368 1 IN THE UNITED STATES DISTRICT COURT 2 DISTRICT OF WYOMING 3 -------------------------------------------------------- 4 THE ESTATES OF DEBORAH MARIE TOBIN and ALYSSA ANN TOBIN, deceased, by 5 TIMOTHY JOHN TOBIN, personal representative; and THE ESTATES OF 6 DONALD JACK SCHELL and RITA CHARLOTTE SCHELL, deceased, 7 by NEVA KAY HARDY, personal representative, 8 Plaintiffs, Case No. 00-CV-0025-BEA 9 vs. May 23, 2001 Volume III 10 SMITHKLINE BEECHAM PHARMACEUTICALS, 11 Defendant. ----------------------------------------------------------- 12 13 14 TRANSCRIPT OF TRIAL PROCEEDINGS 15 16 Transcript of Trial Proceedings in the above-entitled 17 matter before the Honorable William C. Beaman, Magistrate, 18 and a jury of eight, at Cheyenne, Wyoming, commencing on the 19 21st day of May, 2001. 20 21 22 23 Court Reporter: Ms. Janet Dew-Harris, RPR, FCRR Official Court Reporter 24 2120 Capitol Avenue Room 2228 25 Cheyenne, Wyoming 82001 (307) 635-3884 369 1 A P P E A R A N C E S 2 For the Plaintiffs: MR. JAMES E. FITZGERALD Attorney at Law 3 THE FITZGERALD LAW FIRM 2108 Warren Avenue 4 Cheyenne, Wyoming 82001 5 MR. ANDY VICKERY Attorney at Law 6 VICKERY & WALDNER, LLP 2929 Allen Parkway 7 Suite 2410 Houston, Texas 77019 8 For the Defendant: MR. THOMAS G. GORMAN 9 MS. MISHA E. WESTBY Attorneys at Law 10 HIRST & APPLEGATE, P.C. 1720 Carey Avenue 11 Suite 200 Cheyenne, Wyoming 82001 12 MR. CHARLES F. PREUSS 13 MR. VERN ZVOLEFF Attorneys at Law 14 PREUSS SHANAGHER ZVOLEFF & ZIMMER 225 Bush Street 15 15th Floor San Francisco, California 94104 16 MS. TAMAR P. HALPERN, Ph.D. 17 Attorney at Law PHILLIPS LYTLE HITCHCOCK 18 BLAINE & HUBER, LLP 3400 HSBC Center 19 Buffalo, New York 14203 20 INDEX TO WITNESSES 21 PLAINTIFFS' PAGE JOHN MALTSBERGER, M.D. 22 Continued Direct - Mr. Vickery 372 Cross - Mr. Preuss 415 23 Redirect - Mr. Vickery 485 Recross - Mr. Preuss 494 24 RICHARD EWING 25 Voir Dire - Mr. Vickery 427 Voir Dire - Mr. Zvoleff 432 370 1 INDEX TO WITNESSES CONTINUED 2 PLAINTIFF'S PAGE PENNY DURANT 3 Direct - Mr. Fitzgerald 496 4 BONNIE ROSSELLO Videotape Deposition played 531 5 THOMAS OGG 6 Deposition testimony read 545 7 IAN HUDSON, M.D. Videotape Deposition played 564 8 INDEX TO EXHIBITS 9 PLAINTIFF'S RECEIVED 3-A 485 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 371 09:15:59 1 P R O C E E D I N G S 09:15:59 2 (Trial proceedings reconvened 09:15:59 3 9:00 a.m., May 23, 2001.) 09:15:59 4 (Following out of the presence of the jury.) 09:15:59 5 THE COURT: The record should reflect court is in 09:15:59 6 session without the jury at this time because I understand 09:15:59 7 one of the parties wishes to place some information on the 09:15:59 8 record. 09:15:59 9 Mr. Preuss. 09:15:59 10 MR. PREUSS: Yes, Your Honor, it was brought to my 09:15:59 11 attention after Dr. Healy's examination yesterday that there 09:15:59 12 was a visual exchange between Dr. Healy during the course of 09:15:59 13 the testimony and juror number 1 to include some winking and 09:15:59 14 some words were said by Dr. Healy as the jury filed out. 09:15:59 15 My only purpose in putting it on the record -- I know 09:15:59 16 the judge has given the admonition to the jurors and what we 09:15:59 17 can and cannot do, and I'm just concerned that we make sure 09:15:59 18 the jury stay pure and isolated during the course of the 09:15:59 19 trial. 09:15:59 20 THE COURT: Thank you very much. 09:15:59 21 Anything from you, Mr. Vickery? 09:15:59 22 MR. VICKERY: All I was going to say is I did discuss 09:15:59 23 it with Mr. Preuss when I learned about it. Of course as an 09:15:59 24 officer of the court I told all my witnesses to avoid any 09:15:59 25 kind of contact with the jury. I can't say, "Don't look at 372 09:15:59 1 the jury," and I did hear as Dr. Healy started to step off 09:15:59 2 and the jury started to walk out at the same time he stepped 09:15:59 3 back and said, "Go ahead," or something like that, but 09:15:59 4 nothing beyond that. 09:15:59 5 THE COURT: Very well. Thank you very much. 09:15:59 6 We will stand in recess for five minutes. 09:15:59 7 (Recess taken 9:00 a.m. until 9:05 a.m.) 8 (Following in the presence of the jury.) 09:16:12 9 THE COURT: Mr. Vickery, you may recall 09:16:16 10 Dr. Maltsberger. 09:16:26 11 MR. PREUSS: Your Honor, while the witness is taking 09:16:28 12 the stand I would like to renew my objection under the 09:16:31 13 Daubert ruling for purposes of the record and reserve my 09:16:34 14 questions to cross-examination. 09:16:35 15 THE COURT: Very well, so noted. 09:16:40 16 Dr. Maltsberger, I need to remind you again you're 09:16:44 17 still under oath. 09:16:45 18 THE WITNESS: Yes, Your Honor. 19 20 JOHN MALTSBERGER, M.D., 21 called as a witness on behalf of the Plaintiffs, being 22 previously duly sworn, testified further as follows: 23 CONTINUED DIRECT EXAMINATION 09:16:46 24 Q. (BY MR. VICKERY) Good morning, sir. 09:16:50 25 A. Good morning, Mr. Vickery. 373 09:16:52 1 Q. We talked yesterday mainly about your background and 09:16:55 2 experience and credentials, and there are just two things I 09:17:00 3 wanted to do to finish that topic and then we'll move on to 09:17:05 4 others. 09:17:06 5 As a Texan I must ask you this: Where were you born 09:17:10 6 and raised? 09:17:11 7 A. I was born in a small town in southwest Texas, the name of 09:17:15 8 Cotulla, down southwest of San Antonio. I was raised on a 09:17:19 9 cattle ranch. 09:17:20 10 Q. You abandoned that to go east for your education and 09:17:22 11 stayed out there ever since? 09:17:24 12 A. That's right. I found an attractive woman and married 09:17:27 13 her. 09:17:28 14 Q. Dr. Maltsberger, on a different note, we were talking 09:17:34 15 about your interest in suicidality and suicidology as a field 09:17:38 16 of study or endeavor. Has that field matured over the years? 09:17:42 17 A. Yes, there was very little being published back in 1960 09:17:45 18 which was when I first became interested. There's been an 09:17:48 19 explosion of interest in the subject and now there are lots 09:17:53 20 of articles every year. 09:17:55 21 Q. And indeed, last year did someone publish for the first 09:17:59 22 time ever a comprehensive textbook of suicidology? 09:18:07 23 A. That's right. 09:18:07 24 Q. Is this that book? 09:18:08 25 A. Yes, that's it. 374 09:18:09 1 Q. And are you one of the people that were asked by the 09:18:11 2 publishers to write a little jacket endorsement on the back 09:18:15 3 of the book? 09:18:16 4 A. I was asked, yes. 09:18:17 5 Q. And do you know, is there another one that the jury will 09:18:20 6 meet during the course of this trial that was asked to 09:18:22 7 endorse this book? 09:18:23 8 A. Yes, Dr. John Mann also wrote a recommendation for the 09:18:27 9 book. 09:18:34 10 Q. The jury has heard some medical terms, akathisia and 09:18:38 11 mania, and we're going to be talking about those in your 09:18:41 12 testimony. 09:18:46 13 Can you give us a lay term that would be common to 09:18:50 14 our own experience and would be a reasonable approximation of 09:18:55 15 what someone who has akathisia would be experiencing? 09:18:59 16 A. Well, the main characteristic of akathisia is an 09:19:05 17 experience of inner turmoil, tremendous inner restlessness. 09:19:13 18 Turmoil is as good a word as there is, I think. And it is 09:19:18 19 often so intense that the patients will be visibly restless. 09:19:25 20 They will fidget, they will -- they can't sit still. They 09:19:29 21 tap their feet, they get up, they walk about. 09:19:34 22 But the primary central phenomenon is the experience 09:19:37 23 of inner turmoil. 09:19:39 24 Q. And how about the word "mania"? What would be a 09:19:43 25 reasonable approximation just in plain folksspeak? 375 09:19:48 1 A. It is a state of such uncontrollable excitement that the 09:19:52 2 patients could be said to be in a frenzy. 09:19:54 3 Q. Frenzy would be the word? 09:19:56 4 A. That's right. 09:20:08 5 Q. Do some psychoactive drugs that affect the brain cause 09:20:12 6 turmoil and/or frenzy? 09:20:18 7 A. Yes. 09:20:18 8 Q. You've been studying suicide for 41 years now. Do 09:20:19 9 patients who have drug-induced conditions of turmoil or 09:20:23 10 frenzy or both commit suicide? Are those the folks that 09:20:28 11 commit suicide? 09:20:29 12 A. Oh, yes. There is plenty of reason to believe that the 09:20:32 13 people who commit suicide are people that are in such a state 09:20:36 14 of intense inner anguish and turmoil and suffering that they 09:20:42 15 can't stand it another minute and that they have to do 09:20:44 16 something, even if it is suicide, to get away from it. It is 09:20:48 17 a perfectly horrible experience. 09:20:50 18 Q. How about homicide? Do people who are in a state of 09:20:54 19 drug-induced turmoil or frenzy commit homicide? 09:20:59 20 A. Patients who are driven into a frenzy very often are not 09:21:03 21 thinking straight. They very often are suspicious. They may 09:21:08 22 believe that others are after them. They may be -- they may 09:21:12 23 imagine that the police are after them or that awful things 09:21:16 24 are about to happen and they will start to behave really very 09:21:21 25 aggressively. They can't think straight they're so terribly 376 09:21:24 1 excited. 09:21:36 2 Q. Let's move to your gut opinions in this case as delineated 09:21:39 3 in your Rule 26 report and discussed with counsel at your 09:21:42 4 deposition. 09:21:43 5 Is it your opinion that SSRI drugs like Paxil cause 09:21:48 6 some people to become violent and suicidal? 09:21:52 7 A. Yes. 09:21:53 8 MR. PREUSS: Objection, Your Honor. This witness is 09:21:55 9 restricted to the specifics, not general causation by 09:21:58 10 stipulation of counsel. 09:22:01 11 MR. VICKERY: I should have finished the sentence. 09:22:04 12 Q. (BY MR. VICKERY) Let me rephrase. Is it your opinion in 09:22:10 13 this case that Don Schell committed the acts of homicide and 09:22:15 14 suicide that he did because of the Paxil? 09:22:20 15 A. Yes. 09:22:21 16 Q. Do you hold that opinion to a degree of reasonable medical 09:22:24 17 certainty? 09:22:25 18 A. Yes. 09:22:30 19 Q. Now, I want to talk with you about the bases of that 09:22:33 20 opinion. You will recall Mr. Preuss asked Mr. Healy about 09:22:37 21 things you had reviewed. 09:22:39 22 Do you have your report up there with you? 09:22:41 23 A. I forgot and left it back there in the pew, if somebody 09:22:45 24 will -- 09:22:47 25 MR. VICKERY: May I approach him, Your Honor? 377 09:22:49 1 THE COURT: Yes, you may. 09:22:52 2 THE WITNESS: Thank you. 09:22:55 3 Q. (BY MR. VICKERY) Would you just sort of tick off for us 09:22:59 4 the various things that you read or considered before 09:23:02 5 arriving at your opinions? 09:23:06 6 A. Yes. I reviewed the following: A preliminary draft 09:23:14 7 entitled Application for Admission Pro Hac Vice; medical 09:23:22 8 record of Don Schell from Dr. Buchanan; medical record of Don 09:23:28 9 Schell from Dr. Patel; Gillette Police Department reports; 09:23:35 10 autopsy report on Don Schell; an in-house report by Yan Cheng 09:23:41 11 from SmithKline Beecham entitled Paroxetine: Aggression; the 09:23:51 12 Physician's Desk Reference for 1998 on Paxil; same book, same 09:23:56 13 year on Ambien; an article by Dr. S. Donovan and colleagues 09:24:01 14 entitled Deliberate Self-Harm and Antidepressant Drugs; 09:24:06 15 declaration of Dr. Jonathan Cole in the Miller versus Phizer 09:24:11 16 case; and the following deposition transcripts: Neva Hardy, 09:24:19 17 Ian Hudson, M.D., K.L. Patel, M.D., Flo Reavis, Michael 09:24:27 18 Schell, Betty Faye Smith, George Albert Smith, Timothy Tobin, 09:24:33 19 David Wheadon. 09:24:35 20 And there's some other materials that I should 09:24:39 21 mention. I had read already Dr. Healy's book called The 09:24:47 22 Antidepressant Era. Your office supplied me a couple of 09:24:53 23 other articles that he had written, one entitled The 09:24:56 24 Emergence of Antidepressant Induced Suicidality and another 09:25:01 25 one, Zoloft and Suicide. 378 09:25:06 1 And then there was an article by Jan Fausset called 09:25:10 2 The Detection and Consequences of Anxiety and Clinical 09:25:14 3 Depression. 09:25:15 4 Another article on Clinical Features of Inpatient 09:25:18 5 Suicide by Bush and colleagues. 09:25:20 6 Another article by Dr. Fausset on Risk Factors in 09:25:25 7 Depression and Panic Disorder. 