 amount of the Fluoxetine in the blood system that 13 was determined based on the results of the 14 protocols that were done? 15 MR. MYERS: Are you asking her if that 16 was in the final report? 17 MR. GREEN: No, I'm asking her if that 18 was within Lilly's knowledge. 19 A. For the protocols that I 20 followed, I don't recall doing Fluoxetine in 21 blood levels, it was more the normal CBC counts 22 and things like that that we do on a routine 23 laboratory visit. 24 Q. What about for the protocols Page 170 1 that you weren't part of? 2 A. I'm not sure. 3 Q. Okay. Were you ever part of a 4 protocol which tested and compared the dosage of 5 five milligrams of Fluoxetine with dosage of 6 twenty milligrams Fluoxetine? And I'm not just 7 limiting it to those two. 8 A. Right. 9 Q. Were those two included? 10 A. Yes, that was 79. That was 11 Protocol 79, fixed dose study. 12 Q. Was there any difference 13 between the results of the five milligram study 14 and the twenty milligram, not the study but the 15 use of five milligrams in patients and twenty 16 milligrams in patients? 17 MR. MYERS: What results? 18 Q. Was there any difference as to 19 the efficacy of the drug? 20 A. I don't remember. 21 Q. You don't remember? 22 A. I don't remember the specifics. 23 Q. I didn't mean to ask you if you 24 didn't remember. So do you know if there is a Page 171 1 difference in the efficacy of a patient who is 2 taking the drug in five milligram doses and a 3 patient who is taking the drug in twenty 4 milligram doses? 5 MR. MYERS: Hold on, let me object to 6 the form of the question to the extent that 7 you're calling upon her to give medical and 8 scientific testimony which she's not qualified to 9 give. 10 MR. GREEN: So I will limit it to the 11 study, Protocol 79. 12 MR. MYERS: The question is based upon 13 what she knows about the results of that study? 14 MR. GREEN: Yes. 15 A. Whether there was a difference 16 between five and twenty as far as efficacy? 17 Q. Yes. 18 A. I don't remember the specific 19 data between those two arms. 20 Q. Okay. Over the course of the 21 clinical investigation, were there those subjects 22 who would not finish with the investigation? 23 A. Yes. 24 Q. And what were those subjects Page 172 1 called, were they call drop outs? 2 A. No, lost to follow up. 3 MS. WILKINS: Would you repeat that 4 please? 5 THE WITNESS: Lost to follow up. 6 Q. Does that mean that their 7 symptoms were never recorded following their last 8 visit with the investigator? 9 A. If they were lost to follow up, 10 that means that the patient never returned to the 11 investigator's office for a closing summary 12 visit. 13 Q. Okay. What would Lilly do if a 14 patient was lost to follow up, in other words the 15 investigator calls up and says patient 32 16 X-K-Y-Z-Z 10-10 was lost to follow up, what would 17 Lilly do in that event? 18 A. Encourage the investigator to 19 try to contact that patient. 20 Q. And if that failed, did Lilly 21 have any further procedure? 22 A. We would work with the 23 investigator to try to contact that patient and 24 beyond that, there were no specific procedures. Page 173 1 Q. Was the information that had 2 been gathered on that patient to the time of that 3 person being lost to follow up, used in any way 4 by Lilly for determining the efficacy of Prozac? 5 A. The data that had been 6 collected for that patient? 7 Q. Uh-huh. 8 A. Yes, as far as I'm aware. 9 Q. Now, you mentioned that the 10 serious adverse events would be events that the 11 research physicians would have to know about, is 12 that right? 13 A. Yes. 14 Q. Okay. Would that include any 15 hospitalization of any subject? 16 A. Yes. 17 Q. Would that include the death of 18 any subject? 19 A. Yes. 20 Q. Would that include events which 21 might adversely affect the marketing goals of Eli 22 Lilly? 23 A. No. 24 MR. MYERS: Do you know what he means Page 174 1 by that? What do you mean by marketing goals? 