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: DANIEL G. RUSSELL 11 DATE: SEPTEMBER 23, 1993 12 13 * * * * * * * * * * 14 15 16 REPORTER: KATHY NOLD 17 18 KENTUCKIANA REPORTERS SUITE 260 19 730 WEST MAIN STREET LOUISVILLE, KENTUCKY 40202 20 (502) 589-2273 Page 1 1 * * * * * * * * * * 2 3 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA 4 INDIANAPOLIS DIVISION 5 IN RE ELI LILLY AND COMPANY ) Prozac Products Liability ) MDL Docket No. 907 6 Litigation ) 7 * * * * * * * * * * 8 NO. 91-02496-A 9 JACKIE LYNN BIFFLE, ET AL ) IN THE DISTRICT ) COURT OF 10 V. ) DALLAS COUNTY, TEXAS ) 11 ELI LILLY & COMPANY AND ) 14TH JUDICIAL DISTA PRODUCTS COMPANY ) DISTRICT 12 * * * * * * * * * * 13 NO. 92-14775-E 14 RICHARD HAROLD CROSSETT, JR., ) IN THE 15 CHAD H. CROSSETT, AMY MICHELLE ) DISTRICT CROSSETT AND KRISTEN ANN CROSSETT, ) COURT OF 16 INDIVIDUALLY AND AS SURVIVORS OF ) AND ON BEHALF OF THE ESTATE OF ) 17 JOCQUETTA ANN CROSSETT, DECEASED ) ) 18 V. ) DALLAS COUNTY, ) TEXAS 19 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, TEXAS ) 20 PSYCHIATRIC COMPANY, INC. ) D/B/A/ HCA WILLOW PARK ) 101ST JUDICIAL 21 HOSPITAL, JAMES K. WITSCHY, M.D., ) DISTRICT AND DOUG BELLAMY, ED.D. ) Page 2 1 * * * * * * * * * * 2 NO. A-921,405-C 3 MARIA GUADALUPE REVES ) IN THE 4 INDIVIDUALLY AND AS NEXT ) DISTRICT COURT FRIEND OF GRANT JULIAN REVES ) OF 5 A MINOR CHILD, AND ON BEHALF ) OF THE ESTATE OF CHRISTIAN ) 6 MARIE REVES, DECEASED ) ) ORANGE COUNTY, 7 V. ) TEXAS ) 8 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, RAVIKUMAR ) 9 KANNEGANTI, M.D., HOSPITAL ) CORPORATION OF AMERICA, A ) 10 TENNESSEE CORPORATION, HEALTH ) SERVICES ACQUISITION CORP., ) 11 A DELAWARE CORPORATION, ) HCA PSYCHIATRIC COMPANY, A ) 12 DELAWARE CORPORATION, TEXAS ) PSYCHIATRIC CO., INC.. A/K/A ) 13 AND/OR D/B/A HCA BEAUMONT ) NEUROLOGICAL HOSPITAL, AND HCA ) 14 HEALTH SERVICES OF TEXAS, INC. ) 128TH JUDICIAL A/K/A AND/OR BEAUMONT ) DISTRICT 15 NEUROLOGICAL HOSPITAL ) 16 * * * * * * * * * * Page 3 1 IN THE UNITED STATES DISTRICT COURT 2 FOR THE WESTERN DISTRICT OF TEXAS SAN ANTONIO DIVISION 3 ELIZABETH T. SANCHEZ, ) 4 INDIVIDUALLY AND AS THE ) SURVIVING SPOUSE, MARGARET R. ) 5 SANCHEZ, INDIVIDUALLY AND NEXT ) OF FRIEND OF DEBRA JEAN ) 6 SANCHEZ, VERONICA MARIE ) SANCHEZ, EDWARDO ESTEBAN ) 7 SANCHEZ, AND MICHAEL ANTHONY ) SANCHEZ, CHILDREN; AND ALL ON ) 8 BEHALF OF THE ESTATE OF ) EDWARDO SANCHEZ ) 9 ) V. ) CIVIL ACTION NO. 10 ) SA93CA367 ELI LILLY AND COMPANY AND ) 11 DISTA PRODUCTS COMPANY ) 12 * * * * * * * * * * 13 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS 14 HOUSTON DIVISION 15 MARIA SANCHEZ, INDIVIDUALLY ) AND AS NEXT FRIEND OF DEBORAH ) 16 SANCHEZ, VERONICA SANCHEZ, ) EDDIE SANCHEZ, AND MICHAEL ) 17 SANCHEZ, AND ON BEHALF OF THE ) ESTATE OF EDUARDO SANCHEZ ) 18 ) V. ) CIVIL ACTION NO. 19 ) H-93-1469 ELI LILLY AND COMPANY AND ) 20 DISTA PRODUCTS COMPANY, A ) DIVISION OF ELI LILLY AND ) 21 COMPANY ) Page 4 1 * * * * * * * * * * 2 STATE OF NEW YORK 3 SUPREME COURT COUNTY OF JEFFERSON 4 _____________________________________________ 5 STEPHANIE CAPONE, AS EXECUTOR OF THE ESTATE OF JOSEPH J. CAPONE, JR., AND 6 STEPHANIE CAPONE, INDIVIDUALL, NOTICE TO TAKE 7 PLAINTIFF, DEPOSITION UPON ORAL EXAMINATION 8 VS. INDEX NO. 93-251 9 ELI LILLY AND COMPANY, DISTA PRODUCTS 10 COMPANY, A DIVISION OF ELI LILLY AND COMPANY, FLOYD BAJJALY, M.D, 11 DEFENDANTS. 12 _____________________________________________ 13 * * * * * * * * * * 14 SUPREME COURT OF TEH STATE OF NEW YORK COUNTY OF ORANGE 15 --------------------------------------X BRUCE R. MALEN AS EXECUTOR OF THE : INDEX NO. 16 ESTATE OF BARBARA E. MALEN, AND OF : 4119/92 BRUCE R. MALEN, INDIVIDUALLY, : 17 : HON. PETER PLAINTIFF : PATSALOS, 18 : J.S.C. -against- : 19 : ELI LILLY & COMPANY, DISTA PRODUCTS : 20 COMPANY, A DIVISION OF ELI LILLY & : COMPANY, BARRY SINGER AND UNITED : 21 HOSPITAL, : : 22 DEFENDANTS. : --------------------------------------X 23 * * * * * * * * * * Page 5 1 ---------------------------------X 2 VALARIE J. FRIEDMAN AND DAVID : SUPERIOR COURT FRIEDMAN, HER HUSBAND, : OF NEW JERSEY 3 : LAW DIVISION: PLAINTIFF, : MIDDLESEX COUNTY 4 : DOCKET NO. : L-3191-91 5 VS. : : 6 ELI LILLY & COMPANY; DISTA : PRODUCTS INC, A DIVISION OF : 7 ELI LILLY & COMPANY; LISS : PHARMACY; MADISON PHARMACY AND : 8 JOHN DOES NOS. 1-25 (UNKNOWN : ENTITIES), : 9 : DEFENDANTS. : 10 ---------------------------------X 11 * * * * * * * * * * 12 SUPREME COURT OF THE STAET OF NEW YORK COUNTY OF SUFFOLK 13 -------------------------------------x 14 RHOMDA L. HALA and JOSEPH L. HALA, : 15 Plaintiffs, : Index No. 14869/90 16 - against - : 17 ELI LILLY & COMPANY and DISTA : PRODUCTS COMPANY, a DIVISION OF 18 ELI LILLY & COMPANY : 19 Defendants. : -------------------------------------x 20 21 * * * * * * * * * * Page 6 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 PATRICIA BRACH, ) ) 4 Plaintiff ) ) 5 v. )No. 92 L 13369 ) 6 ELI LILLY AND COMPANY, a foreign ) corporation; ALAN N. MILLER, M.D., ) 7 WILLIAM BRUINSMA, Psy.D., and ) CONDELL MEMORIAL HOSPITAL, ) 8 ) Defendants. ) 9 * * * * * * * * * * 10 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 11 COUNTY DEPARTMENT - LAW DIVISION 12 RENATO DI SILVESTRO, Individually ) and as Special Administrator of ) 13 the Estate of JOHN DI SILVESTRO, ) Deceased, ) 14 ) Plaintiff, ) 15 ) v. ) No. 91 L 7881 16 ) ROBERT L. NELSON, et al., ) 17 ) Defendants, ) 18 ) GEORGE MELNICK, M.D. and PETER ) 19 FINK, M.D. ) ) 20 Respondents in Discovery.) 21 * * * * * * * * * * Page 7 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 JOAN M. GRYER, ) ) 4 Plaintiff, ) ) 5 v. ) No. 92 L 7387 ) 6 ELI LILLY AND COMPANY, et al., ) ) 7 Defendants. ) 8 * * * * * * * * * * 9 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 10 COUNTY DEPARTMENT, LAW DIVISION 11 JENNIFER HAMMERLI, as Plenary ) Guardian of the Estate of RAY B. ) 12 HAMMERLI, a disabled person, ) ) 13 Plaintiff, ) ) 14 v. ) No. 92 L 2365 ) 15 ELI LILLY AND COMPANY, THE ) UPJOHN COMPANY, DICKIE KAY, M.D., ) 16 (former Respondent in Discovery), ) and RICHARD CZECHOWICZ (former ) 17 Respondent in Discovery), ) ) 18 Defendants. ) 19 * * * * * * * * * * Page 8 1 IN THE CIRCUIT COURT OF THE SIXTH JUDICIAL CIRCUIT 2 CHAMPAIGN COUNTY, ILLINOIS 3 LINDA GARDNER, Individually and ) as Special Administrator of ) 4 the Estate of SHANE GARDNER, ) deceased, ) 5 ) Plaintiff, ) 6 ) v. ) No. 91 L 1066 7 ) ELI LILLY AND COMPANY, a foreign ) 8 corporation, ) ) 9 Defendant. ) 10 * * * * * * * * * * 11 IN THE NINETEENTH JUDICIAL CIRCUIT COURT 12 LAKE COUNTY, ILLINOIS 13 JAMES E. SHEPPARD, Special ) Administrator of the Estate of ) 14 KENNETH K. SHEPPARD, Deceased, ) ) 15 Plaintiff ) ) 16 v. ) No. 93 L 124 ) 17 GOOD SHEPHERD HOSPITAL, a ) corporation, DR. STEWART SEGAL, ) 18 DR. SANFORD SHERMAN, DR. BRUCE ) CARLSON, DR. R. BERGLUND, and ELI ) 19 LILLY & COMPANY, a corporation, ) ) 20 Defendants. ) 21 * * * * * * * * * * Page 9 1 SUPERIOR COURT OF THE STATE OF CALIFORNIA 2 FOR THE COUNTY OF LOS ANGELES 3 DR. MARIUS SAINES, etc., et al., ) Case No: 4 ) SC 008331 Plaintiffs, ) 5 ) vs. ) 6 ) ELI LILLY & COMPANY, a corporation; ) 7 DISTA PRODUCTS COMPANY, a division ) of Eli Lilly & Company; and DOBS 1- ) 8 100, inclusive, ) ) 9 Defendants. ) ____________________________________) 10 11 * * * * * * * * * * Page 10 1 THE DEPOSITION OF DANIEL G. RUSSELL, TAKEN 2 AT THE OFFICE OF BAKER & DANIELS, 300 NORTH 3 MERIDIAN STREET, SUITE 2700, INDIANAPOLIS, 4 INDIANA 46204, ON SEPTEMBER 23, 1993; SAID 5 DEPOSITION TAKEN PURSUANT TO NOTICE IN ACCORDANCE 6 WITH THE RULES 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. OLTMAN 17 ELI LILLY AND COMPANY LILLY CORPORATE CENTER 18 INDIANAPOLIS, INDIANA 46285 19 DALE A. DIAMOND COUNSEL FOR GOOD SHEPHERD HOSPITAL 20 333 WEST WACKER DRIVE, SUITE 1200 CHICAGO, ILLINOIS 60606-1289 Page 11 1 WILLIAM A. ROGERS 2 COUNSEL FOR DEFENDANTS CZECHOWICZ, FINK, BRUINSMA CLAUSEN MILLER GORMAN CAFFREY & WITOUS 3 10 SOUTH LASALLE CHICAGO, ILLINOIS 60603 4 PAUL J. CLEMENTI 5 COUNSEL FOR DR. DICKIE KAY HINSHAW & CULBERTSON 6 222 NORTH LA SALLE STREET, SUITE 300 CHICAGO, ILLINOIS 60601-1081 7 KATHERINE L. LAWS 8 COUNSEL FOR DRS. WITSCHY AND KANNEGANTI BAILEY AND WILLIAMS 9 3500 NCNB PLAZA 901 MAIN STREET 10 DALLAS, TEXAS 75202-3714 Page 12 1 I N D E X 2 3 DEPOSITION OF DANIEL G. RUSSELL 4 5 DIRECT EXAMINATION BY MS. ZETTLER 14 6 CERTIFICATE 146 7 ERRATA 147 8 9 EXHIBITS 10 PLAINTIFFS' EXHIBIT NO. 1 23 11 PLAINTIFFS' EXHIBIT NO. 2 30 PLAINTIFFS' EXHIBIT NO. 3 34 12 PLAINTIFFS' EXHIBIT NO. 4 35 PLAINTIFFS' EXHIBITS 5 THROUGH 8 37 13 PLAINTIFFS' EXHIBIT NO. 9 80 PLAINTIFFS' EXHIBIT NO. 10 80 14 PLAINTIFFS' EXHIBIT NO. 11 83 PLAINTIFFS' EXHIBIT NO. 12 87 15 PLAINTIFFS' EXHIBIT NO. 13 94 PLAINTIFFS' EXHIBIT NO. 14 110 16 PLAINTIFFS' EXHIBIT NO. 15 130 PLAINTIFFS' EXHIBIT NO. 16 135 17 PLAINTIFFS' EXHIBIT NO. 17 137 PLAINTIFFS' EXHIBITS 18 THROUGH 22 138 18 19 Page 13 1 2 COMES DANIEL G. RUSSELL, CALLED BY THE 3 PLAINTIFFS, AND AFTER FIRST BEING DULY SWORN, WAS 4 DEPOSED AND TESTIFIED AS FOLLOWS: 5 DIRECT EXAMINATION 6 BY MS. ZETTLER: 7 Q. Good morning, Mr. Russell. 8 Welcome back. 9 A. Good morning. 10 Q. I know it's not your most 11 favorite place to be, but unfortunately it's a 12 necessity. I want to make sure I've got the 13 dates that you worked on Prozac straight, okay. 14 If I remember correctly from the last time, you 15 worked on it for about a year in the late '70s? 16 A. Yes. 17 Q. That was about, I think you 18 said, 1978 to part of 1979? 19 A. I don't remember exactly. 20 Q. And at that time you were an 21 MIA, right? 22 A. Yes. 23 Q. But most of your work centered 24 around just answering questions for doctors and Page 14 1 people in-house and things of that nature as 2 opposed to working on trials? 3 A. No, that's not correct. 4 Q. Okay. 5 A. The first year that I worked as 6 an MIA, I was answering the questions from 7 doctors and customers, and after that I started 8 the new type of MIA work. 9 Q. That's what I understood, too. 10 A. I thought you were talking 11 about 1978 or thereabouts, and that's not what I 12 was doing, the answering questions. 13 Q. Okay, now I'm confused. The 14 first year that you worked with Prozac was 15 towards the end of -- it was the late '70s, 16 right? 17 A. In the late '70s. 18 Q. Okay. And at that time you 19 were answering questions? 20 A. No, I was not. 21 Q. What were you doing at that 22 time? 23 A. I was doing the work that I 24 described in the previous deposition, that Page 15 1 project clinical research administrators, as 2 we're now called -- 3 Q. So you were working with 4 clinical trials? 5 A. Right, correct. 6 Q. And then you left working with 7 Prozac for a period of time and then started up 8 again in the early '80s, I think? 9 A. Yes. 10 Q. '82, '83 area? 11 A. I don't remember the exact 12 year. 13 Q. And then at that time what were 14 you doing, when you started up again with Prozac? 15 A. Worked with Prozac clinical 16 trials, various clinical trials. 17 Q. Okay. When were you answering 18 questions, when were you doing that -- there was 19 a period of time when you were just answering 20 questions for Lilly doctors and things like that? 21 A. That was in 1974 or '75. 22 Q. Okay, that was way early on. 23 A. Yes. 24 Q. So at no time when you were Page 16 1 working with Prozac were you just charged with 2 answering questions? 3 MR. MYERS: You mean that was his only 4 Prozac assignment? 5 MS. ZETTLER: Right. 6 A. I don't understand the 7 question. 8 Q. When you first started working 9 with Prozac in the late '70s, you were working on 10 clinical trials? 11 A. Yes. 12 Q. And then you left for a period 13 of time and you came back and you were still 14 working on clinical trials? 15 A. Yes. 16 Q. Was there ever a period of time 17 when you worked with Prozac where your only 18 duties were to answer questions? 19 A. No. 20 Q. What types of clinical trials, 21 Prozac clinical trials, were you working on in 22 the late '70s? 23 A. Depression. That's all I 24 recall. Page 17 1 Q. When you went back to work on 2 Prozac in the early '80s, what types of trials 3 were you working on? 4 A. I don't remember exactly, the 5 sequence of the trials, but I worked on 6 depression and I also worked on obesity trials, 7 and also some smoking trials. But I don't 8 remember the exact years any of those began and 9 ended. 10 Q. Okay. What percentage of your 11 time was devoted to depression clinical trials? 12 MR. MYERS: When? 13 MS. ZETTLER: When he went back in the 14 early '80s. 15 A. Right at the beginning? 16 Q. Yes. 17 A. It was changing, it changed 18 over time. What percentage of time that I worked 19 on depression when I first started doing Prozac 20 again in the '80s? 21 Q. Right. 22 A. I don't remember precisely, but 23 it was more than fifty percent. 24 Q. Do you remember when you Page 18 1 started working on obesity trials? 2 A. No, I don't. 3 Q. How many obesity trials had you 4 worked on? 5 A. Just one. 6 Q. Were you working on that one 7 when you left Prozac in, was it, '93? 8 A. No -- no, I was not. 9 Q. Was the trial completed by 10 then? 11 A. Yes. 12 Q. How about the smoking, how many 13 trials did you work on for smoking? 14 A. I only remember one. 15 Q. Are you still in the medical 16 information -- are you still in medical 17 information -- I'm sorry. What are you doing 18 now? 19 MR. MYERS: There you go. 20 A. I work in health economics 21 research. 22 Q. And that's the same thing you 23 were doing when you were here last, right? 24 A. Yes. Page 19 1 Q. Last time we were here, you 2 testified that there was one clinical 3 investigator that you probably would have not 4 asked to work on other trials in the future. Do 5 you remember that? 6 MR. MYERS: Before he answers, I don't 7 have any problem at all with you asking him about 8 his prior deposition, but since it was rather 9 lengthy, if you could show him the page, maybe 10 that would -- if you could reference a page and 11 line, I think it would move things along, and I'm 12 going to ask that you do that if you ask about 13 his prior testimony. 14 MS. ZETTLER: Well, why don't we -- I 15 mean, if he doesn't remember his testimony, why 16 don't we do it that way, but let's not take the 17 time to do this if we don't have to. 18 Q. Do you remember testifying to 19 that, Mr. Russell, that there was a clinical 20 investigator that you would not have used again? 21 A. I don't remember the specifics 22 of the testimony -- what was the question? 23 MR. MYERS: I think she asked another 24 one. Page 20 1 Q. Okay, page one sixty-eight, 2 lines ten through twelve. 3 A. That's right, and I said I do 4 not remember. 5 Q. Do you remember now? 6 A. No, I don't. 7 Q. Does the name Sheldon Preskorn 8 ring a bell with you? 9 A. I know the name Sheldon 10 Preskorn. 