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: KEVIN MARKS 11 DATE: AUGUST 13, 1993 12 13 * * * * * * * * * * 14 15 16 REPORTER: KATHY NOLD 17 18 KENTUCKIANA REPORTERS SUITE 260 19 730 WEST MAIN STREET LOUISVILLE, KENTUCKY 40202 20 (502) 589-2273 Page 1 1 * * * * * * * * * * 2 3 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA 4 INDIANAPOLIS DIVISION 5 IN RE ELI LILLY AND COMPANY ) Prozac Products Liability ) MDL Docket No. 907 6 Litigation ) 7 * * * * * * * * * * 8 NO. 91-02496-A 9 JACKIE LYNN BIFFLE, ET AL ) IN THE DISTRICT ) COURT OF 10 V. ) DALLAS COUNTY, TEXAS ) 11 ELI LILLY & COMPANY AND ) 14TH JUDICIAL DISTA PRODUCTS COMPANY ) DISTRICT 12 * * * * * * * * * * 13 NO. 92-14775-E 14 RICHARD HAROLD CROSSETT, JR., ) IN THE 15 CHAD H. CROSSETT, AMY MICHELLE ) DISTRICT CROSSETT AND KRISTEN ANN CROSSETT, ) COURT OF 16 INDIVIDUALLY AND AS SURVIVORS OF ) AND ON BEHALF OF THE ESTATE OF ) 17 JOCQUETTA ANN CROSSETT, DECEASED ) ) 18 V. ) DALLAS COUNTY, ) TEXAS 19 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, TEXAS ) 20 PSYCHIATRIC COMPANY, INC. ) D/B/A/ HCA WILLOW PARK ) 101ST JUDICIAL 21 HOSPITAL, JAMES K. WITSCHY, M.D., ) DISTRICT AND DOUG BELLAMY, ED.D. ) Page 2 1 * * * * * * * * * * 2 NO. A-921,405-C 3 MARIA GUADALUPE REVES ) IN THE 4 INDIVIDUALLY AND AS NEXT ) DISTRICT COURT FRIEND OF GRANT JULIAN REVES ) OF 5 A MINOR CHILD, AND ON BEHALF ) OF THE ESTATE OF CHRISTIAN ) 6 MARIE REVES, DECEASED ) ) ORANGE COUNTY, 7 V. ) TEXAS ) 8 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, RAVIKUMAR ) 9 KANNEGANTI, M.D., HOSPITAL ) CORPORATION OF AMERICA, A ) 10 TENNESSEE CORPORATION, HEALTH ) SERVICES ACQUISITION CORP., ) 11 A DELAWARE CORPORATION, ) HCA PSYCHIATRIC COMPANY, A ) 12 DELAWARE CORPORATION, TEXAS ) PSYCHIATRIC CO., INC.. A/K/A ) 13 AND/OR D/B/A HCA BEAUMONT ) NEUROLOGICAL HOSPITAL, AND HCA ) 14 HEALTH SERVICES OF TEXAS, INC. ) 128TH JUDICIAL A/K/A AND/OR BEAUMONT ) DISTRICT 15 NEUROLOGICAL HOSPITAL ) 16 * * * * * * * * * * Page 3 1 IN THE UNITED STATES DISTRICT COURT 2 FOR THE WESTERN DISTRICT OF TEXAS SAN ANTONIO DIVISION 3 ELIZABETH T. SANCHEZ, ) 4 INDIVIDUALLY AND AS THE ) SURVIVING SPOUSE, MARGARET R. ) 5 SANCHEZ, INDIVIDUALLY AND NEXT ) OF FRIEND OF DEBRA JEAN ) 6 SANCHEZ, VERONICA MARIE ) SANCHEZ, EDWARDO ESTEBAN ) 7 SANCHEZ, AND MICHAEL ANTHONY ) SANCHEZ, CHILDREN; AND ALL ON ) 8 BEHALF OF THE ESTATE OF ) EDWARDO SANCHEZ ) 9 ) V. ) CIVIL ACTION NO. 10 ) SA93CA367 ELI LILLY AND COMPANY AND ) 11 DISTA PRODUCTS COMPANY ) 12 * * * * * * * * * * 13 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS 14 HOUSTON DIVISION 15 MARIA SANCHEZ, INDIVIDUALLY ) AND AS NEXT FRIEND OF DEBORAH ) 16 SANCHEZ, VERONICA SANCHEZ, ) EDDIE SANCHEZ, AND MICHAEL ) 17 SANCHEZ, AND ON BEHALF OF THE ) ESTATE OF EDUARDO SANCHEZ ) 18 ) V. ) CIVIL ACTION NO. 19 ) H-93-1469 ELI LILLY AND COMPANY AND ) 20 DISTA PRODUCTS COMPANY, A ) DIVISION OF ELI LILLY AND ) 21 COMPANY ) Page 4 1 * * * * * * * * * * 2 STATE OF NEW YORK 3 SUPREME COURT COUNTY OF JEFFERSON 4 _____________________________________________ 5 STEPHANIE CAPONE, AS EXECUTOR OF THE ESTATE OF JOSEPH J. CAPONE, JR., AND 6 STEPHANIE CAPONE, INDIVIDUALL, NOTICE TO TAKE 7 PLAINTIFF, DEPOSITION UPON ORAL EXAMINATION 8 VS. INDEX NO. 93-251 9 ELI LILLY AND COMPANY, DISTA PRODUCTS 10 COMPANY, A DIVISION OF ELI LILLY AND COMPANY, FLOYD BAJJALY, M.D, 11 DEFENDANTS. 12 _____________________________________________ 13 * * * * * * * * * * 14 SUPREME COURT OF TEH STATE OF NEW YORK COUNTY OF ORANGE 15 --------------------------------------X BRUCE R. MALEN AS EXECUTOR OF THE : INDEX NO. 16 ESTATE OF BARBARA E. MALEN, AND OF : 4119/92 BRUCE R. MALEN, INDIVIDUALLY, : 17 : HON. PETER PLAINTIFF : PATSALOS, 18 : J.S.C. -against- : 19 : ELI LILLY & COMPANY, DISTA PRODUCTS : 20 COMPANY, A DIVISION OF ELI LILLY & : COMPANY, BARRY SINGER AND UNITED : 21 HOSPITAL, : : 22 DEFENDANTS. : --------------------------------------X 23 * * * * * * * * * * Page 5 1 ---------------------------------X 2 VALARIE J. FRIEDMAN AND DAVID : SUPERIOR COURT FRIEDMAN, HER HUSBAND, : OF NEW JERSEY 3 : LAW DIVISION: PLAINTIFF, : MIDDLESEX COUNTY 4 : DOCKET NO. : L-3191-91 5 VS. : : 6 ELI LILLY & COMPANY; DISTA : PRODUCTS INC, A DIVISION OF : 7 ELI LILLY & COMPANY; LISS : PHARMACY; MADISON PHARMACY AND : 8 JOHN DOES NOS. 1-25 (UNKNOWN : ENTITIES), : 9 : DEFENDANTS. : 10 ---------------------------------X 11 * * * * * * * * * * 12 SUPREME COURT OF THE STAET OF NEW YORK COUNTY OF SUFFOLK 13 -------------------------------------x 14 RHOMDA L. HALA and JOSEPH L. HALA, : 15 Plaintiffs, : Index No. 14869/90 16 - against - : 17 ELI LILLY & COMPANY and DISTA : PRODUCTS COMPANY, a DIVISION OF 18 ELI LILLY & COMPANY : 19 Defendants. : -------------------------------------x 20 21 * * * * * * * * * * Page 6 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 PATRICIA BRACH, ) ) 4 Plaintiff ) ) 5 v. )No. 92 L 13369 ) 6 ELI LILLY AND COMPANY, a foreign ) corporation; ALAN N. MILLER, M.D., ) 7 WILLIAM BRUINSMA, Psy.D., and ) CONDELL MEMORIAL HOSPITAL, ) 8 ) Defendants. ) 9 * * * * * * * * * * 10 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 11 COUNTY DEPARTMENT - LAW DIVISION 12 RENATO DI SILVESTRO, Individually ) and as Special Administrator of ) 13 the Estate of JOHN DI SILVESTRO, ) Deceased, ) 14 ) Plaintiff, ) 15 ) v. ) No. 91 L 7881 16 ) ROBERT L. NELSON, et al., ) 17 ) Defendants, ) 18 ) GEORGE MELNICK, M.D. and PETER ) 19 FINK, M.D. ) ) 20 Respondents in Discovery.) 21 * * * * * * * * * * Page 7 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 JOAN M. GRYER, ) ) 4 Plaintiff, ) ) 5 v. ) No. 92 L 7387 ) 6 ELI LILLY AND COMPANY, et al., ) ) 7 Defendants. ) 8 * * * * * * * * * * 9 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 10 COUNTY DEPARTMENT, LAW DIVISION 11 JENNIFER HAMMERLI, as Plenary ) Guardian of the Estate of RAY B. ) 12 HAMMERLI, a disabled person, ) ) 13 Plaintiff, ) ) 14 v. ) No. 92 L 2365 ) 15 ELI LILLY AND COMPANY, THE ) UPJOHN COMPANY, DICKIE KAY, M.D., ) 16 (former Respondent in Discovery), ) and RICHARD CZECHOWICZ (former ) 17 Respondent in Discovery), ) ) 18 Defendants. ) 19 * * * * * * * * * * Page 8 1 IN THE CIRCUIT COURT OF THE SIXTH JUDICIAL CIRCUIT 2 CHAMPAIGN COUNTY, ILLINOIS 3 LINDA GARDNER, Individually and ) as Special Administrator of ) 4 the Estate of SHANE GARDNER, ) deceased, ) 5 ) Plaintiff, ) 6 ) v. ) No. 91 L 1066 7 ) ELI LILLY AND COMPANY, a foreign ) 8 corporation, ) ) 9 Defendant. ) 10 * * * * * * * * * * 11 IN THE NINETEENTH JUDICIAL CIRCUIT COURT 12 LAKE COUNTY, ILLINOIS 13 JAMES E. SHEPPARD, Special ) Administrator of the Estate of ) 14 KENNETH K. SHEPPARD, Deceased, ) ) 15 Plaintiff ) ) 16 v. ) No. 93 L 124 ) 17 GOOD SHEPHERD HOSPITAL, a ) corporation, DR. STEWART SEGAL, ) 18 DR. SANFORD SHERMAN, DR. BRUCE ) CARLSON, DR. R. BERGLUND, and ELI ) 19 LILLY & COMPANY, a corporation, ) ) 20 Defendants. ) 21 * * * * * * * * * * Page 9 1 SUPERIOR COURT OF THE STATE OF CALIFORNIA 2 FOR THE COUNTY OF LOS ANGELES 3 DR. MARIUS SAINES, etc., et al., ) Case No: 4 ) SC 008331 Plaintiffs, ) 5 ) vs. ) 6 ) ELI LILLY & COMPANY, a corporation; ) 7 DISTA PRODUCTS COMPANY, a division ) of Eli Lilly & Company; and DOBS 1- ) 8 100, inclusive, ) ) 9 Defendants. ) ____________________________________) 10 11 * * * * * * * * * * Page 10 1 THE DEPOSITION OF KEVIN MARKS, TAKEN AT THE 2 OFFICE OF BAKER & DANIELS, 300 NORTH MERIDIAN 3 STREET, SUITE 2700, INDIANAPOLIS, INDIANA 46204, 4 ON AUGUST 13, 1993; SAID DEPOSITION TAKEN 5 PURSUANT TO NOTICE IN ACCORDANCE WITH THE RULES 6 OF CIVIL PROCEDURE. 7 * * * * * * * * * * 8 A P P E A R A N C E S 9 10 NANCY ZETTLER COUNSEL FOR GROUP A PLAINTIFFS 11 LEONARD M. RING AND ASSOCIATES, P.C. 111 WEST WASHINGTON AVENUE, SUITE 1333 12 CHICAGO, ILLINOIS 60602 13 LAWRENCE J. MYERS COUNSEL FOR ELI LILLY AND COMPANY 14 FREEMAN & HAWKINS 4000 ONE PEACHTREE CENTER 15 303 PEACHTREE STREET, N.E. ATLANTA, GEORGIA 30308-3243 16 MICHAEL J. HARRINGTON 17 ELI LILLY AND COMPANY LILLY CORPORATE CENTER 18 INDIANAPOLIS, INDIANA 46285 19 DENISE BRODSKY COUNSEL FOR GOOD SHEPHERD HOSPITAL 20 415 WASHINGTON STREET, SUITE 214 WAUKEGAN, ILLINOIS 21 PAUL J. CLEMENTI 22 COUNSEL FOR DR. DICKIE KAY HINSHAW & CULBERTSON 23 222 NORTH LA SALLE STREET, SUITE 300 CHICAGO, ILLINOIS 60601-1081 24 KATHERINE L. LAWS Page 11 1 COUNSEL FOR DRS. WITSCHY AND KANNEGANTI 2 BAILEY AND WILLIAMS 3 3500 NCNB PLAZA 4 901 MAIN STREET 5 DALLAS, TEXAS 75202-3714 Page 12 1 I N D E X 2 3 DEPOSITION OF KEVIN MARKS 4 5 DIRECT EXAMINATIONBY MS. ZETTLER 14 6 QUESTION CERTIFIED 39 7 QUESTION CERTIFIED 41 8 9 CERTIFICATE 95 10 ERRATA 96 11 12 EXHIBITS 13 PLAINTIFFS' EXHIBIT NO. 1 73 14 PLAINTIFFS' EXHIBIT NO. 2 77 15 16 17 Page 13 1 2 COMES KEVIN MARKS, CALLED BY THE 3 PLAINTIFF, AND AFTER FIRST BEING DULY SWORN, WAS 4 DEPOSED AND TESTIFIED AS FOLLOWS: 5 DIRECT EXAMINATION 6 BY MS. ZETTLER: 7 Q. Mr. Marks, good morning, my 8 name is Miss Nancy Zettler and I represent a 9 number of plaintiffs in the Fentress versus Shea 10 Communications case stemming from the Wesbecker 11 shootings in Louisville. I'm going to be asking 12 you a series of questions today and hopefully 13 it's not going to be too long but you never know, 14 depending on how you answer and what you say. 15 Have you ever given a 16 deposition before? 