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: JEFFREY B. POWELL 12 DATE: AUGUST 9, 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 23 Page 5 1 * * * * * * * * * * 2 ---------------------------------X 3 VALARIE J. FRIEDMAN AND DAVID : SUPERIOR COURT FRIEDMAN, HER HUSBAND, : OF NEW JERSEY 4 : LAW DIVISION: PLAINTIFF, : MIDDLESEX COUNTY 5 : DOCKET NO. : L-3191-91 6 VS. : : 7 ELI LILLY & COMPANY; DISTA : PRODUCTS INC, A DIVISION OF : 8 ELI LILLY & COMPANY; LISS : PHARMACY; MADISON PHARMACY AND : 9 JOHN DOES NOS. 1-25 (UNKNOWN : ENTITIES), : 10 : DEFENDANTS. : 11 ---------------------------------X 12 * * * * * * * * * * 13 SUPREME COURT OF THE STAET OF NEW YORK COUNTY OF SUFFOLK 14 -------------------------------------x 15 RHOMDA L. HALA and JOSEPH L. HALA, : 16 Plaintiffs, : Index No. 14869/90 17 - against - : 18 ELI LILLY & COMPANY and DISTA : PRODUCTS COMPANY, a DIVISION OF 19 ELI LILLY & COMPANY : 20 Defendants. : -------------------------------------x Page 6 1 * * * * * * * * * * 2 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 3 COUNTY DEPARTMENT, LAW DIVISION 4 PATRICIA BRACH, ) ) 5 Plaintiff ) ) 6 v. )No. 92 L 13369 ) 7 ELI LILLY AND COMPANY, a foreign ) corporation; ALAN N. MILLER, M.D., ) 8 WILLIAM BRUINSMA, Psy.D., and ) CONDELL MEMORIAL HOSPITAL, ) 9 ) Defendants. ) 10 * * * * * * * * * * 11 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 12 COUNTY DEPARTMENT - LAW DIVISION 13 RENATO DI SILVESTRO, Individually ) and as Special Administrator of ) 14 the Estate of JOHN DI SILVESTRO, ) Deceased, ) 15 ) Plaintiff, ) 16 ) v. ) No. 91 L 7881 17 ) ROBERT L. NELSON, et al., ) 18 ) Defendants, ) 19 ) GEORGE MELNICK, M.D. and PETER ) 20 FINK, M.D. ) ) 21 Respondents in Discovery.) * * * * * * * * * * Page 7 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 JOAN M. GRYER, ) ) 4 Plaintiff, ) ) 5 v. ) No. 92 L 7387 ) 6 ELI LILLY AND COMPANY, et al., ) ) 7 Defendants. ) 8 * * * * * * * * * * 9 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 10 COUNTY DEPARTMENT, LAW DIVISION 11 JENNIFER HAMMERLI, as Plenary ) Guardian of the Estate of RAY B. ) 12 HAMMERLI, a disabled person, ) ) 13 Plaintiff, ) ) 14 v. ) No. 92 L 2365 ) 15 ELI LILLY AND COMPANY, THE ) UPJOHN COMPANY, DICKIE KAY, M.D., ) 16 (former Respondent in Discovery), ) and RICHARD CZECHOWICZ (former ) 17 Respondent in Discovery), ) ) 18 Defendants. ) 19 * * * * * * * * * * Page 8 1 IN THE CIRCUIT COURT OF THE SIXTH JUDICIAL CIRCUIT 2 CHAMPAIGN COUNTY, ILLINOIS 3 LINDA GARDNER, Individually and ) as Special Administrator of ) 4 the Estate of SHANE GARDNER, ) deceased, ) 5 ) Plaintiff, ) 6 ) v. ) No. 91 L 1066 7 ) ELI LILLY AND COMPANY, a foreign ) 8 corporation, ) ) 9 Defendant. ) 10 * * * * * * * * * * 11 IN THE NINETEENTH JUDICIAL CIRCUIT COURT 12 LAKE COUNTY, ILLINOIS 13 JAMES E. SHEPPARD, Special ) Administrator of the Estate of ) 14 KENNETH K. SHEPPARD, Deceased, ) ) 15 Plaintiff ) ) 16 v. ) No. 93 L 124 ) 17 GOOD SHEPHERD HOSPITAL, a ) corporation, DR. STEWART SEGAL, ) 18 DR. SANFORD SHERMAN, DR. BRUCE ) CARLSON, DR. R. BERGLUND, and ELI ) 19 LILLY & COMPANY, a corporation, ) ) 20 Defendants. ) 21 * * * * * * * * * * Page 9 1 SUPERIOR COURT OF THE STATE OF CALIFORNIA 2 FOR THE COUNTY OF LOS ANGELES 3 DR. MARIUS SAINES, etc., et al., ) Case No: 4 ) SC 008331 Plaintiffs, ) 5 ) vs. ) 6 ) ELI LILLY & COMPANY, a corporation; ) 7 DISTA PRODUCTS COMPANY, a division ) of Eli Lilly & Company; and DOBS 1- ) 8 100, inclusive, ) ) 9 Defendants. ) ____________________________________) 10 11 * * * * * * * * * * 12 Page 10 1 I N D E X 2 JEFFREY B. POWELL 3 4 5 DIRECT EXAMINATION BY MS. ZETTLER 15 6 CROSS EXAMINATIONBY MR. CLEMENTI 361 7 REDIRECT EXAMINATIONBY MS. ZETTLER 364 8 9 COMMONWEALTH 368 10 ERRATA 369 11 12 EXHIBITS 13 PLAINTIFFS' EXHIBIT NO. 1 91 PLAINTIFFS' EXHIBIT NO. 29 105 14 PLAINTIFFS' EXHIBIT NO. 2 120 PLAINTIFFS' EXHIBIT NO. 10 125 15 PLAINTIFFS' EXHIBIT NO. 9 126 PLAINTIFFS' EXHIBIT NO. 12 134 16 PLAINTIFFS' EXHIBIT NO. 30 140 PLAINTIFFS' EXHIBIT NO. 31 152 17 PLAINTIFFS' EXHIBIT NO. 14 175 PLAINTIFFS' EXHIBIT NO. 26 182 18 PLAINTIFFS' EXHIBIT NO. 19 201 PLAINTIFFS' EXHIBIT NO. 32 210 19 PLAINTIFFS' EXHIBIT NO. 32 219 PLAINTIFFS' EXHIBIT NO. 35 221 20 PLAINTIFFS' EXHIBIT NO. 36 224 PLAINTIFFS' EXHIBIT NO. 38 247 21 PLAINTIFFS' EXHIBIT NO. 21 256 PLAINTIFFS' EXHIBIT NO. 27 267 22 PLAINTIFFS' EXHIBIT NO. 22 273 PLAINTIFFS' EXHIBIT NO. 3 275 23 PLAINTIFFS' EXHIBIT NO. 4 279 PLAINTIFFS' EXHIBIT NO. 5 287 24 PLAINTIFFS' EXHIBIT NO. 6 291 PLAINTIFFS' EXHIBITS 39 AND 40 295 Page 11 1 PLAINTIFFS' EXHIBIT NO. 15 301 2 PLAINTIFFS' EXHIBIT NO. 41 317 PLAINTIFFS' EXHIBIT NO. 42 322 3 PLAINTIFFS' EXHIBIT NO. 43 329 PLAINTIFFS' EXHIBIT NO. 44 330 4 PLAINTIFFS' EXHIBIT NO. 45 336 PLAINTIFFS' EXHIBIT NO. 46 339 5 PLAINTIFFS' EXHIBIT NO. 47 351 PLAINTIFFS' EXHIBIT NO. 48 355 6 Page 12 1 THE DEPOSITION OF JEFFREY B. POWELL TAKEN 2 AT THE OFFICE OF BAKER & DANIELS, 300 NORTH 3 MERIDIAN STREET, SUITE 2700, INDIANAPOLIS, 4 INDIANA 46204, ON AUGUST 9, 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 NANCY ZETTLER COUNSEL FOR GROUP A PLAINTIFFS 11 LEONARD M. RING AND ASSOCIATES, P.C. 111 WEST WASHINGTON AVENUE, SUITE 1333 12 CHICAGO, ILLINOIS 60602 13 LAWRENCE J. MYERS COUNSEL FOR ELI LILLY AND COMPANY 14 FREEMAN & HAWKINS 4000 ONE PEACHTREE CENTER 15 303 PEACHTREE STREET, N.E. ATLANTA, GEORGIA 30308-3243 16 CURTIS OLTMAN 17 ELI LILLY AND COMPANY LILLY CORPORATE CENTER 18 INDIANAPOLIS, INDIANA 46285 MICHAEL D. KRAUSE 19 COUNSEL FOR GOOD SHEPHERD HOSPITAL 415 WASHINGTON STREET, SUITE 214 20 WAUKEGAN, ILLINOIS 21 MIGUEL A. RUIZ COUNSEL FOR DEFENDANT BRUINSMA 22 CLAUSEN MILLER GORMAN CAFFREY & WITOUS 10 SOUTH LASALLE 23 CHICAGO, ILLINOIS 60603 Page 13 1 PAUL J. CLEMENTI 2 COUNSEL FOR DR. DICKIE KAY HINSHAW & CULBERTSON 3 222 NORTH LA SALLE STREET, SUITE 300 CHICAGO, ILLINOIS 60601-1081 4 KATHERINE L. LAWS 5 COUNSEL FOR DRS. WITSCHY AND KANNEGANTI BAILEY AND WILLIAMS 6 3500 NCNB PLAZA 901 MAIN STREET 7 DALLAS, TEXAS 75202-3714 Page 14 1 2 COMES JEFFREY B. POWELL, CALLED BY THE 3 PLAINTIFFS, AND AFTER FIRST BEING DULY SWORN, WAS 4 DEPOSED AND TESTIFIED AS FOLLOWS: 5 DIRECT EXAMINATION 6 BY MS. ZETTLER: 7 Q. Mister Powell, could you state 8 your full name for the record and spell your last 9 name? 10 A. Jeffrey B. -- Bryan Powell, 11 P-O-W-E-L-L. 12 MS. ZETTLER: Let the record reflect 13 that this is a discovery deposition of Jeffrey 14 B. Powell taken pursuant to the applicable laws 15 of the State of Kentucky in Fentress versus Shea 16 Communications. 17 MR. MYERS: Just for the record, the 18 deposition has also been cross-noticed by Lilly 19 in the MDL proceedings in a number of related 20 state court cases. What do you want to do about 21 the objections since we have our friends from 22 Texas here, form of question and responsiveness 23 of the answer? 24 MS. ZETTLER: If you want to continue Page 15 1 objections as to the form of the questions and 2 responsiveness of the answer before any other 3 objections. 4 MR. MYERS: Right, I think we did form 5 of the question and responsiveness of the answer. 6 MS. LAWS: And the objections of one is 7 good as to all and then we don't all have to 8 object. 9 MS. ZETTLER: That's fine. 10 MR. MYERS: That's fine. 11 Q. (BY MS. ZETTLER) Mister 12 Powell, have you ever given a deposition before? 13 A. No, I have not. 14 Q. I introduced myself earlier, my 15 name is Nancy Zettler and I represent a number of 16 plaintiffs in the Fentress versus Shea 17 Communications case. As you may or may not know, 18 that is the case involved around the shootings at 19 Standard Gravure in Louisville, Kentucky, back in 20 September of '89. Are you familiar with that 21 litigation -- Joseph Wesbecker? 22 A. Wesbecker case, I've heard of 23 that, yes. 24 Q. Let me give you some ground Page 16 1 rules before we get started so that everything is 2 clear. First of all, you have to answer out 3 loud. She can't take down movements of the head 4 and uh-huhs and things of that nature. 5 A. Okay, you'll remind me or 6 somebody will remind me. 7 Q. We will. And also I will do my 8 best to allow you to finish your answer but I 9 also ask that you do your best to allow me to 10 finish the question. Sometimes in a coversation 11 it's normal for people to anticipate what a 12 question or answer is going to be, so we have to 13 do our best for the court reporter's sake to try 14 and keep the questions and answers separated. Is 15 that okay? 16 A. Yes, that's okay. 17 Q. And if at any time you need a 18 break, just let me or Larry or anybody else know 19 and we'll take a break for whatever reason as 20 often as you want. Is that okay? 21 A. Yes, that would be fine. Do we 22 break routinely or just whenever the group is 23 ready? 24 Q. We'll break for lunch but if Page 17 1 you need a break in the meantime, just ask and 2 we'll take one. 3 MR. MYERS: We'll take a break this 4 morning, too. 5 Q. Also if you don't understand my 6 question, or hear my question, or for any reason 7 don't know what I am asking you, please let me 8 know, okay? 9 A. Yes, I will. 10 Q. If you answer the question, we 11 are going to assume that you understood the 12 question as it was asked. 13 A. Yes. 14 Q. All of my questions today are 15 going to be regarding the compound Fluoxetine 16 Hydrochloride and I am not limiting that compound 17 to indicated use of depression, is that 18 understood? 19 A. Yes, it is. 20 MR. MYERS: He may understand that, but 21 where indicated we may or may not have to assert 22 some objections. I understand what you're trying 23 to get at to move the thing along, but we'll just 24 take that as the questions come up. Page 18 1 Q. Unless your counsel objects or 2 you state otherwise, we're going to assume you're 3 answering any question I ask you about Fluoxetine 4 Hydrochloride or Prozac, quote unquote, with 5 regards to any indicated use whatsoever, is that 6 okay? 7 A. Yes. The only indicated use 8 that I'm aware of is for depression. 9 Q. Are you aware that the FDA has 10 recently given preliminary approval for 11 Fluoxetine Hydrochloride for the use of 12 obsessive-compulsive disorder? 13 MR. MYERS: Let me object to the form 14 of the question in that the use of the term 15 preliminary approval is vague and ambiguous and I 16 believe that notwithstanding the question, the 17 facts will belie your representation that there's 18 been any approval given for the use in 19 obsessive-compulsive disorder or any other 20 indication. 21 Q. Are you aware of any recent 22 occurrence with regards to Fluoxetine 23 Hydrochloride and the use -- and its use in 24 obsessive-compulsive disorder by any regulatory Page 19 1 entity whatsoever, recently? 2 A. Am I aware of what again? 3 Q. Are you aware of any regulatory 4 action regarding the use of Fluoxetine 5 Hydrochloride in treatment of 6 obsessive-compulsive disorder? 7 A. There was a recent FDA Advisory 8 Committee meeting concerning that. 9 Q. Okay, and at that Advisory 10 Committee Meeting did the advisory panel give 11 preliminary approval to the use of Fluoxetine 12 Hydrochloride -- 13 MS. ZETTLER: First of all, I'm going 14 to object to you prompting the witness by shaking 15 your head no indicating what kind of answer he 16 should give. 17 MR. MYERS: He's not prompting him. I 18 think what he's doing is indicating that he might 19 give me an opportunity to make an objection to 20 your question so that we're not all talking at 21 once. 22 MS. ZETTLER: So, in other words, he's 23 prompting you, Larry. 24 MR. MYERS: I need all the help I can Page 20 1 get. 2 MS. ZETTLER: I object to any hand 3 signals, head signals or otherwise given to 4 defense counsel in the presence of this witness 5 and we will let the record indicate that that has 6 occurred at least in a couple of occasions so far 7 early on in this deposition. 8 MR. MYERS: Well, I object to the 9 extent there's a question, I again object to the 10 form and the use of the term preliminary 11 approval. 12 Ms. ZETTLER: Could you read back my 13 question? 14 (THE COURT REPORTER READ BACK THE 15 REQUESTED TESTIMONY.) 16 MR. MYERS: Is that the question? 17 MS. ZETTLER: I didn't finish it 18 because I was objecting to the prompting of the 19 witness and co-counsel. 20 Q. (BY MS. ZETTLER) Did that 21 advisory panel give a preliminary approval for 22 the use of Fluoxetine Hydrochloride in the 23 treatment of obsessive-compulsive disorder? 24 MR. MYERS: Same objection. If you can Page 21 1 answer it, go ahead. 2 A. I'm not aware of the outcome of 3 the meeting. I heard that the meeting went well 4 from the Lilly side of things, but I'm not 5 involved in Fluoxetine at this time. I don't 6 work with the compound directly so I'm not aware 7 of what's going on with it. 8 Q. Did you see anything in the 9 print or television media or radio media on the 10 approval of Fluoxetine for use in 11 obsessive-compulsive disorder? 12 MR. MYERS: Same objection. 13 A. Not that I recall. 14 Q. Who told you that the meeting, 15 quote unquote, went well? 16 A. I don't recall. 17 Q. Was it somebody at Lilly? 18 A. Yes. 19 Q. Can you -- what is your date of 20 birth, Mister Powell? 21 A. December 15, 1952. 22 Q. What is your correct address? 23 A. XXXXXXXXXXXXXXXXXXXXXXXXX 24 XXXXXXXXXXXX. Page 22 1 Q. And your social security 2 number? 3 A. XXXXXXXXXXX. 4 Q. And starting with after you 5 graduated from high school, can you give us your 6 educational background? 7 A. I attended Butler University 8 and majored in pharmacy, graduated with a BS in 9 1976. I then worked on my masters in pharmacy 10 part-time over the next several years and 11 obtained that early in -- sometime early in the 12 1980s, it was a masters in pharmacy. 13 Q. Was that also at Butler? 14 A. Yes. 15 Q. Sorry, go ahead. 16 A. That's the extent of mine. 17 Q. Right, you now currently hold a 18 masters in pharmacy? 19 A. Correct. 20 Q. Are you a pharmacologist? 21 A. No, I'm not. 22 Q. What does a masters in pharmacy 23 entail? 24 A. It was primarily pharmacy Page 23 1 administration type classes as well as a few 2 clinical -- clinically oriented classes. 3 Q. You said it was early '80s when 4 you achieved your masters, do you remember what 5 year that was? 6 A. I don't recall exactly, no. 7 Q. Have you taken any other 8 graduate level classes that would be applicable 9 to your masters in pharmacy? 10 A. No, I have not. 11 Q. Have you taken any classes, 12 seminars, symposiums that would be applicable to 13 your position at Eli Lilly at any time? 14 A. Outside seminars, we have 15 training classes and that type of thing at Lilly, 16 but I don't recall any specific -- I have 17 attended various seminars, I guess, but I don't 18 recall when or what they were about specifically. 19 Q. Can you give me a general idea 20 what the seminars you attended were about? 21 A. Most recent would have been 22 dealing with cognitive impairment in the elderly. 23 Q. Where did you take that 24 seminar? Page 24 1 A. It was in Georgetown, 2 Washington, D.C. 3 Q. Is that a seminar that Lilly 4 sent you to? 5 A. Yes, it was. 6 Q. When did you take that seminar? 7 A. It was last fall, September or 8 October. 9 Q. Any other seminars that you can 10 think of that Lilly has sent you to? 11 A. I remember going to San 12 Francisco one time for the American Society of 13 Hospital Pharmacists meeting. 14 Q. Did you go there as a 15 participant or as a speaker? 16 A. Participant. 17 Q. Are you a member of that 18 society? 19 A. Yes, I am. 20 Q. Are you a member of any other 21 societies? 22 A. No. 23 Q. Associations? 24 A. No, I'm not. Page 25 1 Q. Did Lilly ever send you to any 2 seminars related to the reporting of adverse 3 events? 4 A. I went to a Drug Information 5 Association meeting that I'm not sure what the 6 primary emphasis of the meeting was, but there 7 were sessions concerning adverse event reporting. 8 Q. Can you tell me when you went 9 to that meeting? 10 A. No, I could not. 11 Q. Can you give me an idea of a 12 year? 13 A. It was while -- sometime 14 between 1986 and '90. 15 Q. When did you begin working for 16 Lilly? 17 A. In August of 1986. 18 Q. And have you worked for Lilly 19 continuously since that date? 20 A. Yes, I have. 21 Q. Did you ever work for Dista 22 Products Company? 23 A. No, I have not. 24 Q. What is your understanding of Page 26 1 what Dista Products Company is? 2 A. It's a division of Lilly that 3 promotes and manufactures certain products. 4 Q. Is Prozac or Fluoxetine 5 Hydrochloride one of those products? 6 A. I'm not sure that it is now but 7 it was at one time. 8 Q. When you say promotes the 9 product, what do you mean? 10 A. Actually market the compound. 11 Q. Is it your understanding that 12 at one time Dista Products Company marketed 13 Prozac? 14 A. Yes. 15 Q. Can you tell me when that was? 16 A. I don't have specific dates, 17 no. 18 Q. Can you tell me generally? 19 A. I believe it was first approved 20 in late 1988, so I assume starting in 1989. 21 Q. Is it your understanding that 22 Fluoxetine Hydrochloride was approved for the use 23 of treating depression in late 1988? 24 A. I believe that is correct, I Page 27 1 don't recall exactly when. 2 Q. And a short time after it was 3 approved by the FDA, Dista began marketing it? 4 A. I do not know that for a fact, 5 I'm under that assumption. 6 Q. Can you tell me generally what 7 employment you held between the time that you 8 graduated with a BS from Butler University in 9 1976 until August of '86 when you started working 10 for Lilly? 11 A. I worked as a hospital 12 pharmacist, I was primarily at Saint Vincent 13 Hospital. 14 Q. Is that here in Indianapolis? 15 A. Yes, it is. 16 Q. And generally when did you work 17 for Saint Vincent? 18 A. Probably starting in 1977 until 19 my time of employment at Lilly. 20 Q. Was that your only job during 21 that time period? 22 A. I worked part-time for a home 23 health care agency for a brief period. 24 Q. Do you remember the name of Page 28 1 that agency? 2 A. I don't recall. They changed 3 their name while I was there so I'm not sure what 4 it was when I started or ended. 5 Q. What did you do for the home 6 health care agency? 7 A. Prepared IV solutions, home 8 hyperalimentations, feeding solutions and some 9 antibiotics. 10 Q. What did you do between the 11 time you graduated in 1976 and when you started 12 working at Saint Vincents in 1977? 13 A. I was a hospital pharmacist at 14 University Hospital in Indianapolis. 15 Q. I'm sorry, hospital pharmacist, 16 University of Indianapolis Hospital? 17 A. At University Hospital was the 18 name of the hospital in Indianapolis. 19 Q. Why did you leave the 20 University Hospital? 21 A. I had done my externship at 22 Saint Vincent Hospital and I thought it was a 23 nicer facility for employment, more 24 professionally oriented. Page 29 1 Q. Did you leave University 2 Hospital on good terms? 3 A. Yes, I did. 4 Q. Why did you leave Saint 5 Vincent? 6 A. To work for a company where 7 there would be more opportunities, you know, more -- 8 the ability to change jobs and just do a variety 9 of different things. 10 Q. That company would be Lilly, 11 right? 12 A. Yes. 13 Q. Was the decision -- your 14 decision to leave Saint Vincent made before you 15 were hired by Lilly? 16 A. No, it was not. 17 Q. Okay. How is it that you came 18 to work for Lilly? 19 A. I had a friend who worked in -- 20 I'm not sure what area at the time but she said 21 there was an opening in her department at that 22 time and I applied, that probably was a year or 23 two before I was actually hired and apparently my 24 application was kept on record and Lilly later Page 30 1 contacted me about a position that was really 2 better fit. 3 Q. What was your friend's name? 4 A. It was Joannie Ragazonni. 5 Q. Could you spell that please? 6 A. No. R-A-G -- I'm not sure, 7 A-Z-O-N-N-I. She's changed her name since then. 8 Q. What's her current name? 9 A. Joannie Gore. 10 Q. As in Al? 11 A. Pardon me? 12 Q. As in Al Gore, G-O-R-E? 13 A. G-O-R-E, yes. 14 Q. So you first applied for work 15 at Lilly sometime as early as 1975 -- I'm sorry, 16 no, that would not be correct, sorry, 17 1984. 18 A. I don't recall the exact dates. 19 Q. But it was quite sometime prior 20 to when you were actually hired? 21 A. Yes. 22 Q. During college what kinds of 23 work did you do, if any? 24 A. I washed dishes at a sorority. Page 31 1 Q. Dream job? 2 A. Great fun. I worked during the 3 summers also at a pharmacy. 4 Q. Pharmacy in a hospital? 5 A. A retail pharmacy. 6 Q. Which one? 7 A. It was called Waynedale 8 Pharmacy in Fort Wayne, Indiana. 9 Q. During your time at University 10 Hospital, did you ever have an occasion to 11 distribute drugs to patients in a Prozac or 12 Fluoxetine Hydrochloride type of clinical trial? 13 A. Not that I remember, I don't 14 recall dispensing any clinical trial medications. 15 Q. How about Saint Vincent? 16 A. Not that I recall. 17 Q. How about any other clinical 18 trials other than Fluoxetine Hydrochloride? 19 A. Any other what? 20 Q. Clinical trials, any other 21 drugs? 22 A. Other than Fluoxetine? 23 Q. Right. 24 A. I recall preparing antibiotics Page 32 1 for some clinical trial, I don't know what it 2 was. 3 Q. Okay. Was that a Lilly 4 product, to your knowledge? 5 A. Not that I'm aware of. 6 Q. You were hired by Lilly in 7 August of '86. What was your position within the 8 company? 9 A. I was the pharmacist at the 10 Lilly Clinic. 11 Q. How long did you remain as 12 pharmacist at the Lilly Clinic? 13 A. It was approximately two years. 14 Q. What was your next position 15 after that? 16 A. A CRA in the Drug Epidemiology 17 Unit. 18 Q. How long were you a CRA in the 19 Drug Epidemiology Unit? 20 A. Approximately four years. 21 Q. Do you currently hold that 22 position? 23 A. No, I do not. 24 Q. What position did you hold Page 33 1 after the CRA DEU position? 2 A. I have been a CRA in the 3 medical plans area. 4 Q. How about after that, I'm 5 sorry, how long were you a CRA in medical plans? 6 A. It's been approximately a year 7 at this time. 8 Q. Is that your present position? 9 A. Yes, it is. 10 Q. So you have held three 11 positions within Lilly, correct? 12 A. Correct. 13 Q. Who hired you to work in the 14 pharmacy at Lilly? 15 A. I don't know the one particular 16 individual who hired me, I went through a series 17 of interviews. 18 Q. Can you give me an idea of some 19 of the names of the people that you interviewed 20 with for that position? 21 A. Bob Evans was the manager at 22 that time. 23 Q. Was he the manager of the 24 clinic or pharmacy or all of them? Page 34 1 A. He was over the pharmacy, I 2 don't recall if he was over the entire area or 3 not. 4 Q. Anybody else? 5 A. A physician by the name of 6 Doctor Black. 7 Q. Do you remember Doctor Black's 8 first name? 9 A. Henry, Henry Black. 10 Q. Was he a clinical research 11 physician, to your knowledge? 12 A. I'm not sure of what his title 13 was, he was in some sort of an administrative 14 position at the clinic. 15 Q. Did you interview with anyone 16 else besides Doctor Black and Mister Evans? 17 A. I know I interviewed with other 18 people, but I don't recall who, I don't recall 19 names. 20 Q. Do you remember interviewing 21 with Louis Lemberger? 22 A. He was at the clinic at the 23 time, I don't know that I interviewed with him. 24 Q. How about a Doctor Bergstram, Page 35 1 B-E-R-G-S-T-R-A-M? 2 A. I may have interviewed with 3 him. Again, he was at the clinic. I don't 4 recall. 5 Q. All right. Give us an idea of 6 what your duties as a pharmacist in the Lilly 7 Clinic entailed? 8 A. I was responsible for the 9 administration of the pharmacy, I guess, 10 dispensing medications to outpatients who came 11 through the clinic and also the dispensing and 12 preparation of some of the medications that were 13 part of the clinical trials that were going on at 14 the clinic there. 15 Q. Would you prepare medications 16 for off site clinical trials? 17 A. No, I did not. 18 Q. So strictly trials that were 19 conducted at the clinic? 20 A. Yes. 21 Q. And you would prepare and 22 administer medications for patients who were both 23 inpatients and outpatients? 24 A. I did not actually administer Page 36 1 any of the medications, no. I would prepare 2 them, dispense them, but not administer them. 3 Q. When you say dispense, what do 4 you mean? 5 A. Package them -- or it depends 6 on the situation. If it's for an outpatient, it 7 would be like a prescription you would get at any 8 other pharmacy. For the inpatients, for the 9 volunteers on the studies, it depended on the 10 type of drug, how it was actually dispensed. 11 Q. So when you say dispensed in an 12 outpatient situation, the patient may come to you 13 and you would give them whatever medication that 14 they were supposed to take on the trial? 15 A. They were not involved in 16 trials, a few of them were, most of those 17 patients were not involved in trial. 18 Q. The outpatients at Lilly Clinic 19 were not involved in a trial? 20 A. Not the vast majority of them, 21 no. 22 Q. When I say trials, I don't mean 23 just Prozac trials. 24 A. Right. Page 37 1 Q. Then for what purpose were they 2 going to the Lilly Clinic, if you know? 3 A. They had been coming for a 4 number of years. They may have been involved in 5 trials sometime in the past and apparently the 6 physicians there were their physicians. They 7 routinely saw them for a number of years, I'm not 8 sure when it all started. 9 Q. Do you know if Lilly charged 10 the patient for the medications that you 11 dispensed? 12 A. We did not. 13 Q. Do you know if Lilly charged 14 the patients for any services, the psychiatric or 15 medical services that were rendered to them at 16 the clinic? 17 A. I don't believe so. 18 Q. I think earlier you stated that 19 there were some situations where outpatients were 20 on trials, correct? 21 A. There were a few patients, yes. 22 Q. Were those Fluoxetine 23 Hydrochloride trials, to your knowledge? 24 A. Not that I recall, no. Page 38 1 Q. When you prepared and dispensed 2 medications for inpatients, were those inpatients 3 involved in clinical trials? 4 A. Yes. 5 Q. Did you in your experience at 6 the pharmacy at the clinic ever prepare and 7 dispense medications for Fluoxetine trials? 8 A. Not that I recall, no. 9 Q. Was there a procedure or policy 10 in place at Lilly as to how you would prepare and 11 dispense medications in general at the clinic? 12 MR. MYERS: Let me object to the form. 13 When you say dispense in general, he's told you 14 about dispensing to outpatients, he told you 15 about dispensing to inpatients, so which is your 16 question directed at? 17 Q. We'll start with inpatients. 18 A. What was the question again, 19 was there a policy? 20 Q. With regards to inpatients at 21 Lilly Clinic, was there a policy or a practice at 22 the clinic by which you would dispense, prepare 23 and dispense the drugs, in other words? 24 A. Well, it would be based on the Page 39 1 clinical trial protocol and the physician's 2 orders that went along with that. 3 Q. Were you ever involved when you 4 were working at the pharmacy in preparing 5 randomization and double blind studies? 6 A. No, not that I recall. 7 Q. Did you work on double blind 8 studies while you were at the clinic with 9 inpatients? 10 A. I believe most of the studies 11 were single blind, but I don't recall precisely. 12 Q. And a single blind study that 13 you worked on, who to your knowledge would be -- 14 you don't have to give a specific name, but who, 15 in the clinic or the hierarchy at Lilly, would be 16 the person who would know which patients were 17 getting which drugs? 18 A. I don't recall, I don't know. 19 Q. Would that be somebody in the 20 pharmacy? 21 A. It wasn't me and I was the only 22 person in the pharmacy. 23 Q. Okay. What do you mean when 24 you say single blinds? Page 40 1 A. The patient would not be aware 2 of what they were taking, or the volunteer. 3 Q. And in that situation, the 4 physician running the study would be aware of 5 what they were taking? 6 A. Yes, and also the nurse who 7 would be administering the medication. 8 Q. Why is it that the nurse and 9 the doctor would know what the patients were 10 taking, but you, the pharmacist, would not? 11 MR. MYERS: Before he answers, let me 12 object to the form of the question to the extent 13 I think you're now getting into questions of 14 medical judgment, designs of clinical trials, 15 which I don't believe he's competent or qualified 16 as a pharmacist to answer. But subject to that, 17 you can answer if you can. 18 A. If you would repeat the 19 question, please. 20 (THE COURT REPORTER READ BACK THE 21 REQUESTED TESTIMONY.) 22 A. The medications were not 23 dispensed to a given patient, they were dispensed 24 more or less in a bulk supply, and then the Page 41 1 physicians and nurses would actually administer 2 the ones for a given patient based again on the 3 protocol. 4 Q. Would -- so these single blind 5 studies would be placebo studies? 6 A. Some of them, yes. 7 Q. In those situations, would you 8 still be blinded as to what patient was getting 9 either the trial drug or the placebo? 10 MR. MYERS: Let me object to the form. 11 When you say would he still be blinded, he hadn't 12 testified that he was blinded at all. 13 Q. Were you blinded during those 14 studies? 15 A. Not -- I guess I'm not sure 16 what you mean by blinded, I think. 17 Q. You testified earlier that you 18 did not know which patient was getting which 19 medication, correct? 20 A. That's correct, although in 21 some cases, I may have. I -- 22 Q. Okay. 23 A. In general, bulk supplies were 24 given out, yes. Page 42 1 Q. So you'd give the doctors a 2 bulk supply of a trial drug and a bulk supply of 3 a placebo and they would dispense the placebo or 4 the trial drug to individuals? 5 A. I would give it to the nurses, 6 to the nursing unit, yes. 7 Q. So in approximately the end of 8 1988, you moved over to the Drug Epidemiology 9 Unit, is that correct? 10 A. Yes. 11 Q. How is it that you moved from 12 the pharmacy at the Lilly Clinic to DEU? Is it 13 okay if we use DEU on this? 14 A. That's fine with me. 15 Q. DEU means the Drug Epidemiology 16 Unit. 17 A. Correct. 18 Q. Okay, why is it that you went 19 from the Lilly Clinic pharmacy to the DEU? 20 A. My manager at the time asked me 21 if I would move, if I was ready to make a change. 22 Q. Who was your manager at the 23 time? 24 A. I don't recall precisely. Page 43 1 Q. Okay. Were there numerous 2 managers at the pharmacy clinic -- the clinic 3 pharmacy, I'm sorry. 4 A. There were two or three over 5 the time. 6 Q. Can you give me some of those 7 names? 8 A. Bob Evans was there when I was 9 first hired, Joanne Inguli-Fatic was there as a 10 manager. 11 Q. I'm going to have to ask you to 12 try to spell those words. 13 A. I-N-G-U-L-I, I think, hyphen 14 F-A-T-I-C. 15 Q. Anybody else? 16 A. Yes, there was another 17 gentleman, Frank Novello. 18 Q. N-E-V-E-L-L-O? 19 A. Close to that anyway. N-O -- 20 possibly N-O-V-E-L-L-O. 21 Q. Anybody else that you can think 22 of? 23 A. Not while I was there, no. 24 Q. Did you interview for the Page 44 1 switch in position to the DEU or was it just an 2 is that okay, yes, I'll go, and you ended up over 3 there? 4 A. I went, I discussed the 5 position, I don't know that they were actually 6 considered interviews. I guess they would have 7 been, yes. 8 Q. Who did you interview with? 9 A. Mike Noone who was in the DEU 10 at that time. 11 Q. Do you know what position he 12 held within the DEU? 13 A. He was the manager. Whether he 14 was at that time or a later point in time, I 15 don't recall. 16 Q. Okay. Anybody else you 17 interviewed with for that position? 18 A. I don't recall any of the 19 names, no. 20 Q. How many people -- do you 21 remember how many people you interviewed with 22 offhand? 23 A. No. 24 Q. More than two? Page 45 1 A. I really don't remember. It 2 seemed like it took a half a day to a day, so I 3 assumed that there would have been several 4 people, but I'm not sure how many. 5 Q. I take it you decided to take 6 the job and they gave you the job, right? 7 A. Yes. 8 Q. Give us an idea of what your 9 responsibilities were as the CRA in the DEU? 10 A. It was gathering information on 11 adverse events that were reported to Lilly. 12 Q. Any other responsibilities? 13 A. I supervised a few people in 14 the area. 15 Q. Did you have any 16 responsibilities with reporting adverse events to 17 any regulatory entities, like the FDA? 18 MR. MYERS: Objection as to the form. 19 When you say you, do you mean him, personally? 20 MS. ZETTLER: Yes. 21 A. Did I report? I did not send 22 anything directly to the FDA, no. 23 Q. Did you have any 24 responsibilities with preparing any reports to go Page 46 1 to the FDA or any other regulatory entity? 2 A. I actually prepared reports 3 from a given reporter that dealt with possible 4 adverse events that were then put into a computer 5 system, but I did not send those directly to any 6 regulatory authorities. 7 Q. Once you prepared the reports, 8 who would you send them to? 9 A. They went to the drug 10 epidemiology -- well, they went to the research 11 physicians first of all who signed off on -- 12 reviewed the reports and signed off on them, then 13 they went to our drug epidemiology assistants who 14 actually data entered the reports into our 15 computer system. 16 Q. Did the DEA -- can we use DEA 17 for drug epidemiology assistant? 18 A. That's how we referred to it, 19 yes. 20 Q. Did the DEAs have any 21 responsibilities other than entering the data 22 into the computer system? 23 A. No, that's all I recall that 24 they did. Page 47 1 Q. Did you have any 2 responsibilities with regards to following up 3 with reporters on adverse events? 4 A. Yes, to collect additional 5 information, yes. 6 Q. When you started in the DEU, 7 did Lilly give you any training for that 8 position? 9 A. It was primarily working with a 10 coach. 11 Q. Did they give you any seminars 12 or lectures on your responsibilities in the DEU? 13 A. Not that I recall that dealt 14 specifically with that, no. 15 Q. Did they give you any written 16 information such as a manual or a handbook? 17 A. I don't recall. 18 Q. You don't recall whether or not 19 they did or you don't recall them ever giving you 20 written material? 21 A. The question again. 22 Q. When you say you don't recall, 23 you mean you don't recall whether or not they did 24 give you written material or you don't recall Page 48 1 what material it was? 2 A. I don't recall either. 3 Q. You stayed at DEU for about 4 four years? 5 A. Correct. 6 Q. And now you're a CRA in medical 7 plans, is that correct? 8 A. Correct. 9 Q. Are you working in medical 10 plans on any Fluoxetine related materials 11 whatsoever? 12 A. No, I am not. 13 Q. At any time that you were a CRA 14 of medical plans, did you work on any Fluoxetine 15 related projects? 16 A. No. 17 Q. Are you working on any 18 psychotropic drugs whatsoever now? 19 MR. MYERS: Let me object to the form. 20 What do you mean psychotrophic? 21 Q. Do you know what the word 22 psychotropic means? 23 A. Not directly, I guess. I mean 24 it's a CNS compound, I don't know what a Page 49 1 psychotrope is precisely. 2 Q. As a pharmacist, you don't know 3 what a psychotropic drug is? 4 A. I'm not sure they used the term 5 when I went to school, no. 6 Q. Are you working on any 7 medications that will affect the CNS at this 8 time? CNS means central nervous system, correct? 9 A. Yes. 10 Q. Are you working on any 11 medications at this time -- and I don't want you 12 to give me names. 13 A. Yes. 14 Q. You are? 15 A. Yes. 16 Q. Are you working on any 17 antidepressants? 18 A. No. 19 Q. Again, when I asked earlier if 20 you were working on any Fluoxetine related 21 products, I meant Fluoxetine for any use 22 whatsoever, not just used for depression. 23 A. No, I'm not. 24 Q. I would like to concentrate on Page 50 1 that period of time that you worked in the DEU. 2 A. Okay. 3 Q. Who was your immediate 4 supervisor when you first went to the DEU? 5 A. Mike Noone. 6 Q. And earlier you said that your 7 training within the DEU was essentially working 8 with a coach? 9 A. Uh-huh. 10 MR. MYERS: You have to say yes. 11 A. Oh, yes, I'm sorry. 12 Q. Who was your coach? 13 A. Ann Kenney. 14 Q. Anybody else? 15 A. She was my direct coach, yes. 16 Q. Who was above Mike Noone in the 17 hierarchy within the DEU? 18 MR. OLTMAN: At what point in time? 19 MS. ZETTLER: When he first started 20 working in the DEU. 21 A. In the DEU itself? 22 Q. Right. 23 A. Nobody else was really in -- 24 and Mike Noone wasn't really in the DEU, he was Page 51 1 our manager, but there was no other hierarchy 2 within the DEU. 3 Q. Do you know what department 4 Mister Noone was technically in at that time? 5 A. I don't recall the name. 6 Q. Have you ever heard of the 7 initials IPR? 8 A. Yes. 9 Q. What does IPR stand for? 10 A. International Product 11 Registration. 12 Q. How about GPT, have you ever 13 heard of those initials? 14 A. Yes, that's Global Project 15 Tracking. 16 Q. Would the DEU have fallen under 17 the regulatory services department to your 18 knowledge? 19 MR. MYERS: At what point? 20 Q. When you first started working 21 in the DEU. 22 A. It's part of the regulatory 23 area. Whether or not it's regulatory services or 24 not precisely, I don't recall. Page 52 1 Q. What division or department of 2 Lilly is the DEU in today? 3 A. It's still part of regulatory. 4 Q. Is Mike Noone still manager? 5 A. No, he's not. 6 Q. Do you know where he is today, 7 meaning which department? 8 MR. MYERS: Not today? 9 MS. ZETTLER: No. 10 A. He's manager of the CRC group, 11 clinical research coordinators, and he may have 12 other responsibilities, but that's the one I 13 recall. 14 MR. RUIZ: Can you read back that 15 answer? 16 (THE COURT REPORTER READ BACK THE 17 REQUESTED TESTIMONY.) 18 Q. Do you know how long Mike Noone 19 was the manager of your department? 20 A. I can't recall specifically, 21 no. 22 Q. Do you know who was manager 23 after Mister Noone? 24 A. Earlene Ashbrook. Page 53 1 Q. Is she still manager of the 2 department? 3 A. No, she is not. 4 Q. Who became manager after Ms. 5 Ashbrook? 6 A. Ann Nobles. 7 Q. Is Ms. Nobles still manager? 8 A. As far as I'm aware, yes. 9 Q. She was manager when you left 10 the group? 11 A. No, it was a recent change. 12 Q. Was Ms. Ashbrook manager when 13 you left the DEU? 14 A. Yes, she was. 15 (A SHORT RECESS WAS TAKEN.) 16 Q. How many CRAs were working in 17 the DEU when you first started there, do you 18 remember? 19 A. I don't remember. 20 Q. More than two? 21 A. Yes. 22 Q. More than five? 23 A. I don't recall, approximately 24 five or six. Page 54 1 Q. Part of your job within the DEU 2 was to gather information on adverse events that 3 were reported to Lilly, is that correct? 