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 CERTIFIED QUESTION IN DEPOSITION 10 OF 11 DAVID L. DUNNER, M.D. 12 VOLUME I 13 ------------------------------------------------------------- 14 15 16 9:05 a.m. 17 January 17, 1994 18 800 Fifth Avenue, Suite 4100 19 Seattle, Washington 20 21 22 23 24 25 DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 2 1 UNITED STATES DISTRICT COURT 2 SOUTHERN DISTRICT OF INDIANA 3 INDIANAPOLIS DIVISION 4 ------------------------------------------------------------- 5 6 IN RE ELI LILLY AND COMPANY ) 7 Prozac Products Liability ) MDL Docket No. 907 8 Litigation ) All cases 9 10 ------------------------------------------------------------- 11 12 CERTIFIED QUESTION IN DEPOSITION 13 OF 14 DAVID L. DUNNER, M.D. 15 VOLUME I 16 17 ------------------------------------------------------------- 18 19 20 9:05 a.m. 21 January 17, 1994 22 800 Fifth Avenue, Suite 4100 23 Seattle, Washington 24 25 DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 3 1 A P P E A R A N C E S 2 3 FOR PLAINTIFFS FENTRESS, et al.: 4 NANCY A. ZETTLER 5 Leonard M. Ring & Associates, P.C. 6 111 West Washington Street 7 Chicago, Illinois 60602 8 9 FOR PLAINTIFFS, MDL DOCKET: 10 PAUL L. SMITH 11 Attorney at Law 12 8150 North Central Expressway 13 745 Campbell Centre II, LB 48 14 Dallas, Texas 75206 15 16 FOR ELI LILLY AND COMPANY: 17 LAWRENCE J. MYERS 18 Freeman & Hawkins 19 4000 One Peachtree Center 20 303 Peachtree Street, N.E. 21 Atlanta, Georgia 30308-3243 22 23 24 25 DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 4 1 FOR THE WITNESS: 2 P. ARLEY HARREL 3 Williams, Kastner & Gibbs 4 Two Union Square 5 601 Union Street, Suite 4100 6 Seattle, Washington 98101-2380 7 8 9 I N D E X 10 11 EXAMINATION BY: PAGE 12 MS. ZETTLER 38 13 14 15 EXHIBITS FOR IDENTIFICATION PAGE 16 No. 1 - Motion to Quash 5 17 No. 2 - Curriculum Vitae 43 18 No. 3 - Letter dated March 29, 1991 170 19 20 21 22 23 24 25 DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 5 DAVID L. DUNNER, M.D., VOLUME I 1 (Whereupon, Exhibit 1 was marked for 2 identification.) 3 DAVID L. DUNNER, M.D., 4 Sworn as a witness by the Notary 5 Public, testified as follows: 6 MS. ZETTLER: Let the record reflect that this is 7 the deposition of Dr. David Dunner taken pursuant to subpoena 8 and taken under all applicable rules of Kentucky State Court 9 and Kentucky local rules. 10 Before we get started, why don't we take care of 11 some housekeeping things. 12 MR. SMITH: Let's also go on the record to say this 13 deposition is noticed in MDL 907 pending in the Southern 14 District of Indiana, and all Federal Rules and all rules 15 applicable to that proceeding are applicable here. 16 MS. ZETTLER: And just so you know, Arley, Kentucky 17 follows the Federal Rules, so they are essentially the same. 18 MR. MYERS: In connection with the MDL notice, 19 simply for purposes of the record, let me put on there that 20 Lilly reserves its right to later object to the use of this 21 deposition in the MDL, because the MDL notice, while issued, 22 was not timely under the scheduling order or the procedural 23 order that is in place. 24 I'm certainly not going to raise a stink that Mr. 25 Smith is here and might examine the witness. I simply object DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 6 DAVID L. DUNNER, M.D., VOLUME I 1 to the timeliness of the MDL notice. And I'm not agreeing 2 that this is the only deposition that may be taken in the MDL 3 of this witness. 4 MR. HARREL: Arley Harrel; I'm representing David 5 Dunner, M.D. 6 A couple of things. Number one, the only subpoena 7 that we've seen was issued in the case of Joyce Fentress, et. 8 al, versus Shea Communications, et. al, Defendants, Cause 9 Number 93-2-30143-0 in the Superior Court of Washington for 10 King County that apparently was issued related to the 11 Kentucky case. 12 We received a subpoena, we, Dr. Dunner, was served 13 with a subpoena, and then in negotiations with Nancy Zettler, 14 she issued an amended subpoena which was provided to us. I 15 think the amended Exhibit A came to me via facsimile from 16 Leonard Ring and Associates on January 11, 1994, at 4:49 17 p.m., and that is attached to some pleadings that I've 18 provided to Counsel Nancy Zettler this morning. 19 Those have been marked as Exhibit 1a through 1w. 20 Those being first a Notice of Appearance; second, Proposed 21 Order to Quash Subpoena Duces Tecum of David Dunner, M.D.; 22 next, a Motion to Quash Subpoena Duces Tecum of David Dunner, 23 M.D. And In The Alternative for Protective Order; next, 24 Declaration of P. Arley Harrel, and attached appear to be 25 Exhibits A, B and C. And Exhibit C is this amended Exhibit A DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 7 DAVID L. DUNNER, M.D., VOLUME I 1 to the Notice of Deposition by subpoena. 2 I've told Ms. Zettler that I have not noted this 3 motion, it's done to protect the record, if necessary, but 4 I've allowed this witness to be examined today from 9 to 5 5 and Tuesday from 9 to noon. And that's been agreed to by 6 counsel for Plaintiffs as to the time, although she didn't 7 think it would be done, she just agreed that we would finish 8 on Tuesday because the doctor has appointments in the 9 afternoon. 10 With respect to the order that's been issued out of 11 the King County Superior Court, it says, "The subpoena shall 12 be issued in accordance with the Washington Civil Rules of 13 Court." And that order is called Order Direction Clerk Of 14 The Court To Issue Subpoena for Deposition dated December 7, 15 1993, issued by Jack Richey, and of course I didn't get that 16 until January when Dr. Dunner retained me. 17 And so it may not make any difference, but it 18 appears that this is issued pursuant to the Washington Court 19 Civil Rules. If what Ms. Zettler tells me is that they are 20 the same as the Federal Rules, it's probably not going to 21 make a major difference, but I just want to make those 22 points. 23 And so on the record, Ms. Zettler, have I said 24 anything that's inaccurate so far? 25 MS. ZETTLER: Well, I think the exhibit that you DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 8 DAVID L. DUNNER, M.D., VOLUME I 1 just referred to and read into the record deals with 2 subpoenaing and serving the subpoena, not what rules are 3 applicable in this action. It's our position that the 4 Kentucky rules are the rules that are applicable, although as 5 you've noted, it appears that it's probably a moot point 6 since you probably go under the Federal Rules here also. 7 MR. HARREL: They are fairly similar. Some 8 differences. 9 MS. ZETTLER: Okay. So there shouldn't be any 10 major problems. But it is our position that the orders 11 entered by Judge Potter in the Fentress case, any orders that 12 are entered in that case are the ones that control in this 13 case, in this deposition. 14 Also, I received this morning a packet of the 15 proposed motions, et cetera, that Mr. Harrel just talked 16 about. I have not had a chance to read through it. It's our 17 position that if you had a problem with the subpoena or the 18 deposition going forward the way it's going or the way it was 19 noticed that you should have made your objections prior to 20 the deposition. But if you feel it necessary later on to 21 file these, then I guess we'll pick it up with the Court at 22 that time. As far as signing off on them that I've received 23 them, I'm making a record right now that I did receive them. 24 Also, as part of the subpoena we attached a rider 25 which you are correct in saying was amended. That rider DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 9 DAVID L. DUNNER, M.D., VOLUME I 1 briefly asked for Dr. Dunner to produce all documents that he 2 had related in any way to fluoxetine and/or his retainer by 3 Lilly with regards to fluoxetine. 4 You produced to me last night about -- looks like 5 about maybe 100 pages of documents that had been copied and 6 sent over this morning. You also brought in originals of 7 some three-ring binders. One is entitled "New Perspectives 8 in Depression, Advances in Diagnosis and Management" 9 including two videotapes, a number of slides and a number of 10 written text, quite a bit of written text. And we'd like 11 copies of all these slides and videotapes as well as the 12 written portions of the three-ring binder at our cost, of 13 course. 14 Another one that you sent us is "Depression in 15 Medical Practice." This is another three-ring binder. 16 "Diagnosis, Communication and Treatment Strategies," 17 Moderator's Guide. Again, it has a number of slides attached 18 to it and a lot of written text. We'd like copies of all of 19 that. 20 Mr. Harrel, you've informed me that the videotapes 21 that were once housed in this pamphlet are the ones that were 22 transferred to the one that I just talked about previously; 23 correct? 24 MR. HARREL: That's what I've been told by Dr. 25 Dunner. You're free to ask him about that. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 10 DAVID L. DUNNER, M.D., VOLUME I 1 MS. ZETTLER: Okay. 2 The third three-ring binder is entitled "A 3 Specifically Different Antidepressant; Prozac, Fluoxetine 4 Hydrochloride." It has a letter from Dista Products, looks 5 like a general letter not specifically sent to Dr. Dunner 6 under his name, but it also has a number of articles written 7 by various people including Dr. Stark, Dr. Scouinard, 8 S-c-o-u-i-n-a-r-d; Dr. Feighner, F-e-i-g-h-n-e-r; Dr. 9 Wernicke, W-e-r-n-i-c-k-e; Dr. Cooper, C-o-o-p-e-r; Drs. 10 Fabre/Putnam, P-u-t-n-a-m; Dr. Richelson, R-i-c-h-e-l-s-o-n, 11 and a bibliography as well as some other text. We'd like 12 copies of that at our expense also. 13 Finally for the record, let me state that we have 14 subpoenaed Dr. Dunner's deposition to continue day to day 15 until completed. I understand from talking to Dr. Dunner 16 before he retained you, Mr. Harrel, that he would have a 17 problem with completing the deposition tomorrow because of 18 patient schedules that he has. I understand that, that's 19 fine, but I have a strong feeling that we're not going to 20 finish this deposition in a day and a half, and we may well 21 have to bring Dr. Dunner back to complete this deposition. 22 One other thing real quick. We also have a 23 pamphlet that looks like it just encloses -- well, it 24 encloses a couple of pages of text, but also six additional 25 slides entitled National Public Education Campaign on DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 11 DAVID L. DUNNER, M.D., VOLUME I 1 Clinical Depression, "Depression, It's an Illness, Not a 2 Weakness." We'd also like copies of this at our expense. 3 MR. HARREL: A couple of things. On the amended 4 Exhibit A, it's got very specific language and you attempted 5 to summarize it, which I don't agree or disagree with. We 6 looked at the language in amended Exhibit A. 7 Secondly, with respect to the fee, it's my 8 understanding that you've agreed to pay Dr. Dunner or the 9 University of Washington, whoever he indicates the check 10 should be payable to, $500 for today and $500 for tomorrow, 11 and that's been agreed to. Is that fair? 12 MS. ZETTLER: That's fair. 13 MR. HARREL: And secondly, you've agreed to 14 reimburse us for the copying costs we've incurred to date 15 which is what, $36.80; is that correct? 16 MS. ZETTLER: That's correct. 17 MR. HARREL: And thirdly, you have requested that 18 we duplicate the materials that are here on the table, which 19 incidentally, did you get the copy of these -- in the front 20 of your material there should have been a list of those 21 notebooks. 22 MS. ZETTLER: Yes. 23 MR. HARREL: Did it appear to be accurate? 24 MS. ZETTLER: From my quick review of what was 25 provided, yeah. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 12 DAVID L. DUNNER, M.D., VOLUME I 1 MR. HARREL: So this two-page document that we've 2 given you entitled "Summary of Prozac Materials Provided By 3 Dr. Dunner" dated January 14, 1994, you wanted a copy of the 4 entire things listed there? 5 MS. ZETTLER: Yes, I do. 6 MR. HARREL: And the slides, do you want them in 7 slide form? 8 MS. ZETTLER: Yes, why don't you give it to me in 9 slide form. 10 MR. HARREL: And videotapes, you want copies of the 11 videotapes? 12 MS. ZETTLER: Yes, I do. 13 MR. HARREL: And you're willing to pay for whatever 14 costs to get that accomplished? 15 MS. ZETTLER: Yes. Also, with regards to the list 16 of documents that you've just referred to, we also received a 17 one-page document dated January 17, 1994. It says Williams, 18 Kastner and Gibbs, Dr. David L. Dunner Documents Index. You 19 have categories listed on the left-hand margin; Fluoxetine 20 REM Study, Fluoxetine versus Imiprimine, Fluoxetine 21 Depression, Fluoxetine Versus Trazadone, and Study, 22 "Non-Depression." 23 On the right-hand margin of that page you have 24 listed a number of or indicated a number of instances where 25 information has not been produced and/or pages have been DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 13 DAVID L. DUNNER, M.D., VOLUME I 1 produced with information redacted from them. You're 2 asserting that this was done pursuant to a court order 3 entered in the Fentress case, I'm assuming, because it's not 4 listed here. 5 MR. HARREL: It's at the top, the very top. 6 MS. ZETTLER: You're right, okay. Court order 7 entered 12/13/93 in Fentress. 8 Do you have a copy of that order with you? 9 MR. HARREL: Yes, I do. How are you going to 10 handle copies, because I assumed you were probably going to 11 make these lists as exhibits so we'd have some record. I 12 didn't know how you were handling that. 13 MS. ZETTLER: I'll make copies, sure. 14 MR. HARREL: And this is the order that I'm 15 referring to. 16 MS. ZETTLER: Could I take a look at that? 17 Mr. Harrel has handed me a copy of an order entered 18 in the Fentress case signed by Commissioner Sharon Conyer, 19 C-o-n-y-e-r, Clayton, and Judge John W. Potter entered by the 20 Court on 12/13/93. 21 Which section of this order are you asserting bars 22 us from seeing financial information? 23 MR. HARREL: Well, I'm not attempting to interpret 24 what this court order says. What I've looked at is the 25 portion that says at the bottom of it, "Defendant may DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 14 DAVID L. DUNNER, M.D., VOLUME I 1 exclude, among other items already ruled upon, non-depressive 2 indicators." 3 So that's why we've withheld the bottom study which 4 is not related to depression. And then it says, "And trade 5 secret documents excludable including cost, pricing, sales 6 and profit, budget and other strictly confidential 7 information." 8 That portion of it we're not interpreting with 9 respect to the financial. 10 MS. ZETTLER: Could you finish reading that 11 portion, please, into the record? 12 MR. HARREL: Do you want me to read the whole 13 thing? I thought you asked me for my interpretation, why I 14 was -- 15 MS. ZETTLER: Well, okay, that's fine. Go ahead 16 and finish your interpretation. 17 MR. HARREL: Then there's another thing. It says, 18 "Documents regarding third-party requests to conduct 19 fluoxetine studies for any indication." And so there's a 20 third category that we've utilized. 21 And then it says, "Grant information documents 22 related to compounds and products other than fluoxetine, 23 business and/or marketing plans and strategies, personnel and 24 staff requirement information and proprietary systems 25 information." DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 15 DAVID L. DUNNER, M.D., VOLUME I 1 That isn't what I'm relying on, but you asked me to 2 read the whole thing. 3 MS. ZETTLER: Well, our problem with it is you've 4 taken out budget or grant information from these documents. 5 That is clearly not covered and excluded by that order. The 6 order states that grant information other than information 7 related to fluoxetine is to be withheld, not grant 8 information related to fluoxetine. 9 And, frankly, Arley, we've gotten through FOIA 10 requests from the University itself a lot of grant 11 information, so I don't see where that is a trade secret or 12 where that is something that should be considered 13 confidential even under Judge Potter and Commissioner 14 Clayton's order. So we'd like that information to be placed 15 into the documents. We'd like any other documents that Dr. 16 Dunner has related to grant information given to him 17 specifically by Eli Lilly to be turned over. 18 MR. MYERS: Just so the record is clear and only 19 for the record, I've reviewed this document index, and it is 20 Lilly's position that not only does the 12/13/93 order of 21 Commissioner Clayton and Judge Potter control these 22 redactions or withholdings which are indicated on the index, 23 but also likely the March 29, '91 order and an earlier than 24 March 29, '91 order which is the original confidentiality 25 order as well as an order that Judge Potter entered late this DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 16 DAVID L. DUNNER, M.D., VOLUME I 1 summer or early this fall in connection with the issue of 2 non-depression indications. I simply cannot cite that order 3 to you, but there is in fact another order in the case, and 4 that's Lilly's position on the matter. 5 MS. ZETTLER: Right. And Judge Potter's more 6 recent order, which I happen to have a copy with me, 7 specifically excludes nondisclosure of trade secret 8 information that was originally set out in Judge Eckart's 9 March 29, 1991 order, I believe it was. 10 And the premise of the Court or the premise of the 11 judge's rulings are that because there is a confidential 12 order where we cannot disseminate information then that 13 covers it, that it's not a nondisclosure issue, that it is a 14 disclosure of a confidentiality order that's been set in 15 place. So as far as the trade secret information that is 16 asserted on this list, if any, then that has been deemed moot 17 by the Court. 18 MR. MYERS: May I see that order for a second? 19 That may be the order that I'm talking about. 20 MR. HARREL: We've got two orders. 21 MR. MYERS: I know that one by heart. 22 MR. HARREL: I've not seen these orders before and 23 I haven't had a chance to study them. I don't want to 24 withhold something that's not appropriate to withhold. I was 25 provided a copy of that one order and we're intending to DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 17 DAVID L. DUNNER, M.D., VOLUME I 1 comply, although Dr. Dunner is very sensitive to the business 2 of the University, its finances and confidential information. 3 And so we just want to make sure we don't inadvertently 4 release something that should not appropriately be released. 5 One thing you told me that you would provide before 6 the deposition started is the confidentiality order. And is 7 this it, the one that's not quite clearly typed? 8 MS. ZETTLER: Right. The first one should be dated 9 March 29, 1991, at the very end. 10 MR. HARREL: This essentially provides what with 11 respect to the things that Dr. Dunner has given to you, 12 provides what? 13 MS. ZETTLER: Under that order, patient identifying 14 information such as names, et cetera, are not to be disclosed 15 for obvious reasons. Actual third-party reporters of adverse 16 events not including Lilly employees or, for instance, Dr. 17 Dunner, which I see you gave us a 1639 where Dr. Dunner 18 reported an adverse event to Lilly. We're talking about 19 independent third-party prescribing people like Dr. Jones on 20 the street who may give his patient fluoxetine. Same thing 21 with the hospital situation where it's a non-study type of 22 situation. Some manufacturing, any manufacturing type of 23 information, any formula type of information, things of that 24 nature. 25 MR. HARREL: Does this prevent you from DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 18 DAVID L. DUNNER, M.D., VOLUME I 1 disseminating it outside of this litigation? 2 MS. ZETTLER: No. Well, let me put it this way. 3 It prevents me from disseminating anything that has been 4 produced by Lilly in this litigation, okay? If it's 5 something I get from the FDA as a FOIA request, obviously 6 that's not confidential under the order. 7 MR. HARREL: I'm concerned more about what you get 8 from Dr. Dunner in this deposition. 9 MS. ZETTLER: Well, we can agree that we're not 10 going to disseminate that information. If it's a problem, 11 we'll agree that we will not disseminate that information. 12 We'll in fact adopt that order as to Dr. Dunner's documents. 13 MR. HARREL: So the information produced here by 14 Dr. Dunner in his deposition will be used only for the 15 purpose of the Fentress litigation as far as you're concerned 16 and will not be disseminated beyond your law firm or -- 17 MS. ZETTLER: Well, let's put it this way. It may 18 be used for other cases that we have for fluoxetine cases, 19 but I'm not going to make that information public. Only for 20 purposes of my litigation. 21 MR. MYERS: Two things. One, the order that I 22 could not point to earlier is in fact this order entered 23 September 17, 1993, which I think is probably also 24 controlling on the redaction and withholding issue. Insofar 25 as the March 29, 1991 order is concerned, it is Lilly's DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 19 DAVID L. DUNNER, M.D., VOLUME I 1 position that that order allows Lilly to make certain 2 confidential designations with respect to depositions and 3 exhibits after the depositions are transcribed, and we've 4 been making those throughout the course of the litigation. 5 And I suspect, not knowing exactly what exhibits 6 the Plaintiffs are going to use here today, that we would 7 make some such designations in connection with the transcript 8 of the deposition of this witness and exhibits used for the 9 deposition of this witness, particularly exhibits which even 10 though produced by the witness today are as such Eli Lilly 11 documents which are in his possession for one reason or 12 another. 13 MS. ZETTLER: And what Mr. Myers says is true 14 generally. I mean, they are allowed to go through and make 15 confidentiality designations which should at least to the 16 extent that the information that they designate is in fact 17 confidential in nature should protect Dr. Dunner to a certain 18 extent. I'm sure they are going to go through and make what 19 they feel is the appropriate confidentiality designations. 20 And then it's my understanding that the transcript then gets 21 filed and sealed with the court. 22 MR. MYERS: If in fact it gets filed. 23 MS. ZETTLER: Right, if in fact it gets filed. 24 MR. MYERS: That's one point on which Ms. Zettler 25 and I do agree. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 20 DAVID L. DUNNER, M.D., VOLUME I 1 MR. HARREL: So that I clearly understand Ms. 2 Zettler's position, the order governing the production of 3 information and documents by Eli Lilly and Company and the 4 confidentiality of such materials, that order entered by 5 Judge Joseph Eckert on March 29, 1991, and whatever is 6 amended in that court, you're willing to extend the 7 protection such as they are of that order to Dr. Dunner 8 himself? 9 MS. ZETTLER: To the extent that the documents that 10 Dr. Dunner and the information that Dr. Dunner gives us is 11 confidential under the order. 12 MR. HARREL: And so that if after the deposition 13 either Eli Lilly or Dr. Dunner or me on his behalf designate 14 a misconfidentiality on that order, you would abide by that 15 order unless you go to the Court to get relief from it? 16 MS. ZETTLER: Right. I mean, obviously we differ 17 in opinion with Lilly as to what is really confidential and 18 what is not confidential in this case under that order. 19 Those are discussions that are ongoing with the Court. 20 You know, like I said, I'm not going to go out and 21 send all this information to the newspapers or anything like 22 that, but I will agree that whatever is deemed confidential 23 in the order by the Court, we will maintain confidentiality 24 on Dr. Dunner's documents that he produced. 25 MR. HARREL: And what about Mr. Smith who is here DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 21 DAVID L. DUNNER, M.D., VOLUME I 1 also? What is the situation with him? We've got Ms. 2 Zettler, I understand what her position is. 3 Where are we with respect to you, sir? As you 4 know, we didn't get any subpoena from you or notice from you 5 at all. 6 MR. SMITH: I'm riding the coattails of her with 7 respect to her subpoenaing of Dr. Dunner. However, I've 8 noticed the deposition in the MDL. Obviously all proceedings 9 in the MDL are covered by the Multi-District Litigation 10 Confidentiality Order which would be in place if this 11 deposition were taken in that. 12 Under that order, Lilly has a right to mark any 13 document they want confidential or any part of Dr. Dunner's 14 deposition as confidential, and we can't disclose anything 15 unless we go to the Court and request a status of that 16 information as not confidential. So there's no problem as 17 far as MDL is concerned. 18 MR. MYERS: There's a confidentiality order in 19 place in the multi-district litigation dated May 22nd of 20 1992, I believe. I'll be happy to furnish that to you, Mr. 21 Harrel. 22 And I would agree generally with what Mr. Smith 23 said, that to the extent that the deposition is being taken 24 in the MDL subject to our noted objection with respect to the 25 timing of this notice, there is a comprehensive DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 22 DAVID L. DUNNER, M.D., VOLUME I 1 confidentiality order that is similar to but not identical to 2 the March 29, 1991 order in the Fentress case that provides 3 analogous designation guidelines of confidential information 4 for witness testimony and documents produced in the 5 litigation and so that there is a safeguard in the MDL as 6 well. 7 MR. HARREL: Ms. Zettler, are you also in that MDL 8 case? 9 MS. ZETTLER: Yes, I am. 10 MR. HARREL: Will all counsel stipulate that the 11 same provisions of that confidentiality order to the extent 12 they go to Lilly would also extend to Dr. Dunner and either 13 documents designated by Eli Lilly as confidential and/or Dr. 14 Dunner would fall within that confidentiality order of May 15 22, 1992, in the MDL? 16 MS. ZETTLER: Well, let me just clarify a couple of 17 things. First of all, Dr. Dunner under the order does not 18 himself have the right to designate anything confidential, 19 okay? I mean, I think you can probably rely on Lilly to make 20 any identification of what they consider confidential 21 information with regards to that as far as mucking up the 22 waters. 23 Our position is if you had a problem with what we 24 asked you to produce under any order, et cetera, then you 25 should have probably made the motion prior to this DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 23 DAVID L. DUNNER, M.D., VOLUME I 1 deposition. 2 I will agree that both orders are similar to the 3 extent that Lilly has the right to mark what they feel is 4 confidential including portions of Dr. Dunner's testimony. 5 Under those orders the documents and/or the portions of the 6 testimony that they designate as confidential are filed under 7 seal with both courts or various courts. But if we are to 8 make some sort of motion before the Court to disclose this 9 information and the information is found not to be 10 confidential under the order, then we will assert the right 11 to use that information in any way that we choose. But as 12 far as the procedure of putting this stuff under seal with 13 the court, we will stipulate. 14 MR. MYERS: I will agree to Mr. Harrel's 15 stipulation and will also say that subject to my objection 16 regarding the MDL notice that we intend to review the 17 deposition transcripts under both confidentiality orders, the 18 Fentress and the MDL, and to make appropriate confidentiality 19 designations with respect to this witness and any documents 20 produced for or used during the course of the deposition. 21 MR. HARREL: Well, I need clarification from Ms. 22 Zettler, because it doesn't sound like she agreed on this 23 order the same as the other one. The other one I understand 24 she said yes, I'll agree to extend this order in the Fentress 25 case to Dr. Dunner. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 24 DAVID L. DUNNER, M.D., VOLUME I 1 Because what I'm concerned on behalf of Dr. Dunner, 2 if Eli Lilly doesn't designate something confidential and Dr. 3 Dunner for some different reason thinks it's confidential, 4 I'd like to have some protection without the necessity of 5 going down to court today since it's a holiday here in 6 Seattle. 7 And so all I'm asking is that you agree the same as 8 you did in the Fentress case that the MDL, the provisions of 9 that protective order of May 22, 1992, could be invoked by 10 Dr. Dunner himself or through his attorney by designating 11 something confidential if he deems it's confidential and Eli 12 Lilly does not. So I'd like that protection extended to him. 13 And you said you'd do it in Fentress and I didn't understand 14 why you didn't do it in the MDL. 15 MS. ZETTLER: Well, I think maybe we have a 16 misunderstanding here. I think what I said earlier was that 17 the Fentress order in effect covers Dr. Dunner's privileges 18 because Lilly will assert that privilege sort of on his 19 behalf, okay? I mean, they will go through and designate 20 certain documents as confidential. 21 I'm not going to say that the order provides Dr. 22 Dunner any more protection than it provides Eli Lilly. To 23 the extent that it does protect Dr. Dunner as a current or 24 former agent of Lilly in some respect, then that could be 25 asserted in both orders, because I think it's applicable or I DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 25 DAVID L. DUNNER, M.D., VOLUME I 1 think it's similar in both orders, the provisions. 2 But as far as any documents, I mean, if there are 3 any other documents that have not been produced other than 4 the ones that have been produced by copy or an original or as 5 listed in this sheet dated January 17, 1994, I don't think 6 Dr. Dunner has an independent right to determine whether or 7 not these are confidential under either order. 8 Are there any other documents that haven't been 9 produced either by this listing or by actual production? 10 MR. HARREL: He's got some with him here. Those 11 are just some additional things. You can get those out if 12 you want. 13 See, now I'm confused, because previously you said 14 that under Fentress to the extent that Dr. Dunner deemed 15 something confidential, and he has to worry about the 16 physician-patient privilege and other things that Eli Lilly 17 may or may not have to worry about so much, and we've tried 18 to keep the patient identifiers out. 19 And so I guess the question is if he deems 20 something confidential and asks that it be designated 21 confidential after his deposition, because we don't know what 22 you're going to mark in this deposition, it seems to me it 23 would be appropriate for you to say that Dr. Dunner would 24 have the same protection, no more, no less, that Eli Lilly 25 does, the only procedure being that Dr. Dunner designate it DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 26 DAVID L. DUNNER, M.D., VOLUME I 1 as opposed to me having to rely on counsel for Eli Lilly who 2 may have some different interests rather than having to write 3 to him to say please claim that something is -- Mr. Myers, 4 would you claim that something is confidential. 5 So it seems to me that's a reasonable thing to ask, 6 that I be able to designate on Dr. Dunner's behalf the same 7 privilege that Eli Lilly has of confidentiality. 8 MS. ZETTLER: Well, our position, Arley, is that if 9 that was a concern of yours, you should have gone on to some 10 sort of motion prior to this. 11 Also, I think I probably can assuage your concerns. 12 Unless there's some additional documents that Dr. Dunner 13 considers confidential at this point that we haven't already 14 been given or been given notice of by your listing dated 15 January 17, 1994, I don't see where that's going to be a 16 problem. I mean, obviously if you feel like I'm getting into 17 an area in questioning Dr. Dunner where it's going to breach 18 a patient-physician privilege, you can assert that objection 19 and either decide whether or not to instruct him not to 20 answer based on that privilege, et cetera, throughout the 21 deposition. 22 The only other documents that I'm going to possibly 23 mark in this deposition are documents that have either been 24 produced by Lilly under this order or documents that we've 25 obtained through a FOIA request, from the FDA or other DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 27 DAVID L. DUNNER, M.D., VOLUME I 1 entities that we've gotten properly through FOIA requests. 2 So I don't see where it's going to be a problem. 3 What I can agree to do, if you would like, is why 4 don't you -- if Dr. Dunner has a problem with any of the 5 documents that we mark and use as exhibits in the deposition, 6 why don't you contact me and then we can decide. But first 7 of all, I don't think I have the authority to extend this 8 order or any other order to cover Dr. Dunner specifically. I 9 don't see where it's going to be a problem. I mean, if it's 10 something that is really truly confidential in nature or 11 something that's going to breach some kind of a privilege, 12 then obviously he can independently assert that. He doesn't 13 need a court order to assert that. 14 MR. SMITH: Let me say this. We've been doing this 15 litigation all over the country. We have not been in court 16 once in which we have requested or a Court has ordered that 17 the patient-physician privilege be breached in any way. In 18 other words, we're not interested in the names, any 19 identifying names or numbers of patients themselves where we 20 can go back and find the individual patient. So we don't and 21 we won't intend to violate the patient-physician privilege. 22 My suggestion is, and I think Nancy in her concern 23 and me in the MDL, we actually don't have the authority to 24 extend the confidentiality orders any more than where they 25 are. I would suggest if there is a document that is shown or DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 28 DAVID L. DUNNER, M.D., VOLUME I 1 if you have a document that you think might be called upon 2 for production under the subpoena, then you raise the 3 objection of confidentiality and then let that be taken up 4 either under Washington law or the law applicable to whatever 5 jurisdiction we're in. 6 Again, it's not our purpose to breach any type of 7 physician-patient confidentiality here. I think you're being 8 hyperprotective about something that's not going to come up. 9 MR. MYERS: Just so the record is clear, when the 10 deposition is over Lilly intends to make its designations 11 under the terms and conditions of both of these orders as it 12 has done all along. Lilly is not in a position, I don't 13 believe, to make designations on behalf of Dr. Dunner, as Ms. 14 Zettler suggested, as its agent or former agent, because he 15 is not now nor ever has been an agent of Eli Lilly and 16 Company. So we're going to make our designations as we have 17 all along under the applicable laws of both of them. 18 MS. ZETTLER: And if it makes you feel any better, 19 Arley, they usually designate everything as confidential. 20 MR. HARREL: Well, Ms. Zettler, wouldn't you agree 21 that by telephone you told me that I did not have to worry 22 about confidentiality because there was an order and you'd 23 give it to me before the deposition started? 24 MS. ZETTLER: No, I don't agree with that. I 25 agreed that I would provide you with copies of the DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 29 DAVID L. DUNNER, M.D., VOLUME I 1 confidentiality orders that were in place prior to the 2 deposition, because you were concerned about Dr. Dunner's 3 inadvertent violation of those orders. But I think that the 4 information that has been provided to us by Dr. Dunner 5 yesterday and today, clearly none of that with the possible 6 exception of a couple of patient identifying names and 7 documents that have already been redacted by you does not 8 fall under either of the orders that are in place, either the 9 March 29th order, the later order entered that modifies the 10 March 29th order or the order that you yourself have obtained 11 and asserted in this document, the 12/13/93 order. 12 Like I said, I agree with Paul. I don't think it's 13 going to be a major problem, because we're assuming that 14 we've gotten, if not all, the majority of the documents that 15 we intend to produce under any order with whatever redactions 16 that you have felt to be appropriate under your review of the 17 orders. 