1 1 IN THE SUPERIOR COURT OF THE STATE OF WASHINGTON 2 IN AND FOR THE COUNTY OF KING 3 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - JOYCE FENTRESS, et al., ) 4 ) Plaintiffs, ) 5 ) vs. ) No. 93-2-30143-0 6 ) SHEA COMMUNICATIONS, et al., ) 7 ) Defendants. ) 8 ) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9 DEPOSITION UPON ORAL EXAMINATION OF 10 DAVID L. DUNNER, M.D. VOLUME II 11 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12 9:22 a.m. 13 January 18, 1994 800 Fifth Avenue, Suite 4100 14 Seattle, Washington 15 16 17 18 19 20 21 22 23 24 25 DIANE MILLS, RPR-RMR 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 2 1 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA 2 INDIANAPOLIS DIVISION - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3 IN RE ELI LILLY AND COMPANY ) 4 Prozac Products Liability ) MDL Docket No. 907 Litigation ) All cases 5 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6 DEPOSITION UPON ORAL EXAMINATION 7 OF DAVID L. DUNNER, M.D. 8 VOLUME II 9 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10 9:22 a.m. 11 January 18, 1994 800 Fifth Avenue, Suite 4100 12 Seattle, Washington 13 A P P E A R A N C E S 14 FOR PLAINTIFFS FENTRESS, et al.: 15 NANCY? A. ZETTLER 16 Leonard M. Ring & Associates, P.C. 111 West Washington Street 17 Chicago, Illinois 60602 18 FOR PLAINTIFFS, MDL DOCKET: PAUL L. SMITH 19 Attorney at Law 8150 North Central Expressway 20 745 Campbell Centre II, LB 48 Dallas, Texas 75206 21 FOR ELI LILLY AND COMPANY: 22 LAWRENCE J. MYERS Freeman & Hawkins 23 4000 One Peachtree Center 303 Peachtree Street, N.E. 24 Atlanta, Georgia 30308-3243 25 DIANE MILLS, RPR-RMR 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 3 1 FOR. THE WITNESS: 2 P. ARLEY HARREL Williams, Kastner & Gibbs 3 Two Union Square 601 Union Street, Suite 4100 4 Seattle, Washington 98101-2380 5 I N D E X 6 EXAMINATION BY: PAGE 7 MS. ZETTLER 249 MR. SMITH 288 8 9 EXHIBITS FOR IDENTIFICATION PAGE No. 4- Computer Forwarded Message 254 10 No. 5- Letter dated February 13, 1987 267 No. 6- Undated letter 269 11 No. 7- Memorandum dated September 16, 1991 281 No. 8- Dunner Documents Index 287 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DIANE MILLS, RPR-RMR 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 4 1 (Witness previously sworn.) 2 MR. HARREL: Back on the record this morning. I 3 wantthe court reporter to indicate what time it is, please. 4 THE COURT REPORTER: I have 9:22 a.m. 5 MR. HARREL: I asked the court reporter this 6 morning what time it was when Nancy Zettler first showed up. 7 This deposition was scheduled at 9 a.m. She arrived at 9:07 8 a.m., and then she said she had to go confer with her local 9 counsel. And now she's back ready to commence the 10 deposition. 11 It is my position on behalf of Dr. Dunner that 12 yesterday the deposition went from 9 to 5, went from 9 to 12 13 and then we were planning on recommencing on 1:15, I think 14 it probably got started at 1:25 or 1:30, finished last night 15 at5 p.m. It's scheduled today from 9 to noon. 16 Dr. Dunner at Nancy Zettler's request canceled 17 patients all morning this morning, Tuesday, January 18. He's 18 been inconvenienced in coming to this deposition. And by my 19 calculations, at noon today he will have been available for 20 his deposition for9.5 hours. Granted there's some breaks in 21 that time period, but he clearly has been available over 22 eight to eight and a half hours for deposition time. 23 It is my position that he's been examined plenty 24 long enough. And I am putting Nancy Zettler on notice this 25 morning as well as Paul Smith here that there is available DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 5 1 now from what, about 9:28 until noon. I've told Mr. Smith 2 that I don't care how they divide up the time this morning. 3 He was here yesterday. He was writing some notes to Nancy 4 Zettler. I presume she adopted some in her questions. 5 And for further time for this doctor to be deposed 6 again in either Nancy Zettler's case or any of the 7 multi-district litigation, I would like an opportunity to be 8 heard by a Court, an appropriate Court, and presumably one 9 here in the state of Washington that has jurisdiction over 10 Dr. Dunner, and I would like some time limits. 11 And it would be my position that no further time 12 should be taken of this doctor, because I think there's been 13 an incredible waste of time. This deposition could have been 14 done easily within one day rather than just arguing with the 15 doctor and asking compound questions and a variety of 16 objectionable questions. 17 So my position is both of these attorneys here 18 today, Paul Smithand Nancy Zettler, can have at this witness 19 until noon, he'll be available. And thereafter I request 20 that I be given reasonable notice and an opportunity to be 21 heard on the issue of what deposition, if any, shall be 22 allowed of this witness any further and appropriate time 23 limitations and other terms and conditions of that 24 deposition. And that's my position. 25 And I guess further, if the attorney for Eli Lilly DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 6 1 intends to ask any questions, I'd like him to be in the same 2 time frame this morning. So that's it, and the witness is 3 now available for questioning until noon today. He has 4 patients at 12:45. He canceled them until then at Nancy 5 Zettler's request. 6 MS. ZETTLER: Dr. Dunnerwhen I first spoke to him 7 about setting up this deposition originally told me that he 8 would be willing to go after 5:00 on the first day of the 9 deposition to try to complete this. I don't know whose 10 decision it was to cut it off at 5:00, whether it was yours 11 or his, but he originally said that he would go to 8:00. 12 That did not happen. That did not happen at your request or 13 your client's request. 14 Furthermore, this deposition has been subpoenaed 15 to continue day to day until completed, and we intend on 16 bringing Dr. Dunner back. A large part of the time that was 17 wasted in this deposition, as you say, was wasted by you, 18 Mr. Harrel, by making long-winded speech-type objections and 19 otherwise trying to obscure our questioning of this witness. 20 We're going to ask him back. We will send you a 21 letter asking you to provide us additional days for Dr. 22 Dunner's deposition. If you then feel it's necessary to go 23 in on some sort of a motion then that's your prerogative. 24 As far as allotting time this morning for Mr. 25 Myers to ask questions, I'm going to need all the rest of DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 7 1 the time this morning that we have. So if he wants to ask 2 questions then he's going to have to ask him back as well. 3 But I'm sure that he will have more than enough opportunity 4 to ask him questions at a later date when we bring Dr. 5 Dunner back. 6 Also, I'd like to state that, Mr. Harrel, you are 7 clearly unfamiliar with the facts of this case and the 8 discovery orders that are in place and the nature of the 9 case and the nature of Dr. Dunner's involvement in the 10 development and testing of this drug. Dr. Dunner has been 11 involved in a number of aspects of testing, promotionand 12 marketing of the drug and we intend to question all aspects 13 of his involvement. 14 MR. HARREL: My position is that Mr. Smith here 15 has asked for time to ask deposition questions this morning 16 and I think he should be allowed such. 17 Secondly, I want a Court to read this transcript 18 to see what an incredible waste of time there's been in the 19 questioning. We produced at your request, made a tremendous 20 effort on Sunday to get things to your hotel room Sunday 21 night, and as of this deposition we've been here six and a 22 half hours. 23 You haven't asked a single question really as to 24 any of the exhibits we've produced, and you've just wandered 25 around asking hypotheticals and asking questions about tests DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 8 1 and things. You're not getting to this witness's factual 2 knowledge in a way that a reasonable attorney should be 3 getting there. And so we ask the Court to read this 4 transcript or portions thereof. And I think a Washington 5 state court which I think has jurisdiction here will 6 determine that plenty of time has been spent with this 7 doctor. And if you determine to waste your time, then 8 that's your prerogative. So you're on notice that we'll 9 request a court order prior to any further deposition of 10 this witness after noon today. 11 MR. SMITH: Let me ask this for a point of 12 clarification, Counsel. In order to save -- in light of 13 your position that you're going to resist any further 14 attempts to depose Dr. Dunner further, can we contact you 15 and will that be sufficient as opposed to issuing another 16 formal subpoena for Dr. Dunner's convenience? Will you 17 accept notice of the deposition on his behalf? 18 MR. HARREL: Let me confer with my client on 19 that. 20 (Counsel and witness conferred.) 21 MR. HARREL: I think Dr. Dunner travels so much 22 I'm not going to authorize myself to accept service and 23 process for him, because I'd just be worried that you would 24 serve me with something that I wouldn't be able to get in 25 touch with him. So I don't want to waive any of those DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 9 1 formalities. 2 However, I will say if you send things to me, I 3 will more than likely not insist you serve Dr. Dunner. But 4 I just can't say -- he's not like somebody that's always in 5 town that I can just call him up and say Dr. Dunner, I just 6 got served with a subpoena, I'm going to accept service for 7 you, just because he travels so much around thecountry. 8 But I will say that I may well if you send me 9 something, if I can call him up or write him I'll accept 10 service so you don't have to go around serving him and incur 11 that expense. I will do that. But I can't just as an 12 automatic course say I'm authorized to accept service of 13 process for him. I will probably do so, but I'd like to do 14 it on a case-by-case basis. You send it to me, I'll ask him, 15 and I'll try to get back to you verypromptly. Feel free to 16 call me, leave messages on my voice mail so I know that it's 17 coming and I can give the doctor alert. 18 MR. MYERS: Let me put this on the record real 19 quick. As far as Lilly is concerned, if there is an effort 20 either in the Fentress case or the MDL for additional 21 deposition time as to this witness, it's Lilly's position 22 that it would be appropriate to have a court either here in 23 Washington state or federal or one of the applicablecourts, 24 either the Southern District of Indiana or the Jefferson 25 Circuit Court review the transcript and set some kind of DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 10 1 limitation on any additional testimony, if any, that's going 2 to bepermitted. 3 But let's just go ahead. 4 EXAMINATION. 5 Q. (By Ms. Zettler:) Dr. Dunner, you understand that 6 you're still under oath? 7 A. Yes, I do. 8 Q. Are you board certifiedon any specialty? 9 A. I'm board certified in psychiatry by the American 10 Board of Psychiatry and Neurology,Inc. 11 Q. So you're only board certified in psychiatry and 12 not neurology? 13 A. That is correct. 14 Q. Did you take the neurology boardcertification? 15 A. It's a combined board. I had a residency in 16 psychiatry which allowed me to take the tests offered by the 17 American Board of Psychiatry and Neurology in psychiatry, 18 and I'm certified in psychiatry. 19 Q. Did you attempt to get board certified in 20 neurology? 21 A. No, I did not. 22 Q. When did you become board certified in psychiatry? 23 A. 1971. 24 Q. Did you talk to anybody other than your attorney 25 between last evening and this morning about this deposition DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 11 1 or any of the facts related to your involvement with 2 fluoxetine? 3 A. Yes. 4 Q. Who did you talk to? 5 A. I talked to my wife. 6 Q. Anybody else? 7 A. I talked to my brother-in-law, Bill Zolbert. 8 Q. Did you talk to your brother-in-law about the 9 facts in this case or your involvement with Lilly on 10 fluoxetine? 11 A. I talked to him about some of the questions in the 12 deposition. 13 Q. Is your brother-in-law a lawyer? 14 A. Yes, he is. 15 Q. What did you tell him about the questions in the 16 deposition? 17 MR. HARREL: Let me just ask you, did you feel you 18 were discussing anything with Bill Zolbert as your lawyer? 19 THE WITNESS:Actually, he indicated that since I 20 said he was on the record that he would claim 21 attorney-client privilege if he got requested to testify in 22 this. So I think what I was discussing with him was legal 23 matters. 24 MR. HARREL: Did you feel that you were conferring 25 with him not only as your brother-in-law but as your DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 12 1 attorney or as one of your attorneys? 