11 Q. Is that Doctor Preskorn, the 12 investigator that you don't want to use again? 13 A. No. 14 Q. How do you know Mister Preskorn 15 or Doctor Preskorn, who is he? 16 A. He was a Prozac investigator, I 17 don't remember much about working with him. 18 Q. Okay. Do you remember what 19 kind of a trial it was that -- 20 A. No. 21 Q. -- this investigator was 22 working on? You have to let me finish my 23 question. 24 MR. MYERS: Let her finish because she Page 21 1 was talking about Doctor Preskorn, and then she 2 said this investigator. 3 Q. Do you remember if this 4 investigator worked on Desipramine trial, Prozac 5 or Desipramine? 6 A. I don't remember the specifics 7 of this trial. 8 Q. Why was it you didn't want to 9 use him again? 10 A. I said I don't remember. 11 You're talking about Preskorn? 12 Q. No, I'm talking about the 13 investigator that you did not want to use again, 14 what was it that he did or did not do that made 15 you not want to use him again? 16 A. Well, you know, if I felt I 17 didn't want to use somebody again it was because 18 I didn't feel they were as cooperative as maybe 19 they could have been in responding to requests. 20 Q. Is it a typical occurrence that 21 you run into investigators that you don't want to 22 use again? 23 A. I'm sorry? 24 Q. Is it a typical occurrence in Page 22 1 your job -- 2 A. No. 3 Q. -- or was it a typical 4 occurrence in your job that you did not want -- 5 let me finish my question, Mr. Russell, or we're 6 going to be here forever. Was it a typical 7 occurrence that you did not want to use a 8 particular investigator or investigators again? 9 A. No. 10 (PLAINTIFFS' EXHIBIT NO. 1 WAS 11 MARKED FOR IDENTIFICATION AND 12 RECEIVED IN EVIDENCE.) 13 Q. Mr. Russell, if you could turn 14 to Pz 1275 1731. It's about six pages back. 15 MR. MYERS: 1771? 16 MS. ZETTLER: 31. 17 A. Okay. 18 Q. And the first -- well, first 19 let me ask you this: Do you recognize this 20 exhibit? 21 A. Vaguely, yes. 22 Q. Can you tell me what it is? 23 A. It's a status report about 24 Prozac studies. Page 23 1 Q. And Plan D studies are like 2 Phase 4 studies; correct? 3 A. Yes. 4 Q. The first protocol listed is 5 HCDE, Fluoxetine versus Doxepin in depressed 6 geriatric patients, right? 7 A. Yes. 8 MR. MYERS: Doxepin. 9 MS. ZETTLER: Doxepin, okay. 10 Q. And on the right-hand side it 11 says status, Doctor blank is very difficult to 12 communicate with, CRC has given up, no manuscript 13 is forthcoming. Does that refresh your 14 recollection as to whether or not this doctor -- 15 one of these doctors is a doctor that you did not 16 want to use again? 17 MR. MYERS: Whether it was this study? 18 MS. ZETTLER: Right. 19 A. So what is your question? 20 Q. It lists here -- it lists 21 Friedhoff and Pitts, okay, see under number of 22 patients? Those are investigators, I take it? 23 A. Yes. 24 Q. Does this exhibit refresh your Page 24 1 recollection as to who the investigator or 2 investigators that you did not want to use again 3 were? 4 A. It brings to mind one that I 5 might not want to use. 6 Q. Who? 7 A. Doctor Pitts. 8 Q. Why not? 9 A. Because he never wrote a 10 manuscript. 11 Q. Is this the investigator -- is 12 Doctor Pitts the investigator you were thinking 13 of when you told me there was one investigator 14 you would not use again? 15 A. No. I'm not sure I understand 16 your question, I don't remember that I had any 17 particular one in mind, I think it was more of a 18 general notion, is there ever an investigator 19 that you might not want to use again, and I think 20 that's what I intended in my answer, not that I 21 had a specific one. 22 Q. Okay. If you could go back to 23 page one sixty-eight of your last deposition. If 24 you look at line eight through twelve again, the Page 25 1 question was did anyone ever recommend to you 2 that you drop a certain investigator from the 3 study, and your answer was I don't recall anyone 4 ever recommending that we drop an investigator, I 5 can remember not wanting to use another 6 investigator again. 7 A. That's exactly what my point 8 was, that's not a specific investigator, it was 9 not wanting to use another investigator again. 10 It's more of a generic concept. 11 Q. So there was more than one 12 occasion where you would not have used an 13 investigator again? 14 A. Yes. 15 Q. And you don't remember any of 16 those investigators' names? 17 A. I remember one now, Doctor 18 Pitts. 19 Q. Why don't you take a look at 20 Exhibit 1 and see if that refreshes your 21 recollection as to who any of the other 22 investigators are? 23 MR. MYERS: What part? 24 MS. ZETTLER: All of it, his list Page 26 1 studies and status -- 2 MR. MYERS: What's the question? 3 MS. ZETTLER: Whether or not that 4 exhibit as a whole refreshes his recollection as 5 to who some of the other investigators may have 6 been. 7 MR. MYERS: That he would not want to 8 use? 9 MS. ZETTLER: Right. 10 A. I already looked at this once. 11 MR. MYERS: Go ahead and look at it 12 again. 13 A. The first time I looked at it 14 it did not make me think of such a thing, and it 15 doesn't now. No, I don't, it doesn't make me 16 recall anybody that I didn't want to use again. 17 Q. Did you work with any clinical 18 trials that were performed outside the United 19 States? 20 MR. MYERS: As a CRA? 21 MS. ZETTLER: Or any other position. 22 A. My answer has got to be 23 two-fold. Yes, I believe that I did, but I don't 24 remember who. Page 27 1 Q. Okay. You don't remember which 2 studies? 3 A. Yes, I don't remember what 4 studies. 5 Q. Do you remember which 6 countries? 7 A. Canada. 8 Q. Was that Doctor Schnurr? 9 A. No. 10 Q. Was it a depression trial or 11 trials? 12 A. Yes. 13 Q. How many Canada trials did you 14 work on? 15 A. I'm not positive, but I think 16 it was just one. 17 Q. I -- 18 A. Two, I remember two. 19 Q. Do you remember the 20 investigators on those trials? 21 MR. MYERS: If he remembers them, 22 you're going to have to file a motion on that. 23 Judge Potter told you that the identity of 24 investigators, if you're going to ask him those Page 28 1 questions, you have to file a motion to compel. 2 MS. ZETTLER: No, he did not say that, 3 Larry, and you know it. 4 MR. MYERS: At the last hearing, about 5 the identity of investigators. 6 MS. ZETTLER: No, what he said was if 7 it's going to be a matter of having to put 8 everything back and it's going to be a long, long 9 process, then he would consider not, but he 10 doesn't consider that a trade secret, which is 11 what you have been saying it is all along. 12 MR. MYERS: He said if you did consider 13 it, you should file a motion. He's not going to 14 identify investigators. 15 MS. ZETTLER: When are you going to cut 16 out this garbage? 17 Q. All right, Mr. Russell, do you 18 remember who these investigators, any of these 19 investigators from Canada, were? 20 A. No, I don't. 21 MS. ZETTLER: Why am I not surprised. 22 MR. MYERS: Is that a question as to 23 why you're not surprised? 24 Q. Yes. Why am I not surprised, Page 29 1 Mr. Russell? 2 MR. MYERS: That would be speculation, 3 at best, to get inside your mind and understand 4 what you're thinking. 5 MS. ZETTLER: I have a feeling he 6 probably knows why I'm not surprised. 7 Q. Any other outside of the United 8 States trials you've worked on? 9 MR. MYERS: Prozac, Fluoxetine? 10 MS. ZETTLER: Fluoxetine. 11 A. No. 12 Q. Did you work on a collection of 13 data from the OUS clinical trials in preparation 14 for reanalysis of the data in response to the 15 suicidality issue? 16 A. You'll have to repeat that. 17 Q. Have you ever heard of the OUS 18 data collection project? 19 A. I don't specifically remember 20 it, no. 21 Q. Do you remember it generally? 22 A. No. 23 (PLAINTIFFS' EXHIBIT NO. 2 WAS 24 MARKED FOR IDENTIFICATION AND Page 30 1 RECEIVED IN EVIDENCE.) 2 Q. Have you had a chance to review 3 Exhibit 2? 4 A. Yes. 5 Q. Do you recognize that exhibit? 6 A. I don't remember ever seeing it 7 before. 8 Q. Have you ever seen the first 9 sheet of this exhibit, collection sheet for OUS 10 common data elements? 11 A. No. 12 Q. Do you have any idea why this 13 would have been produced as being in your file? 14 A. No. 15 Q. Did you participate in the 16 collection of data for reanalysis by Dr. Beasley 17 in preparation for the British Medical Journal 18 article? 19 MR. MYERS: Any data? 20 MS. ZETTLER: Any data. 21 A. I don't recollect doing that, 22 no. 23 Q. Have you ever heard the phrase 24 rechallenge study? Page 31 1 A. Yes. 2 Q. Can you tell me what a 3 rechallenge study is? 4 A. As I recall, a rechallenge 5 study would have been treating somebody again who 6 had an event previously with the drug to see if 7 they reacted again the same way. 8 Q. Did you work on the preparation 9 for a rechallenge study on Fluoxetine at Lilly? 10 A. I played a small part in 11 putting together a protocol. 12 Q. What part did you play? 13 A. Putting together the protocol. 14 Q. What did you do in putting 15 together the protocol? 16 A. Assisted Dr. Beasley in putting 17 some elements together for the protocol. 18 Q. What elements? 19 A. The elements that comprised the 20 protocol. 21 Q. Can you give me examples? 22 A. Sections. 23 Q. Which sections? 24 A. Dosage administration, Page 32 1 exclusion criteria. I didn't write it, I just 2 helped put it together. 3 Q. Did you work with Catherine 4 Mesner on putting together the protocol? 5 A. No, I didn't. 6 Q. Did she work on that protocol 7 as far as you know? 8 A. I think she worked on it after 9 I did, yes. 10 Q. What else did you do with 11 regards to the rechallenge study? 12 A. All I recall was just putting a 13 draft of the protocol together, helping Doctor 14 Beasley put a draft of the protocol together. 15 Q. How many rechallenge studies 16 were being prepared by Lilly or had been prepared 17 by Lilly? 18 A. I don't know. 19 Q. Do you know if that rechallenge 20 protocol was ever conducted, was a study ever 21 conducted? 22 A. I don't know. 23 Q. When did you stop working on 24 it? Page 33 1 A. After I wrote the protocol. 2 Q. When did you write the 3 protocol? 4 A. I don't remember exactly. 5 Q. Can you give me an 6 approximation? 7 A. If I did, it would be a guess, 8 I don't remember. 9 Q. It was a pretty important study 10 to Lilly, wasn't it? 11 A. I think it was felt that it 12 might be. 13 (PLAINTIFFS' EXHIBIT NO. 3 WAS 14 MARKED FOR IDENTIFICATION AND 15 RECEIVED IN EVIDENCE.) 16 Q. Have you reviewed Exhibit 3? 17 A. Yes. 18 Q. Does that refresh your 19 recollection as to when you worked on the 20 rechallenge study? 21 A. It does, but this exhibit is 22 not about the rechallenge study. 23 Q. What is it about then? 24 A. It's another study. Page 34 1 Q. What study? 2 A. The suicide ideation 3 alternative treatment study. 4 Q. What type of study is this? 5 A. I don't remember the specifics 6 of it. 7 Q. So what was -- what's the 8 difference between this and the rechallenge 9 protocol? 10 A. I believe they're different. 11 (PLAINTIFFS' EXHIBIT NO. 4 WAS 12 MARKED FOR IDENTIFICATION AND 13 RECEIVED IN EVIDENCE.) 14 Q. Have you seen Exhibit 4 before, 15 Mr. Russell? 16 A. I'm not positive, I may have. 17 Q. Does this refresh your 18 recollection as to whether or not the study you 19 just talked about in Exhibit 3 is considered a 20 rechallenge protocol, a rechallenge study? 21 A. No. 22 Q. In Exhibit 3, you state that if 23 anyone setting priorities for CTs has any doubts 24 that they've stated in the Prozac FDA meeting Page 35 1 notes of May 13th are real and very important for 2 us to live up to in the best interest of Prozac. 3 Exhibit 4 is meeting notes from May 13th; 4 correct? 5 A. Yes. 6 Q. It also says -- 7 MR. MYERS: Wait a minute, are you 8 done? 9 THE WITNESS: She keeps assuming that 10 this is the only protocol that may have been 11 going on at that time. 12 MR. MYERS: Let her ask another 13 question, okay? 14 Q. So are you saying that the 15 protocol that you're talking about in Exhibit 3 16 is also referenced in Exhibit 4, are there two 17 studies you promised the FDA to start by 18 September 1st, 1991? 19 A. No, it doesn't say that. 20 Q. It doesn't say what? I'm 21 asking what you're saying, are you saying that 22 this study -- 23 A. I'm saying the reason -- the 24 reason I'm answering the way I'm answering is Page 36 1 there was more than one suicide-type protocol. 2 Q. Okay. That's what I'm trying 3 to find out, Mr. Russell. Now tell me how many 4 of them that you're aware of. 5 A. I believe there were three. 6 Q. Three suicide-type protocols. 7 And the protocol or study that you were talking 8 about in Exhibit 3 was related to suicide? 9 A. Yes. 10 Q. And the rechallenge study 11 that's talked about in Exhibit 4 was related to 12 suicide? 13 A. Yes. 14 Q. What other suicide studies? 15 A. I don't remember the name of 16 it. 17 Q. Can you tell me what it was 18 meant to -- 19 A. I don't remember. 20 Q. Was it the validation study for 21 the MSSIR scale? 22 A. I don't remember. 23 (PLAINTIFFS' EXHIBITS 5 THROUGH 8 24 WERE MARKED FOR IDENTIFICATION AND Page 37 1 RECEIVED IN EVIDENCE.) 2 Q. Have you had a chance to review 3 Exhibits 5, 6, 7 and 8? 4 A. Yes. 5 Q. Are these all protocols? 6 A. Yes. 7 Q. Are any of those protocols the 8 protocols that you were referring to in Exhibit 9 No. 3? 10 A. Yes. 11 Q. Which exhibit is it referring 12 to? 13 A. The Exhibit 8. 14 Q. That's Study B1Y-MC-HCFQ? 15 A. Yes. 16 Q. And the title is 17 Fluoxetine/Desipramine/Placebo Alternative 18 Treatment Study for Patients who Developed 19 Suicidal Ideation While Under Treatment? 20 A. Yes. 21 Q. Did you have anything to do 22 with developing this protocol? 23 A. Yes. 24 Q. Tell me what your involvement Page 38 1 with developing the protocol was? 2 A. On very short notice, helping 3 the clinical research physician take his clinical 4 elements and incorporate them into the standard 5 protocol format. 6 Q. What clinical research 7 physician? 8 A. Doctor Beasley. 9 Q. What elements did you help 10 incorporate? 11 A. All of them to a greater or 12 lesser extent. 13 Q. This draft is dated May 7, 14 1991; correct? 15 A. Yes. 16 Q. Is there another draft of this 17 study that you helped develop? 18 A. I don't recall. 19 Q. Do you know if you were asked 20 to work on this study before or after the meeting 21 with the FDA on May 13, 1991? 22 MR. MYERS: May 7th is before May 13th. 23 MS. ZETTLER: Right. 24 MR. MYERS: We can agree to that? Page 39 1 MS. ZETTLER: Right. I'm asking if he 2 worked on -- he said that he was, on very short 3 notice, asked to help incorporate portions of 4 Doctor Beasley's -- I can't remember the exact 5 terminology, but I want to know if you had to do 6 it before or after May 13, 1991. 7 MR. MYERS: When you say that, are you 8 asking if he worked on this Exhibit 8 before May 9 13, 1991? 