1631 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. June 1, 2001 Volume IX 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 1632 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 DEFENDANT'S PAGE 21 J. JOHN MANN Continued Cross - Mr. Vickery 1634/1731 22 Redirect - Mr. Preuss 1753 23 DEE POWERS Direct - Mr. Gorman 1706 24 Cross - Mr. Fitzgerald 1730 25 1633 1 INDEX TO WITNESSES CONTINUED 2 DEFENDANT'S PAGE ARTHUR MERRELL, M.D. 3 Direct - Mr. Gorman 1757 4 INDEX TO EXHIBITS PLAINTIFF'S RECEIVED 5 62 1676 6 DEFENDANT'S SB-LL 1672 7 SB-MM 1673 SB-NN 1673 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 1634 09:32:52 1 P R O C E E D I N G S 09:32:52 2 (Trial proceedings reconvened 09:32:52 3 9:30 a.m., June 1, 2001.) 09:33:12 4 THE COURT: Dr. Mann, I presume you recall you're 09:33:14 5 still under oath? 09:33:16 6 THE WITNESS: Yes, I do, Your Honor. 09:33:17 7 THE COURT: Mr. Vickery, you may proceed. 09:33:21 8 MR. VICKERY: Thank you, Your Honor. 9 10 J. JOHN MANN, M.D., 11 called as a witness on behalf of the Defendant, being 12 previously duly sworn, testified further as follows: 13 CONTINUED CROSS-EXAMINATION 09:33:23 14 Q. (BY MR. VICKERY) Good morning, sir. 09:33:25 15 A. Good morning. 09:33:28 16 Q. In the ACNP paper which is Joint Exhibit 245, I believe, 09:33:33 17 for our record, you referenced the fact that some unpublished 09:33:39 18 data from SmithKline Beecham had been provided to your task 09:33:43 19 force, correct? 09:33:44 20 A. Yes. 09:33:45 21 Q. And let's just look at the paragraph -- I have it up on 09:33:48 22 the board here -- and read it together. We will save our 09:33:55 23 voices. Would you like to read or me? 09:33:58 24 A. "Data supplied by the manufacturer of paroxetine indicate 09:34:04 25 that in a population of 4,668, patients were randomized to 1635 09:34:09 1 either paroxetine, 2963; placebo, 544; or other active 09:34:15 2 antidepressants, 1,151, for a six-week double-blind control 09:34:21 3 clinical trial and in some cases follow-up continuation 09:34:26 4 pharmacotherapy or maintenance treatment studies. There were 09:34:30 5 five suicides in the paroxetine group, two in the placebo 09:34:34 6 group and three in the other active treatments group." 09:34:39 7 Q. Let me stop you at the end of that sentence. I'm confused 09:34:43 8 and I'm sure you can straighten us out on this. When it says 09:34:46 9 randomized, there are 4,468 patients and they're randomized 09:34:53 10 by two-thirds get paroxetine, 2963, can you explain that for 09:34:59 11 me? 09:35:00 12 A. Well, these were actually a series of different studies 09:35:09 13 and it is not uncommon practice to sometimes have more 09:35:16 14 patients getting the drug you're testing than getting the 09:35:21 15 placebo or the comparison drug. 09:35:25 16 And the reason that's done is so that you can get 09:35:28 17 additional information on the safety and the efficacy of the 09:35:35 18 drug that you're testing because you already have a fair idea 09:35:38 19 what the safety and efficacy of the drug you're comparing it 09:35:42 20 to because those drugs have usually been around for a long 09:35:45 21 time. And since this is a new drug and you want to learn as 09:35:48 22 much about it as you can, it is not uncommon to have more 09:35:52 23 patients on that drug than the comparators. 09:35:55 24 Q. Thank you. We've heard a lot about placebo controls in 09:35:58 25 this trial already, particularly from Dr. Wang on Monday. 1636 09:36:03 1 Would you agree, at least insofar as you're trying to 09:36:06 2 have some control group, that in this case we have almost six 09:36:09 3 times -- a little over five times, I guess, as many people on 09:36:15 4 paroxetine as in the placebo control arm? 09:36:18 5 A. Yes. That's also not uncommon because the -- the reason 09:36:25 6 is that we try to treat as few people as possible with 09:36:29 7 placebo as we can in order to reduce the burden that we're 09:36:36 8 placing on people in participating in these studies. Most 09:36:41 9 people go into the studies hoping to be on the active drug so 09:36:44 10 we try to weight the odds so that they are on the active 09:36:47 11 drug, and they usually go on an active drug after they finish 09:36:50 12 the placebo period. But that's very common to have the 09:36:53 13 fewest number on placebo as possible. 09:36:56 14 Q. Dr. Mann, let me ask you this. I know there were four 09:36:58 15 members of your task force. Did you have access to all of 09:37:02 16 the data, all of the unpublished data, or were you provided 09:37:06 17 with summaries or statistical summaries of the data from 09:37:12 18 SmithKline? 09:37:14 19 A. To be perfectly honest, I can't recall how much of the 09:37:22 20 statistical raw data we received at the time that we put 09:37:26 21 these numbers together. 09:37:27 22 Q. Is it possible that you just had statistical summaries 09:37:30 23 from SmithKline? 09:37:31 24 A. It is conceivable that we got summary tables like the kind 09:37:36 25 from which these data were abstracted. That would be very 1637 09:37:40 1 different than to say the results -- the way Dr. Kahn did his 09:37:48 2 study where I think he basically got comparable results where 09:37:52 3 he actually went to the FDA database and looked at all of the 09:37:56 4 raw data. 09:37:57 5 Q. Okay. Now, did you personally review this data on 09:38:00 6 paroxetine back at the time the task force was working or did 09:38:04 7 one of the other members of your task force do that? 09:38:53 8 A. No, I think we all went through the tables of data that 09:38:53 9 were provided at the time. 09:38:53 10 Q. All right. Let's read on here for a minute and then we'll 09:38:53 11 come back to some other things to talk about. 09:38:53 12 Let me do the next one. 09:38:53 13 "When these data are converted to suicides per 09:38:53 14 patient exposure year, the number of suicides per patient 09:38:53 15 exposure year was .005 in the paroxetine group, .028 in the 09:38:53 16 placebo group and .014 in the active control treatment 09:38:53 17 group." 09:38:53 18 Question: Who made the decision to convert the data 09:38:53 19 to patient exposure years? 09:38:57 20 A. Well, we've reported the data here both ways, but the 09:38:57 21 reason that one is actually -- must present the data in this 09:39:04 22 way, patient exposure years, is that in some studies patients 09:39:07 23 were on the medication for four weeks or six weeks. In other 09:39:10 24 cases the patients were on the medication for months. 09:39:16 25 So the people who were on any particular medication, 1638 09:39:19 1 be it Paxil or a tricyclic, a TCA, or a placebo who were on 09:39:27 2 it for four or six weeks, were only on the medication a short 09:39:30 3 time. The people on it for six months were on it for a much 09:39:34 4 longer time. If you think there's an adverse event that 09:39:37 5 you're looking for or a beneficial effect that you're looking 09:39:40 6 for, you want to see how long the patient has been on the 09:39:43 7 medication because it is not an equal playing field if the 09:39:47 8 patient has only been on the meds for six weeks versus six 09:39:52 9 months. It is not an equal playing field if you're trying to 09:39:56 10 see if it is doing any good and it is not an equal playing 09:39:59 11 field if you're trying to see if the medication is doing any 09:40:02 12 harm. 09:40:02 13 So by converting it to a standard unit, patient 09:40:05 14 exposure years, you get an equivalence in terms of the 09:40:09 15 exposure of the patient to the particular medication. 09:40:14 16 Q. You're very familiar both from his written reports and 09:40:17 17 from his deposition testimony with the position of Dr. Healy 09:40:20 18 regarding this issue, aren't you? 09:40:27 19 A. I have some familiarity. I wouldn't say very familiar. 09:40:29 20 Q. What you know, don't you, is that he says that for that 09:40:32 21 group of people we were discussing yesterday, the small 09:40:36 22 minority of vulnerable people, that the danger period is in 09:40:39 23 the first week, two weeks, maybe the first month, in other 09:40:42 24 words, in the early part of taking the drug. 09:40:45 25 You understand that's his view, don't you? 1639 09:40:48 1 A. I'm sure you know his view better than I do, and if you 09:40:52 2 say so, then let's assume that's the case. 09:40:56 3 Q. All right. Well, Dr. Wang explained to us on Monday that 09:40:59 4 when you convert it to patient exposure years that you're 09:41:03 5 really weighting the experience of the person that was on for 09:41:06 6 a whole year for whom it worked just fine basically 52 times 09:41:13 7 heavier than the guy that was just on it one week and had a 09:41:16 8 real bad experience. 