2 THE WITNESS:As an attorney, yes, rather than my 3 brother-in-law. 4 MR. HARREL: Okay. Then I'll advise him he 5 doesn't have to answer with respect to what he discussed 6 with Bill Zolbert to the extent he was talking to him as an 7 attorney as opposed to being his brother-in-law. 8 Q. (By Ms. Zettler:) So you're claiming, Dr. Dunner, 9 that you have in essence three attorneys representing you on 10 behalf of this deposition; is that correct? 11 A. Well, I'll get all the legal advice I can for this 12 deposition. 13 Q. That's not my question. Are you claiming that Mr. 14 Harrel, Mr. Zolbert as well as Dr. Benjamin are all acting 15 as your attorneys with regard to this matter? 16 MR. HARREL: Numberone, I'm here at this 17 deposition representing him. If he wants to ask other 18 attorneys attorney-client type of questions and 19 attorney-client communications, then that's his prerogative. 20 He does not have three lawyers sitting here today. I've 21 only been the one defending the deposition. 22 Q. (By Ms. Zettler:) That's not my question. Do you 23 understand my question, Doctor? 24 A. Well, it has a funny little word in it so could 25 you repeat it? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 13 1 Q. Which word is funny? 2 A. It has to do with the relationship between an 3 attorney and a client, I think. 4 Q. Are you a lawyer? 5 A. Pardon? 6 Q. You're not a lawyer; right? 7 A. No, I'm not. That's why I'd like some 8 clarification of your question. 9 Q. That's what I'm asking, if you are claiming that 10 in addition to Mr. Harrel, Dr. Benjamin and your 11 brother-in-law are also acting as lawyers representing you 12 or acting as a lawyer in any way with respect to your 13 testimony at this deposition? 14 A. Yes, they are acting as lawyers in some way. 15 Q. What way? 16 MR. HARREL: I'm going to advise him that he 17 doesn't have to reveal any communication with those 18 attorneys. And to the extent you talk about what way, that 19 may reflect legal advice you got from those lawyers. And 20 he's claimed that they are his attorneys, and beyond that 21 he's not -- it's in his mind to determine whether or not 22 they are his attorneys, and he saidthey are. 23 Therefore, you don't have to talk any further 24 about the communications with those lawyers to the extent 25 it's attorney-client communication as opposed to asking your DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 14 1 brother-in-law how is the weather back in wherever he lives. 2 THE WITNESS:They gave me legal advice. 3 Q. (By Ms. Zettler:) To your knowledge, did Mr. 4 Zolbert or Dr. Benjamin talk with anybody on behalf of Eli 5 Lilly? 6 MR. HARREL: I'm going to advise you that you do 7 not have to discuss in this deposition any attorney-client 8 communication you had with any lawyer representing you, 9 however remotely, with respect to this deposition. You're 10 free to seek legal advice and it's privileged. 11 MS. ZETTLER:That's not my question. You don't 12 even knowwhat my question was. It was if to his knowledge 13 either of those gentlemen have communicated with Lilly. I 14 haven't asked him about the substance. I have a perfect 15 right to find out if a conversation did take place. It's the 16 substance of the conversation that isprivileged, not the 17 occurrence of the conversation itself. 18 THE WITNESS:To my knowledge, no such 19 communication occurred. 20 Q. (By Ms. Zettler:) Did you talk to Mr. Myers since 21 the end of the deposition last night? 22 A. Yes. 23 Q. What did you talk to Mr. Myers about? 24 A. I recommended a restaurant to him. 25 Q. Anything else? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 15 1 A. No. 2 MR. HARREL: I'll just state for the record as we 3 left this deposition, as we were walking we were in the same 4 elevator and then ended up out on the street together, but 5 Dr. Dunner did not talk to Mr. Myers about anything 6 substantively. I think he also made recommendations of 7 restaurants to Mr. Smith and Ms. Zettler also. 8 MR. SMITH: Counsel, I object to your continued 9 side bar remarks with respect to these matters. You've 10 indicated that we're wasting Dr. Dunner's time, and your 11 remarks seem to me to be totally inappropriate. Let's 12 continue with this deposition, please. 13 (Whereupon, Exhibit 4 was marked for 14 identification.) 15 Q. (By Ms. Zettler:) Doctor, before you take a look 16 at Exhibit Number 4. 17 MR. HARREL: Do you have a copy for me, Counsel? 18 MS. ZETTLER: No, I don't. 19 MR. HARREL: Is that going to be the procedure 20 this morning, I'm not going to get copies of exhibits? 21 MS. ZETTLER: Since I'm not working out of my own 22 office I can't make copies of every single possible exhibit. 23 I'll be happy to give you exhibits. If you want to read it 24 through, we'll take as much time as you want to read it 25 through. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 16 1 MR. HARREL: It's just that that's a 2 commonpractice out here after we sent you things on Sunday 3 night as to give me an extra copy. 4 MR. SMITH: Counsel, again we're objecting to 5 your wasting time. 6 MS. ZETTLER:Wait a second. I wanted to ask him 7 some questions before he reviewed itand that's what I was 8 starting before you objected. 9 MR. HARREL: Once she's handed you a document 10 andasks you to look at it, you're entitled to finish it. 11 MS. ZETTLER:Well, I said before you look at it, 12 and you objected, you asked me for a copy. I said before he 13 looks at it. I had the court reporter mark it. I didn't 14 give it to him to look at. 15 Q. (By Ms. Zettler:) My question is towards the end 16 of the day yesterday you were talking about a situation 17 where Dr. Leber from the FDA had spoken to a member or an 18 employee of Eli Lilly in the 6:15 a.m. Conversation. Do you 19 recall that questioning? 20 A. I recall that statement. 21 Q. Do you have any knowledge of any such conversation 22 between somebody at the FDA and anybody at Eli Lilly? 23 A. No, I do not. 24 Q. Now you can review it.Have you had a chance to 25 review Exhibit 4, Doctor? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 17 1 A. Yes, I have. 2 Q. Did you read it carefully? 3 A. I read it. 4 Q. Exhibit 4 purports to be a computer message or an 5 E-mail from Leigh Thompson of Eli Lilly to a number of other 6 Lilly employees. Have you ever seen this before, Doctor? 7 A. No, I have not. 8 Q. The substance of the memo, and if you disagree 9 with me please tell me, is a phone call betweenPaul Leber 10 and Tom Laughren of the FDA and Leigh Thompson of Eli Lilly 11 at 6:15 a.m. On July 18, 1990, discussing the issue of 12 suicide; correct? 13 MR. MYERS: Object to the form. Leading. 14 THE WITNESS:Well, it's a document of some kind. 15 It's not signed. And it discusses it seems to be a memo 16 regarding a phone call. Without reiterating what it says 17 here, that's what it is. 18 Q. (By Ms. Zettler:) And the phone call is between 19 Paul Leber and Tom Laughren of the FDA and the author of the 20 memo, Leigh Thompson; correct? 21 MR. MYERS: Same objection. 22 Q. (By Ms. Zettler:) Look at the first paragraph of 23 the memo, Doctor. It says Paul Leber -- 24 A. I understand that. I mean, Leigh Thompson, Leigh 25 is the last word on this, and then it says Thompson Leigh. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 18 1 So I assume that it is Leigh Thompson who is authoring this, 2 but he's also carboned on it. I don't understand this format 3 so I don't understand how this got generated. 4 Q. The signature line at the bottom or at least the 5 name at the bottom at the end of the memo is Leigh 6 Thompson;correct? 7 A. Thompson Leigh. 8 Q. And it says above that Leigh; correct? 9 A. Correct. 10 Q. Do you know Dr. Leigh Thompson? Do you know who 11 he is? 12 A. Yes, I do. 13 Q. Do you know of a Thompson Leigh? 14 A. I don't know a Thompson Leigh. 15 Q. The first paragraph of the memo also reflects that 16 it was a phone call that occurred at 6:15 a.m.; correct? 17 MR. MYERS: Object to the form. 18 THE WITNESS:That's whatthis says. 19 Q. (By Ms. Zettler:) And the subject matter of the 20 memo or the subject matter reflected in the conversation is 21 suicide? 22 MR. MYERS: Same objection. 23 THE WITNESS:Well, the subject matter seems to 24 have been related to a press request I guess from the Wall 25 Street Journal to the FDA regarding issues related to DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 19 1 suicide. And I mean, I don't know what the intent of this 2 is, I didn't write it. I can read it back to you. 3 Q. (By Ms. Zettler:) The first line of the second 4 paragraphsays," The call was about suicide," does it not? 5 A. That's what it says. 6 Q. I'd like you to turn to the second page of the 7 memo, second to the last paragraph, where it says,"Paul is 8 taking a position in talking with outside folks today that 9 Lilly and FDA and working together on the suicide issue and 10 following closely the postmarketing events, that there are 11 no denominators and the best that can be done is to put 12 a'cap'on the number of events." Do you see that? 13 A. Yes, I do. 14 MR. HARREL: Object to the formof the question. 15 You left out one word. 16 MS. ZETTLER:Which word? 17 MR. HARREL: I don't think it's significant, but 18 it says,"but that there are no denominators." 19 Q. (By Ms. Zettler:) " But that there are no 20 denominators." 21 If Dr. Thompson is reflecting the conversation 22 with Paul Leber of the FDA in which Dr. Leber suggested that 23 a cap be put on the number of adverse events related to 24 suicide beingreported, would that be appropriate in your 25 opinion as a former member of the advisory committee? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 20 1 MR. HARREL: Object to the formof the question. 2 It's beyond what this paragraph says. You added words. 3 MR. MYERS: Let me object to the form on the 4 grounds that this witness is not the author of the document, 5 has never seen the document. He's not been given sufficient 6 facts upon which to form any such opinion, and any such 7 answer would be speculative for him to interpret what was 8 meant and thus what was proper. 9 THE WITNESS:Can I have the question repeated, 10 please. 11 (Whereupon, the reporter read back the last 12 question.) 13 MR. MYERS: Same objection. 14 THE WITNESS:You're asking me to speculate on 15 whether this would be appropriate. As a member of an 16 advisory committee, I don't control what the FDA does, I 17 don't know how they do their business. And this may be how 18 they do their business and it may be appropriate. 19 Q. (By Ms. Zettler:) Failing to report adverse 20 events would impact on the FDA's spontaneous reporting 21 system, would it not? 22 MR. MYERS: Object to the form. Leading. 23 THE WITNESS:I find the question kind of vague. 24 Failing by who? 25 Q. (By Ms. Zettler:) In any way. If Lilly didn't DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 21 1 report some adverse events to the FDA they wouldn't end up 2 in their spontaneous reporting system; correct? 3 MR. MYERS: Same objection. 4 THE WITNESS:That's correct. 5 Q. (By Ms. Zettler:) And, therefore, then the 6 numbers would not be accurate? 7 MR. MYERS: Same objection. 8 THE WITNESS:I find the question vague. What 9 numbers? 10 Q. (By Ms. Zettler:) The numbers -- well, let's just 11 use suicidality adverse events. Say Lilly didn't report 12 suicidality-related adverse events to the FDA and they did 13 not end up therefore in the FDA's reporting system, okay? 14 A. Well, I mean, you know, that's afairy tale. I 15 mean, you're inventing something. 16 Q. I don't think I am, Doctor. 17 A. Well, I don't know thatyou aren't. I mean, you 18 pose the question"say that." Suppose? Imean, what if? This 19 goes into my expert witness category things, a hypothetical 20 question. 21 Q. Well, I don't think it's a hypothetical, Doctor. 22 I'm asking you as a former member of the drug 23 advisorycommittee, would this have any impact on the 24 credibility of the information that was presented at the 25 committee with regards to the spontaneous reporting system DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 22 1 and the number of suicide-related adverse events that were 2 contained in that system? 3 MR. MYERS: Object to the form. It's an improper 4 hypothetical. 5 THE WITNESS:I don't understand your question. 6 Q. (By Ms. Zettler:) What don't you understand about 7 it? 8 A. This. Could I have a question to answer, please. 9 Q. If the FDA and Eli Lilly conspired to neglect or 10 not to report adverse events related to suicidality to the 11 spontaneous reporting system which is a public access 12 system; correct? 13 A. Your question is what? 14 Q. Would you agree with me that the spontaneous 15 reporting system of the FDA is something that the public can 16 access under a Freedom of Information Act request? 