09:25:29 8 And yet another article by Dr. Fausset, Time Related 09:25:33 9 Predictors of Suicide. 09:25:35 10 That's the list. 09:25:37 11 Q. Did you continue to read other materials as they became 09:25:41 12 available? 09:25:42 13 A. Yes, other materials that I read before I was deposed were 09:25:50 14 deposition transcripts of Dr. Mark Suhany, Dr. Patrick 09:25:56 15 Buchanan and Dr. Leigh Hemphill, and then there were yet 09:26:02 16 other materials after I was deposed which I've looked at, 09:26:09 17 materials that come from experts for SmithKline Beecham. 09:26:16 18 Q. Now, do those materials that you reviewed after your 09:26:19 19 deposition form any basis of your opinion in this case? 09:26:23 20 A. They had nothing to do with the -- the forming of the 09:26:26 21 basis of my opinion and they've not led me to change my 09:26:33 22 opinion. If anything, they have reinforced my opinion. 09:27:09 23 Q. Let's talk about the issue of specific causation and how 09:27:09 24 someone as yourself, a clinician, goes about deciding that 09:27:09 25 and how. 379 09:27:09 1 Do you prescribe SSRI drugs? 09:27:09 2 A. Sure. 09:27:09 3 Q. Have you ever prescribed Paxil? 09:27:09 4 A. I have. 09:27:09 5 Q. Do you regularly prescribe Paxil now? 09:27:09 6 A. I tend to avoid it. 09:27:09 7 Q. Why? 09:27:09 8 A. Well, I've had some bad experiences with it. I had one 09:27:11 9 patient a while back who was a lawyer, as a matter of fact, a 09:27:14 10 trial lawyer from Boston. I will say no more. 09:27:17 11 Q. Thanks for saying Boston. That rules us all out. 09:27:21 12 A. He is an admirable gentleman because he had horrible 09:27:25 13 depression and nevertheless was able to lead a very 09:27:28 14 successful professional life. 09:27:32 15 Q. What happened to him when you tried him on Paxil? 09:27:34 16 A. And I gave him some Paxil and he said within the first few 09:27:38 17 days of taking it that he couldn't stand this drug, that it 09:27:42 18 made him feel ever so much worse, very uncomfortable on the 09:27:48 19 inside, and that it was so sedative that he could hardly 09:27:55 20 stand it. So I took him off. 09:27:58 21 Then I had -- 09:27:59 22 Q. Any other experiences? 09:28:00 23 A. I had another patient who was in the hospital. He was 09:28:09 24 quite suicidal and he was put on Paxil and within the first 09:28:13 25 few days of taking Paxil he developed the staggers. He could 380 09:28:19 1 hardly walk straight. He was trembling and shaking and he 09:28:23 2 felt very uncomfortable. And we took him off and he got 09:28:27 3 better. 09:28:28 4 Q. When you took him off of the drug did those symptoms that 09:28:30 5 had manifested themselves right after he started on it go 09:28:33 6 away? 09:28:34 7 A. The shaking and the terrible restlessness. Although he 09:28:43 8 had had some before, it was much worse on Paxil. 09:28:45 9 Q. Are there any other instances from your clinical practice, 09:28:48 10 either where you have had the patient as a primary doctor or 09:28:51 11 been consulted in on a case where there have been bad 09:28:54 12 experiences on Paxil? 09:28:55 13 A. Well, I've heard of them, anecdotal reports that I hear. 09:29:05 14 I tend for these reasons not to prescribe it. I don't mean 09:29:08 15 to say it is the only one of the SSRIs that can do this, but 09:29:12 16 having had unpleasant experiences with it, I prefer to give 09:29:15 17 my patients other drugs that I've had better luck with. 09:29:18 18 Q. And when you use other drugs in the SSRI class of drugs, 09:29:24 19 do you take any kind of special protective measures? 09:29:33 20 A. Well, yes, I do. I am -- let me put it this way: I think 09:29:37 21 that what kills most people who are going to commit suicide 09:29:42 22 when they are in a depression is the escalation of inner 09:29:48 23 turmoil and anguish. 09:29:56 24 And if I have a patient -- and I always ask patients 09:29:58 25 to describe to me what their inner experience is before they 381 09:30:01 1 get any drug. I want to know. I ask them about anguish, 09:30:05 2 turmoil, restlessness. And if the patients have a 09:30:13 3 substantial degree of that, I take note of it because that's 09:30:16 4 going to pose problems if I give an SSRI drug. 09:30:25 5 The other thing I'm careful to ask about is if 09:30:28 6 there's been any period in the past of people getting revved 09:30:32 7 up, overactive, excited, anything that suggests the early 09:30:36 8 forms of frenzy. If I can see any warning signals of it 09:30:41 9 coming and if I find any of that in the history, I am also 09:30:46 10 careful with the SSRIs. 09:30:49 11 Now, I might give such a patient -- 09:30:51 12 Q. Well, let me follow up on that. If you decided in your 09:30:54 13 clinical judgment that in spite of one of these histories you 09:30:58 14 were going to give an SSRI drug, what type of protective 09:31:01 15 measure would you take? 09:31:08 16 A. I would prescribe at the same time either a sedative, such 09:31:11 17 as lorazepam. Maybe the jury has heard of that. It is a 09:31:15 18 common prescription drug sold under the name of Ativan, a 09:31:19 19 minor tranquilizer. 09:31:21 20 Q. Is that in the class of benzodiazepines? 09:31:23 21 A. Yes. 09:31:24 22 Q. Or what else might you do? 09:31:26 23 A. I might actually go ahead and give the patient a mood 09:31:29 24 stabilizer, one of the drugs that is used to protect patients 09:31:33 25 against getting into a mania, something like valproic acid. 382 09:31:38 1 Q. And how long would you have to give this other drug in 09:31:41 2 conjunction with an SSRI drug at the start of their taking 09:31:46 3 that drug? 09:31:47 4 A. Well, I never prescribe SSRIs without seeing the patients 09:31:52 5 for the first six or eight weeks at least once a week, and I 09:31:57 6 tend in the first week or ten days to talk to my patients on 09:32:00 7 the telephone in between sessions to see how they're getting 09:32:07 8 along. 09:32:08 9 If things seem to go well and the patients are 09:32:14 10 sleeping well and they're not terribly anxious and they're 09:32:21 11 not agitated or restless, then slowly I would wean off the 09:32:29 12 benzodiazepine. 09:32:29 13 Q. The protective drug? 09:32:32 14 A. That's right. 09:32:32 15 Q. Do you also -- when you're giving an SSRI, particularly 09:32:35 16 to someone who has anxiety as Mr. Schell did, do you do 09:32:39 17 anything with respect to the dosing of that medication? 09:32:45 18 A. Well, I do that as a matter of course and I think it is 09:32:47 19 the best practice and lots of experienced psychiatrists do it 09:32:51 20 with all of the SSRIs, or for that matter, other kinds of 09:32:54 21 antidepressants. 09:32:55 22 I tell my patients to take half the recommended dose 09:33:00 23 for three or four days to see if they're going to get any of 09:33:05 24 the side effects. 09:33:06 25 Q. How do you take half the dose if it is in a capsule? Do 383 09:33:10 1 these medications come in capsules? 09:33:13 2 A. I can't remember how Paxil comes. Some of the other ones 09:33:16 3 are tablets so you can break them in two. I have told people 09:33:21 4 if I want them to take a reduced dose of something in a 09:33:25 5 capsule, open the capsule, mix it with a little bit of 09:33:28 6 applesauce, stir it up with a spoon, take half and put the 09:33:33 7 rest aside for the next day. 09:33:36 8 Q. Mr. Maltsberger, where did you learn about the protective 09:33:39 9 measures -- dosing, titrating or other measures -- to protect 09:33:44 10 them? Did you learn that from the labels of these drugs? 09:33:47 11 A. I certainly didn't. 09:33:48 12 Q. Is there anything on the label of Paxil that would alert 09:33:51 13 you as a physician to take those precautionary measures? 09:33:54 14 A. No. I learned it because I had a good training and I said 09:34:03 15 to some people in a joke that I've been confined to a 09:34:05 16 psychiatric hospital for the last 40 years. That's where I 09:34:09 17 learned it. 09:34:10 18 Q. What about those physicians like Dr. Patel who are not 09:34:14 19 psychiatrists, who don't have the specialized training in 09:34:18 20 mental health that you have had? How are they supposed to 09:34:22 21 learn about these things? 09:34:24 22 A. How should they learn? 09:34:26 23 Q. Yes. 09:34:26 24 A. I think that they should learn from the labeling of the 09:34:32 25 medicines. They should learn it from the pharmaceutical 384 09:34:37 1 representatives who call on them in their offices like 09:34:39 2 Mr. Haase that we heard here the other day. 09:34:43 3 I think it is incumbent on the pharmaceutical houses 09:34:47 4 to print out full information about these drugs and their 09:34:52 5 hazards and to supply that to the doctors and to supply it to 09:34:57 6 their representatives who can supply it to the doctors. 09:35:01 7 The present state of affairs is that the warnings are 09:35:04 8 inadequate so that their own pharmaceutical reps don't know 09:35:09 9 about it and so they can't tell the doctors about it. And 09:35:16 10 the doctors -- 09:35:18 11 MR. PREUSS: Objection, no foundation as to what all 09:35:20 12 reps know or don't know. No foundation as to personal 09:35:24 13 information. 09:35:25 14 THE COURT: Sustained. 09:35:26 15 Q. (BY MR. VICKERY) You were here for Mr. Haase's 09:35:27 16 deposition -- his testimony in court, right? 09:35:29 17 A. Yes. 09:35:29 18 Q. And did you hear him say in six weeks of training at 09:35:33 19 SmithKline Beecham he had had no training whatsoever about 09:35:35 20 this drug causing or precipitating violence or suicide? 09:35:39 21 A. I very surely did. And I think that's shocking. 09:35:47 22 Q. Let me ask you, you say the warnings are inadequate. Is 09:35:49 23 there indeed any warning whatsoever on the package insert of 09:35:52 24 Paxil that alerts physicians, particularly primary care 09:35:58 25 physicians, that this drug might actually be the culprit, it 385 09:36:02 1 might actually trigger violent or suicidal behavior? 09:36:06 2 A. There's nothing in the labeling that says so. 09:36:08 3 Q. You think there should be? 09:36:09 4 A. I sure do. 09:36:10 5 Q. You think it ought to be in a black box to get their 09:36:14 6 attention? 09:36:15 7 A. I do. I do. Any doctor that's going to give this drug 09:36:18 8 ought to be aware that for a small subpopulation these drugs 09:36:26 9 can drive people wild. 09:36:55 10 Q. You were asked in your deposition to draft a warning, were 09:36:55 11 you not, sir? 09:36:55 12 A. Yes, I was. 09:36:55 13 Q. Let's have a look at it. It is in evidence. 09:37:16 14 MR. GORMAN: You say this is in evidence, Andy? 09:37:19 15 MR. VICKERY: Yes, it certainly is. It is 17 and I 09:37:22 16 believe it was offered yesterday. 09:38:26 17 Q. (BY MR. VICKERY) Can you read that on the screen that's 09:38:27 18 close to you? You may be able to read it easier. 09:38:30 19 A. This is better. 09:38:31 20 Q. Would you read that out loud for us, please, sir, 09:38:33 21 Exhibit 17 for our record? 09:38:35 22 A. You can hear me okay? It says, "Physicians should be 09:38:38 23 aware that in rare instances SSRI compounds such as Paxil may 09:38:46 24 produce acute homicidal and suicidal states. Close 09:38:53 25 monitoring of patients is indicated in the course of the 386 09:38:56 1 first six weeks of prescription of these drugs, especially 09:39:00 2 when there is a history of unusual anxiety, hypomania or 09:39:04 3 akathisia." 09:39:14 4 Q. Dr. Maltsberger, are you an expert in drafting warnings? 09:39:23 5 A. I never drafted a warning before I was asked. I think a 09:39:24 6 couple of lawyers different times have asked me to draft a 09:39:28 7 warning. That's the only times I've ever done it. 09:39:31 8 Q. How difficult, how hard was it for you to come up with 09:39:33 9 this language? 09:39:36 10 A. I believe it is called a no-brainer, Mr. Vickery. I mean, 09:39:39 11 it was perfectly obvious what to put in it. 09:39:42 12 Q. Do they have to use your words or just words to convey 09:39:47 13 this kind of message? 09:39:48 14 A. I'm not in a position to dictate to the pharmaceutical 09:39:51 15 companies the exact language, but I think that they ought to 09:39:53 16 have bold warnings in the product information that contains 09:39:58 17 the general sense of what is in there. 