10 MS. ZETTLER: I'm asking if he helped 11 work on development of the protocol. 12 Q. What I'm trying to find out is 13 this the draft you worked on or was there a draft 14 after May 13th that you worked on? 15 A. I don't recall which draft I 16 worked on, I worked on a draft of that protocol. 17 Q. My question is: Do you 18 remember if it was -- if you worked on that draft 19 before or after the May 13th meeting, Exhibit 4. 20 You can look at my copy if you want. 21 A. I believe it was before the 22 meeting. 23 Q. From looking at Exhibit 8, can 24 you tell me whether or not this study was ever Page 40 1 performed? 2 A. No, I can't tell you that. 3 Q. Who would know? 4 MR. MYERS: If you know, who knows. 5 A. Who would know. Doctor Beasley 6 would know. 7 Q. Did you do any work on 8 preparing for the clinical trial reflected in 9 Exhibit 8? 10 A. No, other than order the CT, I 11 did order the CT. 12 Q. What is the CT? 13 A. Clinical trial material. 14 Q. Did you work with any 15 investigators? 16 A. No. 17 Q. Did you work with Doctor Ivan 18 Miller? 19 A. No. 20 Q. Have you ever spoken with 21 Doctor Ivan Miller? 22 A. I don't think so. 23 Q. Did you work with any or speak 24 to any of Doctor Miller's associates? Page 41 1 A. Not that I recall. 2 Q. Was the Fluoxetine, Desipramine 3 suicide study supposed to be a multi-center 4 study? 5 MR. MYERS: Can you tell from looking 6 at the protocol? 7 THE WITNESS: I would have -- 8 MR. MYERS: Go ahead and look and see 9 whether it says whether it's multi-center or not. 10 Q. Take your time. 11 A. I don't see anything that tells 12 me this is a multi-center study. 13 Q. Is this going to be an 14 inpatient or outpatient study, or both? 15 A. It says inpatient and/or 16 outpatient. 17 Q. Does this exhibit refresh your 18 recollection as to whether or not this is a 19 rechallenge study? 20 A. No. 21 Q. If you look under discussion of 22 design and control, it says the purpose of the 23 present study is to compare Fluoxetine with 24 Desipramine and placebo in a rechallenge of Page 42 1 patients who had emergence of substantial 2 suicidal ideation during previous treatment with 3 Fluoxetine, a tricyclic antidepressant or 4 maprotiline. Do you see that? 5 A. Yes, I do. 6 Q. Does that refresh your 7 recollection as to whether or not it's a 8 rechallenge? 9 A. It would make me think this was 10 probably the one that was rechallenged. 11 Q. Would you look through the 12 other exhibits, number 5, 6 and 7, and tell me if 13 any of those were rechallenge protocols, 14 rechallenge studies? 15 A. I don't think so. 16 Q. I'm sorry? 17 A. I don't think so. 18 Q. Did you work on any of those 19 other three protocols? 20 A. Yes, I believe that there are 21 really only two more protocols. These two are 22 the same, they just changed the numbers. 23 Q. When you say these two, which 24 ones are you referring to? Page 43 1 A. Exhibit 7 and Exhibit 5. 2 They're probably different drafts. 3 Q. Okay. Exhibit 7 is 4 B1Y-MC-SZZZ; correct? 5 A. Seven, yes. 6 Q. And it's a draft dated May 7th, 7 1991? 8 A. Yes. 9 Q. And Exhibit 5 is B1Y-MC-S001? 10 A. Yes. 11 Q. And that's a draft dated May 12 30th, 1991; correct? 13 A. Yes. 14 Q. And it's your testimony that 15 you believe these are really the same studies, 16 it's just two separate drafts; correct? 17 A. Yes. 18 Q. Did you work on this protocol, 19 the one reflected in Exhibit 5 and Exhibit 7? 20 A. Yes. 21 Q. What was your involvement with 22 these protocols or this protocol? 23 A. Administratively helping Doctor 24 Beasley construct the clinical elements into a Page 44 1 protocol design. 2 Q. Is this a rechallenge protocol? 3 MR. MYERS: 5 and 7? 4 MS. ZETTLER: Yes. 5 A. I don't believe so. 6 Q. Why don't we just make it 7 easier and concentrate on Exhibit 5 since it's 8 the later draft, okay? 9 A. Yes. 10 Q. Is this your handwriting on the 11 third page of Exhibit 5? 12 A. No. 13 Q. Do you know whose handwriting 14 that is? 15 A. No. 16 Q. Do you know if this trial was 17 ever conducted? 18 A. No, I don't. 19 Q. It says on the first page, 20 under overall design of plan, approximately 21 fifteen premier academic diagnosticians will 22 participate in the collection and analysis of 23 retrospective as well as current data on patients 24 who previously experienced such phenomena; Page 45 1 correct? 2 A. That's what it says. 3 Q. Is this the protocol for the 4 reanalysis of the clinical trial data? 5 A. I don't know that phrase. 6 Q. Is it your understanding that 7 Doctor Beasley collected and analyzed data from 8 clinical trials conducted in the United States 9 and outside the United States? 10 A. I don't know. 11 Q. Did you participate in 12 preparation for the advisory committee meeting 13 that was conducted in September of 1991? 14 A. Only in administratively 15 putting these protocols together. 16 Q. Were any of these protocols -- 17 were any of these protocols constructed in 18 preparation for the advisory committee meeting in 19 1991? 20 A. What was the date of that 21 meeting? 22 Q. September of 1991. 23 A. I don't know about the 24 September of 1991 meeting. My involvement with Page 46 1 this protocol was done long before that. 2 Q. It was done in May of 1991, 3 wasn't it? 4 A. Yes. 5 MR. MYERS: May is before September. 6 MS. ZETTLER: Right. I don't know if I 7 would say it was a long time before that. 8 MR. MYERS: Well, I guess it's all 9 relative. 10 Q. Are you aware that the FDA had 11 an advisory committee meeting in September of 12 1991 to value the safety of Prozac? 13 A. No. 14 Q. Were you working with Prozac in 15 September of 1991? 16 A. Yes. 17 Q. What were you doing in 18 September of 1991? 19 A. Studies other than these, I 20 don't remember the specifics studies. 21 Q. Depression studies? 22 A. Yes. 23 Q. Why in Exhibit 3 did you say 24 that the date stated in the Prozac FDA meeting Page 47 1 notes of May 13th are real and very important for 2 us to live up to in the best interest of Prozac, 3 why did you say that? 4 A. Because I was told that these 5 studies were going to be very important and we 6 had to have the CT ready on time. 7 Q. Did you say why they were very 8 important -- or were you told why they were very 9 important? 10 A. Because the FDA wanted some 11 data. 12 Q. So the FDA asked that Lilly 13 perform these studies? 14 A. I don't know that. 15 Q. Why do you say the FDA asked 16 for data? 17 A. I believe they did. 18 Q. What's the difference between 19 asking for data and performing studies? 20 A. What's the difference between 21 asking for data -- there could be a big 22 difference. 23 Q. Give me an example? 24 A. Data can be data, and data can Page 48 1 come from studies, it can come from two different 2 sources, it doesn't have -- data doesn't have to 3 come from studies. 4 Q. Are you testifying that the FDA 5 was asking for data that was already in 6 existence? 7 A. What I'm telling you is I don't 8 know the specifics of what the FDA was 9 communicating back and forth to Lilly management. 10 Q. Did somebody tell you to write 11 this memo? 12 A. Somebody told me to get the CT 13 ready in a fast order. 14 Q. Did somebody tell you to write 15 this particular memo? 16 A. No, I did that on my own 17 initiative. 18 Q. Did somebody tell you that you 19 should express to other people working in the 20 area that this was very important? 21 A. I don't remember anybody 22 specifically telling me to tell people that, no. 23 Q. This is a fairly emphatic memo, 24 isn't it, Mr. Russell? Page 49 1 A. Yes. 2 MR. MYERS: What do you mean by 3 emphatic? I guess he understands. 4 Q. Why were you so emphatic in the 5 memo? 6 A. Because I wanted the CT done on 7 time. 8 Q. You stated at the bottom of the 9 full paragraph, I can't emphasize enough how 10 important it is for us to meet all deadlines in 11 getting the CT ready for the study; correct? 12 A. That's what I said. 13 Q. But you don't recall whether or 14 not the FDA wanted data or wanted the studies 15 performed? 16 A. No, I don't, I was just told to 17 write the protocols. 18 Q. The sentence above that, you 19 say it's stated in those notes that I sent to you 20 along with the CT order and we have promised the 21 FDA that we will have this study ready to start 22 by September 1, 1991, and provide them with data 23 after the first quarter of 1992; correct? 24 A. That's what I said. Page 50 1 Q. Does that refresh your 2 recollection as to whether or not the FDA wanted 3 preexisting data or data from this study? 4 A. Makes me recall that someone 5 told me that we had promised the FDA that we will 6 have the study ready to start by September 1st 7 and provide them with data after the first 8 quarter of 1992. 9 Q. This other study, -- 10 MR. MYERS: Which one? 11 Q. -- Exhibit 6, are you familiar 12 with this study? 13 A. It's one of the three protocols 14 we've been discussing, and I helped 15 administratively put the protocol together. 16 Q. So you helped put this protocol 17 together also, Exhibit 6? 18 A. Yes. 19 Q. And that's B1Y-MC-S002; 20 correct? 21 A. Yes. 22 Q. And there's no date on this 23 one. 24 A. I don't see any. Page 51 1 Q. Okay. Do you know if this 2 study was ever performed? 3 A. No, I don't. 4 Q. Was this study something that 5 was to be done prior to the rechallenge protocol? 6 A. I don't remember, I don't know. 7 Q. This was a study that was to be 8 done to validate the MSSI-R; correct? 9 A. Yes. 10 Q. And in Exhibit No. 8, the 11 MSSI-R was to be used, correct, in that study? 12 MR. MYERS: Where are you looking at? 13 MS. ZETTLER: Second page of Exhibit 8. 14 A. Where? 15 Q. Look at the bottom, towards the 16 bottom of the page under exclusion criteria. 17 A. The bottom of page two, it 18 mentions the MSSI-R. 19 Q. So it would make sense that if 20 you're going to use it in a study it would be 21 nice to validate the scale before you used it, 22 wouldn't it? 23 MR. MYERS: Let me object to the form. 24 Whether it would be nice to do it or not, I mean Page 52 1 that's not a medical or scientific -- 2 MS. ZETTLER: Okay, if it's not a 3 medical or scientific term, Larry, you're going 4 to say he's not qualified to answer. 5 MR. MYERS: I may do that. 6 Q. Would it be appropriate to 7 validate the scale before you used it in a study? 8 A. It sounds like it would be 9 appropriate, yes. 10 Q. Do you know if the trial talked 11 about in Exhibit 6 was ever conducted? 12 A. No, I do not. 13 Q. Who did you work with in 14 developing this protocol? 15 A. Doctor Beasley. 16 Q. Did you ever discuss the issue 17 of rechallenge with Doctor Beasley outside of 18 just putting together the protocol? 19 A. I don't recall. 20 Q. Do you know if anybody at Lilly 21 had reservations about performing a rechallenge 22 study on suicidality and Fluoxetine? 23 A. Are you done? 24 Q. Yes. Page 53 1 A. I don't know. 2 Q. Who else worked on these three 3 protocols besides you and Doctor Beasley? 4 A. Catherine Mesner. 5 Q. Which one did she work on or 6 which ones? 7 A. I don't know. 8 Q. Did she work with you on 9 developing any of these three protocols? 10 A. No. 11 Q. What did she do? 12 A. She took over the protocols 13 after I helped administratively construct them. 14 Q. Did you work on any of these 15 protocols until there was a final draft done? 16 A. No. 17 Q. Did you work on recruiting any 18 investigators for any of these three studies? 19 A. No. 20 Q. Besides the ordering of the 21 Desipramine, what else did you -- were you 22 charged with preparing for the studies? 23 MR. MYERS: Let me object to the form. 24 I think his prior testimony was he ordered that Page 54 1 Desipramine for one referenced study, I think, I 2 don't know that he said it was for all three. 3 Q. Okay. Did you prepare the CT 4 on all three of these studies? 5 A. I don't even remember if there 6 was a CT used in all three studies, I would have 7 to review the protocol. 8 Q. Go ahead and do that. 9 A. Protocol Exhibit 6, there is no 10 drug used in the protocol. 11 Q. Okay. 12 A. Protocol Exhibit 5, there 13 appears to be no drug used in the protocol. 14 Q. What about Exhibit 6 tells you 15 that there's no drug used in the protocol? 16 A. The primary objective of -- 17 MR. MYERS: Wait a minute, 6? 18 A. Page three or the third page, 19 section three point six, dosage and 20 administration, there would be no study drug in 21 this protocol. 22 Q. Okay. How about Exhibit 5? 23 A. Exhibit 5, other than the fact 24 I can't even find the dosage and administration Page 55 1 section, which would indicate to me there's no 2 drug used. It's just the objective of the study 3 is to more clearly characterize the variety and 4 phenomena constituting psychobehavioral 5 deterioration observed in patients being treated 6 with antidepressants. It seems to be just a 7 broad overview of all treatments. There's no 8 mention of any specific drug treatments. 9 Q. Are you familiar with the term 10 surveillance study? 11 A. I've heard the term. 12 Q. What is your understanding of 13 what a surveillance study is? 14 A. I don't feel qualified to 15 answer that. 16 Q. You don't have an understanding 17 as a lay person? 18 A. Not a clear understanding, no. 19 Q. Can you give me your unclear 20 understanding? 21 A. Surveillance means to watch 22 something or monitor something, I suppose, is 23 about as much as I can -- 24 Q. What about Exhibit No. 5, is Page 56 1 that a surveillance study? 2 A. I don't know. 3 Q. How about Exhibit No. 6, is 4 that a surveillance study? 5 A. I don't feel qualified enough 6 about the definition of a surveillance study to 7 tell you whether either one of these is a 8 surveillance study. 9 Q. All right. Have you ever heard 10 the term prospective study? 11 A. Prospective study? 12 Q. Yes. 13 A. Yes. 14 Q. What is a prospective study? 15 A. Prospective study is one that's 16 designed before whatever is intended to happen. 17 Q. Are any of these three studies 18 prospective studies, Exhibit 5, Exhibit 6 or 19 Exhibit 8? 20 MR. MYERS: Start with five. 21 A. Exhibit 5 is prospective, 6 is 22 a prospective study, and Exhibit 8 is a 23 prospective study. 24 Q. Okay. What's the difference Page 57 1 between a prospective study and a rechallenge? 2 A. My understanding is a 3 rechallenge study would be a prospective study. 4 Q. Okay. So a prospective study 5 is a study that's set up specifically to research 6 a topic in the future instead of doing a 7 retrospective analysis of data that's already 8 been accumulated; correct? 9 A. Very broadly, that's true. 10 Q. Okay. Can a rechallenge study 11 ever be retrospective? 12 A. I don't feel I can say it 13 couldn't be, I don't know. 14 Q. Besides the three studies, 15 Exhibit 5, Exhibit 6 and Exhibit 8, are you aware 16 of any other protocols that were developed or any 17 other studies that were conducted related to the 18 issue of suicidality and the use of Fluoxetine? 