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 11 DEPONENT: JEAN A. ALLAN 12 DATE: JUNE 17, 1993 13 14 * * * * * * * * * * 15 16 17 REPORTER: KATHY NOLD 18 19 KENTUCKIANA REPORTERS SUITE 260 20 730 WEST MAIN STREET LOUISVILLE, KENTUCKY 40202 21 (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 ) Page 3 1 * * * * * * * * * * 2 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF TEXAS 3 SAN ANTONIO DIVISION 4 ELIZABETH T. SANCHEZ, ) INDIVIDUALLY AND AS THE ) 5 SURVIVING SPOUSE, MARGARET R. ) SANCHEZ, INDIVIDUALLY AND NEXT ) 6 OF FRIEND OF DEBRA JEAN ) SANCHEZ, VERONICA MARIE ) 7 SANCHEZ, EDWARDO ESTEBAN ) SANCHEZ, AND MICHAEL ANTHONY ) 8 SANCHEZ, CHILDREN; AND ALL ON ) BEHALF OF THE ESTATE OF ) 9 EDWARDO SANCHEZ ) ) 10 V. ) CIVIL ACTION NO. ) SA93CA367 11 ELI LILLY AND COMPANY AND ) DISTA PRODUCTS COMPANY ) 12 * * * * * * * * * * 13 IN THE UNITED STATES DISTRICT COURT 14 FOR THE SOUTHERN DISTRICT OF TEXAS HOUSTON DIVISION 15 MARIA SANCHEZ, INDIVIDUALLY ) 16 AND AS NEXT FRIEND OF DEBORAH ) SANCHEZ, VERONICA SANCHEZ, ) 17 EDDIE SANCHEZ, AND MICHAEL ) SANCHEZ, AND ON BEHALF OF THE ) 18 ESTATE OF EDUARDO SANCHEZ ) ) 19 V. ) CIVIL ACTION NO. ) H-93-1469 20 ELI LILLY AND COMPANY AND ) DISTA PRODUCTS COMPANY, A ) 21 DIVISION OF ELI LILLY AND ) 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 Page 5 1 2 * * * * * * * * * * 3 ---------------------------------X 4 VALARIE J. FRIEDMAN AND DAVID : SUPERIOR COURT FRIEDMAN, HER HUSBAND, : OF NEW JERSEY 5 : LAW DIVISION: PLAINTIFF, : MIDDLESEX COUNTY 6 : DOCKET NO. : L-3191-91 7 VS. : : 8 ELI LILLY & COMPANY; DISTA : PRODUCTS INC, A DIVISION OF : 9 ELI LILLY & COMPANY; LISS : PHARMACY; MADISON PHARMACY AND : 10 JOHN DOES NOS. 1-25 (UNKNOWN : ENTITIES), : 11 : DEFENDANTS. : 12 ---------------------------------X 13 * * * * * * * * * * 14 SUPREME COURT OF THE STAET OF NEW YORK COUNTY OF SUFFOLK 15 -------------------------------------x 16 RHOMDA L. HALA and JOSEPH L. HALA, : 17 Plaintiffs, : Index No. 14869/90 18 - against - : 19 ELI LILLY & COMPANY and DISTA : PRODUCTS COMPANY, a DIVISION OF 20 ELI LILLY & COMPANY : 21 Defendants. : -------------------------------------x Page 6 1 2 * * * * * * * * * * 3 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 4 COUNTY DEPARTMENT, LAW DIVISION 5 PATRICIA BRACH, ) ) 6 Plaintiff ) ) 7 v. )No. 92 L 13369 ) 8 ELI LILLY AND COMPANY, a foreign ) corporation; ALAN N. MILLER, M.D., ) 9 WILLIAM BRUINSMA, Psy.D., and ) CONDELL MEMORIAL HOSPITAL, ) 10 ) Defendants. ) 11 * * * * * * * * * * 12 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 13 COUNTY DEPARTMENT - LAW DIVISION 14 RENATO DI SILVESTRO, Individually ) and as Special Administrator of ) 15 the Estate of JOHN DI SILVESTRO, ) Deceased, ) 16 ) Plaintiff, ) 17 ) v. ) No. 91 L 7881 18 ) ROBERT L. NELSON, et al., ) 19 ) Defendants, ) 20 ) GEORGE MELNICK, M.D. and PETER ) 21 FINK, M.D. ) ) 22 Respondents in Discovery.) Page 7 1 * * * * * * * * * * 2 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 3 COUNTY DEPARTMENT, LAW DIVISION 4 JOAN M. GRYER, ) ) 5 Plaintiff, ) ) 6 v. ) No. 92 L 7387 ) 7 ELI LILLY AND COMPANY, et al., ) ) 8 Defendants. ) 9 * * * * * * * * * * 10 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 11 COUNTY DEPARTMENT, LAW DIVISION 12 JENNIFER HAMMERLI, as Plenary ) Guardian of the Estate of RAY B. ) 13 HAMMERLI, a disabled person, ) ) 14 Plaintiff, ) ) 15 v. ) No. 92 L 2365 ) 16 ELI LILLY AND COMPANY, THE ) UPJOHN COMPANY, DICKIE KAY, M.D., ) 17 (former Respondent in Discovery), ) and RICHARD CZECHOWICZ (former ) 18 Respondent in Discovery), ) ) 19 Defendants. ) 20 * * * * * * * * * * 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. ) Page 9 1 2 * * * * * * * * * * 3 SUPERIOR COURT OF THE STATE OF CALIFORNIA 4 FOR THE COUNTY OF LOS ANGELES 5 DR. MARIUS SAINES, etc., et al., ) Case No: 6 ) SC 008331 Plaintiffs, ) 7 ) vs. ) 8 ) ELI LILLY & COMPANY, a corporation; ) 9 DISTA PRODUCTS COMPANY, a division ) of Eli Lilly & Company; and DOBS 1- ) 10 100, inclusive, ) ) 11 Defendants. ) ____________________________________) 12 13 * * * * * * * * * * Page 10 1 I N D E X 2 DEPOSITION OF JEAN A. ALLAN 3 4 DIRECT EXAMINATION BY MR. GREEN 14 CROSS EXAMINATION BY MS. ZETTLER 70 5 CROSS EXAMINATION BY MR. CLEMENTI 112 RECROSS EXAMINATION BY MS. ZETTLER 114 6 7 CERTIFICATION 115 8 ERRATA 116 9 EXHIBITS 10 PLAINTIFFS' EXHIBIT NO. 1 23 11 PLAINTIFFS' EXHIBIT NO. 2 28 PLAINTIFFS' EXHIBIT NO. 3 67 12 Page 11 1 THE DEPOSITION OF JAMIE STREET, M.D. TAKEN 2 AT THE OFFICE OF BAKER & DANIELS, 300 NORTH 3 MERIDIAN STREET, SUITE 2700, INDIANAPOLIS, 4 INDIANA 46204, ON JUNE 24, 1993, SAID DEPOSITION 5 TAKEN PURSUANT TO NOTICE IN ACCORDANCE WITH THE 6 RULES OF CIVIL PROCEDURE. 7 * * * * * * * * * * 8 A P P E A R A N C E S 9 10 GREGORY GREEN COUNSEL FOR GROUP B PLAINTIFFS 11 LAW OFFICES OF LEONARD L. FINZ, P.C. 222 BROADWAY, 27TH FLOOR 12 NEW YORK, NEW YORK 10038 13 NANCY ZETTLER COUNSEL FOR GROUP A PLAINTIFFS 14 LEONARD M. RING AND ASSOCIATES, P.C. 111 WEST WASHINGTON AVENUE, SUITE 1333 15 CHICAGO, ILLINOIS 60602 16 LISA M. GOLDMAN COUNSEL FOR ELI LILLY AND COMPANY 17 MCCARTER & ENGLISH FOUR GATEWAY CENTER 18 100 MULBERRY STREET NEWARK, NEW JERSEY 07101-0652 19 CURTIS G. OLTMANS 20 ELI LILLY AND COMPANY LILLY CORPORATE CENTER 21 INDIANAPOLIS, INDIANA 46285 Page 12 1 DENISE BRODSKY 2 COUNSEL FOR GOOD SHEPHERD HOSPITAL 415 WASHINGTON STREET, SUITE 214 3 WAUKEGAN, ILLINOIS 4 MIGUEL A. RUIZ COUNSEL FOR DEFENDANTS CZECHOWICZ, FINK, BRUINSMA 5 CLAUSEN MILLER GORMAN CAFFREY & WITOUS 10 SOUTH LASALLE 6 CHICAGO, ILLINOIS 60603 7 PAUL J. CLEMENTI COUNSEL FOR DR. DICKIE KAY 8 HINSHAW & CULBERTSON 222 NORTH LA SALLE STREET, SUITE 300 9 CHICAGO, ILLINOIS 60601-1081 10 KATHERINE L. LAWS COUNSEL FOR DRS. WITSCHY AND KANNEGANTI 11 BAILEY AND WILLIAMS 3500 NCNB PLAZA 12 901 MAIN STREET DALLAS, TEXAS 75202-3714 13 GREGORY BUBALO 14 COUNSEL FOR DR. LEE COLEMAN OGDEN NEWELL & WELCH 15 1200 ONE RIVERFRONT PLAZA LOUISVILLE, KENTUCKY 40202 16 ROBERT J. MCCULLY 17 COUNSEL FOR THE UPJOHN COMPANY SHOOK, HARDY & BACON 18 1200 MAIN STREET KANSAS CITY, MISSOURI 64105 Page 13 1 COMES JEAN A. ALLAN, CALLED BY THE 2 PLAINTIFFS, AND AFTER FIRST BEING DULY SWORN, WAS 3 DEPOSED AND TESTIFIED AS FOLLOWS: 4 DIRECT EXAMINATION 5 BY MR. GREEN: 6 Q. Good morning. Is it Miss Allan 7 or Doctor Allan? 8 A. Miss. 9 Q. Miss Allan. Could you please 10 give your full name and address? 11 A. Jean A. Allan, 50 North Main 12 Street, Southport, Indiana. 13 Q. And the Zip Code? 14 A. 46227. 15 Q. Miss Allan, my name is Gregory 16 Green and I'm with the law offices of Leonard 17 Finz P.C. We represent a group of plaintiffs in 18 Kentucky litigation wherein Eli Lilly is the 19 defendant. Today I will be asking you some 20 questions, and if any of my questions are unclear 21 to you, just let me know and I will attempt to 22 rephrase the question. I ask that you respond 23 verbally to all questions so that the court 24 reporter can take down everything that's said. Page 14 1 And if you would also keep your voice up so 2 everyone at this long table can hear you, I would 3 appreciate that as well, okay? 4 MS. GOLDMAN: Greg, before you begin 5 your questioning, I would note for the record for 6 purposes of this deposition that this deposition 7 has been cross-noticed in a number of other 8 cases. There have been prior discussions on the 9 subject of cross-notices which have been properly 10 propounded and served. I recognize that 11 plaintiffs, at least some of the plaintiffs, as 12 represented by Ms. Zettler, have a position or 13 view of those cross-notices that is not the same 14 as mine. Rather than burden the court and the 15 record with a repetition at length of our various 16 positions, will it content you to permit the 17 record to state that I have noted that the 18 depositions have been cross-noticed and that you 19 have a view of those cross-notices which is 20 different or is there something else that you 21 would like to say briefly for the record on that 22 issue? 23 MR. GREEN: That would content me, 24 we'll just incorporate all past discussions in Page 15 1 all previous depositions about the cross-notices. 2 MS. GOLDMAN: I think that's fine. 3 MS. ZETTLER: And specifically the 4 objections made in the original deposition of 5 this group of Dan Russell. 6 MS. LAWS: Can we have the same 7 agreement as yesterday regarding objections? 8 MS. GOLDMAN: I have no problem with 9 that. Mr. Green? 10 MR. GREEN: That's fine. 11 Q. (BY MR. GREEN) Miss Allan, 12 what is your highest degree of education? 13 A. It's an MBA. 14 Q. Where did you receive that 15 degree and when? 16 A. Indiana University, 1983. 17 Q. 19 -- 18 A. Eighty-three. 19 Q. And where did you graduate 20 college from? 21 A. My undergraduate college, 22 Earlham College. 23 Q. What was your major at Earlham? 24 A. Biology. Page 16 1 Q. Did you take chemistry courses? 2 A. Yes. 3 Q. Any other college or 4 postgraduate degrees? 5 A. No other degrees. 6 Q. Are you presently employed by 7 Eli Lilly? 8 A. Yes. 9 Q. And when were you first hired 10 by Eli Lilly? 11 A. In 1966. 12 Q. Have you worked for Lilly 13 continuously since 1966? 14 A. Yes. 15 Q. Did you work anywhere prior to 16 1966? 17 A. No, not a full-time job. 18 Q. And when you were hired by Eli 19 Lilly in 1966, what was your initial position, 20 and why don't you give me, just to move things 21 along, your history at Lilly from '66 to present? 22 A. Okay. 23 MS. GOLDMAN: Object to the form of the 24 question, but you can answer that question. Page 17 1 A. In 1966, I hired in to a 2 biochemistry lab, I worked there for ten years, 3 and then I transferred to the medical division in 4 '76, and I have worked continuously in the 5 medical division, except for about two years in 6 the middle, when I went into the purchasing 7 division, and came back to medical after that. 8 Q. And what two years was that? 9 A. I believe that it was about 10 1980 to 1982, I'm not positive of the dates. 11 A. Did you ever have the title of 12 clinical research administrator? 13 A. Yes. 14 Q. And when did you have that 15 title? 16 A. I have that title now. I've 17 had it since they created that name. 18 Q. When did they create that name? 19 A. I don't know what year that 20 was. 21 Q. Prior to the creation of that 22 name, did you have a job which entailed 23 substantially the same duties? 24 A. Yes. Page 18 1 Q. And what was the name of that 2 job? 3 A. Medical information 4 administrator. 5 Q. And when did you become medical 6 information administrator? 7 A. That would be when I went into 8 medical, in 1976. 9 Q. Is your MBA at all related to 10 your position as a clinical research 11 administrator? 12 A. No. 13 Q. Is it a requirement of a 14 clinical research administrator to have an MBA? 15 A. No. 16 Q. Is there a reason you obtained 17 your MBA knowing that you were working within the 18 medical division as a medical information 19 administrator? 20 MS. GOLDMAN: Object to that question, 21 but I'll allow her to answer it. 22 A. I started working on the MBA 23 when I was in the purchasing area. 24 Q. Since 1966 and the beginning of Page 19 1 your employment with Lilly, could you give me a 2 brief outline of the work you've done with Prozac -- 3 MS. GOLDMAN: Objection to the form. 4 Q. -- if any? 5 A. The only recollection I have of 6 working with Prozac at all is that there was a 7 time period when I was in the department that 8 worked on psychotropic drugs. And I can't recall 9 anything specific that I did with Prozac, but I 10 probably had some involvement, it was very 11 minimal. 12 Q. This time period that you're 13 talking about, is that the only time period that 14 you worked with Prozac or Fluoxetine? 15 A. Yes, if I did something then. 16 Q. Okay. When was that time 17 period? 18 A. It would have been around '78 19 or '79, I'm not positive, but that's a guess. 20 Q. Let's take since the end of 21 that time period to the present, have you worked 22 with any other anti-depressants? 23 A. No. 24 Q. Any other psychotropic drugs? Page 20 1 A. No. 2 Q. What drugs, if any, have you 3 worked with since 1979? 4 MS. GOLDMAN: Object to that question. 