18 I'm not ready to nor would I in the interest of my 19 clients counsel you on what -- you know, anything 20 specifically that is something that would be asserted as 21 privileged under an order other than to agree with Paul that 22 we are not intending to try to find out the names of any 23 patients that Dr. Dunner has currently treated, has treated 24 or used as subjects at clinical trials. 25 MR. HARREL: Well, you and I disagree substantially DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 30 DAVID L. DUNNER, M.D., VOLUME I 1 with respect to what I understood you told me about the 2 confidentiality orders. It was my understanding in our 3 telephone call that you said that I did not have to be 4 worried on behalf of Dr. Dunner about any confidentiality 5 because there was a confidentiality order and that you would 6 provide that to me before the deposition started. I got it 7 this morning. And now you're telling me that -- you started 8 to change your position from what I understood earlier in 9 this deposition, that there is no protection for Dr. Dunner. 10 And we got your amended Exhibit A on January 11th. 11 Today is Martin Luther King's holiday, the courts are not 12 open. If you're going to maintain that I needed to bring a 13 Motion to Quash before that, before the deposition commences, 14 which apparently is your position, I've given you a Motion to 15 Quash this morning which I said was to protect the record, 16 because I thought everything had been ironed out pretty well. 17 But it sounds to me like we maybe do have a disagreement. So 18 if you're insisting that we go to court first to preserve our 19 record, then we will have to do that. 20 MS. ZETTLER: I think that the disagreement that we 21 have or maybe the confusion that has been raised is not that 22 I told you that any specific document would be protected 23 under the order or a specific subject would be protected, I 24 told you that we had orders in place that would preserve the 25 confidentiality in non-dissemination of the information DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 31 DAVID L. DUNNER, M.D., VOLUME I 1 that's produced generally. I've already told you that I 2 would agree not to disseminate the information that is deemed 3 confidential under the order on Dr. Dunner's behalf. That in 4 other words, just because Dr. Dunner produced it, the 5 confidentiality order that is in place would not be waived as 6 to specific types of information. 7 Now, for instance, let's use an example, okay? One 8 of the three-ring binders that you have produced today, the 9 one that's entitled "A Specifically Different Antidepressant, 10 Prozac, Fluoxetine Hydrochloride," in that there are a number 11 of different articles written by various people as 12 demonstrated earlier on the record. This is not something 13 that is confidential under the order; therefore, I feel like 14 I could use it in any way I need to use it within or without 15 the litigation. 16 Something like a 1639 form that Dr. Dunner filled 17 out and submitted to Eli Lilly or filled out in conjunction 18 with Eli Lilly that is then given to the FDA is something 19 that's discoverable in a FOIA request; therefore, that is not 20 in the confidentiality order. 21 Now, something that is under the confidentiality 22 order like a specific patient name, I agree, I'm not going to 23 -- if it is something that was missed, I have not gotten a 24 chance to look through all of the documents that you've given 25 me. But, for example, if somebody in redacting has missed a DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 32 DAVID L. DUNNER, M.D., VOLUME I 1 patient name, that is something that is under the 2 confidentiality order, and I would not disseminate that 3 information to anybody and I wouldn't use it in any way. 4 Frankly, I wouldn't use it in any way, but I 5 wouldn't use it in any way other than my litigation if I were 6 so inclined to use that kind of information. We respect the 7 patient-doctor privilege and we are not going to try to 8 breach somebody's privacy by contacting them because they may 9 or may not have had an adverse reaction on fluoxetine. 10 So to the extent that the order does cover specific 11 information, I will agree that it applies to Dr. Dunner, and 12 I'm not going to disseminate information that has been 13 produced that just fall underneath the confidentiality order. 14 What I am objecting to, and not really even objecting to, 15 what I say I cannot do is I cannot agree to let Dr. Dunner 16 arbitrarily make decisions as to what is confidential and 17 what is not confidential. And frankly, I think that he's 18 going to be covered more than adequately by Eli Lilly's 19 designation of documents, because it's been their practice to 20 designate just about every document that's produced in this 21 information as confidential. That is my position. 22 MR. HARREL: Well, maybe we can do this so we can 23 get on with this. What if I will send a letter to counsel, 24 including I guess Ms. Zettler, I don't have a card for Mr. 25 Smith so I don't have his address, but I can send it to you DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 33 DAVID L. DUNNER, M.D., VOLUME I 1 and Mr. Myers indicating after the deposition what Dr. Dunner 2 thinks is confidential. 3 And if Mr. Myers will agree that he will then 4 incorporate that into his designations, and then you would 5 deem at least to that extent the protective orders in the 6 Fentress case and the MDL do apply, and you obviously can 7 move to change them, then I suppose that would satisfy me. 8 Otherwise, if you're going to make me go to court first, it's 9 kind of hard here today because we're on a court holiday. So 10 I guess would Mr. Myers be willing to do that? 11 MR. MYERS: I would be willing to do that in order 12 to cover you or Dr. Dunner's concerns to make those 13 designations. 14 MR. HARREL: And will you agree, then, to the 15 extent Mr. Myers designates documents produced by Dr. Dunner 16 not just as exhibits but actually produced as confidential, 17 you'll abide by the two orders in the cases? 18 MS. ZETTLER: To the extent that the designations 19 of confidentiality are appropriate under the order, sure. In 20 other words -- 21 MR. HARREL: Well, that's an argument, but at least 22 you'll abide by it in the first instance and we can argue 23 about whether or not they are appropriate? Would you agree 24 to that? 25 MS. ZETTLER: Sure. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 34 DAVID L. DUNNER, M.D., VOLUME I 1 MR. HARREL: Mr. Smith? 2 MR. SMITH: Yes. 3 (Off-the-record discussion.) 4 MR. HARREL: And Dr. Dunner does have additional 5 things he brought with him. I don't know if they made my 6 list or not. 7 Maybe for the record, Dr. Dunner, you could just 8 identify what those are to a certain extent, because we don't 9 have any listing of those. 10 THE WITNESS: This is a series of slides with Dista 11 Products Company on them, and it's 31 slides, I think. 12 Here's another series of slides that I think refer 13 to the articles that are in that binder marked "A 14 Specifically Different Antidepressant, Prozac, Fluoxetine 15 Hydrochloride." Now, I think those were produced by Lilly. 16 And I do need to have these slides, because I'm giving a talk 17 to residents on Thursday on selective serotonin reuptake 18 inhibitors. After that talk I can furnish them back to you 19 to get them copied. 20 MR. HARREL: Or you can make copies. I'd just as 21 soon you not have the originals that he's using. 22 MS. ZETTLER: That's fine. I mean, as long as you 23 can provide us a copy of all those, that's fine. 24 So these slides that you've handed me in the small 25 box with the index sticky thing that says Prozac on it are DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 35 DAVID L. DUNNER, M.D., VOLUME I 1 slides that were provided to you by Lilly that you are going 2 to use in a lecture on Thursday? 3 THE WITNESS: I may be using some of them in a 4 lecture on Thursday. 5 MS. ZETTLER: And generally these are slides that 6 talk about fluoxetine, or are these slides that without 7 having to go through each individual one -- 8 THE WITNESS: I think they are all on something 9 related to fluoxetine or serotonin. 10 MS. ZETTLER: Do you know when these slides were -- 11 strike that. 12 When were these slides given to you, Doctor? 13 THE WITNESS: I don't know. 14 MS. ZETTLER: It's been awhile? I mean, it's not 15 something that's been given to you in the last 30 days? 16 THE WITNESS: That's correct. 17 MS. ZETTLER: It's 27 slides in the small box that 18 you've handed me that were produced by Lilly. We don't need 19 them this week or anything. 20 And the other group is what? I'm sorry. Is this 21 something that you believe is related to the three-ring 22 binder marked "A Specifically Different Antidepressant;" 23 correct, this second group? 24 THE WITNESS: Yeah. These slides I believe are 25 related to those studies. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 36 DAVID L. DUNNER, M.D., VOLUME I 1 MS. ZETTLER: The studies that are set out in the 2 binder entitled "A Specifically Different Antidepressant"? 3 THE WITNESS: Correct. 4 MS. ZETTLER: And when you say "these slides" you 5 mean -- 6 THE WITNESS: These slides that were in the box. 7 MS. ZETTLER: That are the 27 in the box, okay. 8 MR. HARREL: Could you count those, Doctor, because 9 she's indicated that there are 27. I don't want it to be 26 10 and then we're saying where is the missing slide. 11 MS. ZETTLER: That would be fine. 12 And you indicated the other group of slides that 13 you handed me, there are 31 and I've counted them, and I'm in 14 agreement with that. It looks like a series of slides that 15 starts out with "Treatment of the Depressed Patient." And 16 just so -- I think I'm getting a little bit confused. This 17 series of 31 slides you believe are also related to this 18 binder that is entitled "A Specifically Different 19 Antidepressant" or is this a different set of slides? 20 THE WITNESS: That's a different set of slides. 21 MS. ZETTLER: What is this set of slides related 22 to, if you know? 23 THE WITNESS: It's related to a program similar to 24 what was in the white binders. 25 MS. ZETTLER: The two other ones we identified DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 37 DAVID L. DUNNER, M.D., VOLUME I 1 earlier, one entitled "New Perspectives in Depression; 2 Advances in Diagnosis and Management," and the other being 3 "Depression in Medical Practice; Diagnosis, Communication and 4 Treatment Strategies;" correct? 5 THE WITNESS: Correct. 6 MS. ZETTLER: So it's something similar to these 7 two but not necessarily directly related to either one of 8 these? 9 THE WITNESS: I think it was a predecessor to the 10 slide set that you'll find in those. 11 MS. ZETTLER: Okay, all right. Do you need any of 12 these back for now? 13 MR. HARREL: I'd like to get everything you're not 14 going to be using back here. 15 MS. ZETTLER: Oh, okay. 16 MR. HARREL: I'd like to get the two he uses back 17 to him, put those away. And are you done with these? I'd 18 like to get these back in the sack, because I don't want to 19 lose them. 20 MS. ZETTLER: Well, I'm not sure I'm done with them 21 or not yet. We'll just leave them here until lunch and I can 22 look them at lunch or whatever. 23 MR. HARREL: Because I noticed things were falling 24 out of them. 25 Doctor, if you can remind me not to leave these. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 38 DAVID L. DUNNER, M.D., VOLUME I 1 Do you have your materials back? 2 THE WITNESS: Yes, I do. 3 EXAMINATION 4 BY MS. ZETTLER: 5 Q. Doctor, could you please state your full name for 6 the record. 7 A. David Louis Dunner, D-u-n-n-e-r. 8 Q. Dr. Dunner, have you given a deposition before? 9 A. Yes, I have. 10 Q. On how many occasions have you given a deposition 11 approximately? You don't have to tell me exactly. 12 A. I don't know. 13 Q. More than five? 14 A. More than five. 15 Q. What I'm trying to get at is I just want to make 16 sure you understand the general ground rules of giving a 17 deposition so that we're all clear on what's going to happen 18 here. Obviously I'm going to ask you a series of questions 19 related to your work on fluoxetine, depression and/or for Eli 20 Lilly as it relates to either of those subjects, okay? Is 21 that understood? 22 A. Yes. 23 Q. In a deposition obviously you have to answer out 24 loud so that the court reporter can take you down. You can't 25 shake your head and say uh-huh, okay? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 39 DAVID L. DUNNER, M.D., VOLUME I 1 A. Yes. 2 Q. If at any time you don't hear or understand one of 3 my questions, please ask me to repeat it or I will either 4 rephrase it or repeat it so that you understand it; is that 5 fair? 6 A. Yes. 7 Q. And if you answer a question under that caveat, I'm 8 going to assume that you answered it as asked, okay? 9 A. That's true. 10 Q. This is not an endurance test, so any time you want 11 to take a break, just let us know and we'll take a break. 12 And also, if you'd like some coffee or water or something 13 else to drink, please let us know and we'll do our best to 14 get it for you, okay? 15 A. Thank you. 16 Q. Can I get your date of birth? 17 A. May 27, 1940. 18 Q. And your Social Security number? 19 MR. HARREL: I don't think you need to do that if 20 you don't want to. 21 I'll advise Dr. Dunner that his Social Security 22 number seems to me to be a confidential matter, an invasion 23 of his privacy. Unless you can somehow tell me why his 24 Social Security number is somehow reasonably calculated to 25 lead to the discovery of admissible evidence, I think I'll DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 40 DAVID L. DUNNER, M.D., VOLUME I 1 advise Dr. Dunner he can refrain from supplying that 2 information. 3 MS. ZETTLER: Well, that's a typical question 4 that's asked in depositions, as you know, Arley, because if 5 Dr. Dunner is to move out of the jurisdiction of where he's 6 living now, if we need to find him it makes it easier to find 7 him. Are you instructing him not to answer? 8 MR. HARREL: I'm going to advise him that I think 9 that would be an invasion of his privacy. I'm not convinced 10 that he would move. 11 How long have you lived in the state of Washington? 12 THE WITNESS: Fifteen years. 13 MR. HARREL: You don't have any intention of moving 14 in the next year out of the state of Washington? 15 THE WITNESS: No. 16 MR. HARREL: How long have you lived at your 17 current address? 18 THE WITNESS: Fifteen years. 19 MR. HARREL: I think on that basis there's no 20 reason to believe that Dr. Dunner is going to be unavailable. 21 And if you need further assurances, he's associated with the 22 University of Washington. So I'm going to advise him I think 23 that's an invasion of your privacy, and you don't need to 24 answer that question, Doctor, absent a court order. 25 Q. (By Ms. Zettler:) Are you going to follow your DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 41 DAVID L. DUNNER, M.D., VOLUME I 1 counsel's instruction, Dr. Dunner? 2 A. Yes. 3 MR. SMITH: Doctor, do you not intend to place your 4 Social Security number or tax ID number on the request for 5 payment that Ms. Zettler is going to submit when you get paid 6 for your testimony here today? 7 MS. ZETTLER: Which, frankly, I cannot submit 8 payment to him unless he provides us with that information 9 considering that it is in an amount over $600. 10 THE WITNESS: I'm going to discuss with counsel at 11 lunch whether this check should be made to the University of 12 Washington or to me, because the bill I submitted for time is 13 for the check to be made payable to the University of 14 Washington. And I need to discuss that with counsel and I'll 15 get back to you about that. 16 MS. ZETTLER: I'd like that question certified, the 17 earlier question about his Social Security number. 18 MR. HARREL: What does certified mean? 19 MS. ZETTLER: Certified in Kentucky is basically 20 she sets it out that it is a question that is asked that you 21 instructed him not to answer and we certify it or just make a 22 technical record that he understood the question. 23 Q. (By Ms. Zettler:) You did understand the question 24 about Social Security number; correct? 25 A. Yes, I did. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 42 DAVID L. DUNNER, M.D., VOLUME I 1 Q. And that we are marking it on the record to bring 2 it before the Court, because we think it needs to be brought 3 for the Court. 4 MR. HARREL: Just so the record is clear, I advised 5 him not to answer as opposed to instructing him. I've had 6 some judges indicate there is a difference. 7 Q. (By Ms. Zettler:) Regardless, you are not 8 answering that question, right, Doctor? 9 MR. HARREL: It's not regardless. Based on advice 10 of his counsel he's not answering it, and I think that's been 11 covered. 12 Q. (By Ms. Zettler:) What's your current home 13 address, Doctor? 14 A. Do I need to do that? I've done depositions 15 before, Ms. Zettler, and no one has ever asked me my Social 16 Security number or my home address, they've always just asked 17 me my office address. 18 My home address is not published because we've had 19 a threat to our family by a former patient and so it's not in 20 published form and it's not in the phone directory. And I'd 21 prefer it not be public information. 22 Q. What is your -- not wanting to put you or your 23 family in danger, I won't pursue that question, okay? 24 What is your current work address? 25 A. Suite 306, 4225 Roosevelt Way Northeast, Seattle, DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 43 DAVID L. DUNNER, M.D., VOLUME I 1 Washington, 98105. 2 Q. What is your current work phone number? 3 A. 206-543-6768. 4 Q. You stated earlier in questioning by your counsel 5 that you've lived at your current residence address for about 6 15 years; is that correct? 7 A. That is correct. 8 Q. Do you have any current plans to move? 9 A. I do not. 10 Q. Do you have any current plans to change jobs? 11 A. I do not. 12 MS. ZETTLER: Arley, you said you had a copy of the 13 doctor's CV? 14 MR. HARREL: Yes, I do. 15 MS. ZETTLER: Can I take a look at that? 16 MR. HARREL: It's actually the only copy I have. 17 (Short break) 18 (Whereupon, Exhibit 2 was marked for 19 identification.) 20 Q. (By Ms. Zettler:) Doctor, we have marked the 21 curriculum vitae that your counsel has provided us as Exhibit 22 2. Is this a current copy? Is this updated? 23 A. Yes, it is. 24 Q. Any additions, changes or corrections you'd like to 25 make to this? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 44 DAVID L. DUNNER, M.D., VOLUME I 1 A. No. 2 MR. HARREL: Recognize that just for the record 3 that it is 26 pages, and I haven't asked Dr. Dunner to go 4 through and read it word for word. And so I'll state for the 5 record I think that would be kind of a waste of time, but I 6 mean, sometimes these are prepared by others and typed by 7 others and there may be some typo in it or something. 8 Q. (By Ms. Zettler:) To your knowledge, is this 9 updated and correct? 10 A. It's updated as to December of '93, and there may 11 be some typos in it, but that's basically it. 12 Q. Can you give us your educational history, Doctor, 13 after high school? 14 A. I attended The George Washington University in 15 Washington, D.C. for three years. I received an M.D. degree 16 from Washington University in St. Louis in 1965, and I did a 17 rotating internship at Philadelphia General Hospital for a 18 year and three years of psychiatric residency at Washington 19 University in St. Louis from 1966 to 1969. 20 Q. You did your undergraduate work at George 21 Washington University; is that correct? 22 A. That's correct. 23 Q. What degree, if any, did you obtain from George 24 Washington University? 25 A. An Associate of Arts two-year degree. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 45 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Did you go on somewhere to get a bachelors? 2 A. No, I didn't. 3 Q. You went from -- I'm sorry, when did you get your 4 associates degree in arts? 5 A. 1960. 6 Q. When did you get your M.D. from Washington? 7 A. 1965. 8 Q. When did you complete your residency? 9 A. 1969. 10 MR. HARREL: I'm going to state for the record, one 11 thing that occurred to me on that Social Security business is 12 that if the doctor does give you his Social Security number 13 for that check that I would suspect there may well be federal 14 rules governing what you could do with it on that basis. 15 It just occurred to me. So the fact that if he 16 does give it to you for that check, I would certainly 17 indicate that whatever federal laws govern that will govern 18 it given pursuant to this deposition. 19 MS. ZETTLER: That's fine. Like I said earlier, 20 the only way or reason we would ever use that information is 21 if Dr. Dunner were to move and we needed to find him. That 22 would be the only reason we would use it, and it just 23 expedites things a lot more. 24 MR. HARREL: For example, you asked him about his 25 home address and that sort of thing, but you actually got it DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 46 DAVID L. DUNNER, M.D., VOLUME I 1 served at his home address so you obviously know it. Whether 2 or not he wants to give it to you, we would appreciate it if 3 you keep that confidential because of the threat to his 4 family. 5 MS. ZETTLER: We have no intention of endangering 6 any lives or safety of either Dr. Dunner or his family. 7 MR. SMITH: Other than any questions we ask of Dr. 8 Dunner. 9 MS. ZETTLER: Yeah, other than in the rather 10 pointed questions. 11 Q. (By Ms. Zettler:) Doctor, when did you first 12 become affiliated in any way with Eli Lilly and Company 13 either as a clinical investigator or any other manner? 14 MR. HARREL: Object to the form of the question in 15 the use of the term "affiliated." It might be vague. 16 Q. (By Ms. Zettler:) Do you understand the question, 17 Doctor? 18 A. I became a clinical investigator with Eli Lilly I 19 believe in the early '80s, but I don't know exactly when. 20 Q. Prior to becoming a clinical investigator for Eli 21 Lilly in the early '80s, did you do any other work on behalf 22 of or at the request of Eli Lilly? 23 A. I don't believe so. 24 Q. I'd like for you to list for me the types of work 25 that you have done either with Lilly or on behalf of Lilly DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 47 DAVID L. DUNNER, M.D., VOLUME I 1 related to the field of psychiatry and in particular 2 depression or fluoxetine hydrochloride. 3 MR. MYERS: Before he answers the question, let me 4 object to it only to the extent that it may as phrased call 5 upon him to disclose information concerning work on compounds 6 other than fluoxetine which is exempted from discovery by 7 court order. And I would at least ask his counsel that he 8 not disclose any other compound other than fluoxetine that 9 he's worked on which may not be approved subject to the form. 10 MR. HARREL: I would advise you, Dr. Dunner, that 11 you should not, number one, reveal any other compounds. 12 Number two, we've identified something that's been marked out 13 of the documents produced. And as best you can, try to avoid 14 either inadvertently mentioning other things than what's 15 covered by the subpoena in this case. 16 Q. (By Ms. Zettler:) Well, first of all, the 17 compounds that Larry is referring to are compounds that are 18 not marketed currently or have never been on the market. So 19 if you've done work on other compounds that are on the 20 market, that is no longer covered by the confidentiality 21 order. But let me do this, let me break down my question. 22 With regards to fluoxetine, if you could list for 23 me the clinical trials that you have run on fluoxetine on 24 behalf of Eli Lilly. 25 A. We participated in a number of clinical trials that DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 48 DAVID L. DUNNER, M.D., VOLUME I 1 were all multi-center studies. I haven't personally run any 2 studies. 3 There was a study comparing fluoxetine with 4 imipramine. There was a study comparing different doses 5 including a low dose of fluoxetine. There was a study 6 comparing fluoxetine with Trazadone. We had a humanitarian 7 protocol to give fluoxetine to patients who were not 8 responsive to other treatments. 9 Q. Do you call those refractory patients, patients who 10 are refractory? 11 A. Patients with refractory depression. We've studied 12 fluoxetine as a means of looking at a new way to decrease 13 placebo response rate. And we have studied fluoxetine 14 compared with another compound not currently available. 15 Q. Paroxetine? Is it a Lilly compound? 16 A. Yes. 17 Q. You've also done fluoxetine compared with studies 18 with paroxetine, have you not? 19 MR. HARREL: I know I was -- I'll wait to see what 20 Eli Lilly counsel says about that. 21 MR. MYERS: I was going to object to the form only 22 because the question is leading. 23 MS. ZETTLER: Do you want to instruct him not to 24 answer based on it being a leading question, Arley? 25 MR. HARREL: No, I will not instruct him not to DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 49 DAVID L. DUNNER, M.D., VOLUME I 1 answer on that because you've got all these orders. So I'm 2 just trying to produce this witness that's in accordance with 3 the orders and not get him out in left field. So I'm looking 4 for some thoughts from Eli Lilly's counsel as to what these 5 orders provide, because there's certain compounds that I've 6 redacted out from the documents produced. 7 MR. MYERS: My only comment on the question would 8 be that paroxetine is a marketed compound. However, I don't 9 know whether the answer to the question relates to work that 10 he's done for somebody other than Lilly, and that may impact 11 our relationships with manufacturers other than Lilly and 12 things of which I don't know. 13 Q. (By Ms. Zettler:) I think the question as it 14 stands right now is whether or not you've done fluoxetine 15 trials that have compared fluoxetine to paroxetine as an 16 initial question. 17 MR. HARREL: Well, is that a product that's 18 manufactured by Eli Lilly? 19 MS. ZETTLER: No, but it is a product that is on 20 the market today. I mean, I think first we're going to 21 establish whether or not he actually did them. If he didn't 22 do them then obviously this is moot. If he did do them and 23 you want to object to further questions on the subject, 24 that's fine. But I think the initial question is fine 25 because both compounds are on the market today. So really my DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 50 DAVID L. DUNNER, M.D., VOLUME I 1 initial question is whether or not the doctor has done 2 studies comparing fluoxetine to paroxetine. 3 MR. HARREL: And if the Eli Lilly counsel says he 4 can answer that question and not violate any protective 5 orders and not violate any guidance from Eli Lilly, is that 6 the understanding? 7 MR. MYERS: My comment relates to if he's done such 8 a study for Eli Lilly and Company, I have no such objection. 9 If he's done a study for another company which neither I nor 10 anybody in this room represents, that may have some impact on 11 the doctor which I'm not aware. If there is some agreement 12 to keep that information confidential, I don't know. 13 MS. ZETTLER: First of all, I'm going to object to 14 you taking any advice as to how you're going to instruct your 15 client from the lawyers from Eli Lilly and Company, because 16 I'm not going to let this deposition degrade into some sort 17 of argument over what is considered confidential and what is 18 not considered confidential. Mr. Myers can make his 19 objections on behalf of his own client as he feels necessary. 20 Second of all, none of these confidentiality orders 21 have anything to do with any other company other than Eli 22 Lilly and Company which is the company that is being sued in 23 this case. 24 Again, my initial question is just whether or not 25 he has done comparative studies on two drugs that are DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 51 DAVID L. DUNNER, M.D., VOLUME I 1 currently on the market. I don't think there is anything 2 objectionable about that question in and of itself regardless 3 of who is going to assert some sort of claim here. 4 MR. HARREL: Do you know? I'm going to rely on you 5 to answer that question with respect to whether or not they 6 are getting into trade secrets that you feel uncomfortable 7 with because of other companies. I don't have any orders 8 that I can guide you on. Now I'm going to look at you to 9 answer that question in accordance with how you best feel 10 that protects you and the University with respect to any 11 other company. 12 THE WITNESS: Can I have the question repeated, 13 please. 14 Q. (By Ms. Zettler:) Sure. My question is simply 15 whether or not you have conducted or participated in clinical 16 trials comparing paroxetine with fluoxetine. 17 A. Yes, I have. 18 Q. So far you've stated that you've participated in 19 multi-center studies on fluoxetine; correct? 20 A. That is correct. 21 Q. You've also participated or conducted a study that 22 compared fluoxetine with imipramine; correct? 23 A. Correct. 24 Q. And a low dose study of fluoxetine? 25 A. Correct. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 52 DAVID L. DUNNER, M.D., VOLUME I 1 Q. A study comparing fluoxetine and Trazadone? 2 A. Correct. 3 Q. A humanitarian protocol on refractory depressed 4 patients? 5 A. Correct. 6 Q. And you did a study on using fluoxetine to study 7 decreased placebo response rate? 8 A. Yes. 9 Q. And you've done studies or a study on comparing 10 fluoxetine and paroxetine; correct? 11 A. That's correct. 12 Q. Any other studies that you can recall? 13 MR. HARREL: What is the question? I mean, any 14 other studies you can recall what? 15 MS. ZETTLER: Any other studies that you can recall 16 that you have done on fluoxetine. 17 MR. HARREL: On behalf of Eli Lilly? 18 MS. ZETTLER: No, any studies that you've done on 19 fluoxetine whatsoever. 20 MR. HARREL: Because the first question had to do 21 with Eli Lilly. 22 Q. (By Ms. Zettler:) Let's start it that way. 23 Any other studies that you can recall that you've 24 done on fluoxetine for Eli Lilly? 25 A. Not that I can recall. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 53 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Any other studies comparing fluoxetine to a 2 currently marketed drug whether or not it was done on behalf 3 of Eli Lilly? 4 A. Not other than the paroxetine study. 5 Q. Any clinical trials -- strike that. 6 Any studies that you have done on behalf of Eli 7 Lilly related to depression other than comparing a compound 8 that is not currently marketed by Lilly? 9 A. We've done some studies on depression for a drug 10 that won't be marketed is my understanding. 11 Q. A drug that will not be marketed? 12 A. It's my understanding. 13 Q. Is that studies that were looking at the safety and 14 efficacy of the drug or were those studies that were done to 15 investigate the disease of depression? 16 A. That's two questions. 17 Q. Let me ask it this way. 18 You have stated that it is your understanding that 19 you have done studies on depression for Lilly using a drug 20 that is not going to be marketed by Lilly, correct, or not 21 going to be marketed? 22 A. I'm not sure that that's what I said. 23 Q. Maybe I'm misunderstanding you. 24 A. Why don't you ask the question again. 25 Q. Any studies that you have done on behalf of Lilly DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 54 DAVID L. DUNNER, M.D., VOLUME I 1 or for Lilly studying depression? 2 A. Yes. 3 Q. What studies are those? 4 MR. MYERS: Before he answers, let me object to the 5 question on the grounds that that may well call for him to 6 disclose trade secret and confidential commercial information 7 of Lilly with respect to drugs previously or presently under 8 investigation which are not marketed. So I object to the 9 question and would request of the doctor on Lilly's behalf 10 that he not disclose those compounds. 11 MS. ZETTLER: And, Larry, you know, you have no 12 standing to instruct the doctor or request of him not to 13 answer any questions in this deposition. 14 MR. MYERS: I'm not instructing him, I'm simply 15 making that request on Lilly's behalf that he not disclose 16 those trade secrets. 17 MS. ZETTLER: You are not his lawyer and you can 18 make your objections for the record, but you have no standing 19 to instruct or recommend or advise him in any way as to 20 whether or not a question that you feel may or may not be 21 appropriate should be answered. 22 MR. MYERS: I've asserted my objection and made 23 that request. Whether he'll follow it or not, that's for the 24 record I'm making that objection. 25 MR. HARREL: Doctor, I will advise you to certainly DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 55 DAVID L. DUNNER, M.D., VOLUME I 1 not disclose any trade secret compounds and other things that 2 you feel should not be disclosed. And so I'll just advise 3 you that that is an appropriate thing for you to refrain from 4 doing absent further court order. 5 And so with that advice, you may now answer, to the 6 extent that you can, under that advice. 7 Q. (By Ms. Zettler:) Let me ask you this, Doctor. 8 These other depression studies that you've done on behalf of 9 Eli Lilly, do they all involve compounds that are not yet 10 marketed by Lilly? 11 A. I believe so. 12 Q. They all do? 13 A. I believe so. 14 Q. Have you done any studies independent of drug 15 clinical trials related to drugs, the efficacy and safety of 16 Lilly drugs that are not marketed related in any way to the 17 disease of depression? 18 A. Try that one again, please. 19 Q. What I'm trying to find out is if you have done any 20 studies on the etiology of depression apart from studying the 21 efficacy and safety of a drug for Lilly. 22 MR. HARREL: Or on behalf of Eli Lilly? 23 MS. ZETTLER: Right. 24 THE WITNESS: Start from the top and ask the 25 question again. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 56 DAVID L. DUNNER, M.D., VOLUME I 1 Q. (By Ms. Zettler:) Okay. I'm not interested in 2 clinical trials on drugs at this point, okay? What I'm 3 interested in is any studies that you have done on behalf of 4 Eli Lilly into the disease of depression itself; the 5 etiology, the symptoms, the possible consequences of 6 depression. Have you done any studies on depression itself 7 for Eli Lilly? 8 A. I don't believe I've done any studies on depression 9 itself for Eli Lilly. 10 Q. How about suicidality? Have you done any studies 11 for Eli Lilly on suicidality? 12 A. No. 13 Q. How about violent or aggressive behavior or 14 homicidality? Have you done any study for Eli Lilly on 15 homicidality? 16 A. No, I have not. 17 Q. Have you ever acted as a consultant on the issue of 18 depression, suicidality or violent and aggressive behavior 19 for Eli Lilly? 20 A. I don't believe so. 21 Q. Have you ever acted as a consultant for Eli Lilly 22 on a rechallenge protocol? 23 A. We talked about it. I don't know what the term 24 consultant means. It never happened. 25 Q. You mean the rechallenge protocol never happened? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 57 DAVID L. DUNNER, M.D., VOLUME I 1 A. I talked to someone on the phone about it and gave 2 some thoughts, and what we thought we should do never 3 happened. 4 Q. Who did you talk to on the phone? 5 A. I'm not certain who it was. 6 Q. Charles Beasley? 7 A. It's possible it was Charles Beasley. 8 Q. Was it a man or a woman? 9 A. Probably a man. 10 Q. When did this conversation take place? 11 A. I don't know. 12 Q. Was it within the last year? 13 A. I doubt it. 14 Q. Was it since the advisory committee meeting in 15 September of 1991? 16 A. I don't know. 17 Q. Who initiated the phone call? 18 A. I didn't initiate the phone call. 19 Q. And this was a person at Lilly that you talked to 20 about the rechallenge protocol; correct? 21 A. Well, we talked about studying patients who had 22 developed suicidal thoughts on Prozac. 23 Q. Were you invited to a meeting at Eli Lilly where a 24 group of people were getting together to discuss the 25 possibility of performing a study or a restudy of people DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 58 DAVID L. DUNNER, M.D., VOLUME I 1 developing suicidality? 2 A. I don't think so. 3 Q. Did you ever attend such a meeting? 4 A. I know I didn't attend such a meeting. 5 Q. Were you ever provided with documents or 6 information by Lilly or anybody else on a prospective study 7 to restudy people developing suicidality on fluoxetine? 8 A. I know I didn't participate in any study. I don't 9 know if I got a protocol draft or not. I don't recall. 10 Q. How long did this phone conversation last that you 11 referenced earlier? 12 A. Not long. 13 Q. Can you estimate for me? Fifteen minutes? 14 A. Probably less. 15 Q. What was discussed during that conversation 16 generally? 17 A. I don't remember details of the conversation. We 18 talked about -- I had a thought about rehospitalizing people 19 who had had suicidal ideations on Prozac and putting them on 20 a Prozac placebo study. 