19 MR. MYERS: Let me object to the form, 20 Nancy, only to the extent that I think he told 21 you that two of these studies were not drug 22 studies, so I don't know that they could be, 23 quote, related to Fluoxetine. 24 Q. Can you answer the question? Page 58 1 MR. MYERS: If you can answer, go 2 ahead. 3 A. Repeat the question. 4 Q. Sure. Besides these three 5 studies, Exhibits 5, 6 and 8, are you aware of 6 any other protocols that were developed or 7 studies that were performed at Lilly related in 8 any way to the issue of suicidality and the use 9 of Fluoxetine? 10 A. Well, two of these are not 11 really dealing with Fluoxetine specifically, and 12 I don't know of any other ones besides the one 13 that does deal with treatment of Fluoxetine. 14 Q. And the two studies that are 15 not related are Exhibit No. 6 and Exhibit No. 5, 16 I believe? 17 A. The two that I testified did 18 not use a drug, right. 19 Q. But these studies were 20 performed or at least these protocols were 21 developed to be used to study the phenomena of 22 suicide and the use of Fluoxetine, weren't they? 23 MR. MYERS: I object to the form, I 24 don't think he's testified to that. If you're Page 59 1 asking him that as an initial matter, go ahead. 2 Is that the case or not, tell her. 3 A. And the use -- I have trouble 4 with the term and the use of Fluoxetine because 5 two of them were designed to provide data on 6 suicide. 7 Q. Let me ask you this: Studying 8 that Exhibit 8, okay, the rechallenge study was 9 being performed by Lilly or was to be performed 10 by Lilly to study the phenomena or lack of 11 phenomena of suicidality and the use of 12 Fluoxetine; correct? 13 A. The phenomena or lack of 14 phenomena. I can only tell you what the 15 objective says that it is. 16 Q. Were they studying the 17 incidence of suicidality and the use of 18 Fluoxetine or not? 19 A. I would have to reread it 20 again. 21 Q. Go ahead. 22 A. Is it studying the incidence -- 23 say your question again? 24 Q. The occurrence of suicidality Page 60 1 and the use of Fluoxetine. 2 MR. MYERS: That's a different 3 question. 4 Q. Is it studying the occurrence 5 of suicidality and the use of Fluoxetine? 6 A. Yes. 7 Q. Okay. To your knowledge, was 8 the study that was talked about in Exhibit No. 6 9 a validation of a scale that was to be used in 10 Exhibit No. 8? 11 A. I only know by what you pointed 12 out to me, that it's being used in Exhibit No. 8, 13 but I couldn't have told you that if you asked me 14 before we looked them over. 15 Q. Do you know of any other 16 studies that were validating any other scales 17 that were to be used in the rechallenge protocol? 18 A. Repeat that? 19 Q. Sure. Do you know of any other 20 studies besides the study talked about in Exhibit 21 6 that were to be performed to validate any other 22 scales that were to be used in the rechallenge 23 protocol? 24 A. No, I don't. Page 61 1 Q. Do you know of any other 2 studies similar to Exhibit No. 5 that are 3 structured to assess the psychobehavioral 4 deterioration of patients while on 5 antidepressants? 6 A. No, I don't. 7 Q. Do you know of any other 8 studies that were performed, related in any way 9 to the issue of suicidality in depressed 10 patients? 11 MR. MYERS: I object to the form only 12 to the extent that your question assumes the 13 studies were performed and he said he didn't 14 know. 15 Q. Let's start with developed. 16 A. So repeat the question then? 17 Q. Sure. Do you know of any other 18 studies that were developed by Lilly where the 19 purpose was to evaluate the cycle of behavioral 20 deterioration of patients while on 21 antidepressants? 22 A. No, I don't. 23 Q. Do you know of any other 24 studies that were developed or performed at Lilly Page 62 1 where the specific purpose was to evaluate 2 suicidality, the occurrence of suicidality, in 3 patients on Fluoxetine? 4 MR. MYERS: Other than 8? 5 MS. ZETTLER: Right. 6 A. No, I don't. 7 Q. Do you know of any studies that 8 were developed or performed at Lilly to study the 9 phenomena of aggressive violent behavior of 10 patients on Fluoxetine? 11 MR. MYERS: I object. Other than what? 12 Q. Do you know of any studies that 13 were performed or developed at Lilly that were to 14 study the occurrence of violent aggressive 15 behavior in patients on Prozac or Fluoxetine? 16 A. No, I don't. 17 Q. And you don't know if any of 18 these studies were ever performed, Exhibits 5, 6 19 or 8? 20 A. I believe I already testified 21 to that fact, I don't. 22 Q. If you look at Exhibit 4. Look 23 under subject number two, incorporate the 24 modified scale for suicidal ideation revised in Page 63 1 ongoing and planned U.S. and UK clinical trials. 2 Do you see that? 3 A. Yes, I see it. 4 Q. Do you know if that was ever 5 done? 6 A. No, I don't. 7 Q. Was it ever done on any of the 8 studies that you worked on? 9 A. No. 10 Q. That scale was never used on 11 any of the studies you worked on? 12 A. No. 13 Q. Have you ever talked with 14 Doctor Teicher? 15 A. No. 16 Q. Have you ever been in a meeting 17 where Doctor Teicher was present? 18 A. Not that I recall. 19 Q. How about Doctor Cole, did you 20 ever talk with Doctor Cole? 21 A. Yes. 22 Q. You have. On what occasions? 23 A. I started up a study that he 24 did for us with Prozac, and I think I had Page 64 1 occasion to visit him one other time. 2 Q. So you went to Doctor Cole's -- 3 A. Site. 4 Q. Site. Where is Doctor Cole's 5 site? 6 A. In Belmont, Massachusetts. 7 Q. Was that before or after the 8 Teicher article was published? 9 A. Before. 10 Q. Was the study where Doctor Cole 11 was an investigator, was that a depression study? 12 A. Yes. 13 Q. Was there a comparitor drug 14 used? 15 A. Yes. 16 Q. What drug? 17 A. I don't remember. 18 Q. Was this part of a multi-center 19 study or was he doing an individual study? 20 A. That was an individual study. 21 Q. Do you remember what year the 22 study was started up? 23 A. No. 24 Q. Was that study completed by the Page 65 1 time the Teicher article was published? 2 MR. MYERS: When you say completed, 3 what do you mean? 4 Q. Was Doctor Cole -- did he 5 complete his work on that study at the time the 6 Teicher article was published? 7 A. I don't remember when the 8 Teicher article was published. 9 Q. If I told you it was in 10 February of 1990, would that refresh your 11 recollection? 12 A. January or February of 1990? 13 Q. February of 1990. 14 A. Then I would say I'm not sure 15 whether the Cole study was done or not, I don't 16 remember. 17 Q. Did Doctor Cole write a 18 manuscript or report of that study? 19 A. There was no manuscript. 20 Q. Why not? 21 A. I don't remember the specific 22 reasons, but there was some reason why he didn't 23 feel that it was a good enough study to warrant 24 writing a manuscript. Page 66 1 Q. What was the purpose of Doctor 2 Cole's study, what were the objectives? 3 A. I don't know. 4 Q. Was it to study the efficacy of 5 Fluoxetine as compared to the comparitor drug? 6 A. Probably. 7 Q. And you went to Doctor Cole's 8 site for the start-up meeting on that study? 9 A. Yes. 10 Q. And you said you had one other 11 occasion to visit with Doctor Cole; correct? 12 A. Yes. 13 Q. What occasion was that? 14 A. I don't recall whether it was -- 15 whether there was any specific need or whether it 16 was just a routine follow-up visit. 17 Q. When you say routine follow-up 18 visit, do you mean routine follow-up on the study 19 that you performed for Lilly? 20 A. Yes. 21 Q. Did you ever talk with Doctor 22 Cole with regards to the Teicher article? 23 A. No. 24 Q. To your knowledge, was Doctor Page 67 1 Cole to be involved in any of the three studies 2 that we talked about earlier, Exhibits 5, 6 and 3 8? 4 A. I don't know. 5 Q. How about Dr. Glod, Carol Glod, 6 have you ever worked with her? 7 A. I don't recognize the name. 8 Q. Under number three on Exhibit 9 4, the last full point, it says the FDA did not 10 have a problem with who gave the MSSI-R 11 questionnaire to other companies to use in their 12 clinical trials; correct? 13 A. That's what it says. 14 Q. Do you know if that was ever 15 done? 16 A. No, I don't. 17 Q. Have you ever worked with any 18 other drug companies with regards to the issue of 19 antidepressants in general? 20 A. No. 21 Q. Have you ever worked with any 22 drug companies at all, besides Lilly? 23 MR. MYERS: What do you mean worked 24 with? Page 68 1 Q. Have you ever done a study in 2 conjunction with another -- 3 A. No. 4 Q. -- drug company. Have you ever 5 done any work whatsoever with other drug 6 companies related to Fluoxetine? 7 A. Indirectly. 8 Q. Okay. What do you mean by 9 indirectly? 10 A. When you had comparitor drugs 11 you had to get their permission to use the 12 comparitor drug in the study. 13 Q. Did anybody ever ask for 14 permission to use Fluoxetine as a comparitor drug 15 in one of their studies? 16 A. I don't know. 17 Q. Tell me about the process of 18 getting permission from another drug company to 19 use their drug as a comparitor? 20 A. When we decided on a 21 comparitor, that job was turned over to our 22 clinical trial materials staff. 23 Q. What would they do? 24 A. Ask for permission, obtain Page 69 1 material. 2 Q. I didn't mean to cut you off. 3 They would call somebody at the other company and 4 ask for permission to use the materials, to use 5 the drug? 6 A. Yes. 7 Q. So in the case of Exhibit 3, 8 let me ask you this: Who is Thomas Jeatran? 9 A. Jeatran. He was in charge of 10 doing that type of function for the clinical 11 trial material group. 12 Q. So he called the manufacturer 13 of Desipramine and asked them for permission to 14 use the drug as a comparitor in the suicidal 15 ideation alternative treatment study? 16 A. I can only assume that he did. 17 Q. Who manufactures Desipramine? 18 A. I don't know. 19 Q. To your knowledge, has Lilly 20 ever conducted a trial where it's compared other 21 serotonin reuptake inhibitors to Fluoxetine? 22 A. Not that I know of. 23 Q. To your knowledge has Lilly 24 ever performed a study where it's compared Page 70 1 Fluoxetine to other serotoninergic drugs in 2 general? 3 A. I'm not aware of it. 4 Q. Have they ever developed a 5 protocol with the intention of performing such a 6 study or studies? 7 A. I don't know. 8 MR. MYERS: What studies are you 9 talking about? 10 MS. ZETTLER: Comparing Fluoxetine to 11 serotoninergic drugs. 12 MR. MYERS: Is your answer the same? 13 THE WITNESS: It's the same, I don't 14 know. 15 Q. Under point number four on 16 Exhibit No. 4, it says descriptive study of 17 patients reported to develop intensive violent 18 suicidal thoughts. Do you know if that study was 19 ever developed? 20 A. Was it ever developed? 21 Q. Right. Was a protocol ever 22 written for such a study? 23 A. I don't know. 24 Q. Did you ever work on such a Page 71 1 study? 2 A. Not unless it's someone 3 referring indirectly to one of these three. 4 These are the only three that I worked on that 5 had anything to do with suicide. I don't believe 6 it's referring to these three, but it may have 7 been. 8 Q. To your knowledge did Lilly 9 perform a study related to suicidal ideation 10 prior to 1990? 11 A. I don't know. 12 Q. If you could look back at 13 Exhibit Number 2, please. 14 MR. MYERS: Two? 15 MS. ZETTLER: Yes. 16 A. Okay. 17 Q. Look at the fourth page in, 18 page number -- actually it's Pz 2441 759. 19 A. Okay. 20 Q. Can you tell me what this is, 21 this document, this portion? 22 A. I'm not familiar with this 23 document at all, so I can't tell you. 24 Q. On the next page, it appears to Page 72 1 be a listing. You tell me if I'm wrong, but it 2 appears to be a listing of various clinical 3 trials; correct? 4 A. It appears to be a listing of 5 some kind of trials. 6 Q. And in the upper left-hand 7 corner it says protocol under A. It's kind of 8 hard to read, I apologize. 9 A. Yes. 10 Q. And then B is title 11 investigator; correct? 12 A. That's what it says. 13 Q. Country, next? 14 A. Yes. 15 Q. And it basically goes on to 16 discuss details about the various studies; 17 correct, such as location, age of patients, 18 whether or not it was a randomized blinded study, 19 things of that nature? 20 A. It has titles like that. 21 Q. If you look at the fourth line 22 from the bottom on that page, it says BPHC 23 thirty-five suicide patients? 24 A. That's what it says. Page 73 1 Q. Are you familiar with that 2 study? 3 A. No, I'm not. 4 Q. It also says year 1987; 5 correct, under column D? 6 A. That's what it says. 7 Q. And you're not familiar with 8 that study? 9 A. No, I'm not. 10 MS. ZETTLER: Let's take a quick break. 11 (A SHORT RECESS WAS TAKEN.) 12 Q. Did you attend any meetings 13 where Doctor Miller was present, Doctor Ivan 14 Miller? 15 A. What's the first name? 16 Q. Ivan Miller. 17 A. No, I don't recall that I did. 18 Q. Did you attend any meetings 19 related to the rechallenge protocol? 20 A. Meetings. I had meetings with 21 Doctor Beasley. 22 Q. Did you ever -- did you attend 23 a meeting where -- other than with, you know, 24 just one or more meetings with Doctor Beasley, Page 74 1 but did you ever attend a meeting where the 2 rechallenge protocol was the specific topic of 3 the meeting? 4 A. I'm not sure. I can only 5 remember attending one multi-person meeting about 6 any of those protocols, and it may have been that 7 one, and it may have been one of the other ones. 8 Q. I'm sorry, you said you 9 remember attending one multi-party meeting 10 regarding the protocols? 11 A. Yes. 12 Q. Can you tell me when that 13 meeting occurred? 14 A. No, I can't. 15 Q. Can you tell me what the 16 subject of the meeting was? 17 A. It was something to do with the 18 protocols. 19 Q. What to do with the protocols? 20 A. I don't remember. 21 Q. Who else was in that meeting? 22 A. I don't remember it, there was 23 some marketing people there, I think. 24 Q. Marketing people were there? Page 75 1 A. I think so. 2 Q. Any people from the legal 3 department there? 4 A. I don't remember. 5 Q. Were any other CRAs there? 6 A. I don't remember. 7 Q. Was there anybody from the DEU 8 there? 9 A. I don't remember. 10 Q. The last time I believe you 11 testified that some of the studies were paid for 12 by the marketing department; is that correct? 13 A. Yes. 14 Q. In general? 15 A. Yes. 16 Q. To your knowledge were any of 17 these three studies paid for by the marketing 18 department? 19 A. I don't know. 20 Q. Was Doctor Leigh Thompson at 21 that meeting? 22 A. No. 23 Q. How about Doctor Zerbe? 24 A. I don't remember for sure. Page 76 1 Q. Any other clinical research 2 physicians besides Doctor Beasley? 3 A. I don't remember. 4 Q. Was Doctor Street there? 5 A. Not that I can recall. 6 Q. Why were they going to use 7 Desipramine as the comparitor drug on the 8 rechallenge protocol? 