17 A. No. 18 MS. LAWS: Can we do our -- 19 MS. ZETTLER: We've made previous 20 agreements as to reserving objections and -- what 21 was the other one? 22 MS. LAWS: Form of responsiveness. 23 MS. ZETTLER: Right. 24 MR. MYERS: One objection for one Page 14 1 defendant is good for all. 2 MS. ZETTLER: One for all, all for one. 3 Plus, I think we agreed previously that the 4 plaintiffs reserve their objections to the cross 5 noticing in these cases and the fact that a 6 number of documents that belong to this witness 7 were not produced and we're just going to make a 8 continuing objection of that type. 9 MR. MYERS: Right, the deposition was 10 cross noticed in the MDL and some related state 11 court cases and some judge or some court can 12 consider that later, and on the subject of 13 documents, let's just -- we understand that some 14 court or some judge will take that up at some 15 point as well. 16 MS. ZETTLER: Continuing objection for 17 failure to produce certain documents in the MDL. 18 Q. Mr. Marks, since you haven't 19 given a deposition, let me give you some ground 20 rules that will make things go a little quicker 21 and make it easier on Kathy, our court reporter. 22 The first thing is you have to answer out loud 23 and can't shake your head or go uh-huh, you have 24 to say yes, no, or some sort of verbal response. Page 15 1 A. Sure. 2 Q. Also, if you have any -- if you 3 want to take a break at any time, let us know and 4 we usually take one, at least one in the morning 5 and a lunch break and one in the afternoon if we 6 go that long, but if you need a break whatsoever 7 at any time, let us know and we'll take a break. 8 A. Okay. 9 Q. And if you don't understand or 10 don't hear one of my questions, I would like you 11 to ask me to repeat it or rephrase it until you 12 understand it. 13 A. Okay. 14 Q. If you answer a question as 15 stated, we are going to assume that you 16 understood it as stated. 17 A. Okay. 18 Q. And one last thing for Kathy's 19 benefit as well as both of our benefits, we are 20 going to have to try the best we can to allow 21 each other to complete our responses or questions 22 before we start talking. It's kind of natural in 23 the conversation that you talk over each other 24 but she can't take us both down at once. Page 16 1 MR. MYERS: If you both talk at once, 2 this nice lady will go crazy. 3 Q. Can you give us your date of 4 birth? 5 A. 9-28-68. 6 Q. And what is your social 7 security number? 8 A. XXXXXXXXXXX. 9 Q. And after high school, can you 10 give us an idea of what your educational history 11 is? 12 A. Yes. 13 Q. Go ahead. 14 A. I attended school at Xavier 15 University in New Orleans, Louisiana, five year 16 program, bachelors of science in pharmacy. 17 Q. And did you receive that 18 bachelors? 19 A. Yes. 20 Q. When did you get that -- when 21 did you receive that? 22 A. May of 1991. 23 Q. And do you have any degrees 24 above bachelors? Page 17 1 A. No. 2 Q. Have you taken any -- are you 3 working towards any degrees at this time? 4 A. No. 5 Q. Okay. How about any seminars 6 or other types of classes other than something in 7 formal education? 8 A. Continuing pharmacy education. 9 Q. Okay. 10 Q. Can you give us an idea of what 11 that entails? 12 A. It entails reading journals, 13 attending seminars. 14 Q. Anything else? 15 A. No. 16 Q. Which journals do you read? 17 A. Psychiatric Times, American 18 Journal of Clinical Psychiatrists, Pharmacy 19 Times, Journal of American Medical Association. 20 Q. Did you say Journal of Clinical 21 Psychiatry? 22 A. Uh-huh. 23 MR. MYERS: Yes. 24 A. Yes. Page 18 1 Q. Do you have an area in pharmacy 2 that concentrated in like psychotropic 3 neuroleptic drugs? 4 A. Yes. 5 Q. Can you tell us what area did 6 you concentrate in? 7 A. I'm sorry, could you expand on 8 that question please? 9 Q. Sure. I guess I'm just 10 noticing that a lot of the journals that you read 11 are based on psychiatry, I was wondering if you 12 have any particular interest in like psychotropic 13 drugs, or neuroleptic or something to be used in 14 psychiatric illnesses, is that the case? 15 A. Yes, I do have an interest in 16 that area. 17 Q. Okay. Is there a formal like 18 specialty within pharmacy, can you choose an area 19 of drugs like antibiotics as opposed to 20 antidepressants or something of that nature or is 21 it more of a general course for the BS? 22 A. It entails all specialties. 23 Q. Okay. Can you give us an idea 24 of what your work history has been other than Page 19 1 like part-time jobs in high school or things of 2 that nature? 3 A. Yes. While in -- after 4 completion of my bachelors program, I had taken a 5 job with Eli Lilly and Company which I'm 6 currently employed as a clinical research 7 administrator. 8 Q. So right from -- you graduated, 9 I believe you said '91, May of '91? 10 A. Correct. 11 Q. You started working for Lilly 12 at that time? 13 A. June of '91. 14 Q. Okay. And you worked 15 continuously for them since? 16 A. Yes. 17 Q. And the whole time have you 18 been a CRA? 19 A. Yes. 20 Q. Is it okay if we use CRA 21 instead of saying clinical research 22 administrator? 23 A. Yes. 24 Q. Now, how about while you were Page 20 1 in school, did you do any pharmacy related work? 2 A. Yes. 3 Q. What kind of jobs did you have 4 in school? 5 A. I worked in a hospital pharmacy 6 as a pharmacy student, technician. 7 Q. What hospital? 8 A. It was East Jefferson General 9 Hospital in Metairie, Louisiana. 10 Q. Was that summer employment or 11 was that full-time, part-time, what kind of 12 employment was that? 13 A. It was part-time. 14 Q. And did you work year around 15 part-time? 16 A. Yes. 17 Q. For how many years? 18 A. Three. 19 Q. Any other pharmacy related work 20 that you did while you were in school? 21 A. For, I'm sorry, could you 22 expand on that? 23 Q. Sure, other than I mean -- I'm 24 not thinking about your course work or things of Page 21 1 that nature, I mean actual employment type of 2 work, was there any other work that you did? 3 A. No. 4 Q. How about internships or 5 anything like that? 6 A. Yes, we did have internships. 7 Q. Where did you do your 8 internship? 9 A. Three different sites. 10 Q. Okay. 11 A. Two of which were retail 12 pharmacy and one was a clinical rotation in 13 general medicine at the hospital. 14 Q. How about retail, what were -- 15 where did you do them? 16 A. A chain called K and B Pharmacy 17 in New Orleans. 18 Q. And anywhere else? 19 A. D and H Pharmacy. 20 Q. How long did those internships 21 last? 22 A. Six weeks each. 23 Q. What kinds of things did you do 24 during internship? Page 22 1 A. Patient counseling, 2 participated with drug dispensing, review the 3 formularity that was on stock, checking for 4 expiration dates, those sorts of things. 5 Q. You say participated in drug 6 dispensing, you mean you actually filled 7 prescriptions? 8 A. I assisted the pharmacist who 9 was registered in preparing -- in the preparation 10 of the prescriptions. 11 Q. When I say prescriptions, like 12 every day somebody will come in and say here's a 13 prescription from my doctor? 14 A. Correct. 15 Q. You said you checked 16 formularities in stock? 17 MR. MYERS: Formularities. 18 A. Formularities. 19 Q. What do you mean by 20 formularity? 21 A. Drugs that were -- 22 Q. Inventory? 23 A. Inventory, that type of things. 24 Q. Okay. Tell us about your Page 23 1 clinical rotation. 2 A. It was held at one of the local 3 hospitals in New Orleans, it was a five hundred 4 bed hospital, it was with a medical training 5 group which consisted of physicians, interns, 6 residents, medical students, as well as pharmacy 7 students and a clinical pharmacist. 8 Q. Okay. What would you 9 personally do as a participant in the rotation? 10 A. We would study patient medical 11 histories and as well as observing the pattern of 12 medications that were used to treat their medical 13 illnesses. 14 Q. Okay. 15 A. And understanding the 16 correlation and the treatment modalities that 17 were used. 18 Q. Did you work with psychiatric 19 patients in that rotation? 20 A. It was -- yes, we did. 21 Q. Did you have any specific 22 recollection of working with any given -- any 23 particular anti-depressant like say Elavil or 24 Imiprimine or anything like that? Page 24 1 MR. MYERS: When you say give. 2 MS. ZETTLER: Given, not give. 3 MR. MYERS: Right, because he can't. 4 MS. ZETTLER: Any given, meaning as an 5 example. 6 MR. MYERS: I'm sorry. 7 A. No. 8 Q. Did you work on any clinical 9 trials of drugs while you were in the clinical 10 rotation? 11 A. No. 12 Q. Have you ever, other than your 13 employment at Eli Lilly, have you worked on any 14 clinical trials of drugs? 15 A. Could you clarify what you mean 16 by work on? 17 Q. I'm assuming your work at 18 Lilly, okay, have you participated in any way in 19 any clinical trial, either as a patient or a CRA, 20 administrative type thing outside of Lilly or 21 through your work at school or anything of that 22 nature, have you done any work whatsoever on a 23 clinical trial and drug? 24 A. No. Page 25 1 Q. How is it that you came to be 2 employed at Lilly? 