17 MR. HARREL: I object to that question as totally 18 compound because you've added about three questions. Could 19 you tell me what question you're asking him to answer? 20 MS. ZETTLER:Arley, if you had been paying 21 attention you'd know I started with a new question. 22 Q. (By Ms. Zettler:) The new question is, Doctor, do 23 you know whether or not the spontaneous reporting system 24 maintained by the FDA on postmarketing spontaneous adverse 25 event reports is something that the public can access? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 23 1 A. I don't know that. 2 Q. Do you know if it's something that somebody on the 3 advisory committee can access if they wanted to? 4 A. I don't know that. 5 Q. Do you know whether or not that information was 6 information that was presented to the advisory committee in 7 September of 1991, a meeting that you attended? 8 A. I think it was -- well, some data was presented 9 related to spontaneous reports by someone from the FDA at 10 the advisory committee meeting, yes. 11 Q. Do you know where that data was gleaned from? 12 A. No, I do not. 13 Q. Did you try to find out where that data was 14 gleaned from? 15 A. No, I did not. 16 Q. Did you accept it as factual? 17 A. I listened to it. 18 Q. Did you take it into consideration in your 19 decision regarding labeling changes? 20 A. Take it into consideration? Yes. 21 Q. Did you believe it when it waspresented? 22 A. It wasn't helpful. It didn't make any -- I mean, 23 the problem with the data presented was there weren't 24 denominators, there were only case reports that didn't 25 reflect the number of people exposed. And from that DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 24 1 perspective it was very hard to put into a context to use 2 pro or con in any decision. 3 Q. Isn't it true that the data suggested that there 4 were quite a few more adverse events reported with regards 5 to fluoxetine than antidepressants that had been on the 6 market at that time? 7 MR. MYERS: Object to the form. Leading. Assumes 8 facts not in evidence. 9 THE WITNESS:I believe that that was the comment 10 that was made, but I also believe that the reporting system 11 -- as I recall what was presented at the time was that the 12 reporting system was also changing over time and it was 13 really subject to what came into the FDA and that it may not 14 have been fair to compare the reports regarding fluoxetine 15 with the reports regarding let's say amitriptyline which had 16 been released several years earlier. 17 Q. (By Ms. Zettler:) If Eli Lilly or any employee of 18 Eli Lilly conspired with any member of the FDA to keep 19 suicidality adverse event reports from being filed with the 20 FDA, in your opinion would that have been appropriate? 21 MR. MYERS: Object to the form on the grounds that 22 that hypothetical question is improper. It includes facts 23 which are not in evidence and includes facts which will 24 never be in evidence. It's improper. 25 THE WITNESS:I think it's already been established DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 25 1 that I'm not a lawyer. I guess for the record, I'm also not 2 a policeman. I think that the answer to that question is 3 more something that has to do with an improper use of 4 influence of government activities that would be a criminal 5 matter or something. And I don't know that I can answer 6 that question from a perspective as a clinical investigator 7 or an FDA advisory committeemember. I'm given information 8 there and I deal with what I have. 9 Q. (By Ms. Zettler:) I'm asking you as a former 10 member of the advisory committee if you feel that it is 11 appropriate for the FDA or somebody from the FDA to conspire 12 with an employee of a drug manufacturer to keep reports of 13 adverse events being placed into the FDA files. 14 MR. MYERS: Same objection. I think he's answered 15 the question. 16 MR. HARREL: I think he has answered the question. 17 If you can add anything further to it, Doctor, you can, but 18 it's the same question. It's asked and answered. 19 THE WITNESS:I think the answer to the question is 20 that a criminal act is independent of my being a member of 21 the advisory committee. A criminal act is a criminal act. If 22 there's a criminal act there needs to be action taken 23 regarding a criminal act. 24 Can we take a few-minute break? 25 MS. ZETTLER: Sure. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 26 1 (Short break) 2 Q. (By Ms. Zettler:) So, Doctor, if in fact somebody 3 at the FDA conspired with Lilly to prevent the reporting of 4 suicidality adverseevents, you feel that that would be 5 something in the nature of a criminal act? 6 MR. MYERS: Same objection as to form. And the 7 question now may call for some sort of a legal conclusion. 8 MS. ZETTLER:I'm asking him about his opinion. 9 MR. MYERS: Same objection. 10 THE WITNESS:Well, conspiracy is a legal term, I 11 think, and carries heavy penalties. 12 Q. (By Ms. Zettler:) So the answer to my question is 13 yes? 14 A. I think the answer to your question is conspiracy 15 is a legal term and carries heavy penalties. 16 Q. Well, you were the one who brought up the 17 word"criminal," Doctor, not me. 18 I just want to clarify what your earlier answer 19 was. Your earlier answer is you didn't feel like you could 20 render opinions on criminal-type activity. So I'm just 21 trying to understand. Is it your testimony that such an act 22 as described in earlier testimony in your answers is 23 criminal in nature? 24 MR. MYERS: Object to the form on the same 25 grounds. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 27 1 THE WITNESS:I'm not clear about what act is being 2 referred to. It might be helpful if we had a direct 3 question. 4 Q. (By Ms. Zettler:) Do you have a problem with your 5 memory? 6 A. Pardon? 7 Q. Do you have a problem with your memory? 8 A. No, ma'am. 9 Q. Are you on any medication that would affect your 10 memory? 11 A. No, ma'am. 12 Q. The question was if the FDA and members of Eli 13 Lilly conspired to prevent the reporting of the 14 suicidality-related adverse events, do you consider that a 15 criminal activity? 16 MR. MYERS: Same objection as to form. 17 THE WITNESS:I'm not a lawyer, I'm not a judge, 18 I'm not a policeman. Conspiracy is -- you know, people get 19 charged with conspiracy, and so under that basis, and 20 speaking as a citizenI guess, that would be an illegal act. 21 Q. (By Ms. Zettler:) Let's talk about the 22 psychiatric board that you are a member of at Eli Lilly. Is 23 that a Psychiatrist Experience Program? 24 A. No. 25 Q. Is that something different than the psychiatric DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 28 1 board, Psychiatrist Experience Program? 2 A. The Psychiatry Experience Program is a program. 3 The program was developed in part with consultation from the 4 psychiatry advisory board. 5 Q. Were you chairman of the psychiatry advisory 6 board? 7 A. No. 8 Q. Were you ever chairman? 9 A. No. 10 (Whereupon, Exhibit 5 was marked for 11 identification.) 12 MR. HARREL: Do you have a copy that I can look 13 at, Counsel? 14 MS. ZETTLER:No. My copy has notes on it. 15 MR. HARREL: I won't read the notes, I'll just 16 look at the text. 17 Q. (By Ms. Zettler:) Do you recognize that document, 18 Doctor? 19 A. Yes, I do. 20 Q. Can you tell me whatit is? 21 A. It's a copy of a letter which we gave to you dated 22 February 13, 1987, from Mr. Saul Kaplan of Dista Products 23 Company to me. 24 Q. Dista Products Company is a division of Eli Lilly, 25 is it not? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 29 1 MR. MYERS: Object to the form. 2 THE WITNESS:I understand it is. 3 Q. (By Ms. Zettler:) What's the subject matter of 4 the letter? 5 A. The subject matter is the development of the 6 Psychiatrist Experience Program. 7 Q. What is a Psychiatrist Experience Program? 8 A. That was a program of symposia to introduce 9 clinicians to use of -- to introduce psychiatrists to data 10 regarding fluoxetine and also its clinical uses and side 11 effects. 12 Q. You mentioned earlier that this was related in 13 some way to the psychiatric board at Eli Lilly; correct? 14 A. I think I said advisory committee. 15 Q. Okay. The advisory committee at Eli Lilly? 16 A. The advisory committee was not at Eli Lilly. 17 Q. It was formed by Eli Lilly? 18 A. Correct. 19 Q. And its function was to advise Eli Lilly; correct? 20 A. Correct. 21 Q. Is this Psychiatrist Experience Program an 22 outgrowth or a result of discussions had by theadvisory 23 commmittee? 24 A. In part. 25 Q. Tell me how it relates to the advisory committee, DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 30 1 and by"it" I mean the Psychiatrist Experience Program. 2 A. As best I can remember, materials regarding this 3 program were presented to the advisory committee and 4 wecommented on them and suggested changes, suggested some 5 things were good and some things were bad and format changes 6 and other matters. 7 Q. In fact, the national advisory panel, or advisory 8 committee as you call it, invited participants to the 9 Psychiatrist Experience Program, did it not? 10 MR. MYERS: Object to the form. Leading. 11 THE WITNESS:I think the plan was to have regional 12 meetings and that people would be invited to attend the 13 regional meetings under signature of people on the advisory 14 committee. 15 Q. (By Ms. Zettler:) Were the people who were 16 invited to attend the regional meetings told that the 17 advisory committee was related to Eli Lilly or formed by Eli 18 Lilly? 19 A. I don't know. 20 (Whereupon, Exhibit 6 was marked for 21 identification.) 22 MR. HARREL: Why don't you just conform it to the 23 original, Doctor. Just handwrite in enclosure and put the 24 number at thebottom. It looks like you cut off part of the 25 bottom. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 31 1 MS. ZETTLER:Yeah. If you want, why don't you just 2 trade your copy for his copy? 3 MR. HARREL: Because that's my only copy. Why 4 don't you trade your copy? 5 MS. ZETTLER:Mine has writing all over it. 6 Q. (By Ms. Zettler:) Have you had a chance to read 7 Exhibit 6? 8 A. Yes, I have. 9 Q. It is numbered DUN 287 and 288 in the bottom 10 right-hand corner; correct? 11 A. Correct. 12 Q. And it's a letter without a date. It looks like a 13 draft letter or a proposed draft on the letterhead of the 14 Psychiatrist Experience Program; correct? 15 A. Correct. 16 Q. And under that heading it says National Advisory 17 Panel and it lists the number of people including yourself; 18 correct? 19 A. Correct. 20 Q. Is this National Advisory Panel the panel that 21 we've discussed a little bit today and yesterday that was 22 formed by Eli Lilly? 23 A. Yes, it is. 24 Q. It doesn't mention in here anywhere that Eli Lilly 25 is affiliated in any way with either the Psychiatrist DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 32 1 Experience Program or the National Advisory Panel, does it? 2 MR. MYERS: Let me object to the form on the basis 3 that the letter speaks foritself. It says whatever it says. 4 THE WITNESS:Actually, there's a Dista logo on it 5 at the top, and the first paragraph says," We have been 6 asked by Dista Products Company, a Division of Eli Lilly and 7 Company, to coordinate the invitation of a select group of 8 psychiatrists to take part in this program." 9 Q. (By Ms. Zettler:) It doesn't say, though, that 10 the panel itself was something that was created by Eli 11 Lilly, does it? 12 MR. MYERS: Same objection. 13 THE WITNESS:It doesn't say it in those words. 14 Q. (By Ms. Zettler:) And in fact, on the second page 15 it says," Our involvement in this program is not an 16 endorsement of this compound. Rather, we are supporting an 17 effort to provide initial clinical experience to 18 psychiatrists as well as a forum for discussion about a new 19 psychotropic agent;" correct? 20 A. That's correct. 21 Q. Do you think that somebody that wasn't familiar 22 with the formation of the advisory panel and its 23 relationship to Eli Lilly would assume that the panel was 24 created by Eli Lilly from this letter? 25 MR. MYERS: Object to the form. It would be DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 33 1 speculation. 2 THE WITNESS:Psychiatrists get a lot of 3 invitations of this kind from pharmaceutical companies as 4 they market new products. And I think it's pretty clear to 5 most psychiatrists who receive this kind of material that 6 the group of the advisory panel or group of physicians 7 mentioned in this is a panel that is selected by the company 8 marketing the drug. It would be unusual to have people 9 assumeanything else. 10 Q. (By Ms. Zettler:) If anything, Doctor, this 11 letter in fact attempts to distance the National Advisory 12 Panel from Eli Lilly, does it not? 13 MR. MYERS: Object to the form. Leading. 