21 MR. HARREL: I'll just remind you, Dr. Dunner, to 22 be sure you answer her questions as opposed to volunteering. 23 Q. (By Ms. Zettler:) Where were you intending on 24 getting the people to use in this study? 25 A. I don't know. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 59 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Do you have a pool of people who had become 2 suicidal on fluoxetine previously that you could have drawn 3 from? 4 A. No. 5 Q. Was it your understanding that there was such a 6 group out there of people who had become suicidal while on 7 fluoxetine that could have been drawn from to conduct such a 8 study? 9 MR. MYERS: Object to the form. Leading. 10 THE WITNESS: Could I have it repeated, please. 11 Q. (By Ms. Zettler:) Sure. You stated earlier that 12 you discussed with this person on the phone during this 13 conversation of a possible restudy of people that have become 14 suicidal that you had an idea to rehospitalize patients who 15 had become suicidal on fluoxetine and do a placebo-controlled 16 study on these people to see if they became suicidal again; 17 correct? 18 A. Let me take that back. I'm not sure exactly what I 19 said. That may have been part of the conversation. I may 20 have wanted to start off with people who were in the hospital 21 for suicidal thoughts, but I don't remember the details of 22 the conversation sufficiently to really say under oath what 23 actually happened. 24 Q. What is your understanding of what a rechallenge 25 study is? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 60 DAVID L. DUNNER, M.D., VOLUME I 1 A. A rechallenge study is where you give a substance 2 that is presumably cause and effect to see if it causes the 3 same effect. 4 Q. And it's your testimony that you wanted to use 5 people who had already been -- may have wanted to use people 6 that were already hospitalized on your proposed study? 7 A. I think my best testimony is that I don't recall 8 what the gist of that conversation was. I sometimes talk and 9 come out with a bunch of ideas. 10 Q. Are you doing that right now, Doctor? 11 A. I don't remember what the conversation was about. 12 Q. You remember that the general subject matter was 13 restudying people who had became suicidal on fluoxetine; 14 correct? 15 MR. MYERS: Object to the form. 16 THE WITNESS: I remember having a conversation 17 about something of that kind. 18 Q. (By Ms. Zettler:) When you say "something of that 19 kind," what do you mean? 20 A. Of patients who -- to determine if patients would 21 become suicidal on Prozac. 22 Q. And it's your understanding that no such study was 23 performed? 24 A. I don't think we performed it. 25 Q. What did this person on the other end of the DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 61 DAVID L. DUNNER, M.D., VOLUME I 1 conversation say about that subject? 2 A. I don't recall. 3 Q. Do you recall the gist of the conversation? Was 4 your proposed study something that they were interested in? 5 MR. HARREL: I'm going to object to the form of the 6 question as mischaracterizing his testimony saying that he 7 proposed a study. 8 THE WITNESS: Could I have it repeated, please. 9 Q. (By Ms. Zettler:) Sure. With regards to the 10 subject of restudying people who had become suicidal while on 11 fluoxetine, did the person on the other end of that 12 conversation have -- strike that. 13 With regards to the conversation that you had 14 regarding restudying people who had become suicidal on 15 fluoxetine, was the person on the other end of that 16 conversation to your knowledge amenable to that study? 17 A. I don't know how to answer that. I don't know what 18 the other person felt. 19 Q. Well, what was your impression from the 20 conversation? Was it something that they seemed to be 21 interested in or was it something that they rejected during 22 the conversation? 23 A. I don't recall. 24 Q. How far in the planning stage did you get regarding 25 the proposed restudying of suicidality in people who use DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 62 DAVID L. DUNNER, M.D., VOLUME I 1 fluoxetine? 2 A. I don't know. We may have written a draft of a 3 protocol or sent an idea off to Lilly as a proposal. 4 Q. Do you have a specific recollection of doing that, 5 Doctor? 6 A. I have a vague recollection of doing that. 7 Q. If you had sent such a study or proposal to Lilly, 8 would you have kept a copy of that in your files? 9 A. For some time, but if we didn't do the study there 10 wouldn't be a copy. 11 Q. Do you have a document retention policy at the 12 University or a personal policy of document retention? 13 A. We get rid of paper quickly at our offices and we 14 try to keep the files trim. 15 Q. How quickly do you get rid of paper at your 16 offices? 17 A. Sometimes monthly, sometimes weekly. 18 Q. Were you sent any information by Lilly or anybody 19 else regarding a restudying of people who had become suicidal 20 on fluoxetine? 21 A. I don't recall. 22 Q. If you had been sent such information, would you 23 have retained that in your files? 24 A. Probably for a short period of time. 25 Q. To your knowledge, why was it that you did not DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 63 DAVID L. DUNNER, M.D., VOLUME I 1 pursue a study and restudy of suicidal patients on 2 fluoxetine? 3 A. I don't know. 4 Q. Were you told that such a study was not going to be 5 pursued by Lilly? 6 A. I don't know why they wouldn't pursue it. 7 Q. Was it a decision that you made not to pursue such 8 a study? 9 A. I think decisions like that would have been 10 something that we would not have made. So I mean, I don't 11 know the circumstances of why we didn't participate in the 12 study. 13 Q. Do you know if the study was ever done by Lilly or 14 anybody on behalf of Lilly? 15 A. No, I don't. 16 Q. Do you know that a study specifically was not done? 17 A. No, I don't. 18 Q. So it's your testimony that if a decision was made 19 not to conduct the study, it was not a decision that was made 20 by you; correct? 21 A. That is correct. 22 Q. When was the last time that you heard anything 23 about a proposed restudying of people who had become suicidal 24 while on fluoxetine? 25 A. I don't know. That phone call was probably -- I DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 64 DAVID L. DUNNER, M.D., VOLUME I 1 don't remember when that was. 2 Q. Other than that phone call, did you have any 3 contact whatsoever with Lilly or anybody on behalf of Lilly 4 with regards to such a study? 5 A. I don't think so. 6 Q. So from a 15-minute conversation with somebody at 7 Lilly over the phone, you felt compelled to possibly write a 8 proposal or a draft of a proposal to send to them regarding 9 such a study? 10 MR. MYERS: Object to the form. Leading. 11 Q. (By Ms. Zettler:) Is that your testimony? 12 MR. HARREL: I'm going to object to the form as far 13 as attempting to characterize it, because it wasn't clear 14 from his testimony which one came first. And so I think 15 you're mischaracterizing him. 16 THE WITNESS: You know, I don't have a full 17 recollection of the phone conversation. It most likely 18 involved would you be interested in doing some study like 19 this, send us a draft protocol. And so we did that. 20 Q. (By Ms. Zettler:) What kind of parameters did this 21 person at Lilly set out for you in this conversation with 22 regards to such protocol? 23 A. I don't know. I mean, I don't recall. 24 Q. Do you recall sending them a draft protocol? 25 A. I think I did. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 65 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Do you recall how the study was set up in your 2 draft protocol? For instance, was it in-patients? 3 A. Without trying to be misleading, I don't have full 4 recollection of the protocol. I think it started off with 5 people who have made suicide attempts and within the 6 hospital. And I don't recall the details after that. 7 Q. Would these be people who have made suicide 8 attempts in the hospital while on fluoxetine? 9 A. Not necessarily. I think that was how we were 10 going to get a lot of patients, because we see a lot of 11 people in our hospitals who make suicide attempts. 12 Q. Were these people who had made suicide attempts 13 while hospitalized while on antidepressants, not necessarily 14 fluoxetine? 15 A. I don't know. 16 Q. What other details do you recall regarding the 17 protocol? 18 A. I don't recall any other specific details. 19 Q. How about generally? 20 A. I think we costed it out at some horrendous amount 21 of money, I remember that, because it involved some hospital 22 stays and we built that into the cost. 23 Q. Did anybody at Lilly ever tell you that they 24 weren't willing to spend the money that you had costed it out 25 at to run such a study? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 66 DAVID L. DUNNER, M.D., VOLUME I 1 MR. MYERS: Object to the form. 2 THE WITNESS: I don't know. 3 Q. (By Ms. Zettler:) Did anybody at Lilly ever set 4 out reservations of any kind that they had with regards to 5 conducting such a study? 6 A. We frequently send protocols to Lilly for doing 7 something and don't hear back. That wasn't unusual. And I 8 think that's probably what happened in that instance. 9 Q. So it's your testimony that it would not be unusual 10 for you to have sent Lilly a draft of a rechallenge type 11 protocol and not heard back from them? 12 MR. MYERS: Object to the form. Leading. 13 THE WITNESS: Say it again, please. 14 Q. (By Ms. Zettler:) Sure. It's your testimony that 15 -- strike that. 16 First of all, it's your testimony that it's not 17 uncommon for you to have submitted a draft protocol for a 18 proposed study to Lilly and not heard back from them; 19 correct? 20 A. That's correct. 21 Q. Is it also your testimony now that you may have 22 submitted a draft rechallenge protocol of some type to Lilly 23 and may not have heard back from them about it? 24 A. Yeah. It may not have been a rechallenge protocol, 25 it just may have been a protocol dealing with people who had DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 67 DAVID L. DUNNER, M.D., VOLUME I 1 made suicide attempts. And that's a little different than a 2 rechallenge protocol. We see very few people who have been 3 suicidal on Prozac, and I know we couldn't have generated a 4 lot of patients just with that population. 5 (Short break) 6 Q. (By Ms. Zettler:) Doctor, I forgot one ground 7 rule. You understand that you're under oath; correct? 8 A. That's correct. 9 Q. And that you are sworn to tell the truth in this 10 matter; correct? 11 A. That's correct. 12 Q. Do you understand that the oath that you have taken 13 here today is the exact oath that you would take in a court 14 of law before a judge or jury? 15 A. I understand that. 16 Q. You also understand that perjury under oath in this 17 deposition carries the same penalties that perjury under oath 18 in a court of law before a judge or jury would carry; 19 correct? 20 A. I understand that. 21 Q. Is the person that you talked to at Lilly regarding 22 the restudying of people who became suicidal on fluoxetine 23 could have possibly been John Heiligenstein? 24 A. I suspect it was Charles Beasley. It could have 25 been John Heiligenstein, I don't know. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 68 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Have you ever heard the name Dan Masica? 2 A. I don't believe so. 3 Q. How about David Wheadon? 4 A. Yes, I have. 5 Q. Could it have been Dr. Wheadon? 6 A. I don't think so. 7 Q. How about Gary Tollefson; have you heard that name? 8 A. Yes, I have. 9 Q. Do you know Dr. Tollefson? 10 A. Yes, I do. 11 Q. Could it have been Dr. Tollefson that you spoke to? 12 A. I don't remember. 13 Q. To the best of your recollection, it was either 14 Charles Beasley or John Heiligenstein? 15 A. That's correct. 16 Q. If you had sent a draft protocol or a proposal for 17 a study of people who had become suicidal on fluoxetine, 18 would that have gone to anybody in particular at Lilly? 19 A. If we had sent it, it probably would have been sent 20 to the person I talked to. 21 Q. Which would have to the best of your recollection 22 been John Heiligenstein or Charles Beasley; correct? 23 A. Correct. 24 Q. Did you make any inquiry into Lilly's review of 25 your draft protocol or proposal? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 69 DAVID L. DUNNER, M.D., VOLUME I 1 A. I'm not sure I actually sent it so I don't recall 2 making an inquiry. 3 Q. Have you conferred with or acted as a consultant 4 with Eli Lilly in any way on the issue of suicidality other 5 than the study we've just been talking about? 6 A. Conferred with? 7 Q. Conferred with anybody at Eli Lilly. 8 A. Yes. 9 Q. On what occasions? 10 A. I don't recall. 11 Q. On how many occasions? 12 A. I don't recall. 13 Q. Do you recall any occasions specifically when 14 you've conferred with anybody at Eli Lilly with regards to 15 suicidality? 16 A. I don't recall specific occasions. 17 Q. What about generally? 18 A. I'm sorry? 19 Q. Do you recall generally conferring with anybody at 20 Eli Lilly on the issue of suicidality other than the study we 21 just talked about? 22 A. Yes. 23 Q. Can you tell me about what you do recall? 24 A. I don't recall specific instances. I know I've 25 talked to sales reps about the problem when I've met with DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 70 DAVID L. DUNNER, M.D., VOLUME I 1 them. 2 Q. I'm sorry, and had met with them? 3 A. When I met with them. 4 Q. Anybody else? 5 A. I've likely talked to everybody I know at Lilly at 6 some point about suicidality. 7 Q. Who do you know at Lilly? 8 A. Am I supposed to produce a list? 9 Q. As best you can, sure. 10 A. I know James Lancaster, Charles Beasley, Gary 11 Tollefson, Steve Paul, David Wong, Ray Fuller, John 12 Heiligenstein. 13 MR. SMITH: Leigh Thompson? 14 MR. HARREL: I'm going to object to two counsel 15 questioning at the same time, all right? If you want to 16 whisper to her or something, that's in your prerogative, but 17 I want one questioner at a time, please. 18 Q. (By Ms. Zettler:) Leigh Thompson? 19 A. I've met him. I don't know that conversing would 20 be -- I've just met him. 21 Q. Anybody else? 22 A. There may be others. 23 Q. Dr. Wheadon? 24 A. He's not at Lilly anymore. 25 Q. I'm talking about anybody -- strike that. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 71 DAVID L. DUNNER, M.D., VOLUME I 1 Anybody else who is no longer at Lilly that you 2 have conversed with? 3 A. Not specifically. 4 Q. How about Max Talbott? 5 A. That's not a familiar name. 6 Q. Steven Paul only recently became an employee of Eli 7 Lilly; is that correct? 8 A. That's correct. 9 Q. Did you know Dr. Paul before he became a Lilly 10 employee? 11 A. Yes, I did. 12 Q. In what capacity had you known Dr. Paul? 13 A. I've known Steve for probably over 20 years as a 14 co-scientist. 15 Q. How is it that you know Dr. Wong? 16 A. I've met him at meetings. 17 Q. Have you talked to Dr. Wong about the issue of 18 suicidality and the use of fluoxetine? 19 A. I don't think so. 20 Q. Who is James Lancaster? 21 A. He works for Eli Lilly and he's I believe the 22 product manager for fluoxetine. 23 Q. What conversations have you had with Mr. Lancaster 24 regarding fluoxetine and suicidality? 25 A. I've likely had many conversations with him about DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 72 DAVID L. DUNNER, M.D., VOLUME I 1 it. 2 Q. In what context have you had conversations with Mr. 3 Lancaster on that subject? 4 A. Pardon? 5 Q. In what context would you have conversations with 6 Mr. Lancaster on that subject? 7 A. In what context? 8 Q. Sure. 9 A. Well, I remember he sent me -- he called me about 10 the Teicher article and sent me a copy of it. 11 Q. Is Mr. Lancaster your detail person on fluoxetine 12 in your private practice? 13 A. No. 14 Q. You say he's a product manager on fluoxetine; 15 correct? 16 A. Correct. 17 Q. And is he in a sales position as far as you know or 18 marketing position? 19 A. He's in I guess a marketing position. I'm not sure 20 his exact title at Lilly. 21 Q. To your knowledge, is he a doctor? 22 A. He's not a physician. 23 Q. Why would you have a conversation with Mr. 24 Lancaster who is not a physician regarding the issue of 25 suicidality and the use of fluoxetine? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 73 DAVID L. DUNNER, M.D., VOLUME I 1 A. Because he was -- in his position at Lilly he 2 talked to a number of us about issues relating to fluoxetine. 3 Q. Why? 4 A. Why? He wanted advice, I guess. 5 Q. When you say he talked to a number of you related 6 to that issue, who are you referring to? 7 A. Well, there is a Lilly psychiatric advisory board 8 that I'm a member of. 9 Q. Is that a marketing psychiatric board or is that a 10 medical psychiatric board? 11 A. I'm not sure I know the difference. 12 Q. Earlier I asked you if you had acted as a 13 consultant with Lilly on the issue of suicidality, depression 14 or fluoxetine use, and you said not to the best of your 15 recollection. Do you recall that? 16 A. For suicidality, right. 17 Q. So are you now saying that your participation as a 18 member of the Lilly psychiatric board was acting as a 19 consultant on any of those issues or those subjects, 20 depression or suicidality? 21 A. I would consult with Lilly as part of that board. 22 I don't consult specifically on suicidal issues as part of 23 that board. I'm sorry if I've misinterpreted your question. 24 Q. How about depression? 25 A. Yes. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 74 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Other than depression, what other subjects do you 2 consult with Lilly as a part of that Lilly psychiatric board? 3 A. Anything they'd like advice about. They bring up 4 the topics. 5 Q. When did you first become a member of that board? 6 A. I'm not sure. 7 Q. Was it prior to the advisory committee that was 8 held in September of 1991? 9 A. Yes. 10 Q. Did you disclose your participation as a member of 11 the Lilly psychiatric board to the FDA or the committee prior 12 to that? 13 A. Yes, I did. 14 MR. HARREL: Try to allow her to finish her 15 question, if you would, please, and then you can answer, 16 because it'll run together. 17 Q. (By Ms. Zettler:) It makes it easier for her to 18 take it down. 19 In what way did you inform the committee of your 20 affiliation with Lilly on that regard? 21 A. It was part of my written disclosure. 22 Q. So as part of your activities as a member of the 23 Lilly psychiatric board, you discussed with Mr. Lancaster the 24 issues of suicidality and the use of fluoxetine; correct? 25 A. Could I have that again? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 75 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Sure. I'm just making sure that I understand your 2 testimony, Doctor. 3 As part of your activities as a member of the Lilly 4 psychiatric board, is your testimony that you spoke with Mr. 5 Lancaster on the issue of suicidality? 6 A. That's correct. 7 Q. Why is it that you're not sure that there's a 8 difference between the Lilly psychiatric board with regards 9 to being a marketing board as opposed to a medical type 10 board? 11 A. I'm not sure what you mean by the phrases. There 12 are medical people who come to those meetings from time to 13 time and marketing people who come to those meetings from 14 time to time. 15 Q. Do you know if that is a board that is set up by 16 the medical department at Lilly or the marketing department 17 at Lilly? 18 A. I don't know. 19 Q. As part of your participation on that board, have 20 you consulted with Lilly or conferred with Lilly regarding 21 marketing of fluoxetine? 22 A. Yes, I have. 23 Q. In what ways? 24 A. As part of being on that board, we help develop the 25 materials for teaching primary care physicians about DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 76 DAVID L. DUNNER, M.D., VOLUME I 1 fluoxetine and depression. We review information they bring 2 to us to get our opinion about brochures. It's an advisory 3 committee. We give them our advice. 4 Q. Were you paid or are you paid as a member of that 5 board? 6 A. I'm sorry, I interrupted you. 7 Q. Are you paid as a member of that board? Is that a 8 paid position? 9 A. It's a position that I get an honorarium from if I 10 go to the meeting. 11 Q. And that honorarium goes to you personally as 12 opposed to the University? 13 A. That's correct. 14 Q. How often are these meetings held? 15 A. Twice a year. 16 Q. Do you get paid for any time that you spend 17 reviewing information that's sent to you either before or 18 after such meetings? 19 A. No. 20 Q. How much is that honorarium? 21 A. It's currently about $2,000 a meeting. 22 Q. What questions did Mr. Lancaster have of you 23 regarding the issue of suicidality and the use of fluoxetine? 24 A. I don't recall. 25 Q. You don't recall any of the conversations that you DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 77 DAVID L. DUNNER, M.D., VOLUME I 1 had with Mr. Lancaster on that issue? 2 A. I don't recall specific questions. 3 Q. Why don't you give me generally what the substance 4 of the conversations were on that issue. 5 A. Well, one of the things I pointed out was that the 6 Teicher article which was one of the starting articles in 7 this area was a surprise to me, because I hadn't really seen 8 any patients on Prozac who developed suicidal thoughts or 9 made suicide attempts. In fact, my experience was just the 10 opposite. And that was what I conveyed to him, that it was a 11 surprise to me that someone could find patients who had 12 treatment-emergent suicidal behavior on Prozac when that 13 wasn't our experience. 14 After that article and some of the publicity that 15 ensued, I had two patients who had treatment-emergent 16 suicidal thoughts on Prozac, which has I think been my 17 experience. There may have been another one somewhere along 18 the way. 19 Q. Did you say you had that experience before or after 20 the Teicher article? 21 A. After. Not at all before. And I probably related 22 that information. I mean, it was my clinical experience 23 treating a lot of patients with Prozac that this was 24 something that wasn't common, if it occurred at all. 25 Q. Prior to the Teicher article, had you treated DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 78 DAVID L. DUNNER, M.D., VOLUME I 1 private patients, your own patients with fluoxetine or were 2 the patients that you treated with fluoxetine subjects of 3 clinical trials? 4 A. That's two questions. 5 Q. Okay. Prior to the Teicher article, did you treat 6 your own private patients with fluoxetine? 7 A. Yes. 8 Q. Obviously prior to the Teicher article you had 9 treated patients with fluoxetine during clinical trials too; 10 correct? 11 A. That's correct. 12 Q. These two patients without giving me their names or 13 any other information about them that you're talking about 14 that became suicidal after the Teicher article, were those 15 your private patients or were those patients on clinical 16 trials? 17 A. One was a patient who was private and one was a 18 patient who was referred to me because of the problem, but 19 she also had never been in a clinical trial. I wasn't 20 treating her at the time that this occurred. 21 Q. Did the suicidality in these two patients stop 22 after they were taken off of fluoxetine? 23 A. Yes. 24 Q. Did you rechallenge either of those patients? 25 A. Yes, I did. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 79 DAVID L. DUNNER, M.D., VOLUME I 1 Q. What happened? 2 A. One of them is still on Prozac and doing fine. And 3 the other one isn't on Prozac, but not because of an increase 4 in suicidal thoughts, it was more nausea or other side 5 effects that were bothersome to her, and she's now on another 6 medication. 7 Q. Initially when you rechallenged both of these 8 patients, did either of them become suicidal again? 9 A. No. 10 Q. Did either of them suffer increased agitation or 11 anxiety? 12 A. No. 13 Q. When you rechallenged these patients did you 14 hospitalize them? 15 A. No, I didn't. 16 Q. Did you prescribe concomitant sedatives? 17 A. I don't know. 18 Q. Do you know if either of these people were on 19 sedatives, concomitant sedatives and they eventually became 20 suicidal while taking fluoxetine? 21 A. I don't recall the details. I tend not to 22 prescribe a lot of sedatives. It was more likely than not 23 that they were not on sedatives. 24 Q. But you don't recall specifically? 25 A. I do not recall specifically. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 80 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Do you recall if they were on any of the 2 concomitant medications besides fluoxetine when you 3 rechallenged them? 4 A. They possibly were, but I don't recall 5 specifically. 6 Q. Do you recall what the diagnosis that each of those 7 patients had while they were initially put on fluoxetine? 8 A. One of the -- well, both of them had major 9 depression that was chronic. 10 Q. Any other diagnosis? 11 A. No. 12 Q. Did you change the diagnoses in either of those 13 patients? 14 A. No. 15 Q. What other medications were they probably on 16 concomitantly? 17 A. I don't know that they were. I know that we tried 18 both of them on other medications, and I'm not sure what they 19 were on when we restarted the Prozac. We restarted the 20 Prozac on both of them because the other medicine hadn't 21 worked. 22 Q. So after they became suicidal while on fluoxetine 23 you took them off the fluoxetine; correct? 24 A. Correct. 25 Q. You put them on other antidepressants; correct? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 81 DAVID L. DUNNER, M.D., VOLUME I 1 A. Correct. 2 Q. Neither of those antidepressants worked; correct? 3 A. That's right. 4 Q. And then you rechallenged them on fluoxetine; 5 correct? 6 A. That's correct. 7 Q. And you don't recall whether or not there were 8 concomitant sedatives that were prescribed with either of 9 these patients; correct? 10 A. That's correct. 11 Q. In your experience in your private practice, have 12 you had patients who have become agitated while taking 13 fluoxetine? 14 A. Can I correct you a little bit? 15 Q. Sure. 16 A. I don't have exactly a private practice. The 17 patients are all billed through the University. 18 Q. Okay. When I say that I just mean as opposed to 19 subjects in a clinical trial, okay? People that you treat 20 outside of the clinical trial process, okay? 21 A. Okay. 22 Q. With regards to those people, that group, just to 23 make it easier, I'd like to call them private patients, okay? 24 A. Okay. 25 MR. HARREL: Is that a term you're comfortable DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 82 DAVID L. DUNNER, M.D., VOLUME I 1 with? 2 THE WITNESS: Yeah. 3 Q. (By Ms. Zettler:) If you're not comfortable with 4 that we can find another term, but I'd rather not spend all 5 day going through a long description. 6 A. As long as the chairman doesn't see this and say he 7 doesn't have private patients, they are all billed through 8 the University. As long as we're clear about that. 9 Q. Okay. Well, we could ask Larry to mark that part 10 confidential, if you'd like that, so he doesn't see it. I'm 11 not here to get you in any kind of trouble with your boss. 12 With regards to this group of private patients, 13 have you ever seen a patient who has become agitated while on 14 fluoxetine? 15 A. Yes, I have. 16 Q. Have you seen patients whose agitation has 17 increased while on fluoxetine? 18 A. I want to say probably, but I can't recall a 19 specific case. 20 Q. On those people that have become agitated while on 21 fluoxetine, have you had to take any of those patients off of 22 fluoxetine? 23 A. Yes, I have. 24 Q. On how many occasions? 25 A. I'm going to guess a handful, about five. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 83 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Approximately how many private patients have you 2 treated with fluoxetine to date? 3 A. I don't know. The number is likely in the hundreds 4 if not thousands. 5 Q. And out of those hundreds or possibly thousands of 6 patients, you recall only taking approximately five people 7 off of the drug because of agitation; correct? 8 A. I think that would be about right. 9 Q. How about initially prescribing concomitant 10 sedatives to anybody who had become agitated on fluoxetine? 11 A. We've done that. 12 Q. I'm sorry. You have done that? 13 A. Yeah. Well, sedatives means what? 14 Q. Well, any drug with a sedating property to it. 15 A. Trazadone is a sedating antidepressant that's 16 frequently used if people have treatment-emergent insomnia, 17 and I frequently give Trazadone with Prozac if people have 18 treatment-emergent insomnia. But that's not a sedative. 19 Q. How about chlorohydrate? 20 A. Rarely use it. 21 Q. How about hypnotics such as Halcion? 22 A. Occasionally use them, but generally not with 23 Prozac. 24 Q. Why not? 25 A. Because I'd rather use either Trazadone or a DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 84 DAVID L. DUNNER, M.D., VOLUME I 1 sedating tricyclic. 2 Q. Why do you use two antidepressants on the same 3 person? 4 A. Well, if you have a treatment-emergent insomnia and 5 the patient gets a sedative then you're just providing some 6 sleep. If you add an antidepressant you're also doubling up 7 the antidepressant effect. 8 Q. So on these patients where you give a concomitant 9 Trazadone, is it your experience those people are reacting 10 positively, if they do react positively, to the fluoxetine or 11 to the Trazadone? 12 A. Who cares? 13 Q. That's not my question. The question is if you're 14 giving them fluoxetine and you feel it's necessary to give 15 them a concomitant additional antidepressant, why not see if 16 it's the Trazadone that is helping them and not the 17 fluoxetine? 18 A. We're talking about clinical practice rather than 19 research. I just care that the patient gets better. It's 20 something that works. 21 Q. Well, Doctor, if you have somebody that is on 22 fluoxetine and they have treatment-emergent insomnia under 23 which you feel like you have to prescribe an additional 24 concomitant tricyclic medication or antidepressant, why not 25 just take them off the fluoxetine if they are responding DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 85 DAVID L. DUNNER, M.D., VOLUME I 1 positively to the other antidepressant? 2 A. I don't know if they are responding positively to 3 the other antidepressant. 4 Q. If they are responding to the other antidepressant 5 positively, why don't you find that out so you don't have to 6 have them on two medications at the same time? 7 A. Sequence problem. If you have a patient on 8 fluoxetine and a week later they have worse insomnia, you 9 don't know that they are going to respond to anything else 10 until you try them on it. So I would rather add another 11 antidepressant and keep them on both of them and see if they 12 get better at two to four weeks later and then keep them on 13 that combination. 14 Q. Those people that you have fluoxetine on that have 15 experienced treatment-emergent insomnia, were they in your 16 opinion getting better on the fluoxetine to begin with? 17 A. Sometimes. 18 Q. What about in those cases where they were not? 19 A. Well, this is in the first week of treatment. Not 20 a lot of patients get better in the first week of treatment. 21 Some do. Very few patients come in at the first week of 22 fluoxetine treatment and say I'm worse. So either they were 23 not changed but had more insomnia or they were better. 24 Q. If they come in and say they're worse, why would 25 you keep them on the fluoxetine? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 86 DAVID L. DUNNER, M.D., VOLUME I 1 A. I didn't say I did. 2 Q. So if they come in and say they are worse then you 3 would take them off the fluoxetine? 4 A. I might. 5 Q. On how many occasions have you done that? 6 A. I haven't done it much. A handful. 7 Q. What percentage of your patients would you say have 8 been successfully treated with fluoxetine? 9 A. That's a hard question to answer. Because somebody 10 gets better during treatment doesn't mean it's the treatment 11 that got them better. But probably 80 percent of the people 12 I treat get better. 13 Q. Out of that 80 percent, how many of those people 14 percentage-wise have you had to administer concomitant 15 sedatives to? 16 A. Including antidepressants? 17 Q. Sure. 18 A. Perhaps a third to half. 19 Q. And of those 80 people that have been treated 20 successfully on fluoxetine, how many of those have been 21 treated with fluoxetine for longer than six months at a time? 22 A. I have a lot of people I keep on long-term 23 fluoxetine. I can't give you a number. 24 Q. More than half of those people? 25 A. Perhaps. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 87 DAVID L. DUNNER, M.D., VOLUME I 1 Q. How long is the onset of actual fluoxetine, to your 2 knowledge? 3 A. Antidepressant effect? 4 Q. Yes. 5 A. Generally two to four weeks. 6 Q. On those occasions that you have had to administer 7 and felt it was necessary to administer concomitant sedatives 8 including antidepressants with sedative properties, how long 9 have you kept the patients on the two medications together? 10 A. Generally for a long time. 11 Q. For the entire time you treated them with the 12 fluoxetine? 13 A. Often. 14 Q. Why? 15 A. Because they are better. 16 Q. The patients are better? 17 A. The patients are better. 18 Q. And still you don't know in those patients whether 19 or not they were responding positively to the fluoxetine or 20 to the concomitant antidepressant? 21 A. Except that the other drug is usually given in 22 very, very low doses and doses below where you often get 23 efficacy. I mean, 25 milligrams of Amitriptyline or 15 24 milligrams of Trazadone is usually not an effective dose of 25 treatment for depression. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 88 DAVID L. DUNNER, M.D., VOLUME I 1 Q. But it's effective to counteract the insomnia in 2 the fluoxetine patients; correct? 3 A. Correct. 4 Q. Is fluoxetine an activating or sedating drug? 5 A. I don't think it's particularly either. 6 Q. Besides nausea, what other adverse events have you 7 seen in your patients who have taken fluoxetine? 8 A. I probably have seen some skin rashes, more so 9 during clinical trials than later. And I'm not sure they 10 were fluoxetine skin rashes, but they occur during clinical 11 trials. 12 Q. Let's limit it just to your private patients right 13 now. 14 A. Okay. Insomnia, nausea, diarrhea, rare skin rash, 15 sometimes agitation, sometimes sedation. 16 Q. Irritability? 17 A. Not particularly, but that might be included under 18 agitation. 19 Q. Hostility? 20 A. No. 21 Q. Psychosis? 22 A. No. 23 Q. Nervousness? 24 A. Yeah. Sometimes people get anxious. I wouldn't 25 use the term nervous, but let's call it nervousness, anxiety DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 89 DAVID L. DUNNER, M.D., VOLUME I 1 occasionally. 2 Q. What's the difference between nervousness and 3 anxiety? 4 A. I'm not sure. 5 Q. Well, you seem to differentiate between the two in 6 your answer. 7 A. It was your term. 8 Q. Do you ever use the term nervousness in describing 9 a patient? 10 A. I use it more anecdotally than -- I would use the 11 term anxious more medically. 12 Q. Describe for me what a person who is anxious is 13 like. How do they manifest this anxiousness? 14 A. They can do that in various ways. They can be 15 pacing, hand wringing, overtly agitated looking at them, they 16 could be having sweaty palms, they can be complaining of a 17 variety of physical symptoms, having panic attacks. 18 Q. Is there a difference in your mind between 19 anxiousness and agitation? 20 A. Yes. 21 Q. What's the difference between those two? 22 A. Anxiety is more a mental state that can have a lot 23 of physical things going on with it, whereas agitation would 24 be more of a physical state which can have a mental state of 25 feeling anxious, but not necessarily. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 90 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Can you describe for me what a person who presents 2 to you as agitated would be like. 3 A. It would be likely having trouble sitting still, 4 standing in the room, hypervigilant, kind of looking around, 5 set off by noises easily. 6 Q. Have you heard the term akathisia? 7 A. Yes, I have. 8 Q. What is akathisia? 9 A. That's an inner restlessness. 10 Q. How would a person who is suffering from akathisia 11 manifest that condition? 12 A. Could I have the question repeated, please. 13 Q. Sure. If somebody came to you suffering from 14 akathisia, how would they manifest that condition? 