5 Witness has already testified that she didn't 6 work with psychotropic medicines, nor did she 7 work with the particular compound. As you know, 8 Lilly is a pharmaceutical company which is 9 involved in research and development of a variety 10 of medications, not all of which are of record 11 publicly and by definition, but through the 12 response the witness has already given, excuse 13 me, not relevant to the pending procedures as 14 they involved neither Fluoxetine nor psychotropic 15 medicines, I don't believe the witness should 16 have to testify on trade secret grounds. 17 MR. GREEN: I don't want her to testify 18 on trade secret grounds, but if she could just 19 give me a very broad idea of the area of your 20 employment since 1980 -- 1979, that would 21 suffice, I would think. 22 MS. GOLDMAN: I don't want to obstruct 23 things, Mr. Green, and I think you have probably 24 taken that meaning from my objection. I would be Page 21 1 willing to allow the witness to testify about the 2 category, and I'm going to be inartfully hearing 3 my own phrasing, and if she can't answer the 4 question, then it will be my fault. I think 5 questions about the medical categories of 6 compounds in which she may be involved might 7 suffice to satisfy you that she truly has had no 8 involvement in anything of relevance in this 9 case, and I will let her answer the question 10 because I do understand your desire to be certain 11 of that. 12 Q. I'm adopting your attorney's 13 question. What's the category or categories that 14 you've been involved with since 1979? 15 A. I have worked on drugs for 16 arthritis, drugs for hypertension and drugs for 17 cancer. 18 Q. And that covers everything that 19 you've worked on since 1979? 20 A. Yes. 21 Q. This time period where you 22 worked with Prozac, was that about two years, 23 1978 to 1979? 24 A. I don't have any recollection Page 22 1 of the timeframe itself. 2 Q. Did it encompass those two 3 years? 4 A. I believe that it was in at 5 least part of those years. 6 Q. Okay. And what was your -- 7 what were your duties at that time? 8 A. I don't recall them, I don't 9 recall having responsibility for Prozac. 10 Q. Okay. 11 A. This is a long time ago. 12 Q. Okay. 13 MR. GREEN: Let's mark this as 14 Exhibit 1. 15 (PLAINTIFF'S EXHIBIT NO. 1 WAS 16 MARKED FOR IDENTIFICATION AND 17 RECEIVED IN EVIDENCE.) 18 Q. During that timeframe, do you 19 recall communicating with any other Lilly 20 employees about Prozac or Fluoxetine? 21 A. I don't recall that. 22 Q. Do you recall doing any writing 23 about Prozac or Fluoxetine? 24 A. I don't recall. Page 23 1 Q. Do you recall communicating 2 with any clinical investigators? 3 A. I don't recall anything with 4 respect to Fluoxetine, Prozac. 5 Q. Do you recall any Lilly 6 employees that you worked with on Prozac or 7 Fluoxetine? 8 A. No, I don't. 9 Q. Miss Allan, I'm showing you a 10 document which you've signed. Does that indicate 11 that you wrote that document? 12 MS. GOLDMAN: Object to the 13 characterization of document. 14 Q. I'm sorry, you haven't signed 15 it, your name is on the bottom. Does that 16 indicate you were the author of that document? 17 A. I believe that I probably wrote 18 this. 19 Q. Is that the only document that 20 you ever wrote about Prozac? 21 A. I can't say that for certain, I 22 don't recall. 23 Q. Is that possible that you only 24 wrote one document in 1978 to '79 about Prozac? Page 24 1 A. It's possible. 2 Q. So part of your job is not 3 generating documents? 4 MS. GOLDMAN: Objection to the form of 5 that question. 6 Q. Is it part of your job to 7 generate any types of documents at all? 8 A. It's part of my job to generate 9 some documents, yes. 10 Q. Was that part of your job in 11 1978 and 1979? 12 A. Yes. 13 Q. So is it possible that for this 14 span of at least a year, that you only generated 15 one document? 16 MS. GOLDMAN: Objection to the form of 17 that question. 18 MS. ZETTLER: I thought that we, at the 19 beginning of these depositions, agreed that we 20 were going to reserve all objections to form. 21 MS. LAWS: Except as to form as 22 necessary. 23 MS. ZETTLER: Except as to form, okay. 24 We're certainly willing to do that so we can Page 25 1 expedite it and we don't have objections to every 2 single question. 3 MS. GOLDMAN: I'm sure that you would. 4 My concern is that, and without belaboring the 5 point, by virtue of the cross-notices that have 6 been served, this deposition may have application 7 at some appropriate time in more jurisdictions 8 than in Texas or in Kentucky. And I'm not, for 9 purposes of this objection, taking issue with her 10 commenting in any way with her position. With 11 respect to the cross-notices, my only point is 12 that it may not be satisfactory for purposes of 13 some of those jurisdictions for me to reserve all 14 objections including objections as to form. And 15 much as I would like to expedite these 16 proceedings, and I share your goal and I thank 17 you for your willingness to make that offer in 18 the name of expediting these proceedings, it 19 would be an unfortunate day for us all if it were 20 to turn out that I was remiss in my obligations 21 and, heaven forbid, you would have to do this all 22 over again because I had erred under the laws of 23 some jurisdiction in which this deposition might 24 be used. Page 26 1 MS. ZETTLER: I'm not aware of any 2 jurisdiction that doesn't allow for agreement by 3 counsel as to reservation of objections. If 4 that's the case, then fine, but I believe it's 5 entirely appropriate for us to agree to reserve 6 certain objections. 7 MS. GOLDMAN: Ms. Zettler, with respect 8 to all objections but form, I'm completely in 9 concurrence with you. I do believe there are 10 some jurisdictions that will not allow you to 11 reserve as to form, and that's the good-faith 12 basis for, I hope, entirely civil and courteous, 13 and, frankly, regretful of rejection of your 14 offer. But I do thank you. 15 Q. (BY MR. GREEN) So your 16 attorney objected to form. You can answer the 17 question. 18 MS. GOLDMAN: Do you remember the 19 question? 20 A. Repeat the question please. 21 Q. I said is it possible -- I'll 22 rephrase it and maybe there won't be an objection 23 to form if I rephrase it. Is it possible that 24 during the time period 1978 to 1979, while you Page 27 1 were involved with Prozac, that you only 2 generated one document? 3 MS. GOLDMAN: Objection to the form. 4 You may answer. 5 A. It's possible that I only 6 generated one document about Prozac. 7 (PLAINTIFF'S EXHIBIT NO. 2 WAS 8 MARKED FOR IDENTIFICATION AND 9 RECEIVED IN EVIDENCE.) 10 Q. By the way, Miss Allan, is 11 there a reason you stopped working on Prozac? 12 MS. GOLDMAN: Objection to the form. 13 A. It's difficult for me to 14 remember since I don't actually recall working on 15 Prozac itself. But about that timeframe is when 16 I went to purchasing, I'm not sure that's the 17 reason, but -- at any rate, it would be because I 18 went to work on some other project. 19 Q. Okay. I'm about to show you 20 Exhibit 2 after your attorney looks at it. 21 MS. GOLDMAN: Excuse me, Mr. Green. As 22 I flipped briefly through what's been marked as 23 Exhibit Allan 2, I noted that there are sticky 24 note tabs, and I noticed at the end of one that Page 28 1 there appears to be handwriting on it. I did not 2 read the handwriting, and let me give you the 3 opportunity to take Allan 2 back if there's 4 anything on it that you don't want me to have 5 before you present it. 6 MR. GREEN I'm just removing the tabs. 7 I think they're all off. 8 Q. And I would like to show you, 9 Miss Allan, a copy of a document entitled 10 protocol title, a controlled study of the 11 treatment of major depressive disorders with 12 Fluoxetine HCL. 13 MS. GOLDMAN: Mr. Green, may I complete 14 my review of that exhibit? I didn't look at 15 certain portions of it because it did have tabs 16 on it when you first passed it to me. 17 (COUNSEL REVIEWS DOCUMENT.) 18 Q. Miss Allan, what's the document 19 which is marked as Exhibit 2? 20 A. This is a document that is a 21 protocol for the study of Fluoxetine. 22 Q. Were you the clinical research 23 administrator for that protocol? 24 A. I don't believe that I was, I Page 29 1 don't recall having an involvement with this. 2 Q. Well, apparently this document 3 was in your file and it was produced at the 4 request of the plaintiffs in this action. 5 A. It was in my personal file? 6 Q. At some point, yes. Is there a 7 reason that you would have a copy of a protocol 8 in which you were not involved within your file? 9 A. It's possible that I could 10 have, as -- our protocols follow a form which we, 11 to write a new protocol or possibly to be 12 involved with a new protocol, we would refer to 13 another protocol as a guideline. 14 Q. Do you recall being involved in 15 any protocols for Prozac or Fluoxetine? 16 A. I don't recall being involved 17 with that. I'm having a lot of trouble recalling 18 1978 and 9, as a matter of fact. 19 Q. Do you recall being a member of 20 a project team? 21 A. I don't actually recall it, but 22 it's entirely possible that I could have had my 23 name on the list of the project team at the time. 24 Q. Okay. What about -- do you Page 30 1 recall the name I. H. Slater, M.D.? 2 A. Yes. 3 Q. Is Doctor Slater still 4 associated with Lilly? 5 A. No. 6 Q. What was Doctor Slater's 7 position in 1978-79? 8 A. Well, he's on this protocol, so 9 he was the clinical monitor of this Fluoxetine 10 protocol. 11 Q. Was he the clinical monitor for 12 Fluoxetine? 13 A. Apparently. 14 Q. During that time? 15 A. In that timeframe apparently he 16 was. 17 Q. What about a Mr. VanMeter? 18 A. I remember him. 19 Q. What was his position in 20 '78-79? 21 A. He was a CRA, although I'm not 22 sure if we were still calling it an MIA at that 23 time. 24 Q. Was he your superior during Page 31 1 that time? 2 A. No. 3 Q. Was he working with Prozac 4 during that time? 5 A. I don't actually recall, but my 6 other memo would indicate that he probably was. 7 Q. Do you recall any meetings of 8 Lilly employees wherein Prozac was discussed? 9 A. I'm sorry, I can't recall, 10 we've had a lot of meetings in the meantime. 11 Q. Do you know the name Dr. Jamie 12 Street? 13 A. Yes. 14 Q. Do you know what his position 15 is at Lilly? 16 MS. GOLDMAN: Object to the form of the 17 question. 18 A. Not exactly. 19 Q. Do you know if he's involved 20 with Prozac? 21 A. I don't know. I know he's one 22 of the clinical physicians, but I don't know what 23 he does. 24 MR. GREEN Do you mind if we take a Page 32 1 little break? 2 MS. GOLDMAN: No problem at all. 3 (A SHORT RECESS WAS TAKEN.) 4 Q. (BY MR. GREEN) Miss Allan, are 5 you familiar with the name of Mike Hanson? 6 A. Mike Hanson? 7 Q. H-A-N-S-O-N? 8 A. Yes. 9 Q. Was he working with Lilly 10 during '78-79? 11 A. I don't know. 12 Q. Do you know what his job title 13 is presently? 14 A. Presently, he's in my reporting 15 structure, I'm trying to think of his exact 16 title, either director, executive director, or 17 vice-president, one of those. He's at the top of 18 my reporting structure. 19 Q. When you say reporting 20 structure, does that mean who you report to? 21 A. Ultimately. He has a lot of 22 people under him. 23 Q. What was the reason that you 24 moved to the purchasing division? Page 33 1 A. I believe that personnel simply 2 offered me the opportunity to try something 3 different, and I did. 4 Q. How did that offer come up? 5 A. I don't know why I was offered 6 that position. 7 Q. Do you recall where you were in 8 relation to your work with Prozac when that offer 9 came up? 10 MS. GOLDMAN: Objection to the form of 11 the question. 12 A. I don't recall. 13 Q. Why did you eventually leave 14 the purchasing division? 15 A. I found it much more rewarding 16 to work with life-saving drugs than to be in the 17 financial side of the corporation. 18 Q. When you say the financial side 19 of the corporation, does that include marketing? 20 MS. GOLDMAN: Object to the form. 21 A. I'm not sure where marketing is 22 in this structure of the corporation, all I meant 23 was I prefer to be in Lilly research 24 laboratories, what we're doing, research. Page 34 1 Q. Would you agree that the 2 marketing of the product or the drug is important 3 to Lilly? 