3 A. Lilly recruits at my 4 university, particularly with the pharmacy 5 program that we have there. 6 Q. And when you say recruits, is 7 that that they have something like a career day 8 or something along those lines? 9 A. Yes. 10 Q. Did Lilly actually have a booth 11 set up at this thing? 12 A. I can't recall if it was a 13 booth or not. 14 Q. Or a table with people from 15 Lilly sitting there? 16 A. Yes, a table. 17 Q. Did they initially contact you 18 to interview or did you contact them? 19 A. I contacted them. 20 Q. Were you aware of any 21 particular position that was available at Lilly 22 at the time you contacted them? 23 A. No. 24 Q. Did you contact other drug Page 26 1 companies as well as Lilly? 2 A. No. 3 Q. Why did you choose Lilly? 4 A. Well, based on several factors 5 in comparison with the other opportunities that I 6 had, Lilly -- the experience that I could have 7 gained from working at Eli Lilly and Company were 8 at the time more superior to the experiences that 9 I would have gained working elsewhere. 10 MS. ZETTLER: I'm going to ask her to 11 read it back only because I spaced out on the 12 first time you answered, okay, I'm sorry. 13 (THE COURT REPORTER READ BACK THE 14 REQUESTED TESTIMONY.) 15 Q. What factors, you said given 16 the factors, what factors were you talking about? 17 A. Mainly the experience factor 18 and the exposure to the actual science of 19 medicine. 20 Q. So when you approached Lilly 21 about a job, you were hoping to work in the 22 research area? 23 A. Not really. 24 Q. What area were you hoping to Page 27 1 work in? 2 A. There weren't -- the area -- 3 there wasn't a particular area. I didn't become 4 aware of the opportunities until actually 5 speaking with the Lilly representative and 6 finding out which opportunities were available. 7 Q. Okay. What was it about Lilly, 8 as opposed to other drug companies like Abbott 9 Labs or Ciba that you thought would represent 10 better experience or a better opportunity for 11 greater experience? 12 A. I did not interview with any 13 other pharmaceutical companies. 14 Q. So when you say in comparison 15 with your other opportunities, you're talking 16 about opportunities outside of the drug 17 manufacturing industry? 18 A. Yes. 19 Q. Do you remember who you 20 interviewed with at Lilly for the job that you 21 have now? 22 A. Yes, one gentleman, would you 23 like his name? 24 Q. Yes. Page 28 1 A. Doctor Wayne McKeen. 2 Q. Spell that last name, please. 3 A. M-C-K-E-E-N. 4 Q. Is he a M.D. or Ph.D? 5 A. I'm not sure. 6 Q. Do you know what area Doctor 7 McKeen is in? 8 A. Well, I think now he's retired. 9 Q. Okay. Do you remember what 10 area he was in when you interviewed with him? 11 A. No, I don't. 12 Q. Do you remember anybody who you 13 interviewed with -- anybody else besides Doctor 14 McKeen at Lilly? 15 A. At the university or -- 16 Q. Either? 17 A. Once I came to Indianapolis, I 18 interviewed with a series of people. 19 Q. Do you remember the names of 20 any of those people that you talked with? 21 A. Yes. 22 Q. Okay. 23 A. Mike Harrell, Deb Hildebrand. 24 Q. Anybody else? Page 29 1 A. That's all I can remember at 2 the time. 3 Q. Have you ever heard the name 4 Jan Fawcett M.D.? 5 A. I've heard of his name. 6 Q. Have you ever worked with 7 Doctor Fawcett? 8 MR. MYERS: I'm going to object to the 9 question and instruct him not to answer and I 10 will just tell you for the record that you're 11 going to learn as you examine this witness that 12 he's worked on a clinical trial before, I'll let 13 you draw your own conclusion from that objection. 14 MS. ZETTLER: When you say he's worked 15 on a clinical trial before, you mean before 16 Lilly? 17 MR. MYERS: No, I'm sorry, I misspoke, 18 he has been a CRA on a clinical trial, this man. 19 MS. ZETTLER: So you're not going to 20 let him answer the question whether or not he's 21 worked with Doctor Fawcett? 22 MR. MYERS: Correct. 23 MS. ZETTLER: Why, based on what? 24 MR. MYERS: Well, it may or may not be Page 30 1 that he is or has been or has been in the past a 2 clinical investigator on a trial but is not a 3 pivotal investigator on a trial related to 4 Prozac. 5 MS. ZETTLER: And Dan Russell testified 6 that he helped him wrap up Fawcett's trial on 7 depressives, related -- depression related trial. 8 I think we at least have a right to know what the 9 subject matter of the trial was in a general 10 nature. 11 MR. MYERS: Tell her in -- what is the 12 question? 13 Q. Have you worked with Doctor 14 Fawcett -- have you worked with Doctor Fawcett, 15 Mr. Marks? 16 MR. MYERS: You can answer that, go 17 ahead. 18 A. I'm not sure if the question is 19 in the proper context for me to answer, worked 20 with meaning -- 21 Q. Do you understand what working 22 means? 23 A. Yes, I do understand what 24 working means. Page 31 1 Q. Do you understand what working, 2 doing work that is related to -- let me ask it in 3 a general sense. Has any of your work at Eli 4 Lilly related to any work that Doctor Fawcett has 5 done on behalf of Eli Lilly? 6 A. Yes. 7 Q. Has that been a clinical trial? 8 A. Yes. 9 Q. Can you tell us generally what 10 the -- let me ask you this, was the clinical 11 trial involving Fluoxetine? 12 A. Yes. 13 Q. When was the clinical trial 14 started to your knowledge? 15 A. March of 1990. 16 Q. March of '90? 17 A. Uh-huh. 18 Q. And that was before you started 19 working there, right? 20 A. Correct. 21 Q. Were you a clinical research 22 assistant on that? 23 MR. MYERS: Administrator. 24 MS. ZETTLER: Administrator, thank you. Page 32 1 Q. On that trial? 2 A. Yes. 3 Q. Was the objective of that trial 4 generally to test Fluoxetine for a given 5 indicated use? 6 A. Yes. 7 Q. It wasn't a study -- a 8 retrospective study on suicidality and Fluoxetine 9 or homocidality and Fluoxetine, was it? 10 A. No, it wasn't. 11 Q. Was it a perspective study on 12 Fluoxetine and suicidality or violent aggressive 13 behavior? 14 A. No. 15 Q. Was it a study that involved 16 depression? 17 A. Yes. 18 Q. Can you give me -- tell me a 19 little bit about the study, was it a comparative 20 study, was there another drug involved? 21 A. It was placebo involved. 22 Q. Was it a double blind study or 23 open study or blind study? 24 A. It was both, double blind and Page 33 1 open label. 2 Q. Two parts? 3 A. Yes. 4 Q. First part double blind? 5 A. First part open label. 6 Q. Were there any other indicated 7 uses that were being tested during this study 8 such as obesity or smoking cessation or 9 obsessive-compulsive disorder? 10 A. No. 11 Q. What were your responsibilities 12 with regards to that study? 13 A. I had responsibilities for 14 handling the administrative work study, which 15 included monitoring the data that comes in-house, 16 validating the data that comes in-house to Lilly, 17 grant payments. 18 Q. Did you have any responsibility 19 with regards to any adverse events that may have 20 been reported by Doctor Fawcett or anybody on his 21 staff during the trial? 22 A. Yes, I did have those 23 responsibilities. 24 Q. What responsibilities did you Page 34 1 have with regards to that? 2 A. To, one, check for validity, 3 making sure that they were all reported. 4 Q. Anything else? 5 A. That encompasses the whole 6 thing. 7 Q. Did you work on any other 8 clinical trials other than Doctor Fawcett's 9 study? 10 MR. MYERS: Before he answers, let me 11 object to the form, you call it Doctor Fawcett's 12 study and I don't know if we established that one 13 way or the other as to whose study it was. Is 14 that just your term that you're using? 15 MS. ZETTLER: Yes, that's my term but 16 if you want me to go through -- 17 MR. MYERS: No, that's fine. 18 Q. Let me clarify it a little bit, 19 was Doctor Fawcett the only investigator on this 20 study? 21 A. No, he wasn't. 22 Q. How many other investigators 23 were involved in this study? 24 A. Four. Page 35 1 Q. Okay. Were they all -- let me 2 ask you this, it is your understanding that 3 Doctor Fawcett is from the Chicago area? 4 A. It is my understanding. 5 Q. And he works out of Rush 6 Presbyterian Hospital in Chicago? 7 A. That's my understanding. 8 Q. Is that where the site of his 9 portion of the study was performed? 10 A. Yes. 11 Q. Was it an inpatient or 12 outpatient study? 13 A. Outpatient. 14 Q. Okay. The other four 15 investigators that were involved in that study, 16 were they all from the Chicago area also or were 17 they from other areas in the country? 18 A. Other areas in the country. 19 Q. Can you give me the names of 20 those gentlemen or ladies? 21 MR. MYERS: Don't answer that, that's 22 confidential, proprietary. I've given you 23 latitude on Fawcett but the other people are not 24 pivotal investigators so he is not going to Page 36 1 answer that. I'll allow him to tell you 2 geographically where they are located, but I'm 3 not going to -- we are not going to go into who 4 they are. 5 MS. ZETTLER: And your definition of 6 pivotal studies, which has changed again, from 7 any use other than depression -- let's get it on 8 the record, Larry. What's your definition of 9 pivotal studies? It changes every time we have a 10 deposition. 