1 1 NO. 90-CI-6033 JEFFERSON CIRCUIT COURT 2 DIVISION ONE 3 JOYCE FENTRESS, et al., 4 Plaintiffs, 5 6 vs. 7 8 SHEA COMMUNICATIONS, et al., 9 Defendants. 10 11 The deposition upon oral examination of 12 DANIEL G. RUSSELL, a witness produced and sworn 13 before me, Wendi K. Sulkoske, Notary Public in and 14 for the County of Marion, State of Indiana, taken on 15 behalf of the Plaintiff at the offices of Baker & 16 Daniels, 300 North Meridian Street, Suite 2700, 17 Indianapolis, Indiana, on June 9, 1993, pursuant to 18 the Indiana Rules of Trial Procedure. 19 20 21 ASSOCIATED REPORTING, INC. 251 E. OHIO, SUITE 940 22 INDIANAPOLIS, INDIANA 46204 (317) 631-0940 23 2 1 APPEARANCES 2 FOR THE PLAINTIFF: LAW OFFICES OF LEONARD M. RING By: Nancy A. Zettler 3 and LAW OFFICES OF LEONARD L. FINZ 4 By: Gregory Green 5 FOR THE DEFENDANT SHOOK HARDY & BACON 6 UPJOHN: By: Robert J. McCully 7 FOR THE DEFENDANT OGDEN NEVELL & WELCH 8 DR. LEE COLEMAN: By: Gregory J. Bubalo 9 FOR THE DEFENDANT BAILEY AND WILLIAMS 10 DRS. WITSCHY and By: Katherine L. Laws KANNEGANT: 11 12 FOR THE DEFENDANT BOEHL STOPHER & GRAVES ELI LILLY: By: Edward H. Stopher 13 14 FOR THE DEFENDANT ELI LILLY and COMPANY ELI LILLY: By: Michael J. Harrington 15 Curtis G. Oltmans 16 FOR THE DEFENDANT FREEMAN & HAWKINS 17 ELI LILLY: By: Lawrence J. Myers 18 FOR THE DEFENDANT CLAUSEN MILLER GORMAN CAFFREY 19 R. CZECHOWICZ, & WITOUS P. Fink and 20 W. Bruinsma: By: Barry Kroot 21 FOR THE DEFENDANT CASSIDY SCHADE & GLOOR 22 GOOD SHEPHERD: By: Denise Brodsky 23 3 1 2 INDEX OF EXAMINATION 3 Page 4 EXAMINATION 5 QUESTIONS BY MS. ZETTLER 5 6 EXAMINATION QUESTIONS BY MR. GREEN 11 7 EXAMINATION 8 QUESTIONS BY MS. ZETTLER 136 9 10 11 12 EXHIBIT INDEX 13 ITEM PAGE 14 Exhibit No. 1 . . . . . . . . . . 209 15 16 17 18 19 20 21 22 23 5 1 D A N I E L R U S S E L L 2 having been first duly sworn to tell the truth, 3 the whole truth, and nothing but the truth was 4 examined and testified as follows: 5 MS. ZETTLER: Let the record 6 reflect this is the deposition of -- 7 Q. Could you state your full name? 8 A. Daniel George Russell. 9 Q. Okay. 10 MS. ZETTLER: Let the record 11 reflect this is the discovery deposition of 12 Daniel G. Russell taken pursuant to notice. 13 Q. Have you ever given a deposition before? 14 A. No, I have not. 15 Q. Let me tell you about some ground rules so 16 things can go smoothly. 17 MS. LAWS: We are here on this 18 case from different states. Under the Texas 19 Rules of Civil Procedure we would reserve all 20 objections except to the form and 21 responsiveness. I don't know how you all 22 want to handle that sort of thing. 23 MR. MYERS: That is fine. 6 1 Miss Zettler has given the court reporter the 2 notice in the Fentress case and the 3 deposition has been cross-noticed in all of 4 what we will call the MDL cases. I will ask 5 that either the caption so reflect, or that 6 the notices be furnished to the court 7 reporter and appended to the deposition. 8 I have no problems with the objections 9 that you would like to reserve. 10 MS. LAWS: Also, along the same 11 lines to speed things along, can we have an 12 agreement between all counsel present that 13 the objection of one defendant is good for 14 all so we do not have to repeat ourselves? 15 MS. ZETTLER: That is fine. I 16 want to address the case being cross-noticed. 17 It is our position that the rules of 18 discovery and evidence in the Kentucky courts 19 apply to this deposition. 20 MR. STOPHER: Let me respond to 21 that by telling you that this was done by 22 agreement and the cross-noticing was done by 23 agreement with the office of Leonard Finz. 7 1 MS. ZETTLER: Cross-noticing to 2 my knowledge was not done by anyone on the 3 plaintiff's side unless you have something in 4 writing to that effect. 5 MR. STOPHER: I do. I did not 6 bring it with me. It is in letters and 7 telephone conferences. Mr. Green represented 8 that he had cleared it with all plaintiffs' 9 counsel. I think your gripe may be with him 10 rather than with us. 11 MS. ZETTLER: I was never copied 12 on any such letter. I was not aware of it. 13 We do not agree to that. To my knowledge, no 14 one from Leonard Finz's office has agreed to 15 that. 16 MR. STOPHER: I beg to differ 17 with you. The document will speak for 18 itself. 19 MS. ZETTLER: I will reserve the 20 right to continue Mr. Russell's deposition 21 pending production of all documents that we 22 have requested related to Mr. Russell's 23 participation with the development and 8 1 otherwise regarding Fluoxetine, 2 hydrochloride otherwise known as Prozac. 3 We asked for documents. Documents were 4 produced to us. It is obvious from a cursory 5 review from just a portion of the documents 6 that there are thousands of document missing. 7 We have no indication as to why they are 8 missing or what those documents are. 9 We attempted to make a motion before 10 Judge Potter to produce those documents or in 11 the alternative -- 12 (AT THIS TIME MR. GREGORY GREEN ENTERED 13 THE ROOM.) 14 MS. ZETTLER: Could you read that 15 last part back? 16 THE COURT REPORTER: "We 17 attempted to make a motion before Judge 18 Potter to produce those documents or in the 19 alternative..." 20 MS. ZETTLER: A listing of what 21 has been removed, why it was removed and what 22 the basis for removal was as far as 23 relevance, et cetera, prejudice, et cetera. 9 1 MR. MYERS: Let me respond to 2 that. On behalf of Lilly, Mr. Russell is 3 here today pursuant to agreement and pursuant 4 to various notices as is evidenced by the 5 attendance of lawyers other than lawyers in 6 just the Fentress case. 7 Insofar as the documents are concerned, 8 Ms. Zettler, our position concerning those 9 documents is set out in Mr. Stanley's various 10 correspondence to you and certain of the MDL 11 co-counsel. 12 We have produced to you the responsive 13 non-privileged documents as indicated in 14 Mr. Stanley's most recent correspondence. 15 Mr. Russell is here today to give his 16 deposition. He has been here today to give 17 his deposition. He will give his deposition 18 today and we do not agree and will not agree 19 that he may be later commanded or directed to 20 appear at another deposition inasmuch as the 21 schedule for the deposition was an agreed 22 schedule. 23 The witness is here. The witness is 10 1 ready, willing and able to testify, but we 2 will not agree that he voluntarily appear for 3 a later deposition in any cases in which the 4 deposition has been noticed pursuant to a 5 specific agreement. 6 MS. ZETTLER: Well, it was agreed 7 by Mr. Stanley that he would provide us with 8 documents responsive to our request. Our 9 request did not state that he would be 10 allowed to arbitrarily remove documents that 11 you deemed to be unresponsive, privileged or 12 irrelevant. 13 We will have to take that up before 14 Judge Potter. 15 MR. MYERS: I think it is fair to 16 say that our position with respect to the 17 documents is well set out in writing. I 18 would take issue with your position about 19 missing documents and the arbitrary removal 20 of documents from any such production. 21 I believe the position of the parties 22 is set out in writing. 23 MS. ZETTLER: You will forgive me 11 1 if I do not necessarily believe that the 2 removal of the documents and the unilateral 3 decision on your part or other people 4 representing Lilly as to what is relevant and 5 what is not, I do not think that is proper 6 under any rules of evidence under any state 7 or federal court regardless. 8 MR. MYERS: Let's proceed with 9 the deposition. 10 MS. ZETTLER: Fine. 11 MR. GREEN: Can I have three 12 minutes with Ms. Zettler before we start up? 13 (AT THIS TIME A SHORT RECESS WAS HELD 14 AFTER WHICH THE FOLLOWING PROCEEDINGS WERE 15 HAD:) 16 EXAMINATION, 17 QUESTIONS BY MR. GREEN: 18 Q. I'm Greg Green. I'm with the law office of 19 Leonard Finz. We are lead counsel in the MDL 20 cases in which your employer, Eli Lilly, is 21 the defendant. 22 Mr. Russell, could you, please -- 23 MS. ZETTLER: He has never given 12 1 a deposition before. I have not gotten 2 around to telling him about the ground rules. 3 Q. I'm not sure how many questions have been 4 asked of you. 5 MR. MYERS: She asked him whether 6 he had given a deposition before and his 7 name. 8 Q. First of all, I'm sorry for being late today. 9 I had some flight troubles in Chicago. I 10 will just be asking you some questions today, 11 and if I ask you any question which you do 12 not understand or which is unclear, just let 13 me know and I will do my best to rephrase it 14 in a manner which you can comprehend it. 15 I would first like to ask you, are you 16 presently employed by Eli Lilly? 17 A. Yes. 18 Q. And how long have you been employed by Lilly? 19 A. Twenty-six years and three months. 20 Q. And what is your title presently? 21 A. I'm clinical research administrator. 22 Q. And what are the characteristics of that job? 23 A. In the job that I'm in right now it is to 13 1 perform health economics research for 2 whatever drugs that I'm assigned to. 3 Q. How long have you had that title? 4 A. I have had that specific title for quite a 5 few years, but it has not been in its present 6 position, which has different implications, 7 for as long. 8 Q. Okay. Were one of the drugs you were 9 assigned to Prozac? 10 A. Correct. 11 Q. When I use the term Prozac, I would like that 12 to be interchangeable, if it is all right 13 with you, with Fluoxetine and any other 14 scientific names and if it is all right with 15 you, we will just call it Prozac today. 16 MR. MYERS: I will not agree to 17 that. Ask him one question at a time and we 18 will see if we have a problem. I understand 19 what you are trying to do. 20 Let's take it one at a time. 21 Q. When were you first assigned Prozac? 22 A. I can't recall exactly, but it was in the 23 late 1970's. 14 1 Q. And since that time have you been assigned to 2 Prozac exclusively? 3 A. No. 4 Q. Have you been assigned to Prozac 5 consistently? 6 A. No. 7 Q. Can you give me the time frames during which 8 you were assigned to Prozac since the late 9 1970's? 10 A. I don't recall precisely, but there was 11 approximately a one-year period in the late 12 1970's that I worked with it. And then I 13 started working with it again -- again, I do 14 not remember precisely. It was early in the 15 1980's, 1982 or 1983. 16 I worked with it for, you know, almost 17 ten years at that time. Then I have not been 18 working with it since I moved in January to a 19 new position in health economics. 20 Q. What was your title during the ten years from 21 1982 to 1983 when you were working with 22 Prozac? 23 A. Clinical research administrator. 15 1 Q. Were you a senior clinical research 2 administrator? 3 A. Yes. 4 Q. Were you a senior research clinical 5 administrator from 1982 to 1983? 6 A. Yes. 7 Q. During that time you were not involved with 8 health economics research? 9 A. No. 10 Q. Were you involved with any other drugs from 11 1982 to 1983 other than Prozac? 12 MR. MYERS: Just for that one 13 year period, or 1982, 1983 forward? 14 MR. GREEN: I'm sorry. 15 Q. 1982 to 1983 forward. 16 A. No. 17 Q. So, sir, forgive me if I have to rephrase 18 this question, you were involved with Prozac 19 for a ten year span from 1982, 1983 to the 20 point in time when you were appointed to your 21 new position? 22 A. And as I said previously, I don't remember 23 exactly when I went back to working with 16 1 Prozac again in the early 1980's. It was 2 somewhere around there in those early years 3 in the 1980's. 4 Q. Okay. In the late 1970's when you were 5 involved with Prozac for one year, what was 6 your function during that time? 7 A. Could you repeat that, please? 8 Q. In the late 1970's, I believe that you said 9 that you were involved with Prozac for a 10 one-year time span? 11 A. My function was the same as it was in the 12 1980's. My title was different then. My 13 title then was medical information 14 administrator. 15 Q. Okay. And how would you describe your title 16 in the 1980's, your job in the 1980's, as far 17 as what your function was regarding Prozac? 18 MR. MYERS: Have you moved 19 forward to the 1980's now? 20 MR. GREEN: Yes. 21 A. My job function in the 1980's as a senior 22 clinical research administrator was to handle 23 administrative details of conducting 17 1 primarily Phase IV clinical studies with 2 Prozac and some Phase III, but mostly 3 Phase IV. 4 Q. Could you describe specifically what the 5 administrative details would be? 6 A. That can take a long time. I will try to 7 give you some idea of it. I was involved in 8 administratively assisting the research 9 physicians in preparing protocols, preparing 10 case report forms for studies that are 11 proposed with the drug, handling the 12 administrative details of collecting the 13 documents that potential investigators are 14 going to be required to submit to be 15 investigators for the drug, and then helping 16 and initiating the studies with start-up 17 meetings. 18 After the studies are started, to 19 handle the administrative details and 20 communicating with the investigators about 21 the progress of the studies, to review the 22 data that comes in and begin the process of 23 analyzing the data. 18 1 And then the administrative details in 2 closing out the studies and collecting the 3 materials from the sites. 4 Q. When you say that you begin the process of 5 analyzing the data, how far into that process 6 do you go? 7 A. Not deeply at all. I did not participate in 8 the analysis in the data at all. When I say 9 begin the process, I mean simply that, to 10 have the data from the investigator prepared 11 and ready for entry into the computer so it 12 can be later analyzed and processed by the 13 people who perform that function. 14 Q. During the 1980's while you were involved 15 with Prozac, were you working within a 16 certain department at Lilly? 17 A. Yes. It is the clinical investigations 18 division of medical. 19 Q. What did you say? Or medical? 20 A. Of medical. I don't know. I'm not even sure 21 if those are official terms. We considered 22 ourself the medical division. Clinical 23 research, clinical investigations. 19 1 Q. Who was your immediate superior? 2 A. When? 3 Q. During the 1980's when you were involved with 4 Prozac? 5 A. I had more than one. 6 Q. Who was your immediate superior at the 7 beginning of that time frame? 8 A. My immediate superior when I first began 9 working in the early 1980's with Prozac was 10 Earleen Ashbrook. 11 Q. And what was the first name? 12 A. Earleen. 13 Q. Did somebody take her place? 14 A. Yes. Later on she was replaced by -- I'm 15 trying to remember the sequence. There have 16 been a number of people. I may not even 17 remember this exactly. 18 Q. Let me ask you this: Who was the last person 19 who was your immediate supervisor while you 20 were involved with Prozac? 21 A. Carol Zapapas. 22 Q. And do you recall what years she was your 23 supervisor? 20 1 A. Between two and three years. 2 Q. Who was your supervisor in the year 1985? 3 A. Earleen Ashbrook. 4 Q. Do you recall was she your supervisor in 5 1986? 6 A. I believe so. 7 Q. Was somebody your supervisor between 8 Ms. Ashbrook and Ms. Zapapas? 9 A. Yes. One problem I have with your question 10 is because our administrative, the way we 11 were administrated was changed in that time 12 period. We went from a department head as 13 our immediate supervisor to a manager as our 14 immediate supervisor. 15 We did not have a department head for 16 awhile. 17 Q. When was that? 18 A. I don't remember exactly. 19 Q. Was Miss Ashbrook the department head? 20 A. She was the department head and then she 21 later became a manager. 22 Q. Okay. And what about Ms. Zapapas? 23 A. She was the department head. 21 1 Q. Are there any other immediate supervisors who 2 you had during that time frame in the 1980's 3 while you were working with Prozac? 4 A. I'm not really sure if I remember exactly the 5 sequence of, you know, of how they changed 6 from department head directing us to a 7 manager and then back to having a department 8 head again. 9 But I have had various department heads 10 and managers that I reported to and I cannot 11 recall, you know, when I was reporting to the 12 department head and then to the manager after 13 them or all that. 14 Q. Do you recall the names? 15 A. I can recall the names of the department 16 heads and managers. 17 Q. Why don't you give us those names? 18 A. Earleen Ashbrook. Mike Harold was a manager. 19 Carol Zapapas was the department head. Then 20 another manager was Louise, and her last name 21 is slipping from my mind. 22 Q. In the case of Ms. Ashbrook, was she 23 responsible for, or let me say, was she 22 1 associated with any drugs other than Prozac? 2 A. Earleen Ashbrook? 3 Q. Yes, during the 1980's? 4 A. Yes. 5 Q. About how many drugs was she working with 6 during that time? 7 A. I had no need to know that and I don't know 8 that. 9 Q. Is that generally the case with the managers 10 and the department heads, they were 11 associated with more than one drug? 12 A. I think so, but I'm not positive because I 13 did not track that. 14 Q. When there was a change from department heads 15 to manager, was the manager generally 16 associated with one drug or more than one 17 drug? 18 A. Say that again, please. 19 Q. When the structure was changed from having 20 department heads to having managers, were the 21 managers associated with one drug or more 22 than one drug? 23 A. One problem I have with that question is that 23 1 the structure was not changed from having 2 department heads to having managers. It 3 was -- we always had managers. 4 It was whether we had department heads 5 in the chain of command between us and the 6 managers. 7 Q. So managers were above department heads? 8 A. Yes. 9 Q. Were there other senior clinical 10 administrators who had similar job 11 assignments that you had during this time 12 frame? 13 A. You mean senior clinical research 14 administrators? 15 Q. Yes. 16 A. I'm not sure because we were not always privy 17 to the title of the other people because it 18 was part of the reward system and everything 19 and for a long time we were not always told 20 how high up on the level of advancement that 21 everyone was. 22 Q. Okay. Were there other people in your 23 department that had essentially the same 24 1 functions as you did regarding Prozac during 2 this time frame? 3 A. Yes. 4 Q. How many people? 5 A. It depends on what year. It fluctuated. 6 Q. Well, what about the year 1983, how many 7 people? 8 A. I really can't remember exactly how many 9 people were working with Prozac in 1983. 10 When you say my function, my function as I 11 stated earlier, was working some of the time 12 with Phase III studies and other times with 13 Phase IV studies. 14 It would depend on what function you 15 mean by that. 16 Q. Were some of the people in your department 17 assigned to Phase I studies? 18 A. No. 19 Q. How about Phase II studies? 20 A. I'm not sure. 21 Q. I'm trying to get an idea, Mr. Russell, of 22 how many people in the department were 23 working on Prozac. 25 1 Do you know the answer to that? 2 A. The answer is that it is a moving target. It 3 is not -- 4 Q. Can you give me some general idea about how 5 the numbers changed in the early 1980's? Was 6 it greater or less than the late 1980's? Or 7 was it the reverse of that or neither? 8 A. In the early 1980's when I first started 9 working with Prozac; is that what you want to 10 know? 11 Q. Yes. 12 A. Versus when I stopped working with Prozac? 13 Q. Yes, I would like to know that. 14 A. There were more people working on Prozac when 15 I stopped working with Prozac at the end of 16 last year than when I started. 17 Q. Okay. How many people were working on Prozac 18 at the end of last year? 19 A. I do not know the numbers exactly. 20 Q. Was it more than ten? 21 A. At my level you mean? 22 Q. Yes. 23 A. As a clinical research administrator? 26 1 Q. Yes. 2 A. It might be. Again, I didn't count them. 3 Some people had different assignments of 4 different drugs. Because they were all 5 working with different projects, you know, I 6 did not keep track of what everyone was 7 working on. 8 Q. You never discussed it with them? 9 A. Only if I needed to discuss it. 10 Q. So you -- did you ever speak about what you 11 were doing at your work with your fellow 12 workers? 13 A. Of course. 14 Q. So did you ever find out from them what they 15 were working on, your colleagues? 16 A. I found out sometimes what they were working 17 on, but I never counted it. 18 Q. How many people were in your department at 19 your level? 20 MR. MYERS: When? 21 Q. In the early 1980's. 22 A. I don't remember the count exactly. I have 23 worked in a lot of departments at Lilly in 27 1 medical over the years. Prozac is not the 2 only drug that I worked with. You are asking 3 me numbers that just are not something that 4 were that significant to me at the time. 5 When I first started to work with 6 Prozac in the 1980's you want to know how 7 many people worked in my department? 8 Q. At your level? 9 A. I really honestly cannot remember exactly. 10 Maybe, maybe six or seven. 11 Q. Okay. 12 A. I'm not sure. 13 Q. And what about at the time you left that area 14 and went to your new position? 15 A. I'm not exactly sure, but, you know, maybe 16 ten to twelve. 17 Q. And what about in the mid 1980's? 18 A. It would just be a guess if I tried to come 19 up with a number. You say mid 1980's and the 20 numbers fluctuated. 21 Q. Would it be better if I named the specific 22 year, 1986? 23 A. I can't remember. I really can't. 28 1 Q. Was it less than six or seven? 