1 NO. 90-CI-6033 JEFFERSON CIRCUIT COURT DIVISION ONE (1) 2 3 JOYCE FENTRESS, ET AL. PLAINTIFFS 4 5 VS. DEPOSITION FOR PLAINTIFFS 6 7 SHEA COMMUNICATIONS, ET AL. DEFENDANTS 8 * * * * * * * * * * 9 10 DEPONENT: CAROL ZAPAPAS 11 DATE: DECEMBER 2 AND 3, 1993 12 13 * * * * * * * * * * 14 15 16 REPORTER: KATHY NOLD 17 18 KENTUCKIANA REPORTERS SUITE 260 19 730 WEST MAIN STREET LOUISVILLE, KENTUCKY 40202 Page 1 1 * * * * * * * * * * 2 3 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA 4 INDIANAPOLIS DIVISION 5 IN RE ELI LILLY AND COMPANY ) Prozac Products Liability ) MDL Docket No. 907 6 Litigation ) 7 * * * * * * * * * * 8 NO. 91-02496-A 9 JACKIE LYNN BIFFLE, ET AL ) IN THE DISTRICT ) COURT OF 10 V. ) DALLAS COUNTY, TEXAS ) 11 ELI LILLY & COMPANY AND ) 14TH JUDICIAL DISTA PRODUCTS COMPANY ) DISTRICT 12 * * * * * * * * * * Page 2 1 SUPERIOR COURT OF THE STATE OF CALIFORNIA 2 FOR THE COUNTY OF LOS ANGELES 3 DR. MARIUS SAINES, etc., et al., ) Case No: 4 ) SC 008331 Plaintiffs, ) 5 ) vs. ) 6 ) ELI LILLY & COMPANY, a corporation; ) 7 DISTA PRODUCTS COMPANY, a division ) of Eli Lilly & Company; and DOBS 1- ) 8 100, inclusive, ) ) 9 Defendants. ) ____________________________________) 10 11 * * * * * * * * * * Page 3 1 THE DEPOSITION OF CAROL ZAPAPAS TAKEN AT THE 2 OFFICE OF BAKER & DANIELS, 300 NORTH MERIDIAN 3 STREET, SUITE 2700, INDIANAPOLIS, INDIANA 46204, 4 ON DECEMBER 2 AND 3, 1993; SAID DEPOSITION TAKEN 5 PURSUANT TO NOTICE IN ACCORDANCE WITH THE RULES 6 OF CIVIL PROCEDURE. 7 * * * * * * * * * * 8 A P P E A R A N C E S 9 10 NANCY ZETTLER COUNSEL FOR GROUP A PLAINTIFFS 11 LEONARD M. RING AND ASSOCIATES, P.C. 111 WEST WASHINGTON AVENUE, SUITE 1333 12 CHICAGO, ILLINOIS 60602 13 LAWRENCE J. MYERS COUNSEL FOR ELI LILLY AND COMPANY 14 FREEMAN & HAWKINS 4000 ONE PEACHTREE CENTER 15 303 PEACHTREE STREET, N.E. ATLANTA, GEORGIA 30308-3243 16 CURTIS G. OLTMANS 17 ELI LILLY AND COMPANY LILLY CORPORATE CENTER 18 INDIANAPOLIS, INDIANA 46285 19 BENJAMIN E. PATTERSON COUNSEL FOR DEFENDANTS CZECHOWICZ, FINK, BRUINSMA 20 CLAUSEN MILLER GORMAN CAFFREY & WITOUS 10 SOUTH LASALLE 21 CHICAGO, ILLINOIS 60603 Page 4 1 I N D E X 2 3 DEPOSITION OF CAROL ZAPAPAS 4 5 DIRECT EXAMINATION BY MS. ZETTLER 7 6 7 CERTIFICATE 393 8 9 ERRATA 394 10 11 12 CERTIFIED QUESTIONS 13 CERTIFIED QUESTION 125 14 CERTIFIED QUESTION 164 CERTIFIED QUESTION 194 15 CERTIFIED QUESTION 223 CERTIFIED QUESTION 251 16 CERTIFIED QUESTION 303 CERTIFIED QUESTION 317 17 CERTIFIED QUESTION 342 CERTIFIED QUESTION 343 18 Page 5 1 EXHIBITS 2 PLAINTIFFS' EXHIBIT NO. 1 126 3 PLAINTIFFS' EXHIBIT NO. 2 128 PLAINTIFFS' EXHIBIT NO. 3 137 4 PLAINTIFFS' EXHIBIT NO. 4 146 PLAINTIFFS' EXHIBIT NO. 5 153 5 PLAINTIFFS' EXHIBIT NO. 6 154 PLAINTIFFS' EXHIBIT NO. 7 156 6 PLAINTIFFS' EXHIBIT NO. 8 174 PLAINTIFFS' EXHIBIT NO. 9 175 7 PLAINTIFFS' EXHIBIT NO. 10 178 PLAINTIFFS' EXHIBIT NO. 11 197 8 PLAINTIFFS' EXHIBIT NO. 12 199 PLAINTIFFS' EXHIBIT NO. 13 200 9 PLAINTIFFS' EXHIBIT NO. 14 203 PLAINTIFFS' EXHIBIT NO. 15 241 10 PLAINTIFFS' EXHIBIT NO. 16 246 PLAINTIFFS' EXHIBIT NO. 17 262 11 PLAINTIFFS' EXHIBIT NO. 18 282 PLAINTIFFS' EXHIBIT NO. 19 284 12 PLAINTIFFS' EXHIBIT NO. 20 292 PLAINTIFFS' EXHIBIT NO. 21 294 13 PLAINTIFFS' EXHIBIT NO. 22 344 PLAINTIFFS' EXHIBIT NO. 23 354 14 PLAINTIFFS' EXHIBIT NO. 24 361 PLAINTIFFS' EXHIBIT NO. 25 368 15 PLAINTIFFS' EXHIBIT NO. 26 370 PLAINTIFFS' EXHIBIT NO. 27 374 16 PLAINTIFFS' EXHIBIT NO. 28 378 PLAINTIFFS' EXHIBIT NO. 29 381 17 PLAINTIFFS' EXHIBIT NO. 30 390 18 Page 6 1 COMES CAROL ZAPAPAS, CALLED BY THE 2 PLAINTIFF, AND AFTER FIRST BEING DULY SWORN, WAS 3 DEPOSED AND TESTIFIED AS FOLLOWS: 4 DIRECT EXAMINATION 5 BY MS. ZETTLER: 6 Q. Please state your full name for 7 the record. 8 A. Carol Zapapas. 9 Q. Spell your last name. 10 A. Z-A-P-A-P-A-S. 11 Q. I was right, okay. Even in 12 some of your own interoffice documents, it's 13 spelled with two P's sometimes, so I wasn't quite 14 sure. 15 MS. ZETTLER: Let the record reflect 16 that this is the discovery deposition of Carol 17 Zapapas taken pursuant to notice in the Fentress 18 versus Shea Communications case, and taken 19 pursuant to all the applicable rules in the State 20 of Kentucky. 21 MR. MYERS: For the record, there is a 22 cross notice out in the multi-district 23 proceedings, and is thus taken under the 24 applicable provisions of the Federal rules. As Page 7 1 well we understand the plaintiffs may have a 2 different view about that. 3 MS. ZETTLER: We're going to reserve 4 the objections like we did in the earlier 5 depositions? 6 MR. MYERS: Right, that's fine, no 7 problem. 8 MS. ZETTLER: I'm probably going to 9 lose my voice a couple of times. 10 Q. (BY MS. ZETTLER) Have you 11 given a deposition before? 12 A. No. 13 Q. Let me explain some of the 14 ground rules to make it easier on us and on 15 Kathy. You have to answer out loud, you can't 16 shake your head and go uh-huh and uh-uh, and you 17 will probably do that and we'll remind you so 18 don't be offended by that. If you don't 19 understand any of my questions, like I said my 20 voice is probably going to be coming and going, 21 please ask me to repeat it and I will. If you 22 answer a question, we'll assume you understood it 23 as asked. Is that fair? 24 A. Yes. Page 8 1 Q. Anytime you need a break, just 2 ask for one and we'll take a break. And the last 3 ground rule is try to let me finish my question 4 before you start your answer. It's also natural 5 in a conversation to sometimes talk over each 6 other, but it's very hard for Kathy to take that 7 down. 8 A. Okay. 9 Q. Give me your Social Security 10 number, please. 11 A. xxxxxxxxxxx. 12 Q. And your date of birth? 13 A. 7-22-59. 14 Q. And current address? 15 A. xxxxxxxxxxxxxxxxxxxx 16 xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx. 17 Q. How long have you lived there? 18 A. xxxxxxxxxxx. 19 Q. Do you have any plans to move 20 in the near future? 21 A. No. 22 Q. Are you married? 23 A. No. 24 Q. Do you have any children? Page 9 1 A. No. 2 Q. Could you give me an idea of 3 what your education was after high school, after 4 you graduated from high school? 5 A. Graduated from Purdue 6 University in 1981. 7 Q. Did you -- what degree did you 8 receive there? 9 A. Bachelor of Science in 10 Agronomy. 11 Q. Agronomy. Can you spell that? 12 A. A-G-R-O-N-O-M-Y. 13 Q. What is agronomy? 14 A. The study of soils and crops. 15 Q. And your education past your 16 Bachelors? 17 A. Yes, Masters in Business. 18 Q. Where did you get that? 19 A. Butler University. 20 Q. So you're a double alumnae with 21 Mister Brickler? 22 A. (Witness moves head up and 23 down.). 24 Q. When did you get your Masters? Page 10 1 A. 1987, I believe -- sorry, '88. 2 Q. Another ground rule. This is 3 really just the best of your recollection, 4 obviously you're going to remember when you 5 graduated from college, but so -- please don't 6 guess. If you know, tell me, if you don't, tell 7 me. I may ask you for a reasonable estimate in 8 some cases, things of that nature, but throughout 9 the course of your deposition, if you want to 10 change one of your answers or want to change 11 something that you forgot, please feel free to 12 jump in anytime. 13 A. Okay. 14 Q. Any graduate degrees after your 15 Masters? 16 A. No. 17 Q. Any seminars or symposiums, 18 things of that nature, that you attended? 19 A. Yes. 20 Q. Why don't we start with 21 symposiums that -- or seminars, et cetera, that 22 you attended that relate to your job at Lilly? 23 A. My current job? 24 Q. Any of your jobs at Lilly. Page 11 1 A. Oh. Let me start forward and 2 work back, it's probably easier. 3 Q. Okay. 4 A. A seminar by Barnett 5 International on supervising CRAs. 6 Q. I'll write a list and then I'm 7 going to go back and get details. 8 A. This may not be inclusive also. 9 Q. That's all right, as many as 10 you can remember. 11 A. American -- it's ASCO meeting, 12 which is an oncolytic scientific meeting. 13 Q. A-S-C-O? 14 A. Yes. American Heart 15 Association meeting, DIA training session. 16 Q. DIA? 17 A. Uh-huh, Drug Information 18 Association. Those are the ones that are current 19 or relatively current. 20 Q. Have you taken any seminars on 21 FDA regulations? 22 A. There have been sections within 23 the seminars on FDA regulations. 24 Q. Are you concentrating now on Page 12 1 seminars that you have taken outside or training 2 that you've gotten outside of Lilly? 3 A. Yes. 4 Q. I mean ouside of Lilly's 5 premises? 6 A. Yes. 7 Q. Any seminars or courses that 8 you've taken specifically on reporting of adverse 9 events? 10 A. No. Let me clarify that. None 11 externally, a course internally. 12 Q. Okay. Where did you take the 13 Barnett course, Barnett International course on 14 supervising CRAs? 15 A. It was in Pittsburgh, I 16 believe. 17 Q. When was that held? 18 A. Approximately two years, three 19 years ago. 20 Q. And can you give me a general 21 idea of the types of things that were taught at 22 that seminar? 23 A. It was generally how to 24 supervise and how to coach CRAs. Page 13 1 Q. When you say coach CRAs, what 2 do you mean? 3 A. Provide feedback, help with 4 their developmental needs. It was not a 5 scientific training session. 6 Q. Management more type thing? 7 A. Yes. 8 Q. How about the ASCO meeting, is 9 that strictly related to oncolytics? 10 A. Yes. 11 Q. Did that have anything to do 12 with reporting of adverse events, things of that 13 nature? 14 A. No. 15 Q. How about the American Heart 16 Association meeting, what was the subject of that 17 meeting? 18 A. It's a scientific meeting, it's 19 their large annual meeting. 20 Q. Did you attend various seminars 21 throughout the meeting? 22 A. Yes. 23 Q. Give me an idea of the types of 24 seminars that you attended at that meeting. Page 14 1 A. They were representing data 2 from clinical trials. 3 Q. When you say representing data 4 from clinical trials, you mean presenting data? 5 A. Yes. 6 Q. Presenting it to the medical 7 community or presenting it for submission to like 8 a regulatory agency? 9 A. To the medical community. 10 Q. In other words, the best ways 11 to write it in a manuscript or present it in a 12 manuscript for publication? 13 A. I'm not sure I understand. 14 Q. I'm trying to get an idea when 15 you said present it to the medical community, you 16 mean through a manuscript or published article? 17 A. No, more through presentations. 18 Q. Okay. So it was a seminar on 19 conducting seminars? 20 A. No. 21 MR. MYERS: I think what she was saying 22 is they were actually presenting scientific 23 information. 24 MS. ZETTLER: Oh, I see. Page 15 1 A. Right. 2 Q. I thought you meant that it was 3 a seminar on how to present scientific 4 information. 5 A. No. 6 Q. What types of scientific 7 information were they putting on? 8 A. It was the American Heart 9 Association's annual meeting, so it's related to 10 cardiac trials, trials involving cardiac 11 medications for one indication or another. 12 Q. So various companies were there 13 presenting their evidence on their drugs and how 14 they worked and things of that nature? 15 A. No. 16 Q. Okay. 17 A. It's more the physicians who 18 are presenting the data, it's not industrial type 19 meeting. 20 Q. Okay. But the physicians are 21 physicians who did clinical trials on the various 22 drugs? 23 A. Yes. 24 Q. So indirectly, it's the company Page 16 1 that is presenting information about their drug? 2 A. No, it is not the company 3 that's presenting the data. 4 Q. Would you agree with me that a 5 clinical investigator is usually retained by a 6 drug company to perform the clinical trial on a 7 drug that the company is producing or wants to 8 produce? 9 A. That varies depending on the 10 situation. 11 Q. Okay. And the seminars that 12 you attended at the American Heart Association 13 meeting, to your knowledge were these clinical 14 investigators working with a drug company? 15 A. No, I don't know that. 16 Q. Okay. Can you give me an 17 example of a situation where a physician would -- 18 that was not working on a clinical trial that's 19 sponsored or commissioned by a drug company would 20 be presenting data? 21 A. If they had received a grant 22 from the NIH to do a trial, for example. 23 Q. Okay. Are you aware that drug 24 companies often give monies to NIH and NIMH to Page 17 1 sponsor grants on drug trials that the company 2 itself is producing? 3 A. Yes. 4 Q. Are you aware that that has 5 happened at Lilly? 6 A. Yes. 7 Q. In that situation where a grant 8 has come through NIH but has been based in part 9 on monies that have been given to NIH by a drug 10 company, do you consider that a clinical trial 11 that was not sponsored by the drug company? 12 A. Yes, I consider that a trial 13 not sponsored by the drug company. 14 Q. Why? 15 A. Because it is not under the 16 auspices of the company, the company is not the 17 sponsor there. 18 Q. Have you personally been in 19 contact with anybody from the NIH or NIMH? 20 A. No. 21 Q. Have you attended meetings 22 where employees of the NIH or NIMH have been 23 present? 24 A. I don't know. Page 18 1 MR. MYERS: Are you saying that because 2 they could have been at one of these meetings and 3 you didn't know that? 4 THE WITNESS: Yes, I am. 5 Q. But as far as say a meeting 6 between Lilly employees and NIH employees? 7 A. No. 8 Q. Do you know Fred Goodwin? 9 A. Who? 10 Q. Fred Goodwin. 11 A. I know the name. 12 Q. Have you ever met Mister 13 Goodwin? 14 A. No. 15 Q. How about Stephen Paul? 16 A. Yes. 17 Q. How do you know Mister Paul? 18 A. He's employed by Lilly. 19 Q. When did Mister Paul become 20 employed by Lilly? 21 A. I believe it was the Summer of 22 '93, this Summer. 23 Q. Do you know where Mister Paul 24 worked prior to coming to Lilly? Page 19 1 A. I believe the NIH, but I don't 2 know any other specifics. 3 Q. Is it your understanding that 4 NIH and NIMH are a branch or arm of the 5 Department of Health and Human Services? 6 A. No, I don't know that 7 specifically. 8 Q. Do you know if they're a 9 governmental agency or if they're an independent 10 agency? 11 A. No, I don't know. 12 Q. Okay. How about the Drug 13 Information Association meeting that you 14 attended, where did you attend that? 15 A. That was in San Diego. 16 Q. When did that take place? 17 A. It was about three or four 18 years ago. 19 Q. Is this similar to the 20 situation with the American Heart Association 21 meeting, it was a group meeting and you attended 22 various seminars in that group meeting? 23 A. Yes. 24 Q. What types of seminars did you Page 20 1 attend at the Drug Information Association 2 meeting? 3 A. There was a presentation made 4 by a Lilly employee on a particular design that -- 5 the design of clinical trials that I wanted to 6 listen to. 7 Q. Any others? 8 A. There was a presentation by Bob 9 Temple from the FDA. 10 Q. What was his presentation on? 11 A. It was primarily on adverse 12 events, reporting of those in trials. 13 Q. Clinical trials as opposed to 14 spontaneous adverse events? 15 A. I don't remember if he was 16 making the distinction or not. 17 Q. Any others? 18 A. I'm sure there were, I was 19 there for a couple of days, but I don't remember 20 them. 21 Q. What was the presentation by 22 the Lilly employee? 23 A. I think that's confidential 24 information. Page 21 1 MR. MYERS: Go ahead and tell her the 2 subject matter of the thing. 3 A. It was unique statistical 4 design. 5 Q. Okay. This was a presentation 6 that was made at the meeting, an association 7 meeting; correct? 8 A. Yes. 9 Q. Why do you -- without telling 10 me the subject matter, why do you consider it 11 confidential if it was made at a public meeting? 12 MR. MYERS: You don't have to tell her 13 that. She'll answer the question. Go ahead and 14 ask her about the trial. 15 Q. Unique statistical methods? 16 A. Yes. 17 Q. Statistical methods for what? 18 A. For enrolling patients. 19 Q. How does statistical methods 20 come into play in enrolling patients? 21 A. How the randomization occurs. 22 Q. And when you say how the 23 randomization occurs, you're talking about 24 patients who have already been enrolled in the Page 22 1 study, how they are randomized? 2 A. When patients are enrolled, 3 they're not necessarily randomized at that point 4 to a treatment. 5 Q. Okay. 6 A. It's the actual randomization 7 that's the unique design on which drug they're 8 assigned to. 9 Q. That's what I'm getting 10 confused about. When you say randomization of 11 statistical methods for enrolling patients, I'm 12 trying to differentiate between a randomization 13 occurring before patients are enrolled in the 14 study and a randomization occurring after 15 patients are enrolled. Do you see where I'm 16 getting confused? 17 A. No, I don't, I'm sorry. 18 Q. In this statistical methodology 19 that was presented at the meeting, is the 20 randomization done after the patients are 21 enrolled? 22 A. Yes. 23 Q. Okay. Why don't you explain to 24 me generally how the statistical methodology is Page 23 1 applied? 2 A. It's based on the outcomes of 3 prior randomized patients of the treatment 4 groups. 5 Q. Who presented this information 6 at the meeting? 7 A. I don't recall. 8 Q. Was it a statistician from 9 Lilly? 10 A. He was in our statistical 11 group, but I don't remember which one. 12 Q. When you say you don't remember 13 which statistical group he was in -- 14 A. No, which statistician. 15 Q. Okay. Was this statistical 16 methods developed in relationship to any 17 particular product at Lilly? 18 A. No. 19 Q. Have these statistical methods 20 been used on any of Lilly's studies of 21 Fluoxetine? 22 A. Yes. 23 Q. Were those depression studies? 24 A. Yes. Page 24 1 Q. Which depression studies? 2 A. I'm not sure I know what you're 3 asking for. 4 Q. Just give me some examples of 5 studies, depression studies on Fluoxetine that's 6 been used, the statistical methodology has been 7 used for? 8 A. It's been used on one 9 depression study. 10 Q. Okay. Do you know which one? 11 A. Yes. 12 Q. Which one? 13 A. Are you wanting the title? 14 Q. Sure. 15 A. It was Fluoxetine in the 16 treatment of depression. 17 Q. Was there a comparitor drug 18 involved? 19 A. Placebo. 20 Q. What was the objective of the 21 study? 22 A. To test this design as a pilot. 23 Q. Was it a validation study? 24 A. I'm not sure how you're Page 25 1 defining validation. 2 Q. To validate the statistical 3 methodology? 4 A. Yes. 5 Q. Was it used in conjunction with 6 any other research tools, for instance a 7 suicidality scale? 8 A. It was used with other research 9 tools, yes, not necessarily the suicidality 10 scale, I don't recall. 11 Q. Has that study been completed? 12 A. Yes. 13 Q. When was it completed? 14 A. How are you defining completed? 15 Q. When was the last patient's 16 information sent back to Lilly? Just a rough 17 idea, you don't have to give me exact dates. 18 A. Within the last couple of 19 years, within a year and a half. 20 Q. Other than a presentation of 21 the information at the DIA meeting, have the 22 results of that study been published or 23 presented? 24 MR. MYERS: Let me object. I don't Page 26 1 know that she said the results of the clinical 2 trial were presented at that meeting. 3 A. That's correct. 4 Q. It was not or it was? 5 A. It was not. 6 Q. Have the results of the study 7 been published anywhere? 8 A. A manuscript has been prepared, 9 I don't think it has been published. 10 Q. Do you know who the manuscript 11 author on the manuscript is? 12 A. No, I don't. 13 Q. Do you know anybody who is 14 listed as an author on that manuscript? 15 A. Yes. 16 Q. What are some of those names? 17 A. Doug Faries, John 18 Heiligenstein. 19 Q. Anybody else? 20 A. No. 21 Q. Does this statistical method 22 have a title, a name? 23 A. Informally it is known as the 24 Urn design. Page 27 1 Q. Urn? 2 A. Urn, U-R-N. 3 Q. Does it have a formal name? 4 A. I don't know. 5 MR. MYERS: What was that, U-R-N? 6 A. U-R-N. 7 Q. As in cremation urn? 8 A. (Witness moves head up and 9 down.). 10 Q. Is that a yes? 11 A. Yes -- well, it's as an urn, 12 the canister, not necessarily a cremation urn. 13 Q. Right, but I mean that's what 14 I'm trying to be sure to get the spelling. 15 A. Yes. 16 Q. Who came up with that informal 17 name? 18 A. I believe the statistician. 19 Q. Have you remembered his name, 20 the statistician's name? 21 A. Remembered him from what? 22 Q. Earlier you couldn't remember 23 the statistician's names who presented the -- 24 maybe I'm getting confused again. The Page 28 1 statistician who came up with the informal name 2 of Urn design, is that the same person who 3 presented the information at the DIA meeting? 4 A. I don't know. 5 Q. Which statisticians are you 6 aware of worked on the manuscript? 7 A. I believe I said Doug Faries. 8 Q. Okay. It was a statistician 9 that made a presentation at the DIA meeting; 10 correct? 11 A. No, I don't remember who that 12 was. 13 Q. The trial -- do you remember 14 the study number for the clinical trial that was 15 used as a pilot trial on the Urn design? 16 A. No, I don't. 17 Q. Okay. Is it a -- do you know 18 if it was an inpatient or outpatient study? 19 A. It was outpatient. 20 Q. Do you remember how many 21 patients were enrolled in the study? 22 A. No. 23 Q. Do you remember how many 24 investigation sites were involved? Page 29 1 A. No. 2 Q. Was it more than one? 3 A. Yes. 4 Q. Was any portion of that study 5 conducted here in Indianapolis? And I don't mean 6 the data gathering, I mean the actual patient 7 enrollment, patient randomizations. 8 A. I don't believe so, but I'm not 9 certain on that. 10 Q. Okay. When was the start-up on 11 this study, approximately? 12 A. Early 1991. 13 Q. So the study lasted for about a 14 year or year and a half? 15 A. Yes. 16 Q. Was Fluoxetine the active drug 17 on the study? 18 A. Yes. 19 Q. Was this study done in any way 20 to study suicidality and the use of Fluoxetine? 21 A. No. 22 Q. How about violent aggressive 23 behavior and the use of Fluoxetine? 24 A. No. Page 30 1 Q. Were any portions of this study 2 conducted outside the United States, to your 3 knowledge? 4 A. No, there were not. 5 Q. Any other studies that you're 6 aware of that use the Urn design? 7 A. Yes. 8 Q. Depression studies? 9 A. Yes. 10 Q. Fluoxetine depression studies? 11 A. No. 12 Q. Depression studies that were 13 run to study the disease of depression itself as 14 opposed to the efficacy or safety of the drug? 15 A. I'm not sure I understand the 16 question. 17 Q. Let me ask it this way: These 18 other depression studies that were run, were they 19 run on other compounds manufactured or designed 20 by Lilly? 21 A. Yes. 22 Q. Okay. Are those products on 23 the market? 24 A. No. Page 31 1 Q. Are there any ongoing 2 Fluoxetine trials that are using the Urn design 3 at this time? 4 A. No. 5 Q. Let's talk about the 6 presentation that was made by Doctor Temple at 7 the DIA meeting. Can you give me an idea of 8 particulars of what he reported on regarding the 9 adverse events at clinical trials? 10 A. No, I can't. 11 Q. Can you give me generally what 12 the types of subjects relating to reporting of 13 adverse events you covered? 14 A. I don't recall other than it 15 was about the reporting of events. 16 Q. Did the presentation have 17 anything to do with changes in the regulations, 18 FDA regulations that relate to the reporting of 19 adverse events? 20 A. I don't recall. 21 Q. Were you given any written 22 materials at Doctor Temple's presentation? 23 A. No. 24 Q. Were you given any written Page 32 1 materials at the Lilly presentation on the Urn 2 design? 3 A. No. 4 Q. Were other people who attended 5 this seminar given written information about the 6 Urn design? 7 A. Not that I am aware of. 8 Q. All right. Any other outside 9 seminars that you can think of? When I say 10 outside, I mean outside of Lilly. 11 A. None that I can recall. 12 Q. Okay. When did you first start 13 working at Lilly? 14 A. 1981. 15 Q. Is that right out of college? 16 A. Yes. 17 Q. How did you become aware of the 18 position at Lilly? 19 A. I applied for a position. 20 Q. Did you apply for a particular 21 position or generally? 22 A. A particular position. 23 Q. What position? 24 A. Summer intern. Page 33 1 Q. Summer intern where? 2 A. Lilly research. 3 Q. Do you have any medical 4 background? 5 A. No medical classes. 6 Q. Do you have any medical 7 experience whatsoever? 8 A. No. 9 Q. How about psychiatric? 10 A. No. 11 Q. Why were you interested in a 12 position with medical at Lilly? 13 A. When are you referring to? 14 Q. When you applied for the Summer 15 intern position? 16 A. That wasn't medical. 17 MR. MYERS: She said Lilly research was 18 where she applied. 19 Q. Okay. What was the position, 20 the Summer internship position with Lilly 21 research? 22 A. What was it? 23 Q. Uh-huh, in what area? 24 A. In agricultural research. Page 34 1 Q. Let me back up a little bit. 2 Prior to -- was that the Spring of '81? 3 A. Summer. 4 Q. Prior to the Summer of '81, 5 give me an idea of what types of jobs that you 6 had other than your usual waitressing type 7 college jobs, things of that nature. 8 A. Fabric store, that's all. 9 Q. That's working? 10 A. Yes. I did have a prior Summer 11 job at Lilly. 12 Q. When was that? 13 A. The Summer of '79, I believe. 14 Q. Was that also a Summer 15 internship? 16 A. No. 17 Q. What was that? 18 A. Summer employee program. 19 Q. What area did you work in? 20 A. Distribution. 21 Q. What did you do in 22 distribution? 23 A. Packed orders, sample orders, 24 for sales reps. Page 35 1 Q. Any other responsibilities in 2 that position? 3 A. No. 4 Q. Do you want to take a break? 5 A. No, I'm okay. 6 (DISCUSSION OFF THE RECORD.) 7 Q. And going back to the Summer 8 intern job in '81. 9 A. Uh-huh. 10 Q. Did you get the job in the 11 agricultural research area? 12 A. Yes. 13 Q. And what was your position in 14 that area, obviously Summer intern, but what were 15 your responsibilities? 16 A. It was working on a research 17 farm doing plant science research. 18 Q. I take it being a Summer intern 19 position it only lasted throughout the Summer? 20 A. That's correct. 21 Q. Did you then subsequently come 22 back to Lilly? 23 A. Yes. 24 Q. When was the next time that you Page 36 1 worked at Lilly? 2 A. September of '81. 3 Q. When did you graduate from 4 college, was it September or December? 5 A. May. 6 Q. So now I'm a little confused. 7 You did a Summer internship in the Summer of '81. 8 A. That's correct. 9 Q. And you left for how long? 10 A. Left where? 11 Q. I thought you testified earlier 12 that you were there for the Summer of '81, and 13 then you came back in September of '81; correct, 14 or was it just -- it kind of flowed into the 15 other position? 16 A. What I said was I was in that 17 position for the Summer of '81, and started with 18 Lilly in September of '81. 19 Q. Okay. So you just went from 20 your Summer internship to a permanent position at 21 Lilly? 22 A. Yes. 23 Q. What position did you move to 24 in September of '81? Page 37 1 A. A sales rep. 2 Q. A detail person? 3 A. It was a sales rep for Elanco. 4 Q. And that's animal 5 pharmaceuticals; correct? 6 A. It's plants and animal. 7 Q. How long were you a sales rep 8 for Elanco? 9 A. About a year and a half. 10 Q. Until the early part of 1983? 11 A. Yes. 12 Q. Did you sell any 13 pharmaceuticals or medical devices whatsoever for 14 human use? 15 A. No. 16 Q. What was your next position 17 with Lilly? 18 A. CRA. 19 Q. Just to make the record clear, 20 that's clinical research administrator; correct? 21 A. Yes. 22 Q. And you were a CRA in what 23 area? 24 A. Oncolytics. Page 38 1 Q. How long were you a CRA of 2 oncolytics? 3 A. About six months. 4 Q. Until about the Fall of '83? 5 A. Summer, Fall, yes, somewhere in 6 there. 7 Q. What was your next position? 8 A. CRA. 9 Q. In what area? 10 A. Anti-infectives. 11 Q. How long were you a CRA in 12 anti-infectives? 13 A. About three years. 14 Q. Summer or Fall of '86? 15 A. Yes. 16 Q. And what was your next 17 position? 18 A. CRA in the gastrointestinal 19 area. 20 Q. Gastrointestinal? 21 A. Yes. 22 Q. And how long were you a CRA in 23 that area? 24 A. About six months. Page 39 1 Q. So to the beginning of '87? 2 A. Right. 3 Q. What was your next position? 4 A. Personnel representative. 5 Q. How long were you a personnel 6 representative? 7 A. A little over a year and a 8 half. 9 Q. Late Summer or early Fall of 10 '89? 11 A. '88, that I finished that. 12 Q. Late Summer, early Fall of '88? 13 A. Yes. 14 Q. When you say you finished that, 15 was there a particular project that you were 16 working on? 17 A. No, finished that assignment. 18 Q. What was your next position? 19 A. Regional personnel 20 representative. 21 Q. What region? 22 A. Western. 23 Q. Were you based out of 24 Indianapolis? Page 40 1 A. No. 2 Q. Where were you based out of? 3 A. Pasadena. 4 Q. How long were you a regional 5 personnel representative? 6 A. About nine months. 7 Q. Spring, late Spring, early 8 Summer of '89? 9 A. Correct. 10 Q. Okay. What was your next 11 position? 12 A. Department head, medical plans. 13 Q. So late Spring-early Summer of 14 '89 you became department head of medical plans; 15 correct? 16 A. Correct. 17 Q. Are you still department head 18 of medical plans today? 19 A. Yes. 20 Q. Has that been a continuous 21 position since early Summer of '89? 22 A. Yes. 23 MS. ZETTLER: Let's take a break. 24 (A SHORT RECESS WAS TAKEN.) Page 41 1 Q. In your positions or position 2 with Elanco, did you have any responsibilities 3 whatsoever that related to Fluoxetine 4 Hydrochloride? 5 A. No. 6 Q. How about in your Summer job at 7 Lilly in '79, did you have any responsibilities 8 related to Fluoxetine? 9 A. No. 10 Q. How about your Summer 11 internship, did you have any responsibilities 12 related to Fluoxetine? 13 A. No. 14 Q. That makes it easier. 15 Generally, in your CRA positions from early '83 16 through the beginning of '87, did your work 17 relate to Fluoxetine? 18 A. No. 19 Q. Was there a period of time from 20 early '83 through the beginning of '87 where you 21 were temporarily assigned to Fluoxetine tasks? 22 A. No. 23 Q. What type of training did you 24 receive either before or when you first became a Page 42 1 CRA related to that position, not as a Fluoxetine 2 CRA, a CRA generally? 3 A. Training consisted of being 4 coached by an experienced CRA as well as 5 traveling in the field with the CRCs, which are 6 clinical research coordinators. 7 Q. Anything else? 8 A. There were outside courses. I 9 don't recall when they were, but I do remember 10 going to at least one outside course for 11 training. 12 Q. Did you take any in-house 13 courses related to your training to become a CRA? 14 A. I don't believe there were 15 formal courses at the time. 16 Q. When you changed from being a 17 CRA in oncolytics to being a CRA in 18 anti-infectives, did you have to take any 19 additional training? 20 A. Continued to be coached. 21 Q. When you say coached by an 22 experienced CRA, is that kind of like a mentor 23 type of system? 24 A. Yes. Page 43 1 Q. Was it just one person that you 2 worked with or did you work with more than one 3 person as mentors? 4 A. More than one. 5 Q. Can you give me a general idea 6 of what your duties as a CRA in oncolytics was? 7 A. I was reviewing clinical report 8 forms as well as initiating a trial. 9 Q. When you say initiating a 10 trial, working on start-up? 11 A. Yes, that was one aspect of it. 12 Q. What other things did you do to 13 initiate a trial? 14 A. Helped draft the protocol, 15 helped draft the clinical report forms, gathered 16 the regulatory documents that were required. 17 Q. Anything else? 18 A. Prepared items for the start-up 19 meeting. 20 Q. When you say gathered 21 regulatory documents, do you mean things such as 22 1572s and 1573s that had to be filed by the 23 clinical investigator, things of that nature? 24 A. Yes. Page 44 1 Q. What other types of regulatory 2 documents would you get together? 3 A. The ethical review committee 4 approvals, the approved informed consents. 5 Q. When you say ethical review 6 committee, you mean the IRB? 7 A. Yes. 8 Q. Any other regulatory documents? 9 A. The CVs of the investigators. 10 Q. Anything else? 11 A. Not that I recall. 12 Q. Tell me what you would do in 13 reviewing clinical report forms? 14 A. Validating the data. 15 Q. How would you validate data? 16 A. Review it for accuracy and 17 reasonability. 18 Q. What do you mean by 19 reasonability? 20 A. An example would be a male 21 patient with a hysterectomy. As part of the 22 data, those are the kinds of things for 23 reasonability. 24 Q. The things that you know can't Page 45 1 possibly be true? 2 A. That's correct. 3 Q. How does that differ from 4 accuracy? 5 A. Data fields that may not be 6 completed, things like that. 7 Q. Did you use computer edits on 8 the oncolytics? 9 A. Yes. 10 Q. Were similar data edits used on 11 the anti-infectives and gastrointestinal clinical 12 trial case report forms that you reviewed? 13 A. Yes. 14 Q. Did you do anything with 15 regards to adverse events on the trials on 16 oncolytics? 17 A. What do you mean? 18 Q. Did you have any 19 responsibilities related to gathering data or 20 reporting of adverse events? 21 A. I reviewed the data and shared 22 that information with the physicians who were 23 responsible for the studies. 24 Q. What did you do in reviewing Page 46 1 the data? 2 A. Looked at the nature of the 3 events. We received morning reports, and those 4 were given to the CRAs and physicians to review, 5 to alert you. 6 Q. What are morning reports? 7 A. They're reports that when data 8 are entered the day before, it shows you new data 9 has come in so you can review them. 10 Q. Would you share all information 11 on every adverse event with the doctors 12 responsible for the studies? 13 A. No. 14 Q. In what situations would you 15 share the adverse event information with the 16 doctors responsible for the studies? 17 A. Well, the doctors also received 18 the same copy, and so if the report looked as 19 though it were serious or if the physicians came 20 to us and asked us for clarifying information, we 21 did interchange on those. 22 Q. You did or you didn't? 23 A. We did. 24 Q. You did what? Page 47 1 A. We exchanged information if 2 they came asking for additional information. 3 Q. When you say if an adverse 4 event is serious, what do you mean? 5 A. That's a regulatory definition 6 that the FDA has pretty strict guidelines on 7 what's defined as serious. 8 Q. What is the FDA's definition of 9 a serious adverse event? 10 A. There are five or six 11 classifications such as hospitalization, 12 congenital anomaly, death. I don't recall all of 13 them. 14 Q. Cancer? 15 A. Yes. 16 Q. Life threatening? 17 A. Yes. 18 Q. How about overdose? 19 A. I don't know at the time that 20 that was part of the definition. 21 Q. Is it your understanding that 22 now the FDA has included overdose in the list of 23 serious adverse events? 24 A. I believe so. Page 48 1 Q. Do you remember when that 2 happened? 3 A. No, I don't. 4 Q. Have you seen a regulation that 5 lists overdose as a serious adverse event? 6 A. No. 7 Q. How did you come to the 8 understanding that overdose is listed by the FDA 9 as a serious adverse event? 10 A. In my current role as 11 department head, it will come up in discussions 12 with CRAs, so in that way, I knew that it was 13 part of the regulation now. 14 Q. Earlier you testified, I 15 believe, that doctors occasionally would ask you 16 to do some follow-up on adverse events that were 17 reported in the morning reports? 18 A. I stated that they asked for 19 additional information. 20 Q. Would that include doing a 21 follow-up if you didn't have the information 22 in-house? 23 A. Possibly, yes. 24 Q. If you were required to do Page 49 1 follow-up on an adverse event, what types of 2 things would you do? 3 A. Call the investigational site. 4 Q. Anything else? 5 A. Depending on whether I was able 6 to reach them via phone call, would also notify 7 the CRCs to help us get additional information, 8 or the CIRs. 9 Q. You said the CRC or CIC? 10 A. CRCs, and the CIRs. 11 Q. What's a CIR? 12 A. Clinical investigational 13 representative. 14 Q. Is their function similar to 15 quality assurance? 16 A. I'm not sure how you define 17 quality assurance. They were -- part of their 18 role was to validate the clinical report forms 19 against source documents, and check the case 20 report forms for completeness before they were 21 sent in. 22 Q. They would do site visits? 23 A. Yes. 24 Q. Did you at any time work as a Page 50 1 CRA on Fluoxetine? 2 A. No. 3 Q. Why did you go from being a CRA 4 to a personnel rep? 5 A. It's part of the developmental 6 programs at Lilly. 7 Q. Explain to me how the 8 developmental program works. 9 A. You're gaining 10 cross-functionalal experience working in employee 11 relations or recruiting, or both, dealing with 12 salary administration and personnel issues and 13 how to manage those. 14 Q. Is this a mandatory program? 15 A. No. 16 Q. How would you get involved in 17 that program? 