4 A. On any event, anything that 5 happened while a patient was taking our products, 6 I would follow up and try to get information. 7 Q. At any time when you were at 8 the DEU, was your work exclusively on Prozac or 9 Fluoxetine or did you work on -- 10 A. It was never totally exclusive 11 to any one product. 12 Q. Was there ever a time when you 13 were in the DEU where the majority of your time 14 was devoted to working with Fluoxetine adverse 15 events? 16 A. Yes. 17 Q. Can you tell me what period of 18 time that was? 19 A. From when I first started until 20 approximately a year before I left. 21 Q. So until about the end of 1992, 22 is that correct? 23 A. No, I left probably closer to, 24 let's see, I left the DEU in '90 -- I don't Page 55 1 recall exactly, the last year I was in the DEU, I 2 was more involved in international projects, 3 coordination. 4 Q. Did the international projects 5 coordination relate in any way to Fluoxetine? 6 A. No. 7 Q. Did you work with any 8 international Lilly affiliates during the time 9 that you worked on Fluoxetine? 10 A. I reviewed reports that came in 11 from the affiliates. 12 Q. Would you give us a description 13 of the process you would go through in the DEU 14 with regards to adverse events that were reported 15 to Lilly, in other words what would happen when 16 an adverse event would come into Lilly, what 17 would be reported? 18 MR. MYERS: If you were the CRA taking 19 the report? 20 MS. ZETTLER: Within his position at -- 21 in the DEU. 22 A. We would prepare a working 23 form. 24 Q. Would you work exclusively on Page 56 1 spontaneous adverse events reports in the DEU or 2 would you work on reports from clinical trials 3 also? 4 A. I worked on spontaneous 5 reports, I did actually see some of the clinical 6 trial reports from the affiliates. 7 Q. The affiliates? 8 A. Before they went to the 9 physicians. 10 Q. Okay. The affiliates meaning 11 the international affiliates? 12 A. Yes. 13 Q. How about in the U.S., did you 14 work on any adverse event reports on adverse 15 events that occurred during the clinical trials? 16 A. No, I did not. 17 Q. Let's concentrate now on U.S. 18 spontaneous adverse events reports, okay? 19 A. Yes. 20 Q. Where would those reports come 21 from? 22 A. Where did I hear about them 23 from? 24 Q. Somebody would report an Page 57 1 adverse event to Lilly, correct, a spontaneous 2 adverse event? 3 MR. MYERS: Are you giving him a for 4 instance? 5 Q. Okay, let's start it this way: 6 Spontaneous adverse events were events that came 7 in from sources outside of Lilly, correct? 8 A. They could be from inside Lilly 9 also. 10 Q. Okay. For instance, a 11 situation that could be from inside Lilly, like 12 if somebody read a newspaper article about 13 something that occurred to somebody while on 14 Prozac, correct? 15 A. Yes. 16 Q. They could also come from 17 people outside of Lilly like doctors who 18 prescribed Prozac, correct? 19 A. Yes. 20 Q. Hospitals? 21 A. Possibly. 22 Q. Pharmacists? 23 A. Yes. 24 Q. They also came in from Lilly Page 58 1 sales representatives, didn't they? 2 A. Yes. 3 Q. In fact, when you initially 4 started working in the DEU, I believe it was 5 1988, the majority of the reports that came into 6 Lilly were made by sales representatives, weren't 7 they? 8 A. I don't recall. 9 Q. Did you ever hear or see a memo 10 that states that sixty-eight percent of the 11 adverse spontaneous adverse reports that were 12 made to Lilly came in through sales 13 representatives or field personnel? 14 MR. MYERS: Before he answers that, let 15 me object to the form of the question to the 16 extent you are apparently referring to some 17 writing and if you have the writing and you want 18 to question the witness about it, show it to the 19 witness. But I'm not going to allow him to 20 answer questions in the dark about a writing that 21 you're referring to. 22 MS. ZETTLER: I'm asking him if he ever 23 heard of that figure. 24 MR. MYERS: You asked him whether he Page 59 1 ever read any memo. 2 MS. ZETTLER: Okay. 3 Q. Have you? 4 A. Have I which? 5 Q. Read a memo -- or let's do it 6 this way: Have you ever heard that the majority 7 of spontaneous adverse events were reported by 8 Lilly field personnel or sales people? 9 MR. MYERS: You've now taken the memo 10 out of it. 11 MS. ZETTLER: Right. 12 MR. MYERS: You asked him if he ever 13 heard. 14 MR. MYERS: Okay. 15 A. Have I heard that the majority 16 of the events have come from -- I don't recall 17 hearing that specifically. 18 Q. In your experience at DEU, what 19 type of people would you take the majority of the 20 adverse event reports from? 21 MR. MYERS: For Fluoxetine or any 22 product? 23 MS. ZETTLER: Any product, start with 24 any product. Page 60 1 A. Who would I take them from? We 2 had them from physicians, we had them from 3 pharmacists, patients. 4 MR. MYERS: Are you through? 5 A. Yes, the question was who -- 6 MR. MYERS: She wanted to know the 7 majority. 8 Q. What types of sources would you 9 get reports from? 10 A. Now you changed the question. 11 MR. MYERS: That's a new question. 12 Q. What sources would you 13 personally -- 14 A. Prepare a report from? 15 Q. Right. 16 A. Newspaper articles. 17 Q. Okay. 18 A. Anybody that contacted the DEU, 19 anybody who would have called, sales 20 representatives -- 21 Q. Patients? 22 A. Patients, pharmacists. 23 Q. People we listed before, 24 physicians, hospitals, things of Page 61 1 that nature? 2 A. Relatives of patient. 3 Q. And out of that group of 4 sources, where would you say the majority of the 5 reports would come from, which source? 6 MR. MYERS: When you say the majority, 7 does that mean more than fifty percent? 8 MS. ZETTLER: Yes. 9 A. I would estimate or guess sales 10 representatives. 11 Q. Okay. Can you give us an idea 12 of the context, or context that they would report 13 an adverse event to you? 14 A. The context? 15 Q. Context of -- under which a 16 sales representative would report an adverse 17 event. In other words would a sales 18 representative be making a call and a physician 19 would say hey, by the way, one of my patients on 20 Fluoxetine experienced this or would it be some 21 other context? 22 MR. MYERS: Are you asking for an 23 example? 24 MS. ZETTLER: Yes. Page 62 1 A. It would be any time they would 2 hear of a patient who had had an event while 3 taking our product. 4 Q. And what if the sales 5 representative would make a report of an adverse 6 event to you at the DEA, what would you do? 7 MR. MYERS: DEU. 8 Q. DEU. What would you do? 9 A. I'm -- what was it again? 10 Q. Once a salesman would make a 11 report to you at the DEU, what would you do in 12 reaction to that report? 13 A. We would write up a working 14 form. 15 Q. And would you then try to 16 contact the source of the salesman's information, 17 in other words if a physician made a report to 18 the salesman, would you then try to contact that 19 physician? 20 A. We would in some cases, it was 21 really our physicians' responsibility to make 22 that decision. 23 Q. When you say your physicians, 24 you mean the clinical research physicians? Page 63 1 A. Yes. 2 Q. When you say the working forms, 3 you mean a working 1639 form, right? 4 A. Yes. 5 Q. And was that working 1639 6 something that was created by Lilly or something 7 that was created by the FDA, the working form? 8 A. The working form was created by 9 Lilly. 10 Q. What kind of information would 11 you gather on the working 1639? 12 A. The name of the reporter who 13 had called in the information, the description of 14 what took place, the name of the product that the 15 patient was taking, the serious -- whether the 16 event met the FDA definition of a serious report, 17 any other medications that the patient may have 18 been on, any significant medical history. 19 Q. Anything else? 20 A. The gender of the patient, and 21 that's all I can recall without seeing a form. 22 Q. When you say the name of the 23 reporter who made the report, would that be in 24 the case of a sales representative, the sales Page 64 1 representive's name? 2 A. No. We consider the original 3 reporter to the Lilly person the reporter. 4 Q. So the salesman's name would 5 not be listed on the working form? 6 A. No, we did capture that but 7 they weren't considered the reporter. 8 Q. Were the sales people ever 9 asked to solicit reports of adverse events from 10 physicians or anybody else? 11 MR. MYERS: Let the me object to the 12 form of the question and the use of the term 13 solicit as being awfully vague and ambiguous. 14 But answer it if you can, if you know. 15 Q. Do you understand what the word 16 solicit means? 17 A. Well, if you could explain it, 18 I guess I would be more clear. 19 Q. Were the sales people at Lilly 20 ever instructed to try to find out from a 21 physician whether or not any of their patients 22 had suffered an adverse event as opposed to just 23 waiting for the physician to report the adverse 24 event on their own without any prompting? Page 65 1 A. I don't recall. 2 Q. Where on the working 1639 would 3 the salesman's name be placed? 4 A. There was a box up toward the 5 top of the form. 6 Q. Okay, was the salesman's name 7 ever reported to the FDA as a reporter? 8 A. No. 9 Q. In the case of a newspaper 10 article, who would be considered the reporter on 11 that? 12 A. The newspaper, I guess. If 13 there was a name of a reporter in the article, 14 that could be used also. 15 Q. How about in a situation where 16 a lawsuit was filed, who would be considered the 17 reporter on that situation? 18 A. I don't recall what we did. 19 Q. Was there ever a situation 20 where you took information on and reported it as 21 an adverse event when the information was taken 22 from a complaint filed? 23 A. A complaint filed, I'm not sure 24 what -- Page 66 1 Q. A complaint at law. 2 MR. MYERS: She's talking about a 3 lawsuit is what she means. 4 A. Would we write a report based 5 upon a lawsuit? 6 Q. Right. 7 A. Yes. 8 Q. You testified that one of the 9 things that you would do with a working 1639 is 10 make a determination of whether or not the event 11 was serious according to the FDA, correct, FDA 12 regulations? 13 A. Yes, there's an FDA regulation 14 that tells precisely what a serious report is. 15 Q. And what is done with a serious 16 report, is there something that has to happen if 17 a report is determined to be serious? 18 A. Well, as far as -- we would 19 actually mark on the form indicating that it was 20 serious. 21 Q. Were all serious reports 22 reported to the FDA? 23 A. Any report was, whether or not 24 it was serious, it would be reported to the FDA. Page 67 1 Q. Were all serious reports 2 entered into the Drug Experience Network? 3 A. We're still talking about 4 spontaneous reports? 5 Q. Right. 6 A. All spontaneous reports were 7 entered into the Drug Experience Network. 8 Q. Regardless of whether or not 9 they were determined to be serious, right? 10 A. Serious by FDA regulation, yes. 11 Q. And the FDA regulations and 12 event is considered serious if it is unexpected, 13 right? 14 A. No. 15 Q. No. What is the FDA definition 16 of a serious event? 17 A. There were a number of 18 categories. The patient -- the report would 19 either involve a death, a life threatening event, 20 hospitalization, overdose, cancer, those are the 21 ones I recall. 22 Q. Congenital anomaly? 23 A. Yes. 24 Q. Anything else? Page 68 1 A. Those are the ones I recall. 2 Q. Do you know if -- was overdose 3 an FDA serious event or a serious outcome term or 4 was that a Lilly serious outcome term? 5 A. It's a FDA. 6 Q. The final 1639 forms that you 7 used at Lilly to report back to the FDA, were 8 those forms produced by Lilly or were those 9 actual FDA forms? 10 A. They may have been a slight 11 modification of the actual FDA form, they're very 12 close but I'm not sure if there are significant 13 differences or not. 14 Q. So as long as an event fell 15 under one of those categories that you just 16 listed, it would be considered serious for 17 purposes of the FDA? 18 A. Yes. 19 Q. Regulation, okay. Have you 20 ever heard of determining whether or not an event 21 was expected or unexpected? 22 A. Yes. 23 Q. How does that work into the 24 reporting picture at all? Page 69 1 A. We would -- I would actually 2 prepare a report, I would indicate whether or not 3 it was serious and then it would be routed to the 4 research physician to evaluate that based upon 5 the package labeling for the product. 6 Q. So whether or not an event is 7 expected depends on what's been previously listed 8 in the package insert? 9 A. Yes. 10 Q. What kind of impact does a 11 determination of expected adverse event have on 12 reporting that event to the FDA? 13 A. They're all reported 14 regardless. 15 Q. Why do you make a determination 16 as to whether or not an event is expected or 17 unexpected? 18 A. The reports that are unexpected 19 go to the FDA in a more expedited manner. 20 Q. Would that be a fifteen day 21 alert report? 22 A. For spontaneous reports, yes. 23 Q. Which means you have to report 24 it within fifteen days to the FDA? Page 70 1 A. Yes. 2 Q. Within fifteen days of the 3 manufacturer finding out about the report, 4 correct? 5 A. Correct. 6 Q. If an event is considered 7 expected, when would that event be reported to 8 the FDA? 9 A. I'm sorry, what was the -- 10 Q. If you consider an event 11 expected -- 12 A. If the physician determines it 13 to be expected? 14 Q. Right. How does that affect 15 the reporting time line to the FDA? 16 A. It's not an immediate report. 17 A fifteen day alert report, it would be reported 18 if it's -- let's see, a spontaneous report on a 19 product during the first three years after 20 approval would be reported quarterly. After a 21 drug has been on the market for three years, 22 they're reported yearly. 23 Q. Okay, so the first three years 24 it's on the market, adverse events are reported Page 71 1 quarterly? 2 A. Yes. 3 Q. Unless they're considered 4 unexpected and serious, correct? 5 A. Yes, for spontaneous they would 6 have to be unexpected. 7 Q. Then they're reported within 8 fifteen days? 9 A. Yes. 10 Q. How does that differ as far as 11 the adverse events that occur within clinical 12 trials? 13 A. How does which part of that 14 process? 15 Q. The reporting time line lag, is 16 there a difference between the reporting time 17 line for events that occur within clinical trials 18 as opposed to spontaneous events? 19 A. Yes. For all reports, for 20 serious reports? 21 Q. Let's start with serious 22 reports in clinical trials. 23 A. Give me the question, unless 24 you have it. Page 72 1 Q. I will rephrase it. Serious 2 reports as far as spontaneous reports are 3 concerned, if they are unexpected, a report is 4 within fifteen days, correct? 5 A. Correct. 6 Q. How about serious unexpected 7 events that occur during clinical trials, are 8 they also reported within fifteen days? 9 A. No. 10 Q. How quickly are they reported? 11 A. There's an additional judgment 12 that needs to be made on that report before it 13 falls into a given time line reporting sequence. 14 Q. What's the additional judgment 15 that needs to be made in regards to an adverse 16 event in a clinical trial? 17 A. If a report is determined to be 18 unexpected, a possible causal relationship needs 19 to be assigned that would determine the reporting 20 time in that. 21 Q. When you say causally related, 22 you mean causally related to the use of the study 23 drug, correct? 24 A. Correct. Again, it's -- I Page 73 1 guess part of the regulations of that is to be, 2 yes. 3 Q. Who decides whether or not it's 4 possibly causally related to the study drug? 5 A. The clinical research 6 physician. 7 Q. If the clinical research 8 physician makes a determination that it is 9 possibly causally related to the study drug, how 10 quickly does it need to be reported to the FDA? 11 A. It would depend on which of the 12 serious criteria are involved. 13 Q. Okay, and the serious criteria 14 that were involved were death, overdose, 15 hospitalization, disability, cancer, congenital 16 anomaly, correct? 17 A. Uh-huh. 18 Q. Give me an idea of how long or 19 how quickly something would have to be reported 20 if it came under the overdose category? 21 A. Ten days if it meets serious, 22 unexpected and reasonably possibly related. 23 Q. This was true for Fluoxetine as 24 well as other clinical trial drugs that Lilly was Page 74 1 working on when you were in the DEU? 2 A. Yes. 3 Q. How about death, how fast would 4 a report of death that is serious, unexpected, 5 and reasonably, possibly related have to be made? 6 A. The FDA would have to be 7 notified by phone within three days. 8 Q. How about hospitalization, same 9 criteria? 10 A. Ten days. 11 Q. Any other of the serious 12 category that would have to be reported within 13 three days? 14 A. We mentioned death, life 15 threatening would be the other. 16 Q. Life threatening was another 17 serious criteria? 18 A. Yes. 19 Q. What would happen to the report 20 describing that? 21 Q. How quickly would the report of 22 an adverse event that was -- that did not fit 23 underneath the serious, unexpected and 24 reasonably, possibly related criteria, how Page 75 1 quickly would that be reported to the FDA? 2 A. For -- 3 MR. MYERS: A spontaneous report? 4 MS. ZETTLER: No, the clinical trial 5 reports. 6 A. I'm not sure. 7 Q. How about non-serious clinical 8 trial adverse events in general, do you know how 9 quickly they would be reported? 10 A. Again, I don't know. 11 Q. Was suicide attempt considered 12 serious under the FDA regulations? 13 A. No, it is not, not by FDA 14 regulation. 15 Q. It's true that a suicide 16 attempt can be life threatening, isn't it? 17 A. It could be. 18 Q. If a suicide attempt is 19 determined to be life threatening, is it reported 20 as a serious outcome of life threatening? 21 A. If a suicide attempt is 22 determined to be life threatening, yes, sure. 23 Q. Could you tell us what the Drug 24 Experience Network is? Page 76 1 A. It's a computer system where 2 the reports that we prepared were actually data 3 entered and then through a weekly printing, it 4 would produce reports which would be submitted to 5 the FDA. 6 Q. Were all adverse event reports 7 entered into the DEN or just the spontaneous 8 adverse event reports? 9 A. All spontaneous reports would 10 be entered and serious clinical trial reports, 11 serious by FDA regulation. 12 Q. One of those categories we 13 discussed earlier? 14 A. Uh-huh, yes. 15 Q. Any other adverse events that 16 would be entered into the DEN, other than the 17 spontaneous reports and the serious clinical 18 trial reports? 19 A. Not that I am aware of. A 20 physician could request that a report be entered 21 if he so chose from clinical trials. 22 Q. Okay. A non-serious, he could 23 request that a non-serious report be entered? 24 A. Yes. Page 77 1 Q. Do you recall any instance 2 where that happened? 3 A. On some of the products, we 4 would put reports of pregnancy in there. 5 Q. Pregnancy that occurred while 6 the person was on a study drug? 7 A. Yes. 8 Q. Do you recall that ever 9 happening with Fluoxetine? 10 A. I am aware that there are 11 reports out there, I don't know that I prepared 12 or saw any of them. 13 Q. How about any other instances, 14 other than pregnancy, where a physician asked 15 that a non-serious adverse event be entered into 16 the DEN? 17 MR. MYERS: Any drug? 18 MS. ZETTLER: Fluoxetine, limited to 19 Fluoxetine. 20 A. Not that I recall, but I just 21 don't know. 22 Q. Are there any other data bases 23 in which the non-serious clinical trial events 24 would be entered other than the DEN? Page 78 1 A. The non-serious clinical trial 2 events? Yes, there are data, clinical trial data 3 bases. 4 Q. Those would be called CT data 5 bases? 6 A. Uh-huh. 7 MR. MYERS: Yes. 8 A. Yes. 9 Q. Mister Powell, don't worry, 10 it's perfectly normal to do that. 11 Any other data bases other than 12 the DEN and the CT data bases in which adverse 13 events would be entered? 14 A. Not that I am aware of. 15 Q. Were not serious clinical trial 16 adverse events reported to the FDA? 17 A. I don't have direct knowledge, 18 but it's my understanding that everything 19 involved from a trial would be. 20 Q. Have you ever heard the word or 21 the name DEN II, D-E-N, Roman Numeral two? 22 A. Yes. 23 Q. What is DEN II? 24 A. It's the same computer system Page 79 1 with some modifications that were made to DEN. 2 Q. When you say modifications, you 3 mean other event terms that were added or other 4 fields of information? 5 A. I'm not sure, that all happened 6 about the same time that I came to the DEU, what 7 I discussed to this point is primarily DEN II, 8 I'm not familiar with the details and workings of 9 DEN. 10 Q. Do you have any knowledge of 11 what the differences between DEN and DEN II were? 12 A. I don't know. 13 Q. Do you know if DEN was changed 14 to DEN II in response to any complaint by the FDA 15 to Lilly's reporting of adverse events? 16 A. Not that I'm aware of. 17 Q. Are you aware of whether or not 18 DEN II was created in response to a problem with 19 reporting of adverse events within Lilly? 20 A. Not that I'm aware of. 21 Q. My understanding of the types 22 of information that are listed in DEN is 23 basically the information that is recorded on the 24 final 1639 form, is that correct? Page 80 1 A. Once again, what's in DEN. 2 Q. We understand that DEN is just 3 spontaneous adverse events, correct, not clinical 4 trial events? 5 A. No, it's also serious clinical 6 trial events. 7 Q. Okay. The types of information 8 for each adverse event, it's my understanding 9 that it's basically the information that is 10 reported in the final 1639 was the information 11 that's entered into the DEN? 12 A. It's actually the information 13 that's on the working form. 14 Q. So there's a difference between 15 information that would be reported in the final 16 1639 and information that is contained on the 17 working form, for instance the name of the 18 salesman who may have made the initial report? 19 A. Yes. 20 Q. Any other information that 21 would be reported on the 1639 working form as 22 opposed to the final, that would not be put on 23 the final 1639? 24 A. The actual name of the patient, Page 81 1 we didn't actually print the name of a patient on 2 the form that went to the FDA. 3 Q. Any other information as far as 4 medical history type information? 5 A. No, nothing else that I can 6 recall. 7 Q. How about information that is 8 related to any lawsuits that may have been filed 9 as a result of the adverse event, is that 10 reported on the final 1639? 11 A. Any information such as? 12 Q. Something that would happen 13 within a lawsuit or medical records that had been 14 gained through the lawsuit or anything of that 15 nature? 16 A. Repeat the question, I guess. 17 Q. In other words, if Lilly got a 18 report that somebody had filed a lawsuit with 19 regard to a specific spontaneous adverse event, 20 okay, would that be reported to the FDA? 21 A. Yes. 22 Q. Would the result of that 23 lawsuit be reported to the FDA? In other words, 24 if the lawsuit was dismissed, would that be Page 82 1 reported to the FDA to your knowledge? 2 A. I don't recall. 3 Q. After a 1639, an initial 1639 4 is filed in an event, Lilly does follow-up on the 5 1639, correct? 6 A. Not on all reports. 7 Q. In some situations it does 8 though? 9 A. Yes. 10 Q. And those situations where an 11 initial 1639 is filed with the FDA and follow-up 12 is done with regards to that 1639 event, would 13 the follow-ups then be reported to the FDA? 14 A. Yes, they would. 15 Q. In all situations? 16 A. If we didn't obtain any 17 additional information, we probably wouldn't -- 18 we wouldn't note that, but any information we 19 would gather that we would add to the report, 20 would go to the FDA, yes. 21 Q. When a report of an adverse 22 event is called in or somehow received by Lilly, 23 is there a number or initials assigned to that 24 report so you can track that information? Page 83 1 A. Yes, there's a number assigned 2 to a report. 3 Q. And is that a patient number, 4 is that a specific patient number that's 5 assigned? 6 A. No, it's a report number. 7 Q. Is that different than a 8 manufacturing number or is that the same? 9 A. Same number. 10 Q. So then everything is -- any 11 information that is collected is filed under that 12 number then, after it's assigned? 13 A. Yes, it would be filed under 14 the same report number. 15 Q. And is there a difference 16 between the manufacturer number and a DEN number? 17 A. No, we use the term 18 synonymously. 19 Q. So any information that's 20 entered into the DEN regarding that event is 21 listed under the DEN number, correct? 22 A. Yes. 23 Q. And when you -- as the CRA in 24 the DEU takes any initial reports on adverse Page 84 1 events, do you assign event terms to those 2 adverse events? 3 A. We preliminarily assign them 4 and then they're reviewed by research physicians 5 for the final assignment. 6 Q. Usually reports come in as a 7 narrative of sorts, correct? 8 A. Correct. 9 Q. And from that narrative you 10 have to make at least a preliminary judgment as 11 to which adverse event term will be assigned, 12 correct? 13 A. Correct. 14 Q. And usually that's like a one 15 or two word description as opposed to a long 16 narrative description? 17 A. The event term? 18 Q. Right. 19 A. Yes. 20 Q. Where did they get the event 21 term? 22 A. From the COSTART Dictionary. 23 Q. COSTART is an event term, the 24 source that's created by the FDA, right? Page 85 1 A. Yes. 2 Q. And at the time you worked in 3 the DEU, Lilly was actually using another 4 thesaurus called ELECT that was based -- created 5 by Lilly based on the COSTART Dictionary, 6 correct? 7 A. Yes, there were some 8 modifications to the COSTART Dictionary. 9 Q. Are you familiar with the 10 COSTART Dictionary, have you used it? 11 A. I have used, I guess, Lilly's 12 version of the COSTART Dictionary. 13 Q. Are you aware of what the 14 differences between Lilly's version of COSTART 15 and COSTART are? 16 A. There's an event term called -- 17 whether or not it's still there, I don't know, 18 but it was called the test tape complaint, 19 something to that effect. 20 Q. Test? 21 A. Test tape complaint and also an 22 event term of surgical procedure that we had 23 added to the dictionary. 24 Q. Anything else? Page 86 1 A. Not that I am aware of. 2 Q. Any differences between COSTART 3 and ELECT with regards to suicide attempts, the 4 term suicide attempt? 5 A. In the present dictionary? 6 Q. In the ELECT dictionary. 7 A. The ELECT dictionary doesn't 8 exist anymore. 9 Q. Right, I'm not asking about 10 whether or not -- at any time when you worked in 11 the DEU, was there a difference between the way 12 suicide attempt would be reported with the 13 COSTART Dictionary and the way it would be 14 reported with the ELECT Dictionary? 15 A. Not that I am aware of. 16 Q. Did you ever compare the 17 COSTART Dictionary with the ELECT Dictionary? 18 A. I didn't compare it directly. 19 Q. Have you ever worked strictly 20 with COSTART? 21 A. I have never actually seen a 22 COSTART Dictionary from the FDA, no. 23 Q. Under ELECT, a suicide attempt 24 with medications is listed as an overdose, isn't Page 87 1 it? 2 A. By me? 3 Q. Right, by people in the DEU. 4 A. A suicide attempt, what was the -- 5 Q. If somebody tries to commit 6 suicide by taking an overdose of pills, it's 7 listed as overdose. 8 A. Yes. 9 Q. And that's according to ELECT, 10 right? 11 A. I'm not sure if it's in there 12 directly that way. 13 Q. A suicidal ideation is reported 14 by DEU as depression in a lot of cases, isn't it? 15 A. Was it at the time I was there, 16 is that -- 17 Q. Yes. 18 A. Yes, suicidal ideation mapped 19 to depression. 20 Q. And an actual suicide in many 21 cases was reported as a suicide attempt in the 22 DEU, wasn't it? 23 A. An actual suicide? 24 Q. Right. Page 88 1 A. Would have been reported -- 2 again it depends if it was an overdose, it would 3 have been listed as overdose. If it was a 4 suicide, successful suicide by other means, it 5 would have been reported as suicide attempt with 6 an outcome of death. 7 Q. And if somebody were to -- 8 somebody were to murder somebody, that would be 9 listed as an intentional injury with the outcome 10 of death, wouldn't it? 11 A. I don't recall. 12 Q. Was murder or homicide an ELECT 13 term, event term? 14 A. Murdered or -- 15 Q. Homicide. 16 A. Not that I recall. 17 Q. Why is it that Lilly would list 18 a suicide attempt or a suicide by injection of a 19 substance as an overdose, as opposed to a suicide 20 or suicide attempt? 21 A. We considered it a more 22 specific means of a suicide attempt. 23 Q. Isn't it true that under FDA 24 policy, while you were in the DEU, accidental Page 89 1 overdoses would also be listed as overdose? 2 MR. MYERS: Object to the form -- hold 3 on -- let me object to the form of the question 4 and the use of the term FDA policy, I mean it's 5 undefined. 6 MS. ZETTLER: I'm sorry, that's wrong, 7 I misspoke. 8 Q. Isn't it true that it was also 9 Lilly policy during the time that you were in the 10 DEU that if somebody were to suffer an accidental 11 overdose that would also be listed as straight 12 overdose, correct? 13 A. I don't recall. 14 Q. How about if a doctor were to 15 make a mistake on prescribing medications and 16 somebody would ingest more than the recommended 17 dosage and suffer an adverse event as a result. 18 A. Uh-huh. 19 Q. That would be listed as 20 overdose, too, correct? 21 A. As opposed to accidental 22 overdose? 23 Q. Right. 24 A. I don't recall. Page 90 1 Q. Who would make the decision on 2 how various adverse events would be reported -- 3 I'm sorry, how various events would be assigned 4 to various adverse events at Lilly? 5 A. They were primarily mapped out 6 in the ELECT Dictionary. 7 Q. Do you know who created the 8 ELECT Dictionary at Lilly? 9 A. No, I do not. 10 Q. Do you know whose decision it 11 was to make any revisions to the dictionary? 12 A. No, I don't know who -- I don't 13 recall who specifically did that, no. 14 (PLAINTIFFS' EXHIBIT NO. 1 WAS 15 MARKED FOR IDENTIFICATION AND 16 RECEIVED IN EVIDENCE.) 17 Q. Mister Powell, we are going to 18 show you what's been marked as Plaintiffs' 19 Exhibit Number 1 for identification. Would you 20 take a look at that, please, and take your time 21 in reading through it. 22 A. Sure. 23 Q. Okay, have you had a chance to 24 review Exhibit Number 1? Page 91 1 A. Uh-huh, I have. 2 Q. Exhibit Number 1 purports to be 3 an E-mail, I believe, of meeting minutes from a 4 CRA staff meeting, is that correct? 5 A. Yes. 6 Q. And the date of that meeting is 7 January 7, 1992? 8 A. That's the top copy, yes. 9 Q. Actually the exhibit is two 10 E-mails regarding two different meetings, 11 correct? 12 A. Yes. 13 Q. The second meeting happening on 14 January 14, 1992? 15 A. It would appear that way, yes. 16 Q. Can you tell us, we know who 17 Earleen Ashbrook is but can you tell us who Anita 18 Clark is? 19 A. She is a CRA in DEU. 20 Q. How about Phyllis Donahue? 21 A. The same. 22 Q. And Mindy Gould? 23 A. The same. 24 Q. How about Robert Hunt? Page 92 1 A. He was a CRA in the DEU at that 2 time. 3 Q. Are all these people, other 4 than Earleen Ashbrook, CRAs or were they CRAs in 5 the DEU at one time or another? 6 A. Melissa Humbert, Humbert is 7 not, she was a department head. 8 Q. Okay. 9 A. Everyone else is, yes. 10 Q. To the right of the names, 11 there is -- looks like a code, IVM1, can you tell 12 us what that stands for? 13 A. I don't know. 14 Q. Could you go down to the first 15 page on Pz 1573 space 1015? 16 Q. Where are we again? 17 Q. The first page. 18 A. Pz 1573 1015. 19 A. Okay. 20 Q. Number seven says Mindy will be 21 sending a message to the affiliates regarding the 22 change in mapping self-inflicted injuries. 23 When did the change occur in 24 mapping self-inflicted injuries, to your Page 93 1 recollection? 2 A. I don't recall that. 3 Q. You don't recall the change or 4 you don't recall when it was made? 5 A. Either one. 6 Q. Any self-inflicted injury 7 that's not a suicide attempt will map to 8 intentional injury instead of accidental injury. 9 Do you recall that ever being the case with 10 regards to reporting self-inflicted injury? 11 A. I don't recall what that dealt 12 with or why that apparent change may have been 13 made. 14 Q. Now, on the second page of the 15 exhibit, which is really the third page 16 apparently of the memo, the second page which we 17 were not given, it says at the top, be raising 18 our concerns about the transition from the ELECT 19 to the COSTART Dictionary. 20 A. Uh-huh. 21 Q. Do you remember when the 22 transition was made from the ELECT to the COSTART 23 Dictionary or if it was ever made after that 24 memo? Page 94 1 A. It was made, I'm not sure of 2 the dates. 3 Q. Okay, was it made before you 4 left the DEU? 5 A. I don't recall. There were 6 discussions but I don't recall exactly when it 7 took place. 8 Q. Do you know why they were 9 making the change from the ELECT to the COSTART 10 Dictionary? 11 A. I don't know. 12 Q. Do you remember what some of 13 the concerns about the transition from the ELECT 14 to the COSTART Dictionary were at the time this 15 memo was written? 16 MR. MYERS: Let me object to the form, 17 that assumes there were some, quote unquote, 18 concerns. 19 MS. ZETTLER: The memo indicates there 20 were concerns with the transition, doesn't it? 21 MR. MYERS: That's not what your 22 question was. 23 MS. ZETTLER: I'm asking him now. 24 Q. The memo, the second page of Page 95 1 the memo indicates that there were concerns by 2 somebody within the CRA staff with the transition 3 from the ELECT to the COSTART Dictionary, 4 correct? No, there was a page that was not 5 produced to us in between those two pages so the 6 top of the second page with the exhibit says be 7 raising our concern about the transition from the 8 ELECT to the COSTART Dictionary, doesn't it? 9 A. Yes, that is what it says, I'm 10 not sure what it's referring to. 11 Q. Do you remember any concerns 12 that the CRA staff had with the transition from 13 the ELECT to the COSTART Dictionary? 14 A. I really don't recall. 15 Q. Do you know generally? 16 A. I would be speculating if I 17 did. 18 MR. MYERS: Don't do that. 19 Q. You worked in the DEU for four 20 years, right? 21 A. That's correct. 22 Q. And you worked every day with 23 the ELECT Dictionary in assigning event terms to 24 adverse events, correct? Page 96 1 A. Primarily for the first three 2 years, yes. 3 Q. And you became fairly familiar 4 with the event terms that were listed in the 5 ELECT Dictionary and how they were to be applied, 6 correct? 7 A. Yes, I became familiar with the 8 event terms. How they were to be applied, I 9 guess I'm not real sure what you mean by that. 10 Q. You became fairly familiar with 11 Lilly's policy as to which event term to assign 12 to any particular adverse event? 13 A. Yes, they were mapped in the 14 dictionary. 15 Q. And those event terms were then 16 collected and entered into the data bases by 17 codes that were assigned to the adverse event, 18 the coded terms, right? 19 A. Well, both terms were assigned, 20 yes. 21 Q. The initial term and the term 22 that was assigned? 23 A. Yes. 24 Q. By the ELECT Dictionary. And Page 97 1 by your own testimony there were differences 2 between the ELECT Dictionary and the COSTART 3 Dictionary, right? 4 A. Correct. 5 Q. And the first page of Exhibit 1 6 indicates that there was going to be or at least 7 it was contemplated a change in the reporting of 8 self-inflicted injury, correct? 9 A. Where again, number? 10 Q. Number seven. 11 A. So what is your question about 12 that? 13 Q. Paragraph seven indicates there 14 was to be a change in the adverse event term that 15 was to be assigned to self-inflicted injury that 16 is not a suicide attempt, right? 17 A. That's what this indicates, 18 yes. 19 Q. Now, this memo is dated 1992, 20 January 7, 1992, correct? 21 A. Yes. 22 Q. Assuming that prior to this 23 date, adverse event terms from the ELECT 24 dictionary were entered into the DEN, correct? Page 98 1 A. Once adverse event terms from -- 2 Q. The ELECT dictionary. 3 A. -- were entered in, right, if 4 they corresponded to the report. 5 Q. According to this memo, prior 6 to at least this date, January 7, 1992, 7 self-inflicted injury was mapped generally to 8 intentional injury, correct? 9 MR. MYERS: Let me object to the form, 10 that's not what it says. 11 A. It doesn't say that they were. 12 Q. This paragraph seven indicates 13 that there was going to be a change in the 14 mapping of self-inflicted injuries, correct? 15 First sentence of that paragraph seven. 16 A. It says regarding the change in 17 mapping self-inflicted injuries. 18 Q. So we agree that that indicates 19 there was going to be a change in the mapping of 20 self-inflicted injuries, right? 21 A. Some sort of a change, yes. 22 Q. Right after that, the next 23 sentence says any self-inflicted injury that is 24 not a suicide attempt, will map an intentional Page 99 1 injury instead of accidental injury, right? 2 A. Uh-huh. 3 Q. You have to say yes or no. 4 A. Yes. 5 Q. And that indicates that prior 6 to the change in mapping, self-inflicted injuries 7 that were not suicide attempts were mapped to 8 accidental injury? 9 MR. MYERS: Before he answers, let me 10 object to the form because he didn't write the 11 memo so he can't speak to what it indicates or 12 what it doesn't indicate, it says what it says. 13 He's already confirmed what it says. 14 Q. Mister Powell, did you attend 15 CRA staff meetings in the DEU? 16 A. I attended some of them, yes. 17 Q. How many of them did you 18 attend, give me a percentage out of the total 19 number that occurred that you attended, would you 20 say? 21 A. The majority. I don't know 22 percentage-wise. 23 Q. Were they held on a weekly 24 basis during part of the time when you worked at Page 100 1 the DEU? 2 A. I believe they were scheduled 3 on a weekly basis. 4 Q. Were they generally held when 5 they were scheduled? 6 A. Not necessarily, no. 7 Q. And then after the CRA staff 8 meeting somebody would type up minutes from them, 9 correct? 10 A. Yes. 11 Q. And Exhibit Number 1 is an 12 example of two sets of minutes from two separate 13 meetings, right? 14 A. Yes. 15 Q. And you received a copy of this 16 memo, correct? 17 A. Apparently I did, yes, my name 18 is on the list. 19 Q. Would you read the minutes when 20 they came in to double check to see if they were 21 accurate? 22 A. I would scan them briefly, I 23 would not typically review them in detail. 24 Q. And a change in mapping of an Page 101 1 adverse event term would directly affect your job 2 in the DEU, wouldn't it? 3 A. It could if I had reports like 4 that. 5 Q. So you would be interested in 6 something like that whether or not it eventually 7 changed? 