4 A. I'm sure it's important, yes. 5 Q. Do you recall during '78-79 a 6 discussion of any goals that the company had with 7 regard to Prozac? 8 A. No, I don't recall. 9 Q. Wasn't it a goal of the company 10 to market the drug Prozac? 11 MS. GOLDMAN: In 1978 and 1979? 12 Q. Wasn't it a goal to market the 13 drug? 14 A. Well, one embarks on research 15 generally with that goal, so that would have been 16 the goal as well with Prozac. 17 Q. Do you consider Prozac a 18 life-saving drug? 19 A. Oh, yes. 20 Q. In the course of your work as a 21 clinical research administrator, and I mean to 22 incorporate medical information administrator as 23 well, does your department ever interact with the 24 marketing division? Page 35 1 A. There's interaction, yes. 2 Q. Could you describe that 3 interaction? 4 MS. GOLDMAN: Objection to the form of 5 the question. The witness has been employed at 6 the company for twenty-seven years, as able 7 counsel to my left has just reminded me. That's 8 a very, very broad timeframe, Mr. Green, and the 9 witness has already testified that any connection 10 that she might have had with the topics of 11 today's deposition may have occurred in a range 12 that may have encompassed 1978 and 1979. 13 MR. GREEN: I really don't see a point 14 for your objection. She testified that there was 15 an interaction, and all I asked is could she 16 describe it. It's a very straightforward 17 question, and if she can't describe it, then I 18 don't see a problem with her saying I've been at 19 the company for a long time. I don't think that 20 we need to have you answer the question for her. 21 MS. GOLDMAN: Well, put me down as 22 having an objection to the form of the question 23 on the grounds that it's unlimited, overbroad in 24 scope and doesn't contain any kind of time Page 36 1 parameter that would make it susceptible to 2 anything other than a very broad narrative 3 response, if the witness were capable of making 4 such a response, which I do not know. 5 MR. GREEN: Since you don't know that, 6 let's see if the witness can make that response. 7 MS. GOLDMAN: I'm going to permit her 8 to answer your inappropriate question, Mr. Green. 9 A. Any interaction that medical 10 had with marketing would not have been at my 11 level particularly. So exactly what kind of 12 interactions they have, I'm not sure. I do know 13 that when we have planning meetings, there are 14 usually marketing people in attendance as well as 15 medical people in attendance. That is planning 16 meetings that are rather global in scope, not 17 planning meetings at the research level. 18 Q. Do you recall any planning 19 meetings being held during 1978 and '79 in 20 relation to Prozac? 21 A. I don't recall any Prozac 22 meetings as a matter of fact. 23 Q. Mister Tolivson, are you 24 familiar with that name? Page 37 1 A. I'm familiar with the name. 2 Q. Is Mister Tolivson with Lilly 3 presently? 4 A. Yes. 5 Q. Do you know what his job title 6 is? 7 A. I don't know. 8 Q. How about a Mike Harrold, 9 H-A-R-R-O-L-D? 10 A. That sounds like a different 11 name than you've said. 12 Q. What is the name that it sounds 13 like? 14 A. It sounds like Mike Harril, 15 H-A-R-R-I-L. 16 Q. What is Mr. Harril's -- is he 17 still with Lilly today? 18 A. He is with Lilly. 19 Q. What is his position? 20 A. He has a newly assigned 21 position, I can't recall the title. 22 Q. What title did he used to have? 23 A. Before that, he was the manager 24 of medical plans, which was like a couple of Page 38 1 weeks ago. 2 Q. Does the manager of medical 3 plans have anything to do with planning meetings? 4 A. It would be speculation on my 5 part. 6 Q. So you don't really know what 7 Mr. Harril does? 8 A. Not related to planning 9 sessions. 10 Q. Can you describe generally what 11 he does? 12 A. Generally he's -- he manages 13 the department that has all of the CRAs in it, so 14 he's involved with a variety of things related to 15 organizing and planning clinical trials. But I 16 am seldom in a meeting directly with him to know 17 exactly what he does. 18 Q. Okay. What about Greg 19 Brickler? 20 A. Yes. 21 Q. Is he presently with Lilly? 22 A. Yes. 23 Q. And what is his title 24 presently? Page 39 1 A. I'm not absolutely sure. He's 2 also in my line of management, executive 3 director, possibly, but I'm not sure. 4 Q. Executive director of the 5 medical department? 6 A. Yes. 7 Q. How about Earleen Ashbrook? 8 A. I know her. 9 Q. Is she presently with Lilly? 10 A. Yes. 11 Q. What is her job title 12 presently? 13 A. I don't have any idea. 14 Q. How do you know her? 15 A. She used to be a CRA. 16 Q. How about Melissa Humbert? 17 A. I know her, too. 18 Q. Did she used to be a CRA? 19 A. Yes. 20 Q. Did she have any other position 21 wherein she was involved with Prozac? 22 A. I don't know if she was 23 involved with Prozac or not. 24 Q. How about Leigh Thompson? Page 40 1 A. Leigh Thompson. 2 Q. Leigh Thompson. 3 A. Yes, I know him. 4 Q. That's a he? 5 A. Yes. 6 Q. Presently with Lilly? 7 A. Yes. 8 Q. And job title? 9 A. I don't know that either, high 10 in the corporation, vice-president. 11 Q. Can you describe the process 12 you went through in 1978-79 in creating a 13 protocol? 14 A. Only in very general terms. 15 Would that be helpful? 16 Q. Yes. 17 A. Usually to begin writing a 18 protocol, a Lilly physician and outside 19 physicians confer on how to study a certain drug, 20 and usually we also use a lot of literature 21 references related to standard methods of 22 studying such types of drugs. And when they've 23 reached a conclusion as to the general process, 24 they usually involve a CRA to help them put that Page 41 1 on paper and to help define exactly how we'll 2 record the data that we will be collecting. Once 3 it's written, there is a -- there's an approval 4 process for the protocol where others with 5 medical expertise who are not directly involved 6 in writing it review it for, you know, clarity 7 and appropriateness, and that sort of thing. 8 Q. Was there a guideline or a 9 manual as to how to develop a protocol that was 10 in effect in '78-79? 11 A. I believe we had a general 12 outline to follow, I don't recall there being a 13 giant document full of regulations related to 14 that. 15 Q. Did that outline have a title 16 or anything that it could be identified by? 17 A. I don't recall a title. 18 Q. Do you recall in '78-79, with 19 regard to Prozac, there being different types of 20 protocols such as a comparison protocol, or a 21 fixed-dose protocol? 22 A. I don't recall the Fluoxetine 23 protocols, so I don't know. 24 Q. Do you recall the Lilly doctor Page 42 1 that you were associated with, if any, from 1978 2 to 1979? 3 A. I can't recall to know in that 4 timeframe who it would be. 5 Q. Do you recall the name Robert 6 Shulman? 7 A. No. 8 Q. Did there come a time when you 9 were asked to produce documents regarding Prozac 10 which were in your files and you were asked by 11 attorneys to get your Prozac documents together? 12 MS. GOLDMAN: Objection to form. 13 A. No, I don't recall that. 14 Q. When did you first learn that 15 you would be coming to a deposition today? 16 A. I don't recall the exact time, 17 but it was a couple of months ago perhaps. 18 Q. Have you met with attorneys 19 since that time? 20 A. Yes. 21 Q. How many times have you met 22 with attorneys since then? 23 A. Twice. 24 Q. And when was the first meeting? Page 43 1 A. I don't recall a date. 2 Q. Do you recall how long that 3 meeting was for? 4 A. I believe it was two hours. 5 Q. And when was the second 6 meeting? 7 A. This morning. 8 Q. And how long was the meeting 9 this morning? 10 A. About an hour and a half. 11 Q. So you met with your attorneys 12 for a total of three and a half hours? 13 A. Yes. 14 Q. At the first meeting, did you 15 tell your attorneys that you didn't remember 16 anything about Prozac? 17 MS. GOLDMAN: Objection to that 18 question, you're inquiring of the witness about a 19 communication with her counsel. Mr. Green, 20 you're a good lawyer, you know that's off limits 21 and I'm going to direct the witness not to answer 22 that question. 23 Q. It seems like a long time, 24 three and a half hours, to talk about what you Page 44 1 don't remember, doesn't it? 2 MS. GOLDMAN: Objection. Don't 3 respond. 4 Q. For the years 1978 to 1979, 5 could you describe the process that you went 6 through as a clinical research administrator in 7 operating or assisting to operate the protocols 8 that were being done at that time? 9 MS. GOLDMAN: Objection to the form of 10 that question to the extent that it's an inquiry 11 about protocols that did not involve Fluoxetine 12 on the grounds that that is irrelevant, that it 13 infringes on the company's trade secrets and 14 confidential business information. In the 15 interest of speeding things along, I will allow 16 the witness to provide general testimony about 17 what being a CRA was like in 1978 and 1979, but I 18 do have to object to anything which infringes on 19 the company's non-Prozac related trade secrets 20 and business. 21 Q. I think she said you can answer 22 the question. 23 A. Would you repeat it, please? 24 Q. Can you describe in general the Page 45 1 functions of the CRA in 1978-1979? 2 MS. GOLDMAN: Same objection. 3 A. A CRA is basically a 4 physician's assistant, the physician being the 5 person charged with planning and keeping track of 6 studies of all the new drugs that we are 7 developing for marketing. The CRA, as I told you 8 a minute ago, was involved in helping to write 9 the protocol, they help to set up the case report 10 form so that it would have appropriate places to 11 write the data that the protocol requires. They 12 help in planning how to put together the 13 medication that has to be packaged specifically 14 for each study, they help in planning how the 15 data will be entered into a computer data base 16 when it arrives at Lilly from the physician's 17 site. They also travel, either with the 18 physician or without him, to clinical trial sites 19 to help them understand the protocol, understand 20 the case report forms and to know what is 21 required to fit the format so that it will indeed 22 become data when it gets into our computer. We 23 review the data as it comes in, we discuss -- we 24 take any unusual untoward circumstances in the Page 46 1 clinical report forms to the physician to be 2 reviewed or in some cases call the clinical trial 3 sites for information when it's not -- when it's 4 not as expected, when it looks odd, when any data 5 they send us conflict with other data they have 6 already sent us, that sort of thing. Basically 7 it amounts to being a physician's assistant. 8 Q. So when the data comes in, if 9 it's conflicting, you want that data to be 10 uniform, right? 11 MS. GOLDMAN: Objection to the form. 12 A. Not uniform, just correct. And 13 if you get something in where the blood pressure 14 says it's five hundred over two hundred, you 15 would call to inquire because it seems 16 impossible. 17 Q. As you are developing the drug 18 for marketing, isn't it important that your 19 efforts go toward the marketing of the drug which 20 you're developing? 21 MS. GOLDMAN: Objection to the form. 22 A. The only real involvement in 23 any of this, this is basic research, it's a 24 search for truth, so as far as involvement with Page 47 1 marketing the drug, of course the outcome of the 2 research studies is used in the marketing to 3 inform people how the drug works and what, you 4 know, what to watch for, what it will do, what it 5 won't do, that sort of thing. So I don't see 6 this as -- this is a rather separate thing from 7 marketing. 8 Q. In the search for truth that's 9 going on, isn't it important that a patient's 10 status, medical status, is recorded as accurately 11 as possible? 12 A. Yes, that's one of the main 13 goals of the CRA. 14 Q. In the case of a psychotropic 15 drug, isn't it important to record something like 16 degree of depression as accurately as possible? 