18 A. Part of it's an interest, part 19 of it is an observed view that you have potential 20 in management. 21 Q. So developmental program is a 22 management directed type of program? 23 A. I'm not sure I understand. 24 Q. Is it a program that people who Page 51 1 have management potential are involved in? 2 A. Typically, yes. 3 Q. Once you're in the program, 4 what happens? 5 A. You act as a personnel 6 representative for the employees that you're 7 responsible for, as well as working with the 8 management of that area, particular areas, either 9 in training them, the management, or coaching, or 10 acting as an intermediary if issues arise. 11 Q. Are there certain positions 12 that you have to -- that you're assigned to 13 within the program? In other words, you went 14 from being a CRA to a personnel representative, 15 to being a regional personnel representative. Is 16 that typical of how the program works? 17 A. No. 18 Q. How do they decide what areas 19 to place you in? 20 A. I don't know exactly. Part of 21 it is availability of openings, part of it is 22 timing of the individual going into those, 23 whether they're ready. 24 Q. Is there a policy or practice Page 52 1 with regards to the program that a person such as 2 yourself will be placed in a position for a year 3 and a half to two years and then changed to 4 another position for a period of time? 5 A. That's not unusual for that to 6 happen. 7 Q. Is that a policy or is that a 8 practice? 9 A. No. 10 Q. If you do not want to be in the 11 developmental program, could you decline that? 12 A. Sure. 13 Q. When you were a personnel 14 representative from the beginning of '87 to late 15 Summer, early Fall of '88, what group did you 16 represent? 17 A. Toxicology and animal science, 18 and part of the systems group. 19 Q. Did any of the people that you 20 represented during that period of time have 21 responsibilities related to Fluoxetine? 22 A. I don't know. 23 Q. How about in your regional 24 personnel representative position, what group did Page 53 1 you represent then? 2 A. Sales reps in the western 3 region. 4 Q. At that time or during that 5 period of time, did any of the people that you 6 represent have responsibilities related to 7 Fluoxetine? 8 A. Yes. 9 Q. You had sales reps that were 10 detailing Fluoxetine during that period of time? 11 A. Yes. 12 Q. What were your responsibilities 13 in that position as regional personnel rep? 14 A. Almost exclusively recruiting 15 for the sales force. 16 Q. Anything else besides 17 recruiting? 18 A. There were a few employee 19 relation issues that I got involved with, but the 20 majority of the time was recruiting. 21 Q. Which employee relation issues 22 did you get involved in? 23 A. Oh, they were standard. 24 Separations that occurred, movement of employees Page 54 1 to different territories. 2 Q. When you say separations, you 3 mean marital separations? 4 A. No, separations from the 5 company. 6 Q. Okay. What states were 7 included in the western region? 8 A. Montana, Wyoming, Arizona, New 9 Mexico, and west. 10 Q. Tell me how you go about 11 recruiting sales reps? 12 A. There were two different ways 13 primarily, one was through campus interviewing, 14 and the second was through referrals from the 15 sales reps themselves. 16 Q. What type of qualifications 17 would you look for in a sales rep? 18 A. At least a Bachelor's degree. 19 Q. In any particular area? 20 A. Preferably pharmacy or the 21 sciences, but not exclusively. Experience as a 22 pharmacist. 23 Q. Anything else? 24 A. Above average grades. Page 55 1 Q. Anything else? 2 A. Interpersonal skills, 3 leadership skills that may have been demonstrated 4 through their education or career. 5 Q. Anything else? 6 A. Uh-uh. 7 Q. You have to say. 8 A. No. 9 Q. How often would you find 10 somebody with experience as a pharmacist? 11 A. That varied. I didn't find 12 them personally. 13 Q. Okay. 14 A. Those were the ones referred 15 from the sales reps. 16 Q. Did you actually conduct 17 on-campus recruiting? 18 A. Yes. 19 Q. What would you do, go to the 20 campus and, like, job fairs or job days, things 21 of that nature? 22 A. Yes. 23 Q. Did you run advertisements in 24 newspapers? Page 56 1 A. No. 2 Q. Besides going to campus during 3 job days or recruiting days, what else would you 4 do on campus? 5 A. Interact with the deans of the 6 pharmacy schools or the dean of business schools, 7 for example, talk to them about what kinds of 8 opportunities we could provide for the students 9 who were graduating. We might follow up with 10 students in particular that we had noticed in 11 previous discussions or job fairs that we had 12 been to at that campus previously. We might 13 conduct dinners, presentations the night before, 14 for the students to see what kinds of positions 15 we were offering. 16 Q. Sales reps are paid on 17 commission? 18 A. No. 19 Q. Did you train any of the sales 20 reps? 21 A. No. 22 Q. Who did the training? 23 A. That was done initially in 24 Indianapolis, and follow-up training both out in Page 57 1 the field and in Indianapolis. 2 Q. When you were a personnel rep 3 here in Indianapolis, did you conduct any 4 training programs? 5 A. Well, I never stated it was 6 here in Indianapolis. 7 Q. Okay. The first time you were 8 a personnel rep in the late Summer -- or the 9 beginning of '87 to the late Summer or early 10 Fall, was that here in Indianapolis? 11 A. No. 12 Q. Where was that? 13 A. Greenfield. 14 Q. Greenfield what? 15 A. Indiana. 16 Q. Did you conduct any training 17 programs for the people that you represented? 18 A. Yes. 19 Q. What kind of training programs? 20 A. They were the transferable 21 skills type training programs. 22 Q. What are transferable skills? 23 A. Communication, leadership, 24 interpersonal skills, the non-technical kinds of Page 58 1 things. 2 Q. When you say transferable, you 3 mean from job to job? 4 A. We call them transferable in 5 the sense that they're not the technical 6 training. Yes, you use them in job to job, 7 that's -- I've not heard it described that way. 8 Q. Let's go back to the sales reps 9 for a minute. When you were a sales rep for 10 Elanco, were you considered an Elanco sales rep? 11 A. Yes. 12 Q. Is that different than a Lilly 13 sales rep? 14 A. Yes. 15 Q. What's the difference? 16 A. They were two separate 17 divisions, there was no connection at all. 18 Q. When you were regional 19 personnel representative for the western region, 20 did you work with DISTA sales reps? 21 A. Yes. 22 Q. And did you work with Lilly 23 sales reps? 24 A. Yes. Page 59 1 Q. What are the differences 2 between the DISTA and Lilly sales reps? 3 A. Based on the products they 4 sell, they're divided into divisions. 5 Q. What types of products did the 6 DISTA reps sell? 7 A. The DISTA reps had Keflex and 8 Prozac. I don't recall other compounds that they 9 detailed. 10 Q. Were there also Lilly sales 11 reps that detailed Prozac or Fluoxetine? 12 A. There were psych reps who 13 detail only Prozac, but I don't recall which 14 division they were in. 15 Q. Keflex is not a psych -- Keflex 16 is an antibiotic, right? 17 A. That's correct. 18 Q. And Lilly manufactures other 19 antibiotics, does it not? 20 A. Yes, it does. 21 Q. Why was Keflex singled out to 22 be detailed by DISTA? 23 A. I don't know the answer to 24 that. Page 60 1 Q. Were there Lilly 2 representatives outside of DISTA that also 3 detailed Keflex, to your knowledge? 4 A. I don't know. 5 Q. Have you ever heard the term 6 Select Product representative? 7 A. Yes. 8 Q. What's a Select Product 9 representative? 10 A. It's another division of reps, 11 and they have their own group of products that 12 they detail. 13 Q. Were there any Select Product 14 representatives that detailed Prozac? 15 A. I don't know if they crossed 16 into the Select group or not. I know Select had 17 Axid and Humulin, I believe, but I'm not sure 18 about Prozac. 19 Q. Is it your understanding that 20 there are two separate groups of sales detail 21 people, one that detailed specifically the mental 22 health care professionals, like psychiatrists, 23 mental health clinics, things of that nature, and 24 one that detailed to non-psychiatric or mental Page 61 1 health care customers? 2 A. Yes. 3 Q. Do you know, number one, why 4 that was differentiated? 5 A. No, I don't know why. 6 Q. Do you know which group 7 detailed specifically to non-psychiatric or 8 health care -- or mental health care type 9 professionals? 10 A. It was the DISTA reps that went 11 to the non-psychiatric professionals. 12 Q. Just so I'm not completely 13 confused, you had the DISTA sales reps, you had 14 the straight Lilly sales reps, and then you had 15 the Lilly Select Product reps? 16 A. Correct. 17 Q. Then we know you had the Elanco 18 reps because that was a different entity; 19 correct? 20 A. Correct. 21 Q. Any other groups of 22 representatives? And we can just limit it to 23 Fluoxetine. 24 MR. MYERS: I'm going to object to the Page 62 1 form because I don't think she said that all 2 three of those sold Fluoxetine. 3 Q. Okay. We know that the Lilly 4 reps, whether or not they were Select, sold 5 Fluoxetine; correct? 6 A. No, I don't know that. 7 Q. You don't know. I thought 8 earlier you testified there were two groups that 9 sold Fluoxetine, DISTA was one, and there was 10 another group. 11 A. Psych reps. And I don't recall 12 which group they fell into. 13 Q. So they could be just straight 14 Lilly reps or they could be Select Product reps? 15 MR. MYERS: Or they could be -- 16 A. They could be DISTA reps, too, 17 I don't know. 18 MR. MYERS: She said she didn't know. 19 A. I don't know. 20 Q. Now I'm completely confused. 21 MR. MYERS: You were doing good up 22 until that point. 23 MS. ZETTLER: No, I wasn't, because I 24 had a completely different idea than what she Page 63 1 just testified to. 2 Q. DISTA were the -- I thought you 3 testified earlier that DISTA were the 4 non-psychiatric representatives. 5 A. There were representatives in 6 the DISTA sales force that called on 7 non-psychiatric physicians, health care 8 professionals. There was also another group 9 called psych reps, as I knew them, but I don't 10 recall which sales force they were in. 11 Q. So it could have been another 12 group within DISTA? 13 A. It could have been, that's 14 correct. 15 Q. It also could have been a group 16 within Lilly? 17 A. Could have been. 18 Q. Or could have been a Select 19 Product representative group? 20 A. Could have been. 21 Q. Okay, now I've got it. 22 A. Okay. 23 Q. Did you attend a training 24 program for sales reps? Page 64 1 A. Which sales reps? 2 Q. When you were in preparation 3 for your position as regional personnel 4 representative. 5 A. No. 6 Q. Okay. Let's talk about your 7 position as department head of medical plans. 8 How is it that you came into that position? 9 A. I was asked to be in that 10 position. 11 Q. Who asked you to be in that 12 position? 13 A. The offer was made by Gene 14 Crum. 15 Q. I'm sorry? 16 A. Gene Crum. 17 Q. C-R-U-M? 18 A. Yes. 19 Q. His first name Eugene? 20 A. Yes, it is. 21 Q. A. E. Crum? 22 A. Yes. 23 Q. Who is Mister Crum? 24 A. He was one of the managers of Page 65 1 medical plans at the time. 2 Q. Is he still with Lilly? 3 A. No. 4 Q. I'm sorry? 5 A. No. 6 Q. When did he leave Lilly? 7 A. When? 8 Q. Yes. 9 A. I believe last year, '92. 10 Q. Why did he leave Lilly? 11 A. He retired. 12 Q. How old is he? 13 A. About sixty-three or four. 14 Q. Do you know where he is living? 15 A. Yes. 16 Q. Where does he live? 17 A. In Indianapolis. 18 Q. Who was your predecessor in the 19 position as department head of medical plans? 20 A. In which position? 21 Q. Okay, that's a good question. 22 Why don't you tell me what your responsibilities 23 have been as department head of medical plans. 24 A. I'm responsible for the CRAs Page 66 1 and support staff from an administration 2 standpoint. 3 Q. Have those responsibilities 4 essentially been the same throughout the time 5 you've been department head? 6 A. As far as the activities 7 themselves, yes. 8 Q. Okay. Has your product focus 9 been different? 10 A. Yes. 11 Q. What product focus did you have 12 when you first became a department head? 13 A. In the cardiovascular area. 14 Q. How long were you a department 15 head in cardiovascular? 16 A. For about a year and a half. 17 Q. So until early '91? 18 A. Yes -- no, I'm sorry, middle to 19 late '90. 20 Q. And then what did your focus 21 change to? 22 A. It gradually changed in that 23 same time to include oncolytics. 24 Q. When did your focus change Page 67 1 next? 2 A. In December of '90. 3 Q. What did it change to? 4 A. Fluoxetine. 5 Q. Specifically? 6 A. Yes. 7 Q. Has that been your focus since? 8 A. Yes. 9 Q. Was there a gradual period 10 before the Summer of '90 when you started working 11 on Fluoxetine? 12 A. No. 13 Q. Why did you change from 14 oncolytics to Fluoxetine? 15 A. There was a vacancy and I was 16 asked to move there. 17 Q. Who did you replace? 18 A. Laura Fludzinski. 19 Q. And you've been in that 20 position ever since? 21 A. Yes. 22 MS. ZETTLER: Let's take another break. 23 (A SHORT BREAK WAS TAKEN.) 24 Q. Who asked you to switch your Page 68 1 concentration to Fluoxetine? 2 A. Gene Crum. 3 Q. And what was Mister Crum's 4 position at that time? 5 A. Manager of medical plans. 6 Q. Was his concentration 7 Fluoxetine at that time? 8 A. No. 9 Q. What was his concentration, if 10 he had one? 11 A. It was the oncolytics 12 cardiovascular internal medicine. 13 Q. Who was manager of Fluoxetine 14 medical plans? 15 A. Mike Harrill. 16 Q. Did you report directly to 17 Mister Harrill? 18 A. Yes. 19 Q. Did you report to anybody else 20 besides Mister Harrill? 21 A. No, not directly. 22 Q. Did you have any 23 responsibilities over at the drug epidemiology 24 unit in your concentration on Fluoxetine? Page 69 1 A. No. 2 Q. Did you have a counterpart on 3 the technical side of Fluoxetine? 4 A. I don't understand your 5 question. 6 Q. You testified that your 7 responsibilities were basically administrative; 8 correct? 9 A. Correct. 10 Q. Did you have -- was there 11 somebody who had responsibilities similar to 12 yours, on your level, that was responsible for 13 the medical aspect? 14 A. Yes. 15 Q. Who would that be? 16 A. Dan Masica. 17 Q. What was Doctor Masica's title? 18 A. Director of psychopharm 19 division. 20 Q. What were his responsibilities, 21 if you know? 22 A. He had the clinical scientists 23 reporting to him. 24 Q. The clinical research Page 70 1 physicians? 2 A. Yes. 3 Q. Is he still in that position 4 today? 5 A. No. 6 Q. Where is he now? 7 A. He's a clinical research 8 physician for the U.S. medical organization. 9 Q. What's the U.S. medical 10 organization? 11 A. It's a component or division 12 focused on the U.S. versus world wide. 13 Q. Does that division have 14 responsibilities related to Fluoxetine? 15 A. Yes. 16 Q. What responsibilities does that 17 division have with regards to Fluoxetine? 18 A. There's a clinical research 19 physician assigned to Fluoxetine for the U.S. 20 Q. And that's Doctor Masica? 21 A. No. 22 Q. Who is that? 23 A. Doctor Blonglen, 24 B-L-O-N-G-L-E-N. Page 71 1 Q. And how does Doctor Blonglen's 2 responsibilities differ from the responsibilities 3 of the clinical research physicians in your 4 division? 5 A. We don't have clinical research 6 physicians in our division. 7 Q. What does your division 8 encompass? 9 A. The administrative and support 10 staff. 11 Q. How does Doctor Blonglen's 12 responsibilities differ from the clinical 13 research physicians in Doctor Masica's former 14 area? 15 A. The USMO, as we call it, is 16 recently formed, so I don't know if you're 17 talking current or historically. 18 Q. When was it formed? 19 A. Early this year. 20 Q. Does the USMO have 21 responsibilities for products other than 22 Fluoxetine? 23 A. Yes. 24 Q. Why was the USMO formed? Page 72 1 A. To create a focus on the U.S. 2 Q. How would Doctor Blonglen's 3 responsibilities differ from the clinical 4 research physicians in medical now? 5 A. She's focused only on U.S. 6 Fluoxetine trials. 7 Q. Would she act as a clinical 8 monitor on U.S. Fluoxetine trials? 9 A. Depending on how you define 10 monitor. 11 Q. Is there a position at Lilly 12 entitled clinical monitor? 13 A. No. 14 Q. Was there ever a position at 15 Lilly entitled clinical monitor? 16 A. I don't know. 17 Q. When you say that Doctor 18 Blonglen would focus on U.S. clinical trials, 19 what responsibilities would she have with regards 20 to those trials? 21 A. She would work with the CRAs 22 who are assigned to the particular studies. 23 She's the one responsible for the final 24 protocols, she's the individual responsible for Page 73 1 reviewing spontaneous reports for the adverse 2 events of the U.S. clinical trials. 3 Q. Does she focus mainly on 4 Fluoxetine? 5 A. Yes. 6 Q. To your knowledge does she have 7 responsibilities with regards to any other Lilly 8 products? 9 A. Yes. 10 Q. Does the USMO have 11 responsibility over all phases of clinical 12 trials, Phase 1 through 4? 13 A. No. 14 Q. Is it just Phase 4 clinical 15 trials? 16 A. No. 17 Q. Which clinical trials? 18 A. Predominantly Phase 3 and 4 19 trials conducted in the U.S. 20 Q. What is Doctor Blonglen's first 21 name? 22 A. Sharon. 23 Q. Was she hired by Lilly 24 specifically to work in the USMO or was she moved Page 74 1 there from another area in Lilly? 2 A. She was hired into Lilly, and 3 then moved into the USMO. 4 Q. What position did she hold 5 prior to working in the USMO? 6 A. Clinical scientist in the 7 psychopharm division. 8 Q. Is a clinical scientist 9 different than a clinical research physician? 10 A. No. 11 Q. Are her duties in the USMO 12 similar to a clinical research physician in 13 medical? 14 A. Yes. 15 Q. Do her responsibilities differ 16 in any way other than being focused just on the 17 United States clinical trials, Phase 3, Phase 4? 18 A. I don't know specifically. 19 Q. Prior to being involved in the 20 USMO, did Doctor Blonglen, to your knowledge, 21 have responsibility for Fluoxetine? 22 A. Yes. 23 Q. What were those 24 responsibilities? Page 75 1 A. She was the clinical scientist 2 for a couple of the ongoing trials. 3 Q. Were those depression trials? 4 A. Yes. 5 Q. Which depression trials? 6 A. Depression studies in cardiac 7 patients and sleep architecture studies, and in 8 cancer patients. 9 Q. Any other physicians in the 10 USMO with responsibilities for Fluoxetine? 11 A. No. 12 Q. Do you know Doctor Charles 13 Beasley? 14 A. Yes. 15 Q. Is Doctor Beasley still with 16 Lilly? 17 A. Yes. 18 Q. What is his current position? 19 A. He's a clinical research 20 scientist in the psychopharm division. 21 Q. Does he still have 22 responsibilities for Fluoxetine? 23 A. Yes. 24 Q. Is that his primary Page 76 1 responsibility? 2 A. No. 3 Q. What's his primary 4 responsibility? 5 A. In the schizophrenic area. 6 Q. Did Doctor Beasley at any time 7 have primary responsibility for Fluoxetine? 8 MR. MYERS: When you say primary 9 responsibility, as far as he was concerned? 10 MS. ZETTLER: Yes. 11 Q. Was his primary responsibility, 12 at any time, Fluoxetine? 13 A. I don't know. 14 Q. When did he start working with 15 schizophrenics? 16 A. Within the last year and a half 17 or so. 18 Q. What are his responsibilities 19 with regard to Fluoxetine at this time? 20 A. He's working on the completion 21 of one study. 22 Q. Is that a depression study? 23 A. Yes. 24 Q. Which study is that? Page 77 1 A. Treatment in long-term -- 2 long-term treatment of depression. 3 Q. Are you familiar with the MSSIR 4 scale? 5 A. No. 6 Q. Are any suicidality rating 7 scales other than the Hamilton Depression Scale 8 being used in that long-term depression study? 9 A. No. Let me clarify that. The 10 Hamilton Depression Scale is not a suicidality 11 scale. 12 Q. Are any suicidality scales 13 being used in the long-term treatment study? 14 A. No. 15 Q. How about anxiety scales? 16 A. I don't know. 17 Q. Is the Ham used in that? 18 A. I don't know. 19 Q. How did you come to your 20 understanding that the Ham-D was not a 21 suicidality rating scale? 22 A. It's a rating scale for 23 diagnosing depression. 24 Q. How did you come to that Page 78 1 understanding? 2 A. Through my training. 3 Q. Is this something that somebody 4 told you or is this something that is set out in 5 writing? 6 A. Both. 7 Q. Who told you that the Ham-D was 8 not a suicidality rating scale? 9 A. I don't know that anybody 10 specifically told me it wasn't, it was more the 11 discussion that it's a diagnostic tool for 12 depression. 13 Q. Where is that information set 14 out in writing? 15 A. In sales training manuals, in 16 the DSM3R. 17 Q. The DSM3R talks about the 18 Hamilton Depression Rating Scale? 19 A. No, it talks about diagnosing 20 depression. 21 Q. Have you had any training 22 specifically on the etiology of depression? 23 MR. MYERS: Has she had any? 24 MS. ZETTLER: Yes. Page 79 1 A. Yes. 2 Q. What training is that? 3 A. The sales training manuals that 4 are used for sales reps. 5 Q. Anything else? 6 A. No. 7 Q. These sales training manuals 8 that talk about the etiology of depression, are 9 these manuals that you were given in preparation 10 for your work in Fluoxetine as a department head? 11 A. No, not in preparation. 12 Q. When did you first review those 13 sales training manuals? 14 A. December-January timeframe, as 15 I joined that position or as I entered that 16 position. 17 Q. When you say that position, you 18 mean as department head of medical plans? 19 A. In Fluoxetine, yes. 20 Q. Is this something that you 21 asked to see or was this something that was 22 provided to you? 23 A. I was made aware that they were 24 available, and I asked for copies of them. Page 80 1 Q. Did you have copies of those in 2 your file? 3 A. No. 4 Q. What did you do in preparation 5 for your deposition today? 6 A. I spoke with my counsel. 7 Q. Larry and Curt? 8 A. Larry and Steve and Mary. 9 Q. When did you first meet with 10 your attorneys? 11 A. Tuesday of this week. 12 Q. When were you first notified 13 that you would be asked to give your deposition 14 in this case? 15 A. A few months ago. 16 Q. How long did you meet with your 17 attorneys on Tuesday? 18 A. For about five hours. 19 Q. Was that the first time that 20 you met with your attorneys? 21 A. Yes. 22 Q. Did you meet with them anytime 23 after Tuesday? 24 A. Yes. Page 81 1 Q. When? 2 A. Yesterday afternoon. 3 Q. Who did you meet with yesterday 4 afternoon? 5 A. Larry and Steve. 6 Q. How long did you meet with 7 Larry and Steve yesterday? 8 A. For about a half hour. 9 Q. Did you review any documents in 10 preparation for the deposition? 11 A. Yes. 12 Q. Which documents did you review? 13 A. I reviewed one report, quality 14 assurance audit report. 15 Q. Audit of what? 16 A. Audit of one of the clinical 17 trials, one of the sites. 18 Q. Which clinical trial? 19 A. Long-term treatment. 20 Q. Were you asked to review that 21 report? 22 A. No. 23 Q. Why did you review that report? 24 A. I was reviewing it for the Page 82 1 information in there on an investigative site for 2 compliance. 3 Q. There was a problem at one of 4 the sites complying with the protocol? 5 A. How are you defining 6 compliance? 7 Q. I don't know, I'm trying to 8 figure out how you define compliance. How do you 9 define compliance, what do you mean when you say 10 compliance? 11 A. That they're following the 12 protocol and regulations. 13 Q. How many sites were involved in 14 that study? 15 A. About five or six. 16 Q. And you were reviewing the 17 audit report specific to one site out of the five 18 or six? 19 A. Yes. 20 Q. Do you remember that there was 21 a problem with compliance at that site? 22 A. Not a problem, there were 23 questions that had been asked, and that was why 24 an audit was done, as is the case with many of Page 83 1 the audits. 2 Q. What questions were asked that 3 prompted the audit? 4 A. I don't know that. 5 Q. Was this a Doctor Beasley study 6 that we were talking about earlier? 7 A. Yes. 8 Q. Were there questions about 9 compliance with regulations at that site? 10 A. I don't believe so. 11 Q. Was it questions about 12 compliance with protocol? 13 A. Yes, more in that area. 14 Q. Any other documents that you 15 reviewed? 16 A. No. 17 Q. Is this audit still in your 18 files, was it something that you requested to 19 see? 20 A. I asked to see it. 21 Q. Did you ask to see any other 22 documents? 23 A. No. 24 Q. When did you review that Page 84 1 document? 2 A. Yesterday morning. 3 Q. And generally what did the 4 audit state with that particular site? 5 A. There were questions raised as 6 to the case report form and the source documents. 7 Q. What questions? 8 A. Whether they were available. 9 Q. When was the audit conducted? 10 A. I don't know. 11 Q. When you say when the case 12 report forms and source documents were available, 13 what do you mean? 14 A. Were there source documents to 15 support the case report forms. 16 Q. Give me some examples of what 17 source documents would be. 18 A. If an investigator used 19 alternative documents to collect data, if they 20 conducted a physical and wrote it on other paper 21 and then later transferred the data from that 22 paper to the case report form, the original sheet 23 would be a source document. Lab data, x-rays are 24 source documents. Page 85 1 Q. So when you say whether 2 clinical report forms and source documents were 3 available, was it Lilly's feeling that there were 4 source documents that were missing? 5 A. No. 6 Q. Was it a problem with clinical 7 report forms missing? 8 A. No. 9 Q. Why was a question raised then? 10 A. The question was raised were 11 they available. 12 Q. Why were you interested in 13 reviewing the documents related to this 14 particular audit at this site? 15 A. I was interested in accuracy of 16 the information, you know, what I had recalled. 17 Q. When you say accuracy of 18 information, what information are you talking 19 about? 20 A. What I had recalled, my memory. 21 Q. And did the documents support 22 your memory? 23 A. Yes. 24 Q. Why is it that you wanted to Page 86 1 refresh your recollection as to that one audit as 2 opposed to other aspects of your position? 3 A. I don't know the answer to 4 that. 5 Q. Were you concerned about being 6 asked questions about that audit? 7 A. No. 8 Q. Was there something about the 9 information that was reported on the clinical 10 report forms from that site that prompted the 11 question as to whether or not source documents 12 were there to back them up? 13 A. No. 14 Q. Then I really don't understand 15 why the audit was done, that's my confusion. If 16 there wasn't a concern about the documents being 17 missing and there wasn't a problem with the 18 information that was reported on the clinical 19 report form, why was the audit conducted? 20 A. It was a very large study, and 21 audits were done on most, if not all, of the 22 sites involved in that study. 23 Q. Okay. Why were you interested 24 in the audit of this particular site? Page 87 1 A. There was follow-up discussion 2 at the time to determine what, if any, actions 3 needed to be taken. 4 Q. With regards to what? 5 A. The findings of the audit. 6 Q. What were the findings of the 7 audit? 8 A. It was more of an 9 interpretation of what was required of the 10 investigator versus what Lilly felt was required 11 to have in the files. 12 Q. It was a problem with the 13 clinical investigator's interpretation of their 14 responsibilities? 15 A. No, not their responsibilities. 16 Q. Okay. 17 MS. ZETTLER: Can you read that back? 18 (THE COURT REPORTER READ BACK THE 19 REQUESTED TESTIMONY.) 20 Q. When you say an interpretation 21 of what was required by the investigator, what do 22 you mean? 23 A. What was required as source 24 documents. Page 88 1 Q. Did Lilly require source 2 documents? 3 A. Those are required by 4 regulations, so, yes, Lilly requires them. 5 Q. What source documents are you 6 talking about? 7 A. Well, many times when 8 physicians conduct physical exams, as an example, 9 they'll use a different sheet to collect the 10 information. That didn't happen, and they used 11 the direct case report form as their source 12 document. 13 Q. Do regulations require that 14 they use a sheet other than the case report form 15 to record their findings? 16 A. No. 17 Q. Is it appropriate for them 18 under the regulations to record their findings 19 and the data directly on the case report form? 20 A. Yes. 21 Q. Then I still don't understand 22 what the problem was. 23 A. It's unusual for investigators 24 to use the clinical report forms directly. Page 89 1 Q. Does Lilly prefer that the 2 investigator use source documents other than the 3 clinical report forms to do the initial recording 4 of the information? 5 A. No, I wouldn't say prefers, it 6 just hadn't been standard practice in the past. 7 Q. So an audit was done on the 8 site to see if they had in fact used source 9 documents to record the initial findings? 10 A. No, I don't know that that was 11 the reason an audit was done. 12 Q. Okay. I'm still confused as to 13 why the audit was done if it wasn't -- 14 MR. MYERS: She told you that there was 15 a big study with all the sites and she felt that 16 most, if not all, had been audited. 17 MS. ZETTLER: I know, but she also told 18 me that she reviewed that particular audit of 19 that particular site, and I'm trying to find out 20 why that audit was done. 21 MR. MYERS: I think she answered that 22 before when you asked her why was the audit done 23 in the first place. You've been talking for the 24 last few minutes about what the audit found, Page 90 1 that's two different things. So as to why the 2 audit was done, she's answered it. Ask her 3 again. 4 Q. Why was the audit done? 5 A. It was routine procedure to 6 audit a large study like this. There weren't any 7 particular reasons, I don't recall, why this 8 audit was done at any given site. 9 Q. So you have a routine audit of 10 a site, right? 11 A. Uh-huh, yes. 12 Q. And the results of the audit 13 were curious, for lack of a better phrase, 14 because there were no source documents used to 15 record the initial findings; correct? 16 MR. MYERS: Let me object to the form 17 as to the initial findings. She gave an example 18 like for example a physical examination, so your 19 question is a lot broader than that. If you can 20 answer it, go ahead, but I object to the form. 21 Q. Were there any source documents 22 used at that site at all? 23 A. Yes. 24 Q. Which source documents were Page 91 1 used at that site? 2 A. I don't know. 3 Q. What source documents were not 4 used at the site? 5 A. Physical exam. 6 Q. Okay. Was it typical for the 7 clinical investigators to keep a chart other than 8 the clinical report forms on their patients? 9 A. Yes, that's typical. 10 Q. And from that chart they would 11 transfer information to the clinical report 12 forms? 13 A. Correct. 14 Q. And at least with regards to 15 the physical findings of this particular site, 16 they did not do that; correct? 17 A. That's correct. 18 Q. And that was unusual? 19 A. Yes. 20 Q. And that's part of the reason 21 the audit was performed? 22 A. No. 23 Q. That was part of the findings 24 of the audit? Page 92 1 A. That's right. 2 Q. What other findings of the 3 audit? 4 A. The dating or the correction 5 process of data on the case report forms was 6 questioned. 7 Q. Any other findings? 8 A. I don't recall other ones. 9 Q. Why was the process of 10 corrections of the data on the clinical report 11 forms questioned? 12 MR. MYERS: I'm sorry, did you say 13 correction or collection? 14 Q. Correction. 15 A. Could you restate that? 16 Q. Do you want her to repeat it? 17 A. Repeat it. 18 (THE COURT REPORTER READ BACK THE 19 REQUESTED TESTIMONY.) 20 A. What was in question was the 21 timing of corrections as to when the data were 22 collected. 23 Q. Okay. So you have data that 24 was collected, say, on the first of the month, Page 93 1 and then there was a period of time between when 2 it was collected and when the corrections were 3 made? 4 A. Yes. 5 Q. Was it an extensive period? 6 A. Define extensive. 7 Q. Was it longer than the typical 8 period in which corrections would be made? 9 A. Not necessarily, no. 10 Q. What was the question regarding 11 the period of time between the collection of the 12 original data and the corrections that were made? 13 A. It was thought to be extensive 14 for the kinds of corrections that were being 15 made. 16 Q. What kinds of corrections were 17 being made? 18 A. Corrections to the efficacy 19 data. 20 Q. Can you give me an example? 21 A. Questions on Hamilton, Ham-D, 22 were changed at a later date. 23 Q. Okay. How much later? 24 A. I don't know exactly. Page 94 1 Q. Can you give me an outside 2 estimate? 3 A. A month or so. 4 Q. Okay. Is that unusual? 5 A. It's -- 6 Q. For that type of information? 7 A. Yes, it's unusual, but not 8 unheard of. 9 Q. How is it determined that the 10 Hamilton depression information needed 11 correcting? 12 A. I don't know. 13 Q. Was that a decision that was 14 made at the site? 15 A. Yes. 16 Q. Is it typical that Hamilton 17 depression rating information would be corrected 18 after the administration of the scale? 19 A. It's not typical, but it does 20 happen. 21 Q. Okay. Any other issues raised 22 either prompting or resulting from the audit? 23 A. Not that I'm aware of. 24 Q. Where was the site located? Page 95 1 A. In Pennsylvania. 2 Q. Was the investigator that 3 worked on that, worked at that site, retained by 4 Lilly in the past to work on Fluoxetine studies? 5 A. Yes. 6 Q. He or she? 7 A. Yes. 8 Q. Was it a he? 9 A. Yes. 10 Q. Can you tell me his name? 11 MR. MYERS: Don't disclose that for 12 right now, only because I don't know whether he's 13 a pivotal investigator or not, and I'll check 14 that and tell you that after lunch. If the 15 person is, we'll disclose, if not we'll object on 16 earlier stated basis, but rather than flat 17 instruct her not to answer, let me check that. 18 MS. ZETTLER: Do you want to take two 19 seconds to check it now? 20 MR. OLTMANS: I'll do it. Go ahead and 21 proceed. 22 Q. (BY MS. ZETTLER) Do you know 23 offhand if the doctor who was in Pennsylvania had 24 worked on a pivotal study prior to the long-term Page 96 1 depression study? 2 A. No, I don't know that. 3 MS. ZETTLER: I thought maybe we could 4 circumvent. 5 MR. MYERS: I used to carry that list 6 around with me, I don't anymore. I just can't 7 remember. Let him check. 8 Q. Has a manuscript been prepared 9 resulting from this study? 10 A. No. 11 Q. Has a submission been made to 12 the FDA? 13 A. No. 14 Q. To your knowledge, does Lilly 15 plan on including the data that was collected at 16 the Pennsylvania site in either the report to the 17 FDA or a manuscript if one is prepared? 18 A. Yes, that's by regulation we 19 have to report that. 20 Q. Okay. That's to the FDA, 21 right? 22 A. Correct. 23 Q. Is it going to be included in 24 the efficacy analysis, the information from the Page 97 1 Pennsylvania site? 2 A. Yes. 3 Q. So even though there were some 4 questions as to corrections, et cetera, that 5 we've already talked about, it's still felt that 6 the data collected at the site is an evaluable? 7 A. Yes. 8 Q. Do you know if Doctor Beasley 9 or anybody else at Lilly plans on publishing an 10 article reporting the findings of the study? 11 A. Yes. 12 Q. Do you know if a manuscript is 13 in the works for that right now or not? 14 MR. MYERS: In the works, you mean 15 somebody is thinking about it? 16 MS. ZETTLER: Or working on it. 17 Q. Is it at the point where 18 somebody started working on the manuscript? 19 A. No. 20 Q. What point are you at in that 21 process? 22 A. The final report is being 23 written. 24 Q. And the objective of that study Page 98 1 was to rate efficacy of Fluoxetine in treating 2 long-term depression or long-term treatment of 3 depression? 4 A. Yes. 5 Q. Any other objectives? 6 A. I'm sure there were secondary 7 objectives, but I don't know what they were. 8 Q. Generally what other studies 9 with Fluoxetine are being conducted by Lilly at 10 this time? 11 A. There are studies going on on 12 obesity, in OCD, and depression. 13 Q. Any of the obesity or OCD 14 studies with objectives to study the incidence of 15 suicidality and the use of Fluoxetine for obesity 16 or OCD? 17 A. No. 18 Q. How about violent aggressive 19 behavior? 20 A. No. 21 Q. Any of those indications? 22 A. No. 23 Q. Agitation, increased agitation? 24 A. Not ongoing. Page 99 1 Q. Okay. I mean just obesity and 2 OCD at this time. 3 MR. MYERS: Let me ask you to clarify. 4 When you say agitation, do you mean to treat it 5 or as some sort of an outcome or side effect or 6 event? 7 MS. ZETTLER: Either way. 8 MR. MYERS: Okay. 9 A. No, not in OCD or obesity. 10 Q. Is there a difference in your 11 mind between anxiety and nervousness? 12 MR. MYERS: Before she answers, let me 13 object only to the extent you may have crossed 14 the medical line, and she's not a medical doctor. 