8 A. Sure. 9 Q. Now, again, paragraph seven 10 indicates that there was going to be a change 11 from any self-inflicted injury being reported as 12 intentional injury as opposed to accidental 13 injury, correct? 14 A. It indicates that, yes. 15 Q. If prior to the change in 16 mapping, self-inflicted injuries that were not 17 suicide attempts were entered in the DEU as 18 accidental injuries, wouldn't that drastically 19 change the information that was entered into the 20 DEN, if it was changed from intentional injury to -- 21 MR. MYERS: Let me object to the form 22 in the use of the term drastically changed as 23 being vague and ambiguous, but if you can answer 24 it. Page 102 1 A. The actual text of the report 2 would have been the same and that would not have 3 changed. Apparently a mapping of that 4 information to a specific event term may have 5 been changed. 6 Q. Okay. When somebody goes into 7 the DEN after information is entered and wants to 8 retrieve information, they do that by entering 9 event terms, correct? 10 A. After reviewing a list of all 11 events for a product. 12 Q. So the answer to the question 13 is yes, you use event terms to pull information 14 out of the DEN? 15 A. That's one way to do it, yes. 16 Q. What's another way to do it? 17 A. You can do free text searches. 18 Q. What are free text searches? 19 A. It's you can put in a string of 20 characters. 21 Q. Okay. 22 A. That would -- could identify 23 reports with that string of characters. 24 Q. Okay, so characters were Page 103 1 assigned to free text? 2 A. Actually free text was just 3 free-hand typed information. 4 Q. So you could put in something 5 like, quote, patient suffered apparent suicide 6 attempt by trying to hang himself, unquote? 7 A. Yes. 8 Q. And then as long as you put 9 that exact terminology back into the computer and 10 asked them to pull up anything that contains that 11 information in the free text, you would get that 12 information back? 13 A. It was typically done with a 14 very abbreviated string of letters. If the 15 example you gave involved suicide attempt, you 16 may type in SUI and then scan all reports for 17 those three characters in that order. 18 Q. Was there a policy at Lilly 19 then in a situation like that where somebody 20 tried to kill themselves by hanging themselves, 21 you had to put in specific words within the free 22 text? 23 A. To -- 24 Q. To be able to reretrieve that Page 104 1 or to retrieve that information again later on or 2 was that something that was left up to the CRA? 3 A. What's the question again. 4 Q. I guess I'm trying to 5 understand how it is that you could -- well, 6 let's do it this way. 7 MS. ZETTLER: Larry, do you have an 8 objection to us going out of numerical order on 9 these exhibits? 10 MR. MYERS: No. 11 (PLAINTIFFS' EXHIBIT NO. 29 WAS 12 MARKED FOR IDENTIFICATION AND 13 RECEIVED IN EVIDENCE.) 14 Q. Mister Powell, you have been 15 given Plaintiffs' Exhibit Number 29 -- or I'm 16 sorry, actually Powell Exhibit Number 29. 17 A. Okay. 18 Q. Could you look at that, please? 19 A. Sure. 20 A. Okay. 21 Q. Have you had a chance to look 22 at Exhibit 29? 23 A. Uh-huh, yes. 24 Q. Could you tell us what Exhibit Page 105 1 Number 29 is? 2 A. It would be a copy of the 3 output from the DEN system on an adverse event 4 involving Fluoxetine. 5 Q. Is this a final 1639 that would 6 actually be sent to the FDA? 7 A. On -- it may have been or may 8 not have been, there may have been updates to 9 this, following this report. 10 Q. Okay, but as far as the form 11 itself, not the information that's on this 12 particular form, but this is the form that would 13 go to the FDA? 14 A. Yes. 15 Q. On the right hand side, upper 16 right hand corner of the page, there's a number 17 that says FRS, or letters, I'm sorry. 18 A. Yes. 19 Q. Can you tell us what FR stands 20 for? 21 A. FR means final report. 22 Q. And what does S mean? 23 A. S indicates it's a spontaneous 24 report. Page 106 1 Q. And next to that is the word 2 unexpected. Is that the term that we talked 3 about earlier, unexpected opposed to expected? 4 A. Yes, according to the FDA 5 regulations and the package labeling. 6 Q. In the upper left hand corner 7 there's a date, 9-12-89. What would that date 8 stand for to your knowledge? 9 A. I'd have to guess, I'm not 10 exactly sure. 11 MR. MYERS: Don't guess. 12 Q. Then under the upper right hand 13 corner that says FDA control number, extension 14 number, things of that nature. 15 A. Yes. 16 Q. On the far right, there is a 17 space that says something to the effect of A 18 something, proper I.D. event? 19 A. I can't read it. 20 Q. In the back upper right-hand 21 corner here? 22 A. I know what you're referring 23 to, but I can't make it out. 24 Q. Are these the serious event Page 107 1 outcome criteria that we were talking about 2 earlier, died, treated with RX drug, resulted in 3 prolonged treatment or hospitalization? 4 A. They appear to be some of them, 5 not all of them. 6 Q. Okay. Is this form something 7 that's created by the FDA or something that's 8 created by Lilly, the first page of this exhibit? 9 MR. MYERS: He answered that question 10 earlier. 11 A. I believe it was. 12 Q. I mean this particular form? 13 A. This one itself, I really don't 14 know. I think it -- I don't know, I wasn't in 15 the DEU at the time they developed it. 16 Q. In the upper left-hand corner, 17 it says Department of Health and Human Services, 18 Public Health Service and Drug Administration. 19 Would that indicate to you whether or not this 20 form was created by Lilly or the FDA? 21 A. We could have labeled it that 22 way. 23 Q. Does Lilly have a habit of 24 representing that a form is created by the FDA Page 108 1 when it isn't? 2 MR. MYERS: Don't answer that question, 3 that's argumentative. Ask him another question, 4 Nancy. 5 Q. Is there any reason why Lilly 6 would put at the top of the form in the left-hand 7 corner, the phrase, Department of Health and 8 Human Services, Public Health Service, Food and 9 Drug Administration Drug Experience Report, when 10 this was in fact a report created by the FDA or 11 by Lilly? 12 A. Because that's who the 13 recipient is. 14 Q. There's no address in that box, 15 is there? 16 A. No address -- street address? 17 Q. Right. 18 A. No. 19 Q. On the second page of the 20 exhibit, it starts at the top and says 21 continuation of FD 1639. 22 A. Yes. 23 Q. FD 1639 is the number of the 24 FDA form that's filled out with regards to Page 109 1 adverse drug event reports, right? 2 A. Yes. 3 Q. Underneath that, it says event 4 terms, intentional overdose. 5 A. Uh-huh. 6 MR. MYERS: Yes. 7 A. Yes. 8 Q. And underneath there's a 9 section that says free text, right? 10 A. Yes. 11 Q. Is the free text reported to 12 the FDA? 13 A. Yes. 14 Q. And this is the free text that 15 you were talking about earlier where you said you 16 could call up adverse events by asking queries in 17 the free text field? 18 A. It would be that field plus the 19 fields on the front page which -- any place where 20 there was essentially free typing would be a free 21 text field, that would include the top box where 22 all the information is filled in. 23 Q. Where it says this patient 24 reportedly overdosed intentionally, et cetera? Page 110 1 A. Yes, as well as the section 2 saying autopsy requested. 3 Q. Okay. 4 A. As well as -- looks like 5 section twenty-three, the patient had extreme 6 obesity. 7 Q. Okay. 8 A. Or anywhere on the final page. 9 Q. So to be able to call up 10 something with -- within the free text fields, 11 you could put in things such as overdosed, 12 obesity, heart disease, and it would pull the 13 report up? 14 A. Yes. 15 Q. This report indicates that at 16 least in May of 1989, suicide attempts using 17 drugs were reported as intentional overdoses by 18 Lilly, correct? 19 MR. MYERS: Let me object to the form 20 to the extent your question assumes that it's a 21 suicide attempt. I haven't read it, I don't know 22 what it says. 23 Q. At the top of the first box of 24 free text, it says this patient reportedly Page 111 1 overdosed intentionally with Prozac and 2 concommitant medications. 3 A. Yes, correct. I'm sorry, was 4 there a question? 5 Q. No. Is there any other word 6 for an intentional overdose other than a suicide 7 attempt, is there any other description you can 8 put on that? 9 MR. MYERS: Let me object to the form 10 again to the extent you're asking him a question 11 about an event term which he has testified 12 previously was mapped by use of a dictionary or 13 dictionaries. You are now asking him whether he 14 knows of another term that can be applied, and 15 you're thus starting to call upon him to exercise 16 some sort of clinical medical judgment as to what 17 an intentional overdose is or is not in a given 18 case and that's a medical opinion and I thus 19 object to the form. 20 Q. Mister Powell, if this report 21 were to come to you on a working -- as an initial 22 report, and the reporter were to tell you that 23 the patient overdosed intentionally with Prozac 24 and concommitant medications -- Page 112 1 A. Uh-huh. 2 Q. You would then assign a 3 preliminary term to that event, right? 4 A. Yes, based upon the 5 dictionaries. 6 Q. Okay, and at least at this time 7 in May of 1989, there appears to have been an 8 event term, intentional overdose, according to 9 the second page, correct? 10 A. Yes. 11 Q. And Exhibit Number 1, on the 12 first page of Exhibit Number 1, indicates that as 13 of January, 1992, self-inflicted injury that is 14 not a suicide attempt maps to intentional injury -- 15 I'm sorry, accidental injury, correct? 16 A. Now you're comparing this with 17 this report? 18 Q. No, I'm just asking you. 19 A. What was the question again? 20 Q. Paragraph seven of Exhibit 21 Number 1, first page, indicates that in January 22 7, 1992, that self-inflicted injury was mapped to 23 accidental injury? 24 MR. MYERS: I object to the form, Page 113 1 that's not what it says. 2 Q. Again, the sentence says any 3 self-inflicted injury that is not a suicide 4 attempt, will map to intentional injury instead 5 of accidental injury, correct? 6 A. That's what the statement says, 7 to that point. 8 MR. MYERS: That was not your earlier 9 question. 10 Q. That at least implies that 11 prior to this change in mapping, self-inflicted 12 injury was mapped to accidental injury? 13 MR. MYERS: Before you answer, let me 14 object again to the form since he was not the 15 writer of this document and he cannot imply what 16 the writer meant. 17 Q. That's what the document says, 18 right? 19 MR. MYERS: Same objection. What's the 20 question? 21 MS. ZETTLER: That this implies that 22 prior to January 7, 1992, for the fifth or sixth 23 time now, Larry, that intentional or that 24 self-inflicted injury mapped to accidental Page 114 1 injury. 2 A. It could imply that, it could 3 imply that there were -- that it was mapped in 4 different ways, I don't know. 5 Q. What did you do in preparation 6 for your deposition today, Mister Powell? 7 A. I had a meeting a couple of 8 weeks ago with Larry and Curt. 9 Q. Okay. Did you review any 10 documents? 11 A. No, I did not. 12 Q. Did you review a copy of the 13 ELECT or COSTART Dictionary? 14 A. No, I did not. 15 Q. Did you review any policy with 16 regards to reporting of various adverse events or 17 assignment of event terms? 18 A. No, I did not. 19 Q. When you met with Mr. Myers and 20 Curt, how long did you meet with them initially? 21 A. Approximately two hours. 22 Q. Okay, did you meet with them 23 again after that or anybody else from Lilly? 24 A. I met with them this morning. Page 115 1 Q. How long did you meet with them 2 this morning? 3 A. Half hour. 4 Q. Have you discussed any of the 5 litigation -- Prozac litigation against Eli Lilly 6 with any other Eli Lilly employees? 7 A. No, I have not. 8 Q. Go to the second page of 9 Exhibit Number 1 again, please, paragraph nine, 10 it says compile the ETR comments. What are ETR 11 comments? 12 A. ETR was an elapsed time report. 13 Q. What's an elapsed time report? 14 A. It's a report that came out of 15 the DEN system that measured the number of days 16 from when a report was received by Lilly and when 17 it was entered into the DEN system. 18 Q. Anybody outside of DEU ever 19 complain about Lilly's practices with regards to 20 the assignment of various terms to various 21 events? 22 MR. MYERS: Let me object to the form 23 as overly broad. When you say anyone outside of 24 DEU, it could be anybody in the world outside of Page 116 1 DEU, overly broad. But subject to that, if you 2 can answer, please do so. 3 A. Did anybody -- 4 Q. Did anybody outside your 5 department, the DEU, ever complain about Lilly 6 practices with regards to the assignment of 7 various event terms to various adverse events? 8 MR. MYERS: Same objection, go ahead if 9 you can answer. 10 A. Not that I'm aware of. Anybody 11 other than people in the DEU? 12 Q. Right. 13 A. I don't know -- a physician may 14 have. 15 Q. Do you remember any specific 16 cases where a physician complained about Lilly's 17 assignment of event terms with regards to events 18 that occurred while somebody was on Prozac or 19 Fluoxetine? 20 A. No. I was thinking of an 21 individual report where they disagreed with an 22 event term that was assigned and they had the 23 right to change that. 24 Q. Okay, when you say a physician, Page 117 1 do you mean the initial reporting physician or 2 clinical research physician? 3 A. The clinical research physician 4 reviewed the report and the ELECT term. 5 Q. Okay. Do you remember a 6 situation where a working or final 1639 was ever 7 sent to an initial reporting physician and they 8 objected to the terminology that was assigned to 9 a specific adverse event? 10 A. I don't recall. 11 Q. Do you ever remember a 12 situation where a Lilly employee complained about 13 Lilly's practices with regards to event terms 14 assigned to various adverse events? 15 A. Once again, do I recall if -- 16 Q. A Lilly employee -- do you 17 recall a situation where a Lilly employee has 18 complained to the DEU or clinical research 19 physicians involved with the DEU about Lilly's 20 policy for reporting or assigning terms to 21 various adverse events? 22 A. Reporting or assigning terms, 23 we would get complaints that we reported things 24 that the physicians didn't think were necessary Page 118 1 to be reported. 2 Q. Such as? 3 A. Newspaper articles. 4 Q. Okay. 5 A. Where they're really -- if 6 they're vague, if they're -- just if they're real 7 vague, how can I clarify that? There was an 8 article written that talked about a given 9 patient, we would obviously prepare that report, 10 but then if it said this has also been reported 11 in other newspaper articles this has been 12 referred to -- 13 Q. Okay. 14 A. Does that make sense? 15 Q. Yes. When you say the 16 physician though again, do you mean the clinical 17 research physician? 18 A. Yes. 19 Q. In your job in the DEU, did you 20 have any dealings with people working in the 21 international affiliate of Lilly? 22 A. I reviewed reports which came 23 in from them. 24 Q. Did you ever have any Page 119 1 interaction with any of the people working at the 2 international affiliates? 3 A. At what point in time? 4 Q. Any point in time when you were 5 in the DEU. 6 A. Yes. 7 Q. Under what context would you 8 have a -- have an interaction with someone in one 9 of the Lilly affiliates? 10 A. Anytime we had questions on any 11 of the reports that they sent through the DEN 12 system or to us directly. 13 (PLAINTIFFS' EXHIBIT NO. 2 WAS 14 MARKED FOR IDENTIFICATION AND 15 RECEIVED IN EVIDENCE.) 16 Q. Could you look at Exhibit 17 Number 2, please? 18 A. Yes. 19 Q. Have you a chance to look at 20 Exhibit 2? 21 A. Yes, I did. 22 Q. Who's Hans Weber? 23 A. He's the medical director in 24 Germany, our German affiliate. Page 120 1 Q. Who's Richard Huddleston? 2 A. He was a CRA in the Drug 3 Epidemiology Unit. 4 Q. Is he still with DEU? 5 A. No, he's not. 6 Q. Is he still with Lilly? 7 A. Yes. 8 Q. Do you know where he is within 9 the corporation now? 10 A. I believe he's in the quality 11 assurance, quality control area. 12 Q. Mr. Huddleston's last name is 13 H-U-D-D-L-E-S-T-O-N, right? 14 A. I believe that's correct. 15 Q. Do you know how long it's been 16 since Mr. Huddleston has moved to QA? 17 A. It was before I changed my 18 position, so at least a year ago. 19 Q. Okay. At the top of where it 20 says regarding the questions on Prozac suicide 21 and C-I-O-M-S? 22 A. Uh-huh. 23 Q. What does C-I-O-M-S stand for? 24 A. I don't remember exactly what Page 121 1 the letters stand for. 2 Q. What is C-I-O-M-S? 3 A. It was more or less a group of 4 international people that got together that 5 established guidelines for reporting of adverse 6 events on a worldwide basis. 7 Q. Are they connected in any way 8 with the World Health Organization? 9 A. I don't know. 10 Q. When you say people, are they 11 regulatory authorities? 12 A. I'm not sure who all was 13 involved. 14 Q. Paragraph one of the memo says -- 15 now is there like DEN -- okay, can we call this 16 CIOMS or do you have to go through C-I-O-M-S all 17 the time? 18 A. CIOMS would be fine. 19 Q. The CIOMS criteria would be 20 reports that are serious, unexpected, reasonably 21 causally related. Those are similar to the 22 clinical trial serious events, correct? 23 A. For alert criteria, yes. 24 Q. Now, CIOMS criteria, to your Page 122 1 understanding -- would that be the situation when 2 the events would be reported, period, or is this 3 another time line type of requirement? 4 A. I don't follow that, I guess. 5 Q. It says CIOMS criteria includes 6 reports that are serious, unexpected, reasonably 7 causally related. Now is this criteria under 8 which an event would be reported, period, or is 9 this similar to the alert status where you have 10 to report within fifteen days? 11 A. These would be the immediate 12 reporting criteria, the ten day, fifteen day. 13 Q. Is this U.S. adverse events or 14 just international adverse events? 15 A. It would include both. 16 Q. And would non-serious events 17 under this criteria be reported to CIOMS? 18 A. I don't recall. 19 Q. Who is Gilad, G-I-L-A-D, 20 Gordon? 21 A. He was a research physician 22 with Lilly. 23 Q. Clinical research physician? 24 A. I believe that was his title, Page 123 1 I'm not real sure. 2 Q. And according to this memo, he 3 was charged with monitoring suicides with regards 4 to Prozac on a weekly basis, at least in late 5 1990, correct? 6 A. Yes, that's what the first 7 statement in number two would imply. 8 Q. And the next sentence says 9 increased frequency was monitored at the very 10 least quarterly. Would that indicate to you that 11 the frequency of suicide with Prozac were 12 monitored at least quarterly? 13 MR. MYERS: Let me object to the form, 14 only that he didn't write the memo so he can't 15 interpret what the person meant. He can just 16 confirm what the memo says or does not say. 17 Answer it if you can. 18 A. I guess, I'm not sure exactly 19 what it says. It implies to me that somebody is 20 looking at them at least quarterly, looking at 21 increased frequency of suicides. 22 Q. Okay, what's a highlighted 23 event for compilation? 24 A. That's a grouping of material Page 124 1 that is reviewed quarterly at the DEN quarterly 2 meeting. 3 Q. Are you familiar -- are you 4 familiar with a gentleman named Claude Boushy, 5 B-O-U-S-H-Y? 6 A. The name sounds familiar, I 7 can't recall who he would be, or she. 8 Q. Have you ever heard of the term 9 Pris, P-R-I-S, quarterly? 10 A. Yes, it has to do with DEN 11 output. 12 (PLAINTIFFS' EXHIBIT NO. 10 WAS 13 MARKED FOR IDENTIFICATION AND 14 RECEIVED IN EVIDENCE.) 15 Q. Would you look at Exhibit 16 Number 10, please? 17 A. Okay. 18 Q. Have you had a chance to look 19 over Exhibit Number 10? 20 A. Yes, I have. 21 Q. I'm sorry, what did you say the 22 P-R-I-S quarterly was? 23 A. I don't recall exactly what it 24 stands for, but it's something about a periodic Page 125 1 reporting system on adverse events that come out 2 of the DEN system. 3 Q. Okay. Do you recall the 4 subject matter of Exhibit Number 10? 5 A. No, I do not. 6 Q. When I say recall, I don't mean 7 specifically, I mean generally, okay, and that's 8 consistent throughout this deposition, so like if 9 you think of it in general terms as opposed to a 10 specific date? 11 A. I don't recall this memo. 12 Q. Do you recall that there was a 13 problem with Prozac quarterly submissions 14 produced by PRIS? 15 A. Not that I remember. 16 Q. Do you recall there ever being 17 a program and dictionary error with reporting in 18 regards to adverse events? 19 A. What again? 20 Q. Program and dictionary error. 21 A. Not that I recall. 22 (PLAINTIFFS' EXHIBIT NO. 9 WAS 23 MARKED FOR IDENTIFICATION AND 24 RECEIVED IN EVIDENCE.) Page 126 1 Q. Would you look at Exhibit 2 Number 9, please? 3 A. Okay. 4 Q. Who's Romy Kaiser, K-A-I-S-E-R? 5 A. She was one of the systems 6 analysts that worked with the DEN system. 7 Q. What did the systems analyst do 8 with the DEN system? 9 A. They would ensure that it's 10 operational, trouble shoot, any problems that 11 might come up, answer questions that we may have 12 had. 13 Q. In the memo, who was Lisa 14 DeVault? D-E-V-A-U-L-T? 15 A. She was in the same group and I 16 believe she was a group leader. 17 Q. When you say in the same group, 18 she was in the DEN? 19 A. A DEN systems analyst, yes. 20 Q. In this memo, Ms. DeVault talks 21 about deflagging reports from PRIS. Do you know 22 what she means by that? 23 MR. MYERS: Object to the form as to 24 what she means by that. I don't know whether Page 127 1 you're asking him what that means, what that term 2 means. I object to him testifying as to what the 3 writer means. 4 Q. What does it mean to deflag a 5 report, if you know? 6 A. I don't know in regards to 7 deflagging from PRIS what that would imply. 8 Q. Did you ever use the term 9 deflagging a report in your work at the DEU? 10 A. We used it in regards to the 11 weekly printing process, yes. 12 Q. What does it mean in regards to 13 the weekly printing process? 14 A. That if we had corrected the 15 spelling of a word, if we had made some sort of 16 minor change to a report, it would be deflagged 17 so that it would not then go to the rest of the 18 world again through the CIOMS criteria. 19 Q. So something was flagged if it 20 was inaccurate? 21 A. No. At any time anything was 22 done to a report, and again we're talking the 23 weekly printing reports, anytime anything was 24 done to a given report, it would be flagged to go Page 128 1 again in the weekly mailing. 2 Q. So the corrected report would 3 go again in the weekly mailing? 4 A. The corrected what? 5 Q. I guess I don't understand what 6 you mean by deflagging. 7 A. Anything that was changed on a 8 report, no matter what it was, how insignificant, 9 if somebody went into that report, it would try 10 to be mailed again that week. 11 Q. Okay. 12 A. And you did have the option to 13 deflag that, to stop that if it was one of those 14 insignificant changes. 15 Q. So deflagging means to stop it 16 from going out in the weekly mailing? 17 A. In the actual mailing to the 18 FDA, yes. It would also appear in groups that 19 were reviewed by the medical directors. 20 Q. Okay. So if Lisa DeVault was 21 using deflagging in the same way that you used it 22 within the DEN, she's saying that they talked 23 briefly about keeping the reports from PRIS from 24 going to the FDA in the weekly mailing? Page 129 1 MR. MYERS: I object to the form 2 because it again calls upon him to speculate as 3 to what the writer intends by writing this 4 particular memo, Exhibit Number 9. 5 MS. ZETTLER: No, Larry, my question is 6 if she's using it in the same way as he just used 7 it. 8 MR. MYERS: It doesn't make any 9 difference. 10 MS. ZETTLER: You are going to object 11 to it anyway no matter what. 12 MR. MYERS: It doesn't make any 13 difference. 14 Q. Do you understand the question? 15 A. I really don't know what it 16 would imply from PRIS, we didn't deal directly 17 with the PRIS system as part of the DEU. 18 Q. Okay, but later on in this 19 memo, it says I'll ask Jeff Powell to follow-up 20 with Prozac doctors for their preference. 21 A. That appears to me, according 22 to this paragraph, is in regards to a cut off 23 date for Prozac and that had to do with the 24 quarterly reports or year end reports when they Page 130 1 would be run. 2 Q. So there's two different 3 subject matters that are being covered in this 4 memo? 5 A. That's the way I read the memo. 6 Q. You would read it that there 7 were two different subject matters? 8 A. I would. 9 Q. Okay. For the moment, will you 10 listen to the response -- this is a response to 11 your phone call about PRIS for Prozac, right, 12 that's the first line? 13 A. Right. 14 Q. Next paragraph says we only 15 talked briefly about deflagging reports from PRIS 16 in the Monday meeting since you were not able to 17 attend, period. Irv agreed this was going to be 18 tricky, dot, dot, dot, I'm not sure that we can 19 ever do it from the systems standpoint because 20 you have to take the whole year, parentheses, or 21 quarter, close paren, into consideration, comma, 22 and previous changes during the period may 23 require the report to go even if currently it's 24 been closed out and deflagged from weekly, Page 131 1 period. We have got a couple of more ideas to 2 check out and then we'll let you know, period. 3 Then the next sentence, which looks like a short 4 paragraph, for Prozac, comma, we'll have to 5 manually pull the reports. Now what reports is 6 she talking about there then? 7 MR. MYERS: Same objection as before as 8 to what she means. 9 Q. Romy's query will help identify 10 them, Prozac cut-off date is December 29th. 11 What's a Prozac cut-off date? 12 A. It would be the cut-off date 13 for reporting interval, value, you know, if it's 14 a year, it would always be cut off at the same 15 date. 16 Q. So you're saying that the 17 Prozac cut-off date at least in your mind in this 18 memo is not related to the deflagging of reports 19 from PRIS? 20 A. No, it would be related to 21 PRIS. I mean PRIS -- the way I understand it, 22 PRIS is the printing of those reports or the 23 running of the reports. And that paragraph talks 24 about, you know, what will a cut-off date be and Page 132 1 it appears to be this is around the Christmas 2 holiday time and they were trying to decide 3 exactly when they should be run. But again, I 4 don't recall the specific -- 5 Q. I'm sorry -- 6 A. I don't recall the specific -- 7 specifically what was going on in this memo. 8 Q. Does Lisa DeVault still work 9 for Lilly, as far as you know? 10 A. I believe so. 11 Q. Do you know if she's here in 12 the United States or has she been transferred to 13 an affiliate? 14 A. I believe she's still here. 15 Q. Do you know which department 16 she works in? 17 A. As far as I know, somewhere in 18 the systems group. 19 Q. Do you know a woman named 20 Danielle, D-A-N-I-E-L-L-E, Muzard, M-U-Z-A-R-D? 21 A. Yes, she works or did work at 22 our French affiliate. 23 Q. Have you ever heard the term 24 Ninety-A day report? Page 133 1 A. Do what again? 2 Q. Ninety-A 3 A. The 9-0-A day report, I'm not 4 familiar with that, I don't recall it. 5 Q. Who is Frederique Leredde, 6 L-E-R-E-D-D-E? 7 A. She also works at the French 8 affiliate. 9 Q. Is Danielle Muzard her superior 10 or would she have been her superior? 11 A. Yes. 12 (PLAINTIFFS' EXHIBIT NO. 12 WAS 13 MARKED FOR IDENTIFICATION AND 14 RECEIVED IN EVIDENCE.) 15 Q. Would you look at Exhibit 16 Number 12, please. 17 A. Do you have just one page. One 18 page -- 19 Q. Yes, that's -- 20 A. Because it looks like it's not 21 finished. 22 Q. Yes, that's all that was 23 produced is one page. 24 A. Okay, I have completed it. Page 134 1 Q. Do you have any idea who wrote 2 this memo? 3 A. I believe that I did. 4 Q. Okay. Now, the first line in 5 it says Danielle, congratulations, I have seen 6 the most recent version of the 90A day report. 7 Does this refresh your recollection as to what a 8 90A day report is? 9 A. I could speculate. I mean I 10 know what it is, I think. I don't know. 11 MR. MYERS: Don't speculate. If you 12 know, tell her. If you don't know, tell her 13 that. 14 A. I know what this memo was 15 about, I don't know of a report specifically 16 called the 90A day report. 17 Q. But you used that phrase in 18 this memo, correct? 19 A. Yes. 20 Q. What is this memo about? 21 A. It deals with the French 22 affiliate being behind on the reporting of 23 follow-up information on adverse events. Lilly's 24 policy is that they have to be in to the DEN Page 135 1 system within two days. 2 Q. Okay. And in that context of 3 that purpose, you do not know what the 90A day 4 report is? 5 A. I don't recall what a 90A day 6 report is, I don't know. 7 Q. Okay, after the second 8 paragraph, there are some subparagraphs, were you 9 asking some questions? 10 A. Uh-huh. 11 Q. What's a FMOH? 12 A. The French Ministry of Health. 13 Q. Okay. And under subparagraph 14 number three, there were some, looks like three 15 cases listed. Would that be correct? 16 A. Yes three different reports. 17 Q. Okay. And then there's a -- 18 first one is numbered FR, that would stand for 19 France, correct? 20 A. Correct. 21 Q. 91093922A, what does A stand 22 for? 23 A. It doesn't have any 24 significance that I'm aware of. Page 136 1 Q. Would it be related to the 90A 2 day report mentioned above? 3 A. I don't believe so. 4 Q. Then there's some information 5 that is in parentheses that's been blacked out. 6 Can you tell me what generally that information 7 would be? 8 A. I really don't recall. 9 Q. Do you know if that's a name or 10 a number? 11 A. It could have been either, I 12 don't know. 13 Q. If it were a number, would it 14 be another number assigned by Lilly? 15 A. It could have been a number 16 assigned by the French affiliate. 17 Q. Okay. Do you have any way of 18 knowing whether or not this adverse event report 19 was something that resulted from a clinical study 20 or if it was a spontaneous report? 21 A. I can't tell from the 22 information here, no. 23 Q. If this were something that 24 came from a clinical trial, would there be Page 137 1 information listed on here such as information 2 that might be contained in these parentheses, 3 indicating that it was from a clinical trial? 4 A. I wouldn't know, I don't know. 5 MS. ZETTLER: This is a good place to 6 stop if you want to stop. 7 MR. MYERS: Fine. 8 * * * * * * * * * * 9 A LUNCH BREAK WAS TAKEN WHEREUPON THE 10 PROCEEDINGS RESUMEd AS FOLLOWS: 11 * * * * * * * * * * 12 Q. (BY MS. ZETTLER) Mister 13 Powell, are you familiar with a gentleman named 14 Merle Amundson, A-M-U-N-D-S-O-N? 15 A. I didn't know him personally, 16 but yes, he was over most of the medical CRA type 17 people. 18 Q. Okay. Did he have any advisory 19 capacity or managerial capacity over your 20 department? 21 A. I'm not sure if he did or not. 22 Q. Have you ever dealt with him 23 personally? 24 A. No, none. Page 138 1 Q. I asked you earlier about a 2 Claude Bouchy or Bouchy, B-O-U-C-H-Y. Do you 3 know if Mr. Bouchy is still with Lilly? 4 A. I'm not certain if he ever was. 5 I mean, the name sounded familiar, but I'm not 6 sure what he did or if he did work for Lilly. 7 Q. I believe I asked you about 8 Hans Weber and you said you thought he still was 9 with Lilly? 10 A. I believe so, I believe he's in 11 Germany. 12 Q. To your knowledge, did Mr. 13 Weber or Mr. Bouchy ever complain to the 14 Indianapolis office that adverse event terms were 15 being changed on report forms that they were 16 sending in from foreign affiliates? 17 MR. MYERS: Did they ever complain to 18 whom? 19 MS. ZETTLER: The Lilly office. 20 MR. MYERS: Here? 21 MS. ZETTLER: Yes. 22 A. Not to me directly, to -- 23 Q. To anybody. I mean do you know 24 if either of those two gentlemen either Page 139 1 complained about practices of changing adverse 2 event terms once they sent in report forms? 3 A. Not -- I don't recall them 4 complaining about that specifically. 5 Q. Do you recall them complaining 6 about any procedure at Lilly with regards to 7 reporting of adverse events? 8 A. I recall in general that Hans 9 Weber would have questions. I don't know that he 10 had complaints in particular about anything, and 11 again, I don't recall Claude Bouchy whether he 12 was or what he might have questioned. 13 Q. Let me ask you this, Mister 14 Powell: Did you review any documents for -- 15 A. Do I what? 16 Q. Did you review any document, a 17 document, for the deposition? 18 A. No, I did not. 19 (PLAINTIFFS' EXHIBIT NO. 30 WAS 20 MARKED FOR IDENTIFICATION AND 21 RECEIVED IN EVIDENCE.) 22 Q. Would you take a look at 23 Exhibit 30, please? 24 A. Uh-huh. Is this -- again, it's Page 140 1 not very legible. Is it the best copy -- 2 Q. Yes, that's the best copy that 3 was produced to us. Have you had a chance to 4 take a look at Exhibit 30, Mister Powell? 5 A. Yes, I have. 6 Q. I apologize for the quality of 7 the copy, that's the best we could do. Are you 8 familiar with this interaction between Hans 9 Weber, Claude Bouchy and what appears to be the 10 topic? 11 A. I'm familiar with the general 12 topic. I don't know that I ever saw this 13 particular memo. 14 Q. Do you have any idea -- you 15 aren't copied on this memo, right, either one of 16 these memos? 17 A. No, I'm not. 18 Q. And neither of these were 19 written by you; correct? 20 A. No, not that I recall. 21 Q. Okay. Do you have any 22 knowledge as to why these would have been kept in 23 your personal employee file at Lilly? 24 A. Again, I was a CRA for Page 141 1 Fluoxetine and I was made aware of a variety of 2 issues, I guess, that may have come up, and I 3 assume that's why I had it. 4 Q. Okay. Are you familiar with 5 Mr. Bouchy's and Mr. Webber's questions regarding 6 why suicide -- I'm sorry, why event terms were 7 changed on the reports that they submitted to 8 Indianapolis? 9 A. Repeat the question one more 10 time. 11 Q. Sure. Are you familiar with 12 the situation that's discussed in these two 13 memos? 14 A. I don't recall very many 15 details. Again, what the general discussion of 16 what's going on here, I remember hearing about. 17 Q. Were you involved in these 18 questions and answers at all? 19 MR. MYERS: As relate to this memo 20 specifically? 21 Q. Let me ask you this: What do 22 you recall about the situation that is 23 memorialized in Exhibit 30? 24 A. I guess I'm not sure exactly Page 142 1 what generated it, what caused it. I did -- we 2 had specific ways of mapping event terms and we 3 may have questioned some that came from their 4 affiliates. I'm still not sure who Claude Bouchy 5 is. 6 Q. Would you look at the second 7 page of Exhibit 30, Pz 1573 104? 8 A. Yes. 9 Q. At the top, and again I know 10 it's difficult to read, but it looks like the 11 third line down under regarding adverse event 12 reporting, it says our point is the following, 13 the physician has reported suicide attempt, do we 14 have a right to change it to some terminology 15 which is -- which we, looks like says consider to 16 be more specific, i.e. overdose, but which is not 17 free from ambiguity and could be regarded as 18 inaccurate or misleading. Do you agree that it 19 appears that that's what that says in that 20 section? 21 A. Yes. Again, I can't read some 22 of the words very well, but that sounds like the 23 gist of what they're saying. 24 Q. Okay. So it appears that Page 143 1 they're questioning changing the phrase suicide 2 attempt to overdose; correct? 3 MR. MYERS: Hold on. Before you 4 answer, I object to the form to the extent that 5 you're asking him to comment on what their intent 6 is in writing this and what they're trying to 7 accomplish by writing this, and that would call 8 upon him to speculate since he was not an author 9 of the document. 10 Q. Okay. Would you agree with me 11 that it appears that what they're saying here -- 12 what they're doing here is questioning changing 13 the term suicide attempt to overdose? 14 MR. MYERS: Same objection. Answer it 15 if you can. 16 A. That's the way I would 17 interpret what they've said, it would be 18 questioning the changing of event terms. 19 Q. Then it goes on to say the term 20 overdose is not free from ambiguities because 21 there are clearly forms of overdose which are not 22 related to suicide attempts; correct? 23 A. That's correct, that's what it 24 says. Page 144 1 Q. Do you agree with that 2 statement? 3 A. That deals with the COSTART 4 terms based -- if you see the event term 5 overdose, you could not tell whether it's an 6 intentional or accidental overdose. I guess my 7 impression is that they're talking about the 8 change of the event term, not the changing of 9 what a reporter had said in the text of a report. 10 Q. Right, okay. But given that 11 context, do you agree with their statement that 12 the term overdose is in a sense ambiguous because 13 there are different forms of overdose besides 14 intentional; correct? 15 MR. MYERS: Let me object to the form. 16 You've asked him first whether he agreed with the 17 statement verbatim, now you've asked him whether 18 he agrees with your paraphrasing of the 19 statement. 20 Q. If my paraphrasing of the 21 statement is wrong, please let me know. 22 MR. MYERS: What is the question? 23 Q. My question is: Do you agree 24 that using the term overdose alone is ambiguous Page 145 1 because there are numerous forms of overdose, 2 i.e. intentional, accidental, error in 3 dispensing, error in prescriptions, et cetera? 4 A. There are different types of 5 overdose. 6 Q. Would you agree with their 7 statement in here, the term overdose is not free 8 from ambiguity because there are clearly forms of 9 overdose not related to suicide attempt? 10 A. Ambiguity in that it's not as 11 specific or that it's more general? 12 Q. Let me ask you this -- 13 A. Define ambiguity for me, I 14 guess, I have a vague idea. 15 Q. Let me ask you this, start over 16 again. Would you agree that suicide attempt 17 implies an intentional act? 18 A. Yes. 19 Q. Okay. Would you also agree 20 that overdose used alone doesn't necessarily 21 imply an intentional act on the part of the 22 person who is overdosed? 23 A. Yes, I would agree that would 24 not necessarily imply that. Page 146 1 Q. When Lilly would use the term 2 overdose, would they use it in the context of 3 overdosing on any substance whatsoever, not just 4 Fluoxetine? 5 MR. MYERS: As an event term? 6 MS. ZETTLER: Right, as an event term. 7 A. Yes, any substance. 8 Q. Any substance, not just 9 Fluoxetine? 10 A. Correct. 11 Q. Is it your recollection that 12 suicidal ideation as an event term would be 13 reported as depression by Lilly in the DEN? 14 A. As I recall. 