11 MR. MYERS: Just so the record is 12 clear, and I really have no interest in 13 quarreling about this so I'll tell you, our 14 definition and the identity of the pivotal 15 investigators is set out in interrogatory answer 16 fifty something in either the Biffle or MDL 17 interrogatory answers. 18 MS. ZETTLER: Which have nothing to do 19 with this case. 20 MR. MYERS: Well, the listing of the 21 names has been set out. 22 MS. ZETTLER: The listing of the names 23 appears to be the listing of the names that were 24 divulged by the FDA and -- Page 37 1 MR. MYERS: That appear in the summary 2 basis of approval and that is our definition, 3 so -- 4 MS. ZETTLER: So you're saying that as 5 long as it appears in the summary basis of 6 approval, that it's pivotal? 7 MR. MYERS: Correct. 8 MS. ZETTLER: And if it doesn't appear 9 in the summary basis of approval, it's not 10 pivotal. 11 MR. MYERS: Correct. 12 MS. ZETTLER: Regardless of the use -- 13 indicated use or the reason for the study. For 14 instance, if it's a depression study but it 15 didn't appear on the FDA, therefore, it's not 16 pivotal. 17 MR. MYERS: That's right, I think 18 that's the definition we've been working with. 19 MS. ZETTLER: It's as clear as it's 20 ever been because frankly every time we go before 21 a judge or anytime the petition comes up, it 22 changes, but if that's your definition, that's 23 fine, that's what we will work with. I think 24 you're way out of line with that. Page 38 1 MR. MYERS: Ask him another question, 2 he's not going to tell you who the other 3 investigators are, I'll let him tell you 4 geographically where they are located. 5 MS. ZETTLER: Certify the question. 6 (QUESTION CERTIFIED.) 7 Q. Where are they located 8 geographically? 9 MR. MYERS: Give her the cities. 10 A. New York, Boston, Salt Lake 11 City, Philadelphia. 12 Q. To your knowledge, did Doctor 13 Fawcett work with any other physicians on his 14 portion of the study? 15 MR. MYERS: Let me object, you said 16 other physicians, where? 17 MS. ZETTLER: At his site. 18 A. In the form of -- I'm sorry, 19 could you clarify that a little bit more? 20 Q. Sure, let me ask you this, is 21 it your understanding that the FDA requires that 22 forms be filled out regarding site and 23 investigator qualifications and feasibilities for 24 studies? Page 39 1 A. Yes. 2 Q. Okay. One of those forms is a 3 1573, correct? 4 A. Not correct. 5 Q. 37? 6 A. 1572. 7 Q. Okay. It's not -- isn't it 8 1573 for the investigator and 1572s are for other 9 personnel on the site? 10 A. Not to my knowledge. 11 Q. Okay. So the 1572, would that 12 list other personnel at the investigator's site? 13 A. Yes, it would. 14 Q. Okay. Were there other M.D.'s 15 listed on the 1572 for Doctor Fawcett's portion 16 of the study? 17 A. Yes. 18 Q. Okay. Other M.D.'s, medical 19 doctors? 20 A. Medical doctors. 21 Q. Can you tell me who those 22 people were? 23 MR. MYERS: That's -- our position is 24 that that as well, is confidential. I understand Page 40 1 you may take that up with somebody but that's our 2 position and I would direct him not to answer 3 that. 4 Q. Are you going to follow your 5 attorney's direction and not answer the question? 6 A. Yes. 7 MS. ZETTLER: Certify the question. 8 (QUESTION CERTIFIED.) 9 MS. ZETTLER: And that again is based 10 on the pivotal, nonpivotal study definition? 11 MR. MYERS: Essentially, yes. 12 Q. Did you have any direct 13 dealings with Doctor Fawcett with regards to his 14 study? 15 A. No. 16 Q. Did you have direct dealings 17 with any other personnel at his sites, study 18 sites? 19 A. Yes. 20 Q. Okay. How many patients were 21 enrolled in that study, do you know? 22 MR. MYERS: Were what? 23 Q. How many patients were enrolled 24 in that study? Page 41 1 A. Eight hundred and thirty-nine. 2 Q. You said that study was begun 3 in March of '90, correct? 4 A. Correct. 5 Q. That was all the investigators, 6 not just Doctor Fawcett? 7 A. All investigators. 8 Q. At that point were the 839 9 patients enrolled or is that when they started 10 the enrollment period? 11 A. That's when it was started. 12 Q. Do you know when they actually 13 got underway with the study, outside the 14 enrollment period? 15 A. No, I don't. 16 Q. Was that before or after you 17 went to work for Lilly? 18 A. That was before. 19 Q. Do you know if they were -- 20 what the purpose of that study was? 21 A. Yes. 22 Q. Can you tell me what it was? 23 A. To observe safety and efficacy 24 of Fluoxetine in majorly depressed patients for a Page 42 1 long period of time. 2 Q. Okay. How long was this study -- 3 is this study still going on? 4 A. It depends on what you mean by 5 still going on. 6 Q. Are the patients still being 7 treated on the study now? 8 A. No. 9 Q. Okay. Are you in the process 10 of collecting data and closing off the study? 11 A. That has been done. 12 Q. And what is there left to do? 13 A. The writing of the report for 14 the study. 15 Q. Okay. So essentially all work 16 is done other than the analysis of data and 17 writing up the report? 18 A. Correct. 19 Q. That report is going to go to 20 the FDA? 21 A. Correct. 22 Q. Is the article going to be 23 published as a result of that study? 24 A. I believe so. Page 43 1 Q. Do you know if that's in the 2 works right now? 3 A. I'm not sure -- well, no, not 4 by me. 5 Q. When you said that it was a 6 study on safety and efficacy of Fluoxetine, could 7 you tell me what safety data were being studied? 8 A. Adverse events, laboratory 9 data, vital sign data. 10 Q. Were any psychiatric tests 11 administered to the patients throughout this 12 study? 13 MR. MYERS: Let me object to form, what 14 do you mean by psychiatric tests? 15 Q. Like the Hamilton depression 16 rating scale, was that given at this study? 17 A. Yes. 18 Q. Any other measures of 19 suicidality that were administered to your 20 knowledge? 21 A. In addition to the Hamilton? 22 Q. Yes. 23 A. Not that I know of. 24 Q. How about any other -- like was Page 44 1 the Co-V rating scale administered? 2 A. I have never heard of that. 3 Q. Okay. How about -- I'm going 4 to forget them all. Were there any other scales 5 that were -- any other psychiatric scales that 6 were given to the patients? 7 A. Yes. 8 Q. Can you give me -- remember 9 some that were given? 10 A. The clinical global impression 11 scale. 12 MR. CLEMENTI: Clinical global 13 depression scale? 14 THE WITNESS: Impression. 15 Q. Any others? 16 A. Major depressive disorder 17 assessment sheet. 18 Q. Is that something that was made 19 a part of the clinical report form or is that 20 something that was done independently? 21 A. That was made part of the case 22 report form. 23 Q. Any others? 24 A. I'm not sure if this is -- Page 45 1 there was another one but I'm not sure if it's an 2 actual scale, it's called a SCID but it was a one 3 time thing. 4 Q. What's a SCID? 5 A. Structured clinical interview 6 diagnosis or something like that. 7 Q. When you say it was a one time 8 thing, what do you mean? 9 A. It wasn't part of the case 10 report form, it just served as additional 11 information at visit one of the study. 12 Q. Do you know if it was used for 13 baseline evaluation of the patients? 14 A. I think it was. 15 Q. So, it's more of a screening 16 test than anything else? 17 A. Yes. 18 Q. Do you know if this SCID has a 19 portion on suicidality? 20 A. I can't recall. 21 Q. How about violence aggressive 22 behavior and hostility? 23 A. I'm not familiar with the 24 contents of the SCID, real familiar with the Page 46 1 content. 2 Q. Do you know if drug diary 3 pamphlets were used on that study? 4 A. Yes. 5 Q. Were they? 6 A. Yes. 7 Q. Do you know what types of 8 information the pamphlets asked for from 9 patients? 10 A. Very vaguely. 11 Q. Can you give me some idea of 12 what they asked for? 13 A. Any adverse events received, 14 any drugs -- concommitant drugs that were taken, 15 I'm not sure which format that was asked. 16 Q. Okay. Do you know if with 17 regards to the adverse events was that something 18 that they would just ask generally or would that 19 be like a checklist of possible adverse events 20 that they could have suffered? 21 A. Could you repeat that question? 22 Q. Sure. Were the patients given 23 an actual checklist of potential adverse events, 24 like say nausea or headache or things of that Page 47 1 nature, or were the drugs, the pamphlets asked 2 for adverse events in a more general sense like 3 can you tell us how you felt today kind of 4 questions? 5 A. It was a bit more general than 6 that. It was, if I can recall, it was blank 7 lines and the patients were instructed to write 8 basically any concommitant medications. 9 Q. Do you know if a checklist of 10 adverse events was ever used at the site during 11 Doctor Fawcett's study? 12 A. Checklist, I'm not familiar 13 with a checklist. 14 Q. How were the sites instructed 15 to glean adverse events information from the 16 patients, if any? 17 A. How were they instructed to -- 18 Q. To get information on adverse 19 events from the patients? 20 A. In an interview with the 21 patients, they would interview patients. 22 Q. And during that interview, were 23 they instructed to ask them about specific 24 adverse events or was it again a more general Page 48 1 question and answer type of thing? 