15 But if she can draw a distinction, that's fine. 16 A. I can't draw a distinction. 17 Q. Have you ever been told by 18 anybody at Lilly that there was a difference 19 between anxiety and nervousness as an adverse 20 event? 21 A. I don't know if I have or not. 22 I would look in the Costart to see if they were 23 defined that way, differently. 24 Q. Have you ever heard of Doctor Page 100 1 Ivan Miller? 2 A. Yes. 3 Q. Can you tell me who Doctor 4 Miller is? 5 A. He's an individual who created 6 a scale that we employed in a study. 7 Q. And that scale was to rate 8 suicidality? 9 A. Yes. 10 Q. Earlier when I asked you about 11 the MSSIR, is that Doctor Ivan -- is that Doctor 12 Miller's scale? 13 A. I don't know if that's the 14 acronym for that scale. 15 Q. The study that Doctor Miller's 16 scale was used in was a study to validate that 17 scale, was it not? 18 A. I don't know if that's true or 19 not. 20 Q. Okay. 21 A. I don't know what prior history 22 that scale had been used by Doctor Miller in 23 other studies. 24 Q. The study that you're referring Page 101 1 to that employed Doctor Miller's scale, was he a 2 clinical investigator on that study? 3 A. Yes. 4 Q. Was he the clinical 5 investigator, the only clinical investigator on 6 that study? 7 A. Yes. 8 Q. What was the objective of that 9 study? 10 A. To characterize those patients 11 who had had suicidal ideations or acts in the 12 past. 13 Q. What do you mean when you say 14 characterize the patients who had suicidal 15 ideation or acts in the past? 16 A. To try to look at any similar 17 patterns of actions or backgrounds or prior 18 history. 19 Q. Is there a study drug used in 20 that study? 21 A. No, there is not. 22 Q. Is it an inpatient study? 23 A. I don't know if it is or not. 24 Q. Who were the CRAs that worked Page 102 1 on that study? 2 A. Dan Russell, initially, and 3 Catherine Mesner, and Ellie Shotz. 4 Q. Is that study still ongoing? 5 A. Yes. 6 Q. Do you know how many patients 7 have been enrolled in that study? 8 A. I think approximately forty. 9 Q. Are there patients still 10 enrolled in the study? 11 A. Not that I'm aware of. 12 Q. Where is the study as far as 13 completion, what stage is the study at now? 14 A. Transferring the data so that 15 statistical analysis can be done. 16 Q. Say that seven times fast. 17 A. No way. 18 Q. So when you say transferring 19 the data, you mean transferring it to the host? 20 A. Yes. 21 Q. And then the SAS programs -- so 22 it can be used with SAS? 23 A. Yes. 24 Q. When did the last patient Page 103 1 complete that study? 2 A. I don't know. 3 Q. Were there any preliminary 4 findings in that study? 5 A. No, it hadn't been analyzed 6 yet. 7 Q. Who is going to do the 8 statistical analysis on that study? 9 A. I don't know. 10 Q. Who is the research physician 11 at Lilly who is responsible for that study? 12 A. I think Doctor Blonglen is. 13 Q. Has she always been responsible 14 for that study? 15 A. No. 16 Q. Who was responsible prior to 17 her? 18 A. I believe Doctor Beasley. 19 Q. To your knowledge, did anybody 20 on that study commit suicide? 21 A. I don't know. 22 Q. Were there any serious adverse 23 events that occurred during that study? 24 A. I don't know. There was no Page 104 1 drug involved, so there wouldn't have been 2 adverse events attributable to any drug, per se. 3 Q. Do you know what the inclusion 4 criteria were for that study? 5 A. No. 6 Q. Do you know whether or not 7 patients on that study were allowed to either 8 begin antidepressant therapy or continue 9 antidepressant therapy that they were on? 10 A. No, I don't know the answer to 11 that. 12 Q. Who would know the answer to 13 that? 14 A. The physician responsible for 15 that. 16 Q. Okay. What responsibilities 17 did Dan Russell have with regards to Doctor 18 Miller's study? 19 A. He was the CRA that initially 20 drafted the protocol. 21 Q. Any other responsibilities that 22 he had on that study? 23 A. No. 24 Q. How about Catherine Mesner, Page 105 1 what were her responsibilities? 2 A. She followed up from Dan, and 3 working with Doctor Beasley on finalizing the 4 protocol and the clinical report forms for that 5 study. 6 Q. Any other responsibilities she 7 had with regards to the study? 8 A. I'm not sure I know what you're 9 after. 10 Q. Just whether or not she did 11 anything, did she do collection of data on the 12 CRFs, things of that nature? 13 A. She reviewed the data, yes, 14 when it came in. 15 Q. Do you know how long Catherine 16 worked on the study? 17 A. No, I don't. 18 Q. Did she have responsibility for 19 reporting any adverse events that may have 20 occurred on the study? 21 A. The clinical scientist would 22 have had that responsibility. 23 Q. But I mean did she do anything 24 as far as -- like earlier you testified that when Page 106 1 you were a CRA you would review adverse event 2 information and if it was serious report it to 3 the clinical research physician. 4 A. Right. 5 Q. Did she have similar 6 responsibilities with regards to Doctor Miller's 7 study? 8 A. Yes, she would have. But the 9 events -- there was no drug involved. So I'm not 10 sure I understand your line of questions. 11 Q. So if there was no drug 12 involved, it's your testimony that it's your 13 understanding that there would be no adverse 14 events reported? 15 A. No, I don't know that. 16 Q. Did Catherine at that time 17 answer to you or did she report directly to you? 18 A. Yes. 19 Q. If I told you that Catherine 20 Mesner testified in her deposition that she 21 filled out adverse event forms on nearly every 22 single person in the study while she worked on it 23 as a CRA, would that surprise you? 24 MR. MYERS: Let me object to the form, Page 107 1 I just don't know that you characterized that 2 testimony correctly, and I don't want to waive 3 the objection you may have, but I object to the 4 form. If you know or you can answer, go ahead. 5 A. Not surprised, no. 6 Q. How about Ellie Shotz, what 7 were her responsibilities with regards to the 8 Miller study? 9 A. She followed Catherine as the 10 CRA responsible for that study. 11 Q. So her responsibilities would 12 have been similar to Catherine's as far as 13 reviewing information, things of that nature? 14 A. That's right. 15 Q. Do you know if there were any 16 protocols on that study? 17 A. No, I don't know. 18 Q. What was the purpose of that 19 study, I believe you said to characterize 20 patients who had suicide ideation or suicidal 21 ideation? 22 A. Yes. 23 Q. Previous suicidal ideation? 24 A. Yes. Page 108 1 Q. Do you know whether or not 2 those people were suicidal when they were 3 enrolled into the study? 4 A. No, I don't know. 5 Q. Have you heard the phrase 6 rechallenge protocol? 7 A. Yes. 8 Q. What is a rechallenge? 9 A. It would be the sign of a 10 patient who had ideated and then treat them again 11 to see if it would occur again. 12 Q. When you say ideated, you mean 13 suffered suicidal ideation? 14 A. Yes. 15 Q. So to make sure that my 16 understanding is correct, you have a patient who 17 is on Fluoxetine, for example, and they become 18 suicidal, and you take them off Fluoxetine and 19 the suicidality goes away; correct, I mean up to 20 this point? 21 A. That, I don't know. 22 Q. But I mean if that were the 23 case, you would then put them back on Fluoxetine 24 to see if they became suicidal again? Page 109 1 A. Yes. 2 Q. What would that be an 3 indication of? 4 MR. MYERS: Let me object to the form, 5 that's a medical question. 6 Q. If you know. 7 MR. MYERS: I object to the form, but 8 if you know, tell her. 9 A. I don't know. 10 Q. To your knowledge, has a 11 rechallenge study on Fluoxetine and suicidality 12 ever been performed by Eli Lilly? 13 A. No. 14 Q. To your knowledge has a 15 rechallenge study ever been considered by Lilly 16 with regards to Fluoxetine and suicidality? 17 A. Yes. 18 Q. To your knowledge does Lilly at 19 this time plan on conducting a rechallenge study 20 on Fluoxetine and suicidality? 21 A. I don't know. 22 MS. ZETTLER: Let's take a lunch break. 23 (A LUNCH BREAK WAS TAKEN.) 24 Q. Ms. Zapapas, before we took our Page 110 1 break, we started talking a little bit about the 2 rechallenge study. Do you remember that? 3 A. Yes. 4 Q. And I believe you testified to 5 your knowledge at this time there's no 6 rechallenge study on Fluoxetine and suicidality 7 being performed by Lilly; correct? 8 A. Yes, that's correct. 9 Q. To your knowledge is there a 10 rechallenge study being performed on Fluoxetine 11 and suicidality by anybody outside of Lilly? 12 A. I don't know the answer to 13 that. 14 Q. For instance the National 15 Institute of Health is not doing a study as far 16 as you know? 17 A. I don't know. 18 Q. How about the National 19 Institute of Mental Health? 20 A. I don't know that. 21 Q. To your knowledge are there any -- 22 is there anybody outside of Lilly that's been 23 contracted by Lilly to perform a rechallenge 24 study at this time? Page 111 1 A. Not to my knowledge, no. 2 Q. I also believe you testified 3 that at some point in time Lilly had considered 4 performing a rechallenge trial on Fluoxetine and 5 suicidality? 6 A. Yes. 7 Q. When did you first become aware 8 that Lilly was considering performing a 9 rechallenge study on Fluoxetine and suicidality? 10 A. Somewhere in the Summer of '91. 11 Q. Was that when Lilly first 12 started considering doing a rechallenge study? 13 A. As far as I know. 14 Q. To your knowledge did the FDA 15 or any other regulatory agency request that Lilly 16 perform a rechallenge study? 17 A. I don't know. 18 Q. Just to be expeditious, can we 19 agree that when I say rechallenge study it will 20 be a rechallenge of Fluoxetine and suicidality? 21 A. Yes, that's fine. 22 Q. How did you first become aware 23 that Lilly was considering performing a 24 rechallenge study? Page 112 1 A. Through staff discussions with 2 physicians that worked on Fluoxetine, as well as 3 Dan Masica. 4 Q. When you say staff discussions, 5 do you mean meetings? 6 A. Yes. 7 Q. What did Doctor Masica tell you 8 about rechallenge? 9 A. I don't recall anything 10 specific, just that it was an option that was 11 under consideration. 12 Q. Were you to play a role in 13 considering whether a rechallenge study should be 14 performed? 15 A. No. 16 Q. When was the first meeting in 17 which rechallenge was discussed that you recall? 18 A. I don't know. 19 Q. How many meetings did you 20 attend where rechallenge was discussed? 21 A. I don't know. We had weekly 22 staff meetings, and it may or may not have come 23 up during any one of those discussions. 24 Q. Do you recall a meeting that Page 113 1 was held specifically for the purpose of 2 discussing rechallenge? 3 A. No. 4 Q. Who would generally attend the 5 staff meetings, the weekly staff meetings? 6 A. The physicians who had 7 responsibility at the time, the medical director, 8 myself, representatives from the other support 9 groups such as systems and stats, medical 10 writing. 11 Q. Marketing? 12 A. On occasion. 13 Q. When you say the physicians who 14 had responsibility at the time, what do you mean? 15 A. Well, there were several 16 physicians who had Fluoxetine responsibility in 17 one way or another. 18 Q. Can you give me some of their 19 names? 20 A. Doctor Heiligenstein, Doctor 21 Beasley, Doctor Thompson. 22 Q. Leigh Thompson or Robert? 23 A. Robert. 24 Q. Okay. Anybody else? Page 114 1 A. Doctor Goldstein, Doctor 2 Wheadon. 3 Q. Doctor Street? 4 A. Not while I was involved, no. 5 Q. How about Leigh Thompson, did 6 he ever attend any of the weekly staff meetings? 7 A. I don't recall any specific 8 meetings that he did attend, I mean those staff 9 meetings. 10 Q. Do you recall attending a 11 meeting where Doctor Thompson was present? 12 MR. MYERS: Any meeting? 13 MS. ZETTLER: Any meeting. 14 A. Yes. 15 Q. What meetings were those? 16 A. Medical awareness programs. 17 Q. Any others? 18 A. He would on occasion come into 19 the administrative staff, which would have been 20 like Greg Brickler's staff, for any given reason. 21 Q. Do you recall ever discussing 22 rechallenge with Doctor Thompson directly? 23 A. No, I never did. 24 Q. Besides Doctor Masica, who else Page 115 1 did you discuss rechallenge with personally? 2 A. Doctor Beasley would have been 3 the primary individual, as well as Doctor 4 Tollefson and Doctor Zerbe. 5 Q. Would Doctor Zerbe attend any 6 of these weekly staff meetings? 7 A. Yes. 8 Q. How about Doctor Tollefson? 9 A. Yes, once he was in that 10 position. 11 Q. What position? 12 A. Well, he replaced Doctor 13 Masica. 14 Q. How about a representative from 15 regulatory, would they be at one of these 16 meetings? 17 A. Yes. 18 Q. Who would that be generally? 19 A. Doctor Talbott or Doctor Weber. 20 Q. Allen Webber? 21 A. Yes. 22 Q. Did you ever work with a Hans 23 Weber? 24 A. No, I haven't personally. Page 116 1 Q. Do you know who Doctor Hans 2 Weber is? 3 A. Yes. 4 Q. Who is Doctor Hans Weber? 5 A. I believe he's currently the 6 medical director in Germany. 7 Q. Do you recall a time when 8 Doctor Weber was working here in the United 9 States? 10 A. Yes. 11 Q. Was he at Indianapolis? 12 A. Yes. 13 Q. What did he do in Indianapolis? 14 A. He was medical director in one 15 of the divisions. 16 Q. Do you know which division? 17 A. No, I don't know. 18 Q. Did he have responsibilities 19 with regards to Fluoxetine while he was here in 20 the United States? 21 A. I don't know that. 22 Q. How long was Doctor Weber here? 23 A. Hans? 24 Q. Yes. Page 117 1 A. I don't know the answer to that 2 either. 3 Q. Have you ever heard of Claude 4 Bouchy? 5 A. No. 6 Q. I may have asked you this, and 7 if I did, I apologize, but when was Hans Weber 8 here? 9 A. I don't remember. 10 Q. Was he here while you were in 11 your current position, not necessarily working 12 with Fluoxetine, but as department head? 13 A. I believe he was, but I'm not 14 certain of that because I never interacted with 15 him for the compounds that I had responsibility 16 for. 17 Q. What did Doctor Beasley tell 18 you about rechallenge? 19 A. To my knowledge it was an 20 option that we were going to consider to look at 21 the potential issue of suicidality. 22 Q. Anything else? 23 A. No. 24 Q. Did anybody discuss the down Page 118 1 sides of conducting such a study? 2 A. Yes. 3 Q. What were some of the down 4 sides that were discussed? 5 A. Part of the discussion was 6 around the -- because of the incidence or the 7 possible incidence of this, the numbers of 8 patients to be included would be extremely large. 9 The other major consideration was ethical 10 consideration of rechallenging these patients. 11 Q. When you say because of the 12 possible incidence, you mean the the possible 13 incidence of suicidality? 14 A. Yes. 15 Q. And how many patients were 16 considered to be necessary for this study to be 17 evaluated? 18 A. I don't recall seeing a number. 19 Q. Do you recall any numbers being 20 talked about in the context of the number of 21 patients having to be large because of the 22 incidence? 23 A. No, I don't. 24 Q. And the ethical considerations Page 119 1 that you spoke about, are you referring to the 2 ethical considerations of possibly causing 3 somebody to become suicidal? 4 A. I don't know if it's that as 5 much as if a patient has already been suicidal, 6 why would you put them on a treatment which may 7 cause it again. 8 Q. So it was thought that it was 9 possible that somebody who had become suicidal on 10 Fluoxetine may become suicidal on Fluoxetine 11 again if placed back on the drug? 12 A. No, I don't think that was the 13 thought. It's a scientific question that they 14 were looking at and they weren't sure of the risk 15 involved, and based on the analysis that had 16 already been done on our data base, did it 17 warrant that. 18 Q. The analysis that was done on 19 the data base that you're talking about, is that 20 the retrospective study of the clinical trials 21 that was done in preparation for Doctor Beasley's 22 meta-analysis article? 23 A. It was the analysis of the 24 controlled studies done under the IND. Page 120 1 Q. Both in the United States and 2 outside the United States? 3 A. Yes. 4 Q. It's my understanding that 5 according to Lilly that analysis showed that 6 there was actually a decreased rate of 7 suicidality in people that took Fluoxetine, did 8 it not? 9 A. I think that's correct, as 10 compared to a placebo. 11 Q. Then what was the risk involved 12 in placing people back on Fluoxetine who were 13 suffering from depression? 14 A. I don't know, I think that's a 15 medical judgment, and I don't have that 16 information. 17 Q. Is it your understanding that a 18 decision was made not to conduct a rechallenge 19 study? 20 A. No, I don't think a decision 21 was made. 22 Q. Is that still under 23 consideration? 24 A. I don't know. Page 121 1 Q. When was the last time you 2 heard anything about rechallenge? 3 A. Within the last year. 4 Q. What was the last thing that 5 you heard about rechallenge? 6 A. That it was still under 7 consideration and whether or not it still should 8 be considered. 9 Q. Just so I understand, are you 10 saying that there was still discussion as to 11 whether or not it should be considered? 12 A. Yes, that's right. 13 Q. What was the prevailing 14 sentiment in that discussion, that it should or 15 should not be considered? 16 A. I don't think there was any one 17 way or another feeling, I think it was an option 18 that was looked at. 19 Q. Who told you that Lilly was 20 still considering performing the rechallenge? 21 A. I asked the question of Doctor 22 Beasley. 23 Q. Why did you ask the question? 24 A. Because I'm the individual Page 122 1 responsible for business planning and trying to 2 look at resources needed, projecting what staff 3 we would need on the paramedical side, and trying 4 to include that or not into the business plan. 5 Q. What did Doctor Beasley tell 6 you at that time? 7 A. He said it was still an option. 8 Q. If they did in fact decide to 9 go forward with the rechallenge, you would be 10 involved in staffing the rechallenge basically? 11 A. Yes, that's right. 12 Q. During the period of time when 13 a rechallenge was first being considered, what 14 was your role? 15 A. It was in the planning aspect, 16 resource planning. 17 Q. How far did they get with the 18 plans for the rechallenge? 19 A. We had drafted a protocol and 20 had it reviewed by outside consultants. 21 Q. Had clinical investigators been 22 recruited for the study? 23 A. No, they had not. 24 Q. Was Jan Fawcett one of the Page 123 1 outside consultants that was asked to review the 2 protocol? 3 A. I don't remember if she was. 4 Q. Do you remember how many 5 outside consultants were involved? 6 A. There were approximately ten to 7 twelve, I believe. 8 MS. ZETTLER: Before I forget, did we 9 find out whether or not the investigator in -- 10 MR. MYERS: It wasn't a pivotal 11 investigator. 12 MS. ZETTLER: So you're going to 13 instruct her not to give -- instruct her not to 14 give me the name of the investigator in 15 Pennsylvania who was working on the long-term MMD 16 study? 17 MR. MYERS: Right, for the same reasons 18 we voiced in previous depositions which, you 19 know, we talked about a number of times. 20 Q. Ms. Zapapas, do you recall the 21 question that I asked you as to who was the 22 investigator on the Pennsylvania site on the 23 long-term Prozac study that we talked about 24 earlier? Page 124 1 A. Yes. 2 Q. Are you going to follow your 3 counsel's instruction and not give me the answer 4 to the question? 5 A. I'm going to follow counsel. 6 MS. ZETTLER: Certify it, Kathy. 7 (QUESTION CERTIFIED.) 8 Q. These ten to twelve outside 9 consultants related to the rechallenge study, 10 were these all psychiatrists? 11 A. I don't know. 12 Q. Were reports written by the 13 outside consultants with regards to the 14 rechallenge study? 15 A. I don't know. 16 Q. Who would know that? 17 A. I presume Doctor Beasley. 18 Q. To your knowledge was there 19 ever a meeting where all of the outside 20 consultants were brought together to discuss 21 rechallenge? 22 A. Yes. 23 Q. Where was that meeting held? 24 A. In Indianapolis. Page 125 1 Q. Was there more than one or just 2 one? 3 A. Just one, as far as I know. 4 Q. When was that meeting held? 5 A. I don't recall the date. 6 Q. Do you remember what year? 7 A. No, I don't. 8 Q. To your knowledge was a 9 protocol for the rechallenge study ever submitted 10 to the FDA for approval? 11 A. No, not to my knowledge, 12 because it was never finalized. 13 (PLAINTIFFS' EXHIBIT NO. 1 WAS 14 MARKED FOR IDENTIFICATION AND 15 RECEIVED IN EVIDENCE.) 16 Q. Have you had a chance to review 17 Exhibit 1? 18 A. Yes. 19 Q. Does this refresh your 20 recollection as to whether or not a protocol was 21 submitted to the FDA for approval regarding 22 rechallenge? 23 A. Well, it does not refresh my 24 memory, I never saw this. Page 126 1 Q. Okay. It appears at least from 2 the cover page of the exhibit that this was, this 3 protocol or draft of the protocol, was submitted 4 to the FDA; correct? 5 A. It does appear that way, yes. 6 Q. Have you ever seen any part of 7 this exhibit? 8 A. I've seen the draft protocol. 9 Q. How about this first portion of 10 this submission after the transmittal form that 11 says Approach To Study Of Potential Association 12 Of Suicidality To Antidepressant Therapy, have 13 you seen that before? 14 A. I don't recall it, no. 15 Q. On the front page of Doctor 16 Zerbe's letter to the FDA, it says that this 17 draft protocol is still being refined by Lilly 18 and will be reviewed by expert consultants 19 outside of Lilly. Do you see that? 20 A. Yes. 21 Q. Does that refresh your 22 recollection as to when the consultant meeting 23 was held? 24 A. I presume it was after this Page 127 1 date, but that's only a presumption. 2 Q. This exhibit appears to be a 3 letter from Doctor Zerbe to the FDA with the 4 submission of a draft rechallenge protocol 5 attached; correct? 6 A. Yes. 7 Q. And it's dated March 29, 1991; 8 correct? 9 A. Yes. 10 (PLAINTIFFS' EXHIBIT NO. 2 WAS 11 MARKED FOR IDENTIFICATION AND 12 RECEIVED IN EVIDENCE.) 13 Q. Have you had a chance to review 14 Exhibit 2? 15 A. Yes. 16 Q. Exhibit 2 purports to be the 17 first portion of the actual submission that's 18 reflected in Exhibit 1 entitled Approach To Study 19 Of Potential Association Of Suicidality To 20 Antidepressant Therapy; correct? 21 A. Yes. 22 MR. MYERS: Let me object to the form 23 because they do appear to be strikingly similar, 24 but there is a different date on the two. Page 128 1 MS. ZETTLER: I was going to get to 2 that. 3 MR. MYERS: So I object to the form 4 because they're not the same. 5 MS. ZETTLER: Okay. 6 MR. MYERS: They're strikingly similar. 7 Q. Attached to the narrative, for 8 lack of a better phrase, that's represented in 9 Exhibit 2 is a cover page; correct? 10 A. Yes. 11 Q. And that's dated March 15th, 12 1991? 13 A. Yes. 14 Q. And your name is listed as a 15 recipient on that, is it not? 16 A. Yes, it is. 17 Q. Does this refresh your 18 recollection as to whether or not you had seen 19 this narrative before? 20 A. No, it doesn't. I receive lots 21 of interoffice mail. 22 Q. When you say lots of 23 interoffice mail, what do you mean? 24 A. Significant quantities of Page 129 1 electronic and paper. 2 Q. What do you do with the paper 3 that you receive? 4 A. I review it and distribute it 5 to the appropriate CRA who is working on the 6 study if it pertains to a study. 7 Q. What if it doesn't pertain to a 8 study, what do you do with it? 9 A. It depends on what it is. 10 Q. Do you keep personal files? 11 A. Yes. 12 Q. A document such as Exhibit 2, 13 what would you have done with this document? 14 A. I would have given it to the 15 CRA responsible. 16 Q. And depending on who was 17 working on it at that time, could have been Dan 18 Russell -- 19 A. Or Catherine. 20 Q. Catherine? 21 A. (Witness moves head up and 22 down.). 23 Q. How about Ellie Shotz? 24 A. I don't -- no, she had not come Page 130 1 into the area at that time. 2 Q. Have you been asked 3 periodically to turn over Fluoxetine down to the 4 legal department at Lilly? 5 A. Yes. 6 Q. When did that first start 7 happening? 8 A. It happened prior to my joining 9 the Fluoxetine cluster. 10 Q. And you joined the Fluoxetine 11 cluster in? 12 A. December of '90. 13 Q. Do you remember how long it was 14 prior to that that it started? 15 A. No, I don't. 16 Q. How many times approximately 17 have you turned documents over to Lilly legal 18 regarding Fluoxetine? 19 A. On a quarterly basis, since 20 requested. I believe that's the frequency that 21 we're asked. 22 Q. When a request comes in that 23 you turn over the Fluoxetine documents, what do 24 you do to comply with that request? Page 131 1 A. There's a clerk in the area who 2 I ask her to review the files for items that 3 hadn't been copied previously. 4 Q. What's the largest amount of 5 documents that you've turned over to Lilly legal 6 on any given quarter related to Fluoxetine? 7 MR. MYERS: When you say she, she 8 herself or files? 9 MS. ZETTLER: Her files. 10 A. A box. 11 Q. Okay. Have you turned over 12 more than one box? 13 A. Yes. 14 Q. About how many boxes total 15 would you say you've turned over? 16 A. A couple, two or three. 17 Q. Were you ever told specifically 18 not to turn over any given Fluoxetine document to 19 the legal department? 20 A. No. 21 Q. Do you maintain any documents 22 on computer disks, floppy disks? 23 A. Yes. 24 Q. What types of documents do you Page 132 1 maintain on floppy disks? 2 A. Performance appraisals, notes 3 to file on employees, personnel related notes, 4 presentations that I may have prepared. 5 Q. Do you keep any of the E-mails 6 that you talked about receiving? 7 A. Yes. 8 Q. All of the E-mails? 9 A. Yes, since we were asked. 10 Q. Since you were asked to 11 maintain E-mails on floppies? 12 A. No. 13 MR. MYERS: I was going to ask you, you 14 kind of shifted gears. You asked her did you 15 keep E-mails, and I didn't know whether you asked 16 her did you keep them in hard copy or did you 17 keep them on floppy. That was not clear to me. 18 Q. Do you keep E-mails on floppy 19 disks? 20 A. No. 21 Q. When you say keep E-mails, what 22 do you mean? 23 A. On a hard copy. 24 Q. Who asked to you start keeping Page 133 1 copies of the E-mail? 2 A. The legal department. 3 Q. When did they ask you to do 4 that? 5 A. I don't recall. 6 Q. Was it prior to starting the 7 Fluoxetine cluster? 8 A. No, I think it was after. 9 Q. Was this a request that was 10 made of everyone? 11 A. Yes. 12 Q. Prior to printing out a hard 13 copy of the E-mails and keeping it, were they 14 stored in any manner, the E-mails? 15 A. I don't, no. 16 Q. Do you know if anybody stored 17 E-mails or did prior to keeping hard copies? 18 A. I don't know. 19 Q. Approximately how long have you 20 been printing out and keeping hard copies of the 21 E-mails? 22 A. About a year, year and a half, 23 something like that. 24 Q. Did you have a specific file Page 134 1 just for E-mails? 2 A. Yes. 3 Q. How large is that file? 4 A. It's emptied quarterly. 5 Q. Are you given copies back of 6 the documents you turn over to legal? 7 A. I'm sorry? 8 Q. When you turn over documents to 9 legal, do they give you copies of those documents 10 back? 11 A. Not on the mail messages, I do 12 not get copies back. 13 Q. Approximately how many E-mails 14 are in a given submission that you make to the 15 legal department? 16 A. That's going to vary, from ten 17 to fifty. 18 Q. If you could look at Exhibit 2, 19 please. Are you familiar with the three 20 approaches that are outlined in Exhibit 2? 21 A. I recall these as discussions. 22 Q. And they are three possible 23 approaches in an epidemiology study; correct? 24 A. That's one of them, yes. Page 135 1 Q. A large prospective 2 double-blind parallel comparison study? 3 A. Yes. 4 Q. And a rechallenge study; 5 correct? 6 A. Yes. 7 Q. To your knowledge has Lilly 8 performed a large prospective double-blind 9 parallel comparison study on Fluoxetine related 10 specifically to the issue of suicidality? 11 A. No, not to my knowledge, we 12 have not. 13 Q. How about an epidemiology 14 study? 15 A. No, we have not, to my 16 knowledge. 17 Q. Is Lilly still considering 18 performing either one of those studies? 19 A. I haven't heard those under 20 discussion recently, no. 21 Q. Is it your understanding that 22 Lilly has ruled out performing either one of 23 those studies? 24 A. No, I don't know the answer to Page 136 1 that. 2 (PLAINTIFFS' EXHIBIT NO. 3 WAS 3 MARKED FOR IDENTIFICATION AND 4 RECEIVED IN EVIDENCE.) 5 Q. Have you had a chance to review 6 Exhibit 3? 7 A. Yes. 8 Q. The first page of Exhibit 3 is 9 similar to the first page of Exhibit 2; correct, 10 except that there's some handwriting in the upper 11 right-hand corner of Exhibit 3? 12 A. Yes, that's correct. 13 Q. Is that your handwriting in the 14 upper right-hand corner? 15 A. There are two different 16 handwritings here, one of them is mine. 17 Q. Which one is yours? 18 A. Bob, CC Mike H, please, thanks, 19 CZ. 20 Q. Do you recognize the other 21 handwriting in the upper right-hand corner? 22 A. Yes, I do. 23 Q. Whose handwriting is that? 24 A. Mike Harrill's. Page 137 1 Q. How do you recognize that as 2 Mister Harrill's handwriting? 3 A. I recognize it. 4 Q. You've seen his handwriting on 5 a number of occasions? 6 A. Yes. 7 Q. The first four pages of Exhibit 8 3, other than the handwriting, is identical to 9 Exhibit 2; correct? 10 A. Correct, it looks as though it 11 is. 12 Q. And then attached to the first 13 four pages of Exhibit 3 is an outline, a 14 five-page outline, entitled antidepressant 15 randomized rechallenge study protocol outline; 16 correct? 17 A. Correct. 18 Q. Are you familiar with this 19 outline? 20 A. I have seen it, yes. 21 Q. Do you know who drafted this 22 outline? 23 A. No, I don't. 24 Q. The second page of the outline, Page 138 1 which is marked on the bottom right-hand corner 2 as Pz 1275 1943, do you see that? 3 A. Yes. 4 Q. It looks like a copy of post-it 5 note on some sort of a piece of note paper that's 6 put on a blank sheet of white paper; correct? 7 A. I don't know where it had been, 8 it looks like a post-it note. 9 Q. And on there is a note that 10 states how long had patients been on Prozac when 11 they presented with the suicidal ideation; 12 correct? 13 A. Yes. 14 Q. Is that Mister Harrill's 15 handwriting also? 16 A. It looks like it. 17 Q. Do you remember that question 18 being an issue with regards to the rechallenge 19 study? 20 A. No, I don't. 21 Q. Have you seen this note before? 22 A. I don't recall seeing this, no. 23 Q. Have you ever spoken with 24 Doctor Teicher? Page 139 1 A. No, I have not. 2 Q. Have you ever spoken with 3 Jonathan Cole? 4 A. No, I have not. 5 Q. To your knowledge has anybody 6 from Lilly spoken to Doctor Teicher? 7 A. I do not know. 8 Q. Did you attend any meetings 9 with the FDA? 10 A. Yes. 11 Q. Related to Fluoxetine? 12 A. Yes. 13 Q. Which meetings did you attend? 14 A. The advisory committee meeting 15 on September 21st, '91. 16 Q. On September 21st, '91? 17 A. I think that's the date. 18 Q. How many days was that meeting? 19 A. One day. 20 Q. Did you play a role in that 21 meeting? 22 A. Not in the meeting itself. 23 Q. Did you play a role in 24 preparation for that meeting? Page 140 1 A. Yes. 2 Q. What was your role? 3 A. It was coordinating the 4 resources of different people working in the 5 different cross-functional areas to ensure that 6 progress was being made on the different 7 questions and the presentation itself, the 8 outline, flow of information. 9 Q. Who had primary responsibility 10 for preparing for the advisory committee meeting? 11 A. Doctor Tollefson. 12 Q. Who assigned that job to Doctor 13 Tollefson, if you know? 14 A. I don't know. 15 Q. Was Doctor Tollefson working 16 for Lilly at the time? 17 A. At which time? 18 Q. When he was assigned the job to 19 prepare for the advisory committee meeting. 20 A. Yes, he was. 21 Q. Is it your understanding that 22 Doctor Tollefson was formerly a clinical 23 investigator for Lilly before being hired on as a 24 Lilly employee? Page 141 1 A. Yes. 2 Q. When was Doctor Tollefson hired 3 by Lilly? 4 A. I believe it was around May of 5 '91. 6 Q. Was Doctor Tollefson hired 7 specifically to work on preparation for the 8 advisory committee meeting? 9 A. I don't know that. 10 Q. What was his title at that 11 time? 12 A. Executive director 13 psychopharmacology division. 14 Q. Was Doctor Tollefson, to your 15 knowledge, a psychiatrist? 16 A. Yes. 17 Q. Are you familiar with any of 18 the members of the drug advisory committee 19 meeting that sat on September 20th or 21st, 1991? 20 A. I recall them by name, but I 21 don't believe I've ever met any of them. 22 Q. Have you ever worked with 23 Doctor David Dunner as a clinical investigator? 24 A. I personally have not, no. Page 142 1 Q. Is it your understanding that 2 Doctor Dunner has performed clinical trials on 3 Fluoxetine for Lilly? 4 A. Yes. 5 Q. How about Doctor Claghorn? 6 A. I don't know that name. 7 Q. Anybody else on the advisory 8 committee that had previously performed clinical 9 trials for Lilly on Fluoxetine? 10 A. I believe that they stated -- 11 each of the members stated that information up 12 front at the beginning of the meeting, and I do 13 think there was more than one, but I don't recall 14 which ones. 15 Q. What were the results of the 16 advisory committee meeting? 17 A. I believe it was a unanimous 18 vote that Fluoxetine did not cause suicidal acts 19 or ideations. 20 Q. Is it your understanding that 21 the advisory committee meeting was called 22 specifically to review Fluoxetine and 23 suicidality? 24 A. No, I don't think that was the Page 143 1 case? 2 Q. Why was it called? 3 A. It was called to review it with 4 antidepressants. 5 Q. Was a causality judgment made 6 with regards to the use of any other 7 antidepressant other than Fluoxetine and 8 suicidality? 9 A. I don't remember that. 10 Q. But you specifically recall the 11 advisory committee meeting concluding that there 12 was no increased use of suicidality with 13 Fluoxetine? 14 A. Yes, that's correct. 15 Q. Was that published in written 16 form? 17 A. Yes. 18 Q. Where is that published? 19 A. In the minutes of the meeting, 20 transcripts. 21 Q. Have you seen the transcripts? 22 A. Yes. 23 Q. How many volumes is it? 24 A. I believe it's only one. Page 144 1 Q. Have you ever personally spoken 2 to anybody at the FDA with regards to Fluoxetine? 3 A. No, I have not. 4 Q. Besides the advisory committee 5 meeting, have you attended any meetings with the 6 FDA regarding Fluoxetine? 7 A. The recent advisory committee 8 meeting on OCD. 9 Q. When was that held? 10 A. July of this year. 11 Q. What was the result of that 12 committee meeting? 13 A. The committee recommended 14 approval of Fluoxetine for the treatment of 15 obsessive compulsive disorders. 16 Q. Do you remember the names of 17 some of the people on that committee? 18 A. No. 19 Q. Are they any of the same people 20 that sat on the September '91 drug advisory 21 committee meeting on antidepressant use and 22 suicidality? 23 A. I don't recall, I would have to 24 look at the member sheets. Page 145 1 Q. Is Doctor Dunner on the 2 committee? 3 A. I don't know if he was for the 4 OCD meeting or not, I don't recall that. 5 (PLAINTIFFS' EXHIBIT NO. 4 WAS 6 MARKED FOR IDENTIFICATION AND 7 RECEIVED IN EVIDENCE.) 8 Q. Okay. Have you had a chance to 9 review Exhibit 4? 10 A. Yes. 11 Q. Do you recognize this exhibit? 12 A. Not immediately, I didn't, no. 13 Q. It purports to be a memorandum 14 dated May 15, 1991 written by Doctor Kotsanos; 15 correct? 16 A. Yes. 17 Q. And the title of the memo is 18 FDA Meeting To Discuss Fluoxetine Rechallenge 19 Protocol, comma, May 13, 1991; correct? 20 A. Yes. 21 Q. Did you attend this meeting? 22 A. No, I did not. 23 Q. Are you familiar with the 24 subject matter of the memo? Page 146 1 A. Yes, as it relates to the 2 rechallenge study or other potential studies. 3 Q. Does this refresh your 4 recollection as to whether or not the FDA wanted 5 Lilly to perform the rechallenge study? 6 A. I don't know that this states 7 that they wanted us to do the rechallenge. 8 Q. The first line of the 9 memorandum under the title, it says, "At the FDA 10 meeting, Lilly agreed to do the following 11 projects:", correct? 12 A. Yes. 13 Q. So at least at this point in 14 time when this meeting was held in May of 1991, 15 this memo indicates that Lilly had committed to 16 at least starting the project; correct? 17 A. We agreed to initiate data 18 about the alternative, yes. 19 Q. Under the first bullet point -- 20 or actually the first section, section number 21 one, Proceed With The Rechallenge Study. Have 22 you seen that? 23 A. Yes. 24 Q. The third bullet point says, Page 147 1 "We agreed to have the rechallenge protocol ready 2 to go by September 1, 1991 and to provide data 3 after the first quarter which would provide 4 information on six months of experience."; 5 correct? 