2 MR. MYERS: He has answered the 3 question. 4 MR. GREEN: I'm trying to refresh 5 his recollection. I think I have a right to 6 refresh his recollection, or at least attempt 7 to. 8 Q. Was it less than six or seven? 9 MR. MYERS: If you know, tell 10 him. If you do not know, tell him that. 11 Q. If you do not know the answer to a question 12 do not hesitate to say that. 13 A. I do not remember in 1986 how many people 14 were working in that department. 15 Q. Okay. Do you recall if it was more than ten 16 or twelve? 17 A. I do not believe it was. 18 Q. At the time that you left Prozac for your new 19 position, when there were ten or twelve 20 people approximately in the department at 21 that time at your level, how many of those 22 people were working on Prozac that you know 23 of? 29 1 A. You want me just to try to count it in my 2 mind how many people I think were working on 3 Prozac? 4 Q. Just the people that you know of. You may 5 have spoken to someone and asked them if they 6 were working on Prozac. 7 A. At the time that I left last year how many 8 people at my level do I believe approximately 9 were working on Prozac? 10 Q. Yes. 11 A. It would be an approximate guess. I do not 12 know precisely. I do not remember precisely. 13 I would say eight or nine. 14 Q. Okay. How many people approximately during 15 the 1980's were working within the department 16 but were below your level? 17 A. I'm not sure I understand your question 18 completely. Below my level as a clinical 19 research administrator, or below my level 20 period? 21 Q. Below your level as a clinical research 22 administrator? 23 A. But still clinical research administrator? 30 1 Q. Yes. 2 A. I don't know because I don't remember, or did 3 not know exactly who was a senior clinical 4 research administrator and who was not. 5 Q. Let's leave out the clinical -- 6 MR. MYERS: Are you through with 7 your answer? Are you through? 8 THE WITNESS: I think so. 9 Q. Let's leave out the clinical research 10 administrators and the senior clinical 11 research administrators. 12 How many people were working in the 13 department approximately throughout the 14 1980's? 15 A. It fluctuated from maybe, and I do not 16 remember exactly, but people working as 17 clinical research administrators throughout 18 the 1980's were maybe as few as five or six 19 and as many as ten or twelve and maybe more 20 than that. 21 Q. Let me rephrase the question. I'm asking the 22 question about other employees within the 23 department. 31 1 A. Yes. 2 Q. Other than clinical research administrators, 3 senior or otherwise? 4 A. I did not understand that. I thought you 5 meant clinical research administrators. 6 Q. Do you understand the question now? 7 A. Please rephrase it. 8 Q. How many employees were within the department 9 who were not or who were below the clinical 10 research administrators? 11 A. Throughout the 1980's? 12 Q. Throughout the 1980's? 13 A. I do not remember. 14 Q. Was it near fifty? 15 A. No. 16 Q. Twenty-five? 17 A. No. Fewer than clinical research 18 administrators unless you include -- did you 19 want to include secretaries? 20 Q. Yes. 21 A. Anyone -- 22 Q. Yes. 23 A. -- that is at a lower level than a clinical 32 1 research administrator? 2 Q. Yes. 3 A. Throughout the 1980's, again it has to be a 4 complete guess on my part, but from maybe as 5 few as five or six to as many as eight to 6 twelve. 7 Q. What were some of the job titles that those 8 people had? 9 A. What are some of the job titles below the 10 level of research administrator that worked 11 throughout the 1980's on Prozac? 12 Q. Yes. 13 A. Secretary. Clerk. 14 Q. Any other scientists that filled any position 15 below that of clinical research 16 administrator? 17 A. I would not call them scientists. I would 18 not call myself a scientist. 19 Q. What is the highest degree that you have? 20 A. I have an M.B.A. in marketing. 21 Q. Have you ever been involved with marketing at 22 Eli Lilly? 23 A. Only in sales. 33 1 Q. Were you involved in sales in the 1980's? 2 A. No. 3 Q. I just want to clear something up because you 4 stated that you have been involved with a lot 5 of drugs over the years since you started at 6 Lilly. 7 Did you work on any other drugs from 8 1982, 1983 up until you got your new position 9 six months ago other than Prozac? 10 A. No. 11 Q. Now, you gave me the name of your department 12 that we have been discussing that you were 13 involved with during the 1980's, but then you 14 said you are not sure if that was the real 15 name or not. 16 Was that name that you gave, clinical 17 investigation medical department, is that 18 what you said? 19 A. I said we are the medical -- we are the 20 medical division. That is what we call 21 ourselves. I think officially it was 22 probably clinical investigations and it has 23 had different names. Clinical 34 1 investigations. 2 Q. Okay. Does this department store documents? 3 A. Only temporarily. 4 Q. Where are the documents temporarily stored? 5 Let me ask you this, where is the 6 department of clinical investigations located 7 at the Eli Lilly plant? 8 A. Several floors in several buildings. 9 Q. Could you describe those, or just name those 10 floors and what buildings they are? 11 A. I probably will not remember all of them. 12 Building 31-2, 31-3, 31-4. Building 11-2. 13 Building -- I'm not sure if I remember this 14 correctly, Building 8, Level 2. Building 8, 15 Level 3. 16 Q. Where was your office located, if you had an 17 office, or where was your work? 18 A. Building 31-2. 19 Q. Did you ever have occasion to visit the other 20 areas which you have just listed on a regular 21 basis? 22 A. Some of them. 23 Q. Which ones? 35 1 A. I'm not sure if I understand your question. 2 Visit on a regular basis? 3 Q. I'm saying as part of your job did you ever 4 go to 11-2? 5 A. To do business? 6 Q. Yes. 7 A. To 11-2 to do business throughout the 1980's? 8 Any time during the 1980's? 9 Q. Yes, I'm just using 11-2 as an example. I'm 10 wondering where you were located during your 11 employment. Your work site was 31-2. 12 Did you ever report to another area on 13 a regular basis? 14 A. I'm not sure if I understand your question 15 correctly. It is a little vague. Where I'm 16 running a little bit vague on your question 17 is doing business and reporting to, you know, 18 I don't know what you mean by that. 19 Q. Well, your job certainly carries certain 20 functions with it? 21 A. Uh-huh. 22 Q. Were any of these functions performed in any 23 other area other than 31-2? 36 1 A. The vast majority of my function was on 31-2. 2 There were times when I might need to go and 3 talk to somebody on some of the other floors, 4 but not that much. 5 Q. Okay. Was there anyone that you went and 6 talked to regularly as part of your job? 7 A. Yes. 8 Q. Who was that? 9 A. The clinical research physician and my 10 department head. 11 Q. Okay. Who was the clinical research 12 physician? 13 A. I had many different ones. 14 Q. Who was the clinical research physician when 15 you began working with Prozac in 1982, 1983? 16 A. In 1982, 1983 I believe it was -- I cannot 17 remember exactly. That was a time of quite a 18 bit of fluctuation. I had more than one that 19 I reported to because different clinical 20 physicians would have different protocols 21 they were responsible for. 22 One clinical research administrator 23 might have more than one project which would 37 1 involve more than one research physician. 2 Q. Was Dr. Jamie Street ever the clinical 3 research physician? 4 A. No. 5 Q. Who was the clinical research physician more 6 times than anyone else -- 7 A. I have not answered your question. 8 Q. I know you have not. That is why I thought 9 you were not going to. Would you like to? 10 A. I was trying to clarify so that you would 11 understand why the answer was not a straight 12 forward one-person answer. 13 When I first started in 1982 you wanted 14 to know what physician I reported to? 15 Q. Right. 16 A. Like I said, different physicians had 17 different protocols and one CRA might have 18 more than one protocol. That is why it is 19 difficult for me to say who I worked with as 20 a clinical research physician at the time. 21 It could have been John Houston. I 22 think it was John. It was Dr. Houston. John 23 Heiligenstein. 38 1 Q. Can you spell that? 2 A. I believe it is H-E-I-L-I-G-E-N-S-T-E-I-N. 3 Q. Any others that come to mind? 4 A. Well, your question was about 1982 or 5 whenever I first started in the 1980's? 6 Q. As we progress through the years do any 7 others come to mind in 1984 or 1985 or 1986? 8 A. You want to know any physicians that I worked 9 with on Prozac throughout the 1980's? 10 Q. Were these physicians assigned to certain 11 protocols? 12 A. Yes. 13 Q. Were you assigned to a broader number of 14 protocols? 15 A. Correct. Usually. 16 Q. I think what you are trying to tell me is 17 there were more physicians than clinical 18 research administrators? 19 A. No. I'm trying to tell you the opposite. 20 Q. There were more clinical research 21 administrators than physicians dealing with 22 Prozac? 23 A. Correct. 39 1 Q. After Dr. Heiligenstein, do you recall any 2 others? 3 A. After Dr. Heiligenstein? I can remember 4 Dr. Houston and Dr. Heiligenstein. These are 5 the ones that I worked with. Dr. Wernicke, 6 Dr. Beasley, Dr. Goldstein. And there may 7 have been others. Those are the ones that 8 come fresh to my mind. 9 Q. What would the clinical research physicians 10 do? What was their function as far as the 11 Prozac clinical investigations lab? 12 A. I don't think I'm really qualified to totally 13 describe their job descriptions, but they 14 handled more of the scientific aspects where 15 we handled the administrative aspects. 16 Q. Does Dr. Houston still work for Lilly as far 17 as you know? 18 A. No. 19 Q. Do you know where Dr. Houston is located? 20 A. No. 21 Q. Does Dr. Heiligenstein still work for 22 Eli Lilly as far as you know? 23 A. Yes, sir. 40 1 Q. Do you know that doctor's first name? 2 A. John Heiligenstein. 3 Q. Do you know what department Dr. Heiligenstein 4 is associated with presently? 5 A. He is working with Prozac. 6 Q. What about Dr. Goldstein, is he still with 7 Lilly? 8 A. He is still with Lilly. I don't think he 9 works with Prozac. I think he works with 10 Lovan. He may work with other things, too. 11 Q. Do you recall which of those physicians you 12 spoke with on a regular basis as part of your 13 job during the time frame from 1986 through 14 1988? 15 A. I'm sorry? Would you say that again? 16 Q. Do you recall which of these physicians you 17 spoke with as a regular part of your job from 18 1986 through 1988? 19 A. From 1986 through 1988? Probably the one 20 primary one was Dr. Beasley. I worked with 21 him more than any of the others in those 22 years. 23 I'm sorry. That may be too early. I 41 1 cannot remember exactly when Charles Beasley 2 started. 1986 through 1988? It is very 3 difficult because the changing projects and 4 changing physicians to remember these things. 5 1986 through 1988? That probably was 6 Dr. Wernicke. 7 Q. All right. Are you done with your answer? 8 A. I think so. 9 Q. Okay. Now, as part of your job as a senior 10 clinical research administrator, and because 11 you worked only on Prozac for ten years, did 12 you generate documents regarding, or which 13 mentioned or which discussed Prozac during 14 that ten-year period? 15 A. Sure. 16 Q. Did you receive documents which discussed 17 Prozac during that ten-year period? 18 A. Yes. 19 Q. Did you receive documents from Dr. Wernicke 20 which discussed Prozac during that ten-year 21 period? 22 A. Yes. 23 Q. Did you receive documents from Dr. Beasley 42 1 which discussed Prozac during that ten-year 2 period? 3 A. Yes. 4 Q. Where did you keep these documents or did you 5 keep these documents? 6 A. If they were things that had to do with my 7 projects I had a project folder. 8 Q. You had a project folder? 9 A. Uh-huh. 10 Q. Well, how many projects did you have over the 11 course of ten years? 12 A. Many. 13 Q. More than a hundred? 14 A. No. 15 Q. More than fifty? 16 A. No. 17 Q. More than twenty? 18 A. No. 19 Q. More than ten? 20 A. Probably. 21 Q. Around ten approximately? 22 A. I never counted them. Probably between ten 23 and twenty. 43 1 Q. When you say project, what exactly are you 2 referring to? 3 A. Protocol. 4 Q. So tell me if I'm wrong, were you the 5 administrator for approximately ten protocols 6 regarding Prozac during that ten-year period? 7 A. I was the administrator for something 8 between, I believe, and this is just a 9 guesstimate, ten and twenty protocols. 10 Q. Now, when a project was concluded did you 11 maintain any documents regarding that 12 project? 13 A. We maintained documents after a project was 14 concluded, but they go to storage. 15 Q. Okay. I'm talking about you in your office 16 or your work area. Is it an office that you 17 work in? 18 A. It is an office. Am I correct you are asking 19 me -- tell me again your question. 20 Q. My question was during the time that a 21 project was ongoing did you keep documents 22 regarding that project in your office? 23 A. I thought you were talking about after a 44 1 project was concluded. While a project kept 2 going, yes, I did. 3 Q. Okay. Did you ever have any documents over 4 that ten-year period which discussed Prozac 5 which you either generated or which were 6 given to you which you received which did not 7 involve directly the project on which you 8 were working? 9 A. Sometimes. 10 Q. Did you keep those documents? 11 A. If they were not my project I probably would 12 not have kept them. 13 Q. So did Dr. Wernicke ever give you a document 14 where he discussed Prozac which did not 15 involve your project? 16 A. Did Dr. Wernicke ever give me a document that 17 did not involve my project? I mean, I can't 18 think of any specifics, but it is certainly 19 possible. 20 Q. Okay. Well, then, if he did give it to you, 21 are you telling me that you would not keep 22 it, you would discard it or store it in some 23 other place other than your office because it 45 1 did not discuss your project? 2 A. The person who had primary responsibility for 3 the document would always make sure that they 4 kept a permanent copy of it. If it was just 5 something for information or something -- 6 Q. What type of document? 7 MR. MYERS: Wait a minute. 8 Finish the answer. 9 MR. GREEN: I did not mean to 10 interrupt him. 11 A. I'm trying to say there is a very specific 12 procedure on the responsibility for 13 maintaining documents. All documents are 14 maintained. 15 Q. Okay. 16 A. There are some situations where it would 17 be -- and you are trying to get to the 18 specifics on documents that are not on my 19 project that mention Prozac or something. 20 I might not retain all those. They are 21 retained by the people who are responsible 22 for the project or the information that was 23 generated. It was not always my 46 1 responsibility to maintain everything on 2 Prozac. 3 Q. Okay. There was a procedure for maintaining 4 documents though? 5 A. Absolutely. 6 Q. Could you describe that procedure? 7 A. Just that if something was generated on 8 Prozac it would be kept, or on any drug at 9 Lilly. 10 Q. Would that not only be something that was 11 generated or something that you would receive 12 from an outside source outside of Lilly, say, 13 from a clinical investigator, would you keep 14 that document as well? 15 A. That would be, that would be considered 16 project specific. It would be kept with the 17 project. 18 Q. Okay. Within your office while a project was 19 ongoing, how would you maintain the documents 20 regarding that project? 21 A. In a folder. 22 Q. What kind of folder? How big was the folder? 23 Let me ask this question, how many 47 1 pages could the type of folder that you are 2 talking about hold? 3 A. I don't know. A lot. If it became too thick 4 for one folder to hold then we would have a 5 supplemental folder. It was an infinite 6 number. It would depend on what the project 7 generated. 8 Q. If a project generated twenty folders would 9 you consider that just the folder where the 10 documents were? 11 A. I don't know if it had that many. The most I 12 have ever seen is two. 13 Q. Okay. Do you recall the numbers of the 14 protocols that you were associated with? 15 A. No, I don't. 16 Q. Do you recall that they were, in fact, 17 numbered? 18 A. I believe early on the protocols had numbers. 19 I don't think we had numbers for them -- I 20 don't recall if we had numbers for them later 21 or not. I just remember names. If you asked 22 me specific names that would be my 23 recollection on them. 48 1 Q. Okay. Once the project was complete, where 2 would the documents be sent? 3 A. To document control. 4 Q. And is there somebody who was in charge of 5 the Prozac documents at document control? 6 A. I'm not sure what you mean by in charge. 7 Q. I mean when the project was complete and you 8 had two folders of documents, would you 9 call -- 10 A. Do you want to know who handled the documents 11 or who was in charge of the department? 12 Q. Let's start off with who handled the 13 documents? 14 A. There were people, sure. 15 Q. Do you know the names of the people? 16 A. I doubt if I can remember all of them. 17 Q. Okay. 18 A. Do you want me to start naming people that I 19 can remember? 20 Q. I will ask you that. Who was in charge of 21 the department of document control? 22 A. Jody Hyche. 23 Q. Can you spell that last name? 49 1 A. I believe it is, and I'm not positive, 2 H-Y-C-H-E. 3 Q. And is that a man or woman? 4 A. It is a woman. 5 Q. I'm sorry? 6 A. A woman. 7 Q. Is Ms. Hyche still the head of document 8 control? 9 A. I don't believe so. 10 Q. Does she still work at Lilly? 11 A. Yes. 12 Q. Do you know who the head of document control 13 is presently? 14 A. I'm not sure who it is. 15 Q. Okay. 16 A. I could take a guess. 17 MR. MYERS: Do not guess. 18 Q. When you say that Ms. Hyche was the head of 19 document control, was she the head of 20 document control for Prozac documents, or was 21 she the head of document control for all of 22 Lilly or something in between? 23 A. She was the head of document control of all 50 1 of Lilly. 2 Q. Was there anyone who was in charge of 3 document control just for the Prozac 4 documents? 5 A. I'm having difficulty with your question 6 because -- you mean -- to me they were not in 7 charge and they were just handlers. 8 Q. Okay. Was there a handler who handled only 9 Prozac documents, say, at the time that you 10 left? 11 A. There were, I believe, there was more than 12 one. 13 Q. All right. Did they have the responsibility 14 of assigning numbers to the documents? 15 A. I don't know anything about numbers to the 16 documents. 17 Q. All right. When you received documents from 18 the clinical investigators were they 19 numbered? 20 A. What do you mean? 21 Q. I mean did they have numbers on them on the 22 bottom margin, in the corner, along the side, 23 in the margin? 51 1 A. Okay. You mean case report form numbers? 2 Q. I do not mean -- 3 A. What do you mean? 4 Q. Like this set of documents goes from Page 1 5 through 50. I mean, did the clinical 6 investigators number or name the document, 7 not name the documents, but did they number 8 the documents in any way? Did they stamp 9 them with the number? 10 A. It depends on what kind of document you are 11 talking about. You have to be more specific. 12 Q. Okay. So some documents they would number 13 and others you would not? 14 MR. MYERS: That is not what he 15 said. I object to the question. That is not 16 what he said. 17 A. You have to be more specific. 18 Q. Okay. As far as the documents regarding 19 specific projects which you kept in your 20 office, the projects which were ongoing at 21 the time that you kept the documents, did 22 anyone have access to those documents other 23 than you? 52 1 A. Theoretically they had access to them. I 2 mean, they were not locked up. 3 Q. Did anyone look at those documents regularly 4 as part of their job? 5 A. No. 6 Q. Did anyone get copies of the documents that 7 you got from the clinical investigators? 8 A. It depends on what kind of document it was. 9 Q. Okay. 10 A. Some yes and some no. 11 Q. Can you recall which documents were copied 12 and sent to other people at Lilly? 13 A. Well, if it was a correspondence or something 14 from the investigator I would probably copy 15 the clinical scientist, if it was a case 16 report from Lilly. 17 Q. When you say clinical scientist, is that the 18 same as the physician -- 19 A. Yes. 20 Q. -- that we were discussing earlier? 21 A. Uh-huh. 22 Q. Who were some of the clinical, or who were 23 the clinical investigators that you worked 53 1 with? 2 MR. MYERS: Just a minute. I 3 will object to that question. You know, 4 Mr. Green, and have known all along, we have 5 voluntarily disclosed the names of the 6 clinical, pivotal clinical investigators. 7 There may well be an order in Kentucky 8 requiring us to disclose some names of 9 clinical investigators non-pivotal. That 10 will be done in due course when the project 11 is done. 12 This witness will not sit here and make 13 wholesale disclosures of the non-pivotal and 14 I direct him not to. 15 MS. ZETTLER: You have tried to 16 cram this deposition down our throats in 17 these cases. In my state courts in Illinois 18 there are no protective orders out there. If 19 you are really going to try to hold us to 20 this state court deposition routine, then he 21 must answer all questions. 22 MR. MYERS: It does not have 23 anything to do with the protective order. We 54 1 claim confidentiality and privileges. 