09:41:17 9 That's true, isn't it? 09:41:19 10 A. That's why it is useful to see the data presented in more 09:41:24 11 than one type of fashion. But the fact of the matter is that 09:41:31 12 that doesn't tell the whole story the way you've described 09:41:34 13 it. 09:41:35 14 Let's assume -- 09:41:37 15 Q. Excuse me. If we can, let's proceed on questions and 09:41:40 16 answers, okay? 09:41:41 17 A. Okay. 09:41:42 18 Q. Now, the -- the way that you chose to present the data in 09:41:47 19 the ACNP paper was in terms of patient exposure years, right? 09:41:52 20 A. That's correct. 09:41:52 21 Q. And are you the person that made the decision to weight it 09:41:55 22 and portray it in that fashion or did someone else on your 09:41:59 23 task force make that recommendation? 09:42:02 24 A. The entire content of the paper represents a consensus 09:42:05 25 statement. I was one of the people that had input into that. 1640 09:42:10 1 Q. All right. Now, let's read on. 09:42:15 2 "There were no statistically significant differences 09:42:18 3 across the three treatment groups. With regard to attempted 09:42:21 4 suicides, there were also no significant differences among 09:42:24 5 the three groups. The number of suicide attempts per patient 09:42:28 6 exposure year was 0.40 in the paroxetine group, 0." -- is 09:42:38 7 that an 83 in the placebo group? 09:42:40 8 A. Yes. 09:42:42 9 Q. -- "and 0.55 in the other active treatment groups." 09:42:48 10 Now, the suicide attempts are actually just in terms 09:42:51 11 of the raw data much higher? 09:42:53 12 A. Yes. Could I interrupt you there because I'm glad you 09:42:56 13 mentioned that. I'm sure you've noticed this, actually, but 09:43:01 14 it is important that others be aware of this -- 09:43:03 15 Q. Excuse me, Doctor. 09:43:05 16 THE COURT: Let's let him finish. We're not going to 09:43:07 17 interrupt the witness. Let him finish his statement. 09:43:12 18 A. You asked about the attempted suicide. That number, 09:43:16 19 that's a typographical error, I'm sure you know that. 09:43:20 20 Q. (BY MR. VICKERY) I didn't know that. 09:43:21 21 A. Well, if you look at the Montgomery paper which reviewed 09:43:24 22 the data in much greater detail, you will see that the 09:43:28 23 numbers are all identical except for the number that relates 09:43:33 24 to the suicide attempt number. That .40 should be .04. 09:43:46 25 Q. I didn't know that. I appreciate your telling me. 1641 09:43:52 1 Now we're going to go look at those 2963 patients in 09:43:57 2 a minute, but before we do that there's another statement 09:44:00 3 that I want to ask you about. 09:44:02 4 "Even if the FDA spontaneous reporting system were to 09:44:06 5 pick up only 1 out of every 100 instances" -- I know why the 09:44:11 6 rest of the sentence is there, but I want to ask you about 09:44:14 7 the first part of the sentence. 09:44:16 8 Why did you write down the FDA might only pick up 1 09:44:19 9 out of 100 instances? 09:44:23 10 A. Okay, that's unrelated to the paroxetine data paragraph. 09:44:29 11 Of course that's referring to the previous paragraph which 09:44:32 12 talks about Prozac. 09:44:33 13 Q. Isn't it talking about the effectiveness of the FDA's 09:44:37 14 spontaneous reporting system to pick up adverse events? 09:44:41 15 A. Yes. I just wanted to clarify that that is completely 09:44:44 16 unrelated to the paroxetine data we just discussed. 09:44:51 17 The FDA reporting system is an effort to try and 09:44:54 18 track reports of serious adverse unexpected kinds of events 09:45:03 19 that occur with medication, and I'm sure you've heard from 09:45:07 20 Dr. Wang and Dr. Wheadon on this, but the rate of report -- 09:45:12 21 reporting of such adverse events depends heavily on a lot of 09:45:17 22 things, for example, how serious the problem is; how much 09:45:24 23 publicity the problem may have received in the literature and 09:45:28 24 so on, in other words, how aware doctors are of this. 09:45:34 25 So we took a number, 1 in every 100 events as the 1642 09:45:40 1 most extreme, conservative underreporting of an event. So 09:45:45 2 our assumption is that the event -- the number of reports was 09:45:51 3 actually much likely more frequent than 1 in every 100, at 09:46:00 4 least what doctors were seeing, but we wanted to take it to 09:46:03 5 an extreme so that nobody would quarrel with the conclusion 09:46:05 6 we were discussing in the previous paragraph. But since you 09:46:08 7 don't know what is in the previous paragraph, this becomes a 09:46:12 8 bit theoretical. 09:46:13 9 Q. Well, they will have it. The jury will have it to read. 09:46:16 10 The reason, kind of bottom line, that you put that in 09:46:19 11 there is that you recognize that there is significant 09:46:22 12 underreporting of adverse events to the FDA, right? 09:46:29 13 A. Yes, we recognize there is underreporting and we were 09:46:33 14 taking that into account in drawing conclusions about a 09:46:36 15 lower-than-one-would-predict suicide rate on Prozac even 09:46:41 16 though it was prescribed to depressed patients. 09:46:53 17 Q. Let's look at the 2964 people, if we may, and first we'll 09:46:56 18 look at the first page of the exhibit. This is Plaintiff's 09:46:59 19 Exhibit 12, for the record, and this is the compilation of 09:47:05 20 data that was submitted in support of the new drug 09:47:09 21 application for paroxetine. 09:47:11 22 This is the same data that was available to you, 09:47:14 23 isn't it, or do you know? 09:47:23 24 A. You mean for the purpose of preparing this paper? I don't 09:47:29 25 know. 1643 09:47:29 1 Q. Okay. If it turns out that there are 2963 patients on 09:47:35 2 paroxetine in this document, would you think that's probably 09:47:38 3 the exact same database that you were looking at when you 09:47:41 4 wrote the task force paper? 09:47:42 5 A. I think if the numbers match in the three treatment 09:47:46 6 groups, that sounds like a reasonable assumption. 09:47:49 7 Q. Okay. Now, the date, of course, that this was submitted 09:47:52 8 was November 1989, and we all know by now that was about 09:47:58 9 three months before the Teicher and Cole article brought the 09:48:03 10 concerns about suicide into the public consciousness, 09:48:07 11 correct? 09:48:20 12 A. 1989 was earlier, yes. 09:48:35 13 Q. Dr. Mann, in this exhibit there are some tables of adverse 09:48:38 14 experiences which occurred during active treatment. In this 09:48:41 15 particular table, V-1, it is in the non-U.S. phase II and III 09:48:50 16 studies. 09:48:51 17 And do you see how they're categorized -- let me zoom 09:48:55 18 out a bit first -- that they're categorized in several ways, 09:49:01 19 first by preferred term -- 09:49:03 20 A. I'm not sure if this matters or not, but now I can't see 09:49:08 21 it at all. I don't know if the jury can see it, but I 09:49:11 22 certainly can't. 09:49:12 23 Q. Let me zoom in just a little bit, then. 09:49:22 24 A. Bigger would be better. 09:49:24 25 Q. I'll zoom in in a second. I'm trying to show the 1644 09:49:27 1 different field, okay? 09:49:29 2 A. Sure. 09:49:29 3 Q. You see there's first a preferred term, then there's a 09:49:32 4 treatment paragraph which tells us if this person is on the 09:49:35 5 placebo or the control group or whether they're on 09:49:39 6 paroxetine. 09:49:42 7 Have you seen this kind of presentation of data 09:49:44 8 before? 09:49:45 9 A. Question is have I seen this before? 09:49:51 10 Q. This type of presentation of data where this is the kind 09:49:51 11 of information presented in data fields? 09:49:59 12 A. Can we go over that again? 09:50:00 13 Q. Yes, sir. Have you seen this kind of a database presented 09:50:06 14 before to show information about a patient's adverse 09:50:10 15 experiences on a drug? 09:50:13 16 A. Yes, I have. Can you make it bigger? 09:50:17 17 Q. Yes, I will make it bigger. 09:50:19 18 A. Thanks, that's much better. 09:50:22 19 Q. And we will zoom left or right -- 09:50:26 20 A. No, it was fine before. 