6 A. Yes. 7 Q. It indicates that they expected 8 to start the rechallenge protocol sometime after 9 September of 1991, does it not? 10 A. It looks like that was the 11 original intent. 12 Q. To your knowledge, did Lilly 13 ever communicate to the FDA that they had not 14 made up their mind as to whether or not they were 15 going to do the rechallenge? 16 A. I don't know the answer to 17 that. 18 Q. The next section says, 19 "Incorporate the modified scale for suicidal 20 ideation - revised" -- "in ongoing and planned US 21 and UK clinical trials."; correct? 22 A. Yes. 23 Q. To your knowledge has that been 24 done? Page 148 1 A. I don't know if it has. I do 2 believe we included it in the study, but I'm not 3 sure which one. 4 Q. In a depression study? 5 A. Yes. 6 Q. Do you recall if that study was 7 performed here or in the UK? 8 A. I believe it was in the U.S. 9 Q. It's not Doctor Miller's study 10 that you're thinking of, is it? 11 A. No. 12 Q. Do you know if it was a 13 comparitor study? 14 A. I don't know. I don't recall 15 which study it was, so I couldn't say. 16 Q. Is there some way you could 17 find out what study it was, is that possible? 18 A. Yes. 19 Q. How would you go about doing 20 that, finding out which study it was? 21 A. I would ask somebody in systems 22 to search for that questionnaire, and review it 23 that way. 24 Q. When you say the questionnaire, Page 149 1 you mean the MSSI-R? 2 A. Yes. 3 Q. Approximately how many 4 depression studies are ongoing on Fluoxetine in 5 the United States right now? 6 A. About a half dozen. 7 Q. Can you tell me what the 8 objectives of those studies are? 9 A. You said depression, not just 10 Fluoxetine, is that right? 11 Q. Right. 12 A. There's about three or four in 13 depression. 14 Q. Okay. 15 A. One of them is in atypical 16 depression, another is in cancer patients with 17 depression, and there are two in cardiovascular 18 patients with depression. 19 MR. MYERS: I'm not objecting, but 20 didn't you say that this morning? 21 THE WITNESS: I did. 22 MR. MYERS: I remember the thing about 23 cancer. 24 Q. So two cardiovascular and one Page 150 1 cancer, and what, atypical depression? 2 A. Correct. 3 Q. Is the MSSI-R being used in any 4 of these four studies? 5 A. I don't know. 6 Q. Could you find out which study 7 the MSSI-R is being used and then let Larry know 8 so he can pass that information on to me? 9 A. Yes. 10 MR. MYERS: Assuming it is. She said 11 she thought it was. 12 MS. ZETTLER: Assuming it is. Let's 13 take a quick break. 14 (A SHORT RECESS WAS TAKEN.) 15 Q. If you could go back to Exhibit 16 4, the second page, third point. Under the 17 second bullet, under number three, being titled 18 Use Of The MSSI-R, it says, "The FDA also 19 suggested testing the questionnaire in 20 hospitalized patients with depression". Do you 21 see that section? 22 A. Yes. 23 Q. Do you know if that was ever 24 done, the MSSI-R was tested in hospitalized Page 151 1 patients? 2 A. Well, that could be what Doctor 3 Miller was doing. 4 Q. And you stated earlier that you 5 don't know what the results of Doctor Miller's 6 clinical trial are yet, right? 7 A. That's correct. 8 Q. Do you know if there were plans 9 to publish the results of Doctor Miller's study? 10 A. No, I don't know if there are 11 or not. 12 Q. Is that a determination that is 13 going to be made after the statistical analysis? 14 A. I don't know. 15 Q. Who would know that? 16 A. I don't know. 17 Q. Under number four, it says 18 descriptive study of patients reported to develop 19 intensive violent suicidal thoughts; correct? 20 A. Yes. 21 Q. Do you know if such a study has 22 been done by Lilly? 23 A. I don't know for sure because I 24 don't fully understand that particular point. Page 152 1 Q. That makes two of us. Have you 2 ever heard of the study assessment of patients 3 with psychobehavioral deterioration? 4 A. No, I do not recall that. 5 Q. Are you familiar with study 6 number B1Y-MC-S001? 7 A. I recall the code being used. 8 Q. Do you know if that study was 9 performed, S001? 10 A. I don't believe it was. 11 Q. Are you familiar with the term 12 surveillance study? 13 A. Yes. 14 Q. What is a surveillance study? 15 A. To my knowledge that's more of 16 the epidemiologic study that they had posed. 17 (PLAINTIFFS' EXHIBIT NO. 5 WAS 18 MARKED FOR IDENTIFICATION AND 19 RECEIVED IN EVIDENCE.) 20 Q. Have you had a chance to review 21 Exhibit 5? 22 A. Yes. 23 Q. Exhibit 5 purports to be a 24 draft of a protocol for a study B1Y-MC-S001, Page 153 1 entitled assessment of patients with 2 psychobehavioral deterioration; correct? 3 A. Yes. 4 Q. Does it refresh your 5 recollection as to, first of all, what this study 6 was or is? 7 A. I recall us having S001 and 8 S002 as two different protocols, but the design 9 of this looks similar to the one that Doctor 10 Miller conducted just as a cursory review. 11 Q. You mean upon your cursory 12 review of the protocol? 13 A. Of this, yes. 14 (PLAINTIFFS' EXHIBIT NO. 6 WAS 15 MARKED FOR IDENTIFICATION AND 16 RECEIVED IN EVIDENCE.) 17 Q. Have you had a chance to review 18 Exhibit 6? 19 A. Yes. 20 Q. Exhibit 6 purports to be a 21 draft of -- at least it looks -- well, it doesn't 22 say draft on it, I take that back. It purports 23 to be a protocol for B1Y-MC-S002, entitled 24 Suicide Ideation Scale Validation In Depressed Page 154 1 Patients; is that correct? 2 A. Yes, that's correct. 3 Q. After having reviewed Exhibit 5 4 and Exhibit 6, are you able to tell which one of 5 these protocols is related to Doctor Miller's 6 study? 7 A. I believe it's S002. 8 Q. And that is the suicide 9 ideation scale validation; correct? 10 A. Correct. 11 Q. S001, to your recollection, has 12 not been conducted? 13 A. That's correct. 14 Q. Do you know if there are plans 15 to conduct S001? 16 A. It was under consideration. 17 Q. When was that, when did you 18 last hear discussion about performing S001? 19 A. I don't recall exactly, I don't 20 know. 21 Q. Is it still under consideration 22 as far as you know? 23 A. Not as far as I know, no. 24 Q. Has a decision been made not to Page 155 1 perform the study? 2 A. I don't know that. 3 Q. If a decision was made to 4 perform S001, would you be involved as far as 5 staffing the study? 6 A. Yes, I would be. 7 Q. Does the USMO have an 8 administrative arm such as the medical division? 9 A. Not specifically. We have 10 individuals who are working on trials conducted 11 in the U.S. that when we do business planning are 12 delineated between global versus USMO. 13 Q. If USMO was going to conduct 14 either the rechallenge study or S001, would your 15 staff still be involved? 16 A. Yes. 17 Q. So you would still know whether 18 or not this was being conducted? 19 A. Yes, that's right. 20 (PLAINTIFFS' EXHIBIT NO. 7 WAS 21 MARKED FOR IDENTIFICATION AND 22 RECEIVED IN EVIDENCE.) 23 Q. Have you had a chance to review 24 Exhibit 7? Page 156 1 A. Yes. 2 Q. Exhibit 7 purports to be a 3 draft of the rechallenge protocol with the first 4 page being handwritten notes; correct? 5 A. Yes. 6 Q. And various notes written 7 throughout the protocol; correct? 8 A. Yes. 9 Q. Do you recognize the 10 handwriting on the first page? 11 A. Possibly, yes. 12 Q. Whose handwriting does it look 13 like to you? 14 A. It looks like Doctor Beasley's. 15 Q. Are you familiar with Doctor 16 Beasley's handwriting? 17 A. Yes. 18 Q. Have you seen it on a number of 19 occasions? 20 A. Yes. 21 Q. Are you familiar with this 22 exhibit? 23 A. I'm familiar with the draft 24 protocol, not necessarily with Doctor Beasley's Page 157 1 notes, if that's whose they are. 2 Q. Going back to Exhibit No. 4. 3 After reviewing Exhibit Number 5, the protocol 4 for study S001, does Exhibit No. 5 purport to be 5 or seem to be to you a protocol for the study 6 mentioned on the second page of Exhibit 4 under 7 the fourth section? 8 MR. MYERS: Does this appear to be that 9 kind of study? 10 MS. ZETTLER: Yes. 11 A. I don't know. 12 Q. At the bottom of the second 13 page of Exhibit 4, under the last paragraph 14 starting with the FDA mentioned three more items. 15 A. Uh-huh. 16 Q. At the very bottom it says they 17 wanted as much information from us as soon as 18 possible as they were anticipating writing a 19 response to the HRG petition. Do you see that? 20 A. Yes. 21 Q. Do you know what the HRG is? 22 A. I believe it was a petition 23 related to the Church of Scientology that they 24 had put through. Page 158 1 Q. They put through to the FDA? 2 A. Yes. 3 MR. MYERS: They do that sometimes, you 4 know. 5 MS. ZETTLER: The Church of 6 Scientology? 7 MR. MYERS: Send a petition in now and 8 then. 9 MS. ZETTLER: You would know more about 10 that than me, Larry, you have had more dealings 11 with those people, they like you. 12 (DISCUSSION OFF THE RECORD.) 13 Q. Ms. Zapapas, to your knowledge 14 is Lilly performing any clinical trials related 15 to depression as a disease other than just the 16 treatment of depression? 17 A. Could you restate that, please? 18 Q. Sure. What I'm trying to find 19 out is, we know that there are about four 20 Fluoxetine depression clinical trials that are 21 being conducted right now. 22 A. Right. 23 Q. And that Doctor Miller's 24 validation study has just been completed or is in Page 159 1 the process of being analyzed; correct? 2 A. Correct. 3 Q. Are there any other studies 4 that are being conducted by Lilly related to 5 suicidality at this time? 6 A. Not that I'm aware of. 7 Q. How about violent aggressive 8 behavior? 9 A. Not to my knowledge, no. 10 Q. How about aggression or 11 agitation? 12 A. No, not to my knowledge, not 13 that are ongoing. 14 Q. How about suicide studies that 15 have been completed other than Doctor Miller's? 16 A. No, not to my knowledge. 17 Q. How about agitation? 18 A. Yes. 19 Q. What study has been done on 20 agitation? 21 A. A two-center study in depressed 22 patients with agitation -- or agitated depressed 23 patients, I'm not sure how it's worded. 24 Q. Okay. Page 160 1 MR. MYERS: So the record is clear, 2 you're talking patients who have -- that are 3 being treated, depressed patients with agitation 4 as opposed to agitation as some sort of event. 5 We got into this before. 6 MS. ZETTLER: That's what I was going 7 to ask her next. 8 MR. MYERS: I'm sorry. 9 Q. When you say a study has been 10 conducted on agitated depressed people, are you 11 talking about a study that is -- where the 12 objective is to test Fluoxetine efficacy in 13 treating that type of patient or are you talking 14 about a study to measure agitation or increased 15 agitation as an adverse event? 16 A. It was a study to look at 17 patients with agitation initially, not as an 18 outcome of treatment. 19 Q. Was that a comparitor study? 20 A. Yes. 21 Q. Was there another active drug 22 besides Fluoxetine involved in that as a 23 comparitor? 24 A. I believe there is, yes. Page 161 1 Q. Do you remember what that 2 comparitor was? 3 A. I believe it was Imipramine. 4 Q. Has that study been published? 5 A. Not to my knowledge. 6 Q. Has the statistical analysis 7 been done on that study? 8 A. Yes. 9 Q. When was the statistical 10 analysis done? 11 A. Sometime between last Summer 12 and this Summer, the Summer of '92 and '93. 13 Q. Is a manuscript being prepared 14 for publication on that study? 15 A. I believe it is. 16 Q. Who is the Lilly physician on 17 that study? 18 A. Doctor Heiligenstein. 19 Q. Was the emergence of agitation 20 measured on that study at all? 21 A. I don't know. 22 Q. Was the suicidality rating 23 scale used on that study, the MSSI-R? 24 A. I don't believe so because it Page 162 1 was initiated prior to the development of that 2 scale. 3 Q. Was the study initiated prior 4 to your becoming Fluoxetine cluster department 5 head? 6 A. Yes. 7 Q. Do you know how many patients 8 were enrolled in that study? 9 A. About a hundred and twenty. 10 Q. Was that an inpatient or 11 outpatient study? 12 A. I believe it was outpatient. 13 Q. Where were the two sites 14 located? 15 A. In Wisconsin and Minnesota. 16 Q. Do you know the names of the 17 investigators on that study? 18 A. Yes. 19 Q. Who were the investigators on 20 the study? 21 MR. MYERS: Ask her anything you want 22 about the study, but don't ask her that because 23 she's not going to answer that for the same 24 reason. Page 163 1 MS. ZETTLER: Do you know that they're 2 not pivotal, Larry? 3 MR. OLTMANS: I don't believe so, but 4 we'll have to check. 5 MR. MYERS: I'll check. If they're 6 pivotal, we'll tell you. 7 THE WITNESS: I don't think they were 8 pivotal. 9 MR. MYERS: We'll check, just like the 10 other one. 11 Q. Men or woman, or both? 12 A. The primary were men. There 13 may have been female subs, I don't know. 14 Q. Had either of these gentlemen 15 worked as clinical investigators for Lilly in the 16 past? 17 A. I don't know. 18 Q. Are you going to follow your 19 attorney's instructions and not give the names of 20 those investigators? 21 A. Yes, I am going to follow his 22 instruction. 23 MS. ZETTLER: Certify it. 24 (QUESTION CERTIFIED.) Page 164 1 Q. Anybody commit suicide on that 2 study? 3 A. I don't know. 4 Q. Anybody attempt suicide on that 5 study? 6 A. I don't know. 7 Q. Who was the clinical research 8 administrator on that study? 9 A. There have been two different 10 ones. 11 Q. Who were they? 12 A. Initially Becky McHenry, and 13 subsequently Linda Burgland. 14 Q. B-U-R-G -- 15 A. B-U-R-G-L-A-N-D. 16 Q. Was Doctor Heiligenstein going 17 to be the main author on that study or on that 18 manuscript? 19 A. I don't know. 20 Q. To your knowledge are there any 21 studies being contemplated by Lilly at this time 22 related in any way to suicidality? 23 MR. MYERS: Other than the ones you've 24 been talking about? Page 165 1 MS. ZETTLER: Right. 2 A. Not to my knowledge. 3 Q. To your knowledge, at this 4 time, are there any studies that are contemplated 5 by Lilly related to violent aggressive behavior? 6 A. No, not to my knowledge. 7 Q. Any further studies on 8 agitation that are being contemplated by Lilly? 9 A. No. 10 Q. What is your understanding of 11 what Lilly's relationship to the National 12 Institute of Mental Health is? 13 A. I don't know that there is a 14 formal relationship. 15 Q. Is it your understanding that 16 Lilly has given an IMH educational grant from 17 time to time? 18 A. I don't know that. 19 Q. How about National Institute of 20 Health, what is your understanding of Lilly's 21 relationship with the National Institute of 22 Health? 23 A. I don't know of relationships 24 involved with either of those. Page 166 1 Q. Earlier you said you weren't 2 aware of a formal relationship between Lilly and 3 the National Institute of Mental Health. Are you 4 aware of an informal relationship between Lilly 5 and that institution? 6 A. I'm aware of different 7 collaborations that go on, just cursory, you 8 know, more of basic research. 9 Q. What type of collaborations? 10 A. I don't know specific. 11 Q. Are you aware of the D/ART 12 program, D slash ART program? 13 A. No. 14 Q. Are you aware of the National 15 Institute of Mental Health Depression Awareness 16 Program? 17 A. I am, yes. 18 Q. What is your knowledge of that 19 program, your understanding of that program? 20 A. It's my understanding that was 21 a program to raise awareness to the public of 22 depression. 23 Q. And who sponsored that program? 24 A. I don't know. Page 167 1 Q. Are you aware of any depression 2 awareness programs that are sponsored by Lilly? 3 A. Yes. 4 Q. What programs? 5 A. It's a depression awareness. I 6 don't know that it's a formal program, but 7 activities in general for depression awareness. 8 Q. Have you ever heard of National 9 Depression Screening Day? 10 A. Yes. 11 Q. What is that? 12 A. Well, I believe it's a day 13 highlighted for individuals to contact area 14 mental health professionals for depression. 15 Q. What is your understanding of 16 Lilly's involvement in that program? 17 A. I don't have any knowledge of 18 that. 19 Q. Do you know whether or not they 20 are involved? 21 A. No, I don't. 22 Q. What is your understanding of 23 the relationship between Lilly and the FDA? 24 A. Could you be more specific? Page 168 1 Q. Well, I mean what's the FDA's 2 function, in your opinion? 3 A. They're the government body 4 that regulates the approval and sale of 5 pharmaceutical agents, medical devices and such. 6 Q. Have you heard of Paul Weaver? 7 A. Yes. 8 Q. Who is Paul Weaver? 9 A. He's an employee of the FDA. 10 Q. Do you know what Doctor Leigh 11 Thompson's relationship, if any, to Doctor Paul 12 Weaver is? 13 A. No, I don't know. I know 14 they're acquainted, but that's it. 15 Q. Has Doctor Thompson ever worked 16 at the FDA to your knowledge? 17 A. I don't know. 18 Q. Has he ever worked at a 19 government regulatory agency, any government 20 regulatory agency? 21 A. I don't know. 22 Q. Have you heard of the Rocky 23 Mountain Poison Control Center Overdose Study? 24 A. Yes. Page 169 1 Q. Could you tell me what that is? 2 A. It's a -- I believe an 3 independent IND study. 4 Q. What is an IND study? 5 A. It's a study conducted under 6 IND, but not ours. 7 Q. You mean an IND study or IND 8 for another drug? 9 A. An IND, it could be for the 10 same drug. 11 Q. Okay, wait. Are you saying 12 and, A-N-D or A-N. 13 A. No, an, A-N. 14 Q. So there could be more than one 15 IND for Fluoxetine? 16 A. Yes. 17 Q. When you say more than one IND, 18 you mean for another indication? I'm confused on 19 what you mean by how the Rocky Mountain Poison 20 Control Center could be an IND study, but still 21 be a Fluoxetine study. 22 A. The regulations allow for an 23 investigator or a site to file for an IND to 24 conduct a study. So it's a regulatory or Page 170 1 regulated decision as to whether an independent 2 IND could be granted. 3 Q. Why is such a study done on an 4 independent IND as opposed to being done through 5 Lilly? 6 A. I said it could be an 7 independent IND, I'm not sure. 8 Q. But if it was, what kind of 9 situation would that happen? 10 A. It would allow the 11 investigators to act as a sponsor of the study 12 and not Lilly. 13 Q. Okay. So Lilly would not be 14 funding the study then? 15 A. That's not what I said. 16 MR. MYERS: Let me object to the form. 17 You're hung up on a word. Some of the 18 terminology is regulatory, and I think you're 19 hung up on the word sponsor. That's a regulatory 20 term. 21 Q. Define sponsor for me. 22 A. The body, group of individuals 23 who are responsible for reporting -- collection 24 and reporting of data. Page 171 1 Q. So you mean sponsor as it 2 relates to the drug itself as opposed to somebody 3 who is sponsoring a particular study? 4 A. Yes. 5 Q. So in that situation, then, 6 Rocky Mountain Poison Control Center would not be 7 considered the sponsor, Lilly would still be 8 considered the sponsor? 9 MR. MYERS: I object to the form. When 10 you say that situation, you mean one of these 11 independent INDs? 12 MS. ZETTLER: Right. 13 Q. All I want to know is in what 14 situation would Rocky Mountain Poison Control 15 Center seek to have an independent IND study 16 where Lilly -- instead of going through Lilly's 17 IND and Prozac, in other words instead of Lilly 18 submitting it as an IND study? 19 A. Well, one option could be that 20 they could get it done quicker that way. 21 Q. Who is they? 22 A. Whoever is the body that wants 23 to conduct the study, be it an individual 24 investigator or an institution. Page 172 1 Q. If Lilly were funding Rocky 2 Mountain Poison Control Center's study, could 3 Rocky Mountain Poison Control Center still apply 4 for an individual IND? 5 MR. MYERS: Independent. 6 A. Yes. 7 Q. Okay. Other than getting the 8 study done faster, what other reasons would a 9 control center apply for its own independent IND? 10 A. I don't know specifically, but 11 it could be somewhat of ownership of the data, 12 and in most situations, I don't think we are, 13 quote, the owners of the data, the individuals 14 are, so they would be at liberty to publish in 15 that way. 16 Q. When you say most situations, 17 do you mean in most situations with an 18 independent IND or in most situations, period? 19 A. No, with an independent IND. 20 Q. Any other independent IND 21 studies that you're aware of -- assuming that the 22 Rocky Mountain study is an independent IND study, 23 are you aware of any other independent IND 24 studies that have been or are currently being Page 173 1 performed related to suicidality? 2 A. No, not to my knowledge. 3 Q. How about overdose? 4 A. No, that's the only one I'm 5 aware of. 6 Q. How about violent aggressive 7 behavior? 8 A. I don't think so. 9 Q. How about agitation? 10 A. No. 11 Q. Do you have independent NDA 12 studies? 13 A. No. 14 Q. Why not? 15 A. I don't think the regulations 16 allow for that, I've never heard of them. 17 (PLAINTIFFS' EXHIBIT NO. 8 WAS 18 MARKED FOR IDENTIFICATION AND 19 RECEIVED IN EVIDENCE.) 20 Q. Have you had a chance to review 21 Exhibit 8? 22 A. Yes. 23 Q. Do you recognize this exhibit? 24 A. Part of it. Page 174 1 Q. Which part do you recognize? 2 A. The first two pages. 3 Q. Are you familiar with this 4 study? 5 A. Yes. 6 Q. What is this study? 7 A. This is the Rocky Mountain 8 Overdose Study. 9 Q. The first two pages of the 10 exhibit are a memo from John Heiligenstein to 11 you, Gary Tollefson, Gary Tauscher and a handful 12 of other people; correct? 13 A. Right. 14 Q. It's dated March 18, 1993; 15 correct? 16 A. Yes. 17 Q. Was there another study that 18 was done with the Rocky Mountain Poison Control 19 Center? 20 A. Not to my knowledge, there 21 wasn't. 22 (PLAINTIFFS' EXHIBIT NO. 9 WAS 23 MARKED FOR IDENTIFICATION AND 24 RECEIVED IN EVIDENCE.) Page 175 1 Q. Have you had a chance to review 2 Exhibit 9? 3 A. Yes. 4 Q. What is Exhibit 9? 5 A. It looks to be the quarterly 6 reporting of the overdoses from this study, from 7 the Rocky Mountain study. 8 Q. Is a manuscript being written 9 on the Rocky Mountain study at this time? 10 A. There are plans, I don't know 11 if it's been in draft form yet or not. 12 Q. Has all the data been collected 13 from the study? 14 A. Not by us. 15 Q. Is anybody from Lilly going to 16 be an author on that manuscript? 17 A. I don't know. 18 Q. The people referred to in 19 Exhibit 8, and I understand that they're blacked 20 out, but can you tell from that exhibit if those 21 are personnel from the Rocky Mountain Poison 22 Control Center? 23 A. It looks that way. 24 Q. Statistical analyses that are Page 176 1 going to be performed on this data, are they 2 going to be done at Lilly? 3 A. Not to my knowledge, no. 4 Q. Do you know where they're going 5 to be done? 6 A. No, I don't. 7 Q. Are you involved at all in this 8 study? 9 A. Not me personally, no. 10 Q. Anybody on your staff involved? 11 A. Yes. 12 Q. Who is involved in this study 13 from your staff? 14 A. Linda Burgland. 15 Q. What is her role? 16 A. She's a CRA. 17 Q. But specifically what is her 18 role with regards to this study? 19 A. The monitoring of the quarterly 20 follow-up. 21 Q. What do you mean by quarterly 22 follow-up? 23 A. They have been asked to submit 24 to us on a quarterly basis, this information Page 177 1 that's shown. 2 Q. What information? 3 A. In Exhibit 9. 4 Q. Okay. The line listings, 5 overdoses? 6 A. Yes. 7 Q. What does she have to do with 8 that information? 9 A. I take that back, I don't think 10 it's Linda, sorry. 11 Q. That's okay. 12 A. It is Paula Robison. 13 Q. Paula Robison? 14 A. Robison. 15 Q. R-O-B-I-S-O-N? 16 A. Yes. 17 Q. She's a CRA? 18 A. Yes. 19 Q. Do you know if there's a target 20 date for publication of the manuscript resulting 21 from the Rocky Mountain Poison Control Center 22 study? 23 A. Not to my knowledge, no. 24 (PLAINTIFFS' EXHIBIT NO. 10 WAS Page 178 1 MARKED FOR IDENTIFICATION AND 2 RECEIVED IN EVIDENCE.) 3 Q. Have you had a chance to review 4 Exhibit 10? 5 A. Yes. 6 Q. Do you recognize it? 7 A. Yes. 8 Q. Tell me what it is. 9 A. It's a projection of resource 10 requirements. 11 Q. For which studies? 12 A. For the S001 and S002. 13 Q. Are you sure it's S001 and 14 S002? 15 A. No. It's a rechallenge study, 16 and looks like S001. 17 Q. Okay. Is this your 18 handwriting? 19 A. Yes. 20 Q. In Exhibit 10 is a page of 21 handwritten notes; correct? 22 A. Yes, it is. 23 Q. And that's your signature at 24 the bottom, at least with the first initial of Page 179 1 your last name? 2 A. Yes. 3 Q. Who is Bob? 4 A. I believe it was Bob Zerbe. 5 Q. And then there are two columns, 6 one says assumption? 7 A. Yes. 8 Q. And under that it says 9 behavioral deterioration? 10 A. Yes. 11 Q. And on the right-hand side it 12 says alternative treatment, paren, rechallenge, 13 close paren? 14 A. Yes. 15 Q. What is an assumption? 16 A. It was the two different 17 studies, and then from there, based on the 18 columns, what the projected resources would be. 19 Q. For each study? 20 A. Yes. 21 Q. And then on the left-hand 22 margin we have, looks like, data, CT, start-up 23 resources, and ongoing monitoring, et cetera? 24 A. Correct. Page 180 1 Q. So under the column for 2 behavioral deterioration, under data, you say no 3 data in-house; correct? 4 A. Correct. 5 Q. Report from investigators or 6 investigation? 7 A. Correct. 8 MR. MYERS: What is investigation or 9 investigator? 10 A. It looks like investigators. 11 Q. What do you mean by that report 12 from investigators, data in-house? 13 A. If there were no drug involved, 14 it's possible that we could just receive a 15 manuscript at the end of the study and not 16 receive the raw data. 17 Q. Were either the rechallenge or 18 the S001 independent IND studies? 19 A. They were never classified as 20 any type. 21 Q. Okay. So it never got that 22 far? 23 A. That's correct. 24 Q. How about Exhibit 1, though, at Page 181 1 least at that time, it looked like there was a 2 preliminary submission of the rechallenge 3 protocol to the FDA; correct? 4 A. Yes, to the FDA. 5 Q. Would that indicate if that was 6 going to be a Lilly study or an independent IND 7 study? 8 A. This doesn't show that it would 9 be independent or under ours, I don't believe. 10 It was submitted to our IND, but that doesn't 11 mean it would necessarily be done under our IND. 12 Q. All right. Continuing on 13 Exhibit 10, under CT on the behavioral 14 deterioration study, you have none; correct? 15 A. Yes. 16 Q. Is that also because a study 17 drug was not contemplated being used? 18 A. Yes, that's correct. 19 Q. Under start-up resources, you 20 have one FTE; correct? 21 A. Yes. 22 Q. What's an FTE? 23 A. Full-time equivalent. 24 Q. Would that be a CRA? Page 182 1 A. It could be several individuals 2 working part-time, hence one full-time 3 equivalent, not necessarily one person full-time. 4 Q. And then under final you have -- 5 I can't tell if it's point six or six FTE, can 6 you tell from that? 7 A. No, I can't tell either. 8 Q. So it could be as many as six 9 full-time equivalents? 10 A. It could be, but it would be 11 unlikely. 12 Q. So it's more likely it would be 13 point six? 14 A. More likely, yes. 15 Q. Under the alternative treatment 16 rechallenge column, that says under data, CRFs 17 in-house? 18 A. Correct. 19 Q. What do you mean by CRFs 20 in-house? 21 A. CRFs would be submitted to 22 Lilly. 23 Q. Like a normal clinical trial 24 that would be transferred from the investigation Page 183 1 site to Lilly for data processing analysis? 2 A. It would be a trial done under 3 our IND where we would collect data, yes. 4 Q. Under CT, you have double-blind 5 placebo and Desipramine? 6 A. Yes. 7 Q. Do you know if the drug 8 Desipramine was ever ordered for that rechallenge 9 study? 10 A. No, I don't know. 11 Q. If a drug is ordered such as 12 Desipramine, do you go directly to that drug's 13 manufacturer to order the drug? 14 A. Sometimes, yes. 15 Q. If you don't go directly to the 16 manufacturer, where would you go? 17 A. I personally don't go anywhere 18 to get it, but we would buy it on the outside 19 market as another option. 20 Q. If you're going to buy it on 21 the outside market, where would you go to buy it? 22 A. I have no idea. 23 Q. If you ordered the drug 24 directly from -- and when I say you, I mean Page 184 1 generally. 2 A. Okay. 3 Q. If a drug is ordered from the 4 drug's manufacturer, are you obligated to tell 5 that manufacturer what you're going to use the 6 drug for? 7 A. Yes. 8 Q. Do they have the right then to 9 decline selling you the drug? 10 A. Yes. 11 Q. To your knowledge has Lilly 12 ever done that with Fluoxetine? 13 A. Done what? 14 Q. Declined selling the drug to 15 another manufacturer, to somebody else, who 16 wanted to perform a study on Fluoxetine? 17 A. Not to my knowledge, no. 18 Q. Have you ever heard of that 19 happening with any Lilly drugs, without being 20 specific as to the drug? 21 A. Not to my knowledge. 22 Q. To your knowledge has any other 23 antidepressant manufacturer refused to sell 24 Lilly's drug to use as a comparitor in one of Page 185 1 Lilly's Fluoxetine trials? 2 A. No, not to my knowledge. 3 Q. In what situation would you go 4 to the open market or the outside market as 5 opposed to directly to the manufacturer to obtain 6 the study drug? 7 A. If we weren't going to blind 8 the trial. 9 Q. I'm sorry, if you were not 10 going to? 11 A. If we were not going to blind 12 the trial for some reason, there would not be a 13 need to go to the manufacturer. The primary 14 reason to go to the manufacturer is to get 15 blinded material, meaning their drug and a 16 similar looking placebo. 17 Q. Okay. So say you've got 18 Amytryptiline, you wouldn't want Amytryptiline 19 written on the pill to use as a blinded drug? 20 A. Right. 21 Q. And then under start-up, under 22 the rechallenge column, you have two full-time 23 equivalents? 24 A. Right. Page 186 1 Q. What is the difference between 2 the rechallenge and the behavioral deterioration 3 study that would call for two full-time 4 equivalents for the rechallenge? 5 A. Based on us not having the data 6 come in-house on the behavioral deterioration, we 7 would not be the ones to design case report forms 8 or design a data entry system. 9 Q. Does this exhibit, Exhibit No. 10 10, refresh your recollection as to whether or 11 not either of these two studies was rejected, so 12 to speak, by Lilly? 13 A. No. 14 Q. Does it refresh your 15 recollection as to whether either one of these 16 studies were undertaken and then stopped? 17 A. I have already stated that the 18 rechallenge was never started, and I'm not aware 19 of the behavioral deterioration ever starting 20 either. 21 Q. Okay. Under ongoing monitoring 22 and the rechallenge, it says point five full-time 23 equivalents? 24 A. Correct. Page 187 1 Q. Is that again because there is 2 going to be CRFs coming into Lilly? 3 A. Yes. 4 Q. And under behavioral 5 deterioration it has zero under ongoing 6 monitoring because none of the data was going to 7 be coming in for routine analysis or routine 8 validation by Lilly? 9 A. Correct. 10 Q. And the same goes for the two 11 full-time equivalents listed under rechallenge 12 for final? 13 A. That's predominantly for the 14 analysis, systems and staff effort that would be 15 required if we were doing the analysis in-house, 16 the data would be in-house, and the management of 17 that data. 18 Q. Why is it that you thought that 19 you would be getting the behavioral deterioration 20 study reports from the investigators as opposed 21 to doing reports in-house at Lilly? 22 A. It was an option to consider if 23 we didn't have to collect the data in-house, why 24 would we, and just receive a manuscript at the Page 188 1 end. 2 Q. Why did you list point six 3 full-time equivalents under the behavioral 4 deterioration column for the final? 5 A. If we were going to review it, 6 if the investigator would ask us for comments, it 7 would take effort in that regard as well as us 8 receiving then a final copy, we would presumably 9 submit it to the FDA. 10 Q. Okay. When you're determining 11 what the full-time equivalent need would be for 12 any of these various things, are you taking into 13 consideration the participation of a Lilly 14 physician? 15 A. Yes, I am. 16 Q. Let me clarify a couple of 17 things with you. The study that you may be 18 using, the MSSI-R, the study that you think might 19 have used it or may be using it, is that an 20 ongoing study or is that a study that has been 21 completed? 22 A. I don't know since I'm not sure 23 which study it is. 24 MR. MYERS: Before you go on, she had -- Page 189 1 at the break she told me something about this 2 Exhibit 7 which has a handwritten note on the 3 front, and then there was a couple of pages of 4 handwritten notes, Pz 2445 229. She's unclear, 5 and I'll let her tell you, but she is unclear 6 that that is Doctor Beasley's handwriting. A 7 good deal of the other, I think she testified 8 was, but that appeared different. 9 Q. So with regards to Exhibit 7, 10 you're not sure if the handwriting on Pz 2445 229 11 is Doctor Beasley's handwriting? 12 A. Correct. 13 Q. Does that handwriting look 14 familiar to you as anybody else's handwriting in 15 particular? 16 A. Not that I know of, no. 17 Q. But the rest of the handwriting 18 on the exhibit appears to you to be Doctor 19 Beasley's handwriting? 20 A. Yes. 21 Q. Fair enough. Have you ever 22 heard of subsyndromal syndrome? 23 A. Yes. 24 Q. Why are you smiling? Page 190 1 A. It's just now getting 2 initiated. 3 Q. What is subsyndromal syndrome? 4 A. As I understand it, a state of 5 depression that does not meet the DSMIII criteria 6 for major depressive disorder, so it has less 7 than the five symptoms required. So it will have 8 either one to four or two to four of the 9 symptoms. 10 Q. Is this a recognized medical 11 condition or psychiatric condition as far as you 12 know? 13 A. I don't believe it is yet. I 14 think it's going to be included in the DSMIV 15 edition. 16 Q. And is there a clinical trial 17 currently being conducted on subsyndromal 18 syndrome on Fluoxetine? 19 A. It's just now getting initiated 20 this month. 21 Q. Has there been a start-up 22 meeting on it? 23 A. No, not yet. 24 Q. Is that a double-blind Page 191 1 comparitor study? 2 A. Yes, it is. 3 Q. I'm sorry, I didn't mean to 4 interrupt you. 5 A. That's all right. 6 Q. What's the comparitor on that 7 study or comparitors? 8 A. I don't know if there is an 9 active comparitor, placebo is in there. 10 Q. Is this an inpatient or 11 outpatient study? 12 A. I believe it's outpatient. 13 Q. Is it a multi-site study? 14 A. Yes. 15 Q. How many sites involved? 16 A. Three. 17 Q. Where are the sites located? 18 A. Pennsylvania, Texas and 19 California. 20 Q. Doctor Fabre going to be the 21 investigator on that study? 22 A. No. 23 Q. When you say Pennsylvania, is 24 the investigator on the study the same as the Page 192 1 investigator on the study that we were talking 2 about earlier? 3 A. No. 4 Q. The long-term depression study? 5 A. No, it's not. 6 Q. Is Doctor Feighner the 7 investigator on this study? 8 A. No. 9 Q. I'm going to have to do it 10 again. Who are the investigators on this study? 11 MR. MYERS: She's not going to tell you 12 that for the same reasons. 13 Q. Are you aware if any of these 14 investigators were pivotal trial investigators on 15 Fluoxetine? 16 A. I don't know that. 17 Q. Are you going to follow your 18 counsel's advice and not answer the question 19 regarding who the investigators on the 20 subsyndromal syndrome study were? 21 MR. MYERS: I hope so at this late 22 hour. 23 A. Yes, I am. 24 MS. ZETTLER: Certify it. Page 193 1 (QUESTION CERTIFIED.) 2 Q. Who is the CRA on that study? 3 A. Linda Burgland. 4 Q. Any other CRAs? 5 A. No. 6 Q. Who is the Lilly physician on 7 that study? 8 A. There are two as of right now. 9 Q. Who are they? 10 A. Doctor Pande and Doctor 11 Blonglen. 12 Q. Is Doctor Pande in the USMO? 13 A. No. 14 Q. He is in medical? 15 A. Yes. 16 Q. It's a he, right? 17 A. Yes, it is. 18 Q. Is the subsyndromal syndrome 19 study in any way related to suicidal ideation as 20 a specific objective of the study? 21 A. Not to my knowledge, it is not. 22 Q. How about violent aggressive 23 behavior? 24 A. No, I don't believe so. Page 194 1 Q. Agitation? 2 A. No. 3 Q. Is it an efficacy study? 4 A. Yes, it is. 5 Q. How long is it calculated that 6 the study will last? 7 A. Enrollment is expected to last 8 for eighteen months, eighteen to twenty-four 9 months. 10 Q. Are you familiar with the 11 phrase pilot study? 12 A. Yes. 13 Q. What is a pilot study? 14 A. It's usually a smaller scale 15 study to test some aspect of design or 16 measurement or something of that nature. 17 Q. Are you aware of any pilot 18 studies that have been done using Fluoxetine? 19 A. Yes. 20 Q. What pilot studies do you have 21 knowledge of? 22 A. That was the Urn study. 23 Q. Any others besides the Urn 24 study? Page 195 1 A. Not to my knowledge. 