15 MR. MYERS: Let me object to the form. 16 You said suicidal ideation as an event term, do 17 you mean it is an event term or what term would 18 it map to? 19 Q. What term would suicidal 20 ideation map to in the DEN? 21 A. As I recall it, it would map to 22 depression. 23 Q. Do you remember why it was 24 mapped to depression and it wasn't listed as Page 147 1 suicidal ideation? 2 A. I don't recall for that 3 particular event, but in general, the philosophy 4 was that the FDA, they didn't have -- they didn't 5 want to list every possible terminology as an 6 event term, anything that could possibly exist, 7 so they had ways that they grouped them and 8 classified them. 9 Q. And they had their own 10 dictionary, i.e. COSTART, that would indicate 11 what terms they would want events mapped to; 12 correct? 13 A. They had a limited number of 14 terms that they had mapped that way, yes. 15 Q. And I think your testimony this 16 morning was that you had never seen a COSTART 17 dictionary? 18 A. That's true. 19 Q. So -- and the ELECT dictionary 20 is Lilly's version of the COSTART dictionary; 21 correct? 22 A. It's the COSTART dictionary 23 with some modifications made, yes. 24 Q. Has anybody at Lilly ever Page 148 1 represented to you that the term suicidal 2 ideation would be mapped to depression in the 3 COSTART dictionary? 4 A. I don't recall anybody ever 5 mentioning that one way or the other. 6 Q. Do you know for a fact that 7 suicidal ideation is mapped to depression in 8 COSTART? 9 A. No, I do not know that for a 10 fact. 11 Q. But suicidal ideation is mapped 12 to depression in the ELECT dictionary; correct? 13 A. It was mapped that way. Again, 14 if other changes were made after I left, I don't 15 know. 16 Q. What is your recollection as to 17 what suicide attempt without an overdose would 18 map to on the ELECT dictionary? 19 A. I believe there were two 20 different terms over the course of the years. At 21 one time there was a term suicide attempt, no 22 drug used. 23 Q. Okay. 24 A. And as I recall at a later Page 149 1 point in time that was changed simply to suicide 2 attempt. 3 Q. Throughout the time that you 4 worked in the DEU, was depression -- was suicidal 5 ideation always mapped to depression? 6 A. As far as I'm aware, but I 7 really don't recall, I don't remember exactly. 8 Q. How about suicide attempt with 9 an overdose, was that always mapped to overdose? 10 A. Are you asking if I always 11 mapped it that way or could anybody have? 12 Q. Well, I mean was there a policy 13 at Lilly in place at various times as to what 14 events, what term an event should be mapped to? 15 In other words, was there a policy at Lilly that 16 you should map a suicide attempt with an overdose 17 to overdose in all situations? 18 A. I believe we had guidelines to 19 that effect, but we recommended doing that 20 precisely. When that was all put in place, I 21 don't know. 22 Q. Were these written guidelines? 23 A. I don't remember. 24 Q. Was there ever a manual on how Page 150 1 to assign adverse event terms to various events? 2 A. Not -- not that I recall. 3 Q. Have you ever heard the phrase 4 DEN dictionary? 5 A. Yes, I have heard the phrase. 6 Q. What is a DEN dictionary? 7 A. I knew you were going to ask me 8 that. There are certain defined fields in the 9 DEN system where certain -- only certain codes 10 can be used, for instance a country code of FR 11 may stand for France. That would be part of the 12 DEN dictionary. 13 Q. Was there a hard copy form of 14 the DEN dictionary? 15 A. Yes. 16 Q. Did the DEN dictionary include 17 any event terms, to your knowledge? 18 A. Not that I remember, no. 19 Q. Was the DEN dictionary 20 something that was created specifically for 21 Fluoxetine or was that across the board with all 22 Lilly products? 23 A. It would have been across the 24 board. Page 151 1 Q. Have you ever heard of a man 2 named Paul Leber, L-E-B-E-R? 3 A. Yes. 4 Q. Who is Mr. Leber? 5 A. He works for the FDA in some 6 position. 7 Q. Have you ever had any contact 8 with Mr. Leber? 9 A. No, I have not. 10 Q. Are you aware of whether or not 11 anybody from Lilly has had any contact with Mr. 12 Leber directly? 13 A. Not that I'm aware of directly, 14 no. 15 (PLAINTIFFS' EXHIBIT NO. 31 WAS 16 MARKED FOR IDENTIFICATION AND 17 RECEIVED IN EVIDENCE.) 18 Q. Before you take a look at that, 19 Mister Powell, to your knowledge were Mr. 20 Webber's and Mr. Bouchy's questions regarding the 21 mapping of various event terms answered? 22 A. Were they answered in the 23 previous memo? 24 Q. Right. Page 152 1 A. I guess I would have to review 2 it again. 3 Q. Okay. 4 A. Again, I can't read it all 5 precisely, I'm not sure exactly what they're 6 asking other than just the general issue of the 7 use of some of the terms. 8 Q. Okay. Page one of Exhibit 30 -- 9 MR. MYERS: We're still on 30? 10 MS. ZETTLER: Yes, I'm sorry. Who is 11 Allan Weinstein, if you know? 12 A. I believe he's a vice-president 13 over the medical area at this time. 14 Q. Do you know if the group was 15 actually put together to resolve Mr. Webber's and 16 Mr. Bouchy's questions? 17 A. It talks about a group -- I'm 18 not aware of it. 19 Q. Okay. Were the names COSTART 20 and ELECT used interchangeably at Lilly for 21 talking about where the event terms came from? 22 A. In many cases I believe that 23 they were, yes. 24 Q. To your knowledge, did Lilly Page 153 1 report to the FDA that the event terms that they 2 assigned to various events were terms that came 3 from ELECT as opposed to coming from COSTART? 4 A. I'm not aware if that was done 5 or not. 6 Q. Would you take a look at the -- 7 looks like the third paragraph down on page one 8 of Exhibit 30, starts with this nosology, slash 9 classification controversy. Do you have an 10 understanding of what nosology is, 11 N-O-S-O-L-O-G-Y? 12 A. No, I would have to guess. 13 MR. MYERS: Don't guess. 14 Q. And after the end of that 15 sentence, this nosology slash classification 16 controversy rages around us, looks like it says 17 D-R-O's? 18 A. I don't know what that would be 19 referring to, DRO's. There is a DRG, if that's 20 what it says. 21 Q. Okay. What is a DRG? 22 A. It doesn't have anything to do 23 with COSTART terms or anything, it's some sort of 24 payment method involving hospitals. I believe it Page 154 1 stands for Diagnosis Related Groups. 2 Q. What do you mean when you say 3 payment of hospitals? 4 A. Well, a patient may be admitted 5 to a hospital and they're classified under a 6 certain DRG, diagnosis related group, that's some 7 sort of, I think it's an numericode, and then the 8 government would only reimburse up to a certain 9 fee based upon the diagnosis group that a patient 10 was put in. And again, that's from my hospital 11 days many years ago. 12 Q. Were the events terms referred 13 to by number ever? In other words, was suicide 14 attempt ever referred to as, for example, number 15 twenty-seven or something along those lines? 16 A. We never used numbers. Whether 17 or not the system actually assigned a number, I 18 don't know. 19 Q. Okay. Were there numbers 20 listed in the ELECT dictionary? 21 MR. MYERS: Corresponding? 22 Q. Corresponding to various event 23 terms? 24 A. I don't recall. Page 155 1 Q. When you, as a CRA and a DEU, 2 would assign an event term, though, you would 3 write out the actual term, you wouldn't code it 4 with a number or anything of that nature, right? 5 A. Correct. 6 Q. Are you familiar with the word 7 snomed? 8 A. No, I'm not. 9 Q. Are you familiar with any 10 adverse event dictionary or Thesaurus other than 11 ELECT or COSTART? 12 A. No, I'm not. 13 Q. Okay. Go ahead and take a look 14 at 31 now. 15 A. Okay. 16 Q. Have you a chance to take a 17 look at Exhibit 31? 18 A. Yes, I have. 19 Q. Do you know who wrote this memo 20 by any chance? 21 A. I don't know for sure. 22 Q. Do you recall this situation 23 that's talked about in the memo? 24 A. I vaguely recall it. Page 156 1 Q. Do you know who Teicher is? 2 A. Yes, I do. 3 Q. Who is Teicher? 4 A. He's a psychiatrist at McClean 5 Hospital in Boston, he had written an article 6 about Fluoxetine being associated with increased 7 suicidal ideations in a number of patients, I 8 don't recall the details. 9 Q. Okay. Did you ever try to 10 contact Dr. Teicher? 11 A. Did I? 12 Q. Uh-huh, yes. 13 A. Not that I remember, no. 14 Q. Do you know if anybody at Lilly 15 tried to contact Dr. Teicher after he published 16 his article? 17 A. I would be speculating. Again, 18 I don't know. 19 Q. Did you ever have occasion in 20 your position as a DEU, CRA to contact people who 21 published studies or articles regarding 22 Fluoxetine outside of Eli Lilly? 23 A. I don't recall ever having done 24 that, no. Page 157 1 Q. To your knowledge, are there 2 any studies currently being conducted on 3 Fluoxetine that measure suicidality in people 4 taking the drug? 5 A. Not that I'm aware of. 6 Q. On the top of 31, page one, it 7 says telephone call to blank regarding Teicher 8 quote. Do you know who blank is? 9 A. I don't know the name of the 10 person, no. 11 Q. If is says something on the 12 second line, I spoke with blank regarding 13 Teicher's quote and her comments at blank. Do 14 you know where at blank was? 15 A. No, I can't -- I don't recall. 16 Q. Could JHH be John 17 Heiligenstein? 18 A. It could be, yes, I'm not sure 19 what his middle initial is. 20 Q. Who is Leigh Thompson, 21 L-E-I-G-H, Thompson? 22 A. Leigh Thompson has held several 23 positions at Lilly. I believe he started as a 24 research physician, he's currently chief Page 158 1 scientific officer. 2 Q. Were you ever involved in 3 putting together a study on suicidality and 4 Prozac or Fluoxetine? 5 MR. MYERS: Let me object to the form. 6 What do you mean by study, in the clinical trial 7 or do you mean something else? 8 MS. ZETTLER: Any study whatsoever at 9 Lilly. 10 A. Study trying to -- no, I guess 11 I interpret that as a clinical trial study. To 12 me, that's what a study is and no, I have not. 13 Q. Have you ever been involved in 14 reporting the incident or rate of suicidality on 15 people who took Fluoxetine to any regulatory 16 agency like, say, the FDA or any international 17 regulatory agency? 18 A. I worked primarily with 19 spontaneous reports where you can't really come 20 up with an incident rate, so I wouldn't have been 21 involved in anything like that. 22 Q. Have you ever heard the term 23 suicidality update? 24 A. I don't recall specifically. Page 159 1 Q. Do you recall generally? 2 A. During the time of all the 3 publicity about Prozac and suicidality, we would, 4 you know, look at the reports in the system and 5 provide numbers of reports, that type of thing, 6 which was part of the DEN quarterly that we 7 talked about previously, the DEN quarterly 8 report. 9 Q. You would provide numbers of 10 reports to who? 11 A. I provided them to the 12 physicians, the clinical research physicians. 13 Q. Were you ever involved in 14 meetings with regard to Prozac and suicidality? 15 A. I don't recall any specific 16 meetings, I may have been. 17 Q. Would you look back at Exhibit 18 No. 1, please. Would you look at the third page 19 of the exhibit, Pz1573 1018? 20 A. Yes. 21 Q. At the bottom in paragraph six, 22 it says the new dictionary does not contain all 23 the synonyms terms that are in the DEN 24 dictionary. Earlier, you testified that to your Page 160 1 knowledge the DEN dictionary did not contain 2 terms? 3 A. That's correct, as I understand 4 it. 5 Q. Are you aware of any other of 6 the synonym terms in either the ELECT dictionary 7 or the DEN dictionary other than event terms? 8 MR. MYERS: Let me object to the form, 9 he said the DEN didn't contain event terms, you 10 just included it. 11 Q. Right. What I want to know -- 12 well, let me ask it this way: When you say 13 something is mapped to a term -- 14 A. Uh-huh. 15 Q. -- overdose is the term that a 16 given event may map to; correct. 17 A. Yes. 18 Q. And various given events that 19 could map to overdose are considered to be 20 synonyms; correct? 21 A. Yes, I believe that's how 22 they're labeled in the dictionary. 23 Q. Okay. Are there any other 24 synonyms other than the event terms, such as Page 161 1 overdose and the synonyms under overdose, that 2 are included in the ELECT dictionary? 3 A. I guess I don't follow that. 4 You've talked about the synonym terms and the 5 mapping, and from there what was the question 6 again? 7 Q. Okay. Other than the synonyms 8 that are used with the event terms, like 9 overdose, synonyms may be intentional overdose, 10 accidental, et cetera, did you ever use the word 11 synonym for any other words listed or terms 12 listed in the ELECT dictionary? In other words -- 13 MR. MYERS: Are you asking him whether 14 there's another set of synonyms for something 15 other than event term mapping? 16 MS. ZETTLER: Yes. 17 A. Not that I'm aware of. 18 Q. How about the DEN dictionary, 19 is there another set of synonyms that are 20 contained in the DEN dictionary? 21 A. Not that I'm aware of. Again, 22 that was very specific things like country codes 23 and -- I'm not aware of any synonyms. 24 Q. So do you have any idea what Page 162 1 this person means when they say the new 2 dictionary does not contain all the synonym terms 3 that are in the DEN dictionary? 4 MR. MYERS: I object to the form, only 5 to the extent that it calls upon him to 6 speculate, but if he can -- 7 A. Again, that's what I would have 8 to do, I would have to speculate. 9 MR. MYERS: Don't do that. 10 THE WITNESS: Okay. 11 Q. Again, you're listed as being 12 sent the meeting minutes, right? 13 A. Uh-huh. 14 MR. MYERS: Yes? 15 A. Yes, I am. 16 Q. This memo appears to have been 17 written by Sarah McKenzie, right? 18 A. Yes. 19 Q. After the reference to the DEN 20 dictionary, she states an attempt was made to 21 clean up the dictionary which may cause some 22 problems for us. Do you have any idea what she 23 means by that? 24 MR. MYERS: Same objections. If you Page 163 1 know. 2 A. There were -- when the 3 dictionaries were -- periodically the 4 dictionaries would change or be updated when the 5 COSTART dictionary was updated, and in 1992 -- I 6 think in 1992, we went strictly to the COSTART 7 dictionary which changed -- no, it didn't change 8 it actually, some of the synonym terms that we 9 had listed in the previous dictionary were no 10 longer included, so there was not a direct map, 11 they were more or less just left up in the air. 12 You could not go to the dictionary and find that 13 mapping. 14 Q. And when you say some of the 15 terms from the other dictionary, you mean the 16 ELECT dictionary? 17 A. The ELECT, yes. 18 Q. So the ELECT dictionary had in 19 some cases more synonyms between or listed under 20 terms than the COSTART dictionary? 21 A. Correct, although I never saw a 22 COSTART dictionary. 23 Q. Okay. Referring back to the 24 first page of Exhibit 1, under paragraph seven Page 164 1 again. Would that have been a situation where 2 there was a synonym listed in the ELECT 3 dictionary that was not listed in COSTART? 4 A. I would have to guess. 5 MR. MYERS: Don't guess. 6 Q. Did anybody ever tell you that 7 a synonym for accidental injury at one time under 8 the ELECT dictionary was suicide attempt? 9 A. I don't recall. 10 Q. Have you ever, in your position 11 as a CRA in the DEU, listed a suicide attempt as 12 an accidental injury? 13 A. I have no way of remembering 14 that, I don't know. 15 Q. Suicidal ideation and suicide 16 attempts on people using Prozac was an important 17 issue to Lilly, wasn't it? 18 A. Excuse me, please repeat the 19 question. 20 Q. The issue of suicidality in 21 people who use Prozac or Fluoxetine was a serious 22 issue to Lilly, wasn't it? 23 A. Certainly. 24 Q. They would want you to be very Page 165 1 careful of how you reported various adverse 2 events as they related to suicidal ideation and 3 suicide attempts, wouldn't they? 4 A. We were very cautious of how we 5 mapped them, that we mapped them consistently, 6 yes. 7 Q. Were you ever aware of a policy 8 that Lilly had with regards to the phrase 9 overdose as it applied as an adverse event term? 10 A. We mapped reports to overdose. 11 Q. Okay. Which types of reports 12 would map it to overdose to the best of your 13 recollection? 14 A. A report that talked about an 15 overdose, be it intentional, accidental. 16 Q. Why was it that Lilly would put 17 both intentional and accidental overdoses under 18 the category of overdose as opposed to breaking 19 them down into intentional or unintentional, 20 accidental? 21 A. As I recall, they were being 22 done inconsistently originally, that certain CRAs 23 would map them one way and other CRAs would map 24 them another way. And to clarify it and Page 166 1 standardize it, I don't remember where the word 2 came from, but that is how we did it at a certain 3 point in time so that they were done 4 consistently. 5 Q. Are there occasions when one 6 patient may suffer more than one adverse event at 7 a time? 8 A. That's possible, sure. 9 Q. In those situations, were all 10 adverse events entered into the DEN? 11 A. Anything we heard about would 12 have been entered. Again, you're talking about 13 spontaneous reports? 14 Q. Right. 15 A. Yes, they would all be entered 16 into the DEN system. 17 Q. How about clinical trial 18 reports, would the nonserious adverse events be 19 enterred into the DEN? 20 A. The nonserious? 21 Q. Right. 22 A. No, they would not. 23 Q. Would all the serious clinical 24 trial adverse events be entered into the DEN? Page 167 1 A. Yes. 2 Q. If an event term was changed, 3 okay, under the new dictionary, going from the 4 ELECT to the COSTART, how would that be handled 5 in the computer system, the DEN? 6 MR. MYERS: Excuse me, you said 7 referring to the Exhibit 1, what are you 8 referring to to ask him that question? 9 MS. ZETTLER: I'll strike it. 10 MR. MYERS: I'm sorry. 11 A. So the question is again? 12 Q. Let me ask it this way: At 13 some point you went from ELECT to COSTART; 14 correct? 15 A. Yes. 16 Q. And it appears that there may 17 have been some confusion, for lack of a better 18 phrase, on how to handle certain events where a 19 synonym was in ELECT but not in COSTART; correct? 20 A. Yes. 21 Q. Just for purposes of an 22 example, let's say that under ELECT accidental 23 overdose maps to overdose, okay? 24 A. Uh-huh. Page 168 1 Q. And under COSTART, accidental 2 overdose does not map to overdose. 3 A. Okay. 4 Q. How would that resolve, how 5 would the controversy between the ELECT 6 dictionary and COSTART dictionary resolve? 7 A. I don't recall. As I recall, 8 that was about the time I was leaving the drug 9 epidemiology unit. 10 Q. Okay, do you know if there were 11 any plans made or if anybody actually went back 12 and reassigned COSTART terms to the ELECT terms 13 that were different from the COSTART terms? 14 A. I don't recall. 15 Q. Do you know who made the 16 decision to go from ELECT to COSTART? 17 A. Somebody in management, I would 18 assume, I don't know. 19 Q. Do you know why they decided to 20 go from ELECT to COSTART? 21 A. No, I do not. 22 Q. Do you know why they used the 23 ELECT dictionary instead of COSTART to begin 24 with? Page 169 1 A. No. Again, that was in place 2 before I came to the DEU. 3 Q. Do you ever personally have any 4 questions about assigning event terms such as 5 depression to suicidal ideation or intentional 6 overdose or just to overdose? 7 A. About those two in particular? 8 Q. Uh-huh. 9 A. No. 10 Q. Did you ever have any questions 11 about how -- when I say questions, I mean -- 12 let's put it this: Were you ever uncomfortable 13 with assigning certain event terms to certain 14 events under the ELECT dictionary? 15 A. Any terms? 16 Q. Right. 17 A. Yes, there were some that the 18 FDA had mapped completely different than what 19 they mean. 20 Q. Such as? 21 A. There were terms that were 22 very, very rarely used, and I just remember 23 hearing of the examples, and they were some kind 24 of oculary technique that -- but they meant Page 170 1 exactly the opposite of what the event term said. 2 Q. How do you know that it was an 3 event term assigned by the FDA? 4 A. When we went to -- I don't 5 know, I've never seen the COSTART dictionary, but 6 I was under the impression that we got an exact 7 copy of the dictionary that was put into place. 8 Q. I guess I'm a little confused. 9 You got an exact copy of the dictionary that was 10 put into place, what does that mean? 11 A. I believe we received an 12 electronic copy of the dictionary that was 13 somehow put into our system. 14 Q. The COSTART dictionary? 15 A. Yes, and then I think we again 16 added those two terms. And I think somebody at 17 Lilly, at some time, had a COSTART dictionary, 18 yes. 19 Q. And how is it that you found 20 out that under the COSTART dictionary specific 21 terms mapped to other terms that were opposite 22 than what the original term meant? 23 A. Somebody just ran across them 24 apparently, whether it was by chance or whether Page 171 1 there was some sort of computer check, I don't 2 know how that was done. 3 Q. Was a computer check ever done 4 on ELECT event terms of overdose or depression? 5 A. Was there a computer check when 6 the dictionaries were changed? 7 Q. No, was there a computer check 8 or was there ever a determination made similar to 9 the ocular event that you just talked about as to 10 how the COSTART would have listed an event under 11 overdose or suicide attempt? 12 A. I don't know if that was ever 13 done or not, no. 14 Q. Have you ever heard that Lilly 15 would map all forms of overdose under overdose 16 because it became a more serious event? 17 MR. MYERS: Let me object to the form 18 to the extent you used the word serious and I 19 don't know whether you're using it in its numeric 20 sense or regulatory sense. 21 MS. ZETTLER: Regulatory sense. Unless 22 I specify otherwise, it will be the regulatory 23 sense. 24 MR. MYERS: I object to the form Page 172 1 because you can't make it any more serious, it's 2 either serious or not given the definition you 3 gave. 4 Q. The question is: Did you ever 5 hear of a Lilly policy wherein various terms 6 would be mapped to overdose because overdose was 7 a more serious event, i.e. overdose was more 8 serious under the regulatory definition than a 9 suicide attempt? 10 MR. MYERS: Also I object to the form 11 because it assumes there was such a policy and I 12 don't know if there was or not. Have you ever 13 heard of such a thing? 14 THE WITNESS: I still don't follow it. 15 Q. Was there a policy at Lilly, 16 first of all, that suicide attempts would map to 17 overdose? I believe you testified earlier that 18 it would be mapped to overdose. 19 MR. MYERS: If a -- 20 Q. If it involved an overdose. 21 A. Uh-huh. 22 Q. Was that a policy at Lilly? 23 A. A policy or practice, yes. 24 Q. Did anybody ever tell you that Page 173 1 those various synonyms were mapped to overdose 2 because overdose automatically became a more 3 serious even than, say, a suicide attempt in and 4 of itself? 5 A. I don't recall. 6 MR. MYERS: I object to the form, 7 again, because as he told you before if it's an 8 overdose, it is serious, it can't be more 9 serious. 10 Q. Is a suicide attempt in and of 11 itself always a serious event according to the 12 FDA? 13 A. No, it is not. 14 Q. Now somebody at Lilly or did 15 anybody at Lilly ever tell you that you always 16 put a suicide attempt with an overdose under 17 overdose because that made it an automatic 18 serious event? 19 A. I don't recall. 20 Q. Did anybody ever tell you at 21 Lilly that the reason you would map overdose, 22 intentional overdose, accidental suicide attempt 23 with an overdose to overdose because then it 24 would become more specific? Page 174 1 A. I don't recall anybody ever 2 saying that directly, no. 3 Q. As far as you recall, the only 4 reason that they decided to use overdose for 5 those various synonyms was because there was a 6 problem with consistency in reporting by the CRA, 7 right? 8 A. That's what I recall, yes. 9 MR. MYERS: We've been going about an 10 hour, can we take a real short break? 11 MS. ZETTLER: Sure. 12 (A SHORT RECESS WAS TAKEN.) 13 (PLAINTIFFS' EXHIBIT NO. 14 WAS 14 MARKED FOR IDENTIFICATION AND 15 RECEIVED IN EVIDENCE.) 16 Q. Would you look at Exhibit 17 Number 14, please, Mister Powell? 18 A. I have completed the review. 19 Q. Okay. Just for the record, 20 have you had a chance to review Exhibit Number 21 14? 22 A. Yes. 23 Q. Can you tell us what Exhibit 24 Number 14 is? Page 175 1 A. Just what the title says, it 2 talks about the spontaneous reporting system that 3 the FDA division of epidemiology and surveillance 4 has set up. Basically what the system is for, 5 some of the limitations. 6 Q. Are you familiar with that 7 document, have you seen it before? 8 A. Not that I recall. 9 Q. Do you know why it would have 10 been produced as having been part of your file at 11 Lilly? 12 A. I don't recall. 13 Q. Spontaneous reporting system I 14 believe is a computerized system at the division 15 of epidemiology and surveillance at the FDA; 16 correct? 17 A. Yes. 18 Q. Would this be the division that 19 the 1639 reports would be sent to at the FDA? 20 A. I'm not sure exactly where they 21 go once we mail them to the FDA. 22 Q. Would you look at the second 23 page of the exhibit, Pz1573 1076? 24 A. Uh-huh. Page 176 1 Q. In paragraph four, it says 2 since reporting is voluntary, it depends on many 3 factors, this leads to reporting artifacts which 4 must be kept in line by anyone reviewing this 5 data. And then it lists A through J, looks like, 6 artifacts or factors to be taken into 7 consideration. Were you ever aware of any of 8 these items listed in A through J before? 9 A. I guess a lot of them, I saw it 10 as common sense, I don't know that I've seen them 11 on a list like this. 12 Q. Were you aware that it was 13 important to the FDA to know the size of the 14 manufacturer's sales force, for instance? 15 A. I realized it would have an 16 impact on the number of reports. 17 Q. Why is that? 18 A. The more contacts a sales 19 representative would have with physicians or 20 pharmacists, whomever, the more chances are that 21 an event would be reported, that something would 22 come up in the conversation. 23 Q. Do you know if Lilly had 24 training for their sales force for collecting Page 177 1 adverse reactions? 2 A. Yes, they did. 3 Q. What did that training entail, 4 if you know? 5 A. Representative from the DEU 6 actually met with the new sales training members 7 just to discuss a way to report events, the 8 policy Lilly has on reporting events. They also 9 came in for a follow-up class, either after being 10 in the field for six months or twelve months, 11 again as a refresher course, to remind them of 12 our policy. 13 Q. Did you ever conduct one of 14 these meetings or class with the sales force? 15 A. Yes, I did. 16 Q. And what was Lilly's policy 17 with regard to what information should be 18 collected by the sales force representatives with 19 regards to adverse reactions? 20 A. I guess there were a few 21 essentials that we asked them to always capture, 22 and then depending on the willingness of a 23 reporter to report an event or experience, just 24 to find out what they could. I don't know that -- Page 178 1 they would not always come up with a detailed 2 report. 3 Q. Okay. What were the essentials 4 that you wanted them to capture from the 5 reporter? 6 A. The name of the reporter, the 7 product involved and the adverse event and any 8 serious outcome. 9 Q. And they were aware of the 10 regulatory criteria for serious outcomes? 11 MR. MYERS: Hold on. Let me object to 12 the form. Are you asking if they knew or whether 13 he told them, because he can't know what they 14 know. 15 Q. Did you make the sales force 16 aware -- sales representatives aware of what the 17 regulatory definition of a serious outcome was? 18 A. I believe that was part of the 19 training class. 20 Q. Okay. Now did the sales force 21 have forms that they were to fill out when they 22 got these reports from the reporters? 23 A. No, they called the DEU, they 24 had twenty-four hours to call the DEU. Page 179 1 Q. Would this be a hotline, DEU 2 hotline? 3 A. Yes. 4 Q. Was that used for all adverse 5 events or just for serious adverse events? 6 A. For all adverse events. 7 Q. Was it Lilly's policy that if 8 the sales representative of any adverse event, be 9 it serious or nonserious, they were to report it 10 to Lilly within twenty-four hours? 11 A. Yes. 12 Q. Would you turn to page three of 13 Exhibit 14, Pz1573 1077? 14 A. Uh-huh. 15 Q. What is that extension number? 16 Did they use extension numbers on Lilly forms? 17 MR. MYERS: Whether the FDA did? 18 MS. ZETTLER: No, whether Lilly did. 19 A. We used our manufacturer 20 control numbers is how we identified the reports. 21 This is apparently a number that they assigned. 22 Q. Were you ever made aware of 23 what the FDA extension number was for any given 24 report made by Lilly? Page 180 1 A. No, I was not. We sent the 2 reports in and we didn't hear back. If they had 3 a question on a report, they would give us our 4 number. 5 Q. So your understanding that the 6 events listed in the 1639 that Lilly sent to the 7 FDA were entered into the spontaneous reporting 8 system? 9 A. Of the FDA? 10 Q. Right. 11 A. They essentially assigned their 12 own event terms. The way I understand it, they 13 had -- we had unlimited numbers of event terms 14 that could be listed on a given report, and I 15 believe they had maybe four that could be listed 16 for a given report. So they would select the 17 most, in their opinion, the most appropriate or 18 significant event term out of the report to put 19 into their system. 20 Q. When you say the most 21 significant, do you mean the most significant or -- 22 I'm sorry, the most serious under the 23 regulations? 24 A. I would be guessing, Page 181 1 speculating, as to how they selected those. 2 Q. To your knowledge, did anybody 3 at Lilly ever compare the event terms assigned to 4 a particular event by Lilly with the event terms 5 assigned to that event by the FDA? 6 A. I don't know if it was done 7 directly or not. 8 Q. Did anybody at the FDA ever 9 question Lilly's practice of assigning the term 10 overdose to intentional overdose, accidental 11 overdose, suicide attempt with overdose, 12 prescription error, things of that nature? 13 A. Not that I am aware of. 14 Q. Did they ever question Lilly's 15 assigning the term depression to a suicidal 16 ideation? 17 A. Not that I am aware of. 18 (PLAINTIFFS' EXHIBIT NO. 26 WAS 19 MARKED FOR IDENTIFICATION AND 20 RECEIVED IN EVIDENCE.) 21 Q. Would you look at -- I'm not 22 sure if it's twenty-six or twenty -- it's a 23 one-page exhibit, Pz172 956. 24 MR. MYERS: Twenty-six. Page 182 1 A. I have reviewed Exhibit 26. 2 Q. Is that a memorandum authored 3 by you? 4 A. It appears so, yes. 5 Q. I think I probably asked you 6 this before, but who is Gordon Gilad, G-I-L-A-D? 7 A. He was one of our clinical 8 research physicians. 9 Q. Was he at Lilly? 10 A. Yes. 11 Q. By the way, what does OUS mean? 12 A. Outside the United States. 13 Q. About halfway down the memo, 14 after the parentheses part, it says example, 15 overdose using someone else's Prozac, close 16 paren. 17 A. Okay. 18 Q. It says a report is included in 19 only one category based upon the most severe 20 event described in the report, paren, act, comma, 21 fatal? 22 A. Okay. 23 Q. I'm not sure if that's supposed 24 to be an arrow or greater than act, another Page 183 1 arrow, ideation, close paren. What do you mean 2 by that sentence? 3 A. We actually took the Prozac 4 reports that in any way involved suicidality and 5 looked at them to see whether or not they 6 involved a -- well, suicidality in any way and 7 then across suicidality, whether they involved a 8 fatal act of suicide, an act that was not fatal, 9 or whether there was ideation and no act. And 10 then we -- Gilad received a report of those 11 numbers based upon the review of the report. 12 Q. So I understand this, in other 13 words if somebody actually completed the act of 14 suicide, you wouldn't list it under suicidal 15 ideation, although obviously if they killed 16 themself they probably experienced suicidal 17 ideation, right? 18 A. If we had information in the 19 text of the report, we would leave that the way 20 it was, we would assign event terms based on the 21 mapping and dictionaries for all of those, but 22 for the sake of this report, in grouping these 23 and tracking numbers of reports, we would follow 24 this, this fatal act versus ideation. Page 184 1 Q. Fatal act is not an event term; 2 correct? 3 A. No. 4 Q. Ideation is not an event term 5 either, is it? 6 A. Correct. 7 Q. When was this report done, to 8 your knowledge? 9 A. I don't recall, I don't know. 10 Q. Is there any reason why there 11 isn't a date on this memorandum? 12 A. Not that I can think of. 13 Q. Is there generally a date on a 14 memorandum? 15 A. I don't know, I look at 16 messages every day. I assume there's a date 17 there somewhere. 18 Q. Okay. The last -- well, 19 besides the please contact me if you have any 20 questions, the last full sentence, looks like it 21 says the listings do not contain reports that may 22 have been received prior to October 12, 1990. 23 That was not in the DEN as of that date? 24 A. Uh-huh. Page 185 1 Q. Does that refresh your 2 recollection as to when this report may have been 3 put together? 4 A. Well, by reading it, it would 5 be somewhere around October 12, 1990. It could 6 have been a week after, a month after, I don't 7 know. 8 Q. Prior to October 12, 1990, were 9 the event terms that we discussed used, for 10 instance, overdose, used for suicide attempt with 11 an overdose, intentional overdose, accidental 12 overdose, were these used to enter the 13 information into the DEN? 14 A. I don't recall dates when that 15 was done or not done. 16 Q. At any time while you were in 17 the DEU, did they ever switch from using suicide 18 attempt from suicide to fatal act for suicide as 19 an event term? 20 A. There was not an event term of 21 fatal act suicide. 22 Q. How is it determine whether or 23 not an act was a fatal act as opposed to a 24 suicide attempt? Page 186 1 A. By reviewing the text of the 2 report and the serious outcome of death, and in 3 conjunction with a suicide attempt term. 4 Q. If you wanted information on a 5 completed suicide, could you pull up all reports 6 with a serious outcome of death and look at it 7 that way? 8 A. I don't recall if I could have 9 at this time. There was a change made to DEN 10 where you could do outcome searches, outcome 11 meaning the serious criteria. Exactly when that 12 was put into place, I don't recall. 13 Q. Okay. 14 A. The other way of going about it 15 was to print all suicides and manually look 16 through them or the systems analyst could 17 actually go in and do that also, go in and 18 identify them through their means or program. 19 Q. But earlier you testified that 20 suicide attempt with overdose was not listed as 21 suicide attempt, it was listed as overdose, 22 right? 23 A. Once again? 24 Q. Earlier you testified that a Page 187 1 suicide attempt, including an overdose, by 2 injection of, for example, an overdose of 3 Fluoxetine, was not listed as suicide attempt, it 4 was listed as overdose, right? 5 A. That's correct, and in this 6 review we would include overdose, it was a very 7 broad look at all terms that could be related to 8 it. 9 Q. How would -- other than looking 10 through -- other than pulling up all overdoses 11 and looking through the reports manually, how 12 would you be able to differentiate the category 13 of overdose, which of those overdoses were in 14 fact suicide attempt, with an overdose of 15 substance? 16 A. The way to do that would be to 17 review them. 18 Q. Sit there and look through each 19 and every single hard copy, 1639; correct? 20 A. Yes. I remember it being great 21 fun. 22 Q. You actually -- you've actually 23 done that, sat and looked through 1639s to 24 determine what was a suicide and what was a Page 188 1 nonintentional overdose? 2 A. I've done what again? 3 Q. You've actually looked through 4 the 1639s to try to differentiate which of the 5 overdoses referred to as a suicide attempt as 6 opposed to an accidental overdose? 7 A. I pulled them all out, reviewed 8 them, and what we did with them we separated them 9 into stacks, like these are very clearly suicide 10 attempts, these we can't really tell from the 11 texts of the report, these we don't think are, 12 those were then reviewed by the research 13 physicians to agree or disagree with that. I did 14 review them, yes. 15 Q. They would go through each 16 category, though, the ones you were sure were 17 suicide attempts, the ones you weren't sure 18 either way, and the ones you were sure were not? 19 A. Yes. 20 Q. Would that be the final 21 arbitors of what would be considered a suicide 22 attempt and what was not? 23 MR. MYERS: The research physicians? 24 MS. ZETTLER: Right. Page 189 1 A. The research physicians and -- 2 yes, they had the final sign-off on all the 3 reports. 4 Q. Who were the research 5 physicians that you worked with during this 6 period of time where you had to review the 1639s 7 to differentiate between suicide attempt and a 8 nonsuicide attempt? 9 A. I don't recall, we had several 10 Fluoxetine physicians. 11 Q. Can you give me the names of 12 the Fluoxetine physicians that you worked with 13 generally while you were at the DEU? 14 A. John Heiligenstein, Carl 15 Beasley, Jamie Street. I can't recall others 16 specifically. 17 Q. Dr. Goldstein? 18 A. David Goldstein, yes. 19 Q. Who -- how about Jim Kotsanos? 20 A. He worked on Fluoxetine at some 21 point in time, whether it was while I was in the 22 DEU, I don't recall. He also worked in a 23 pharmacoepidemiology area. 24 Q. How about Dan Masica, Page 190 1 M-A-S-I-C-A? 2 A. Dan Masica was the medical 3 director of the area. 4 Q. Would he have input as to 5 whether or not it would be considered a suicide 6 attempt or accidental overdose? 7 A. I don't recall conferring with 8 him specifically, the physicians may have. 9 Q. On exhibit -- 10 A. And again, it would be -- they 11 never changed the text of the report, which is 12 what we got from the reporter, they may have 13 decided how to categorize them for our internal 14 review in looking at the different categories, 15 whether it was one of these three categories. 16 Q. Was there a situation when you 17 were rereviewing the 1639s when somebody said we 18 listed this event as an overdose, but it was a 19 suicide attempt by somebody trying to hang 20 themself? 21 A. I don't recall that 22 specifically, but that may have happened. 