2 A. I believe it was general but 3 I'm not definitely sure because I was never in on 4 an interview with the patient. 5 Q. Okay. To your knowledge, has 6 Doctor Fawcett participated in any other clinical 7 trials on Fluoxetine other than the one we've 8 been talking about the past few minutes? 9 A. I'm not familiar. 10 Q. Do you recall what the protocol 11 number of this study was? 12 A. This one? 13 Q. Yes. 14 A. Yes, B1YMCHCEX. 15 Q. H-C-E-X? 16 A. Uh-huh. 17 Q. Would that be the protocol 18 number or the study number or is that the same? 19 A. They're interchangeable. 20 Q. And the other four 21 investigators involved with that, this number 22 would be applied to their studies also? 23 A. Yes. 24 Q. Do you recall what Doctor Page 49 1 Fawcett's investigator number was on that study? 2 A. Yes. 3 Q. What was it? 4 A. Two. 5 Q. Okay. 6 Q. On that study, were the 7 patients assigned numbers or initials? 8 A. They were assigned numbers 9 which corresponded to their initials. 10 Q. Okay. But if something was 11 reported an adverse event, would that be reported 12 by their initials or their numbers or both? 13 A. By their -- definitely by their 14 numbers. 15 Q. Did you start out with a larger 16 number than eight hundred and thirty-nine and 17 eight hundred and thirty-nine were the ones who 18 made it through the inclusion-exclusion process 19 and the screening process? 20 A. Yes. 21 Q. Do you remember how many 22 patients were started out? 23 A. Yes, one thousand four. 24 Q. When you say this eight hundred Page 50 1 thirty-nine patients were enrolled, did eight 2 hundred thirty-nine patient complete the studies? 3 A. No. 4 Q. How many patients completed it, 5 if you know? 6 A. I don't have an exact number as 7 far as the number of completed patients. 8 Q. Can you give me a general idea 9 how many? 10 A. Yes. 11 Q. Go ahead? 12 A. Approximately eighty patients. 13 Q. Eighty patients out of eight 14 hundred thirty-nine actually completed the study? 15 A. Yes. 16 Q. That's including both phases? 17 A. That's including both phases. 18 Q. The first phase was an open 19 label phase? 20 A. Correct. 21 Q. How long was that phase? 22 A. Twelve weeks. 23 Q. How many patients, if you can 24 recall, completed the first phase? Page 51 1 A. Let me clarify something. 2 MR. MYERS: Sure, go ahead. 3 A. The study actually was three 4 phases, phase one was from the one thousand four 5 to the eight thirty-nine which was a -- it was a 6 wash out phase, no drug involved. 7 Q. So was it placebo at all or 8 anything like that or was it nothing? 9 A. None. 10 Q. How long did that last? 11 A. Just one to two weeks. 12 Q. So, then after that, one 13 thousand four patients started out in that first 14 phase and by then eight hundred and thirty-nine 15 patients were left? 16 A. Correct. 17 Q. Okay. So any particular reason 18 why almost two hundred patients dropped out 19 during that phase? 20 A. They didn't meet the criteria. 21 Q. So, it was a matter of being 22 excluded as opposed to excluding themselves? 23 A. Both. 24 Q. Okay. Do you know if it was Page 52 1 more of a higher percentage of patients that were 2 dropped during that phase, were they dropped by 3 Lilly or was it their decision? 4 A. I'm not sure. 5 Q. Then what was phase two of that 6 study? 7 A. Phase two was the open label 8 phase. 9 Q. Okay. And everybody -- did 10 everybody get Fluoxetine during that phase? 11 A. Yes. 12 Q. And that's the phase that 13 lasted twenty-three weeks? 14 A. Correct. 15 Q. How many patients were left 16 after that phase, is that the eighty? 17 A. No. 18 Q. Okay. 19 MR. MYERS: Did you say that was twelve 20 weeks, is that what he said? 21 MS. ZETTLER: Yes. 22 A. Three hundred ninety-five. 23 Q. And then the third phase, was 24 that a double or single blind? Page 53 1 A. Double. 2 Q. Using Fluoxetine and a placebo? 3 A. Yes. 4 Q. And three hundred ninety-five 5 patients entered that third phase? 6 A. Yes. 7 Q. And at the end there were 8 eighty left approximately? 9 A. Approximately. 10 Q. How long was the second phase, 11 the double blind study? 12 MR. MYERS: You mean the third phase? 13 MS. ZETTLER: The third phase, I'm 14 sorry. 15 A. Fifty weeks. 16 Q. Of the -- you're making me do 17 math here? 18 (A SHORT RECESS WAS TAKEN.) 19 Q. And this was HCEX, right? 20 A. Yes. 21 Q. When the patients were enrolled 22 in the study, were they asked to participate 23 throughout all three phases? 24 A. Yes. Page 54 1 Q. And including the fifty week 2 double blind portion, correct? 3 A. Yes. 4 Q. So it wasn't a matter of giving 5 them the option after the end of phase two to 6 continue on with the double blind portion if they 7 wanted to? 8 A. Given the option, no. 9 Q. Okay. Were you involved in 10 reviewing the clinical report forms that came in 11 on the study? 12 A. Yes. 13 Q. Three hundred and ninety-five 14 patients went into the second phase, the open 15 label phase, right? 16 A. Correct. 17 MR. MYERS: No. 18 Q. I'm sorry, the third phase, the 19 double blind phase? 20 A. Yes. 21 Q. Okay. I want to make sure I'm 22 getting this right. And that was down from eight 23 hundred thirty-nine people approximately? 24 A. Yes. Page 55 1 Q. Now, what reasons did people 2 drop out of that study generally? 3 MR. MYERS: At what point? 4 MS. ZETTLER: Before the third phase. 5 Q. Out of approximately four 6 hundred people that dropped out of the study, 7 what were the various reasons? 8 A. Patient decision. 9 Q. Okay. 10 A. Some adverse events, we had -- 11 I lost my thought here, excuse me. Efficacy 12 criteria not met and some patients were what we 13 called lost to follow-up. 14 Q. Okay. To your knowledge, did 15 anybody commit suicide on that study? 16 A. You mean successfully? 17 Q. Let's start with successfully, 18 did anybody actually kill themselves while 19 participating in that study? 20 A. No. 21 Q. Did anybody try? 22 A. Yes. 23 Q. How many people, to your 24 knowledge? Page 56 1 A. It was a small number, around 2 ten or less. 3 Q. Were any of those people on 4 Doctor Fawcett's portion of the study? 5 A. I don't recall. 6 Q. Were those some of the people, 7 do you remember what phase these people tried to 8 kill themselves? 9 A. Specifically? 10 Q. Uh-huh, yes. 11 A. All patients. 12 Q. Well, I mean if some of them 13 tried and -- 14 A. It was random, however most of 15 them occurred in phase two but it was random. 16 Q. Phase two is the twelve week 17 open label Fluoxetine portion, correct? 18 A. Yes. 19 Q. To your knowledge, did any 20 patients suffer suicidal ideation other than an 21 actual attempt while on the study? 22 A. Yes. 23 Q. How many occasions did that 24 happen to your knowledge? Page 57 1 A. I don't know. 2 Q. Was it more than ten? 3 A. I would really be guessing. 4 MR. MYERS: Don't guess. 5 Q. Do you remember during which 6 phase of the study that occurred, most 7 predominantly? 8 A. No. 9 Q. To your knowledge, is Doctor 10 Fawcett a consultant for Eli Lilly on the 11 suicidality issue at any time? 12 A. I'm not aware of any. 13 Q. Do you know if he ever 14 participated in a retrospective analysis of 15 clinical trial data other than his own study with 16 regards to suicidality in Fluoxetine? 17 A. I'm not familiar. 18 Q. Are you aware of any 19 rechallenging studies that are being performed or 20 have been performed on Fluoxetine at Lilly or on 21 behalf of Lilly? 22 A. No. 23 Q. Are you aware of any studies 24 that have been done specifically to measure Page 58 1 suicide or suicidal ideation in patient on 2 Fluoxetine? 3 MR. MYERS: By -- 4 MS. ZETTLER: By Lilly or anybody on 5 behalf of Lilly. 6 A. Not that I can recall. 7 Q. Are you working on any other 8 Fluoxetine studies right now other than the HCEX? 9 A. No. 10 Q. Have you worked on any other 11 studies yet besides HCEX? 12 A. No. 13 Q. Do you keep an investigative 14 file on the investigators on HCEX? 15 A. Yes. 16 Q. What kinds of materials were in 17 those files? 18 A. Letter of agreement, grant 19 information, budget information, correspondence, 20 clinical trial shipment material information, 21 shipment of material, that's basically it. 22 Q. Would the 1572 forms we were 23 talking about earlier, would they be contained in 24 that file? Page 59 1 A. Yes. 2 Q. Are you familiar with what an 3 investigational review board is? 4 A. Briefly. 5 Q. Okay. Can you tell me what 6 your understanding of what that is? 7 A. They are -- they're a review 8 board that is responsible for the institutional -- 9 for the institution where the clinical trial is 10 being conducted and every study that goes on 11 under that in that institution must be approved 12 by that review board. 13 Q. Okay. Earlier you testified 14 that it was your belief that Doctor Fawcett's 15 portion of this study was performed at Rush 16 Presbyterian Hospital in Chicago, correct? 17 A. Correct. 18 Q. Would the investigational 19 review board be something that was set up by Rush 20 Presbyterian as opposed to Lilly? 21 A. To the best of my knowledge, it 22 would have been by Rush Presbyterian. 23 Q. The investigational review 24 boards are not related to Lilly? Page 60 1 A. No . 