15 A. Often by not being able to sit still, sometimes 16 with leg movements. Or typically something like this, but 17 you can't put that down on your tape. 18 Q. Bouncing your legs up and down? 19 A. Right. Sometimes complaining of feeling restless. 20 Q. Sounds sort of like agitation, doesn't it? 21 A. It can be similar to agitation. 22 Q. How would you differentiate between the two, as a 23 psychologist? 24 A. Again, agitation would be more of a physical thing 25 involving more than just leg movements, and it would be more DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 91 DAVID L. DUNNER, M.D., VOLUME I 1 in the context of looking at a patient. It's possible that 2 someone who had akathisia could be seen as being agitated. 3 Q. In fact, akathisia is commonly misdiagnosed as 4 nervousness or agitation, is it not? 5 A. I believe that's true. 6 Q. Have you had patients that have suffered from 7 akathisia while on fluoxetine? 8 A. I don't believe so. 9 Q. Earlier we talked about prescribing concomitant 10 sedatives including sedative tricyclic antidepressants. Have 11 you prescribed such medications to people that you felt were 12 anxious on fluoxetine as well as the agitated people? 13 A. Yes, I have. 14 Q. And what percentage of cases have you done that? 15 A. I think that was subsumed in that other percent 16 that I gave you. 17 Q. So you're talking about from I believe you said it 18 was a third to a half of the people that you had treated you 19 had given concomitant medications to sedatives; correct; 20 MR. MYERS: Object to the form. 21 THE WITNESS: Correct. 22 Q. (By Ms. Zettler:) Included in that one-third to 50 23 percent would be people who you felt were anxious on 24 fluoxetine as well as agitated; correct? 25 A. Correct, or had insomnia. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 92 DAVID L. DUNNER, M.D., VOLUME I 1 Q. How many of those people that you treated who were 2 anxious or agitated were also suffering from insomnia? 3 A. I don't know. Likely a high percentage. 4 Q. That seems to be something that kind of went hand 5 in hand with you, the agitation or the anxiousness? 6 A. Often, but not necessarily. 7 Q. How many people that you have treated with 8 fluoxetine have suffered from insomnia on a percentage-wise 9 basis? 10 A. Twenty percent. 11 Q. Why is it that you feel that fluoxetine is neither 12 an activating nor a sedating drug? 13 A. Well, it does both, but it does both less than the 14 time that it does neither. So most of the time you get 15 neither activation nor sedation. And you can treat people 16 who are anxiously depressed with fluoxetine, I've done that a 17 lot of times, with fluoxetine alone. You can't treat people 18 who have anxiety and insomnia and panic attacks with 19 fluoxetine and get everything better in four weeks. And, you 20 know, for the most part, you don't get a profile of either 21 agitation or sedation with a drug, you get neither. 22 Q. Would you agree with me that the majority of the 23 treatment-emergent side effects that you have seen with your 24 patients are stimulant type of side effects? 25 MR. MYERS: Object to the form. Leading. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 93 DAVID L. DUNNER, M.D., VOLUME I 1 MR. HARREL: I'm just going to state for the 2 record, I've allowed a lot of leading questions just to speed 3 this along. But when it's getting so many leading questions, 4 I suppose I'm not going to advise him not to answer, but it 5 just seems to me how are you entitled to lead this witness 6 under your rules? Certainly in the state of Washington I 7 don't know how you can lead him. 8 I hate to have the whole deposition not be valid 9 and do it over again. If he objects to leading, it's 10 probably right. How do you get to lead a witness that's -- 11 Dr. Dunner, it seems to me, should be asked non-leading 12 questions, and I guess I'm going to start complaining a 13 little bit. If he has to come back again because you asked 14 leading questions that are inappropriate, I'm going to ask 15 for terms to have to do that. So it seems to me with just 16 non-leading questions we would be a lot better off and then 17 we wouldn't have to do this again. 18 MS. ZETTLER: Well, first of all, this is getting 19 completely ridiculous with Larry interjecting his little 20 opinions and you jumping on the bandwagon. 21 Second of all, this is a deposition that is taken 22 essentially under the Rules of Federal Procedure which are 23 pretty much identical to the Kentucky rules, because Kentucky 24 has adopted the Federal Rules of Evidence, and this 25 deposition is taken as if it were an evidence deposition in DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 94 DAVID L. DUNNER, M.D., VOLUME I 1 this case. So if I were to call Dr. Dunner as an adverse 2 witness in my case, I could lead him all I wanted to, okay? 3 Second of all, I don't think my questions are very 4 leading. I think I'm asking him very few, if any, leading 5 questions. And you guys can make your objections if you'd 6 like, and if you'd like, we can even agree to reserve form 7 objections or objections as to leading, if you would like, 8 just to speed this along, if you're really concerned. 9 MR. MYERS: I'm not willing to do that. I intend 10 to make certain form objections including objections to 11 leading questions. I'll make them brief, but I feel it 12 necessary that I make such objections. 13 And all I can say is that under the Washington 14 rules or the Federal Rules or Kentucky rules, I'm not aware 15 that you've yet articulated a reason why you should be able 16 to ask this witness other than background and -- 17 MS. ZETTLER: Well, first of all, they are not 18 leading, that's your opinion. And you can make your 19 objection as you feel appropriate. 20 MR. MYERS: I will. 21 MS. ZETTLER: Second of all -- forget it, I've made 22 my record. Are you going to -- I mean, if you're going to 23 say that you're somehow not going to bring Dr. Dunner back 24 because you feel the questions that I've asked him are 25 leading, then I think that's fairly ridiculous. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 95 DAVID L. DUNNER, M.D., VOLUME I 1 And second of all, the rules that govern in this 2 case are the Kentucky rules, not the Washington rules. 3 MR. HARREL: What I'm saying is I don't understand 4 how you can establish him as an adverse witness, which you 5 said you've relied upon. What I'm saying is if you ask a 6 series of leading questions, to which Mr. Myers has objected 7 to some and not all, and I would say some are clearly 8 leading, all I'm saying is Dr. Dunner is here until noon 9 tomorrow, and you've already indicated you plan on doing it 10 again. 11 But all I'm saying is that if you in the future 12 need to redo a bunch of questions because they are in fact 13 leading and the Court rules that you can't use those, I'm 14 putting you on notice that we will certainly claim terms and 15 expenses and my fees and his fees for having to have 16 additional deposition that is really because it's then going 17 to be non-leading. 18 And, for example, if you bring him back again, if 19 you want to do it again, I would certainly reserve the right 20 to say to the Court she's doing it again because she first 21 asked all these leading questions and now she's got to ask 22 non-leading questions. And I don't think that's appropriate 23 and they should pay him a standard fee, which you've refused 24 to do so far. And so I'm just making that point for the 25 record that it would seem to be a lot more fair to this DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 96 DAVID L. DUNNER, M.D., VOLUME I 1 witness and save a lot of judicial time to just ask 2 non-leading questions. 3 MS. ZETTLER: I'll ask questions as I feel 4 appropriate. If you want to make your objections, you can 5 make them as you feel appropriate. 6 MR. HARREL: I'm not going to object to every 7 leading question because it's not my case and I don't have to 8 worry about trying the case, but I'm here to protect this 9 witness and I will do that to the best of my ability. And 10 you're now put on notice that I'm not going to object to a 11 whole lot of leading questions and I don't intend to. But 12 I'm putting you on notice that I'm not going to allow this 13 witness to be examined again purely because you've got to 14 eliminate the leading nature of your questions. 15 MS. ZETTLER: Could you read back the last 16 questions, please. 17 (Whereupon, the reporter read back the following: 18 "Q. Would you agree with me that the majority of 19 the treatment-emergent side effects that you have seen with 20 your patients are stimulant type of side effects?") 21 MR. MYERS: And I objected to the form as leading 22 and still do. 23 MR. HARREL: And clearly I'd say that that's a 24 leading question. 25 MS. ZETTLER: Well, let me change it. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 97 DAVID L. DUNNER, M.D., VOLUME I 1 Q. (By Ms. Zettler:) Are the majority of the adverse 2 events that you have seen in your patients stimulant type 3 adverse events? 4 A. No. 5 Q. Do you consider nausea a stimulant type adverse 6 event? 7 A. I do not. 8 Q. How about for nervousness? 9 A. Possibly. 10 Q. How about agitation? 11 A. Yes. 12 Q. How about anxiety? 13 A. Yes, possibly. 14 Q. How about insomnia? 15 A. Possibly. 16 Q. How about irritability? 17 A. Not necessarily. 18 Q. How is irritability not a stimulant side effect? 19 A. I don't know how to answer that question. 20 Q. Well, you say it's possibly not a stimulant-related 21 side effect; correct? 22 A. Say it again. 23 Q. Sure. You just testified that irritability is not 24 necessarily a stimulant-related side effect; correct? 25 A. That's right. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 98 DAVID L. DUNNER, M.D., VOLUME I 1 Q. In what ways is it not considered a 2 stimulant-related side effect? 3 A. It can occur in patients who have 4 psychomotor-retarded depressions, for example. People can be 5 irritable who are not agitated or in any way stimulated. 6 Q. What percentage of your patients have experienced 7 sedation while on fluoxetine? 8 A. Probably around 15 percent. 9 Q. 1-5? 10 A. 1-5. 11 Q. Have you had to administer any concomitant 12 medications to those people? 13 A. I don't think so. Well, sometimes we've asked them 14 to drink more caffeine. 15 Q. Have you done any research into the serotonin 16 system? 17 A. Yes. 18 Q. What type of research have you done into the 19 serotonin system? 20 A. I've done biological research into the serotonin 21 system. 22 Q. Have you published any of this research? 23 A. Yes, I have. 24 Q. Tell me about the research that you've done that 25 you've ultimately published. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 99 DAVID L. DUNNER, M.D., VOLUME I 1 A. We did some studies giving L-tryptophane to 2 patients with depression measuring spinal fluid, changes in 3 the metabolite of serotonin in the brain called 4 5-hydroxyindoleacetic acid, 5-HIAA. 5 Q. Can the body's production of serotonin be measured 6 by measuring this metabolite? 7 A. Theoretically, I guess. 8 Q. Tryptophan is an essential amino acid that the body 9 needs to produce serotonin; correct? 10 A. That's correct. 11 Q. And this 5-hydroxy -- I'm not even going to try to 12 finish the rest of it, this metabolite, we can break this 13 down to 5-HIAA; right? 14 A. That's correct. 15 Q. This metabolite 5-HIAA, is that a metabolite of 16 tryptophan or a metabolite of serotonin? 17 A. It's a metabolite of serotonin. 18 Q. In your research did you study the correlation 19 between L-tryptophane intake and the level of the metabolite 20 for serotonin? 21 A. Yes, we did. 22 Q. Did you find a correlation? 23 A. Yes, we did. 24 Q. What correlation? 25 A. We found that we could increase brain 5-HIAA at DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 100 DAVID L. DUNNER, M.D., VOLUME I 1 turnover levels by administering L-tryptophane to depressed 2 patients. 3 Q. And what impact did increasing the 5-HIAA turnover 4 levels have on depressed patients, if any? 5 A. None. 6 Q. Did you do similar studies on patients that were 7 taking fluoxetine? 8 A. No. 9 Q. Why not? 10 A. Why not? Those studies were done in the 1960s. 11 The methodologies have changed. Our interest in doing those 12 -- what we do has changed. We didn't have -- it's a 13 non-feasible study to give L-tryptophane in combination with 14 fluoxetine. 15 Q. Why is it not feasible to give fluoxetine and 16 L-tryptophane to study subjects? 17 A. It's reported to produce toxicity. 18 Q. Toxicity from what? 19 A. It's called the serotonin syndrome. 20 Q. What's the serotonin syndrome? 21 A. It's a clinical syndrome defined by having an 22 excess of serotonin characterized by sweating, 23 gastrointestinal problems, confusion that can apparently lead 24 to death. 25 Q. In your study of tryptophan patients with a DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 101 DAVID L. DUNNER, M.D., VOLUME I 1 correlation of increased 5-HIAA metabolite, did you see a 2 nugget of impact on the increase of that metabolite on 3 patients? 4 A. I don't understand your question at all. It 5 doesn't make any sense to me, Ms. Zettler. 6 Q. Okay, let me try it again. 7 You said earlier that you studied the serotonin 8 metabolite levels in people who you administered tryptophan 9 to; correct? 10 A. Correct. 11 Q. And you also testified earlier -- and if I'm wrong 12 please tell me -- that you didn't see any effect on these 13 peoples' depression by the increased turnover I believe you 14 said? 15 A. Well, we didn't see an effect of L-tryptophane 16 administration on the depressed status of unipolar depressed 17 patients. We also did spinal fluids and measured an increase 18 in serotonin brain turnover by an increase in cerebrospinal 19 fluid 5-HIAA. 20 Q. So in layman's terms -- and again, if I'm wrong 21 please correct me -- an increase in serotonin to the brain 22 didn't show any impact on a person's depression, at least 23 according to your research? 24 MR. MYERS: Object to the form. Leading. 25 THE WITNESS: I think that would be correct. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 102 DAVID L. DUNNER, M.D., VOLUME I 1 Q. (By Ms. Zettler:) Did you see any negative impact 2 on the increase of serotonin in the brain of these subjects 3 that you gave L-tryptophane to? 4 A. No one got worse. 5 Q. Did you see any toxicity? 6 A. Absolutely none. 7 Q. Do you have an understanding as to why patients who 8 take L-tryptophane while being on fluoxetine may experience 9 this toxicity or the serotonin syndrome that you talked 10 about? 11 A. No, I don't. 12 Q. What is your understanding of how fluoxetine works 13 on the serotonin system? 14 A. Fluoxetine is a selective serotonin reuptake 15 inhibitor. One of its effects is to block the reuptake of 16 serotonin back into the presynaptic nerve making it more 17 available to the postsynaptic nerve to fire off serotonergic 18 neurons. 19 Q. Have you ever seen any physiological or biological 20 research that in your mind proves that fluoxetine does have 21 that effect of blocking the reuptake of serotonin? 22 A. I think I have. It's probably in that blue book or 23 something. I mean, Ray Fuller -- a lot of people have done 24 this work. You know, I probably have. 25 Q. Have you seen human studies, biological studies or DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 103 DAVID L. DUNNER, M.D., VOLUME I 1 animal studies? 2 A. I've seen animal studies. There are other models, 3 but the platelet imipramine binding model for serotonin 4 reuptake, which I believe serotonin reuptake inhibitors also 5 affect. 6 Q. How would somebody measure in a human being 7 biologically or physiologically whether or not fluoxetine is 8 actually acting to block the uptake of serotonin to the 9 presynaptic neuron? 10 A. I think the platelet imipramine binding model might 11 be a good one to do that. I don't know if modern imaging 12 techniques are sufficient to do that nor do I know of anybody 13 who is doing it. That would be another possible way of doing 14 it. 15 Q. Could you measure the serotonin metabolite in the 16 spinal fluid? 17 A. Yes. 18 Q. If you were to measure the serotonin metabolite in 19 the spinal fluid and fluoxetine was acting as it is said to 20 act, what would you find in the spinal fluid, theoretically? 21 A. You might find no change because that isn't 22 measuring turnover. 23 Q. What do you mean when you say turnover? 24 A. Turnover is a term used to reflect the ability of a 25 compound to be renewed over a certain period of time. It DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 104 DAVID L. DUNNER, M.D., VOLUME I 1 would be -- the usual example is if you have a party and you 2 look in the room at any one time and there are five people 3 there, you don't know how many people attended the party in 4 the evening. The number of people who attended the party is 5 the turnover versus the cross-sectional level of something 6 which is the five people. 7 Q. How is the serotonin metabolite affected by 8 turnover? I mean, is the metabolite something that is 9 produced into the -- 10 A. The metabolite would be largely unchanged unless 11 you've blocked its outflow from the cerebrospinal fluid by 12 giving probenecid which is a drug used in the treatment of 13 gout which blocks acid transport across membranes. 14 5-hydroxyindoleacetic acid is an acid, and so its transport 15 out of the cerebrospinal fluid into the regular body would be 16 blocked by giving probenecid, and then you would measure an 17 accumulation. 18 Q. Would that be done on patients receiving 19 fluoxetine? 20 A. Could it be done? Yes. 21 Q. Has it been done, to your knowledge? 22 A. No. 23 Q. Does the blocking of the reuptake or uptake of 24 fluoxetine into the presynaptic nerve affect the body's 25 metabolizing of the serotonin? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 105 DAVID L. DUNNER, M.D., VOLUME I 1 MR. MYERS: Object to the form, because you said 2 uptake of fluoxetine and I think you meant to say uptake of 3 serotonin. 4 Q. (By Ms. Zettler:) You're right. 5 If fluoxetine blocks the uptake or reuptake of 6 serotonin, does that affect the amount of serotonin that's 7 metabolized? 8 A. I don't know. 9 Q. Have you done any physiological studies or testing 10 on patients receiving fluoxetine to see if there's some way 11 to measure the serotonin level or the serotonin activity in 12 such patients? 13 A. No. 14 Q. Have you seen animal studies that Lilly has done 15 that suggest that there is an initial shutting down or 16 down-regulation of serotonin system in animals once they are 17 administered fluoxetine? 18 MR. MYERS: Object to the form. It's leading and 19 it assumes facts that are not or never will be in evidence. 20 MR. SMITH: How can you say that, that they will 21 never be in evidence? 22 MR. MYERS: I know that. 23 MR. SMITH: It's incredible that you can say that 24 something will never be in evidence. 25 MR. MYERS: I know that. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 106 DAVID L. DUNNER, M.D., VOLUME I 1 MR. SMITH: It's astounding. 2 MR. MYERS: I know. 3 MS. ZETTLER: I warned you they were going to do 4 this all day. 5 THE WITNESS: Could I have it repeated? 6 (Whereupon, the reporter read back the previous 7 question.) 8 MR. MYERS: Same objection. 9 THE WITNESS: I don't know. 10 Q. (By Ms. Zettler:) You don't know if you've seen 11 it? 12 A. That's correct. 13 Q. Are you aware of that theory, that there is initial 14 shutting down of serotonin or serotonin activity? 15 MR. MYERS: Same objection. 16 Q. (By Ms. Zettler:) When people are receiving 17 fluoxetine? 18 A. I don't think so. 19 Q. Doctor, do you agree with the theory that 20 depression is related to a level of serotonin or the 21 serotonin activity in a person's brain? 22 A. Oh, that's a nice little question. Partly. 23 Q. What part do you agree with? 24 A. Well, it's a more complicated issue than that. 25 When I was being trained we didn't know about serotonin. We DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 107 DAVID L. DUNNER, M.D., VOLUME I 1 knew about dopamine and norepinephrine and so we had a lot of 2 theories that norepinephrine was related to depression. 3 Those theories have not generally withheld the test of time. 4 I think there's probably a better line of evidence 5 that serotonin, some alternation of serotonin metabolism is 6 somehow related to depression and it comes from a whole bunch 7 of different studies. But I don't know that it necessarily 8 explains all depressions or is sufficient to really explain 9 enough about depression that I would feel comfortable in 10 saying this is what we truly know. 11 Q. How is it that fluoxetine is successful in treating 12 some peoples' depression, then? 13 A. I don't know. 14 Q. Do you feel comfortable in prescribing medication 15 to people that you don't really know how it works? 16 A. We do it all the time. 17 Q. How much would you say in your practice of the 18 improvement that you've seen in people generally that you've 19 given antidepressants to is a placebo effect as opposed to 20 the drug actually working? 21 A. There is some placebo effect, and we've studied 22 that. And it would vary depending on the type of patient who 23 is being seen from a low percentage to a high percentage, 24 let's say from 10 or 15 percent to 60 or 70 percent depending 25 on the characteristics of the patient. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 108 DAVID L. DUNNER, M.D., VOLUME I 1 Q. What characteristics have you seen the higher 2 percentage of placebo effect in? 3 A. The higher percentage seems to occur in patients 4 with acute onset depressions who are recurrent. Patients who 5 often have seasonal depression or winter depression seem to 6 show a high placebo responsivity, perhaps higher than anybody 7 else in contrast to patients who have more chronic or 8 long-lasting depressions. 9 Q. What percentage of people have you seen with 10 seasonal depression that have had a placebo effect? 11 A. A high percentage. 12 MR. HARREL: I was going to object to the form of 13 the question because it was ambiguous, but if you understood 14 it. 15 THE WITNESS: A high percentage. 16 Q. (By Ms. Zettler:) Can you give me a percentage? 17 A. It would be in the 60 -- well, it would be in the 18 60 to 70 percent range probably. 19 Q. Of the 80 percent of the people that you have 20 successfully treated with fluoxetine, what percentage of 21 those people would you say were successfully treated because 22 of the placebo effect? 23 A. I don't have any way of telling that. 24 Q. With the benefit of your own research into the 25 area, what percentage would you estimate were responding to DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 109 DAVID L. DUNNER, M.D., VOLUME I 1 the placebo effect as opposed to the drug itself? 2 A. Considering that most of the people I see are 3 chronic and refractory depressions, I would say a low 4 percentage are responding to placebo because they don't have 5 the characteristics of placebo responders. 6 Q. Can you give me a percentage, a number? 7 A. A high percent of my patients are 8 treatment-resistant patients. I don't know that I could give 9 you a -- a half maybe. I don't know. I'm under oath. I 10 don't want to give you a false number. 11 Q. I'm just asking for an estimate. So you're saying 12 approximately half of the people that you have treated 13 successfully with fluoxetine have been successfully treated 14 because of the placebo effect? 15 MR. MYERS: Object to the form. 16 THE WITNESS: No. I'm saying that it's likely in 17 at least half of the patients I've successfully treated with 18 fluoxetine that there was minimal placebo effect. And it's 19 possible that another half that may have been appreciable of 20 placebo effect or course of illness effects. 21 Q. (By Ms. Zettler:) In other words, the illness just 22 got better on its own? 23 A. Correct. 24 Q. I asked you this earlier and I'm not sure I quite 25 got an answer to my question so I'm going to try it again. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 110 DAVID L. DUNNER, M.D., VOLUME I 1 Do you feel comfortable in prescribing a medication 2 to somebody when you're not really sure how it works? 3 A. We don't know how anything in psychiatry works. I 4 do it all the time. Yes, I feel quite comfortable. 5 Q. Are you satisfied with the state of the research on 6 fluoxetine's effect on the serotonin system? In other words, 7 is there something else that you'd like to see researched? 8 A. I don't think anything particularly comes to mind 9 offhand. 10 Q. Would you like to see any more biological or 11 physiological research done on patients who are on 12 fluoxetine? 13 A. I think it would be great if they did that. I 14 don't know that I would be particularly needful of them. 15 (Deposition convened for lunch at 12 noon and 16 reconvened at 1:20 p.m.) 17 Q. (By Ms. Zettler:) Doctor, do you know Dr. Teicher? 18 A. Yes, I do. 19 Q. Have you met him? 20 A. Yes, I have. 21 Q. Have you spoken to him? 22 A. Yes, I have. 23 Q. Have you ever discussed his study with him? 24 MR. MYERS: Before the doctor answers, let me just 25 object to the form in using the term study. I don't know DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 111 DAVID L. DUNNER, M.D., VOLUME I 1 that it's a study. 2 THE WITNESS: I don't think so. 3 Q. (By Ms. Zettler:) What is your opinion of Dr. 4 Teicher as a scientist? 5 A. I don't know that I have an opinion as a scientist. 6 I don't really know him well enough. 7 Q. What is his reputation, if you know, throughout the 8 psychiatric community? 9 A. I don't know that I'd care to speak for the 10 psychiatric community. 11 Q. Do you have any knowledge of what his reputation is 12 within that community? 13 A. I think it's likely mixed. 14 Q. Was it mixed before his article on emergent 15 suicidality and the use of fluoxetine came out, as far as you 16 know? 17 A. I don't know what his reputation was before that. 18 Q. Did you know Dr. Teicher before his article came 19 out? 20 A. Yes, I did. 21 Q. Had you met him before then? 22 A. Yes, I had. 23 Q. On what occasions did you meet with Dr. Teicher, if 24 at all, after his article came out? 25 A. There was one occasion -- well, two occasions. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 112 DAVID L. DUNNER, M.D., VOLUME I 1 Once he was at the FDA advisory board meeting on 2 antidepressants and suicidal behavior, and I did not 3 particularly talk to him that day. And the other was I was 4 presenting a poster at a medical meeting and he stopped by 5 and we chatted about the poster. 6 Q. And what was the poster? 7 A. It was on treatment-emergent antidepressant 8 thoughts during treatment with paroxetine. 9 Q. When you say thoughts, what do you mean? 10 A. It's in my CV. Can I look it up? 11 Q. Sure. 12 A. The title of the poster was "Reduced suicidal 13 thoughts and behavior (suicidality) with paroxetine." 14 Q. Can you tell me what page of your CV you're 15 referring to? 16 A. 25. 17 Q. Which number? 18 A. Number 126. 19 Q. And what was the results that you set forth in that 20 paper? 21 A. It was a poster. The study examined the worldwide 22 data base of paroxetine in depression compared with the 23 placebo treatment or reference compound treatment and looked 24 at a variety of suicidal measures including suicide attempts, 25 suicides and increase in ratings for suicidal thoughts. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 113 DAVID L. DUNNER, M.D., VOLUME I 1 And the findings were that these were all highest 2 with placebo treatment and lowest with paroxetine, 3 statistically significantly different than placebo treatment. 4 And in most cases the reference compound, standard 5 antidepressant treatment also was associated with a decrease 6 in suicidal behaviors, attempts, acts or thoughts. And if 7 anything, paroxetine tended to at some points be better than 8 the reference compounds also. 9 Q. When you say the reference compounds, what do you 10 mean? 11 A. Reference compounds were standard comparators that 12 were used in various studies. Generally since it was a 13 worldwide data analysis the studies included drugs available 14 in Europe that were not available here such as Biancerin or 15 Chlormipramine, imipramine in the United States. And I don't 16 know the other -- probably other tricyclic compounds in the 17 United States. 18 Q. Were there any other serotonin reuptake inhibitors 19 that were looked at besides paroxetine in that study? 20 A. Probably Anaphronyl was looked at as one of the 21 comparators, but the comparators were broken out by how much 22 they contributed to the data. 23 Q. Is Anaphronyl a selective serotonin reuptake 24 inhibitor? 25 A. No, it's not. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 114 DAVID L. DUNNER, M.D., VOLUME I 1 Q. It has serotonergic properties to it? 2 A. It has serotonin reuptake properties to it. 3 Q. Was fluoxetine a part of that study? 4 A. No, it was not. 5 Q. And just so I make sure I understand you, this was 6 not a double-blind-controlled study that you yourself had 7 conducted, this is a review of studies that had already been 8 published? 9 A. It was a review of non-published data on file at 10 SmithKline Beecham from double-blind placebo-controlled 11 trials. 12 Q. What suicidality scales did they use during those 13 trials, if you know? 14 MR. HARREL: Do you feel perfectly comfortable 15 discussing some other company's clinical studies you did? If 16 you do, that's fine. I just want to caution you. We're way 17 afield from the subpoena and we talked about keeping this 18 narrowed to what you feel comfortable with. So if she's 19 going to go down this path, there was some general ones 20 before, but if this is going to keep going, you just make 21 sure that you're comfortable with trade secrets of another 22 company. 23 Q. (By Ms. Zettler:) Let me ask you this, Doctor. 24 Did you discuss what rating scales were used in these various 25 studies that you reviewed? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 115 DAVID L. DUNNER, M.D., VOLUME I 1 A. Yes. 2 Q. And that was at a public industry meeting; correct? 3 A. No, it was at a closed conference. 4 Q. Closed conference meaning what? 5 A. Meaning that to get there you had to be a member of 6 the American College of Neuropsychopharmacology or an invited 7 guest. 8 Q. And this wasn't limited to people just at 9 SmithKline or who worked on behalf of SmithKline; correct? 10 A. That's correct. 11 Q. So other people theoretically from like Eli Lilly 12 could have been there if they met the qualifications of being 13 a member of the College; correct? 14 A. Correct. 15 Q. What suicidality rating scales were used in the 16 paroxetine studies that you reviewed? 17 A. I hope I have them all. It was the Hamilton 18 Depression Scale, Item 3; the Montgomery-Asberg Depression 19 Rating Scale, Item 10. It seems to me there was one other on 20 -- it might have been the SCL-90, but I'm not certain about 21 that, or SCL something, it's not 90 anymore. And then they 22 looked at frequency of suicide attempts and frequency of 23 actual suicides. 24 Q. And this was data that was generated during the 25 clinical trials performed on paroxetine; correct? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 116 DAVID L. DUNNER, M.D., VOLUME I 1 A. Correct. 2 Q. Were any scales specifically designed to rate 3 suicidality used in any of those studies, to your knowledge? 4 A. Well, the Hamilton Depression Scale and the 5 Montgomery-Asberg Scale measure suicidal behavior, although I 6 don't know that they were specifically designed to do that. 7 It was part of -- you know, it's an item on those rating 8 scales that was specifically designed to do that. 9 Q. My understanding of the Hamilton Scale and the 10 Montgomery Scale is that they are essentially designed to 11 rate depression; correct? 12 MR. MYERS: Object to the form. Leading. 13 THE WITNESS: I don't know what your understanding 14 of the scale is. 15 Q. (By Ms. Zettler:) Well, is it true that those 16 scales are essentially designed to rate depression as opposed 17 to specifically suicidality? 18 MR. MYERS: Same objection. 19 THE WITNESS: Those scales, you know, were designed 20 to measure depression as component parts, because each of 21 those items contribute to the severity scores. So they 22 measured both the severity of depression and specifically 23 suicidal thoughts or behaviors. 24 Q. (By Ms. Zettler:) Are there scales that have been 25 developed out there that are available to the scientific DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 117 DAVID L. DUNNER, M.D., VOLUME I 1 community that have been created specifically to rate 2 suicidality and suicidal ideation? 3 A. Other than the HAMD and the Montgomery, I don't 4 know. 5 Q. Do you believe that one question on a scale such as 6 a Hamilton Depression Rating Scale is sufficient to rating 7 suicidality in depressed patients? 8 MR. HARREL: While he's thinking about that 9 question, as you recall before this deposition started, we 10 asked that he be paid his expert witness rate. You said no, 11 he's only going to be a fact witness on fluoxetine. And we 12 after some discussion ultimately accepted your payment in 13 lieu of his rate. 14 It seems to me that you've gone far beyond fact 15 witness and are now asking him opinion testimony, and I think 16 he should be paid as an expert if you're going to get expert 17 opinions. You've gone from fluoxetine to SmithKline Beecham 18 products on into giving opinions about testing scales. So 19 you're two steps removed from him being a fact witness. As 20 you said, you wouldn't pay him his expert rate, so could you 21 explain to me why he should answer this kind of opinion 22 testimony two steps removed from the facts of this case? 23 MS. ZETTLER: Well, first of all, Mr. Harrel, I'm 24 aware that you aren't familiar with the facts of this case, 25 but the Hamilton Depression Rating Scale was used in the DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 118 DAVID L. DUNNER, M.D., VOLUME I 1 testing of fluoxetine and I'm sure that Dr. Dunner recalls 2 that. 3 Second of all, I never said that we weren't going 4 to ask him opinion testimony or opinions in this case. What 5 I said was that he was being subpoenaed as a fact witness. 6 Under the statutes here in this state as well as in Kentucky 7 as well as under the Federal Rules, we aren't obligated to 8 pay him anything other than the statutory fee, which we have 9 done. And we have also offered, generously I feel, $500 a 10 day for his testimony. 11 Third of all, Dr. Dunner himself has testified and 12 has requested through letter that we not pay him, that we pay 13 the University. So, therefore, I don't think that we're 14 talking about expert fees that are going to be paid directly 15 to Dr. Dunner in the first place if he wants us to make a 16 contribution of sorts to the University. 17 I don't think you have any standing to object to 18 the questioning that has gone on so far in this deposition. 19 And, frankly, under the case law that I've seen from this 20 state, you have no basis to object to him giving expert 21 testimony or requiring that we pay him a fee. Because even 22 if we called him as a treating physician and asked him for 23 opinion testimony, in this state we wouldn't have to 24 compensate him as an expert and you know it. 25 MR. HARREL: He's not a treating physician. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 119 DAVID L. DUNNER, M.D., VOLUME I 1 MS. ZETTLER: I'm saying even if he were a treating 2 physician and we were to call him and ask him questions based 3 on opinions then we do not have to pay him as an expert in 4 this case, expert fees. So if you're going to instruct him 5 not to answer these questions based on that, that's fine. If 6 not, stop cluttering up the record and wasting our limited 7 time with these kinds of non-objections. I'd appreciate that 8 so we can get this over with. 9 MR. HARREL: Number one, you're not entitled to 10 this witness's expert opinions for free, because he is an 11 expert, he testifies in many types of litigation and there's 12 a normal fee for that. Secondly, you're not calling him here 13 as a treating physician. 14 And third, you maintained you were going to call 15 him on factual matters, and I would request that you limit it 16 to that unless we discuss the expert fee that you'd be 17 willing to pay him. 18 MS. ZETTLER: Well, we're not paying him as an 19 expert. We have not subpoenaed him as an expert, we 20 subpoenaed him as a fact witness. The expert testimony or 21 the opinion testimony that we may ask him about is directly 22 related to his experiences with Eli Lilly and Company and 23 with regards to fluoxetine. 24 MR. HARREL: I thought we were on SmithKline 25 Beecham and one of their products. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 120 DAVID L. DUNNER, M.D., VOLUME I 1 MR. SMITH: No, where we are is the doctor has 2 testified that he had a conversation with Martin Teicher. 