17 MS. GOLDMAN: Objection to the form of 18 the question. Objection to the question also to 19 the extent that it calls for a medical expert 20 opinion which this witness has already testified, 21 by virtue of her description of her training, 22 that she is not by definition equipped to give. 23 If she can attempt to answer within the limit of 24 her expertise, I will permit her to do that. Page 48 1 A. As a general rule, when you do 2 any study, you categorize the patients carefully 3 so that you will know exactly what type of 4 patient you're studying. 5 Q. Do you recall how suicidality 6 was measured in Prozac protocols in 1978 to 1979 -- 7 MS. GOLDMAN: Objection to the form. 8 Q. -- if at all? 9 A. I have no recollection of the 10 protocols, I'm sorry. 11 MS. ZETTLER: I'm sorry, could you read 12 the question back? 13 (THE COURT REPORTER READ BACK THE 14 REQUESTED TESTIMONY.) 15 Q. So part of your job as a CRA 16 was to screen documents as they came back to 17 Lilly; is that correct? 18 A. Yes, that's correct. 19 Q. And as you screened the 20 documents, you looked for information which may 21 be conflicting or incorrect? 22 A. Yes. 23 Q. Is that right? 24 A. And also important information Page 49 1 about the patient. 2 Q. Did you look for information 3 which may adversely affect marketing? 4 MS. GOLDMAN: Objection to the form of 5 the question, although I will allow the witness 6 to attempt a response. 7 A. No, marketing has no impact at 8 all on research study. 9 Q. Well, isn't that the reason 10 you're doing research is so the drug can be 11 marketed? 12 MS. GOLDMAN: Objection to the form of 13 the question, also objection on the grounds of 14 asked and answered. Nonetheless, I will allow 15 the witness to attempt yet another response to 16 the question. 17 Q. You wouldn't be doing research 18 if you weren't going to market the drug, right? 19 MS. GOLDMAN: Objection to the form. 20 A. We do research to see if we 21 have a drug and whether we can market it. We 22 don't decide before we do the research. 23 Q. How do you know that that 24 decision is not made before research? Page 50 1 MS. GOLDMAN: Objection to the form of 2 that question. 3 A. Because we reject thousands of 4 drugs before they ever get to the market, but 5 after we've begun research on them. 6 Q. Are you familiar with a 7 committee within Lilly called the clinical 8 project review committee? 9 A. Yes. 10 Q. Are those -- is that review 11 committee specific to Prozac or is it -- does it 12 serve a broader purpose? 13 A. It reviews all drugs we study. 14 Q. Do you know who would be 15 members of that committee today? 16 A. Only in general. I know that 17 it's selected physicians, researchers, 18 administrators, but I can't name them. 19 Q. Have you ever known anyone that 20 was on such a committee? 21 MS. GOLDMAN: Objection to the form. 22 A. Well, I'm sure I've known them, 23 but I'm not sure that I can name who exactly they 24 were. Page 51 1 Q. Are you familiar with the term 2 within Lilly of research management staff? 3 A. Yes. 4 Q. And is that a group of people? 5 A. Yes. 6 Q. And is that group focused on 7 single drugs or a broader spectrum? 8 A. A broad spectrum. 9 Q. Who is on the research 10 management staff presently? 11 A. I honestly don't know. We have 12 so many committees that have changed components 13 recently that I have not -- I'm not sure who is 14 on any one of them at this point. 15 Q. Has there been a major 16 realignment of Lilly staff in recent years? 17 MS. GOLDMAN: Objection to the form. 18 A. We're continuously organizing 19 and changing our organization to meet our current 20 needs. So I would say that there was a 21 continuing evolution of changes in the staff. 22 Q. So the changes in the 23 realignment are for meeting current needs? 24 A. Yes. Page 52 1 Q. Is there any other reason for 2 the changes in realignment? 3 MS. GOLDMAN: Objection to the form of 4 that question, objection to the scope of that 5 question as directed to this witness, but I'll 6 allow her to attempt an answer. 7 A. I would only be guessing. Any 8 business reorganizes to make itself more 9 efficient and more responsive to the market 10 place. 11 Q. When you were moved to the 12 purchasing department and then out of the 13 purchasing department, was that the result of a 14 realignment? 15 A. No, that was my own personal 16 move. 17 Q. Within Lilly, have you ever 18 heard of project steering committee? 19 A. That doesn't even sound 20 familiar. There could very well be one. 21 Q. In 1978 to 1979, you mentioned 22 that a protocol was started when a Lilly M.D. and 23 an outside M.D. would get together and discuss 24 the protocol. How would these outside M.D.s come Page 53 1 to be involved with the Lilly M.D.? 2 A. There were a lot of ways that 3 they were acquainted. Often they're acquainted 4 because of their professional involvement outside 5 of Lilly. We have a field personnel who visit 6 physicians all over the country and -- to see who 7 would be appropriate to do studies for us. 8 Sometimes Lilly hires consultants just as 9 consultants to help us to plan studies. I'm sure 10 there are more ways than that. 11 Q. As part of these -- as part of 12 the field staff that would go out and meet 13 possible -- would you call these outside 14 physicians investigators, clinical investigators? 15 A. Yes. 16 Q. As part of the field staff, was 17 Brooks Bradley a part of that staff in '78-79? 18 A. I don't know if he was in '78 19 or '79. 20 Q. Is he presently? 21 A. Yes. 22 Q. And how about Jim Hafner? 23 A. I don't know about '78 and '79. 24 Q. Is he presently? Page 54 1 A. I can't think of where he's 2 gotten to, I'm not sure. 3 Q. Are these clinical 4 investigation coordinators assigned different 5 parts of the country? 6 MS. GOLDMAN: Objection to the form. 7 A. Yes. 8 Q. Do you know how the country is 9 divided up for these coordinators? 10 A. I can't tell you, but I have a 11 map that shows their areas. 12 Q. Do you recall if New York is 13 separate as a distinct geographic area? 14 A. I don't recall, I just always 15 look at the map. 16 Q. Did the coordinators work with 17 one drug or do they work with a broader array of 18 drugs? 19 A. When? 20 Q. In 1978 and '79. 21 A. '78-79, I believe they were 22 divided into two categories then. 23 Q. What were those categories? 24 A. General diseases is one Page 55 1 category and infectious diseases was the other. 2 Q. Do you recall the name of -- 3 let me make sure I get it right, I think it's 4 Louis -- Dr. Louis Fabre, F-A-B-R-E? 5 A. No, I don't believe so. 6 Q. Do you recall doing any work 7 with Dr. Fabre, he was -- as being located in 8 Houston, Texas during 1978 and '79? 9 A. I don't recall. 10 Q. Do you recall ever traveling to 11 Houston during that time period? 12 A. No, I don't recall that. 13 Q. Do you recall there being any 14 criticism of the way Dr. Fabre conducted his 15 protocol for Prozac? 16 MS. GOLDMAN: Objection to the form. 17 MR. GREEN: What's wrong with the form, 18 I just asked if she recalled any criticism of Dr. 19 Fabre? 20 MS. GOLDMAN: I know, and I objected to 21 the form. 22 MR. GREEN: What's wrong with the form? 23 MS. GOLDMAN: I don't have to tell you 24 what is wrong with the form, Mr. Green, my Page 56 1 response -- 2 MR. GREEN: I would like to rephrase 3 the question, so if you could tell me what's 4 wrong with the form I would appreciate it. 5 MS. GOLDMAN: Mr. Green, if you would 6 like to rephrase your question, that's, of 7 course, your privilege. 8 MR. GREEN: I don't know how because I 9 think the question's fine. 10 MS. GOLDMAN: Mr. Green, as I told you 11 before, you're a good lawyer and I'm sure you'll 12 do what you think is right and appropriate. 13 MR. GREEN: I guess it will be 14 explained to the judge at the time of trial, but 15 if you could answer. 16 MS. GOLDMAN: I said I would allow her 17 to attempt a response. 18 A. I don't recall a Dr. Fabre, so 19 no, I don't recall anything. 20 Q. Do you recall any discussion 21 about Dr. Fabre that the patients he used in his 22 Prozac protocol were patients from an alcoholic 23 rehabilitation center? 24 A. No, I don't recall. Page 57 1 Q. Was it part of the clinical 2 research administrator's job duty to present a 3 contract to the clinical investigator? 4 A. A contract? 5 Q. Yes. 6 A. Like a business agreement to be 7 signed? 8 Q. Yes. 9 A. When? 10 Q. Prior to the clinical 11 investigator beginning a study of Prozac. 12 MS. GOLDMAN: Objection to the form of 13 the question, objection to the question as based 14 on the witness' prior testimony it is not within 15 the scope of her training and expertise. I will 16 allow her to attempt a response to the question 17 if she has one. 18 Q. In '78 and '79. 19 A. I don't recall anything 20 specific about Prozac, but I don't believe we 21 signed actual business agreements with 22 investigators in that timeframe, that's my 23 recollection. 24 Q. Does the phrase start-up Page 58 1 meeting mean anything to you? 2 A. Yes. 3 Q. And what is that? 4 A. That is -- it can be used two 5 different ways. Often it is a group meeting 6 where a number of investigators, a number of 7 CRAs, field personnel, all get together and go 8 over a new protocol, new clinical report forms, 9 and discuss how the study will be run. At other 10 times, we use the same phrase when we simply mean 11 one CRA or one CRA with a Lilly physician going 12 to a study site and training the personnel 13 individually at that site. 14 Q. Do you recall attending any 15 start-up meetings of either type regarding 16 Prozac? 17 A. No, I don't recall ever 18 attending any. 19 Q. When the clinical administrator 20 and physician meet with the investigator and his 21 group of colleagues, are there any training 22 manuals or videotapes or anything of that sort? 23 A. What year? 24 Q. Presently. Page 59 1 A. Presently. Presently we use 2 just about every means of training we can think 3 of. I believe some people have used videotapes. 4 We have guidelines that we give out, we have -- 5 studies usually have a specific set of rules to 6 help understand what's required. We have 7 numerous, numerous means of training people. 8 Q. And how is that different than, 9 if at all, than in '78 and '79? 10 A. I seriously doubt that anyone 11 did a videotape in '78 or '79. We did the same 12 training process, we just didn't use as many aids 13 as we do now. We had sets of rules for each 14 study and we went over them with the site and all 15 the people involved. It's simply become a more 16 formalized process in the meantime. 17 Q. Now with regard to the Prozac 18 protocols in '78 and '79, do you recall any 19 discussion of any of the entry or exclusion 20 criteria? 21 A. I don't recall Prozac at all. 22 Q. You don't recall it at all? 23 A. (Witness moves head from side 24 to side.). Page 60 1 Q. Would there have been a 2 clinical investigation manual in effect during 3 that timeframe? 4 MR. OLTMAN: For any or all drugs, 5 what's the scope of your question? 6 MR. GREEN: For Prozac. 7 A. I wouldn't know that. 8 Q. Was that the common practice? 9 A. I can't remember whether we 10 were doing those in '78 or not, it's rather hard -- 11 it's kind of a continuous time here, I can't 12 remember what years we did what very well. 13 Q. In 1978 to '79, did they have a 14 systems analyst? 15 A. Yes. 16 MS. GOLDMAN: Objection to the form. 17 Q. They, meaning Lilly. And did 18 you work with any systems analyst during that 19 timeframe? 20 A. I had to work with the systems 21 analyst, whatever I was working on, to plan the 22 data base and make the computer system work for 23 the study, yes. 24 Q. Do you recall the name of the Page 61 1 systems analyst that you worked with during that 2 time period? 3 A. I don't recall. 4 Q. How about Paul Banta, is he a 5 systems analyst? 6 A. That's a familiar name, but I 7 can't quite remember who that person is. 8 Q. How about Laurie Sheldon? 9 A. Likewise a familiar name, but 10 I'm not sure who that is. 11 Q. What did the systems analyst 12 do, could you give me a brief description? 