09:50:28 21 Q. So we have the treatment, then we have a patient 09:50:30 22 identifier, right? 09:50:32 23 A. Uh-huh. 09:50:33 24 Q. You need a verbal answer, please, sir, for our record. 09:50:36 25 A. Yes. 1645 09:50:36 1 Q. And then we have an age? 09:50:40 2 A. Uh-huh. 09:50:41 3 Q. Correct? 09:50:41 4 A. Yes. 09:50:41 5 Q. And then the sex? 09:50:42 6 A. Yes. 09:50:43 7 Q. Then we have the term that the investigator used to 09:50:47 8 describe the event, correct? 09:50:50 9 A. Yes. 09:50:52 10 Q. Then we have the date of onset, how long they had been on 09:50:56 11 the drug before this started, correct? Is that correct, sir? 09:51:02 12 A. I assume that's what that represents, onset, yes. 09:51:06 13 Q. And then we show the dose that they're on, right? 09:51:10 14 A. Right. 09:51:17 15 Q. And then we show when they stopped the drug, correct? 09:51:22 16 A. Right. 09:51:22 17 Q. Then we show the drug relatedness, true? 09:51:30 18 A. I assume that -- I don't know. It says drug relate, 09:51:34 19 right. 09:51:35 20 Q. Let's look down at the bottom and see what that means. Do 09:51:51 21 you see along the bottom where the people determining if this 09:51:53 22 is related to the drug have five different choices? They can 09:51:56 23 say either this is definitely not related, that's a 1, or it 09:52:02 24 is probably not, possibly it is related, it is probably 09:52:05 25 related or it is definitely related to the drug; you see 1646 09:52:09 1 where they can make those choices? 09:52:13 2 A. Yes, I see the scale. 09:52:15 3 Q. Let's go back up and see what they decided with respect to 09:52:19 4 this first one here. This is a 46-year-old male who 09:52:27 5 attempted suicide on day 18, correct, sir, the first entry? 09:52:34 6 A. Yep. 09:52:36 7 Q. And what did SmithKline Beecham indicate was its 09:52:38 8 relatedness to the drug? 09:52:40 9 A. Well, I'm not sure who completed these forms and who made 09:52:44 10 these estimations. 09:52:47 11 Q. Didn't I just show you the cover sheet that said it was 09:52:50 12 Beecham Laboratories? 09:52:52 13 A. Said Beecham Laboratories, said it was a report. I don't 09:52:55 14 know who made the ratings. How can you tell? 09:52:58 15 Q. Whoever made this report, did they decide that it was 09:53:01 16 definitely related to the drug? 09:53:03 17 A. They gave it a 5, sure. I don't know who that is, though. 09:53:07 18 Q. How about the next one, 23-year-old female attempted 09:53:10 19 suicide on day 11, was that a 5? 09:53:13 20 A. Sure, I see that. 09:53:15 21 Q. Look down here halfway through -- and I don't know if my 09:53:20 22 highlight shows up on your screen. 09:53:23 23 A. It does. 09:53:23 24 Q. See this 61-year-old female that made a suicide attempt on 09:53:27 25 day 1 of the drug, and what did they say there? 1647 09:53:33 1 A. Score is a 3. 09:53:36 2 Q. Possibly. There's a 63-year-old male that had suicide 09:54:10 3 ideation. He had been on it 42 days but did they say that 09:54:10 4 was definitely related to the drug? 09:54:10 5 A. That's what the table says. 09:54:10 6 Q. And down here, a 21-year-old female on day 17, suicide 09:54:11 7 attempt, definitely related to the drug? 09:54:15 8 A. That's what it indicates. 09:54:18 9 Q. We can go on and on with this, but were you provided with 09:54:21 10 this information in 1991? 09:54:26 11 A. As you can see from the previous discussion, my 09:54:31 12 recollection is we were given the summary tables that 09:54:36 13 provided the data that went into this paper. 09:54:48 14 Q. Were you given summary tables like this one where the 09:54:52 15 2,963 patients were on paroxetine and 2 of them had delusions 09:54:58 16 but it was just rounded down to zero percent? Is that the 09:55:03 17 kind of summary tables that were provided to your task force? 09:55:18 18 THE COURT: What exhibit is that? 09:55:20 19 MR. VICKERY: It is all a part of 12, Your Honor. 09:55:22 20 THE COURT: All right. 09:55:23 21 A. You may recall -- it is difficult to say exactly what the 09:55:30 22 format and content of these tables were. We had data from -- 09:55:34 23 I think from the top of my head, for at least four different 09:55:40 24 compounds. Each company had its own way of laying out the 09:55:44 25 data and presenting the data. 1648 09:55:48 1 I don't have access to the original material that was 09:55:50 2 provided for this particular paper, so if I were to say, it 09:55:54 3 would have to be a guess, so I don't know. 09:55:57 4 But if there's a particular point about this table 09:55:59 5 that you would like me to respond to, I am happy to do that. 09:56:03 6 Q. Okay, I would. You just saw that two patients had 09:56:08 7 delusions, right? That's not on this one, it is on the sheet 09:56:13 8 I just had up. 09:56:15 9 A. Okay, yes. 09:56:16 10 Q. And we now see that eight had hallucinations, right? 09:56:21 11 A. That's correct. 09:56:22 12 Q. Now, Dr. Mann, are delusions and hallucinations the 09:56:26 13 hallmark symbols of psychosis? 09:56:33 14 A. That would represent some kind of psychotic 09:56:33 15 symptomatology, that's correct. 09:56:35 16 Q. And in your judgment, sir, is it fair to take the 09:56:43 17 real-life experiences of eight people that were having 09:56:46 18 hallucinations and round them down to zero percent in a 09:56:50 19 statistical analysis? 09:56:53 20 A. I don't understand why you think this table is doing that. 09:56:55 21 This table presents you -- and that's how you're able to make 09:57:00 22 your point -- with both the absolute number of cases that 09:57:05 23 have hallucinations, delusions, 1 case of hostility. It also 09:57:11 24 tells you the total number of subjects, patients that were 09:57:14 25 involved and that's almost 3,000. 1649 09:57:21 1 You have 8 people out of 3,000 for hostility, you 09:57:26 2 have 1 person out of 3,000, and you can calculate a 09:57:27 3 percentage which is easier for people to understand when you 09:57:31 4 have different numbers of people getting paroxetine, 09:57:34 5 different numbers of people getting placebo and different 09:57:38 6 numbers of people getting tricyclics. 09:57:42 7 It is hard to -- for a person who is going to try to 09:57:42 8 calculate a percentage across the three treatment groups, so 09:57:45 9 you need the percentage there to allow the comparison, 09:57:49 10 otherwise people have to pull out a calculator in order to 09:57:52 11 figure out what is going on. At the same time by having in 09:57:56 12 the absolute number of cases, no one is trying to hide the 09:57:58 13 exact number of cases that had all of these reports. 09:58:02 14 Now, in math we all -- there's a general principle if 09:58:09 15 you're reporting percentages and it is .1 percent and you're 09:58:13 16 rounding it up or down to the nearest percentage -- if it is 09:58:17 17 .1, that's below .5, that's going to go down to zero. If it 09:58:21 18 was .5 or .6, you would be rounding it up to 1 percent. 09:58:26 19 There's nothing mysterious or magical. This table provides 09:58:31 20 all of the data. 09:58:33 21 Q. Would you say that's sort of like what our president 09:58:37 22 described as fuzzy math? 09:58:45 23 A. This has nothing to do with fuzzy math. This tells you 09:58:49 24 the exact number of people, 8 with hallucinations, 1 with 09:58:57 25 hostility out of 3,000 patients. You have both the absolute 1650 09:59:01 1 number and the percentage. There's nothing being hidden 09:59:04 2 here. 09:59:04 3 Q. Let's look at akathisia. Here we have a 49-year-old 09:59:08 4 female who had excitement, irritability and akathisia on 09:59:13 5 day 9 on 30 milligrams, definitely related to paroxetine, 09:59:20 6 right? 09:59:22 7 A. That's what it indicates. 09:59:24 8 Q. Dr. Mann, does it offend you, having been summoned as an 09:59:29 9 expert witness for SmithKline Beecham to sit there and see 09:59:32 10 these tables where they have said yes, suicide attempt, 09:59:36 11 definitely related to our drug; yes, akathisia, definitely 09:59:42 12 related to our drug? Does that offend you? 09:59:45 13 MR. PREUSS: Objection, argumentative, Your Honor. 09:59:47 14 THE COURT: Sustained. 10:00:07 15 Q. (BY MR. VICKERY) In addition to the hallucinations and 10:00:08 16 delusions there were also three people who had psychosis and 10:00:11 17 one who had a psychotic depression, right? 