2 Q. And they're not related 3 directly to the FDA, are they? 4 A. No. 5 Q. But the FDA requires 6 investigational review board committee approval 7 of a study before a study can be conducted, 8 correct? 9 A. Correct. 10 Q. Did you have an investigator 11 file on each of those five investigators that 12 participated in HCEX? 13 A. Yes. 14 Q. Were there any other CRAs that 15 worked on this study besides you? 16 A. Yes. 17 Q. What were their names? 18 A. Pam Burke. 19 Q. B-U-R-K-E? 20 A. E, I believe. Carol Drew, 21 D-R-E-W, Jan Pfeil-Doyle. 22 Q. Spell that one for sure. 23 A. P as in Paul, F-E-I-L hyphen 24 D-O-Y-L-E. Page 61 1 Q. Anybody else? 2 A. That's it. 3 Q. Okay. Who's the clinical 4 research physician or physicians who worked on 5 that study? 6 A. Doctor Charles Beasley. 7 Q. Okay. Is that it? 8 A. That's it. 9 Q. Is Doctor Beasley your direct 10 superior in the group on that study? 11 A. No. 12 Q. Who was your direct superior? 13 A. Carol Zapapas, Z-A-P-A-P-A-S. 14 Q. Have you participated in any 15 way on the analysis of the data gathered from 16 HCEX? 17 A. The actual analysis of the 18 data, no. 19 Q. Besides filling out -- you 20 doing the clinical report forms or what was 21 entered into the data bases, et cetera, were you 22 involved in any way in either gathering the 23 information or analyzing it for the report, final 24 report? Page 62 1 A. I did no analyzing, that was 2 all done by statistics, by our statistician and 3 research physician. 4 Q. Do you have any idea as to how 5 the blinded portion of the study was randomized? 6 A. Yes. 7 Q. Can you explain that to us? 8 A. There were four arms involved 9 in the randomized phase of the study. 10 Q. Okay. 11 A. Which consisted of Fluoxetine 12 for fifty weeks, that was one arm, another arm 13 was placebo for fifty weeks, third arm was 14 Fluoxetine for fourteen weeks and placebo for the 15 the remainder of the fifty week period, then the 16 fourth and final arm was Fluoxetine for 17 thirty-eight weeks and placebo for the remaining 18 twelve weeks. 19 Q. Do you know what department at 20 Lilly, if any, packaged the drugs and randomized 21 it during the double blind phase? 22 A. Clinical trial designs 23 coordinations group. I'm not sure if that's the 24 exact name of the group but -- Page 63 1 Q. Do you know what somebody 2 within that division or that department would be 3 the person who would have ultimate knowledge as 4 to what patient was getting Fluoxetine and what 5 patient was getting placebo at any given time? 6 A. Yes. 7 Q. Would anybody within your 8 group, any CRA for instance, in your group have 9 that information? 10 A. Yes. 11 Q. Would you have that 12 information? 13 A. No. 14 Q. Who in your group had that 15 information? 16 A. We had an unblinded CRA who 17 handled all that. 18 Q. I'm sorry? 19 A. We had an unblinded CRA which 20 may or may not have been the same person 21 throughout the full length of the study. 22 Q. Who was that person? 23 A. While I had the study, it was 24 Charles Robinson. Page 64 1 Q. So if somebody who was 2 participating in the study said we need to be 3 hospitalized for some reason, the doctor could 4 contact Mr. Robinson and find out what that 5 patient was taking at that particular time? 6 A. Correct. 7 Q. Are you familiar with a disease 8 called tardive dyskinesia? 9 A. Yes. 10 Q. Is that a concern during the 11 HCEX study? In other words, was that something 12 that the investigators were looking for? 13 A. Not to my knowledge. 14 Q. How about akathisia, have you 15 ever heard of that disease? 16 A. Yes. 17 Q. Were they looking for that, 18 symptoms of that throughout the study? 19 A. Would you clarify as to whether 20 or not what you mean by were they looking for it? 21 Q. Were they paying particularly 22 close attention to possible adverse events 23 related to either one of those disorders? 24 A. Yes and no. Page 65 1 Q. Okay. What do you mean by 2 that? 3 A. If they -- if those disorders 4 were identified, then they were handled in a very 5 serious manner. Now meaning if they went -- if 6 they specifically went out to look for that, I 7 don't think so, I don't think that was the 8 objective of the study. 9 Q. Okay, fair enough. Are you 10 familiar with the ELECT dictionary? 11 A. Yes. 12 Q. Can you tell us what that is? 13 A. It's the Eli Lilly and Company 14 classification terms dictionary. 15 Q. When you came on at Lilly, were 16 they using the ELECT dictionary for terminology 17 with adverse events? 18 A. Yes. 19 Q. Were you -- at some point in 20 time did they switch from the ELECT dictionary to 21 the COSTART dictionary? 22 A. Not for my study. 23 Q. Okay. Did they ever switch 24 dictionaries on your study? Page 66 1 A. They meaning? 2 Q. Did Lilly ever switch, in other 3 words was it used consistently throughout the 4 study you worked on? 5 A. Yes. 6 Q. How about the World Health 7 Organization, the WHO dictionary, was that used 8 at anytime during your study? 9 A. No, the -- you mean the 10 COSTART? 11 Q. Have you ever hard of the WHO 12 ART dictionary? 13 A. Yes. 14 Q. Was the WHO ART dictionary used 15 during your study? 16 A. No. 17 Q. Do you know what the host is, 18 have you ever heard of the host? 19 A. I know what a host is. 20 Q. Okay. Have you ever heard of 21 the host data base? 22 A. Yes, I know what a host data 23 base is. 24 Q. What's the host data base? Page 67 1 A. It's the main data base, it's 2 the main computer, it's a data base for a 3 computer frame where all the data from the PCs 4 are placed into. 5 Q. Okay. Have you ever heard of a 6 PIP-V, P-I-P-V? 7 A. Yes. 8 Q. What's that? 9 A. Stands for patient investigator 10 visit and another P -- project. 11 Q. What's a kit number, if you 12 know, K-I-T number? 13 A. Kit number is the number that 14 corresponds to the randomized therapy, it tells 15 you exactly what therapy the patient was on. 16 Q. Okay. Was the COSTART 17 dictionary used at any time during the HCEX 18 study? 19 A. No. 20 Q. What's your understanding of 21 what happens with regards to reporting of adverse 22 events that occurred during the clinical trials? 23 A. They are reported to the Food 24 and Drug Administration. Page 68 1 Q. What's the process for -- 2 what's the process at Lilly as far as what 3 happens when the reports come in? 4 A. The reports -- first of all, 5 the adverse events are reviewed on a daily basis 6 by both the CRA and the research physician, 7 checking for consistency in the class terms as 8 well as the actual term. Depending on whether or 9 not it's a serious adverse event, it is -- if 10 it's a serious adverse event, it is reported to 11 the FDA on a form called a 1639. If it's not a 12 serious adverse event, it's still followed up, we 13 still take a look at the event to determine the 14 severity of it, and whether or not it abated on 15 some other terminations from that. 16 Q. Did you say if it's not a 17 serious event, you still look at it? 18 A. Yes. 19 Q. Are non-serious events reported 20 to the FDA? 21 A. Yes. 22 Q. At some point in the process, 23 somebody assigns an event term from the ELECT 24 dictionary to that adverse event, correct? Page 69 1 A. Yes. 2 Q. To your knowledge, were those 3 event terms ever changed after it was entered in 4 the DEN dictionary -- I'm sorry, the DEN data 5 base? 6 MR. MYERS: Let me object to the form, 7 I don't know there's been any testimony about DEN 8 yet. 9 Q. Let me ask you this, after the 10 information is gathered and the event terms are 11 assigned, at some point in time the information 12 is entered into a data base, correct? 13 A. Correct. 14 Q. This is the Drug Experience 15 Network data base? 16 A. Correct. 17 Q. Okay. And that information is 18 collected within the data base for the entire 19 study, correct? 20 A. Yes. 21 Q. At any point in time were the 22 event terms that were assigned to the adverse 23 events that occurred during the HCEX, assigned 24 new event terms pursuant to dictionaries other Page 70 1 than the ELECT dictionary? 2 A. Not to my knowledge. 3 Q. Okay. To your knowledge, was 4 that done with any other study? 5 MR. MYERS: Was what done? 6 MS. ZETTLER: Changing of the event 7 terms assigned to adverse events. 8 MR. MYERS: At what point? 9 Q. At any point in time that you 10 were aware of? 11 A. I'm only familiar with one 12 actual event changing accidental injury to injury 13 accident or vice versa, I can't recall, that's 14 the only thing. 15 Q. Was that done on the HCEX 16 study? 17 A. Yes. 18 Q. Why was that done, do you know? 19 A. For consistency purposes. 20 Q. Consistency with what? 21 A. To make sure every event across 22 the whole Fluoxetine data base was used 23 consistently, instead of having one event as 24 being termed as accidental injury and another Page 71 1 injury accidental -- injury accident, they looked 2 like two different events when actually they were 3 the same event, so to try to be more consistent. 4 Q. Okay. I don't -- what's the 5 difference as far as -- in other words are you 6 saying that people, some people were calling it 7 accidental injury and some people were calling it 8 injury accidental? 9 A. Correct. 10 Q. So it was really just a matter 11 of solidifying what everybody was calling it 12 across the board? 