3 MR. HARREL: Just a second. 4 MR. SMITH: Let me finish my statement, Counsel. 5 MS. ZETTLER: He has a right to make a record here 6 too, Arley. 7 MR. HARREL: Well, I don't think he has any right 8 to even be here, but I've let him sit in and I've let him 9 object. We haven't gotten any subpoenas in the federal MDL 10 case. 11 MR. SMITH: I've noticed it in the MDL anyway. But 12 the point is is that he was asked questions concerning his 13 discussions with Dr. Teicher. He said he discussed a poster 14 with Dr. Teicher concerning the SmithKline studies and his 15 poster in connection with the SmithKline antidepressant, so 16 this is all legitimate inquiry. I do feel that you're being 17 obstructive and wasting our limited time in making these 18 objections. 19 MR. HARREL: I'll just state for the record that 20 you need to stick to this witness's facts if you're not going 21 to pay him as an expert witness. And you need to stick to 22 facts and not get what I feel are free opinions from an 23 internationally-known psychiatrist. You're not entitled to 24 free opinions from him without retaining him and paying for 25 fees. And so I'll ask you to stick to the factual basis DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 121 DAVID L. DUNNER, M.D., VOLUME I 1 about what you've said you've subpoenaed him for in this 2 case. 3 Q. (By Ms. Zettler:) Do you recall the question, 4 Doctor? 5 A. No, I don't. 6 MS. ZETTLER: Could you read it back, please. 7 (Whereupon, the reporter read back the following: 8 "Q. Do you believe that one question on a scale 9 such as a Hamilton Depression Rating Scale is sufficient to 10 rating suicidality in depressed patients?") 11 THE WITNESS: I think the Item 3 of the HAMD is 12 sufficient to assess suicidal behavior and suicidality in 13 depressed patients. 14 Q. (By Ms. Zettler:) Do you know of the MSSIR scale? 15 A. Pardon me? 16 Q. The MSSIR scale. 17 A. Can you spell that out for me? 18 Q. Sure. 19 A. I mean, I know the letters. What does it stand 20 for? 21 Q. That's what I'm trying to remember. Do you 22 remember? 23 MR. SMITH: Don't look at me. 24 Q. (By Ms. Zettler:) Have you heard of the Beck 25 Suicidality Scale? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 122 DAVID L. DUNNER, M.D., VOLUME I 1 A. I've heard of the Beck Depression Scale. I don't 2 know that I've heard of the Beck Suicidality Scale. 3 Q. I'll find it at the break. 4 So what did Dr. Teicher say about your poster? 5 A. He liked it. 6 Q. Did he have any specific comments about it? 7 A. Yes. 8 Q. What were those comments? 9 A. I can't remember them verbatim, but basically he 10 thought the analysis was quite impressive. 11 Q. Anything else that he said about the analysis? 12 A. I can't recall. 13 Q. You have done a number of clinical trials on 14 fluoxetine on behalf of Eli Lilly; correct? 15 A. Yes, I have. 16 Q. And the University has been given grants as a 17 result of your conducting or participating in those clinical 18 trials, has it not? 19 A. Yes. 20 MR. MYERS: Object to the form. Leading. Ask him 21 direct questions, Counsel. 22 Q. (By Ms. Zettler:) You were also a member of Lilly 23 psychiatric advisory board; correct? 24 A. Yes, I am. 25 Q. And you've already testified that you were paid an DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 123 DAVID L. DUNNER, M.D., VOLUME I 1 honorarium for attending meetings of that committee; correct? 2 A. That is correct. 3 Q. You've also acted as a consultant to Eli Lilly 4 employees on issues of suicidality and depression, have you 5 not? 6 A. The term consultant means what? I mean, how are we 7 using that term? 8 Q. Do you have an understanding of what the word 9 consultant means? 10 A. Well, I mean, I've talked to people about it. I 11 don't know if consultant means paid or consultant means just 12 giving advice. 13 Q. Paid or unpaid, have you acted as a consultant? 14 A. If you talk about consultants being paid or unpaid, 15 I've acted as a consultant with people employed by Eli Lilly 16 regarding depression and suicidal behaviors. 17 Q. Do they call you on a fairly regular basis to get 18 your advice on various issues related to depression and 19 suicidality? 20 A. No. 21 Q. How often have people from Lilly contacted you to 22 get your advice on those subjects? 23 A. A handful of times. Four or five times. I don't 24 know. I mean -- 25 MR. HARREL: I'm just -- go ahead and finish. Are DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 124 DAVID L. DUNNER, M.D., VOLUME I 1 you finished? 2 THE WITNESS: Yeah. 3 MR. HARREL: I'm troubled by your use of the term 4 consultant, paid or unpaid. I thought you'd used the word 5 consultant earlier in this deposition. And when you start 6 talking about consultants on an unpaid basis, I think that's 7 getting pretty broad and makes it pretty ambiguous in some of 8 your earlier terms. I'm just stating that for the record. 9 MS. ZETTLER: Are you making an objection? Is this 10 some sort of question, Arley, or are you just making a speech 11 for the record? 12 MR. HARREL: Well, you're creating some ambiguity 13 and perhaps some ambiguity in prior questions. 14 MS. ZETTLER: I think if Dr. Dunner has a problem 15 with my question he can tell me and I'll rephrase it. And if 16 you want to make a specific objection to a specific question, 17 fine, but I object to you wasting our time by making 18 speeches. 19 Q. (By Ms. Zettler:) What is your understanding of 20 what the word consultant means, Doctor? 21 A. Usually it means someone who is paid to give 22 advice. 23 Q. Well, let's use your definition, is that okay? Can 24 we use that definition as a consultant? 25 A. We can use that definition. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 125 DAVID L. DUNNER, M.D., VOLUME I 1 Q. And you've already testified that you as a member 2 of the advisory board at Eli Lilly, the psychiatric advisory 3 board, have been paid to give your advice under that 4 auspices; correct? 5 MR. MYERS: Object to the form. Leading. 6 THE WITNESS: Could you restate that, please. 7 Q. (By Ms. Zettler:) Sure. You've already testified 8 in this deposition that you are a member of the Lilly 9 psychiatric advisory board; correct? 10 A. Correct. 11 Q. And as a member of that board you were paid an 12 honorarium? 13 MR. HARREL: I'm going to say asked and answered. 14 You talk about wasting time. I think that's the third or 15 fourth time you've asked that same question, unless you have 16 some others. So I object as asked and answered and 17 repetitive. 18 MR. MYERS: I join in that. He has answered that a 19 few times. 20 THE WITNESS: Correct. 21 Q. (By Ms. Zettler:) And as part of your function on 22 that advisory board, you give them advice on various issues 23 related to suicidality and depression; correct? 24 MR. MYERS: Objection. Leading. 25 THE WITNESS: I give them advice on whatever they DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 126 DAVID L. DUNNER, M.D., VOLUME I 1 ask me to give advice about. 2 Q. (By Ms. Zettler:) So would you consider yourself a 3 consultant in that position? 4 A. Yes. 5 Q. Any other situations such as that where you would 6 consider yourself a consultant for Eli Lilly? 7 A. I'm not sure what "such as that" means. 8 Q. Such as the advisory committee or the advisory 9 board function that we've just discussed. 10 Any other situations, Doctor, where you get paid 11 for giving advice to Lilly employees? 12 MR. HARREL: Object to the form of the question as 13 compound. 14 THE WITNESS: It's a vague question. I guess it's 15 yes. 16 Q. (By Ms. Zettler:) What situations have you been 17 paid to give advice to Lilly employees other than the 18 advisory board that we just talked about? 19 A. Before Prozac was launched I was part of a group 20 that came to Indianapolis that was presented with data 21 related to Prozac, and we discussed things about the drug and 22 gave our opinion about things about the drug at that time. I 23 was paid for that. 24 Q. How much were you paid for that? 25 A. I don't remember. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 127 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Was it more than $2,000? 2 A. No. 3 Q. When you go to these meetings for the psychiatric 4 advisory board that you work with at Lilly, are you paid your 5 expenses on top of your honorarium? 6 A. The shape of the question, I'm rephrasing, is it's 7 not at Lilly. 8 Q. Well, I meant for Lilly. Let me ask it again. 9 These advisory board committee meetings that you 10 attend and you get a $2,000 honorarium for, above and beyond 11 the honorarium, are your expenses to travel to these 12 committee meetings paid for? 13 A. Yes. And it's only $2,000 recently. It wasn't 14 that in the past. 15 Q. And these are once a year, I think you testified to 16 earlier? 17 A. I testified that they occurred twice a year. 18 Q. And how long have these been going on? 19 A. I don't know. 20 Q. Who is paying for your lawyer today? 21 A. As far as I know, I have a contract with Mr. 22 Harrel. 23 Q. Are you going to pay for it personally or is 24 somebody at Eli Lilly going to pay for it? 25 A. As far as I know, I'm paying for it personally. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 128 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Why is there a question in your mind? 2 A. Because I don't have any other arrangements that 3 say I'm going to do otherwise. 4 Q. Has Lilly offered to indemnify you or represent you 5 in any way related to liability that you may incur as a 6 clinical investigator on fluoxetine? 7 A. Yes, they have. 8 Q. Have you ever had to take them up on that offer? 9 A. No, I haven't. 10 MR. HARREL: So there's no misunderstanding, for 11 the record, I've asked Mr. Myers and his law firm on behalf 12 of Dr. Dunner that his legal fees be reimbursed by Eli Lilly, 13 and it's my understanding that they are going to do that. So 14 I don't know that Dr. Dunner is privy to all that. Once Dr. 15 Dunner called me, I asked that they do that, because it 16 seemed to me it was related to Eli Lilly, at least the grants 17 he did. So they've indicated that they would reimburse him 18 for his legal fees and expenses. 19 Q. (By Ms. Zettler:) Other than reimbursing for legal 20 fees and expenses as your lawyer just set out, has Lilly 21 agreed to pay you anything for your time in coming to these 22 depositions? 23 A. No, they haven't. 24 Q. Have you asked them? 25 A. No, I haven't. I'll ask you. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 129 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Has anybody? 2 MR. HARREL: And she refused. 3 Q. (By Ms. Zettler:) Has anybody at Lilly asked you 4 to render expert testimony of any kind in this case? 5 A. No. 6 Q. Are you familiar with the Joseph Wesbecker 7 incident? 8 A. Not very much. 9 Q. What do you know about that incident? 10 A. Somebody killed people and suicided, and he was 11 treated with -- he had a complicated psychiatric disorder and 12 was treated with a bunch of drugs, one of which was Prozac. 13 And it happened in Kentucky, I guess. 14 Q. Where did you get that information from? 15 A. Newspapers. 16 Q. How about the advisory committee meeting that was 17 held by the FDA in September of 1991? Did you get any of 18 that information from anybody involved with that meeting? 19 A. I don't recall -- I mean, it could have been 20 brought up at that meeting. I don't specifically recall it 21 having been brought up. There was a lot brought up at that 22 meeting from public testimony. 23 Q. The studies that you conducted for Lilly that were 24 paid for to the University by Lilly, do you draw a salary 25 from those grants? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 130 DAVID L. DUNNER, M.D., VOLUME I 1 A. No, I do not. 2 Q. You've never drawn a salary from a grant that has 3 been provided to the University on behalf of a drug company? 4 A. That is correct. 5 Q. You also told us earlier that you speak on a 6 regular basis on behalf of Eli Lilly; is that correct? 7 MR. MYERS: Object to the form. 8 THE WITNESS: Is regular the right word? I don't 9 know that I would use the term regular. 10 Q. (By Ms. Zettler:) Do you occasionally speak for 11 them? 12 A. Yes. 13 Q. And are you paid for speaking for Lilly? 14 A. Yes. 15 Q. And you also told us, I believe, that when you were 16 going through the slides and other documents that you brought 17 with you today that you're speaking for Lilly on Thursday of 18 this week; correct? 19 A. No, that's incorrect. I'm speaking to residents at 20 our Department of Psychiatry as part of my job as a teacher 21 in the Department of Psychiatry. I'm not getting paid for 22 that except that that's how I earn my salary. 23 Q. (By Ms. Zettler:) And the information or at least 24 that information that is included in the slides that you're 25 going to use during that lecture were provided to you by Eli DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 131 DAVID L. DUNNER, M.D., VOLUME I 1 Lilly; correct? 2 MR. MYERS: Object to the form. Leading. 3 THE WITNESS: Some of the slides that I will 4 present at that talk will come from Lilly. 5 Q. (By Ms. Zettler:) On what occasions have you 6 spoken for Lilly? 7 A. Numerous. 8 Q. Numerous times? 9 A. Numerous times. 10 Q. Approximately how many times have you been a 11 speaker for Lilly? 12 A. I couldn't give you a number. 13 Q. More than 100? 14 A. I don't know. 15 Q. Less than 100? 16 A. I don't know. 17 Q. More than 50? 18 A. Probably more than 50. 19 Q. On those occasions are you paid by Lilly? 20 A. Sometimes. 21 Q. On what occasions are you paid by Lilly? 22 A. If the talk is arranged by Lilly people and they've 23 contacted me directly to do a talk. 24 Q. Can you tell me any of those times that you 25 remember where you've been paid by Lilly to give a talk? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 132 DAVID L. DUNNER, M.D., VOLUME I 1 A. I gave a talk to some primary care physicians in 2 Bellevue using that stuff, one of those white binders. It 3 was in the fall sometime. 4 Q. How much were you paid for that speaking 5 engagement? 6 A. I think it was $1,000. 7 Q. Were your travel expenses paid? 8 A. Yes, they were. 9 Q. Any other occasions that you recall specifically 10 where you were paid for a speaking engagement by Lilly? 11 A. I've given a number of talks where I've been paid 12 by Lilly. You know, without the specific topic in front of 13 me -- I've talked for five different drug companies, Ms. 14 Zettler. I would hate to perjure myself by saying that I 15 gave a talk that Lilly sponsored when someone else sponsored 16 it. 17 Q. Doctor, you're only going to perjure yourself if 18 you knowingly lie under oath. 19 What I'm asking for is your best estimate, the best 20 that you can recall. 21 MR. HARREL: You don't have to guess, Doctor, and 22 if you don't recall you don't have to say so. If you can 23 give her your best estimate, fine, but you don't have to 24 guess. 25 THE WITNESS: Could you repeat the question. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 133 DAVID L. DUNNER, M.D., VOLUME I 1 Q. (By Ms. Zettler:) I'm just trying to get an idea 2 of how many times -- a best estimate of how many times you 3 have spoken as a paid speaker paid by Lilly. 4 A. More than 50. 5 Q. Have you spoken at Lilly-sponsored seminars? 6 A. Yes, I have. 7 Q. And on those occasions when you speak at 8 Lilly-sponsored seminars, are you paid to speak at those 9 seminars? 10 A. Yes, I am. 11 Q. How did you first become aware of Dr. Teicher's 12 article? 13 A. I think it was Mr. Lancaster sent it to me, and 14 that was a few days before it was published. 15 Q. Do you know how Mr. Lancaster got ahold of a copy 16 of the article before it was published? 17 A. No, I don't. 18 Q. When you participated in the conducting of the 19 clinical trials on fluoxetine you acted at Lilly's direction; 20 correct? 21 MR. MYERS: Object to the form. Leading. 22 THE WITNESS: I don't understand what "at Lilly's 23 direction" means. 24 Q. (By Ms. Zettler:) Well, you conducted those 25 studies according to Lilly's protocols, did you not? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 134 DAVID L. DUNNER, M.D., VOLUME I 1 MR. MYERS: Same objection. 2 THE WITNESS: We conducted the study in accordance 3 with the protocol that was supplied to us by Eli Lilly, yes. 4 Q. (By Ms. Zettler:) And that protocol set forth a 5 patient criteria as far as inclusion and exclusion; correct? 6 A. Yes. 7 MR. MYERS: Object to the form. 8 Q. (By Ms. Zettler:) It also set forth how the study 9 drug was to be administered, did it not? 10 MR. MYERS: Object to the form. Leading. 11 THE WITNESS: It gave doses and daily doses. 12 Q. (By Ms. Zettler:) It also directed how forms were 13 to be filled out to gather information from those patients, 14 did it not? 15 MR. MYERS: Object to the form. Leading. 16 THE WITNESS: Actually, the protocol didn't do 17 that. 18 Q. (By Ms. Zettler:) They provided you with forms to 19 fill out? 20 MR. MYERS: Same objection. 21 Q. (By Ms. Zettler:) Correct? 22 A. Lilly provided forms for us to fill out. 23 Q. And they also directed you on how to submit that 24 information to Lilly, did they not? 25 MR. MYERS: Objection to the form. Leading. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 135 DAVID L. DUNNER, M.D., VOLUME I 1 MR. SMITH: Do you want a running objection? 2 MR. MYERS: No. 3 THE WITNESS: They went over how to fill out the 4 forms and how they were to be finally sent to Indianapolis. 5 Q. (By Ms. Zettler:) If something was to be done that 6 was outside the protocol that was set up by Lilly, was that 7 something that you could do on your own or did you have to 8 get approval from Lilly? 9 A. If Lilly set up something outside or if we set up 10 something outside? 11 Q. If you wanted to deviate from the protocol in any 12 way, could you do that without Lilly's approval? 13 A. No. 14 Q. Have you talked with anybody at Eli Lilly prior to 15 this deposition about this deposition? 16 A. Yes. 17 Q. Who did you talk to? 18 A. An attorney there. 19 Q. What's that attorney's name? 20 A. I don't remember. 21 Q. Male or female? 22 A. I don't remember. 23 Q. Kurt Oltmans? 24 A. That's a familiar name, but I don't know that he's 25 the one that I talked with. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 136 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Jim Burns? 2 A. That's not a familiar name. 3 Q. When did you talk to this attorney? 4 A. The day I got the subpoena. 5 Q. Did you call that attorney or did that attorney 6 call you? 7 A. I called that attorney. 8 Q. Why did you call him? 9 A. Because I had not the faintest idea what Fentress 10 or Shea was all about, but the Appendix A had Eli Lilly all 11 over it and I figured they might know what it was all about. 12 Q. What did you say to this attorney? 13 A. I said I just got this subpoena, what is this all 14 about. 15 Q. And what did the attorney say? 16 A. He said that it was about the Westbecker matter and 17 that they had been told that some of the clinical 18 investigators were going to be subpoenaed, and that another 19 Lilly attorney -- I'm sorry, another attorney who I think 20 represents Lilly but I don't know if she works for Lilly, I 21 should call her. 22 Q. What was her name? 23 A. Thurman. 24 Q. Do you remember where this female attorney was 25 located? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 137 DAVID L. DUNNER, M.D., VOLUME I 1 A. She had a southern accent. 2 Q. Could it have been Atlanta? 3 A. It could have been, I don't know. 4 Q. Did you call that attorney? 5 A. Yes, I did. 6 Q. What did that attorney tell you? 7 A. Actually, she asked for me to fax the subpoena to 8 her, which I believe I did. And that was more or less the 9 extent of our conversation. 10 Q. Did you talk to anybody else about this case prior 11 to this deposition? 12 MR. HARREL: Anybody else other than me? 13 Q. (By Ms. Zettler:) Besides your attorney. 14 A. Yes. 15 Q. Who? 16 A. My wife. 17 Q. What did you talk to your wife about? 18 A. About getting subpoenaed on the night of our 19 wedding anniversary at home. 20 Q. It wasn't intentional, Doctor. I hope you 21 understand that. 22 A. No, I don't. 23 Q. Anything else that you talked about with your wife 24 about the subpoena or the case? 25 MR. HARREL: I'm going to caution you, Doctor, in DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 138 DAVID L. DUNNER, M.D., VOLUME I 1 the state of Washington there's an interspousal privilege, 2 and I don't know quite why she's asking these questions. And 3 I don't have it in front of me, I don't know exactly what the 4 privilege allows. But if there's anything you feel 5 uncomfortable with, I could probably get a law book around 6 here and look up the interspousal privilege. Because there 7 is one in the state of Washington, and in general you don't 8 have to talk about what you told your wife. So unless we're 9 almost at the end of what you told her, if you feel 10 uncomfortable about it, we can adjourn and look that up. 11 Because I don't want you to be without advice that there is a 12 privilege. 13 THE WITNESS: I've kept her aware of the progress 14 of this matter. 15 Q. (By Ms. Zettler:) Other than the two attorneys you 16 talked about earlier and your wife, have you talked with 17 anybody else about this case? 18 A. Yes, I have. 19 MR. HARREL: Other than Arley Harrel? 20 MS. ZETTLER: Right. 21 MR. HARREL: And people in our office? 22 THE WITNESS: Yes. 23 Q. (By Ms. Zettler:) Who? 24 A. The University attorney. 25 Q. Anybody else? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 139 DAVID L. DUNNER, M.D., VOLUME I 1 A. Yes. 2 Q. Who? 3 A. The chairman of our department. 4 Q. Anybody else? 5 A. Yes. 6 Q. Who? 7 A. A psychologist who is also an attorney with the bar 8 association. 9 Q. Who is that? 10 A. His name is Andy Benjamin. 11 Q. Who is the chair of your department? 12 A. Dr. Gary Tucker. 13 Q. Who is the University attorney that you talked 14 with? 15 A. Mr. Steven Milem. 16 Q. Milo? 17 A. M-i-l-e-m. 18 Q. Anybody besides Mr. Milem, Dr. Tucker and Dr. 19 Benjamin? 20 MR. HARREL: Object to the form of the question. 21 It's vague. Now you've got your whole list of people and now 22 you've made an all-encompassing one excluding all the others. 23 Q. (By Ms. Zettler:) Have you talked to anybody else 24 besides your attorney and the people that you've already 25 listed today? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 140 DAVID L. DUNNER, M.D., VOLUME I 1 A. Yes, I have. 2 Q. Who? 3 A. Some friends. 4 Q. Specifically which friends? 5 A. Do you want their names? 6 Q. Yes. 7 A. Mr. and Mrs. Alexandro. 8 Q. Alexandro? 9 A. Right. 10 MR. HARREL: Just for the record, Counsel, you're 11 complaining about wasting time. You're talking about his 12 friends. It seems to me that that's not a very fruitful 13 expenditure of time in this deposition. 14 MS. ZETTLER: I think you're making a major 15 assumption that's all he said. 16 Q. (By Ms. Zettler:) Anybody else that you've talked 17 to? Strike that. Other friends? 18 A. Yes. 19 Q. Who? 20 A. My brother-in-law. 21 Q. What's your brother-in-law's name? 22 A. Bill Zolbert. 23 Q. Anybody else from Eli Lilly that you've talked with 24 regarding the deposition? 25 A. I got a phone call from an attorney from Eli Lilly, DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 141 DAVID L. DUNNER, M.D., VOLUME I 1 I'm not sure I remember his name, about this. 2 Q. When did that phone call occur? 3 A. Last Friday. 4 Q. What was the subject matter besides more 5 specifically than this deposition? 6 A. Well, he was the person who suggested that I call 7 Mr. Harrel. 8 Q. Did he specifically give you Mr. Harrel's name? 9 A. Yes. 10 Q. Have you ever talked to Mr. Harrel prior to 11 retaining Mr. Harrel for this deposition? 12 A. No. 13 Q. Have you ever met Mr. Harrel prior to retaining him 14 for this deposition? 15 A. No. 16 Q. Just so I get this straight, you got Mr. Harrel's 17 name from the lawyer representing Eli Lilly; correct? 18 A. Well, I don't know that he was representing Eli 19 Lilly or worked at Lilly. I don't know -- 20 Q. He was affiliated with Lilly in some manner as far 21 as you know? 22 A. That sounds okay. 23 Q. Did he say anything else besides giving you Mr. 24 Harrel's name? 25 A. No. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 142 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Did anybody from Eli Lilly or on behalf of Eli 2 Lilly contact you about the documents that you have in your 3 possession? 4 A. No. 5 Q. Anybody else from Lilly that's contacted you about 6 this deposition? 7 A. No. 8 Q. Have you talked to anybody else from Eli Lilly 9 between the date that you received the subpoena for this 10 deposition and today? 11 A. I may have, but not about the deposition. 12 Q. You didn't raise the issue with whoever -- if you 13 talked to someone with Lilly, you did not raise the issue 14 with them? 15 A. That's correct. 16 Q. Were you contacted by Dr. Beasley, Dr. 17 Heiligenstein or Dr. Masica regarding the deposition? 18 A. No. 19 Q. What did you discuss with Steve Milem about the 20 deposition? 21 MR. HARREL: Well, I'm going to object and advise 22 the doctor not to discuss any communications with the lawyer 23 for the University on the basis of attorney-client privilege. 24 And so with that advice you probably are unable to 25 answer that question. But if there's something that's not in DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 143 DAVID L. DUNNER, M.D., VOLUME I 1 the nature of attorney-client privilege communication, you 2 may reveal that. But otherwise, he would be the attorney for 3 the University. 4 THE WITNESS: I think everything I discussed with 5 him would be under the nature of attorney-client privilege. 6 Q. (By Ms. Zettler:) What's your definition of 7 attorney-client privilege, Doctor? 8 A. Well, things that I would discuss regarding my 9 testifying to the subpoena. We didn't discuss other things. 10 Q. Did you generally discuss issues regarding 11 fluoxetine with him? 12 MR. HARREL: Just a second. I'm going to advise 13 you not to do any answering that even indicates what you're 14 talking about. In other words, the attorney-client privilege 15 is absolute. 16 By way of example, if you say Steve, let's go to 17 lunch, I mean, that may not be privileged, or where are we 18 going to go for lunch. But anything in the attorney-client 19 privilege you should not answer in any way I will so advise 20 you, whether or not she asks you a bunch of questions that 21 you answer in the negative or not. So you should just 22 indicate it. But if it relates to attorney-client privilege, 23 you should just say I'm unable to answer that question on the 24 basis of attorney-client privilege. 25 MS. ZETTLER: So simply because this is an attorney DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 144 DAVID L. DUNNER, M.D., VOLUME I 1 that works for the University, you're claiming some sort of 2 privilege applies in this case? 3 MR. HARREL: I'm claiming that, you bet. 4 MS. ZETTLER: Based on what? 5 MR. HARREL: Based on attorney-client privilege in 6 the state of Washington. 7 MS. ZETTLER: How is the privilege established? 8 They aren't representing him in this action. 9 MR. HARREL: I'm not going to argue with you on the 10 record. I'll just tell you I'm claiming the attorney-client 11 privilege. His communication with Steve Milem at the 12 University of Washington, Assistant Attorney General 13 representing the University I'll claim is an attorney-client 14 privilege. And I'm not going to allow him to answer those 15 questions unless you get a court order. And I would like 16 notice and an opportunity to brief the matter from whatever 17 court you bring it in. 18 Q. (By Ms. Zettler:) Are you going to follow your 19 attorney's advice, Doctor? 20 A. I'm going to refuse to answer your questions on 21 grounds of attorney-client privilege. 22 Q. You're not a lawyer, are you? 23 A. No. 24 Q. You don't really know what attorney-client 25 privilege is, do you? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 145 DAVID L. DUNNER, M.D., VOLUME I 1 MR. HARREL: Well, you're just badgering him now 2 and you're laughing and you're being snide, and so I'm not 3 going to allow him to even answer questions like that. He's 4 not a lawyer, he's obviously not a lawyer, he's a 5 psychiatrist. And if you want to bring that issue on before 6 a court of competent jurisdiction, please give me adequate 7 notice to brief it. And I'm not going to allow you to badger 8 or argue with him. 9 MS. ZETTLER: I'm not badgering or arguing with 10 him. Why don't you certify those questions, please. 11 Q. (By Ms. Zettler:) What did you talk to Gary Tucker 12 about? 13 MR. HARREL: Let me just caution you on one other 14 thing. To the extent that you got privileged attorney-client 15 information from Steve Milem that you then discussed with 16 your department chair or if you got -- let's keep that in one 17 thing. Then if you got privileged communications from me 18 that you discussed with Gary Tucker, that would be a 19 different question and I'd like to discuss that with you. 20 But to the extent Steve Milem gave you legal advice 21 and you then discussed it with the chairman of your 22 department, you should not reveal that on the basis of 23 attorney-client privilege. If you're not revealing anything 24 you could tell her that. 25 But beyond that, you may discuss what you discussed DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 146 DAVID L. DUNNER, M.D., VOLUME I 1 with Gary Tucker so long as it does not reveal 2 attorney-client privilege and so long as it does not reveal 3 any physician-patient privileged information that would -- 4 you know, that you should not reveal on a public record. 5 Q. (By Ms. Zettler:) Who did you talk to first, Mr. 6 Milem or Dr. Tucker? 7 A. Mr. Milem. 8 Q. What did you talk to Dr. Tucker about? 9 A. I informed him of the deposition. 10 Q. When you informed him of the deposition, what did 11 you tell him? 12 A. I said I got a subpoena to be deposed in this 13 strange case that I didn't have anything to do with. That 14 would be probably not in the office sometime this week. 15 Q. Other than that did you talk with him about 16 anything else related to the deposition? 17 A. No. 18 Q. Did you talk with him about anything related to the 19 testing of fluoxetine or work that you had done for Eli 20 Lilly? 21 A. No. 22 Q. How about Andy Benjamin? What did you talk to Andy 23 Benjamin about? 24 MR. HARREL: Again, to the extent that you're 25 seeking attorney -- if you deem him to be your attorney, DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 147 DAVID L. DUNNER, M.D., VOLUME I 1 because you told me previously he did some -- I thought he 2 had done some legal work for you. To the extent that you got 3 legal advice from him, you should not reveal that if you 4 deemed he was your attorney. So I'll give you that advice 5 and you may answer accordingly. 6 THE WITNESS: That's a hard call, because I was 7 asking him legal advice. 8 Q. (By Ms. Zettler:) Is Dr. Benjamin also a lawyer? 9 A. Yes, he is. 10 Q. Did you contact Dr. Benjamin before you contacted 11 Mr. Milem? 12 A. No, I did not. 13 Q. Is Dr. Benjamin connected with the University? 14 A. Yes, he is. 15 Q. Is he an attorney for the University? 16 A. No, he's not. 17 Q. When you were asking him about legal advice, were 18 you asking him as a friend who is also a lawyer? 19 A. Well, as a colleague I guess, yeah. 20 Q. But he is not representing you or is not 21 representing you either on behalf of the University or in 22 your deposition here today; correct? 23 A. That is correct. 24 Q. It was really more a friendly conversation and 25 what-do-you-think-because-I-know-you're-a-lawyer-type of DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 148 DAVID L. DUNNER, M.D., VOLUME I 1 thing? 2 A. Is that a question? 3 Q. Yes. 4 A. Yes. 5 Q. What did you talk to Dr. Benjamin about? 6 MR. HARREL: I'll just give you advice, Doctor. 7 It's not clear to me whether or not there has been an 8 attorney-client communication in that regard. It's not clear 9 to me whether or not you retained him as an attorney. But I 10 will caution you that if you're sensitive at all about the 11 communication, that you deemed it kind of attorney-client 12 things that you don't think should be out in the public, then 13 you don't have to describe that until you and I maybe go have 14 a conversation about whether or not he's really your 15 attorney. And I may have to look at a case to see whether or 16 not he was really employed as an attorney. 17 In fact, there's no payment, but there's got to be 18 some intent basically in your mind. And so if you thought he 19 was your attorney then you should not answer the question on 20 the privilege communication. If you really didn't think he 21 was your attorney in this instance, you know, then you can 22 answer the question. And I can't represent that's the case. 23 I don't have a case in front of me, but I think that's 24 generally the law. I think it's your intention. It's the 25 mind of the client. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 149 DAVID L. DUNNER, M.D., VOLUME I 1 MS. ZETTLER: He just testified that he was having 2 a friendly conversation with a colleague of his who was also 3 a lawyer. I don't think that establishes an attorney-client 4 privilege under any stretch of the imagination. 5 THE WITNESS: Except I wanted to ask him very 6 specific legal advice about the subpoena itself, and I did. 7 Q. (By Ms. Zettler:) After you talked to Mr. Milem? 8 A. Yes. 9 Q. Who you are asserting attorney-client privilege 10 with? 11 A. Yes. 12 Q. Did you feel incapable of asking Mr. Milem those 13 questions? 14 A. Andy happens -- 15 MR. HARREL: Well -- 16 THE WITNESS: No. 17 MR. HARREL: I'm not going to allow you to answer 18 or backdoor into what you discussed with Mr. Milem, okay? 19 I'll advise you not to reveal any attorney-client privilege. 20 MS. ZETTLER: He already answered, Arley. 21 MR. HARREL: That's just because you jumped in 22 there and he answered before I was allowed to object. 23 Q. (By Ms. Zettler:) Other than asking him specific 24 questions about this subpoena, what else did you discuss with 25 Dr. Benjamin? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 150 DAVID L. DUNNER, M.D., VOLUME I 1 A. That was pretty much it. 2 Q. Did you discuss the facts of the case with him? 3 A. I don't know the facts of the case. 4 Q. Did you discuss your involvement with Eli Lilly and 5 Company? 6 A. No. 7 Q. Did you discuss your research on fluoxetine? 8 A. No. 9 Q. Did you discuss your consulting with Eli Lilly on 10 suicidality and/or depression? 11 A. No. 12 Q. How about with Gary Tucker, did you discuss any of 13 those issues? 14 MR. HARREL: I think that's vague as to "any of 15 those issues." I think that's overly broad. That was about 16 six questions. I think that's multiple and compound and hard 17 to remember them all. 18 Q. (By Ms. Zettler:) Did you discuss your involvement 19 with Eli Lilly with Dr. Tucker? 20 A. No, I did not. 21 Q. Did you discuss your research on fluoxetine with 22 Dr. Tucker? 23 A. No, I did not. 24 Q. These other people that you listed, your friends, 25 the Alexandros and your brother-in-law, Mr. Zolbert I believe DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 151 DAVID L. DUNNER, M.D., VOLUME I 1 it was, did you discuss your involvement with Eli Lilly with 2 them? 3 A. What involvement with Eli Lilly? 4 Q. Your research on fluoxetine. Did you discuss that 5 with them? 6 A. No. 7 Q. Did you discuss your consulting with Eli Lilly? 8 A. No. 9 Q. Did you discuss anything at all related to 10 depression and/or fluoxetine with any of those people? 11 A. I don't think so. 12 Q. Who else is on the Lilly psychiatric advisory 13 committee that we discussed earlier? 14 MR. HARREL: In what time frame? 15 MS. ZETTLER: When you first became a member of the 16 committee. 17 THE WITNESS: The first group I think is in one of 18 these exhibits. 19 MR. SMITH: I'm sorry, I didn't hear you, Doctor. 20 MS. ZETTLER: He said the first group is in one of 21 the exhibits that he's given us. He thinks. 22 THE WITNESS: I can give you some names. Paula 23 Clayton, Bill Zung, Burt Goldstein, John Rush. I think there 24 might have been eight people. 25 Q. (By Ms. Zettler:) How about Jan Fawcett? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 152 DAVID L. DUNNER, M.D., VOLUME I 1 A. It's possible. I don't know that he was definitely 2 on, but it's possible. He has been on the committee. Okay. 3 Paula Clayton, David Dunner, Jan Fawcett, Burt Goldstein, 4 John Rush, Alan Schatzberg, Peter Stokes and Bill Zung. 5 Q. Bill Zung? 6 A. Yes. 7 Q. Can I see that? 8 A. It's Page 287 in your book. 9 (Short break) 10 Q. (By Ms. Zettler:) Doctor, let's talk about grants 11 again for a couple of minutes. You do clinical research 12 through the University as well as teach there; correct? 