2 MR. GREEN: You told me what their 3 strategy -- that the marketing 4 people developed the strategy to inform the 5 psychiatrist about Prozac and the psychiatrists 6 were the target and if the event was that a 7 suicide attempt was made, would that be reported 8 to the research physician because it may 9 adversely affect the marketing goal, in other 10 words Lilly would have to go to the psychiatrist 11 and say this person was on Prozac and attempted 12 suicide. 13 A. That never played into it. 14 When you described serious, as far as 15 hospitalization and death and life threatening, 16 those are included in the standard definition of 17 serious by the FDA and it's a definition that we 18 used on our case report forms. 19 Q. I just have a few questions 20 about statisticians now. Did you ever work -- 21 what were the names of the statisticians that you 22 worked with on Prozac from 1983 to 1988? 23 A. Scott Offen. 24 Q. Would you spell that? Page 175 1 A. O-F-F-E-N. Bruce Dornseif, 2 D-O-R-N-S-E-I-F. Janet Bosomworth. 3 Q. Was David Hardison a 4 statistician? 5 A. I don't recall working with 6 David. 7 Q. Do you know if Bruce Dornseif 8 works for Lilly anymore? 9 A. I don't know. 10 Q. Did Paul Banta work with 11 Prozac? 12 A. Yes. 13 Q. As a systems analyst? 14 A. Yes. 15 Q. Now, in your work following 16 1988 in the medical regulatory department, is 17 that right? 18 A. Medical regulatory affairs. 19 Q. Did you say you were a 20 supervisor? 21 A. Yes. 22 Q. Could you just give me a 23 general idea as to what your responsibilities 24 were with regard to Prozac during that time? Page 176 1 A. I supervised clerical people 2 who worked with Prozac files. 3 Q. Exactly what clerical people, 4 is that people within the regulatory? 5 A. They were paramedical 6 regulatory affairs, their titles were senior 7 assistants and assistants and clerks. 8 Q. Correct me if I'm wrong, is 9 that getting the documents that you would submit 10 to the FDA in the proper order? 11 A. Right. Colate the documents, 12 put page numbers on them, et cetera. 13 Q. Okay. Did you make or did you 14 have any other responsibilities other than what 15 you described to me there? 16 A. There were some assistants who 17 worked with the package literature as well that 18 was part of regulatory services. 19 Q. Is that writing the literature? 20 A. No, they were the ones that 21 would enter it into the computer. 22 Q. And when you went to work with 23 the DEU in 1990, what did you do if anything with 24 Prozac during that time? Page 177 1 A. I supervised the group and 2 there were people in that group who were assigned 3 to that therapeutic class to work on reports. 4 Q. What would that group actually 5 do? 6 MR. MYERS: The whole group or the 7 Prozac? 8 MR. GREEN: Prozac. 9 A. The Prozac? 10 Q. Yes. 11 A. Their primary responsibility 12 was to collect adverse event information and 13 document that on the 1639 forms that then was 14 entered into the DEN data base to ensure that 15 they were submitted into the appropriate 16 timeframe. 17 Q. When in 1990 did you get your 18 responsibilities as a DEU? 19 A. I believe it was September. 20 Q. Now as manager of natural 21 products and research, do you have anything to do 22 with Prozac? 23 A. No. 24 MR. GREEN: May we go off the record Page 178 1 for a second? 2 (A SHORT RECESS WAS TAKEN.) 3 (PLAINTIFFS' EXHIBIT NO. 10 WAS 4 MARKED FOR IDENTIFICATION AND 5 RECEIVED IN EVIDENCE.) 6 Q. Ms. Humbert, have you had a 7 chance to read Plaintiffs' Exhibit 10? 8 A. Yes. 9 Q. Okay, it is marked Pz 188 258. 10 In all honesty, I'm not too sure what this is, it 11 was a page that was incorporated in the document 12 production of Eli Lilly as served on the 13 plaintiffs. I see a couple of dates on it, data 14 transfer toward the bottom, the data was 15 transferred on 3-31-88, thanks, agenda for next 16 week 4-12-88. But I wanted to ask you about one 17 paragraph in particular. First of all, is that 18 your signature at the bottom of this? 19 A. Yes. 20 Q. Does that indicate that you are 21 the author of the document? 22 A. With Laura, yes. 23 Q. My question is about the 24 paragraph that begins about a third of the way Page 179 1 down the page, it begins with the word since. 