2 Q. Are you familiar with a Doctor 3 Hardison, H-A-R-D-I-S-O-N? 4 A. No. 5 Q. I believe you testified earlier 6 that you had some responsibilities with regards 7 to preparing for the drug advisory committee 8 meeting on Fluoxetine in September of 1991; 9 correct? 10 A. Yes. 11 Q. Are you familiar with who the 12 consultants on suicidal ideation that were used 13 in preparation for that meeting were used by 14 Lilly? 15 A. Yes. 16 Q. Can you give me some of those 17 names? 18 A. Jan Fawcett was one. 19 Q. Any others? 20 A. I believe Charlie Nemeroff was 21 the second one, N-E-M-E-R-O-F-F, I think. 22 Q. Any others? 23 A. I think those are the -- well, 24 those are the two that went with us to the Page 196 1 advisory committee meeting. 2 Q. Anybody that you used as 3 consultants that did not go to the advisory 4 committee meeting? 5 A. Yes. I don't recall their 6 names. 7 Q. How many were there? 8 A. Less than five. 9 Q. Were they all here from the 10 U.S.? 11 A. I don't know that. 12 Q. How about violent aggressive 13 behaviors, did you use any outside consultants in 14 preparation for the advisory committee meeting 15 related to violent aggressive behavior? 16 A. I don't know. 17 Q. Have you heard of the 18 Saskatchewan Database - Deliberate Self-harm 19 Morbidity And Mortality? 20 A. No. 21 (PLAINTIFFS' EXHIBIT NO. 11 WAS 22 MARKED FOR IDENTIFICATION AND 23 RECEIVED IN EVIDENCE.) 24 Q. Have you had a chance to review Page 197 1 Exhibit 11? 2 A. Yes, I have. 3 Q. Does this refresh your 4 recollection as to what the Saskatchewan Data 5 Base is? 6 A. No. 7 Q. Do you have any idea why this 8 would have been produced as being in your file? 9 A. No, I do not. 10 Q. Are you aware at this time of a 11 study being done on deliberate self harm 12 morbidity and mortality subsequent to 13 antidepressant pharmacotherapy such as the one 14 described in Exhibit 11 being conducted either by 15 Lilly or on behalf of Lilly? 16 A. I'm not aware of this, no. 17 Q. Do you know who Stephen Bandak 18 is? 19 A. Yes. 20 Q. Who is Stephen Bandak? 21 A. He's the medical director for 22 Canada. 23 Q. Could you turn to the fifth 24 page of the exhibit, which is Pz 2335 1470? Page 198 1 A. Uh-huh. 2 Q. Do you see that? 3 A. Yes. 4 Q. Do you recognize the 5 handwriting on this page? 6 A. No, I don't. 7 Q. Do you recognize the 8 handwriting on any portion of this exhibit? 9 A. No, I do not. 10 (PLAINTIFFS' EXHIBIT NO. 12 WAS 11 MARKED FOR IDENTIFICATION AND 12 RECEIVED IN EVIDENCE.) 13 Q. Have you had a chance to review 14 Exhibit 12? 15 A. Yes. 16 Q. Exhibit 12 is three pages of 17 handwritten notes on, looks like, a form called 18 Communication Record; correct? 19 A. Yes. 20 Q. Do you recognize this exhibit? 21 A. Yes. 22 Q. What is it? 23 A. It is handwritten notes from 24 Mike Harrill. Page 199 1 Q. Okay. Have you seen this 2 before? 3 A. I don't recall it. 4 Q. But you recognize the 5 handwriting as Mike Harrill's? 6 A. Yes. 7 Q. Do you recognize any of the 8 subjects addressed in the exhibit? 9 A. Only as it was discussion about 10 the different options, it looks like, for 11 studying suicide. 12 Q. Related to the options that 13 were discussed in Exhibit 3 and in Exhibit 2 -- 14 the notes that are reflected in Exhibit 12, are 15 those related in some way to the subject matter, 16 not necessarily the document, but the subject 17 matter talked about in Exhibits 2 and 3, the 18 epidemiology study, the prospective study and 19 rechallenge study? 20 A. I think it's more general 21 subject matter than specific to the three 22 studies. 23 (PLAINTIFFS' EXHIBIT NO. 13 WAS 24 MARKED FOR IDENTIFICATION AND Page 200 1 RECEIVED IN EVIDENCE.) 2 Q. Have you had a chance to review 3 Exhibit 13? 4 A. Yes. 5 Q. It purports to be six pages of 6 handwritten notes; correct? 7 A. Yes. 8 Q. Do you recognize this exhibit? 9 A. No. 10 Q. Do you recognize the 11 handwriting on this exhibit? 12 A. Yes. 13 Q. Whose handwriting is this? 14 A. It looks to be like Doctor 15 Tollefson's. 16 Q. Are you familiar with Doctor 17 Tollefson's handwriting? 18 A. Yes. 19 Q. Have you seen it on a number of 20 occasions? 21 A. Oh, yes. 22 Q. Up at the top of the first page 23 it says CRPC image. Do you know what CRPC means? 24 A. Yes. Page 201 1 Q. What is CRPC? 2 A. Clinical research plans 3 committee. 4 Q. And the next group of notes it 5 says Judd meeting. Do you know what that means? 6 A. Not in particular, no. 7 Q. How about Paracetamol, it looks 8 like, listed about three inches down the page. 9 Do you know what that is? 10 A. No, I don't. 11 Q. How about Tranxiom? 12 A. I do not know that. 13 Q. Do you know why this document 14 would have been produced as part of your file? 15 A. No, I don't. 16 Q. Did Doctor Tollefson write you 17 a lot of notes? 18 A. On occasion, not a lot. 19 Q. Would you have kept notes that 20 he wrote to you in your files? 21 A. Yes. Depending on what the 22 notes were, whether they would stay with me or go 23 to a CRA. 24 Q. Is it possible this is Page 202 1 something you received, Exhibit 13 is something 2 you received but gave to a CRA to file? 3 A. It's possible, yes. 4 Q. Okay. 5 (PLAINTIFFS' EXHIBIT NO. 14 WAS 6 MARKED FOR IDENTIFICATION AND 7 RECEIVED IN EVIDENCE.) 8 Q. Have you had a chance to look 9 at Exhibit 14? 10 A. I have. 11 Q. Are you familiar with that 12 exhibit? 13 A. Yes. 14 Q. Could you tell me what it is? 15 A. It's a note identifying when 16 the transfer of data to the host will be. 17 Q. What computer system was used 18 to gather and store the data prior to it being 19 transferred to the host on S002? 20 A. Now I've spaced out -- it's our 21 current data base. 22 Q. Okay. Is it AS-400? 23 A. Thank you, yes, it is. 24 Q. Do you know if this was a CTE Page 203 1 study or CTM study? 2 A. No, it was not. 3 Q. Is the correct term CTM? 4 A. CTM. 5 Q. So it was paper, hard form 6 paper CRF? 7 A. Yes, that's correct. 8 Q. What are extractors? 9 A. They're programs, computer 10 programs to do any calculations that are required 11 on data before the analysis can be done. 12 Q. What types of calculations? 13 A. For example if you collect 14 Ham-D, all that's collected are the scores from 15 the individual questions. A total score would be 16 calculated, and so that would get that extractor, 17 that addition is an extractor. 18 Q. Total scores per visit on the 19 Ham-D? 20 A. Total score on a Ham-D taken. 21 Not necessarily per visit because there may be 22 more than one per visit, but on a particular 23 scale. 24 Q. So if the Ham-D was Page 204 1 administered, the report may have the individual 2 question scores but the extractor would produce 3 the total from the question scores? 4 A. Correct. 5 Q. To your knowledge was there a 6 time when the Ham-D scores were not totaled by 7 the investigator at the site? 8 A. I don't know. I mean usually 9 they would total them just in their head to know 10 whether they should continue in the protocol, but 11 we would not collect that because that could be 12 in error, so we would calculate that ourselves as 13 part of the analysis. 14 Q. So it may be written on the CRF 15 but wouldn't be put into the data base, I mean 16 the total? 17 A. No. 18 Q. Because I've seen CRFs where 19 the totals have been written on the CRF. 20 A. Okay. 21 Q. In situations like that, what 22 would happen with that total? 23 A. I don't know, it could be 24 entered into the data base. Page 205 1 Q. Okay. Because the Ham-D totals 2 are important to the study for efficacy purposes, 3 are they not? 4 A. That's right. 5 Q. And it would be important for a 6 clinical investigator to note visit by visit what 7 the totals for a particular Ham-D that was given 8 would have been, would they not? 9 MR. MYERS: Do you say to note or to 10 know? 11 MS. ZETTLER: To note. 12 A. That's probably more of a 13 medical judgment, I mean I would think so just 14 for their own knowledge. But they would still 15 remain in the study. 16 Q. Would you agree with me that 17 the primary depression scale that was used in the 18 Fluoxetine depression studies, generally, not 19 specifically, was the Hamilton Depression Rating 20 Scale? 21 A. Yes, I would say that's true. 22 Q. If somebody was becoming worse 23 while on the study for whatever reason, and that 24 was reflected in the Ham-D, wouldn't that have Page 206 1 been important to know from a visit -- on a 2 visit-to-visit basis? 3 MR. MYERS: I object to the form only 4 because I think that may approach a medical 5 question. But if you know, tell her. 6 A. I don't know. Because the 7 studies are blinded, they don't know which 8 treatment a given patient would be on. 9 Q. Would you agree with me that 10 there are generally a number of people on any 11 given site study, there could be anywhere from 12 three to fifty or sixty or whatever, people, that 13 one investigator is working with; correct? 14 A. You mean patients? 15 Q. Right. 16 A. Yes. 17 Q. And the doctor isn't going to 18 be able to remember every single person's 19 individual Ham-D score from week to week; 20 correct? 21 A. Correct. 22 Q. If he doesn't write it down, is 23 he going to have to recalculate it every single 24 time he looks at the person's previous Ham-D? Page 207 1 A. I don't know how they review 2 from visit-to-visit, whether they use source 3 documents or the case report forms. 4 Q. What other extractors are used 5 generally on the information before it's 6 analyzed? 7 A. We collect birth date and an 8 age will be developed from that. 9 Q. Okay. 10 A. Just as an example. 11 Q. Any other testing related 12 extractors? 13 A. I don't know. I have almost 14 zero systems background, so I try not to get into 15 the knowledge in that field. 16 Q. Okay. In Exhibit 14, it says 17 that S002 will be a separate transcript. What 18 does that mean? 19 A. It would be transferred by 20 itself, no other studies would be included. 21 Q. Is that unusual? 22 A. No. 23 Q. In what situation would that 24 happen? Page 208 1 A. If a study was completed and we 2 wanted to analyze the data before the next 3 scheduled transfer was to occur. 4 Q. Are there regular scheduled 5 transfers? 6 A. Yes. 7 Q. How often? 8 A. Currently on an annual basis. 9 Q. Was there a time when they were 10 more frequent transfers on Fluoxetine studies? 11 A. Yes. 12 Q. When was that? 13 A. While my involvement, it was 14 post-introduction or post-approval of Fluoxetine 15 for three years. 16 Q. Okay. And how often would the 17 information be transferred during that period of 18 time? 19 A. Quarterly. 20 Q. Would that be in line with the 21 quarterly or annual reports that have to be 22 submitted to the FDA? 23 A. Yes. 24 Q. This memo is dated August 27th, Page 209 1 1993; correct? 2 A. Yes. 3 Q. It states in here that the 4 transfer will be done in October or November. Is 5 that typical, that time lag? 6 MR. MYERS: Lag between what, I'm 7 sorry? 8 MS. ZETTLER: Well, strike that. 9 Q. How long does it usually take 10 to do the extractors on a study? 11 A. I do not know. 12 Q. You know Doctor David Wheadon; 13 correct? 14 A. Yes. 15 Q. Is Doctor Wheadon still with 16 Lilly? 17 A. No. 18 Q. Do you know where he is today? 19 A. I believe he's at Smith-Kline. 20 Q. Do you know Doctor Wernicke? 21 A. I knew of him. 22 Q. Have you ever worked with 23 Doctor Wernicke? 24 A. No, I did not. Page 210 1 Q. Do you know where Doctor 2 Wernicke is today? 3 A. No, I don't. 4 Q. I take it he's no longer with 5 Lilly? 6 A. That's correct. 7 Q. How about Paul Stark, have you 8 ever heard of Paul Stark? 9 A. I have heard of him. 10 Q. Who was Doctor Stark? 11 A. He was an employee working with 12 the Fluoxetine group early on in development. 13 Q. Is Doctor Stark with Lilly? 14 A. No, he's not. 15 Q. Do you know where Doctor Stark 16 is? 17 A. He's with a CRO right now, but 18 I don't know where. 19 Q. What's a CRO? 20 A. Clinical research organization -- 21 or contract research organization. 22 Q. Is that Doctor Feighner, would 23 that ring a bell with you, as it applies to 24 Doctor Stark? Page 211 1 A. I'm not sure I understand your 2 question. 3 Q. It's my understanding that 4 Doctor Stark may be with Doctor Feighner's 5 organization out in California. 6 A. Oh, I don't know that. 7 Q. How about Dorothy Dobbs, have 8 you ever heard of Dorothy Dobbs? 9 A. Yes. 10 Q. Who is Dorothy Dobbs? 11 A. She was a clinical physician 12 employed by Lilly. 13 Q. Did you ever work with Doctor 14 Dobbs? 15 A. Yes. 16 Q. In what capacity? 17 A. When I was a CRA. 18 Q. Which drug or drugs? 19 A. Confidential, it's a 20 non-marketed drug. 21 MR. MYERS: Tell her the therapeutic 22 class. 23 A. Oncolytics. 24 Q. That's what I was interested Page 212 1 in. And she was a clinical research physician on 2 the oncolytic drugs you were working on? 3 A. Yes. 4 Q. To your knowledge has Doctor 5 Dobbs ever had any responsibilities with regards 6 to Fluoxetine? 7 A. I don't know if she did or not. 8 Q. Is Doctor Dobbs still with 9 Lilly? 10 A. No, not to my knowledge. 11 Q. Do you know where she is? 12 A. No, I don't. 13 Q. Do you remember the names of 14 any of the consultants with regards to the 15 rechallenge study, the ten to twelve consultants 16 we talked about earlier? 17 A. Yes. 18 Q. Can you give me some of those 19 names? 20 A. Fred Quitkin was one. 21 Q. Spell the last name? 22 A. Q-U-I-T-K-I-N. 23 Q. Okay. 24 A. Zajecka, I think it's John. Page 213 1 And I think the spelling is Z-A-J-E-C-K-A, 2 something like that. 3 Q. Any others? 4 A. Jay Amsterdam was another. I 5 don't recall others off the top of my head. 6 Q. Where is Doctor Amsterdam from? 7 A. I think he's a Philadelphia. 8 Pittsburgh or Philadelphia, I forget which. 9 Q. I always get those two 10 confused. 11 A. I do too. 12 Q. How about Doctor Quitkin? 13 A. New York, New York. 14 Q. Doctor Zajecka? 15 A. I do not know. 16 Q. How about Doctor Dunner, is she 17 a consultant on rechallenge? 18 A. I don't remember if she was or 19 not. 20 Q. Any women? 21 A. I don't recall. 22 Q. Do you know who Greg Brophy is? 23 A. Yes. 24 Q. Who is Greg Brophy? Page 214 1 A. He's an employee at Lilly. 2 Q. What does he do for Lilly? 3 A. He's currently in Japan, I 4 don't know what his function is. 5 Q. When did he go to Japan? 6 A. Sometime in the last two years, 7 I guess. 8 Q. What did he do at Lilly before 9 going to Japan? 10 A. He was -- I think he was in a 11 strategic planning assignment. 12 Q. Do you know if he worked with 13 Fluoxetine? 14 A. Yes. 15 Q. Was he in a strategic planning 16 assignment in Fluoxetine? 17 A. No. 18 Q. What did he do with Fluoxetine? 19 A. He was in toxicology at the 20 time. 21 MS. ZETTLER: This is a good place to 22 stop. 23 * * * * * * * * * * 24 Page 215 1 (A THIS POINT, THE DEPOSITION WAS 2 RECESSED UNTIL THE FOLLOWING MORNING, DECEMBER 3, 3 1993, AND THE DEPOSITION CONTINUED AS FOLLOWS:) 4 5 * * * * * * * * * * 6 7 DIRECT EXAMINATION 8 BY MS. ZETTLER: 9 Q. Yesterday we talked a little 10 bit about the subsyndromal syndrome. 11 A. Yes. 12 Q. Can you tell me what symptoms 13 of depression are included in that syndrome? 14 MR. MYERS: I object to the form only 15 to the extent it may be a medical question. But 16 if you know, tell her what you know. 17 A. It's not any specified 18 symptoms, it's just fewer than the five that are 19 considered for major depression. 20 Q. Is it something like do the 21 symptoms have to last a shorter period of time or -- 22 A. I don't know that. 23 Q. Okay. And you said that that 24 study is just about to get underway? Page 216 1 A. Yes. 2 Q. Have you attended any meetings 3 regarding the study? 4 A. Yes, I have. 5 Q. Tell me when those meetings 6 occurred? 7 A. First one was Fall of '91, I 8 believe. 9 Q. When was the next one? 10 A. I don't know, subsequent to 11 that. 12 Q. Approximately how many have you 13 attended on the subsyndromal syndrome study? 14 A. Two to four. 15 Q. Who was at the Fall of '91 16 meeting? 17 A. Doctor Tollefson, myself, a 18 statistician, and three consultants, potential 19 investigators. 20 Q. Did these three consultants in 21 fact become investigators on the study? 22 A. Yes. 23 Q. Anybody from medical writing? 24 A. I don't believe so. Page 217 1 Q. How about Doctor Beasley? 2 A. I don't recall. 3 Q. Leigh Thompson, was he there? 4 A. No. 5 Q. What was discussed at the 6 meeting? 7 A. The protocol design. 8 Q. Was the etiology of the 9 syndrome discussed? 10 A. I don't recall. 11 Q. Who discovered, for lack of a 12 better phrase, this syndrome? 13 A. As far as I know it was out of 14 a very large -- it's not a surveillance study, 15 but it's a catchment study. 16 Q. What's a catchment study? 17 A. Well, I can't recall the 18 definition of it, but it was a many thousand type 19 patient study, more of a surveillance type 20 epidemiological study, I think. 21 Q. C-A or C-A-T-C-H? 22 A. C-A-T-C-H. 23 Q. You said it was a many thousand 24 type patient epidemiology study? Page 218 1 A. Type study, yes. 2 Q. Who conducted the study? 3 A. That, I don't know. 4 Q. Was it conducted by Lilly? 5 A. No. 6 Q. Do you know if it was a result 7 of the National Institute of Mental Health's 8 depression awareness program? 9 A. No, I don't know that. 10 Q. Were any of these three 11 consultants that worked with you on the protocol 12 and then became investigators, were they involved 13 in the catchment study? 14 A. One of them was involved in the 15 analysis of that data, but I don't know if he was 16 involved in the study itself. 17 Q. Is there any literature 18 published about this syndrome, to your knowledge? 19 A. I don't know. 20 Q. Was the results of the 21 catchment study published? 22 A. I believe it was. 23 Q. When was this catchment study 24 done? Page 219 1 A. I don't know. 2 Q. Sometime prior to the Fall of 3 '91; correct? 4 A. Yes. 5 Q. Any other syndromes that were 6 discovered from this catchment study to your 7 knowledge? 8 A. I do not know. 9 Q. To your knowledge have there 10 been any other studies done on this syndrome, not 11 necessarily just by Lilly? 12 A. I don't know that. 13 Q. Is Doctor Tollefson still 14 working on this study? 15 A. He's not the clinical scientist 16 on the study, no. 17 Q. Does he have responsibility for 18 the study at all? 19 A. No, he does not. 20 Q. What was his involvement in the 21 beginning? 22 A. Prior to the assignment of a 23 clinical scientist at the time. 24 Q. So he was kind of filling in Page 220 1 until they found somebody to take over as a 2 clinical scientist? 3 A. That's right. 4 Q. The other meetings about the 5 subsyndromal syndrome study, what was discussed 6 generally at those meetings? 7 A. Still protocol design, patient 8 numbers, which would help me with the planning 9 process on resource requirement. 10 Q. When you say patient numbers, 11 you mean numbers of patients? 12 A. Numbers of patients that were 13 going to be involved in the study. 14 Q. Anything else? 15 A. Not to my knowledge. 16 Q. Who was the gentleman who was 17 involved in the analysis of the catchment study 18 that was published? 19 MR. MYERS: Don't tell her that if it's 20 one of those three investigators, on the same 21 basis. You asked her that -- you asked her 22 yesterday who the investigators were, and I 23 instructed her not to answer. And if that person 24 is one and the same of those three investigators, Page 221 1 I instruct her not to answer. 2 MS. ZETTLER: Larry, what's your 3 objection -- what's your basis? 4 MR. MYERS: The basis is the same 5 objection we've used every month all along, that 6 this information is proprietary, it's 7 confidential, it is governed by the Federal 8 regulations, and thus I instruct her not to 9 answer. I don't think you can get indirectly 10 from her what you cannot get directly. 11 MS. ZETTLER: So you're saying that 12 it's number one trade secret? 13 MR. MYERS: Right. 14 MS. ZETTLER: You know that there's no 15 such thing as a trade secret portion of the 16 protective order anymore. And the other basis is 17 that it is governed or protected somehow by the 18 Federal regulations? 19 MR. MYERS: What about it? 20 MS. ZETTLER: That it protects this 21 person's name from being disclosed? 22 MR. MYERS: Protects the disclosure of 23 these names. 24 MS. ZETTLER: You can't tell me which Page 222 1 regulation that is? 2 MR. MYERS: I can tell you it's 21 CFR, 3 somewhere around 314, but don't hold me to it. 4 Is the person one of the investigators? 5 THE WITNESS:: Yes. 6 MR. MYERS: Okay, then don't answer 7 that. 8 Q. So you're going to follow your 9 counsel's advice? 10 A. Yes, I am. 11 MS. ZETTLER: Certify it. 12 (QUESTION CERTIFIED.) 13 Q. Do you know if this person's 14 name is on the published study? 15 A. No, I don't know that. 16 Q. To your knowledge, are there 17 any other studies being run by Lilly regarding 18 the subsyndromal syndrome study except for the 19 Fluoxetine study? 20 A. No, there are not. 21 Q. Did you attend any meetings 22 with regards to Doctor Miller's study? And when 23 I say Doctor Miller's study, I mean the suicide 24 scale validation study. Page 223 1 A. I don't recall if I did or not. 2 Q. Was that study started before 3 or after you became department head of 4 Fluoxetine? 5 A. After. 6 Q. Are you familiar with the 7 Prozac safety team? 8 A. Yes. 9 Q. Can you tell me what the Prozac 10 safety team is? 11 A. It was a group of individuals 12 to monitor the activities and plan what we were 13 doing. 14 Q. When you say monitor the 15 activities, what do you mean? 16 A. Clinical activities, the 17 different issues that were coming up that the 18 physicians were addressing, manuscript 19 generation. 20 Q. What were some of those issues? 21 A. The suicidality issues. 22 Q. How about violent aggressive 23 behavior, was that included? 24 A. It was part of the discussion. Page 224 1 Q. How about agitation? 2 A. I don't know specifically on 3 that one. 4 Q. When was the safety team 5 created? 6 A. I don't know. 7 Q. Was it before you became 8 involved in the group? 9 A. Yes. 10 Q. Who was on the safety team? 11 A. Doctor Tollefson, Doctor 12 Beasley, Doctor Heiligenstein, Greg Enas, Jan 13 Potvin, myself, someone from systems, and that 14 varied, Doctor Goldstein, Doctor Wheadon at the 15 time. 16 Q. Leigh Thompson? 17 A. No. 18 Q. Jim Kotsanos? 19 A. Yes. 20 Q. Anyone else? 21 A. Al Webber. 22 Q. You said Al, not Hans, right? 23 A. Al, that's right. 24 Q. Anybody else? Page 225 1 A. Not that I can recall. 2 Q. What was Doctor Tollefson's 3 role on the safety team? 4 A. He led the group. 5 Q. How about Doctor Beasley? 6 A. A participant. 7 Q. What was his role as far as how 8 did he participate, what was his contribution? 9 A. I'm not sure I know how to 10 answer that, can you be more specific? 11 Q. Sure. Let me do it this way, 12 and then we'll go back the other way. What were 13 some of the types of things that were being done 14 or some of the activities that were being 15 monitored by the group related to suicidality? 16 A. Preparing manuscripts, 17 monitoring the DEU, some of the different events. 18 Q. When you say events, you mean 19 adverse events? 20 A. Yes. 21 Q. Anything else? 22 A. Updates on trials. 23 Q. Clinical trials? 24 A. Yes. Page 226 1 Q. Anything else? 2 A. I don't recall anything else. 3 Q. Submissions to the FDA? 4 A. They would have been discussed 5 there, yes. 6 Q. Submissions to other regulatory 7 agencies? 8 A. Yes, if they were occurring at 9 that time. 10 Q. And when you say yes if they 11 would be occurring, you mean other countries' 12 regulatory agencies or other regulatory agencies 13 here in the United States? 14 A. Other countries' regulatory 15 agencies. 16 Q. What manuscripts were prepared? 17 A. When? 18 Q. At any time on suicidality. 19 MR. MYERS: As part of the safety team? 20 MS. ZETTLER: Well, she said monitoring 21 activities. 22 Q. So which manuscripts were 23 monitored by the safety team? 24 A. They were outside manuscripts Page 227 1 as well as ones that were being drafted 2 internally. 3 Q. Which manuscripts that were 4 being drafted internally? 5 A. The suicide analysis. 6 Q. Doctor Beasley's meta-analysis 7 article? 8 A. Yes. 9 Q. Is that what you mean when you 10 say suicide analysis? 11 A. Yes, it is. 12 Q. Any other internal manuscripts? 13 A. There were a lot of them that 14 were being worked on at the time, but I don't 15 recall what they were, I was never involved with 16 them in specifics. 17 Q. Suicidality articles as they 18 related to other indications? 19 A. I don't know if they were 20 discussed at that meeting. 21 Q. Is there a list of the articles 22 that were produced on the issue of suicidality? 23 A. I don't know. 24 Q. If I wanted to find out what Page 228 1 articles were written or in the process of being 2 written on that issue of suicidality and the use 3 of Fluoxetine, where would I go to find that out? 4 A. To the individual clinical 5 scientists. 6 Q. So I would have to go to Doctor 7 Beasley and ask him what articles he's been 8 working on, and Doctor Tollefson, and down the 9 line? 10 A. That's right. 11 Q. There's no one central area 12 where that information is kept or one person who 13 is responsible for keeping track of that 14 information? 15 A. I don't know that it would be 16 complete. 17 Q. Why not? 18 A. Why not what? 19 Q. Why wouldn't it be complete, 20 why wouldn't it be a complete list? 21 A. If the person keeping it wasn't 22 involved in all the articles, they may not know 23 what all is being worked on at the time. 24 Q. How about violent aggressive Page 229 1 behavior, what articles were written internally 2 regarding violent aggressive behavior? 3 A. I believe Doctor Heiligenstein 4 wrote an article. 5 Q. Any others? 6 A. Not that I'm aware of. 7 Q. Are you aware of any articles 8 that were related either to suicidality or 9 violent aggressive behavior that were undertaken 10 but not completed? 11 A. Completed in what way? 12 Q. Finished, submitted for 13 publication. 14 A. I'm not aware of any. 15 Q. Are you aware of any articles 16 that were submitted for publication but were 17 rejected? 18 A. No. 19 Q. With regards to the monitoring 20 of the manuscripts, the in-house manuscripts, 21 what was Doctor Tollefson's role, if any? 22 A. I believe he has approval 23 responsibility for those. 24 Q. How about Doctor Beasley, what Page 230 1 was his role, I mean obviously he wrote one of 2 them, right? 3 A. He would have been an author. 4 Q. How about Doctor Heiligenstein? 5 A. An author. 6 Q. Greg Enas? 7 A. I don't know if he was an 8 author or not. 9 Q. Jan Potvin? 10 A. Helped edit. 11 Q. Doctor Goldstein? 12 A. Author. 13 Q. Doctor Wheadon? 14 A. Author. 15 Q. Doctor Kotsanos? 16 A. I don't know if Jim authored 17 any papers or not. 18 Q. If he didn't, what would his 19 role have been? 20 A. Review, assist in reviewing. 21 Q. How about Al Webber? 22 A. I don't believe he would have 23 had a role. 24 Q. The other group of manuscripts Page 231 1 that were monitored by the safety team, outside 2 manuscripts, right? 3 A. Yes. 4 Q. What are outside manuscripts? 5 A. Published articles by non-Lilly 6 individuals or non-sponsored studies by Lilly, 7 studies not sponsored by Lilly. 8 Q. What would be done to monitor 9 those, in what way would they be monitored? 10 A. The physicians have their names 11 on either circulation lists or their own 12 journals, subscriptions, that they would review 13 them. 14 Q. So it would be a matter of just 15 keeping an eye out for what was being published 16 and letting the rest of the members of the team 17 know when something was published? 18 A. Well, since that wasn't part of 19 my responsibility or my areas of responsibility, 20 I don't know that for sure. 21 Q. Have you ever heard of Lilly 22 trying to prevent outside manuscripts from being 23 published? 24 A. No. Page 232 1 Q. Have you ever heard of journals 2 or publications contacting Lilly prior to the 3 publication of a manuscript or letter? 4 MR. MYERS: When you say a Lilly 5 manuscript or -- 6 MS. ZETTLER: No, outside manuscript. 7 A. You said have we heard of 8 publications contacting us? 9 Q. Right. For instance, as an 10 example, say the Journal of the American Medical 11 Association prior to publishing an article 12 contacting Lilly and saying we're going to 13 publish this article. 14 A. That, I don't know. 15 Q. In your opinion would it be 16 appropriate for Lilly to try and stop the 17 publication of an article that was critical of 18 one of its products? 19 MR. MYERS: Before she answers, let me 20 object to the form. The question is hypothetical 21 in nature, I think, it doesn't include enough 22 facts upon which to give an opinion, but if 23 you've got one, go ahead and tell her. 24 A. No. Page 233 1 Q. I don't remember the question. 2 You don't have an opinion, is that what you're 3 saying? 4 A. I don't feel it's appropriate. 5 It's not a company opinion, it's a personal 6 opinion. 7 MR. MYERS: She remembered the 8 question. 9 MS. ZETTLER: Thanks. 10 Q. Have you ever heard of Seymore 11 Fischer, Doctor Seymore Fischer? 12 A. No. 13 Q. Have you done any work directly 14 or indirectly on package inserts for other 15 countries on Prozac or Fluoxetine? 16 A. No, I have not. 17 Q. Have you supervised any of your 18 people on projects related to package inserts 19 used in other countries? 20 A. I don't believe so. 21 Q. Have you directly or indirectly 22 done any work with regards to product 23 registrations in other countries on Fluoxetine? 24 A. Yes. Page 234 1 Q. What countries? 2 A. Australia and Canada. 3 Q. How about Germany? 4 A. I don't recall that one in 5 particular. 6 Q. How about France? 7 A. Not to my knowledge. 8 Q. How about Yugoslavia? 9 A. I don't recall. 10 Q. What work did you do related to 11 Fluoxetine registration in Australia? 12 A. Helped gather information for 13 the affiliate to use as response, for them to 14 prepare their response. 15 Q. Response to what? 16 A. Their regulatory agency's 17 questions. 18 Q. Do you remember what the 19 regulatory agency in Australia is called? 20 A. No, I don't. 21 Q. What information did you help 22 gather? 23 A. Related to a different 24 indication other than depression. Page 235 1 Q. Lovan? 2 A. No, that's not the one I was 3 thinking of. 4 Q. Bulimia? 5 A. Yes. 6 Q. Has Fluoxetine been approved 7 for use in bulimia in Australia? 8 A. I don't know. 9 Q. What is Fluoxetine, what's the 10 trade name or brand name of Fluoxetine for 11 bulimia in Australia? 12 A. I don't know. 13 Q. Specifically what kind of 14 information did you gather or help gather related 15 to the approval of Fluoxetine for the use of 16 bulimia in Australia? 17 A. It was a coordinating function 18 as receiving the different pieces of information 19 from other parts of the company. 20 Q. Okay. I'm trying to get an 21 idea of what types of information. Are you 22 talking about adverse event information, clinical 23 trial efficacy information, what types of 24 information are you talking about? Page 236 1 MR. MYERS: Before she answers, let me 2 just put this on the record. To the extent 3 anything she gathered was efficacy information, 4 I'll let her testify generally if it had to do 5 with efficacy, and I don't know if it was. 6 MS. ZETTLER: That's all I'm asking, is 7 general stuff. 8 A. There were a section of -- a 9 large section of it related to toxicology. There 10 was some clinical data asked for. 11 Q. Anything else? 12 A. I don't recall other pieces. 13 Q. Clinical data that was 14 requested, is that efficacy information or was 15 that safety information? 16 A. Both. 17 Q. What safety information was 18 gathered? 19 A. The additional data that the 20 affiliate did not have after the initial 21 submission. 22 Q. What was the subject matter of 23 the safety information, was it related to 24 suicidality? Page 237 1 A. No, it was not. 2 Q. Was it related to agitation? 3 A. No, it was not. 4 Q. Was it related to violent 5 aggressive behavior? 6 A. No, it was not. 7 Q. What was it related to? 8 A. Additional safety data on the 9 bulimia studies that had been collected after the 10 initial submission was made. 11 Q. What aspect of safety? 12 A. Adverse events. 13 Q. What adverse events? 14 A. None in particular. 15 Q. So when you say it didn't have 16 anything to do with suicidality, violent 17 aggressive behavior or agitation, are you saying 18 that those three types of adverse events were 19 excluded? 20 A. No, that's not what I was 21 saying. 22 Q. So those were included in the 23 adverse event information on the bulimia studies? 24 MR. MYERS: I object to the form only Page 238 1 to the extent it assumes there were some, there 2 may or may not have been. 3 A. That's right. 4 Q. You can answer my question. 5 A. There may or may not have been. 6 Had they been there, they would have been 7 produced. 8 Q. Did the Australian regulatory 9 agency have any specific questions as to adverse 10 events? 11 A. I don't recall. 12 Q. Who had primary responsibility 13 for registration of the drug in Australia, at 14 Lilly, in Indianapolis? 15 MR. MYERS: For this project that she 16 worked on on approved indication? 17 MS. ZETTLER: No, I want to know if 18 there was a person at Lilly who was the point man 19 at Indianapolis, so to speak, for the regulatory 20 agency in Australia or the affiliate working with 21 them. 22 A. There was not a primary person 23 who had regulatory responsibility in 24 Indianapolis. Page 239 1 Q. With regards to any country or 2 just Australia? 3 A. I believe that's true with any 4 country. The affiliates have their own 5 regulatory people there. 6 Q. To your knowledge were there 7 any bulimia studies that were performed in 8 Australia? 9 A. I do not know. 10 Q. The information that you 11 gathered, was that information sourced from the 12 United States or was that outside the United 13 States information as well? 14 A. There was U.S. information 15 there, I don't know if there was any 16 international data there or not. 17 Q. How about Canada, what did you 18 do with regards to product registration in 19 Canada? 20 A. Again, helped coordinate the 21 collection of information to help them with their 22 preparation of the response. 23 Q. What indication was that for? 24 A. OCD and bulimia. Page 240 1 Q. To your knowledge, is 2 Fluoxetine approved for use in OCD and bulimia in 3 Canada at this time? 4 A. Yes, it is. 5 Q. For both? 6 A. Yes. 7 Q. Does the drug go by any brand 8 name in Canada for those indications? 9 A. I don't know. 10 Q. When was Fluoxetine approved 11 for use in OCD in Canada? 12 A. It's been within the last two 13 years, but I don't recall when. 14 Q. How about bulimia, when was it 15 approved for use in bulimia in Canada? 16 A. Within that same time frame. 17 (PLAINTIFFS' EXHIBIT NO. 15 WAS 18 MARKED FOR IDENTIFICATION AND 19 RECEIVED IN EVIDENCE.) 20 Q. Have you had a chance to review 21 Exhibit 15? 22 A. Yes, I have. 23 Q. Do you recognized the exhibit? 24 A. Vaguely. Page 241 1 Q. Can you tell me what it is? 2 A. It's a protocol. 3 Q. For which study? 4 A. For the agitated depression 5 study. 6 Q. Is this the agitated depression 7 study we were talking about yesterday? 8 A. Yes, it is. 9 Q. To your knowledge were there 10 any other studies that have been performed 11 regarding Fluoxetine and agitated depressed 12 people? 13 A. Not to my knowledge. 14 Q. To your knowledge are there any 15 studies that are going to be performed related to 16 Fluoxetine and agitated depressed people? 17 A. Not to my knowledge. 18 Q. To your knowledge is Fluoxetine 19 approved for the use of treating any indication 20 whatsoever in Australia? 21 A. I don't know. 22 Q. Are you aware of any countries 23 where a petition or application for approval for 24 the marketing of a drug has been rejected by any Page 242 1 country? 2 A. No, I don't know the answer to 3 that. 4 Q. Are you aware of any country 5 taking Fluoxetine off the market after it's been 6 approved? 7 A. I don't know. 8 Q. Who would know that? 9 A. The regulatory individuals in 10 each of the different affiliates. 11 Q. Would there be any group or 12 person at Indianapolis, Lilly in Indianapolis, 13 that would know? 14 A. International Product 15 Registration was a group of individuals who would 16 have some of that information. 17 Q. Is that a group that's at Lilly 18 in Indianapolis? 19 A. Yes, it is. 20 Q. Is that a department or 21 division in and of itself? 22 A. No. 23 Q. Where is that group housed, 24 which division or department? Page 243 1 A. In regulatory. 2 Q. Is there a department head or 3 manager of that group? 4 A. Yes. 5 Q. Who is that at this time? 6 A. Ann Noble. 7 Q. Prior to Ms. Noble, who held 8 that position? 9 A. Mike Noone. 10 Q. How about prior to Mister 11 Noone? 12 A. I don't know. 13 Q. What is the International 14 Product Registration group's function? 15 A. Well, they're no longer in 16 existence, per se, as that is known. 17 Q. What was their function? 18 A. To act as a facilitator for the 19 affiliates in answering questions or getting 20 questions answered. 21 Q. Was this a group that was set 22 up specifically for Fluoxetine? 