13 A. That's correct. 14 Q. The patients that you see that you say pay the 15 University as opposed to paying you directly, do you see 16 those patients on a continuing regular basis? 17 A. Patients who pay University physicians for clinical 18 services are seen on a consultation basis or continuing 19 basis. 20 Q. So you have patients that you see as part of that 21 University clinic, so to speak, that are your patients then 22 come back to see you from time to time? 23 A. Yes. 24 Q. Outside of the University work you do, do you have 25 your own clinical practice? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 153 DAVID L. DUNNER, M.D., VOLUME I 1 A. No, I do not. 2 Q. Are you paid by the University for work you do on 3 clinical trials conducted through the University? 4 A. I'm paid by the University for being there. 5 There's some tenure. What I do is independent of the pay. I 6 could do nothing and I would be paid. 7 Q. Are you paid a separate salary for the work you do 8 as a psychiatrist in the clinic there? 9 A. I get two checks, one from the University of 10 Washington and one from the University of Physicians. The 11 total of that is my University agreed salary which is 12 independent of seeing any patients. 13 Q. The check that you get from the University itself 14 pays you for services rendered as a professor there and also 15 any work that you do on clinical trials that are conducted 16 through the University, is that true? 17 A. I don't think so. I think the pay I get from the 18 University of Washington is for being a professor at the 19 University of Washington. My duties are more spelled out. 20 Administratively, there's never been a mention of clinical 21 trials in any job description that I've ever had. 22 Q. So you are not paid in any way to your knowledge 23 for the work you do on clinical trials; is that your 24 testimony? 25 A. That's correct. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 154 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Is anybody paid salary, to your knowledge; any 2 administrative people, people that work for you, people that 3 work with you in the clinical trials out of the grant money 4 that's provided to the University? 5 A. Say it again. 6 Q. Sure. People that you work with when you work on 7 clinical trials like administrative people, people that 8 assist you, anybody who works with you on clinical trials, 9 are any of those people paid out of the grant money that is 10 given to the University by the drug companies? 11 A. Yes. 12 Q. Who? 13 A. The people who work on the clinical trials 14 themselves are paid from those grants. 15 Q. What is your function on these clinical trials? 16 A. I'm usually the principal investigator. I see most 17 of the patients or many of the patients involved in the 18 trials themselves and I supervise the work of the people in 19 that unit, the psychopharm research unit. 20 Q. And you don't get paid for any of these services 21 that you provide? 22 A. I get paid for being a professor at the University 23 of Washington. 24 Q. Do you have a contract with the University? 25 A. I don't really know. I got a letter from the DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 155 DAVID L. DUNNER, M.D., VOLUME I 1 president a couple of years ago with a reappointment. It was 2 a piece of paper with a reappointment of my salary, but I 3 haven't gotten one recently. They seemed to have stopped 4 doing that. 5 Q. Is it your understanding that if you decided you 6 didn't want to work on clinical trials anymore that your 7 salary would be adjusted in any way? 8 A. It would not be adjusted in any way. 9 Q. It would not? Is that what you said, it would not? 10 A. It would not be adjusted in any way. 11 Q. When you spoke to Dr. Teicher on those couple of 12 occasions that we talked about earlier, did you express 13 criticism of his article? 14 A. I think mostly he spoke to me more than my speaking 15 to him. And I don't recall discussing that article, his 16 article. 17 Q. Did you ever inform Dr. Teicher that you had seen 18 two patients who reportedly became suicidal while on 19 fluoxetine? 20 A. I don't recall doing that. 21 Q. What is your opinion of the results of Dr. 22 Teicher's study? 23 A. It wasn't a study, it was a report of five 24 patients. I think its conclusions went beyond its data. 25 Q. What do you mean by that? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 156 DAVID L. DUNNER, M.D., VOLUME I 1 A. I think the conclusions from the study were 2 overstated compared to the information in the case reports of 3 the patients. 4 Q. In what way? Give me an example of what you mean. 5 A. Patients who were complicated and had multiple 6 drugs on board. One other person who was familiar with one 7 of the patients indicated that he felt that the scenario 8 posed by the patient was different than what was reported 9 from that patient in the trial. 10 Q. You're talking about Dr. Jonathan Cole, are you 11 not? 12 A. No, I'm not. 13 Q. Who are you talking about; Ms. Glad, Dr. Glad? 14 A. No. 15 Q. Who? 16 A. Dr. Rosenbaum. It wasn't clear how the suicidal 17 ideation was ascertained. It seemed from what I had 18 understood that it wasn't a usual brief psychopharm encounter 19 but may have involved a rather lengthy and somewhat 20 dynamically interpretable encounter with the patient. And I 21 think it's difficult to know what to make of things that come 22 in that particular kind of setting. 23 Q. So you're saying that a brief interaction with a 24 patient is more reliable in determining whether or not they 25 are suffering from suicidal ideations than a more thorough DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 157 DAVID L. DUNNER, M.D., VOLUME I 1 encounter with a patient? 2 MR. MYERS: Object to the form. 3 THE WITNESS: I think that the encounter with the 4 patient is pseudo-thorough in that it brings up information 5 that then gets interpreted by the person listening to it and 6 the interpretations are put into the mix. The more lengthy 7 time spent with a patient can be very, very misleading, yes. 8 Q. (By Ms. Zettler:) Are you saying, Doctor, that you 9 feel that Dr. Teicher's interviews with these patients were 10 done at least with the assumption that he was going to find 11 increased suicidality with these people? 12 A. No. 13 Q. I don't understand what you mean by more 14 pseudo-lengthy interaction. 15 A. I think sometimes when you're not relying on overt 16 data from the patient but interpreting what they say you can 17 make wrongful interpretations of what they say. 18 Q. Isn't the practice of psychiatry based in large 19 part on interpretation of what people tell you when you're 20 treating them? 21 A. Sometimes. 22 Q. Do you feel that if Dr. Teicher had administered a 23 HAMD and the HAMD-3 scores on those patients had shown them 24 to be suicidal as compared to a base line of a HAMD score 25 that that would have been more reliable? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 158 DAVID L. DUNNER, M.D., VOLUME I 1 A. If the information was that they had no suicidal 2 ideation at times one, at times three and time N and sometime 3 later they had a marked increase in suicidal ideation, I 4 think that would have been a better way of observing the 5 data. But I'm not sure that's how the data was ascertained 6 by Dr. Teicher. 7 Q. On the studies that you performed on fluoxetine on 8 behalf of Eli Lilly, was patients who posed a serious 9 suicidal risk an exclusion criteria? 10 A. Generally. 11 Q. What constitutes a patient who is a serious 12 suicidal risk? 13 A. Many of the patients we treated in the studies had 14 made suicide attempts in prior depressive episodes at some 15 times in the past. I think we would exclude a patient from 16 participating in the studies if they had made a recent 17 suicide attempt or if they came to us saying that they had 18 thoughts of hurting themselves and suicidal intent, so that 19 any such patients would have -- and that that intent was 20 current, I think they would have been clearly excluded. 21 Q. What is considered a recent suicide attempt? 22 A. Oh, I think something -- again, you have to factor 23 in the severity of the attempt and what was going on in time, 24 but anywhere from a month to a day would fit. But we're 25 unlikely to take anybody who made a suicide attempt in the DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 159 DAVID L. DUNNER, M.D., VOLUME I 1 week prior to coming into the clinical trial. We're not 2 comfortable with treating patients like that with placebos 3 and we wouldn't have entered such patients. 4 Q. What about somebody who had made a suicide attempt 5 a month prior to the study beginning? 6 A. It's possible that they could have been entered 7 depending on the circumstances of the attempt. 8 Q. What about somebody who had made an attempt a year 9 prior to the study beginning? 10 A. Again, it's possible that they could have been 11 entered or not entered, but in that case I think we would 12 rely more on what the suicidal ideation was at the time now. 13 Also, it may have depended a bit on the form of the 14 illness, because if someone had annual depressions and made 15 suicide attempts every year and was coming in now with a 16 depression, I don't know that we would have entered that kind 17 of patient. 18 Q. Did you ever conduct any study for Eli Lilly on 19 fluoxetine where people who may have posed a suicidal or 20 serious suicidal risk were included? 21 A. I don't think so. 22 Q. Are you aware of any studies where that's the case, 23 those patients were included? 24 A. Well, we talked about that this morning where there 25 was some discussion of a study that I don't think we DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 160 DAVID L. DUNNER, M.D., VOLUME I 1 participated in involving people with suicidal ideation and 2 being treated with fluoxetine, but I don't know very much 3 about that. 4 MS. ZETTLER: I'm sorry, I just kind of spaced out 5 in the middle of your answer. Could you read that back? 6 (Whereupon, the reporter read back the last 7 question.) 8 Q. (By Ms. Zettler:) To your knowledge, was that 9 study conducted? 10 A. I have no knowledge of what happened to that study. 11 Q. And this is the study we were talking about earlier 12 where you may or may not have submitted a draft protocol or a 13 proposal; right? 14 A. That's correct. 15 Q. Have you heard of Dr. Ivan Miller? 16 A. No. 17 Q. Have you heard of the Scale for Suicidal Ideation? 18 A. No. 19 Q. How is whether or not a person was actively 20 suicidal or suffering some suicidality or suicidal ideation 21 judged with regards to the exclusion criteria in your 22 studies? 23 A. Well, all of the patients entered into our trials 24 were seen by psychiatrists, and that assessment was made by 25 the investigator who interviewed the patient and made that DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 161 DAVID L. DUNNER, M.D., VOLUME I 1 determination by taking their history and by asking them 2 about their suicidal intent and by really reviewing the 3 Hamilton Depression Scale in particular which gives you a 4 fairly good rating of how suicidal they may be now and by 5 asking about suicidal behaviors in the past. 6 Q. Do you feel that the HAMD-3 is a good predictor of 7 suicidality or suicide? 8 A. I don't think it predicts suicidality, I think it 9 assesses suicidality. I think it's very good for doing that. 10 Q. What's the difference between predicting and 11 assessing suicidality? 12 A. Predicting is telling what's going to happen in the 13 future and assessing is telling what's happening now. 14 Q. Would you say that to a certain extent it's a 15 judgment call on the part of the person interviewing the 16 patient as to whether or not they're actually suicidal at the 17 time they interviewed them? 18 MR. MYERS: Object to the form. 19 THE WITNESS: One never knows how suicidal a 20 depressed patient really is, and in that sense it's a 21 judgment call. 22 Q. (By Ms. Zettler:) What kind of a score would a 23 person have to get on the HAMD-3 before they would be 24 considered suicidal or actively suicidal? 25 A. Well, there are different levels of being suicidal. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 162 DAVID L. DUNNER, M.D., VOLUME I 1 I think if one is concerned about suicidal intent, a rating 2 of 3 would clearly mark that because that's suicidal thoughts 3 and plans. A rating of 4 would be a recent suicide attempt 4 and that also would be suicidal. Many of the patients we see 5 with depression who are working people have ratings of 2, and 6 they have suicidal thoughts but deny suicidal intent and are 7 routinely entered into clinical trials. 8 Q. Is there a difference between suicidal thoughts and 9 suicidal intent? 10 A. Yeah. I think people can have thoughts of taking 11 their life without plans of taking their life, and that 12 really is the difference between a 2 and a 3. And if there's 13 a question about that, we go over that with our patients, 14 because we don't like to have people who might be exposed to 15 placebos and being in danger on these clinical trials getting 16 worse during a clinical treatment. And we have sometimes 17 said we don't think you're right for this study and we really 18 feel you need this kind of treatment, instead of being 19 honest, because we're not comfortable in turning you in. 20 Q. How often does that happen? 21 A. How often? I can't give you a precise how often. 22 It's not uncommon. Let's say between 5 and 10 percent of the 23 time, something like that. 24 Q. Do you consider somebody who rates a 2 on the 25 HAMD-3 a serious suicidal risk? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 163 DAVID L. DUNNER, M.D., VOLUME I 1 A. Say that again. 2 Q. Do you consider somebody who rates a 3 or a 2 on 3 the HAMD-3 score a -- 4 A. A rating of 2 on the HAMD Item 3 represents 5 suicidal thoughts, and they do not necessarily represent a 6 suicidal risk. 7 As I said, you don't know what the real suicidal 8 thoughts are of any patient whether they say it's none or 9 they've just made an attempt. You really can't predict the 10 future with that. But most of the patients who rate 2 on 11 Item 3 of the Hamilton Depression Rating Scale are considered 12 suitable for clinical trials, and we've routinely entered 13 them into such trials whether sponsored by Eli Lilly or other 14 companies. 15 Q. When you say that the HAMD Item 3 is not good at 16 predicting suicide, do you mean just suicide attempts or 17 suicidal ideation also? 18 A. The question doesn't make sense. 19 Q. In what way? 20 A. A rating of 3 -- 21 Q. Let me ask it again. 22 Earlier I believe you stated that you didn't think 23 that the HAMD Item 3 was a good predictor of suicide 24 attempts, okay? What I'm trying to find out is if you're 25 also talking about whether or not it's a good predictor of DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 164 DAVID L. DUNNER, M.D., VOLUME I 1 whether or not somebody is going to become suicidal without 2 necessarily making an attempt. 3 MR. HARREL: I'm going to object to the form of the 4 question. I thought you mischaracterized his testimony. 5 Q. (By Ms. Zettler:) If I did, Doctor, please tell 6 me. 7 A. Well, no scale can predict accurately who is going 8 to be suicidal. Patients will change in their rating of 9 suicidal measurements on any scale you want to give them from 10 time one to time two. Some patients will change none, some 11 patients will change for the better and some patients will 12 change for the worse. And I don't think there's a scale that 13 can predict what the next score is going to be based on a 14 score right now. 15 Q. Isn't it true that some patients are less than 16 truthful when they answer questions that are asked during a 17 psychiatric examination? 18 A. That's true. 19 Q. And, therefore, it's possible that a patient could 20 answer the HAMD-3 question untruthfully; correct? 21 A. That's true. 22 Q. Based on that, is it still your opinion that the 23 HAMD-3 is a good assessment? 24 A. The HAMD Item 3? 25 Q. Right, of suicidality. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 165 DAVID L. DUNNER, M.D., VOLUME I 1 A. Yes, it is. 2 Q. Why? 3 A. It's as good as anything you have going as long as 4 you're going to ask a question and get an answer. You also 5 are looking at how the patient responds to the question. So 6 a lot of times it's not only the response, it's how the 7 response comes out. And I've often picked up on that and 8 changed the rating score based on probing further to very 9 direct questions. 10 I mean, it's not just a yes or no and you are gone, 11 it's sometimes a hesitation or part of the general depression 12 picture that one explores. And often, you know, if I feel 13 that someone is seriously depressed, I'll go back to that 14 item and reexplore it again. Because I am concerned about 15 the patients we treat whether we treat them clinically or 16 whether we treat them in research studies. 17 Q. In your research on fluoxetine, did you ever have 18 an occasion to observe a patient who was according to the 19 HAMD scale getting better but suffering from agitation or 20 nervousness? 21 A. I probably did. 22 Q. Why do you say that? 23 A. I can't recall any specific issues. 24 Q. Why do you say you probably did? 25 A. Well, because it's likely that occurred. I mean, DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 166 DAVID L. DUNNER, M.D., VOLUME I 1 just theoretically I can't recall a specific patient. 2 Q. Why do you say it's likely it had occurred? 3 A. Probablistic. 4 Q. You mean from a statistical standpoint? 5 A. Yeah. You asked me if I ever did and I said 6 probably. I mean, it's likely that that happened, I just 7 don't know that -- I can't cite a specific patient. And I 8 don't know that it actually did happen, but it probably did 9 happen. 10 Q. In people that you have used in clinical trials, 11 have you had occasion to observe somebody who had gotten 12 worse but thought they had gotten better? 13 A. And I object to the form of the question, because I 14 don't like the words "used in clinical trials." Let's say 15 "entered into clinical trials." Can we do that? 16 Q. Sure. 17 A. Now can you repeat the rest of the question. 18 Q. Sure. In your experience in having patients 19 participating in clinical trials, have you observed somebody 20 who was getting worse that actually thought they were getting 21 better on fluoxetine? 22 MR. MYERS: Well, let me object to the form. Your 23 question assumes that the investigator knew what drug the 24 patient was on, and we've been talking about blind trials all 25 along. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 167 DAVID L. DUNNER, M.D., VOLUME I 1 THE WITNESS: Yeah. And I need to answer the same 2 way. You know, I just do the rating. I don't know what the 3 patient is taking or what they are assigned to. And my 4 concern is not what they are assigned to, my concern is how 5 they are doing and my assessment of that and also the 6 decision about continuing on or not continuing on for another 7 week. So that there are patients I've seen who rate worse 8 and look better and there are patients I've seen who rate 9 better and look worse. 10 Q. (By Ms. Zettler:) And when you say look worse, you 11 mean they physically look worse? 12 A. They physically look worse. 13 Q. And how does that play into your diagnosis as to 14 how depressed they are? 15 A. It will enter into some points on the rating scale, 16 but it also is cause for a little bit of rechecking it and 17 making sure we're still talking coherently to the patient 18 about the same symptoms. 19 Q. After the study is over, are you ever privy to the 20 unblinded information? 21 A. Yes. 22 Q. Has your review of the unblinded information on 23 fluoxetine ever shown to you people who were suffering from 24 serious -- and I don't mean necessarily FDA serious -- 25 adverse events who were apparently doing better on the HAMD-3 DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 168 DAVID L. DUNNER, M.D., VOLUME I 1 scale? 2 A. I don't recall ever doing that kind of analysis. 3 Occasionally we would look up a particular patient or 4 sometimes we would see someone who had -- I remember the 5 rashes were mostly on imipramine, which surprised me, in our 6 particular trial where we had a lot of rashes. 7 Q. Did you do any unblinded studies for Lilly on 8 fluoxetine? 9 A. I don't recall it, except for the humanitarian 10 protocol. 11 Q. Tell me about the humanitarian protocol. Was that 12 all people that were discontinued on fluoxetine? 13 A. Well, actually there were -- there may have been 14 two kinds of that. One of them followed the Trazadone study, 15 there was a continuation study, and I think people in that 16 study got fluoxetine no matter what they were on. The other 17 was actually humanitarian protocol which is different, so 18 that we arranged with our institute review board and with 19 Lilly to obtain fluoxetine for selected patients who were 20 treatment-resistant and we treated a few patients under that 21 protocol. 22 Since it was not an approved drug, we needed to 23 have a consent form and had to go through the University of 24 Washington Human Subjects Committee and we needed to have 25 permission from Lilly to get the drug, and we did all that. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 169 DAVID L. DUNNER, M.D., VOLUME I 1 And that was open label. 2 Q. Have any of the patients that you've treated with 3 fluoxetine either as participants in a clinical trial or 4 through the clinic at the University ever refuse to go back 5 on fluoxetine after suffering a side effect or an adverse 6 event? 7 A. Yes. 8 Q. On how many occasions has that happened? 9 A. A few. 10 Q. What types of adverse events were those people 11 suffering? 12 A. Mostly elderly people who were feeling quite 13 agitated. 14 Q. Did you administer concomitant sedatives or 15 sedative antidepressants to those people? 16 A. Well, they took a couple of doses, felt terrible, 17 came in, said I don't want this anymore or ever again, and we 18 never had a chance to give them any concomitant medication. 19 We changed the medication. 20 Q. Do you think that Dr. Teicher is a competent 21 psychiatrist? 22 A. I have no way of assessing that. 23 Q. Do you think that he is qualified to rate 24 suicidality in a patient? 25 A. I have no way of assessing that. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 170 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Why not? 2 A. I've never seen him practice. 3 Q. Have you read any of his writings besides the 4 article that came out in January of 1990? 5 A. I don't think so. 6 Q. Have you ever done research to see if somebody has 7 created a scale specifically to rate suicidality? 8 A. No. 9 Q. Why not? 10 A. It wasn't my main research interest. 11 Q. Have you ever been interested in specifically 12 researching suicidality in patients who take fluoxetine other 13 than the study we already talked about? 14 A. What study we already talked about? 15 Q. The one we talked about earlier in suicidal 16 patients. 17 A. Oh, no. 18 (Whereupon, Exhibit 3 was marked for 19 identification.) 20 (Short break) 21 Q. (By Ms. Zettler:) Doctor, Exhibit 3 purports to be 22 a copy of a protocol entitled "Fluoxetine/Desipramine/Placebo 23 Rechallenge Study in Patients Who Developed Suicide Ideation 24 While Under Treatment." Do you see that? 25 A. Yes, I do. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 171 DAVID L. DUNNER, M.D., VOLUME I 1 Q. Also as part of that document is an introductory 2 overview of issues regarding alternative study designs, do 3 you see that, the first couple of pages after the form, the 4 FDA form? 5 A. Right. 6 Q. Have you seen either the overview entitled 7 "Approach to Study of Potential Association of Suicidality to 8 Antidepressant Therapy" or the protocol that's attached as 9 part of Exhibit 3? 10 A. As far as I know, I did not. 11 Q. I'd like you to take a few minutes and look at the 12 first three pages entitled "Approach to Study of Potential 13 Association." If you could read that to yourself. You don't 14 have to read it out loud. 15 (Short break) 16 MR. HARREL: Back on the record. We've been handed 17 by Plaintiffs' counsel, Nancy Zettler, a check for $1,000 18 payable to David Dunner. And we're going to accept her 19 promise to reissue that check to the University of Washington 20 for $1,000 even. And she has promised to submit that to 21 their bookkeeper on no later than Monday, January 24, 1994, 22 and have it out to Dr. Dunner no later than Friday, January 23 28, 1994. Is that correct, Counsel? 24 MS. ZETTLER: That's correct. I'd also like to 25 make the record clear that the $1,000 check was offered by us DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 172 DAVID L. DUNNER, M.D., VOLUME I 1 to compensate Dr. Dunner for his time in giving his 2 deposition today and tomorrow, and he has chosen instead to 3 ask us to contribute that money to the University on his own 4 decision; is that correct? 5 MR. HARREL: Well, the original bill he sent you 6 which was for quite a bit more than that was to the 7 University of Washington also. But it is for his -- I agreed 8 on his behalf as his lawyer to accept $500 per day for these 9 two days of deposition to Tuesday tomorrow noon. And that 10 check in that $1,000 amount payable to the University of 11 Washington is for that purpose. 12 MS. ZETTLER: To compensate him for his time? 13 THE WITNESS: It's not going to compensate me, it's 14 because I'm representing the University of Washington as 15 their employee. 16 MS. ZETTLER: I hope you understand that your 17 deposition is not being taken as a representative of the 18 University of Washington, your deposition is being taken as 19 an agent of Eli Lilly and Company as we have laid out in the 20 answers to your questions about this deposition. 21 MR. MYERS: Wait a second. He is not an agent of 22 Eli Lilly and Company. There's never been any such testimony 23 that he's Lilly's agent. He's certainly not here in that 24 capacity, because if he was I would be representing him, and 25 I'm not. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 173 DAVID L. DUNNER, M.D., VOLUME I 1 MS. ZETTLER: He sort of is, Larry, because you're 2 paying Mr. Harrel. But we can argue that in front of the 3 judge on a later date after the questioning of this 4 deposition. 5 But it's our position that we offered to pay Dr. 6 Dunner $500 a day for his testimony as a subpoenaed witness 7 in this case, and a generous offer, I believe, because we 8 only had to pay him statutory witness fees. And Dr. Dunner 9 has chosen to forego being paid for his time in lieu of a 10 contribution to the University of Washington; correct? 11 MR. HARREL: Well, we can spend a lot of time 12 arguing about this if you want to. As his lawyer, we sought 13 additional amounts, because Dr. Dunner's normal rate is 14 higher than what you offered. When he sent you the bill 15 before, which was for a much higher amount, I think it was 16 for $6,500, it was also to be paid to the University of 17 Washington; am I correct, Doctor? 18 THE WITNESS: That's correct. 19 MR. HARREL: And so we're just following through on 20 that. It is in fact for his time being here, but technically 21 he believes that for this deposition he just thinks that the 22 money should go to the University of Washington instead of 23 him personally, and so we've just asked you to reissue the 24 check to the University of Washington. 25 We just asked you to give it to him payable to DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 174 DAVID L. DUNNER, M.D., VOLUME I 1 David Dunner and he was going to sign it over to the 2 University of Washington and put the University of 3 Washington's tax ID number on it. You refused to give me the 4 check on that basis. If you'll tender me the check on that 5 basis, we'll do it that way. But as I understand it, you 6 wouldn't give it to me. 7 So we're now asking you to reissue the check 8 payable to the University of Washington and then he'll fill 9 out the tax ID number of the University of Washington and 10 send the tax number back to you. 11 MS. ZETTLER: Let's just make sure the record is 12 clear here, Arley. I did not refuse to give you the check, I 13 refused to let you assign the University of Washington's tax 14 ID code to the federal forms that are required by the 15 government for tax purposes for a check that I issued and 16 paid to Dr. Dunner. To me that's a fraud on the government. 17 But since you've I think realized that there is a 18 dichotomy in doing it that way, you have asked that we 19 reissue the check in the name of the University of 20 Washington. We have agreed to do that and we will do that. 21 MR. HARREL: Okay. There's no intent to committing 22 fraud on the government, and Dr. Dunner was going to 23 immediately pay it over to the University of Washington. But 24 I think we've reached agreement. We've beat this to death, 25 and we'll look forward to having Dr. Dunner having the check DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 175 DAVID L. DUNNER, M.D., VOLUME I 1 by January 28, 1994. 2 MS. ZETTLER: Should we send it to Dr. Dunner or 3 should we send it to the University of Washington? 4 THE WITNESS: You can send it to me at my office. 5 Q. (By Ms. Zettler:) Dr. Dunner, when you testify as 6 an expert witness, do you ask the people you testify on 7 behalf of to pay the University of Washington directly or do 8 you ask them to pay you? 9 A. If I'm representing the University of Washington, I 10 don't get paid as an expert witness. If I represent any 11 other matter, I have myself paid. 12 Q. In what situations where you testify as an expert 13 witness do you consider yourself testifying on behalf of the 14 University of Washington? 15 A. I've consulted with the University of Washington 16 regarding potential medical malpractice issues. 17 Q. I'm talking about people outside the University of 18 Washington. When do you consider yourself as representing 19 the University of Washington when you testify as an expert 20 witness on behalf of another party or a party to a lawsuit? 21 A. I don't -- 22 Q. You've never testified in a deposition or at court 23 on behalf of a party of a lawsuit to render expert testimony? 24 A. I have. 25 Q. In the situation like that, do you charge your DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 176 DAVID L. DUNNER, M.D., VOLUME I 1 client, so to speak, personally or do you have them pay the 2 University of Washington? 3 A. I charge them personally because I'm not 4 representing the University of Washington in those matters. 5 I feel that I am representing the University of Washington in 6 these matters, because the research that we did that was 7 contracted with the Eli Lilly was done as a University 8 employee and I'm therefore bound by University regulations in 9 these studies. And I feel that my presence here is because I 10 am in the University of Washington and employed by the 11 University of Washington, and that's why the money should go 12 to the University of Washington. 13 Q. Has anybody told you that you are representing the 14 University of Washington at this deposition or is that an 15 assumption that you've made on your own? 16 A. Can I not answer that based on privileged 17 information? 18 MR. HARREL: Yes, absolutely. Whatever you get 19 from counsel, then you don't have to answer that based on 20 attorney-client privilege. 21 Q. (By Ms. Zettler:) So that isn't an assumption that 22 you've made on your own, that is an assumption that somebody 23 else has told you; correct? 24 A. I think I answered the question. 25 Q. Have you had a chance to review Exhibit Number 3? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 177 DAVID L. DUNNER, M.D., VOLUME I 1 A. Yes, I have. 2 Q. And I believe it was your testimony earlier that 3 you don't recall ever seeing this exhibit before? 4 A. I don't remember seeing this before. 5 Q. Have you had a chance to review the first three 6 pages of Exhibit 3, the "Approach to Study of Potential 7 Association of Suicidality to Antidepressant Therapy"? 8 A. Yes, I have. 9 Q. Does any of the possible approaches that are listed 10 in that portion of the exhibit memorialize what you had in 11 mind when you talked to the Lilly employee about rechallenge? 12 A. Considering I don't remember exactly what I had in 13 mind, I don't know. 14 Q. Would you as a practicing psychiatrist like to see 15 a study to further investigate whether or not fluoxetine does 16 cause or agitate or increase suicidality in people taking 17 fluoxetine? 18 MR. HARREL: I'm going to state for the record that 19 I think you're again getting into expert opinions. It 20 doesn't have anything to do with what he did in these 21 clinical studies, and so you're again trying to get expert 22 opinions without paying for expert opinions. 23 So I mean, I don't know how far you're going to go 24 down this path, but this certainly is not the factual basis 25 upon what you represented you were deposing this witness for. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 178 DAVID L. DUNNER, M.D., VOLUME I 1 You're asking purely speculative opinion-type opinions. 2 MR. MYERS: I will join in that objection only to 3 the extent that while arguably some of your earlier opinion 4 questions may well relate to some work that he did, this does 5 not. And I think that you've crossed that line and are 6 attempting to use him as basically an undesignated expert 7 witness subject to the question or the form of the question. 8 Q. (By Ms. Zettler:) Can you answer the question? 9 A. Can I have it repeated, please. 10 (Whereupon, the reporter read back the following: 11 "Q. Would you as a practicing psychiatrist like 12 to see a study to further investigate whether or not 13 fluoxetine does cause or agitate or increase suicidality in 14 people taking fluoxetine?") 15 MR. HARREL: I'm going to state for the record 16 that clearly is asking for opinions. And I'm going to 17 reserve my right now to go back to the Court and ask for 18 expert opinions, because I concluded previously that I could 19 not get that because you represented he was going to be 20 purely a fact witness. And now I reserve the right to get 21 additional expert witness fees if you're going to follow up 22 on this type of questioning. 23 MS. ZETTLER: Arley, you can do whatever you feel 24 is necessary, but I think that this whole expert opinion fee 25 routine is just some sort of smoke screen to try to obstruct DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 179 DAVID L. DUNNER, M.D., VOLUME I 1 this whole proceeding. And I object to it being raised in 2 the first place and I object to you continuing to raise it. 3 MR. HARREL: And the second point I'd like to make 4 is that I may not advise him and I probably will not advise 5 him not to answer that question. By doing so I'm not 6 intending to waive subsequent instructions I might make or 7 subsequent advice I may have give him to say they've gone way 8 too far afield and you'll have to get an order to get those 9 kinds of expert opinions. 10 So I'm going to go question by question, but by not 11 speaking up and making an objection, I'm not going to waive 12 my position that you should pay fees for expert opinions as 13 the court rule provide in the state of Washington. 14 MS. ZETTLER: We aren't going to agree that you can 15 reserve objections to a later date. If you have an objection 16 to a question, I suggest you make it. 17 MR. HARREL: Well, if you'd like me to advise him 18 not to answer that question, if that's your position then I 19 might advise him not to answer, because you're asking for 20 expert opinions. 21 MS. ZETTLER: And your sole basis for -- if you 22 advise him not to answer, your sole basis for advising him 23 not to answer is because you dispute the fee issue? 24 MR. HARREL: No, because you've misrepresented to 25 me. You told me when you were coming here you were going to DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 180 DAVID L. DUNNER, M.D., VOLUME I 1 ask him fact basis. You refused to pay him an expert witness 2 fee because you said he's only going to be a fact witness. 