2 MS. ZETTLER: There is no order 3 to that effect in any of the state court 4 cases. Unless you want to stop this 5 deposition and go into court in Illinois and 6 enter protective orders to that effect, he 7 should answer questions of that effect right 8 now. 9 There are no protective orders in the 10 Kentucky cases that allow you to pick and 11 choose who Mr. Russell is going to disclose 12 to us in response to the questions. 13 MR. MYERS: So the record is 14 clear, Judge Potter entered an order after 15 the last pretrial conference directing us to 16 disclose the identify of certain non-pivotal, 17 but not the identity of others. 18 MS. ZETTLER: I suggest you take 19 him outside this door and ask him who he 20 worked with and -- 21 MR. MYERS: We made our position 22 clear. He is not going to answer that 23 question. 55 1 MS. ZETTLER: I reserve the 2 right, not only in my state court cases in 3 Illinois since there is no protective order, 4 and in the Kentucky cases, to bring 5 Mr. Russell back for purposes of deposing him 6 on his relationship with the clinical 7 investigators that he has worked with in the 8 development of Fluoxetine or Prozac for any 9 investigation whatsoever. 10 MR. MYERS: In the Fentress case, 11 as directed by the Court, we will comply with 12 the Court and we fully intend to do so. You 13 are not going to sit here and have this 14 witness identify all of these people. You 15 will learn later. 16 MS. ZETTLER: We reserve the 17 right to bring him in and interrogate him 18 further about his relationship with any of 19 those people. 20 MR. MYERS: I made my position 21 perfectly clear with your ability or not to 22 bring the witness back. 23 MR. GREEN: I reserve my right as 56 1 well in the MDL cases and all of the state 2 court cases to bring Mr. Russell back again. 3 Hopefully we will not have to do that. If we 4 do, it will be good to see you again. 5 Q. I would like to ask you about some people who 6 may have worked for Lilly at one time or who 7 may still work for Lilly and your association 8 with them, if any. 9 Steven P. Paul, are you, have you 10 ever -- 11 A. I know of him. 12 Q. Have you ever communicated with him regarding 13 Prozac? 14 A. No. 15 Q. How about D. T. Wong? 16 A. Yes. 17 Q. Have you communicated with him regarding 18 Prozac? 19 A. Yes. 20 Q. Was that on a regular basis? 21 A. No, it was not. He was just a -- really it 22 was very informal. He is a friend. I never 23 talked to him formally about Prozac. 57 1 Q. Do you recall the last time you spoke to 2 Mr. Wong about Prozac? 3 A. Yes. 4 Q. When was that? 5 A. Maybe two weeks ago. 6 Q. Who initiated the conversation? 7 A. I did. 8 Q. What did you say to him? 9 A. I don't remember. I think I just -- we were 10 having lunch. Mr. Wong was at my wedding 11 with my wife. He has worked with Prozac so 12 it was natural just to mention Prozac. I 13 really do not remember what I said. 14 Q. Did you tell him about this deposition? 15 A. No. 16 Q. Have you spoken with Mr. Wong regularly on an 17 informal basis about Prozac? 18 A. No. 19 Q. How about J. S. Horng, H-O-R-N-G? 20 A. No. 21 Q. Did you ever speak to him about Prozac or 22 communicate in any way? 23 A. No. 58 1 Q. When I read these names, my question is have 2 you ever communicated with them in any way 3 about Prozac? 4 MR. MYERS: That is the sole 5 question? 6 MR. GREEN: Yes. At this point, 7 yes. 8 Q. Mr. Bimaster? 9 A. No. 10 Q. Richard Burkstrum? 11 A. Yes. 12 Q. Okay. What was the situation? Was it formal 13 or informal, your discussion? 14 A. Formal. 15 Q. So it was within the job context? 16 A. Yes. 17 Q. What is the professional relationship that 18 you have with Mr. Burkstrum? 19 A. Mr. Burkstrum worked with some of the details 20 of the pharmacological data that was 21 collected. 22 Q. What details did he work with? 23 A. Analyzing pharmacological data as much as I 59 1 know. 2 Q. Is he a statistician? 3 A. I really don't know what his training is. 4 Q. How often on an average would you speak with 5 him or communicate with him regarding Prozac? 6 A. Not very often. 7 Q. Once a month? 8 A. Maybe. 9 Q. Do you know what department Mr. Burkstrum is 10 in? 11 A. I only know where he works. I don't really 12 know what his department is called. 13 Q. Where does he work? 14 A. At the Eli Lilly Clinic at Wishard Hospital. 15 Q. Okay. How about Tanna Kreigh? 16 A. Tanna Kreigh? I had no formal working 17 relationship with her. She was another CRA. 18 She was at my level. 19 Q. Okay. Is she still a CRA? 20 A. I really don't know what she is doing. 21 Q. Do you know if she still works for Lilly? 22 A. I think she does. I believe she does. 23 Q. Was she working on Prozac at the time you 60 1 left? 2 A. No. 3 Q. Okay. 4 A. Not that I know of. 5 Q. How about Dr. Jamie Street? 6 A. No. 7 Q. Have you read communications written by 8 Dr. Street regarding Prozac? 9 A. I may have, but I do not recall any. She was 10 not a physician that I worked with. 11 Q. Okay. Who did work with her? 12 A. I don't remember. 13 Q. Okay. How about K. L. Howser? 14 A. No. 15 Q. You already mentioned a Dr. Wernicke? 16 A. Yes. 17 Q. I believe you said that you communicated with 18 Dr. Wernicke regarding Prozac. Could you 19 give us that time frame just to clarify it? 20 A. It was sometime in the mid 1980's, early to 21 mid 1980's. 22 Q. Uh-huh. Did these clinical research 23 physicians direct you in any way of how to 61 1 perform your job? 2 A. It was not their job to tell us how to do our 3 job. 4 Q. Okay. How about a Dr. Molloy, M-O-L-L-O-Y? 5 A. No. 6 Q. How about a Mr. Fuller? 7 A. No. 8 Q. You never communicated with Mr. Fuller about 9 Prozac in any way? 10 A. Not on a formal basis. Not as part of my 11 job. 12 Q. How about on an informal basis? 13 A. A couple times. 14 Q. When was the last time you communicated with 15 Mr. Fuller, or should I say Dr. Fuller, about 16 Prozac? 17 A. I don't remember. It has been a long time. 18 Q. Did you discuss this deposition with him? 19 A. No. 20 Q. Did you ever discuss the fact that Lilly was 21 involved in a lawsuit because -- 22 A. No. 23 Q. How about K. W. Perry? 62 1 A. K. W. Perry? No. Do you know that person's 2 full name? 3 Q. No, I don't. 4 A. I do not believe so. 5 Q. How about Zerbe, Z-E-R-B-E? 6 A. Yes. 7 Q. Did you communicate -- is it Dr. Zerbe? 8 A. Yes. 9 Q. Did you communicate with Dr. Zerbe on a 10 regular basis? 11 A. I would not call it on a regular basis. 12 Q. How often would you communicate with him? 13 A. About Prozac? 14 Q. Yes. 15 A. Just a few times. 16 Q. How about M. W. Talbot? 17 A. I don't recall if I ever discussed Prozac 18 with him. 19 Q. Okay. 20 A. It is possible. I do not believe so. 21 Q. When you spoke with Dr. Zerbe was that under 22 a certain condition or situation that you 23 would speak with him regarding Prozac? 63 1 A. Well, he signs some documents and that would 2 have been my primary communication. 3 Q. You would take documents to him to be signed? 4 A. Yes. 5 Q. What documents would you take to him to be 6 signed? 7 A. Contracts. 8 Q. The contract between Lilly and the clinical 9 investigator? 10 A. Uh-huh. 11 MR. MYERS: Is that a yes? 12 A. Yes. 13 Q. Were the clinical investigators paid by 14 Eli Lilly? 15 A. I do not consider it paid by Lilly. They had 16 a contract for their expenses to conduct the 17 study. 18 Q. Was the contract for funds, do you think that 19 is a fair way to call the exchange of funds? 20 It was a contract for funds in return for 21 their clinical investigation; wasn't it? 22 MR. MYERS: To the extent you are 23 trying to put some sort of legal definition 64 1 on it, I will object. If you are trying to 2 work through the question with the witness 3 that is fine. 4 To the extent it imparts any legal 5 meaning, I object to the question. He is not 6 a lawyer. 7 MR. GREEN: I'm just trying to 8 work through the question with the witness. 9 Q. You do not consider it payment. I do not 10 want to call it payment. Would you call it a 11 contract for funds in return for the clinical 12 investigation as performed with the clinical, 13 or by the clinical investigator? Is that 14 fair to say? 15 In other words, Lilly was exchanging 16 money for clinical investigation work? 17 MR. MYERS: Do you understand the 18 question? 19 THE WITNESS: I'm not sure if I 20 do. 21 Q. Okay. You would not call it payment. What 22 would you call it? 23 A. I'm not sure if you are trying to get me to 65 1 say that I agree with your description of it, 2 or are you asking me how to describe how 3 money -- 4 Q. Believe it or not, I'm trying to find a 5 description that you can agree with. Why 6 don't you just tell me? 7 MR. MYERS: He gave you the 8 description earlier. 9 MR. GREEN: Let's have the 10 reporter read that back. 11 MR. STOPHER: He called it a 12 contract for expenses. 13 MR. GREEN: That is okay. We do 14 not have to read it back. 15 MS. ZETTLER: Let's take a quick 16 break. 17 (AT THIS TIME A SHORT LUNCH RECESS WAS 18 HELD AFTER WHICH THE FOLLOWING PROCEEDINGS 19 WERE HAD:) 20 Q. Mr. Russell, where and when did you obtain 21 your M.B.A.? 22 A. I got my M.B.A. in 1967 from Michigan State 23 University. 66 1 Q. And where did you get your undergraduate 2 degree? 3 A. Michigan State. 4 Q. What year did you graduate? 5 A. Undergraduate? 6 Q. Yes. 7 A. 1965. 8 Q. Was that a Bachelor of Science? 9 A. It was a Bachelor's in Business. 10 Q. After you graduated from MSU in 1967 with 11 your Master's, did you begin employment at 12 that time? 13 A. Yes. 14 Q. And where did you work? 15 A. At Eli Lilly and Company. 16 Q. Have you worked anywhere other than Eli Lilly 17 since then? 18 A. Yes. 19 Q. Where did you work? 20 A. Various places for the United States Army. 21 Q. What years were you with the Army, or in the 22 Army? 23 A. From the fall of 1967 until, I believe, the 67 1 fall of 1970. 2 Q. When you got out of the Army did you go back 3 to work with Eli Lilly? 4 A. Yes. 5 Q. And since the fall of 1970 have you worked 6 anywhere other than Lilly? 7 A. No. 8 Q. When you were in the Army did you have any 9 specific job assignment? 10 A. Sure. 11 Q. What was it? 12 A. It was the club officer at Fort McCarthur, 13 California. 14 Q. What is the club officer? 15 A. He runs all administrative aspects of an 16 officer's club including restaurant and 17 banquets and the bar and the liquor store and 18 the whole gashmeer. 19 Q. Did you begin with Lilly in 1970 or had you 20 worked with them before the Army? 21 A. Yes, I started to work with Lilly in 1967. 22 It was actually in March of 1967 and in the 23 fall of 1967 I was going to be drafted so I 68 1 went to officer candidate school instead. 2 Q. What job did you have with Lilly during that 3 brief period? 4 A. I was in training. 5 Q. In training for what? 6 A. Sales. 7 Q. Was that training to be a detail man? 8 A. Yes. 9 Q. When you came back to Lilly in the fall of 10 1970, what did you do at Lilly at that point? 11 A. I took a job in sales. 12 Q. And how long were you in sales? 13 A. From that point until April of 1974. 14 Q. And then what did you do? 15 A. And then I came to Indianapolis to take a job 16 as a medical information administrator. 17 Q. Okay. 18 A. And specifically to answer telephone calls 19 from customers and letters from customers on 20 questions about our drugs. 21 Q. Prior to April of 1974 where were you located 22 in the course of your employment with Lilly? 23 Was it in Indianapolis or somewhere else? 69 1 A. In my sales jobs? 2 Q. Yes. 3 A. I was in Racine, Wisconsin. 4 Q. Okay. Did your job title change after you 5 became a medical information administrator? 6 What did you do next? 7 A. My job title did not change until -- I can't 8 remember when they changed it. In my time 9 from 1974 to present to the end of last year 10 I was either a medical information 11 administrator or clinical research 12 administrator. 13 I cannot remember the exact year when 14 they changed that title. Basically the same 15 people that were medical information 16 administrators became clinical research 17 administrators except the first year when I 18 was a medical information administrator I had 19 the job of answering these questions and 20 phone calls and letters, but then the medical 21 information administrator job took on another 22 aspect. 23 Some people with that title started to 70 1 do this work that I described earlier when 2 you wanted me to describe what a clinical 3 research administrator was, but they also had 4 the title medical information 5 administrator. 6 Q. What about your present job, the health 7 economics? 8 A. Health economics research? 9 Q. Yes. What does that entail? 10 A. Basically it entails doing research to prove 11 and demonstrate the economic value of Lilly 12 drugs, as opposed to clinical research, which 13 does work to prove the efficacy and safety of 14 the drugs. 15 Q. When did you first hear the term Prozac? 16 A. Probably -- I don't remember the exact year. 17 Q. Was it prior to 1974? 18 A. No. 19 Q. Now, when you were describing the work that 20 you did with Prozac, you said one of the 21 things that you did was to prepare protocols. 22 What did you mean by that? 23 A. Well, the preparation of protocols is when a 71 1 specific research proposal on a company drug 2 is formulated, a specific protocol has to be 3 written to conduct that research to be 4 acceptable to the Food and Drug 5 Administration. 6 Q. Would you actually write the protocol? 7 A. Only the aspects of it that are routine, not 8 the scientific parts. 9 Q. Could you describe those routine aspects to 10 me, please? 11 A. Sure. Some of them would be things like, oh, 12 there are sections on the consent form and 13 sections on exclusion criteria, many of which 14 were already established in basic and then 15 you do some consulting with the clinical 16 research physician to make sure that you have 17 a complete list for that study to see if 18 there is anything additional that needs to be 19 added or anything that needs to be 20 subtracted. It is like dosages and 21 administrations. Most of that was pretty 22 standard. 23 Q. When you say a complete list, do you mean a 72 1 complete list of topics covered, or a 2 complete list of materials required, or what 3 do you mean? 4 A. A complete list. And I was specifically 5 referring to the exclusion criteria sections 6 of the protocol. It is a list of what kinds 7 of situations would exclude a patient from 8 entering the protocol. 9 If they were safety concerns where a 10 certain patient should not be entered, there 11 would be an exclusion criteria. 12 Q. Well, who came up with the exclusion 13 criteria? Was that you? 14 A. No. But at any point that you started a new 15 study there were established exclusion 16 criteria for the drugs that were in 17 existence. And you would take that list and 18 go over it with the clinical research 19 scientist and make sure that it was complete. 20 Q. So it was your responsibility to refer to 21 that list and communicate it to the clinical 22 investigator? 23 A. To go over it with him. 73 1 Q. Who actually formulated the exclusion 2 criteria? 3 A. I would assume the physicians, the clinical 4 research physicians. 5 Q. And what about dosage and administration, is 6 that something that you came up with? 7 A. No. 8 Q. Who came up with the dosage and 9 administration? 10 A. I believe that is done in consultation with 11 Lilly physicians and the FDA. It is based on 12 efficacy and pharmacokinetics and toxicology 13 data. 14 Q. Is that something that you would discuss with 15 the clinical investigator, or was that 16 something that Lilly required of the clinical 17 investigator? 18 A. I do not understand required. 19 Q. The dosage and administration in a particular 20 protocol, is that something that Lilly 21 decided on, or did Lilly decide on the dosage 22 and administration with the clinical 23 investigator, or did the clinical 74 1 investigator decide on that or anything else? 2 A. I was not directly involved in that process 3 so I do not think I'm qualified to answer it 4 with certainty. 5 Q. Well, what about the consent form, did you 6 create the consent form? 7 A. Again, we would take existing consent forms 8 from studies that were already in, that had 9 already protocols and I would go to the 10 clinical research physician to make sure that 11 everything for disclosure to the patient was 12 fully discussed in every detail to be in 13 compliance with the regulations. 14 Q. Was there any part of the protocol which you 15 created, which you had responsibility for 16 writing pretty much from scratch? 17 A. You know, I do not recall. There were so 18 many protocols and so many projects and I do 19 not recall specifically any that I wrote from 20 scratch without consultation with any of the 21 physicians. 22 Q. Okay. 23 A. I assisted. 75 1 Q. How would you get in touch with a clinical 2 investigator who would be a candidate to 3 perform a protocol or one of the 4 investigations? 5 A. We had a separate team of people who worked 6 in the field to identify investigators, 7 potential investigators, qualified 8 investigators, and give us a list of 9 potential names that we could review their 10 qualifications and review their papers and 11 review their capabilities for conducting the 12 kind of research that needed to be done. 13 Q. Was that ever your responsibility to make 14 first contact with the potential 15 investigator? 16 A. No. No. 17 Q. At what point would you begin your 18 communication with the investigator? 19 A. I would only begin communication after the 20 list was identified and the physician was 21 chosen. 22 Q. Would that physician at that time be aware 23 that Lilly wished to enter into a contract 76 1 with that physician? 2 A. That would be approximately the time when we 3 would begin discussion of it, of the research 4 contract. 5 Q. Was that your responsibility to begin the 6 discussion of the research contract with the 7 investigator? 8 A. Partially, but only in consultation with a 9 clinical research physician and we -- 10 contracts are written based on budgets and 11 numbers of patient. 12 Also, the cost of the research. 13 Q. Okay. 14 A. And always in concert with the clinical 15 research physician. 16 Q. Okay. Now, you also said it was part of your 17 responsibility to prepare clinical report 18 forms. 19 A. Uh-huh. 20 Q. Is that correct? 21 A. Uh-huh. 22 MR. MYERS: Yes? 23 THE WITNESS: I'm sorry, yes. 77 1 Q. Describe what a clinical report form is. 2 A. That is a paper document to capture the data 3 from the study which is pertinent to the 4 research findings. 5 Q. Would you select which data was relevant or 6 pertinent to the research findings? 7 A. Would I select? 8 Q. Yes. 9 A. No. 10 Q. Who would actually make that decision? 11 A. Who actually would make the decision of what 12 data would be collected? The clinical 13 physician, I believe, and also the FDA. 14 Q. By the way, you said there were people who 15 would create lists of potential 16 investigators. Were those people assigned to 17 create lists of potential investigators of 18 Prozac only? 19 In other words, were they working 20 solely within the Prozac field? 21 A. No. 22 Q. Okay. What department were those people in? 23 A. Clinical research coordination. 78 1 Q. Was there an individual or group of 2 individuals who had the responsibility of 3 finding Prozac clinical investigators? 4 A. The individuals that worked in that division, 5 I think, worked with many drugs. 6 Q. Do you recall any particular person who found 7 more than five clinical investigators to 8 investigate Prozac? 9 A. No, I don't recall that. 10 Q. Okay. 11 A. No. 12 Q. To get back to the clinical report forms, 13 what would you do with the data that was on 14 the clinical report forms? 15 A. The data that was on the clinical report 16 forms was entered into a computer data base 17 and it was checked for omissions. 18 If there were omissions you had to get 19 back with the investigator and make sure that 20 the correct data was filled in. 21 Q. Okay. 22 A. You just generally verify that everything on 23 there was correct. 79 1 Q. Would you actually enter the information into 2 the computer data base? 3 A. No. 4 Q. Okay. 5 A. Not the initial information. If there were 6 omissions and corrections from the 7 investigator, I would add that. 8 Q. Okay. Would you work from an errata sheet if 9 there were omissions, or how did that work if 10 there were corrections to be made? 11 MR. MYERS: I don't think he 12 knows what an errata sheet is. We all know 13 what it is. 14 Q. Let me phrase the question this way: What 15 was the process that you went through to, 16 first of all, obtain a correction and then 17 enter it into the computer? 18 A. We would write a letter to the investigator 19 or call them on the telephone, either him or 20 his study coordinator, and discuss the 21 section of the case report form and make sure 22 that the absolute correct data was there and 23 then get a written correction from the 80 1 investigator and get it transferred into the 2 system. 3 Q. So you could look at a clinical report form 4 and be able to judge whether or not the 5 correct data was there or not? 6 A. There is more than one way to do that. Some 7 of it you can see by observing. In a 8 omission if something is wrong, you can see 9 that. Something is -- obviously, if it is 10 out of the range of normal acceptance, you 11 know, like if somebody is over 500 pounds you 12 might want to question that. 13 There are also computer generated edits 14 which check for basic errors and omissions 15 and inconsistencies to assist in that 16 process. 