23 A. No. 24 Q. Was it a group that was set up Page 244 1 for Lilly products across the board? 2 A. Yes. 3 Q. Why was it -- why is it no 4 longer in existence? 5 A. They have realligned 6 themselves. 7 Q. Who is they? 8 A. Those group of individuals. 9 Q. How did they reallign 10 themselves? 11 A. More by therapeutic area. 12 Q. Is there a group or a person 13 that's responsible for facilitating product 14 registration in psychopharmacology at this time? 15 A. For facilitating registration? 16 Q. A person who would act in the 17 capacity that the International Product 18 Registration group had acted before it was 19 disbanded. 20 A. Yes. 21 Q. Who was that? 22 A. Sue Worthe, W-O-R-T-H-E. 23 Q. Does she work with Fluoxetine? 24 A. Does she, yes. Page 245 1 Q. When you say that the 2 International Product Registration group acted as 3 a facilitator to help the affiliates get products 4 registered, what would they do to help, how would 5 they help facilitate? 6 A. They would be the receiver of 7 questions from the affiliates, and then disburse 8 the questions depending on what type they were to 9 the appropriate individuals. 10 Q. When an application for 11 registration or petition for registration for 12 approval for marketing in a country is filed, 13 does the information that is gathered and 14 submitted in support of that application or 15 petition come solely from Indianapolis? 16 A. I don't know the answer to 17 that. 18 (PLAINTIFFS' EXHIBIT NO. 16 WAS 19 MARKED FOR IDENTIFICATION AND 20 RECEIVED IN EVIDENCE.) 21 Q. Have you had a chance to review 22 Exhibit 16? 23 A. Yes, I have. 24 Q. Do you recognize the exhibit? Page 246 1 A. No, I don't. 2 Q. Do you recognize the subject 3 matter of the exhibit? 4 A. Yes. 5 Q. Tell me what the subject matter 6 of the exhibit is? 7 A. It's an outline of a protocol. 8 Q. The first page of this exhibit 9 is marked Pz 2441 2371 in the lower right-hand 10 corner; correct? 11 A. Yes. 12 Q. And I believe it goes 13 consecutively to Pz 2441 2388; correct? 14 A. Correct. 15 Q. And the first page it looks 16 like a letter to John Heiligenstein; correct? 17 A. Right. 18 Q. And the letter -- the name of 19 the person who wrote the letter is blacked out. 20 A. Yes. 21 Q. Do you recognize the 22 handwriting, not on the first page, but on the 23 second page of the exhibit or the fifth page of 24 the exhibit? Page 247 1 A. No, I don't. 2 Q. What study was this or is this? 3 A. It's a cost effectiveness 4 study. 5 Q. Is the study ongoing at this 6 time? 7 A. Yes, it is. 8 Q. And it uses Fluoxetine? 9 A. Yes, it does. 10 Q. Is this a Lilly funded study? 11 A. Not completely. 12 Q. Is this an independent IND 13 study? 14 A. It could be. 15 Q. Who else was funding this 16 study? 17 A. I don't know. 18 Q. Yesterday we were talking about 19 the independent IND studies generally, and you 20 told me that at least in some cases where it's an 21 independent IND, Lilly would not own the rights 22 to the information that was gathered; correct? 23 A. That's a possibility. 24 Q. To your knowledge does Lilly Page 248 1 own the rights to this information on this study? 2 A. I don't know the answer to 3 that. 4 Q. Do you know what other entities 5 are involved in this study besides Lilly, and I'm 6 not talking about an investigator at this point, 7 but in other words is another drug company 8 involved in this study? 9 A. Not to my knowledge. 10 Q. How about the National 11 Institute of Mental Health, is that involved in 12 this study? 13 A. I don't know. 14 Q. Is this study related to the 15 Rocky Mountain Poison Control Center study? 16 A. No. 17 Q. How is it that you know that 18 this study is only partially funded by Lilly? 19 A. For this size of a study, the 20 amount of money would not fund an entire study 21 that we're providing. 22 Q. What's the size of the study? 23 A. It looks to be about six 24 hundred patients based on this protocol. Page 249 1 Q. Can you tell from the protocol 2 how much money Lilly is funding? 3 A. No. 4 Q. Do you know how much money 5 Lilly funded for the study? 6 A. Approximately -- 7 MR. MYERS: Don't -- tell her yes or 8 no, don't tell her how much. 9 A. Yes. 10 Q. You do know? 11 A. Approximately. 12 Q. How much? 13 MR. MYERS: Don't tell her. 14 MS. ZETTLER: Based on what, Larry? 15 MR. MYERS: The commissioner's ruled on 16 that, among other things, and it's proprietary. 17 MS. ZETTLER: So how is it that when 18 the commissioner rules in your favor, it's okay, 19 but when the judge or commissioner rules in our 20 favor, you ignore it? 21 MR. MYERS: I'm not going to respond to 22 that. 23 Q. Are you going to follow your 24 counsel's instructions? Page 250 1 A. Yes, I am. 2 MS. ZETTLER: Certify that question. 3 (QUESTION CERTIFIED.) 4 Q. So based on the amount of money 5 that you have at least approximate knowledge of 6 that was funded by Lilly, it's your feeling that 7 the study was not completely funded by Lilly? 8 A. That's correct. 9 Q. Is this a multiple site study? 10 A. I don't know. 11 Q. Who is the CRA on this study? 12 A. Paula Robison. 13 Q. Any other CRAs? 14 A. No. 15 Q. Who is the Lilly physician on 16 this study? 17 A. John Heiligenstein. 18 Q. Is there a study number for 19 this study, to your knowledge? 20 A. No, I don't believe so. 21 Q. Why not? 22 A. Because it's not being done 23 under our IND. 24 Q. When is the study expected to Page 251 1 be completed? 2 A. I don't know. 3 Q. Do you know how long it has 4 been ongoing? 5 MR. MYERS: What do you mean by 6 ongoing, what are you sort of taking as your 7 starting point? 8 Q. From conception and -- start 9 with -- well, let me ask it this way: Do you 10 know when the study was first proposed? 11 A. No, I do not. 12 Q. Was it before or after you 13 became involved with the Fluoxetine group? 14 A. I don't know. 15 Q. Do you know when the protocol 16 was submitted? 17 MR. MYERS: To? 18 Q. To the FDA. 19 A. No, I don't. 20 Q. When was the start-up meeting 21 held on this? 22 A. It's been within the last two 23 years. 24 Q. Have patients been enrolled in Page 252 1 this study? 2 A. As far as I know, yes. 3 Q. Do you know how many patients 4 have been enrolled? 5 A. No, I don't. 6 Q. Do you know how many 7 investigators are involved in this study? 8 A. No, I don't. 9 Q. More than one? 10 A. I don't know. 11 Q. Why don't you turn to page 2441 12 2381. Do you understand here what they're saying 13 when it says pilot work? 14 MR. MYERS: Does she understand the 15 relationship of this section to the whole? 16 MS. ZETTLER: Whole study, right. 17 A. Not specifically, no. 18 Q. Is it your understanding that 19 there was a pilot phase of this study to validate 20 and study instruments? 21 A. I don't know that. 22 Q. Who would know that? 23 A. Doctor Heiligenstein. 24 Q. If you were going to refer to Page 253 1 this study at Lilly, if you were talking to 2 Doctor Heiligenstein, what would you call it? 3 A. Puget Sound study. 4 Q. Is one of the sites in Puget 5 Sound? 6 A. Yes. 7 Q. Have you discussed this study 8 with Doctor Heiligenstein? 9 A. In what manner? 10 Q. Any way, for any reason. 11 A. Yes. 12 Q. When did you first discuss this 13 study with Doctor Heiligenstein? 14 A. I don't recall. 15 Q. Have you had any meetings 16 specifically on this study? 17 A. No, I don't believe I have. 18 Q. What was the context in which 19 you discussed this study with Doctor 20 Heiligenstein? 21 A. The timing of the study and 22 resource requirements, what it was going to take. 23 Q. What do you mean when you say 24 the timing of the study? Page 254 1 A. The duration, initiation. 2 Q. Did Doctor Heiligenstein have a 3 proposed start-up date for the study? 4 A. I don't recall. 5 Q. Is there a date when he would 6 like the study to be completed by? 7 A. I hope so. 8 Q. Do you know what that date is? 9 A. No, I don't. 10 MS. ZETTLER: Let's take a break. 11 (A SHORT RECESS WAS TAKEN.) 12 Q. Yesterday I asked you if you 13 were aware of any studies that were ongoing 14 related to depression, and you gave me four 15 studies, I believe it was, two cardiac, cancer 16 and atypical depression study; correct. 17 A. Yes. 18 Q. Why is it that you don't 19 consider this a depression study? 20 A. Because it's not being done 21 under our IND. 22 Q. Are there any other studies 23 that you're aware of that are ongoing regarding 24 Fluoxetine that are not being done under Lilly's Page 255 1 IND? 2 A. Yes. 3 Q. What studies? 4 A. There's another cost study, 5 there's a panic study. 6 Q. Any others? 7 A. Yes, a group of studies done in 8 various categories of diseases. 9 Q. Any other studies that are 10 being done within this group on depression? 11 A. I don't know specifically. 12 Q. What are some of the other -- 13 just generally, what are some of the other 14 diseases that are being studied in this group? 15 A. PMS, post-traumatic stress, 16 trichotillomania. 17 Q. Can you spell that? 18 A. This probably won't be right, 19 but T-R-I-C-H-O-T-I-L-M-A-N-I-A. 20 Q. Do you know what 21 trichotillomania is? 22 A. I believe it's hair pulling. 23 Kleptomania. 24 Q. Okay. Any others? Page 256 1 A. Yes, I don't recall what they 2 are specifically. 3 Q. Why do you say that this is a 4 group of studies? 5 A. They are in a different 6 category, we just lump them together in that 7 fashion. 8 Q. When you say a different 9 category, what do you mean? 10 A. They're done under different 11 regulations. 12 Q. Why? 13 A. Because that's how the FDA says 14 they're to be done. 15 Q. Why do these studies, according 16 to the FDA, fall under a different group of 17 regulations? 18 A. There are regulations that 19 specify whether they're to be done under an IND 20 or not, and the FDA makes that judgment. 21 Q. Are these studies being done 22 under an IND? 23 A. No, they're not. 24 Q. And when I say under an IND, I Page 257 1 mean Lilly's IND or any IND. 2 A. No, they are not. 3 Q. What are they being done under? 4 A. They're not being done under an 5 IND, they're exempt from IND regulations. 6 Q. Do you know what it is about 7 these areas that makes them exempt from the IND? 8 A. No, I don't. 9 Q. Are these Lilly studies that 10 are being done or are these studies that are 11 being done by somebody else? 12 A. Do you want to clarify that? 13 Q. Sure. I'm trying to 14 differentiate between -- earlier we were talking 15 about independent IND studies. 16 A. Right. 17 Q. Are these Lilly funded studies? 18 A. In some fashion, yes. 19 Q. This group of non-IND studies, 20 are they double-blind controlled studies? 21 A. Some of them are, I don't know 22 if all of them are. 23 Q. Is the information that's being 24 collected on the double-blind controlled studies Page 258 1 being sent to Lilly? 2 A. No, it's not. 3 Q. Are these studies being done by 4 a single entity in addition to Lilly or are they 5 various entities or are they the same? 6 A. There are various individuals 7 running the different studies. 8 Q. Is there another corporate 9 entity at this time that's involved in these 10 studies besides Lilly? 11 A. I don't know. 12 Q. Is there a governmental agency 13 or regulatory agency that's participating in 14 these studies? 15 A. I don't know. 16 Q. Who are the Lilly doctors who 17 are responsible for these studies? 18 A. Doctor Goldstein and Doctor 19 Heiligenstein. 20 Q. Do they both have dual 21 responsibility for all of these studies in this 22 group or is it assigned, like, for instance, 23 Doctor Goldstein has the PMS study, Doctor 24 Heiligenstein has the Kleptomania study. Page 259 1 A. Most of them fall under Doctor 2 Goldstein's responsibilities. 3 Q. What is Doctor Heiligenstein's 4 responsibilities with regards to these studies? 5 A. If he had had prior involvement 6 in the study, and if it had been decided by the 7 FDA to be exempt from the IND regulations, then 8 Doctor Heiligenstein would have continued the 9 responsibility with it. 10 Q. How is it determined -- what is 11 the process that it's gone through to determine 12 whether or not a study such as these is exempt 13 from the regulations. 14 A. A proposal and a letter is sent 15 to the FDA asking them. 16 Q. Asking for the exemption or 17 asking them to determine whether or not -- 18 A. Asking them to determine if it 19 falls under the exemption. 20 Q. Tell me about the other cost 21 study, how is that different from the study, the 22 Puget Sound study? 23 A. I don't know. 24 Q. Who is the Lilly doctor on that Page 260 1 study? 2 A. Doctor Heiligenstein. 3 Q. Is that study in process right 4 now, have patients been enrolled? 5 A. I don't know for sure. 6 Q. How would you refer to the 7 other cost effectiveness study if you were going 8 to talk to somebody about it at Lilly? 9 A. Kaiser study. 10 Q. Besides the Puget Sound study, 11 the Kaiser study, the panic study, and the group 12 of studies that are exempt from the IND, are you 13 aware of any other studies that are being 14 performed regarding Fluoxetine for any reason 15 whatsoever, whether or not they're Lilly INDs? 16 A. Not to my knowledge, no. 17 Q. Are you aware of suicide being 18 studied as an issue at Lilly prior to 1990? 19 A. I wouldn't know that. 20 Q. Are you aware of any studies 21 that were performed with Fluoxetine prior to 1990 22 that studied the use of Fluoxetine in suicidal 23 patients? 24 A. No, I'm not aware of any Page 261 1 studies. 2 Q. How about agitated depressed 3 patients other than what we've already talked 4 about? 5 A. I don't know. 6 Q. How about studies conducted to 7 look at violent aggressive behavior in patients 8 using Fluoxetine prior to 1990? 9 A. I don't know. 10 (PLAINTIFFS' EXHIBIT NO. 17 WAS 11 MARKED FOR IDENTIFICATION AND 12 RECEIVED IN EVIDENCE.) 13 Q. Have you had a chance to review 14 Exhibit 17? 15 A. Yes, I have. 16 Q. Do you recognize the exhibit? 17 A. Vaguely. 18 Q. It purports to be a two-page 19 memo dated June 20, 1991 authored by Jim 20 Katsanos? 21 A. Correct. 22 Q. And it's addressed to the 23 Prozac safety team with some CCs; correct? 24 A. Yes. Page 262 1 Q. On the second page of the 2 exhibit towards the bottom under number nine, it 3 says Safety Library (computerized system), and it 4 has the initials CZ in parens. 5 A. Correct. 6 Q. Are those your initials? 7 A. Yes, they are. 8 Q. Can you tell me what the safety 9 library -- what was the safety library? 10 A. It's not anything. 11 Q. What was it -- what is Doctor 12 Kotsanos referring to in number nine? 13 A. There had been discussion about 14 creating a library to prevent us from spinning 15 our wheels if we were to get the same response 16 from different regulatory agencies or internal or 17 external people. If the same question was being 18 answered, we wouldn't have to go back and go 19 after the data again, it would already be there. 20 Q. And is it your testimony that 21 that project was never done? 22 A. Yes, it is. 23 Q. Why not? 24 A. We didn't have the resources, Page 263 1 it was not prioritized as a task. 2 Q. Did you do anything instead to 3 try and prevent a duplicating effort? 4 A. No. 5 Q. Were you responsible directly 6 or indirectly for any other task that's listed in 7 Exhibit 17? 8 A. No -- yes, sorry. 9 Q. Okay. Which one? 10 A. Under the objectives, number 11 four, the quarterly reports. 12 Q. Okay. What are the quarterly 13 reports? 14 A. Those were required by the 15 Federal regulations as follow-up to approval on a 16 quarterly basis. 17 Q. Quarterly reports of what? 18 A. Of safety data. 19 Q. When you say safety data, what 20 do you mean? 21 A. Adverse event data from 22 clinical trials as well as spontaneous data, 23 spontaneous events. 24 Q. Were final reports of clinical Page 264 1 trials that were completed in the previous 2 quarter reported in those quarterly reports? 3 A. Not to my knowledge. 4 Q. Were the final reports on the 5 clinical trials submitted on a regular basis or 6 was that done, say, yearly? 7 A. They were submitted as they 8 were completed. 9 Q. Under number four, it says 10 complete one safety project every quarter in 11 1991. Do you see that? 12 A. Yes. 13 Q. What does it mean, what's a 14 safety project? 15 A. I don't know. 16 Q. You didn't -- you had no 17 responsibility for that task? 18 A. No, I did not. 19 Q. Are you familiar with the 20 Costart dictionary? 21 A. Yes, I am. 22 Q. Would you tell us what the 23 Costart dictionary is? 24 A. It's a dictionary of terms used Page 265 1 by the FDA to classify events. 2 Q. Are you familiar with the ELECT 3 dictionary? 4 A. Yes, I am. 5 Q. What is the ELECT dictionary? 6 A. It was a similar dictionary to 7 the Costart that Lilly used for a period of time. 8 Q. Have you worked with the ELECT 9 dictionary? 10 A. On occasion, yes. 11 Q. Is Lilly using the ELECT 12 dictionary today? 13 A. No. 14 Q. It's not using it for any 15 indication -- or, I'm sorry, any product? 16 A. I don't know that. 17 Q. It's not using the ELECT for 18 Fluoxetine; correct? 19 A. Correct. 20 Q. When did they stop using ELECT? 21 A. I don't know. 22 Q. Do you know why they stopped 23 using ELECT? 24 A. I believe it was to be more in Page 266 1 line and follow what the FDA was using. 2 Q. When did the Costart dictionary 3 come into existence? 4 A. I don't know. 5 Q. Was it before or after Lilly -- 6 or was it before Lilly started using it? 7 A. Yes. 8 Q. Was it before you became 9 involved in the Fluoxetine cluster? 10 A. Yes. 11 Q. What are the differences 12 between the ELECT dictionary and the Costart 13 dictionary, if you know? 14 A. In the ELECT dictionary there 15 are additional synonym terms used as well as a 16 couple of extra classification terms used. 17 Q. When you say classification 18 terms, what do you mean? 19 A. Those are the terms used to 20 group similar events that may have the same -- 21 events that may be called similar things. 22 Q. How is that different from the 23 synonyms? 24 MR. MYERS: Are you asking her what the Page 267 1 difference is between classification terms and 2 synonyms? 3 Q. Classification and synonyms. 4 A. The synonyms are any terms that 5 physicians may use to describe an event. The 6 classification terms are used to group the same 7 terms that could be stated differently. 8 Q. Can you give me an example? 9 A. Upset stomach, nausea, those 10 may both be grouped as nausea, for example. 11 Q. So nausea would be the 12 classification term? 13 A. Possibly. I don't know 14 specifically, but something like that. 15 Q. And then the synonyms would be 16 those terms listed under nausea if that were the 17 classification term? 18 A. I'm not sure I understand your 19 question. 20 Q. So the problem is I don't 21 understand what the difference between the 22 classification terms and the synonyms is? 23 A. Well, if you have a synonym 24 term given to you, then it maps it to a Page 268 1 classification term. 2 Q. Okay. So say you have rash as 3 a classification term, you could have all 4 different kinds of rashes or types of skin 5 problems that may be listed as synonyms under the 6 classification term. 7 A. Could you restate that? 8 (THE COURT REPORTER READ BACK THE 9 REQUESTED TESTIMONY.) 10 A. Depending on how the different 11 events are classified, that's a possibility. 12 Q. What additional classification 13 terms were in the ELECT dictionary that were not 14 in the Costart dictionary? 15 A. Surgical procedure, and injury 16 accidental. 17 Q. Any others? 18 A. Not that I'm aware of. 19 Q. Surgical procedure and injury 20 accidental were two classification terms that 21 were in ELECT but not in Costart? 22 A. Correct. 23 Q. Were there any classification 24 terms that were in Costart that were not in Page 269 1 ELECT? 2 A. I don't know about that. 3 Q. What types of adverse events 4 would have fallen under surgical procedure? 5 A. I don't know specifically. 6 Q. Would stitches fall under 7 surgical procedure? 8 A. I don't know. 9 Q. How about injury accidental, 10 what kind of adverse event would have fallen 11 under injury accidental? 12 A. I don't know specifically 13 without looking at the dictionary. 14 Q. So when Lilly changed from 15 ELECT to Costart, surgical procedure and injury 16 accidental were no longer classification terms? 17 A. In the new dictionary, that's 18 correct. 19 Q. In the new Costart dictionary? 20 A. That's right. 21 Q. Was there a time when surgical 22 procedure and injury accidental were listed as 23 cross-indication terms in Costart, to your 24 knowledge? Page 270 1 A. I don't know. 2 Q. I believe you testified also 3 that there were synonyms additional to the ELECT 4 dictionary that were not included in the Costart? 5 A. That's correct. 6 Q. What were some of those 7 synonyms? 8 A. I don't know, it was a lot of 9 them. It was just -- it was a way for us to 10 easily use the computer so the computer could use 11 the dictionary. So we would add synonyms terms 12 as they came in to the dictionary. 13 Q. You mean to the ELECT 14 dictionary or to the Costart dictionary? 15 A. Either one. 16 Q. So you would add terms to the 17 Costart dictionary? 18 A. I don't know if we added 19 synonym terms to the Costart dictionary or not. 20 Q. Has the Costart dictionary that 21 is used by Lilly been changed in any way from the 22 Costart that is produced, authored by the FDA? 23 A. I don't know. 24 Q. Are you familiar with the SSAI Page 271 1 dictionary? 2 A. Yes. 3 Q. What is the SSAI dictionary? 4 A. It's a dictionary that was used 5 prior to the ELECT dictionary. 6 Q. Have you personally used the 7 SSAI dictionary? 8 A. Yes. 9 Q. What are the differences 10 between SSAI and the ELECT? 11 A. I don't know. 12 Q. Do you know when they went from 13 using the SSAI to the ELECT dictionary? 14 A. No, I don't. 15 Q. Was it before or after you 16 became involved in the Fluoxetine cluster? 17 A. It was before I became involved 18 in the Fluoxetine cluster. 19 Q. Were you involved at all in the 20 change from the ELECT dictionary to the Costart 21 dictionary? 22 A. Indirectly, yes. 23 Q. What was your involvement? 24 A. When we switched from ELECT to Page 272 1 Costart, each physician made the determination as 2 to when to switch based on ongoing studies or 3 submissions that were being made. 4 Q. Were you involved with 5 Fluoxetine at the time? 6 A. Yes. 7 Q. When did Fluoxetine, the 8 Fluoxetine group decide to switch from ELECT to 9 Costart? 10 A. I don't know. 11 Q. Were you in the Fluoxetine 12 group when they made that switch? 13 A. I believe so, yes. 14 Q. What I mean is did the switch 15 from ELECT to Costart have preexisting data from 16 clinical trials? 17 A. I don't recall a specific 18 impact. The discussion about what the impact 19 would be was part of the decision process. 20 Q. Were you involved in that 21 discussion? 22 A. Yes. 23 Q. What discussion was had about 24 the subject of what the impact would be? Page 273 1 A. I don't recall. 2 Q. Was it contemplated that 3 adverse events that had been assigned according 4 to ELECT would be changed to adverse events that 5 were assigned according to Costart? 6 A. Do you want to clarify that, 7 please? 8 Q. What I'm trying to find out is 9 obviously there's some point in time when you 10 went from using the ELECT dictionary to Costart 11 dictionary. 12 A. Correct. 13 Q. And there were some differences 14 between ELECT and Costart that we were just 15 discussing. 16 A. Correct. 17 Q. How do those differ from, 18 number one, impact on the data that had been 19 collected, the adverse event data that had been 20 collected under the ELECT dictionary? 21 A. It's my understanding with only 22 the two classification terms being different that 23 those were managed individually where the events 24 occurred, and those were reviewed. Page 274 1 Q. Okay. What about the 2 differences in the synonyms? 3 A. That wouldn't have mattered. 4 Q. There was no change to the 5 preexisting data made relating to the difference 6 in the synonyms? 7 A. Not to my knowledge, there 8 wasn't. 9 Q. Was there a decision made to 10 change those adverse event terms that were 11 impacted by the difference in the classification 12 terms? 13 A. To change which terms? 14 Q. The original terms that were 15 assigned according to ELECT. 16 A. We did not change the original 17 synonym terms. 18 Q. How about the cross-indication 19 terms? 20 A. That, I don't recall. 21 Q. If changes were made, how would 22 that be done physically? 23 A. I don't recall specifically. 24 We would have outlined a process so that Page 275 1 everybody was doing it the same way. 2 Q. Would you have people go in and 3 look at the hard copy CRF and change event terms 4 on the CRF or would they be changed on the 5 computer? 6 MR. MYERS: Let me object to the form 7 only to the extent that you're talking about 8 event terms, and the discussion up to now has 9 been synonym terms and classification terms. So 10 I don't know what you're talking about. 11 MS. ZETTLER: Okay. Classification 12 terms. 13 A. I don't recall specifically 14 what process was used, the process that was 15 decided upon, what it was, as to whether we went 16 back to hard copy or not. 17 Q. Can you tell me what the 18 difference is between SSAI and ELECT? 19 A. No. 20 Q. Have you heard the term PIEFER, 21 P-I-E-F-E-R? 22 A. Yes. 23 Q. What are PIEFERS? 24 A. I don't know what the acronym Page 276 1 stands for specifically, I believe it's increased 2 frequency reports, spontaneous reports. 3 Q. And those are reports that are 4 made to the FDA? 5 A. I don't know specifically since 6 I don't deal in the regulatory area. 7 MR. MYERS: I take it when you said 8 those reports, you meant PIEFERS as opposed to 9 spontaneous reports? 10 MS. ZETTLER: Yes. 11 MR. MYERS: You understood it that way. 12 THE WITNESS: Yes. 13 Q. How about CIOMS, have you ever 14 heard of CIOMS, C-I-O-M-S? 15 A. Yes. 16 Q. What is CIOMS? 17 A. I don't know. 18 Q. Does your area have any 19 responsibilities with regards to reporting of 20 adverse events? 21 A. Yes. 22 Q. What are those 23 responsibilities? 24 A. On occasion they'll help Page 277 1 complete the FD 1639 report. 2 Q. Does your area have any 3 responsibilities with regards to adverse events 4 that were reported from outside the United 5 States? 6 A. No, I don't believe so. 7 Q. What area would have that 8 responsibility? 9 A. Each of the individual 10 affiliates. 11 Q. Were the affiliates responsible 12 for reporting adverse events that happened in 13 their areas to the FDA? 14 A. Did each affiliate have 15 responsibility to submit to the FDA? 16 Q. Right. For instance, say an 17 adverse event occurred in France, what would 18 happen with that adverse event information? 19 A. It would get submitted into our 20 system, the DEN system. 21 Q. Okay. Would the French 22 affiliate have the responsibility to report that 23 adverse event to the FDA? 24 A. No, I don't believe so. Page 278 1 Q. Would Lilly have the 2 responsibility to report that adverse event to 3 the FDA? 4 MR. MYERS: When you say Lilly, you 5 mean Lilly Indianapolis? 6 MS. ZETTLER: Right. 7 A. I don't know the regulations 8 that allow for international reporting. 9 Q. So you've heard of CIOMS, but 10 you're not sure of what it is? 11 A. Yes. 12 Q. What about the atypical 13 depression study that is going on now, is that 14 related in any way to the subsyndromal syndrome 15 study? 16 A. No. 17 Q. What is atypical depression, if 18 you know? 19 A. I don't know specifically. 20 Q. Okay. How does it differ from 21 subsyndromal syndrome, if you know? 22 A. They're two different 23 diagnoses. 24 Q. Do you know what the difference Page 279 1 is between the two diagnoses? 2 A. That's more medical, I can't 3 answer that. 4 Q. Who is the physician who has 5 responsibility for the atypical depression study? 6 A. There are two of them 7 currently, Doctor Pande and Doctor Blonglen. 8 Q. When you say there are two of 9 them, two doctors or two studies? 10 A. Two doctors. 11 Q. Have you ever heard of study 12 drug diaries? 13 A. Yes. 14 Q. What are study drug diaries? 15 A. They're diaries that are given 16 to the patients that are enrolled in trials. 17 Q. For what purpose? 18 A. For the purpose of recording 19 information that's requested of them. 20 Q. What types of information? 21 A. It varies depending on the 22 study. 23 Q. Have you seen study drug 24 diaries that have requested adverse event Page 280 1 information? 2 MR. MYERS: For any kind of study? 3 MS. ZETTLER: Yes, let's start with it 4 generally. 5 A. No, I haven't, not to my 6 knowledge, I haven't. 7 Q. To your knowledge, was a study 8 drug diary used on a long-term treatment of 9 depression study? 10 A. What about it? 11 Q. Did they use that study drug 12 diary on that study? 13 A. I don't know. 14 Q. Are you aware of study drug 15 diaries being used on any depression study with 16 Fluoxetine? 17 A. Yes. 18 Q. Which depression studies? 19 A. Oh, I'm sorry, not depression. 20 Q. Which studies generally? 21 A. Obesity. 22 Q. Any others? 23 A. Not to my knowledge. 24 Q. Is it your testimony that study Page 281 1 drug diaries were not used on the depression 2 studies? 3 A. No, that's not what I said. 4 Q. You're just not sure if they 5 were or not? 6 A. That's correct. 7 (PLAINTIFFS' EXHIBIT NO. 18 WAS 8 MARKED FOR IDENTIFICATION AND 9 RECEIVED IN EVIDENCE.) 10 Q. Have you had a chance to review 11 Exhibit 18? 12 A. Yes, I have. 13 Q. Do you recognize that exhibit? 14 A. No, I don't. 15 Q. Have you seen study drug 16 diaries? 17 A. Yes. 18 Q. Does that look like a study 19 drug diary that you've seen in the past? 20 A. No. 21 Q. What is the difference about 22 that diary as compared to what you've seen in the 23 past? 24 A. The one I've recognized in the Page 282 1 past asked for physical activity, it's a larger 2 fold-out kind of thing. 3 Q. Okay. On the second page of 4 that exhibit in the left-hand corner, it asks for 5 any unusual -- I'm sorry, the right-hand corner. 6 It asks for any unusual symptoms that are 7 experienced; correct? 8 MR. MYERS: Well I object to the form. 9 What it says is any symptoms or illnesses, it 10 doesn't use the word unusual. 11 Q. Okay. Any symptoms or 12 illnesses? 13 A. That's correct. 14 Q. On the study drug diaries that 15 you've seen on the obesity studies; correct? 16 A. Yes. 17 Q. Does it have a section such as 18 that on there? 19 A. I don't know. 20 Q. Who would know whether or not 21 study drug diaries are used in the depression 22 studies or have been used in the depression 23 studies? 24 A. CRAs are responsible for Page 283 1 initiating those studies. 2 MS. ZETTLER: Let's take a break. 3 (A SHORT BREAK WAS TAKEN.) 4 (PLAINTIFFS' EXHIBIT NO. 19 WAS 5 MARKED FOR IDENTIFICATION AND 6 RECEIVED IN EVIDENCE.) 7 Q. Have you had a chance to review 8 Exhibit 19? 9 A. Yes, I have. 10 Q. Do you recognize this exhibit? 11 A. Vaguely, yes. 12 Q. It purports to be an E-mail 13 dated December 10, 1990 written by Catherine 14 Mesner; correct? 15 A. Correct. 16 Q. And you're listed as a 17 recipient; correct? 18 A. That's right. 19 Q. Can you tell me what the 20 subject matter of this E-mail is? 21 A. It's on the changing of edits. 22 Q. What are edits? 23 A. They are tools created to help 24 us review and validate the data. Page 284 1 Q. Why are the edits being 2 changed? 3 A. To assist in the process. It 4 appears from this that they weren't well defined 5 up front. 6 Q. Okay. Is this related to the 7 OUS data-gathering project? 8 A. Yes. 9 Q. When it says international 10 data, is that what it's referring to at the top? 11 A. It's referring to the 12 depression data that was collected 13 internationally. 14 Q. Depression data related to 15 suicidality? 16 A. The depression data. 17 Q. The project where employees 18 from Lilly Indianapolis went over to various 19 affiliates in Europe and reviewed CRFs from 20 depression trials? 21 A. Yes, that's correct. 22 Q. If you know, what does 23 Catherine mean under number one where it says 24 since the patient edit and visit-visit edits Page 285 1 cannot be combined daily? 2 MR. MYERS: Before she answers, I 3 object. It would be speculative to what Ms. 4 Mesner meant, but if she knows, certainly she can 5 tell you. 6 A. I don't know what she's 7 referring to specifically. I know what these 8 types of edits are, but I don't know in 9 particular to these studies what they were 10 correcting. 11 Q. What is a patient edit? 12 A. It's a review of the entire 13 patient's data. 14 Q. For what purpose? 15 A. For reviewing it and validating 16 it. 17 Q. Would it be fair to say that a 18 patient edit is a group of edits? 19 A. Yes. 20 Q. What is included in the group 21 of edits on patient edits? 22 A. It would be any edit defined 23 for fields of the clinical report forms. 24 Q. Were there patient edits Page 286 1 related to adverse events? 2 A. I don't know that specifically. 3 Q. Who would know that? 4 A. Catherine. 5 Q. How about visit edits, what are 6 visit edits? 7 A. I think that says visit to 8 visit edits. 9 Q. Okay, visit to visit edits. 10 A. Those are edits looking at data 11 that's carried forward from one visit to the next 12 to see if its data continues, if it's appropriate 13 or there are stop dates in there. 14 Q. What types of information would 15 be carried from visit to visit? 16 A. Concomitant medications. 17 Q. Anything else? 18 A. Adverse events. 19 Q. Anything else? 20 A. Visit dates in general, 21 demographic data to ensure consistency. 22 Q. How does the concomitant 23 medication edit work, the visit to visit edit? 24 A. If a concomitant med is listed Page 287 1 in visit two, for example, and there's no stop 2 date in visit two, it's expected to show up in 3 visit three. And if it doesn't show up in visit 4 three, then a message kicks out. 5 Q. Is that also true for adverse 6 events? 7 A. Yes. 8 Q. So the key there is whether or 9 not a stop date is listed? 10 A. That's right. 11 Q. And the computer is programmed 12 to flag, say, visit three if there's an adverse 13 event that's listed in visit two without a stop 14 date? 15 A. Yes, I think that's right. 16 Q. What are complete patients 17 under number two? 18 A. That usually refers to patients 19 that have all the visits in sequential order, as 20 well as the study summary. 21 Q. When you said a study summary, 22 you mean the final report for the study? 23 A. No. 24 Q. What's the difference between Page 288 1 the study summary and the final report? 2 A. The summary of each individual 3 patient. 4 Q. What is included in a patient 5 summary, a study summary? 6 A. Demographic data, last, the 7 visit date of that particular visit, reason 8 discontinued, and comments field. 9 Q. Why would edits from complete 10 patients be sent to the cluster? 11 A. To review the data that is in 12 the entire patient rather than having to review 13 the patients multiple times where the data aren't 14 there. 15 Q. Okay. When you say complete 16 patients, you mean patients who have completed 17 the study either because the study is over or 18 because it discontinued or is that something 19 that's done on a visit-by-visit basis? 20 A. A complete patient will be all 21 the data from that patient, from the beginning to 22 the study summary, and all visits inclusive. 23 Q. Okay. Just so I'm sure and I'm 24 not confused, if, say, a patient is enrolled in Page 289 1 the study and is randomized to an active drug, 2 but after the fourth or fifth visit drops out, 3 discontinues, that would be a completed patient? 4 A. Yes, if we had the study 5 summary on it. 6 Q. Okay. 7 A. In our definition, a complete 8 patient is just where all the data is together. 9 Q. Is there a study summary per 10 visit or after all the data is together? 11 A. A study summary is at the end 12 of the patient's trial data. 13 Q. And that summary lists the 14 patient's demographic data as well as what they 15 experience from visit to visit? 16 A. No, that's not right. 17 Q. Okay. What does the study 18 summarize -- that's what I'm getting confused on 19 is what the study summary involved. 20 A. The study summary is just the 21 information on the last visit that relates to why 22 the patient discontinued, and demographic data 23 for that patient, and any comments that the 24 investigator chooses to write. Page 290 1 Q. Okay. But it's done after the 2 patient has either discontinued or completed the 3 study? 4 A. It's done at the same time. 5 Q. Okay. But what I'm saying is 6 that it's not done on visit per visit basis? 7 A. That's correct. 8 Q. The study summaries, are they 9 computerized or are they hard copy? 10 A. It depends on the system where 11 the data is being collected. 12 Q. Okay. How about the AS 400? 13 A. It would be hard copy. 14 Q. What system -- on which system 15 would it be computerized? 16 A. CTM. 17 Q. So for those studies that are 18 using the CTM, it would be computerized, and 19 those studies where the hard copy is being used -- 20 hard copy CRFs are being used, it would be hard 21 copy? 22 A. That's correct. 23 Q. What does it mean to clean 24 patient information? Page 291 1 A. Validating the data and 2 ensuring the completeness of the data. 3 Q. What is a HPB? 4 A. I believe it's the regulatory 5 body for Canada. 