13 A. Correct. 14 Q. It wasn't different types of 15 events? 16 A. No. 17 Q. Are you familiar with the WHO 18 ART dictionary, World Health Organization 19 dictionary? 20 A. My understanding is that the 21 WHO ART, what you're calling it, creates the 22 COSTART. 23 Q. Okay. Have you ever seen a 24 COSTART dictionary? Page 72 1 A. Yes. 2 Q. Do you remember which edition 3 you saw? 4 A. No, I didn't. 5 Q. Are you familiar with the 6 dictionary? 7 MR. MYERS: Which one? 8 MS. ZETTLER: COSTART. 9 A. Not real familiar since I 10 haven't worked with it. 11 Q. Are you familiar that it's 12 broken down into four or five, what they call 13 indexes? 14 A. No. 15 (PLAINTIFFS' EXHIBIT NO. 1 WAS 16 MARKED FOR IDENTIFICATION AND 17 RECEIVED IN EVIDENCE.) 18 Q. Have you had an opportunity to 19 review Exhibit 1, Mr. Marks? 20 A. I'm sorry. 21 Q. Have you had an opportunity to 22 review Exhibit 1? 23 A. Uh-huh. 24 MR. MYERS: Yes. Page 73 1 A. Yes. 2 Q. Are you familiar with the 3 subject of that E-mail? 4 A. Yes. 5 Q. What are WHO terms? 6 A. Specific WHO terms? 7 Q. Generally first, what are WHO 8 terms? 9 A. Terms set up by the World 10 Health Organization dictionary. 11 Q. Now, and per your definition, 12 the World Health Organization dictionary is the 13 same thing as COSTART? 14 A. Yes. 15 Q. Are you saying that they're one 16 and the same or that they're identical in their 17 purpose? 18 A. I'm saying that COSTART 19 contains World Health Organization terms. 20 Q. It's your understanding that 21 World Health Organization has their own separate 22 dictionary? 23 A. Yes. 24 Q. Why did they say here that they Page 74 1 were using WHO terms as opposed to COSTART terms, 2 if you know? 3 A. I don't know. 4 Q. Was something similar to that 5 done on the HCEX study? 6 A. No. 7 Q. Why is it done on these five 8 studies and not on the HCEX study, if you know? 9 A. I have no idea. 10 Q. Did you work with quality 11 assurance people on the HCEX study? 12 A. Yes. 13 Q. My understanding is there's two 14 separate groups at Lilly, ones a QA group and the 15 other is I think a CIA or CIR or something that 16 go out and do audits of the sites? 17 A. Yes. 18 Q. Any of those people ever 19 complain about the quality of the work that's 20 being done at any of the sites on HCEX? 21 MR. MYERS: I object to the form, what 22 do you mean by complain? 23 Q. Did they ever notify you that 24 there were any problems with the work that was Page 75 1 being done at the sites, for instance, any 2 problems with reporting or problems with protocol 3 compliance or anything of that nature? 4 A. None that I can remember. 5 Q. Have you ever had the occasion 6 to report an investigator to the FDA as a result 7 of something that was done on a study? 8 A. No. 9 Q. You smiled at that, why did you 10 smile -- you smiled when I asked you that, why 11 did you smile? 12 A. Just an amazing question. 13 Q. Fair enough. Are you familiar 14 with the Fluoxetine international project? 15 A. No. 16 Q. Did you have any responsibility 17 with regards to the collecting of data from 18 international trials? 19 A. No, I didn't. 20 Q. Are you familiar with an 21 investigator name Doctor Cohn, C-O-H-N? 22 A. No. 23 Q. Do you know what the subject 24 matter of any of the studies listed in Exhibit 1 Page 76 1 mean? 2 A. Specifically, no. 3 Q. Generally were they all related 4 to Fluoxetine? 5 A. According to the message, yes. 6 MS. ZETTLER: Can we take a ten minute 7 break? 8 MR. MYERS: Sure. 9 (A SHORT BREAK WAS TAKEN.) 10 (PLAINTIFFS' EXHIBIT NO. 2 WAS 11 MARKED FOR IDENTIFICATION AND 12 RECEIVED IN EVIDENCE.) 13 Q. Mr. Marks, have you had a 14 chance to review Exhibit 2? 15 A. Yes, I have. 16 Q. Do you recognize that document? 17 A. Yes. 18 Q. Can you tell me what it is? 19 A. An electronic mail of a site 20 inspection report from my clinical research 21 monitors who were at one of my investigative 22 sites. 23 Q. Okay. Now, on the first page 24 in the large letters, it says PFEIL. Page 77 1 A. Uh-huh. 2 Q. What's that mean, if you know? 3 A. That's someone's name. 4 Q. Okay. This is that -- 5 MR. MYERS: Miss Pfeil-Doyle. 6 Q. Pfeil-Doyle that you were 7 talking about earlier? 8 A. Yes. 9 Q. At the top of the first -- or 10 second page, I'm sorry of the exhibit, actually 11 about almost halfway down, it looks like a 12 warning, a little box with a warning. 13 A. Okay . 14 Q. It says the following has been 15 received from an external organization. 16 A. Uh-huh, yes. 17 Q. And in this case, what would 18 the external organization be? 19 A. It was PRN Contract Research 20 Nursing Group that we hired to monitor the study. 21 Q. So Miss Pfeil-Doyle was with 22 this PRN group? 23 A. No, that's not correct. Miss 24 Pfeil-Doyle was my partner in the study. Page 78 1 Q. What does it mean that the 2 following has been received of an external 3 organization, what has been received, this 4 message? 5 A. Correct. 6 Q. Would this Janet Lewis and Pat 7 Prior who are listed under site inspection 8 report, would they be the nurses? 9 A. Correct. 10 Q. Right above that box on the 11 lefthand side it says Reimherr, R-E-I-M-H-E-R-R, 12 can you tell me what that is, if you know? 13 A. Above the warning? 14 Q. The warning box on the left 15 hand side. 16 A. Reimherr? 17 Q. Right. 18 A. Appears to be a name. 19 Q. Okay. Do you know whose name 20 that is? 21 A. That's the name of one of my -- 22 of one of the affiliated clinical investigators 23 on the study. 24 Q. Is this the HCEX study? Page 79 1 A. Yes. 2 Q. And this would be a Doctor 3 Reimherr who was a clinical investigator on that 4 study? 5 A. Correct. 6 Q. So in addition to Doctor 7 Fawcett, Doctor Reimherr was one of the 8 investigators? 9 A. Yes. 10 Q. And this report that makes up 11 Exhibit 2 is an audit report on Doctor Reimherr's 12 site? 13 A. It's a site inspection report. 14 Q. For his site or her site, is it 15 a he or she? 16 A. His site. 17 Q. So is it a report regarding his 18 site? 19 A. Site inspection report. 20 Q. What's Doctor Reimherr's first 21 name? 22 A. I believe it's Fred. 23 Q. Okay. Earlier when we were 24 talking about the numbers of patients that were Page 80 1 enrolled in the study, was that a total number of 2 patients that were enrolled or was that just for 3 Doctor Fawcett's portion of the study? 4 A. That was a total. 5 MR. MYERS: Nancy, when you asked that 6 question, are you talking about the several 7 groups of numbers that you talked about? 8 MS. ZETTLER: Right, I just want to 9 know if we are talking about the entire study all 10 together or just Doctor Fawcett's individual 11 study. 12 Q. So your answer was that it was 13 the entire study? 14 A. Yes. 15 Q. At the bottom or sort of 16 towards the bottom, it says CRA responsible, does 17 that list your name, correct? 18 A. Correct. 19 Q. What does CTM study mean? 20 A. Clinical trials management 21 system. 22 Q. What is that? 23 A. It's a computer system that 24 allows the sponsor and the investigative sites to Page 81 1 transmit the data to the sponsor electronically. 2 Q. Did Doctor Reimherr use 3 computers at his site to record information 4 gathered on patients? 5 A. Yes. 6 Q. So through the CTM study he 7 could transfer that information electronically as 8 opposed to sending hard copy forms to the CRF? 9 A. Correct. 10 Q. Is that true with Doctor 11 Fawcett also? 12 A. Correct? 13 Q. Where is Doctor Reimherr 14 located? 15 A. Geographically? 16 Q. Right. 17 A. Salt Lake City, Utah. 18 Q. So cool, we get to go to Salt 19 Lake. 20 A. You may not like it. 21 Q. Who is Monica Frey, F-R-E-Y? 22 A. She is the manager of Janet 23 Lewis and Pat Prior, so she works for PRN. 24 Q. To your knowledge, was it a Page 82 1 common occurrence on the HCEX study where an 2 outside source would be hired to do audits? 3 A. At the time it was not a common 4 occurrence, it was a pilot basically, this study 5 was one of the first studies that utilized 6 outside contractors to monitor. 7 Q. Okay. Do you know did they do 8 that on a regular basis now? 9 A. Yes. 10 Q. They -- 11 MR. MYERS: They who? 12 MS. ZETTLER: Lilly. 13 A. Lilly, yes. 14 Q. At the bottom it says 15 enrollment and it lists some numbers and says 16 enter screen, do you see that area? 17 A. Yes. 18 Q. What does that mean where it 19 says one hundred seventeen entered screened? 20 A. It means that one hundred 21 seventeen patients were placed into study period 22 one. 23 Q. And then the numbers afterwards 24 was fifty-eight discontinued before enrolled, Page 83 1 does that mean that those fifty-eight did not 2 enter study period one? 3 A. No. 4 Q. What does that mean? 5 A. It means that fifty-eight did 6 not enter study period two. 7 Q. Okay. And fifty-nine were 8 enrolled in -- did enter study period two and 9 were randomized or is that study period three? 10 A. That's study period three. 11 Q. Okay. 12 Q. Are these numbers just for this 13 site? 14 A. Yes, just for this site. 15 Q. If only fifty-eight people 16 entered study period two, how did fifty-nine 17 people become enrolled in study period three? 18 A. Well, I'm sorry, let me clarify 19 something. 