9 A. Why did they want to use 10 Desipramine? 11 Q. Right. 12 A. I don't know. 13 Q. To your knowledge, did they 14 consider using any other drugs as comparitors in 15 that protocol? 16 A. None that I'm aware of. 17 Q. Did Carol Zapapas work on any 18 of the protocols to your knowledge? 19 A. Not directly. 20 Q. Do you know if she attended the 21 meeting that -- do you recall her attending 22 regarding the rechallenge protocol? 23 A. She may have been there, but I 24 don't remember for sure. Page 77 1 Q. How about Doctor Kotsanos, did 2 he work on any of these to your knowledge? 3 A. I believe he was consulted. 4 Q. Was he at that meeting? 5 A. I don't remember. 6 Q. What's an FTE, do you know what 7 a FTE is? 8 A. Not right offhand, I don't. 9 Q. How about Greg Enas, was he at 10 the meeting? 11 A. I don't remember if he was. 12 Q. How many people were at that 13 meeting? 14 A. I don't know. 15 Q. More than five? 16 A. More than five. 17 Q. More than fifteen? 18 A. I'm not sure. 19 Q. What about Doctor Wheadon, was 20 he there? 21 A. I don't remember if he was. 22 Q. Doctor Weinstein? 23 A. I can't remember. 24 Q. Doctor Masica? Page 78 1 A. I don't remember. 2 Q. Doctor Heiligenstein? 3 A. I don't remember. 4 Q. Was anybody from outside of 5 Lilly at that meeting? 6 A. Yes. 7 Q. Who? 8 A. I don't remember who he was. 9 Q. It was a he? 10 A. Yes. 11 Q. Just one person? 12 A. As I recall, it was one outside 13 person, right. 14 Q. Was he a consultant? 15 A. I think he must have been in 16 some consulting capacity, even if it was just for 17 one time. 18 Q. Did you ever meet Doctor Ivan 19 Miller? 20 A. Not that I recall, but he could 21 have even been the person, I just don't remember 22 if he was or not. 23 Q. Was the MSSI-R discussed during 24 that meeting? Page 79 1 A. I think it was. 2 (DISCUSSION OFF THE RECORD.) 3 (PLAINTIFFS' EXHIBIT NO. 9 WAS 4 MARKED FOR IDENTIFICATION AND 5 RECEIVED IN EVIDENCE.) 6 Q. Have you had at chance to 7 review Exhibit 9? 8 A. Yes. 9 Q. Do you recognize this exhibit? 10 A. No. 11 Q. Have you ever seen it before, 12 to your knowledge? 13 A. Not to my knowledge. 14 Q. Were you involved in the 15 development or implementation of the training 16 program for raters of the MSSI-R? 17 A. No. 18 Q. Are you aware of whether or not 19 such a program was implemented where people were 20 trained to implement the -- to administer the 21 MSSI-R? 22 A. No, I'm not. 23 (PLAINTIFFS' EXHIBIT NO. 10 WAS 24 MARKED FOR IDENTIFICATION AND Page 80 1 RECEIVED IN EVIDENCE.) 2 Q. Have you had at chance to 3 review Exhibit 10? 4 A. Yes. 5 Q. Are you familiar with that 6 exhibit? 7 A. No, I'm not. 8 Q. The meeting that you attended, 9 the multi-person meeting on the rechallenge 10 protocol, did you attend that before or after you 11 helped develop the protocols? 12 A. I believe it was in the middle 13 of the time that I was working on drafts. I 14 think I had done some work, and then we had some 15 kind of a meeting and then did some more work. 16 Q. Okay. Exhibit 10 talks about a 17 meeting on April 11, 1991 discussing a meeting 18 with somebody whose name is blanked out of this 19 exhibit, discussing suicidal ideation and the 20 modified version of the scale for suicidal 21 ideation. Does it refresh your recollection as 22 to whether or not you attended that meeting? 23 A. No. 24 Q. Have you ever heard of William Page 81 1 Norman? 2 A. William Norman? 3 Q. Yes. 4 A. No, I have not. 5 Q. How about Stephen Bishop? 6 A. Doesn't -- I don't recall 7 Stephen Bishop. 8 Q. How about Michael Dow, D-O-W? 9 A. I don't recall Michael Dow. 10 Q. Who is Carol Andrejasich, 11 Andrejasich? 12 A. Carol Andrejasich is a Lilly 13 employee. 14 Q. What does she do? 15 A. She works in health economics 16 research. 17 Q. That's the department you're in 18 now? 19 A. Yes. 20 Q. What does she do at health 21 economic research? 22 A. She works primarily with 23 quality of life studies. 24 Q. To your knowledge, was that Page 82 1 department involved in the rechallenge protocol? 2 A. I don't know. 3 Q. Would they typically get 4 involved in protocols and clinical trials other 5 than such as like a quality of life trial or 6 something like that? 7 A. Only with studies that are 8 specific to health economic research. 9 (PLAINTIFFS' EXHIBIT NO. 11 WAS 10 MARKED FOR IDENTIFICATION AND 11 RECEIVED IN EVIDENCE.) 12 Q. Have you had a chance to review 13 Exhibit 11? 14 A. Yes, I have. 15 Q. Do you recognize this exhibit? 16 A. No, I don't. 17 Q. You were working on Fluoxetine 18 in '88, weren't you? 19 A. Yes, I was. 20 Q. Were you aware of this 21 protocol, this study? 22 A. No, I wasn't. 23 Q. Did anybody ever tell you there 24 was a concern about the incidence of suicidality Page 83 1 and the use of Fluoxetine prior to 1990? 2 A. Did anybody ever tell me -- 3 Q. Whether or not Lilly had a 4 concern about the incidence or the recurrance of 5 suicidality on patients using Fluoxetine prior to 6 1990? 7 A. I don't recall. 8 Q. Is there anything that would 9 refresh your recollection? 10 A. Beg your pardon? 11 Q. Is there anything that would 12 refresh your recollection as to whether or not 13 somebody ever mentioned that issue to you prior 14 to 1990? 15 A. Is there anything that would 16 refresh my recollection? 17 Q. Right. 18 A. Not that I know of. 19 Q. Let's talk about consent forms, 20 okay. I remember the last time you testified 21 that part of your job as a CRA was to put 22 together consent forms for studies that you 23 worked on; is that true? 24 A. Yes. Let me paraphrase that. Page 84 1 To put together sample consent forms as models 2 for investigators to use as a starting point in 3 constructing their own consent forms. 4 Q. Was it a part of the 5 investigator's responsibility to write the 6 consent forms to be used in their studies? 7 A. I'm sorry, say that again. 8 Q. Sure. Was it part of the 9 clinical investigator's responsibility as a 10 clinical investigator to write the consent forms 11 to be used in their studies? 12 A. Yes. 13 Q. You just testified that you 14 developed samples to give to them to use in 15 writing those consent forms, right? 16 A. Yes, we developed minimum 17 content models for them to use that had minimum 18 content that they had to contain. 19 Q. What areas of content did you 20 want them to contain, what -- well, let me ask it 21 this way: Were there specific requirements that 22 Lilly had for what should be contained in the 23 consent forms? 24 A. They were specific requirements Page 85 1 that legal required that consent forms had to 2 contain, right. 3 Q. Can you give me some examples? 4 A. I really can't, there's so much 5 detail, I can't remember. 6 Q. How about adverse events? 7 A. They had to contain -- as I 8 recall, they had to contain all of the -- and 9 this could have been just at one point in time 10 because it could change over time, but I remember 11 at one point in time, if you want an example, 12 that they had to contain all the package 13 literature adverse events that could happen with 14 a drug. That's the only example of adverse 15 events that I can think of. 16 Q. So is it your testimony that 17 all adverse events that were listed in the 18 package insert had to be contained in the consent 19 form? 20 A. I just said that at one point 21 in time, if you take one picture, at one point in 22 time, it was a policy, to the best of my 23 recollection, that we had to have everything. If 24 it was listed in the package literature, it had Page 86 1 to be revealed to the patients in a consent form. 2 Q. What point in time was that? 3 A. A few years ago or a couple of 4 years ago. 5 Q. Before or after 1990? 6 A. I don't remember whether it was 7 a policy before 1990 or not. 8 Q. Was it after the drug was 9 approved for use in depression? 10 A. It was after the drug was 11 approved for use in depression that I remember 12 that we had to be sure that all those things were 13 in there. 14 Q. All the adverse events listed 15 in the package insert? 16 A. Right. 17 Q. Prior to that time, what were 18 the requirements for listing of adverse events? 19 A. I don't remember. 20 (PLAINTIFFS' EXHIBIT NO. 12 WAS 21 MARKED FOR IDENTIFICATION AND 22 RECEIVED IN EVIDENCE.) 23 Q. Do you recognize Exhibit 12? 24 A. Yes, I do. Page 87 1 Q. Does it refresh your 2 recollection as to when the package insert 3 adverse events were incorporated into consent 4 forms? 5 A. Adverse events were always 6 incorporated in the consent forms, this just 7 represented a fine tuning of how that was done. 8 Q. My question is: Does this 9 refresh your recollection as to when the adverse 10 events listed in the package insert that we just 11 talked about, when that was incorporated into the 12 consent forms? 13 A. The only problem I have with 14 your question is it's -- I didn't mean to imply 15 that package insert adverse events were not 16 listed at all on consent forms prior to that, 17 there was this point in time, and this document 18 reflects that, when there was a communication 19 that we had to make absolutely certain that 20 everything that was listed in the package insert 21 was also listed in the consent form. 22 Q. Okay. Just so I make sure that 23 I understand your testimony, okay, at some point 24 in time, and I believe you said it's reflected in Page 88 1 this exhibit, you were to make sure that all the 2 adverse events that were listed in the package 3 insert were incorporated into the consent form; 4 correct? 5 A. All I'm saying is that at one 6 point in time we put out a communication that 7 stated that we were going to use this attachment 8 to the adverse event to the consent form, which 9 would include all the adverse events that were 10 listed in the package literature. 11 Q. Okay. Does Exhibit 12 reflect 12 that decision, in other words is this the 13 communication that you just spoke about that was 14 sent out? 15 A. Yes. 16 Q. And it's dated October 27, 17 1989; correct? 18 A. Yes, it is. 19 Q. Then after this date, there was 20 an attachment to the consent forms that listed 21 the adverse events that were -- that appeared in 22 the package insert or -- I guess I'm not really 23 sure what you mean by attachments. 24 A. There was an addendum, I Page 89 1 believe that's what we called it, to the consent 2 form which listed all of the additional adverse 3 events other than the ones that were the most 4 common and most severe. Those are always listed 5 in the regular body of the consent form, but all 6 the additional ones that occurred much less 7 frequently or were not considered as severe, were 8 listed in this addendum. 9 Q. And prior to using the 10 addendum, the less severe adverse events were not 11 included in the informed consent? 12 A. I'm not saying that, I'm just 13 saying there was this new format for listing, 14 which included an addendum for the ones that were 15 less frequent and less severe. 16 Q. The addendum was more 17 exhaustive? 18 A. I believe it was. 19 Q. Prior to the addendum 20 incorporating all the adverse events listed in 21 the package insert being used, what was the 22 policy as far as adverse events being listed in 23 consent forms? 24 A. The policy, as I understood it, Page 90 1 was that the physician, the clinical research 2 physician, in conference with our legal people, 3 decided which events had to be listed in the 4 consent form. 5 Q. Okay. Did the clinical 6 investigators have the option of adding adverse 7 events to the consent form? 8 A. Did the clinical investigators 9 have the option? I'm not sure. If they do, I 10 would think they would have to consult with Lilly 11 if they wanted to add additional ones. 12 Q. Did they have the option to 13 subtract adverse events from the forms? 14 A. Not from our minimal content 15 forms. 16 Q. Did the minimal content 17 requirements of the adverse event portion of the 18 informed consents change while you were a CRA 19 working on Prozac, other than the one we just 20 talked about where the addendum was used? 21 A. I think they were reviewed and 22 revised and updated periodically based on current 23 data. 24 Q. Where did that data come from? Page 91 1 A. From all the data compiled from 2 clinical trials and adverse event reporting world 3 wide. 4 Q. So if an adverse event was seen 5 in clinical trials, in previous clinical trials, 6 it may have been incorporated into the informed 7 consent used in trials that were being developed? 8 A. If new information on the 9 adverse event profile of a drug is discovered, 10 and was considered to be information that was 11 important to be revealed to the patients in 12 clinical trials, it would have been incorporated 13 as it was discovered, correct. 14 Q. Who made the decision on what 15 adverse events to incorporate in the informed 16 consents and which ones not to? 17 A. I don't know, ultimately, other 18 than legal and clinical research physicians. 19 Q. Did you work with the clinical 20 investigators in drafting the consent forms? 21 A. Me personally? 22 Q. Yes. 23 A. All I had to do with the 24 informed consent documents was to provide the Page 92 1 minimal language document that was attached to 2 the protocol. 3 Q. Were you charged with reviewing 4 the consent forms after they were drafted by the 5 clinical investigators to ensure that all the 6 minimal inclusions were met? 7 A. Either we would do it or 8 on-site people would review them to make sure 9 that they met the requirements. Usually they -- 10 as I recall, they had to return them to us and we 11 would check them for complete content or for 12 things that shouldn't be in them. 13 Q. I'm sorry, things that should 14 not be in them? 15 A. If they added things. 16 Q. Like what? 17 A. Like anything that would throw 18 up flags and it might not be appropriate. 19 Q. Can you give me an example? 20 A. They might say that Lilly was 21 liable for something that our legal department 22 might not agree they were liable for. That would 23 be an example. 24 Q. To your knowledge was suicidal Page 93 1 ideation ever included as an adverse event prior 2 to October of 1989 when the entire package insert 3 was incorporated? 4 A. I don't remember. 5 (PLAINTIFFS' EXHIBIT NO. 13 WAS 6 MARKED FOR IDENTIFICATION AND 7 RECEIVED IN EVIDENCE.) 8 Q. Do you recognize this document? 9 A. Not the specific protocol, but 10 I recognize that it's an informed consent 11 document for a Prozac study with an attached 12 addendum. 13 Q. So the last three pages of 14 Exhibit 13, is that an example of the addendum 15 that you were just talking about that was enacted 16 in October of 1989? 17 A. It's an example of the addendum 18 that would have been used at that point in time, 19 correct. 20 Q. What point in time, the point 21 in time of what exhibit? 22 A. June -- July 23rd, 1991. 