17 Q. Who is responsible for entering the data into 18 the computer? 19 A. That is the data entry, data entry group. 20 Q. Was there a data entry group that worked 21 specifically with Prozac data? 22 A. I think they worked with all data. 23 Q. By the way, at the time you left to go to 81 1 your new area about six months ago, were 2 there any ongoing projects regarding Prozac? 3 A. When I just left at the end of the year were 4 there ongoing projects? 5 Q. Yes. 6 A. No. 7 Q. Do you know how many were ongoing? 8 A. No. 9 Q. Was it more than five? 10 A. I really don't know. 11 Q. When we say projects, those are protocols; 12 right? 13 A. That is what we agreed to earlier when you 14 asked for a clarification. I said a project 15 is a protocol, that is correct. 16 Q. All right. Do you know -- you left then in 17 December of 1992 and started your new job in 18 January? 19 A. I started in January of 1993, right. 20 Q. Were any of those projects involved with 21 studying the possible link of Prozac to 22 suicidal tendencies? 23 A. I don't know. 82 1 Q. Were any projects ongoing under your 2 administration, under your supervision? At 3 the time you left were you in the middle of a 4 project? 5 A. No. 6 Q. Do you know which clinical research 7 administrator was in the middle of a project 8 at the time you left? 9 MR. MYERS: Of a Prozac or 10 Fluoxetine project? 11 MR. GREEN: Yes. 12 A. Can I name a clinical research administrator 13 who had an ongoing Prozac study at the time 14 that I left? Yes. 15 Q. Who is that? 16 A. I could name people. I could not tell you 17 what study they were working on. 18 Q. If you could just name the people that would 19 be a good start. 20 A. I'm not sure of all of the people. I might 21 be able to come up with a couple names. 22 Kevin Marks. I'm not going to be able to 23 remember all of the names. Kevin Marks. 83 1 The problem is a lot of these people 2 have shifted to other projects. I'm not 3 sure. I cannot remember who was working with 4 Prozac and who shifted to other drugs. 5 Q. Right now Kevin Marks is the only one that is 6 a possibility? 7 A. There are other possibilities, but I would be 8 speculating because I'm not sure who was 9 working with Prozac and who was working with 10 other drugs. I could remember for sure that 11 Kevin was. 12 Q. Do you recall the investigator that Mr. Marks 13 was working with? 14 MR. MYERS: Do not answer that. 15 We are not going into that. 16 MR. GREEN: Okay. Just mark that 17 as a question to be discussed before the 18 judge. 19 MS. ZETTLER: Could you just 20 certify that? 21 MR. GREEN: Yes, certify that. 22 Q. As far as the projects that you worked on 23 during your ten-year period in the 1980's, 84 1 was one of those investigators who worked on 2 one of the projects a Louis Lemberger? 3 A. Yes. 4 Q. Okay. Do you recall what year -- is it 5 Dr. Lemberger? 6 A. Yes. 7 Q. Dr. Lemberger worked on a project? 8 A. I don't remember the specific year. 9 Q. Recalling Dr. Lemberger, does that help to 10 refresh your recollection of the protocol 11 number that you worked on and that 12 Dr. Lemberger worked on? 13 A. No. It was some kind of a pharmacokinetics 14 study. I do not recall which protocol it 15 was. 16 Q. Okay. Did you ever work with a clinical 17 investigator by the name of Abuzzahab, 18 A-B-U-Z-Z-A-H-A-B? 19 A. No. 20 Q. How about Dr. Feighner, F-E-I-G-H-N-E-R? 21 A. Yes. 22 Q. Would that have been Protocol 29-A? 23 A. I don't recall. 85 1 Q. How about a Dr. Kiev? 2 A. No. 3 Q. Dr. Herbert Meltzer? 4 A. No. 5 Q. Adolf Pfefferbaum? 6 A. No. 7 Q. James Cleghorn? 8 A. No. 9 Q. Melvin Vanwoert? 10 A. No. 11 Q. John H. Menkes? 12 A. No. 13 Q. Joyce Small? 14 A. No. 15 Q. Baron Shopsin? 16 A. Yes. 17 Q. S-H-O-P-S-I-N. Would that have been Protocol 18 Number 13? 19 A. I honestly do not remember the protocol 20 numbers that I worked on with those people. 21 Q. Do you recall -- 22 A. That was a long time ago. 23 Q. -- Alfred Fasola? 86 1 A. No. 2 Q. Louis Fabre, F-A-B-R-E? 3 A. You are talking did I work with these people 4 as an investigator of Prozac? Louis Fabre? 5 Yes. 6 Q. Okay. 7 A. I need to make a correction then. I did not 8 work with Feighner, I worked with Fabre. 9 Q. Did you work with Feighner at some other 10 point? 11 A. No, the name is very familiar, but I did not 12 work with him. 13 Q. How about Lawrence Gosenfeld? 14 A. Yes. 15 Q. How about a James Bremner? 16 A. Yes. 17 Q. How about a Howard Masco, M-A-S-C-O? 18 A. I was working with Prozac at the time when 19 the initial contacts were made with him, but 20 the study was not initiated before I left 21 Prozac. 22 Q. Are you talking about just this past year? 23 A. No, I'm talking fourteen or however many 87 1 years ago it was. That is when I worked with 2 most of these people you are naming. 3 Q. Okay. Harold Goldberg? 4 MR. MYERS: What was the name? 5 MR. GREEN: Harold Goldberg. 6 A. I do not believe so. 7 Q. Carl Rickels, R-I-C-K-E-L-S? 8 A. No. 9 Q. Guy Chouinard? 10 A. No. 11 Q. Jay Cohn? 12 A. I do not believe so. 13 Q. David Dunner. 14 A. I think I may have worked with him. I am not 15 positive. 16 Q. Bernard Grosser? 17 A. I don't think I did work with Dunner. 18 Q. Okay. How about Bernard Grosser? 19 A. I do not believe so. 20 Q. Burton Goldstein? 21 A. No. 22 Q. John Davis? 23 A. No. 88 1 Q. Ward Smith? 2 A. No. 3 Q. Rudolph Noble? 4 A. Yes. 5 Q. Stanley Fahn, F-A-H-N? 6 A. F-A-H-N? No. 7 Q. G. R. Arnolf? 8 A. No. 9 Q. J. J. Manigan? 10 A. No. 11 Q. Donald F. Klein? 12 A. I don't think so. 13 Q. Samuel Turner? 14 A. No. 15 Q. Roland J. Branconnier? 16 A. No. The reason I have to think about some of 17 these is, you know, I have worked with Prozac 18 a long time. A lot of the names are very 19 familiar. 20 When you work with probably over 21 hundreds of investigators it is sometimes 22 difficult to remember whether you worked with 23 them directly or if you just are familiar 89 1 with their studies or heard of their studies 2 from others. 3 Q. Alan Childs? 4 A. No. 5 Q. Lynn Crismon? 6 A. No. 7 Q. Roland Fieve? 8 A. No. 9 Q. Eric Dessain, D-E-S-S-A-I-N? 10 A. Yes. 11 Q. Ram K. Shrivastava? 12 A. That sounds familiar. I can't say for sure 13 that I worked with him. 14 Q. You also said that part of your job was 15 collecting documents; is that correct, 16 collecting documents from the clinical 17 investigators? 18 A. Right. 19 Q. What documents would you collect from the 20 investigators? 21 A. Well, all of the ones that are required by 22 regulation, FD Form 1573, their C.V.'s, their 23 budgets and their final protocols and consent 90 1 forms. That is probably not a complete list, 2 but basically that was the kind of thing that 3 we collected from them. 4 Q. That is all prior to the actual beginning of 5 the investigation; isn't it? 6 A. Right. 7 Q. As the investigation began and as the 8 investigation progressed, would you collect 9 documents during that time period? 10 A. Correspondence, case report forms. 11 Q. At the termination of the clinical 12 investigation, would you collect documents 13 then? 14 A. We get a return materials form that we send 15 out to them and get it back with the left 16 over materials in the study. I think that is 17 basically it. 18 Q. Would you have start-up meetings with 19 clinical investigators? 20 A. Yes. 21 Q. And would you meet them face to face? 22 A. Yes. 23 Q. And would you usually meet them at their 91 1 place of operation or here in Indianapolis? 2 A. It depended on the protocol. 3 Q. What would be the deciding factor on that? 4 A. Usually the size of the group, how many 5 investigators were going to do the studies. 6 If it was a large group we may have a group 7 start up. It could be here or in some cases 8 it was in other cities even though it was a 9 group start up. 10 Q. What would be discussed at these start-up 11 meetings? 12 A. The regulations, the requirements from the 13 FDA, Lilly's standards of clinical study 14 ethics and then the protocol and the case 15 report form and the study documents that they 16 were required to present to us. 17 Q. Were the Lilly standards of clinical ethics 18 something that was discussed verbally, or was 19 there a printed list of clinical ethics that 20 was handed out? 21 A. Usually both. 22 Q. Do you have a copy of that list of clinical 23 ethics? 92 1 A. There is a little -- I do not remember what 2 it is called. There is some little book on 3 clinical studies -- yes, I do not have a copy 4 any more. If I had to, I could get my hands 5 on a copy. 6 Q. It is a little book that is published by 7 Lilly? 8 A. Yes, it does not specifically discuss Prozac. 9 Q. This is a book you would hand out to all of 10 the investigators? 11 A. Yes. 12 Q. What is the title of the book? 13 A. I just said that I do not remember. Lilly 14 Principles of Clinical Practice or something 15 like that. 16 Q. Do you recall how many pages it is? 17 A. No, I don't. 18 Q. Were there ever clinical investigators that 19 did more than one protocol? 20 A. Yes. 21 Q. If they did do a second protocol, would they 22 receive any incentive through a better 23 contract, say, to do a second protocol? 93 1 A. No, I do not believe so. 2 Q. You also said that part of your job was to 3 begin the process of analyzing the data; is 4 that correct? 5 A. I said that I handled the data up to the 6 point where it is ready to be analyzed. I do 7 not analyze the data. 8 Q. Okay. Do you interpret the data in any way? 9 A. No, I never did. 10 Q. Do you work with any statisticians or did you 11 during this time frame? 12 A. We had statisticians that are assigned to the 13 projects, correct. 14 Q. And what statistician was assigned to the 15 project that, for instance, Dr. Dessain was 16 involved with? 17 A. I don't remember. 18 Q. Could you, please, tell me the name of any 19 statistician that you remember who was 20 involved with Prozac data? 21 A. Yes. Greg Ennis, Bruce Dornseif, Mary 22 Saylor. Those are the names that come 23 freshest to my mind. 94 1 Q. Did you give the data directly to the 2 statisticians or did it go through -- 3 A. They had access of the data through a data 4 base. 5 Q. Would you ever work with the statisticians to 6 accomplish some goal? 7 A. They would give input on the statistical 8 section of the protocol and they would be 9 involved in the analysis, but not myself. 10 Q. When they were involved with the analysis, 11 did you have anything to do with them at that 12 point? 13 A. Not directly. I mean not concerning the 14 analysis. I did not get involved in the 15 analysis part of what they were doing. I 16 knew they were in the stage where they were 17 doing it. It was not an aspect of my job to 18 work with them on the analysis. 19 Q. Okay. Was it also part of your job to review 20 the data as it came in from the clinical 21 investigators for the purpose of seeing if 22 there were omissions or mistakes? 23 A. I think we already have that in the record. 95 1 MS. ZETTLER: Could you repeat 2 the question? 3 Q. Was it also part of your job to review the 4 data for the purposes of determining if there 5 were omissions or mistakes? 6 A. And I said I thought that was already in the 7 record. We had some discussion about it 8 already. 9 Q. If we had the discussion, then I believe your 10 answer was yes? 11 A. Yes. 12 Q. Was there any other purpose for you to review 13 the data? 14 A. That was the purpose, to make sure that the 15 data was as correct as we could possibly make 16 it. If there was any doubt that the 17 investigator had made a mistake or left 18 something out, it was our job to communicate 19 to them to make sure that what was in there 20 was what the investigator intended. 21 Q. Okay. Do you have an understanding as to how 22 the drug Prozac works in the body? 23 MR. MYERS: Before he answers, 96 1 let me interpose an objection. He has 2 established that he is not a doctor. You are 3 calling upon him to give a medical and 4 scientific explanation. If he has some 5 fundamental understanding I think he can give 6 that. He is not qualified or competent to 7 testify. 8 MS. ZETTLER: The question was 9 whether he had any understanding. It is a 10 preliminary foundational question. 11 MR. GREEN: That is right. 12 MR. MYERS: It still calls for 13 the same information. He can take a stab at 14 it if he would like. 15 MS. ZETTLER: I think now it 16 calls for a yes or no answer. 17 MR. MYERS: Who is asking the 18 questions? 19 MS. ZETTLER: I'm representing 20 the client here. I am objecting to you 21 preparing your witness by telling him how to 22 answer questions inadvertently through your 23 objections. 97 1 MR. MYERS: I think you are 2 supposed to object to questions. 3 MS. ZETTLER: I can object to 4 anything that I want. 5 MR. GREEN: She can respond to 6 your objections. Could you read back the 7 question, please? 8 9 THE COURT REPORTER: Do you have 10 an understanding as to how the drug Prozac 11 works in the body? 12 MR. MYERS: Same objection. 13 A. I have a rudimentary, or some basic 14 understanding, but not very deep. I would 15 not bet my life on it. I'm not a scientist. 16 I have never tried to be the scientific 17 representative of the drug. 18 Q. In the course of your work did you deal with 19 adverse reaction reports? 20 A. Yes. 21 Q. And could you describe what happened as far 22 as that goes? Would you receive them in the 23 mail or exactly what was the process? 98 1 A. Well, there are various ways to receive 2 adverse reaction reports. The standard way 3 is on a case report form in the adverse event 4 section. But we were careful to review the 5 entire case report form in addition to the 6 adverse event section for any hint of any 7 adverse events such as in the comment section 8 or in any section. 9 If there was anything that indicated 10 there may have been an adverse event which 11 was not listed in the adverse event section 12 then we would communicate with the 13 investigator to make sure that if there were 14 an adverse event that it would get recorded 15 officially as an adverse event. 16 Then the investigator, if it was of a 17 serious nature, was instructed to contact us 18 directly by telephone. So we would get 19 occasional telephone communications of 20 adverse events. 21 There could be something in 22 correspondence if somebody wrote to us and 23 mentioned an adverse event that would get 99 1 recorded officially as an adverse event, 2 also. 3 In any way, shape or form if we heard 4 about an adverse event anywhere, on 5 television, from a friend or neighbor, if we 6 saw it in the newspaper, I mean, we were 7 instructed that anything that we heard of 8 that had a connection with one of our drugs 9 that sounded like an adverse event, it was 10 reported. 11 Q. Uh-huh. What would you call the people who 12 were actually a part of the various clinical 13 investigations? Subjects? Or would you call 14 them patients? How would you actually -- 15 A. I don't know. I have called them subjects 16 and I have called them patients. I don't 17 know that there is a -- it may be semantics. 18 I don't know. 19 Q. Well, during the course of your tenure period 20 where you were working on Prozac on the 21 various projects that you had, did any of the 22 subjects commit suicide? 23 A. I do not recall any on my studies. 100 1 Q. Did any of the subjects attempt to commit 2 suicide? 3 A. I don't recall any specific ones, but it is 4 possible. 5 Q. Was there a definition for a suicide attempt 6 that Lilly used in order to categorize events 7 which occurred to subjects? 8 A. Again, I want to be helpful. If there were a 9 definition, I do not remember it. I know 10 that we were very broad in our net of 11 catching these things. 12 I mean, anything that sounded anything 13 like it would certainly get reviewed as a 14 possible suicide attempt. 15 Q. Would an overdose of Prozac be considered a 16 suicide attempt? 17 A. As I recall, I think it was. I'm not 18 positive. 19 Q. What about drinking a bottle of hard liquor 20 and taking an overdose of Prozac, would that 21 be considered a suicide attempt? 22 A. As I mentioned in my previous answers, I do 23 not remember all of the specifics of what was 101 1 defined in the final analysis of what a 2 suicide attempt was. 3 It may have been considered under that. 4 Q. What about inflicting wounds on oneself with 5 a piece of glass, would that be considered a 6 suicide attempt? 7 A. You know, your questions seem to be heading 8 me in a direction that I do not feel 9 comfortable with. I think that was a 10 scientific judgment that the physicians made. 11 We were only instructed to catch anything, 12 and the things that you have mentioned would 13 be ones that would have been funneled to the 14 physicians for consideration. 15 But how they were finally analyzed and 16 everything, that is what I could not tell 17 you. All of those things would have been 18 brought to the attention of the physicians as 19 potential suicide or possible categorizations 20 of that. 21 Q. So you don't know how they were finally 22 analyzed? 23 A. No, I don't. 102 1 Q. Do you know what the result of the final 2 analyzing was, whether or -- 3 A. No. 4 Q. Did you ever get back that, yes, this was an 5 attempted suicide, or, no, it was not, after 6 you funneled it to the physician? 7 A. I do not recall any. 8 Q. Do you happen to know the name of 9 Jan Fawcett? 10 A. Yes. 11 Q. And did you work with Dr. Fawcett on Prozac? 12 A. Only after, I believe, after his study was 13 completed I helped, I was the -- I helped 14 with the wrap up of the study. 15 Q. Why did you step in at that stage? 16 A. Because the person that had been working with 17 it left the project and some details of 18 closing out the study had to be 19 administratively done. 20 Q. Do you recall what year that was? 21 A. No. 22 Q. Do you recall if it was before 1988? 23 A. No, it was not before 1988. 103 1 Q. Was it between -- was it in 1989? 2 A. You are getting into speculation. I don't 3 know. 4 Q. Okay. Well, do you recall was it before 5 January 1, 1992? 6 A. Before January 1, 1992? Again, I think you 7 are going to have to repeat the question 8 again. 9 Q. Was the point where you stepped in to wrap up 10 the project -- 11 A. Yes. Yes. It was before January of 1992. 12 Q. Okay. Was it before January of 1991? 13 A. I don't know. 14 Q. Okay. Do you know if it was after January of 15 1988? 16 A. No. 17 Q. Okay. So it was -- was it between January of 18 1988 and December of 1991? 19 A. I would -- I'm not sure. I don't know. 20 Q. Have you ever been the author of any articles 21 which were published which discussed Prozac? 22 A. Have I been the author? 23 Q. Or Fluoxetine? 104 1 A. No. 2 Q. Okay. 3 A. I think my name was on an abstract with 4 Dr. Burkstrum. I'm not even sure of that. I 5 believe that he did include my name as a -- 6 way down the list on one abstract that was 7 done. 8 Q. How did you help Dr. Burkstrum work on that 9 article? 10 A. I provided him with the results of the blood 11 level data on that study. 12 MR. GREEN: Do you mind if we 13 take a little break? 14 MR. MYERS: Not at all. 15 (AT THIS TIME A SHORT RECESS WAS HELD 16 AFTER WHICH THE FOLLOWING PROCEEDINGS WERE 17 HAD:) 18 Q. Mr. Russell, how did you prepare for this 19 deposition? Did you review any documents? 20 A. No. 21 Q. Did you meet with your attorney before this 22 deposition? 23 A. I met with Lilly attorneys. 105 1 Q. And when did you meet with them? 2 A. This morning and once before which was 3 several weeks ago. I do not remember the 4 exact date. 5 Q. Did they tell you what you should avoid 6 discussing? 7 MR. MYERS: We are not going into 8 anything that was discussed at that meeting. 9 He testified that he met and that is fine. 10 All that is privileged and he is not going to 11 answer that. 12 Q. Did there come a time when your -- let me 13 withdraw that question. 14 Did the Lilly attorneys ask you to 15 produce your Prozac documents for them? 16 A. No. 17 Q. Did you ever get together any documents 18 regarding Prozac at the request of any 19 attorneys? 20 A. No. No. No. 21 Q. Okay. 22 A. I mean, let me clarify your question. In 23 preparation for this deposition, or did I 106 1 ever get together any documents for Lilly 2 attorneys, period? 3 Q. Period? 4 A. Of course I did because we have sent 5 everything to the legal... 6 Q. When did you send these documents to the 7 legal department? 8 A. They are being constantly sent over. Every 9 quarter we send all of the documents that 10 have not been sent up to that point over. 11 Q. So you send documents not only to document 12 control, but also to the legal department? 13 A. Everything that has to do with Prozac has to 14 go to some legal group that is making 15 documents available to you, I believe. 16 Q. Uh-huh. So my question is: When you send 17 documents to document control, do you also 18 send documents to the legal department at 19 that point? 20 A. No. 21 Q. Do you send the same documents to document 22 control that you send to the legal 23 department? 107 1 A. Do I? 2 Q. Yes. 3 A. I'm not sure how to answer that question. 4 All of those documents get sent to the legal 5 department, but not necessarily by me. 6 Q. Okay. Who do the clinical physicians report 7 to, the Lilly clinical physicians? 8 A. Right now? 9 Q. Right now. 10 A. They report to Mike Hanson. 11 Q. And what is Mr. Hanson's title? 12 A. He is a vice president and I don't know the 13 exact title. 14 Q. And prior to Mr. Hanson, who did they report 15 to? 16 A. The director of the divisions that they 17 worked in. 18 Q. Is there a Prozac division or was there at 19 the time you worked on Prozac? 