09:40:05 18 Q. Let me ask you about something. We know, we all know, 09:40:09 19 that the FDA is part of that picture as well, correct? 09:40:12 20 A. Yes. 09:40:13 21 Q. And in your report in this case you quoted a couple of 09:40:18 22 questions and answers from the testimony of the 09:40:21 23 vice-president of SmithKline Beecham, gentleman named David 09:40:26 24 Wheadon, right? 09:40:28 25 A. I did. 387 09:40:28 1 Q. Would you read for us from your report those two questions 09:40:33 2 and answers? 09:40:35 3 A. Sure. I would rather read the paragraph before as well. 09:40:50 4 Q. All right. If you would, to put it -- is that necessary 09:40:54 5 to put it in context? 09:40:55 6 A. I think so. 09:40:56 7 THE COURT: What are we reading from? 09:40:58 8 MR. VICKERY: His Rule 26 report, Your Honor. 09:41:00 9 THE COURT: What page? 09:41:01 10 THE WITNESS: Page 7, Your Honor, the first one dated 09:41:04 11 the 20th of January, 2001. 09:41:13 12 Q. (BY MR. VICKERY) Go right ahead. 09:41:15 13 A. "It is well-known that none of the marketers of SSRI 09:41:19 14 compounds have ever carried out randomized double-blind 09:41:24 15 trials to determine whether these drugs can cause suicide. 09:41:28 16 But I wish to emphasize this point: The daily practice of 09:41:33 17 medicine, of which psychiatry is a branch, does not require 09:41:40 18 pristine, rigorous evidence that a drug can drive rare, 09:41:45 19 dangerous events. Clinicians should be guided as to whether 09:41:49 20 there is reason to believe that such rare events probably 09:41:53 21 occur in association with SSRI drugs. There is ample reason 09:42:01 22 to believe that this is the case, but pharmaceutical houses 09:42:05 23 continue to avoid publishing black box warnings emphasizing 09:42:09 24 that there is such a risk when SSRI drugs are prescribed. I 09:42:14 25 would draw attention to the following testimony in this 388 09:42:16 1 case" -- 09:42:20 2 Q. Tell you what, so it is clear who is asking the questions, 09:42:22 3 let me ask the questions I asked of Dr. Wheadon in the 09:42:26 4 deposition and you read the answers he gave. 09:42:29 5 "And do the regulations, FDA regulations, 09:42:32 6 specifically say that you do not have to wait for proof of 09:42:35 7 causation of an adverse event?" 09:42:39 8 A. "The regulations do say that causation is not necessary 09:42:41 9 to be established." 09:42:43 10 Q. "So just if there is evidence" -- I'm sorry -- "so just 09:42:49 11 if there is reasonable evidence that the drug might cause 09:42:51 12 this, then a warning is appropriate, right?" 09:42:54 13 A. "That would be reason for discussion around adding a 09:42:57 14 warning, yes." 09:42:59 15 Q. Okay. Thank you, sir. 09:43:14 16 I would like to turn to the case of Don Schell and 09:43:17 17 ask you to provide, if you would, your clinical wisdom on 09:43:21 18 this case for us. 09:43:24 19 Now, you never got to see this man or know him or 09:43:27 20 treat him, did you? 09:43:29 21 A. Oh, no. 09:43:30 22 Q. You, like the other experts in this case, have to rely on 09:43:34 23 information that you can glean about what happened? 09:43:36 24 A. That's right. 09:43:37 25 Q. And is there a process within the field of suicidology, 389 09:43:42 1 process or method that a doctor such as you uses to analyze a 09:43:47 2 suicide and try to figure out why it happened? 09:43:50 3 A. Yes. 09:43:51 4 Q. What is it called? 09:43:52 5 A. Psychological autopsy. 09:44:01 6 Q. Is that what you did here? 09:44:02 7 A. In a rough manner of speaking. I analyzed all of the data 09:44:06 8 I had about this man and what preceded his suicide and came 09:44:09 9 to some conclusions. 09:44:11 10 That data included the testimony from members of the 09:44:14 11 family, people who knew him well, doctors' records, the 09:44:22 12 evidence that was collected in the preparation of this 09:44:25 13 lawsuit. 09:44:27 14 Q. Your report mentions that in his prior history he had 09:44:32 15 "several episodes of mild depression." Can you explain your 09:44:37 16 assessment of his prior medical history and its significance 09:44:40 17 to your opinions in this case? 09:44:42 18 A. Yes. It is clear that so far as we can tell that the 09:44:49 19 first time he came to medical attention because of depression 09:44:53 20 was in 1984, and he had a succession of depressive episodes 09:45:00 21 after that. They were all really very much the same. 09:45:08 22 The depressions that he had were anxious ones. He 09:45:12 23 was very tense. He was very agitated. I believe all of them 09:45:20 24 contained references to not sleeping well. It was a worried, 09:45:28 25 anxious, uneasy kind of depression. 390 09:45:38 1 And he was discouraged and had a lot of -- there was 09:45:39 2 crying in many of them. He had some morbid ideas, although, 09:45:44 3 so far as we can tell, he never had ideas of killing himself. 09:45:48 4 He had trouble concentrating. He didn't enjoy things very 09:45:57 5 much. His energy was not good. And that was the general 09:46:03 6 color of these depressions. 09:46:06 7 Q. Let me ask you a few specifics about those. Were they 09:46:11 8 usually confined in periods of time; in other words, rather 09:46:17 9 than -- I want the jury to get the correct picture. Are you 09:46:20 10 saying he was just that way for 15 years before his death or 09:46:23 11 are you saying there was some discrete instances? 09:46:27 12 A. It appears these were fairly discrete, separate episodes, 09:46:31 13 as far as we can tell. 09:46:33 14 He would typically get down. He would then after two 09:46:36 15 or three weeks go see the doctor. He would get some medicine 09:46:39 16 and he was then generally out of his depression within two or 09:46:43 17 three months, although one of them was somewhat longer. 09:46:46 18 But they were not terribly severe. They were not the 09:46:50 19 kind of depression that require hospital treatment. It was 09:46:57 20 not the kind of depression that necessarily alarmed anybody. 09:47:03 21 Large numbers of people in the general population 09:47:05 22 will have depressive episodes like this from time to time. 09:47:10 23 Q. So far as we can tell from the existing medical records, 09:47:14 24 the recollections of the doctors who treated him and his 09:47:17 25 family members, was there usually some kind of precipitating 391 09:47:23 1 life event, like stress at work or the death of a family 09:47:26 2 member, something like that? 09:47:28 3 A. Well, he tended to worry quite a lot about his work, and 09:47:32 4 particularly in the '80s, there were real difficulties in his 09:47:38 5 work. He was -- he worked in the oil industry. He had 09:47:47 6 responsibility to go around and check on wells that were 09:47:50 7 being pumped. 09:47:52 8 He was very afraid of getting laid off in the '80s. 09:47:56 9 That was not an unrealistic fear, and he does seem to have 09:48:04 10 gotten stressed out about that. 09:48:06 11 Later on, in the year before his death, there were a 09:48:10 12 couple of losses. He lost his father-in-law, Gerald, that he 09:48:17 13 was pretty close to, and sometime before that he lost a 09:48:22 14 brother. 09:48:24 15 He showed what to me would be expectable signs of 09:48:27 16 distress, but it was not anything that would alarm a 09:48:32 17 psychiatrist. I mean, he said he was -- he got kind of mad 09:48:37 18 when his father-in-law died. 09:48:39 19 Q. I wanted to ask you about that. What is your take -- one 09:48:41 20 of the witnesses in the depositions you read said he said 09:48:45 21 something -- I don't remember exactly, but like, "I never 09:48:51 22 liked him anyway," about his dead father-in-law. What's your 09:48:57 23 take on that? 09:48:58 24 A. I think if you lose somebody and it hurts, one way to deal 09:49:03 25 with it is to sort of say, "Well, that person didn't matter 392 09:49:06 1 to me anyway. I don't have them anymore but I didn't love 09:49:11 2 them anyway. They don't matter to me." 09:49:15 3 So some degree of irritation is not at all unusual in 09:49:19 4 the face of a bereavement. I remember one perfectly normal 09:49:23 5 woman who came into the emergency room after her husband, who 09:49:29 6 was a friend of mine, had died suddenly. And when they told 09:49:33 7 her the bad news, she flew into a rage and hit the wall with 09:49:39 8 her fist and said, "Goddammit. It is not fair." 09:49:45 9 So an angry reaction is sometimes predictable when 09:49:50 10 there's a loss and it doesn't necessarily mean anything 09:49:52 11 terribly sick. 09:49:53 12 Q. While we're talking about his past medical history, I want 09:49:57 13 to ask you about a couple things Mr. Preuss said in his 09:50:05 14 opening statement. 09:50:06 15 What's the significance to you that at least a couple 09:50:08 16 of those references reflect that he was out of work for a 09:50:12 17 month and in one instance each more than a month? 09:50:16 18 A. I think you have to put it in context. If one of you 09:50:19 19 lawyers fell into a depression and you didn't go to work, I 09:50:23 20 would bet because regular attendance to your office duties is 09:50:27 21 extremely important to your career, that it would probably 09:50:30 22 point in the direction of a rather substantial depression. 09:50:36 23 Most professional people who get into a depression such as 09:50:38 24 the lawyer I mentioned earlier who was my patient get up and 09:50:43 25 go to work even though they're horribly distressed. 393 09:50:51 1 Other people, particularly when the nature of their 09:50:53 2 work permits it, may elect to take some time off, especially 09:50:57 3 if it is easy to arrange some coverage. 09:51:00 4 And I think that's what Don Schell was doing. That's 09:51:03 5 my interpretation of his work absences. I think they were 09:51:11 6 more or less elective work absences and it was not that he 09:51:11 7 was so horribly depressed that he had no choice about it. 09:51:15 8 Q. Another thing that Mr. Preuss mentioned in his opening was 09:51:18 9 that some of these prior references talk about him being 09:51:22 10 irritable in conjunction with this. And what significance, 09:51:29 11 if any, does that have to you as you look at his past medical 09:51:33 12 history? 09:51:34 13 A. There are passing references to irritability in the 09:51:36 14 medical records, not on all of the occasions when he was 09:51:40 15 depressed but on three of them. I'm not sure I'm allowed to 09:51:46 16 mention Dr. Merrell's summary. It is a good one in that he 09:51:51 17 puts together the full data that comes to hand, including 09:51:57 18 some data that was gathered after I was deposed. 09:52:00 19 He identified six episodes, what he called six 09:52:08 20 episodes of depression. They were all mild. In the first, 09:52:11 21 third and sixth -- 09:52:13 22 MR. PREUSS: I will object to testimony coming out of 09:52:15 23 Dr. Merrell's report, particularly since that contains 09:52:18 24 information which the witness did not review and has told us 09:52:22 25 earlier did not rely on. 394 09:52:24 1 MR. VICKERY: That's fine. 09:52:25 2 THE COURT: Sustained. 09:52:27 3 A. Well, let me say -- maybe this will be permissible: That 09:52:31 4 there is reason to believe that -- 09:52:33 5 MR. PREUSS: Your Honor, could we proceed by question 09:52:35 6 and answer form, please? Objection. 09:52:38 7 Q. (BY MR. VICKERY) We have to do that here, 09:52:39 8 Dr. Maltsberger. I'm sorry. Let me ask you a question. 09:52:42 9 Is there anything in the prior medical history that 09:52:47 10 you have reviewed, including any matters highlighted from 09:52:53 11 information gleaned after your deposition, that causes you to 09:52:56 12 change your assessment and opinions about Paxil triggering 09:52:59 13 the homicide and suicide, an issue in this case? 09:53:07 14 A. No. May I add this, mild irritability is very common in 09:53:11 15 garden variety mild depressions. It is not an alarming 09:53:14 16 finding. 09:53:15 17 Q. Do you believe Don Schell had garden variety depressions 09:53:20 18 over the course of the years with these six episodes? 09:53:22 19 A. Yes. 09:53:23 20 Q. Your report also mentions the fact that there was this 09:53:28 21 anxiety component to his depression, particularly the last 09:53:34 22 one. 09:53:35 23 Of what significance is that in your assessment of 09:53:38 24 Don Schell's situation? 