6 (PLAINTIFFS' EXHIBIT NO. 20 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Have you had a chance to review 10 Exhibit 20? 11 A. Yes, I have. 12 Q. Do you recognize that exhibit? 13 A. Yes. 14 Q. Can you tell me what it is? 15 A. It's a response that was 16 prepared to regulatory questions from Canada's 17 regulatory agency. 18 Q. The exhibit is three page -- 19 two-page exhibit, first page being a memorandum 20 authored by you; correct? 21 A. Correct. 22 Q. Who is Colin Burrell? 23 A. He is the regulatory scientist 24 in Canada. Page 292 1 Q. Do you recall the question that 2 was asked that you were responding to here? I 3 thought you said that was in response to a 4 question by the Canadian regulatory authority. 5 A. Correct. 6 Q. What was the question asked? 7 A. The question is stated there in 8 1a on the second page. 9 Q. Where it says, "As a more 10 stringent measure of the patient response rate, 11 the percentage of patients achieving greater than 12 or equal to 35% reduction from baseline on the 13 Yale-Brown Obsessive-Compulsive Scale," paren, 14 (Y-B-O-C-S), close paren, "should be provided for 15 the visit-wise and end-point analyses of data 16 from the pivotal clinical trials." 17 A. Correct. 18 Q. The studies that were done on 19 OCD, would they just include pharmacological arms 20 or were there therapy arms included also, 21 psychotherapy arms? 22 A. I'm not sure I understand your 23 question. 24 Q. Were patients just tested as to Page 293 1 the -- be administered the drug itself, or were 2 they also given psychotherapy at the same time? 3 A. I don't know the answer to 4 that. 5 (PLAINTIFFS' EXHIBIT NO. 21 WAS 6 MARKED FOR IDENTIFICATION AND 7 RECEIVED IN EVIDENCE.) 8 Q. Have you had a chance to review 9 Exhibit 21? 10 A. Yes, I have. 11 Q. Do you recognize this exhibit? 12 A. No, I don't. 13 Q. Are you familiar with the 14 subject matter of the exhibit? 15 A. No, I'm not. 16 Q. Have you heard the term 17 messenger templates before? 18 A. Not -- no, not messenger 19 templates. 20 Q. Have you heard of templates 21 before? 22 A. Yes. 23 Q. What are templates? 24 A. Templates are a form-type Page 294 1 process used to complete something, like 2 performance appraisals, I have templates used. 3 Q. Are templates paragraphs of 4 wording that have been created that's just used 5 sort of as a form instead of having to rewrite a 6 letter, say, or a report? 7 A. Sometimes. 8 Q. Exhibit 21 is a three-page 9 exhibit starting with Pz 1573 1167 and going to 10 Pz 1573 1169; correct? 11 A. Yes. 12 Q. And the title of it -- it 13 appears to be an E-mail dated October 15, 1991 14 and authored by Melissa Humbert; correct -- or, 15 I'm sorry, Anita Clark; correct? 16 A. Correct. 17 Q. Have you had a chance to read 18 through the statements made on here under the 19 various wording like, for instance, the first one 20 looks like it's OVRDOSE1? 21 A. Not carefully, I haven't. 22 Q. Could you read the first 23 couple, two or three of them, for me? 24 A. Okay. Page 295 1 Q. Do you recognize the subject 2 matter of any of the first few paragraphs under 3 OVRDOSE1, OVRDOSE2, OVRDOSE3? 4 A. No, I don't. 5 Q. What are OUS IMMs? 6 A. I do not know. 7 Q. Do you know why this would have 8 been turned over as part of your file? 9 A. No, I don't. 10 MR. MYERS: Was it in fact in her 11 documents or somebody else's? 12 MS. ZETTLER: No, it was in hers. 13 Q. To your knowledge, is it policy 14 with regards to the adverse event term attempted 15 suicide to use a drug as a method to list it 16 under an overdose? 17 A. I don't know the policies for 18 listing overdoses in DEN. 19 Q. Are you aware of whether or not 20 the ELECT dictionary was used in Indianapolis as 21 well as the affiliates when it was used? 22 A. No, I'm not certain as to what 23 they used. 24 Q. Are you aware of any event term Page 296 1 dictionary that was used outside the United 2 States that was not used here? 3 A. I'm not aware of any, no. 4 Q. Have you heard of a World 5 Health Organization? 6 A. Yes. 7 Q. Are you aware that they have an 8 event terms dictionary? 9 A. No, I was not aware of that. 10 Q. Are you aware that in the 11 Costart dictionary, there's a section that lists 12 the Costart terms and the corresponding Who-Art 13 terms? 14 A. You're saying that's in the 15 Costart dictionary? 16 Q. Right. 17 A. No, I didn't know that. 18 MS. ZETTLER: I'm going to read some 19 names off to you and I would like you to tell me 20 if you recognize the names. 21 A. Okay. 22 Q. M. L. Elks, E-L-K-S? 23 A. No. 24 Q. B. M. Nielson? Page 297 1 A. No. 2 Q. I not sure if I can say this 3 right, K. Behnke, B-E-H-N-K-E? 4 A. Spell that again. 5 Q. B-E-H-N-K-E, first initial K. 6 A. No. 7 Q. P. Arup, A-R-U-P? 8 A. No. 9 Q. A. Geisler, G-E-I-S-L-E-R? 10 A. No. 11 Q. E. Ipsen, I-P-S-E-N? 12 A. No. 13 Q. B. Maach-Moller, M-A-A-C-H, 14 hyphen, Moller, M-O-L-L-E-R? 15 A. No. 16 Q. S. C. Ohrberg, O-H-R-B-E-R-G. 17 A. No. 18 Q. L. M. Nagy, N-A-G-Y? 19 A. No. 20 Q. C. A. Morgan? 21 A. No. 22 Q. S. M. Southwick, 23 S-O-U-T-H-W-I-C-K? 24 A. No. Page 298 1 Q. D. S. Charney, C-H-A-R-N-E-Y? 2 A. Is that David Charney? 3 Q. It just has D. S. here. 4 A. I'm familiar with a Charney, I 5 don't know if it's the same. 6 Q. F. K. Judd, J-U-D-D? 7 A. I know a Judd, I don't know if 8 the initials are F. K. 9 Q. K. Moore, M-O-O-R-E? 10 A. No. 11 Q. T. R. Norman? 12 A. No. 13 Q. G. D. Burrows? 14 A. No. 15 Q. R. K. Gupta, G-U-P-T-A? 16 A. No. 17 Q. G. Parker? 18 A. No. 19 Q. J. De Wilde, D-E-W-I-L-D-E? 20 A. No. 21 Q. R. Spiers, S-P-I-E-R-S? 22 A. No. 23 Q. C. Mertens, M-E-R-T-E-N-S? 24 A. No. Page 299 1 Q. F. Bartholome? 2 A. No. 3 Q. G. Schotte, S-C-H-O-T-T-E? 4 A. No. 5 Q. S. Leyman, L-E-Y-M-A-N? 6 A. No. 7 Q. Edward Williams -- I'm sorry, 8 R. Williams? 9 A. No. 10 Q. R. A. Edwards? 11 A. No. 12 Q. G. M. Newburn? 13 A. No. 14 Q. R. Mullen? 15 A. No. 16 Q. D. B. Menkes, M-E-N-K-E-S? 17 A. No. 18 Q. C. Segkar, S-E-G-K-A-R. 19 A. No. 20 Q. Who is David Charney? 21 A. I believe he's a clinician that 22 studied Fluoxetine in the past. 23 Q. Is he currently working on any 24 studies on Fluoxetine, to your knowledge? Page 300 1 A. Not to my knowledge, no. 2 Q. When I say any studies on 3 Fluoxetine, I mean including all the studies 4 we've talked about so far. 5 A. Okay. 6 Q. I'm sorry, did you say that you 7 believe he has worked on a Fluoxetine study in 8 the past? 9 A. Yes. 10 Q. How recently? 11 A. I don't know. 12 Q. How about Judd, who is the Judd 13 that you know? 14 A. Lou Judd. 15 Q. Is he a doctor? 16 A. Yes. 17 Q. Who is Doctor Judd? 18 A. He's chairman of the psychiatry 19 department at San Diego State or one of the 20 universities in California. 21 Q. Is Doctor Judd currently 22 working on any Fluoxetine studies? 23 A. Can you define that more 24 clearly? Page 301 1 Q. Is he involved in the proposal, 2 preparation, running, conducting, analysis of any 3 Fluoxetine clinical trial or study? 4 A. Yes. 5 Q. Which study? 6 (Witness confers with counsel.) 7 MR. MYERS: I'm going to instruct her 8 not to answer because -- I'll tell you this, 9 though, it's one of the studies that I earlier 10 told her not to answer about, so draw whatever 11 conclusion you want and narrow it down. 12 MS. ZETTLER: Well, she's already said 13 that he's a clinical investigator on a study. 14 MR. MYERS: Right. 15 MS. ZETTLER: So what are you basing 16 your objection on? 17 MR. MYERS: That you shouldn't be able 18 to get the information indirectly that I earlier 19 instructed her not to give you in a direct 20 fashion when you asked the question. 21 MS. ZETTLER: Based on what, Larry? 22 MR. MYERS: The same objection that we 23 urged before. 24 MS. ZETTLER: The proprietary trade Page 302 1 secret? 2 MR. MYERS: Right. And who does our 3 studies and specifically what studies that they 4 do for us is otherwise proprietary trade secret 5 information. 6 Q. Are you going to follow your 7 counsel's advice? 8 A. Yes, I am. 9 MS. ZETTLER: Certify it. 10 (QUESTION CERTIFIED.) 11 MR. MYERS: You've got another list of 12 names, that one was pretty funny, I haven't heard 13 a lot of those before. 14 MS. ZETTLER: Really? 15 Q. Doctor Judd is in San Diego, as 16 far as you know? 17 A. As far as I know, yes. 18 Q. Okay. We have another list 19 here. Same question, do you recognize any of 20 these people, okay? 21 A. Okay. 22 Q. Faruk -- I'm sorry, I can never 23 say this guy's name, Abuzzahab? 24 A. No. Page 303 1 Q. Jay Amsterdam? 2 A. Yes. 3 Q. George Arnoff? 4 A. Yes. 5 Q. J. Ananth, A-N-A-N-T-H? 6 A. No. 7 Q. Stephen Aronoff? 8 A. I'm not sure I know the 9 difference between the two Aronoffs. 10 Q. Okay. One is spelled 11 A-R-N-O-F-F, George, and the other is spelled 12 A-R-O-N-O-F-F. Does that help you out? 13 A. No. 14 Q. Do you know an Aronoff, but 15 you're not sure if it's George or Stephen? 16 A. That's right. 17 Q. Richard Atkinson? 18 A. Yes. 19 Q. B. Baker? 20 A. No. 21 Q. James Ballenger? 22 A. Yes. 23 Q. J. B. Bastani, B-A-S-T-A-N-I? 24 A. No. Page 304 1 Q. Robert Beilski, B-E-I-L-S-K-I? 2 A. No. 3 Q. Richard Bergenstal? 4 A. No. 5 Q. Charles Blatt, B-L-A-T-T? 6 A. Yes. 7 Q. Richard Borison? 8 A. No. 9 Q. Guy Chouinard? 10 A. Yes. 11 Q. James Claghorn? 12 A. Yes. 13 Q. Duncan Clark? 14 A. No. 15 Q. Emil Coccaro? 16 A. Yes. 17 Q. Steven Cohen-Cole? 18 A. Yes. 19 Q. Cal Cohn? 20 A. No. 21 Q. Jonathan Cole? 22 A. No. 23 Q. Roberto Dominguez? 24 A. Yes. Page 305 1 Q. John Downs? 2 A. No. 3 Q. Robert DuPont? 4 A. No. 5 Q. Stanley Fahn, F-A-H-N? 6 A. No. 7 Q. Maurizio Fava? 8 A. Yes. 9 Q. Jan Fawcett? 10 A. Yes. 11 Q. F. Fawzy, F-A-W-Z-Y? 12 A. Yes. 13 Q. John Feighner? 14 A. Yes. 15 Q. James Ferguson? 16 A. No. 17 Q. David Folks? 18 A. No. 19 Q. R. Fontaine? 20 A. No. 21 Q. John Foreyt? 22 A. Yes. 23 Q. Robert -- I'm sorry, Rohn 24 Friedman? Page 306 1 A. No. 2 Q. Alexander Glassman? 3 A. Yes. 4 Q. Harold Goldberg? 5 A. No. 6 Q. Scott Goldsmith? 7 A. No. 8 Q. Gary Gotlieb? 9 A. No. 10 MS. ZETTLER: Do you recognize these 11 guys? 12 MR. MYERS: A few more. 13 Q. Donna Greenberg? 14 A. Yes. 15 Q. We finally get a woman in the 16 group. John Greist, G-R-E-I-S-T? 17 A. Yes. 18 Q. D. Grover? 19 A. No. 20 Q. Michael Gulley, G-U-L-L-E-Y? 21 A. No. 22 Q. Angelos Halaris? 23 A. No. 24 Q. Craig Heim? Page 307 1 A. No. 2 Q. Mark Hertzman? 3 A. No. 4 Q. J. Hoffman? 5 A. No. 6 Q. Jimmie Holland? 7 A. Yes. That's a woman also. 8 Q. Good. James Hooper? 9 A. No. 10 Q. James Jefferson? 11 A. Yes. 12 Q. Dilip Jeste, J-E-S-T-E? 13 A. No. 14 Q. Kenneth Jobson? 15 A. No. 16 Q. Richard Kamarath? 17 A. Yes. 18 Q. S. Katz, K-A-T-Z? 19 A. Yes. 20 Q. Donald Klein? 21 A. No. 22 Q. Lorrin Koran, K-O-R-A-N? 23 A. No. 24 Q. R. Arthur Korsnick, Page 308 1 K-O-R-S-N-I-C-K? 2 A. No. 3 Q. Kevin Kruse, K-R-U-S-E? 4 A. No. 5 Q. Ronald Landbloom? 6 A. No. 7 Q. Louis Lemberger? 8 A. Yes. 9 Q. Robert Levine, L-E-V-I-N-E? 10 A. No. 11 Q. I'm sorry? 12 A. No. 13 Q. Benjamin Levy? 14 A. I don't know if it's the same. 15 Q. Norman? 16 A. E. S., I think that's right. 17 Q. There's also an Alan? 18 A. I think it's Norman. 19 Q. Charles Lucas? 20 A. No. 21 Q. Edward Mascioli, 22 M-A-S-C-I-O-L-I? 23 A. No. 24 Q. R. J. McDevitt? Page 309 1 A. No. 2 Q. Harris McIlwain, 3 M-C-I-L-W-A-I-N? 4 A. No. 5 Q. Frank Menolascino, 6 M-E-N-O-L-A-S-C-I-N-O? 7 A. No. 8 Q. Marnett Meyers? 9 A. No. 10 Q. James Mitchell? 11 A. No. 12 Q. Raj Nakra, N-A-K-R-A? 13 A. No. 14 Q. Craig Nelson? 15 A. No. 16 Q. Charles Nemeroff? 17 A. Yes. 18 Q. John Peteet, P-E-T-E-E-T? 19 A. No. 20 Q. Carol Phillips? 21 A. No. 22 Q. George Porter? 23 A. No. 24 Q. M. Presser? Page 310 1 A. No. 2 Q. Fred Quitkin? 3 A. Yes. 4 Q. Stephen Rappaport? 5 A. Yes. 6 Q. R. Reid, R-E-I-D? 7 A. No. 8 Q. Fred Reimherr, R-E-I-M-H-E-R-R? 9 A. Yes. 10 Q. R. Remick, R-E-M-I-C-K? 11 A. No. 12 Q. William Richardson? 13 A. No. 14 Q. M. Riddle, R-I-D-D-L-E? 15 A. I recognize the name. 16 Q. Karen Ritchie? 17 A. No. 18 Q. Barry Rittberg? 19 A. No. 20 Q. Jerrold Rosenbaum? 21 A. Yes. 22 Q. Sidney Rosenblatt? 23 A. Yes. 24 Q. Jesse Rosenthal? Page 311 1 A. No. 2 Q. Murray Rosenthal? 3 A. No. 4 Q. James Rosenzweig, 5 R-O-S-E-N-Z-W-E-I-G? 6 A. Yes. 7 Q. John Rush? 8 A. Yes. 9 Q. Sherwyn Schwartz? 10 A. No. 11 Q. Baron Shopsin? 12 A. No. 13 Q. Ram Shrivastava? 14 A. No. 15 Q. Gary Small? 16 A. No. 17 Q. Peter Stokes? 18 A. Yes. 19 Q. Andrew Thieneman? 20 A. No. 21 Q. D. Trachtenberg? 22 A. No. 23 Q. Victor Vertes, V-E-R-T-E-S? 24 A. Yes. Page 312 1 Q. R. Winchel? 2 A. No. 3 Q. Rena Wing? 4 A. Yes. 5 Q. Is that a man or woman? 6 A. It's a woman. 7 Q. D. Winstead? 8 A. No. 9 Q. Jaron Winston? 10 A. No. 11 Q. Jose Yaryura-Tobias? 12 A. No. 13 Q. Okay. Is Doctor Fawcett doing 14 any work for Lilly at this time, Jan Fawcett? 15 A. I don't know. 16 Q. Have you ever talked with 17 Doctor Fawcett? 18 A. I've met him briefly. 19 Q. When was that? 20 A. The day prior to the advisory 21 committee meeting. 22 Q. When was the last time that you 23 were aware that Doctor Fawcett was doing work for 24 Lilly? Page 313 1 A. I'm not sure I understand your 2 question. I didn't say earlier that I knew that 3 he's doing it now, I don't know -- 4 Q. Well, I mean obviously -- 5 A. That he's done it in the past. 6 Q. Well, he represented Lilly at 7 the advisory committee meeting, did he not? 8 A. Yes. 9 Q. And earlier you testified that 10 he was a consultant prior to the advisory 11 committee meeting; correct? 12 A. Yes. 13 Q. But other than that, are you 14 aware of any other consultation or work that he's 15 done on Lilly's behalf or as a result of being 16 hired by Lilly? 17 A. Not that I can recall, no. 18 Q. Has Doctor Fawcett ever 19 conducted a clinical trial on Fluoxetine for 20 Lilly? 21 A. I don't know. 22 Q. How about Doctor Amsterdam, how 23 do you know Doctor Amsterdam? 24 MR. MYERS: Before she answers, I'm Page 314 1 going do let her tell you whether or not these 2 people have investigated Fluoxetine. Since 3 you've obviously got a laundry list, I don't know 4 where you got it from, but I'm not going to 5 permit her to tell you what studies they 6 performed, but I'll let her tell you whether they 7 were investigators or not, since you have a list, 8 and whether they have any other relationship with 9 Lilly. So go ahead and answer that. 10 MS. ZETTLER: So you're going to agree 11 to certify any question that I ask her that 12 you're not going to allow her to answer or do I 13 have to go through the motions -- 14 MR. MYERS: No, you don't have to go 15 through the motion on every single one of those 16 names. 17 MS. ZETTLER: Are you going to allow 18 her to answer whether or not they're currently 19 working for Lilly in some capacity generally? 20 MR. MYERS: Yes. And beyond that, 21 we'll have to see how the questions unfold. 22 Q. Okay. How do you know Doctor 23 Amsterdam? 24 A. He was one of the consultants Page 315 1 on the rechallenge study as well as a previous 2 investigator. 3 Q. On Fluoxetine? 4 A. Yes. 5 Q. Is he working on any -- and 6 again, just to save time, when I say clinical 7 trial on Fluoxetine, I mean any of the studies we 8 talked about earlier. 9 A. Okay. 10 Q. Is he working on a study right 11 now on Fluoxetine for a clinical trial? 12 A. Yes. 13 MS. ZETTLER: And I think just to make 14 things easier, I'm going to ask her which one. 15 MR. MYERS: I'm not going to let her 16 tell you which one. So you don't have to go 17 through the routine. 18 MS. ZETTLER: Let the record reflect 19 that as to each of these people we're going to go 20 over, I'm going to ask her if they're currently 21 working on a study and which study. 22 MR. MYERS: Right, that's fine. 23 MS. ZETTLER: And you're going to 24 instruct her not to answer. Page 316 1 MR. MYERS: Correct. 2 Q. And you're going to follow his 3 instructions on those questions? 4 A. Yes, that's right. 5 MS. ZETTLER: Let's certify all of 6 these questions right off the bat so we don't 7 have to waste any time on it. 8 (QUESTIONS CERTIFIED.). 9 Q. Where is Doctor Amsterdam 10 located, if you know? 11 A. He's in Pennsylvania. 12 Q. Other than the rechallenge 13 study, has he worked as a consultant for any 14 other purpose for Lilly? 15 A. I don't know. 16 Q. How about Doctor Arnoff, 17 whether it's A-R-N-O-F-F, George, or 18 A-R-O-N-O-F-F, Stephen, how do you know him? 19 A. I know the name as a previous 20 investigator. 21 Q. Is Doctor Arnoff currently 22 doing any work for Lilly on any studies? 23 A. Not to my knowledge. 24 Q. Okay. What about Atkinson? Page 317 1 A. What's your question? 2 Q. Do you know him? 3 A. Yes. Not personally, no. 4 Q. How do you know him? 5 A. He's an investigator. 6 Q. Currently? 7 A. Yes. 8 Q. Has he been an investigator in 9 the past? 10 A. I don't know. 11 Q. Is he working on a consultant -- 12 as a consultant on anything for Lilly right now? 13 A. I don't know. 14 Q. Was he a rechallenge 15 consultant? 16 A. No. 17 Q. Where is he located? 18 A. I don't know. 19 Q. How about B. Baker -- I'm 20 sorry, James Ballenger? 21 A. Currently an investigator. 22 Q. Where is Doctor Ballenger 23 located? 24 A. I don't know. Page 318 1 Q. Is he currently working and a 2 consultant for Lilly? 3 A. I don't know. 4 Q. Has he previously worked as a 5 consultant for Lilly? 6 A. I don't know. 7 Q. Was he on rechallenge? 8 A. Not to my knowledge, no. 9 Q. How about Charles Blatt? 10 A. An investigator. 11 Q. Currently? 12 A. Yes. 13 Q. I'm sorry, did you say Doctor 14 Amsterdam is currently an investigator? 15 A. Yes. 16 MS. ZETTLER: Are you going to let me 17 ask her if they're working on depression as 18 opposed to other indications? 19 MR. MYERS: You can ask her that. 20 Q. Is Doctor Amsterdam, the study 21 that he's working on, is it a depression study? 22 A. Yes, it is. 23 Q. How about Doctor Atkinson? 24 A. Other indication. Page 319 1 Q. How about Doctor Ballenger? 2 A. Other indication. 3 Q. Doctor Blatt? 4 A. Depression. 5 Q. If I ask you this -- I'm sorry, 6 but do you know where Doctor Blatt is located? 7 A. No, I don't. 8 Q. Has Doctor Blatt ever worked as 9 a consultant for Lilly on Fluoxetine? 10 A. I don't know. 11 Q. When I say that, I mean 12 currently or previously. 13 A. Okay. 14 Q. Is that your answer? 15 A. I still don't know. 16 Q. How about Guy Chouinard, how do 17 you know Doctor Chouinard? 18 A. Previously investigator and 19 consultant. 20 Q. Consultant on rechallenge? 21 A. No. 22 Q. What was he a consultant on? 23 A. Another protocol, 24 non-Fluoxetine. Page 320 1 Q. You mean non-Fluoxetine at all 2 or non-depression indication? 3 A. Not Fluoxetine. 4 Q. Is he currently working with 5 Lilly in any capacity, to your knowledge? 6 A. Not to my knowledge. 7 Q. When you say non-Fluoxetine, 8 was he working as a consultant on a protocol for 9 another compound? 10 A. Yes. 11 Q. How about James Claghorn? 12 A. I recognize the name. 13 Q. Do you know how you recognize 14 it or where you recognize it from? 15 A. No, I don't. 16 Q. To your knowledge is Doctor 17 Claghorn currently working for Lilly in any 18 capacity? 19 A. I don't know. 20 Q. How about Steven Cohen-Cole? 21 A. Again, I recognize the name, 22 but that's it. 23 Q. How about Roberto Dominguez? 24 A. Prior investigator, current Page 321 1 investigator, not on Fluoxetine currently. 2 Q. On another Lilly compound? 3 A. Yes. 4 Q. Previously did he work on 5 Fluoxetine? 6 A. Yes. Can I take a ten-minute 7 break? 8 Q. Sure. 9 (A SHORT RECESS WAS TAKEN.) 10 Q. We left off on Doctor 11 Dominguez. Has he been a consultant for Lilly at 12 any time as far as you know? 13 A. Yes, I believe he has been. 14 Q. On Fluoxetine? 15 A. Yes. 16 Q. In what aspect? 17 A. I don't know. 18 Q. Do you know if he was on 19 rechallenge? 20 A. No, I don't know. 21 Q. Maurizio Fava, M-A-U-R-I-Z-I-O? 22 A. Maurizio. 23 Q. Maurizio Fava. How do you know 24 Doctor Fava? Page 322 1 A. He's been an investigator. 2 Q. On Fluoxetine? 3 A. Yes. 4 Q. Is he currently an 5 investigator? 6 A. He has submitted a proposal, so 7 if you consider that in process. 8 Q. Is it a proposal for a 9 depression study? 10 A. Yes. 11 Q. With Fluoxetine? 12 A. Yes. 13 Q. Is that proposal being 14 considered? 15 A. Yes. 16 Q. Has Doctor Fava worked as a 17 consultant for Lilly at any time? 18 A. I don't know. 19 Q. We've already covered Doctor 20 Fawcett; correct? As far as you know he's not a 21 consultant at this time? 22 A. That's correct. 23 Q. Doctor Fawzy, F-A-W-Z-Y? 24 A. An investigator. Page 323 1 Q. Currently? 2 A. That, I don't remember. 3 Q. On Fluoxetine? 4 A. Yes. 5 Q. Depression? 6 A. Yes. 7 Q. Has Doctor Fawzy ever been a 8 consultant for Lilly? 9 A. I don't know. 10 Q. Doctor Feighner? 11 A. I recognize the name. 12 Q. Other than that, you don't 13 recall any detail? 14 A. No, that's correct. 15 Q. Doctor Foreyt, F-O-R-E-Y-T? 16 A. An investigator. 17 Q. Currently? 18 A. Yes. 19 Q. Fluoxetine? 20 A. Yes. 21 Q. Depression? 22 A. No. 23 Q. Has he ever worked as a 24 consultant? Page 324 1 A. I don't know. 2 Q. Where is Doctor Foreyt located? 3 A. I don't know. 4 Q. Doctor Dominguez, where is he 5 located? 6 A. Florida. 7 Q. Do you know where in Florida? 8 A. Miami. 9 Q. Doctor Fava? 10 A. Out east, but I don't know 11 where. 12 Q. Doctor Fawzy, F-A-W-Z-Y? 13 A. I don't know. 14 Q. How about Rohn Friedman? 15 A. I don't know that I recognized 16 that name initially. 17 Q. Alexander Glassman? 18 A. An investigator. 19 Q. Currently? 20 A. Yes. 21 Q. Where is he located? 22 A. I don't know. 23 Q. Is he an investigator on 24 Fluoxetine? Page 325 1 A. Yes. 2 Q. For depression? 3 A. Yes. 4 Q. Has he ever acted as a 5 consultant? 6 A. I don't know. 7 Q. How about Donna Greenberg? 8 A. An investigator. 9 Q. Do you know where she's 10 located? 11 A. No. 12 Q. Is she currently an 13 investigator? 14 A. Yes. 15 Q. On Fluoxetine? 16 A. Yes. 17 Q. Depression? 18 A. Yes. 19 Q. Has she ever acted as a 20 consultant for Lilly? 21 A. I don't know. 22 Q. John Greist? 23 A. An investigator. 24 Q. Where is he located? Page 326 1 A. Wisconsin. 2 Q. Currently an investigator? 3 A. Yes. 4 Q. On Fluoxetine? 5 A. Yes. 6 Q. Depression? 7 A. Back up, I'm sorry, it's not 8 Fluoxetine. 9 Q. Another compound manufactured 10 by Lilly? 11 A. Yes. 12 Q. Depression? 13 A. What about depression? 14 Q. Is it a depression study? 15 A. Yes. 16 Q. Has Doctor Greist ever worked 17 as an investigator for Lilly on Fluoxetine? 18 A. Yes. 19 Q. Is that a depression study 20 also, or studies? 21 A. Yes. 22 Q. Has he ever been a consultant 23 for Lilly? 24 A. Yes. Page 327 1 Q. Is he currently a consultant? 2 A. Not to my knowledge. 3 Q. Was he a consultant related to 4 Fluoxetine? 5 A. Yes. 6 Q. In what area? 7 A. Obsessive compulsive disorder. 8 Q. Was he involved as a consultant 9 in any way on suicidality or violent aggressive 10 behavior? 11 A. I don't recall. 12 Q. Is he involved in rechallenge? 13 A. I don't believe so. 14 Q. Jimmie Holland? 15 A. An investigator. 16 Q. Currently? 17 A. Yes. 18 Q. On Fluoxetine? 19 A. Yes. 20 Q. Depression? 21 A. Yes. 22 Q. Where is she located? 23 A. I don't know. 24 Q. Where is Doctor Greist located -- Page 328 1 is it Greist? 2 A. Wisconsin, as I said. 3 Q. I'm sorry, okay. Did Doctor 4 Holland ever work as a consultant for Lilly? 5 A. I don't know. 6 Q. James Jefferson? 7 A. Investigator. 8 Q. Currently? 9 A. I don't know. 10 Q. He was in the past? 11 A. Yes. 12 Q. On Fluoxetine? 13 A. Yes. 14 Q. Depression? 15 A. Yes. 16 Q. Has he ever worked as a 17 consultant? 18 A. I don't know. 19 Q. Do you know where Doctor 20 Jefferson is located? 21 A. No, I don't. 22 Q. Doctor Kamarath? 23 MR. MYERS: How do you spell that? 24 MS. ZETTLER: K-A-M-A-R-A-T-H. Page 329 1 A. I recognize the name only. 2 Q. S. E. Katz? 3 A. Investigator. 4 Q. Currently? 5 A. I don't believe so. 6 Q. Fluoxetine? 7 A. I believe so, yes. 8 Q. Depression? 9 A. I don't know. 10 Q. Has Doctor Katz ever worked as 11 a consultant for Lilly? 12 A. I don't know. 13 Q. Donald Klein? 14 A. Did I recognize that initially? 15 MR. MYERS: I don't think so, I didn't 16 mark that. 17 Q. I had it marked, but I could 18 have been wrong. 19 A. I don't recall that one. 20 Q. How about -- do you know where 21 Doctor Katz is located? 22 A. No, I don't. 23 Q. Louis Lemberger? 24 A. Lilly employee. Page 330 1 Q. Currently? 2 A. No. 3 Q. Do you know where Doctor 4 Lemberger is now? 5 A. No, I don't. 6 Q. Do you know when he left Lilly? 7 A. It's been within the last two 8 years. 9 Q. How about Norman Levy? 10 A. An investigator. 11 Q. Currently? 12 A. No. 13 Q. On Fluoxetine? 14 A. Yes. 15 Q. Depression? 16 A. I don't know the answer to 17 that. 18 Q. Has he ever acted as a 19 consultant for Lilly? 20 A. I don't know. 21 Q. Do you know where he's located? 22 A. No. 23 Q. Doctor Arnoff, we talked about 24 a little bit earlier. Do you know where Doctor Page 331 1 Arnoff is located? 2 A. I believe he's in Tennessee. 3 Q. Is he currently working for 4 Lilly in any capacity? 5 A. Yes. 6 Q. What is he doing now? 7 A. An investigator. 8 Q. Fluoxetine? 9 A. No. 10 Q. Depression? 11 A. Yes. 12 Q. And we know he acted as a 13 consultant prior to the advisory committee 14 meeting; correct? 15 A. The suicide advisory committee, 16 yes. 17 Q. Has he acted as a consultant in 18 any other capacity for Lilly other than in 19 preparation for the advisory committee meeting? 20 A. I don't know. 21 Q. Fred Quitkin? 22 A. Investigator. 23 Q. Currently? 24 A. Yes. Page 332 1 Q. Fluoxetine? 2 A. Yes. 3 Q. Depression? 4 A. Yes. 5 Q. Where is he located? 6 A. New York. 7 Q. I believe you said yesterday he 8 acted as a consultant in rechallenge? 9 A. Yes, that's right. 10 Q. To your knowledge has he acted 11 as a consultant for Lilly in any other capacity? 12 A. I don't know. 13 Q. Has he done any other work for 14 Lilly other than being a clinical investigator on 15 Fluoxetine or acting as a consultant on 16 rechallenge? 17 A. Could you be more specific? 18 Q. No, I can't. Has he done 19 anything else besides consulting with regards to 20 the rechallenge study or performing clinical 21 trials on Fluoxetine? 22 A. Not to my knowledge. 23 Q. Stephen Rappaport? 24 A. Recognize the name. Page 333 1 Q. Any other details that you can 2 give me? 3 A. No. 4 Q. Fred Reimherr, R-E-I-M-H-E-R-R? 5 A. An investigator. 6 Q. Currently? 7 A. Yes. 8 Q. Where is he located? 9 A. I believe in Utah. 10 Q. Is he an investigator on 11 Fluoxetine? 12 A. Yes. 13 Q. Depression? 14 A. Yes. 15 Q. Has he ever acted as a 16 consultant for Lilly? 17 A. I don't know. 18 Q. Earlier I believe you said that 19 you might recognize the name of M. A. Riddle, but 20 you weren't sure? 21 A. That's correct. 22 Q. Have you remembered anything 23 else about Doctor Riddle? 24 A. I recognize the name as an Page 334 1 author on a manuscript or on a publication. 2 Q. A Lilly publication? 3 A. I don't believe so. 4 Q. Any other details? 5 A. No. 6 Q. Jerrold Rosenbaum? 7 A. Investigator. 8 Q. Currently? 9 A. Yes. 10 Q. On Fluoxetine? 11 A. Yes. 12 Q. Depression? 13 A. Yes. 14 Q. Do you know where Doctor 15 Rosenbaum is located? 16 A. No. 17 Q. Has Doctor Rosenbaum ever acted 18 as a consultant for Lilly? 19 A. I don't know. 20 Q. Has Doctor Rosenbaum done any 21 other work for Lilly as far as you know other 22 than performing clinical trials? 23 A. I don't know. 24 Q. I'm sorry, did I ask you if you Page 335 1 know where he's located? 2 A. Yes, I don't know where he is. 3 Q. Sidney Rosenblatt? 4 A. An investigator. 5 Q. Currently? 6 A. Yes. 7 Q. Fluoxetine? 8 A. Yes. 9 Q. On a depression study? 10 A. No. 11 Q. Another indication? 12 A. Yes. 13 Q. Has Doctor Rosenblatt ever 14 acted as a consultant for Lilly? 15 A. I don't know. 16 Q. Do you know where he's located? 17 A. No, I do not. 18 Q. James Rosenzweig? 19 A. Rosenzweig. 20 Q. Okay. 21 A. An investigator. 22 Q. Still trying to get his name 23 spelled right. Do you know where he's located? 24 A. No. Page 336 1 Q. Current investigator? 2 A. Yes. 3 Q. On Fluoxetine? 4 A. Yes. 5 Q. Depression? 6 A. No. 7 Q. Another indication? 8 A. Yes. 9 Q. Has he ever acted as a 10 consultant for Lilly? 11 A. I don't know. 12 Q. Has he done any other work 13 other than conducting clinical trials on behalf 14 of Lilly for Lilly? 15 A. I don't know. 16 Q. John Rush? 17 A. Investigator. 18 Q. Currently? 19 A. Yes. 20 Q. Fluoxetine? 21 A. Yes. 22 Q. Depression? 23 A. Yes. 24 Q. Do you know where he's located? Page 337 1 A. Texas. 2 Q. Has he ever acted as a 3 consultant for Lilly? 4 A. I don't know. 5 Q. Other than performing clinical 6 trials currently, has he done any other work for 7 Lilly as far as you know? 8 A. He's done historical trials. 9 Q. On Fluoxetine? 10 A. Yes. 11 Q. What are historical trials? 12 A. Trials that are over with, 13 completed trials. You asked for current trials, 14 I thought. 15 Q. Oh, I'm sorry, so you meant 16 past trials? 17 A. Yes. 18 Q. I thought you meant a 19 historical trial as being a trial that's 20 conducted. 21 A. I'm sorry. 22 Q. That's okay. So he's currently 23 doing a trial on Fluoxetine and he's done past 24 trials on Fluoxetine? Page 338 1 A. That's correct. 2 Q. The past trials that he 3 conducted, were they depression trials? 4 A. Yes. 5 Q. Peter Stokes? 6 A. I recognize the name. He was a 7 speaker from the floor at the advisory committee 8 meeting on September 21st. 9 Q. To your knowledge has Doctor 10 Stokes ever performed a clinical trial on behalf 11 of Lilly? 12 A. I don't know. 13 Q. Did Doctor Stokes, when he 14 spoke from the floor, identify himself as having 15 had any connection with Lilly? 16 A. I don't recall. 17 Q. Is he currently doing any 18 studies for Lilly? 19 A. No, not to my knowledge, he's 20 not. 21 Q. Has he ever acted as a 22 consultant for Lilly? 23 A. I don't know. 24 Q. Do you know where he's located? Page 339 1 A. No, I don't. 2 Q. Victor Vertes, V-E-R-T-E-S? 3 A. Investigator. 4 Q. Currently? 5 A. Yes. 6 Q. Fluoxetine? 7 A. Yes. 8 Q. Depression? 9 A. No. 10 Q. Another indication? 11 A. Yes. 12 Q. Do you know where he's located? 13 A. No, I don't. 14 Q. Has he ever performed 15 depression trials on Fluoxetine for Lilly? 16 A. I don't know. 17 Q. Has he ever acted as a 18 consultant for Lilly? 19 A. I don't know. 20 Q. Besides performing the current 21 clinical trials that he's working on, has he done 22 any other work for Lilly, to your knowledge? 23 A. I don't know. 24 Q. Rena Wing? Page 340 1 A. Investigator. 2 Q. Currently? 3 A. Yes. 4 Q. Fluoxetine? 5 A. Yes. 6 Q. Depression? 7 A. No. 8 Q. Other indication? 9 A. Yes. 10 Q. Do you know where Doctor Vertes 11 is located? 12 A. No, I don't. 13 Q. How about Doctor Wing? 14 A. No. 15 Q. Has she ever performed a 16 clinical trial on Fluoxetine as far as you know 17 for depression? 18 A. I don't know. 19 Q. Has she ever acted as a 20 consultant for Lilly? 21 A. I don't know. 22 Q. Are you aware of any depression 23 trials that are currently being run on Lilly 24 products where Fluoxetine is used as a Page 341 1 comparitor? 2 A. Yes. 3 Q. When I say Fluoxetine used as a 4 comparitor, I mean not as a main focus of the 5 study, but as an active comparitor. 6 A. Yes. 7 Q. How many studies? 8 MR. MYERS: Don't answer that, it's 9 proprietary, trade secret, confidential, and all 10 the rest. 11 MS. ZETTLER: On the number of studies? 12 MR. MYERS: No. I'll let her confirm 13 one way or another whether she did, but beyond 14 that, that has nothing to do with anything going 15 on in this case or these cases. 16 Q. Are you going to follow your 17 counsel's advice? 18 A. Yes. 19 MS. ZETTLER: Certify it. 20 (QUESTION CERTIFIED.) 21 Q. Is the main focus study drug in 22 these studies a compound that is marketed by 23 Lilly currently? 24 A. No. Page 342 1 Q. These are depression trials? 2 MR. MYERS: Don't answer that. 3 MS. ZETTLER: She already did, Larry, 4 she already said they were. 5 MR. MYERS: No, you asked her if it was 6 a comparitor drug. 7 MS. ZETTLER: And I asked her if the 8 comparitor drug was on depression and she said 9 yes. 10 Q. Were they depression studies? 11 MR. MYERS: Don't answer that. If 12 she's already answered it, she's answered it, but 13 don't answer it again. 14 Q. Are you going to follow your 15 counsel's advice? 16 A. Yes. 17 MS. ZETTLER: Certify it. 18 (QUESTION CERTIFIED.) 19 Q. To your knowledge are there any 20 other studies being conducted by Lilly related to 21 the disease depression, not as an efficacy study 22 or a safety study, but just on studying the 23 disease of depression in any way? 24 MR. MYERS: You mean not a drug study? Page 343 1 MS. ZETTLER: Right. Being performed 2 by Lilly. 3 A. I don't know. 4 Q. How about suicidality, are 5 there any studies that you know that are ongoing 6 or have been done by Lilly that deal with the 7 subject of suicidality in and of itself apart 8 from a drug treatment? 9 A. Only the ones mentioned earlier 10 in this deposition. 11 Q. Are you aware of any studies 12 that are in the proposal stage related to 13 suicidality? 14 A. No. 15 Q. How about violent aggressive 16 behavior? 17 A. No. 18 Q. Agitation? 19 A. No. 20 (PLAINTIFFS' EXHIBIT NO. 22 WAS 21 MARKED FOR IDENTIFICATION AND 22 RECEIVED IN EVIDENCE.) 23 Q. Have you had a chance to review 24 Exhibit 22? Page 344 1 A. Yes, I have. 2 Q. Do you recognize this exhibit? 3 A. No, I don't. 4 Q. Do you recognize the 5 handwriting on the exhibit? 6 A. No, I don't. 7 Q. Have you ever seen a list 8 similar to this purporting to be adverse events 9 appearing in a Prozac insert? 10 A. Yes. 11 Q. Okay. When did you see such a 12 list? 13 A. While CRAs put together 14 informed consents. 15 Q. When you say -- is this a list 16 that's included in the informed consent? 17 A. No. 18 Q. What is the purpose of the list 19 in conjunction with the informed consents? 20 MR. MYERS: When you say the list, you 21 mean the list that she's familiar with and not 22 the list in front of her? 23 MS. ZETTLER: Right. 24 A. It helps the CRAs prepare the Page 345 1 consent form as far as including the adverse 2 events in there. 3 Q. Okay. And the list that you've 4 seen is a list of adverse events that appear in 5 the package insert for Prozac? 6 A. Yes, that's right. 7 Q. Are they instructed to include 8 all of those adverse events in the informed 9 consent or just certain adverse events? 10 A. I don't know. 11 Q. How does the list that you've 12 seen differ from the list that is reflected in 13 Exhibit 22? 14 A. I just don't know that they're 15 the same list. 16 Q. Okay. Is there something about 17 this list that makes you believe that this is not 18 the same list that you've seen? 19 A. This predates me, I believe. 20 Q. How do you know that? 21 A. Jamie Street is listed as an 22 individual in this note, and I was never working 23 with her in conjunction at the same time, I don't 24 believe, on Fluoxetine. Page 346 1 Q. So just to make sure I'm not 2 confused, you're saying that when you started 3 working on Fluoxetine that Doctor Street was no 4 longer working on Fluoxetine? 5 A. That's right. 6 Q. The list that you've seen of 7 adverse event terms listed in the Prozac insert, 8 is it longer than this list or shorter? 9 A. I don't know. 10 Q. Are there any adverse event 11 terms that are listed in the list that you have 12 seen that are not reflected in the list in 13 Exhibit 22? 14 A. I don't know. 15 Q. Can you take a couple of 16 seconds and review that again? 17 A. I still wouldn't know, even 18 after reviewing it thoroughly, whether they would 19 be included or not. 20 Q. Why not? 21 A. Well, the list is extensive, 22 and I would have to go through item by item with 23 what I've seen in the past, and I don't have 24 that. Page 347 1 Q. Has the list that you've seen 2 been changed or modified in any way that you know 3 of since the first time you've seen one? 4 A. As compared to what? 5 Q. In other words, have terms been 6 added or deleted? 7 A. Yes. 8 Q. What terms have been added, to 9 your knowledge? 10 A. I don't know. As the package 11 insert gets updated, so do the lists. 12 Q. Have any terms been deleted 13 from that list to your knowledge? 14 A. I don't know. 15 Q. Who drafts the list generally? 16 A. Initial drafts, it will be the 17 CRA. 18 Q. And who finalizes the list? 19 A. It will be a group of 20 individuals. 21 Q. What area within medical or 22 regulatory or whatever would have that 23 responsibility? 24 A. Regulatory scientist, Page 348 1 physician, CRA, those would probably be the 2 predominant individuals. 3 Q. How about legal department, 4 does legal department have any responsibility 5 with regards to the list of event terms that 6 appear in the package insert? 7 MR. MYERS: Let me object to form. Are 8 you talking the insert as opposed to this list? 9 MS. ZETTLER: No, the list. 10 A. I don't think they have input 11 as to which terms get added. 12 Q. Okay. If you could turn to 13 page -- I'm sorry, it's the fifth or sixth page 14 in, Pz 2445 841. Looks like a memo from Donna 15 Pearson to Jamie Street, Charles Beasley, Jim 16 Katsanos, Doctor Wheadon, Doctor Goldstein, and 17 Doctor Masica; correct? 