20 A. Yes. 21 Q. And who was the director of that division 22 when you first began in 1982 and 1983? 23 A. When I first began in 1982 and 1983? Well, 108 1 it was not called the Prozac division then. 2 It was some other name and I do not remember 3 exactly what it was. 4 Q. Okay. 5 A. Who was the director? I don't even remember 6 that. 7 Q. When it became the Prozac division, who was 8 the director at that point? 9 A. I believe when it officially became the 10 Prozac division it was Gary Tollefson, 11 T-O-L-L-E-F-S-O-N. 12 Q. Thank you. Who succeeded Mr. Tollefson? 13 A. No one. He is the director. 14 Q. He is still the director. When did he become 15 the director? 16 A. I do not remember exactly. 17 Q. Is his title director of the Prozac division? 18 A. I'm not sure of that either. 19 Q. Is Mr. Tollefson the person that you report 20 to as well, or that you reported to when you 21 were working on Prozac? 22 A. I reported directly to my department head, 23 Carol Zapapas. 109 1 Q. Did she report to Mr. Tollefson? 2 A. No. 3 Q. Who did she report to? 4 A. She reported to Mike Harrill, H-A-R-R-I-L-L. 5 Q. Did Mr. Harrill report to Mr. Tollefson? 6 A. No. 7 Q. Who did Mr. Harrill report to? 8 A. Mr. Harrill? At what time? 9 Q. At the time you left. 10 A. At the time I left he reported to 11 Greg Brickler. 12 Q. Did Mr. Brickler report to Mr. Tollefson? 13 A. No. 14 Q. Did anyone along the line starting with you 15 as a clinical research administrator 16 eventually report to Mr. Tollefson? 17 A. No. 18 Q. Was Mr. Tollefson only -- 19 A. That is Doctor. 20 Q. Was Dr. Tollefson only the director of the 21 Prozac division -- well, was he only 22 concerned with the physicians? 23 A. To my knowledge, yes. 110 1 Q. Well, who would hold a similar role in 2 relation to the administrators? 3 A. Greg Brickler. 4 Q. What is Greg Brickler's title? 5 A. I do not remember his title exactly. 6 Q. Do you know his position? 7 A. Director over all of the medical clinical 8 investigations divisions. 9 Q. And what about Harrill, what is his title? 10 A. Mike Harrill's title now or then? 11 Q. Now. 12 A. Now he is manager of medical planning, or 13 something to that effect. 14 Q. Was there one person who oversaw the work of 15 both Mr. Tollefson and Mr. Brickler? 16 MR. MYERS: When you say oversaw, 17 do you mean that they both reported to? 18 MR. GREEN: Yes. 19 A. Ultimately, yes. 20 Q. Who was that? 21 A. Vaughn Bryson. 22 Q. So other than your regular visits to a 23 clinical physician regarding the project that 111 1 you were working on, the only time the 2 clinical administrator and the clinical 3 physicians overlapped or met was under 4 Mr. Bryson; is that correct? 5 A. No. No. You asked me to think of somebody 6 that they all reported to. He is the chief 7 executive -- 8 Q. Was there ever communication between the two 9 groups other than your personal communication 10 with a certain physician? 11 A. There are all kinds of very complex groups 12 which I really have never bothered to try to 13 fully understand or I could not describe 14 them. 15 Q. Okay. 16 A. It is a complex organization. 17 Q. Do you know why it is complex? 18 A. Well, I think it is because clinical research 19 is a very complex process. 20 Q. Okay. 21 A. That is about the best answer that I can give 22 you. 23 Q. You said earlier that you worked on some 112 1 Phase III clinical trials; is that correct? 2 A. Yes. 3 Q. Could you define a Phase III clinical trial? 4 A. Well, a Phase III clinical trial is part of 5 the pivotal studies for an indication. 6 Q. And what is a Phase IV? 7 A. A Phase IV is a post-marketed study. It is 8 for, it is a study for an indication that is 9 already approved. 10 Q. Now, in the course of your work how many 11 Phase III projects did you work on? 12 A. You have to be more specific. Do you mean 13 all of the studies that I ever worked on, or 14 Prozac? 15 Q. I mean the Prozac. I'm discussing the 1982 16 to -- 17 A. You have to be specific. There are a lot of 18 different time periods that you talked about 19 earlier. You want to know how many -- can 20 you rephrase it? 21 Q. Yes. I would like to know since 1982 how 22 many Phase III studies that you worked on for 23 Prozac? 113 1 A. Not very many. Mostly Phase IV. Maybe, and 2 I'm not exactly sure, but maybe two. 3 Q. Okay. When did you start working on the 4 Phase IV studies? 5 A. Very early in the 1980's, very early after I 6 started to work with Prozac. I had some 7 Phase IV ever since I first came back to 8 Prozac in the early 1980's. I had Phase IV 9 and then, like I said, a couple Phase III. 10 Q. And a Phase IV study is a study that is done 11 after the drug has been approved for an 12 indication? 13 A. Right. 14 Q. Wasn't Prozac approved in 1988? 15 A. That is right. Technically a Phase IV study 16 can be a study that is for an indication that 17 has already been submitted to the FDA. If it 18 has been submitted to the FDA for approval 19 than anything additional that is not going to 20 be part of that initial package is a Phase IV 21 study. 22 Q. So it is a study that is not done on an 23 approved indication, but on an indication for 114 1 which approval has been submitted to the FDA? 2 A. Either submitted or already obtained, right. 3 Q. The study that Dr. Fawcett conducted, was 4 that Phase III or Phase IV? 5 A. I don't know. 6 Q. Did you have conversations with Dr. Fawcett 7 at the time that you came in to wrap up his 8 project? 9 A. No. 10 Q. Okay. 11 A. I never talked to him. 12 Q. You never spoke to him? 13 A. Never. 14 Q. Did you write him a letter to say I'm the new 15 clinical administrator here? 16 A. I don't think so. I don't think it is 17 necessary. I think it was beyond the point 18 of that. I think the time that I started 19 working with that study it was beyond the 20 point of any need to communicate further with 21 him. 22 Q. I thought you said that you came in at the 23 time to wrap up the study. Was communication 115 1 not necessary at that point? 2 A. I think that is right. I think we were 3 waiting on him to send some manuscript to 4 somebody. 5 Q. He was sending a manuscript? 6 A. Uh-huh. 7 Q. Not the results of the clinical 8 investigation? 9 A. You know, I do not remember precisely. 10 Because of the fact that I never communicated 11 with him, I think that was the case. 12 Q. Well, do you know if it was a pivotal or 13 non-pivotal study? 14 A. No. 15 Q. I -- 16 A. I don't think it was. 17 Q. Do you know if it was a double blind study? 18 A. I do not remember the specifics of the study. 19 Q. Well, did he know who to send his manuscript 20 to at Eli Lilly? 21 A. Yes, I think the clinical research physician. 22 Q. So you were not waiting for the manuscript? 23 The clinical physician was waiting for the 116 1 manuscript? 2 A. I think that is who he would have sent it to. 3 Q. So what exactly were you going to do to wrap 4 up Dr. Fawcett's study? 5 A. Close it out after I had received word that 6 the manuscript had been received. 7 Q. What does that mean, close it out? 8 A. That means just do a -- there is a very 9 simple report on the system to show that the 10 study, that everything has been completed. 11 Q. Okay. 12 A. It is called a synopsis, I think. 13 Q. Regarding the study done by Dr. Dessain, do 14 you recall if that was a pivotal or 15 non-pivotal study? 16 A. Non. 17 Q. Non? 18 A. The one that I recall was non. 19 Q. And do you recall what Dr. Dessain was 20 studying, what the topic was? 21 A. Yes. He was a co-investigator and it was a 22 study of depression in elderly patients, but 23 I'm not positive about that. 117 1 Q. Do you know if it was a blind study or double 2 blind study? 3 A. It was double blind. 4 Q. By the way, as a general rule, in a double 5 blind study who actually determined who got 6 what drug, who got the Prozac and who got the 7 placebo? 8 A. It is a totally randomized system, random 9 tabled. So it is strictly -- 10 Q. There was no predetermination of any kind? 11 A. No. 12 Q. Is that part of the requirement of Lilly? 13 A. I think that is a requirement from the FDA. 14 Q. Okay. 15 A. I think it is just generally accepted good 16 research practice. 17 Q. Did a physician, a clinical investigator, 18 ever report to you that he or she could 19 determine who was on Prozac or the placebo 20 simply by observation? 21 A. No. 22 Q. You never heard that? 23 A. No. 118 1 Q. You never heard that from any clinical 2 investigator? 3 A. No. 4 Q. Was Lilly ever concerned that a subject who 5 was depressed would receive a placebo and not 6 some form of medication to alleviate the 7 depression? 8 MR. MYERS: When you say Lilly, 9 do you mean anyone in the company, or that he 10 is aware of? 11 MR. GREEN: Anyone that he is 12 aware of. 13 Q. All of my questions only go to what you are 14 aware of. 15 A. Your question is: Was Lilly concerned that 16 someone who was depressed would get a 17 placebo? 18 Q. Yes. 19 A. I don't know how to answer other than the 20 fact that these are the way studies are 21 designed by accepted clinical practice and 22 regulations and the FDA. 23 Although it would be nice that everyone 119 1 with a disease would get a drug that would 2 treat it immediately, this is the only way 3 that clinical research can be done. 4 Q. You discussed at one point exclusion 5 criteria, I believe; is that right? We 6 discussed that briefly? 7 A. Yes. 8 Q. Was there also an entry criteria? 9 A. Yes. 10 Q. Could you tell me some of the characteristics 11 that were listed as part of the entry 12 criteria? 13 A. Boy, do you have time for me to be thinking 14 about this? 15 Q. Well, let's just discuss -- 16 A. There is a long list of very technical 17 language and it involved numbers and figures 18 that, you know, I will not recall. 19 Q. Well, let's take it this step, was there 20 entry criteria as far as the level of the 21 depression that a -- 22 A. Yes. It had to be DSM-III-R, you know, it 23 was very narrowly defined by these criteria. 120 1 Q. And who diagnosed the DSM-III-R? 2 A. In the patient? 3 Q. Yes. 4 A. The physicians. 5 Q. The clinical investigator? 6 A. Yes. 7 Q. Were there a select group of types of 8 studies, in other words, one type would be 9 double blind and another type would be blind 10 and another type would be whatever, was there 11 a select group? 12 A. I don't know what you mean by select group. 13 Q. I mean, was there a group of studies that 14 every project would fall into a category as 15 either double blind or it would fall into a 16 category of blind, or were the investigations 17 selected in a more haphazard way? 18 In other words, did the clinical 19 investigators design the investigation and 20 then it was approved and then it was 21 categorized, or did it have to fit a category 22 before it was approved? 23 MR. MYERS: I will object to the 121 1 question. I think you have asked him about 2 three or four questions there. I think you 3 ought to take them one at a time. 4 Q. Once a clinical investigation was approved by 5 Lilly as an investigation which would become 6 one of your projects, who determined the type 7 of clinical trial that that investigation 8 was? 9 A. It depended on whether it was for submission 10 to the FDA or not for an indication. It 11 depended on discussions between the Lilly 12 physicians and the statisticians and 13 regulatory and sometimes the FDA. 14 Q. So who had the responsibility of determining 15 the type of clinical trial that that was? 16 A. Ultimately the physicians, the Lilly 17 physicians. 18 Q. Okay. And that would be the five or six 19 people that you recall that you named for me? 20 A. Yes, the people that filled those kinds of 21 positions, whether I named them all I do not 22 know. 23 Q. Okay. Who determined the dosage of the 122 1 medication that would be used in these 2 various projects? 3 A. Ultimately the physicians. 4 Q. When you say physicians, do you mean the -- 5 A. The Lilly physicians. 6 Q. The Lilly physicians? 7 A. Uh-huh. 8 Q. That would be the same five or six people 9 that you remember? 10 A. Correct. But, again, their decisions were 11 not just stand-alone decisions. They were 12 based on the data that was discovered on 13 Prozac and toxicology and pharmacokinetics 14 and discussions with the FDA, too. Dosage is 15 very, very narrowly regulated by all of 16 those. 17 Q. Well, when Lilly began the clinical trials 18 for Prozac did they have any idea what 19 dosages would be used in the clinical trials? 20 A. I think you are asking me to describe the 21 whole process of how dosages are defined. Is 22 that what you want me to do? 23 Q. Yes. 123 1 A. It is a long process. You have to do animal 2 studies on a drug to determine the toxicology 3 and you have to do some early dosing in human 4 volunteers that are healthy volunteers to 5 determine, you know, tolerances of the drug 6 in humans. 7 And then you do some dose ranking 8 studies to get the effects of the drugs in 9 higher and lower doses and then you have to 10 go into, you know, broader studies and you 11 have to do pharmacokinetics, full range 12 pharmacokinetic studies, and then you have to 13 do broader studies and then you expand it 14 into the full double blind, pivotal, 15 Phase III studies. 16 You know, it is a progression of 17 obtaining information and discussing and 18 reviewing and evolving the dose. 19 Q. Okay. What were the ranges or what was the 20 range of doses used in the projects that you 21 worked on? 22 A. I think in all of the time that I worked on 23 Prozac it was probably 20 to 80 milligrams. 124 1 Q. Who was responsible for determining that 2 range? 3 A. The physicians and the whole process that I 4 just described. 5 Q. What about the exclusion and the entry 6 criteria, were the physicians responsible for 7 that, making up that set of criteria? 8 A. Yes. Yes. 9 Q. The clinical trial that Dr. Noble worked on, 10 was that a pivotal or non-pivotal? 11 A. It was a, I believe that would have been 12 considered a pivotal study. 13 Q. Okay. 14 A. It was a Phase III study for an indication. 15 Q. Do you recall which indication? 16 A. Yes, it was obesity. 17 Q. Do you recall how much money Dr. Fawcett 18 received from Lilly for his study? 19 A. No. 20 Q. Were you responsible for determining the 21 amount of money a physician received? 22 A. Only -- not how much the original grant was 23 for, but for how much they earned by the 125 1 amount of work they had done. 2 They were only paid for work completed. 3 Q. What were they paid? 4 A. What were they paid? Money. 5 Q. How much money? 6 A. They were paid for the work they completed. 7 It depended on how much of the work they did. 8 Every physician completed differing amounts 9 of work. 10 Q. Well, there must have been a way you figured 11 out how much work they did and how much money 12 that was? 13 A. Well, it was based on the budget and the 14 budget per patient and then how many patients 15 they did and how many of the required 16 functions on the patient they actually 17 performed. 18 Q. What was the budget per patient? 19 A. It was different for every study. 20 Q. What was the budget for a patient for the 21 study that Dr. Fawcett did? 22 A. I have no recollection. 23 Q. Who was the person working, the clinical 126 1 administrator, working with Dr. Fawcett prior 2 to you? 3 A. I think it was Catherine Mesner, M-E-S-N-E-R. 4 Q. Is she still with Lilly? 5 A. Yes. 6 Q. And what is her title at this point in time? 7 A. I don't know her title now. 8 Q. Is she still with the Prozac group? 9 A. No. 10 Q. The study performed by Dr. Shopsin, was that 11 a pivotal or non-pivotal? 12 MR. MYERS: You have been given a 13 list of the pivotal studies in our sworn 14 Interrogatory Answer. 15 MS. ZETTLER: He testified that 16 Dr. Dessain was a non-pivotal. 17 A. The study that I worked with him on. 18 MR. MYERS: You have been given a 19 list of the pivotal trials. 20 Q. Did the study that Dr. Shopsin worked on, was 21 it pivotal or non-pivotal? 22 A. I don't know. 23 Q. Do you recall what indication the study was 127 1 for? 2 A. Depression. 3 Q. Do you recall what indication the study was 4 that Dr. Fabre did? 5 A. Depression. 6 Q. And was that a pivotal study? 7 A. I don't know. That was -- like I said, 8 fourteen years or so ago. I didn't know what 9 a pivotal study was then. 10 Q. What about Dr. Gosenfeld, was that pivotal? 11 A. Same answer and same time period. 12 Q. You don't know if it was pivotal or not? 13 A. No, I don't. 14 Q. And it was for depression? 15 A. Yes. 16 Q. And Dr. Bremner? 17 A. The same. 18 Q. Okay. 19 A. All of the studies when I worked with those 20 people -- I worked with those people in the 21 '70's. They may have done studies after 22 that. 23 Q. You worked with Fabre, Gosenfeld and Bremner 128 1 in that one year period? 2 A. Yes. 3 Q. And all of the others that you worked with in 4 the 1980's that you mentioned? 5 A. We have to go over the list. 6 Q. Lemberger, Dessain, Noble, Shopsin and 7 Fawcett? 8 A. Shopsin was in the '70's, also. 9 Q. That leaves us with four names, one of which 10 was only for a wrap up, Dr. Fawcett. Dr. 11 Lemberger, Dr. Dessain and Dr. Noble, so that 12 leaves us with those three names as to people 13 that you worked with in the 1980's. 14 In the one year in the '70's you worked 15 with Shopsin, Fabre, Gosenfeld and Bremner; 16 is that right? 17 A. Yes. 18 Q. How long did the study that Dr. Dessain do, 19 how long did that take? 20 A. He was not the principal investigator, but 21 that study took approximately two years, two 22 to three years. 23 Q. So on that particular study, were you working 129 1 on another project during that time, a second 2 project, or was that the only project that 3 you were working on? 4 A. I was working on other projects, other 5 protocols. 6 Q. And what about the project that Dr. Noble was 7 doing, how long did that take? 8 A. I think that was, again, around two years, 9 give or take. 10 Q. During those two to three years of 11 Dr. Dessain's study you, obviously, were 12 involved at the beginning of the study and 13 you were involved in the wrap up. 14 During the two or three years in 15 between the beginning and the wrap up did you 16 do anything other than the occasional 17 communication with Dr. Dessain? 18 A. I went to see him once, I think, after the 19 start up. 20 Q. Anything else? 21 A. We took care of the case report forms and did 22 the things that I have described that I do 23 with every study. 130 1 Q. As far as the exclusion criteria, did that 2 include, was one of the criteria if the 3 subject were suicidal? 4 A. I think so. As I recall, there was an 5 exclusion criteria for suicidality. 6 Q. Do you know how -- 7 A. It was not always there, so I do not remember 8 exactly when we introduced that as an 9 exclusion criteria. 10 Q. Was it in the 1980's? 11 A. I don't remember. 12 Q. How was suicidality measured by the clinical 13 investigators? 14 A. I don't know. I don't remember. 15 Q. Do you know if Lilly had any instructions or 16 requirement as to how to measure suicidality? 17 A. I don't recall. 18 Q. Do you know if Lilly had any medical tests 19 which they required their investigators to 20 perform on the subjects prior to becoming 21 subjects in the clinical investigations? 22 A. They had to have a physical examination and 23 they had to, they had to have examinations to 131 1 determine some of the things that were in the 2 exclusion criteria including baseline 3 laboratory studies. 4 In some cases they had to have x-rays 5 and EKG's and things like that. Which 6 protocols required which ones, I do not 7 remember. There were things like that that 8 were performed baseline with the patient to 9 aid in the, making sure they met the entry 10 criteria. 11 Q. For the depression protocols, were there any 12 physical tests done on the brain, any 13 chemical tests done on the brain or any brain 14 wave pattern tests or anything of that 15 nature? 16 A. I don't think so. 17 Q. Did you ever hear of a Dr. Lipinski? 18 A. It does not ring any real bells. 19 Q. Did you ever hear of the abnormal and 20 voluntary movement scale? 21 A. No. 22 Q. Did you ever hear of the Brief (Phonetic) 23 psychiatric rating scale? 132 1 A. I have heard of that. 2 Q. Do you know what it is? 3 A. No. 4 Q. Have you ever heard of the Hamilton rating 5 scales? 6 A. Yes. 7 Q. Do you know if they were used by the clinical 8 investigators? 9 A. We used a HAMD scale, yes. That is what the 10 jargon is for, Hamilton depression score. 11 Q. What did you use that for? 12 A. It was one of the efficacy measurements done 13 in the study to see how the patient improved 14 in their score on the HAMD. 15 Q. To see how the patient improved from what to 16 what? 17 A. From a baseline HAMD depression rating to 18 subsequent HAMD depression ratings. 19 Q. Do you know if the HAMD scale measured any 20 scale of suicidality? 21 A. I think there was a question that included 22 it. 23 Q. Do you know for sure? 133 1 A. Yes. 2 Q. Was there a question? 3 A. I believe so. I would not bet my life on it, 4 but I think there is. 5 Q. Did Lilly provide to the clinical 6 investigators at any point, including at your 7 start-up meeting, any warning about what to 8 watch out for as far as predictors to 9 suicide? 10 A. Repeat that, please. 11 Q. Did Lilly provide any characteristics to look 12 out for in subjects as indicators of possible 13 suicide? 14 A. I don't recall. 15 Q. When you did these start-up meetings with the 16 clinical investigators, was suicide ever 17 discussed? 18 A. I think it was discussed as a part of the 19 protocol in the inclusion and exclusion 20 criteria. 