23 Q. Okay. And in that situation 24 would you go back in and then change the event Page 191 1 term in the DEN? 2 A. If it was obviously incorrect, 3 yes. 4 Q. Was a determination whether or 5 not a person's overdose was in fact a suicide 6 attempt, was that a judgment call on the part of 7 the CRP? 8 A. Physicians? 9 Q. Clinical research physicians. 10 A. Again, was it -- 11 Q. A judgment call on their part? 12 A. If it was -- again, -- 13 Q. Whether or not it was a suicide 14 attempt? 15 A. It depends on what the words in 16 the text said. I mean, if the text mentioned 17 suicide attempt, if that's what the reporter had 18 related to us, essentially there's no judgment at 19 that point. Some of the reports were very, very 20 sketchy with very few details, and it was their 21 opinion based on what information was available, 22 yes. 23 Q. Can you give me an example of 24 what a sketchy report would be? Page 192 1 A. A patient was found dead with 2 several bottles of medication by them, and that 3 may be all we ever got. 4 Q. Okay. What other information 5 would you or the clinical research physician 6 would have liked to have had to be able to make a 7 determination as to whether or not in that 8 scenario it was an actual suicide attempt? 9 A. Drug levels, possible drug 10 levels, autopsy results, history of the patient, 11 you know, whether they were -- whether it was 12 their product or not, whether they were on 13 Fluoxetine or whatever products. Again, the 14 details that we went back to on every report, 15 just as much detail as we could get. 16 Q. Why is a person's history 17 relevant to the determination of whether or not 18 they suffered a particular adverse event while 19 being on Fluoxetine? 20 MR. MYERS: Before you answer, let me 21 object to the form only to the extent that you 22 now have moved into matters of medical clinical 23 judgment, but he's obviously not a physician, but 24 subject to that if you can answer that as a lay Page 193 1 person, go ahead. 2 A. Yes, if I could have the 3 question once again? 4 (THE COURT REPORTER READ BACK THE 5 REQUESTED TESTIMONY.) 6 A. Depending on the event and the 7 history, an example would be a patient who has 8 had three or four myocardial infarctions, they 9 started Fluoxetine and three years later they had 10 a myocardial infarction. It helps put it in 11 perspective to know that they have certain risks 12 factors that could have something to do with an 13 event that happened or that was reported. 14 Q. Just because something is 15 reported as an adverse event, that in and of 16 itself doesn't denote any causal relationship 17 between the event and the use of the drug; 18 correct? 19 A. That's correct. In fact even 20 the terminology of adverse event is somewhat 21 misleading. You'll hear them talk about as 22 adverse experiences or -- essentially a 23 manufacturer is obligated to report anything they 24 hear about, whether or not it's associated with Page 194 1 the drug. I followed up on reports where the 2 physicians -- you know, it's a report that came 3 through a sales rep and the physician said I 4 don't want to report that, it's not an event, it 5 doesn't have anything to do with your drug, we 6 were just talking about something and this came 7 up in the conversation for some reason. 8 Q. Do you have a specific example 9 of that situation that you can give us? 10 A. I don't recall any specifics, 11 it wasn't an uncommon situation. 12 Q. Can you tell me generally the 13 types of things that a doctor would not want to 14 report because he or she did not feel it was 15 something that was related to the use of Prozac? 16 MR. MYERS: Are you asking for an 17 example, what he's experienced? 18 MS. ZETTLER: Yes. 19 A. I can't think of any. The 20 situation would be where a physician would be 21 trying to get medical information, and in the 22 course of the conversation that they're just 23 exploring all kinds of different possibilities, 24 they don't think it's probably related to the Page 195 1 drug, but if our medical information area hears 2 about it again through the sales rep, it's 3 reported as a possible adverse event. 4 Q. So let me make sure I have this 5 straight. A physician may call Lilly and say I 6 have a question about Prozac, using Prozac in a 7 situation X, and during that conversation they 8 may say well, one of my patients became nauseous 9 or something, for example, while I used it, and 10 he's suffering from an ulcer, and I want to know 11 if the nausea is related, I don't think it is, 12 but I want to know. If he said that I don't want 13 to report this because I don't feel it's related, 14 then it will not be reported unless you hear 15 about it again through the sales rep? 16 A. No, if he reported it to the 17 medical information area, it would be reported. 18 If he reported it to any Lilly representative, 19 whether he intended to report it or not. 20 Q. Then would his wishes be 21 followed if he said I don't want to report it, 22 would you then not report it to the FDA or would 23 you still report it to the FDA? 24 A. We would report it. Page 196 1 Q. And his name would be put down 2 as the initial reporter on the 1639? 3 A. Yes. 4 Q. To go back to 26, Exhibit 26. 5 I guess I'm a little confused as to where it says 6 the report is included in only one category based 7 upon the most severe event described in the 8 report. Included in what, included in the 9 computer printout? 10 A. It's whatever the attachment 11 was to this memo. We looked at reports, a given 12 report could say a patient had suicidal ideation 13 and followed by an act. We would list both event 14 terms on the report, in the text of the report, 15 as well as with the COSTART terms. For the sake 16 of this report, we were counting that as what we 17 saw as the most serious, the act itself. 18 Q. Okay. Again, when you say -- 19 I'm sorry. 20 A. Does that follow? 21 Q. Yes, that's a little clearer. 22 Again, when you said the COSTART term, you really 23 mean the ELECT term, right? 24 A. Whatever dictionary was in use Page 197 1 at that time, yes. 2 Q. As far as you know, you did not 3 use the COSTART dictionary, you only used the 4 ELECT dictionary during the period of time you 5 worked in the DEU, right? 6 A. The ELECT dictionary is the 7 COSTART dictionary with changes. Now that's hard 8 to separate them completely. 9 Q. Okay. So -- and it's your 10 understanding that there were only a few changes 11 made to the COSTART dictionary that then became 12 the ELECT dictionary? 13 A. That's my understanding. As 14 far as classification terms, there were those two 15 additions or whatever, I think there were two 16 additions. 17 Q. Why is it that Lilly would only 18 make a couple of additions and then have to 19 rename the entire dictionary, couldn't they have 20 just said these are the additions to the COSTART 21 dictionary? 22 A. The COSTART dictionary itself 23 was actually changed, too, at some point in time 24 in there. Page 198 1 Q. Changed by the FDA? 2 A. Yes, and then exactly how all 3 that fit into place, I don't recall. 4 Q. At any time while you were 5 working in the DEU, did you ever use just the 6 pure COSTART dictionary form? 7 A. Not that I'm aware of, no. 8 Q. And other than those couple of 9 additions that you were aware of, you don't know 10 what the additions are between the ELECT 11 dictionary and the COSTART dictionary, if any? 12 A. Those are the ones that I'm 13 most aware. We had more synonym terms mapped to 14 COSTART, classification terms. I mean we used 15 the FDA's dictionary and we added some to be 16 consistent in mapping. 17 Q. Explain to me how the ELECT 18 dictionary was set up. Was there an actual list 19 of ELECT terms and COSTART terms that would 20 indicate what the ELECT term might map to in 21 COSTART? 22 A. No, there was a listing of 23 synonym terms and then a listing of 24 classification terms. Page 199 1 Q. And those classifications 2 weren't differentiated between ELECT and COSTART? 3 A. No. 4 Q. It was just a list? 5 A. Yes. 6 Q. Was there ever any indication 7 in ELECT as to how a term would be mapped in 8 COSTART as opposed to ELECT? 9 A. No. 10 Q. How would you know that terms 11 that you spoke about just a few answers ago would 12 map to a COSTART term? 13 A. Once again -- 14 Q. I think you just testified a 15 few minutes ago that a term that would indicate -- 16 you would know that a term would map to a COSTART 17 term? 18 A. That would map? 19 Q. That would map to a COSTART 20 term? 21 A. Uh-huh. 22 Q. How would you know that a term 23 would map to a specific COSTART term? 24 A. It's -- I'm confused at this Page 200 1 point. 2 Q. Me too. 3 A. How do we go back? 4 MR. MYERS: Do you want to ask the 5 question again? 6 MS. ZETTLER: No, because frankly I 7 don't remember exactly what he said. Could you 8 go back three or four questions? 9 (THE COURT REPORTER READ BACK THE 10 REQUESTED TESTIMONY.) 11 Q. What did you mean when you said 12 more synonym terms mapped to the COSTART 13 classification? 14 A. I meant more synonym terms, I 15 guess, mapped to ELECT classifications. We used 16 the term synonymously for several years, and I 17 think that might be where some confusion is 18 coming from. 19 Q. In that response, when you said 20 COSTART, you meant ELECT? 21 A. Yes. 22 Q. You were referring to ELECT? 23 A. Yes. 24 (PLAINTIFFS' EXHIBIT NO. 19 WAS Page 201 1 MARKED FOR IDENTIFICATION AND 2 RECEIVED IN EVIDENCE.) 3 Q. Would you look at Exhibit 19, 4 please? 5 A. Okay. We're talking about the 6 third page? 7 Q. Yes. It's Pz 1573 1016. 8 A. Okay. 9 Q. It says topics discussed, 10 number one, date of DEN quarterly to be 11 determined, and then it says, paren, by the Gods, 12 close paren. Who were the Gods, if you know? 13 A. My assumption is that that was 14 a joke on the part of the person entering this, 15 somebody in management. 16 Q. Okay. Second topic, it says 17 the DEA is taking on some additional 18 responsibilities. I think earlier you testified 19 that the DEA were basically data entry clerks; is 20 that correct? 21 A. Yes. They also took hotline 22 reports, and exactly where that transition took 23 place, I don't recall. 24 Q. So at some point in time they, Page 202 1 in addition to entering the data into the data 2 bases, also took in the hotline report? 3 A. Right, and that was a data 4 entry function, and that essentially was the same 5 type of function. 6 Q. When they took in the hotline 7 reports, would they take them down in long hand 8 or would they just type them right into the 9 computer? 10 A. I believe they typed them 11 directly into the computer as they did that. 12 Q. Would there be a working form 13 1639 that was set up on the computer? 14 A. It was similar to that form. 15 Q. Was it called a hotline form or 16 what was it titled, if you remember? 17 A. I don't recall. 18 Q. The fifth item in the last 19 sentence, it says try looking in both the yellow 20 and white pages. Do you know what yellow and 21 white pages are? 22 A. There were pages in the ELECT 23 dictionary, and I don't recall whether the yellow 24 ones mapped one way. One was a listing by Page 203 1 synonym term to classification term, and the 2 other one was just the reverse, that 3 classification term and what synonym terms mapped 4 to that classification term. Essentially they 5 were the same thing in reverse order. 6 Q. So for instance, overdose would 7 be a classification term? 8 A. Yes. 9 Q. And if you wanted to see what 10 synonyms were mapped over to overdose as a 11 classification term, you could look at it in 12 either the yellow pages, if those were the ones 13 that had it listed classification synonym or 14 white pages, whichever one it would -- 15 A. Correct, you could find it in 16 either set of pages. 17 Q. And on the other hand, if you 18 had a term that you didn't know if it was a 19 classification term or a synonym, you would look 20 it up in the other listing. For instance, 21 accidental overdose, look it up and see where it 22 mapped to, classification? 23 A. Yes. 24 Q. Under number seven it says Page 204 1 Merle is coordinating the project of copying all 2 Prozac documents for legal. Would Merle be Merle 3 Edmonson? 4 A. No, that would be a -- I don't 5 recall her last name, she was a clerk that worked 6 in the DEU. 7 Q. Okay. Do you know if that 8 Merle is still there? 9 A. I believe that she is. 10 Q. Do you recall having your 11 documents and your files copied by the people in 12 the legal department? 13 A. By the people -- we actually -- 14 I mean we copied some and we also had some out 15 source, I don't know if it was by the legal 16 department, I'm not sure who actually copied 17 them. 18 Q. When it says out source, does 19 that mean outside copy service? 20 A. Yes. 21 Q. So at some point everybody in 22 your department sent Fluoxetine documents, Prozac 23 documents, to an outside copy source to be copied 24 for legal? Page 205 1 A. Either that or we sent 2 originals or we copied some of them ourselves if 3 they were a small volume. 4 Q. Do you remember the first time 5 you had to copy documents in your files for the 6 legal department? 7 A. I don't recall. 8 Q. Would you have to periodically 9 copy additional documentation to be sent to the 10 legal department? 11 A. Yes. 12 Q. How often would that happen? 13 A. We received reminder notices, I 14 really don't remember how often. 15 Q. Would that happen every week? 16 A. Not that frequently. 17 Q. How about every month? 18 A. That could be, could be 19 monthly, I really don't remember. 20 Q. What would happen to the 21 document after you sent them to legal? 22 A. If we sent the originals, that 23 would be the last we saw of them. If they 24 received a copy, they just came back to our Page 206 1 files. 2 Q. When the originals came back to 3 your files, would they be different in any way 4 than when you sent them out? In other words, 5 would there be numbers on the documents or 6 anything of that nature? 7 A. I think they were stamped in 8 some manner. 9 Q. Okay. Stamped such as on this 10 exhibit with a Pz number on the bottom or in the 11 right-hand corner? 12 A. This one? 13 Q. Right. 14 A. I don't remember seeing 15 anything with a number like that. 16 Q. Okay. Do you remember what the 17 stamp was that was placed on the documents? 18 A. I believe it was a Pz, just a 19 Pz. 20 Q. Do you know what the Pz stood 21 for? 22 A. I would assume Prozac. 23 Q. Were you ever asked to create a 24 log or index of the documents that you were Page 207 1 sending to the legal department? 2 A. I did not do that, Merle or the 3 clerks may have done that. 4 Q. Do you remember ever seeing a 5 log or an index of the documents that your 6 department sent to legal? 7 A. I don't remember seeing one, 8 no. 9 Q. Was this done with any of the 10 other drugs you worked on at Lilly other than 11 Prozac? 12 A. I don't recall any. 13 Q. Let's go back to the second 14 page of Exhibit 19. Are you aware of an 15 epidemiology pilot project on Prozac? 16 A. This is one I reviewed earlier. 17 I would like time to -- are you going to address 18 specifically just the first topics? 19 Q. Go ahead and read it. 20 A. Okay. I finished that page of 21 Exhibit No. 19, page number one, ten fifteen. 22 Q. I'm sorry? 23 A. I finished reviewing the first 24 page of Exhibit 19. Page 208 1 Q. Okay. On topic discussed 2 number one, it says epidemiology pilot project 3 was discussed in the Prozac strategy meeting. 4 Did you attend Prozac strategy meetings? 5 A. No, I did not. 6 Q. Were you aware of an 7 epidemiology pilot project that was to be done or 8 was done on Prozac? 9 A. I don't recall any details. 10 Q. Do you remember generally 11 whether or not an epidemiology pilot project was 12 begun on Prozac? 13 A. At one time, the group was 14 working with the epidemiology group to see if 15 there were ways to, I guess, get data, complete 16 data, similar to the clinical trial data, out of 17 the DEN system, out of DEN reports. And that, I 18 believe, is what it's referring to. Specifically 19 if any were done or if any particular events were 20 looked at, I don't know. 21 Q. Have you ever heard the phrase 22 rechallenging? 23 A. Yes. 24 Q. What is your understanding of Page 209 1 that word, its meaning? 2 A. It would be if a patient may 3 have been on a drug or was on a drug at one time, 4 it may have been discontinued and they were given 5 the drug again, could be a rechallenge. 6 Q. Are you aware of any 7 rechallenging studies that were done on Prozac 8 with suicidality while you were in the DEU? 9 A. Again, clinical trial studies? 10 Q. Yes. 11 A. No. 12 Q. Were you aware of any 13 rechallenging studies done whatsoever? 14 A. Not that I'm aware of, no. 15 Q. What's a routing slip that's 16 mentioned in the third topic discussed? 17 A. A routing slip was attached to 18 a DEN report if we got additional or follow-up 19 information, it would be a listing of the event 20 terms with a place for the the research physician 21 to sign off on the new information. 22 Q. Okay. 23 (PLAINTIFFS' EXHIBIT NO. 32 WAS 24 MARKED FOR IDENTIFICATION AND Page 210 1 RECEIVED IN EVIDENCE.) 2 A. I have finished reviewing 3 document 32. 4 (A SHORT RECESS WAS TAKEN.) 5 Q. Okay, great. Before the break 6 we were talking about routing slips. Is the 7 first page of Exhibit 32 an example of a 1639 8 routing slip? 9 A. Yes, it is. 10 Q. And to your knowledge was this 11 a form created by Lilly? 12 A. Yes, it is. 13 Q. At the top, next to the title 14 1639 routing slip, it says, and you testified 15 earlier, to be used for adding follow-up 16 information to existing reports or to attach to 17 telexes entered into the DEN. What telexes are 18 they talking about? 19 A. Certain of the affiliates did 20 not have the ability to enter reports directly 21 into the DEN system, they would actually telex 22 the information to us. 23 Q. Do you remember which 24 affiliates those were? Page 211 1 A. No, I don't recall, the smaller 2 affiliates in general. 3 Q. Okay. Then to the right of 4 that information is a box and it says circle Y, N 5 or U for each question. Are those the outcomes 6 that we talked about earlier, the serious 7 outcomes? 8 A. Yes. The first series of 9 categories are, there are also some under the 10 black boxes that are not serious outcomes. 11 Q. Those are more asking questions 12 as to what happened with regards to the event 13 when the drug was stopped, right? 14 A. Yes. 15 Q. And then the next one it says 16 asked if the event reappeared after the drug was 17 reintroduced? 18 A. Yes. 19 Q. To your knowledge, was the drug 20 ever reintroduced to anybody who had suffered an 21 adverse event? 22 MR. MYERS: Let me object. When you 23 say ever to anybody, does that mean anybody in 24 the whole world ever? Page 212 1 Q. Let's say Fluoxetine. 2 A. Any of the reports that I dealt 3 with? 4 Q. Right. 5 A. I don't recall any specifics, 6 but I'm sure it was, it wasn't real unusual. 7 Q. It wasn't unusual to put a 8 person back on the drug after they suffered an 9 adverse event while on the drug? 10 A. Correct. Again, because a lot 11 of the reports were experiences the physicians 12 didn't know whether they were related or not. If 13 the drug was of benefit to the patient, they may 14 well try to rechallenge them with the drug. 15 Q. Were you ever aware, in your 16 experience at the DEU, were you ever aware of an 17 incident when somebody suffered suicidal ideation 18 while on Fluoxetine and was rechallenged with the 19 drug after experiencing an event? 20 A. I don't recall any specific 21 cases. Again, there may have been some. 22 Q. And the other criteria, the 23 serious criteria, says resulted in death, 24 resulted in or prolonged inpatient Page 213 1 hospitalization, resulted in severe or permanent 2 disability, life threatening, resulted in cancer, 3 resulted in overdose, resulted in congenital 4 anomaly or other reasons serious? 5 A. Yes. 6 Q. What other reasons would there 7 be for a report to be determined to be serious? 8 A. I guess it's a medical judgment 9 again, a physician would usually make that call 10 if there was something that was -- I guess I 11 don't know how they made that determination, I'm 12 not aware of any guidelines directing them to do 13 that or not do that. 14 Q. If somebody on Fluoxetine 15 killed somebody else, how would that be indicated 16 on this outcome section? 17 A. I don't recall, it could have 18 been coded as resulting in death, although -- I 19 don't know, I'm not sure how that would have been 20 coded. 21 Q. Are you aware of any situation 22 at Lilly where a homicide committed by a patient 23 on Prozac was listed as an intentional injury 24 with a serious outcome of death? Page 214 1 A. I don't recall any 2 specifically. 3 Q. Do you remember whether or not 4 Lilly had a policy of practice of how they would 5 list such a situation where somebody on 6 Fluoxetine killed somebody else? 7 A. I don't recall. 8 Q. Looking back at Exhibit 32, the 9 first page, were there ever any changes made to 10 routing slips that would be more specific just to 11 Prozac? The slip in general, not information 12 that was entered onto the slip. 13 A. The actual type copied? 14 Q. The actual form. 15 A. There were some questions about 16 Prozac added to the routing slip, I believe. 17 Q. What questions were those, if 18 you can remember? 19 A. I don't recall specifically, 20 they had to do with whether it involved a 21 suicidal act. And that's all I recall. 22 Q. Do you remember whether those 23 questions were added to the routing slip? 24 A. Around the time of all the Page 215 1 Prozac publicity. 2 Q. Do you know if that was done in 3 response to Prozac publicity? 4 A. I don't recall the exact 5 reason, no. 6 Q. What was the purpose of adding 7 the suicide questions? 8 A. To make it easier to identify 9 them in the system, to track them in the system, 10 to pull those reports out. 11 Q. So the information from the 12 routing slips themselves are placed -- is placed 13 in the DEN system? 14 A. I don't recall exactly what 15 information from the routing slip is put in or is 16 not put in. 17 Q. Okay. 18 A. I don't know if the physician's 19 signature and date is put in. 20 Q. At the top, under the 21 manufacturer control number, there's a series of 22 boxes, one says primary event. 23 A. On -- we're on the same page? 24 Q. Yes, I'm sorry, the first page. Page 216 1 One said date, event, things of that nature. 2 Under event it says actual term, and there's a 3 space. Is that where the term that was used by 4 the initial reporter would be placed? 5 A. Yes. 6 Q. Now again you testified earlier 7 that many times the initial report would come in 8 as a narrative and not just as a single term; 9 correct? 10 A. Yes. 11 Q. How would the actual term be 12 fit into that space then? 13 A. You would pull out the most 14 appropriate or most significant terms. That is 15 the only way I could describe it, I guess. 16 Q. So isn't it the case that, in 17 essence, that an initial determination of what 18 was meant by the initial reporter is made and 19 placed as a term in the actual term space here? 20 A. The reporter would usually 21 indicate what the event is, although it wouldn't 22 be an exact fit for a COSTART term. It would say 23 this patient experienced suicidal ideation or 24 whatever it may be. And they may expound upon Page 217 1 that, but they really, in most cases, had a 2 rather specific description of what took place. 3 Q. Okay. So if, say, the initial 4 reporter stated something to the effect of 5 patient reported feeling suicidal and wanting to 6 kill herself while on Fluoxetine, that would be 7 listed in the actual term as suicidal ideation? 8 A. Or feeling suicidal. 9 Q. Okay. And then from that 10 actual term, the COSTART term would be 11 determined? 12 A. Yes. 13 Q. Now, here again it says COSTART 14 term. In actuality that was the ELECT term; 15 correct? 16 A. Yes. 17 Q. Under primary event, I'm not 18 sure if this is supposed to be an X or an 19 initial, but is that a spot to indicate whether 20 or not this term listed here is the primary 21 event? 22 A. Yes. 23 Q. And again that goes back to, I 24 think, I believe, Exhibit 26 where you say the Page 218 1 most serious or severe event is described in the 2 report? 3 A. I would have to go back and 4 review that exhibit, is that one we looked at 5 before? 6 Q. Yes, 26. 7 A. These don't necessarily 8 correspond one-to-one, no. You could have a 9 report involving several different events and, 10 you know, one may be one of these acts and one 11 may be something entirely different. 12 Q. Okay. Is there a hierarchy on 13 this form, it's listed on the outcome as death, 14 hospitalization, permanent disability, life 15 threatening, et cetera. Is that meant to be a 16 hierarchy of sorts, in other words death being 17 the most serious outcome, or does it matter? 18 A. I've never heard it explained 19 that way, but I would regard death as the most 20 serious, yes. 21 (PLAINTIFFS' EXHIBIT NO. 32 WAS 22 MARKED FOR IDENTIFICATION AND 23 RECEIVED IN EVIDENCE.) 24 Q. If you look at the second page Page 219 1 of Exhibit 2. 2 MR. MYERS: 32? 3 Q. I'm sorry, 32, thanks. 4 A. Uh-huh. 5 Q. It's a form that looks at event 6 terms. What's the difference between this form 7 and the routing form? 8 A. The first one has a few 9 additional questions on it, you know, a few 10 different blanks at the top for tracking the name 11 of the drug. 12 Q. Okay. 13 A. I believe that this page is the 14 second page of another form or a third page or a 15 fourth page. 16 Q. The second page of Exhibit 32, 17 the event term page? 18 A. No, no, of an actual form. You 19 know, we actually have pages that capture free 20 text description of what took place, the 21 patient's age, all the information we talked 22 about before that was on the 1639, and then this 23 would be one of those pages that's part of that 24 form. Page 220 1 (PLAINTIFFS' EXHIBIT NO. 35 WAS 2 MARKED FOR IDENTIFICATION AND 3 RECEIVED IN EVIDENCE.) 4 Q. Would you look at Exhibit 35, 5 please? 6 A. I have finished reviewing 7 Exhibit 35. 8 Q. Okay. Is this the report you 9 were just talking about where the information on 10 the initial report would be taken and written 11 down? 12 A. Yes. 13 Q. Okay. And eventually this 14 information from Exhibit 35 would be transferred 15 to a final 1639 and filed with the FDA? 16 A. This information was actually -- 17 is actually entered into the DEN system and then 18 a report is printed, yes. 19 Q. And is this the form that you 20 believe the second page of Exhibit 32 should be a 21 part of, the event terms slip, Exhibit 35? 22 A. Once again, Exhibit 35 -- 23 Q. Earlier you testified that you 24 believe the second page of Exhibit No. 32, the Page 221 1 event terms slip, should be a part of a form 2 taking in the initial information. Would Exhibit 3 35 be the form that you were referring to? 4 A. Yes, that or something very 5 similar to it, yes. 6 Q. Was there another form that was 7 used to take information on the initial reports? 8 A. There was a form for 9 spontaneous reports and there was a form for 10 clinical trial reports. 11 Q. Okay. 12 A. So there may be a few slight 13 differences. 14 Q. Okay. So this event term sheet 15 which is the second page of Exhibit 32 could have 16 been attached to the spontaneous report working 17 form or the clinical trial report working form? 18 A. Right. 19 Q. Would you look at the third 20 page of Exhibit 32, please? 21 A. Okay. 22 Q. Can you tell us what that is? 23 A. It appears to be a screen print 24 from the DEN system. Page 222 1 Q. Okay. And earlier you talked 2 about being able to pull up words from the free 3 text portions of the working 1639 from the DEN. 4 The stuff at the bottom of the page, right 5 underneath the -- says DEN II pretext. Would 6 this be the text of information you were talking 7 about earlier? 8 A. We could pull information from 9 that area, yes. 10 Q. Okay. So in that situation, if 11 you wanted to know if somebody was experiencing 12 high blood pressure, you could enter the words 13 blood and pressure and possibly pull up this 14 event? 15 A. Yes, this report. 16 Q. This report. The same thing 17 above thereabout, says DEN II, event summary? 18 A. Yes. 19 Q. You could theoretically enter 20 delirium and stupor and pull up this report, too? 21 A. Yes. 22 Q. If you could do this with the 23 DEN reports, why was it that you had to go 24 through all the 1639s on suicide attempt Page 223 1 individually in hard copy form to be able to 2 determine if somebody was an actual suicide 3 attempt? 4 A. Just to be reassured that we 5 didn't miss anything either way. In fact, I'm 6 not even sure if at the time they were reviewed 7 that we were aware that we could go in and do 8 this. 9 (PLAINTIFFS' EXHIBIT NO. 36 WAS 10 MARKED FOR IDENTIFICATION AND 11 RECEIVED IN EVIDENCE.) 12 Q. Okay. If you could look at 13 Exhibit No. 36, please? 14 A. Okay. I have completed the 15 review of Exhibit 36. 16 Q. Okay. Would you compare 17 Exhibit 36 to Exhibit 35, please. 18 A. Compare -- 19 Q. Actually compare the second two 20 pages of Exhibit 35 with the Exhibit 36 and tell 21 me if whether or not in your opinion Exhibit 35 22 is the working form for Exhibit 36? 23 A. Using the second two pages? 24 Q. The last two pages, I'm sorry, Page 224 1 of Exhibit 35. 2 A. Yes, it appears to me to be the 3 same report. 4 Q. Okay. On Exhibit 36, second 5 page at the top, it states event terms, death, 6 hostility, suicide attempt. 7 A. Yes. 8 Q. On the front, the first page, 9 under the described event. 10 A. Of the same? 11 Q. The same exhibit, yes. It says 12 patient is to have reported to have stabbed her 13 two children, ages four and two and a half years, 14 to death before committing suicide by stabbing 15 herself. Does that refresh your recollection as 16 to whether or not the event term of death was 17 assigned to an event where somebody on Prozac 18 killed somebody else? 19 MR. MYERS: Let me object to the form, 20 Nancy, only to the extent that your question 21 earlier asked him, it did not include the patient 22 themself committing suicide and this includes 23 that as well. So you're trying to mix apples and 24 oranges. Page 225 1 MS. ZETTLER: No, I'm asking if this 2 refreshes his recollection. If it doesn't, it 3 doesn't. 4 A. If what then, I'm sorry? 5 Q. Does this refresh your 6 recollection as to whether or not the outcome 7 term of death is assigned to a situation when 8 somebody on Prozac kills somebody else? 9 MR. MYERS: Same objection. Answer if 10 you can. 11 A. I don't recall if it was to be 12 done that way. Without having the page of the 13 event terms, it's difficult to say how these were 14 mapped. 15 Q. Okay. 16 A. I can't -- 17 Q. I didn't mean to cut you off. 18 A. I can't tell here what the 19 death corresponds to. 20 Q. Okay. Can you tell -- you mean 21 you can't tell what the death corresponds to 22 because you don't have the ELECT dictionary in 23 front of you? 24 A. That, plus the page from this Page 226 1 working form that maps the event. 2 Q. In other words, the page that 3 would have been the second page of Exhibit 32, 4 the event term sheet? 5 A. The event term sheet, yes. 6 Q. Let me ask you this: If all 7 you had in front of you was that section of 8 Exhibit 36, second page, that states event terms, 9 death, hostility and suicide attempt, would you 10 be able to glean from that what happened as 11 reported on page one of Exhibit 32? 12 MR. MYERS: If that's all he had and 13 not the rest of the page? 14 MS. ZETTLER: Right. 15 A. No. 16 Q. Okay. If you had been the 17 person taking this initial report on this case, 18 what event term would you have assigned to it? 19 A. That would be difficult without 20 a dictionary to use. I would use suicide attempt 21 and probably -- I really would like to see the 22 dictionary. Without having that in front of me, 23 I would say hostility, with the outcome of death, 24 not necessarily as an event term. Page 227 1 Q. Okay. You mean death not 2 necessarily as an event term? 3 A. Correct. 4 Q. Okay. So in this case -- I'm 5 sorry, I didn't mean to cut you off. 6 A. I guess I'm just not sure, I 7 haven't dealt with that many of this type of 8 report that I would recall the best way to handle 9 it. 10 Q. So death could be used as an 11 event and as an outcome, right? 12 A. Yes. 13 Q. Was death always used as an 14 event in cases where a suicide was completed? 15 MR. MYERS: An event term? 16 MS. ZETTLER: Right. 17 A. I can only recall some of the 18 reports I had done, and I would have used death 19 as an outcome in most situations. I would not 20 typically list death as an event term unless the 21 event that caused the death or was associated 22 with the death was not known. For instance a 23 patient was found dead, I would use the event 24 term death, but if the patient was in an Page 228 1 automobile accident and was found dead, I would 2 not use the event term of death, I would use 3 injury accident or whatever that term was. 4 Q. Okay. Do you recall ever 5 listing death as an event term in a situation 6 where somebody on Prozac killed somebody else, 7 you yourself in any of your experiences in the 8 DEU? 9 A. On this report it appears to be 10 my writing, and I may have used it on this, I 11 don't recall, without having all the 12 documentation. 13 Q. So on Exhibit 35, the last page 14 where the handwritten text material looks to you 15 to be your handwriting? 16 A. Yes. 17 Q. Would there be any other 18 situation where the event term hostility would be 19 used other than the situation set out in Exhibit 20 36, where somebody -- where this woman killed her 21 two children? 22 MR. MYERS: I'll object to the form, 23 that's overbroad. I mean under any circumstances 24 other than the circumstances presented in this Page 229 1 report? 2 Q. Well, let me ask this: Was the 3 event term hostility used in any circumstance 4 other than a person on Fluoxetine murdering 5 somebody else? 6 A. I don't recall specific 7 instances, but I do not see why it would not have 8 been. 9 Q. With regards to Exhibit 35, 10 what other pages are you missing from this form, 11 if any? 12 A. That would be the only one that 13 I could think of. 14 Q. The event term sheet? 15 A. Uh-huh. 16 Q. You have -- 17 A. The event term sheet, yes. 18 Q. And Exhibit 35 would be used 19 regardless of the source of the spontaneous 20 report? In other words, if it were a literature 21 source or litigation source or a salesperson? 22 A. A salesperson report could be 23 directly entered into the hotline system, so that 24 would be a different format. I really don't -- Page 230 1 it looks like a literature report would be 2 captured here. I don't recall any other specific 3 types other than the clinical trial form. 4 Q. Were the reports that came in 5 related to a litigation handled differently than 6 reports that came in that were not related to 7 litigation? 8 A. There's a question on the form 9 on the event term page that -- 10 Q. Exhibit 32? 11 A. Is there a reasonable 12 possibility that the experience may have been 13 related to the drug, and is a patient identified 14 as a real person. There's a category there where 15 the research physician could indicate litigation 16 where an initial reporter is not a health care 17 practitioner. 18 Q. Okay. It's not real clear on 19 the copy, but it looks like an asterisk -- 20 A. Yes. 21 Q. -- almost, says equal, 22 litigation where an initial reporter is not a 23 health care practitioner? 24 A. Yes. Page 231 1 Q. What situation would that 2 asterisk be chosen over yes or no to the answer 3 to the previous question? 4 A. Again, I didn't assign that, I 5 would say it's when we receive a legal case, the 6 first time we hear of the case is through a legal 7 source. 8 Q. Okay. 9 A. Litigation is involved. 10 Q. What effect, if any, with 11 regards to the entering of this information into 12 the DEN would the litigation determination have? 13 MR. MYERS: Would it go in or not go 14 in? 15 Q. Any effect at all. 16 A. Not that I'm aware of, they 17 would all be entered and processed the same way. 18 Q. And the question before that 19 is: Is there a reasonable possibility that the 20 experience may have been related to the drug and 21 is the patient identified as a real person. What 22 does it mean is the patient identified as a real 23 person? 24 A. As opposed to -- there have Page 232 1 been reports that patients on Fluoxetine have had 2 headaches, I mean you don't really have -- it 3 depends on how the information comes in and is 4 received and how it's related to Lilly. 5 Q. Okay. 6 A. You need to know that there was 7 a patient involved, not an animal. I mean we 8 have reports on animals on occasion. 9 Q. You mean spontaneous reports on 10 animals? 11 A. Yes. Again, they contact our 12 medical information area and they would send them 13 over to us. You know, my dog ate a Prozac 14 capsule. 15 Q. Not that I am giving my dog 16 Prozac or anything, he seems a little depressed 17 today. Were there ever occasions where you 18 investigated an event report, adverse event 19 report, and found out after the fact that it was 20 an animal and not a human being that was being 21 reported about? 22 A. I recall of hearing of cases 23 like that, yes, where they involved insulin 24 products. But again, just vaguely I recall Page 233 1 those. 2 Q. Exhibit 32, is that routing 3 slip used for the United States as well as for 4 OUS spontaneous adverse event reports? 5 A. The first page here? 6 Q. Right, the routing slip. 7 A. There was a computer generated 8 routing slip which would print on any of the 9 reports which were entered by the affiliates, but -- 10 and again, it depends on the point in time you're 11 discussing, that was an enhancement made to the 12 DEN system while I was there. 13 Q. Okay. And the first page of 14 32, manufacturer of control number, UK, that's 15 the United Kingdom, isn't it? 16 A. Correct. 17 Q. So that indicates that this is 18 a report, I don't know if we know that it's 19 spontaneous or not, that came in from the United 20 Kingdom? 21 A. Correct. 22 Q. Now, to go back to that 23 question, is there a reasonable possibility that 24 the experience may have been related to the drug, Page 234 1 is that a determination made by the clinical 2 research physician? 3 A. That's correct. 4 Q. And if it was determined that 5 there was a real person involved with the event, 6 and in the clinical research physician's opinion 7 that the experience was related to the drug, 8 would there be a difference in how this 9 information was treated as opposed to if there 10 wasn't a real person or the clinical research 11 physician decided that the experience wasn't 12 related to the drug? 13 MR. MYERS: Let me object to the form. 14 You've asked him about four questions there and 15 then you say treated differently, do you mean 16 whether it was input to the DEN differently or 17 whether it was reported to the FDA differently? 