10:00:25 18 A. Yes, I see that. 10:00:26 19 Q. And both of those you see also were rounded down to zero 10:00:30 20 percent, true? 10:00:32 21 A. Same response as before, they tell you exactly how many 10:00:35 22 cases had those two conditions. 10:00:41 23 Incidentally, if you look at the paroxetine data in 10:00:48 24 the ACNP task force report, you will see that we did not 10:00:53 25 address the question of emergent suicidality and some of the 1651 10:00:59 1 issues, hallucinations, delusions and all of those things 10:01:03 2 that you brought up here. It was confined to the suicides 10:01:06 3 and the suicide attempts. 10:01:08 4 We also did report that there were suicide attempts, 10:01:11 5 we just didn't attempt to attribute the cause of those 10:01:14 6 suicide attempts. We showed that the suicide attempt rates, 10:01:18 7 in fact, with the typographical correction, you see it is .04 10:01:25 8 on the paroxetine group, that's a tenth -- that's exactly the 10:01:31 9 same as the other treatment group. That's half of what you 10:01:37 10 see in the placebo group. 10:01:39 11 There's no effort here to say it was due to the 10:01:43 12 paroxetine, it wasn't due to the paroxetine. This table 10:01:46 13 explains everything: When you compare the paroxetine to the 10:01:53 14 TCA or the placebo, you don't see more suicide attempts on 10:01:57 15 the paroxetine and you don't see more suicide. 10:02:00 16 Q. Dr. Mann, if in 1992 you had seen the tables that I just 10:02:05 17 showed you this morning where SmithKline Beecham submitted a 10:02:09 18 document to the FDA that said suicide attempt, definitely 10:02:13 19 related; suicide attempt, definitely related; suicide 10:02:18 20 attempt, definitely related -- if you had seen that in 1992, 10:02:23 21 would you have written this paragraph differently? 10:02:27 22 A. If I had seen those data in 1992, I would have looked at 10:02:32 23 the rest of the report and the rest of the tables, because 10:02:35 24 clearly, as we've seen in the last day or so going through 10:02:44 25 things, taking one little thing here and one little thing 1652 10:02:44 1 there, you don't always get the whole picture. 10:02:47 2 So, you know, I'm interested in knowing what keeps 10:02:50 3 patients safe, and I treat patients. I don't sell pills. I 10:02:55 4 would go and have a look at the rest of the data. 10:02:58 5 Q. Do doctors that treat patients deserve both from the 10:03:03 6 standpoint of just medical practice and basic human morality 10:03:09 7 to have whatever relevant information the drug company has 10:03:12 8 about side effects for the patients? 10:03:19 9 A. Certainly that's the purpose of the information, labeling 10:03:24 10 information, package insert. 10:03:28 11 Q. Now, let's talk about suicide, if we may. You are a 10:03:57 12 suicidologist, correct? 10:04:00 13 A. Yes. 10:04:00 14 Q. And I have previously in taking your deposition 10:04:03 15 acknowledged that you're one of the most if not the premier 10:04:08 16 suicidologist in the world, and that's true, isn't it? 10:04:12 17 A. You may have said that. Physicians are not engaged in 10:04:27 18 beauty contests. 10:04:27 19 Q. But other people do say that about you, don't they? 10:04:28 20 A. Is that a question? 10:04:29 21 Q. Yes, sir. 10:04:30 22 A. If you say so. 10:04:32 23 Q. Okay. You were originally asked to be one of the three 10:04:35 24 authors on the comprehensive textbook of suicidality, aren't 10:04:40 25 you? 1653 10:04:40 1 A. Yes, I was. 10:04:41 2 Q. But your time commitments would not permit you to do it, 10:04:44 3 right? 10:04:45 4 A. That's correct. 10:04:45 5 Q. And so Dr. Silverman filled in instead of you? 10:04:52 6 A. He did. 10:04:53 7 Q. But you did write a jacket endorsement for this book, 10:04:56 8 didn't you? 10:04:56 9 A. I did. 10:04:57 10 Q. Let me hand it to you and just ask you to read it. 10:05:07 11 A. "Maris, Berman and Silverman" -- the three editors of this 10:05:12 12 book or writers -- "are to be congratulated on this 10:05:16 13 important new initiative. Although there have been many 14 books published in the field of suicidology, a comprehensive 10:05:19 15 textbook has been lacking. All readers who want to have 10:05:22 16 wealth of knowledge about suicide and suicidal behavior will 10:05:25 17 greatly value having this book on their shelves. Its 10:05:29 18 richness, breadth and internal consistency make it an 10:05:34 19 excellent resource for clinicians and academicians." 10:05:38 20 Q. You wouldn't have written it if you didn't mean it, would 10:05:40 21 you? 10:05:41 22 A. That's correct. 10:05:42 23 Q. Now, I want to go back to the diagram you did yesterday -- 10:05:58 24 THE COURT: If you would refer to the exhibit number. 10:06:01 25 MR. VICKERY: Thank you, Your Honor. SB-LL. 1654 10:06:04 1 Q. (BY MR. VICKERY) And I would ask you to help me complete 10:06:06 2 it, if you would. Would you mind stepping down and labeling 10:06:12 3 this little area right here? That's the prefrontal cortex, 10:06:16 4 isn't it? 10:06:19 5 A. Not exactly. The prefrontal cortex is this part of the 10:06:27 6 brain here, approximately. It is the front third of the 10:06:30 7 brain. 10:06:30 8 Q. And what would you call this little area that you've drawn 10:06:33 9 in with the hash marks that represents that portion of the 10:06:38 10 brain that affects inhibition control and suicide and 10:06:42 11 violence? What is it called? 10:06:45 12 A. That's generally called the orbital prefrontal cortex, 10:06:52 13 above the eyes, or sometimes the ventral prefrontal cortex 10:06:57 14 because ventral is this part of the brain down here, bottom 10:07:02 15 part. 10:07:03 16 Q. Is it part of the prefrontal cortex? 10:07:05 17 A. It is. 10:07:06 18 Q. Would you mind labeling it as such on your drawing -- you 10:07:11 19 do have a Magic Marker. Fine, thank you. 10:07:14 20 A. So this whole big area here is called the prefrontal 10:07:21 21 cortex and this bit here is called the ventral, I'm putting 10:07:40 22 PFC for short. 10:07:44 23 Q. Now, Dr. Mann, you explained yesterday how it has been 10:07:47 24 your goal to help really prevent all suicide by targeting 10:07:54 25 ways to affect this area of the brain, correct? 1655 10:07:59 1 A. That's not exactly what I said. 10:08:02 2 Q. Well, I don't want to put words in your mouth. That's 10:08:05 3 sort of how I understood it. 10:08:06 4 What has been your goal with respect to identifying 10:08:09 5 this area of the brain as that portion of the brain that 10:08:12 6 affects violence and suicide and doing something about it? 10:08:16 7 Just put it in your own words. 10:08:18 8 A. Well, as I said yesterday, we believe that this part of 10:08:22 9 the brain here is an important factor that determines whether 10:08:26 10 or not people act on powerful feelings and that the amount of 10:08:31 11 serotonin coming into this area of the brain plays a role in 10:08:36 12 how well this functions, and that people who are more 10:08:40 13 predisposed to act on powerful feelings such as suicidal or 10:08:44 14 homicidal feelings probably have less serotonin coming into 10:08:48 15 this area of the brain. 10:08:50 16 And I thought this might be useful one day for 10:08:53 17 clinical purposes because if we could develop a way of 10:08:58 18 imaging the brain, looking at the biochemistry of the brain, 10:09:01 19 we might be able to see, as we can already see in the brain 10:09:05 20 of people who have killed themselves, a biochemical 10:09:09 21 abnormality here while people are still alive, see -- they 10:09:13 22 order a brain scan and that might help physicians know this 10:09:16 23 patient is at risk for suicide if they've got a depression 10:09:19 24 and this patient is at lower risk for suicide if they've got 10:09:25 25 depression and the high-risk patients will get more intensive 1656 10:09:26 1 monitoring and treatment. 10:09:28 2 Q. We're not quite there yet in terms of radiology and being 10:09:31 3 able to do that, are we? 10:09:33 4 A. That's correct. 10:09:52 5 Q. Let me flip back to another chart. This is SB-II and it 10:10:28 6 was a drawing by Dr. Wheadon, I believe, to help us 10:10:28 7 understand the way that serotonin reuptake inhibitors work. 10:10:28 8 And my question to you is is this area right here 10:10:28 9 between the neurons called the synaptic cleft? 