21 Q. Okay. 22 A. And it is an adverse event that it had to be 23 reported no matter how minor or insignificant 134 1 the event or the attempt may have appeared to 2 be. 3 Q. So suicide was considered an adverse event? 4 A. Uh-huh. Yes. Yes. 5 Q. Was the indication of depression always the 6 target indication for Prozac as far as you 7 can remember? 8 A. Say that again. 9 Q. Well, you mentioned that some of these other 10 clinical investigations, I think you said one 11 involved obesity. 12 A. Yes. 13 Q. In 1985 before the drug was approved for 14 depression, an indication of depression, was 15 the target market ever considered to be 16 obesity as an indication? 17 A. We were doing obesity studies then. 18 Q. Were you doing as many obesity studies as you 19 were doing depression studies? 20 A. No. 21 Q. Was there ever a point in time that you know 22 of where there was a greater interest in the 23 indication of obesity? 135 1 A. Greater than what? 2 Q. Greater than depression. 3 A. No. 4 Q. At any time while you were setting up the 5 clinical investigation at a start-up meeting, 6 did Lilly ever provide to the investigator a 7 profile to determine who would be sensitive 8 to Prozac? 9 A. Sensitive to Prozac? 10 Q. Yes. 11 A. Not that I'm aware. There could have been, 12 but I'm not aware of it. 13 Q. Okay. 14 A. I think maybe to answer that question more 15 fully, I think that is what the inclusion and 16 exclusion criteria attempted to do is exclude 17 people who may be, by your description, what 18 you mean to be sensitive. 19 Q. Okay. 20 A. It attempted to exclude people who might not 21 benefit from being given the treatment. 22 Q. Okay. 23 MR. GREEN: Let's go off the 136 1 record. 2 (AT THIS TIME A SHORT RECESS WAS HELD 3 AFTER WHICH THE FOLLOWING PROCEEDINGS WERE 4 HAD:) 5 EXAMINATION, 6 QUESTIONS BY MS. ZETTLER: 7 Q. I will re-introduce myself. I'm Nancy 8 Zettler. I represent a group of the 9 plaintiffs in the Kentucky case versus Shea 10 Communications. I will have some follow-up 11 questions of what Greg asked you and then 12 have some other areas that I will get into. 13 I will go through some basic 14 preliminary things. 15 What is your current address? 16 A. XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX. 17 Q. Where were you born? 18 A. XXXXXXXXXXXXXXXXXXXX. 19 Q. What is your birth date? 20 A. 10/6/43. 21 Q. What is your Social Security Number? 22 A. XXXXXXXXXXX. 23 Q. Are you a family man? 137 1 A. Yes. 2 Q. Do you have any kids? 3 A. Three. 4 Q. Do you have an Indiana driver's license? 5 A. Yes. 6 Q. Could I see that, please? Will you show it 7 to your counsel? 8 MR. MYERS: What do you want his 9 driver's license for? 10 MS. ZETTLER: I want to see if 11 his picture is as bad as mine. 12 Let the record reflect that Counsel has 13 tendered to me the Indiana driver's license 14 of Daniel G. Russell, License Number 15 XXXXXXXXXX. Thank you. 16 MR. MYERS: You are welcome. 17 Q. Do you have any medical training whatsoever? 18 A. No. 19 Q. Did you ever sell any medical devices or 20 pharmaceuticals before working for Eli Lilly? 21 A. No. 22 Q. And I want to make sure that I understood you 23 earlier. You started in 1967 with Lilly? 138 1 A. Yes. 2 Q. Almost immediately you went into the service? 3 A. Six months later. 4 Q. That six-month period of time you worked in 5 sales? 6 A. Right. Sales training. 7 Q. Did that training period include anything 8 related to medicines or things of that nature 9 other than the things that you would sell, 10 pharmaceuticals? 11 A. A very cursory coverage of that kind of 12 thing. 13 Q. At that time in 1967, I take it, you were not 14 involved in Fluoxetine, hydrochloride or 15 Prozac or anything of that nature? 16 A. No. 17 Q. Were you given any training by Lilly or 18 anyone during that six-month period of time 19 about depression? 20 A. No. 21 Q. Once you got back from the service, and I 22 believe you said it was 1970? 23 A. Yes, 1970. 139 1 Q. Did you complete your training with Eli 2 Lilly, or did you start as a salesman right 3 away? 4 A. I had another month of training at that 5 point. 6 Q. During that month were you given any training 7 whatsoever related to either psychological or 8 medical illnesses or pharmaceuticals other 9 than selling them? 10 A. No. Not anything to do with depression or 11 drugs to treat it. 12 Q. Not on what effects the drugs may have or how 13 they work on the body? Just on how to sell 14 the drugs? 15 A. Are you talking about depression drugs? 16 Q. Any drugs? 17 A. I'm sure there was some discussion, but 18 again, at a very layman-type level. It did 19 not go in deep. It was not any full, deep 20 course on medical terminology and medicine 21 and physiology and all that stuff. 22 It was very basic stuff surrounding the 23 drugs that we were working with. 140 1 Q. Okay. And your first contact -- when we talk 2 about Prozac, I believe you agreed earlier 3 that that would cover Fluoxetine and 4 hydrochloride and any indicated uses 5 whatsoever? 6 MR. MYERS: We agreed to go along 7 and see how that went. 8 Q. Have you had a problem with that definition 9 as far as using Prozac to cover Fluoxetine, 10 hydrochloride and any indicated uses? 11 A. What is the question? 12 Q. Okay. I just want to make sure that we are 13 of the same mind here. When I say Prozac I 14 mean Fluoxetine and hydrochloride for any 15 indicated use, not just for depression and 16 not just Prozac, per se. 17 A. Yes. 18 Q. Have you been answering all of the questions 19 under that assumption so far today? 20 A. As far as I can remember. 21 Q. Okay. Does any instance stick out in your 22 head where you limited your answer just to 23 depression? 141 1 A. No. 2 Q. Okay. So the first contact you had with 3 Prozac under that definition we just talked 4 about was when you became, I believe, a 5 medical research -- what was the title that 6 you had prior to -- 7 A. Medical information administrator. 8 Q. Thank you. Is that correct? 9 A. Yes. 10 Q. You did not sell Prozac or Fluoxetine? 11 A. No. 12 Q. And that was some time in 1974 that you 13 became a medical -- 14 A. When I became that, yes. It was April in 15 1974. 16 Q. Between 1970 when you finished your training 17 and April of 1974 you sold, you were a 18 salesman, a detail man for Lilly? 19 A. Yes. 20 Q. Once you became a medical -- medical 21 information administrator, were you given any 22 training by Eli Lilly or anyone else for that 23 position? 142 1 A. Very little. 2 Q. Okay. How did your responsibilities as a 3 medical information monitor -- is that right? 4 A. Administrator. 5 Q. I'm sorry. And a detail man differ? 6 A. It was totally different. A detail man is 7 responsible for presenting physicians and 8 customers with details about our drugs and 9 hopefully selling them on the benefits of 10 Lilly medicine. 11 And clinical research is administrators 12 administrating over clinical studies. It is 13 different work. 14 Q. Did you have any prior experience before 15 becoming a medical information administrator 16 that you felt was applicable to that position 17 prior to obtaining that position? 18 In other words, how did your job as a 19 detail man or any other job help you make the 20 transition into becoming a medical 21 information administrator? 22 A. Well, I, you know, if you ask me why I think 23 I was qualified for that job, I had some 143 1 chemistry and biology and mathematical and 2 statistical courses in college. I did learn 3 a lot on the job in sales in those years 4 talking to physicians about the drugs and 5 doing some studying on my own. I did a lot 6 of reading and boning up on diseases that I 7 was working specifically with the drugs that 8 I had to detail. 9 Then in the process of being a medical 10 information administrator and having to 11 research to answer the questions of 12 physicians and pharmacists that called in 13 with questions or wrote in with questions, 14 that gave me more comfort with some of those 15 disease fields and drugs and then the 16 on-the-job training. 17 Q. Okay. Am I correct in assuming that the 18 medical information administrator is really 19 the same thing as the CRA position that you 20 had right before you went, or changed jobs at 21 Lilly? 22 Is that the same position with a 23 different title, or is there a difference 144 1 between a medical information administrator 2 and a CRA? 3 A. When I first described those jobs earlier I 4 said that the medical information 5 administrator job that I got in April of '74 6 was to answer the questions from physicians 7 and pharmacists and nurses and customers. 8 Q. You are right. 9 A. About a year later, the title stayed the 10 same, but they started using persons with 11 what they felt were qualifications to help 12 physicians in the administrative aspects of 13 clinical studies, which is a different 14 function than I was doing in April of 1974. 15 Q. Okay. So it was not, at first it was not the 16 title that changed, it was the 17 responsibilities that changed under the 18 medical information administration position? 19 A. Yes. 20 Q. They changed to responsibilities that are 21 similar to, if not the same, as? 22 A. Yes, exactly. They are totally the same. 23 Q. Okay. So when you first became a medical 145 1 information administrator your basic 2 responsibility was to just answer doctors' 3 questions regarding certain drugs? 4 A. Correct. 5 Q. Okay. 6 A. Correct. 7 Q. And that included Prozac at that time? 8 A. Prozac did not exist at that time. 9 Q. Okay. When you became involved with Prozac, 10 you were still a medical information 11 administrator; correct? 12 A. Yes. In the '70's, yes. 13 Q. Okay. And did your responsibility -- why did 14 you leave -- maybe I missed this. Why did 15 you leave that project at the end of 1979? 16 You said there was a period there where 17 you were not with the Prozac project and then 18 you came back in 1982 or 1983? 19 A. The whole process that Eli Lilly was using to 20 do those kinds of studies was changing. At 21 that time I had five different drugs that I 22 was responsible for and now, you know, there 23 are a number of people on one drug so that 146 1 was starting to change. 2 There was a movement going on. I moved 3 to the Lilly Clinic at Wishard Hospital and 4 worked with cancer drugs. 5 Q. Okay. So when you first started getting 6 involved with Prozac in '79 you had 7 responsibilities with other drugs as well? 8 A. Right. 9 Q. And then you came back and your only 10 responsibility was Prozac? 11 A. Yes. 12 Q. Okay. Is there, are there more than one 13 clinical research administrators assigned to 14 each protocol? 15 A. Only some protocols. 16 Q. Okay. Are there cases where there is only 17 one? 18 A. Yes. 19 Q. There are cases where there is more than a 20 couple? 21 A. Yes. 22 Q. Which kinds of -- I take it the large 23 multi-center studies -- 147 1 A. Have multiple CRA's. 2 Q. The types of studies that you worked on, did 3 you work on any multi-center studies? 4 A. Yes. 5 Q. How many? 6 A. I can only recall one with Prozac. 7 Q. I'm sorry. My questions are limited to 8 Prozac now. You do not have to search your 9 memory for every drug that you worked on. 10 Do you recall what the purpose of that 11 study was? 12 A. It was obesity. 13 Q. Was that the obesity study that you talked 14 about earlier with Dr. Dessain? 15 A. No, Dr. Noble. 16 Q. Noble. I'm sorry. That was the only 17 multi-center study that comes to mind at this 18 point? 19 A. With Prozac. 20 Q. Again, all my questions are limited at this 21 time to Prozac unless I indicate otherwise. 22 Can you give me an idea of what some 23 other purposes of the studies were? We know 148 1 there was an obesity study. Did you work on 2 any depression studies? 3 A. Yes. 4 Q. How many of those would you say that you 5 worked on? 6 A. Many. 7 Q. Earlier you testified that you think you 8 worked between ten to twenty Prozac studies 9 total. 10 Can you tell me how many out of that 11 ten or twenty were for depression? 12 A. Almost all. 13 Q. Okay. Any other purposes of any of the 14 studies that you worked on? 15 A. Do you mean indications? 16 Q. Well, indications. We will take depression 17 in a minute and break it down. Obesity. Was 18 there any smoking? 19 A. Yes. 20 Q. Okay. Let's see, anything with bipolar 21 disorder? 22 A. No. 23 Q. Anything with obsessive-compulsive disorder? 149 1 A. No. 2 Q. Any other treatments or indications that you 3 can think of? 4 A. Atypical depression. 5 Q. What is atypical depression? 6 A. I cannot remember. It is very technical and 7 based on another whole set of criteria. I'm 8 not qualified to tell you that. 9 Q. Does bipolar, does that ring a bell with you? 10 A. I have heard of what it is. I have a vague 11 idea of what it is. I never worked with it. 12 Q. Do you recall who it was that you worked on 13 the atypical depression study with, what 14 investigator? 15 MR. MYERS: If the investigator 16 is not on the list you do not tell her for 17 the same reason I said before. 18 A. It is not on that list. 19 Q. Do you remember the purpose of Dr. Fawcett's 20 study? 21 A. No, I don't. 22 Q. Do you remember whether or not it was a 23 depression study? 150 1 A. I'm not certain, but I think that it was. 2 Q. Okay. Do you remember if Dr. Fawcett was on 3 site or off site as far as Lilly was 4 concerned? Did he do a study here in town? 5 A. It was off site. 6 Q. Do you remember where he was located? 7 A. No. 8 Q. If I said the word Rush-Presbyterian, St. 9 Luke's Hospital in Chicago, would that ring a 10 bell with you? 11 A. No. 12 Q. Who told you to help close up Dr. Fawcett's 13 study, do you recall? 14 A. Earleen Ashbrook. 15 Q. Okay. 16 A. I'm not positive. It was probably Earleen. 17 It could have been somebody after her. 18 Q. Okay. Anyone else that rings a bell? Do you 19 have any idea who it could have been? 20 A. One of the other people that we listed. 21 Q. It depends on who you were reporting to at 22 the time? 23 A. Exactly. 151 1 Q. Okay. Were you in school before you worked 2 at Lilly? 3 A. Yes. 4 Q. Did you have any jobs related to 5 pharmaceuticals or medical -- 6 A. No. 7 Q. -- in college? 8 A. No. 9 Q. In regards to preparation for your deposition 10 today you said that you met twice with 11 attorneys for Eli Lilly; is that correct? 12 A. Yes. 13 Q. One meeting was several weeks ago? 14 A. Yes. 15 Q. Can you give me an idea, was it about a month 16 or month and a half? 17 A. I do not remember exactly. 18 Q. Okay. How long did that meeting last, if you 19 can recall, the first meeting? 20 A. I don't remember exactly. Maybe an hour and 21 a half, two hours. 22 Q. Okay. How many lawyers were in that meeting? 23 A. I think they were all lawyers and I think 152 1 three. 2 Q. Did you talk to anyone else about your 3 deposition today other than the lawyers in 4 that first meeting? 5 A. No. 6 Q. Did you tell your wife you were coming here? 7 A. Yes. 8 Q. Did you tell your wife why you were coming 9 here? 10 A. No. 11 Q. How about any of your fellow employees at 12 Lilly, did you talk to them about your 13 deposition today? 14 A. No. 15 Q. Have you gotten anything in writing from any 16 of the lawyers in this case regarding the 17 deposition other than telling you that -- 18 A. Just a calendar, putting it on my calendar. 19 Q. Okay. Just a letter telling you that you got 20 to show up on such and such a date? 21 A. No letter. 22 Q. What do you mean by calendar? 23 A. I mean I have a calendar. I have a computer 153 1 calendar system. 2 Q. So they sent you a note on your computer 3 calendar system and said that your deposition 4 was scheduled on June 9? 5 A. I can't remember if they put it on there or 6 if I did from a note. 7 Q. Have you gotten any interoffice memorandum 8 about the deposition from anyone in the 9 company? 10 A. No. 11 Q. Do you know if Fawcett's study was a Phase IV 12 or Phase III study? 13 A. I do not remember. 14 Q. Earlier you testified that you thought that 15 you closed it out sometime between 1987 and 16 1990, I believe? 17 A. I believe that I said I was not sure. 18 Q. At one point I think that you said it did not 19 happen before 1987? 20 A. I do not think I could remember exactly. 21 Q. Okay. How did you meet Dr. Wong? 22 A. How did I meet David Wong? It was before I 23 knew of Prozac. A long time ago. 154 1 Q. Okay. How did you meet him? 2 A. I do not remember. Just at work. 3 Q. Through Lilly? 4 A. Yes. 5 Q. Had you worked together on any other 6 projects? When I say projects in this 7 context I do not mean protocol, but any other 8 drugs other than Prozac? 9 MR. MYERS: You said on any other 10 projects. I don't think he testified that 11 they worked on a project with respect to 12 Prozac. 13 Q. Did you work with Dr. Wong on Prozac? 14 A. Did I work with him on Prozac? Not directly. 15 Q. Was he working on Prozac at the same time you 16 were working on Prozac? 17 A. I assume so. 18 Q. Did you work in conjunction with, or with Dr. 19 Wong on any other medication or medical 20 device produced by Lilly? 21 A. No. 22 Q. What is neuroendocrinology? 23 A. It is a field, I can't define it. 155 1 Q. Okay. 2 A. It is a field of medical research. 3 Q. Okay. 4 A. It has to do with the brain. 5 Q. One time were you senior clinical research 6 administrator medical plans 7 neuroendocrinology? 8 A. Uh-huh. 9 Q. That was your entire title? 10 A. That was the title where he was asking me if 11 I could remember the title of the divisions, 12 and they changed over time. That is what 13 they called it at one time, 14 neuroendocrinology. 15 Q. Okay. 16 A. Nobody ever asked me to define it. 17 Q. Do you have any idea what it means 18 whatsoever? 19 A. I said it has to do with research on the 20 brain and affects on the brain. 21 Q. Do you know what endocrinology is? 22 A. It is a system of the body. The endocrine 23 system, the study of it. 156 1 Q. Do you know what an enantiomer is? 2 A. No. 3 Q. I'm a little bit confused about what happens 4 to the clinical report forms once they are 5 filled out and turned back into you guys, 6 okay, at your department. 7 My understanding from what you 8 testified to earlier, and in looking at 9 various documents, is that the clinical 10 investigators fill out the form and at some 11 point or another turn them back into you or 12 someone within your department; is that 13 correct? 14 A. Who filled it out? 15 Q. Clinical investigators, and they are turned 16 over once they are filled out to yourself or 17 someone else like you in your department? 18 A. They initially come into document control and 19 then data entry and then to me. 20 Q. Okay. And they go to data entry first? 21 A. Document control first. 22 Q. Okay. Then data entry and then you? 23 A. Correct. 157 1 Q. Data entry is where they put it into the 2 computer data base? 3 A. Yes. 4 Q. Who makes the corrections on the case report 5 or the clinical reporting forms? I know at 6 one point you said that you have 7 responsibility for it, but if they do not 8 come to you until after they go to the data 9 entry program then you have to go back and 10 correct them in the data base? 11 A. Well, we have the data base on the computer 12 screen at our desk. 13 Q. So the person who, the typist, for lack of a 14 better phrase, types all of the information 15 on the form and you look at it while it is on 16 the computer? 17 A. Correct. And we look at the paper copy, too. 18 Q. You double check to make sure that the paper 19 copy is in sync with the computer? 20 A. Yes. 21 Q. Who double checks the information that comes 22 in on the report form? 23 A. We do. 158 1 Q. How? 2 A. We look at it and use the edits that I 3 discussed previously. 4 Q. I will get to that. How do you know that the 5 information on the clinical report form that 6 is sitting in front of you that has been 7 entered into the computer is correct? 8 A. As I described earlier, I look it over for 9 omissions, for obvious errors and 10 inconsistencies, and then I look at the edits 11 which are a further check, and then any and 12 all of the things that we have any questions 13 about we contact the investigators and 14 discuss them to make sure that what is in the 15 case report form is absolutely correct. 16 Q. Okay. I guess then maybe I'm confused as to 17 what the clinical report forms themselves 18 are. 19 Is the Hamilton rating scale built into 20 that? 21 A. Yes. 22 Q. The actual 21 questions? 23 A. Yes. If it is 21 questions. Some of them 159 1 have different Hamiltons. 2 Q. Okay. Do you then input every single 3 question from the Hamilton into the computer? 4 A. It is built in. The whole case report form 5 is built into the computer for the study. I 6 do not put it in there. 7 Q. When I say you, I mean your department in 8 general. You said your department was, or 9 the data processing department does that; 10 correct? 11 A. Yeah, the computer people. 12 Q. So the computer people. Say you have this 13 report form, this CRF, and on there there is 14 some form of the Hamilton depression scale; 15 right? 16 A. Yes. 17 Q. Assuming -- 18 A. In a depression study, yes. 19 Q. All these questions are being asked on this 20 test? 21 A. Yes. 22 Q. I assume there are answers to these questions 23 for any given visit? 160 1 A. Yes. 2 Q. So does then Miss Secretary or Miss Typist 3 sit there and say the answer to Question 4 Number 1 is such and such? 5 A. The data entry person does that, correct. 6 Q. Okay. And also somewhere on that form are 7 the results of that rating scale for that 8 particular visit; correct? 