09:53:40 25 A. Well, we know that people who fall into turmoils or 395 09:53:46 1 frenzies, akathisias or manias, when they get into the full 09:53:55 2 states, they are profoundly anxious and nervous. We know 09:54:02 3 that they cannot sleep and we know that they are very 09:54:05 4 agitated. 09:54:11 5 In Dr. Patel's notes when Dr. Patel examined him 09:54:19 6 before giving him the Paxil, there's comments that the 09:54:22 7 patient was sleepless, very restless and agitated and there 09:54:26 8 was one thing in particular that bothered me. He said his 09:54:30 9 mind was racing at a hundred miles an hour. 09:54:33 10 Q. This is before he gets the Paxil, right? 09:54:35 11 A. That's right. 09:54:35 12 Q. What's the significance? 09:54:36 13 A. That suggests to me that there are warning signs that this 09:54:40 14 man might -- I couldn't say for sure, but a good practitioner 09:54:44 15 would know that these are warning signs that if this man gets 09:54:48 16 more revved up and more excited and more jazzed up by a drug, 09:54:55 17 that it is possible -- you would have to be afraid of a 09:55:02 18 possible turmoil or frenzy. 09:55:06 19 So I would not have given him an SSRI drug. That's 09:55:09 20 one thing. 09:55:09 21 The other thing is if I had, I would have given him 09:55:12 22 substantial coverage with some Ativan or a benzodiazepine to 09:55:16 23 protect against making him more nervous than he already was. 09:55:20 24 Q. Would you have titrated his dose as Mr. Haase says he 09:55:24 25 tells doctors to do when a patient has an anxious -- 396 09:55:27 1 A. I never would have started him out on a full dose. I 09:55:30 2 would have given him a half dose and I would have said, "Now 09:55:34 3 I want to hear from you by phone in the next day or two about 09:55:39 4 how you're feeling and in the meantime I want you to start 09:55:43 5 taking something for your anxiety. Start taking Ativan, 09:55:47 6 lorazepam. Take some benzodiazepine. Let's see if we can't 09:55:52 7 quiet the anxious side down." 09:55:54 8 Q. Dr. Maltsberger, you said a good practitioner would know 09:55:59 9 that. Are you referring to good psychiatrists such as 09:56:01 10 yourself? 09:56:02 11 A. Yes. 09:56:03 12 Q. How about people not trained in mental health? Would they 09:56:06 13 have any reason or way to know if these people don't give 09:56:10 14 them warnings like the one you drafted? 09:56:12 15 A. I don't see how Dr. Patel could be expected to know it. I 09:56:15 16 know it because, as I was joking, I've been in psychiatric 09:56:21 17 hospitals for 40 years and I know about these states and I 09:56:23 18 know about these drugs and I don't have to rely on the 09:56:27 19 product insert information to know a lot more about the SSRIs 09:56:34 20 than the pharmaceutical houses put out. 09:56:35 21 But people like Dr. Patel, they're not psychiatrists, 09:56:37 22 they don't see large numbers of psychiatric patients. They 09:56:41 23 pretty much have to rely on what they're told by the 09:56:44 24 pharmaceutical companies. 09:56:46 25 Q. Okay. Now, you said you would have given him something 397 09:56:50 1 like Ativan, a benzodiazepine. Why doesn't the Ambien that 09:56:57 2 Dr. Patel gave him -- why wasn't that adequate for that 09:57:00 3 purpose? 09:57:02 4 A. Well, Ambien could be called a sedative but more properly 09:57:06 5 is should be called a hypnotic drug. It is a drug to put you 09:57:09 6 to sleep. 09:57:10 7 Now, there was nothing wrong with giving him some 09:57:13 8 Ambien, but there's one thing about Ambien, it does have the 09:57:18 9 quality or the capacity to quiet down anxiety the way that 09:57:22 10 benzodiazepines do. It would make him sleepy, yes, so we 09:57:28 11 would hope, but there's nothing about Ambien that's going to 09:57:33 12 quiet down somebody who is in a state of turmoil, 09:57:36 13 restlessness and agitation. It is not supposed to be 09:57:40 14 prescribed for that and it isn't prescribed for that. It 09:57:43 15 wouldn't work for that. 09:57:45 16 Q. Do you fault Dr. Patel in any way for the deaths of the 09:57:53 17 Schell and Tobin family members? 09:57:55 18 A. I think that Dr. Patel was uninformed, but that it wasn't 09:57:59 19 his fault. And I don't fault him. 09:58:03 20 Q. Now, in your report you also mentioned the possibility 09:58:06 21 that Ambien can itself cause psychosis or, you know, 09:58:13 22 something else horrible. I forget the exact words you used. 09:58:19 23 Did you consider the possibility that in this case 09:58:20 24 Ambien could have been a culprit? 09:58:22 25 A. Yes, I wanted to be fair, and I went and I looked it up 398 09:58:26 1 and I thought about it. 09:58:28 2 And in the product information for Ambien there is a 09:58:33 3 statement that it can cause confusion and agitation and 09:58:38 4 hallucinations and psychosis. 09:58:43 5 But my experience with drugs like that is that that 09:58:46 6 happens when patients take overdoses, when they really get so 09:58:50 7 drugged up on it that they get, well, delirious. And there's 09:58:56 8 no indication that Mr. Schell took any kind of large 09:59:00 9 overdose. He didn't take any overdose at all. There was 09:59:06 10 Ambien found in his body at the time of autopsy and it was 09:59:09 11 appropriate to his having taken the amount of Ambien that had 09:59:13 12 been prescribed. 09:59:16 13 Q. Dr. Maltsberger, your report also mentions the fact that 09:59:21 14 two of the family members, the only two people who are alive 09:59:25 15 that had any contact with Don Schell himself while he was 09:59:29 16 under the influence of Paxil, recall two different things. 09:59:34 17 His mother-in-law, Flo, recalled when she talked to 09:59:38 18 him his voice was -- I think the night after he got the first 09:59:43 19 pill his voice was quivering to the point almost she couldn't 09:59:49 20 recognize him, and his son-in-law Tim testified that when he 09:59:53 21 talked to him the night before these deaths that he was 09:59:56 22 very -- I forget your word -- very abrupt with him, out of 10:00:00 23 character abrupt. 10:00:01 24 A. Yes. With respect to the telephone exchange that he had 10:00:04 25 with Tim Tobin, Tim was accustomed when he would call his 399 10:00:11 1 father-in-law's home that there would be some of the usual 10:00:15 2 things that people do over the phone like, "Hi, how you 10:00:19 3 doing? How are you feeling? Nice day we're having. Could I 10:00:24 4 please speak to my wife?" 10:00:27 5 This time it wasn't like that and Tim noticed that 10:00:30 6 his father-in-law was abrupt and, recognizing Tim, he said, 10:00:36 7 "Oh, just a minute. I will get Deb." 10:00:39 8 It seems to be a minor manner but it is consistent 10:00:43 9 with his being upset and anxious. 10:00:45 10 And in the matter of his speaking to his wife's 10:00:50 11 mother, it is a little unclear to me when they talked. They 10:00:57 12 appear to have talked on the same day that he -- that Don 10:01:03 13 Schell visited Dr. Patel. I can't tell whether he had taken 10:01:11 14 any of the Paxil before he spoke to his mother-in-law or not, 10:01:20 15 but she testifies that when she did talk to him he seemed 10:01:25 16 quite upset and very anxious and not at all himself. 10:01:29 17 Q. All right. When patients come in to doctors, whether 10:01:34 18 they're psychiatrists or any other kind of doctor, is there a 10:01:38 19 process called the taking of a history? 10:01:42 20 A. Yes. 10:01:42 21 Q. And would you just explain to the jury what the taking of 10:01:45 22 a history is and what are the representative obligations of 10:01:49 23 the doctor on the one hand, the patient on the other, with 10:01:52 24 respect to that process? 10:01:55 25 A. One presumes that the doctor is sufficiently trained and 400 10:02:02 1 sufficiently informed so that he knows something about the 10:02:06 2 general possible spectrum of what might be and the illness 10:02:22 3 that the patient presents, in this case a depression. 10:02:22 4 Now, a good psychiatrist would begin by saying to 10:02:23 5 somebody like Don Schell, "Now when was the last time you 10:02:26 6 felt perfectly okay? And what have you noticed about 10:02:30 7 yourself since that time that seems to be out of order?" 10:02:37 8 And then one would begin to get a history of 10:02:40 9 depression. One would ask him about all of the components 10:02:46 10 that we recognize as part of depression. And I would say, 10:02:52 11 "Well, now, Mr. Schell, how has your mood been?" And I would 10:02:59 12 get him to describe his mood. And I would find out if he was 10:03:02 13 able to enjoy the usual things in his life that were fun, if 10:03:06 14 he liked to look at his favorite TV show or whatever -- I 10:03:12 15 think he liked to fish, and I would find if he was off his 10:03:17 16 usual enjoyments. 10:03:19 17 And then I would want to know about his sleep and I 10:03:22 18 would want to know about his self-respect. And I would 10:03:26 19 inquire about whether he was blaming himself in unreasonable 10:03:30 20 ways, if he seemed to have any unreasonable guilty feelings. 10:03:35 21 Q. Dr. Maltsberger, let me stop you for a minute. As you're 10:03:38 22 doing that I'm seeing you gesture and you're like ticking off 10:03:42 23 things on fingers. 10:03:43 24 Are you sort of going down a checklist of diagnostic 10:03:48 25 symptoms or criteria for depression as you're doing this? 401 10:03:51 1 A. Yes. 10:03:52 2 Q. And how many are there? 10:03:55 3 A. There's six or eight. 10:03:56 4 Q. And are those diagnostic criteria for depression listed in 10:04:01 5 the PDR for Paxil? Is that something that somebody is 10:04:05 6 supposed to go down and check off those things before they 10:04:08 7 prescribe Paxil? 10:04:09 8 A. I think they're not listed in the product insert 10:04:12 9 information. Depression is mentioned, but not all of these 10:04:16 10 things. 10:04:17 11 Q. Do they come right out of a book called the DSM-IV? 10:04:21 12 A. Yes. 10:04:22 13 Q. And I think we've got one right here. Is this the DSM-IV? 10:04:28 14 A. That's right. 10:04:29 15 Q. What is this book? 10:04:30 16 A. That book is published by the American Psychiatric 10:04:33 17 Association and it is essentially a -- it contains the 10:04:38 18 definitions of different -- of all the different psychiatric 10:04:42 19 disorders according to the symptoms that you may expect to 10:04:46 20 find. 10:04:47 21 So it essentially is a definition of how we 10:04:50 22 understand depression. 10:04:55 23 Q. And is it useful in diagnosing conditions like depression? 10:04:58 24 A. Yes. 10:04:58 25 Q. Well, in this history taking -- 402 10:05:00 1 A. It ain't perfect, but it is better than nothing. 10:05:03 2 Q. Okay. You and I have had debates about the DSM-IV and I 10:05:08 3 don't know that that's appropriate for today. 10:05:11 4 Let me ask you this: As you describe that process to 10:05:14 5 us, it sounds like the doctor is the one that has to elicit 10:05:23 6 the information that's relevant to each of these categories. 10:05:26 7 Is that true? 10:05:27 8 A. That's right. 10:05:27 9 Q. Do you expect the patient to know when they come in and 10:05:29 10 start to give you a history what is significant to the 10:05:33 11 doctor? Is the patient supposed to look this up and say, 10:05:37 12 "Okay, I think I'm depressed so I need to be sure and tell 10:05:40 13 the doctor about these eight different criteria"? 10:05:45 14 A. Don't be ridiculous. Of course the patients aren't going 10:05:47 15 to know it. If they knew all about that, they wouldn't need 10:05:55 16 the doctor. 10:05:56 17 Q. You know and I think we all know why I say that. You 10:05:59 18 heard Mr. Preuss say in his opening that Don Schell withheld 10:06:05 19 information from Dr. Patel? 10:06:06 20 A. I have no reason to believe that whatsoever. 10:06:08 21 Q. Did Dr. Patel do a good job in taking a history? 10:06:11 22 A. I believe he did. I think it was an unusually good job of 10:06:17 23 history taking considering he's not a psychiatrist. 10:06:20 24 Q. Is there anything you know -- 10:06:21 25 A. There's nothing in Dr. Patel's notes that suggest that he 403 10:06:24 1 thinks Don Schell was withholding information. And 10:06:29 2 Dr. Suhany, one of his other doctors, in his deposition said 10:06:33 3 that he felt that he was a fully compliant and reliable 10:06:36 4 patient. 