23 Q. The last three pages of Exhibit 24 13, starting with Pz 1275 1408, is this the Page 94 1 addendum that you're talking about in October of 2 1989? 3 A. It's an example of an addendum, 4 but it could have changed from the one that was 5 used at that time. I couldn't verify that it 6 reflects the same thing, it could have additional 7 things added. But it's an example of that type 8 of addendum, right. 9 Q. And the addendum may or may not 10 have been revised according to whether or not the 11 package insert was revised? In other words, was 12 the addendum meant to keep up with the package 13 insert and what the package insert said? 14 A. Generally speaking, it was 15 meant to keep up with the package insert, yes. 16 Q. Prior to October of '89, when 17 the decision was made to use the addendum, 18 typically adverse events that were seen in other 19 clinical trials are reported would be included in 20 the package insert -- I'm sorry, the informed 21 consent? 22 A. Which adverse event? 23 Q. Adverse events -- serious 24 adverse events, let's use serious adverse events. Page 95 1 They were typically included in the informed 2 consent? 3 A. When you say serious adverse 4 events, you mean serious as defined by the FDA? 5 Q. We can start with that. 6 Serious adverse events that were defined by the 7 FDA. 8 A. Yes, they would have been 9 listed in the body of the minimal consent form 10 example that was attached. 11 Q. And I'm talking prior to '89? 12 A. Yes. 13 Q. Before you started including 14 everything? 15 A. Yes. 16 Q. Any other adverse events that 17 would be included? 18 A. Yes. 19 Q. Okay. 20 A. Lots of adverse events would be 21 included. 22 Q. What types of adverse events -- 23 was there a cut-off where you wouldn't include 24 them anymore or certain ones would not be Page 96 1 included, certain ones would? We've established 2 that the FDA serious events would be -- 3 A. The definition of what needed 4 to be included and what wasn't included was 5 something decided by legal and by our clinical 6 research physicians. So I don't know what that 7 definition was. 8 Q. What was the FDA's definition 9 of serious adverse events again? 10 A. I don't remember. 11 Q. Is it the categories like 12 resulted in death, hospitalization, overdose, 13 things of that nature? 14 MR. MYERS: Are you asking him if those 15 are examples? 16 MS. ZETTLER: Right. 17 A. Those sound like examples, but 18 I don't remember the exact precise definition of 19 serious. 20 MS. ZETTLER: Do you want to take a 21 break for lunch? 22 MR. MYERS: That would be fine. 23 (A LUNCH BREAK WAS TAKEN.) 24 Q. Mr. Russell, are you aware of Page 97 1 any clinical trials that were performed in Taiwan 2 or are being currently performed in Taiwan? 3 A. No. 4 Q. What's an investigator 5 affirmation statement? 6 A. That was -- I'm not an expert 7 on it, but it was a -- I think it was really 8 designed for some specific subgroup of studies or 9 something like that, but -- and I don't know what 10 that subgroup was, but it was just a statement 11 for the records that the investigator, at the 12 conclusion of the study, affirmed that all the 13 patients listed that were entered into his 14 protocol were indeed the patients that he treated 15 and he certified it by signing it. 16 Q. Did that subgroup of studies 17 include the three protocols we talked about 18 earlier related to rechallenge? 19 A. I don't know. 20 Q. Do you know why they did that 21 in some studies and not in others? 22 A. I don't remember what the 23 subgroup was and why it was done. It seems like 24 it was something foreign, foreign studies, or Page 98 1 something, that it was designed to be done for, 2 but I don't remember. 3 Q. Did you work with a trial that 4 used the investigator affirmation statements? 5 A. No, I know I used it on a 6 couple, but I don't remember which ones. 7 Q. You did use it on a couple? 8 A. Yes. 9 Q. Were they the Canada studies? 10 A. Could have been, I don't 11 remember. 12 Q. Are you familiar with 13 indemnification agreements for clinical 14 investigators? 15 A. Yes. 16 Q. Can you tell me what those are? 17 MR. MYERS: Well, wait a minute. 18 Before he answers, let me object to the form only 19 to the extent it may call upon him to give a 20 legal opinion or draw some legal conclusion as to 21 what an indemnification agreement is. But if you 22 know -- subject to that, and if you know, tell 23 her. 24 Q. To the best of your knowledge, Page 99 1 Mr. Russell. 2 A. It's some kind of a legal 3 document which in some studies, if requested, 4 there can be signed between Lilly and an 5 investigator that will indemnify them from 6 certain things that they do, from being totally 7 responsible for the expense of a lawsuit or 8 something, but I really don't understand all of 9 the ramifications on it. 10 Q. When you say the expense of the 11 lawsuit, what do you mean, if they were sued? 12 A. You're getting too deep into 13 the legal. I don't really feel that I understand 14 it enough to start getting into specifics. 15 Q. The indemnification agreement 16 was only used upon request of the investigator? 17 A. That's correct. 18 Q. Do you remember any of the 19 investigators that requested indemnification? 20 A. No, I don't. 21 Q. Did you ever work with Doctor 22 Masco? 23 A. Yes. 24 Q. Did he request indemnification, Page 100 1 to the best of your recollection? 2 A. I worked with him like fifteen 3 or more years ago, I don't remember. 4 Q. You testified the last time, I 5 believe, that part of your responsibility as a 6 CRA on Fluoxetine was to negotiate grants or 7 payments of the investigators on studies; is that 8 correct? 9 A. I would like to see where I 10 said that. 11 Q. If that's not correct, tell me. 12 A. Well, you used the word 13 negotiate. 14 MR. MYERS: Why don't you show him 15 where, and we'll see if we can get at it that 16 way. 17 MS. ZETTLER: Do you want him to read 18 it? 19 MR. MYERS: I'm looking at it, and I 20 don't see what you're talking about. 21 MS. ZETTLER: It says here -- 22 MR. MYERS: What question? 23 MS. ZETTLER: Well, the question was 24 did he negotiate grants with the clinical Page 101 1 investigators -- here it says contracts. 2 MR. MYERS: It doesn't say negotiated 3 them, though. 4 MS. ZETTLER: Okay. 5 MR. MYERS: That's what I -- that's 6 what he questioned. 7 MS. ZETTLER: Okay. 8 Q. What were your responsibilities 9 with regards to the contracts between Lilly and 10 the clinical investigators? 11 A. To act as an intermediary 12 between them and the clinical research physician. 13 Q. Okay. Is it your understanding 14 that at least in some of the cases on clinical 15 trials that the investigators would not be paid 16 completely or fully until a manuscript was 17 produced? 18 A. That was commonly the 19 stipulation. 20 Q. Was it a percentage of the 21 payment that was withheld until the manuscript 22 was produced by the investigator or was that the 23 entire payment? 24 A. When you say entire payment -- Page 102 1 Q. Entire contract payment, grant, 2 however you want to term it. 3 A. It wasn't the entire grant. 4 Q. Was it a percentage? 5 A. It could vary. Sometimes it 6 was a percentage, but sometimes it would be just 7 what was remaining in the contract or what was 8 remaining that they had earned but hadn't been 9 paid, it wasn't always the same. 10 Q. And you said it was common for 11 a portion of the grant or contract monies to be 12 withheld until a manuscript was produced? 13 MR. MYERS: I object to the form, 14 that's not what he said, that's what you said. 15 MS. ZETTLER: Could you read that back? 16 (THE COURT REPORTER READ BACK THE 17 REQUESTED TESTIMONY.) 18 MR. MYERS: The question was in some of 19 the cases. 20 MS. ZETTLER: Right, and his answer 21 said commonly, and I just said -- I just asked 22 him if that was what his testimony was. 23 A. Commonly in some of the cases, 24 yes. Page 103 1 Q. Can you give me an example of a 2 situation where that would not be the 3 stipulation? 4 A. There were lots of studies that 5 I can give you an example on. 6 Q. Okay. 7 A. Every study was handled 8 differently, it could be handled differently. 9 Q. Can you give me an example of 10 where it was not a stipulation that a manuscript 11 be produced until final payment was made? 12 A. I can't think of specific 13 examples, but there were lots of studies that it 14 wasn't required. 15 Q. Was it a requirement when it 16 was expected that a manuscript would be produced 17 as a result of the study? 18 A. I'm sorry, could you repeat the 19 question? 20 Q. Sure. In those cases where it 21 was expected that a manuscript would result from 22 the study, okay, from the information gathered by 23 the study, in other words it was expected that a 24 manuscript would be written, was it always a Page 104 1 requirement? 2 A. No. 3 Q. In what percentage of the time 4 was it a requirement? 5 A. I don't remember what 6 percentage, I'm not even privy to that 7 information. 8 Q. What percentage in the trials 9 that you worked on required that a manuscript be 10 written before final payment was made? 11 A. It depends on what point in 12 time you're talking about. 13 Q. Total. 14 A. I can't remember, I wouldn't 15 know. 16 Q. Was it more than fifty percent? 17 A. I don't know. 18 Q. More than forty percent? 19 A. I don't know. 20 Q. Where would I find that 21 information? 22 A. I would have to look at each 23 individual investigator's file to see how the 24 concluding payment was made and on what basis. Page 105 1 Q. Would that be contained in the 2 letters of agreement? 3 A. Could be in the letters of 4 agreement, but it may not have even been carried 5 out even though it was in the letter of 6 agreement. It could have been by-passed and just 7 paid him anyway because of other circumstances 8 or, you know, maybe the study was concluded too 9 early beyond his control. There are just too 10 many other exceptions to answer that question. 11 Q. Is it your understanding that 12 articles have been published as a result of some 13 of the clinical trials that were performed on 14 Fluoxetine? 15 A. Is it my understanding that 16 articles have been published as a result of 17 Fluoxetine? 18 Q. Right. 19 A. Yes. 20 Q. And in those circumstances, 21 were payments withheld until those manuscripts 22 were written? 23 A. Sometimes. 24 Q. Can you remember any specific Page 106 1 case where that was the case, any specific 2 article? 3 MR. MYERS: Now you're talking about 4 articles. Are you talking about the manuscript 5 for the article before the article was published? 6 MS. ZETTLER: Well, for an article to 7 be published a manuscript has to be written at 8 some point, right? 9 MR. MYERS: Right. 10 MS. ZETTLER: Okay. I'm talking about 11 actual published articles. 12 A. I guess -- 13 MR. MYERS: Wait a minute. Are you 14 asking him if the payment was not made until the 15 article was published or the manuscript prepared? 16 MS. ZETTLER: No, no, no, no, until the 17 manuscript was prepared and released by the 18 investigator. 19 A. Can you repeat the question? 20 Q. Okay. Out of those articles 21 that have been published, that you are aware of, 22 how many of them -- in how many of those cases 23 was a manuscript required before payment was 24 made? Page 107 1 A. I have no idea. 2 Q. How about Doctor Fawcett's 3 study that you worked on the close up on? 4 A. I don't remember. 5 Q. Do you remember if a paper was 6 published, do you remember that study? 7 A. I can't remember. 8 Q. To your knowledge was a 9 protocol drafted with regards to Doctor Beasley's 10 meta-analysis of the clinical trial materials? 11 A. I'm not aware of it. 12 Q. Have you ever worked on any 13 Prozac studies involving tardive dyskinesia? 14 A. No. 15 Q. Have you worked on any Prozac 16 studies regarding movement disorders in general? 17 A. No. 18 Q. Are you aware of any studies 19 like that being done? 20 A. No. 21 Q. Have you ever heard of an FDA 22 form thirty-five hundred? 23 A. No. 24 Q. Have you ever heard of a Page 108 1 situation where a clinical investigator was 2 promised by somebody at Lilly that he would not 3 be deposed if Lilly would be sued because of 4 Fluoxetine? 5 MR. MYERS: By deposed she means give a 6 deposition, I think. 7 MS. ZETTLER: Like today. 8 A. Ask the question again, please? 9 Q. Have you ever heard of a 10 situation where a clinical investigator working 11 on Prozac or Fluoxetine was promised by somebody 12 at Eli Lilly that if Lilly were to be sued 13 regarding Fluoxetine, that they would not have to 14 give a deposition or be involved in litigation? 15 A. I don't know anything about 16 that. 17 Q. Are you aware of clinical 18 trials or studies being done at Lilly with 19 regards to anxiety and Fluoxetine? 20 A. Yes. 21 Q. Which studies are those? 22 A. I don't know. 23 Q. How many studies? 24 A. I don't know. Page 109 1 Q. How is it that you were aware 2 that studies were done or developed? 3 A. I'm aware that studies were 4 done for that, but I don't know anything more 5 about them. 6 Q. For the treatment of anxiety? 7 A. I believe so, anxiety disorder. 8 Q. Panic attacks? 9 A. I don't know the definition. 10 Q. How about akathisia, have you 11 ever heard that term? 12 A. Yes. 13 Q. To your knowledge, have any 14 studies been done at Lilly or on behalf of Lilly 15 with regards to akathisia and the use of 16 Fluoxetine? 17 A. I don't know. 18 (PLAINTIFFS' EXHIBIT NO. 14 WAS 19 MARKED FOR IDENTIFICATION AND 20 RECEIVED IN EVIDENCE.) 21 Q. Do you recognize Exhibit 14, 22 Mister Russell? 23 A. Do I recognize this document? 24 Q. Right. Page 110 1 A. I don't remember seeing it 2 before. 3 Q. Are you familiar with the 4 subject matter of the document? 5 A. Yes. 6 Q. Can you tell me what a Prozac 7 alert summary is? 8 A. I can't remember how to define 9 it. 10 Q. I'm sorry? 11 A. I can't remember how to define 12 what an alert summary was. 13 Q. Do you have an understanding of 14 what an alert summary is? 15 A. I'm not sure. 16 Q. What is a DEN quarterly? 17 A. It's some kind of a report done 18 quarterly by the DEN group. 19 Q. The first sentence of the memo 20 says: The following outlines or objectives in 21 approach to continue to write Prozac alert 22 summaries for the DEN quarterly book this year, 23 paren, internal purposes, close paren; correct? 24 A. That's what it says. Page 111 1 Q. To your knowledge are the DEN 2 quarterlies something that were done for 3 submission to the FDA? 4 A. To my knowledge, that's what 5 they were done for. 6 Q. What's the difference between 7 quarterly reports that were submitted to the FDA 8 and the quarterly reports that were used 9 internally at Lilly? 10 A. I don't know. 11 Q. What were your responsibilities 12 with regards to reporting of adverse events while 13 you were a CRA? 14 A. That's a pretty broad question. 