14 THE WITNESS:I don't think so. It says in the 15 first paragraph," We have been asked by Dista Products 16 Company, a Division of Eli Lilly and Company, to coordinate 17 the invitation of a select group of psychiatrists to take 18 part in this program." 19 I don't think that's distancing at all. I think it 20 mentions upfront that there is a relationship between we, 21 the National Advisory Panel, and Dista Products Company, a 22 Division of Eli Lilly. 23 Q. In this one instance? 24 A. I'm sorry? 25 Q. It connects the two in this one instance with DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 34 1 regards to the invitation to the program. It doesn't say in 2 there that we are affiliated with or we were created by Eli 3 Lilly, does it? 4 MR. MYERS: Object to the form. Leading. 5 THE WITNESS:Well, it doesn't say it in those 6 words, but I don't know what other conclusion you'd 7 logically draw from something where a group of people says 8 we have been asked by this company to do something. I think 9 the logical conclusion is that the company selected us to do 10 that task. 11 Q. (By Ms. Zettler:) Well, the logical conclusion is 12 that the company went to the panel and said would you help 13 us with this program; correct? 14 A. No, not usually. I mean, most psychiatry panels 15 of this sort are set up by companies, and, you know, there's 16 no freestanding National Advisory Panel. I mean, this is a 17 group that doesn't exist outside of Eli Lilly forming it. 18 Q. And it's your belief that a psychiatrist who is 19 not involved in research or in working with drug companies 20 would know that? 21 A. Yes, it is. 22 Q. Based on what? 23 A. Based on having been involved with a number of 24 similar kinds of programs for other drug companies for the 25 past ten plus years. And it's usual and common to have this DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 35 1 kind of meeting and it's clearly sponsored by a 2 pharmaceutical company. And it would be clear to anyone 3 getting this invitation that this is something formed by 4 that particular company, in this case DistaProducts, a 5 Division of Eli Lilly. 6 Q. Were you chairman of the symposia that was 7 conducted in the region for this program? 8 A. I don't know. I may have been, but I don't know. 9 Q. Did you disclose your participation in this 10 program to the FDA prior to the September 1991 advisory 11 committee meeting on fluoxetine? 12 A. I disclosed to the FDA that I was an advisor to 13 Eli Lilly and that I was giving talks for them for 14 honorarium. I don't know that I particularly mentioned this 15 particular program, because I don't know when this program 16 was taking place vis-a-vis when I started on the FDA and 17 when I filled out these forms. 18 Q. Well, Exhibit Number 5 is dated February of'87, is 19 it not? 20 A. Yes, it is. 21 Q. And that exhibit talks about having symposia prior 22 to or shortly after the marketing of the approval of Prozac 23 for marketing in the United States, does it not? 24 A. That's correct. 25 Q. Does that refresh your recollection as to whether DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 36 1 or not the symposia took place before or after the advisory 2 committee meeting? 3 A. Before or after -- 4 Q. The advisory committee meeting in September of 5 1991. 6 A. Oh, I'm sure it was before. I mean, these programs 7 started about six months after the drug was released. 8 Q. Did you disclose all of your activities related to 9 Eli Lilly to the advisory committee regardless of whether or 10 not they happened before or after or were to happen after 11 the advisory committee meeting in September of 1991? 12 A. I disclosed the information that was requested to 13 me regarding the advisory committee meeting which was 14 ongoing and planned activities regarded to drug companies 15 that were felt to pose particular conflict at that meeting 16 which included Eli Lilly. 17 Q. They didn't ask you for any past affiliations you 18 had with the drug companies, is that what you're saying? 19 A. I think they wanted current grants and future 20 arrangements. It was my understanding that a talk given 21 sometime in the pastthey didn't want to know about or they 22 didn't want to list. It wasn't important or something. 23 Q. Was grants that were previously given for research 24 projects important to them? 25 MR. MYERS: Object to the form as to what was DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 37 1 important to the FDA. That would be speculative, I think. 2 MS. ZETTLER:I'm using his words, Larry. 3 THE WITNESS:Maybe I could describe the process. I 4 would talk to someone fromFDA, an investigator or someone 5 who reviewed all this stuff, and I would discuss anything 6 that I was doing, and I was more than forthcoming with all 7 the information. They determined what needed to go on the 8 disclosure form for particular meetings, for any particular 9 meeting. 10 And when I started at the FDA I listed all ongoing 11 grants and different drug companies and ongoing grants and 12 support in terms of the form that needed to be filled out 13 for every individual meeting that was updated for current 14 grants and speaking engagements or other consulting firms. I 15 gave them all the information that they wantedto use. I gave 16 them probably more information than they wanted to use. 17 Q. (By Ms. Zettler:) Is it your testimony that they 18 had a running file of your grant activity with other drug 19 companies prior to the September of 1991 advisory committee 20 meeting? 21 A. They didn't ask for specific grants as much as 22 getting grant support from a company is my understanding. I 23 would tell them what grants I had and I think they lumped it 24 with ongoing grants. 25 Because from I think -- and here I may be DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 38 1 speculating because I'm talking about something that I think 2 they were doing, but from their perspective it seemed --from 3 my perspective in dealing with them, it seemed that one 4 grant or a hundred grants were the same, that there was a 5 conflict if you had one or more and it didn't matter about 6 the number. 7 And the same was true with speaking engagements, 8 that one speaking engagement in the future or several 9 wereirrelevent. The fact that you had a commitment made a 10 conflict. 11 Q. So you don't feel there's a difference in the 12 nature of the conflict of interest if you're talking about 13 one current grant or a hundred current grants, is that what 14 you're saying? 15 MR. MYERS: Object to the form. Leading and 16 mischaracterizes his testimony. 17 THE WITNESS:I think they asked for ongoing grants 18 and I gave them information, but I think it was pooled in 19 terms of grant support on the disclosure statement, as best 20 I recall. And I tried to give them ongoing grants and things 21 that were in process as best I could. I think that the way 22 the disclosure statements were worded was ongoing grant 23 support. 24 Q. (By Ms. Zettler:) That wasn't my question, 25 Doctor. My question was in your opinion is there a DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 39 1 difference between a conflict of interest created by a 2 single grant that is pending or a single project that is 3 pending with a drug company and multiple projects that are 4 pending? 5 MR. HARREL: Object to the formof the question. 6 From whose perspective? Previously you were asking FDA and 7 now you're asking his. 8 MS. ZETTLER:From his perspective as a former 9 member of the drug advisory committee for the FDA. 10 THE WITNESS:My understanding was that as long as 11 you had one grant you were in conflict and that that had to 12 be resolved either by you not coming to the meeting, which 13 happened to me in some instances, or by your being allowed 14 to come to the meeting at their discretion and listing what 15 information you had. 16 Q. (By Ms. Zettler:) Were there times when you were 17 not allowed to come to meetings because of conflicts that 18 you had? 19 A. Yes. 20 Q. In what cases? 21 A. I was not allowed to attend the sertraline 22 meeting, which I found confusing because I had been allowed 23 to attend the clozapine meeting. And for clozapine I was 24 giving a talk for Sandoz sometime after the meeting where I 25 would personally get an honorarium but I had no ongoing DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 40 1 grants with Sandoz. 2 For sertraline I was giving no talks for Pfizer so 3 I was not personally getting any money, but we did have a 4 grant with another compound ongoing with Pfizer where I 5 personally don't get any of the money. And I found that 6 very confusing, but they felt it was a conflict and they 7 excluded me from that meeting. 8 Q. When you say they, who do you mean? 9 A. The FDA. People at the FDA. I don't know who the 10 people were offhand. 11 Q. Do you know if Paul Leber or anybody from his 12 division have any say in whether or not a conflict of 13 interest can be waived? 14 A. I don't know how the FDA reviewed conflict of 15 interest. I talked to people at the FDA about what I was 16 doing and they made decisions about whether it was waived or 17 not waived. 18 Q. Sertraline is a specific serotonin reuptake 19 inhibitor, is it not? 20 A. Yes, it is. 21 Q. How aboutclozapine? 22 A. Clozaril. 23 Q. Clozaril, I'm sorry. 24 A. Clozaril. I gave you the generic before. And 25 clozapine I think is the generic. And that is an DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 41 1 antipsychotic drug. 2 Q. It's not a serotonin reuptake inhibitor? 3 A. That's correct. 4 Q. Did you disclose to the advisory committee prior 5 to the advisory committee convening in September of 1991 6 that you were on the National Advisory Panel for Eli Lilly? 7 A. I had disclosed I think in my initial disclosure 8 form to get onto the FDA that I was a consultant for Eli 9 Lilly. 10 Q. Did you redisclose that information specifically 11 in relation to the advisory committee meeting that was 12 convened in September of 1991? 13 A. I indicated to the FDA, the people who called me 14 from the FDA that I was still a consultant with Eli Lilly. 15 Q. Did you find it unusual that they would give you a 16 conflict of interest waiver for the September of 1991 17 advisory committee meeting but not for the sertraline 18 advisory committee meeting? 19 A. I didn't understand how they operated. I figured 20 how they operated was how they wanted to operate. I was at 21 their disposal to be an advisory committee member, and when 22 they wanted me to come I tried to come and if they excluded 23 me I wouldn't go. 24 Q. What's the brand name of sertraline? Is that 25 Zoloft? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 42 1 A. Zoloft. 2 Q. How about the paroxetine advisory committee 3 meeting? Were you allowed on that one? 4 A. No, I wasnot. 5 Q. For what reasons? 6 A. Actually for multiple reasons. And I was a 7 current consultant with SmithKline Beecham, we had ongoing 8 grants with SmithKline Beecham. And it seemed to me that 9 there had been some change in conflict of interest rulings 10 from the first meeting I went to to as we went on, and it 11 was clear to me that I was going to be excluded from that. 12 And so I just told them that. They agreed that I wouldn't 13 come. 14 Q. And paroxetine is another serotonin reuptake 15 inhibitor, is it not? 16 A. That's true. 17 Q. Any other advisory committee meetings where you 18 were not allowed to attend because of conflict of interest? 19 A. I think those were the only two. By the way, I was 20 allowed to attend them, I was told I could attend them, I 21 just couldn't speak or vote, and I thought that was stupid 22 so I didn't go. 23 MR. SMITH: Kind of like me. I figured it was 24 stupid for me to come up here, and I haven't been able to 25 ask a question yet. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 43 1 (Whereupon, Exhibit 7 was marked for 2 identification.) 3 Q. (By Ms. Zettler:) Have you had a chance to read 4 Exhibit 7? 5 A. Yes, I have. 6 Q. Have you seen this letter before, Doctor? 7 A. I signed it. 8 Q. That is your signature on the third page of the 9 letter? 10 A. Yes, it is. 11 Q. Can you tell me what this is? 12 A. This is a disclosure memorandum for the public 13 record. 14 Q. Related to your participation in the September 15 1991 drug advisory committee meeting; correct? 16 A. Yes. 17 Q. To your knowledge, is there any other document 18 that reflects -- other than the documents that you filled 19 out, are there any other documents generated by the FDA that 20 reflect your conflicts or your associations with drug 21 companies other than thisexhibit? 22 A. Yeah. There was the initial one I filed when I 23 became a member of the advisory committee. 24 Q. Let me stop you there. I'm not talking when you 25 filed, I'm talking about other letters that were generated DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 44 1 by FDA personnel. 2 MR. HARREL: I'm going to object to you cutting 3 him off, because he wasn't finished with histestimony. 