13 A. Since I'm not one, I'm not -- I 14 can tell you what the end that I see of what they 15 do. They put up whatever data entry system we 16 have for the data from the protocols, and they 17 take care of the computer system, solve any 18 problems, fix it if it crashes, whatever goes 19 wrong. And they write their programming that 20 produces the output tables that we use when we 21 write up a study. They don't do that -- I mean 22 they do the programming, the medical folks do the 23 planning of what's going on the table. 24 Q. Do they work with a specific Page 62 1 drug? 2 A. Not always. Generally -- the 3 best answer may be generally they're probably, at 4 any given time, working on one category of drugs. 5 Q. Do you know who the systems 6 analyst is for Prozac at the present time? 7 A. I have no idea. 8 Q. In 1978 to '79, did you work 9 with any statisticians? 10 A. Yes, I did, I had to because 11 CRAs always work with statisticians. 12 Q. Do you recall the name? 13 A. I don't recall who it would be. 14 Q. How about Kevin Marks? 15 A. I don't know that name. 16 Q. How about Ivan Bennett? 17 A. Ivan Bennett was a physician. 18 Q. Was he a statistician? 19 A. Not to my knowledge. 20 Q. How about Bruce Dornseif? 21 A. I don't know who that is, I've 22 heard that name, but I don't know. 23 Q. I'll give you one more name, 24 David Hardison. Page 63 1 A. Doesn't sound familiar. 2 Q. Do you know the names of any 3 statisticians who presently work with Prozac? 4 A. I don't know who works with 5 Prozac. 6 Q. Within Lilly, are you familiar 7 with a clinical grants committee? 8 A. Yes. 9 Q. Do you know, is that committee 10 specific to one drug? 11 A. No, it's not. 12 Q. Do you know who is on that 13 committee presently? 14 A. No, I don't. 15 Q. In 1978 to '79, do you recall 16 the name of R. W. Fuller? 17 A. Yes. 18 Q. And what was Dr. Fuller's 19 function within Lilly in 1978 and '79? 20 A. I know that his function is 21 research scientist in a lab, but I'm not entirely 22 sure if he was there in '78 and '79. He was -- 23 he's been there a long time. 24 Q. Do you know if he had anything Page 64 1 to do with Prozac? 2 A. I don't know. 3 Q. How about Zerbe, same 4 timeframe, '78-79? 5 A. I had not heard of the name 6 Zerbe in that timeframe. 7 Q. Do you know if Zerbe had 8 anything to do with Prozac? 9 A. I don't know. 10 Q. Are you familiar with the term 11 treatment emergent symptom? 12 A. Yes. 13 Q. What is that? 14 A. That's any untoward event that 15 happens to a patient that happens -- that they 16 did not have when they entered the study, 17 something new that happens to them after you 18 start treatment. 19 Q. When you say something new, 20 does that mean that it's a side affect that is 21 previously unrecorded? 22 MS. GOLDMAN: Objection to the form of 23 that question, it's beyond this witness' training 24 and expertise. Page 65 1 MR. GREEN: Would you allow her to 2 answer? 3 MS. GOLDMAN: I'll let her try. 4 A. First of all, side affect may 5 not convey the right meaning. It simply is 6 something you wouldn't expect to happen to a 7 patient that has happened, it's usually bad. 8 It's not necessarily a side affect, it's anything 9 that happened to the patient during this time 10 period you're looking at. 11 Q. Is it previously unrecorded? 12 A. It was previously not happening 13 to the patient, right, prior to the drug being 14 given. 15 Q. Is it something that had not 16 been seen in other patients? 17 A. There's no relation to other 18 patients in this definition. 19 Q. When a treatment emergent 20 symptom is noted, is a form filled out by anybody 21 along the line of clinical investigator to CRA to 22 clinical physician? 23 MS. GOLDMAN: Objection to the form of 24 the question. Is this with respect to a Page 66 1 particular timeframe? 2 MR. GREEN: No, I'm just asking general 3 practice. 4 A. Okay. In general practice, 5 everything that happens to the patient during the 6 study is written down. It doesn't need to be 7 treatment emergent, it's everything ongoing that 8 happens to them is recorded. 9 Q. Was that done in '78 and '79? 10 A. To the best of my knowledge, 11 yes. 12 Q. Was a form filled out? 13 A. The clinical report form, yes. 14 Q. So it was incorporated within 15 the clinical report form? 16 A. Yes. 17 (PLAINTIFF'S EXHIBIT NO. 3 WAS 18 MARKED FOR IDENTIFICATION AND 19 RECEIVED IN EVIDENCE.) 20 Q. Miss Allan, I've just showed 21 you Exhibit 3. It appears to be a letter dated 22 January 31, 1979 addressed to Dr. Fabre, and it's 23 apparently signed by Doctor Slater. Did I ask 24 you about Doctor Slater, do you remember him? Page 67 1 A. I remember him, yes. 2 Q. What was his title at Lilly's 3 in 1979? 4 A. He was the clinical research 5 physician. 6 Q. Okay. There's a handwritten 7 note at the bottom of this document. Is that 8 your handwriting? 9 A. No, it's not. 10 Q. Okay. That's not a J. A. at 11 the bottom and your signature? 12 A. No, it's not. 13 Q. Okay. 14 A. I don't know whose -- I can't 15 read it, either. 16 Q. It looks like a J. A. 17 A. It does, but it's not. 18 MR. GREEN: This Exhibit 3 is Pz 517 19 1564. 20 Q. What was the extent of the 21 involvement of the Lilly physician when the 22 discussion with the outside physician was held as 23 to how to conduct a certain study, a protocol for 24 a certain drug? Page 68 1 MS. GOLDMAN: Objection to the form of 2 that question. 3 A. I'm not sure how to interpret 4 extent. I know that Lilly physicians working 5 with outside investigators have a lot of give and 6 take in their scientific ideas about how drugs 7 should be studied and that sort of thing. 8 Ultimately, of course, the decision has to rest 9 with the Lilly physician because he has to work 10 with many outside investigators and come to an 11 agreement on how to do this study because they 12 all need to do it in the same way. 13 Q. Are you familiar with the term 14 Zung, Z-U-N-G, SDS scale? 15 A. Z-U-N-G? 16 Q. Yes. 17 A. I don't recall that. 18 Q. In '78 and '79, when a protocol 19 was being created, do you remember what 20 literature was referred to? 21 MS. GOLDMAN: Objection to the form of 22 the question. 23 A. Only in general terms. I know 24 that you would use standard rating scales for Page 69 1 certain diseases or references in the literature 2 that showed a certain way of studying a type of 3 drug you were trying to do a protocol on, but not 4 any specific references. 5 Q. With regard to psychotropic 6 drugs, do you have any recollection as to 7 specific references? 8 A. I remember one rating scale 9 that was used was the Ham D. 10 Q. And you remember that that was 11 used within the Prozac studies? 12 A. I don't remember that, no. I 13 just remember that it is a standard psychiatric 14 rating scale that was used in other studies. 15 MR. GREEN: I have no further 16 questions. 17 (A SHORT RECESS WAS TAKEN.) 18 * * * * * * * * * * 19 CROSS EXAMINATION 20 BY MS. ZETTLER: 21 Q. Miss Allan, my name is Nancy 22 Zettler and I represent other of the defendants 23 in the Kentucky case that Mr. Green told you 24 about earlier. I have got a few follow-up Page 70 1 questions for you and hopefully we can get out 2 fairly quickly. Just a couple of real quick 3 background-type questions. What is your date of 4 birth? 5 A. May 14, 1943. 6 Q. And other than your MBA, have 7 you taken any other postgraudate, and I don't 8 mean working towards a degree, but any other 9 classes or seminars or things, continuing 10 education types of courses? 11 A. I went to the University of 12 Chicago for a year in their biochemistry program 13 before I came to Lilly, and I've gone to many 14 training sessions outside of Lilly and inside of 15 Lilly relative to doing clinical trials. 16 Q. Can you give me an idea about a 17 couple of those? 18 A. One group that has good 19 training sessions is Drug Information Association 20 which is not associated with Lilly. It's a group 21 that many companies attend and present talks on, 22 attend to learn, but it's an ongoing 23 organization, so I've been to several of those. 24 And within Lilly, we have a lot of training Page 71 1 sessions related to how to write protocols, how 2 to deal with data, a number of things. 3 Q. These drug information 4 association seminars that you attended, were 5 those -- did Lilly send you to those or did you 6 go to those on your own? 7 A. Yes. 8 Q. Is that -- 9 A. Actually both. I went to one 10 myself and they sent me to some. 11 Q. When you first became -- I 12 believe you said you became a medical information 13 associate in 1976; correct? 14 A. Yes. 15 Q. Okay. Were you given any 16 training before you started in that position, 17 regarding that position? 18 A. Before, meaning while I was 19 still at my previous job, not before? 20 Q. When you were transferred from 21 biochemical labs to the medical division, were 22 you given any training related to your position 23 as a medical information administrator? 24 A. Yes. I had -- it was not a Page 72 1 formal class at that point in time, it was daily 2 sessions with the other people doing a similar 3 job, and there was -- it was a smaller group of 4 people that many years ago. So the manager of 5 the department had some involvement as well in 6 training anybody that was new in what was needed 7 and some of the medical information that was 8 needed. 9 Q. Okay. So it was really kind of 10 like hands-on training more than a formal 11 classroom setting? 12 A. It was -- yes, or it was not 13 necessarily hands-on, but simply -- 14 Q. Apprenticeship type? 15 A. Consultation kind of thing, 16 yes. 17 Q. How long did that last, that 18 training period last? 19 A. That's very hard to say. It's 20 obviously an ongoing process, this is not a small 21 thing to learn, so -- but initially it was quite 22 intensive, of course, to get up to speed. You 23 don't really need to learn the entire process to 24 begin. Wherever the drug is in its development Page 73 1 is the part you must learn to do the job. So the 2 training for the rest would be, you know, 3 ongoing, as needed. 4 Q. Were you ever officially 5 assigned to another person within the department 6 to sort of tag along with for a certain period of 7 time to learn your responsibilities or duties? 8 A. Not an official assignment. 9 Q. It would be kind of like as the 10 assignment came up, if you needed help on it they 11 would help you out? 12 A. Or go with this person today to 13 learn that and that person another time to learn 14 something, yes. 15 Q. And that could happen 16 periodically throughout a long period? 17 A. Yes. 18 Q. Were you ever given any formal 19 classes from the time that you became a medical 20 information administrator up until the time that 21 you went to the purchasing division with regards 22 to your position as a medical information 23 administrator? 24 A. Formal like -- Page 74 1 Q. Within the company. 2 A. Classroom setting kind of? 3 Q. Right. 4 A. I don't recall any. 5 Q. Somebody -- I guess you had 6 testified earlier that somebody from personnel 7 approached you about transferring to the 8 purchasing division; is that correct? 9 A. To the best of my recollection, 10 that's how it began, yes. 11 Q. Do you have any reason why they 12 chose you from the medical division to become a 13 member of the purchasing division? 14 A. The fact that I was in medical 15 wasn't related, the job was purchasing scientific 16 equipment for laboratories. So it was related to 17 the fact that I had been in the laboratory ten 18 years, I suppose. 19 Q. Okay. Do you know that for a 20 fact? 21 A. I don't know that for a fact, 22 but it makes sense. 23 Q. Okay. There was still a 24 biochemistry laboratory at the time that you went Page 75 1 to purchasing; correct? 2 A. Meaning where I had come from 3 before? 4 Q. Right. 5 A. Yes, there are lots of 6 biochemistry laboratories. 7 Q. Earlier you said that you 8 believe that Fluoxetine or Prozac is a 9 life-saving drug. Why do you believe that? 10 A. Because patients can endanger 11 their own lives when they're seriously depressed. 12 Q. And you believe that Prozac 13 keeps them from endangering their own lives? 14 A. Yes. 15 Q. Why is it that you believe 16 that, what information do you have that leads you 17 to that conclusion? 18 A. Only the information that it's 19 good for depressed patients. 