9 A. The total, yes. 10 Q. So both the actual answers and the totals are 11 inputted into the computer data base? 12 A. Yes. 13 Q. Okay. Then, again, on this CRF, say you have 14 a protocol that requires that every visit or 15 every other visit they are supposed to take 16 blood, okay, and send it to a lab or 17 whatever. 18 Now, I assume that you do not send the 19 clinical report form to the lab with the 20 blood for them to fill in the little space 21 that says what is the result of the blood 22 test; correct? 23 A. I have to ask you -- there are different 161 1 kinds of blood tests that can be done. What 2 blood test are you talking about? 3 Q. Let's do it for levels of Prozac. 4 A. Because it is entirely different. 5 Q. What I really want to do to is, I want to 6 know is this clinical report form something 7 that follows everything with this patient 8 around, say, with the patient's blood or 9 urine? 10 If you are going to have a chest x-ray, 11 does this report stay in one place and all 12 this raw data comes from all over the place 13 and is entered into this report form? 14 A. The majority of the data is filled in by the 15 investigation site at each visit. 16 Q. On the actual report form? 17 A. On the report form collected on lab studies 18 and x-rays and the HAMD results and all that. 19 Q. Does the investigator or someone, his 20 assistant, have to sit there and say here are 21 the results of the x-rays and we will take 22 this and put it in the report form? 23 A. Yes. Yes. 162 1 Q. Okay. Then the report form is what comes to 2 you? 3 A. Yes. 4 Q. Okay. All right. This raw data does not 5 come to you? 6 A. It is maintained by the investigator. 7 Q. But it does not come to you? 8 A. No. 9 Q. You do not check this raw data against what 10 is reported on the form? 11 A. We have field people who do audits of that 12 periodically. 13 Q. Okay. When they do an audit what do you 14 mean? 15 A. They go out and they actually check all of 16 the raw data with what is on the forms. 17 Q. Every single patient and every visit? 18 A. I do not know. I do not recall. I think it 19 is done at the beginning of a lot of studies 20 until they are comfortable that the site is 21 doing it correctly. It is different for each 22 study. 23 Q. It is kind of checking up on the 163 1 investigators? 2 A. Yes, it is an audit check. 3 Q. To keep them honest? 4 A. Yes. 5 Q. What did you call these people who went there 6 to do the checking? 7 A. Clinical investigation representatives. 8 Q. I will write this down so I do not have to 9 ask you 15 times. Clinical -- what was the 10 second word? 11 A. Clinical investigation representatives. And 12 we have had those people stationed all over 13 the country responsible for different 14 territories. 15 Plus we have an internal quality 16 assurance auditing group which makes 17 periodic, you know, short-term announced 18 visits to audit studies, too. 19 Particularly if there is any reason to 20 doubt the integrity of the data. 21 Q. Did any of these people ever complain to you 22 about any of the investigators that were 23 working on any of the studies? 164 1 A. Yes. 2 Q. Which investigators did they complain about? 3 A. I don't remember specifics. 4 Q. How about Dr. Fabre, did they ever complain 5 about him? 6 A. We did not have clinical investigation 7 representatives that long ago. 8 Q. Okay. So you did not have anyone checking up 9 on Dr. Fabre? 10 A. We just had the physicians and then myself 11 and the CRC's who had contact with the 12 investigators. 13 Q. Who are the CRC's? 14 A. Clinical research coordinators. They are the 15 people that go out and find potential 16 investigators. 17 Q. As far as actually judging the integrity of 18 the data that was produced to you, you had no 19 one at the time Dr. Fabre was running the 20 study? 21 A. We had the physicians or the CRC's who had 22 that responsibility. 23 Q. They would go out to Dr. Fabre's research 165 1 place and look through his raw data and 2 double check it with what he was reporting on 3 his clinical report forms? 4 A. I do not remember doing that myself. I don't 5 know what our policy was then. 6 Q. Okay. Earlier you said that you recall one 7 of these clinical investigative 8 representatives or someone from quality 9 assurance complaining about the investigators 10 or one that worked on one of your studies. 11 Was it more than one investigator or 12 just one? 13 A. Well, you know, what do you mean by complain? 14 If somebody has -- 15 Q. Let's start with -- 16 MR. STOPHER: Let him finish his 17 answer. 18 A. It is a very vague question. 19 Q. Well, you answered it earlier. 20 A. There are all kinds of degrees. We have very 21 strict standards that we stick to and so a 22 complaint about one of our investigators 23 might be nothing for another drug company. I 166 1 don't know. 2 But I know that we kept very strict 3 standards. And so when I say complain, that 4 may have been something that was a minor 5 problem, but to me it was a complaint because 6 they said we have a problem here and we have 7 to work together to make sure that they get 8 the message that they have to be diligent 9 about always reporting this or always doing 10 this, or always carrying something forward 11 from visit to visit or whatever. 12 Q. Okay. So let's start with the general term 13 complaint, okay, and then we will break it 14 down. 15 There was more than one instance where 16 there were complaints about one or more of 17 the clinical investigators; correct? 18 A. Yes. 19 Q. Now you just gave us an example where you 20 said that somebody came to you and said we 21 have to work together to impress on this 22 person they have to be more diligent in their 23 reporting? 167 1 A. Yes. 2 Q. Do you remember who that person was? 3 A. No. 4 Q. Was there more than one instance of that with 5 this person or any other investigator? 6 MR. MYERS: Instance of what? 7 MS. ZETTLER: The need to be more 8 diligent in their reporting. 9 A. It depends on the degree that you are talking 10 about. We were constantly monitoring what 11 investigators were doing. You know, if they 12 made mistakes -- you know, that is what I 13 mean by a complaint. You know, we dealt with 14 it immediately. 15 Q. I got the impression that you have one 16 instance in your head. 17 A. No. 18 Q. This is just like a general type of thing? 19 A. Yes. 20 Q. Did you find it was hard sometime to keep 21 these guys in line as far as reporting things 22 diligently in general? 23 MR. MYERS: Who are these guys? 168 1 MS. ZETTLER: Clinical 2 investigators. 3 A. Was it hard to keep them in line? 4 Q. Sure. Did you have to ride shotgun over 5 them? 6 A. You had to do your job. I did not think that 7 it was that difficult. 8 Q. Did anyone ever recommend to you that you 9 drop a certain investigator from a study? 10 A. I don't recall anyone ever recommending that 11 we drop an investigator. I can remember not 12 wanting to use another investigator again. 13 Q. Which investigator was that? 14 A. I do not remember. 15 Q. Have you used any -- do you remember any 16 instances where you used investigators more 17 than once on Prozac or Prozac and another 18 drug at another time? 19 A. Pardon? 20 Q. I will say that again. 21 Do you find that there are just a 22 certain number of clinical investigation type 23 people out there? It is not an endless pit 169 1 of investigators? 2 A. Yes, it is finite. 3 Q. And do you find that once in awhile you may 4 use, as an example, say you use Dr. Fabre in 5 Drug A and you ended up using him again in 6 Drug B as a clinical investigator. Have you 7 ever found that to be the case? 8 A. Yes. 9 Q. Are there any of these guys that you talked 10 about earlier, or any of these guys that you 11 talked about working on Prozac that you used 12 before or after Prozac with other drugs? 13 A. Well, I have only worked with Prozac for the 14 last umpteen years. I cannot tell you that. 15 Q. Earlier I think you testified that when you 16 first started to work with Prozac you had 17 some responsibility with other drugs besides 18 Prozac? 19 A. Right. 20 Q. Do you remember using any of these guys that 21 you talked about with the Prozac trials in 22 connection with any of the other drugs that 23 you were working on initially? 170 1 A. No. 2 Q. Can you tell me what kind of training you 3 actually got when you came on as a medical 4 information administrator? 5 A. I do not remember. That was 19 years ago. 6 Q. Okay. Was it in-house or out-of-house 7 training? 8 A. Yes, it was in-house. 9 Q. They did send you to school? 10 A. No, I do not believe there was any formal 11 training at all. 12 Q. Okay. So it was kind of like 13 on-the-job-as-you-are-doing-it training? 14 A. Yes, and working with a physician and the 15 physician would help you through it. It was 16 administrative work. 17 Q. Okay. Now, once they changed the 18 responsibilities of the medical information 19 administrator, did they give you any 20 additional training at that point? 21 A. At which point? 22 Q. When they changed the description of the 23 medical information administrator from 171 1 basically doing research for doctors who had 2 questions about drugs -- 3 A. That was not research. That was just 4 answering questions. No. There was no 5 training other than on-the-job training. 6 Q. Okay. All right. Did they ever send you to 7 any seminars or things of that nature? 8 A. We went to scientific meetings. 9 Q. As a student or as a presenter? 10 A. I presented. 11 Q. What kind of papers, or did you present 12 papers? 13 A. I presented a paper. I presented a paper on 14 The Treatment of Anaerobic Infections with 15 Cefamandole. 16 Q. When was that? 17 A. 1977. 18 Q. Okay. 19 A. That was in New York City. 20 Q. Is that when you were in the Army? No. That 21 was '67. At this time you were working as a 22 detail man; right? 23 A. No. I came in 1974, remember, to be an MIA. 172 1 Q. That is right. I'm sorry. More than ten 2 years and I get confused. 3 You were working on Prozac at the same 4 time? 5 A. I don't think I was working on Prozac yet at 6 that point. I know I was not. I was working 7 with Cefamandole. 8 Q. When they first asked you to get involved 9 with -- let me ask you this: How was it that 10 you came to become involved with Prozac? 11 A. They asked me to. 12 Q. Okay. When you say they, who is they? 13 A. My supervisor. 14 Q. Do you remember who your supervisor was at 15 that time when you first came on board? 16 A. Yes. 17 Q. Who was that? 18 A. Mr. Eastes. 19 Q. What did Mr. Eastes say to you when he asked 20 you to start working -- 21 A. How would you like to work on Fluoxetine? 22 Q. Did you know what it was at that time? 23 A. No. 173 1 Q. Did you say gee, what is that? It sounds 2 wonderful, but I don't know what it is. 3 A. Yes. 4 Q. What did he say? 5 A. He said great, you will do a good job. 6 Q. Did he tell you what it was? 7 A. I don't think he did. I think the physicians 8 did. 9 Q. You are talking about the clinical research 10 physicians, the ones that you talked about 11 earlier? 12 A. Uh-huh. 13 Q. You have to say yes or no. 14 A. I'm sorry. Yes. 15 Q. Did he hire or did they hire any other, at 16 that time, medical information administrators 17 to work on Prozac or promote anyone into that 18 position? 19 A. When I first started to work with it, no. 20 Q. Okay. Your position when you switched over 21 to your present position was senior clinical 22 research administrator? 23 A. Yes. 174 1 Q. When did you become senior clinical research 2 administrator? 3 A. I think it was in 1978 or 1979. 4 Q. Okay. So was it at the same time you became 5 involved with Prozac initially, or was that 6 before that? 7 A. It may have been. It was somewhere around 8 that time. 9 Q. Okay. So was it a matter of -- 10 A. It was because of the work that I did on 11 Cefamandole and presenting it that I got the 12 promotion. 13 Q. Okay. What is a pharmacokinetic study? 14 A. It is a study of the effects of the drug on 15 the systems of the body or of the species 16 being studied. 17 Q. Would that be more in the line of the 18 Phase II study as opposed to a Phase III or 19 Phase IV? 20 A. It can be either. I think it can be Phase II 21 or a part of a Phase III. 22 Q. Okay. So if you -- 23 A. Generally speaking, it would probably be a 175 1 Phase II if it is part of data for 2 submission. 3 Q. So Phase II is generally a toxicology study? 4 A. No. 5 Q. No? What is a Phase II? 6 A. Phase II is mostly pharmacokinetic, I think. 7 That is my understanding. 8 Q. What is your understanding of what a Phase I 9 study is? 10 A. Toxicology, animal. 11 Q. Strictly animal or human and animal? 12 A. I think it is both. 13 Q. Do you recall what the purpose of Dr. 14 Feighner's study was? 15 A. Depression. 16 Q. Do you know if it was a comparative study or 17 if it was a dosage study? 18 A. I don't know. I do not remember. 19 Q. How about Dr. Shopsin? 20 A. I do not remember. 21 Q. Do you know if Dr. Fawcett holds any position 22 within Lilly itself? 23 A. Not that I know of. 176 1 Q. Okay. You kind of laughed there. How come 2 you laughed there a little bit? 3 A. It just surprised me. I never thought that 4 he was any part of Eli Lilly. 5 Q. Okay. What is an FD Form 1573? 6 A. It is a report, FD Form 1573 is the form that 7 an investigator has to fill out for the Food 8 and Drug Administration to show that he is 9 qualified to do a clinical study. 10 Q. Okay. And whose qualifications do they go 11 by, the FDA qualification or the 12 qualifications set out by Eli Lilly? 13 A. I don't know. 14 Q. Did you say earlier that you were involved in 15 picking the investigators for the various 16 studies? 17 A. No. 18 Q. No? 19 A. No. 20 Q. How about finding and approving patients who 21 would be submitted in the studies? 22 A. Finding patients? No. 23 Q. Would you have to approve them? Would 177 1 somebody like yourself have to approve the 2 patients? 3 A. Patients are screened by the investigators. 4 If we see a patient in reviewing the report 5 form that was entered in the study that did 6 not meet the inclusion and exclusion 7 criteria, we would talk to the site 8 investigator about the problem. 9 Q. Okay. Let's go back to the report form. I 10 do not think we got as far as I wanted to as 11 far as what happens to the information once 12 it leaves the investigator's control. 13 So other than these people that you 14 said occasionally went out there to make 15 either set-up or surprise visits to make sure 16 that the raw data was being correctly put on 17 the forms, there was no way for anyone back 18 at Eli Lilly to double check; correct? 19 A. You will have to repeat that. 20 Q. You talked earlier about these people that 21 you sent out, Eli Lilly sent out, to kind of 22 check up on the investigators and they would 23 either show up unannounced -- 178 1 A. Then you are talking about quality assurance. 2 Q. Either one. I'm concerned about anyone in 3 general whose responsibility it is to keep an 4 eye on the investigators with regard to the 5 reporting on the report forms before it comes 6 to Lilly. 7 So if we are in agreement, there are 8 two different categories, the quality 9 assurance people and the CIR, I believe you 10 said? 11 A. Yes. 12 Q. They were charged with the responsibility of 13 double checking whether or not the raw data 14 that was collected by the investigator was 15 correctly reported on the forms, the CRF? 16 A. Yes. 17 Q. Not on a regular basis, but kind of on an ad 18 hoc basis to keep them on their toes to see 19 that they were not sloughing off? 20 A. Yes. 21 Q. If they saw something wrong with the 22 reporting they would come back to you and 23 give you a report or complain to you, for 179 1 lack of a better phrase, Doctor so and so is 2 slipping on this or he did not do this or 3 whatever? 4 A. It would depend on the severity of the 5 problem. If the quality assurance people go 6 out they do a formal report. 7 Q. Regardless of what they found? 8 A. Correct. Even the CIR people would fill out 9 a report of their findings, too, every time. 10 Q. Where would these reports, who would then get 11 the reports? 12 A. They would go in the investigator's folder. 13 Q. There was a folder for each investigator? 14 A. Yes. 15 Q. Is this kind of like a 16 keeping-an-eye-on-these-people folder, or was 17 it directly related to the study they were 18 working on? 19 A. It was directly related to the protocol. 20 Q. If Faber worked on six or seven studies 21 during the time he was working with Lilly 22 there would be six or seven different 23 investigative files and not just one big 180 1 investigative file? 2 A. If he was working on six or seven protocols, 3 yes, there were different files. 4 Q. Whether you maintain a big file or little 5 file, you maintain some sort of file on the 6 investigator related to his performance on 7 each of the studies that he worked on? 8 A. Yes. 9 THE WITNESS: Can we take a 10 break? 11 (AT THIS TIME A SHORT RECESS WAS HELD 12 AFTER WHICH THE FOLLOWING PROCEEDINGS WERE 13 HAD:) 14 Q. Was there some sort of warning system to the 15 investigators such as, you know, we found 16 that you have been lax in doing this on a 17 number of occasions and if you do not knock 18 it off we will drop you from the study? 19 A. Yes, if they were not performing up to our 20 standards we sent them. We had a whole 21 system. The field people and clinical 22 investigation representatives would talk to 23 them about any problems they were having 181 1 getting things going up to speed, and if we 2 felt it was necessary we would call them and 3 write to them. 4 Q. Did you ever withhold payment for services, 5 grant money, or the like from an investigator 6 for not performing correctly? 7 A. I cannot recall any such instance. 8 Q. For example, earlier you stated that, you 9 know, depending on how many patients or how 10 much work they got done was how much they got 11 paid in effect? 12 A. Yes, that is a different thing. 13 Q. Okay. Let's talk about protocol violations. 14 Would something like forgetting to record a 15 HAMD score, would that be considered a 16 protocol violation? 17 A. No. 18 Q. Can you give me a couple of examples? 19 A. A protocol would have to do with the 20 inclusion and exclusion criteria or following 21 the procedures in the protocol. 22 Q. Okay. That being something like you have to 23 administer the HAMD at every visit? 182 1 A. Well, yeah, but that is a protocol violation 2 if you do not do something that is in the 3 protocol. I think it is something where it 4 would exclude some patients from being 5 eligible from the study, you know, like they 6 did not meet the entry criteria or they were 7 not dosed correctly or something like that. 8 Q. Okay. Let's take a depression study. Did 9 you feel that neglecting to administer a HAMD 10 on, say, Visit 3 would not necessarily be a 11 protocol violation? 12 A. It is technically a protocol violation, but 13 it would not exclude the patient from being 14 in the study unless they did not do it at 15 all. 16 Q. So missing one HAMD on one visit did not 17 taint the study? 18 A. No. Sometimes they were missed because the 19 patient could not do it. 20 Q. How about missing two HAMD's? 21 A. I do not remember if it was a policy about 22 what to do about that. 23 Q. Okay. Your major rating of efficacy, as far 183 1 as depression was concerned, was based on the 2 HAMD? 3 A. Right. I mean, one of the major efficacy 4 criteria. 5 Q. What were the other major ones? 6 A. I think the global clinical impressions and 7 the patient global self-rating scale. 8 Q. How about the COVI? 9 A. Some studies had that. I did not look at 10 that very much. 11 Q. Once the clinical report forms got to data 12 processing they came in by themselves, right? 13 They did not have any of the raw data with 14 them? 15 A. That is correct. 16 Q. And then the data processor would type the 17 information that was reported on the clinical 18 report form on the form that was set up into 19 the computer? 20 A. Yes, that is virtually a replication of the 21 case report form. 22 Q. So if you pulled it up it would have the same 23 form? 184 1 A. In the same order, yes. 2 Q. Okay. Somebody would check the accuracy of 3 the data processing work, in other words, 4 transferring what was reported on the case 5 report form to the report form that was on 6 the computer? 7 A. That was our job. 8 Q. Okay. That was one of your jobs as far as 9 accuracy? 10 A. Yes. 11 Q. I think earlier you said that there was a 12 couple other ways that you could correct or 13 check the accuracy of the information. 14 Would you refresh my memory on that? 15 A. Yes, there are several ways. You look for -- 16 you check the screen against the case report 17 form. You check the case report form for 18 omissions and obvious inconsistencies and 19 errors and then you check the edits to see 20 what they found. 21 Q. Okay. If you found an omission, for example, 22 let's use the HAMD again. If you found one 23 of the HAMD's was not reported on, say, Visit 185 1 3, would you call up the investigator and say 2 did you do a HAMD on Visit 3, and if you did, 3 what are the results? 