10:10:28 10 A. Yes, it is. 10:10:28 11 Q. And are we able today to measure the amount of serotonin 10:10:28 12 represented by these little red dots in the synaptic cleft of 10:10:35 13 a living human being? 10:10:36 14 A. Not directly. 10:10:38 15 Q. Okay. Now you see on this diagram that we have -- see 10:10:42 16 right here where I'm pointing, that's the reuptake pump, he 10:10:48 17 explained, and then there's several different types of 5HT or 10:10:56 18 serotonin receptors? 10:10:58 19 A. Yes. 10:10:59 20 Q. 5HT, we've labeled 1, 2 and 3. There are actually how 10:11:02 21 many different kinds now? 10:11:03 22 A. Over a dozen. 10:11:06 23 Q. A dozen? Is it your belief, sir, that the effect of SSRIs 10:11:11 24 on the 5H1 receptor in the ventral portion of the prefrontal 10:11:20 25 cortex prevents suicide? 1657 10:11:25 1 A. I don't think anybody knows that for sure. 10:11:30 2 Q. Is it your belief that that is a viable working 10:11:33 3 hypothesis? 10:12:34 4 A. It is a hypothesis. It is not the only hypothesis. If 10:12:34 5 you've got over a dozen receptors, you could start by 10:12:34 6 assuming you have got a dozen targets that you've got to 10:12:34 7 think about, but the 5HT1 receptor is one of them. 10:12:34 8 Q. Back when you wrote the Mann and Kapur you were trying to 10:12:34 9 explain biologically if there were a small group of patients 10:12:34 10 that were at risk, just how that risk occurred, weren't you? 10:12:34 11 A. That's a standard scientific approach. If you're 10:12:34 12 analyzing an alleged risk in a discussion of the evidence of 10:12:34 13 the strength of how likely that is to be an observable fact, 10:12:34 14 part of the discussion is to think about is there a viable 10:12:34 15 mechanism that might produce that risk, yes. 10:12:34 16 Q. And did you do it? 10:12:34 17 A. We did have a discussion like that. 10:12:34 18 Q. And at that time you thought about -- you postulated that 10:12:39 19 it was some kind of effect the SSRI drugs would have on the 10:12:42 20 5H1A receptor, true? 10:12:45 21 A. Yes, but not the receptor that you're looking at over 10:12:48 22 here. 10:12:50 23 Q. A 5H1 receptor in a different part of the brain? 10:12:54 24 A. That's correct. 10:12:55 25 Q. Where, basal ganglia? 1658 10:12:59 1 A. Basal ganglia? No. 10:13:06 2 Q. I got you, didn't I? 10:13:10 3 A. No, it is funny. There are no 5HT1A receptors in the 10:13:17 4 basal ganglia. Never mind. 10:13:21 5 It is in the brain stem. This is a serious topic. 10:13:23 6 Q. It is very serious. 10:13:24 7 A. That's where all the cells are located, and on the cells 10:13:29 8 and they send their fibers all the way -- all over the brain, 10:13:36 9 but it is only this section that we think is relevant, 10:13:41 10 supplying this section that matters for suicide. 10:13:43 11 Mr. Vickery, I believe, is referring to 5HT1A 10:13:48 12 receptors that are located here on the cells themselves. 10:13:52 13 Q. What you told me in your deposition in this case a few 10:13:54 14 weeks ago is that research in the intervening years has 10:13:58 15 convinced what you then thought was the biological mechanism 10:14:01 16 that could trigger violence and suicide really isn't -- it is 10:14:05 17 really not the 5H1A receptor, right? 10:14:13 18 A. That somewhat significantly misstates what I said. 10:14:17 19 Q. I don't want to do that. Please just tell me what you 10:14:21 20 said. Did you or did you not tell me that you've changed 10:14:24 21 your mind about the possibility of the 5HT1A receptor being 10:14:31 22 the potential culprit in this situation? 10:14:34 23 A. Yes, I'm happy to explain that a little more carefully. 10:14:40 24 Perhaps if I use a clean sheet of paper -- 10:14:45 25 Q. I don't mind the explanation, but if you've concluded that 1659 10:14:47 1 5HT1A is not the problem, I'm with you on that. I'm not 10:14:53 2 going to quarrel with you about it, so unless you think it is 10:14:56 3 helpful to us for you to explain why your 1991 theory is no 10:15:00 4 longer a viable one, I'd just as soon move onto something 10:15:05 5 else. 10:15:05 6 A. Okay. I will be extremely brief in that case. 10:15:08 7 Q. Okay. 10:15:12 8 A. First of all, we didn't find scientific evidence, credible 10:15:15 9 scientific evidence of a clinical association between suicide 10:15:19 10 and these SSRIs. And as I said yesterday at the very 10:15:23 11 beginning, we were surprised that one would propose such an 10:15:29 12 association because it went exactly in the opposite direction 10:15:30 13 of all of the biological data which suggested that SSRIs 10:15:37 14 should be helpful for suicidal risk, not harmful. 10:15:40 15 So in trying to think about this, the thought was, 10:15:43 16 well, what happens is maybe there is a mechanism. Maybe the 10:15:49 17 mechanism is that what happens in the brain is this, the cell 10:15:52 18 over here releases serotonin that goes into here and provides 10:15:56 19 this restraint system. 10:15:58 20 But, you give an SSRI and you produce a tremendous 10:16:02 21 surge of serotonin, but some of it is also coming back here, 10:16:05 22 like this. So here's the cell, just blowing this up with the 10:16:10 23 fiber coming like this and sending serotonin, releasing 10:16:14 24 serotonin down the -- into here, but it also has a little 10:16:18 25 fiber that comes back on itself like this, and that little 1660 10:16:22 1 fiber also releases serotonin. 10:16:24 2 And that's its feedback loop, so it is an electrical 10:16:28 3 signal. The cell fires. What stops it firing? This little 10:16:33 4 loop here, serotonin -- doesn't matter what it is doing over 10:16:36 5 here -- feeds back on itself and shuts off the firing, and 10:16:39 6 that's how the system stops firing continuously. Otherwise 10:16:43 7 you get overshoot. 10:16:44 8 It is just a feedback mechanism, very simple. The 10:16:49 9 receptor that mediates this or at least one of them is the 10:16:53 10 5HT1A receptor that you heard counsel referring to. It 10:16:57 11 mediates this feedback. We thought maybe what happens, you 10:17:02 12 get a big surge of serotonin, you get this big feedback and 10:17:06 13 you shut off the system and it becomes low in function, and 10:17:11 14 because it is low in function the person becomes vulnerable. 10:17:15 15 But now we have more sophisticated devices to measure 10:17:19 16 exactly what is going on, and, you know, what we see with 10:17:24 17 these medications is that, yes, you get a release of 10:17:28 18 serotonin, which you can't measure in the synaptic cleft, it 10:17:34 19 is too tiny, but you can measure the spillover. 10:17:38 20 What happens when they take a drug, an SSRI, the 10:17:40 21 increase in the amount of serotonin that's been -- that's in 10:17:45 22 the intrasynaptic cleft goes up progressively over a period 10:17:51 23 of weeks. It never goes down below normal. And at the time 10:17:57 24 I wrote the article we didn't know that. We thought maybe 10:18:00 25 that was a possibility. 1661 10:18:01 1 It doesn't go below normal. It goes up a little at 10:18:06 2 the beginning and progressively more and more as time goes 10:18:09 3 by, which is why the medications have a better and better 10:18:12 4 therapeutic effect as time goes by. 10:18:15 5 That's the current view of the situation. So if you 10:18:18 6 want to add anything to what we knew then, it appears not 10:18:22 7 only do we not see a clinical association with suicide or 10:18:25 8 suicide attempts, but even the mechanism that we thought 10:18:29 9 might explain such an association, if there were one and 10:18:32 10 there isn't, appears to be unsupported by new scientific 10:18:35 11 evidence. 10:18:37 12 Q. Before you take your seat back, flip the chart back for 10:18:40 13 me, if you would. 10:18:42 14 We've been talking about 5HT1A, and I want to get 10:18:46 15 back to your brain diagram there. 10:18:49 16 A. This one or the one we had before? 10:18:51 17 Q. Yes, sir. Are there any 5HT2 receptors in the ventral 10:18:58 18 portion of the prefrontal cortex? 10:19:00 19 A. Yes, there are. There are 5HT -- I think you're thinking 10:19:04 20 of the 5HT2A receptor. 10:19:07 21 Q. Would you just label that on that drawing, please, that 10:19:10 22 there are indeed 5HT2A receptors in there? 10:19:15 23 THE COURT: Would the record mention the exhibit 10:19:16 24 number? 