3 And this doctor is very well sought after as an international 4 expert, he is well-known as a psychiatrist, he's paid $500 an 5 hour by a variety of sources including the State of 6 Washington, Group Health Cooperative and a variety of 7 companies pay him including King County here. And so I think 8 a court in this jurisdiction will find him very well 9 qualified and will insist that you pay him an expert witness 10 fee. 11 I did not bring that on because you represented to 12 me he was going to be a fact witness. And I concluded after 13 looking at the cases, and you've sent me some and so did your 14 local counsel, that on a fact basis I could not get expert 15 witness fees. But if you're here seeking expert witness 16 opinions, then you have to pay for expert witness fees. 17 And so based on your saying you're going to insist 18 on preserving it now, I'll advise the doctor that he's not 19 required to give expert opinions beyond the factual basis why 20 she said she was here. And she's now witness to the test. 21 She said if you answer that question you can't preserve it. 22 And, therefore, I'm giving you advice that if you feel you're 23 out on the expert witness beyond your factual basis that you 24 said you're here for, then you don't have to answer that 25 pending a Court ruling as to the reasonableness. And the DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 181 DAVID L. DUNNER, M.D., VOLUME I 1 court is open tomorrow, we can go down tomorrow and get an 2 order as to how much they should be. 3 MS. ZETTLER: First of all, I'd like to correct the 4 record, because you're wholly mischaracterizing what I have 5 said to you over the phone about this issue. What I told you 6 for the fourth or fifth time now, Arley, is that we were 7 subpoenaing him, that we were not hiring him as an expert, 8 that under the rules and case law in this state, if we are to 9 ask him expert opinions based on his qualifications as an 10 expert in any given area that that is something that even 11 under your case law would not render him as an expert for the 12 fees issue. 13 I've never represented to you that I was not going 14 to ask him opinion testimony. I've told you that I've 15 subpoenaed him as a fact witness under the subpoena rules, 16 and that is all I have told you on the issue as far as expert 17 opinion testimony. 18 If you feel like you need to go in on some sort of 19 a motion then that's your prerogative, but I will tell you 20 that I will make whatever counter-motion is necessary and ask 21 for sanctions in the amount of fees, my fees and costs of 22 coming out here. And if I have to come out here again to ask 23 him questions that are clearly proper under the subpoena, 24 I'll ask for sanctions also. 25 MR. HARREL: Well, I gave you the option to DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 182 DAVID L. DUNNER, M.D., VOLUME I 1 continue on that I didn't waive it, and you insisted that if 2 I allowed him to answer then I would be deemed to waive it, 3 and therefore I have taken that position. 4 MS. ZETTLER: I'm certainly not going to be bullied 5 into agreeing to some sort of reservation of objections that 6 you can then assign to various questions that I ask him at 7 will at a later date. I'm sure that you'd be counseled by 8 co-counsel for Eli Lilly in doing something like that. I am 9 not going to get into that situation. 10 If you have an objection to make then you make it. 11 If you're going to instruct your witness not to answer you 12 can go ahead and do that, that's your prerogative. But you 13 better make sure you're doing it properly, because I will 14 bring on a motion and I will bring Dr. Dunner back and I will 15 not pay him $500 a day in that case. 16 MR. HARREL: Doctor, I'll stand by my advice to 17 you. She represented that she was coming out here on factual 18 matters related to clinical studies you did. She now has 19 gone beyond that and asked you what appears to me to be 20 expert opinions that were beyond the factual basis of what 21 you did. 22 You can decide in your own mind whether or not this 23 is related to your factual matters that you're here for or 24 whether or not she's just asking you to give opinions. And 25 if you'd like to consult with me on the side, we can have a DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 183 DAVID L. DUNNER, M.D., VOLUME I 1 side bar and we can discuss our position on this matter if 2 you'd like to do that. 3 THE WITNESS: I'd like to do that. 4 MR. HARREL: Okay, we'll take a break while we 5 consult. 6 MS. ZETTLER: Make sure he understands I do have 7 the right to go in and test his refusal to answer these 8 questions before the Court and then bring him back to answer 9 them if I win. 10 (Short break) 11 MR. HARREL: Back on the record. I'll state as a 12 preliminary matter that Ms. Zettler said they are going to 13 have the deposition of Dr. Dunner in any event another day, 14 they said they weren't going to finish. They told me when we 15 started the deposition today they aren't going to finish by 16 Tuesday noon. So I don't feel it's fair for her to say they 17 are going to ask for terms to fly back out here when they 18 were planning on doing it anyway. 19 Secondly, the doctor has advised me that he feels 20 this is an expert opinion. It doesn't relate to any of the 21 factual matters he's here for today, and you can confirm 22 that. And so on the basis you refused to pay him as an 23 expert witness, then I think you should limit his opinions to 24 the facts. 25 Q. (By Ms. Zettler:) So based on that you're going to DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 184 DAVID L. DUNNER, M.D., VOLUME I 1 refuse to answer that question, Doctor? 2 A. Well, this is certainly a very complicated question 3 to answer and does require the opinions of an expert in the 4 area. And I have reviewed a lot of the literature in the 5 area, and it's not a very simple question. I think it goes 6 beyond any research studies we did with Lilly with a 7 murder-suicide in Kentucky. 8 Q. You were a member of the pharmaceutical drug 9 advisory committee that was convened in 1991, September of 10 the 1991 on the issue of suicidal ideation, violent and 11 aggressive behavior and the use of antidepressants, were you 12 not? 13 A. Yes, I was. 14 Q. And during that committee data was presented by Eli 15 Lilly and others related to that issue, was it not? 16 A. Yes, it was. 17 Q. Is there any additional data that you would have 18 liked to have seen or any additional studies that you would 19 have liked to have seen outside of the data you saw or heard 20 throughout that meeting that was not presented? 21 A. I don't recall. There was additional data that I 22 think I asked about at the meeting that the FDA person 23 presented relating to the denominator of the exposure rate. 24 And what the FDA was presenting, if I can recall that meeting 25 correctly, I may not, was that there was an increase in DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 185 DAVID L. DUNNER, M.D., VOLUME I 1 reports to the FDA over a specified period of time and that 2 that was unusual for them to have an increase of that kind. 3 On the other hand, they had no data to really discuss how 4 many exposures likely occurred in that period of time that 5 were relevant. 6 Frankly, I tended to discount most of the data from 7 sponsors, not only Lilly but other people. I listened to it, 8 but I think what impressed me most at that meeting in terms 9 of data were two points. One was that there was an absolute 10 decrease in the rate of suicide in the United States after 11 the introduction of fluoxetine, and I believe the numbers 12 were 12.9 to 12.8 per 100,000 per year. 13 And the second point was the presentation made by 14 Bill Potter of the National Institute of Mental Health where 15 he discussed the epidemiological studies of depression and 16 suicidal behaviors and reviewed those in the context of how 17 many suicide attempts would likely have occurred just on the 18 basis of the epidemiology of depression with the number of 19 people known to have been treated with fluoxetine in that 20 particular interval. And it was some several times more than 21 the number reported to the FDA. 22 Those were actually the two bits of information 23 that I needed for my decision on that day, because I felt 24 that they were the most independent bits of data that were 25 produced and were also in line with my own clinical practice DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 186 DAVID L. DUNNER, M.D., VOLUME I 1 and in line with everybody else that was presenting data, 2 albeit how slanted the data may have been. And I have no 3 sense that the data was necessarily slanted, except I'm 4 always skeptical of when people present data from a 5 pharmaceutical company or from a university, I'm skeptical. 6 That's part of what I do as a university professor. 7 There may have been other bits of information that 8 would have been useful to have at that time, but I don't 9 think they were necessarily practical. There may have been 10 other things that I wanted to have seen at that time, but I 11 don't know that I can recall them specifically right now. 12 Q. What information would you have liked to have seen 13 that you feel may not necessarily be practical? 14 A. A prospective study of violence would have been 15 wonderful, but that's not a practical study. 16 Q. Why? 17 A. Because you can't predict who is necessarily going 18 to be violent. You can't do that study in an ethical manner, 19 at least I can't think of a way of doing a placebo-controlled 20 or multi-armed study as placebo-controlled in people who 21 might potentially kill others, in an ethical manner. That 22 would be a very difficult study to design. And the rarity of 23 the event itself would lead one to the impracticality of 24 developing a study that would make any sense. 25 Q. This absolute decrease of suicide that you just DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 187 DAVID L. DUNNER, M.D., VOLUME I 1 testified to, do you consider it statistically significant, 2 the decrease from 12.9 to 12.8? 3 A. No, I didn't. What was interesting, though, was 4 that it didn't go up. You know, the world is made simply 5 when it works well. And if fluoxetine or other 6 antidepressants increased suicidal behaviors, suicidal 7 ideation, suicidal attempts and suicide, then there should 8 have been an increase in that rate. It may not have been 9 statistically significant. 10 The fact that there was a decrease in that rate was 11 to me rather impressive. In other words, those numbers, 12 which were kind of just anecdotally produced for the 13 committee, I guess they came from the FDA or somebody, I 14 don't even know who they came from, were rather impressive to 15 me that that actually was a number -- you know, that it went 16 in the opposite direction. 17 You would have to go very hard to show that 18 something caused more suicide if the actual rate in the 19 United States showed a decrease in suicide. And let's say 20 fluoxetine was used fairly ubiquitously in depression during 21 that, you should have seen many more suicides. The rate 22 should have gone up. 23 Q. Were those numbers, the 12.9 down to 12.8, adjusted 24 for statistical error, to your knowledge? 25 A. I don't know anything about the numbers. All I DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 188 DAVID L. DUNNER, M.D., VOLUME I 1 know is that they were presenting time one/time two data. I 2 don't know how those numbers were obtained. I don't remember 3 that now. All I remember was reading it and saying that's 4 interesting, and then Bill Potter's data I found very 5 interesting. And then the rest of the data presented at the 6 advisory committee was supportive of the conclusion that 7 antidepressants decrease suicidal ideation and behaviors and 8 not increase suicidal ideation and behaviors. 9 Q. What other drug manufacturers presented information 10 at the drug advisory committee? 11 A. Not many. I think there was a little bit presented 12 from Mead Johnson about Trazadone, but I think it was 13 inconsequential, just a statement or two. I don't know that 14 other manufacturers -- I just don't recall who else was there 15 who presented. 16 Q. In fact, Doctor, wasn't a statement made at the 17 beginning of the meeting that other drug manufacturers were 18 invited to present data but had declined and the only one 19 that did present data was Eli Lilly? 20 A. I don't remember that statement. I do remember 21 something about Mead Johnson and Bristol-Myers and Squibb 22 giving information as committee members. 23 Q. Were you given that in written form or verbal form? 24 A. I think it was in written form and it was just a 25 statement. I don't think it was much data to it. I remember DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 189 DAVID L. DUNNER, M.D., VOLUME I 1 something from that company. 2 Q. In fact, the majority of the meeting revolved 3 around suicidality and using fluoxetine or violent and 4 aggressive behavior while using fluoxetine, did it not? 5 A. Yes, it did. 6 MR. MYERS: Object to the form. 7 Q. (By Ms. Zettler:) Were you given written 8 information before or after the committee meeting was held? 9 A. I don't specifically remember, but what usually 10 happened with advisory committee meetings for the FDA was 11 that we were given some information some time before the 12 meeting to review prior to the meeting, and I feel that that 13 kind of information was provided. And I don't recall what 14 was in it particularly, but it may have been that suicide 15 rate data was in it. 16 Q. Have you seen the suicide rate data that you just 17 talked about published anywhere or mentioned anywhere besides 18 at the advisory committee meeting? 19 A. I've seen suicide rate data presented in other 20 formats, but not particularly over that time frame. 21 Q. The same type of data? 22 A. No. 23 Q. Indicating a decrease in suicidality? 24 A. That was the data that was presented to us. 25 Q. At the advisory committee? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 190 DAVID L. DUNNER, M.D., VOLUME I 1 A. Yes. 2 Q. My question is have you ever seen any data other 3 than at the advisory committee meeting that suggested that 4 there has been a decrease in suicidality since fluoxetine was 5 put on the market? 6 MR. HARREL: Can you repeat that? I couldn't hear 7 that. 8 Q. (By Ms. Zettler:) Sure. My question is other than 9 the information that was presented at the advisory committee 10 meeting, have you seen any other data published anywhere or 11 disseminated in any way that suggests a decrease in 12 suicidality? 13 A. Not in that form. There are two other bits, 14 though. One is as the director of the psychiatric service of 15 a large metropolitan hospital, because I was director of 16 Harborview Medical Center and Psychiatry Service which had 17 the major trauma center/emergency room in the city of 18 Seattle. 19 I was well aware of the frequency of suicide 20 attempts in the city of Seattle over years, and we had asked 21 them to notify us if patients with fluoxetine came in with 22 suicide attempts. And it took a long time before any patient 23 was brought to my attention who had made a suicide attempt on 24 fluoxetine, a long time meaning probably at least a year 25 after the release of fluoxetine. That was quite unusual. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 191 DAVID L. DUNNER, M.D., VOLUME I 1 The second is that in our own clinical experience 2 in treating patients who had had suicidal behaviors and 3 treating such patients with fluoxetine, we noticed a decrease 4 in suicidal behaviors over time of treating them. And that 5 was a personal observation of patients I've personally 6 followed. 7 And the third data was the paroxetine data that I 8 presented at ACMP which showed a -- with a different drug and 9 not an overall population frequency rate, but a clear 10 decrease in any way you wanted to measure suicidal behaviors 11 with treatment. 12 Q. And that was information that was provided to you 13 by the drug company itself; correct? 14 A. That's correct. 15 Q. Which you said that you were to some extent suspect 16 of during the advisory committee meeting, I mean that type of 17 information? 18 MR. HARREL: Object to the form of the question as 19 mischaracterization. 20 MR. MYERS: And it's leading. I'll object to the 21 form. 22 THE WITNESS: That's correct, but in this case I 23 had a chance to go over the actual data with Dr. Dunbar. 24 Q. (By Ms. Zettler:) Did you look at all of the -- 25 A. I didn't look at the case report forms, but I asked DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 192 DAVID L. DUNNER, M.D., VOLUME I 1 that things be analyzed in certain ways and had a fair amount 2 of input into the actual data analysis. 3 Q. Have you heard the statistical term garbage in 4 garbage out? 5 A. Sure. 6 Q. So you didn't look at the original data on those 7 studies, you just looked at their compilation of data? 8 A. Correct. But that doesn't mean it was garbage in 9 garbage out. 10 Q. My original question, Doctor, was with regards to 11 the statistics on the decrease of suicidality, just with 12 regards to published statistics or published data or data 13 disseminated from any other source other than at the advisory 14 committee meeting, have you ever seen any other data that 15 suggests statistically that there is a decrease in 16 suicidality? 17 A. I'm not aware of any data about suicide rates in 18 the United States at any other point in time other than those 19 two data points. 20 Q. If those numbers were generated by somebody at 21 Lilly or on behalf of Lilly, would you be suspect of those 22 numbers? 23 A. Not necessarily. I don't know that those data 24 would be generated by Lilly. I think those data likely would 25 have been generated by people accessing large data bases from DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 193 DAVID L. DUNNER, M.D., VOLUME I 1 metropolitan hospitals and metropolitan cities. I mean, we 2 keep a data base in Seattle on suicides per 100,000 per year. 3 That's published data and I've seen that data in Seattle, but 4 that's not national data. 5 Q. Again, my question is not whether or not it was 6 done by somebody else, my question is if those numbers were 7 numbers that were presented by somebody on behalf of Lilly or 8 by Lilly, would you be more suspect of that information? 9 MR. MYERS: Asked and answered. 10 MR. HARREL: Same objection. He just answered that 11 question the best he could. 12 MS. ZETTLER: I think it's a yes or no. 13 MR. HARREL: I don't think it is. 14 THE WITNESS: I think I answered the question. Do 15 you want to ask it again? 16 MS. ZETTLER: I'd like an answer. 17 MR. MYERS: Same objection. 18 Q. (By Ms. Zettler:) I think your answer was 19 non-responsive, Doctor. 20 A. I think I would like to know what data bases were 21 pulled. If someone from Lilly had been involved in the 22 analysis of those data, I would like to know what were the 23 data bases that were pulled to form the data. 24 Q. Did you ask that question during the advisory 25 committee meeting? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 194 DAVID L. DUNNER, M.D., VOLUME I 1 A. No, I did not. 2 Q. Did you ask where that information came from at 3 all? 4 A. I don't think so. 5 Q. Dr. Potter was a member of a psychiatric 6 association of some kind, was he not? I mean, like some sort 7 of support group type of thing or community association? 8 A. Bill Potter, I don't know his exact title, but I 9 think it was more or less associate director of the National 10 Institute of Mental Health. He was a government employee. 11 Q. If Eli Lilly had a financial stake in the group 12 that Dr. Potter was involved in, would that cause some 13 suspicion in your mind as to the validity of the studies he 14 presented at the advisory committee meeting? 15 MR. MYERS: Object to the form. Assumes facts not 16 in evidence. 17 THE WITNESS: I find Bill Potter to be one of the 18 most honest people in science that I've ever met. 19 Q. (By Ms. Zettler:) Are you familiar with Fred 20 Goodwin? 21 A. Yes, I am. 22 Q. Who is Fred Goodwin? 23 A. Fred Goodwin is a psychiatrist at the National 24 Institute of Mental Health who was the -- I don't know what 25 Fred's title is now. He was the -- I'm going to get it DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 195 DAVID L. DUNNER, M.D., VOLUME I 1 wrong. Something equivalent of the scientific director of 2 the National Institute of Mental Health. 3 Q. Do you think it's appropriate for somebody who was 4 at least in Dr. Goodwin's position such as you just described 5 to consult with a drug sponsor of a drug or a drug company as 6 to how to respond to accusations about that company's product 7 to the public? 8 MR. MYERS: Object to the form. Assumes facts not 9 in evidence. 10 MR. HARREL: Is this somehow going to relate to the 11 facts in this case, Counsel? 12 MS. ZETTLER: Sure it does. It relates directly to 13 the facts of this case. 14 MR. HARREL: It seems kind of far afield again in 15 opinions. 16 THE WITNESS: I think people at NIMH frequently 17 consult with industry, and I don't see anything particularly 18 wrong with that. 19 Q. (By Ms. Zettler:) Do you think there's something 20 wrong with a drug company educating somebody like Dr. Goodwin 21 as to what they should say, in other words telling them what 22 they should say in public about a drug? 23 MR. HARREL: Object to the form of the question as 24 compound. 25 MR. MYERS: Same objection as I earlier urged. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 196 DAVID L. DUNNER, M.D., VOLUME I 1 MR. HARREL: You said educating and then telling, 2 so that's two questions. 3 Q. (By Ms. Zettler:) Okay, let's just be blunt about 4 it. 5 Do you think it's appropriate for somebody such as 6 Dr. Goodwin to allow a drug company to tell them how to 7 answer questions in public about one of the drug company's 8 drugs? 9 MR. MYERS: Object to the form. Assumes facts that 10 are not in evidence. 11 MR. HARREL: What time frame? 12 MS. ZETTLER: Any time. 13 THE WITNESS: We always hear things from drug 14 companies. You know, what you do with it is another matter. 15 I mean, you're always getting told from a drug company 16 something, and you take it in and you sift it out and it gels 17 with what you know or you don't know. Whether it's a sales 18 rep or a meeting where you go to where something is 19 presented, you put it in the context of everything else. 20 It doesn't mean that you change how you think, it 21 means that you evaluate what you hear, and I find Fred 22 Goodwin able to evaluate what he hears quite well. And 23 because he's in the position that he's in at the National 24 Institute of Mental Health, I'm sure he has everybody telling 25 him their opinions on just about every issue. And I'm sure DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 197 DAVID L. DUNNER, M.D., VOLUME I 1 he listens to them, because he's a reasonably good listener. 2 Q. (By Ms. Zettler:) What if he were to take what is 3 said to him or told to him by a drug company and to repeat it 4 verbatim at the request or direction of the drug company 5 without regards to his own opinions? 6 MR. MYERS: Same objection. 7 Q. (By Ms. Zettler:) In other words, what if he were 8 to be a mouthpiece in effect for the drug company given his 9 governmental position? 10 MR. MYERS: Object to the form. Same objection. 11 THE WITNESS: I would assume that if Fred Goodwin 12 did that that it was because that's what he believed in, 13 because I don't think that he would do something that he 14 didn't believe in. 15 Q. (By Ms. Zettler:) Do you feel the same way about 16 Dr. Paul Leber at the FDA? 17 A. I think Paul Leber is very cautious about his 18 contacts with the industry. 19 Q. Do you think it's cautious for somebody like Dr. 20 Leber to have a 6:15 a.m. phone call with an Eli Lilly 21 employee in which he discusses putting caps on the number of 22 adverse events related to suicidality on fluoxetine? 23 MR. MYERS: Object to the form. Assumes facts that 24 are not and will not be in evidence. 25 THE WITNESS: I don't have the faintest idea what DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 198 DAVID L. DUNNER, M.D., VOLUME I 1 that would be about. 2 MR. SMITH: Let's put it into evidence right now. 3 Since he says it will never be in evidence, let's put it into 4 evidence right now. 5 (Short break) 6 MS. ZETTLER: Well, I seem to have left it back at 7 the hotel, so we'll have to use it tomorrow. 8 MR. HARREL: Is the record clear that the document 9 she was going to show him isn't being shown to him; is that 10 correct? 11 MS. ZETTLER: Right. 12 MR. SMITH: We lied. There is no such document. 13 MS. ZETTLER: Larry's right. It's never going to 14 be entered into evidence anywhere. 15 Q. (By Ms. Zettler:) Doctor, does fluoxetine 16 manipulate the brain chemistry at all? 17 MR. MYERS: Object to the form and the term 18 manipulate as being vague. 19 THE WITNESS: Yeah, I don't know that that would be 20 the right term. 21 Q. (By Ms. Zettler:) Does it affect brain chemistry? 22 A. Fluoxetine affects brain chemistry. 23 Q. How do you know that? 24 A. Well, you can study it in animals and show that it 25 affects brain chemistry in animals, and it affects behavior DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 199 DAVID L. DUNNER, M.D., VOLUME I 1 in people presumably by affecting brain chemistry in people. 2 Q. But that's an assumption, is it not, in people when 3 it affects brain chemistry? 4 MR. SMITH: Did I hear you right? Did you say 5 fluoxetine affects behavior in people? 6 THE WITNESS: Yes. 7 Q. (By Ms. Zettler:) Whether or not fluoxetine 8 affects brain chemistry in people is really an assumption, an 9 extrapolation, is it not? 10 MR. MYERS: Object to the form. Leading. 11 THE WITNESS: I don't know of any direct evidence 12 in man of fluoxetine affecting chemistry. That would be a 13 true statement. 14 Q. (By Ms. Zettler:) So fluoxetine was created and 15 developed by Eli Lilly under the assumption that it would 16 affect the reuptake of serotonin in the human brain; correct? 17 MR. MYERS: Object to the form. Leading. Assumes 18 facts that are not in evidence as well. 19 THE WITNESS: I don't have the faintest idea why 20 Eli Lilly developed fluoxetine. 21 Q. (By Ms. Zettler:) Did they do it for the good of 22 man? 23 A. I don't have the faintest idea why Eli Lilly 24 developed fluoxetine. 25 Q. They are in the business of making money, aren't DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 200 DAVID L. DUNNER, M.D., VOLUME I 1 they? 2 MR. MYERS: Object to the form. Leading. 3 THE WITNESS: All American companies are in the 4 business of making money. 5 Q. (By Ms. Zettler:) If the drug isn't tested and 6 marketed under the premise that it is going to affect the 7 reuptake of serotonin, why else would it have been put on the 8 market? 9 MR. HARREL: I guess that's a different question. 10 THE WITNESS: Let me try it again. 11 Nobody knows how depression comes about or what 12 makes it work. Because a drug tends to work in a certain way 13 in animals, there is a belief that the drug may have putative 14 action on some behavior whether that is sleep or appetite or 15 depression or aggression or something else. And based on 16 those studies, drugs are then tested further in animals to 17 determine safety and then tested in people to determine 18 safety and then tested in patients with the target disease to 19 determine dosing, side effects and effects on behavior. 20 Now, because a drug is thought to work in a certain 21 way doesn't mean that that's necessarily how it works. And 22 there are theories about tricyclic antidepressants that have 23 been around for a long time that they block reuptake of 24 catecholamines, norepinephrine and serotonin. But there also 25 are some later theories that they down-regulate beta DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 201 DAVID L. DUNNER, M.D., VOLUME I 1 receptors, and perhaps their mechanism of action was through 2 that -- I'm sorry, you're moving around. 3 MS. ZETTLER: Go ahead. I just wanted to go get 4 something while you were talking. Go ahead. 5 MR. HARREL: If that's distracting, Doctor, you can 6 wait until she gets back. She's walking over at the other 7 end of the room and is thumbing through notebooks so -- 8 THE WITNESS: Well, there are several examples of 9 drugs that work as antidepressants where we don't know what 10 they do in animals, B-propion being a very good example of 11 that, lithium which doesn't fit the hypothesis of 12 down-regulation which is a very different hypothesis about 13 how antidepressant effect comes about. 14 And I think really the proof is in the pudding. If 15 you give it to people with a problem and you find that it 16 works then it becomes an antidepressant. And if it has all 17 the drug screens in the world that says it's going to do that 18 but it doesn't work in patients with the disease, then it's 19 not an antidepressant. 20 Q. (By Ms. Zettler:) You've already testified today 21 too that every patient on any drug is going to some extent 22 react to a placebo effect; correct? 23 MR. MYERS: Object to the form. 24 THE WITNESS: No, I didn't say that. I said that 25 there is a placebo effect in depression, and that one doesn't DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 202 DAVID L. DUNNER, M.D., VOLUME I 1 know if a patient who gets better responds because of the 2 medication or because of what is called the placebo effect 3 which is a combination of a whole bunch of things including 4 psychological as well as getting better because of the 5 natural course of a disease running its course. 6 Q. (By Ms. Zettler:) And you've also testified today 7 that at least in some of your fluoxetine patients you felt it 8 necessary to prescribe concomitant sedating-type 9 antidepressants such as tricyclics; correct? 10 A. Correct. 11 Q. And in those cases when somebody is getting better 12 and they are on both drugs, you're not sure if it's the 13 fluoxetine or the other antidepressants that caused them to 14 get better; correct? 15 A. But more likely the fluoxetine because of the doses 16 of the concomitant medications. 17 Q. So your testimony is different than what it was 18 this morning? 19 A. That's what I said this morning. 20 MS. MYERS: Object to the form. You're 21 mischaracterizing what he said. 22 Q. (By Ms. Zettler:) But you've never taken, at least 23 to the best of your recollection, somebody who is on a 24 concomitant tricyclic antidepressant off the fluoxetine to 25 see if it is in fact the tricyclic that is causing their DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 203 DAVID L. DUNNER, M.D., VOLUME I 1 improvement as opposed to the fluoxetine; right? 2 A. I doubt that I would ever do that. I'll bet you 3 I've had patients who have done that and gotten worse and 4 went back on the drug. 5 Q. Do you remember any specific case where that has 6 happened, Doctor? 7 A. I don't remember specific cases, but I've treated 8 an awful lot of people and it's probably happened. 9 Q. Where they've taken themselves off of fluoxetine in 10 that situation? 11 A. Yes. 12 Q. Why would they do that? 13 A. Cost. 14 Q. But you can't point to one -- 15 A. Sexual dysfunction, another side effect I didn't 16 mention earlier. 17 Q. Is sexual dysfunction a side effect of fluoxetine? 18 A. Yes. Go ahead. 19 Q. No, go ahead. Are you finished with your answer? 20 A. I finished what I wanted to say. 21 Q. Sexual dysfunction is a side effect that has only 22 recently come to light in the past couple of years, isn't 23 that true? 24 MR. MYERS: Object to the form. Assumes facts not 25 in evidence. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 204 DAVID L. DUNNER, M.D., VOLUME I 1 THE WITNESS: Sexual dysfunction has been around 2 since there's been sex. 3 Q. (By Ms. Zettler:) I'm talking about as a side 4 effect or an adverse event related to fluoxetine, Doctor. 5 A. Actually, sexual dysfunction was reported in the 6 earlier clinical trials, but not to a great extent. 7 Q. In the two clinical trials that you were involved 8 in on fluoxetine, in clinical trial protocol 27 and 62, is it 9 not true that the conclusion that was come to was that 10 fluoxetine was not efficacious? 11 A. I don't know what your numbers refer to, Ms. 12 Zettler. The first study that we did with imipramine, 13 fluoxetine and placebo, none of the drugs worked better than 14 each other; i.e., that the placebo response and the 15 imipramine response were the same which invalidated the study 16 from efficacy and therefore made the study only valid for 17 side effects. 18 I don't recall the results of another study being 19 negative. I thought earlier studies were positive, but I may 20 be wrong. And I'm not sure what your numbers refer to. 21 Q. Are you familiar with any claim made by Eli Lilly 22 or anybody else that fluoxetine is more efficacious than 23 tricyclic antidepressants? 24 MR. MYERS: I object to the form. 25 THE WITNESS: I'm not familiar with that. In fact, DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 205 DAVID L. DUNNER, M.D., VOLUME I 1 everything that we've put into our educational packets 2 indicated that efficacy is really similar among all of the 3 antidepressants. 4 Q. (By Ms. Zettler:) So really it's just a side 5 effect profile that is something different to offer with 6 fluoxetine; correct? 7 A. You've heard the message. 8 Q. Over and over. 9 So in fact, one of the best features about 10 fluoxetine is it's very difficult to kill yourself on that 11 drug, is it not? 12 A. That's true. 13 Q. And based on that and reported ease in prescribing 14 as well as some lack of anticholinergic side effects is the 15 basis for promoting the use of fluoxetine to primary care 16 physicians; correct? 17 MR. MYERS: Object to the form. Leading and 18 assumes facts not in evidence. 19 THE WITNESS: Well, I think primary care physicians 20 for some strange reason like to give single daily dosing. 21 That's something that I wasn't familiar with, because 22 psychiatrists don't really care about single daily dosing. 23 We like to give pills all throughout the day. That was our 24 manner of prescribing tricyclics. So that wasn't an 25 important issue for us. Apparently it is important to DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 206 DAVID L. DUNNER, M.D., VOLUME I 1 primary care physicians. 2 I think with any new antidepressant that comes out, 3 safety from overdosing is a very critical factor. And that 4 certainly is something that makes the newer drugs, fluoxetine 5 and the other SSRI's stand quite apart from the tricyclics. 6 I think when one looks at the side effect profile 7 that's left, one has a tradeoff between anticholinergic side 8 effects, histaminergic side effects and alpha-adrenergic side 9 effects which are common among the tricyclic antidepressants 10 versus what I'll call the serotonin side effects which are 11 common among the serotonin drug. And so one has to decide 12 which of those profiles would be better for the patient that 13 you've treated. 14 Q. (By Ms. Zettler:) Prior to serotonin reuptake 15 inhibitors, were primary care physicians very comfortable 16 with treating depressions with psychotropics? 17 A. I don't think primary care physicians are 18 comfortable to this day about either recognizing depression 19 or treating depression. 20 Q. Do you have any idea of how many primary care 21 physicians are prescribing Prozac for people that they 22 believe to be depressed at this time? 23 A. I do not. 24 Q. You've on at least a couple of occasions talked to 25 primary care physicians about identifying depression and DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 207 DAVID L. DUNNER, M.D., VOLUME I 1 treating it; correct? 2 A. Yes, I have. 3 Q. You've done that on behalf of Eli Lilly; correct? 4 A. And other companies, correct. 5 Q. Have you talked to primary care physicians about 6 prescribing Prozac to treat depression? 7 A. Yes, I have. 8 Q. And what have you told them are the benefits of 9 using Prozac as opposed to other drugs, if anything? 10 A. Pretty much what I said before, it's a tradeoff for 11 side effects. There's no difference in efficacy when one 12 chooses an antidepressant or not to choose a drug really 13 looking at the side effect profile. 14 And there may be other situations that impinge on 15 choice of antidepressants. For example, if someone has 16 responded very nicely to a certain drug in the past, it might 17 make sense to prescribe that drug for them again. If someone 18 has a family member who seems to have responded to a certain 19 drug, it may make sense to prescribe that medication for them 20 also since there is some very soft data that there may be a 21 familial response to antidepressant treatment. 22 On the other hand, all things being equal, I think 23 that you have pros and cons about any drugs you choose for an 24 individual patient. And the important thing is to be aware 25 of both the pros and the cons, but especially the cons, DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 208 DAVID L. DUNNER, M.D., VOLUME I 1 because if you're choosing a tricyclic, you have dose 2 escalation problems, side effects to manage, you need to know 3 how to do that. 4 If you're choosing an SSRI like fluoxetine, you 5 have to also know something about its side effect profile and 6 how to get rid of its particular side effects such as nausea, 7 how to deal with other things that may come along such as 8 headaches or insomnia or sedation or whatever. 