2 And it says since there was some concern about 3 the process of sending corrections to the 4 investigators, expressed by Don Price in a memo 5 to the managers, the correction process was 6 discussed. Could you tell me what that means? 7 A. There was a process for getting 8 back with the investigational site to discuss the 9 case report form, if there was an omission or a 10 question on the case report forms. 11 Q. Okay. Was that process the 12 current guideline that's mentioned in the next 13 sentence where it says the cluster is following 14 the current guidelines and using the appropriate 15 forms? 16 A. Yes. 17 Q. Were those guidelines ever 18 printed in hard copy? 19 A. I can't recall a specific 20 document. 21 Q. Who is Don Price? 22 A. He was in medical quality 23 assurance. 24 Q. What exactly does medical Page 180 1 quality assurance do? 2 A. They do quality control checks 3 on medical procedures. 4 Q. Okay. Where it states that 5 there was concern about the process of sending 6 corrections to the investigators, were those 7 corrections sent by the CRA? 8 A. The corrections are sent by the 9 CRA, I mean the communication on corrections goes 10 through the CRAs, but what I'm unclear about in 11 this paragraph, is it doesn't look like it 12 related to the Prozac cluster since it was a memo 13 to the managers of medical plans. So I'm really 14 unsure or I'm not aware of what that specifically 15 relates to. 16 Q. You mean that may have been a 17 company wide or medical plans wide memo, not just 18 directly to the Prozac cluster? 19 A. It went to managers, so, yes. 20 Q. Do you happen to have a copy of 21 those guidelines? 22 A. No. 23 Q. Do you recall if the guideline 24 was titled or had any other identifying -- Page 181 1 A. I can't remember it 2 specifically. 3 (PLAINTIFFS' EXHIBIT NO. 11 WAS 4 MARKED FOR IDENTIFICATION AND 5 RECEIVED IN EVIDENCE.) 6 A. Okay. 7 Q. Okay, Ms. Humbert, have you had 8 a chance to read Plaintiffs' Exhibit 11? 9 A. Yes. 10 Q. That's Pz 224, page number 873? 11 A. Uh-huh. 12 Q. I'm going to start with the 13 sentence that begins with after you have, and I'm 14 quoting from the document. By the way did you 15 author this document? 16 A. Yes, looks like I did. 17 Q. Okay. And you addressed it to 18 Doctor Lemberger? 19 A. Right. 20 Q. And he's in the clinical 21 research or Lilly research labs? 22 A. Yes. 23 Q. And in part you state, after 24 you have discussed these questions with her, I Page 182 1 will forward the clinical protocol review form 2 through the ranks, this includes Doctor Dobbs, 3 Doctor Hardison, Doctor Marsden and yourself. At 4 that time, the protocol can be submitted, this is 5 the current procedure for protocol approval as 6 told to me by Doctors Zerbe and Marsden in 7 dealing with outside clinic studies, okay? 8 A. (Witness moves head up and 9 down.). 10 Q. Does that accurately describe 11 the procedure for protocol approval? 12 MR. MYERS: At the time the memo was 13 written or when? 14 MR. GREEN: At the time the memo was 15 written. 16 A. When you say for protocol 17 approval, this was a Phase 1 clinical study, 18 different than the clinical trials that I 19 participated on that we talked about earlier. 20 And I don't recall this specific procedure for 21 protocol approval as documented here. 22 Q. Okay, let me ask you one 23 question about it. Was the procedure for 24 protocol approval different for a Phase 1 study Page 183 1 than for a Phase 4 study? 2 A. In general, no, specifically 3 yes, this included Doctors Marsden and Doctors 4 Lemberger who both worked at the Lilly clinic. 5 Q. Do you remember Doctor Dobbs? 6 A. Yes. 7 Q. Does she still work with Lilly? 8 A. No. 9 Q. Do you know when she left 10 Lilly? 11 A. I don't remember. 12 Q. Do you know where she's located 13 presently? 14 A. I don't know. 15 Q. Do you know why she left Lilly? 16 A. I don't know. 17 Q. Do you know if she works for 18 another drug company now? 19 A. I don't know where Donna went 20 to. 21 Q. Do you know if she worked for 22 Abbot Laboratories prior to working for Lilly? 