10:06:37 5 Q. Does that word "compliant patient" have a special meaning 10:06:42 6 to doctors? 10:06:42 7 A. It means that the patient is cooperating and that he will 10:06:45 8 cooperate in giving a history, answering the questions. He 10:06:49 9 will tell you the truth. He's not going to be telling you a 10:06:52 10 lot of lies -- although perhaps no patient is ever entirely 10:06:55 11 honest, especially with a new doctor -- and that he's going 10:06:59 12 to cooperate in the treatment that is recommended. 10:07:04 13 Q. Dr. Maltsberger, you mentioned Dr. Suhany and so I want to 10:07:08 14 move to that in a minute. But while we're still on the 10:07:11 15 subject of the history that was taken by Dr. Patel, did you 10:07:16 16 see in the history where Don Schell said, "I have taken 10:07:23 17 Prozac and," quote, "it didn't help"? Did you see that in 10:07:34 18 the history? 10:07:34 19 A. Yes, I did. 10:07:35 20 Q. Knowing what you know about these drugs, if a man came in 10:07:40 21 and was obviously anxious or related a history of being 10:07:43 22 anxious and a past history of being treated with Prozac and 10:07:46 23 it didn't help, would that send off any alarms or bells in 10:07:51 24 your head? 10:07:52 25 A. Oh, sure. I can tell you what I would ask. 404 10:07:54 1 Q. What? 10:07:55 2 A. I would say, "Well, what was there about it you didn't 10:07:58 3 like?" I would try to get him to put it in his own words: 10:08:02 4 "What didn't you like about it?" I would hear what he had to 10:08:05 5 say and I would follow it up. 10:08:07 6 I would say, "Did it make you very nervous? Did it 10:08:10 7 make you very anxious? Did it interfere with your sleep? 10:08:13 8 Did it make you feel speeded up?" 10:08:16 9 Q. Dr. Maltsberger, would you ask him -- would you draw out 10:08:20 10 from the patient, knowing what you know about it, whether the 10:08:22 11 prior experience on Prozac put him in turmoil or frenzy? 10:08:27 12 A. That's exactly what I would be reaching for, or whether it 10:08:30 13 put him into mild states of turmoil and frenzy. 10:08:34 14 Q. Why would you do that? 10:08:36 15 A. Because if it had I wouldn't want to give him another drug 10:08:40 16 like it for fear that I might really drive him into a 10:08:44 17 big-time turmoil or frenzy. 10:08:48 18 Q. Now, how is a nonpsychiatrist like Dr. Patel supposed to 10:08:52 19 know when the patient says, "I had Prozac and it didn't 10:08:57 20 help" -- how is he supposed to know to draw out from the 10:09:02 21 patient whether he's been in turmoil or frenzy on Prozac? 10:09:07 22 MR. PREUSS: Objection, Your Honor, speculation, no 10:09:09 23 foundation. 10:09:11 24 THE COURT: The witness may answer the question if he 10:09:13 25 knows. 405 10:09:15 1 A. No doctor could ask those questions unless he had been 10:09:18 2 properly educated. 10:09:20 3 Q. (BY MR. VICKERY) How do you get properly educated? 10:09:22 4 A. General practitioners and internists prescribing Paxil and 10:09:26 5 other drugs like it rely heavily on what they're told by the 10:09:30 6 pharmaceutical representatives and by what is printed in the 10:09:34 7 product information. 10:09:37 8 Q. All right. Now, let me follow up on that one because, you 10:09:40 9 know, we know what Dr. Patel has said about drug reps, but 10:09:45 10 the product information, the product insert, is that 10:09:51 11 information that's published in a book called the PDR, the 10:09:56 12 Physician's Desk Reference? 10:09:57 13 A. Yes, that's the prescribing information. 10:09:58 14 Q. Is that information that's provided to the publisher of 10:10:02 15 that book by SmithKline Beecham? 10:10:05 16 A. That is my understanding. 10:10:11 17 Q. You said if you were aware that he was in turmoil or 10:10:20 18 frenzy on the Prozac -- 10:10:22 19 A. Or approaching it. 10:10:23 20 Q. -- or approaching it, then you wouldn't give him another 10:10:27 21 drug in that class. Can you kind of use some analogy to 10:10:31 22 explain to us why you wouldn't? 10:10:33 23 A. Well, I mean, if one drug has been agitating and exciting 10:10:40 24 to the patient, one would be very suspicious that he might 10:10:44 25 have a similar response to other drugs in the same family. 406 10:10:50 1 Prozac and Paxil are first cousins. It is sort of 10:10:54 2 like -- 10:10:55 3 MR. PREUSS: Objection, Your Honor, no foundation. 10:10:57 4 THE COURT: Sustained. 10:11:00 5 A. Let's suppose that I was your GP and you came in and you 10:11:03 6 told me that you weren't feeling so well, that you had had 10:11:06 7 some indigestion and I took a history about diet and I 10:11:11 8 learned that you had a terrible allergy to lobster and you 10:11:15 9 had some lobster a while back and it made you so sick you 10:11:19 10 nearly had to go to the hospital. 10:11:22 11 I would tell you, "You better watch out for other 10:11:25 12 shellfish." 10:11:28 13 Q. (BY MR. VICKERY) Can't have shrimp? 10:11:32 14 A. "Don't eat shrimp, or if you do, eat only a tiny piece and 10:11:36 15 wait an hour to see if it disagrees with you." 10:12:03 16 Q. Your report also talks about spontaneous psychosis. Let's 10:12:08 17 put in some background. Did you in your own mind sort of 10:12:11 18 list all of the things that could be a culprit? 10:12:13 19 A. More or less I did. I tried to think about how could this 10:12:18 20 extraordinary frenzy that this man developed on the 12th or 10:12:26 21 the 13th of February -- how could this be explained. 10:12:31 22 Q. And let me follow up on that. Why do you say it was an 10:12:34 23 extraordinary frenzy? What is there about the circumstances 10:12:38 24 of these deaths that leads you to say that? 10:12:40 25 A. Well, I mean, this guy was not cold-bloodedly planning out 407 10:12:48 1 and killing these people. He was, I would infer -- 10:12:55 2 MR. PREUSS: Your Honor, objection. This is total 10:12:59 3 speculation. 10:13:00 4 THE COURT: Sustained. 10:13:01 5 Q. (BY MR. VICKERY) Dr. Maltsberger, you were here when I 10:13:04 6 read the stipulated facts at the start of this trial, were 10:13:06 7 you not? 10:13:07 8 A. Yes, I was. 10:13:08 9 Q. And did you hear both sides stipulated and agreed that 10:13:14 10 there were multiple gunshot wounds to each of the victims? 10:13:17 11 A. I did. 10:13:18 12 Q. Did you hear that each of the three women were shot with 10:13:21 13 two different guns, a small-caliber gun and a large-caliber 10:13:26 14 gun? 10:13:26 15 A. Yes. 10:13:27 16 Q. Is that significant to you in any way as you assess what 10:13:30 17 happened to this man? 10:13:32 18 A. Any man, any person who is going to shoot a little baby 10:13:36 19 multiple times, not just with one but with two guns, is in 10:13:43 20 some kind of a frenzy. 10:13:46 21 MR. PREUSS: Objection, Your Honor, total 10:13:47 22 speculation, move to strike. 10:13:49 23 MR. VICKERY: Your Honor, that's not total 10:13:50 24 speculation. That's the very kind of thing this man is 10:13:52 25 trained to do. That's the whole psychological autopsy 408 10:13:56 1 process. It is the stuff that he's done for years. 10:14:00 2 THE COURT: I will let it stand. 10:14:04 3 Q. (BY MR. VICKERY) Dr. Maltsberger, we started down this 10:14:07 4 road talking about considering all of the things that could 10:14:10 5 cause this behavior, and in your report you mentioned 10:14:14 6 spontaneous psychosis. 10:14:17 7 Would you just explain what that is and why you 10:14:19 8 thought about it, why you ultimately determined that that's 10:14:23 9 not what we have here? 10:14:26 10 A. Well, we have to entertain the possibility that if Don 10:14:31 11 Schell hadn't been taking anything at all, if he had just 10:14:35 12 been going along and had never been exposed to any SSRI drug, 10:14:41 13 whether this would have happened anyway. 10:14:46 14 And I can tell you that in a 60-year-old person who 10:14:53 15 has no previous history of anything frenzied like this, never 10:14:59 16 before in their lives, if somebody 60 years old or over gets 10:15:05 17 into such a state, there is a physical factor at work and you 10:15:12 18 have to assume that that's the case until you prove 10:15:14 19 otherwise. 10:15:15 20 Q. You mean something biological, something wrong with their 10:15:18 21 body? 10:15:19 22 A. Something is going on in their body to drive them wild. 10:15:24 23 This man never had a psychosis before. I mean, the 10:15:27 24 kind of things like manic-depressive disease, the kinds of 10:15:32 25 illnesses that put people into hospitals, these things come 409 10:15:35 1 on in youth. 10:15:37 2 This man had never had anything approaching this 10:15:41 3 state in his whole life. If he had had a history of repeated 10:15:46 4 breakdowns and hearing voices or delusions and had had to go 10:15:52 5 to the hospital multiple times because he would get 10:15:54 6 assaultive, it would be one thing. 10:15:57 7 There is not one whisper in this man's history of 10:16:01 8 such a thing. Suddenly, a 60-year-old man gets into such a 10:16:06 9 state. The presumption must be that there is some biological 10:16:12 10 physical factor at work. 10:16:14 11 Now, we know he didn't have a brain tumor because 10:16:17 12 there was an autopsy. There is no evidence that he had a 10:16:20 13 raging fever. There is no evidence whatsoever that he was 10:16:24 14 raging drunk. There's only one thing, Paxil; Paxil 10:16:30 15 superimposed on an anxious, agitated depression. 10:16:36 16 Q. Is Paxil a psychoactive drug? 10:16:38 17 A. It certainly is. 10:16:39 18 Q. What does that mean? 10:16:41 19 A. It means that it acts on the central nervous system, has 10:16:44 20 effects on the central nervous system that alter subjective 10:16:49 21 states and may alter behavior. 10:16:52 22 Q. Okay. There's one other area I want to cover with you and 10:17:01 23 it relates to a couple items you mentioned in your report. 10:17:29 24 Let me ask you a follow-up question. You said there 10:17:32 25 was no evidence of a brain tumor or anything on the autopsy. 410 10:17:34 1 Was there evidence that he had Paxil in his blood in the 10:17:37 2 autopsy? 10:17:38 3 A. Yes, there was. There was evidence that he had Paxil in 10:17:41 4 his body at autopsy. 10:17:43 5 Q. Okay. You mentioned an article in your report by Donovan, 10:17:57 6 and the title of the article is Deliberate Self-Harm and 10:18:05 7 Antidepressant Drugs. 10:18:06 8 Now, you've been studying suicide for 41 years. Does 10:18:10 9 deliberate self-harm get your attention as a suicidologist? 10:18:16 10 A. Sure. It means -- 10:18:18 11 MR. PREUSS: I object to any testimony on this 10:18:20 12 article. By stipulation he's not for general causation. It 10:18:24 13 is a general causation article. 10:18:26 14 THE COURT: What's the purpose of the proof? 10:18:27 15 MR. VICKERY: The purpose of the proof is it relates 10:18:28 16 to his specific causation opinion. It is contained -- I can 10:18:32 17 show the Court, it is right in his Rule 26 report that he 10:18:35 18 relies on this for his opinion. 10:18:38 19 THE COURT: Overruled. 10:18:39 20 Q. (BY MR. VICKERY) Investigation of a possible link: Now, 10:18:45 21 were you here -- and I know these video depositions aren't 10:18:48 22 the most scintillating thing in the world, but were you here 10:18:52 23 when the video deposition of Dr. Yamada was being played? 10:18:56 24 A. Yes, I suffered through it. 10:18:57 25 Q. I think you slept through it. I'm sorry, I didn't mean 411 10:19:00 1 that on the record. 10:19:01 2 Dr. Maltsberger, in all seriousness, did you hear 10:19:06 3 Dr. Yamada when he was asked to read the acknowledgments and 10:19:17 4 the fact that this study was funded in part by SmithKline 10:19:17 5 Beecham? 10:19:17 6 A. Yes, I did. 10:19:17 7 Q. What significance to you is it that SmithKline Beecham 10:19:20 8 itself funded this study? 10:19:23 9 A. Well, I suppose they wouldn't pay out good money -- 10:19:26 10 MR. PREUSS: Objection, Your Honor, speculation. 10:19:29 11 THE COURT: Yes, how does this witness know this? 10:19:31 12 Let's go on. 10:19:32 13 MR. VICKERY: That's a valid objection. 10:19:51 14 Q. (BY MR. VICKERY) In Table 2 of this article there is a 10:19:51 15 listing -- I'm looking at the wrong table. 10:20:00 16 A. That's the overdose table. 10:20:01 17 Q. Let me put up Table 3. Table 3 of this article lists 10:20:16 18 relative risks of self harm on various drugs, right? 