20 Q. Who told you that it's good for 21 depressed patients? 22 A. Well, the press, if nothing 23 else, it's everywhere. 24 Q. Anybody in the company tell you Page 76 1 that it's good for depressed patients? 2 A. Not specifically walk up and 3 say hey, this is good, no, not like that. 4 Q. Okay. Have you ever talked to 5 anybody in the company about the question of 6 whether or not Prozac could in fact induce 7 suicidal or homicidal behavior? 8 A. Not really. 9 Q. Have you seen things in the 10 press? 11 A. I have seen press releases. 12 Q. You have seen the press 13 releases from Lilly? 14 MS. GOLDMAN: Objection. 15 A. No. In the newspaper, all the 16 stuff in the newspaper. 17 Q. So you've read articles in the 18 paper that say that there's a possibility at 19 least that Prozac can cause suicidal or homicidal 20 behavior? 21 A. I've seen that in the paper. 22 Q. Do you believe those reports? 23 MS. GOLDMAN: Objection to the form. 24 If you want to try to answer it, you can. Page 77 1 A. I don't know. 2 Q. Do you believe the reports that 3 say that Lilly can help save lives, though, don't 4 you? 5 MS. GOLDMAN: Objection to the form. 6 You can answer it. 7 A. Yes. 8 Q. Why is it that you believe 9 those reports and you don't believe the reports 10 that say that it might in fact cause them to kill 11 themself? 12 MS. GOLDMAN: Objection to the form and 13 a mischaracterization of the witness' prior 14 testimony. Would you like to try to again? 15 MS. ZETTLER: I think she can answer 16 that question. 17 MS. GOLDMAN: I don't believe she can, 18 Ms. Zettler, because it contains a 19 mischaracterization. 20 MS. ZETTLER: Where is the 21 mischaracterization? 22 MS. GOLDMAN: We can have the record 23 read back if you like. 24 (THE COURT REPORTER READ BACK THE Page 78 1 REQUESTED TESTIMONY.) 2 MS. GOLDMAN: That's the pending 3 question to which I have imposed an objection. 4 MS. ZETTLER: Let me rephrase it. 5 Q. Why is it that you believe the 6 reports that say that Prozac can help save lives, 7 but you don't know whether or not the reports 8 regarding the possibility that Prozac could 9 actually cause people to kill themself are true 10 or not? 11 MS. GOLDMAN: Objection to the form, 12 you can attempt an answer. 13 A. I believe that the reports that 14 it can save lives are based on scientific 15 research, whereas the individuals that are in the 16 press are simply anecdotal evidence. 17 Q. Have you ever read any medical 18 literature out there regarding Prozac and 19 suicidalities? 20 A. I have not. 21 Q. Have you ever read any of the 22 medical literature that would support your belief 23 that Prozac is a life-saving drug? 24 A. I have read the package insert Page 79 1 information on the drug. 2 Q. Have you read any of the 3 medical literature that's been published by 4 people associated with Lilly? 5 MS. GOLDMAN: Objection to the form. 6 A. Not if you mean like AMA-type 7 publications, I have not read those kinds of 8 things. 9 Q. How about general medical 10 publications like Annals Of Clinical Psychiatry 11 or things of that nature? 12 A. No. 13 Q. Earlier when you were talking 14 with Mr. Green about physicians with Lilly 15 working with outside physicians and setting up 16 protocols, were you referring to the Lilly 17 physicians that -- the Lilly physicians that you 18 were referring to, would they be the clinical 19 research physicians? 20 A. Yes. 21 Q. Did you become a CRA -- I mean 22 did the title of the position change before or 23 after you went to purchasing, if you remember? 24 A. I don't remember when it Page 80 1 changed. 2 Q. When you came back from 3 purchasing to the medical division, either as a 4 CRA or as a medical information administrator, 5 how is it that you got back into that position 6 from purchasing? 7 A. I actively sought to go back 8 because I feel it was more rewarding to be in 9 medical. 10 Q. What kinds of things did you do 11 in purchasing? 12 A. I dealt with outside 13 corporations, you know, instrument companies in 14 buying instruments for laboratories. 15 Q. Okay. What does Melissa 16 Humbert do now? 17 A. I don't know. 18 Q. Is she still with Lilly? 19 A. Yes. 20 Q. Are you familiar with the 21 phrase double-blind study? 22 A. Yes. 23 Q. Can you tell us what a 24 double-blind study is? Page 81 1 A. That's a study in which the 2 medication is not identified as to whether it's 3 an inactive or an active drug, and the physician 4 doing the study is unaware of what he's giving 5 the patients and we -- and the patient is also 6 unaware of what they're receiving. 7 Q. Is it true that when you're 8 conducting a double-blind study that somebody 9 needs to know who is getting the placebo and who 10 is getting the active drug? 11 A. At some point in time it is 12 true. 13 Q. Isn't it true that when the 14 study itself is set up or begun, before the first 15 patient is given either the placebo or the active 16 drug, somebody in effect has to assign either the 17 placebo or the active drug to specific patients 18 so that they can ultimately determine who was on 19 what at what -- what drug or what placebo at what 20 point? 21 MS. GOLDMAN: Objection to the form. 22 You can attempt to answer. 23 A. There's a lot more to that 24 question than it sounds, but in very general Page 82 1 terms, a double-blind study is done with the 2 patients randomly assigned to receive whichever 3 drug is going to be, and that is often, I'm sure 4 not always, but often, a computer generated 5 random list so that nobody knows what any patient 6 will get as you start, it's just a random list. 7 Q. Okay. So assuming you're using 8 a computer, just for the sake of the question, 9 lot numbers are assigned to the various drugs or 10 placebos; correct? 11 A. Not necessarily in the computer 12 program. 13 Q. Okay, but at -- 14 A. Something identifies, you know, 15 this is the one and this is the other. 16 Q. Because when the pills go to 17 the doctors, they look exactly the same, correct, 18 the doctors can't tell by looking at the pills 19 what is a placebo and what is not a placebo, 20 right? 21 A. Right. 22 Q. So somehow it has to be 23 identified and those pills have to be identified 24 as either a placebo or an active drug for Page 83 1 purposes of evaluating later on; correct? 2 A. At some place in that site, 3 they have to be identified, someone has to know 4 what they are. 5 Q. Okay. And, also, a group of 6 patients that are going to be assigned the 7 specific pills, either placebo or non-placebo, 8 are also at some point identified so that they 9 can be matched up with the various groups of 10 pills; correct? 11 A. That didn't sound quite right. 12 It's not planned like here's the patients and 13 here's the pills, it's like Monday morning's 14 patient gets whatever is first on the list, and 15 Monday afternoon's patient gets whatever is 16 second on the list, and the list is random. So 17 nobody putting the patient in has any control 18 over who gets which, you don't look at the 19 patient first and say I would like to give him X, 20 it's not that way. 21 Q. Okay. So -- 22 MS. GOLDMAN: I'm not sure she finished 23 her answer. 24 Q. I'm sorry, go ahead. Page 84 1 A. One thing that frequently is 2 done is if it's an institution, the pharmacy will 3 have control of the drug, and the doctor simply 4 knows that today I'll have this patient, and the 5 pharmacy, you know, I send patient number one to 6 the pharmacy. The pharmacist knows what it is 7 and gives it to the patient, but the physician 8 nor the patient never knows what it was. 9 Q. So in that situation, the 10 pharmacist would have all the groups of pills; 11 correct? 12 A. Yes. 13 Q. And then, say, just for the 14 sake of the question, groups are numbered one, 15 two, three, four, five, okay, and you have 16 patient A, B, C, D, E. The doctor will send 17 patient A to the pharmacy and the pharmacy will 18 say okay, patient A gets group number one. 19 Somewhere, somebody knows what group number one 20 is, right? 21 A. Yes. 22 Q. Who at Eli Lilly or otherwise 23 would know what group number one is? 24 MS. GOLDMAN: Objection to the form. Page 85 1 You can try if you can. 2 A. It's difficult for me to put 3 this in exactly the timeframe of '78 to '79, but 4 in general -- 5 Q. I'm not limiting my question to 6 '78 and '79. 7 A. Okay. In general, there would 8 be -- the one obvious person who knows is the 9 person who generated the computer program, okay. 10 Q. Anybody else? 11 A. It's also -- I'm thinking this 12 over because I'm not sure at what point it gets 13 the identifier that's on it at the site. There 14 must be someone in the clinical trial preparation 15 area, I believe, who would know what it was as 16 well. 17 Q. Without saying, I mean since 18 you've already testified that you don't have any 19 recollection of working with Prozac, I'm going to 20 ask you this generally, okay? You said somebody -- 21 whoever generated the computer program would be 22 the person who ultimately had the information? 23 A. Uh-huh. 24 Q. Is there a certain department Page 86 1 that that person is in? 2 A. It's a department that the 3 computer analysts are in. I can't tell you the 4 exact name, it's something strange. 5 Q. Do you know what the title of 6 such a person would be, would it be a computer 7 analyst? 8 A. It would be a computer analyst, 9 but I'm not sure what title they go by. 10 Q. You also stated that there 11 would be somebody who was in the group that's in 12 fact running the study; is that correct? 13 A. No, not running the study, I 14 mean where the medication was put together. 15 Q. Okay. 16 A. My hesitancy was related to 17 whether the computer program has on it the 18 identifier that they have on it or whether they 19 are unacquainted with the computer. So that's 20 why -- 21 Q. I'm confused. 22 A. That's why I hesitated to say 23 that if you called them from out in the world, 24 would they know what the patient got. I suspect Page 87 1 they need the analyst. 2 Q. So there's somebody within the -- 3 because I think earlier you said that one of your 4 duties as medical information administrator was 5 to help put together the tablets to be sent to 6 the site. 7 A. Right, but that's not related 8 to doing the identifying of it, it's related to 9 designing the packaging. 10 Q. Okay. Who -- but there was 11 somebody that was in the group that was involved 12 with running the study that would have at least 13 access to the information we talked about that 14 the computer analyst would have? 15 MS. GOLDMAN: Objection to the form. 16 A. There always has to be a 17 source, it's done in different ways and I haven't 18 done a double-blind study lately to be sure. But 19 there's always a source of information because if 20 something happens to the patient you must be able 21 to find out what they were taking. And, of 22 course, you must in the end know what every 23 patient took. 24 Q. But that would be somebody that Page 88 1 would be within the group running the clinical 2 trial? 3 A. It's not the ones running the 4 trial, but that's why the analyst is involved, 5 because he's not really managing the trial, he's 6 over here with the computer. 7 Q. Okay. 8 A. That assures that we who deal 9 with the data don't know what -- which kind of 10 patient we're doing. 11 Q. Is there a person within your 12 group that would be able to, under an emergency 13 situation, such as a patient, something happening 14 with a patient, be able to contact the analyst 15 and say -- 16 A. Yes. 17 Q. Who would that person generally 18 be within the group? 19 A. I don't know. 20 Q. Could it be a CRA? 21 A. It could be. 22 Q. Is it somebody that would be 23 assigned depending on the study? 24 A. It could be done any number of Page 89 1 ways. Each group, I'm sure, has their own 2 pathway to get the information. It needs to be 3 controlled, so you don't do that when you 4 shouldn't as well. You can do it when you need 5 to. 6 Q. Okay. Have you done any work 7 with any post-marketing studies on drugs that 8 you've been a CRA on? 9 A. No, I don't think I ever have, 10 I don't recall ever doing a post-marketing. 