10:19:17 25 MR. VICKERY: Yes. Once again the exhibit number is 1662 10:19:20 1 SB-LL. It has still not been admitted, Your Honor. 10:19:55 2 Q. (BY MR. VICKERY) If you would take your seat, I'm going 10:19:58 3 to ask you to read two paragraphs from the year 2000 10:20:01 4 textbook. Do you see here we're looking in the chapter on 10:20:21 5 the biology of suicide? 10:20:23 6 A. Yes, I do. 10:20:25 7 Q. And do you see that we're looking in the portion of that 10:20:28 8 chapter that discusses selective serotonin reuptake 10:20:32 9 inhibitors? 10:20:33 10 A. Right. 10:20:35 11 Q. I would like you to read, if you would, these three 10:20:38 12 sentences that I've highlighted on the second page of that 10:20:41 13 discussion. 10:20:44 14 THE COURT: What's the page number? 10:20:45 15 THE WITNESS: It is page 394, Your Honor. 10:20:50 16 A. "SSRIs have well-established efficacy for major 10:20:54 17 depression, obsessive-compulsive disorder, panic disorder and 10:21:00 18 bulimia" -- that means people who binge eat. "These 10:21:06 19 indications relate directly to the fact that SSRIs cause 10:21:10 20 desensitization of 5HT1A receptors leading to more 10:21:22 21 serotonergic transmission in the prefrontal cortex, basal 10:21:22 22 ganglia, limbic cortex/hippocampus and hypothalamus. The 10:21:29 23 stimulation of 5HT2 receptors by the SSRIs leads to possible 10:21:34 24 adverse effects of agitation, akathisia, meaning 10:21:42 25 restlessness, pacing, fidgetiness, anxiety, panic attacks, 1663 10:21:48 1 insomnia/myoclonic jerks and sexual dysfunction." 10:21:53 2 Q. In discussing the biology of suicide and SSRIs in the year 10:21:58 3 2000, the textbook that you endorsed said that stimulation of 10:22:03 4 the 5HT2 receptors by SSRIs leads, among other things, to 10:22:10 5 akathisia, true, sir? 10:22:15 6 A. Well, I should point out I did not write this chapter. I 10:22:18 7 did endorse the book. It doesn't mean I agree with every 10:22:22 8 single fact in this mammoth textbook. I want to make that 10:22:26 9 very, very clear. I agree with the facts I wrote in 10:22:30 10 scientific articles myself. 10:22:31 11 I can take responsibility, as you've pointed out, for 10:22:33 12 every word, every sentence, in those articles going back ten 10:22:37 13 years. But I can't vouch for agreeing with every single fact 10:22:42 14 in this textbook. On the whole I think the textbook is very 10:22:46 15 good and very helpful. I can't agree with every single word 10:22:49 16 in it. 10:22:50 17 Q. You're aware that another neuropsychopharmacologist, 10:22:54 18 specifically Dr. Healy, testified here last week that the 10:22:59 19 5HT2 receptor and the impact of the serotonergic drugs like 10:23:06 20 SSRIs on that receptor is a matter of extreme concern with 10:23:09 21 respect to violence and suicide? You know that he took that 10:23:15 22 view, don't you? 10:23:16 23 A. I don't. 10:23:17 24 Q. Okay. Let's move on to something else. 10:23:20 25 Yesterday you were giving a little history of the 1664 10:23:27 1 antidepressants, right? 10:23:30 2 A. Yes. 10:23:31 3 Q. And was that based on your own review or was it based on 10:23:34 4 Dr. Healy's book The Antidepressant Era? 10:23:39 5 A. I have to say that was my own work. 10:23:42 6 Q. You have read Dr. Healy's book, haven't you? 10:23:46 7 A. Parts of it. 10:23:47 8 Q. And your Rule 26 report in this case says that you 10:23:51 9 intended to talk about his book, among other things, or you 10:23:56 10 might in your testimony, right? 10:23:58 11 A. I might. 10:23:59 12 Q. Now, he chronicles the experience of zimelidine causing 10:24:05 13 Guillain-Barre Syndrome in his book, doesn't he? 10:24:10 14 A. Perhaps. 10:24:30 15 Q. In talking about the history, you talked about the MAOIs 10:24:30 16 and how they really worked, correct? 10:24:30 17 A. I did describe them briefly, that's correct. 10:24:30 18 Q. And they really worked on hospital depressions, didn't 10:24:30 19 they? 10:24:31 20 A. I don't agree with that. 10:24:32 21 Q. No? Well, the jury will remember it more. My notes say 10:24:37 22 you described the MAOIs as working on hospitalized 10:24:40 23 depression. Do you now say they don't? 10:24:43 24 A. That's simply not what I said. What I said was that the 10:24:51 25 discovery and drugs of the MAOIs was a very important 1665 10:24:56 1 breakthrough, even though they had these difficulties with 10:25:00 2 the diet and so on and so forth because we didn't have any 10:25:03 3 working antidepressants that were really any good before 10:25:06 4 that. 10:25:07 5 And I gave an illustration of patients who had been 10:25:09 6 hospitalized with depression who then took MAOIs and were 10:25:13 7 able to go home. 10:25:15 8 Q. Okay. Now, it is true, is it not, Dr. Mann, that the 15 10:25:24 9 percent mortality figure given from the Swedish study about 10:25:29 10 people that kill themselves on depression is for 10:25:33 11 hospital-based depression? That's true, isn't it, sir? 10:25:38 12 A. Which Swedish-based study are you referring to? 10:25:42 13 Q. Gusea. 10:25:45 14 A. I assume that counsel is referring to Sam Gusea who passed 10:25:52 15 away not so long ago, but he was from the Midwest and his 10:25:57 16 work with Robbins was done in the Midwest, not in Sweden. 10:26:02 17 Q. I may have misspoke. The Lundby study, is that the one 10:26:06 18 that has the 15 percent figure? 10:26:08 19 A. There were several. Lundby was Scandinavian. There are 10:26:13 20 several studies that have been carried out and estimated that 10:26:17 21 the lifetime mortality due to people suffering from 10:26:21 22 depressions was about 15 percent. 10:26:23 23 Q. And those studies are focusing on people that are -- in 10:26:26 24 hospitalized depressed patients rather than 10:26:30 25 walking-around-in-society kind of people; isn't that true, 1666 10:26:32 1 Dr. Mann? 10:26:36 2 A. Many of the patients in those studies were hospitalized, 10:26:39 3 not necessarily all of them, and I assume that what your 10:26:42 4 point is, you're really heading towards the question of the 10:26:48 5 reanalysis of those data by Bostwick and Pankrantz. 10:26:53 6 Q. I very well could be. The incidence, the risk of suicide 10:27:03 7 for people that have mild to moderate major depression, is 10:27:03 8 much lower than 15 percent, isn't it, Dr. Mann? 10:27:07 9 A. It may be lower than 15 percent, that's correct. 15 10:27:10 10 percent is an average that represents the mortality, i.e. 10:27:19 11 suicide, in people with a variety of severities of illness. 10:27:24 12 There are going to be milder depressions that have a lower 10:27:26 13 mortality due to suicide. 10:27:29 14 Q. Now, neither Paxil nor any of the other SSRIs have ever 10:27:37 15 been shown to work in hospital-based depression; isn't that 10:27:41 16 true, sir? 10:27:43 17 A. That's not correct. 10:27:45 18 Q. Well, let's look at the Paxil label. 10:27:47 19 MR. VICKERY: This is, for the record, Joint 10:27:50 20 Exhibit 200-B. 10:27:55 21 Q. (BY MR. VICKERY) And do you see here on the label where 10:27:57 22 it says, "Indications and usage: The antidepressant action 10:28:01 23 of Paxil in hospitalized depressed patients has not been 10:28:06 24 adequately studied"? 10:28:08 25 Is this label wrong? 1667 10:28:14 1 A. Where is this coming from? Are you saying this is the 10:28:16 2 package insert? 10:28:18 3 Q. That's exactly what I'm saying, the 1998 package insert. 10:28:24 4 Is it wrong? 10:28:25 5 A. You asked the question about SSRIs in general. 10:28:29 6 Q. Oh, okay. So this is -- is this right? Is Paxil not 10:28:33 7 adequately studied in hospital-based depression? 10:28:37 8 A. The amount of data available on the efficacy of Paxil on 10:28:44 9 inpatients is definitely much less. Most of the studies were 10:28:47 10 done in depressed outpatients. 10:28:48 11 Q. Now, you are as a psychopharmacologist very familiar with 10:28:57 12 the pharmacokinetic, pharmacodynamics, in other words, the 10:29:04 13 differences between the SSRI drugs, aren't you? 10:29:07 14 A. I have some knowledge of that. 10:29:10 15 Q. Is Paxil a more potent inhibitor of serotonin reuptake 10:29:14 16 than the other SSRIs? 10:29:16 17 A. Paxil has a very high affinity for blocking the serotonin 10:29:24 18 transporter or pump, as you described it. It is one of the 10:29:28 19 highest affinity drugs amongst the SSRIs, that's correct. 