23 A. That rings a bell because you 24 said that, I don't specifically recall that. Page 184 1 Q. Do you happen to recall whether 2 or not she left Abbot Laboratories because of a 3 disagreement she had with Abbot Labs? 4 A. Oh, I don't know anything 5 about -- no, I don't know. 6 (PLAINTIFFS' EXHIBIT NO. 12 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Ms. Humbert, are you done 10 reading Plaintiffs' Exhibit Number 12? 11 A. Yes. 12 Q. For the record, it's marked Pz 13 513 page 2225 through 2227. Ms. Humbert, did you 14 author this document? 15 A. Yes, it has my name on it. 16 Q. Okay. This document is 17 addressed to Doctor Zerbe, isn't it? 18 A. Yes. 19 Q. As of May 16, 1985, what was 20 his role? 21 A. I'm unsure of his exact title. 22 Q. Was he superior to Doctor 23 Wernicke? 24 A. Yes. Page 185 1 Q. Was he an executive director? 2 A. That's what I'm not sure of, I 3 don't know what his title was at that particular 4 time. 5 Q. Is he an executive director 6 today? 7 A. He's a vice-president today. 8 Q. Is this an internal memo? 9 A. Yes. 10 Q. As a matter of course, did you 11 direct your internal memos to Doctor Zerbe? 12 A. As a matter of course, you mean 13 what? When it was appropriate I did. What does 14 as a matter of course mean? 15 Q. I mean did your position 16 require you to send memos to Doctor Zerbe on a 17 regular basis? Let me redefine regular basis. 18 How many times a week would you send memos to 19 Doctor Zerbe? 20 A. I don't recall how often I did, 21 it was not often. 22 Q. Would you say it was more than 23 twice a week? 24 A. I don't recall. Page 186 1 Q. Okay. On the first page of 2 this document, the second to last paragraph says 3 for the proposed fixed low dose study, it has 4 been suggested that we need ten investigators to 5 complete four hundred fifty patients within the 6 nine months alloted by the CRPC on 5/15/85. What 7 is the CRPC? 8 A. I believe that's clinical 9 research plans committee. 10 Q. Do you recall as of May 15, 11 1985 who was on that committee? 12 A. Specifically, no, I don't. 13 Q. Do you recall the names of 14 anybody who was on that committee? 15 A. That committee was comprised of 16 medical management and one person would be Doctor 17 Zerbe. 18 Q. Okay. When you say medical 19 management, does that mean only medical people 20 were on that committee or did it just include 21 some people from medical management? 22 A. I can't recall who the official 23 members were on the medical management. 24 Q. Do you know if anybody from the Page 187 1 sales department was on that committee? 2 A. As an official member, I don't 3 know. 4 Q. As any other kind of member? 5 A. Maybe as an attendee. 6 Q. Did the CRPC in this instance 7 set forth a time frame by which the fixed low 8 dose study would be completed? 9 A. Based on this memo, it says 10 nine months, I don't recall the specifics of 11 that. 12 Q. Was that the practice within 13 Eli Lilly that the CRPC would set out the 14 timeframe in which a study would be completed? 15 A. As I recall a plan would be 16 presented at CRPC and target dates could be 17 established, I'm not real certain. 18 Q. Do you know what factors would 19 be considered when determining a target date? 20 A. For a study completion? 21 Q. Yes. 22 A. The anticipated enrollment -- 23 speed of enrollment would be one factor. 24 Q. I think you're telling me about Page 188 1 factors that would be considered in trying to 2 figure out how long the study would take to 3 complete and I'm really asking the opposite side 4 of the question. What I'm asking is how would 5 the CRPC determine the target date, is it 6 different? 7 A. I don't know, I did not 8 participate in those meetings. 9 Q. Is what you just mentioned 10 about the speed of enrollment, I think that is 11 basically discussed in the balance of this memo, 12 isn't it? 13 A. Yes. 14 Q. And by the way, is this fixed 15 dose study the study which eventually became 16 Protocol 79? 17 A. Yes, the fixed dose study with 18 ICRC was Protocol 79. 19 Q. It was your responsibility to 20 ensure that this study was completed within the 21 timeframe set down by the CPRC, right? 