15 We received the case report forms, and we 16 reported the adverse events that were listed on 17 the case report form according to the guidelines 18 we had at that time as far as, you know, the 19 different definitions of different degrees of 20 severity and whatever the events, which I don't 21 even remember what the definitions were. 22 MS. ZETTLER: Could you read the last 23 question and answer? 24 (THE COURT REPORTER READ BACK THE Page 112 1 REQUESTED TESTIMONY.) 2 Q. So there were different 3 guidelines to be followed depending on the 4 adverse event that was reported or listed on the 5 CRF? 6 A. Depending on the severity, 7 there were FDA guidelines. 8 Q. Have you ever seen FDA 9 guidelines? 10 A. Probably. 11 Q. Do you remember specifically 12 looking at FDA guidelines defining severity of an 13 adverse event? 14 A. No, I don't. 15 Q. Earlier you talked about a 16 serious event, and what would be the guidelines 17 for serious events, and when I say serious, I 18 mean serious according to the FDA, what would be 19 Lilly's guidelines for reporting those? 20 MR. MYERS: Let me object to the form. 21 You assume Lilly's guidelines, and he told you 22 they were FDA guidelines. 23 Q. Let me ask it this way: Was it 24 your responsibility to report these events Page 113 1 directly to the FDA regardless of the severity? 2 A. Mine directly to the FDA, no. 3 Q. Was it any CRAs -- within your 4 group, any CRA's direct responsibility to report 5 adverse events directly to the FDA? 6 A. No. 7 Q. What was the procedure that 8 Lilly required of you as a CRA with regards to 9 the reporting of serious adverse events? And 10 when I say serious I mean according to the FDA 11 guidelines. 12 MR. MYERS: Occurring in a clinical 13 trial? 14 MS. ZETTLER: Right. 15 A. I don't remember the specifics. 16 Q. How many times would you report 17 adverse events, Mister Russell, more than a 18 hundred? 19 A. Sure. 20 Q. More than a thousand? 21 A. I don't remember. 22 Q. Would you do it on a daily 23 basis when you were a CRA? 24 A. No. Page 114 1 Q. Would you do it on a weekly 2 basis when you were a CRA? 3 A. It depended on the study or the 4 drug. 5 Q. So your testimony as you sit 6 here today is that you do not recall what the 7 guidelines or the procedures, the Lilly 8 procedures, for rereporting of adverse events -- 9 A. That's absolutely correct. I 10 can speculate. 11 MR. MYERS: We don't want you to do 12 that. 13 Q. Were there forms that you were 14 to fill out when an adverse event came in? 15 A. Yes. 16 Q. What forms were those? 17 A. It was an FD -- 18 Q. 1639, does that sound familiar? 19 A. 1639, yes. 20 Q. Were there working forms or 21 forms that you filled out in preparation for 22 completing the 1639? 23 A. Yes. 24 Q. Were those forms that were FDA Page 115 1 forms or Lilly forms? 2 A. Which? 3 Q. Not the 1639s, the other ones 4 that you filled out in preparation for completing 5 the 1639? 6 A. I think they were Lilly forms, 7 but I'm not positive. 8 Q. I'm still talking about the 9 clinical trial adverse events, okay? 10 A. Yes. 11 Q. And you used those working or 12 preliminary forms that you used in preparation 13 for filling out the 1639s with regards to adverse 14 events that occurred during clinical trials? 15 A. You're going to have to repeat 16 that. 17 Q. Can we recall the forms -- does 18 the word working forms, working 1639s, does that 19 sound familiar? 20 A. 1639 working form, or something 21 like that. 22 Q. Were those 1639 working forms 23 used when you were reporting an adverse event 24 that occurred in the clinical trials, as opposed Page 116 1 to a spontaneous adverse event report? 2 A. I'm sorry, you're going to have 3 to repeat it again. 4 Q. Do you know the difference 5 between a spontaneous adverse event report and a 6 clinical trial adverse event report? 7 A. I don't remember the precise 8 difference. 9 Q. Are you aware that there were 10 adverse event reports that occurred after the 11 drug was approved for use in depression and 12 outside of clinical trials? In other words if a 13 doctor had a patient on Prozac and an adverse 14 event occurred, he may or may not report it to 15 Lilly; correct, and that doctor does not have to 16 be participating in a clinical trial? 17 A. What's the question? 18 Q. Do you understand that there 19 are two different ways or two different means 20 that the adverse events can become -- that Lilly 21 can be made aware of the adverse events? 22 A. I understand that there are two 23 ways, right. 24 Q. And one of those is spontaneous Page 117 1 adverse event report? 2 A. Yes, okay. 3 Q. And that spontaneous adverse 4 event report is an adverse event that's outside 5 of the clinical trial? 6 A. I'm not sure if that's the 7 exact definition of spontaneous. 8 Q. Are you aware that there are 9 adverse events that are made or that occur 10 outside of clinical trials; correct? 11 A. Yes. 12 Q. I'm limiting my questions right 13 now just to the adverse events that occurred 14 during clinical trials, okay, a patient that's 15 participating in a clinical trial suffers an 16 adverse event. 17 MR. MYERS: She's not asking you, she's 18 just telling you. 19 Q. I'm just telling you what I'm 20 limiting it to. 21 A. Okay. 22 Q. The working 1639s that you 23 used, did you use those with those types of 24 adverse events, and I mean adverse events that Page 118 1 occurred during clinical trials? 2 A. Yes. 3 Q. Were the working 1639s also 4 used for adverse events that occurred outside of 5 clinical trials that were reported to Lilly? 6 A. I don't recall. And this 7 working form was not always used, you have to 8 confine that to a certain time because it didn't 9 always exist. 10 Q. When did they start using them? 11 A. I don't remember. 12 Q. Was it a matter of they were 13 using them when you became a CRA and stopped 14 using them at a certain point, or was it a matter 15 of they were not using them until a certain point 16 while you were a CRA? 17 A. There was a certain point when 18 we began using them, but I don't remember what it 19 was. 20 Q. What did you do before using 21 the working 1639? 22 A. I think we just used a xerox of 23 the 1939 form. 24 Q. And filled it out? Page 119 1 A. In rough, and then had it typed 2 up. 3 Q. What was done with the working 4 1639s after the final 1639 was completed? 5 A. It's filed somewhere, but I 6 don't remember where. 7 Q. Is that true for the xeroxes 8 that were used prior to using the working 1639 9 forms? 10 A. I'm not sure. 11 Q. When you said there were 12 different guidelines depending on the severity of 13 the adverse event, what do you mean as far as 14 guidelines, reporting it to specific areas within 15 Lilly or? 16 A. I'm talking about the FDA 17 guidelines. 18 Q. Is it your understanding that 19 in some cases the FDA required that adverse 20 events be reported to the FDA, and on other 21 cases, they did not require that? 22 MR. MYERS: Clinical trial adverse 23 event? 24 MS. ZETTLER: Sure, we'll start at Page 120 1 clinical trials. 2 A. Am I aware that there were 3 certain cases where they didn't require it? 4 Q. Right. 5 A. I don't recall that. 6 Q. You don't recall either way or 7 you don't recall? 8 A. I don't recall if there was any 9 situation where it required that they be 10 reported. 11 Q. Was it just a matter of the 12 means in which it had to be reported to the FDA? 13 A. The timing. 14 Q. The alert reports, fifteen day 15 alert reports for very serious adverse events? 16 MR. MYERS: I'll object to the form to 17 the extent I don't think there's anything under 18 the regulatory guidelines such as a very serious 19 adverse event report. 20 Q. Do you understand that there 21 are requirements -- the FDA has requirements that 22 in certain circumstances you had to report an 23 adverse event within three days of being informed 24 of the adverse event? Page 121 1 A. I know there was one that had 2 to be reported in a very short time period, I'm 3 not sure if it's three days. 4 Q. And there's another one that 5 had to be reported within fifteen days? 6 A. I remember that. 7 Q. And there were other situations 8 where it had to be reported in quarterly or 9 yearly safety updates, things of that nature? 10 A. Yes. 11 Q. With regards to the adverse 12 events that had to be reported in a very short 13 period of time, what was Lilly's requirement as 14 far as collecting and reporting to Lilly that 15 adverse event? 16 A. I don't remember. 17 Q. How about the fifteen day alert 18 events? 19 A. I don't remember that either. 20 Q. Did you have guidelines or some 21 sort of written directive to Lilly that you could 22 have referred to when you were a CRA if you had 23 questions regarding reporting? 24 A. Yes. Page 122 1 Q. What guideline was that, what's 2 the title of that? 3 A. There was something from the 4 DEN group, I believe, that spelled out everything 5 precisely that we were to do, and we referred to 6 that to figure out which slot it fit in. 7 Q. And those were written 8 instruction directives? 9 A. Somewhere it was written, yes, 10 I can't remember where. 11 Q. Do you remember the name of 12 that document? 13 A. No, I don't. 14 Q. In the middle of the first page 15 of Exhibit 14 it says process now, Dan Russell 16 will confirm with Jeff Powell that the way we 17 have been writing alert summaries has not 18 changed, if so Dan will follow up with Harry 19 Hubble to confirm. 20 A. Yes. 21 Q. Does that refresh your 22 recollection as to what an alert report is, an 23 alert summary? 24 A. No. Page 123 1 Q. Were alert summaries done as a 2 regular course within Lilly on all drugs? 3 A. I believe, but I'm not 4 positive. 5 Q. Underneath that paragraph that 6 we just read, it says Dan and Becki. 7 A. Becki. 8 Q. Looks like an A. Standard form 9 from Rod Usher on the format for writing the 10 alert summaries. To your knowledge was there a 11 form that was used? 12 A. Yes. 13 Q. To your knowledge was that form 14 being used at Lilly this year when you left 15 medical? 16 A. I don't know. 17 Q. At the bottom of the page it 18 says Dan and Becki will have their secretaries 19 type the summaries. In paren, Jana, please 20 discuss the format with their secretaries, close 21 paren. Would this be given to Jana to combine 22 the info, do you remember that occurring? 23 A. Yes. 24 Q. And were disks used? Page 124 1 A. I believe so. 2 Q. Were they floppy disks? 3 A. I don't know. 4 Q. Were they used with a regular 5 PC? 6 A. I don't know. 7 Q. What type of computer, and I 8 don't need the exact make and model, did your 9 secretary use back then? 10 A. I don't remember. 11 Q. Was it a regular PC sitting on 12 her desk? 13 MR. MYERS: What do you mean by a 14 regular PC? I'm not a computer person, but that 15 could mean a lot of different things. 16 Q. Was it a regular terminal with 17 keyboard, personal computer, used for everyday 18 typing? 19 A. I believe so. 20 Q. Who is Jana? 21 A. Jana was a secretary. 22 Q. Was she your secretary? 23 A. No. 24 Q. Who was your secretary? Page 125 1 A. I don't remember who it was 2 then. 3 Q. You don't remember who your 4 secretary was in 1991, Mister Russell? 5 A. I sure don't. 6 Q. How many secretaries have you 7 gone through in the past three years? 8 A. Six, seven, eight. 9 Q. Why? 10 A. They change a lot. 11 Q. Under that it says, on April 12 12th, Dan and Becki anticipated to have completed 13 writing summaries. Do you remember completing 14 writing summaries? 15 A. I remember that the job was 16 completed, yes. 17 Q. Do you remember writing 18 summaries? 19 A. Vaguely. 20 Q. What's included in a summary? 21 A. I don't remember, just some 22 details about some event. 23 Q. What types of events? 24 A. I don't remember. Page 126 1 Q. All events? 2 A. No. 3 Q. Serious events? 4 A. I don't remember. 5 Q. Suicide related events? 6 A. I don't remember. 7 Q. Violent aggressive related 8 events? 9 A. I don't remember. 10 Q. At the top of page under 11 objections it says, number two, continue to keep 12 up with the volume of work to avoid last minute 13 rush to summarize and analyze perhaps more than a 14 thousand reports for the annual report. Did you 15 and Becki have to summarize more than a thousand 16 reports? 17 A. No, we did not. 18 Q. Do you remember how many 19 reports you had to summarize? 20 A. No, it was a group of people if 21 I recall. I know that usually there's a group of 22 people that worked on these, we were just two of 23 a group. 24 Q. How many people were in that Page 127 1 group? 2 A. I don't recall. 3 Q. What's a DEN quarterly book? 4 A. Something that holds DEN 5 quarterlies, I guess, I really don't know what it 6 is. 7 Q. On the next page, under April 8 29th, it says DEN quarterly meeting, under agenda 9 it says overview, Mindy Gould, mortality, Dan 10 Russell slash Jim K. Who is that, Jim Kotsanos? 11 A. Yes. 12 Q. What were you to do with 13 regards to mortality? 14 A. Whatever it was, I never ended 15 up doing it. 16 Q. Why? 17 A. I think Jim Kotsanos did it. 18 Q. What did they mean by 19 mortality? 20 A. Mortality. Sounds like it has 21 to do with death. I guess that's what it means 22 to me. 23 Q. Are you aware that the FDA made 24 periodic audits or visits to clinical Page 128 1 investigation sites? 2 A. I know that they're allowed -- 3 I know that they can do that, yes. 4 Q. Do you know if generally those 5 sites are unannounced or, I'm sorry, those visits 6 are unannounced? 7 A. I don't know if they're always 8 unannounced or if they're sometimes unannounced, 9 I'm not sure. 10 Q. Were you ever made aware of a 11 pending FDA audit of any given investigation site 12 on Fluoxetine trials you worked on? 13 MR. MYERS: When you say pending, you 14 mean before it happened? 15 MS. ZETTLER: Right. 16 A. I don't remember specifics. 17 Q. Did you have occasion to report 18 an investigator to the FDA as a result of 19 Fluoxetine trials? 20 A. No. 21 Q. To your understanding or 22 knowledge did the FDA have requirements by which 23 Lilly would be obligated to report certain 24 inadequacies at investigation sites to the FDA? Page 129 1 A. I'm not sure what the 2 guidelines were on that topic. 3 Q. Okay. Are you aware that there 4 were guidelines? 5 A. I'm not sure that there are. 6 (PLAINTIFFS' EXHIBIT NO. 15 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Do you recognize Exhibit 15, 10 Mister Russell? 11 A. I don't remember it. 12 Q. Do you remember the substance 13 of Exhibit 15? 14 A. I mean this is some kind of a 15 press release. We get these from time to time, 16 but I don't specifically remember this one. 17 Q. Why would you be included on a 18 list of people getting a press release on 19 Sertraline being launched in the United Kingdom? 