9 So I think it's important that if you're using a 10 drug that you know how to manage the side effects of that 11 particular drug. 12 Q. What do you tell primary care physicians to do if 13 they have a patient on fluoxetine that starts suffering from 14 insomnia? 15 A. I think there are lots of things they can do. What 16 I generally try to do is ask them what they do first and find 17 out what their usual drug treatments are for that kind of 18 problem. Some drug treatments are perhaps more preferable 19 than others. Some are perhaps more illogical than others. 20 Some are outright dangerous when you get right down to it. 21 Q. What do you generally recommend that doctors do 22 when they find a patient who suffers from insomnia on 23 fluoxetine? 24 A. For treatment-emergent insomnia I would recommend 25 that they prescribe a small dose of Trazadone if the patient DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 209 DAVID L. DUNNER, M.D., VOLUME I 1 is a woman. And if the patient is a man that they prescribe 2 a small dose of a tricyclic, sedating tricyclic 3 antidepressant such as doxepin or amitriptyline or 4 imipramine. 5 Q. Why is there a differentiation between men and 6 women? 7 A. Because Trazadone has a particular side effect in 8 men called priapism, a large erection of the penis, and we 9 don't recommend that Trazadone be given for treatment for 10 men. 11 Q. What about agitation? If they have somebody who is 12 agitated, what do you generally recommended they do to 13 counteract that? 14 A. Usually if someone is agitated it's going to be 15 beyond the primary care physician's sense of what to do, and 16 I think they probably are best off sending that patient to a 17 psychiatrist for consultation or calling their local 18 Department of Psychiatry for consultation. 19 Q. Is that what you would recommend for them to do? 20 A. I think that that's what I would generally 21 recommend to do if they get a side effect that goes beyond 22 what they ordinarily deal with. 23 One of the things that I think is a bad idea to do 24 is to prescribe an antipsychotic drug, for example, which 25 some primary care physicians might do, but that leads to a DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 210 DAVID L. DUNNER, M.D., VOLUME I 1 whole host of other problems. I mean, you know, primary care 2 physicians are I don't think well-trained in psychiatry. I 3 mean, that's my experience in dealing with them. 4 It's unusual that they tolerate many side effects 5 coming out of their patients. What they would like to do is 6 to put the patient on a drug and have the patient never come 7 back and that would be wonderful. So if the patient comes 8 back or calls in four days and says this is happened, it 9 bothers the primary care physician because they are kind of 10 over their head. And any side effect that is more 11 complicated than some sedation or insomnia quickly gets over 12 their head. 13 Q. So just to make sure I understand you, it's your 14 experience that primary care physicians prefer to prescribe a 15 drug that they are confident are not going to produce as many 16 side effects as, say, another drug in the same class? 17 A. I think that's true of all physicians whatever the 18 illness. I mean, you would hesitate to prescribe a big side 19 effect drug if a low side effect drug is available with equal 20 efficacy no matter what the condition is. 21 Q. But as far as dealing with depression and other 22 psychiatric illnesses on the part of the primary care 23 physician, they are already out of their realm, so to speak, 24 as far as a specialty; correct? 25 A. Actually, their major problem is recognition, and DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 211 DAVID L. DUNNER, M.D., VOLUME I 1 there are lots of research studies that demonstrate that 2 primary care physicians do very poorly in recognizing 3 depression. So that I think the major educational effort 4 supported by all of the pharmaceutical companies that make 5 antidepressant drugs has been toward recognition much more so 6 than treatment, because, you know, the treatment is a choice 7 of drugs that work equally, but the key is to get the illness 8 recognized. And I think that's really where most of the time 9 in these conferences or talks or whatever is spent. 10 Once you get the patient on a drug then you have to 11 worry about how to deal with that drug. But the problem is 12 most primary care physicians don't ever get that far, they 13 just miss the diagnosis. 14 Q. Would you as a psychiatrist prefer that primary 15 care physicians refer all potential psychiatric cases to 16 somebody who specializes in that area be it a psychologist or 17 a psychiatrist? 18 A. Well, I don't think it's practical. I think that 19 for the most part people don't come into a psychiatrist's 20 office with a garden variety depression, they usually go to 21 their primary care doc, and they don't necessarily recognize 22 that they have a depression. The patient may not recognize 23 they have a depression. 24 The patient may say I have a headache or I have 25 weakness or I'm having GI problems or I'm not sleeping. And DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 212 DAVID L. DUNNER, M.D., VOLUME I 1 what often happens is the primary care physician is 2 symptom-oriented and will make a diagnosis of headache, 3 stomach problems, insomnia and prescribe something directly 4 for that condition without giving it too much thought and 5 really miss the idea that depression is a syndrome with a lot 6 of these different symptoms incorporated in it, and that the 7 syndrome can be treated very easily with a prescription of a 8 variety of antidepressant drugs. 9 I think that that's what the world needs, because 10 frankly, I would much rather spend my time seeing more 11 complicated patients than the ones who are so really very 12 easy to treat. I mean, it's nice to get somebody better 13 quickly, but it's not needed for my expertise to do that. 14 And I think most psychiatrists are increasingly comfortable 15 with the role of being the referral of someone who hasn't 16 done well in primary care settings. 17 Q. What is a garden variety depressed patient? 18 A. That's somebody who has never been treated who has 19 a bunch of symptoms, who has a moderate degree of depression, 20 is probably still working but not functioning all that well, 21 and who comes in complaining of something related to 22 depression and can be quickly treated with any of the drugs 23 that are on the market and probably get mostly better in four 24 weeks. 25 Q. Do you believe that every person that is allegedly DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 213 DAVID L. DUNNER, M.D., VOLUME I 1 suffering from depression should be treated with an 2 antidepressant? 3 A. No. 4 Q. In what cases should a person -- 5 A. I said moderate depression, didn't I? See, I think 6 the practice guidelines for depression also point toward 7 moderate depression -- mild depression being treated 8 primarily with psychotherapy designed for depression such as 9 cognitive therapy or interpersonal therapy which 10 psychotherapists have been studying for depression. Severe 11 depression requires private hospitalization and ECT. 12 Moderate depression, I think the data supports the notion 13 that that responds much better to antidepressants than to the 14 psychotherapies designed for depression. 15 The treatment outcome studies from the NIMH, for 16 example, clearly show that -- well, don't clearly show 17 anything, but probably a good interpretation of the studies 18 is that the sicker you are the more you need an 19 antidepressant, in that case imipramine. 20 Q. Is a suicidal ideation or suicide attempts an 21 indication of a more severely depressed patient? 22 A. A suicide attempt in the absence of other 23 depressive symptoms is a very difficult problem for someone 24 to deal with. 25 Q. You're talking about somebody who has been DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 214 DAVID L. DUNNER, M.D., VOLUME I 1 diagnosed as suffering from depression? 2 A. No, but someone who has depressive symptoms, makes 3 a suicide attempt and says I feel all better now is a very, 4 very difficult patient to deal with. So that it creates a 5 real problem as to whether the patient is actually covering 6 up depressive symptoms, whether they've temporarily gone 7 away, whether the person is really at risk to suicide. And I 8 think most psychiatrists would opt for a more restrictive 9 in-patient treatment for that kind of patient not willing to 10 take the chance of an out-patient treatment. 11 Q. So is the answer to my question yes or no? 12 A. Could I try the question again, please. 13 Q. Sure. When we're talking about somebody who has 14 been diagnosed with depression and they become suicidal, does 15 that indicate a worsening of the depression? 16 A. It can. 17 Q. What about fluoxetine causes somebody to become 18 suffering from insomnia? What is it about the fluoxetine? 19 A. Serotonin has a role in sleep. It's interesting 20 that all of the serotonin drugs have about as much sedation 21 as insomnia associated with the side effect profiles. And if 22 anything, they all tend to be a little bit more sedating than 23 producing insomnia, but it's about 15 percent for each. 24 So I don't know how to answer that question since 25 most of the patients who get treated with Prozac or other DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 215 DAVID L. DUNNER, M.D., VOLUME I 1 SSRI's have no sleep change. It doesn't necessarily produce 2 insomnia in everybody and in some people it produces 3 sedation. 4 Q. What is it about fluoxetine that causes agitation 5 in some of the patients that take it? 6 A. I don't know why that occurs. I think it may occur 7 as a result of drug-drug interactions. Our general style is 8 if someone is on an antidepressant and we switch to 9 fluoxetine, we cut the dose of the antidepressant. We 10 haven't seen in our clinical experience the agitation and 11 some of these early side effects that other clinicians 12 report. And I can't ascribe it to any other causes other 13 than we are probably lowering the dose of concomitant 14 medication first and probably better than the other doctors 15 who are probably keeping the dose of some other 16 antidepressant on board and adding fluoxetine, getting the 17 drug-drug interaction. And that's why they are seeing more 18 agitation than we are. I don't have another way to explain 19 it. 20 Q. Did you see agitation in the clinical trials that 21 you participated in for Eli Lilly? 22 A. We probably saw some. We didn't see much. 23 Q. There is a connection at least in the literature 24 between serotonin and suicidality and violent aggressive 25 behaviors, isn't that true? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 216 DAVID L. DUNNER, M.D., VOLUME I 1 MR. MYERS: Object to the form. Leading. Assumes 2 facts not in evidence. 3 THE WITNESS: There is literature about that. 4 Q. (By Ms. Zettler:) There is literature? 5 A. Yes. 6 Q. Can you say unequivocally that fluoxetine has never 7 caused somebody to become suicidal in any case? 8 MR. MYERS: Let me object to the form of the 9 question to the extent it's a hypothetical. I don't think 10 you've given him sufficient facts to form an opinion. 11 THE WITNESS: I don't think I could say much 12 unequivocally. 13 Q. (By Ms. Zettler:) Well, let's limit it just to my 14 question. 15 Can you say unequivocally that there is not one 16 case of somebody who became suicidal on fluoxetine where 17 fluoxetine did not at least contribute to that suicidal 18 ideation? 19 MR. MYERS: Same objection. 20 THE WITNESS: It's a compound question. I'm not 21 sure I understand how to answer it yes or no, Ms. Zettler. 22 Could you read it again. Maybe I should write it down. 23 (Whereupon, the reporter read back the last 24 question.) 25 MR. MYERS: Same objection as the other question DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 217 DAVID L. DUNNER, M.D., VOLUME I 1 posed to the witness. 2 MR. HARREL: I'm going to object to the form of the 3 question. Because he has to diagram it out to answer it, 4 it's obviously complex and compound. 5 MS. ZETTLER: I think he just needs to listen to 6 the question without everybody making objections and talking 7 and give him a chance to really listen to it. 8 (Whereupon, the reporter read back the last 9 question.) 10 THE WITNESS: Hang on a second. I don't even know 11 if I can say the sentence, Ms. Zettler. There are two 12 negatives in it. 13 Q. (By Ms. Zettler:) Okay. Well, let's break it 14 down. We'll make it easier for you, Doctor. 15 A. I think I know the gist of what you want me to say. 16 Q. Well, I want to make sure that you understand it 17 completely so let me rephrase it. 18 There are people that have become suicidal or have 19 experienced increased suicidality while taking fluoxetine; 20 correct? 21 A. That's correct. 22 Q. Can you say unequivocally in any of those cases or 23 in all of those cases that fluoxetine did not contribute at 24 least to those persons either becoming suicidal or suffering 25 increased suicidality? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 218 DAVID L. DUNNER, M.D., VOLUME I 1 MR. HARREL: I'll object to the form of that 2 question. It's ambiguous. Any of those cases or all of 3 those cases? 4 Q. (By Ms. Zettler:) Let me ask it one more time, 5 because I know there's a few people in this room who don't 6 understand simple English. 7 My question is with regards to those people who -- 8 A. Excuse me. I think I understand simple English. I 9 have a lot of difficulty with compound questions. 10 Q. Well, we've moved on from that question. Let's not 11 talk about that question. That question is long over with. 12 My question now is in those people who have become 13 suicidal or have suffered increased suicidality while taking 14 fluoxetine, can you say unequivocally that in none of those 15 cases fluoxetine has contributed to the suicidality or 16 increased suicidality? 17 MR. MYERS: Same objection as to the form. It's a 18 defective hypothetical without sufficient facts for him to 19 form such an opinion. 20 MS. ZETTLER: These objections are getting really 21 old. 22 THE WITNESS: I guess the answer is no, if I have 23 the tenses right and the negatives right. 24 Q. (By Ms. Zettler:) Well, what about the tenses and 25 the negatives do you question, Doctor? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 219 DAVID L. DUNNER, M.D., VOLUME I 1 A. Well, I didn't get that one written down, but if I 2 got the thing right, I think the answer is no. 3 MR. SMITH: Well, we better make sure we're 4 communicating here. Why don't you have him repeat what his 5 understanding is of your question? 6 Q. (By Ms. Zettler:) Okay, yeah, why don't you go 7 ahead and do that. 8 A. Well, it's my understanding that you're supposed to 9 ask me the questions. 10 Q. Well, I just want to make sure -- I don't know how 11 I can make it any clearer, Doctor. 12 A. I've been telling you that you're asking questions 13 that are paragraphs, Ms. Zettler, and I've been having 14 trouble writing them down because they often have double 15 negatives. I understand the meaning of the term unequivocal, 16 that's not a problem. The issue is that everything is double 17 in here. 18 Q. Do you understand "contribute to?" Do you 19 understand what that means? 20 A. I think we're okay with "contribute to." 21 Q. Do you understand -- 22 A. "Contribute to" is recent. 23 Q. Unbelievable. Let me ask it one more time. 24 A. Do it slowly and I'll write it down. 25 Q. Well, I'm going to ask you a series of questions DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 220 DAVID L. DUNNER, M.D., VOLUME I 1 instead of asking you one big long one so you can really 2 understand it, okay? 3 My first question is would you agree with me that 4 there are people who have been on fluoxetine and while on 5 fluoxetine have either become suicidal or have suffered 6 increased suicidality; is that correct? 7 A. That's correct. 8 Q. Okay. We'll break it down. 9 With regards to those people who become suicidal 10 while on fluoxetine, okay? 11 A. Suicidal meaning -- 12 Q. They suffer suicidal ideation, they become actively 13 suicidal. I'm talking about where suicidality, whatever form 14 it takes, starts while they are on the fluoxetine, okay? 15 Can you say that there is not one case out there 16 where somebody has become suicidal on fluoxetine? 17 A. Hang on, it's a negative. Okay. 18 Q. Where fluoxetine -- 19 A. Is this supposed to be simple? 20 Q. It is. 21 A. We're in our third clause. Go ahead. 22 Q. Where fluoxetine has not contributed to that 23 suicidal ideation or suicidality? 24 Why don't you read it back as you have it written 25 down there. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 221 DAVID L. DUNNER, M.D., VOLUME I 1 A. Well, you've got two negatives again. 2 Q. You're an educated guy, Doctor. You can't figure 3 out what negatives mean in a sentence? 4 MR. MYERS: I have the same objection as to the 5 form. I won't say it again. 6 THE WITNESS: Someone who became suicidal on 7 fluoxetine where fluoxetine has not contributed to the 8 suicidal ideation? 9 MR. HARREL: I see what the doctor's point is. I'm 10 going to object to the form of the question. It has double 11 negatives and is therefore ambiguous. 12 THE WITNESS: I think the answer to that question 13 is yes. 14 Q. (By Ms. Zettler:) Why don't you read back the 15 question as you have it written down. 16 A. Can I say unequivocally that where there are 17 patients who have become suicidal on fluoxetine that there is 18 not one case where someone became suicidal on fluoxetine 19 where fluoxetine has not contributed to the suicidal 20 ideation? 21 Q. No, that's not it. I'm going to object to this 22 entire process. 23 A. Ms. Zettler, I wrote down what you said. 24 Q. Well, you wrote it down wrong. 25 The question is there are people that have become DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 222 DAVID L. DUNNER, M.D., VOLUME I 1 suicidal while on fluoxetine; correct? 2 A. Correct. 3 Q. And we already have discussed fluoxetine having an 4 effect on brain chemistry; correct? 5 A. Correct. 6 Q. Can you say that there is no case out there, not 7 one case out there where somebody has become suicidal where 8 the drug has not at least contributed to that person becoming 9 suicidal? 10 MR. MYERS: Same objection to the form. 11 MR. HARREL: I object to the form of the question. 12 It's double negatives and he's had trouble with it. It's 13 ambiguous as he's interpreted it, and I object to the form of 14 the question as ambiguous. 15 THE WITNESS: I'd like to write it down again. 16 It's the same form. There's a double negative in there. I 17 was following you just fine until we got to the second 18 negative. I could have answered it I think really well. 19 It's the double negative that is very confusing to me. 20 MR. SMITH: Could I ask one question? 21 MR. HARREL: No. I'm going to object to you asking 22 any questions out of turn. 23 MR. SMITH: I'm just trying to help him. He's 24 having problems. I'm trying to be of assistance. To be a 25 friend of the Court down in Texas is what we say. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 223 DAVID L. DUNNER, M.D., VOLUME I 1 MS. ZETTLER: I think to a certain extent this 2 misunderstanding has been orchestrated, but let's try it one 3 more time. 4 THE WITNESS: I'm sorry. Are you impuning that I 5 am doing this for some reason other than I don't understand 6 your question? Because that's not true, Ms. Zettler. 7 Q. (By Ms. Zettler:) Let's continue with the 8 questioning, Doctor. Let's see if we can get this part over 9 with before we finish up today, okay? 10 MR. HARREL: Why don't you just not use a double 11 negative? Why don't you just delete the double negative and 12 try it that way? 13 Q. (By Ms. Zettler:) Is it possible that fluoxetine 14 can cause suicidal ideation? 15 A. Yes. 16 Q. In what cases is it possible? 17 A. I don't know. 18 Q. Is it possible that fluoxetine can cause violent 19 and aggressive behavior? 20 MR. MYERS: Object to the form. Same objection as 21 before. 22 THE WITNESS: Yes. 23 Q. (By Ms. Zettler:) I'm sorry, your answer was yes? 24 A. Yes. 25 Q. Are you aware of any instances where fluoxetine has DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 224 DAVID L. DUNNER, M.D., VOLUME I 1 caused violent and aggressive behavior in a patient taking 2 it? 3 A. Not that's been proven I'm not aware. 4 Q. In what situation could fluoxetine cause violent 5 and aggressive behavior in somebody who is taking it? 6 MR. MYERS: Object to the form. What you're asking 7 him now to do is speculate in not giving him any facts about 8 a given individual or patient. It's a speculative question. 9 I'll object to the form. 10 MS. ZETTLER: Then why don't you just make your 11 objection instead of making a speech? 12 Q. (By Ms. Zettler:) In what situation could 13 fluoxetine cause somebody to become violent and aggressive? 14 MR. MYERS: Same objection. 15 THE WITNESS: You ask me is it possible? I believe 16 that was the question before, and I answered yes. I don't 17 know where it could be possible, but I assume it could be 18 possible. I don't have anybody in mind. I don't know the 19 particulars of the patient who might become that way, but I 20 guess it could be possible. 21 Q. (By Ms. Zettler:) Is it beyond the realm of 22 possibilities that since fluoxetine manipulates or affects 23 brain chemistry that it cannot affect brain chemistry in a 24 negative way? 25 MR. MYERS: Object to the form as vague and DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 225 DAVID L. DUNNER, M.D., VOLUME I 1 ambiguous as to the manipulation. It's otherwise speculative 2 and does not give him sufficient facts to form an opinion. 3 MS. ZETTLER: Kind of like Lilly in this case. 4 THE WITNESS: That doesn't have negatives in it, 5 but I mean, the answer to the first part of the question of 6 is it beyond the realm of possibilities, nothing is beyond 7 the realm of possibilities. 8 All drugs that affect brain chemistry have positive 9 and negative effects, because the body has something that is 10 called homeostasis that corrects for changes so that when you 11 change something in one direction you get a change in the 12 opposite direction to compensate for it in some way. 13 I don't know that that answers your question, but I 14 think it was a two-part question and I think I answered both 15 parts. 16 Q. (By Ms. Zettler:) Would that homeostasis response 17 I think you called it, would that also be applicable to the 18 fluoxetine and its effect on the brain? 19 A. I assume that there would be changes in the brain 20 toward normalization of the effect of the drug after it's 21 been given. 22 Q. Is it possible that -- 23 A. Including fluoxetine. 24 Q. That some of this effect with fluoxetine could 25 cause a shutdown of serotonin production for a period of DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 226 DAVID L. DUNNER, M.D., VOLUME I 1 time? 2 A. You know, you're asking the wrong person. Anything 3 is possible, Ms. Zettler. I'm not a brain neurochemist. I 4 don't know. It may be that that is not possible. I just 5 don't have that expertise. I'm not a pharmacologist, if you 6 would. 7 Q. If decreased serotonin levels have been linked in 8 the literature to suicidality, depression, violent and 9 aggressive behaviors, things we talked about earlier, and 10 serotonin does shut down at least for awhile as a result of 11 administering fluoxetine, why is it that suicidality cannot 12 occur from the use of fluoxetine? 13 MR. MYERS: Same objection. 14 THE WITNESS: Because there's no direct link that 15 the decreases in serotonin are what causes the suicidal 16 behavior. 17 On a similar line, if you give drugs that enhance 18 epinephrine turnover or enhance dopamine turnover in the 19 brain, you also decrease serotonin behavior. But in those 20 instances we didn't see people get worse with depression. 21 Indeed, we saw more people getting better with depression 22 when we gave them dopa and decreased brain serotonin than we 23 did when we gave trypotophan and increased brain serotonin. 24 Q. (By Ms. Zettler:) Then why use a serotonin 25 reuptake inhibitor? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 227 DAVID L. DUNNER, M.D., VOLUME I 1 A. They seem to work in people. 2 Q. Norepinephrine -- what is that? 3 A. Norepinephrine. 4 Q. -- reuptake inhibitors don't affect serotonin 5 receptors as much as a serotonin reuptake inhibitor does, do 6 they? 7 MR. MYERS: Object to the form. Leading. 8 THE WITNESS: Probably that's true. Again, I'm not 9 a pharmacologist who would know the precise answer to that, 10 but I think that would be generally a true statement. 11 Q. (By Ms. Zettler:) And the only real evidence, as 12 you say, that there is a positive effect or people react 13 positively to fluoxetine is clinical trial data; correct? 14 A. And clinical experience. 15 Q. Actually putting people on the drugs to see how 16 they do? 17 A. Yes. 18 Q. At the advisory committee did you vote for or 19 against changing the package insert, changing the packaging 20 to include a warning? 21 A. I voted against that. 22 Q. Why? 23 A. I think I've already talked about my reasons for 24 doing that based on the data about the suicide rate and the 25 presentation by Bill Potter, clinical experience and DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 228 DAVID L. DUNNER, M.D., VOLUME I 1 everything else that happened. 2 Q. Would you have been amenable to including in the 3 package insert for fluoxetine a discussion on the literature 4 outstanding on suicidality and the use of fluoxetine? 5 MR. MYERS: Object to the form, because it assumes 6 that the question at the meeting had to do with the 7 fluoxetine insert only. 8 THE WITNESS: Can I have that again, please. 9 (Whereupon, the reporter read back the last 10 question.) 11 THE WITNESS: My understanding of the package 12 insert is that they all have -- no matter what the 13 antidepressant drug, they all have warnings about suicidal 14 behavior in them. I don't think anything more was 15 necessarily needed. 16 Q. (By Ms. Zettler:) They all have almost the exact 17 same wording about suicidal behavior, do they not? That 18 suicide is a part of depression and that you should monitor 19 your patients closely when you first administer an 20 antidepressant? 21 A. I haven't read the package insert of every 22 antidepressant. I assume that's pretty close to what they 23 say. 24 Q. The two patients that you talked about earlier that 25 you saw I believe on a referral basis that had become DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 229 DAVID L. DUNNER, M.D., VOLUME I 1 suicidal while on fluoxetine, did you ever try to make a 2 causal connection between the fluoxetine in those people with 3 increased suicidality? 4 A. Well, I rechallenged them basically and didn't find 5 that they became suicidal again. It was a very peculiar -- I 6 rechallenged one. Well, I think I rechallenged both of them. 7 It was a very peculiar circumstance in that those 8 are the first patients that I had seen with that phenomenon. 9 Having treated a lot of people with fluoxetine before that, 10 it was sort of unusual. And it's also interesting that I 11 really haven't seen it since. 12 Q. On those two patients I believe you testified 13 earlier that you may have prescribed concomitant sedatives or 14 sedative-type antidepressants when you rechallenged them? 15 MR. MYERS: I'll object to the form. I don't think 16 that you've characterized his testimony precisely. 17 THE WITNESS: I don't recall exactly what I did 18 with those patients. My general style is to add a drug and 19 take them off or lower what they are on and see how they do 20 on the new drug and if they get no side effects then add 21 another drug. So I probably wouldn't have started something 22 on day one other than Prozac. 23 Q. (By Ms. Zettler:) How long would it have taken you 24 if you had added a concomitant sedative? 25 A. I probably would have done it -- if they had DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 230 DAVID L. DUNNER, M.D., VOLUME I 1 treatment-emergent insomnia, I probably would have done it in 2 a week or so when I saw them. 3 Q. Peter Stokes you said was one of the members of the 4 advisory board that you were on at Lilly; correct? 5 A. Correct. 6 Q. Was he a member of that advisory board at the time 7 of the advisory committee meeting in 1991? 8 A. I think so, but I'm not sure. 9 Q. Did you have a problem with him speaking to the 10 committee and not divulging his connections to Eli Lilly? 11 A. I thought that was peculiar. 12 Q. Did you voice those objections? 13 A. No, because I didn't voice objections to anybody 14 speaking. I figured people could speak how they wanted to 15 speak. 16 Q. Did you inform any of the other members of the 17 committee of Dr. Stokes' affiliation with Eli Lilly? 18 A. No. 19 Q. Why do you think Dr. Stokes did that without 20 informing the committee he had an association with Eli Lilly? 21 A. I think you'd have to ask Dr. Stokes. 22 Q. Was there anybody else who was either on the 23 committee or spoke to the committee who you were aware had 24 affiliations with Eli Lilly? 25 A. Other than people from Eli Lilly who presented at DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 231 DAVID L. DUNNER, M.D., VOLUME I 1 the meeting? 2 Q. Right. 3 A. I don't know. 4 Q. Was Dr. Claghorn? 5 A. He was on the committee. 6 Q. Right. Do you know if he had any affiliations with 7 Eli Lilly at the time of the committee meeting? 8 A. I don't know. I mean, that was a matter of public 9 record. 10 Q. Did you disclose all of your affiliations with Eli 11 Lilly to the advisory committee? 12 A. I did the very best job I could before every 13 advisory committee to tell them what I was doing and to note 14 companies that I was involved with. And for that particular 15 meeting since it dealt with antidepressant drugs, I was 16 actually consulting with a company that makes a drug not 17 available in the United States. And I told them about that, 18 and they said since it wasn't a U.S.-marketed drug it didn't 19 have to be listed. But I did let them know. 20 Q. Did you tell them about your past affiliations with 21 Lilly? 22 A. That was a matter of public record on my initial 23 disclosure form. 24 Q. Did you tell them about the prospective 25 affiliations you had with Eli Lilly like future clinical DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 232 DAVID L. DUNNER, M.D., VOLUME I 1 trials that were pending at the time of the committee 2 meeting? 3 A. I don't know what the -- I told them what I was 4 doing. Some of those things if they weren't grant yet were 5 not included per their decision. And I don't know if that -- 6 I mean, when you talk to somebody from a company about doing 7 a study, you don't have a study, you only have a study when 8 you get the protocol in and you start the study and you get a 9 check. So, you know, I don't know what was done about 10 discussions of maybe protocols, frankly. 11 I know that any time we had a protocol or were 12 putting something through our human subjects committee so it 13 was more than just a pie in the sky idea, let's talk about 14 doing this, that I informed the committee of that. 15 Q. Is it your testimony that there was information 16 that you gave to the committee about your affiliations with 17 various drug companies including Eli Lilly that wasn't 18 included by the committee in the disclosure? 19 A. I don't know that they didn't include anything 20 about Eli Lilly. It did include something about a company 21 that made a drug marketed in Europe that I consulted with, an 22 antidepressant, because they felt that that was not relevant 23 to that meeting. 24 Q. Did you see a copy of the disclosure that they made 25 as a result of what you told them? DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 233 DAVID L. DUNNER, M.D., VOLUME I 1 A. Yes, I did. 2 Q. Was there anything missing off there besides that 3 one drug that you can recall? 4 A. They told me they weren't going to put it on. I 5 mean, this was done some time beforehand and they said that 6 wasn't necessary. 7 Q. But that's not my question. Was there anything 8 else that was missing that you had told them from that 9 disclosure that they put out about you? 10 A. I don't think so. 11 Q. Did you feel comfortable participating as a member 12 of the committee with all of your affiliations, especially 13 with Eli Lilly, on fluoxetine? 14 A. Actually, I advise a lot of different groups. I 15 advise competitors to Eli Lilly. And I always take the 16 position that they are spending some time to hire me to give 17 them my opinion. They may not take my opinion, it's an 18 advisory committee, but I do the very best job I can for that 19 setting. And I felt that I could make a decision based on 20 what I heard and data that would be an honest decision or 21 else I wouldn't have been there. 22 Q. How much money in grants had Eli Lilly given to the 23 University of Washington related to your research on 24 fluoxetine prior to the advisory committee meeting? 25 MR. MYERS: Before he answers that question, let me DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 234 DAVID L. DUNNER, M.D., VOLUME I 1 object to it on the grounds that that information has been 2 exempted from discovery under those orders we talked about 3 for about an hour this morning. 4 MS. ZETTLER: Absolutely not, Larry, and you know 5 it. Furthermore, that information was given to us in 6 response to a Freedom of Information request. 7 MR. MYERS: It hasn't been given to you by me. 8 MS. ZETTLER: Well, it's publicly disseminated 9 through a Freedom of Information request. I'm asking him if 10 he knows how much money that the University had gotten in 11 grants as a result of his work with Lilly on fluoxetine. 12 MR. MYERS: Well, I object to the question on the 13 same grounds notwithstanding whatever you got from whatever 14 source. And that information was not disclosed in these 15 documents and I don't -- you know, if it's not been disclosed 16 in the documents, I would request that until there's an order 17 from the Court that it not be disclosed unless you've got a 18 document from an independent source. 19 MS. ZETTLER: That's what I'm telling you. I've 20 got documents from the FOIA request. And also, the December 21 13th order specifically says that only grant information for 22 products other than fluoxetine is confidential. We can look 23 at the order again, if you would like. 24 MR. MYERS: We can look at the order -- 25 Q. (By Ms. Zettler:) Let me ask you this, Doctor. Do DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 235 DAVID L. DUNNER, M.D., VOLUME I 1 you know how much money the University has gotten in grants 2 from Eli Lilly and Company with regards to fluoxetine? Just 3 yes or no, I'm not asking how much. We all know that they 4 got grants. I just want to know if you know how much. 5 A. No. 6 Q. If I told you it was close to one and a half 7 million dollars -- 8 MR. HARREL: That's a different question. I 9 allowed him to answer the yes or no to see if he had 10 background to answer the question. And then I think you can 11 go back to the orders, and we went through that this morning. 12 And so it's my understanding that those orders -- that's why 13 we did the production the way we did it. If you go to court 14 and Eli Lilly loses on that order, it's my understanding and 15 position that we just tried to comply with the court orders. 16 I don't want to get this doctor in trouble under these court 17 orders. And so if Eli Lilly gets that order modified then 18 I'll tell Dr. Dunner to answer that. 19 I noticed my alarm went off and it is the end of 20 the day. 21 MS. ZETTLER: Well, I have five to 5. I have five 22 more minutes here. Well, that's fine. We can quit for now 23 and we'll start up tomorrow morning. 24 MR. SMITH: I didn't know we went by an alarm 25 clock. DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 236 DAVID L. DUNNER, M.D., VOLUME I 1 MS. ZETTLER: We're going by his watch. 2 MR. HARREL: Yeah. That's why I started this 3 morning on my watch. See you in the morning. 4 (Deposition concluded at 5:00 p.m.) 5 (Signature reserved) 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 237 DAVID L. DUNNER, M.D., VOLUME I 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 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 DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875 238 DAVID L. DUNNER, M.D., VOLUME I 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 proceedings 15 given and occurring at the time and place of said testimony; 16 that I am in no way related to any party to the matter, nor 17 to any counsel, nor do I have any financial interest in the 18 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 DIANE HEMRICH, RPR-CM 1305 FINANCIAL CENTER, 1215 4TH AVENUE SEATTLE, WASHINGTON 98161 622-6875