10:20:21 19 A. Yes. 10:20:21 20 Q. The lowest we see is amitriptyline at 1.0 and for 10:20:27 21 paroxetine, or Paxil, we see it is 4.0. 10:20:32 22 A. That's right. 10:20:33 23 Q. What is the significance of that to your opinion about Don 10:20:35 24 Schell's suicide in this case? 10:20:37 25 MR. PREUSS: Objection, Your Honor, no foundation. 412 10:20:38 1 It calls for testimony beyond his background and experience 10:20:41 2 in epidemiology. 10:20:45 3 THE COURT: Oh, overruled. I think that the witness 10:20:47 4 can comment on this. 10:20:50 5 A. What this shows is those who were prescribed Paxil were 10:21:00 6 four times more likely to hurt themselves on purpose than is 10:21:03 7 the case of amitriptyline which is an old-fashioned 10:21:10 8 antidepressant. 10:21:22 9 MR. VICKERY: I seem to have misplaced Dr. Cole's 10:21:26 10 declaration. 10:21:27 11 Q. (BY MR. VICKERY) But in your report you mentioned one of 10:21:31 12 the things you relied on was a declaration from Dr. Jonathan 10:21:44 13 Cole. Why did you find that to be helpful information in 10:21:47 14 arriving at your opinions in this case? 10:21:49 15 A. Dr. Cole makes it very plain that it is not necessary that 10:21:56 16 there should be double-blind, randomized, placebo-controlled 10:22:01 17 trials in order to draw clinical conclusions about the 10:22:05 18 comparative safety of these drugs. 10:22:08 19 Q. So what? Is there something about the fact that Jonathan 10:22:11 20 Cole says it that makes it more likely so in your judgment? 10:22:15 21 A. Well, I know Dr. Cole and in some respect he's even been 10:22:19 22 my teacher. He is one of the most respected 10:22:26 23 psychopharmacology experts in the world. He has been 10:22:31 24 described as the father of modern psychopharmacology. 10:22:33 25 And he is very clear in his own thinking that you 413 10:22:38 1 don't have to have pristine, randomized placebo trials in 10:22:44 2 order to draw reasonable clinical inferences about the safety 10:22:48 3 or lack thereof of drugs. 10:22:56 4 Q. Dr. Maltsberger, in your judgment if Dr. Patel had been 10:23:00 5 given a warning like the one you drafted or something similar 10:23:03 6 to it, would he be alive today? 10:23:09 7 MR. PREUSS: Objection, Your Honor, no foundation, 10:23:10 8 calling for speculation as to how Dr. Patel would have acted 10:23:13 9 with that information. 10:23:14 10 MR. VICKERY: I can show the Court right where it is 10:23:16 11 in his report. 10:23:20 12 THE COURT: Do so, please. 10:23:42 13 THE WITNESS: It is in the one dated the 15th of 10:23:44 14 March. It is in the supplementary -- 10:23:48 15 MR. VICKERY: Yes, I found it there. It is the final 10:24:02 16 paragraph of the supplemental report of March 15th, Your 10:24:09 17 Honor. Be glad to read it, if you want me to. 10:24:12 18 MR. PREUSS: I don't doubt it is in the report but it 10:24:15 19 is still speculation. 10:24:16 20 THE COURT: What's the -- this witness' ability to 10:24:22 21 make that opinion? 10:24:23 22 MR. VICKERY: Just 41 years of experience as a 10:24:25 23 doctor, Your Honor. I think it is a reasonable professional 10:24:30 24 opinion of what would be the consequence of a proper and 10:24:32 25 adequate legal warning. 414 10:24:38 1 MR. PREUSS: Your Honor, it calls for what Dr. Patel 10:24:41 2 is going to do with whatever new information that this doctor 10:24:43 3 feels is appropriate and that calls for speculation. He 10:24:46 4 can't testify to that. 10:24:49 5 MR. VICKERY: We will have the other side of the coin 10:24:51 6 later from -- we have exactly the same kind of statements in 10:24:55 7 the Rule 26 reports from the defendants, except they just 10:24:58 8 have the opposite opinion. 10:25:02 9 THE COURT: I will let the witness answer the 10:25:03 10 question. You ask the question again and he may answer the 10:25:05 11 question. 10:25:07 12 Q. (BY MR. VICKERY) Dr. Maltsberger, if Dr. Patel had been 10:25:12 13 provided -- 10:25:14 14 THE COURT: Ask it like you did the last time. 10:25:16 15 MR. VICKERY: I don't know I can say it exactly the 10:25:19 16 same. 10:25:19 17 THE COURT: I'll ask the reporter to read it back. 10:25:37 18 MR. VICKERY: Would you read it back, please, ma'am? 10:25:40 19 (Previous question read.) 10:25:43 20 MR. PREUSS: I renew my objection. 10:25:45 21 THE WITNESS: I believe Dr. Patel is alive today. I 10:25:47 22 believe you meant to ask me about Don Schell. 10:25:52 23 MR. VICKERY: It was a misplaced modifier. 10:25:53 24 Q. (BY MR. VICKERY) If Dr. Patel had been given the warning, 10:25:56 25 would this man and his wife and child be alive today? 415 10:26:02 1 A. I think there's a very good chance had he paid attention 10:26:04 2 to it, and I have no reason to doubt he would have paid 10:26:07 3 attention to it -- 10:26:08 4 THE COURT: This goes way beyond the question. He 10:26:11 5 answered the question. 10:26:15 6 MR. VICKERY: I pass the witness, Your Honor. 10:26:17 7 THE COURT: Thank you very much. 8 CROSS-EXAMINATION 10:26:20 9 Q. (BY MR. PREUSS) Good morning, Doctor. 10:26:37 10 A. Good morning, Mr. Preuss. 10:26:45 11 Q. Now, as I understand your background, sir, your primary 10:26:47 12 method of treating patients that you see is psychotherapy; is 10:26:55 13 that correct? 10:26:55 14 A. No, I practice general psychiatry which includes 10:26:55 15 psychotherapy, but I also prescribe psychoactive drugs. 10:27:01 16 Q. Well, do you use psychotherapy more with your patients 10:27:06 17 than you do treatment with drugs? 10:27:08 18 A. Some of my patients are treated with psychotherapy only. 10:27:12 19 About half of them are given prescriptions for drugs which 10:27:20 20 they take while I give them psychotherapy. And a very small 10:27:24 21 proportion, typically people who have had a period of 10:27:31 22 psychotherapy and are doing well, may return only about once 10:27:35 23 a month for renewal of their prescriptions. 10:27:39 24 Q. So some are pure psychotherapy patients, some are 10:27:42 25 combination with meds, medications, and some are just 416 10:27:46 1 medications only; is that correct? 10:27:49 2 A. Fair enough. 10:27:50 3 Q. Is that true with respect to your treatment of patients 10:27:53 4 for depression, sir? 10:27:54 5 A. Oh, yes. 10:27:55 6 Q. So that same -- how would you divide a 100 percent figure 10:27:59 7 of your depressed patients that you are treating in terms of 10:28:06 8 sole psychotherapy and medication combination, please? 10:28:12 9 A. Most of the depressed patients in my practice will get a 10:28:15 10 prescription as well as psychotherapy. Then as time goes by, 10:28:21 11 they're feeling better and we've addressed what can be 10:28:24 12 addressed in psychotherapy, they very often elect to continue 10:28:27 13 to take an antidepressant. So they may come in once a month 10:28:31 14 or sometimes even less often for a session and a renewal of 10:28:36 15 the prescription. 10:28:37 16 Q. And what antidepressants do you use for medication? 10:28:42 17 A. The one that I most commonly prescribe is Zoloft which is 10:28:46 18 an SSRI. 10:28:48 19 Q. I see. What percentage of those patients you have on 10:28:54 20 medication use Zoloft? 10:28:59 21 A. Probably half of them. 10:29:02 22 Q. Now, you don't have a degree in epidemiology, do you, sir? 10:29:06 23 A. Certainly not. 10:29:07 24 Q. And you don't hold yourself out as an epidemiologist? 10:29:10 25 A. Oh, no. 417 10:29:14 1 Q. And you don't hold yourself out as an expert in 10:29:16 2 determining the cause of a particular adverse medical event, 10:29:20 3 do you? 10:29:22 4 A. Well, I have had a lot of experience in psychological 10:29:27 5 autopsy work, but I am not a drug expert in terms of 10:29:34 6 understanding all about psychopharmacology and 10:29:38 7 psychoneuropharmacology and the more arcane details of drugs. 10:29:51 8 Q. As to the methodology to establish that a drug may or may 10:29:54 9 not cause a particular adverse effect, you're not an expert 10:29:58 10 in that area, are you? 10:29:59 11 A. No, I'm just an ordinary doctor. 10:30:02 12 Q. And you're not a biostatistician or a statistician? 10:30:07 13 A. Nope. 10:30:08 14 Q. And you don't consider yourself an expert in pharmacology, 10:30:10 15 do you? 10:30:12 16 A. No. 10:30:16 17 Q. And you have had no training in regulatory matters with 10:30:18 18 the FDA, have you? 10:30:19 19 A. None whatever. 10:30:20 20 Q. And you've never drafted warnings for package inserts that 10:30:26 21 were submitted to the FDA, have you? 10:30:28 22 A. That's correct, unless SmithKline Beecham has decided to 10:30:30 23 send off my warning without my knowing it. 10:30:36 24 Q. And you've never submitted your warning to the FDA, have 10:30:41 25 you? 418 10:30:41 1 A. No, sir. 10:30:43 2 Q. You've never submitted any warning to the FDA, have you? 10:30:47 3 A. No. 10:30:48 4 Q. And you've never studied the regulations that govern the 10:30:51 5 warnings that pharmaceutical companies give to their 10:30:54 6 physicians that prescribe the pills, right? 10:30:56 7 A. I have never studied those regulations. 10:31:00 8 Q. And you've never consulted with a pharmaceutical company 10:31:02 9 on the safety and efficacy of their drugs, have you? 10:31:08 10 A. Yes, I have, on a couple of occasions called up the 10:31:13 11 pharmaceutical house and asked them when I was dealing with a 10:31:16 12 patient who reported a certain adverse event -- I've called 10:31:20 13 them and asked them if they have any comment about it. 10:31:23 14 Q. So if you had an experience with a drug, you would call 10:31:25 15 in. 10:31:25 16 Have you ever been hired by a pharmaceutical company 10:31:28 17 to advise them concerning safety and efficacy of their drug 10:31:31 18 or the drug labeling? 10:31:33 19 A. Oh, no. 10:31:35 20 Q. And you don't hold yourself out as an expert in the 10:31:38 21 labeling of pharmaceutical products, do you? 10:31:40 22 A. No. 10:31:44 23 Q. Nor do you hold yourself out as an expert in drug safety, 10:31:47 24 do you? 10:31:51 25 A. It is hard to answer that. You know, I think an ordinary 419 10:31:56 1 physician has to have a reasonable expertise in understanding 10:32:01 2 the risks and the benefits of what he prescribes, and I hope 10:32:04 3 that I'm well informed, maybe even expert to the best that I 10:32:12 4 can be about the drugs that I prescribe for my patients. 10:32:15 5 Now, I'm not an expert in terms of giving 10:32:19 6 pharmaceutical houses advice or in conducting research trials 10:32:24 7 or any of these things that I rather imagine you have in 10:32:29 8 mind, but maybe you'll go ahead. 10:32:32 9 Q. With respect to adverse reaction reports that you just 10:32:35 10 mentioned -- in other words, you had an experience with a 10:32:38 11 drug and you called the company -- you've never done that 10:32:41 12 with respect to an SSRI, have you? 10:32:51 13 A. I have. 10:32:51 14 Q. When did you do that, sir? 10:32:51 15 A. Some years ago I was giving a patient Zoloft and she 10:32:55 16 complained that it was making her hair fall out. It seemed 10:32:58 17 to me that that was a strange matter, so I called up the 10:33:01 18 company and asked them. 10:33:02 19 Q. I would like you to look at page -- your deposition, sir. 10:33:07 20 Let me get a copy for you. Would you turn to page 27, 10:34:05 21 please, sir? 10:34:05 22 A. I have it. 10:34:05 23 Q. And line 16 through line 24. 10:34:05 24 A. Yes. 10:34:08 25 MR. VICKERY: Excuse me, Your Honor. To put this in 420 10:34:08 1 context I would ask that they read from line 2. 10:34:12 2 THE COURT: Well, I think I'm going to go back to the 10:34:14 3 old way we do this and let you take that up on redirect. 10:34:18 4 MR. VICKERY: Okay. I will certainly do that. 10:34:25 5 MR. PREUSS: I don't have any objection if you would 10:34:27 6 like it. 10:34:27 7 THE COURT: If you wish to, you may. 10:34:29 8 Q. (BY MR. PREUSS) "Question: Have you ever consulted with 10:34:31 9 the FDA or anyone else in regard to pharmaceutical products 10:34:34 10 other than in litigation? 10:34:36 11 "Answer: Over the years I may have reported a 10:34:37 12 side effect a very few times to a pharmaceutical company. I 10:34:41 13 think never to the FDA. I had a patient one time who swore 10:34:44 14 that her hair was falling out and she was taking Zoloft, so I 10:34:48 15 inquired about it. We filed a report. 