4 You're cutting him off. 5 MS. ZETTLER:Well, I don't think he understood my 6 question, that's why I did that, and I apologize to the 7 doctor. 8 MR. HARREL: Were you finished with your answer, 9 Dr. Dunner? 10 THE WITNESS:I don't know what the question was 11 that I was answering. 12 MR. HARREL: Well, would you read the question 13 back that he was answering, please, before she cut him off? 14 Q. (By Ms. Zettler:) I'm withdrawing that question. 15 Let me ask you another question. 16 This memorandum is not something that you created; 17 correct, Doctor? 18 A. That is correct. 19 Q. You signed this, however; right? 20 A. That is correct. 21 Q. And you reviewed it when you signed it; right? 22 A. That is correct. 23 Q. Do you know who created this memorandum? 24 A. It was presented to me at the advisory committee 25 meeting. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 45 1 Q. Other than this memorandum, are you aware of any 2 other documents that weren't generated by you other than 3 what's generated by you that reflect your affiliations with 4 various drug companies? 5 A. I don't know if it happened at this instance, 6 because I certainly had some lectures and consulting with 7 companies listed here. And I think I mentioned -- I'm sure 8 I mentioned those at the time I signed them, and there may 9 have been an addendum to this filed at themeeting. They 10 sometimes did that where they filed an addendum to the 11 disclosure records, because if I felt that something wasn't 12 correct, I did my very best to correct it. 13 Q. Do you know for a fact that an addendum was filed 14 to this exhibit? 15 A. I don't know. 16 Q. Do you have any recollection whatsoever in 17 attempting to have an addendum filed to this exhibit? 18 A. I know that if there were things in here that I 19 felt were not correct, because sometimes I would go to 20 meetings and I would be giving a talk-- this information 21 was obtained over the phone -- this information would have 22 been obtained sometime prior to the meetingby a phone 23 conversation with someoneat the FDA meeting and they would 24 review all of this. And if there were changes in that, I 25 would make those changes known at the time of the meeting to DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 46 1 individuals at the -- and I believe that there were addendum 2 filed to this declaration. 3 Q. Now you say you believe that there were addendum 4 filed? 5 A. At times, but I don't know if it was filed for 6 this particular one. 7 Q. So you're saying for other meetings you recall 8 addendum being filed for various disclosure statements? 9 A. I think I do, but, you know, again, I don't know 10 -- I mean, I tried to be as upfront with my arrangements 11 with pharmaceutical companies as possible and I fully 12 informed the FDA of what I was doing. 13 Q. Do you recall who you talked to with regards to 14 this disclosure statement at the FDA? 15 A. No. 16 Q. At the top it says"memorandum for the Public 17 Record," do you see that? 18 A. Yes, I do. 19 Q. Does that indicate to you that this was 20 information that was to be disseminated to the public 21 regarding your affiliations with various drug companies? 22 A. Yes, it does. 23 Q. Your membership on the National Advisory Panel is 24 not reflected in this document, is it? 25 A. That is correct. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 47 1 Q. Do you know why that is? 2 A. I do not know. 3 Q. Does that bother you that it wasn't reflected on 4 this document? 5 A. Well, I don't know that it's to the point. I mean, 6 it's obvious that I have a number of commitments for a 7 variety of pharmaceutical companies, and my understanding 8 from the FDA perspective is that one commitment was as bad 9 as any more in terms of excluding me from meetings in the 10 past. So I just took it to mean that. 11 Q. So you have been excluded from meetings in the 12 past because of one affiliation or one conflict that you 13 have had with a company; correct? 14 A. I was excluded from the sertraline meeting because 15 I had an ongoing tandospirone grant that was run through the 16 University. I had no other arrangements with Pfizer. And 17 tandospirone was not the drug being studied at the advisory 18 committee meeting, but the fact that I was the principal 19 investigator on a tandospirone grant running through the 20 University of Washington from their perspective excluded me 21 from that meeting. 22 Q. This is the $100,000 grant that you're referring 23 to on the exhibit at the bottom of the first page? 24 A. Yes. 25 Q. So let me make sure I understand you. Because of DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 48 1 your ongoing $100,000 grant with Pfizer, you were not 2 allowed to participate or vote on the committee that was 3 reviewing sertraline. Yet you had at least as listed on 4 this document two ongoing $100,000 studies with Eli Lilly at 5 the time of the September 1991 advisory committee meeting 6 and you also listed participating on occasional lecturing 7 for Lilly; correct? 8 A. That's correct. 9 Q. And what is not reflected in this memorandum is 10 your ongoing membership in the National Advisory Panel to 11 Eli Lilly regarding psychiatric issues as well as 12 antidepressants; correct? 13 A. That's right. 14 (Short break) 15 MS. ZETTLER: We've got a little over an hour 16 left with this witness today and I'm nowhere near finished 17 with my questioning, and I will be inviting Dr. Dunner back 18 to complete this deposition per our subpoena. I'm going to 19 defer to Paul Smith who is here representing the MDL, allow 20 him some questioning this morning. 21 Thank you, Doctor. 22 MR. HARREL: My prior position on this matter 23 stated at the start of this deposition today stands. 24 MS. ZETTLER:I'm sorry, real quick, I want to just 25 mark this as an exhibit, if that's okay, for the record. It DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 49 1 is the January 17, 1994 listing of documents produced by Dr. 2 Dunnerincluding the documents that had been withheld or from 3 which information had been removed pursuant to Dr. Dunner's 4 attorney's perception of the 12/13/93 order in the Fentress 5 case. 6 MR. HARREL: I have no objection to marking that 7 as an exhibit. It's a three-page exhibit, the first being an 8 indication of what was removed and the second two pages 9 being just a further list of what was produced and not 10 copiedbut you've asked for copies of. 11 And by way of clarification, Dr. Dunner advises me 12 that the slides that are in the bag are available in hard 13 copy which will be a lot cheaper than getting slides 14 reproduced. 15 MS. ZETTLER:Okay, that would be fine. 16 MR. HARREL: And then his, he only has slides. 17 It'll be more expensive to get his done because he doesn't 18 have hard copy. 19 MS. ZETTLER:That's fine. And we've agreed to pay 20 for the expenses. Are those hard copies in color? I'm just 21 concerned if there are any charts-- I don't have the slides 22 in front of me. I'm just concerned that if there are any 23 charts reflected in color that you can stillunderstand the 24 chart. 25 THE WITNESS:I'm sure you can understand the DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 50 1 chart. 2 MS. ZETTLER: That's fine. 3 MR. HARREL: So for clarification, Exhibit 8a is a 4 listing of documents we've produced to you on Sunday night 5 and an indication of what was removed. Exhibit 8b and 8c 6 are the bag of materials that were produced to you when the 7 deposition started of which you requested a copy. 8 MS. ZETTLER: Right. 9 EXAMINATION 10 BY MR. SMITH: 11 Q. Dr. Dunner, my name is Paul Smith. I'm an attorney 12 and I practice in Dallas, Texas. I represent several 13 clients and families of clients of individuals who have 14 taken Prozac, fluoxetine hydrochloride, and developed 15 suicidal ideation and attempted or completed suicide while 16 they were on treatment with Prozac. Do you understand that? 17 A. Yes, I do. 18 Q. If I ask you a question that you don't understand, 19 would you please let me know? 20 A. I'll be happy to. 21 Q. As I understand it, Dr. Dunner, you were one of 22 the investigators who participated in the clinical trials 23 involving fluoxetine; is that correct? 24 A. That's correct. 25 Q. And you did a number of studies of that product DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 51 1 for Eli Lilly and Company; correct? 2 A. Correct. 3 Q. And you did a study, as I understand it, in 4 accordance with the Protocol Number 27 where you compared 5 Prozac with imipramine and a placebo and in studying 6 Prozac's efficacy and safety in treating individuals with 7 major depressive disorders, is that not correct? 8 A. We did such a study. I don't know that it was 9 Protocol Number 27. 10 MR. HARREL: Do you have a number, Counsel? You're 11 reading from a document. 12 MR. SMITH: No. 13 Q. (By Mr. Smith:) I have in front of me, Dr. 14 Dunner, what has been provided to me by Eli Lilly and 15 Company as a final report, an old Protocol Number 27 that 16 lists David L. Dunner, M.D. As the author of that or as the 17 principal investigator of that study. 18 MR. HARREL: Date? 19 MS. SMITH:There is no date on it. 20 Q. (By Mr. Smith:) Did you do a study in accordance 21 with Protocol Number 27? 22 A. Well, I don't keep track of protocols by numbers. 23 And we did a study comparing fluoxetine to imipramine to 24 placebo that was sponsored by Eli Lilly. 25 Q. Did you do more than one study where you compared DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 52 1 fluoxetine or Prozac with imipramine? 2 A. I don't think so, but I'm not certain of that. 3 Q. Well, would you recall it, Dr. Dunner, if you had 4 done more than one study where you compared Prozac with 5 imipramine? 6 A. We do an awful lot of studies, Mr.Smith, and I 7 just don't know all the studies that we've ever done. We did 8 a number of studies on fluoxetine, and I don't recall if we 9 did more than one study with imipramine or not. 10 Q. So there may have been more than one study you did 11 for and on behalf of Eli Lilly and Company where you were 12 the investigator where you compared Prozac with imipramine? 13 MR. HARREL: Can you show him that document, 14 Counsel? Maybe it could refresh his recollection. You have 15 it and hedoesn't. You have a document a half inch thick. 16 MR. SMITH:I'm going to give it to him in a 17 minute, but I'm asking him direct questions concerning his 18 recollection of the clinical trials he did with respect to 19 this drug. 20 MR. HARREL: I just object to you asking him 21 questions about a document and not giving him a document. 22 THE WITNESS:We started studies with Eli Lilly on 23 fluoxetine about eight or ten years ago, and I can't 24 remember every study that we did with them. 25 Q. (By Mr. Smith:) Well, let me show you -- DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 53 1 A. I know we did a study with fluoxetine with 2 imipramine with placebo for Eli Lilly. 3 Q. Do you recall whether you did more than one is my 4 question, Doctor. 5 A. I don't recall if we did more than one. 6 Q. Well, let me hand you, and I don't have an extra 7 copy, but let me hand you this to refresh your recollection. 8 There's probably not going to be any need to mark this 9 document, but that is a document entitled"protocol Number 10 27, Fluoxetine versus Imipramine," and it's a final report 11 that lists you as the investigator? 12 A. That's correct. 13 Q. Do you normally prepare the final reports with 14 respect to those studies or was that something done by 15 individuals back there in Indianpolis with Eli Lilly and 16 Company? 17 A. I don't know who prepared the final report. We did 18 not. 19 Q. You did not? 20 A. That's correct. 21 Q. Does looking at that document refresh your 22 recollection that you did do a study identified as Protocol 23 Number 27 or Study Number 27 where you compared imipramine 24 with Prozac with placebo? 25 A. Yes, it does. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 54 1 Q. And do you recall when you did that study? 2 A. We did a study in the early'80s. I assume that -- 3 well, it's likely that this is that study. 4 Q. And was that study done before Prozac went on the 5 market and was marketed by Eli Lilly and Company for doctors 6 to prescribe to the general public? 7 A. Yes, it was. 8 Q. And you as a clinical investigator were entitled 9 under the applicable regulations to give patients Prozac in 10 order to study the safety and efficacy of Prozac; correct? 11 A. Actually, I don't think the word Prozac was known 12 at this time and so we were giving fluoxetine. 13 Q. Well, can we say fluoxetine hydrochloride or 14 Prozac interchangeably so that we'll know we're talking 15 about that drug that was later marketed as under the trade 16 name Prozac? 