18 MS. ZETTLER: I think I gave him 19 opposing situations. Why don't you read it back, 20 Kathy, please. 21 (THE COURT REPORTER READ BACK THE 22 REQUESTED TESTIMONY.) 23 Q. Again the question is: Is 24 there a reasonable possibility that the Page 235 1 experience may have been related to the drug, and 2 is the patient identified as a real person. 3 There's some information in parentheses that says 4 to answer yes to this question, basically you 5 have to answer -- both must be true, right? 6 A. Yes. 7 Q. Okay. If that question is 8 answered yes, is there a difference in the way 9 this information is treated as opposed to when 10 that question is answered no? 11 A. It would actually be keyed into 12 the DEN system differently, the actual answer is 13 keyed in, and if it's a spontaneous report, is 14 that -- 15 Q. Yes. 16 A. They would go to the FDA in the 17 same manner. That question does not affect the 18 reporting of spontaneous events to the FDA. 19 Q. Okay. Does it affect the 20 reporting of spontaneous events to CIOMS? 21 A. I believe that it does. 22 Q. It does affect it? 23 A. Uh-huh. 24 Q. And if this question is Page 236 1 answered no, the event would not be reported to 2 the CIOMS; correct? 3 A. That's correct, not in the 4 weekly alert mailings. Whether there are other 5 mailings that go out to them, I'm not sure 6 whether they receive periodic updates or not. 7 Q. And if this question was 8 answered no, and therefore not reported to the 9 CIOMS, would this report then be considered to be 10 flagged, like we talked about earlier? 11 A. No, no, flagged is -- flagged 12 is more -- it doesn't affect just CIOMS or just 13 FDA, it's more general than that, I guess. 14 Q. Look at the bottom of the first 15 page of Exhibit 32. 16 A. Okay. 17 Q. It says one of the questions 18 flagged for weekly print. 19 A. Uh-huh. 20 Q. What does that mean? 21 A. Should it be included in the 22 weekly printing, the alert mailing that would be 23 going out. 24 Q. Okay. Does this handwriting on Page 237 1 the first page of Exhibit 32, does this look like 2 your handwriting also? 3 A. The signature or the 4 information up above? 5 Q. The information up above. 6 A. Yes, it does. 7 Q. Would the U.S. CRA fill out the 8 information at the bottom where it says flagged 9 for weekly prints and for follow-up for trial 10 reports, would you fill out that information or 11 would that be done by the clinical research 12 physician? 13 A. It would be done by the 14 clinical research physician. 15 Q. And there was no information 16 that's indicated on this page, correct, none of 17 those questions are answered on this page? 18 A. The questions are not answered, 19 and in that case the system defaults to send it. 20 Q. I'm sorry, the system defaults 21 what? 22 A. The system defaults to send the 23 report in the weekly mailing, if it qualifies. 24 Q. How does the system know if it Page 238 1 qualifies? 2 A. It would look at the serious 3 criteria, at the expectancy, and at the possible 4 relationship. 5 Q. Okay. In this situation, the 6 question regarding the possible relationship 7 isn't answered, though, is it? 8 A. That's correct. 9 Q. So what would happen in that 10 case with this report? 11 A. Just having what I have on this 12 one page with that event term, this report would 13 not go as an alert report because it's considered 14 an expected event according to the FDA definition 15 of expected. 16 Q. Okay. 17 A. There could be other event 18 terms that are part of this report that may 19 affect it also. 20 Q. Okay. This is a UK report, 21 right? 22 A. Correct. 23 Q. And UK reports or other 24 international reports are reported to the FDA if Page 239 1 they fit the criteria; correct? 2 A. Correct. 3 Q. And the COSTART term listed on 4 the first page of Exhibit 32 is overdose, right? 5 A. Exhibit 32? 6 Q. Yes. 7 A. COSTART term is overdose, yes. 8 Q. And according to the FDA 9 regulations, an overdose is a serious outcome, 10 right? 11 A. That's correct. 12 Q. Can you tell from just this 13 page, the first page of Exhibit 32, why this 14 overdose is an expected adverse event? 15 A. By looking simply at this page? 16 Q. Right. 17 A. And not looking at the package 18 literature? 19 Q. Right. 20 A. No, I can't. 21 Q. If you had -- say you had the 22 package -- when you say the package literature, 23 you mean the package insert, right? 24 A. Correct. Page 240 1 Q. If you had the package 2 literature here, would there be something in that 3 literature that would indicate that simply 4 overdose is an expected adverse event? 5 A. If it's included in the package 6 insert, it's considered an expected event. 7 Q. Okay. Can you tell from this 8 page alone, what information you have on this 9 page, whether or not this is an intentional, 10 accidental, overdose or a suicide attempt? 11 A. No, it would be part of another 12 report, you would never just have this page, that 13 I'm aware of. 14 Q. From this page alone, you 15 wouldn't be able to tell whether or not it's 16 actually listed in the package insert, right? 17 A. Once again, I wouldn't be able 18 to tell from this page? 19 Q. Right. 20 A. I guess it depends on what's in 21 the package insert, and if the word overdose -- 22 yes, you're correct, I would have to have the 23 whole report to make that determination. 24 Q. Let's put it this way: Lilly Page 241 1 never expected people to just plain overdose on 2 Prozac, right? 3 A. Expected? 4 MR. MYERS: Let me object to the form. 5 In terms of Lilly expect the -- I don't know who 6 you're defining as Lilly, that's an undefined 7 term. 8 Q. Okay. I would hope I wouldn't 9 have to define it for you. Eli Lilly, as a whole 10 generic entity, or anybody who works for Lilly, 11 never expected an overdose to be an adverse event 12 associated with the use of Prozac? 13 MR. MYERS: Let me object to the form 14 because it omits what is or is not in the package 15 insert, which depends whether or not it gets 16 classified as expected or unexpected. 17 Q. Do you understand the question, 18 Mister Powell? 19 A. Yes, I'd like to hear it again, 20 I mean expected does mean different things. 21 Q. Okay, let me ask you this: To 22 your knowledge, was intentional overdose ever 23 listed as an adverse reaction in Prozac package 24 inserts? Page 242 1 MR. MYERS: I object to the form 2 because whether it's listed as an adverse 3 reaction or it's anything else depends on whether 4 it gets classified, it just need not appear as a 5 reaction. The criteria is whether it appears in 6 the insert, as he told you two or three times. 7 Q. Oh, I get it, okay. So if in 8 the package insert it says the word overdose 9 anywhere, then it's an expected event for 10 purposes of this form? 11 A. I guess it depends on -- 12 MR. MYERS: Object to the form, it's 13 not for purposes of the form, it's for purposes 14 of the regulations. 15 Q. Okay, for purposes of the 16 regulations. If the word overdose appears 17 anywhere within the package insert, then it's 18 considered expected for the purposes of the 19 regulations, as Mr. Myers said? 20 A. I would think that's the way 21 you would interpret it. If it's a word typed all 22 by itself on the bottom of the page, I mean it 23 would have to be in some sort of context. 24 Q. According to Mr. Myers' Page 243 1 definition, anything that -- 2 MR. MYERS: No, Nancy, you identified 3 it as an adverse reaction, you said it would have 4 to appear in the insert as an adverse reaction in 5 order to be classified as expected or unexpected. 6 That's what you said. 7 MS. ZETTLER: Right, and you said all 8 it had to do was appear in the package insert 9 itself. 10 MR. MYERS: I said it need not be so 11 limited as you described it to be, as he's told 12 you. 13 MS. ZETTLER: Okay. Calm down, Larry. 14 MR. MYERS: Well, we've been over this 15 serious and unexpected two or three times on two 16 or three different occasions with this witness. 17 MS. ZETTLER: Well, I guess I have a 18 right to find out how it's used in various 19 contexts at Lilly then, don't I? 20 Q. The question is: Is it your 21 testimony that as long as the word overdose 22 appears in the package insert, then it's 23 considered expected for purposes of the FDA 24 regulations? Page 244 1 MR. MYERS: He's already answered that 2 question, don't answer it again. Ask him another 3 question. 4 Q. Do you understand the question? 5 MR. MYERS: He's answered it, he's not 6 going to answer it yet again. 7 MS. ZETTLER: Can you read back that 8 question? 9 (THE COURT REPORTER READ BACK THE 10 REQUESTED TESTIMONY.) 11 Q. Let me ask you this: If the 12 term overdose is used within any context within a 13 package insert, is it then considered expected 14 for purposes of FDA regulations? 15 A. I guess I can't interpret the 16 FDA regulations, I'm not sure what they say in 17 that regards. 18 Q. But you implied -- I'm sorry, 19 go ahead. 20 A. There's a section, you know, 21 there are different sections in the package 22 insert that talks about warnings, precautions, 23 and I would be speculating if I commented any 24 further, I guess. Page 245 1 Q. But your job in the DEU was to, 2 in effect, interpret the FDA regulations on 3 assigning serious as to an adverse event, right? 4 A. I didn't really interpret the 5 regulations, I just answered the questions based 6 on what the reporter said. 7 Q. And how about as far as -- 8 well, let me ask you this: As far as Exhibit 32 9 is concerned, did you fill out the portion of the 10 form where it says if an event is serious is it 11 expected, did you answer that question or did 12 somebody else answer that question? 13 A. I believe that was Jamie 14 Street, I may -- I don't know. 15 Q. Did you ever answer that 16 question on any of these 1639 routing slips or 17 any other adverse event related documents? 18 A. I may have answered them. 19 Again, subject to the physician's review. 20 Q. I believe you testified earlier 21 that the CIOMS, CIOMS criteria for reporting 22 events was that it was serious, unexpected and 23 possibly causally related to the drug; correct? 24 A. As I recall, that is correct, Page 246 1 yes. 2 Q. And if it didn't meet all three 3 of those criteria, being serious, unexpected and 4 causally related, then it would not be reported 5 in the CIOMS; correct? 6 A. Yes, correct. 7 Q. Although it would still be 8 reported to the FDA? 9 A. Yes. 10 Q. So, using the CIOMS criteria, 11 the event reported in the first page of Exhibit 12 No. 32 would not be reported to the CIOMS? 13 A. Not in a weekly alert mailing. 14 Q. And you're not sure whether or 15 not they were reported at some other time down 16 the line; correct? 17 A. Correct. 18 (PLAINTIFFS' EXHIBIT NO. 38 WAS 19 MARKED FOR IDENTIFICATION AND 20 RECEIVED IN EVIDENCE.) 21 Q. Could you look at Exhibit 39, 22 please? 23 MR. MYERS: What are you looking at? 24 MS. ZETTLER: I'm sorry, it's Pz 986 Page 247 1 1140. 2 MR. MYERS: Yes, that's it, that's 38. 3 MS. ZETTLER: International event 4 report? 5 MR. MYERS: Yes. 6 Q. Would you take a look at 7 Exhibit 38, please? 8 A. I have reviewed Exhibit 38, I'm 9 having difficulty reading the last page, some of 10 the written comments. 11 Q. Okay. Let's look at the first 12 two pages of Exhibit 38. At the top of the first 13 page, it says international event report; 14 correct? 15 A. Yes. 16 Q. And then in the upper right 17 corner, it says not available. What does that 18 mean? 19 A. When the affiliates first enter 20 a report, there's no -- let's see, it's the 21 physicians -- they simply put it in the report, 22 more or less, as the CRAs would prepare it, it's 23 not -- it's then routed to the physicians who 24 assign expectancy and causality, and the Page 248 1 expectancy, actually, prints up here. And in 2 this report, it's in the system without 3 expectancy assigned. 4 Q. Okay. 5 A. That's not gone to a research 6 physician at that point. 7 Q. So on the left-hand side where 8 it says possibility determined to be U, is that 9 also related to causality -- I'm sorry, did you 10 say causality or expectancy? 11 A. Expectancy at the top. This 12 would be causality on this side, yes. 13 Q. Okay. So upper right-hand 14 corner is expectancy, left-hand side possibility 15 to be determined as causality? 16 A. Yes. 17 Q. The describing event listed on 18 the first page of Exhibit 38 is suicide attempt; 19 correct? 20 A. Correct. 21 Q. And the event term assigned to 22 that is suicide attempt also; correct? 23 A. Correct. 24 Q. But in the free text, the Page 249 1 person who filled out the form stated this was a 2 suicide by hanging; correct? 3 A. Correct. 4 Q. Why is suicide attempt an event 5 term for a suicide by hanging? 6 A. Well, we know -- according to 7 the report, we know that the patient did in fact 8 attempt suicide, it was a successful suicide. I 9 don't think there's any other event term that 10 would correspond to hanging. 11 Q. I guess my question is why is 12 there an event term for suicide attempt but 13 there's not an event term for suicide? 14 A. It's the way the dictionary was 15 set up. You try and capture the outcome. I 16 guess the fact that the patient died, you would 17 capture through the outcome. 18 Q. Okay. And in this case, there 19 was no overdose included, so it's not listed as 20 overdose, it's listed as straight suicide 21 attempt? 22 A. Correct. 23 Q. With a serious outcome of 24 death? Page 250 1 A. Uh-huh. 2 MR. MYERS: Yes? 3 A. Yes, I'm sorry. 4 Q. Okay. On the second to the 5 last page, Exhibit 38, it lists the described 6 event as myocardial infarc -- 7 A. Yes. 8 Q. -- comma, death. Are those two 9 separate events? 10 A. Based on the free text, it 11 would appear that way. Apparently a patient did 12 have a myocardial infarction, they did die, it 13 doesn't say that that was the cause of the death, 14 however. We had a patient who died at that 15 point, but we really didn't know why is the way I 16 would read that report. 17 Q. This is a follow-up report, 18 isn't it? 19 A. There's follow-up information, 20 yes, exactly, and it was received on the 23rd of 21 May and then apparently there was follow-up on 22 the 29th of May, yes. 23 Q. I'm sorry, where do you see it 24 was follow-up on the 29th of May? Page 251 1 A. On the second page. 2 Q. On the second to the last page, 3 the outcomes of death and life threatening are 4 both checked; correct? 5 A. Correct. 6 Q. Can you read what's written 7 underneath the life threatening? 8 A. No, I can't tell. 9 Q. So unless you knew that the 10 myocardial infarction was the cause of the 11 person's death, the outcome of death would be 12 related to death; correct? 13 A. Correct. 14 Q. Eventual death. And the life 15 threatening outcome would be related to the 16 myocardial infarction? 17 A. That would be my 18 interpretation. I can't look at this and say 19 exactly which is associated with which. The 20 serious outcome will print no matter what event 21 term it's associated with. 22 Q. Is this your handwriting on the 23 last page of Exhibit 38? 24 A. No, it's not. Page 252 1 Q. Is any of the handwriting on 2 the last page of 38 yours? 3 A. No. 4 Q. Do you recognized the 5 handwriting as anybody else's in particular? 6 A. The comment off to the right 7 side would appear to be Donna Pearson. 8 Q. And that reads changes per 9 Doctor -- I believe that's L. Thompson and Dr. 10 Beasley, 6-8-90? 11 A. That's correct. 12 Q. Then somebody has circled Dr. 13 Thompson's name? 14 A. Uh-huh. 15 MR. MYERS: Yes? 16 A. Yes. 17 Q. Do you have any idea what 18 changes she's referring to there? 19 A. No, I can't tell. 20 Q. Looks like somebody crossed out 21 a portion of the pretext which states conclusion, 22 colon, very strong circumstantial evidence 23 indicates that the anti-depressant taken, Prozac, 24 caused the ventricular fibrillation, period. Two Page 253 1 previous cases and another case of myocardial 2 infarction are known to have occurred in patients 3 taking Prozac. Do you have any idea why that is 4 crossed out? 5 A. Without seeing the entire file, 6 it would be hard to say. There's something 7 written off to the side there also, and I can't 8 tell if it's crossed off. And again, I assume 9 this message may explain some of it, but I can't 10 tell, I don't know. 11 Q. Can you tell from this page 12 whether or not the conclusion that was crossed 13 off is the conclusion of the coroner or the 14 person filling out the pretext or somebody else, 15 for that matter? 16 A. The conclusion of whom again, 17 the coroner? 18 Q. The conclusion that's crossed 19 out, can you tell from this page whether or not 20 that conclusion was the conclusion of the coroner 21 that's mentioned above, the person filling out 22 the form or somebody else, for that matter? 23 A. I can't tell by reading this, 24 no. Page 254 1 Q. In your opinion if it was the 2 conclusion of the coroner, would it have been 3 appropriate for them to remove this information 4 from the 1639? 5 A. It would depend on what 6 information may have been found subsequent to 7 that. But again, there is a line that says 8 communication with coroner is continuing, and I 9 don't know if this note has something to do with 10 the follow-up information that was obtained at 11 that point, I don't know. 12 Q. Okay. Who is Robert Hunt, if 13 you know? 14 A. He's a CRA that worked in the 15 drug epidemiology area. 16 Q. Earlier you said that -- you 17 referred to an epidemiology area. Is that 18 different than the drug epidemiology area? 19 A. Yes, there's a 20 pharmacoepidemiology area, which is really 21 distinct from the drug epidemiology. 22 Q. If an epidemiology were to be 23 done on Prozac, would the pharmacoepidemiology 24 area be involved in that study in any way, to Page 255 1 your knowledge? 2 A. They could be, it would depend 3 on the study, I would assume. 4 Q. To your knowledge, did anybody 5 in the pharmacoepidemiology department in fact 6 work on Prozac at any time, or Fluoxetine? 7 A. Jim Kotsanos did at one time, 8 and whether it was Fluoxetine first and then 9 pharmacoepidemiology or the reverse, I don't 10 recall. 11 Q. So you don't know if when Mr. 12 Kotsanos was working on Fluoxetine if he was in 13 the epidemiology unit as opposed -- or department 14 as opposed to some other department? 15 A. Right. 16 Q. Okay. Who is Sue Zink? 17 A. She was a CRA in the drug 18 epidemiology unit also. 19 Q. How about Carol Cattorjohn? 20 A. The same. 21 (PLAINTIFFS' EXHIBIT NO. 21 WAS 22 MARKED FOR IDENTIFICATION AND 23 RECEIVED IN EVIDENCE.) 24 Q. Would you look at Exhibit 21, Page 256 1 please, Pz 1573 105. 2 A. Correct. I have finished 3 reviewing Exhibit 21. 4 Q. Okay. It purports to be a memo 5 from Rick Huddleston to to Mike Noone and Max 6 Talbott dated November 28, 1990; correct? 7 A. Correct. 8 Q. And the text of the memo reads: 9 The following is an extension of Leigh's response 10 slash explanation to Claude Bouchy regarding the 11 changing of event terms and/or text on ADE's from 12 Europe, right? 13 A. Correct. 14 Q. ADE's are adverse drug 15 experience reports, I take it? 16 A. Correct. 17 Q. And Leigh that's mentioned is 18 Leigh Thompson, to your knowledge? 19 A. Yes. 20 Q. It says although not specified 21 as a Prozac issue, the event terms questioned are 22 most often associated with Prozac ADE, thus the 23 following discussion will center on Prozac 24 policy; correct? Page 257 1 A. Correct, that's what it says. 2 Q. Then underneath there, it 3 states since late '88 or early '89 for Prozac 4 research physician requests, colon, intentional 5 overdoses have been mapped to overdose in order 6 to standardize and be consistent in the recording 7 of these events, period. And I believe you 8 testified earlier that that was your 9 understanding of the policy behind mapping 10 various types of overdoses to overdose; correct? 11 A. Correct. 12 Q. Who was the research physician 13 making the request, to your knowledge? 14 A. I don't recall. 15 Q. Okay. Would this have been -- 16 is a Prozac research physician the same as a 17 clinical research physician? 18 A. Yes, Prozac would be a little 19 more specific, it's one of the clinical research 20 physicians that's worked on Prozac, yes. 21 Q. To your knowledge, would this 22 have been Dr. Robert Zerbe who made this request? 23 A. I would not think so, he wasn't 24 a clinical research physician at that time. Page 258 1 Q. How about Charles Beasley? 2 A. It may have been, I don't know. 3 Q. Then that same section is kind 4 of cut off because it was the end of page on the 5 E-mail, but it states reports of the accidental 6 overdoses, use the event term overdose. 7 A. Correct. 8 Q. And presumably for the same 9 reason, to standardize and be consistent in 10 reporting? 11 A. That's the way I would 12 interpret that, yes. 13 Q. It says suicide attempt is used 14 on all reports involving nonspecific means or 15 meanings other than overdose; correct? 16 A. Yes, that's correct. 17 Q. Under that it says overdose is 18 more specific as to the type of suicide attempt; 19 correct? 20 A. Correct. 21 Q. As we talked about earlier, 22 overdose doesn't necessarily imply suicide 23 attempt, right? 24 A. No, it would be a broader term Page 259 1 to include intentional overdoses as well as 2 accidental. 3 Q. And you would list an overdose 4 with the serious outcome of death if somebody had 5 died from an overdose, right? 6 A. Yes. 7 Q. That doesn't necessarily imply 8 that it was a suicide or a suicide attempt, does 9 it? 10 A. Not without reading the entire 11 report, yes. 12 Q. Then under that it says the 13 text of the report should still reflect the 14 terminology used by the reporter. Suicide 15 attempt by overdose is appropriate textual 16 reporting, but the event term of overdose should 17 be used. The same is true for suicidal ideation 18 and the use of event term depression. Then under 19 that it says note, colon, Jeff provided the 20 explanation or provided explanation. Would the 21 Jeff referred to there be you? 22 A. I would think so, yes. 23 Q. Now, the portion right above 24 that part where is says Jeff provided Page 260 1 explanation, what did he mean by this, if you 2 know? 3 MR. MYERS: I object to the form, it 4 calls upon him to speculate what the writer 5 meant. 6 MS. ZETTLER: Well, according to the 7 writer, he got his explanation from Jeff. 8 MR. MYERS: I understand that, I can 9 read. Same objection. If you know what he 10 meant, tell her, otherwise don't speculate. 11 A. He would mean that we were not 12 to change the text of the report, the actual text 13 that the reporter gave to us would not be 14 changed. 15 Q. Okay. So in -- if in the text 16 it says patient tried to commit suicide by taking 17 three hundred tablets of Prozac, you wouldn't 18 change that; correct? 19 A. Correct. 20 Q. And the same would be true for 21 suicidal ideation, if the patient were to say 22 something to the effect that -- or reporter were 23 to say something to the effect that the patient 24 reported feeling suicidal and wanted to kill Page 261 1 herself by taking Prozac, you wouldn't change 2 that? 3 A. Right, we would report what 4 they told us. 5 Q. But the event term depression 6 would be assigned to that scenario? 7 A. To a later case, yes. 8 Q. Does this refresh your 9 recollection as to whether or not you were aware 10 of the outcome of the questions by Claude Bouchy 11 and Hans Webber about the changing of the event 12 terms for affiliates? 13 A. I still don't recall who Claude 14 Bouchy is, and again Hans Webber was in Germany. 15 I don't recall exactly what happened, no. 16 Q. Do you know whether or not this 17 explanation was ever given to Claude Bouchy? 18 A. I don't know. 19 Q. What's PADER, P-A-D-E-R? 20 A. I believe it stands for 21 periodic adverse drug experience report. 22 Q. How is that different from 23 CIOMS or DEN? 24 A. DEN is actually a computer Page 262 1 system where the reports are entered. A PADER 2 would be information that would come out of DEN. 3 And what was the other part of that question? 4 Q. What's the difference between 5 PADERS and CIOMS's and DEN? 6 A. CIOMS is more or less a setup 7 criteria that would establish reporting of alert 8 reports. 9 Q. Weren't reports actually sent 10 to CIOMS database or entered into the CIOMS 11 database? 12 A. There's no such thing as a 13 CIOMS database, no. 14 Q. I thought you testified earlier 15 that CIOMS was a reporting entity? 16 A. If I did, I did not mean to say 17 that. It was a group of people that got together 18 and established guidelines on world wide adverse 19 event reporting. It's not an entity that exists, 20 nothing is sent directly to CIOMS's. 21 Q. Okay. Where would CIOMS 22 reports be sent then? 23 A. To our affiliates following the 24 CIOMS's guidelines or principles. Page 263 1 Q. They would be sent to the 2 affiliates? 3 A. Correct. 4 Q. And then what would the 5 affiliates do with them? 6 A. They would then send them to 7 their regulatory authorities if appropriate, if 8 the product was manufactured or even made in that 9 country. I will be speculating beyond that. I 10 know they went to our affiliates. 11 Q. But the reports came from your 12 affiliates, didn't they? 13 A. Not all of them, no. Our U.S. 14 reports could be sent to Germany or to the UK. 15 Q. So for purposes of using your 16 examples, Germany or the UK, the same criteria 17 was used for the event that occurred in the 18 United States that may have had to be reported to 19 a regulatory agency in one of those countries? 20 A. Even whether or not they may 21 have had to have been related, I mean Lilly 22 essentially reported anything that we thought 23 should be reported. Some of the countries may 24 not have had regulations, but we followed the Page 264 1 CIOMs guidelines in reporting to their regulatory 2 bodies, anyway, I guess. 3 Q. Do you know for sure whether or 4 not the Germany regulalatory agency required that 5 serious adverse events that occurred in the 6 United States be reported to it? 7 A. I don't know. I know that 8 Germany requested reports from the DEN system, 9 you know, other than our weekly printings. And 10 what exactly they requested or why, I don't know. 11 Q. What would happen -- how would 12 CIOMs be applied to an adverse event that came in 13 from a European affiliate? 14 A. It would -- the report would be 15 handled exactly the same way as far as how it's 16 received in the DEU, how it's reviewed by a 17 research physician, how it's entered into the 18 database, and then the DEN database would 19 actually apply the CIOMs criteria to determine 20 whether it would be mailed to the affiliates on a 21 weekly basis. 22 Q. So I want to make sure I'm not 23 getting confused, okay. Say if somebody in 24 Germany reports an adverse event that takes place Page 265 1 in Germany -- 2 A. Uh-huh. 3 Q. -- to the office in 4 Indianapolis, your office. 5 A. Yes. 6 Q. The CIOMs requirements are 7 applied to that by somebody in Indianapolis? 8 A. By computer essentially, yes. 9 Q. Okay. And if it's determined 10 under the CIOMs regulations that it's a serious 11 event, serious, unexpected and possibly causally 12 related, then it's sent back to the affiliate to 13 be reported to a regulatory agency, if necessary? 14 A. Which they may have already 15 done. The local affiliates would -- they would 16 do what they had to do to meet their regulatory 17 needs in the given country. 18 Q. So the affiliates on their own 19 without approval from anybody at the home office 20 in Indianapolis may or may not report various 21 adverse events if they fit the CIOMs criteria? 22 A. They had to follow the 23 regulatory criteria in the country that they are. 24 Q. What's an EARS group, E-A-R-S, Page 266 1 do you know? 2 A. It was a -- the letters stand 3 for the European Adverse Reaction Reporting 4 System, the EARS system, something similar to 5 that. 6 Q. Is that a Lilly -- 7 A. Yes. 8 Q. Is that something separate and 9 apart from the DEN? 10 A. It was a separate system that 11 existed at one time where the data from that 12 system was passed directly to the DEN system. 13 (PLAINTIFFS' EXHIBIT NO. 27 WAS 14 MARKED FOR IDENTIFICATION AND 15 RECEIVED IN EVIDENCE.) 16 Q. Would you look at Exhibit 27, 17 please? 18 A. Again, it's just a one-page 19 exhibit, isn't it? 20 Q. Yes. 21 A. I guess I don't follow this, 22 the second half of the page appears to have been 23 cut off or copied in mid-sentence. 24 Q. The second half of the page -- Page 267 1 A. Starting December 3rd. 2 Q. Right. But it looks like part 3 of the text is forwarded from the previous 4 message, doesn't it? 5 A. Yes. 6 Q. Let's concentrate on the top 7 part, then. 8 A. Okay. 9 Q. This appears to be an E-mail 10 from Hans Webber to Gilad Gordon. 11 A. Gilad Gordon, yes. 12 Q. And in the E-mail, Mr. Webber 13 says the highlighted event compilation arrived to 14 you two days ago. Do you know what a highlighted 15 event compilation is? 16 A. We talked about that 17 previously, that was the information put together 18 for the quarterly DEN report review. 19 Q. Let's see. Then under, looks 20 like the fifth line down, it says also, comma, I 21 understand that an event which is serious, 22 unexpected and possibly causally related goes to 23 the CIOMS. Do you understand what he means by 24 goes to the CIOMS, is that something where you Page 268 1 don't send adverse reaction reports? 2 A. I guess the terminology was 3 frequently confused, it meant that it was mailed 4 out following the CIOMs guidelines. 5 Q. And then it goes on to say a 6 suicide certainly is serious, and as I learned 7 unexpected. Therefore it seems to depend on 8 assessment of relationships whether it goes to 9 CIOMs, right, is that what it says? 10 A. That's what it says, yes. 11 Q. And after that it states in, 12 looks like, the second quarter of 1990, we had 13 forty-six suicides, four went to CIOMs; correct? 14 A. That's correct. 15 Q. And in the third quarter of 16 1990, we had a hundred and twenty-two total, 17 nineteen of them to CIOMs. So that's correct, 18 right? 19 A. That's correct. 20 Q. So according to your 21 explanation a couple of seconds ago, four were 22 sent out in the second quarter of 1990 and 23 nineteen were sent out in the third quarter of 24 1990? Page 269 1 A. That's what the numbers would 2 indicate. 3 Q. Then my question exactly is how 4 we distinguish between reports that are possibly 5 causally related or unrelated, question mark. 6 With my local opportunities I cannot identify a 7 specific pattern for one or the other. Was there 8 a specific pattern to decide whether or not a 9 suicide attempt was -- or a suicide was causally 10 related for purposes of the CIOMs? 11 A. Not that I'm aware of, it was 12 an individual physician's judgment based on 13 information in the report. 14 Q. Was Hans Webber a doctor? 15 A. I believe that he is. 16 Q. Then it says with my local 17 opportunities, I cannot identify a specific 18 pattern for one or the other. What do you think 19 he means by local opportunities? 20 MR. MYERS: I object to the form, that 21 calls upon him to speculate as to what Mr. Webber 22 meant. 23 A. I agree with that, I'm not sure 24 what he means. Page 270 1 Q. Okay. The last paragraph says 2 further, I want to suggest again the assessment 3 of, quote, possibly related, unquote, if a report 4 is made spontaneously by a health care 5 practitioner. This is another story, but I refer 6 to the final report of the CIOMS working group, 7 the page with definitions, assessment of 8 causality. Is that correct? 9 A. That's what it says, yes. 10 Q. Are you aware -- what is a 11 final report of the CIOMs working group? 12 A. I never saw that document that 13 I recall, I would be guessing. 14 Q. Was there a CIOMs working group 15 in existence at one time? 16 A. That's the group that put 17 together the initial guidelines that we talked 18 about. Whether they were an active group after 19 that, I don't know. 20 Q. So that's not a Lilly group, 21 that's a CIOMs actual group that was put together 22 by CIOMs? 23 A. That's the way I would 24 interpret this. Again, I don't know. Page 271 1 Q. Do you have any reason to 2 believe that there was no CIOMs working group 3 final report? 4 A. Do I have what? 5 Q. Any reason to believe that a 6 CIOMs working group final report does not exist? 7 A. No, I have no reason to doubt 8 that. 9 Q. Do you know what this final 10 report of the CIOMs working group has a 11 definition or guidelines on how to determine 12 whether or not something is possibly related, 13 causally related? 14 MR. MYERS: He already said he's never 15 seen it. 16 A. I don't know. 17 MS. ZETTLER: Could you read the last 18 question? 19 (THE COURT REPORTER READ BACK THE 20 REQUESTED TESTIMONY.) 21 MS. ZETTLER: Before I go on, I forgot 22 to mention earlier, I got a call from Gregory 23 Green this morning whose office represents the 24 Group B plaintiffs in this case and because of a Page 272 1 medical emergency in his family yesterday he was 2 not able to make it this morning. I don't know 3 if he's going to have additional questions for 4 this witness or not on behalf of his clients, but 5 he asked me to make a record that he intended on 6 being here but because of the emergency, was not 7 able to make it. Off the record. 8 (DISCUSSION OFF THE RECORD.) 9 (PLAINTIFFS' EXHIBIT NO. 22 WAS 10 MARKED FOR IDENTIFICATION AND 11 RECEIVED IN EVIDENCE.) 12 Q. Anyway, would you look at 13 Exhibit 22, Mister Powell, please? 14 A. I have finished the review of 15 Exhibit 22. 16 Q. Okay, good. Could you look at 17 the first page of Exhibit 22, it looks like an 18 E-mail from Richard Huddleston to Hans Webber; 19 correct? 20 A. Correct. 21 Q. And you're carbon copied on 22 that, right? 23 A. Yes. 24 Q. Do you have any idea what Mr. Page 273 1 Huddleston means when he asks Mr. Webber if he 2 can give him a unique identifier for the patient 3 that Claude Bouchy referenced in his message? 4 MR. MYERS: Object to the form, it 5 calls on him to speculate what the writer meant. 6 Q. Do you have any idea what he 7 means by that? 8 A. I don't recall a specific 9 report. Again, it would be speculation. 10 MR. MYERS: Don't speculate. 11 Q. Do you know what he means by 12 identifier? 13 MR. MYERS: Same objection. 14 A. The same response, I don't know 15 know. 16 Q. Have you ever used the term 17 identifier within your capacity as a CRA and DEU? 18 A. Not that I recall. 19 Q. The memo goes on to say, he 20 described a patient that you have that committed 21 suicide, had no concomitant meds, and the 22 reporting physician stated suicide was caused by 23 a surge of serotonin. According to Claude, the 24 Indy monitor judged the report to be not related. Page 274 1 Correct, is that what it says? 2 A. Correct. 3 Q. Do you have any idea why the 4 Indy monitor would judge a report by a physician 5 relating an event to a surge of serotonin as not 6 related to Prozac? 7 MR. MYERS: I object to the form. It 8 calls upon him to speculate not as to what the 9 writer meant, but as to what someone other than 10 the writer referred to, meant or might have 11 meant, and otherwise ventures into the sphere of 12 medical and clinical judgment. He's not 13 qualified to answer that question. 14 Q. Can you answer the question, 15 Mister Powell? 16 A. It's the research physician's 17 call, I don't know what they used to influence 18 their decisions one way or the other. 19 (PLAINTIFFS' EXHIBIT NO. 3 WAS 20 MARKED FOR IDENTIFICATION AND 21 RECEIVED IN EVIDENCE.) 22 Q. Would you look at Exhibit 3, 23 please? 24 MR. MYERS: Excuse me? Page 275 1 MS. ZETTLER: Exhibit 3. 2 A. I've finished reviewing Exhibit 3 3. 4 Q. Do you know who Bob Peterson 5 is? 6 A. Not other than what it says in 7 this memo. 8 Q. Okay. What is mark the plans? 9 A. I will be speculating, some 10 part of marketing. 11 Q. Have you ever heard of a select 12 representative? 13 A. There's a select sales force. 14 Q. What's a select sales force? 15 A. It's a sales force that markets 16 certain products. 17 Q. What's a Dista representative? 18 A. A representative that markets 19 certain products that essentially -- I don't know 20 what the difference is in what products they 21 market or don't market between the different 22 groups. 23 Q. Is there a difference between a 24 select representative and a Dista representative, Page 276 1 though? 2 A. I think they're a different arm 3 of marketing or different -- they're different 4 people. 5 Q. This memo talks about a trend 6 analysis on Prozac details. What is a Prozac 7 detail? 8 A. That's marketing language for a 9 call on a physician, a Prozac detail, a call on a 10 physician or a pharmacist, I believe. 11 Q. Okay. Are you familiar with 12 the trend analysis that's discussed in Exhibit 13 No. 3? 14 A. I don't recall what it was 15 about. 16 Q. Do you recall generally that 17 there was a trend analysis done on a Prozac 18 detail AD? 19 A. I don't recall anything other 20 than what's in this memo. 21 Q. Who's Barbara Walden? 22 A. She was a DEA in the drug 23 epidemiology area. 24 Q. Do you have an understanding of Page 277 1 what it means for a sales rep to proactively 2 address suicidal ideation in details? 3 A. I don't recall exactly what 4 happened. 5 Q. Do you recall generally? 6 A. Again, I can interpret this as 7 the representives asking physicians if they have 8 any patients with those experiences. Proactive 9 to me means they're questioning them rather than 10 waiting for the physicians to question them or 11 bring up instances. 12 Q. Okay. So the select 13 representive or the Dista representive would 14 actually initiate a discussion with the customer, 15 being the physician or pharmacist, as you 16 mentioned earlier, as to whether or not they, in 17 this case, experienced any suicidal ideation with 18 any of their patients on Prozac? 19 A. No. 20 MR. MYERS: Are you asking whether he 21 knows that as a fact or whether this memo 22 references it somehow? 23 MS. ZETTLER: Whether the memo 24 references it somehow. Page 278 1 A. That's how I would interpret 2 this. 3 Q. And on the second full 4 paragraph, it says number two on August 31st, a 5 letter was sent to three hundred and thirty-seven 6 thousand physicians concerning the same issue. 7 Would you interpret that as meaning that three 8 hundred seventy-three thousand letters went out 9 to doctors asking whether or not any of their 10 patients suffered from suicidal ideation while on 11 Prozac? 12 MR. MYERS: Let me object, you're 13 asking him once again with these other exhibits 14 to interpret what the writer means in preparing 15 this memo. It says clearly what it says, and 16 what it means beyond that, he can't comment on 17 because he didn't write it. 18 A. That's correct. There was a 19 letter that went to physicians, what exactly it 20 involved, I don't know. 21 (PLAINTIFFS' EXHIBIT NO. 4 WAS 22 MARKED FOR IDENTIFICATION AND 23 RECEIVED IN EVIDENCE.) 