20 A. Why would I get it, because I 21 was working with Prozac, and it had to do with a 22 competitive drug. 23 Q. What responsibilities did you 24 have as a CRA or any other position you had with Page 130 1 Lilly with respect to competitive drugs? 2 A. Really none. 3 Q. There were many, many people 4 working on Prozac in December of 1990, weren't 5 there? 6 A. When was this? 7 Q. December of 1990. 8 MR. MYERS: When you say many people, 9 many people where? 10 MS. ZETTLER: At Lilly, working on 11 Prozac. 12 MR. MYERS: At Lilly in general? 13 MS. ZETTLER: Yes. 14 MR. MYERS: Go ahead. 15 A. Yes. 16 Q. And there were only seven 17 people listed as recipients of this particular 18 memo; correct? 19 A. That's what I see listed. 20 Q. So is it your testimony that 21 everybody who worked on Fluoxetine would have 22 gotten this press release? 23 MR. MYERS: I object to the form, 24 that's not what he said. Page 131 1 MS. ZETTLER: I'm asking him if that's 2 his testimony. 3 A. It's not my testimony. My 4 testimony is that I got it because I was working 5 with Prozac, but apparently it wasn't sent to 6 everybody. I don't remember what list of people 7 were sent these things, but that's obviously why 8 I got it. 9 Q. Who is Amy Chappell? 10 A. Amy Chappell was a clinical 11 research physician. 12 Q. In fact, all the rest of these 13 people on this list are clinical research 14 physicians, weren't they or aren't they? 15 A. Yes. 16 Q. Okay. And you're the only one 17 who isn't a clinical research physician; correct? 18 A. Yes, but let me just point out 19 one thing. This is probably a messenger message 20 that was forwarded on by somebody who just picked 21 a list of people they wanted to send it to. 22 Q. Why do you assume that? 23 A. Because it looks like that. So 24 I don't think you can draw any conclusions from Page 132 1 it. 2 Q. What about this memo makes you 3 believe that it was forwarded? 4 A. Just the format of it, the way 5 it's written, it looks like a forwarded message. 6 Q. This is the format of an 7 electronic mail message, isn't it? 8 A. That's what it looks like. 9 Q. And on an electronic mail 10 message, if it's something that's forwarded, it 11 usually has a forwarded message indication on 12 there somewhere, doesn't it? 13 A. Unless it wasn't in the part 14 that got xeroxed. 15 Q. Who would have forwarded this 16 message to you? 17 A. I don't recall. You know, I 18 don't recall seeing this message, so I certainly 19 don't recall who forwarded it to me. 20 Q. To your knowledge, has there 21 been a study either developed or performed at 22 Lilly or on behalf of Lilly comparing Sertraline 23 and Fluoxetine? 24 A. Not to my knowledge. Page 133 1 Q. Who is Laura Fludzinski, if you 2 know? 3 A. Laura Fludzinski was my 4 manager. 5 Q. At what time? 6 A. I don't remember the exact 7 years. 8 Q. Was she a statistician? 9 A. No. 10 Q. Was she a CRA? 11 A. When she was the manager -- 12 MR. MYERS: Is she or was she? 13 Q. Pardon? 14 MR. MYERS: I asked -- your question 15 was is she or was she? 16 MS. ZETTLER: Was she. 17 A. At one time she was a CRA. 18 Q. Prior to becoming manager of 19 the department? 20 A. Yes. 21 Q. What is she doing now? 22 A. She's -- I don't know what 23 capacity she's in -- over in the United Kingdom. 24 Q. To your knowledge was she ever Page 134 1 a statistician? 2 A. No. 3 Q. How long was she a manager? 4 A. She's been a manager for quite 5 a few years now, I don't remember the exact 6 number of years. 7 Q. Was she a manager when you 8 first became a CRA or MIA? 9 A. No. 10 Q. Do you remember when she became 11 your manager? 12 A. No, I don't. 13 Q. Was it before or after you came 14 back to work with Prozac, Fluoxetine? 15 MR. MYERS: When you say came back, the 16 early '80s? 17 MS. ZETTLER: Right. 18 A. It was after that. 19 (PLAINTIFFS' EXHIBIT NO. 16 WAS 20 MARKED FOR IDENTIFICATION AND 21 RECEIVED IN EVIDENCE.) 22 Q. Can you tell me what Exhibit 16 23 is? 24 A. It's a letter that Doctor Page 135 1 Wernicke sent to some investigator telling them 2 about reporting drug events, and sending him a 3 supply of 1639s. 4 Q. Have you seen the second page 5 of Exhibit 16 before? 6 A. I don't remember seeing it. 7 Q. Have you seen the page that's 8 similar to that or document similar to that, 9 constructing adverse events or other people to 10 call Lilly if certain events happened? 11 A. I recall seeing something like 12 that before. 13 Q. Does it refresh your 14 recollection as to what a serious adverse event 15 might be? 16 A. Well, this would draw my 17 attention to what the list would include at one 18 point in time on the clinical trials. 19 Q. Have you ever seen a list that 20 had different adverse events listed? 21 A. I'm sure, I know they changed 22 over the years. 23 MS. ZETTLER: Let's take a quick break. 24 (A SHORT RECESS WAS TAKEN.) Page 136 1 (PLAINTIFFS' EXHIBIT NO. 17 WAS 2 MARKED FOR IDENTIFICATION AND 3 RECEIVED IN EVIDENCE.) 4 Q. Do you recognize Exhibit 17, 5 Mister Russell? 6 A. Yes. 7 Q. Does this refresh your 8 recollection as to whether or not this is one of 9 the investigators that you would not have wanted 10 to use again? 11 A. No. 12 Q. What is Nardil? 13 A. It must be a Phenelzine. 14 Q. What kind of drug is that? 15 A. It's a M-A-O-I inhibitor. 16 Q. Tell me what happened, why was 17 a doctor being asked to return monies back to 18 Lilly? 19 A. Because he was never able to 20 enroll any patients that met the entry criteria. 21 Q. And that study was then 22 transferred to another doctor? 23 A. It never actually was, it was 24 speculated that they do that, but it never was Page 137 1 transferred. 2 Q. Was this study ever done, 3 Prozac versus Nardil? 4 A. No, not this study. 5 Q. Why not? 6 A. We couldn't get anybody who 7 could find patients that met the entry criteria. 8 Q. What entry criteria were those? 9 A. As I recall, they had to be 10 patients who had never been exposed to Fluoxetine 11 before, and there are populations that had great 12 difficulty meeting all the other stringent 13 criteria of the protocol. And having never been 14 exposed, been treated with Fluoxetine before, it 15 was a major clinic that had used a lot of 16 Fluoxetine, I guess, and the patients didn't meet 17 the criteria. It wasn't the investigator's 18 fault. 19 Q. Is that your handwriting at the 20 bottom of the page? 21 A. Uh-huh, yes. 22 (PLAINTIFFS' EXHIBITS 18 THROUGH 23 22 WERE MARKED FOR IDENTIFICATION 24 AND RECEIVED IN EVIDENCE.) Page 138 1 Q. Okay. Mister Russell, looking 2 at Exhibits 18 through 22, can you tell me first 3 of all if any of those documents are in your 4 handwriting? 5 A. None of them are. 6 Q. Do you recognize the 7 handwriting in these documents? 8 A. No. 9 Q. Are you familiar with any of 10 these documents? 11 A. No. 12 Q. Have you ever seen any of these 13 documents before? 14 A. I don't remember seeing them 15 before. 16 Q. Were you ever a member of the 17 Prozac strategy group? 18 A. Not to my recollection. 19 Q. Do you know what the Prozac 20 strategy group is? 21 A. Only from the title, I don't 22 know anything about it. 23 Q. To your knowledge, there was a 24 group that was called the Prozac strategy group? Page 139 1 A. Just from -- I couldn't have 2 told you there was a Prozac strategy group prior 3 to looking at that title on that piece of paper. 4 Q. The title on Exhibit 19? 5 A. Correct. 6 Q. Would you look at Exhibit 22, 7 please? 8 A. Okay. 9 Q. Are you familiar with any of 10 those trials? 11 A. Yes. 12 Q. Which ones? 13 A. The first one there on Fawcett, 14 Preskorn and Zung, and the second one, Cole, the 15 third one, Friedhoff and Pitts, and the next to 16 the last one, Desipramine, Schatzberg, Bowden and 17 Rosenbaum. The one above that, Rosenbaum. 18 Q. Okay. The first one, the 19 Amitriptyline study with Fawcett, Preskorn and 20 Zung? 21 A. Yes. 22 Q. Is that the study that you 23 worked on with Doctor Fawcett where you were 24 closing off the study? Page 140 1 A. Yes. 2 Q. To your knowledge was a paper 3 written based on that study? 4 A. I don't remember. 5 Q. The Doxepin study underneath 6 that with Doctor Cole, was that Doctor Cole that 7 worked with Doctor Teicher? 8 A. Doxepin. 9 Q. Doxepin, I'm sorry. Is that 10 Jonathan Cole? 11 A. Yes. 12 Q. Is that the study that you did 13 the start-up on? 14 A. Yes. 15 Q. At the bottom, the Desipramine 16 study? 17 A. Okay. 18 Q. Is that study different than 19 the study that you ordered the Desipramine on the 20 CTs? 21 A. Yes, it's different. 22 Q. What is that study about? 23 A. Which one? 24 Q. The Desipramine study as Page 141 1 reflected in Exhibit 22. 2 A. I don't remember the specifics 3 of it. Again, that was one I just helped close 4 out. 5 Q. Was that a study that was 6 measuring suicidality? 7 A. No, it was not. 8 Q. Was it comparing efficacy and 9 safety of Fluoxetine against Desipramine in 10 depressed patients? 11 A. I can't remember what the title 12 of it was. 13 Q. What is Doctor Rosenbaum's 14 first name, if you know? 15 A. Allen. I believe it's Allen. 16 Q. How about Doctor Bowden? 17 A. Charles Bowden. 18 Q. Bowden. How about Doctor 19 Schatzeberg? 20 A. That's Allen, too. 21 Q. Is the Doctor Rosenbaum listed 22 by the Desipramine study the same as the Doctor 23 Rosenbaum listed across from the geriatric study? 24 A. I think those are two different Page 142 1 Rosenbaums. 2 Q. Do you happen to know what the 3 other Doctor Rosenbaum's name is? 4 A. No, I don't remember. 5 Q. The last time we were here, you 6 talked about the Lilly legal department's 7 requirement that documents be turned over -- 8 Fluoxetine documents be turned over to legal. Do 9 you remember that? 10 A. Yes. 11 Q. Were you ever in charge of 12 collecting documents to turn over to legal? 13 A. I was assigned to coordinate 14 collecting documents for one group of people. 15 Q. What group was that? 16 A. The people in the immediate 17 vicinity of my office on the floor that I was on. 18 Q. Okay. Do you recall a time 19 when each individual person was assigned the task 20 of putting Pz numbers on documents that they 21 turned over to legal? 22 A. Do I recall when people were 23 assigned the task of putting Pz numbers on it? 24 Q. In other words, they were Page 143 1 required to stamp the documents with Pz numbers? 2 A. I remember the requirement to 3 stamp the documents with Pz numbers, I don't 4 remember that there was a time when everybody sat 5 down and did it. 6 Q. Were individuals assigned 7 specific Pz numbers, in other words if you look 8 at Exhibit No. 22, there's the Pz number 711 983. 9 A. That, I don't know either. We 10 had a different Pz, I thought you were talking 11 about a Pz stamp that we put on things that went 12 to legal. That's not -- I had nothing to do with 13 that. 14 Q. What Pz stamp were you required 15 to put on there? 16 A. We had a Lilly stamp that would -- 17 that just said Pz, and if an item was stamped we 18 knew that it had already gone to legal and we 19 didn't have to send it again. 20 Q. So it didn't involve numbers, 21 it just said Pz? 22 A. Yes. 23 Q. Pz is an indication for Prozac? 24 A. Yes. Page 144 1 MS. ZETTLER: I think that's all I 2 have. We're reserving the right, though, to 3 bring Mister Russell back again if more documents 4 are produced from that twenty-three boxes of 5 documents that were required, if necessary. 6 MR. MYERS: You'll have to make an 7 application to do that. 8 MS. ZETTLER: Can I have an application 9 form, Larry? 10 MR. MYERS: What? 11 MS. ZETTLER: Do you have a form for 12 that application? 13 MR. MYERS: I don't have a form for 14 that application. 15 MS. ZETTLER: Are you going to make one 16 up for me? 17 MR. MYERS: No, you'll have to make 18 your own up. I have no questions. 19 (THE WITNESS WAS EXCUSED.) Page 145 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 DANIEL G. RUSSELL 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 11TH DAY OF 19 OCTOBER, 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 146 1 E R R A T A S H E E T 2 3 COMMONWEALTH OF KENTUCKY ) : SS 4 COUNTY OF JEFFERSON ) 5 6 I, DANIEL G. RUSSELL, THE UNDERSIGNED 7 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 8 OF MY DEPOSITION AND WITH THE CHANGES NOTED 9 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 10 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 11 THE 23RD DAY OF SEPTEMBER, 1993 AT THE TIME AND 12 PLACE STATED THEREIN. 13 PAGE NO. LINE NO. CHANGE REASON Page 147 1 PAGE NO. LINE NO. CHANGE REASON 2 3 4 5 6 7 8 _____________________________ 9 DANIEL G. RUSSELL 10 SWORN TO AND SUBSCRIBED BEFORE ME THIS 11 _____ DAY OF __________, 1993. 12 _____________________________ NOTARY PUBLIC, STATE OF 13 KENTUCKY AT LARGE Page 148 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Page 149 1 DIRECT EXAMINATIONBY MS. ZETTLER:..................1 2 PLAINTIFFS' EXHIBIT NO. 1..........................8 3 PLAINTIFFS' EXHIBIT NO. 2.........................14 4 PLAINTIFFS' EXHIBIT NO. 3.........................17 5 PLAINTIFFS' EXHIBIT NO. 4.........................18 6 PLAINTIFFS' EXHIBITS 5 THROUGH 8..................20 7 PLAINTIFFS' EXHIBIT NO. 9 ........................55 8 PLAINTIFFS' EXHIBIT NO. 10........................56 9 PLAINTIFFS' EXHIBIT NO. 11........................57 10 PLAINTIFFS' EXHIBIT NO. 12........................61 11 PLAINTIFFS' EXHIBIT NO. 13........................67 12 PLAINTIFFS' EXHIBIT NO. 14........................81 13 PLAINTIFFS' EXHIBIT NO. 15........................96 14 PLAINTIFFS' EXHIBIT NO. 16.......................101 15 PLAINTIFFS' EXHIBIT NO. 17.......................102 16 PLAINTIFFS' EXHIBITS 18 THROUGH 22...............103 17 18 19 20 21 22 23 24 Page 150 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Page 151 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Page 152 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Page 153 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Page 154 1 DIRECT EXAMINATIONBY MS. ZETTLER:.................14 2 PLAINTIFFS' EXHIBIT NO. 1.........................23 3 PLAINTIFFS' EXHIBIT NO. 2.........................30 4 PLAINTIFFS' EXHIBIT NO. 3.........................34 5 PLAINTIFFS' EXHIBIT NO. 4.........................35 6 PLAINTIFFS' EXHIBITS 5 THROUGH 8..................37 7 PLAINTIFFS' EXHIBIT NO. 9 ........................80 8 PLAINTIFFS' EXHIBIT NO. 10........................80 9 PLAINTIFFS' EXHIBIT NO. 11........................83 10 PLAINTIFFS' EXHIBIT NO. 12........................87 11 PLAINTIFFS' EXHIBIT NO. 13........................94 12 PLAINTIFFS' EXHIBIT NO. 14.......................110 13 PLAINTIFFS' EXHIBIT NO. 15.......................130 14 PLAINTIFFS' EXHIBIT NO. 16.......................135 15 PLAINTIFFS' EXHIBIT NO. 17.......................137 16 PLAINTIFFS' EXHIBITS 18 THROUGH 22...138 17 COMMONWEALTH.....................................146 18 E R..............................................147 Page 155