4 A. If there was nothing on the report form to 5 indicate why it was not filled out I would 6 call them, yes. 7 Q. Okay. And is there an actual space on the 8 case report form to indicate why something 9 was not reported like -- 10 A. That is what the comment section is for, to 11 catch anything like that, any explanations of 12 anything that would be out of the norm. 13 Q. Okay. If you found an error, say, let's just 14 say on the data processing work she reported 15 a 3 that should have been a 4 or something 16 along those lines. Other than changing it on 17 the computer, is there any other procedure 18 that you would have to go through to note 19 that there was an error made and what you did 20 to change it? 21 A. It has been so long ago since I found 22 anything like that that I don't know what the 23 current policy is. 186 1 At that time I would just correct it 2 and usually I would let the person in charge 3 of the data entry group know that this 4 person, especially if they made more than one 5 error, I would let them know. 6 Q. What were the more common type errors that 7 you found on the case report forms once they 8 were on the computer? 9 A. Any kind of error? 10 Q. Yes, what pops in your head as being a fairly 11 common error that is made? 12 A. Not carrying one concomitant drug forward 13 from the last visit that showed it was 14 continuing, but they did not put it in the 15 next visit. The dates not being consistent 16 between one visit and the next, there are 17 dates when they stopped and started and if 18 they did not match. 19 Q. So if it was longer than a week in between 20 visits and the protocol calls for a week -- 21 A. Yes, and consistency of carrying events and 22 drugs forward. I would say that is the most 23 common error. 187 1 Q. Could you explain carrying drugs forward? 2 A. People -- we have to report every drug that 3 the patient is taking concomitantly. If they 4 did not -- 5 Q. If they are taking Fluoxetine -- 6 A. That has its own place on the case report 7 form. I was talking about concomitant drugs. 8 That applied to Fluoxetine, too, if that 9 showed they were continuing, which they 10 should be, then it should show up at each 11 visit and there should not be any gaps in the 12 dates. If there are, we ask why. 13 Q. How about whether or not the scores on the 14 various scales did not jive for some reason? 15 Say the HAMD shows a person is severely 16 depressed and another of the scales does not 17 indicate they are that depressed? 18 A. I don't think there was a check like that. I 19 don't know that there was any real easy way 20 to, on the studies that I did, there was no 21 comparable scales or anything like that. 22 Q. So you were not asked to compare the 23 compatibility of the scores on the various 188 1 tests? 2 A. Not on the studies that I did. 3 Q. Okay. 4 A. I can't think of any way that it would have 5 been meaningful. 6 Q. So if the HAMD shows somebody is doing better 7 on the Fluoxetine, but the COVI self-rating 8 scale shows that the person is, in their own 9 mind, becoming a lot worse -- 10 A. As I said earlier, I did not work much with 11 the COVI self-rating scale. I do not have a 12 recollection of that. 13 Q. In a situation like that you would not be 14 asked to compare the two? 15 A. I don't know. 16 Q. Okay. Anything similar in any of your 17 studies like say, you know, if somebody says, 18 Mr. Russell, we would like you to look at the 19 HAMD scores to make sure they jive with the 20 Raskin rating scores? 21 A. No. 22 Q. If you found that somebody was not carrying 23 over concomitant -- is that what you said? 189 1 A. Yes. 2 Q. Drugs, what would you do? What would you do 3 in response to that? 4 A. Call the investigator up and get them to 5 correct it. 6 Q. What if the investigator said, sorry, 7 Mr. Russell, you know, this is the 8 concomitant drugs that are carried over to 9 this week. 10 Would you then fix the case report 11 form, or would they have to send you 12 something official? 13 A. I would have them send a corrected page with 14 their initials and date and the reason why it 15 was changed. 16 Q. Would the change be made and -- 17 A. The corrections would be made in the system 18 and the corrected page would be attached as 19 an additional page in the case report form. 20 Q. Okay. So I think Greg earlier was talking 21 about errata sheets. I think that is sort of 22 what he was alluding to, you know, a 23 correcting page and the reason why a 190 1 correction was made. 2 Was that done as a matter of course? 3 A. It was when I was working with the studies. 4 Q. Okay. And that would all be kept -- the hard 5 copy would all be kept together? 6 A. Yes. 7 Q. Would there be any indication on the computer 8 data base that the correction was made? 9 A. The computer shows, I believe, there is a 10 date of any change to any screen in the 11 computer that shows there was a change made. 12 Q. Okay. Did you say earlier that you had some 13 responsibility with communicating with people 14 from marketing or advertising? 15 A. No. 16 Q. No responsibility whatsoever? 17 A. Now I have some. 18 Q. Okay. But back when you were working as a 19 clinical -- 20 A. Well, I cannot say there is no communication 21 between medical and marketing, but it is 22 minimal. 23 Q. When you did get involved, what types of 191 1 things would you get involved in in marketing 2 or advertising? 3 A. Well, I was working with marketed studies and 4 they paid for them. 5 Q. So marketing and advertising paid for the 6 marketed studies? 7 A. I would not call it advertising, no. The 8 marketing group paid for marketed studies. 9 It paid for the studies. 10 Q. So the money from the studies comes from the 11 marketing department at Eli Lilly? 12 A. Correct. 13 Q. How about any outside agencies, were they 14 involved in that? 15 A. Not through me. 16 Q. Okay. Did you ever come in contact with 17 anyone from the National Institute of Mental 18 Health? 19 A. No. 20 Q. Have you ever been involved in any way with 21 either fund raising or the giving of grants 22 to any associations such as the National 23 Psychiatric Association or the National 192 1 Institute of Mental Health? 2 A. No, I was not. 3 Q. Okay. Were you aware of anyone who was 4 either within your department or within 5 Eli Lilly? 6 A. No. 7 Q. Earlier you said that you presented a paper 8 at a convention, I believe, and I could not 9 remember the name of the drug. 10 A. Cefamandole. 11 Q. What kind of drug was that? 12 A. It was the International Congress of 13 Antimicrobial Agents and Chemotherapy. 14 Q. Okay. Where was that held? 15 A. New York City. 16 Q. Any other papers that you published or 17 presented? 18 A. No. 19 Q. That abstract that you talked about earlier 20 that you may have been listed on with Dr. 21 Burkstrum, was that published as far as you 22 know? 23 A. I don't know. I don't know. I don't know. 193 1 Q. But that was not an intra-office type of 2 publication? It was something that was, some 3 reporting on a study that you worked on? 4 A. It was an abstract. He presented it as a, as 5 a -- I'm not sure about that. I'm not sure 6 what he did with it. 7 Q. Okay. Was that an obesity study? 8 A. No. 9 Q. Okay. Do you remember what kind of study 10 that was related to, the abstract? 11 A. It was depression in the patients who were on 12 renal dialysis. 13 Q. Were you ever listed on an abstract for an 14 obesity study? 15 A. Not that I recall. 16 Q. You personally have not, though, published or 17 sought to publish any papers related to 18 Prozac? 19 A. No. No. 20 Q. You are not an M.D. or Ph.D.? 21 A. No. 22 Q. Do you keep in contact with Dr. Wong? 23 A. Yes, he is a friend. 194 1 Q. I think you said you saw him a couple weeks 2 ago for lunch? 3 A. He is a friend, yes. 4 Q. Can you tell me what kinds of studies you 5 were working on, or I guess you said earlier 6 that you were not working on anything 7 specific when you switched from Prozac to 8 your present position? 9 A. I was not working on anything specifically. 10 There were not any ongoing studies. They 11 were just a few of those phase studies that 12 were done, but they had not -- the final 13 report had not been written up on them. 14 Q. Do you remember what any of the studies were 15 about? 16 A. Atypical depression. 17 Q. Okay. Anything else? 18 A. The renal dialysis study. 19 Q. That was one that was just -- 20 A. That was a two-phase study. The abstract was 21 written on the first phase and the second 22 phase is the one that was pending the final 23 report at the time that I changed jobs. 195 1 Q. Okay. What kind of provisions for following 2 up with the patient on clinical studies on 3 Prozac or Fluoxetine of any kind were made 4 with following up with the patient after they 5 were done participating in the studies? 6 Does that make sense, or did I mess 7 that one up? 8 A. I'm not sure what you mean by following up. 9 Q. Okay. Okay. All right. My understanding is 10 a lot of these studies would typically run 11 six to eight weeks. 12 A. Yes. 13 Q. And sometimes longer if it was like an open 14 label study or something along those lines? 15 A. Yes. 16 Q. So, say, a person is in the study and they 17 sign up for the six to eight week study and 18 halfway through the study they drop out of 19 the study for some reason. 20 Is there any provision for following up 21 with that person as to why they dropped out? 22 A. Yes. 23 Q. What provisions are made for that? 196 1 A. Due diligence in every regard, telephone 2 calls and writing to them to find out, if it 3 was not filled out on the case report form, 4 to find out why. 5 Q. Okay. All right. Could the report on the 6 case report form as to why they dropped out 7 be something as simple as patient decided 8 they did not want to continue, or would it be 9 required that it be a little more elaborate 10 than that? 11 A. There are a number of categories that could 12 be checked. I cannot list them all for you. 13 I think patient decision may have been one of 14 them. Those were not supposed to be just 15 cursory decisions. 16 They were supposed to be done through 17 probing the patient to find out the real 18 reason, you know, if it was not already 19 known, like an adverse event or something, 20 the real reason why they were dropping out. 21 If it was patient decision you are 22 supposed to try to probe them further to find 23 out why. Why that decision. 197 1 Q. Okay. Would a person in that situation 2 then -- say you got in touch with the patient 3 that dropped out and you found out that they 4 had an adverse reaction of some kind, would 5 you then after that period of time or after 6 that day, some period of time later, try to 7 follow up with them again? Like check back 8 with them in two weeks to see how they are 9 doing? 10 A. There was not any provision for that on the 11 case report form. You know, the investigator 12 should, by good clinical practice, do that. 13 Anything that had any bearing on the conduct 14 of the study or the effects of the study, you 15 know, they were told to let us know and to 16 report to us on it. 17 Q. Okay. So unless something was wrong -- well, 18 strike that. 19 So it was more incumbent on the 20 investigator to do any following up that was 21 done after finding out that the person had 22 dropped out? 23 A. Right. It is their responsibility. They are 198 1 trained to be diligent especially if it is 2 important or serious. 3 Q. You did not require them to do that. You did 4 not say you must follow up with this patient? 5 A. If it was serious we would require it. 6 Q. What if the person said I do not feel like 7 doing it now? 8 A. Then we would follow up and find out why they 9 did not want to do it and narrow down the 10 specific -- 11 Q. How about the person that makes it through 12 the six or eight week trial, what kind of 13 provisions of following up on that patient 14 are made? 15 A. If the investigators were aware of anything 16 that had a bearing on the treatment under the 17 study they were told to let us know. 18 Q. Okay. So then it is incumbent on the 19 investigator to follow up themselves with 20 these people after they completed the study? 21 A. Yes. 22 Q. So unless the investigator two weeks after 23 they completed the study says come in for an 199 1 exam to make sure you are doing okay, unless 2 they are doing that, you have no way of 3 knowing what happened to these people unless 4 someone reports it to the investigator? 5 A. If the investigator does not find out, we 6 probably would not find out unless we heard 7 it from some other indirect way. 8 Q. Isn't it a little unusual to put someone on a 9 drug like Prozac for four to six weeks and 10 then discontinue them from the study and then 11 not follow up on what happened to them? 12 MR. MYERS: Let me object. It is 13 highly vague and ambiguous in the use of the 14 term unusual, and also the term to put them 15 on a drug like Prozac. 16 MS. ZETTLER: Okay. 17 Q. Isn't it bad clinical practice to put 18 somebody on an anti-depressant of the caliber 19 of Prozac, leave them on it for six to eight 20 weeks or four to six weeks, and then once 21 they are done with the study, not follow up 22 with them? 23 MS. LAWS: I will object to the 200 1 extent that bad clinical practice calls for a 2 medical definition. I think you mean 3 clinical trials. 4 MS. ZETTLER: Right. 5 MR. MYERS: You do mean clinical 6 trials and not medical standard of care? 7 MS. ZETTLER: I'm talking about 8 clinical research practice. We can narrow it 9 down to clinical trials, that is fine. 10 MR. MYERS: To the extent it is a 11 medical question about medical judgment, I 12 would object. 13 MS. ZETTLER: I think there is a 14 difference between a doctor putting a patient 15 on Prozac and, you know, making a decision to 16 take them off and not following up, you know, 17 to see how they are doing, and a person being 18 drafted for a study and being put on the drug 19 and then basically being abandoned at the end 20 of the study without any following up. 21 Q. That is what I'm getting from you, 22 Mr. Russell. 23 A. Do not put words in my mouth. 201 1 Q. If I am misstating it, I want you to tell me 2 how. 3 A. I do not think that I have answered the 4 question yet. 5 Q. I believe that you testified earlier that 6 unless the clinical investigators themselves 7 follow up with the people, that unless the 8 clinical investigators follow up with the 9 person after they are done with the study 10 there is no way of knowing what is going on 11 with that person unless for some reason or 12 another they report back to the investigator? 13 A. I said follow up of the patient is the 14 responsibility of the investigator. 15 Your question was if they completed the 16 trial and finished the final visit, whose 17 responsibility is it to follow up. And I 18 said the investigator. 19 Q. My second question was: Do you think it is 20 good clinical practice to put a person on a 21 drug such as Prozac, an anti-depressant that 22 is being tested that is not on the market 23 yet, and let them sit on the drug for six to 202 1 eight weeks and when they complete the study 2 to take them off and then not follow up? 3 MS. LAWS: Same objection. 4 A. I don't think that is bad clinical practice. 5 It is the investigator's responsibility to 6 follow the patient. 7 Q. Okay. Was there a form that was used for a 8 report on a follow-up with the CRF? 9 MR. MYERS: Upon completion, 10 trial completion? 11 MS. ZETTLER: We will start with 12 that. 13 A. There is no follow-up form that I'm aware of. 14 Q. Aren't you making the assumption that these 15 people are following up? 16 A. Yes, we are making that assumption that they 17 are following up as to the clinical degrees 18 necessary. 19 Q. Okay. What clinical -- 20 A. That is why we pick investigators that meet 21 all of the FDA requirements. 22 Q. What do you think the clinical degree is 23 necessary for following up? 203 1 A. I feel like the questions are getting too 2 technical for me. 3 MR. MYERS: Your question has to 4 do with clinical judgment on the part of an 5 investigator who is a physician, and you are 6 putting your questions to a layperson acting 7 in an administrative position. 8 He does not have the knowledge or 9 expertise to identify that degree of judgment 10 necessary for an investigator to follow up or 11 to not follow up. 12 Q. The bottom line is Lilly did not require 13 these guys to follow up with the patient 14 unless something happened when they dropped 15 out that indicated a serious adverse event or 16 something along those lines? 17 MR. MYERS: Let me object. You 18 have answered that question about six 19 different ways. You do not have to answer it 20 again. Ask him something else. 21 I will instruct him not to answer a 22 question that he has answered about six 23 different ways. 204 1 MS. ZETTLER: I disagree with 2 you. 3 Q. Are you going to follow your Counsel's 4 instructions? 5 MR. MYERS: Yes. 6 A. Yes. 7 MS. ZETTLER: Certify the 8 question, please. 9 (AT THIS TIME A SHORT DISCUSSION WAS 10 HELD OFF THE RECORD AFTER WHICH THE FOLLOWING 11 PROCEEDINGS WERE HAD:) 12 MR. MYERS: We have been off the 13 record for a few minutes. There has been 14 various discussion among counsel concerning 15 the ability to complete this deposition 16 today. 17 On behalf of Eli Lilly, I understand 18 that there may be some time constraints in 19 the completion of the deposition. 20 I understand you disagree with some of 21 the document production and about the time 22 situation. Your representation is that there 23 are, you know, in the neighborhood of three 205 1 hours to remain, so we have, I think, agreed 2 to recess the deposition to a later date to 3 be completed and not to be recommenced and 4 there will not be any examination of the 5 witness on matters by parties who have 6 already examined him to re-examine him on 7 those matters. To that extent, we will 8 agree. 9 To the extent there is any dispute 10 concerning the documents, I think that needs 11 to be resolved in a separate forum outside 12 this deposition. 13 MS. ZETTLER: And do you have, 14 are you saying that you want to finish this 15 deposition before we resolve the document 16 situation? 17 MR. MYERS: I'm not going to 18 speak to that until I have some full 19 understanding about what your problem is. 20 What I'm saying is the discussion about that, 21 the record of this deposition is not a place 22 to have that discussion. 23 As you said, you have not finished 206 1 going through those documents yet. 2 MS. ZETTLER: Well, I'm talking 3 about the documents that are not here. There 4 are, without even having gone through all of 5 the documents that are here, very, very many 6 of them that are missing. 7 I guess the reasoning for that or 8 whatever is that we are going to have to 9 resolve that before Judge Potter. I don't 10 intent to resume this gentleman's deposition 11 until I have all of the documents that I feel 12 that I deserve in this case. 13 MR. MYERS: I think we made our 14 position with respect to the documents clear. 15 From a timing standpoint, I'm not going to 16 object or protest to the adjournment of this 17 man's deposition to a later date yet to be 18 defined, so long as it is clearly understood 19 that we are not going to revisit or replow 20 the same ground with him. 21 MS. ZETTLER: Well, to the extent 22 that we have not asked questions in certain 23 areas, I will not agree with you. We will 207 1 not go over stuff we have gone over. I will 2 not get into an argument with you now or at a 3 later date as to whether or not a certain 4 question was asked or whether or not we are 5 closed out into going into specific areas. 6 There is no order or agreement in any 7 of the depositions that we cannot take as 8 many days as we need to complete the 9 deposition. When we get into the deposition 10 and we find out the person knows a heck of a 11 lot more, then we have every right to pursue 12 every avenue. 13 MR. MYERS: That goes to the 14 matter of scheduling and scheduling one day 15 or half a day or two days. I can tell you 16 that this round of six deposition that I'm 17 here for and these other people are here for 18 were scheduled by agreement slotting a day 19 for each witness. That is all that I can 20 tell you. 21 MS. ZETTLER: I think you gave 22 Mr. Russell a half a day. 23 We are trying to find some sort of 208 1 compromise here. 2 MR. MYERS: The thing is 3 Mr. Stopher could have taken his deposition 4 in about two hours. This is enough of a 5 record. I think we agree where we agree and 6 where we disagree. 7 MS. ZETTLER: Okay. 8 AND FURTHER THE DEPONENT SAITH NOT. 9 10 ___________________________________ DANIEL G. RUSSELL 11 12 13 14 15 16 17 18 19 20 21 22 23 209 1 STATE OF INDIANA ) ) 2 COUNTY OF MARION ) 3 I, Wendi Kramer Sulkoske, a Notary 4 Public in and for said county and state, do 5 hereby certify that the deponent herein was 6 by me first duly sworn to tell the truth, the 7 whole truth, and nothing but the truth in the 8 aforementioned matter; 9 That the foregoing deposition was taken 10 on behalf of the Plaintiff; that said 11 deposition was taken at the time and place 12 heretofore mentioned with counsel present as 13 noted; 14 That said deposition was taken down in 15 stenograph notes and afterwards reduced to 16 typewriting under my direction; and that the 17 typewritten transcript is a true record of 18 the testimony given by said deponent; 19 And that the deposition upon oral 20 examination was taken down in stenograph 21 notes and afterwards reduced to type writing 22 under my direction and thereafter presented 23 to said witness for signature; that this 210 1 certificate does not purport to acknowledge 2 or verify the signature hereto of the 3 deponent. 4 I do further certify that I am a 5 disinterested person in this cause of action; 6 that I am not a relative of the attorneys for 7 any of the parties. 8 IN WITNESS WHEREOF, I have hereunto set 9 my hand and affixed my notarial seal this 10 10th day of June 1993 11 12 13 14 15 16 ____________________________________ WENDI KRAMER SULKOSKE, Notary Public 17 18 My commission expires: 19 January 27, 1995 20 21 22 23