24 Q. Would you look at Exhibit No. Page 279 1 4, please? 2 A. I have finished reviewing 3 Exhibit No. 4. 4 Q. Would you look at the second 5 page of the exhibit? 6 A. Yes. 7 Q. It appears that the bottom 8 portion of the page is an E-mail authored by you; 9 is that correct? 10 A. That's correct. 11 Q. It says regarding minutes of 12 meeting held on May 31, 1990 to discuss reporting 13 of Prozac international adverse event reports 14 slash how to optimize the process; correct? 15 A. Correct. 16 Q. Do you remember writing that? 17 A. No, I do not. 18 Q. Do you remember the meeting? 19 A. No, I do not. 20 Q. What did you mean under 21 recommendations where you said number one, to 22 ensure proper follow-up on OUS reports, all 23 messages sent to the affiliates concerning ADR's 24 should include the CC list -- in the CC list, the Page 280 1 medical director and medical monitor of the 2 country involved. 3 A. Who would send reports and send 4 messages to the affiliates asking for follow-up 5 information on some of their reports. And again, 6 I don't recall specifically what went on earlier, 7 but they would not always answer our requests as 8 soon as we would like to receive additional 9 information, so we also included the medical 10 director on those messages that went out as well 11 as the medical monitor, so that if the initial 12 addressee was on vacation or gone from the office 13 or whatever, there would be somebody else there 14 receiving the message that we had sent so that 15 somebody could follow up. 16 Q. Prior to adding the medical 17 director and medical monitor of the country onto 18 the CC list, who would the questions go to at the 19 affiliate? 20 A. There was a listing of 21 individuals that worked at affiliates, I'm not 22 sure who they were or what capacity they were in. 23 Q. Would it generally be a CRA at 24 one of the affiliates, somebody of that nature? Page 281 1 A. I really don't know. 2 Q. The second recommendation, it 3 says that the report involves an event deemed to 4 be of high significance by the U.S. monitor. 5 Messages should be sent to you even if the 6 additional report implies that additional 7 information may not be available. What do you 8 mean by an event being deemed to be of high 9 significance? 10 A. Anything that in the opinion of 11 the U.S. monitor was significant. You know, 12 myocardial infarction probably would be a high 13 significance versus a headache or -- there's a 14 variety of events that could be included there. 15 Q. It doesn't necessarily imply 16 that the incident would be serious under the 17 CIOMs criteria? 18 A. Not necessarily, no. 19 Q. On page three of that exhibit, 20 there are four people listed, starting with your 21 name at the top. 22 A. Yes. 23 Q. Who is Heinrich Klech, 24 K-L-E-C-H? Page 282 1 A. I'm not sure. 2 Q. Who is Martin Dossenbach? 3 A. He was our contact person at 4 one of the affiliates, as far as DEN reports. I 5 don't recall which affiliate. 6 Q. On the last page of that 7 exhibit, it's a little difficult to read again, 8 it says Jeff and Mike, spoke to Leandro Herrero 9 this morning regarding UK needs. Who was Leandro 10 Herrero? 11 A. I don't recall, he was a 12 physician, I believe, but what position, I don't 13 know. 14 Q. Then it says following 15 displacement it lists a number of different 16 things and under numnber three it says CSM 17 question on drug interaction. What is CSM? 18 A. It's one of the UK regulatory 19 authorities, counsel for safety in medicines, I 20 believe, is what it stands for. 21 Q. Let me go back to Exhibit 3, 22 okay. Sorry. Do you know offhand if a report of 23 an adverse event was received by a select 24 representative or a Dista representative through Page 283 1 proactive discussions with customers, would they 2 be reported as adverse events? 3 A. Yes. 4 Q. Do you know offhand how many 5 adverse event reports were obtained by Lilly 6 through the proactive discussions between its 7 sales representives and customers? 8 A. No, I do not. 9 Q. Is there any way to tell from a 10 specific report if it has been obtained from a 11 customer through a proactive discussion with a 12 Lilly representative as opposed to a spontaneous 13 report by the customer? 14 MR. MYERS: I object to the form of the 15 question, the use of the term customer. Lilly 16 did not sell drugs directly to physicians. Go 17 ahead and answer. 18 A. Repeat the question if you 19 would, please? 20 (THE COURT REPORTER READ BACK THE 21 REQUESTED TESTIMONY.) 22 A. Is the question that the 23 customer -- the physician as a customer or the 24 patient as a customer? Page 284 1 Q. Let me ask it this way: Lilly 2 representatives went to potential prescribing 3 physicians to promote Prozac and other drugs; 4 correct? 5 A. I believe so, yes. 6 Q. And they also went to 7 pharmacists saying, you know, we would like you 8 to stock Prozac, et cetera, whatever, right? 9 A. Whatever they say when they're 10 out there, I don't know. 11 Q. And in some cases they might 12 even go to the hospitals and ask them to use 13 Prozac in certain circumstances if prescribed by 14 physicians, et cetera, things of that nature. In 15 other words, they contacted more than just 16 pharmacists, right? 17 A. As part of this effort? 18 Q. As part of their efforts for 19 selling Prozac or any other Lilly drug. 20 A. I guess I really don't know 21 exactly how they go about it, I assume they 22 contact different individuals. Whether they 23 specifically contact hospitals, I don't know. 24 Q. Assuming that they contact Page 285 1 prescribing physicians, hospitals and pharmacists -- 2 A. Okay. 3 Q. -- let's call that group 4 customer generically just for the purposes of 5 these questions. And assume that they contacted 6 them in the context of Exhibit No. 3 and spoke 7 with the various customers proactively regarding 8 suicidal ideation, okay? 9 A. Uh-huh. 10 Q. Is your answer still the same 11 that any reports of adverse events that would 12 have been given to them during the course of 13 those proactive discussions would have been 14 reported by Lilly as adverse events? 15 A. Yes. 16 Q. My next question is, if you 17 were to look at the 1639s or any of the related 18 forms, the working 1639s, the routing slips, et 19 cetera, that we already talked about, would there 20 be any way to tell from any of those forms 21 whether or not the adverse event was one that was 22 gleaned from these proactive conversations? 23 A. Not that I'm aware of, no. 24 Q. Did you ever see any reports of Page 286 1 numbers of adverse drug experience reports that 2 were reported as a result of these proactive 3 discussions between Lilly representatives and 4 customers? 5 MR. MYERS: He already answered that. 6 Q. I forgot. What was your 7 answer? 8 A. Not that I recall, no. 9 Q. I'm sorry, I forgot, I'm sorry 10 if I asked you that already. Would you look at 11 Exhibit 5, please. 12 (PLAINTIFFS' EXHIBIT NO. 5 WAS 13 MARKED FOR IDENTIFICATION AND 14 RECEIVED IN EVIDENCE.) 15 A. Okay, I have reviewed Exhibit 16 No. 5. 17 Q. Exhibit 5 purports to be 18 handwritten notes, and it looks like it might be 19 your signature at the bottom. Is that your 20 signature? 21 A. That's correct, yes. 22 Q. Are those notes that you wrote? 23 A. They appear to be my 24 handwriting, yes. Page 287 1 Q. Who is Doug Tillman? 2 A. He was a Lilly Prozac attorney. 3 Q. Do you know if he's still with 4 Lilly? 5 A. I don't know. 6 Q. Do you know in the first 7 paragraph of notes, it looks like there's a date 8 here that's partially removed. But during 9 conversations with Doug Tillman concerning a 10 letter we were sending blank, he asked if a 11 report had been filed on the statement made by 12 blank concerning other suicides on the blank. Do 13 you know who the first blank is? 14 A. No, I don't recall. 15 Q. Okay. Do you know what the 16 second blank is? 17 A. No, I do not. 18 Q. How about the third blank? 19 A. No, I do not. 20 Q. Then in the second paragraph it 21 says in discussion with Max Talbott and Donna 22 Pearson, Max stated that the statement by blank 23 did not qualify for an FDA 1639 report as we 24 could not identify any patients; correct? Page 288 1 A. Correct. 2 Q. Still do you know in that 3 second paragraph, do you know who blank is? 4 A. No, I do not. 5 Q. What's an FDA informational 6 report? 7 A. It's a report that would go to 8 the FDA on an expedited or weekly printing basis 9 that really doesn't qualify as a serious or an 10 alert report. So it's a way of sending the FDA 11 information just in an expedited manner. 12 Q. Is that submitted on a 1639? 13 A. Yes, it would be. 14 Q. Is it indicated on the 1639 15 that this is not -- that this is just an 16 informational report as opposed to being an 17 adverse reaction report? 18 MR. MYERS: You mean adverse 19 experience? 20 MS. ZETTLER: Yes. 21 A. It's on the same form, I 22 believe there's an additional typed statement or 23 just brief message that appears saying that for 24 FDA information purposes, and essentially we Page 289 1 treat it the same way as we would an adverse 2 event report. 3 Q. Have you ever heard of the 4 initials ICI? 5 A. Not that I recall, no. 6 Q. How about IPR? 7 A. IPR is, at Lilly, international 8 product registration. 9 Q. How about PRA? 10 A. Again, I can't recall what that 11 would be. 12 Q. What's a global MD, if you 13 know? 14 A. Global MD would be a position 15 with world wide responsibilities on a given 16 product. 17 Q. Do you remember a time when a 18 Dr. David Wheadon was assigned the position of 19 global monitor for Fluoxetine? 20 A. He was one of the Prozac 21 research physicians. Whether or not he had ever 22 had that title or not, I don't know. 23 Q. Are you aware of any person at 24 Lilly being considered global monitor for Page 290 1 Fluoxetine? 2 MR. MYERS: When? 3 MS. ZETTLER: At any time whatsoever. 4 A. I don't recall. I think the 5 global physician positions were new at that, you 6 know, when I was in the DEU. 7 (PLAINTIFFS' EXHIBIT NO. 6 WAS 8 MARKED FOR IDENTIFICATION AND 9 RECEIVED IN EVIDENCE.) 10 Q. Would you look at Exhibit 6, 11 please? Look at the last message on the first 12 page of Exhibit 6. Is that a message that was 13 written by you? 14 A. Yes. 15 Q. It states, I spoke with Dr. 16 Wheadon today, he indicated that he had responded 17 to both of the messages we had discussed, paren, 18 in Germany, close paren. You will be seeing his 19 name on international Fluoxetine messages rather 20 than Bob Thompson as Dr. Wheadon is now the 21 global monitor for Fluoxetine. 22 What do you mean by Dr. Wheadon 23 is now the global monitor for Fluoxetine? 24 A. Apparently that was his new Page 291 1 assignment, new position. 2 Q. Do you know why he replaced Bob 3 Thompson as global monitor for Fluoxetine? 4 A. I do not know that, I believe 5 that was a reorganization that took place. 6 Q. Do you know where Bob Thompson 7 is now? 8 A. No, I don't recall. 9 Q. Do you know if he still works 10 for Lilly? 11 A. Yes. I don't know when I last 12 saw him, but as far as I know he still does. 13 Q. And Bob Thompson isn't the same 14 person as E. Thompson; correct? 15 A. No, he's not. 16 Q. Have you ever heard of the 17 acronym SIADH, S-I-A-D-H? 18 A. Yes. 19 Q. What does that stand for? 20 A. Syndrome of Inappropriate 21 Anti-Diuretic Hormone. 22 Q. Is S-I-A-D-H related in any way 23 to suicidality in Fluoxetine as far as you know? 24 MR. MYERS: Before you answer, I think Page 292 1 you're getting into questions of medical 2 expertise and I object on that basis. But if he 3 has some idea, he can tell you. 4 A. I'm not aware of any way that 5 the two would be related. 6 Q. What is R.F. Sieck, S-I-E-C-K? 7 A. What is the spelling again? 8 Q. S-I-E-C-K, it's Robert Sieck? 9 A. That name doesn't sound 10 familiar, doesn't ring a bell. 11 Q. How about P.R. Reid, R-E-I-D? 12 A. There is one of our physicians 13 whose name was Phil Reid, if that's him. I don't 14 know what his middle initial is. 15 Q. Okay. How about M. Medlock, 16 M-E-D-L-O-C-K? 17 A. M period? 18 Q. Yes, Medlock, M period Medlock. 19 A. I don't recall who that is, if 20 I ever knew. 21 Q. Do you know anybody else with 22 the last name of Medlock? 23 A. Not that I recall. 24 Q. Are you aware of whether or not Page 293 1 Lilly has ever used any outside consultant to 2 review case reports on suicide and suicide 3 attempts by people on Prozac? 4 A. I don't know. 5 Q. You don't know if they've ever 6 done that? 7 A. I don't know. 8 Q. Have you ever been asked to 9 produce information on various 1639s or DEN 10 reports for submission to consultants for 11 evaluation? 12 MR. MYERS: Didn't he just answer that 13 in the last question? 14 MS. ZETTLER: No. 15 A. I prepared information for a 16 research physician, but I don't always know what 17 happened to it at that point. 18 Q. Have you ever heard the name 19 Dr. Jan Fawcett, F-A-W-C-E-T-T? 20 A. Not that I recall, no. 21 MR. MYERS: Do you want to look at 22 either one of these? 23 MS. ZETTLER: Yes. 24 MR. MYERS: Which one? Page 294 1 MS. ZETTLER: Both of them. 2 MR. MYERS: One at a time, any 3 particular order? 4 MS. ZETTLER: Start with 39. 5 (PLAINTIFFS' EXHIBITS 39 AND 40 6 WERE MARKED FOR IDENTIFICATION AND 7 RECEIVED IN EVIDENCE.) 8 A. I have finished reviewing both 9 of those documents, Exhibits 39 and 40. 10 Q. Okay. Have you ever seen the 11 documents that comprise Exhibit 39 before? 12 A. No, I don't recall if I have or 13 not. 14 Q. Who was Dr. P. Keohane, 15 K-E-O-H-A-N-E? 16 A. Patrick Keohane was a Lilly 17 employee in Basingstoke. 18 Q. Where is Basingstoke? 19 A. It's in the United Kingdom, our 20 affiliate in the United Kingdom. 21 Q. Who is James Kotsanos? I'm 22 sorry, I believe you said earlier that you worked 23 on Fluoxetine, but you're not sure if he was in 24 epidemiology? Page 295 1 A. He worked in both, but I'm not 2 sure what sequence. 3 Q. Do you have any knowledge as to 4 why this document would be contained in your 5 employee file as a DEU, Exhibit 39? 6 A. In my employee file? 7 Q. In your files that you kept. 8 Do you have any idea why this document would have 9 been kept in there? 10 A. Because it would have involved 11 the adverse events. I would have -- I would be 12 speculating, I guess, as to the exact reason it 13 would be in there. 14 Q. Would this information listed 15 on the second and third pages of Exhibit No. 39, 16 to your knowledge, would it have been entered in 17 the DEN as follow-up information on these two 18 events? 19 A. As far as I'm aware, it would 20 have been, yes. 21 Q. And the numbers that are 22 blacked out on page two of that exhibit, would 23 those be the manufacturer numbers, to your 24 knowledge? Page 296 1 A. You mean the first black mark? 2 Q. Right. 3 A. I don't know if that's a number 4 or a name or, I can't tell. 5 Q. Okay. Do you know is there any 6 reason why this person who's writing to Dr. 7 Keohane would have those people's names? 8 A. Why he would have -- you mean 9 if the first category were a name, why this 10 person would have a name? 11 Q. Right. 12 A. I don't know. 13 (PLAINTIFFS' EXHIBIT NO. 40 WAS MARKED 14 FOR IDENTIFICATION AND RECEIVED IN 15 EVIDENCE.) 16 Q. Okay. Exhibit 40, do you 17 remember seeing this document before? 18 A. I don't recall, no. 19 Q. Do you recognize the 20 handwriting in the upper right-hand corner of the 21 first page of the exhibit? 22 A. No, I do not recognize that 23 handwriting. 24 Q. Okay. At the bottom it says Page 297 1 thanks, Jim K. Does that refresh your 2 recollection? 3 A. I don't recognize the 4 handwriting. Jim K would probably be Jim 5 Kotsanos. 6 Q. Do you know what he means when 7 he says something, I believe, we sent these in, 8 please confirm? 9 MR. MYERS: I object to the form as to 10 what the writer meant, that the calls upon him to 11 speculate. 12 A. I would speculate that he's 13 asking me to be sure that these are in the DEN 14 system. 15 Q. What does FXM mean? 16 A. FXM, where does that appear? 17 Q. After -- in each of these 18 descriptions on the first page. Do you see, it 19 says male 26. Anxiety depression. Used FXM for 20 a year? 21 A. I don't recall ever seeing that 22 abbreviation used. 23 Q. Does that mean Fluvoxamine, 24 F-L-U-V-O-X-A-M-I-N-E? Page 298 1 MR. MYERS: That would call upon him to 2 speculate and he's said he's never seen it 3 before. 4 A. I didn't say I'd never seen it, 5 I just don't recall. 6 MR. MYERS: I'm sorry, I stand 7 corrected. 8 Q. On the second page of Exhibit 9 40, top of the page, it says Fluvoxamine, quote, 10 reports of aggression, unquote. 11 Q. Do you recall if there was -- 12 there ever being a comparison of reports of 13 aggression in Fluvoxamine as opposed to other 14 anti-depressant or other drugs in general? 15 A. I don't recall that, no, I 16 don't know. 17 Q. Was Fluvoxamine, to your 18 knowledge, a drug produced by Lilly? 19 A. Fluvoxamine? 20 Q. Yes. 21 A. Not unless it was another 22 country's name for Fluoxetine. I don't know how 23 the products are named in other countries. 24 Q. Okay. You don't recall ever Page 299 1 filling out an adverse event report regarding 2 Fluvoxamine as a drug produced by Lilly? 3 A. Of Fluvoxamine? 4 Q. Fluvoxamine. 5 A. Fluvoxamine, no. 6 Q. I'm sorry, Fluvoxamine. 7 A. No, I don't recall that. 8 Q. This drawing listed on page 9 two, okay. 10 A. No. 11 Q. Assuming FXM is Fluvoxamine, 12 would that change your recollection as to whether 13 or not Mr. Kotsanos, wanted these events entered 14 into the DEN? 15 A. I really don't recall. If it 16 was not our product, he would not want them 17 reported in the DEN system. 18 Q. Okay. Who is Barbara 19 Schumacker? 20 A. She works in the German 21 affiliate. 22 Q. Is she still with Lilly? 23 A. I don't know. 24 Q. Who is Charles Scimpert, Page 300 1 S-C-I-M-P-E-R-T? 2 A. Again, he works in the German 3 affiliate. 4 (PLAINTIFFS' EXHIBIT NO. 15 WAS 5 MARKED FOR IDENTIFICATION AND 6 RECEIVED IN EVIDENCE.) 7 Q. Would you look at Exhibit 15, 8 please? 9 A. I have reviewed Exhibit 15. 10 Q. Okay. Do you recognize Exhibit 11 15? 12 A. Yes, I do. 13 Q. Can you tell us what it is? 14 A. There are a series of abstracts 15 that were a part of a presentation to be taken to 16 the European affiliates who use the DEN system. 17 Q. Second page of Exhibit 15, at 18 the bottom it, it says provide summary of first 19 eleven months of affiliate DEN II entry. What 20 does that mean? 21 A. DEN II had been in operation 22 for eleven months, and it was -- it would be some 23 of the slides that follow that, a number of 24 reports, a percentage of reports, where they came Page 301 1 from. 2 Q. The next page, it says at the 3 top adverse event reporting topics? 4 A. Uh-huh. 5 Q. Number one, review October '90 6 through August of '91. Is that the eleven-month 7 period that DEN II was first in place? 8 A. That would be the same time 9 period -- I believe I misspoke. It would have 10 been the time period that the affiliates had been 11 using the DEN II system, I believe. 12 Q. Did you know how long the DEN 13 II system was in place prior to the affiliates 14 beginning to use it? 15 A. I don't recall. 16 Q. So October '90 through August 17 '91, listed in the third page of Exhibit 15, 18 would be the time period that the affiliates 19 would have been using DEN II? 20 A. Would have entered reports 21 directly into the DEN II system, yes. 22 Q. Is DEN II -- beginning of DEN 23 II, was that when the affiliates first began 24 reporting directly into the system? Page 302 1 A. Not even at the beginning of 2 DEN II, they reported to the EAR system, which I 3 believe we mentioned previously, then transferred 4 the data to the DEN system. And exactly when, it 5 appears from this that October '90 is when they 6 began direct entry into the DEN system. 7 Q. When the affiliates reported 8 the data directly to the EARS or DEN systems, 9 would that then bypass CRAs or DEA or the DEU and 10 go directly to clinical physicians for review or 11 would somebody still review it on the lower 12 levels of the DEU? 13 A. Usually the CRAs would review 14 those reports also. 15 Q. Next page is a, looks like, a 16 congratulations or something on there. What's 17 that all about, if you remember? 18 A. Just feedback to them in 19 encouragement that they have been doing a good 20 job, keep up the good work. 21 Q. Next page is says total number 22 of international reports, five thousand six 23 hundred and forty-eight. Would those be reports 24 that were considered serious under CIOMs? Page 303 1 A. Not necessarily, it would have 2 been any report that they had reported. 3 Q. That they had reported to the 4 DEN? 5 A. Yes. 6 Q. And out of those four thousand, 7 one hundred thirty-three were spontaneous reports 8 and one thousand five hundred fifteen were trial 9 reports? 10 A. Yes. 11 Q. Were those trials that were 12 conducted in the various European countries or 13 various countries outside the U.S.? 14 A. Correct. 15 Q. Next page, it's got like an eye 16 chart percentage of international reports by 17 country. Can you tell us what those various 18 letters on the right-hand side of the page stand 19 for? 20 A. They stand for the individual 21 countries. 22 Q. Okay, what does AS stand for? 23 A. I don't recall. 24 Q. What about BE? Page 304 1 A. Belgium. 2 Q. What about CA? 3 A. Canada. 4 Q. DA? 5 A. I don't recall. 6 Q. FR? 7 A. France. 8 Q. GE? 9 A. Germany. 10 Q. IT? 11 A. Italy. 12 Q. JA? 13 A. Japan. 14 Q. NL? 15 A. Netherlands. 16 Q. UK dash BA? 17 A. UK affiliate at Basingstoke. 18 Q. And UK dash EW? 19 A. Our UK affiliate at Earlwood. 20 Q. Could AS stand for Australia? 21 A. It could, it could stand for 22 Austria. 23 Q. Do you know if Prozac was 24 approved for use in Australia when you were a CRA Page 305 1 or DEU? 2 A. I don't recall. 3 Q. The next page is another pie 4 chart, and it says percentage of international 5 reports by product; correct? 6 A. Correct. 7 Q. That's hard to tell from this 8 because it's a copy, but do you happen to know 9 which drug constituted sixty percent of the 10 adverse reports from international affiliates? 11 A. It would have been Fluoxetine. 12 Q. And this included all adverse 13 events, not just the serious adverse events; 14 correct? 15 A. That's correct. 16 Q. Next page it says adverse event 17 reporting product, specific guidelines. Would 18 you have different guidelines for reporting 19 adverse events related to different products? 20 A. They were more related to the 21 actual event that would happen. 22 Q. So in the case of Fluoxetine, 23 as page Pz 1573 1046, states suicidality is 24 something that would be Fluoxetine specific? Page 306 1 A. You could have a suicidality 2 report with any product. 3 Q. Okay, but would a suicidality 4 report for Fluoxetine be different in any way 5 from a suicidality report on any other product? 6 A. Not that I'm aware of, we would 7 follow the same basic reporting principles. 8 Q. To your knowledge of, say, if 9 that suicidality report came in on Ceclor, color, 10 would suicidality be back to depression like it 11 was in Fluoxetine? 12 A. What? 13 Q. Would suicidality or suicide 14 ideations be back to depression like it was in 15 Fluoxetine? 16 A. Yes, it would. 17 Q. Do you know what drug Ceclor is 18 used for? 19 A. Infections. 20 Q. Would suicide ideation be 21 mapped to depression if a person wasn't in fact 22 suffering from depression? 23 A. Would what again? 24 Q. Would suicidality be mapped to Page 307 1 depression on a Ceclor adverse event of suicide 2 ideation? 3 A. Yes, that was a mapping in the 4 event dictionary. 5 Q. To your knowledge, was ELECT 6 used on all terms across the board at Lilly or 7 just on Fluoxetine? 8 A. All drugs. 9 Q. And Ceclor was, you said, an 10 antibiotic? 11 A. Correct. 12 Q. So it would be assumed that if 13 somebody was suffering from suicidal ideation or 14 suicide ideation while they were on Ceclor, they 15 must have been suffering from depression? 16 MR. MYERS: I object to the form. You 17 mischaracterized his testimony, he simply said 18 that's how it would map, that was his testimony. 19 Q. Okay. Is there a policy at 20 Lilly that any suicidal ideation was a cause of 21 depression or result of depression? 22 A. Is there a policy that -- 23 Q. Suicidal ideation was caused by 24 depression? Page 308 1 A. Not that I'm aware of, no. 2 Q. On page Pz 1573 0146, it states 3 under suicidality, past history of suicidal 4 ideation or suicide attempt, past psychiatric 5 history. Is this the type of information that 6 you want them to collect regarding the adverse 7 event of suicidality? 8 A. Those would be guidelines, you 9 would hope that they could obtain that 10 information, yes. 11 Q. The next page, Pz 1573 1047, it 12 states adverse event reporting product specific 13 guidelines, and again it lists Fluoxetine. And 14 underneath that it says ELECT terms; correct? 15 A. Correct. 16 Q. And there's twenty-three 17 categories or columns and the first says text, 18 the second says actual term and the the third 19 says ELECT term; correct? 20 A. Correct. 21 Q. Under that it says -- under 22 text it says suicide attempt other than overdose. 23 And if you follow it across, the actual term is 24 listed as SA. Page 309 1 A. Correct. 2 Q. Or suicide attempt, right? 3 A. Correct. 4 Q. And the ELECT term is suicide 5 attempt? 6 A. Correct. 7 Q. And then underneath that it 8 says suicide attempt by overdose, again it says 9 SA, suicide attempt under the actual term; 10 correct? 11 A. Yes. 12 Q. When they say actual terms, are 13 they actual terms that would be listed on the 14 routing forms, the 1639 routing forms, or the 15 event term forms that we looked at earlier? 16 A. That's correct. 17 Q. And then that suicide attempt 18 or SA that's listed as the actual term would 19 automatically be given the term overdose under 20 the ELECT term, right? 21 A. Once again, the SA -- 22 Q. The SA -- the SA or suicide 23 attempt under actual term? 24 A. Uh-huh. Page 310 1 Q. In that case suicide attempt by 2 overdose would be listed as overdose; correct? 3 A. Correct. 4 Q. Under that it says more 5 specific, under overdose in ELECT term. What 6 does it mean by more specific? 7 A. It's a more specific means of 8 the suicide attempt than just suicide attempt. 9 Q. The next two text terms that 10 are listed are suicidal thoughts and worsening 11 depression; correct? 12 A. Uh-huh. 13 MR. MYERS: Yes? 14 A. Correct, yes. 15 Q. And under the actual term for 16 suicide thought it says SI or suicide thoughts; 17 correct? 18 A. Correct. 19 Q. And the ELECT term for that is 20 depression; correct? 21 A. Correct. 22 Q. And under worsening depression, 23 the actual term listed is worsening depression? 24 A. Correct. Page 311 1 Q. And the ELECT term for that is 2 also depression; correct? 3 A. That's correct. 4 Q. So if you were to look at 5 specifically an ELECT term that was assigned to 6 the -- assigned without any indication what the 7 actual term was, you wouldn't know if that 8 depression related to suicidal thoughts or 9 worsening depression; correct? 10 A. You would have to go to the 11 original report and read the text. 12 Q. Then the last category says no 13 improvement in depression is the text term? 14 A. Uh-huh. 15 Q. You have to say yes or no. 16 A. Yes. 17 Q. The actual term listed is also 18 no improvement in depression? 19 A. Correct. 20 Q. And the ELECT term is lack of 21 drug effect; correct? 22 A. That's correct. 23 Q. On the next page is adverse 24 event reporting, product specific guidelines Page 312 1 again for Fluoxetine. And listed under that is 2 aggression; correct? 3 A. Correct. 4 Q. The ELECT term in that case was 5 aggression, it says equals hostility? 6 A. I don't recall, that is a 7 confusing slide, I'm not sure if the ELECT term 8 would be aggression or it would be hostility. 9 Q. Okay. 10 A. It appears that it would be 11 hostility. 12 Q. And aggressive behavior did 13 appear to be mapped to personality disorder? 14 A. Correct. 15 Q. Do you remember if that in fact 16 was the case? 17 A. Yes. 18 Q. That aggressive behavior was 19 mapped to personality disorder on ELECT? 20 A. I don't recall precisely. 21 Q. Then three areas down it says 22 if injury or death occurs to victim, use event 23 term of international injury with appropriate 24 serious outcome? Page 313 1 A. Of intentional injury? 2 Q. I'm sorry intentional injury 3 with appropriate serious outcome. 4 A. Okay. 5 Q. So in the case of somebody on 6 Prozac murdering somebody else, it would be 7 listed as intentional injury with the outcome of 8 death? 9 A. If the action resulted in 10 death, yes. 11 Q. And then it says in the pretext 12 section, indicate that it applies to aggression? 13 A. Correct. 14 Q. So again, if you were to look 15 at just the event terms that are assigned to 16 injury or death occurring to a victim, you 17 wouldn't know necessarily that the intentional 18 injury listed there was injury or death to 19 another person, right? 20 A. Once again, if you -- 21 Q. If you were just to look at the 22 event term, intentional injury. 23 A. Just event term? 24 Q. Right. Page 314 1 A. Nothing else in the report? 2 Q. Right, without any pretext 3 section or any other information in the report, 4 if you were just to look at the intentional 5 injury, you wouldn't know just from that word 6 alone or that term alone whether or not this was 7 something -- an intentional injury to the 8 person's self or to somebody else; is that 9 correct? 10 A. That's correct. 11 Q. Then under that it says 12 self-inflicted injury, paren, harms self not 13 suicide attempt. How would you, as a CRA, make a 14 determination that a self-inflicted injury was 15 not a suicide attempt? 16 A. You would have to question the 17 reporter, I couldn't make that determination. 18 Q. Then underneath that it looks 19 like it's cut off, it appears to say ELECT term 20 equals injury, accidental? 21 MR. MYERS: It says accident. 22 A. Injury, accident, yes. 23 Q. Does injury, comma, accident 24 mean injury, accidental, accidental injury? Page 315 1 A. I guess I'm not sure what it 2 means, that's the way it mapped in the ELECT 3 dictionary. 4 Q. So according to this, a 5 self-inflicted injury other than a suicide would 6 map to an injury, comma, accident? 7 A. Yes. 8 Q. Do you know if these policies 9 were the same in the United States as they were 10 with the OUS affiliates? 11 A. I believe so, as far as I know 12 they were. 13 Q. Were you ever aware of a 14 twelve-month special monitoring of Fluoxetine 15 that was done at one of the international 16 affiliates? 17 A. I would not know what that's 18 referring to, no. 19 Q. Okay. I believe I asked you 20 who Dr. Leandro Herrero was earlier? 21 A. He's a physician in the UK 22 somewhere. 23 Q. Do you know if he was ever 24 charged with doing a special monitoring of Page 316 1 Fluoxetine? 2 A. I don't know, I'm not aware of 3 that. 4 Q. Have you ever heard of a 5 committee for drug uses and adverse reactions? 6 A. I don't recall the name, no. 7 (PLAINTIFFS' EXHIBIT NO. 41 WAS 8 MARKED FOR IDENTIFICATION AND 9 RECEIVED IN EVIDENCE.) 10 A. I have reviewed the document, 11 Exhibit 41. 12 Q. Okay. Who is A.I. Scott? 13 A. I don't know, the name does not 14 sound familiar. 15 Q. Does this exhibit refresh your 16 recollection as to what the committee for drug 17 usage and adverse reactions might be? 18 A. No, it does not. 19 Q. Were you aware of such a 20 committee that existed within Lilly? 21 A. No, I had not heard of that as 22 being part of Lilly. 23 Q. Do you have any idea why this 24 memo would be produced as part of the documents Page 317 1 that you had produced or collected regarding 2 Fluoxetine? 3 A. No, I do not recall. 4 Q. Have you ever heard the acronym 5 NEJM? 6 A. New England Journal of 7 Medicine. 8 Q. Okay. Have you ever heard of a 9 Dr. Dewan, D-E-W-A-N? 10 A. Not that I recall. 11 Q. Had you ever heard of Professor 12 Inman, I-N-M-A-N? 13 A. Yes. 14 Q. Who is Professor Inman? 15 A. He's a physician in the United 16 Kingdom who maintains some sort of event 17 reporting system. 18 Q. Event monitoring study? 19 A. Possibly, I don't know. 20 Q. Was Dr. Inman's study -- I'm 21 sorry, you said -- what kind of study did you say 22 it was again? I apologize, it's getting late and 23 my memory is not as good as it was. 24 A. I don't know that he had a Page 318 1 specific study, he had some sort of system for 2 reporting of adverse events on new products. 3 Q. On new products? 4 A. That's the way I understand it, 5 I don't know how new -- what time period, but he 6 did not track medications for ever and ever. 7 Q. Was this a system that was 8 separate and apart from other systems in place at 9 Lilly or any of its affiliates? 10 A. Yes. 11 Q. Is this something that Lilly 12 asked Dr. Inman to do or is this something that 13 he did on his own, to your knowledge? 14 A. I don't know, he does it on 15 products in the country, it doesn't have anything 16 to do with Lilly, per se, he tracks any new 17 products in the UK. 18 Q. Okay. So Dr. Inman was not a 19 Lilly employee? 20 A. No. 21 Q. He did not work as a Lilly 22 affiliate? 23 A. No, he did not. 24 Q. Do you know if he was hired as Page 319 1 a consultant by Lilly on Fluoxetine? 2 A. I do not know. 3 Q. Have you ever heard of a DAWN, 4 D-A-W-N, manual? 5 A. Yes. 6 Q. Can you tell us what that is? 7 A. I believe it stands for Drug 8 Abuse Warning Network, something similar to that. 9 Q. National Institute on Drug 10 Abuse, is that part of the FDA, to your 11 knowledge? 12 A. I don't know the answer to that 13 question. 14 Q. Have you ever seen a copy of 15 the DAWN semi-annual report? 16 A. Yes, I have. 17 Q. Why would you be interested in 18 looking at the DAWN semi-annual report? 19 A. It was a report from the 20 emergency rooms of the number of occurrences of 21 overdoses on patients, that type of information, 22 and we would review that for Lilly products and 23 report them to the DEN system. 24 Q. So if you picked up an adverse Page 320 1 event that was listed in the DAWN semi-annual 2 report that you hadn't previously entered into 3 the DEN, you would enter it into the DEN? 4 A. Yes. 5 Q. Would you then report it to the 6 FDA also? 7 A. Yes, anything that went into 8 the DEN system would go to the FDA. 9 Q. Again, that would be regardless 10 of if it was a serious or nonserious event; 11 correct? 12 A. As far as I recall, yes. 13 Q. Are you aware that in one of 14 the semi-annual reports, DAWN semi-annual 15 reports, it's stated that Fluoxetine was 16 inadvertently mixed in with the category with 17 Imipramine? 18 MR. MYERS: If you're reading from a 19 document or quoting a document, I think you 20 should give him the benefit of showing it to him. 21 MS. ZETTLER: I'm asking him if he 22 recalls that. 23 Q. Do you recall it? 24 A. I don't recall it, no. Page 321 1 (DISCUSSION OFF THE RECORD.) 2 (PLAINTIFFS' EXHIBIT NO. 42 WAS 3 MARKED FOR IDENTIFICATION AND 4 RECEIVED IN EVIDENCE.) 5 Q. Have you had a chance to review 6 Exhibit No. 42, Mister Powell? 7 A. I reviewed it, I didn't read 8 every word, yes. 9 Q. Do you recognize that document? 10 A. I don't recognize this 11 document, per se, I recognize the format, the 12 type of information. 13 Q. Okay. Can you tell us what you 14 recognize about the format? 15 A. Just the different categories, 16 the way the reports are written up. These are 17 summaries of DEN reports. 18 Q. Okay. Do you know why this 19 type of a document would be created, is this 20 something for internal use or is this something 21 that would be submitted to a regulatory agency 22 either on its own or as part of another report? 23 A. I believe that it's part of the 24 annual report. Page 322 1 Q. Annual report that's submitted 2 to the FDA? 3 A. Yes. 4 Q. If you look at the first page 5 of 42, it says death, cause unknown. 6 A. Yes. 7 Q. And patient, and it says 8 unknown? 9 A. Correct. 10 Q. Why would the patient be listed 11 as unknown, under what circumstances? 12 A. We didn't have the name of the 13 patient in the DEN system. 14 Q. Then under that it says patient 15 blank. Would that indicate to you that the blank 16 would be the patient's name? 17 A. It would appear that way, yes, 18 or initials. 19 Q. Then in the situation of the 20 first page that's listed unknown, would any 21 information that was entered into the DEN be 22 entered per the manufacturer control number? 23 A. What again? 24 Q. Any information entered in the Page 323 1 DEN, would that be entered under the manufacturer 2 control number? 3 A. Correct. 4 Q. So if you wanted to see 5 everything under the patient, you could enter 6 that control number and pull up all the 7 information that was entered in the DEN on this 8 patient? 9 A. Yes. 10 Q. At the end of the description 11 on the first patient on page one, it says 12 Comment: The relationship of death to Fluoxetine 13 is unclear. Also this event has not been 14 confirmed. To your knowledge is that typical in 15 these types of summaries that are attached to the 16 annual report? 17 MR. MYERS: Let me object to the form, 18 number one, to the extent you used the term 19 typical as being vague and ambiguous. Second, 20 when you handed the witness the document before 21 you took a break, you told him you were going to 22 ask him some general questions about it, and now 23 we're starting to ask specific question about 24 specific cases, and I don't think he was the Page 324 1 author of the document. 2 MS. ZETTLER: Let me rephrase my 3 question, you're right, save us a lot of time and 4 trouble. 5 MR. MYERS: Sure. 6 Q. Let me ask you this: In this 7 type of a document, the summaries of adverse 8 event reports, is there generally a comment 9 section such as the one that is listed or is 10 listed at the end of the summary for the first 11 patient on page one? 12 A. I have not seen other annual 13 reports, I don't know. 14 Q. Do you know if the comment 15 section listed as far as patients, for this 16 patient on page one, is related to the comment 17 section on the 1639? 18 A. The comment section on the 19 1639, I don't recall a comment section on the 20 1639. 21 Q. I'm sorry, look at the comment 22 section on the working 1639. 23 A. That would be Exhibit? 24 Q. Thirty-five, fourth page. Page 325 1 A. No, this comment here is a 2 comment that the physician makes in reviewing the 3 report for the purposes of this annual report. 4 Q. Okay. Do you know why it is 5 that in this particular document, so many of the 6 patients listed are unknown, listed as unknown? 7 A. In general, patient identities 8 are kept confidential by reporters. We 9 frequently did not get that information. 