17 A. I suppose so. 18 Q. When you refer to Prozac now, do you refer to it 19 as Prozac or fluoxetine hydrochloride? 20 A. I refer to it both ways at times. 21 Q. Can we use that term when we visit here for this 22 short period of time interchangeably? 23 A. Certainly. 24 MR. HARREL: I guess I'm just going to object to 25 the extent it creates confusion in the dates. Because if it DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 55 1 wasn't known, then you may create some ambiguity in your 2 confusion of the dates. 3 Q. (By Mr. Smith:) Who was the medical monitor at 4 Eli Lilly and Company that oversaw that clinical trial? 5 A. Well, it was likely Paul Stark. 6 Q. I think that we've established through discovery 7 that the march of clinical monitors there wasI. Slater, Paul 8 Stark and then Joe Wernicke during the clinical trials. Does 9 that comport with your recollection of the various medical 10 monitors involved in Prozac at that time? 11 MR. MYERS: Object to the form. 12 THE WITNESS:I'm not familiar with Slater. 13 Q. (By Mr. Smith:) Those medical monitors that you 14 have worked with in connection with your studies of Prozac, 15 fluoxetine hydrochloride, was Dr. Stark and Dr. Wernicke? 16 A. That's correct. 17 Q. What was your understanding of Dr. Paul Stark's 18 educational background? 19 A. He had a Ph.D. And I also understand that he was 20 an attorney. 21 Q. Did you have any understanding in connection with 22 whether or not he was a medical doctor? 23 A. He was not a medical doctor. 24 Q. Did you know that he was not a psychologist? 25 A. I don't know what his Ph.D. Was in. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 56 1 Q. Did you know he wasn't a psychiatrist? 2 A. I knew he was not a psychiatrist. 3 Q. In that study you administered fluoxetine 4 hydrochloride to patients in accordance with a protocol that 5 was provided to you; is that correct? 6 A. We did our very best job to do it that way, yes. 7 Q. You did not prepare the protocol with respect to 8 that study, did you? 9 A. That is correct. 10 Q. That protocol was prepared by somebody at Eli 11 Lilly and Company as far as you know, wasn't it? 12 A. That's correct. 13 Q. And did Eli Lilly and Company as far as you can 14 recall ever consult you at any time during the study with 15 respect to whether or not the protocol was adequate to study 16 the drug? 17 A. This is a very standard design. Most drug 18 companies consider it adequate. I don't recall anybody 19 talking about the design during the trial. 20 Q. Dr. Dunner, we have a limited amount of time and 21 I'm trying to make my questions as direct to you as 22 possible. Listen to my question, and it can be answered as I 23 understand it with a yes or no. 24 Did anybody at Eli Lilly and Company ever consult 25 with you as the investigator concerning Protocol Number 27 DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 57 1 with respect to whether or not it was adequate to study the 2 drug? 3 A. I don't believe so. 4 Q. Did you ever give any input voluntarily to anybody 5 at Eli Lilly and Company concerning whether or not Protocol 6 Number 27 was adequate to study fluoxetine hydrochloride 7 forefficacy or safety? 8 A. I don't believe so. 9 Q. How many investigators participated in your Study 10 Number 27? 11 A. At our site? 12 Q. Yes. 13 A. I don't recall the exact number. Probably -- well, 14 I don't recall the exact number. Roughly three or four. 15 Q. Were all of those three or four investigators that 16 participated in administering this study medical 17 doctors,psychiatrists? 18 A. Yes. We did have some residents involved in some 19 studies at some times. They were all medical doctors and 20 senior residents and chosen by us and evaluated by us. They 21 wouldn't be called psychiatrists. And I don't know if they 22 participated in this particular study or not. 23 Q. Were there ever occasions in which any of the 24 clinical report forms were filled out by individuals other 25 than individuals with a medical doctor? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 58 1 A. Certainly. 2 Q. What would those occasions be, Doctor? 3 A. The physicians were responsible for filling out 4 certain areas of the case report forms and the coordinators 5 were responsible for filling in other areas of the case 6 report forms. 7 Q. What areas did the physicians fill in on the case 8 report forms? 9 A. The physicians filled in information regarding 10 rating scales, side effects, demographic data, any data 11 required regarding concurrent medications and any medical 12 history data and signed off on the case report form for any 13 other data. 14 Q. Were the Hamilton Depression Scales always 15 administered by M.D. Physicians? 16 A. Always, yes. 17 Q. And is the Hamilton Depression Scale something 18 that any individual that can read and write can administer? 19 A. Well, it requires some training. 20 Q. What type of training did you receive in 21 connection with how to administer a HAMD scale? 22 A. I've been trained in this for several years. 23 Usually by starting off with the first study that we did 24 where we were given videotapes of patients and all the 25 investigators rated the HAMD and then it was discussed. And DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 59 1 this was prior to the Lilly studies. 2 And usually before the start of any particular 3 study there is a similar training session for rating scales 4 where patient interviews are shown on videotapes to 5 investigators and their ratings are compared and there's a 6 discussion of the HAMD. 7 Q. We've taken Dr. Paul Stark's deposition, and Dr. 8 Stark's testimony at least in part was that on occasion he 9 would travel to the particular site where the study was 10 being done and show videotapes and give assistance in 11 training individuals at the sites on how to administer the 12 Hamilton Depression Scale. 13 Did that occur at your site where Dr. Stark either 14 came to Seattle or sent people with videotapes on how to 15 administer the HAMD Depression Scale? 16 A. You know, I've been to several startup meetings. I 17 don't know if he came to Seattle or if we went to someplace 18 specifically. 19 Q. But in any event, Eli Lilly and Company gave some 20 of your people who were filling out the Hamilton Depression 21 Scale rating instructions on how to administer that test and 22 to score that test? 23 A. We have been trained by various companies to score 24 the HAMD, and in addition to those companies Eli Lilly also 25 trained us. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 60 1 Q. So do you have recollections concerning whether or 2 not Lilly actually gave any input on adminstering the HAMD 3 that was done as part of any of the fluoxetine studies, 4 Doctor? 5 A. I don't remember specific investigator meetings 6 regarding fluoxetine, but my general recollection of studies 7 that we did with Paul Stark was that he was very meticulous 8 in going over rating scales and papers, and that was done 9 verythoroughly. And I could say that it is more likely than 10 not that a videotape was shown by Paul Stark and that 11 investigators reviewed the material and rated the HAMD. 12 Q. Did the Feighner Research Institute coordinate 13 Protocol Number 27, the testing of Protocol Number 27? 14 A. I don't know. We did some studies with Lilly and 15 we did some studies that were coordinated with Feighner 16 Research Institute. And I don't recall particularly -- 17 since I don't remember specifically when we did this study, 18 I don't know whether Feighner Research Institute was 19 involved with it or not. 20 Q. The Feighner Research Institute is a contract 21 organization, is it not? 22 A. I don't know the incorporated status of the 23 Feighner Research Institute. 24 Q. They are a contract organization -- 25 A. They contract with companies to monitor studies. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 61 1 Q. In other words, Eli Lilly and Company or any other 2 drug company can hire the Feighner Research Institute to 3 coordinate a study that the particular drug company wants in 4 connection with a particular drug? 5 A. That's my understanding. 6 Q. That's a for-profit group, is it not? 7 A. That's my understanding. 8 Q. In other words, the University of Washington when 9 they receive a grant for a study, that goes to the 10 University of Washington, is for the benefit of the 11 University as opposed to any particular individual, isn't 12 it, Doctor? 13 A. That's correct. 14 Q. However, the Feighner Research Institute is a 15 company that has as its business goal the administration and 16 coordination of clinical research for private pharmaceutical 17 firms? 18 MR. MYERS: Object to the form, leading. 19 THE WITNESS:That's my understanding, but I don't 20 know that for certain because I don't know the business of 21 the Feighner Research Institute. 22 Q. (By Mr. Smith:) I understand that, but you know 23 Dr. Feighner? 24 A. Yes, I do. 25 Q. You've done studies under the Feighner Research DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 62 1 Institute, haven't you? 2 A. Yes, we have. 3 Q. And it's your understanding that that's their 4 business, to conduct clinical trials for private 5 pharmaceutical firms? 6 A. To coordinate clinical trials. 7 Q. Correct. And when you say coordinate, that means 8 secure investigators, make sure that the particular trial is 9 receiving the support that it needs, and it frees up the 10 pharmaceutical company not to have to worry about the 11 coordination of a particular trial? 12 MR. MYERS: Object to the form. 13 THE WITNESS:There's a lot of questions inthere. 14 Q. (By Mr. Smith:) Is there any part of it that you 15 couldn't follow or understand? 16 A. Well, it's two differentphases. I think all of 17 that is correct. 18 Q. Then it would be appropriate to answer yes, then, 19 in those situations. 20 A. There's multiple components to it. 21 Q. But if the answer to all the multiple components 22 is answered yes, Doctor, you're more than free to answer yes 23 to the question even though it may be two questions,all 24 right? 25 A. Okay. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 63 1 Q. As I understand it, you're not a lawyer. 2 MR. HARREL: I'll object. You're telling him how 3 to answer. I let that compound question go if he could 4 follow it, but he's free to ask that the question be broken 5 down if they get too long and hard to follow. It's a 6 compound question. It's an appropriate thing to ask to have 7 it broken down. 8 Q. (By Mr. Smith:) How long have you known Dr. 9 Feighner? 10 A. Since 1966. 11 Q. Is Dr. Feighner a psychiatrist? 12 A. Yes, he is. 13 Q. And do you know whether or not he has any 14 particular training or skills in treating individuals with 15 depression? 16 A. Yes, I do. 17 Q. And what is your knowledge concerning his training 18 or skills in treating individuals with depression? 19 A. We were residents together at Washington 20 University in St. Louis, and so we trained together, 21 conversed extensively together, often covered for each 22 other's patients at timeswhen one of us was away. And I 23 think he had very extensive training in the diagnosis and 24 treatment of depression. 25 Q. And have you followed his practice since you've DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 64 1 been here at Washington and he's been down in the San Diego 2 area? 3 A. I'm not sure what"followed his practice" means. 4 Q. Well, kept up generally with the type of patients 5 he's seeing and the types of treatment he's administering to 6 those patients. 7 A. Not particularly. 8 Q. So you don't know how many depressed individuals 9 he treats in his practice at all, do you? 10 A. That's correct. 11 Q. And you don't know what -- 12 A. Except for patients I've referred to him on 13 occasion where he's treated them. 14 Q. When is the last time you referred a depressed 15 patient to Dr. Feighner for treatment? 16 A. Probably within the last month. 17 Q. And before that when was the last time? 18 A. I don't recall. 19 Q. Give me your best estimate of that. 20 A. It was probably within a year. 21 Q. Why is it that you've had an occasion to refer 22 patients to Dr. Feighner down in San Diego? 23 A. Because a patient who I had consulted with had 24 become more depressed and was in San Diego, and I felt that 25 that was an appropriate referral. Other times I'd get phone DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 65 1 calls from people in San Diego requesting me to see them, 2 and it may be more practical for them to see Dr. Feighner. 3 Q. Do you consider Dr. Feighner as being the 4 psychiatrist in the San Diego area that's most competent -- 5 or that you're familiar with, of course, that's most 6 competent to treated depressed individuals in the San Diego 7 area? 8 A. Yes, I do. 9 Q. Now, back to the Protocol Number 27. That protocol 10 excluded individuals that presented serious suicidal risk, 11 did it not? 12 A. It would save some time if you give me the page 13 that says that, but it's likely that -- 14 Q. Why don't you look under exclusion criteria. 