18 A. Yes. 19 Q. And the first line of the list 20 or -- I'm sorry, of the memo, says attached is 21 the list of adverse event terms in the Prozac 22 package insert from Mary Huff. Do you see that? 23 A. Yes. 24 Q. You're aware that Ms. Huff is Page 349 1 in the legal department? 2 A. Yes, I am. 3 Q. And to your knowledge does Ms. 4 Huff have any responsibility for compiling the 5 list of adverse event terms that appear in the 6 package insert? 7 A. No, not to my knowledge. 8 Q. To your knowledge does the 9 legal department have authority to approve or 10 amend the list in any way? 11 MR. MYERS: You say the list, are you 12 talking this list the CRAs are working off of as 13 opposed to the insert itself? 14 MS. ZETTLER: Right. 15 A. As far as legal's involvement 16 in working with the CRAs, they are there to help 17 provide counseling as it relates to our 18 regulatory requirements or other legal 19 requirements. 20 Q. Is there a purpose for this 21 list other than to compile the informed consent? 22 MR. MYERS: I hate to keep 23 interrupting, but when you say this list, you 24 mean the list to which she's referring and not Page 350 1 the exhibit? 2 MS. ZETTLER: Right. 3 A. Could you restate that then? 4 Q. Sure. The list that you have 5 seen. 6 A. Yes. 7 Q. And it's a list of event terms 8 that are allegedly appearing in the package 9 insert at the time; correct? 10 A. Yes. 11 Q. Assuming it's updated. 12 A. Yes, that's right. 13 Q. Is there any use for that list 14 other than for the CRAs to compile the consent 15 forms? 16 A. Not to my knowledge, there's 17 not. 18 Q. Are you familiar with the 19 phrase, expectancy? 20 A. Yes, I am. 21 Q. What does expectancy mean? 22 A. It's a regulatory definition 23 for adverse events. 24 Q. And what is the impact of an Page 351 1 adverse event being found to be unexpected? 2 A. Could you state that again? 3 Q. Sure. My understanding of how 4 the regulations work is that there are 5 definitions, FDA definitions, as to what should 6 be considered expected and what should not be 7 considered expected; correct? 8 A. I don't know that. 9 Q. If an adverse event term is 10 considered unexpected, it impacts the reporting 11 process in some manner, in other words how 12 quickly it should be reported and things of that 13 nature. 14 A. Correct. 15 Q. Of course that also goes in 16 line with seriousness. 17 A. Yes. 18 Q. Are you aware of a list such as 19 the one reflected in Exhibit 22 or in your 20 experience and what you've seen where there are 21 lists of event terms that are used to assign 22 expectancy to an adverse event? 23 A. Only in that Donna's notes 24 state this is such a list. Page 352 1 Q. Exhibit 22? 2 A. That's correct. 3 Q. Were you aware that such a list 4 existed before seeing Donna's note? 5 A. No, I was not. 6 Q. Are you aware of any occasion 7 where Lilly has sought to have a T.V. or radio 8 program not aired because it was critical of 9 Prozac? 10 MR. MYERS: I object to the form only 11 to the extent I think your question assumes that 12 as a fact, but if you know, tell her. 13 A. I don't know. 14 Q. If that were the case, in your 15 opinion would that be appropriate? 16 A. That's a personal opinion, not 17 a corporate opinion. 18 Q. I'm asking for your opinion. 19 MR. MYERS: Before she answers, to the 20 extent it's hypothetical I object to the form 21 because it doesn't give her sufficient facts upon 22 which to base the opinion. But if you've got a 23 personal opinion, tell her. 24 A. I'd rather not. Page 353 1 MR. MYERS: That's fine. If you've got 2 an opinion, if you don't have an opinion, tell 3 her. 4 Q. Who is Ed West? 5 A. He is an employee. 6 Q. A Lilly employee? 7 A. Yes. 8 Q. What is his job? 9 A. Director of corporate affairs. 10 Q. What is corporate affairs? 11 A. It's a component that deals 12 with media. 13 (PLAINTIFFS' EXHIBIT NO. 23 WAS 14 MARKED FOR IDENTIFICATION AND 15 RECEIVED IN EVIDENCE.) 16 Q. Have you had a chance to review 17 Exhibit No. 23? 18 A. Yes, I have. 19 Q. Are you familiar with this 20 exhibit? 21 A. I recall it. 22 Q. It's a four-page exhibit 23 starting with Pz 2501 2775 going through 2501 24 2778; correct? Page 354 1 A. Yes. 2 Q. And it's a memorandum from a 3 Kelly Weston to three pages -- or two and a half 4 pages worth of -- actually three pages worth of 5 recipients; correct? 6 A. Yes. 7 Q. And you are one of the 8 recipients? 9 A. That's right. 10 Q. And it's dated February 3rd, 11 1993; correct? 12 A. Yes. 13 Q. What do you recall about this 14 incident that's reflected in Exhibit 23? 15 A. Nothing other than receiving 16 the message and reading it. 17 Q. Okay. The subject matter of 18 the memo is a program that was to be run in 19 Washington, D.C., I believe in the Fall of 1992; 20 correct? 21 A. It looks that way. 22 Q. And the program related to the 23 association of Prozac and suicide; correct? 24 A. That's how the memo reads. Page 355 1 Q. And it appears from the memo 2 that there were numerous protests made by NAMI, 3 N-A-M-I, representatives of the NDMDA and NMHA; 4 correct? 5 A. Yes. 6 Q. As well as Ed West from Eli 7 Lilly; correct? 8 A. Yes. 9 Q. And it appears from the memo 10 that the show was canceled because of the 11 protests; correct? 12 A. It looks that way. 13 Q. Do you have a problem with 14 that? 15 A. No. 16 Q. Why not? 17 A. It's been historical that the 18 press hadn't been very even-sided in representing 19 issues like this. 20 Q. What do you mean when you said 21 not been very even-sided? 22 A. They tend to produce one side 23 of facts and not the other to balance. I'm not 24 even sure there are facts. Page 356 1 Q. The second paragraph talks 2 about the show being entitled, quote, The Pros 3 and Cons of Prozac, on February 3, 1993; correct? 4 A. It states that, yes. 5 Q. And it also -- that paragraph 6 also talks about additional efforts by mental 7 health organizations and Lilly as well as others 8 to prevent the airing of the program; correct? 9 A. Yes. 10 Q. What makes you think that both 11 sides of the story were not going to be told by 12 the program? 13 MR. MYERS: Before she answers, let me 14 object to the form because your questioning on 15 this paragraph is clearly out of context since 16 you omit the references to the Church of 17 Scientology -- excuse me, the Citizen's 18 Commission on Human Rights' role in the show, and 19 thus your questions are taken out of context and 20 are -- thus may lead to some sort of a misleading 21 interpretation in her answer. 22 MS. ZETTLER: I think that Carol 23 Zapapas is probably intelligent enough to point 24 out that the memo says that it's influences are Page 357 1 CCHR. 2 MR. MYERS: I just object to the form, 3 that's all. 4 Q. But the title of the program as 5 reflected in this exhibit is The Pros And Cons Of 6 Prozac; correct? 7 A. That's what it says. 8 Q. Now I want to know why you 9 believe that this was going to be a one-sided 10 program? 11 A. Because it looks as though the 12 Citizen's Commission on Human Rights was 13 influencing the shows and the outcome of what 14 they were going to air. 15 Q. And where does Kelly Weston get 16 her information that the Citizens' Commission on 17 Human Rights has influence over this show, if you 18 know? 19 A. I don't know. 20 Q. Have there ever been any shows 21 that have been aired that have been critical of 22 Prozac that Lilly has not felt has been 23 influenced by the CCHR? 24 A. I don't know the answer to Page 358 1 that. 2 Q. Are there other programs that 3 you're aware of where Lilly has made an effort to 4 prevent them from being aired? 5 MR. MYERS: Let me object to the form. 6 I don't know that that doesn't accurately 7 characterize what happens. There may be a 8 difference between somebody complaining about 9 something and it not being aired, and somebody 10 preventing something from being aired. 11 Q. The second portion of that memo 12 says continued efforts by mental health 13 organizations, Lilly and others, have not been 14 successful in preventing this program again; 15 correct? 16 MR. MYERS: Is that a question? She 17 wants to know if that's what it says. 18 A. Yes, that's what it says. 19 Q. My question is: To your 20 knowledge has Lilly ever made any other concerted 21 efforts to try to prevent a program from being 22 aired that was critical of Prozac? 23 A. I don't know of other efforts. 24 Q. Do you believe that the Page 359 1 information that's put out by Lilly regarding 2 Fluoxetine is unbiased? 3 A. What information are you 4 referring to? 5 Q. Information on the safety of 6 Fluoxetine. 7 A. Yes, I believe it's unbiased. 8 Q. Have you ever seen a statement 9 made by Lilly or a manuscript published that 10 criticizes the safety profile of Fluoxetine in 11 any way? 12 MR. MYERS: I object to the form. You 13 used criticizes, and that could mean almost 14 anything, particularly in a medical article. But 15 if you know, tell her. 16 A. I don't know. 17 Q. What is your understanding of 18 what the word criticize means? 19 A. Critical of either the data or 20 the process that was used to collect the data or 21 how it's being represented. 22 Q. Have you ever seen an article 23 that's been published by Lilly that is critical 24 of Fluoxetine or any data that supports it under Page 360 1 your definition of the term? 2 A. I'm not aware of any, I don't 3 know. 4 Q. Have you ever seen a 5 publication, an article or any other publication, 6 that has been put out by Lilly that has talked 7 about a negative -- in any negative way the 8 safety profile of Fluoxetine? 9 MR. MYERS: Same objection as to in any 10 negative way, because in the medical literature 11 that can mean almost anything. 12 Q. Okay. Do you understand the 13 question? 14 A. Not fully, no. 15 Q. Have you ever seen an article 16 published by Lilly related to Fluoxetine that has 17 ever portrayed the safety profile of Fluoxetine 18 in a negative light? 19 A. I don't know if I have or not. 20 MS. ZETTLER: Let's take one more 21 break. 22 (A SHORT RECESS WAS TAKEN.) 23 (PLAINTIFFS' EXHIBIT NO. 24 WAS 24 MARKED FOR IDENTIFICATION AND Page 361 1 RECEIVED IN EVIDENCE.) 2 Q. Have you had a chance to review 3 Exhibit 24? 4 A. Yes. 5 Q. Do you recognize this exhibit? 6 A. No, I don't. 7 Q. Exhibit 24 is a nine-page 8 exhibit starting with Pz 2335 1911, and runs 9 through 2335 1919; correct? 10 A. Yes. 11 Q. The first page of the exhibit 12 is a memo from Kati Copley-Merriman and Jim 13 Kotsanos to Max Talbott and Fred Dies; right? 14 A. Yes. 15 Q. Dated September 10, 1991; 16 correct? 17 A. Yes. 18 Q. It talks about a Lilly, Eli 19 Lilly safety surveillance system plan. Are you 20 familiar with that plan? 21 A. No, I'm not. 22 Q. Are you familiar with the 23 pharmacoepidemiology group? 24 A. Yes, I am. Page 362 1 Q. What is the 2 pharmacoepidemiology group? 3 A. It's a group of individuals 4 outside of medical. 5 Q. And what is their purpose? 6 A. I don't know their exact 7 purpose since I have not worked in their area. 8 Q. Are they part of another 9 department? You said it was outside of medical, 10 are they their own department or are they part of 11 another department? 12 A. I don't know that. 13 Q. What is Doctor Kotsanos' 14 affiliation with the pharmacoepidemiology group? 15 A. He's one of the physicians in 16 that group. 17 Q. Do you know how long he's been 18 a physician in that group? 19 A. No, I don't. 20 Q. How about Kati Copley-Merriman? 21 A. She's a CRA in that group. 22 Q. Was that group in existence 23 when you became involved with the Fluoxetine 24 cluster? Page 363 1 A. Yes, I believe they were. 2 Q. Who is Harry Hubble? 3 A. He's an employee of Lilly. 4 Q. What does he do for Lilly? 5 A. He's an attorney in the legal 6 division. 7 Q. How about Lisa E, hyphen, D? 8 A. I believe that's Lisa 9 Egeeauneau-Davis. 10 Q. Lisa what? 11 A. Eg -- I don't know. I still 12 don't know, E-G-E-E-A-U-N-E-A-U. 13 Q. And who is Lisa 14 Egeeauneau-Davis? 15 A. She's a physician. 16 Q. In what area? 17 A. She was in the -- she may have 18 been part of the pharmacoepi group, I'm not sure. 19 Q. How about Carol Andrejasich? 20 A. Andrejasich. 21 Q. Thanks. I was really close, 22 right. A-N-D-R-E-J-A-S-I-C-H. 23 A. She's a CRA in that group. 24 Q. The -- Page 364 1 A. The pharmacoepi group. 2 Q. Deb Hildebrand? 3 A. Deb is an individual in our 4 training department right now. 5 Q. How about back in the latter 6 part of '91? 7 A. She was a department head in 8 medical plans. 9 Q. Did she work on Fluoxetine? 10 A. No. 11 Q. When you say she is working in 12 the training department now, what is the training 13 department? 14 A. Developing curriculum for 15 training. 16 Q. Across the board or just one 17 specific area? 18 A. It's across the board, but for 19 medical employees. 20 Q. How about Melissa Humbert, is 21 she involved in the pharmacoepidemiology group? 22 A. No, she's not. 23 Q. Was she ever to your knowledge? 24 A. No, not to my knowledge, she Page 365 1 wasn't. 2 Q. How about halfway through the 3 second paragraph, it says in conjunction with the 4 DEU department we have initially started working 5 on the comprehensive reports and descriptive 6 summaries of selected spontaneous adverse events. 7 Do you see that? 8 A. Yes, I do. 9 Q. What is the comprehensive 10 reports of spontaneous adverse events? 11 A. I don't know. 12 Q. Have you ever heard of the Eli 13 Lilly safety surveillance system? 14 A. No. 15 Q. On the second page of the 16 exhibit, it talks about under the first point, 17 background, the current DEN system is described 18 in the Drug Experience Network, Version 2 or DEN 19 II book. Do you know what that is? 20 A. I know what our DEN is. 21 Q. Have you ever heard of the Drug 22 Experience Network book or DEN book? 23 A. This -- no, I haven't. 24 Q. Is Doctor Kotsanos, to your Page 366 1 knowledge, an epidemiologist? 2 A. Yes, I believe he is. 3 Q. Does the department of 4 epidemiology -- I'm sorry, it's 5 pharmacoepidemiology, have its own research 6 physicians? 7 A. They have their own physicians, 8 I don't know if they're considered research 9 physicians or not. 10 Q. Is Doctor Kotsanos in the 11 pharmacoepidemiology department at this time? 12 A. I don't know. 13 Q. Would you look at the last page 14 of the exhibit. At the bottom of the page, under 15 number four, it says example, Regenstrief is 16 conducting a prospective, randomized study 17 observing outcomes of usual care versus 18 interventional care for patients diagnosed with 19 depression. 20 A. I see that. 21 Q. Okay. Who is Regenstrief? 22 A. I believe they're a clinic, a 23 medical clinic. 24 Q. Do you know where they're Page 367 1 located? 2 A. I believe they're at the IU 3 School of Medicine. 4 Q. Are you familiar with the study 5 that it's talking about in that example? 6 A. No, I'm not. 7 Q. It says independently funded. 8 What does it mean, if you know? 9 A. I don't know. 10 (PLAINTIFFS' EXHIBIT NO. 25 WAS 11 MARKED FOR IDENTIFICATION AND 12 RECEIVED IN EVIDENCE.) 13 Q. Have you had a chance to review 14 Exhibit 25? 15 A. Yes, I have. 16 Q. Do you recognize this exhibit? 17 A. No, I don't. 18 Q. Are you familiar with any of 19 the subject matter of the exhibit? 20 A. Vaguely, yes. 21 Q. It purports to be an exhibit 22 that starts with Pz 2441 2862 running 23 consecutively to page 2441 2882; correct? 24 A. Yes. Page 368 1 Q. And the title of the document 2 is Epidemiology Catchment Area - Index of 3 Codebook; correct? 4 A. Yes. 5 Q. What portion of this exhibit 6 are you familiar with? 7 A. The title, the epidemiology 8 catchment area, that was the study I was 9 referring to earlier in this deposition. 10 Q. Okay. Is that the study you 11 were talking about yesterday or was that today? 12 A. I don't recall which day. 13 Q. Me either. I think just to 14 save some time, why don't you refresh my 15 recollection as to which study that was. 16 A. This is where the 17 multi-thousand patient study observed the 18 possible syndrome of subsyndromal. 19 Q. Okay. When it says 20 epidemiology catchment area, is there an area or 21 department at Lilly that does catchment work? 22 A. Not to my knowledge, no. 23 Q. In the context of the study, 24 what establishes subsyndromal syndrome, what is Page 369 1 the catchment area? 2 A. I don't know. 3 Q. So epidemiology catchment is 4 what you recognize as related to the subsyndromal 5 syndrome study? 6 A. Yes. 7 Q. Other than the title, do you 8 recognize any other part of this exhibit? 9 A. No, I don't. 10 Q. Would you turn to page four of 11 the exhibit. 12 A. Yes. 13 Q. On the left-hand side of the 14 paragraph, it has, looks likes, some sort of a 15 code, DIS? 16 A. Yes. 17 Q. Do you know what that is? 18 A. No, I don't. 19 Q. To your knowledge are there any 20 codes that are used in entering information into 21 the computer, say, about adverse events? Not 22 just on this study, but any at Lilly. 23 A. No, not to my knowledge. 24 (PLAINTIFFS' EXHIBIT NO. 26 WAS Page 370 1 MARKED FOR IDENTIFICATION AND 2 RECEIVED IN EVIDENCE.) 3 Q. Have you had at chance to 4 review Exhibit 26? 5 A. Yes, I have. 6 Q. It's a one-page exhibit, 7 numbered Pz 1640 181, dated August 26, 1991; 8 correct? 9 A. That's right. 10 Q. It appears to be a memo from 11 Gary Tollefson to a number of people, including 12 you? 13 A. Yes. 14 Q. What is an FDA advisory, Foci? 15 A. It is trying to define focus 16 for each one of the individuals. 17 Q. What does F-O-C-I stand for? 18 A. I believe it's pleural for 19 focus. 20 Q. And you have an assignment on 21 this memo; correct? 22 A. That's right. 23 Q. What is your assignment? 24 A. Fluoxetine protocols. Page 371 1 Q. What was your task with regards 2 to Fluoxetine protocols? 3 A. To take with us copies of the 4 protocols, to have with us available if they 5 needed to be referenced. 6 Q. All protocols done on 7 Fluoxetine in that period of time? 8 A. No. 9 Q. Which protocols? 10 A. The protocols that were part of 11 the analysis that was being presented. 12 Q. The double-blind controlled 13 studies? 14 A. Those were in there, yes. 15 Q. Okay. Were all double-blind 16 controlled studies included in the analysis? 17 A. I don't know. 18 Q. Were there studies that were 19 included that were not double-blind controlled? 20 A. That, I don't know either. 21 Q. How many protocols did you take 22 with you, do you remember? 23 A. No, I don't know the exact 24 number. Page 372 1 Q. Were you able to carry them by 2 yourself? 3 A. Yes. 4 Q. Was it more than a box? 5 A. No, it was not. 6 Q. Did it fit in a briefcase? 7 A. Yes. 8 Q. Big briefcase, trial size 9 briefcase, or regular size briefcase? 10 A. A large briefcase. 11 Q. Did you have any other tasks 12 outside the capacity listed on this exhibit? 13 A. Not defined, no. 14 Q. How about undefined? 15 A. I assisted Vicki with the 16 slides and in finding back-up slides if they were 17 asked for. 18 Q. You say Vicki, you mean Vicki 19 Thompson? 20 A. Yes, I do. 21 Q. Any other undefined tasks? 22 A. Reviewing the submission that 23 was made. 24 Q. The submission prior to the Page 373 1 advisory committee meeting? 2 A. That's right. 3 Q. What portions of the submission 4 did you review? 5 A. There weren't specified 6 portions that I was asked to review. 7 Q. Do you recall which portions 8 that you did review? 9 A. I reviewed all of it. 10 Q. Okay. In what context were you 11 reviewing it, for content or form or both? 12 A. More form, flow of information, 13 clarity. 14 Q. Did you make any changes or 15 recommendations on the submission? 16 A. I don't recall. Editing 17 changes, I would imagine. 18 Q. Punctuation, spelling, things 19 of that nature? 20 A. Yes. 21 Q. Any other undefined tasks? 22 A. No, not to my knowledge. 23 (PLAINTIFFS' EXHIBIT NO. 27 WAS 24 MARKED FOR IDENTIFICATION AND Page 374 1 RECEIVED IN EVIDENCE.) 2 Q. Have you had a chance to review 3 Exhibit 27? 4 A. Yes. 5 Q. Do you recognize this exhibit? 6 A. No, I don't. 7 Q. Do you recognize the 8 handwriting? 9 A. No, I don't. 10 Q. Do you recognize the substance 11 of the exhibit? 12 A. Yes. 13 Q. It is a two-page exhibit 14 starting with Pz 843 1386 and ending with 843 15 1387; correct? 16 A. Yes. 17 Q. And it looks like two pages of 18 handwritten notes; correct? 19 A. Yes. 20 Q. What is the subject matter of 21 the exhibit? 22 A. Looks to be the agenda for the 23 DEN quarterly meeting. 24 Q. Okay. What is a DEN quarterly Page 375 1 meeting? 2 A. It was, and is, I don't know, a 3 quarterly meeting held on a quarterly basis to 4 review DEN data. 5 Q. Adverse event data? 6 A. Yes. 7 Q. Spontaneous adverse event data? 8 A. Yes. 9 Q. Does the DEN quarterly report 10 review any clinical trial adverse events that are 11 non-serious? 12 A. I don't know. 13 Q. Do you know if at this time 14 anything but serious clinical trial adverse 15 events are reported to the DEN system? I'm 16 talking about -- I mean I know spontaneous 17 reports are put in the DEN system, but as far as 18 the clinical trial adverse events? 19 A. Yes. 20 Q. Okay. What else is reported? 21 A. Pregnancies that occur while on 22 treatments, while on trial. 23 Q. Okay. Anything else? 24 A. I don't know of others. Page 376 1 Q. So as far as you know right 2 now, the adverse events that are included in the 3 DEN system are all spontaneous adverse events; 4 correct? 5 A. Yes. 6 Q. Serious, as defined by the FDA 7 clinical trial adverse events; correct? 8 A. Yes. 9 Q. And pregnancy adverse events or 10 pregnancies that occur in trials? 11 A. Yes. 12 Q. And that's across the board, 13 that's not just for Fluoxetine? 14 A. That, I don't know. 15 Q. It may be just as far as the 16 pregnancy portion, it may just be for Fluoxetine? 17 A. Could be. 18 Q. Can you tell from this exhibit 19 when this meeting occurred? 20 A. November 15th, but I don't know 21 what year. 22 Q. Okay. Who is Mario Savelloni? 23 A. He's an employee of Lilly. 24 Q. What does he do for Lilly? Page 377 1 A. He's a clinical research 2 coordinator. 3 Q. Who is Molly Gormley? 4 A. She's a CRA. 5 Q. In medical? 6 A. Yes. 7 (PLAINTIFFS' EXHIBIT NO. 28 WAS 8 MARKED FOR IDENTIFICATION AND 9 RECEIVED IN EVIDENCE.) 10 Q. Have you had a chance to review 11 Exhibit 28? 12 A. Yes, I have. 13 Q. Are you familiar with the 14 subject matter of the exhibit? 15 A. Yes, I am. 16 Q. It's a one-page exhibit stamped 17 Pz 2501 2684, and it appears to be an E-mail 18 dated September 22, 1993 written by Molly 19 Gormley; correct? 20 A. Yes. 21 Q. The recipient is Mario 22 Savelloni, and you're listed as a cc; correct? 23 A. That's right. 24 Q. Tell me about this exhibit, Page 378 1 what are they talking about here? 2 A. An investigator had called in 3 asking to destroy the records, clinical trial 4 records, and we were dealing with the issue. 5 Q. Okay. Is study HCDL a 6 depression study? 7 A. Yes, it is. 8 Q. Do you recall what about 9 depression, is it a comparitor study on treating -- 10 an efficacy comparison or what type of depression 11 study is it? 12 A. I don't recall off the top of 13 my head which one that is. 14 Q. Is it a study that's still 15 ongoing? 16 A. Yes -- oh, no, sorry. 17 Q. It's been completed? 18 A. With that code, yes, it would 19 have been completed. 20 Q. Okay. What is it about that 21 code that makes you think that the study is 22 completed? 23 A. On how we determine our 24 protocol codes. HC is Fluoxetine, and the last Page 379 1 two letters are subsequently given as protocols 2 are written. 3 Q. Okay. Is the code used for 4 Fluoxetine different now? 5 A. No. 6 Q. What is it about this code, 7 though, that makes you think it's not an ongoing 8 study? 9 A. The letter D. 10 Q. Okay. How is D assigned? 11 A. I said they were subsequently 12 given, the last two letters. You'll run through 13 the alphabet in any given compound, and each 14 compound has their own two-letter code 15 assignment. And then as protocols are written, 16 they're given a code assignment, starting with 17 the alphabet. So HCAA would be an old, early 18 study, HCZZ would be a very late study. 19 Q. Okay. So you're past the 20 letter D on the assignment of letters to the last 21 two letters of the HC, right? 22 A. Yes, that's correct. 23 Q. Can you tell from that exhibit 24 if the study was ongoing at the time the exhibit Page 380 1 was written, September of '93? 2 A. It would not have been ongoing, 3 no. 4 Q. So this was an investigator who 5 was calling to see if he could destroy records 6 that he had been maintaining since the completion 7 of his study? 8 A. That's right. 9 Q. Do you know if this 10 investigator in fact destroyed the Fluoxetine 11 records? 12 A. No, I don't know the answer to 13 that. 14 Q. What are Prozac alert 15 summaries? 16 A. I don't know. 17 (PLAINTIFFS' EXHIBIT NO. 29 WAS 18 MARKED FOR IDENTIFICATION AND 19 RECEIVED IN EVIDENCE.) 20 Q. Have you had a chance to review 21 Exhibit 29? 22 A. Yes, I have. 23 Q. Are you familiar with the 24 exhibit? Page 381 1 A. Vaguely. 2 Q. Does it refresh your 3 recollection as to what Prozac alert summaries 4 are? 5 A. Yes, it does. 6 Q. It's a two-page exhibit dated 7 March 21, 1991, written by, it appears to be, Jim 8 Kotsanos? 9 A. It appears that way. 10 Q. Okay. Entitled Prozac alert 11 summaries for DEN quarterly; correct? 12 A. Right. 13 Q. Tell me about the subject 14 matter of the exhibit? 15 A. This is part of the DEN 16 quarterly that was referred to earlier. 17 Q. Okay. What are alert 18 summaries? 19 A. They are summaries of each of 20 the reported events that quarter, spontaneous 21 events that were reported that quarter. 22 Q. Reported to the FDA or reported 23 to Lilly? 24 A. I'm not sure which. Page 382 1 Q. Does whether or not a summary 2 was printed or compiled depend on the severity of 3 the adverse event, in other words is it a serious 4 unexpected adverse event or anything of that 5 nature? 6 A. I don't recall that that was 7 part of the definition. Spontaneous reports 8 don't have to be serious by regulatory 9 definition. 10 Q. Okay. So to the best of your 11 recollection, it's all reports that are made 12 spontaneously? 13 MR. MYERS: What it is, I don't 14 understand. 15 MS. ZETTLER: The alert summaries. 16 MR. MYERS: The question is are there 17 alert summaries or all spontaneous? 18 Q. For all spontaneous adverse 19 events reported in a quarter. 20 A. To my knowledge, yes. 21 MS. ZETTLER: Let's take one more 22 break, we're almost done. 23 (A SHORT RECESS WAS TAKEN.) 24 Q. Have you ever heard the term Page 383 1 hits? 2 MR. MYERS: Ever? 3 Q. As it relates to Fluoxetine. I 4 don't mean what I would like to do to Larry 5 sometime. 6 MR. MYERS: Make sure you get that 7 down, court reporter. 8 A. Yes. 9 Q. Okay. What are hits? 10 A. It was used in reviewing data. 11 Q. What data? 12 A. The international data. 13 Q. Any specific portion of the 14 international data? 15 A. I'm not sure I understand what 16 you're referring to. 17 Q. Other people have testified in 18 depositions, other Lilly employees, that hits 19 related to suicidality related adverse events 20 that were collected outside the U.S. and in the 21 U.S. clinical trials. Is that your recollection? 22 A. Yes. 23 MR. MYERS: Well, I'll belatedly object 24 to the form because I understand what you're Page 384 1 getting at, but I don't think that's precise as 2 to what they said it meant. 3 MS. ZETTLER: In what way? 4 MR. MYERS: I think they said a hit was 5 an affirmative response to a string of words that 6 was later reviewed to see if it was in fact 7 suicidality related. 8 MS. ZETTLER: I disagree. 9 MR. MYERS: Whatever. Go ahead, just 10 go ahead. 11 Q. What was your involvement in 12 reviewing the list, if any? 13 A. None. 14 Q. What was your understanding of 15 what was done with the hits? 16 A. Hard copy of the clinical 17 report forms were reviewed by physicians. 18 Q. Do you know how many hits were 19 reviewed by physicians? 20 A. No, I don't. 21 Q. Is it your understanding that a 22 determination was made by Lilly physicians as to 23 whether or not a hit was in fact a suicide 24 attempt, suicidal ideation? Page 385 1 A. I'm confused on what you're 2 asking. 3 Q. Okay. You stated that the hits 4 were reviewed by Lilly physicians; correct? 5 A. Right. 6 Q. And those physician were here 7 in Indianapolis? 8 A. Yes, to the best of my 9 knowledge. 10 Q. And I'm not talking when they 11 reviewed them, they're Indianapolis-based 12 physicians? 13 A. Yes. 14 Q. Who were those physicians? 15 A. Doctor Wheadon, Doctor Beasley, 16 I don't know of others. 17 Q. Doctor Heiligenstein? 18 A. I don't know. 19 Q. What was the purpose in having 20 Doctor Beasley and Doctor Wheadon review the 21 hits? 22 A. To review them to see if they 23 were in fact ideations or acts. 24 Q. Did anybody outside of Lilly Page 386 1 review those hits also? 2 A. I don't know. 3 Q. To your knowledge was a 4 determination made on each of the hits by Doctor 5 Wheadon and Doctor Beasley, or either of them, as 6 to whether or not they were suicidal acts? 7 A. Yes, I believe a determination 8 was made on each of them. 9 Q. What was done after they 10 completed their -- what was done with the hits 11 after the review was completed? 12 A. That, I don't recall. 13 Q. Do you know how many of the 14 hits were determined to be related to suicide, 15 suicidal ideation, suicidal acts? 16 A. No, I don't. 17 Q. Do you know the number of hits 18 that were reviewed? 19 A. No, I don't. 20 Q. Were the patients who were 21 considered hit patients, was there -- was it kept 22 track of somehow? In other words, is there a 23 list of those patients from the various studies 24 who were considered to have suffered a possible Page 387 1 suicidality related event? 2 A. I don't know if there was or 3 not. 4 Q. Who would know that? 5 A. I don't know. 6 Q. Is it your understanding that 7 there was a review of hits, both from U.S. data 8 as well as OUS data? 9 A. I wasn't around during the 10 review of the U.S. data, so I don't know that. 11 Q. Were all studies reviewed in 12 the OUS data or only certain studies? 13 A. Reviewed for what? 14 Q. Reviewed as part of the OUS 15 data gathering project. 16 A. No. 17 Q. Which studies were reviewed? 18 A. Studies that were considered 19 closed, controlled, comparitor. By controlled, I 20 meant comparitor. And double-blind, I believe. 21 Depression studies. 22 Q. When you say comparitor, do you 23 mean active or placebo or both? 24 A. Yes. Page 388 1 MR. MYERS: Does that mean any of the 2 above? 3 THE WITNESS: Yes. 4 Q. So the comparitor could be a 5 controlled study with a single comparitor of a 6 placebo? 7 A. Yes, it could be. 8 Q. Could it be a controlled study 9 with a single comparitor of another active drug? 10 A. Yes. 11 Q. Or it could be a controlled 12 study including a placebo and an active drug as 13 two comparitors? 14 A. Yes, that's right. 15 Q. Do you know whether or not the 16 information or the studies that were reviewed in 17 the U.S. data review also fell under this purview 18 of being closed, controlled, comparitor, 19 double-blind depression studies? 20 A. Yes. 21 Q. Yes, they were also? 22 A. Yes, that's right. 23 Q. Are you aware that at one point 24 in time there was an issue as to whether or not Page 389 1 there was a potential for abuse of Fluoxetine, I 2 mean like drug abuse? 3 A. No, I'm not aware of that. 4 Q. Have you heard of a Doctor 5 Nancy Kennedy? 6 A. No, I'm not familiar with that 7 name. 8 (PLAINTIFFS' EXHIBIT NO. 30 WAS 9 MARKED FOR IDENTIFICATION AND 10 RECEIVED IN EVIDENCE.) 11 Q. Have you had a chance to review 12 Exhibit 30? 13 A. Yes, I have. 14 Q. Do you recognize that exhibit? 15 A. Vaguely, yes. 16 Q. A three-page exhibit starting 17 with Pz 2110 146, and going through Pz 2110 148? 18 A. Yes. 19 Q. And the first page is a 20 memorandum, looks like it's authored by Jim 21 Kotsanos? 22 A. Yes. 23 Q. What is the date of that? 24 A. December 17th, 1991. Page 390 1 Q. I don't have a copy of it in 2 front of me, so -- I gave you my own copy. The 3 subject of the memo appears to be abuse potential 4 with regards to Fluoxetine; correct? 5 A. That's right. 6 Q. Can you tell me what you 7 remember about this issue, if anything? 8 A. I don't remember much about 9 this. I recall the issue as it's relayed here, 10 but nothing further. 11 Q. Do you know if there was 12 anything else that was done regarding that issue 13 other than what's reflected in Exhibit 30? 14 A. No, I don't know. 15 MS. ZETTLER: I guess that's all I have 16 for right now. 17 THE WITNESS: Thanks. 18 MR. MYERS: What do you mean? 19 MS. ZETTLER: Assuming no more 20 documents are produced. 21 MR. MYERS: Our position is that the 22 deposition is concluded, and if you have any 23 perceived need to recommence it, you'll need to 24 apply to do that later, but I think we understand Page 391 1 each other's positions. Thank you. 2 MS. ZETTLER: You're welcome. 3 (THE WITNESS WAS EXCUSED.) Page 392 1 COMMONWEALTH OF KENTUCKY ) 2 : ss COUNTY OF JEFFERSON ) 3 4 I, MARY KATHLEEN NOLD, A NOTARY PUBLIC IN 5 AND FOR THE STATE OF KENTUCKY AT LARGE, DO HEREBY 6 CERTIFY THAT THE FOREGOING TESTIMONY OF 7 CAROL ZAPAPAS 8 WAS TAKEN BEFORE ME AT THE TIME AND PLACE AS 9 STATED IN THE CAPTION; THAT THE WITNESS WAS FIRST 10 DULY SWORN TO TELL THE TRUTH, THE WHOLE TRUTH, 11 AND NOTHING BUT THE TRUTH; THAT THE SAID 12 PROCEEDINGS WERE TAKEN DOWN BY ME IN STENOGRAPHIC 13 NOTES AND AFTERWARDS TRANSCRIBED UNDER MY 14 DIRECTION; THAT IT IS A TRUE, COMPLETE AND 15 CORRECT TRANSCRIPT OF THE SAID PROCEEDINGS SO 16 HAD; THAT THE APPEARANCES WERE AS STATED IN THE 17 CAPTION. 18 WITNESS MY SIGNATURE THIS THE 16TH DAY OF 19 DECEMBER, 1993. 20 MY COMMISSION EXPIRES MARCH 10, 1994. 21 22 23 _________________________ MARY KATHLEEN NOLD 24 COURT REPORTER AND NOTARY PUBLIC STATE OF KENTUCKY AT LARGE Page 393 1 2 3 E R R A T A S H E E T 4 5 COMMONWEALTH OF KENTUCKY ) : SS 6 COUNTY OF JEFFERSON ) 7 8 I, CAROL ZAPAPAS, THE UNDERSIGNED 9 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 10 OF MY DEPOSITION AND WITH THE CHANGES NOTED 11 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 12 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 13 THE 2ND AND 3RD OF DECEMBER, 1993 AT THE TIME AND 14 PLACE STATED THEREIN. 15 PAGE NO. LINE NO. CHANGE REASON Page 394 1 2 PAGE NO. LINE NO. CHANGE REASON 3 4 5 6 7 8 9 _____________________________ 10 CAROL ZAPAPAS 11 SWORN TO AND SUBSCRIBED BEFORE ME THIS 12 _____ DAY OF __________, 1994. 13 _____________________________ NOTARY PUBLIC, STATE OF 14 KENTUCKY AT LARGE Page 395 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 DIRECT EXAMINATIONBY MS. ZETTLER:..................1 19 COMMONWEALTH.....................................149 20 PLAINTIFFS' EXHIBIT NO. 15........................22 21 PLAINTIFFS' EXHIBIT NO. 16........................26 22 PLAINTIFFS' EXHIBIT NO. 17........................39 23 PLAINTIFFS' EXHIBIT NO. 18........................55 24 PLAINTIFFS' EXHIBIT NO. 19........................57 Page 396 1 PLAINTIFFS' EXHIBIT NO. 20........................64 2 PLAINTIFFS' EXHIBIT NO. 21........................65 3 PLAINTIFFS' EXHIBIT NO. 22.......................109 4 PLAINTIFFS' EXHIBIT NO. 23.......................117 5 PLAINTIFFS' EXHIBIT NO. 24.......................123 6 PLAINTIFFS' EXHIBIT NO. 25.......................129 7 PLAINTIFFS' EXHIBIT NO. 26.......................131 8 PLAINTIFFS' EXHIBIT NO. 27.......................134 9 PLAINTIFFS' EXHIBIT NO. 28.......................137 10 PLAINTIFFS' EXHIBIT NO. 29.......................140 11 PLAINTIFFS' EXHIBIT NO. 30.......................147 12 13 14 15 16 17 18 19 20 21 22 23 24 Page 397 1 2 3 4 Page 398 1 DIRECT EXAMINATIONBY MS. ZETTLER:......216 2 COMMONWEALTH.......393 3 (QUESTION CERTIFIED.)...125 4 (QUESTION CERTIFIED.....164 5 (QUESTION CERTIFIED.....194 6 (QUESTION CERTIFIED.)...223 7 (QUESTION CERTIFIED.)...251 8 (QUESTION CERTIFIED.....303 9 (QUESTIONS CERTIFIED.)..317 10 (QUESTION CERTIFIED.)...342 11 (QUESTION CERTIFIED.....343 12 PLAINTIFFS' EXHIBIT NO. 1....126 13 PLAINTIFFS' EXHIBIT NO. 2.........128 14 PLAINTIFFS' EXHIBIT NO. 3.........137 15 PLAINTIFFS' EXHIBIT NO. 4....146 16 PLAINTIFFS' EXHIBIT NO. 5....153 17 PLAINTIFFS' EXHIBIT NO. 6....154 18 PLAINTIFFS' EXHIBIT NO. 7....156 19 PLAINTIFFS' EXHIBIT NO. 8....174 20 PLAINTIFFS' EXHIBIT NO. 9....175 21 PLAINTIFFS' EXHIBIT NO. 10...178 22 PLAINTIFFS' EXHIBIT NO. 11...197 23 PLAINTIFFS' EXHIBIT NO. 12...199 24 PLAINTIFFS' EXHIBIT NO. 13...200 Page 399 1 PLAINTIFFS' EXHIBIT NO. 14...203 2 PLAINTIFFS' EXHIBIT NO. 15...241 3 PLAINTIFFS' EXHIBIT NO. 16...246 4 PLAINTIFFS' EXHIBIT NO. 17...262 5 PLAINTIFFS' EXHIBIT NO. 18...282 6 PLAINTIFFS' EXHIBIT NO. 19...284 7 PLAINTIFFS' EXHIBIT NO. 20...292 8 PLAINTIFFS' EXHIBIT NO. 21...294 9 PLAINTIFFS' EXHIBIT NO. 22...344 10 PLAINTIFFS' EXHIBIT NO. 23...354 11 PLAINTIFFS' EXHIBIT NO. 24...361 12 PLAINTIFFS' EXHIBIT NO. 25...368 13 PLAINTIFFS' EXHIBIT NO. 26...370 14 PLAINTIFFS' EXHIBIT NO. 27...374 15 PLAINTIFFS' EXHIBIT NO. 28...378 16 PLAINTIFFS' EXHIBIT NO. 29...381 17 PLAINTIFFS' EXHIBIT NO. 30...390 18 19 Page 400