10 Q. So unknown in this context 11 means that you don't -- you simply don't know the 12 name of the person? 13 A. Yes, that we didn't have that 14 information. 15 MR. CLEMENTI: If you had a 16 report where you didn't know the name of the 17 person you were reporting on? 18 THE WITNESS: The patient involved, 19 yes, that's possible. 20 MR. CLEMENTI: Would that go to the FDA 21 in the normal channels or would that stop because 22 it didn't have that patient name? 23 THE WITNESS: No, it would go anyway. 24 Most of the time we did not have a patient's Page 326 1 name. 2 MR. CLEMENTI: Thank you. 3 Q. Have you ever heard the name 4 Francois Rossignol, R-O-S-S-I-G-N-O-L? 5 A. Not that I recall. 6 Q. How about Felice Clore, 7 C-L-O-R-E? 8 A. Yes. 9 Q. Who is Felice? 10 A. She was a DEA in the drug 11 epidemiology area. 12 Q. How about Michael Doyle, 13 D-O-Y-L-E? 14 A. He worked in the Basingstoke 15 affiliate, he was a Lilly employee. 16 Q. Do you know what position he 17 held at that affiliate? 18 A. No. 19 Q. Have you heard of Cesar 20 Ricciarelli, R-I-C-C-I-A-R-E-L-L-I? 21 A. He was a Lilly employee at the 22 Italian affiliate. 23 Q. How about Louise Henry? 24 A. She's a Lilly employee in the Page 327 1 U.S. medical plans area. 2 Q. How about Carol Foxworthy? 3 A. She was a CRA in the drug 4 epidemiology unit. 5 Q. Stephen Twiss? 6 A. He was a Lilly attorney. 7 Q. William Smith? 8 A. I don't recall who that was or 9 is. 10 Q. Have you ever heard of the 11 phrase, white paper? 12 A. It sounds familiar, but I 13 cannot recall what it is. 14 Q. Did you ever hear of the 15 Australian Drug Evaluation Committee? 16 A. It sounds familiar, but I don't 17 recall what it is. 18 Q. Do you know if that committee 19 is a Lilly committee or if that's a committee set 20 up outside of Lilly? 21 A. I have not heard it having been 22 a Lilly committee. 23 Q. Have you ever heard of the 24 Prozac safety team? Page 328 1 A. Again, I don't recall 2 specifically who or what it might have been, it 3 sounds familiar. 4 Q. Do you remember if you were 5 ever a member of such a team? 6 A. I may have been as a CRA or 7 DEU. 8 Q. Who was Rod Usher? 9 A. He was a CRA in the Fluoxetine 10 medical plans area. 11 Q. How about Leslie Chiplar, 12 C-H-I-P-L-A-R? 13 A. She is a CRA in the DEU. 14 MS. ZETTLER: Just a few more, Mister 15 Powell. 16 (PLAINTIFFS' EXHIBIT NO. 43 WAS 17 MARKED FOR IDENTIFICATION AND 18 RECEIVED IN EVIDENCE.) 19 Q. Would you look at Exhibit 43, 20 please? 21 A. Yes. 22 Q. Have you reviewed Exhibit 43? 23 A. Yes. 24 Q. Okay. Have you ever seen this Page 329 1 exhibit before? 2 A. Not that I recall. 3 Q. Have you ever seen anything 4 similar to this exhibit as far as the form or 5 content or anything of that nature? 6 A. Not that I remember. 7 Q. Is this something that would 8 have been produced by Lilly? 9 A. It does not appear to be, no. 10 Q. Do you have any idea why this 11 has been produced as having been in your file in 12 the DEU? 13 A. I don't know. 14 (PLAINTIFFS' EXHIBIT NO. 44 WAS 15 MARKED FOR IDENTIFICATION AND 16 RECEIVED IN EVIDENCE.) 17 Q. Okay. Look at Exhibit 44, 18 please. 19 A. I have finished reviewing 20 Exhibit 44. 21 Q. Okay. Does this refresh your 22 recollection as to what a white paper is? 23 A. Yes, I believe it was a 24 document that Leigh Thompson prepared to send to Page 330 1 the FDA. 2 Q. What is it when you say Section 3 5-E, the DAWN data summary is clearly and 4 accurately stated, what do you mean by the DAWN 5 data summary? 6 A. I don't recall without seeing 7 the document, it's in Section 5-E. I mean I 8 assume that there was some sort of summary based 9 on the DAWN data was in that section of the 10 report. 11 Q. So these would be reports of 12 events that would be from DAWN semi-annual 13 reports that we talked about earlier? 14 A. I don't know if they were 15 specific events or -- I really don't know what 16 they were. 17 Q. Section 7-B, you say that the 18 percentage -- the percentage of serious Prozac 19 reports should be eighteen rather than sixteen. 20 And the next sentence is, do we need to qualify 21 this by stating that the classification serious 22 in this case is based on FOI seriousness. What 23 do you mean by FOI seriousness? 24 A. There is a Freedom of Page 331 1 Information Service that we receive data on. It 2 would be the number of serious reports from that 3 information. 4 Q. Would that be FOI Services in 5 Maryland? 6 A. Yes, I believe that's correct. 7 Q. Would you contact them on a 8 regular basis or how do you receive information 9 from them? 10 A. Do I cantact them? 11 Q. Generically, does somebody from 12 Lilly contact them? 13 A. I don't know how that 14 information comes in, it comes from a different 15 area. 16 Q. What area does it come in 17 through? 18 A. I don't know, I just know that 19 Bob Hunt in the DEU looked at it at times. 20 Q. What is your understanding of 21 what FOI Services is? 22 A. It's just an organization that 23 provides information. Whether it's from the FDA 24 or government in general, I don't know. Page 332 1 Q. Why would you want to report 2 back to the FDA information that was gleaned from 3 FOI Services in the form of an FOI request? 4 A. I don't know, I don't recall, I 5 don't know. 6 Q. To your knowledge, was FOI 7 reporting adverse events to the FDA or any other 8 regulatory agency? 9 A. Does FOI report to the FDA? 10 Q. Right. 11 A. I don't know. 12 Q. In here you say do we need to 13 qualify this by stating that the classification 14 of seriousness based on FOI seriousness rather 15 than regulatory seriousness. Why would there be 16 a difference between FOI seriousness and FDA 17 seriousness? 18 A. I can't answer that, it appears 19 that they included less serious outcomes, but 20 they only included death, hospitalization or 21 disability. 22 Q. Okay. Section 7-H, it says the 23 correct number of medical correspondence is 24 thirty thousand three hundred and eighty-three Page 333 1 through June 14, 1991. Would that be 2 correspondence in regards to questions asked by 3 the physicians or is this related to that other 4 post-analytical? 5 A. I'm not sure what you're 6 referring to as a post-analytical. 7 Q. I know I'm getting it wrong, I 8 can't remember offhand what it is now. The 9 letters that we talked about earlier that were 10 sent out to doctors regarding suicidality and 11 Prozac, does anybody remember what those are? 12 MR. MYERS: Proactive. 13 Q. Section 7-H, is that at all 14 related to the proactive correspondence or 15 interactions between the sales force and Lilly 16 customers? 17 A. I don't recall the date of that 18 letter, but the numbers seem to be so much 19 different, I wouldn't think they would be 20 related. 21 Q. Could this have been Section 22 7-H, would that be related to medical 23 correspondence to physicians in response to 24 questions they had in regards to Fluoxetine? Page 334 1 A. It could be, I don't recall 2 exactly. 3 Q. The section states, Section 7-H 4 states the correct number for medical 5 correspondence is thirty thousand three hundred 6 and eighty-three through June 14, 1991. These 7 are responses to all health care professionals, 8 paren, not just physicians, close paren. What 9 other health care professionals would be included 10 in this definition? 11 A. I don't recall exactly who that 12 would be from the medical correspondence area. 13 Q. Would Lilly sales force be 14 considered a health care professional? 15 A. It was not in the DEU for 16 reporting purposes, but they weren't the initial 17 reporters. I don't know how the medical 18 correspondence area functioned at Lilly. 19 Q. It says statement could read, 20 colon, quote, from initial marketing through June 21 14, 1991, Lilly has made three thousand three 22 hundred -- I'm sorry thirty thousand three 23 hundred and eighty-three written and telephone 24 responses to the U.S. health care professionals Page 335 1 requesting information about Fluoxetine, comma, 2 has proactively. Do you know if this refers to 3 questions about Fluoxetine by the health care 4 professionals to Lilly or questions about 5 Fluoxetine from Lilly to the health care 6 professionals? 7 A. It would be from Lilly to the 8 U.S. health care professionals. The responses 9 were made to them based upon their requests for 10 information, is the way I read that. 11 Q. So the initial question would 12 come from the health care professional, it 13 wouldn't be Lilly inquiring of the health care 14 professional? 15 A. Yes. 16 Q. And then how were you using 17 proactively in that context? 18 A. I would have to see the rest of 19 the statement, I'm not sure what that's referring 20 to. 21 (PLAINTIFFS' EXHIBIT NO. 45 WAS 22 MARKED FOR IDENTIFICATION AND 23 RECEIVED IN EVIDENCE.) 24 Q. Would you look at Exhibit 45, Page 336 1 please? 2 A. I have reviewed Exhibit No. 45. 3 Q. Okay. Does this refresh your 4 recollection regarding the Prozac safety team? 5 A. Not other than apparently these 6 people were the members and we intended to look 7 at a variety of topics, I don't recall if 8 anything -- what happened after that point. 9 Q. Okay. Do you recall gathering 10 information or materials on issues of cancer or 11 MAOI, as listed on the second half of the memo? 12 A. I don't recall doing that, no. 13 (PLAINTIFFS' EXHIBIT NO. 46 WAS 14 MARKED FOR IDENTIFICATION AND 15 RECEIVED IN EVIDENCE.) 16 Q. Okay. Could you look at 17 Exhibit 46, please? 18 A. I have reviewed Exhibit 46, 19 although not in great detail, I'm familiar with 20 what it is. 21 Q. Do you recognize the exhibit? 22 A. I recognize this type of output 23 from the DEN system, I don't recall the specific 24 set of data. Page 337 1 Q. Okay. What can you tell us 2 about the type of output this exhibit is? 3 A. It would be the result of -- 4 well the first page would list the variety of 5 parameters, it was a group report search with no 6 date parameters. It would include all 7 manufacturers, it would be for Prozac. We would 8 be looking for the event term drug, drug 9 interaction. And then it's different ways of 10 sorting that information, would be the bottom 11 left-hand corner of the first page. 12 Q. Okay. What do you mean when 13 you say group report search? 14 A. There were certain searches set 15 up in the DEN system that the CRAs could go in 16 and use. I don't know what was included in group 17 report search, I guess it was a very broad term 18 to search in a lot of different ways. 19 Q. Is there any way of telling who 20 asked for this search to be done? 21 A. Not that I'm aware of. 22 Q. Okay. Did you ask for similar 23 searches to be done? 24 A. Looking specifically at these Page 338 1 same parameters? 2 Q. Did you ever ask that this type 3 of document be generated? 4 A. Yes. 5 Q. In the center of the page, it 6 says drugs chosen, Prozac, Prozac, Prozac, 7 Prozac. Then across it says general, and then at 8 the bottom pulvules, and then bulimia, 9 depression, general, obesity, 10 obsessive-compulsive disorder, smoking and 11 general. Are these different -- what are these 12 indications of, if anything? 13 A. There are Prozac reports in the 14 system that may have been for different 15 indications if they are clinical trial reports. 16 It appears to me that this is a report that's 17 asking for Prozac reports on all indications of 18 all uses. 19 Q. Bottom left-hand corner, it 20 says periodic parameters? 21 A. Yes. 22 Q. What is sort by global project 23 tracking ID mean? 24 A. To print the reports out in the Page 339 1 order of -- it's an identification system that 2 Lilly uses to track its clinical trials. 3 Q. Okay. Would that be inside and 4 out of the U.S.? 5 A. Yes. 6 Q. Okay. And is the global 7 project tracking ID a number that's assigned to 8 various cases, is that an ID number? 9 A. Yes, there's an ID number that 10 corresponds to a patient in a trial. 11 Q. Okay. So it could have a 12 patient in a trial in the United States that is 13 assigned a number, a patient number, within that 14 trial, but then they're also assigned a global 15 project tracking ID number? 16 A. As far as I'm aware, they're 17 one and the same number that's utilized. 18 Q. Okay. Can you tell me what 19 would make up that number, would it include the 20 protocol that the person was involved with as far 21 as a trial protocol? 22 A. Yes, it would. 23 Q. Would it include the initials 24 for the individual trials? Page 340 1 A. I guess that's what I thought 2 you were referring to. 3 Q. Like C-A-C-A-C might be a 4 specific protocol initials? 5 A. Correct. 6 Q. And then the patient's 7 individual numbers within that trial? 8 A. Yes. 9 Q. Any other numbers or initials 10 that would be included in the project or global 11 project tracking ID number? 12 A. It would also include the drug 13 code. 14 Q. Okay. 15 A. I'm aware that the site -- 16 where the monitoring site for that trial is. 17 Q. Would that correlate to the 18 investigator's number? 19 A. The investigator's number would 20 be part of that also. 21 Q. Did Prozac always have the same 22 product code? 23 A. Product code as in -- 24 Q. Like you mentioned earlier, Page 341 1 that the product code would also be included in 2 the global project tracking. 3 A. I'm not sure if that's what 4 it's referred to, but as far as I know that 5 number was always the same, yes. 6 Q. Do you remember offhand what 7 Prozac's code was? 8 A. I'm not absolutely sure. 9 Q. If you could look at the 10 seventh page, it's Pz 1573, page 57. 11 A. Yes. 12 Q. At the bottom it says event 13 terms and it says spontaneous trial, spontaneous 14 is nine thirteen? 15 A. Correct. 16 Q. Would that necessarily mean 17 there are nine hundred and thirteen people who 18 reported adverse events according to this 19 document? 20 A. No, it would not. 21 Q. So that's specifically the 22 number of event terms that were reported? 23 A. Correct, a given patient could 24 have multiple events. Page 342 1 Q. Does this mean that -- does 2 this serious event term actually mean individual 3 event or would that mean the event terms used? 4 A. Individual events or the event 5 term, I don't know. I guess I need clarification 6 on that, I'm not sure what it is. 7 Q. The phrase says event terms, it 8 doesn't say adverse event; correct? 9 A. Correct. 10 Q. So is this an indication that 11 there were nine hundred and thirteen terms 12 assigned to various events or does this mean that 13 there were nine hundred and thirteen events 14 suffered by Prozac patients? 15 A. It would be the number -- total 16 number of events. 17 Q. Okay. And then when it says 18 total reports for drug underneath that. 19 A. That would be the number of 20 individual patient reports. 21 Q. Okay. So there were two 22 hundred and seventy-six patients according to 23 this report, at this time period, within the 24 parameters that it asks for. There were two Page 343 1 hundred and seventy-six patients suffering a 2 total of nine hundred and thirteen adverse 3 events, right? 4 A. Correct. 5 Q. Go to the next page. About a 6 couple of inches down it says report number on 7 the left-hand side, do you see that? 8 A. Yes. 9 Q. Next to that it's got vertical 10 letters REP. Are those related? 11 A. Related to the report number? 12 Q. To each other, or is this like 13 R and then E space E and P? I'm just trying to 14 figure out what these different symbols mean. 15 A. I'm not sure. 16 Q. It might even be REF, my copy 17 looks like it may be. 18 MR. MYERS: It looks like a P, like she 19 said. 20 Q. Okay. And then across from 21 that it say CNT. Do you have any idea what that 22 means? 23 A. It would be country. 24 Q. Okay. And what does RY stand Page 344 1 for? 2 A. I don't know. 3 Q. Patient ID obviously is a 4 patient ID, initials or number; correct? 5 A. I believe so, yes. 6 Q. Then across from there 7 obviously age, sex, dose, regimen, duration of 8 therapy? 9 A. Yes. 10 Q. Drug start date? 11 A. Yes. 12 Q. Event onset date? 13 A. Yes. 14 Q. And first date submitted to the 15 FDA; correct? 16 A. Yes. 17 Q. And underneath there is a 18 space. Now is that -- if the report was in fact 19 submitted to the FDA, would the date be listed 20 when it was first submitted in that category? 21 A. It would be listed below that 22 date, yes. 23 Q. If you have a situation like 24 the third patient listed or third report listed Page 345 1 down where there was no date, would that indicate 2 that this event was not reported to the FDA? 3 A. It would indicate that it had 4 not yet been submitted to the FDA, yes. 5 Q. Then to the right-hand side of 6 the first date submitted to the FDA are a series 7 of letters. Do you know what those letters 8 indicate? 9 A. They represent the various 10 serious criteria. 11 Q. Okay. Then on the top line, D 12 would be death? 13 A. The DE would be death, yes. 14 Q. HO is hospitalization? 15 A. Yes. 16 Q. What's DI stand for? 17 A. I believe it's disability. 18 Q. And OT, would that be overdose? 19 A. I believe the OD is the 20 overdose. 21 Q. Okay. What would OT be? 22 A. There was a category of other 23 reasons, serious. 24 Q. Okay. CA would be cancer? Page 346 1 A. Cancer, yes. 2 Q. BD? 3 A. BD would be birth defect, 4 congenital anomaly. 5 Q. How about LT? 6 A. Life threatening. 7 Q. FD? 8 A. I'm not sure what that comment 9 was. 10 Q. EX? 11 A. Expectancy. 12 Q. And PR? 13 A. Possibly reasonably related. 14 Q. Okay. And the AB, would that 15 mean abated after discontinuance? 16 A. Correct. 17 Q. And RE would be rechallenged? 18 A. Or recur. 19 Q. Then underneath those 20 categories, for the first pages there's a number 21 of X's that indicate no? 22 A. Yes. 23 Q. And what do the X's under the 24 abating and readministered categories stand for? Page 347 1 A. I'm not sure. 2 Q. Would the U's a couple of 3 patients down indicate unknown? 4 A. Again, I'm unsure, that would 5 be my guess. 6 Q. Okay. And how about the 7 asterisks a couple more patients down, would that 8 be the litigation indication we talked about 9 earlier? 10 A. I don't believe that would 11 occur under abate and rechallenge, I'm not sure 12 what that indicates. 13 Q. If you go over to -- between, 14 at the top again, does regimen and duration of 15 therapy. 16 A. Yes. 17 Q. Do you know what these 18 asterisks would indicate that are listed under 19 that category? 20 A. No, I do not. 21 Q. How about before the age it 22 says, before age, a couple of pages down it says 23 E. Do you know what that would indicate? 24 A. No, I do not know. Page 348 1 Q. And then if that patient where 2 it's listed as E under the event terms it says 3 fever and cyanosis. 4 A. Which one -- okay, the CA eight 5 nine one one? 6 Q. Right. 7 A. Okay. 8 Q. There's asterisks next to fever 9 and cyanosis. Do you know why those asterisks 10 are there? 11 A. No, I do not know. 12 Q. Would you go to four more pages 13 back, Pz 1573 61. 14 A. Yes. 15 Q. For patient FR eight nine one 16 two zero five three six A. 17 A. Yes. 18 Q. If you go under it says in the 19 middle of the page, personality disorder. Can 20 you tell me what that relates to? 21 A. That would be one of the event 22 terms. 23 Q. So it's listed along with drug 24 interaction anxiety, personality disorder? Page 349 1 A. Yes. 2 Q. Is there any way you could tell 3 which would come first, would it be drug 4 interaction, anxiety, personality disorder? 5 A. To come first chronologically 6 to -- 7 Q. Listing on the form. I take it 8 these are taken off the 1639; correct? 9 A. Yes. I don't know how it 10 printed those, in what order. 11 Q. So you don't know if 12 personality disorder came before drug interaction 13 and anxieties? 14 A. I do not know. 15 Q. Would you go to the second page 16 of Exhibit 46? 17 A. Yes, that would be fifteen 18 seventy-three fifty-two? 19 Q. Right. Under body system terms 20 down in the dictionary there's something marked 21 out there. Do you know what that would be? 22 A. Looks like it may have been 23 highlighted, I'm not sure if it was marked out. 24 When the dictionaries changed, there could be an Page 350 1 event term that ended up not being in the current 2 dictionary that had been in previous 3 dictionaries, and if that was the case for this 4 particular report query, it would actually print 5 that there. It didn't have body system to group 6 it with because it no longer exists. 7 Q. Okay. Do you remember an event 8 term drug level altered? 9 A. Yes, that was an event term at 10 one time. 11 Q. Would that be an event term 12 that might be listed under this? I don't know if 13 you can read through that or not. 14 A. It appears that it could be. 15 (PLAINTIFFS' EXHIBIT NO. 47 WAS 16 MARKED FOR IDENTIFICATION AND 17 RECEIVED IN EVIDENCE.) 18 Q. Okay. Would you look at 19 Exhibit 47? 20 A. Okay. I have finished 21 reviewing Exhibit 47. 22 Q. Did you author this document? 23 A. Did I what? 24 Q. Is this your handwriting? Page 351 1 A. Yes, it is. 2 Q. Can you tell us why you put 3 this document together? 4 A. It was at the request of either 5 one of the research physicians or possibly Leigh 6 Thompson trying to get the numbers of reports by 7 quarter. 8 Q. Okay. And at the top of the 9 first page it says spontaneous Prozac DEN reports 10 by quarter; correct? 11 A. Correct. 12 Q. And it says one category U.S., 13 paren, serious, close paren, and then another 14 international, paren, serious, close paren; 15 correct? 16 A. Correct. 17 Q. Does the -- where it says U.S. 18 serious, does that indicate that the number in 19 the paren indicates the number of serious adverse 20 events for that period? 21 A. Yes. 22 Q. So prior to 1988, there was one 23 serious event or -- I'm sorry, there was one 24 adverse event that was reported in the United Page 352 1 States and there were no serious adverse events; 2 correct? 3 A. That's correct. 4 Q. And international, prior to 5 1988, there were fifteen events that were 6 reported total and three were serious? 7 A. That is correct. 8 Q. Okay. Then the first quarter 9 of 1988 there were two hundred seventy-one 10 reported adverse events and twenty were serious? 11 A. Correct. 12 Q. When you say that they were 13 reported, you mean reported to the FDA or that 14 those -- 15 A. I believe these were -- I don't 16 recall exactly. These were probably reported to 17 Lilly at that time. 18 Q. Okay. They were reported to 19 Lilly and entered into the DEN? 20 A. Yes. 21 Q. For the quarter of 1988, there 22 were eleven hundred and thirty-one adverse events 23 reported to Lilly in the U.S. with a hundred and 24 fifty-two being serious; correct? Page 353 1 A. Correct. 2 Q. And there were only sixteen in 3 the international that were reported as being 4 serious? 5 A. I believe the number is six, I 6 can't read it. 7 Q. Okay. Do you have any idea why 8 there were so few adverse events reported from 9 the international markets for that period? 10 A. It probably had to do with the 11 number of countries that had Fluoxetine approved, 12 I'm not sure where it was approved first. 13 Q. Offhand, do you know how many 14 countries approved Fluoxetine for use during the 15 period of time that you worked in the DEU? 16 A. No, I do not. 17 Q. Those countries that we listed 18 earlier, related to one of the exhibits, included 19 Italy, France, Germany, et cetera. Were those 20 all countries where the drug had been approved at 21 that time or were those countries where the drug 22 had been either approved or trials were going on? 23 A. I would have to look at the 24 list, I'm not sure if it included both or not. Page 354 1 (PLAINTIFFS' EXHIBIT NO. 48 WAS 2 MARKED FOR IDENTIFICATION AND 3 RECEIVED IN EVIDENCE.) 4 Q. Okay. If you could look at 5 Exhibit 48. 6 A. Okay. I have reviewed this 7 document, Exhibit 48. 8 Q. You're familiar with that 9 document? 10 A. Yes. 11 Q. Could you tell us what it is? 12 A. It's a listing of reports in 13 the DEN system that involved -- it was Fluoxetine 14 reports involving suicidal ideation, suicidal 15 acts, or suicidal acts which were fatal. 16 Q. So this is related to the, what 17 we talked about earlier, where it said fatal 18 acts, suicide, SI or something? 19 A. I don't recall the precise 20 document that you had been referring to. 21 Q. When you say -- when we were 22 talking about earlier reporting the most serious 23 out of the three, that's what you were talking 24 about in this document here? Page 355 1 A. It would have been done the 2 same way, yes. 3 Q. On the left hand side, it says 4 record number. Is this number in any way related 5 to information that's reported into the DEN or is 6 this just for purposes of this document, the 7 number on the left? 8 A. I believe it's just for this 9 document, just a count. 10 Q. And are these listed 11 chronologically, do you know? 12 A. They appear to be, yes. 13 Q. Would these be all suicidal 14 ideation events prior to July of 1990, 15 spontaneous suicidal ideation events, to your 16 knowledge? 17 A. Spontaneous suicidal ideation 18 prior to July, '90. According to the title, yes, 19 that's how I would interpret it. 20 Q. And the pages -- the third 21 through eighth pages would be all suicidal acts 22 prior to July of 1990? 23 A. Through which page? 24 Q. Like Pz 1573 through Pz -- I'm Page 356 1 sorry, 1573 240 through 245. 2 A. Yes. 3 Q. Okay. And these aren't 4 necessarily -- these aren't fatal acts of 5 suicide; correct? 6 A. Not this particular set, 7 correct. 8 Q. And according to this, there 9 were two hundred and seventy-five suicidal acts 10 reported sponeaneously prior to July of 1990; 11 correct? 12 A. Correct. 13 Q. In the U.S.? 14 A. Yes. 15 Q. And then the last two pages of 16 the exhibit are fatal acts reported prior to July 17 of 1990, spontaneously in the United States; 18 correct? 19 A. Correct. 20 Q. Do we know from this whether or 21 not these are completed suicides or if they were 22 homicides? 23 A. It's my recollection that they 24 would be suicides. Page 357 1 Q. What happened to the working 2 1639's once the information was entered into the 3 DEN? 4 A. They were kept as part of the 5 file. 6 Q. Would you keep the copies of 7 the working 1639's that you worked on? 8 A. No, I would not, they were put 9 in the central files. 10 Q. Did anybody from Lilly's legal 11 department ever ask you to create a document with 12 regards to any litigation that's currently 13 pending against Lilly without naming the 14 litigant? 15 A. Create a document concerning 16 what? 17 Q. Anything related to any pending 18 litigation against Lilly like, for instance, the 19 Wesbecker case, were you ever asked to create a 20 document related in any way -- 21 MR. MYERS: Before you answer that -- 22 don't answer that because if it was asked, it 23 would be at the request of counsel, it would be 24 privileged work product and trial preparation Page 358 1 material, so he's not going to answer that. He's 2 not going to answer any questions about any 3 communications with Lilly's lawyer. 4 Q. You just shook your head no, 5 didn't you? 6 A. Pardon me? 7 MR. MYERS: Don't respond to that. Ask 8 a real question. 9 MS. ZETTLER: Let the record reflect -- 10 first of all, it's not an attorney/client 11 privilege question. Whether or not he's asked to 12 create a document in general is not 13 attorney/client privilege. 14 MR. MYERS: You asked him whether he 15 created a document with respect to a piece of 16 litigation, you gave him the Wesbecker case as a 17 for instance, that's privileged work product and 18 everything else and we're not going to go into 19 that. 20 MS. ZETTLER: You're wrong, Larry. The 21 question goes to the documents that are missing 22 from Mister Powell's file. As usual, there are 23 thousands of documents that were missing from 24 Mister Powell's file, so. Let the record reflect Page 359 1 that in response to my question Mister Powell did 2 shake his head no. 3 Mister Powell, that's all I have for 4 you right now, with the caveat that once we 5 receive the documents that were improperly 6 removed from the file before the documents were 7 produced to us, we may have additional questions 8 that we may want to ask Mister Powell. And with 9 also the caveat that, as I mentioned earlier, 10 Greg Green was unable to, because of personal 11 reasons, unavoidable personal reasons, be here 12 today to represent his clients within the various 13 litigations which he was cross-noticed. So he 14 may want to ask Mister Powell some additional 15 questions also. 16 MR. MYERS: Just so the record is 17 clear, it's our position that the documents 18 produced are the documents that should have been 19 produced. Additionally, while sensitive to Mr. 20 Green's situation, I can't make any agreement one 21 way or another to return this witness for a 22 deposition for any purposes because he has been 23 thoroughly and exhaustably examined by you here 24 today. But we'll let a judge rule on that, Page 360 1 there's no reason to muddy up the record with any 2 of that. Anybody else have any questions? 3 MR. CLEMENTI: I just have a few. 4 * * * * * * * * * * 5 CROSS EXAMINATION 6 BY MR. CLEMENTI: 7 Q. My name is Paul Clementi and I 8 have a couple of short questions. 9 A. Sure. 10 Q. Do you know who Dr. Dicky Kay 11 is, K-A-Y? 12 A. It does not sound familiar. 13 Q. Do you know who Dr. Miller is? 14 A. A Doctor -- 15 MR. MYERS: No first name? 16 MR. CLEMENTI: No first name. 17 A. No. 18 Q. Allen Miller? 19 A. Again, I don't recall that 20 name. 21 Q. Do you know what a Dear Doctor 22 letter is? 23 A. A Dear Doctor letter? 24 Q. Did you ever use a term called Page 361 1 a Dear Doctor letter? 2 A. I did not use it, I have heard 3 the term used. 4 Q. What does that mean, a Dear 5 Doctor letter? 6 A. A letter that would be sent to 7 a large number of physicians. 8 Q. Did you ever help prepare these 9 Dear Doctor letters? 10 A. No, I did not. 11 Q. Did you ever approve a Dear 12 Doctor letter? 13 A. Not that I remember. 14 Q. Did you ever see any Dear 15 Doctor letters regarding Fluoxetine, that you 16 remember? 17 A. I remember seeing a letter that 18 went out to all of the physicians about the 19 suicidality issue concern after it went out. 20 Q. Can you tell me a little bit 21 about what that letter said, what you remember, 22 if anything? 23 A. I don't remember. 24 Q. Is that a letter that you would Page 362 1 have in your records somewhere? 2 A. I don't know. 3 Q. Do you know when that letter 4 went out approximately? 5 A. No. 6 Q. Before or after 1990? 7 A. It was after all the, you know, 8 the publicity started, but I don't know when it 9 was. 10 Q. Do you know how Lilly decided 11 which doctors would get that letter? 12 A. No, I do not. 13 Q. And you don't know the names of 14 those doctors or where I would be able to find 15 out those names, do you? 16 A. The doctors that it went to? 17 Q. Yes. 18 A. No, I really don't know. 19 MR. CLEMENTI: That's all I have, thank 20 you. 21 MR. MYERS: Anybody else? 22 MS. ZETTLER: I have one more quick 23 one. 24 * * * * * * * * * * Page 363 1 REDIRECT EXAMINATION 2 BY MS. ZETTLER: 3 Q. Earlier we talked about the 4 transferring of documents to the Lilly legal 5 department at their request, the Prozac 6 documents. Do you recall that? 7 A. The copying of the documents, 8 yes. 9 Q. Can you tell me how you 10 transferred those documents, were they put in 11 boxes and transferred? 12 A. Yes, they were put in boxes. 13 Q. And were they put in boxes such 14 as the box that's over in the corner there, the 15 small banker-size box? 16 A. They were similar in size to 17 that, yes. 18 Q. How many documents would you 19 say, boxes of documents from Prozac did you 20 transfer personally from your files to the legal 21 department at Lilly? 22 A. I really don't remember, I 23 didn't actually do that work, the clerk in the 24 DEU did. Page 364 1 Q. Do you know if it was more than 2 two boxes of documents? 3 MR. MYERS: He said he didn't know. 4 A. I really don't remember. 5 Q. Would you say that in your 6 files over the years that you worked in the DEU 7 as a CRA that you had more than two or three 8 boxes that size full of documents on Prozac? 9 A. Not if you did not include the 10 adverse event files -- 11 Q. Okay. 12 A. -- the old 1639s, the DEN 13 reports. 14 Q. Okay. 15 A. Which were not part of my 16 files. 17 Q. Okay. But you did in many 18 circumstances create those documents, correct, 19 the working 1639's on various cases? 20 A. I did prepare the working form, 21 yes. 22 Q. And on how many occasions would 23 you say over the years that you worked as a CRA 24 in the DEU did you prepare working 1639's? Page 365 1 A. I don't know. 2 Q. Can you give me an estimate on 3 how many times a day you would prepare such a 4 form? 5 A. I really don't know. 6 Q. Would it be more than five 7 times a day? 8 A. Depending on the day, it could 9 be. 10 Q. How about on a monthly basis, 11 can you give me an estimate of how many times you 12 would prepare such forms in a given month? 13 A. I really don't remember the day 14 or -- I don't know. 15 Q. Would you say that over a 16 period of time -- would it be fair to say that 17 over the period of time that you worked in the 18 DEU, that you prepared over five hundred such 19 reports? 20 A. I have never thought about it. 21 Q. Can you give me an estimate, 22 would it be more than a hundred? 23 A. Would I have prepared more than 24 one hundred adverse event reports while I worked Page 366 1 in the DEU? 2 Q. Right. 3 A. Yes. 4 Q. Would you have prepared more 5 than a thousand? 6 A. I don't know. 7 Q. It's possible you prepared more 8 than a thousand? 9 A. It's possible. 10 Q. Is it a possibility that you 11 prepared more than two thousand? 12 A. I really don't recall the 13 number. 14 MS. ZETTLER: That's all I have. 15 MR. CLEMENTI: No further questions. 16 MR. OLTMAN: No questions. 17 MS. LAWS: We'll reserve our questions. 18 MR. KRAUS: No questions. 19 MR. MYERS: No questions. 20 (THE WITNESS WAS EXCUSED.) Page 367 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 JEFFREY B. POWELL 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 12TH DAY OF 19 AUGUST, 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 368 1 2 3 E R R A T A S H E E T 4 5 COMMONWEALTH OF KENTUCKY ) : SS 6 COUNTY OF JEFFERSON ) 7 8 I, JEFFREY POWELL, THE UNDERSIGNED 9 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 10 OF MY DEPOSITION AND WITH THE CHANGES NOTED 11 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 12 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 13 THE 9TH OF AUGUST, 1993 AT THE TIME AND PLACE 14 STATED THEREIN. 15 PAGE NO. LINE NO. CHANGE REASON Page 369 1 2 PAGE NO. LINE NO. CHANGE REASON 3 4 5 6 7 8 9 _____________________________ 10 JEFFREY POWELL 11 SWORN TO AND SUBSCRIBED BEFORE ME THIS 12 _____ DAY OF __________, 1993. 13 _____________________________ NOTARY PUBLIC, STATE OF 14 KENTUCKY AT LARGE Page 370 1 2 3 4 5 6 7 8 9 10 Page 371 1 CROSS EXAMINATIONBY MR. CLEMENTI:................360 2 REDIRECT EXAMINATIONBY MS. ZETTLER:..............363 3 COMMONWEALTH.....................................367 4 (PLAINTIFFS' EXHIBIT NO. 1........................90 5 (PLAINTIFFS' EXHIBIT NO. 29......................104 6 (PLAINTIFFS' EXHIBIT NO. 2.......................119 7 (PLAINTIFFS' EXHIBIT NO. 10 .....................124 8 (PLAINTIFFS' EXHIBIT NO. 9.......................125 9 (PLAINTIFFS' EXHIBIT NO. 12......................133 10 (PLAINTIFFS' EXHIBIT NO. 30......................139 11 PLAINTIFFS' EXHIBIT NO. 31.......................151 12 (PLAINTIFFS' EXHIBIT NO. 14......................174 13 (PLAINTIFFS' EXHIBIT NO. 26......................181 14 (PLAINTIFFS' EXHIBIT NO. 19......................200 15 (PLAINTIFFS' EXHIBIT NO. 32......................209 16 (PLAINTIFFS' EXHIBIT NO. 32......................218 17 (PLAINTIFFS' EXHIBIT NO. 35 .....................220 18 (PLAINTIFFS' EXHIBIT NO. 36......................223 19 (PLAINTIFFS' EXHIBIT NO. 38......................246 20 (PLAINTIFFS' EXHIBIT NO. 21......................255 21 (PLAINTIFFS' EXHIBIT NO. 27......................266 22 (PLAINTIFFS' EXHIBIT NO. 22......................272 23 (PLAINTIFFS' EXHIBIT NO. 3.......................274 24 (PLAINTIFFS' EXHIBIT NO. 4.......................278 Page 372 1 (PLAINTIFFS' EXHIBIT NO. 5.......................286 2 (PLAINTIFFS' EXHIBIT NO. 6.......................290 3 PLAINTIFFS' EXHIBITS 39 AND 40...................294 4 (PLAINTIFFS' EXHIBIT NO. 15......................300 5 PLAINTIFFS' EXHIBIT NO. 41.......................316 6 (PLAINTIFFS' EXHIBIT NO. 42......................321 7 PLAINTIFFS' EXHIBIT NO. 43.......................328 8 (PLAINTIFFS' EXHIBIT NO. 44......................329 9 (PLAINTIFFS' EXHIBIT NO. 45......................335 10 (PLAINTIFFS' EXHIBIT NO. 46......................336 11 (PLAINTIFFS' EXHIBIT NO. 47......................350 12 (PLAINTIFFS' EXHIBIT NO. 48......................354 13 14 15 16 17 18 19 Page 373 1 CROSS EXAMINATIONBY MR. CLEMENTI:................361 2 REDIRECT EXAMINATIONBY MS. ZETTLER:..............364 3 COMMONWEALTH.....................................368 4 (PLAINTIFFS' EXHIBIT NO. 1........................91 5 (PLAINTIFFS' EXHIBIT NO. 29......................105 6 (PLAINTIFFS' EXHIBIT NO. 2.......................120 7 (PLAINTIFFS' EXHIBIT NO. 10 .....................125 8 (PLAINTIFFS' EXHIBIT NO. 9.......................126 9 (PLAINTIFFS' EXHIBIT NO. 12......................134 10 (PLAINTIFFS' EXHIBIT NO. 30......................140 11 PLAINTIFFS' EXHIBIT NO. 31.......................152 12 (PLAINTIFFS' EXHIBIT NO. 14......................175 13 (PLAINTIFFS' EXHIBIT NO. 26......................182 14 (PLAINTIFFS' EXHIBIT NO. 19......................201 15 (PLAINTIFFS' EXHIBIT NO. 32......................210 16 (PLAINTIFFS' EXHIBIT NO. 32......................219 17 (PLAINTIFFS' EXHIBIT NO. 35 .....................221 18 (PLAINTIFFS' EXHIBIT NO. 36......................224 19 (PLAINTIFFS' EXHIBIT NO. 38......................247 20 (PLAINTIFFS' EXHIBIT NO. 21......................256 21 (PLAINTIFFS' EXHIBIT NO. 27......................267 22 (PLAINTIFFS' EXHIBIT NO. 22......................273 23 (PLAINTIFFS' EXHIBIT NO. 3.......................275 24 (PLAINTIFFS' EXHIBIT NO. 4.......................279 Page 374 1 (PLAINTIFFS' EXHIBIT NO. 5.......................287 2 (PLAINTIFFS' EXHIBIT NO. 6.......................291 3 PLAINTIFFS' EXHIBITS 39 AND 40...................295 4 (PLAINTIFFS' EXHIBIT NO. 15......................301 5 PLAINTIFFS' EXHIBIT NO. 41.......................317 6 (PLAINTIFFS' EXHIBIT NO. 42......................322 7 PLAINTIFFS' EXHIBIT NO. 43.......................329 8 (PLAINTIFFS' EXHIBIT NO. 44......................330 9 (PLAINTIFFS' EXHIBIT NO. 45......................336 10 (PLAINTIFFS' EXHIBIT NO. 46......................337 11 (PLAINTIFFS' EXHIBIT NO. 47......................351 12 (PLAINTIFFS' EXHIBIT NO. 48......................355 13 14 15 16 17 18 19 Page 375