11 Q. Do you know if it's a practice 12 at Lilly to do post-marketing efficacy and safety 13 studies on drugs? 14 A. I know they do studies after 15 marketing the drug, yes. 16 Q. You just haven't been involved 17 with that? 18 A. I haven't been involved with 19 that. 20 Q. Now I'm not limiting to Prozac, 21 I mean anything. 22 A. No, I haven't done any that I 23 can think of. 24 Q. Would a measurement of an Page 90 1 adverse event be something that would be 2 contained in the protocol? In other words, if 3 you're getting, for instance, the Hamilton D 4 depression scale, to attempt to measure adverse 5 reactions or adverse events, would that be 6 something that would be included in the protocol? 7 A. I would expect it to be part of 8 the structure of the study data that you were 9 collecting. 10 Q. Can you tell me what the term 11 adverse event means? 12 A. Adverse event. There are so 13 many words for things that happen to patients 14 during studies that that's a difficult one. We 15 try not to use the word adverse event on our case 16 records because we don't want to imply that it 17 had to be something the drug did, we're trying to 18 connect everything bad or unexpected that 19 happened to the patient while he took the drug. 20 So in lay terms, adverse event is something bad a 21 drug does to you, but we sort of try to avoid 22 using that too much. Our event page says record 23 of events on it in order to not put on people a 24 thought about it that we don't intend. Page 91 1 Q. So you prefer treatment 2 emergent symptom? 3 A. Treatment emergent symptom is 4 basically something we use when we analyze the 5 data. So once we know everything that happened 6 to the patient, when we analyze it and say, okay, 7 these began after you began the drug. That's 8 when we call it a treatment emergent sign or 9 symptom. 10 Q. Is that pretty general 11 throughout all the drugs you've done studies on? 12 A. Yes, it's -- right, it's become 13 rather standard practice. 14 Q. Okay. How about adverse 15 experience, do you see a difference between the 16 phrase adverse experience as opposed to adverse 17 event? 18 A. Just semantics, I guess, I 19 can't tell you a difference. 20 Q. Okay. Are the case report 21 forms, or clinical report forms sent out to the 22 investigators fairly consistent in form on the 23 ones that you worked on? 24 MS. GOLDMAN: Objection to the form. Page 92 1 A. On a real general basis, they 2 are, they look rather similar at any given time 3 period, although our process changes over time, 4 of course. So if you look at one that's fifteen 5 years old, it probably looks quite different from 6 one today. 7 Q. Why is it that you're familiar 8 with the Hamilton depression scale? 9 A. I was working in the 10 psychopharmacology area back in the '70s. 11 Q. Okay. I believe Mr. Green 12 asked you earlier if you worked with any 13 psychotropic drugs. Had you, at any point into 14 your career, as either a medical information 15 administrator or a CRA, worked with psychotropic 16 drugs? 17 A. He asked me what I worked on 18 since '79. 19 Q. Right. I'm asking now. 20 A. Prior to that, I did work on a 21 psychotropic drug. 22 Q. Just one? 23 A. Yes. 24 Q. And it wasn't Fluoxetine? Page 93 1 A. No. 2 Q. With regard to the information 3 that is gathered at the various investigation 4 sites, I want to talk a little bit about the 5 procedure for doing that and the studies that you 6 worked on. And if you want -- without knowing 7 the name of drug or anything, if you want to use 8 the psychotropic drug that you worked on as an 9 example, that would be fine. It's up to you, you 10 can tell me generally or with regards to that one 11 specific drug. My understanding of how generally 12 the studies work is that the information is 13 gathered at the sites, the individual clinic 14 sites, is that correct, the investigation sites? 15 MS. GOLDMAN: Objection to the form, 16 you can answer. 17 A. Correct. 18 Q. And generally the information 19 is recorded on case report forms; correct? 20 A. Correct. 21 Q. And this includes the recording 22 of raw data, for instance basic vital signs or if 23 you have blood work done, whatever the results of 24 the blood work come in in the raw data form are Page 94 1 recorded on case report forms; correct? 2 A. Correct. 3 Q. What happens to the case report 4 form once the study is completed or that person 5 finishes the study for one reason or another? 6 A. That case report form is sent 7 to Lilly. This is one procedure, okay, one 8 general procedure. It is sent to Lilly and is 9 entered into our medical computer, the data are, 10 and it is checked every which way for possible 11 errors or problems with patients. 12 Q. And one of the CRA's duties is -- 13 when you say it's one procedure, are you just 14 referring to the one psychotropic drug? 15 A. I guess in general terms that 16 is the way that drug was done, but a lot of 17 others have been done that way as well. 18 Q. Okay. Are there any procedures 19 that vary from that general -- I just want to 20 make sure that if we're talking about a 21 generalization here as to how this is handled, 22 that's fine. If there are circumstances where 23 the procedure for getting the information from 24 the site to Lilly is way different, I would like Page 95 1 to know about that, too. 2 MS. GOLDMAN: Objection to the form, 3 you can attempt to answer that. 4 A. There are general procedures 5 that are quite different, yes, where the computer 6 terminal is placed in the investigator's office 7 and he enters the data. It's still checked at 8 Lilly in a rather similar way. 9 Q. Is that something that's a 10 relatively recent occurrence that the computers 11 have been sent to the investigator site? 12 A. Relatively new. 13 Q. Do you know when they enter the 14 stuff on there, is that a pen-based system? In 15 other words, do they have a little laser pen 16 thing that they write in on or -- 17 A. I have no idea. 18 Q. But generally what happens is 19 the CRFs get back to Lilly in some form or 20 another? 21 A. Somewhat. 22 Q. Either a computer or a hard 23 copy. 24 A. Right. Page 96 1 Q. What happens to the raw data 2 that's collected at the individual sites? In 3 other words, say they send out blood work and it 4 comes back and the results are recorded on the 5 CRS, what happens to that raw data that's 6 collected by the investigators? 7 A. That's kept as an official 8 record at the investigator's site to be available 9 for future auditing. 10 Q. Okay. And once you guys get a 11 hold of it -- when I say you guys, I mean the 12 CRAs, are you checking for accuracy? That's 13 already -- all the information has already been 14 entered into the computer; correct? 15 A. Correct, because we use 16 computer means of helping us check. 17 Q. Okay. And who double-checks 18 the accuracy of the information that comes in on 19 the CRF? 20 A. Checks it, at what -- I don't 21 understand the question. 22 Q. What assurances do you have 23 that the raw data that's collected by the 24 investigators is actually the same as what is Page 97 1 reported on the CRF? 2 A. In some cases it's checked 3 in-house, at Lilly, and it's obviously, say, one 4 or the other items is wrong here because they 5 don't agree. That's one way. Personnel who 6 visit the investigative sites and audit to be 7 sure that what they have in their actual own 8 records agrees with what they say. 9 Q. You say in some cases where the 10 raw data is actually checked against the reported 11 information? 12 A. Yes. 13 Q. What cases is that, when does 14 that occur? 15 A. Well, it's an ongoing process 16 that occurs continuously throughout the study as 17 the data is sent in on the sites. 18 Q. So at some point the raw data 19 is sent from the investigator's site to Lilly for 20 verification? 21 A. No, no, field people go to 22 their site. And if they retain a copy of what 23 they sent to us, so it's all right there to be 24 checked. Page 98 1 Q. So you call up the investigator 2 and say double-check the raw data on patient such 3 and such against what was reported on the CRF? 4 A. I do that from in-house, yes, 5 that's a different process from the field check. 6 Q. Okay. And the field check is 7 something that's done from a quality assurance 8 point of view? 9 A. Yes. 10 Q. Earlier you said that you used 11 a computer to help double-check the accuracy of 12 the information on the case report forms? 13 A. Yes. 14 Q. Can you give us an idea in what 15 ways you used the computer to help you do that? 16 A. Okay. Every study, when it's 17 set up, has a set of computer edits designed to 18 look for logic errors in the data. Something as 19 simple as entering the wrong year, entering a lab 20 piece of information that's impossible, or a 21 number of things that can be checked with the 22 computer without thought, you know, and what we 23 have is a list of these possible or probable 24 errors. Page 99 1 Q. Okay. 2 A. And we pursue them. 3 Q. Would that be something like if 4 a measurement of a temperature falls outside of 5 normal range or a probable range? 6 A. Yes. 7 Q. Say they report a hundred and 8 fifty degree temperature as opposed to a hundred 9 and five? 10 A. Uh-huh. 11 Q. What other ways can you use a 12 computer to help double-check for errors? 13 A. That's the main one as far as 14 the initial process. 15 Q. What happens when the computer 16 finds an error such as the one where they record 17 a temperature of a hundred fifty? 18 A. That comes to the CRA and a 19 listing, and the CRA pursues it, calls the site 20 and finds out what it really should be and checks 21 to make sure it was keyed properly from the piece 22 of paper we have. 23 Q. Have you ever heard of the term 24 COSTART? Page 100 1 A. Yes. 2 Q. What's COSTART? 3 A. COSTART is the acronym that I 4 can't say the words for, it's an adverse reaction 5 dictionary. 6 Q. Okay. Is that a dictionary put 7 together by the FDA, to your knowledge? 8 A. I'm not sure who put it 9 together, it's generally used. 10 Q. And that's a computer program, 11 correct, or is there actually a hard copy of it? 12 A. I mean it is put into the 13 computer. There's hard copies of it as well. 14 Q. Have you ever heard the word 15 ELECT? 16 A. Yes. 17 Q. What is ELECT? 18 A. That was the Lilly version of 19 the COSTART dictionary that we used for several 20 years. 21 Q. Do you still use it? 22 A. I don't know for sure. 23 Q. When you say it was the Lilly 24 version of the COSTART, what -- do you know what Page 101 1 the differences were between COSTART and ELECT? 2 A. I know some of the differences, 3 I'm not sure if they're all of them. As we used 4 the dictionary, we -- the dictionary has two sets 5 of terms, a term that will be part of the data 6 analysis, a nice general term, like nausea. It 7 has other terms that map to these general terms 8 simply because you can't analyze data when you 9 have one each of a million things, right, you 10 have to categorize. 11 Q. When you say dictionary, are 12 you talking ELECT or COSTART? 13 A. COSTART -- well, either one of 14 them works in the same way. 15 Q. Okay. I just wanted to make 16 that clear. 17 A. So the classification terms are 18 what you analyze the data based on, this is what 19 generally the world uses it for. There are a 20 whole list of synonym terms for those 21 classification terms to help people consistently 22 choose the same classification term for the same 23 kinds of ailments. And those synonym terms are 24 what we added to in the course of using the Page 102 1 dictionary and trying to help people use it 2 consistently in choosing the proper 3 classification term. So if it's -- if you have a 4 term for something stupid, leg pain, the real 5 term that's going to be on your output that 6 you're going to count how many you had is leg 7 pain, but you might have in the synonym column 8 pain, comma, leg, pain in the right leg, pain in 9 the left leg, pain in the legs. Because being a 10 computer, it can only use the one actual term, 11 but it takes a human being to make that bridge. 