22 A. This study was contracted to 23 the ICRC who took on the responsibility for 24 ensuring its completion. Page 189 1 Q. But you did analyze the 2 difference between having ten investigators and 3 five to six investigators, didn't you? 4 A. Yes. 5 Q. And when you analyzed that, you 6 analyzed it along the terms of -- one term of 7 being the timeframe, didn't you? 8 A. It looks like the timeframe of 9 enrollment was a factor of analyses, yes. 10 Q. For instance you say on page 11 three of the memo, the very last paragraph, it is 12 possible to complete this study in a timely 13 fashion and for less money with fewer 14 investigators. 15 MR. MYERS: Is that a question? 16 Q. You do say that, right? 17 A. That's what's here, yes. 18 Q. So isn't it a concern of you, 19 as the CRA, to finish the study and make sure 20 that the study is completed in a timely fashion? 21 A. It was part of my role of 22 liason with the ICRC, yes. 23 Q. What about a study where ICRC 24 was not involved? Page 190 1 A. Part of the job of a CRA was to 2 track enrollment by investigator and if a 3 particular investigator looked like he or she was 4 not enrolling at an appropriate rate, we would 5 talk to them. 6 Q. Because you were concerned that 7 the study be completed in a timely fashion? 8 A. Yes. 9 Q. Why was that a concern? 10 A. To complete the study? 11 Q. In a timely fashion. 12 A. Well, we needed to complete the 13 study so that we could analyze the data. As far 14 as being in a timely fashion, it's important that 15 if the company is collecting data that we analyze 16 it in a timely fashion so that it can be shared 17 with the FDA in a timely fashion as well. 18 Q. Because that would speed up the 19 approval process, right? 20 A. That could be part of it, if 21 that study is part of that case submission. 22 MR. GREEN: I have no further 23 questions. 24 MR. CLEMENTI: I have one short Page 191 1 question. 2 * * * * * * * * * * 3 CROSS EXAMINATION 4 BY MR. CLEMENTI: 5 Q. My name is Paul Clementi, I 6 represent a number of the doctors who are 7 involved in this lawsuit, including a Doctor Kay 8 and a Doctor Miller. Have you ever spoken with 9 or communicated with a Doctor Kay or a Doctor 10 Miller from the Chicago area? 11 A. No. 12 MR. CLEMENTI: Thank you, that's all I 13 have. 14 MS. LAWS: We'll reserve our questions. 15 MS. SMITH: We'll reserve ours, too. 16 (THE WITNESS WAS EXCUSED.) Page 192 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 MELISSA HUMBERT 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 1ST DAY OF 19 JULY, 1993. 20 MY COMMISSION EXPIRES MARCH 10, 1994. 21 22 23 _________________________ MARY KATHLEEN NOLD 24 COURT REPORTER AND NOTARY PUBLIC STATE OF KENTUCKY AT LARGE Page 193 1 2 3 E R R A T A S H E E T 4 5 STATE OF ) : SS 6 COUNTY OF ) 7 8 I, MELISSA HUMBERT, THE UNDERSIGNED 9 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 10 OF MY DEPOSITION AND WITH THE CHANGES NOTED 11 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 12 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 13 JUNE 23, 1993 AT THE TIME AND PLACE STATED 14 THEREIN. 15 PAGE NO. LINE NO. CHANGE REASON Page 194 1 2 PAGE NO. LINE NO. CHANGE REASON 3 4 5 6 7 8 9 _____________________________ 10 MELISSA HUMBERT 11 SWORN TO AND SUBSCRIBED BEFORE ME THIS 12 _____ DAY OF __________, 1993. 13 _____________________________ NOTARY PUBLIC, STATE OF 14 AT LARGE Page 195 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Page 196 1 DIRECT EXAMINATIONBY MR. GREEN:...................15 2 CROSS EXAMINATIONBY MR. CLEMENTI:................192 3 (PLAINTIFFS' EXHIBIT NO. 1........................30 4 (PLAINTIFFS' EXHIBIT NO. 2........................91 5 (PLAINTIFFS' EXHIBIT NO. 3.......................109 6 (PLAINTIFFS' EXHIBIT NO. 4 .....................116 7 (PLAINTIFFS' EXHIBIT NO. 5.......................120 8 (PLAINTIFFS' EXHIBIT NO. 6.......................125 9 (PLAINTIFFS' EXHIBIT NO. 7.......................133 10 (PLAINTIFFS' EXHIBIT NO. 8.......................148 11 (PLAINTIFFS' EXHIBIT NO. 9 ......................161 12 PLAINTIFFS' EXHIBIT NO. 10.......................179 13 (PLAINTIFFS' EXHIBIT NO. 11......................182 14 PLAINTIFFS' EXHIBIT NO. 12.......................185 15 16 17 18 Page 197