10:34:50 16 "Question: Is that the only time you've ever filed a 10:34:52 17 report regarding an SSRI? 10:34:53 18 "To the best of my memory. 10:34:55 19 "And you have never ever reported to the FDA about 10:34:57 20 any adverse reaction the patient had on an SSRI; is that 21 correct? 10:35:03 22 "That's correct. 10:35:04 23 "Have you ever reported to the FDA an adverse 10:35:07 24 reaction a patient had on any drug? 10:35:09 25 "Not to my memory, no, I can't remember ever doing 421 10:35:11 1 it." 10:35:13 2 A. Yes, I will stand by that testimony. 10:35:34 3 Q. You mentioned a couple experiences you had with patients 10:35:36 4 on Paxil. In fact, you mentioned two. Are those the only 10:35:40 5 two you've ever prescribed Paxil for, sir? 10:35:42 6 A. I hesitate to say. I've treated a lot of patients but 10:35:45 7 those are the only two I can recall this morning. 10:35:47 8 Q. At your deposition you indicated that you had only 10:35:49 9 prescribed Paxil two or three times? 10:35:52 10 A. I think that's right. 10:35:53 11 Q. And you don't have any current patients for whom you're 10:35:57 12 prescribing Paxil; is that right? 10:35:59 13 A. That's right. 10:36:00 14 Q. And none of your Paxil patients have committed suicide or 10:36:04 15 homicide, have they? 10:36:06 16 A. None of my patients whatever have ever done either. 10:36:09 17 Q. By the way, is there a risk of suicide with patients that 10:36:13 18 are just being treated by psychoanalysis, psychotherapy? 10:36:28 19 A. Well, I mean, sure, people can commit suicide no matter 10:36:32 20 what treatment they're getting. 10:36:34 21 Q. Or what treatment they're not getting? 10:36:36 22 A. Sure. 10:36:36 23 Q. And depressed patients are always at a risk of suicide, 10:36:39 24 are they not? 10:36:42 25 A. That's why we have to be carefully trained to know what 422 10:36:45 1 we're doing. Sure they're at risk. 10:36:48 2 Q. You have never done any reading on the pharmacokinetics or 10:36:54 3 pharmacodynamics of Paxil; isn't that right, sir? 10:36:59 4 A. Only what's in the PDR. 10:37:01 5 Q. You've never done any clinical research with respect to 10:37:03 6 Paxil? 10:37:04 7 A. No, sir. 10:37:13 8 Q. And for purposes of this case you're offering no opinions 10:37:15 9 on the general causation question as to whether or not Paxil 10:37:18 10 can cause suicide or homicide or aggression, right? 10:37:22 11 A. Well, I don't know exactly what general causation means. 10:37:28 12 Q. Something other than specifically relates to Donald 10:37:32 13 Schell, sir? 10:37:33 14 A. I'm not following you, Mr. Preuss. 10:37:37 15 Q. Well, you understand that at your deposition that there 10:37:41 16 was an understanding between your -- Mr. Vickery and 10:37:45 17 ourselves that you would not be offering any testimony with 10:37:48 18 respect to the general proposition as to whether Paxil can 10:37:52 19 cause homicide and suicide or aggression? 10:37:55 20 A. Well, I know there was some colloquy between the attorneys 10:37:59 21 at that time and there was a certain amount of technical talk 10:38:02 22 that I didn't pay much attention to. 10:38:04 23 Q. All right. Now, when were you first engaged to -- by any 10:38:12 24 individual with respect to litigation involving SSRIs? 10:38:18 25 A. By Mr. Vickery last year, I believe. 423 10:38:20 1 Q. All right. And prior to that time, sir, you were -- you 10:38:25 2 had no familiarity, no personal knowledge at all with respect 10:38:28 3 to what any pharmaceutical house that manufactures an SSRI 10:38:33 4 had done by way of research or study of their products; isn't 10:38:37 5 that right? 10:38:39 6 A. Well, I for years have read the -- 10:38:44 7 Q. PDR? 10:38:45 8 A. -- PDR and I read the psychiatric journals, so I have some 10:38:50 9 general education and information. 10:38:53 10 Q. Have you ever looked at any clinical trials or any of the 10:38:56 11 supporting material for any NDA application by any 10:39:01 12 pharmaceutical company that manufactures an SSRI? 10:39:04 13 A. Specifically pertaining to NDA applications? 10:39:07 14 Q. Sure. 10:39:08 15 A. Never. 10:39:12 16 Q. And you had no knowledge before being contacted by 10:39:14 17 Mr. Vickery whether any pharmaceutical house that 10:39:19 18 manufactures an SSRI had carried out a randomized 10:39:22 19 double-blind trial to determine whether these drugs may cause 10:39:26 20 suicide, right? 10:39:27 21 A. I'm not sure when that came to my attention. Let's say 10:39:31 22 that my attention has certainly been focused on that since I 10:39:35 23 became involved with Mr. Vickery. I may have had some 10:39:38 24 appreciation of it before, but I honestly don't remember. I 10:39:42 25 have sure thought a lot more about it since I met 424 10:39:45 1 Mr. Vickery. 10:39:50 2 Q. And with respect to -- you remember the two questions read 10:39:52 3 to you with respect to Dr. Wheadon's testimony? 10:39:56 4 A. Yes. 10:39:57 5 Q. And the question was, "So just if there is a reasonable 10:40:01 6 evidence that the drug might cause this, then a warning is 10:40:04 7 appropriate, right?" Do you remember that question? 10:40:07 8 A. Yes. 10:40:10 9 Q. And if there were not reasonable evidence, then I take it 10:40:12 10 in your view a warning would not be necessary? 10:40:16 11 A. It is a clinical call, Mr. Preuss. 10:40:20 12 Q. Could I have a yes or no answer to that, please? 10:40:23 13 A. Well, would you repeat it? 10:40:26 14 Q. Yes. Again the question, so you have it in mind, "So just 10:40:30 15 if there is a reasonable evidence that the drug might cause 10:40:33 16 this, then a warning is appropriate, right?" 10:40:37 17 My question is, if there were not reasonable 10:40:39 18 evidence, you wouldn't expect that a warning should be 10:40:42 19 changed, right? 10:40:43 20 A. Well, I cannot give you a yes or no answer. I can give 10:40:46 21 you a qualified yes. You and I may not agree about what is 10:40:50 22 reasonable. 10:40:56 23 Q. Or what isn't reasonable? 10:40:59 24 A. Yes. 10:41:12 25 Q. Now, even though you don't hold yourself out as a 425 10:41:15 1 pharmacologist and by your own admission your opinions in 10:41:18 2 this area are limited, do you understand that there are 10:41:22 3 chemical differences between the various SSRI products? Is 10:41:26 4 that right? 10:41:27 5 A. Yes, I think that Paxil is a substitute for piperazine and 10:41:37 6 the others have naphtha bases. The molecules are different. 10:41:42 7 Q. And patients may respond differently to various SSRIs, 10:41:47 8 right? 10:41:48 9 A. Yes, that's right. 10:41:49 10 Q. What might work for one patient may not work for another, 10:41:53 11 right? 10:41:55 12 A. Well, you know, there are two proverbs. One of them is 10:41:59 13 one man's meat is another man's poison and the other one is 10:42:03 14 what is sauce for the goose is sauce for the gander. 10:42:07 15 Now, all of these drugs, the SSRIs, work in the same 10:42:10 16 way. They selectively inhibit the reuptake of serotonin. 10:42:14 17 Q. My question was do some patients respond better to certain 10:42:20 18 SSRIs than others? 10:42:22 19 A. Yes. 10:42:22 20 Q. And vice versa? 10:42:24 21 A. Yes. 10:42:24 22 Q. And if you were going to prescribe an SSRI, one of your 10:42:26 23 job responsibilities in treating that patient is to try to 10:42:29 24 find the best medication that fits that particular person's 10:42:33 25 makeup? 426 10:42:34 1 A. No doubt about it. 10:42:39 2 Q. Now, as I understand it, you have had some experience with 10:42:44 3 Prozac as well, right? 10:42:45 4 A. A good deal. 10:42:49 5 Q. And you believe that Prozac is more likely to produce 10:42:53 6 akathisia in a patient than other SSRIs, right? 10:42:56 7 A. I think it is very likely to. I am not aware of any 10:43:03 8 studies that compare the akathisia-provoking potential of 10:43:06 9 Prozac in strict comparison to other SSRIs. They are all 10:43:11 10 somewhat likely to do so, some more than others, I presume. 10:43:17 11 I think that they can all do it. 10:43:22 12 Q. And your experience has been that Prozac is also more 10:43:26 13 activating than other SSRIs, including Paxil? 10:43:32 14 A. My experience? 10:43:34 15 Q. Yes. 10:43:35 16 A. Well, I have not prescribed a great deal of Paxil, so I 10:43:40 17 have to be careful about how I answer this question in terms 10:43:43 18 of my experience. I've prescribed a great deal more Prozac 10:43:50 19 than I have Paxil and I know it to be very aggravating. 10:43:55 20 I know by scientific reports that Paxil can be 10:43:58 21 activating and I know that in two of my patients it had a 10:44:02 22 disturbing effect. 10:44:06 23 THE COURT: Mr. Preuss, we will take the morning 10:44:08 24 recess at this time. We will take a 20-minute recess because 10:44:12 25 the Court has another matter to attend to, so I will add an 427 10:44:15 1 extra five minutes to this. 10:44:18 2 We will stand in recess for 20 minutes. 3 (Recess taken 10:35 a.m. until 10:50 a.m.) 11:01:53 4 (Following out of the presence of the jury.) 11:01:53 5 THE COURT: Court is in session outside of the 11:01:55 6 presence of the jury in order to resolve a matter of 11:01:56 7 foundation of documents. 11:01:57 8 MR. VICKERY: Thank you, Judge. May I proceed? 11:01:59 9 This man hasn't been sworn and I've been waiting for 11:02:02 10 years to question him under oath. 11:02:05 11 THE COURT: You will get that opportunity. 12 (Witness sworn.) 13 14 RICHARD EWING, 15 called as a witness on behalf of the Plaintiffs, being first 16 duly sworn, testified as follows: 17 DIRECT EXAMINATION 11:02:18 18 Q. (BY MR. VICKERY) State your name, please. 11:02:19 19 A. Richard Ewing. 11:02:20 20 Q. Mr. Ewing, are you a lawyer in the state of Texas? 11:02:24 21 A. I am. 11:02:24 22 Q. And are you of counsel in my law firm? 11:02:28 23 A. I am. 11:02:28 24 Q. How long have you been licensed to practice in the state 11:02:30 25 of Texas? 428 11:02:31 1 A. Since December 1957. 11:02:33 2 Q. Okay. The exhibit in issue is Exhibit 2 and it concerns 11:02:39 3 two different printouts of adverse event materials retrieved 11:02:44 4 from the FDA. Could you just explain for the judge how you 11:02:48 5 went about assembling that material and why it appears in 11:02:52 6 this fashion? 11:02:53 7 A. Yes. We ordered this material from a commercial company 11:02:58 8 in Gettysburg, Maryland. This company we had used before as 11:03:04 9 an intermediary with the FDA. They have the ability to 11:03:09 10 expedite the recovery of data from the FDA. This company is 11:03:14 11 called FOI Services, Inc., and the name is self-explanatory. 11:03:21 12 We had used them in 1997 to obtain the data on 11:03:28 13 Prozac, and at that time the FDA itself furnished the data on 11:03:32 14 computer disks, actually a couple of floppy disks. And later 11:03:38 15 the same company, when we went back to obtain additional data 11:03:44 16 last year about this time, this company had acquired the 11:03:49 17 entire FDA database up until 1997. 11:03:55 18 And I might add quickly that that's a public record 11:03:59 19 and that the Court himself, for example, could download that 11:04:03 20 database. The problem is that it is a million point two 11:04:12 21 records that are more than 400 characters each, and when you 11:04:15 22 download it it is about 100 megabytes on your computer. And 11:04:22 23 then you're faced with the problem how you separate out that 11:04:27 24 various data by drug names and by the particular outcomes and 11:04:30 25 symptoms that you're looking for. 429 11:04:32 1 So we used a commercial company. When we found out 11:04:37 2 they had that database and that capability, we were thrilled 11:04:40 3 to death because the Prozac database had cost me some of my 11:04:45 4 remaining hair and hundreds of hours. So we were delighted 11:04:51 5 to avail ourselves of that commercial service. 11:04:55 6 Q. Mr. Ewing, did you define search parameters to this 11:05:01 7 commercial service so as they got the information retrieved 11:05:04 8 under the Freedom of Information Act it would be limited, 11:05:08 9 useful information? 11:05:09 10 A. Yes. 11:05:09 11 Q. What did you do in that regard? 11:05:10 12 A. We had had the experience with the Prozac database and, if 11:05:14 13 I might explain quickly, Your Honor, there were some 2500 11:05:19 14 Prozac deaths. Of those, approximately 1800 were related to 11:05:26 15 suicide or murder, and of those, there were three central 11:05:32 16 terms that they were clustered under: Suicide attempt, and 11:05:42 17 injury intent, and overdose intent. 