15 That's generally the easiest way to find itI've found in 16 looking through these protocols. 17 MR. HARREL: For the record, am I going to be able 18 to get a copy of this or attached tothe deposition? 19 MR. SMITH:We'll mail it to you or something like 20 that if you would like a copy. Or I'm sure Mr. Myers would 21 be happy to furnish it for you since he furnished it to us. 22 MR. HARREL: Can you give me some time frame when 23 you'll mail it to me? Within the next ten days? 24 MR. SMITH: No, I absolutely cannot give you a 25 time frame. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 66 1 Q. (By Mr. Smith:) Look with me at Page 3, also a 2 page marked PZ 41919 on that document and see if that 3 document doesn't list individuals with serious suicidal risk 4 as individuals who are to be excluded from that trial. 5 A. Yes. 6 Q. Define for me, Doctor, the diagnostic criteria for 7 an individual who presents a serious suicidal risk. 8 MR. MYERS: I'll object to the question only 9 because I think he was questioned about this yesterday. 10 MS. ZETTLER: He was questioned about the HAMD 11 aspect of it only. 12 THE WITNESS:Well, I think I was questioned about 13 ityesterday. In fact, I'll give you the answer to that 14 question. I think that is really a judgment on the 15 individual evaluating the patient. 16 Q. (By Mr. Smith:) Let me stop you therefor a 17 minute. Now, that individual who is evaluating the patient 18 in connection with the study in which you were the principal 19 investigator, did you yourself make that determination or 20 did you leave that determination up to other medical doctors 21 under your direction? 22 A. I generally see a large proportion of patients in 23 any clinical trial that we perform where I'm the principal 24 investigator. So I made that judgment myself in all the 25 patients that I evaluated for this study, which I don't know DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 67 1 how many that was, but in general, I evaluated a third of 2 the patients or so for any given study. 3 Q. That's my question -- 4 A. Any other evaluation of that would have been done 5 by one of the psychiatrist co-investigators. 6 Q. Do you recall who the co-investigators were with 7 you on the Protocol Number 27? 8 A. I don't recall specifically who were the 9 co-investigators on that study. 10 Q. Can you give me generally who you think those 11 individuals might be? 12 A. I don't know who they were. I mean, we had a 13 variety of people working with us over the years that 14 changed from time to time. We were doing studies of this 15 kind from when I started in Seattle in 1978. 16 Q. I understand that, but I thought that there might 17 be one of your colleagues, M.D.s or psychiatrists there at 18 the University of Washington who was doing this back then 19 and is still with you in doing this today. 20 A. I don't know exactly who was on this particular 21 study, Mr. Smith. 22 Q. Is there any way you can tell who helped you in 23 doing Protocol Number 27? Would there be records of that 24 somewhere? 25 A. Not unless it's in the material that we've DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 68 1 furnished you, and that's what I was trying to look through, 2 because we did have some protocols and other 3 co-investigators. For example, on this study we listed 4 co-investigators on Page 001 of this material. I was looking 5 through this book, and I don't recall who exactly was on the 6 study. 7 Q. Had you had other co-investigators, you would have 8 at least advised Eli Lilly and Company of the names of those 9 individuals? 10 A. That was regulatory, that was any person who was a 11 co-investigator had to be listed on a 1572 or 1573, a list 12 of co-investigators and their curriculum vitae supplied to 13 the sponsor, in this case Eli Lilly. 14 Q. So whoever they were, either you or one of your 15 co-investigators with respect to Protocol Number 27 would 16 have been making that evaluation which call for a judgment 17 of the individual evaluating the patient in connection with 18 whether or not that patient presented a serious suicidal 19 risk such that that patient should be excluded from the 20 particular clinical trial? 21 A. That is correct. 22 Q. What checklist was gone over by you in making your 23 determination and your judgment in connection with respect 24 to whether or not an individual presented a serious suicidal 25 risk? What factors did you consider as an M.D. Psychiatrist DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 69 1 concerning whether or not that patient met that exclusion 2 criteria of a serious suicidal risk? 3 A. I do think I answered this question yesterday. 4 There is no physical checklist. It is the sum of a variety 5 of factors related to the individual patient, and those 6 factors would include the diagnosis, the course of illness. 7 Q. What do you mean by diagnosis? 8 A. Diagnosis of major depression or its sub type of 9 diagnosis such as whether it's recurrent or chronic, the 10 course of illness, the prior history of suicidal behavior, 11 information about the timing of previous suicide attempts, 12 the influence of other factors such as whether attempts were 13 made in the past related to alcohol, for example, or whether 14 attempts were made in the past in relation to psychosocial 15 factors such as breakup of relationships, the current 16 depressive status of the patient in terms of its severity, 17 the way the person -- the ratings on the Hamilton Scale for 18 suicidal behavior on Item 3. 19 Q. Well, did you administer the HAMD scale before you 20 made a determination in connection with whether or not that 21 patient was a serious suicidal risk? 22 MR. HARREL: I'm going to object, Counsel. You're 23 cutting him off every time. You've cut him off twice in his 24 answer here, and that isn't appropriate, at least under our 25 court rules. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 70 1 Were you finished with your answer, Doctor? You 2 can come back and ask for clarification, but he's entitled 3 to finish. 4 Were you finished with your answer, Dr. Dunner? 5 THE WITNESS:No, I was not. 6 MR. HARREL: Please finish your answer with 7 respect to the prior question. 8 THE WITNESS:There were factors taken into account 9 in terms of what the course of the current episode of 10 depression or the recent information about the patient might 11 be that we would take into account as well as questioning 12 them about current suicidal ideation, plans to make a 13 suicide attempt or not, current substance abuse problems or 14 relationship problems that might pose factors in terms of 15 that particular patient making a suicide attempt or not that 16 might be part of their history. 17 As I mentioned yesterday, there are some patients 18 who may be seasonally depressed who have made suicide 19 attempts every year and we're seeing them again at a 20 particular time again where they've historically made a 21 suicide attempt. And these factors would be taken into 22 account. 23 So there would be a whole series of factors that 24 would come into play along with how the person responds to 25 questions about suicidal behaviors and their physical way of DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 71 1 responding to those questions that may lead to some decision 2 on the part of whether the person might or might not pose a 3 serious suicidal riskat this time. 4 Q. (By Mr. Smith:) It sounds to me like that's a 5 relatively sophisticated type of judgment that has to be 6 exercised by the physician, whether or not a person is a 7 serious suicidal risk according to the protocol. 8 A. That wasn't a question I don't think. 9 Q. Isn't it a fairly sophisticated judgment that has 10 to be exercised by the physician who is making that 11 determination? 12 A. I think those judgments can be made by other 13 people, but I think that in our hands we had physicians, 14 psychiatrists making those judgments. 15 Q. Well, I'm not implying that they can't be made by 16 other people, but it sounds to me like this is a situation 17 that you and members of your group examined relatively 18 closely. 19 A. That is correct. 20 Q. And exercised your best medical judgment to make 21 the proper determination in connection with whether or not a 22 person presented a serious suicidal risk? 23 A. That's correct. 24 Q. It doesn't sound like it's an easy question to me. 25 Is it? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 72 1 A. Well, actually it's not all that complicated when 2 it gets right down to it, because in the one situation a 3 person clearly seems to pose a serious suicidal risk. The 4 person says I really am intent on killing myself, if I don't 5 get better in a week I'm going to do myself in, I've got a 6 gun at home. I think that person is saying that they are a 7 serious suicidal risk and I would not enter that patient in 8 the study. 9 On the other hand, there are people who deny 10 suicidal thoughts that you don't know whether they really 11 have them or not. And I always feel more comfortable if 12 people talk about how their suicidal thoughts are 13 progressing during the depression to make a judgment about 14 serious suicidal risk. It's only in the rare patient who 15 says they don't have any suicidal thoughts that I become 16 more suspicious. 17 Many patients will say I've had these kinds of 18 suicidal thoughts. You know, I sometimes wake up in the 19 middle of the night and feel that life isn't worth living or 20 sometimes I wake up in the middle of the night and say that 21 I should end it all right now. And these are passing modes 22 and we'll talk about them quite frankly. And yet those 23 patients pose some suicide risk as does any depressed 24 patient, but it's not in the line of what I would consider a 25 serious suicide risk. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 73 1 Q. In other words, if what I understand you're saying 2 is correct, the mere fact that an individual has expressed 3 to a psychiatrist that they've had suicidal thoughts doesn't 4 necessarily mean that they present a serious suicidal risk, 5 does it, Doctor? 6 A. That is correct. 7 Q. And some of those individuals might even be 8 accepted by you or members of your group to study Prozac to 9 determine its safety and efficacy as an antidepressant? 10 A. We would have included such patients in 1981. 11 Q. And would you now? 12 A. Certainly, except -- well, certainly. 13 Q. You mention other factors in addition to the 14 severity of the person's illness of depression in connection 15 with whether or not that person presents a serious suicidal 16 risk, didn't you? 17 A. Yes, I did. 18 Q. So do I take it from that that just because an 19 individual is depressed doesn't necessarily mean they 20 present a serious suicidal risk? 21 A. That is correct. 22 Q. Many people in your experience can be depressed 23 and be not suicidal at all, isn't that correct, Doctor? 24 MR. MYERS: Let me object to the formof the 25 question. That's a different question. DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 74 1 THE WITNESS:Many people can be depressed and not 2 be suicidal, that is correct. 3 Q. (By Mr. Smith:) And the mere fact that a person 4 has been suffering from depression does not mean that they 5 are suicidal, does it, said another way? 6 MR. MYERS: Object to the form. Leading. 7 THE WITNESS:That's possible. 8 Q. (By Mr. Smith:) And it's not conclusive from a 9 medical standpoint that an individual who is depressed and 10 their depressions gets worse is going to commit suicide, is 11 it, Doctor? 12 A. That is correct. 13 Q. Not all suicides are the result of a worsening of 14 depression, are they, Doctor? 15 A. That's correct 16 MR. MYERS: Object to the form. 17 Q. (By Mr. Smith:) There are many factors that must 18 be considered in connection with with respect to whether or 19 not an individual suicide is a result exclusively of 20 depression, isn't it, Doctor? 21 A. That is correct. 22 Q. Have you ever done yourself in part of any study 23 studying any specific serotonin reuptake inhibitor whether 24 or not there is a causal relationship between the ingestion 25 of the specific serotonin reuptake inhibitor and a DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 75 1 particular suicidal ideation or suicide attempt? 2 A. I cited the paroxetine data that we presented at 3 ACMP and I talked about that yesterday, and I believe that 4 that study would qualify as a yes answer to your question. 5 Q. Other than that, have you done any other studies 6 to determine whether or not there's a causal relationship 7 between specific serotonin reuptake inhibitors and 8 suicidality? 