12 So many more synonym terms were added to help in 13 using the dictionary consistently in mapping to 14 the right final term. So ELECT, basically, 15 simply has more synonyms, it has the same COSTART 16 terms that come out in your output. 17 Q. So just like COSTART says 18 nausea, and it has like stomachache, upset 19 stomach, things of that nature underneath it, in 20 ELECT you may have added a few more synonyms? 21 A. Yes, just to help with 22 consistency in choosing terms. 23 Q. Okay. So say you have the word 24 nervous, nervousness, you could enter things like Page 103 1 jittery or jumpy or things of that nature? 2 A. Possibly. 3 Q. And would that be something 4 then that the person who is entering the data 5 into the computer would choose? In other words, 6 they would look up the word jittery and see where 7 it fell into this column and then use nervousness 8 or is that something where they could enter 9 jittery and it shows up as nervous? 10 A. Actually both terms are entered 11 into the data base, both the real term -- 12 whatever the investigator described, as well as 13 of the mapping term, so both. 14 Q. So if I -- under the ELECT, say 15 you have nervousness and jittery is one of those 16 synonyms, they put in jittery -- it's going to 17 turn up jittery and nervous? 18 A. No, it's two separate data 19 fields because when you use a dictionary, you 20 also don't want to lose the actual real 21 description of what exactly happened, okay, but 22 you have to map it to categories of terms just so 23 you can analyze data. So we have retain both in 24 our data base. Page 104 1 Q. For analysis purposes, during -- 2 I'm just asking examples, jittery might be 3 categorized as nervous? 4 A. It might be, I have no idea if 5 it is. And that allows you to analyze your data 6 ultimately when someone else wrote very jittery 7 in the field, and you count that as one, it's two 8 jitteries that map to nervousness. 9 Q. Okay. Do you know who it was 10 that added the synonyms to the ELECT program? 11 A. Those were done over the years 12 based on what the investigative sites sent us. 13 But who physically put them in the computer, I 14 haven't the faintest idea. 15 Q. Did anybody ever contact any of 16 the investigators and say well, in your opinion 17 this person is jittery, but could you say that 18 they're anxious or nervous? 19 A. Sometimes that's part of the 20 cleaning process. The jittery, if that's what he 21 wrote, obviously is correct. But the question is 22 is this a proper mapping if he wrote jittery -- 23 because this dictionary is at the investigative 24 site and they're choosing the proper mapping. Page 105 1 But of course, as in anything else, it's 2 occasionally incorrect. So that's the only time 3 we would be talking about mapping of that term. 4 Q. Okay. Now I'm confused. At 5 the investigation -- let me see if I understand 6 what you're saying. At the investigation site, 7 they have a copy of the dictionary? 8 A. Yes. 9 Q. They have -- let's use nervous 10 again as an example. So say you have the 11 category of nervous, nervousness, and underneath 12 it says jittery, restless, jumpy, hyperactive, 13 whatever, underneath the possible synonyms that 14 they would use, the investigator has a patient 15 who comes in and says, you know, I'm just really 16 feeling jumpy today, and he writes down on the 17 case report form or whatever he's using to 18 collect that sort of data, hyperactive. Okay, 19 does he then, when reporting it on the case 20 report form, refer to the dictionary to see what 21 categories that's placed under? 22 A. He writes both, he writes the 23 real term and he looks at the dictionary and 24 writes what it maps to. Page 106 1 Q. Okay. This is on a hard copy 2 form, he has an actual hard copy dictionary? 3 A. Yes. If he's doing a paper 4 study now as opposed to the computer, and I'm not 5 sure how they do that. 6 Q. Does he have a copy of both 7 COSTART and ELECT or ELECT? 8 A. That depends on the study 9 because we were using ELECT for a certain number 10 of years and then we went to pure COSTART, so 11 there's not really an answer, it's whichever that 12 study is doing -- the study can't afford to 13 change, so it's whatever that study is operating 14 under. 15 Q. But if at the time you were 16 using ELECT during a particular study, they would 17 have a copy of ELECT and not necessarily COSTART 18 also? 19 A. Right, yes, they would 20 presumably have only the one or other. 21 Q. Do you know when they went from 22 using the straight COSTART to ELECT? 23 A. Well, it was the other way 24 around, in fact, but I don't know the dates. We Page 107 1 used the ELECT first and COSTART after. 2 Q. Okay. Wasn't ELECT based on 3 COSTART, though? 4 A. Yes. It's sort of like 5 semantics, you're almost not talking about a 6 change, you know. There are categories -- when 7 you get these terms out in tables and look at 8 your data, they're categorized by body systems, 9 and there are some differences in the 10 categorizations, too, I believe. 11 Q. Give me one second, I think I 12 only have a couple more. Did you ever have any 13 involvement with the final reports written based 14 on studies that you worked on? 15 A. Any studies? 16 Q. Any studies, yes. 17 A. Yes. 18 Q. Okay. What kind of involvement 19 did you have in that, just generally? 20 A. Generally helped to write the 21 final reports. 22 Q. Do you know what an AB form is, 23 ever heard that term before? 24 A. I've heard it, but I don't know Page 108 1 what it is. 2 Q. Okay. Have you ever been 3 involved in writing package inserts for any 4 drugs? 5 A. Yes. For any drug, only helped 6 in trying to get the list of adverse reactions 7 from a study that we put in there. 8 Q. Is it important in a final 9 report to list all negative reactions or 10 reactions to a particular drug in the final 11 report? 12 MS. GOLDMAN: Objection to the form, 13 you can answer. 14 A. Yes, it's very important. 15 Q. Can you think of any reason why 16 that might not be done in any given report? 17 MS. GOLDMAN: Objection to the form. 18 A. Well, there probably are a lot 19 of reasons that it might not, data errors are 20 always possible, but I can't think of any reason 21 that you would choose not to put something 22 negative in the final report. 23 Q. Okay. As far as reports of 24 treatment emergent events, let's take it that Page 109 1 way. As far as treatment emergent events are 2 concerned, would it be the practice on the 3 reports that you worked on to include every 4 treatment emergent event or only those events 5 reported by a certain percentage of people? 6 A. In the final report, I would 7 expect to put every treatment emergent event in. 8 Q. When I say final report, I mean 9 reports that may or may not be submitted to the 10 FDA that are prepared for submission. 11 A. Prepare for submission, right. 12 Q. Have you ever heard the term 13 pivotal study? 14 A. Yes. 15 Q. Can you tell us what that 16 means? 17 A. It's generally one of the 18 studies that we expect the FDA to base their 19 decision about approval of the drug on, it's part 20 of the FDA regulations that say you must have, I 21 think it's two, pivotal studies. They leave kind 22 of -- I don't think it's terribly clearly defined 23 what exactly that is, but. 24 Q. Okay. Is it your understanding Page 110 1 that the pivotal study -- the FDA requires that a 2 study is double-blinded? 3 A. I don't believe that is the 4 case in every drug. 5 Q. There are certain circumstances 6 when they may require that? 7 A. There probably are some that 8 may require that. 9 Q. Is it left up to the discretion 10 of the manufacturer to choose which studies are 11 pivotal and which are not? 12 A. I don't know how they choose. 13 Q. You said earlier that there has 14 to be at least two studies that are pivotal? 15 A. I believe that's in the FDA 16 regulations. 17 Q. So you may do fifty or sixty 18 studies on a drug, but may only submit two 19 reports? 20 MS. GOLDMAN: Objection to the form of 21 that question. 22 A. Many studies are submitted that 23 are not pivotal. Pivotal is only like the 24 flagship, there are a lot of other studies and Page 111 1 applications. 2 Q. And is that under the 3 requirements set up by the FDA? 4 MS. GOLDMAN: Objection. 5 A. I don't exactly know the 6 requirement as far as that goes. 7 Q. Have you ever heard of the name 8 Doctor Jan Fossett? 9 A. I don't think so. 10 Q. Earlier you testified that you 11 didn't know whether or not Dr. Zerbe worked on 12 Prozac, but are you familiar with Dr. Zerbe? 13 A. I've known him since that 14 timeframe. 15 Q. Okay. And what does Dr. Zerbe 16 do at Lilly, if anything, at this point? 17 MS. GOLDMAN: Objection to the form. 18 A. I don't know where he is now. 19 MS. ZETTLER: I believe that's all I 20 have. 21 * * * * * * * * * * 22 CROSS EXAMINATION 23 BY MR. CLEMENTI: 24 Q. Have you had any contact with Page 112 1 the doctors who actually prescribed Prozac? This 2 is not doctors within Eli Lilly or through the 3 studies, just outside. 4 A. Outside, yes. 5 Q. What was your contact with 6 those doctors, what were they contacted about? 7 MS. GOLDMAN: Object to the form. 8 A. My doctors -- my mother's 9 doctor, she's in a nursing home, prescribed 10 Prozac for her. 11 Q. Is that the only instance that 12 you have of speaking with doctors who prescribed 13 Prozac outside of the Lilly study? 14 MS. GOLDMAN: Objection to the form. 15 A. That's the only one I can 16 recall. 17 Q. Do you know why your mother was 18 prescribed Prozac? 19 A. She was depressed. 20 Q. Is your mother alive today? 21 A. Yes. 22 MR. CLEMENTI: That's all the questions 23 I have. 24 * * * * * * * * * * Page 113 1 RECROSS EXAMINATION 2 BY MS. ZETTLER: 3 Q. Did your mother ever try to 4 take her life prior to putting her on Prozac? 5 MS. GOLDMAN: Objection to the form. 6 A. No. 7 Q. How is she doing on the drug 8 now? 9 MS. GOLDMAN: Objection. You can 10 answer if you like. 11 A. Sure. She improved 12 substantially on it. 13 MS. ZETTLER: That's all I have. 14 MR. GREEN: No further questions. 15 MR. CLEMENTI: No further questions. 16 MS. GOLDMAN: No questions. 17 MR. OLTMAN: No questions. 18 MR. BRODSKY: No questions. 19 MS. CLEMENS: No questions. 20 MS. LAWS: No questions. 21 MR. RUIZ: No questions. 22 MR. McCULLY: No questions. 23 (THE WITNESS WAS EXCUSED.) Page 114 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 JEAN A. ALLAN 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 9TH DAY OF 19 JULY, 1993. 20 MY COMMISSION EXPIRES MARCH 10, 1994. 21 22 23 _________________________ MARY KATHLEEN NOLD 24 COURT REPORTER AND NOTARY PUBLIC STATE OF KENTUCKY AT LARGE Page 115 1 E R R A T A S H E E T 2 3 STATE OF ) : SS 4 COUNTY OF ) 5 6 I, JEAN A. ALLAN, 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 17TH DAY OF JUNE, 1993 AT THE TIME AND PLACE 12 STATED THEREIN. 13 PAGE NO. LINE NO. CHANGE REASON Page 116 1 2 PAGE NO. LINE NO. CHANGE REASON 3 4 5 6 7 8 9 _____________________________ 10 JEAN A. ALLAN 11 SWORN TO AND SUBSCRIBED BEFORE ME THIS 12 _____ DAY OF __________, 1993. 13 _____________________________ NOTARY PUBLIC, STATE OF 14 AT LARGE Page 117 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Page 119 1 DIRECT EXAMINATIONBY MR. GREEN:....................1 2 CROSS EXAMINATIONBY MS. ZETTLER:...................48 3 CROSS EXAMINATIONBY MR. CLEMENTI:.................83 4 RECROSS EXAMINATIONBY MS. ZETTLER:.................84 5 COMMONWEALTH......................................86 6 PLAINTIFF'S EXHIBIT NO. 1..........................9 7 PLAINTIFF'S EXHIBIT NO. 2.........................12 8 PLAINTIFF'S EXHIBIT NO. 3.........................45 9 10 11 12 13 14 15 16 17 18 Page 120 1 COMES JEAN A. ALLAN,..............................14 2 DIRECT EXAMINATIONBY MR. GREEN:...................14 3 CROSS EXAMINATIONBY MS. ZETTLER:..................70 4 CROSS EXAMINATIONBY MR. CLEMENTI:................112 5 RECROSS EXAMINATIONBY MS. ZETTLER:...............114 6 E R R A T A......................................116 7 COMMONWEALTH.....................................115 8 PLAINTIFF'S EXHIBIT NO. 1.........................23 9 PLAINTIFF'S EXHIBIT NO. 2.........................28 10 PLAINTIFF'S EXHIBIT NO. 3.........................67 11 12 13 14 15 16 17 18 Page 121