10:29:31 20 Q. So does this mean it is more potent in blocking the 10:29:34 21 reuptake? 10:29:35 22 A. The potency in blocking the reuptake in any individual 10:29:38 23 patient is going to be directly related to both the affinity 10:29:44 24 or how tightly the drug binds to the transporter and how much 10:29:50 25 you give of the drug. 1668 10:29:52 1 So, for example, some drugs -- some SSRIs you give 10:29:56 2 higher doses and other drugs you give lower doses. The whole 10:30:02 3 goal is to block the transporter as much as possible in order 10:30:05 4 to maximize the therapeutic effect. 10:30:09 5 Far more important in some ways than the differences 10:30:12 6 in affinity between one drug and another is the fact that the 10:30:15 7 blood level of any individual drug varies 20-fold between 10:30:25 8 people and it varies 20-fold between people because we break 10:30:28 9 down these drugs at very different rates so that you have to 10:30:31 10 titrate the dose and try to get a dose that works for each 10:30:34 11 individual patient. 10:30:36 12 Q. That's not what the package insert says, is it? It 10:30:39 13 doesn't say to titrate the dose; it doesn't say there's a 10:30:44 14 20-fold difference in patients; it just says the recommended 10:30:50 15 dose is 20 milligrams a day? Isn't that true? 10:30:55 16 A. The reason that one can -- 10:30:57 17 Q. Doctor, I don't mind you explaining, but just tell me; 10:31:00 18 isn't that true? 10:31:01 19 A. Well, I think it would be helpful -- the package insert is 10:31:04 20 several pages long. There is some discussion about metabolic 10:31:07 21 rate and that sort of stuff and the fact it might vary, and 10:31:10 22 they present ranges of the half-life of these drugs because 10:31:14 23 they vary. The half-life is directly related to the 10:31:17 24 metabolic rate. 10:31:18 25 They don't present a single number in the package 1669 10:31:21 1 insert for the metabolic rate. They present a range of 10:31:24 2 half-lives in the metabolic range, a range of hours, and 10:31:27 3 that's because it is shorter in some people because they 10:31:30 4 break it down faster and it is longer in other people because 10:31:33 5 they break it down slower, and the ones that break it down 10:31:36 6 slower are going to get a higher blood level with exactly the 10:31:39 7 same amount of pills. 10:31:42 8 Q. Would you expect that because of its potency, or to use 10:31:47 9 your words, its affinity for the reuptake -- 10:31:50 10 A. Transporter. 10:31:51 11 Q. -- transporter, that whatever side effects were going to 10:31:54 12 be caused by Paxil would happen quicker than the side effects 10:31:58 13 on the other SSRIs? 10:32:01 14 A. No, not necessarily at all. It is not a question of the 10:32:07 15 affinity, it is a question of how many transporters you 10:32:12 16 block. 10:32:12 17 Q. Okay. Tell me, if you will, which of these drugs -- 10:32:15 18 Paxil, Prozac or Zoloft -- has the greater impact on the 10:32:20 19 5HT2A receptor? 10:32:26 20 A. None of those drugs directly affect the 5HT2A receptor. 10:32:37 21 Q. They have indirect effects, right? 10:32:37 22 A. They all have indirect effects. 10:32:37 23 Q. And can you tell us which of them has the greater indirect 10:32:39 24 effect? 10:32:40 25 A. That's going to be entirely a function of the dose and the 1670 10:32:44 1 blood level and how many of the transporters you block in the 10:32:48 2 person. 10:32:49 3 Q. Okay. 10:32:50 4 THE COURT: Mr. Vickery, we will take our morning 10:32:52 5 recess. 10:32:54 6 MR. VICKERY: Very good. 10:32:55 7 THE COURT: Ladies and gentlemen, we will stand in 10:32:56 8 recess for 15 minutes. 10:33:00 9 (Recess taken 10:30 a.m. until 10:50 a.m.) 10:59:02 10 THE COURT: Dr. Mann, you understand you're still 10:59:05 11 under oath? 10:59:06 12 THE WITNESS: Yes, Your Honor. 10:59:15 13 MR. VICKERY: May I proceed, Your Honor? 10:59:17 14 THE COURT: Yes, you may, Mr. Vickery. 10:59:19 15 Q. (BY MR. VICKERY) Dr. Mann, of the 70 million 10:59:22 16 prescriptions a year you mentioned yesterday for the SSRIs, 10:59:26 17 would it be fair to say the big three -- Zoloft, Paxil and 10:59:32 18 Prozac -- comprise the vast majority of those? 10:59:36 19 A. I'm not an expert in the marketing figures for SSRIs, but 10:59:41 20 I believe that that is correct. 10:59:43 21 Q. I mean, one of them in this country, Luvox, cannot even be 10:59:48 22 marketed for depression, right? 10:59:52 23 A. Its indication is principally OCD, obsessive-compulsive 10:59:59 24 disorder. 11:00:00 25 Q. And it doesn't have a depression indication, though, does 1671 11:00:03 1 it? 11:00:04 2 A. That's correct, although physicians do use it for 11:00:06 3 depression as well. 11:00:07 4 Q. The fifth one, Celexa, just came on the market in the 11:00:11 5 country a couple years ago? 11:00:14 6 A. Recently, yes. 11:00:15 7 Q. Remember, we were talking about whether these drugs were 11:00:17 8 studied adequately for hospital-based depression? 11:00:20 9 A. Yes. 11:00:21 10 Q. Well, the package inserts for both Prozac and Zoloft are 11:00:25 11 in evidence. They're Joint Exhibits 229 and 230, and I'm 11:00:35 12 going to give those to you. For your convenience I have 11:00:38 13 highlighted the portions that deal with hospital-based 11:00:42 14 depression, so if you would flip to the highlighted portion 11:00:45 15 and tell us whether Prozac or Zoloft have been adequately 11:00:51 16 studied in hospital-based depression. 11:01:10 17 A. Given that, of course, this is a product information and 11:01:17 18 not necessarily a systematic review of literature the way 11:01:23 19 others might do it, it says here in the Prozac product 11:01:28 20 information on page 895, "The antidepressant action of Prozac 11:01:33 21 in hospitalized depressed patients has not been adequately 11:01:38 22 studied." 11:01:39 23 Q. And would you have a look at the Zoloft label and see if 11:01:43 24 it doesn't say the same thing? 11:02:04 25 A. "The antidepressant action of Zoloft in hospitalized 1672 11:02:09 1 depressed patients has not been adequately studied." Same 11:02:12 2 wording. 11:02:13 3 Q. All right. Now, let me take those back, if I may. 11:02:22 4 MR. VICKERY: Your Honor, SB-LL, this drawing, was 11:02:27 5 offered yesterday and I asked the Court to withhold ruling on 11:02:29 6 it until I had a chance to cross-examine the witness on it, 11:02:33 7 and I will join in the offer of that exhibit at this point. 11:02:36 8 THE COURT: Very well. Defendant's Exhibit LL may be 11:02:39 9 received in evidence. 11:02:42 10 (Defendant Exhibit SB-LL received in evidence.) 11:02:44 11 MR. PREUSS: Your Honor, I would like to offer, while 11:02:46 12 we're on that, MM, and then I marked the last drawing NN, at 11:02:52 13 this time. 11:02:53 14 MR. VICKERY: Let's see which ones they are. 11:03:01 15 MR. PREUSS: That would be MM, there's two pages, and 11:03:08 16 then I marked that and asked that that could be NN. 11:03:11 17 THE COURT: Do we have an exhibit sticker on both 11:03:13 18 pages? 11:03:14 19 MR. VICKERY: We do not. 11:03:16 20 MR. PREUSS: I will get one on the second page, Your 11:03:18 21 Honor. 11:03:18 22 THE COURT: All right. 11:03:19 23 MR. VICKERY: I have no objection. 11:03:20 24 THE COURT: Defendant's Exhibit MM may be received in 11:03:24 25 evidence. And did you also mention NN? 1673 11:03:27 1 MR. PREUSS: Yes, Your Honor, that would be the last 11:03:28 2 drawing that Dr. Mann drew right before the break, if you 11:03:32 3 recall that. 11:03:33 4 THE COURT: During cross-examination? 11:03:34 5 MR. PREUSS: Right. 11:03:34 6 THE COURT: Any objection? 11:03:35 7 MR. VICKERY: No, sir. 11:03:35 8 THE COURT: NN may be received in evidence. 11:03:38 9 (Defendant Exhibits SB-MM, SB-NN received in evidence.) 11:03:40 10 Q. (BY MR. VICKERY) Let's talk, if we may, about the biology 11:03:43 11 or neurobiology of violence and suicide, okay? 11:03:50 12 Are they, both violence and suicide, almost always by 11:03:55 13 definition multifactorial? 11:04:00 14 A. Yes, they are. 11:04:03 15 Q. And is one of the factors that triggers them in your 11:04:09 16 experience invariably biological? 