9 A. I don't believe so. 10 Q. Have you ever done any study on behalf of Eli 11 Lilly and Company to determine whether or not Prozac causes 12 individuals to become suicidal in any way? 13 A. No. 14 Q. You have had two individuals who have become 15 suicidal while being treated with fluoxetine or Prozac, have 16 you not? 17 A. That is correct, two patients that I've treated. 18 Q. And as I understand it, with respect to those two 19 patients it was your judgment that Prozac, fluoxetine 20 hydrochloride, was in part a causal factor in those 21 individuals' suicide or suicidality? 22 MR. MYERS: Object to the form. You've 23 mischaracterized his testimony from yesterday. 24 THE WITNESS:I don't think that's exactly true, 25 because I -- DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 76 1 Q. (By Mr. Smith:) Then tell me if I've 2 mischaracterized what you said, Doctor, what it was in 3 connection with that, because we don't want to have any 4 misunderstandings here. 5 A. These were two people who took Prozac who while 6 they were taking Prozac said they had an increase in 7 suicidal thoughts. This also occurred at a time during a lot 8 of publicity about Prozac and suicidal behaviors. What was 9 intriguing to me was that I had not seen this before and it 10 had never been spontaneously reported to me before by 11 patients that they had an increase in suicidal thoughts 12 during Prozac treatment nor had I actually heard this after 13 these two patients that said that they had suicidal thoughts 14 during treatment. And my recollection at the time was that I 15 thought it was the media reports that were producing this 16 rather than the drug. 17 Q. All right. Did you ask any of your patients if 18 they had read media reports concerning Prozac and 19 suicidality? 20 A. I don't recall specifically asking them. 21 Q. Then what information did you have that made you 22 think it was a result of media attention that these poor 23 individuals who had experienced suicidal thoughts while on 24 fluoxetine were doing it as a result of some media 25 attention? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 77 1 A. I think they both spontaneously mentioned it when 2 they came to see me. 3 Q. So what is it, what facts did you have that made 4 you think those two individuals were reporting suicide 5 because they read it in the paper? 6 A. Suicidal thoughts. 7 MR. MYERS: Object to the form. I think he's 8 answered. 9 THE WITNESS:The fact that it was a unique 10 experience for me. I had treated several patients with 11 Prozac and not had that experience. All of a sudden I had 12 two patients who said that that was occurring. It hasn't 13 occurred again, and it seemed to me that that change may 14 have been caused by media reports rather than anything else. 15 Q. (By Mr. Smith:) But those patients didn't report 16 that their suicidal thoughts were a result of any media 17 attention, did they? 18 A. They did not report it that way. 19 Q. Did you believe that those patients had had 20 suicidal thoughts? 21 A. Yes, I did. 22 Q. Did you have any reason whatsoever to discount the 23 veracity of those individuals in reporting to you their 24 suicidal thoughts that occurred and emerged while they were 25 being treated by you with Prozac? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 78 1 MR. MYERS: Object to the form. It's 2 mischaracterizing his earlier testimony. 3 THE WITNESS:I believe these patients were 4 truthful. 5 Q. (By Mr. Smith:) Did you call Dr. Teicher in 6 Boston or Cambridge, Massachusetts when this arose? 7 A. No, I did not. 8 Q. Did this arise before or after Dr. Teicher's 9 article? 10 A. It was during the publicity, what I'll call the 11 publicity wave, and I'm not sure exactly when the publicity 12 wave was in relation to Dr. Teicher's report in the American 13 Journal of Psychiatry. 14 Q. Well, at the time they reported this to you, were 15 you aware that Dr. Teicher had reported this in patients 16 that he had seen? 17 A. I don't know. I don't know when they reported this 18 vis-a-vis the Teicher article. 19 Q. When these patients reported to you that they had 20 Prozactreatment-emergent suicidal ideation, had you ever 21 heard of that concept before? 22 MR. MYERS: Object to the form. 23 THE WITNESS:I believe I have. 24 Q. (By Mr. Smith:) How did you first learn of the 25 concept of Prozac-emergent suicidal thinking? DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 79 1 A. I don't recall. 2 Q. Did you know it before you were sent this article 3 by the fellow at Eli Lilly that Dr. Teicher had authored? 4 A. I don't recall if there were reports in the public 5 press prior to the Teicher article or not, Mr. Smith. And I 6 don't recall when these events occurred. 7 Q. I'm asking you as a scientist who had studied 8 Prozac, fluoxetine hydrochloride, who had conducted clinical 9 trials and who at that time was a member of the psychiatric 10 advisory board for Eli Lilly and Company, had you ever heard 11 of Prozac treatment-emergent suicidal ideation before this 12 fellow at Lilly sent you Dr. Teicher's article? 13 A. And I think I answered that I don't know whether 14 the Teicher report preceded the public press accounts or if 15 the Teicher report came after the public press accounts. 16 Q. When did you first learn that there was an 17 allegation that individuals were having treatment-emergent 18 suicidal ideation while on Prozac? 19 A. I don't know when. 20 Q. It was my understanding that you first learned of 21 it -- from your deposition testimony yesterday that you 22 never heard of it before somebody at Lilly sent you the 23 article that was written by Dr. Teicher. 24 A. Well, I know I received the article. I was told 25 about the article that was coming out in the American DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 80 1 Journal shortly before it came out from Lilly. I don't 2 recall if there were press reports before that or not 3 regarding treatment-emergent suicidal ideation. 4 Q. But it was the press reports that you first 5 learned of this? 6 A. I don't know. It may have been the Teicher 7 article. 8 Q. One of the two? 9 A. Right. 10 Q. Doctor, I've got to go catch a plane and -- 11 A. I'm here until 12, Mr. Smith. 12 Q. I understand that, but when I understood that you 13 were only going to be here until 12 I had to make a 1:00 14 flight to get out. It's foggy, and I think I need to go 15 ahead and leave so I won't either increase my anxiety or 16 depression in trying to get to the plane. So I'm going to 17 pass -- even though I'm not completed, I'm going to pass the 18 questions back to Ms. Zettler, if you have time. 19 MS. ZETTLER: Well, yesterday Dr. Dunner and his 20 attorney said that we would be finishing around 11:30 today 21 because of Dr. Dunner's schedule, and we have made 22 arrangements to travel based on that assertion yesterday. 23 MR. MYERS: You were out of the room when that 24 discussion took place, Nancy. We had a casual discussion off 25 the record that Paul raised that initially. I mean -- DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 81 1 MR. SMITH: Well, gentlemen, do any of you have 2 any interest in me or Ms. Zettler missing our flight and 3 being stuck here in Seattle for eight or ten hours? 4 MR. MYERS: That's not the point. 5 MR. SMITH:Then do you have any objection to 6 either one of us leaving at this time? I understand Dr. 7 Dunner might be able to be here another 30 minutes, but if 8 we continue to examine him for a another 30 minutes we'll 9 each be stuck in Seattle for eight or tenmore hours. We 10 don't want that. Is that something that either one of you 11 counselwants? 12 MR. MYERS: I can hear you perfectly well. I have 13 no objection to you leaving, I have no objection to you 14 catching your plane. I'm simply making a point that 15 terminating the deposition was not instigated by Mr. Harrel 16 and certainly not by me. 17 MR. HARREL: I've never heard of anything other 18 than we were going to go to 12 today. I'm not objecting to 19 you catching your plane. You know my position at the start 20 of this deposition was after 12:00 today we would request 21 that we be given a hearing and an opportunity to be heard by 22 a court, a court hopefully in the state of Washington, 23 before Dr. Dunner has to come again for his deposition. 24 Because we think he's given enough time -- 25 MR. SMITH: I don't even have enough time to DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 82 1 argue with you, Counsel. 2 MS. ZETTLER: We're going to be asking Dr. Dunner 3 back. If we have to go before a judge we'll go before a 4 judge. 5 MR. HARREL: I request reasonable notice so I can 6 be heard. 7 MS. ZETTLER: Well, if you care to come down to 8 Louisville which is maybe where the hearing will take place, 9 I'll be happy to let you know. 10 MR. HARREL: I'd like it to be here in the state 11 of of Washington where Dr. Dunner resides. 12 MS. ZETTLER: It will be under whatever rules and 13 whatever court the subpoena reports. 14 MR. SMITH: Thank you, Dr. Dunner. 15 MR. HARREL: Let the record reflect that Ms. 16 Zettler and Mr. Smith are leaving and we're reserving 17 signature. 18 MR. MYERS: Let me just tell you what we're going 19 to do about thetranscript. As I understand it, a copy and 20 the signature page will be sent to Dr. Dunner and his lawyer 21 for review and signature. I've asked that the court reporter 22 send me the original, as we've been doing with the 23 transcripts prepared by Kathy Knowles, so that the 24 confidential designations can be made on the original and 25 then returned to the court reporter so that the court DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 83 1 reporter will have the original returned to her which will 2 have the confidentiality designations made. 3 And then we'll also receive back from Dr. Dunner 4 and his lawyer the errata sheet and the correction page 5 which can then be transmitted to you for safekeeping, 6 because I think that Kathy Knowles has maintained in the 7 other ones. She just happens to be in Louisville. But 8 that's what I would like to happen. If you want an expedited 9 copy, that's another question. 10 MS. ZETTLER: Only with the provision you get us 11 an errata sheet back in 30 days, as is the rule, and it 12 doesn't happen in the many, many occasions prior. 13 MR. MYERS: I think they've all been made in a 14 timely fashion. 15 MR. HARREL: Just so the record reflects it, 16 Nancy, the University of Washington tax ID number is 17 916001537 for the purpose of payment. 18 MS. ZETTLER: What I'll do is I'll send the form, 19 because it's going to have to be signed by somebody at the 20 University. I'll send it with the check. 21 MR. HARREL: As far as I'm concerned, the 22 deposition is concluded at this time. And your position is 23 that it's continued, and we'll argue that out at some future 24 forum. 25 MS. ZETTLER: I think that's been established in DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 84 1 the record, Arley. I don't think we need to belabor the 2 point any longer. And I'd like the record to reflect that 3 Paul and I are leaving the room. 4 (Deposition concluded 11:35 a.m.) 5 (Signature reserved) 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 85 1 A F F I D A V I T 2 3 STATE OF WASHINGTON) 4 ) ss. 5 COUNTY OF KING ) 6 7 I have read my within deposition and the same 8 is true and accurate except for any changes and/or 9 corrections, if any, as noted by me on the Correction Notes 10 page hereof. 11 12 VOLUME II 13 DAVID L. DUNNER, M.D. 14 15 16 SUBSCRIBED AND SWORN to before me 17 on this day of , 1994. 18 19 20 Notary Public, County of King 21 22 residing at 23 24 Commission expires 25 DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 86 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 87 1 C E R T I F I C A T E 2 3 STATE OF WASHINGTON) 4 ) ss. 5 COUNTY OF KING ) 6 I, Diane Hemrich, the undersigned Notary Public do 7 hereby certify: 8 That the deposition, a transcript of which is attached, 9 was given before me at the time and place stated therein; 10 said deponent before examination was by me duly sworn to 11 testify the truth, and the testimony thereupon given was by 12 me stenographically recorded and typewritten under my 13 supervision; that the foregoing transcript contains a full, 14 true and accurate record of all the testimony and 15 proceedings given and occurring at the time and place of 16 said testimony; that I am in no way related to any party to 17 the matter, nor to any counsel, nor do I have any financial 18 interest in the event of the cause. 19 WITNESS MY HAND AND SEAL: 20 Diane Hemrich 21 Notary Public for the State of 22 Washington, residing in King 23 County, commission expires 10/15/94 24 CSR #HE-MR-ID-M380N3 25 DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161 88 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DAVID L. DUNNER, M.D., VOLUME II 1305 FINANCIAL CENTER, 1215 4TH AVE. 622-6875 SEATTLE, WASHINGTON 98161