20 Q. Okay. 21 A. The point at which that 22 information was based off of was study period 23 three, so out of a hundred seventeen people who 24 went into -- who were enrolled into the study Page 84 1 initially, only fifty-nine went on to study 2 period three. 3 Q. Okay. 4 A. Fifty-eight of the one hundred 5 seventeen were discontinued between study periods 6 one and three. 7 Q. Okay. What's the extension 8 phase, is that that third phase? 9 A. Yes. 10 Q. Why does it say not applicable 11 active and extension phase? 12 A. Because at the time in which 13 the CRMs or clinical research monitors conducted 14 their work, the study was over at that site. 15 Q. So this is more or less a 16 review of the information after this study was 17 completed? 18 A. Correct. 19 Q. Do you know if there were any 20 audits at this site while it was still ongoing? 21 A. Yes, there were audits at this 22 site. 23 Q. Would you have kept reports 24 like this in your file regarding those audit Page 85 1 visits? 2 A. In our main investigative 3 files, yes. 4 Q. So the investigator files that 5 you kept on Doctor Fawcett and Doctor Reimherr 6 and the other three, I believe, investigators 7 would have contained this type of information if 8 it existed? 9 A. Yes. 10 Q. On the second page or I'm 11 sorry, the third page Pz 2109 92. 12 A. Uh-huh, yes. 13 Q. Is that what we were talking 14 about earlier, the screening questionnaires? 15 A. Yes. 16 Q. It says here SCIDs are 17 incomplete for all patients blank, do you have 18 any idea what blank is? 19 A. I have no idea. 20 Q. Okay. What do they mean by 21 data missed is not consistently the same section 22 for each patient? 23 A. It would mean that whatever 24 data that was omitted in completing the SCID was Page 86 1 not consistently omitted across all patients. 2 Q. Okay. So he may have filled 3 out one section on one patient but not on another 4 patient? 5 A. Correct. 6 Q. Is that a problem? 7 A. No. 8 Q. Is that a protocol violation? 9 A. No. 10 Q. And the SCIDs are used to 11 basically screen the patients too, aren't they? 12 A. Yes. 13 Q. Do you know, was it an 14 exclusion criteria in that study to -- was it a 15 criteria in that study to exclude anybody who was 16 suffering from serious suicidal ideation? 17 A. It was an exclusion criteria 18 for patients who were at risk for suicidal 19 ideation. 20 Q. Okay. Did the SCIDs, to your 21 knowledge, have a section on suicidal ideation or 22 suicide attempt? 23 A. Specifically, I don't recall. 24 Q. On the fourth, under number two Page 87 1 or D it says SCID data was not transferred 2 correctly to visit one and there are many 3 discrepancies between, and it looks like SCID 4 again, and then MDDA, DSM, and GAF. Is that MDDA 5 the scale you were talking about earlier on major 6 depressive disorders? 7 A. Yes. 8 Q. Is DSM, is that the DSM 3 9 criteria? 10 A. Yes. 11 Q. How about the GAF, what is GAF? 12 A. Global assessment functioning 13 scale. 14 Q. Okay. 15 Q. Did you ever personally have a 16 problem with any of the work that your 17 investigators did on HCEX? 18 A. Personally? 19 Q. Right. 20 A. No. 21 Q. Did you use all of those 22 investigators again on other trials? 23 A. I don't make those decisions. 24 Q. If you had the choice, would Page 88 1 you? 2 A. I really can't -- I really 3 can't make that type of statement as to whether 4 or not because -- 5 Q. I'm not going to ask you about 6 anybody in particular. 7 A. Well, I don't think that I'm 8 qualified to select the qualifications, the 9 proper qualifications for clinicians. 10 Q. I'm not talking their 11 qualifications, I'm talking about the work that 12 you observed that they did on their various 13 trials on their HCEX. Based on that, if you were 14 given the chance, would there be any of those 15 five investigators that you would not ask to do 16 another clinical trial? 17 MR. MYERS: Mr. Marks, before you 18 answer, if you are able to answer the question 19 certainly do that but if you're not able to do 20 that, tell Ms. Zettler that. 21 A. And that question I'm not able 22 to answer. 23 Q. Has anybody at Lilly told you 24 not to criticize the work of any of those Page 89 1 investigators? 2 A. No. 3 Q. Other than your 4 responsibilities with regards to HCEX that we 5 already talked about, do you have any other 6 responsibilities with regards to Fluoxetine at 7 the present time? 8 A. No. 9 Q. Are you still working on HCEX? 10 A. Yes. 11 Q. What are you doing right now? 12 A. Preparing the final report. 13 Q. What are you doing to prepare 14 the final report? 15 A. Working with our statistician, 16 medical writer, research physician, and basically 17 just assembling the data into an easy to read 18 report format. 19 Q. Are you going to be listed as 20 one of the authors on that report? 21 A. Yes. 22 Q. Have you been listed as an 23 author on any other reports? 24 A. No. Page 90 1 Q. Are you going to be listed -- 2 if they publish an article, are you going to be 3 listed as one of the authors on that? 4 A. I'm not sure. 5 Q. You already said that the 6 clinical research physician is Doctor Beasley, 7 correct? 8 A. Correct. 9 Q. Who's the statistician? 10 A. Paul Roback. 11 Q. Can you spell the last name? 12 A. Yes, R-O-B-A-C-K. 13 Q. And who was the medical writer 14 on that? 15 A. Her name is Jan Potvin. 16 Q. Anybody else working on that 17 report with you and Doctor Potvin, and Doctor 18 Beasley and Mr. Roback? 19 A. Yes, we had a systems analyst. 20 Q. Who's that? 21 A. His name is Charlie Haddad. 22 Q. Is another investigator on HCEX 23 Doctor Kline? 24 A. No. Page 91 1 Q. To your knowledge, have any 2 clinical investigators working on Fluoxetine been 3 fired by Lilly in the course of their work on the 4 clinical trial? 5 A. Not to my knowledge. 6 Q. To your knowledge, have any of 7 the investigators working on Fluoxetine been 8 reported to the FDA by Lilly? 9 A. Not to my knowledge. 10 Q. Are you aware that the FDA does 11 periodic site audits of various clinical trial 12 sites? 13 A. Yes. 14 Q. Has anybody from the FDA ever 15 contacted you or anybody at Lilly to your 16 knowledge, regarding the quality of work that was 17 done on HCEX? 18 A. No. 19 MS. ZETTLER: That's all I have. No 20 further questions. 21 MR. MYERS: Let me put this on the 22 record, Nancy, obviously the study documents for 23 HCEX have not been collected and thus have not 24 been prepared for production and the reason for Page 92 1 that is because the study has not been completed 2 yet in terms of the report, and I just want that 3 to be clear on the record. If it's not -- if you 4 already were not produced that and at such time 5 as those documents are collected and prepared and 6 produced, we will simply have to deal with that 7 issue as it relates to Mr. Marks. 8 MS. ZETTLER: Okay -- well, two things. 9 First of all, I don't think the investigator file 10 is something that needs to be collected and 11 prepared before they could be produced in the 12 situation and those were obviously in Mr. Marks' 13 files and they were not produced. Number two, I 14 had asked that in collecting and preparing the 15 document for HCEX that you do not take out things 16 that have not been ruled on by Judge Potter yet, 17 such as patient numbers and investigator numbers 18 and other identifying information that has been 19 done previously on other documents. You will 20 save yourself a lot of time and money not to do 21 that at this point. 22 MR. MYERS: Just to respond so it is 23 clear, I don't want to quarrel about it, we are 24 going to prepare the documents pursuant to the Page 93 1 order or orders that exist or that will exist in 2 the case. 3 MS. ZETTLER: Okay. No further 4 questions. 5 MS. LAWS: No questions. 6 MR. CLEMENTI: No questions. 7 MS. BRODSKY: No questions. Page 94 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 KEVIN MARKS 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 7TH DAY OF 19 SEPTEMBER, 1993. 20 MY COMMISSION EXPIRES MARCH 10, 1994. 21 22 23 _________________________ MARY KATHLEEN NOLD 24 COURT REPORTER AND NOTARY PUBLIC STATE OF KENTUCKY AT LARGE Page 95 1 2 E R R A T A S H E E T 3 4 COMMONWEALTH OF KENTUCKY ) : SS 5 COUNTY OF JEFFERSON ) 6 7 I, KEVIN MARKS, THE UNDERSIGNED 8 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 9 OF MY DEPOSITION AND WITH THE CHANGES NOTED 10 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 11 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 12 THE AUGUST 13, 1993 AT THE TIME AND PLACE STATED 13 THEREIN. 14 PAGE NO. LINE NO. CHANGE REASON Page 96 1 2 PAGE NO. LINE NO. CHANGE REASON 3 4 5 6 7 8 9 _____________________________ 10 KEVIN MARKS 11 SWORN TO AND SUBSCRIBED BEFORE ME THIS 12 _____ DAY OF __________, 1992. 13 _____________________________ NOTARY PUBLIC, STATE OF 14 KENTUCKY AT LARGE Page 97 1 DIRECT EXAMINATIONBY MS. ZETTLER.................14 2 (QUESTION CERTIFIED...............................39 3 (QUESTION CERTIFIED.).............................41 4 (PLAINTIFFS' EXHIBIT NO. 1.......................73 5 (PLAINTIFFS' EXHIBIT NO. 2 ......................77 6 COMMONWEALTH......................................95 7 E R R A T A.......................................96 8 9 10 11 12 13 14 15 16 17 18 Page 99