11:05:47 18 Those are clearly suicide terms or murder terms, and 11:05:52 19 there were about 1580 of those. 11:05:58 20 Another 300 were scattered among probably 15 more 11:06:02 21 terms. They're just a question mark. There's no way to 11:06:08 22 reduce that to certainty, but at least raises the question. 11:06:14 23 If I might explain, we weren't interested in doing 11:06:18 24 sharpshooting on the exact number of deaths because we're 11:06:23 25 talking about between 1 to 10 percent of the actual events, 430 11:06:26 1 so it would be ridiculous to try to do sharpshooting. 11:06:33 2 What we were trying to do was look at the same flow 11:06:35 3 of data the drug companies had available to them on the issue 11:06:39 4 of duty to test and duty to warn. We just wanted to see what 11:06:47 5 they have been seeing so we could form some educated opinion 11:06:50 6 about what they should have been doing about it. That was 11:06:54 7 our interest. 11:06:55 8 Q. Mr. Ewing, after you got the data collected under these 11:06:58 9 various terms, did you then go through as a function of word 11:07:04 10 processing and winnow it down to the things really relevant 11:07:07 11 here? 11:07:08 12 A. Well, there are two different sets of data. As you can 11:07:11 13 see from the exhibit, Your Honor, there's one set of 11:07:19 14 printouts that are what we ordered from that company. We 11:07:23 15 used the same criteria that we used with Prozac, the same 11:07:28 16 terminology. 11:07:29 17 And that batch of printouts was the product of that. 11:07:33 18 In the second instance -- and you will recognize it 11:07:38 19 because we've kept down the print to about six points. It is 11:07:41 20 hard to read. There's about five or six per page -- that's 11:07:47 21 the entire Paxil database from November of 1997 when the FDA 11:07:56 22 changed their database -- they redid their database -- until 11:08:04 23 the end of 1999 because we had ordered this in the spring of 11:08:07 24 2000. 11:08:15 25 That's a single document, Your Honor. I could send 431 11:08:18 1 you an e-mail and attach that document to it. You wouldn't 11:08:22 2 be very pleased because it would be enormous. 11:08:26 3 Q. How many pages? 11:08:27 4 A. 415 pages in six-point type, which means there's five or 11:08:31 5 six adverse incidents per page. 11:08:34 6 Q. Does that entire 415-page document contain lots of things 11:08:37 7 which bear no relevance to this case at all? 11:08:40 8 A. Oh, sure. 11:08:40 9 Q. How did you whittle it down? 11:08:43 10 A. What we did was take a word processor, start at the 11:08:48 11 beginning of the document and search on terms. We searched 11:08:53 12 on suicide. When the program found the first instance of 11:08:56 13 suicide in the document, we then blocked it and transferred 11:08:59 14 it to a companion document and just went through that tedious 11:09:06 15 process of blocking out that material and transferring it to 11:09:16 16 a different document. 11:09:17 17 In addition to suicide, we searched on akathisia, 11:09:20 18 aggression, we searched on suicidal ideation. And in this 11:09:25 19 instance, because of this case, we separated it between the 11:09:31 20 beginning of that new database in November of 1997 and the 11:09:36 21 start of the -- I mean, the events in this case in February 11:09:41 22 of 1998. 11:09:45 23 So, for example, there were about six suicides in 11:09:48 24 that brief month and then some 50 that followed it. We 11:09:56 25 separated those out so that the Court could look at what the 432 11:09:59 1 drug company looked at before the deaths in this case. 11:10:03 2 Q. Just one more question. The declaration that you did said 11:10:05 3 February of '99. Was that a typo? In fact -- 11:10:09 4 A. That was a typo. 11:10:11 5 MR. VICKERY: That's all the foundation I have, Your 11:10:13 6 Honor. 11:10:13 7 THE COURT: Thank you. 11:10:41 8 Mr. Zvoleff. 11:10:41 9 MR. ZVOLEFF: Morning, Your Honor. 11:10:41 10 THE COURT: Good morning. 11 CROSS-EXAMINATION 11:10:41 12 Q. (BY MR. ZVOLEFF) Good morning, Mr. Ewing. Do you have 11:10:41 13 the exhibit in front of you? 11:10:41 14 A. No, I really don't. 11:10:41 15 MR. VICKERY: I have one right here. 11:10:45 16 Q. (BY MR. ZVOLEFF) Would you please turn to what you 11:10:47 17 denominated in your declaration as Attachment 1? 11:10:51 18 A. Yes, Attachment 1 would be what we ordered from FOI. 11:10:57 19 Q. Thank you. When you were answering Mr. Vickery's 11:11:01 20 questions, you mentioned, I believe, that Attachment 1 was 11:11:06 21 something that you ordered a search done from this 11:11:09 22 third-party contractor of a database that they had, correct? 11:11:14 23 A. The database is the FDA database that was resident on 11:11:18 24 their computers. 11:11:19 25 Q. How do you know it is the FDA database that's resident on 433 11:11:23 1 their computer? 11:11:24 2 A. I have to accept their representation on that and I 11:11:27 3 guarantee you it looks like the stuff I did. I mean, it is 11:11:30 4 the same setup. 11:11:33 5 Q. Now, what search terms were used to generate Attachment 1? 11:11:37 6 A. We had given them a list of the terms that we used. The 11:11:41 7 primary terms were suicide attempt, injury intent and 11:11:46 8 overdose intent. 11:11:49 9 There's 12 or 15 more terms that we considered 11:11:54 10 secondary terms when I did the Prozac database, and they're 11:12:01 11 roughly -- oh, probably 20 percent of the events can be 11:12:05 12 subsumed under those 12 or 15 terms. 11:12:10 13 Q. And what are those 12 or 15 terms? 11:12:12 14 A. There's depression psychotic; overdose; react aggravated, 11:12:21 15 whatever that means; drug interaction; agitation; drug level; 11:12:29 16 depression; reaction unevaluated; nervousness; hostility; 11:12:38 17 anxiety; akathisia; tremor; hallucination. 11:12:46 18 Q. Now what we see on Attachment 1, then, are all the entries 11:12:49 19 that were generated by that search, as you understand it? 11:12:53 20 A. That's correct. 11:12:53 21 Q. And that's assuming that this third-party vendor performed 11:12:57 22 the search correctly? 11:12:59 23 A. That's correct. 11:12:59 24 Q. Now, would you please look at the first page of 11:13:01 25 Attachment 1? 434 11:13:02 1 A. Yes. 11:13:03 2 Q. Up on the top it says, "List reported with terms related 11:13:08 3 to suicide." The terms related to suicide are the terms you 11:13:13 4 just listed for me? 11:13:15 5 A. Yes. 11:13:15 6 Q. And that's because you believe those terms are related to 11:13:18 7 suicide? 11:13:19 8 A. Well, clearly on these first three, but on the others it 11:13:22 9 is a matter of surmise, question of deduction or surmise. 11:13:30 10 Q. Then it says, "37 reported reactions." That 37 reflects 11:13:37 11 all of the events listed on these three pages? 11:13:40 12 A. No -- yes, the 37 represents all of the reactions, but it 11:13:52 13 goes on to say, "28 unique reactions." 11:13:55 14 Q. And what's the term "unique" mean? 11:13:59 15 A. It means per patient. 11:14:00 16 Q. And is unique something that's in the FDA database? 11:14:03 17 A. Unique is a description of the data that's assembled by 11:14:06 18 case number by the FDA. 11:14:08 19 Q. You added the term "unique," correct? The term "unique" 11:14:17 20 doesn't appear in the FDA database? 11:14:19 21 A. No, it is a descriptor of what happens when you separate 11:14:21 22 the cases out. You see, you can have multiple reactions. 11:14:25 23 Q. I will get into that in a second. But it is your 11:14:28 24 descriptor, correct? 11:14:30 25 A. Yes. 435 11:14:30 1 Q. And after that it says, "28 unique reactions." Who came 11:14:35 2 up with the 28? 11:14:42 3 A. That's simply the computer determines how many unique 11:14:45 4 numbers there are in this patient number field. 11:14:47 5 Q. And who told the computer to do that? You did? 11:14:50 6 A. That would be the company, of course. 11:14:52 7 Q. And you instructed the company to do that, correct? 11:14:55 8 A. Right. 11:15:01 9 Q. You mentioned there will be multiple entries for really 11:15:04 10 the same patient here? 11 A. That's correct. 11:15:07 12 Q. At the top we see two entries in a row: Age, 62; sex, 11:15:13 13 female? 11:15:14 14 A. Sure. 11:15:15 15 Q. It is your assumption that that's in fact below Outcome, 11:15:20 16 so it looks like two people died, it would be your assumption 11:15:23 17 that that's actually the same person, right? 11:15:26 18 A. Yes. 11:15:26 19 Q. And then it says on the first line "suicide attempts" 11:15:30 20 under Reaction, but it says as the outcome "die." Can you 11:15:36 21 explain to me how the outcome of a suicide attempt is die 11:15:44 22 rather than a suicide? 23 A. The costar terminology that was in use until November 1997 11:15:46 24 was 15 single-spaced pages of medical terms and they didn't 11:15:52 25 have suicide, they didn't have murder. What they called 436 11:15:57 1 suicide was suicide attempt. 11:16:00 2 Q. And this is your testimony about what these terms mean, 11:16:02 3 aren't they, right? 11:16:04 4 A. I have been through them one by one, 43,000 of them on 11:16:08 5 Prozac. 11:16:09 6 Q. Now, let's go down a number of lines. And I'll try to 11:16:12 7 move this along quickly. If you go down about eight lines, 11:16:18 8 the first one there where you say "157 underage" and then 11:16:23 9 "female"? 11:16:24 10 A. Yes. 11:16:24 11 Q. And now there are four entries that say in a row "15 11:16:27 12 female die," correct? 11:16:30 13 A. Right. 11:16:30 14 Q. How do you -- is there any way to tell other than the 11:16:35 15 assumption that because the age and sex is the same that it 11:16:40 16 is the same person whether or not those are duplicative 11:16:43 17 entries from anything on this form? 11:16:44 18 A. You see the field there that's called control number? 11:16:49 19 Q. Yes, I do. 11:16:50 20 A. That's the key to these databases, the old and the new. 11:16:55 21 Q. There are two different control numbers for the 11:16:57 22 15-year-old female, aren't there? 11:16:59 23 A. There can be if they go into a subsequent patient. There 11:17:02 24 can be. That was one of the things that was corrected in the 11:17:08 25 1997 renewal of the database. 437 11:17:15 1 Q. Let me suggest to you that if we go through these first 11:17:18 2 three pages and count up all of the ones that appear to be 11:17:22 3 duplicates, we will not come up with 28 unique reactions, we 11:17:27 4 will come up with 22. Have you tried to do that to see if 28 11:17:33 5 unique reactions is the right number? 11:17:35 6 A. If you will notice, you can just barely see down here at 11:17:38 7 the bottom some semi-erased numbers. Yes, I have tried to do 8 that. 11:17:44 9 Q. Well, do you think 28 is the right number then? 11:17:47 10 A. I suspect 22 is probably closer. 11:17:49 11 Q. But it says 28 on this document? 11:17:51 12 A. I understand. It found 28 different numbers. 11:17:56 13 MR. ZVOLEFF: Your Honor, I could go on and on with 11:17:58 14 these documents and the problems with them. They are not 11:18:01 15 accurate copies of public records. They're not authenticated 11:18:05 16 by this testimony. They're something that could have been 11:18:09 17 prepared -- they could have made an FOI request and gotten a 11:18:14 18 real FOI response from the FDA and then we wouldn't have 11:18:19 19 these problems. 11:18:20 20 There's numerous problems. If I went on in our 11:18:24 21 discussions I could elicit testimony that he doesn't know how 11:18:27 22 they were characterized, who characterized them. These do 11:18:31 23 not fit within any exception to the hearsay rule. I would be 11:18:34 24 happy to continue to point out to the Court some of the many 11:18:39 25 problems with these, but I think it is just absolutely clear 438 11:18:42 1 they're not admissible. 11:18:45 2 I will continue if the Court would like me to. I can 11:18:47 3 show the problems in Attachment 2 that are similar. 11:18:56 4 THE COURT: I haven't seen the exhibit. I don't know 11:18:58 5 what the information is. 11:19:01 6 MR. ZVOLEFF: Hopefully we have a copy. 11:19:03 7 MR. VICKERY: If the Court has your 11:19:04 8 bench book there, it should be there under Plaintiff's 11:19:07 9 Exhibit