11:04:13 17 A. That's not how we look at it. First of all, the notion 11:04:20 18 that they're multi-factorial means that in any -- in people 11:04:24 19 who commit suicide, for example, one factor is almost 11:04:29 20 invariably present, that is, they have a psychiatric 11:04:32 21 condition. And then there are usually other factors required 11:04:36 22 as well which explain why not all depressed patients kill 11:04:39 23 themselves. So there are differences between the people at 11:04:43 24 risk for suicide and the people who aren't at risk for 11:04:46 25 suicide. 1674 11:04:47 1 Where does biology fit into this? To answer your 11:04:50 2 question, the biology of the brain is an aspect of everything 11:04:55 3 we do, think and experience. You know, all of our feelings, 11:05:03 4 ideas, thoughts, speech, impulses and so on and so forth are 11:05:06 5 not taking place in some magic spot. They're taking place in 11:05:11 6 a physical organ, the brain. 11:05:14 7 So you can measure and detect the biological effects 11:05:18 8 of genetics, parenting, stress and psychiatric illnesses. 11:05:27 9 Q. Okay. I can dig it out if you like, but haven't I asked 11:05:30 10 you at least on two previous occasions under oath if one of 11:05:34 11 the factors always affecting suicide is biological and 11:05:38 12 haven't you told me that it was? 11:05:42 13 A. If you would like to refer to the specific place, I think 11:05:45 14 you will find that my response was almost exactly the same as 11:05:49 15 it is today. 11:05:50 16 Q. Okay. I will do that momentarily. 11:06:32 17 MR. VICKERY: This is page 53, Counsel, of Dr. Mann's 11:06:36 18 deposition in this case. 11:06:38 19 Q. (BY MR. VICKERY) I will read the questions I asked you. 11:06:39 20 This is just a few weeks ago, right? 11:06:45 21 A. Yes, April 12th. 11:06:47 22 Q. Of this year? 11:06:48 23 A. Yes. 11:06:49 24 Q. And I'm going to read the questions I asked you and please 11:06:52 25 just read the answer that you gave under oath at that date 1675 11:06:56 1 without elaboration. 11:06:58 2 Starting on line 5, "A couple of quick things: Is 11:07:02 3 suicide by nature multi-factorial? 11:07:05 4 A. "The factors that trigger are multifactorial, yes. 11:07:12 5 Q. "Is one of them almost invariably biological? 11:07:15 6 A. "Well, the brain is biological so everything goes on in 11:07:19 7 the brain, biology always plays a role. 11:07:23 8 Q. "And is serotonin related to aggression and suicide? 11:07:27 9 A. We believe so, yes." 11:07:29 10 Q. Okay. Now, would you find, then, since we're -- we've got 11:07:33 11 the practice here of writing down everything and putting it 11:07:37 12 into evidence, would you just mind writing for me suicide is 11:07:41 13 multi-factorial and biological? 11:08:15 14 A. I don't understand why I should write -- this is your 11:08:18 15 statement, not mine. 11:08:19 16 Q. You said suicide is multi-factorial, didn't you? 11:08:24 17 A. If you would like me to write what I said, I would be 11:08:25 18 happy to, but I'm not sure what -- 11:08:25 19 Q. We just read what you said. 11:08:27 20 THE COURT: Let's not have the conversation between 11:08:29 21 the witness and counsel. Let's have the witness -- if he's 11:08:33 22 going to make an exhibit, let's have him make an exhibit 11:08:36 23 based upon what he said. 11:08:40 24 And tell us what you said, Doctor. 11:08:43 25 THE WITNESS: Thank you, Your Honor. 1676 11:09:02 1 A. All functions in the brain have a biological component. 11:09:16 2 Q. (BY MR. VICKERY) Fine. Would you mind initialing that 11:09:18 3 for us so we remember you did it? 11:09:20 4 A. Okay. 11:09:36 5 MR. VICKERY: We will label that as Plaintiff's 11:09:39 6 Exhibit 62 and I'll offer it at this time, Your Honor. 11:09:41 7 MR. PREUSS: No objection. 11:09:43 8 THE COURT: Plaintiff's Exhibit 62 is received in 11:09:44 9 evidence. 11:09:46 10 (Plaintiff Exhibit 62 received in evidence.) 11:09:47 11 Q. (BY MR. VICKERY) Now, by multi-factorial do you mean that 11:09:51 12 there are always a number of different causes that operate 11:09:55 13 concurrently to result in a suicide? 11:10:03 14 A. Our hypothesis is that suicides are usually explained by 11:10:09 15 more than one factor. 11:10:11 16 Q. So even in someone that's depressed, you expect there to 11:10:17 17 be something else in addition to the depression that is 11:10:21 18 triggering the suicide, right? 11:10:23 19 A. That's correct. 11:10:23 20 Q. Have you had any occasion since you've been here in 11:10:27 21 Cheyenne to share those thoughts with Dr. Merrell who will be 11:10:30 22 testifying this afternoon? 11:10:33 23 A. Dr. Merrell? 11:10:34 24 Q. Yes, this tall, handsome gentleman raising his hand right 11:10:39 25 there. 1677 11:10:42 1 A. It would not be correct to say I've had a conversation 11:10:45 2 with him about these kinds of matters. 11:10:47 3 Q. Okay. Now, in your report you said that Don Schell's 11:11:01 4 actions were undoubtedly caused by depression plus something 11:11:08 5 else, right? 11:11:11 6 A. I prefer to look at the exact language, since we're all so 11:11:17 7 particular about that. 11:11:36 8 Q. Do you have your report there? 11:11:37 9 A. Yes, I do. Where are you -- where would you like to 11:11:41 10 begin? 11:11:42 11 Q. I tell you what we'll do, we will put it right up here so 11:11:46 12 we can all see it. 11:11:52 13 In paragraph 29 of your report did you say, "There 11:11:56 14 are usually several factors involved in any suicide and also 11:12:01 15 in any suicide/homicide"? 11:12:08 16 A. Yes, "There are usually several factors involved in any 11:12:12 17 suicide and also in any suicide/homicide," correct. 11:12:20 18 Q. While we're talking about suicide/homicide, you have been 11:12:23 19 active in all the major professional organizations in this 11:12:27 20 country dealing with suicide for years, haven't you? 11:12:30 21 A. I've been involved with at least a couple of them, yes. 11:12:32 22 Q. And you feel like you know all of the major players, if 11:12:38 23 you will, in the field of suicidology, don't you? 11:12:43 24 A. I would say I know most of the people who are leading 11:12:46 25 investigators and experts in the field, that's true. 1678 11:12:51 1 Q. Like you know Dr. Maris and Dr. Berman and Dr. Silverman, 11:12:59 2 don't you? 11:13:04 3 A. Yes, I do. 11:13:04 4 Q. And you know Dr. Shneidman who wrote an endorsement and 11:13:04 5 Dr. Maltsberger who is our witness who also wrote an 11:13:10 6 endorsement? You know those gentlemen, don't you? 7 A. I do know them, yes. 11:13:16 8 Q. Did you ever meet Ken Tardiff? 11:13:18 9 A. Yes. 11:13:19 10 Q. Where did you meet him? 11:13:22 11 A. I was at Cornell for ten years, and we overlapped. 11:13:26 12 Q. You've never seen him at any of these functions, any of 11:13:27 13 these meetings of the American Association of Suicidology or 11:13:31 14 anything, have you? 11:13:32 15 A. Not to my knowledge, but I've only been to two meetings of 11:13:35 16 the American Association of Suicidology, so if he was a 11:13:37 17 regular attender himself he might have seen me. 11:13:42 18 Q. In paragraph 29 of your report you wrote that, "What other 11:14:01 19 factors may have played a role remain unknown," true, sir? 11:14:08 20 A. What other factors in addition to the ones I mentioned 11:14:13 21 earlier in that paragraph. 11:14:16 22 Q. Right. And then, again, in paragraph 31 you wrote, 11:14:20 23 "Therefore, we do not know and will likely never know exactly 11:14:24 24 what other factors contributed to this suicide," true? 11:14:29 25 A. That's correct. 1679 11:14:32 1 Q. You know there are some, you just don't know what they 11:14:34 2 are? 11:14:35 3 A. That's correct. 11:14:48 4 Q. We do know he was on Paxil, don't we? 11:14:51 5 A. We know a lot of things about Mr. Schell. 11:14:53 6 Q. We do know he was on Paxil, don't we? 11:14:57 7 A. That's one piece of information, yes. 11:14:58 8 Q. We do know the amount of Paxil in his blood was consistent 11:15:04 9 with someone who had taken Paxil for a couple of days, don't 11:15:08 10 we? 11:15:09 11 A. That's correct. 11:15:10 12 Q. Dr. Mann, have you ever in your experience seen a 11:15:15 13 situation like this one where a 60-year-old male with no 11:15:21 14 prior history of violence, no prior suicide attempt, anything 11:15:28 15 like that, committed an unspeakable act like this without 11:15:33 16 there being some kind of organic problem, something wrong 11:15:36 17 with their body? Have you ever seen one? 11:15:41 18 A. I'm puzzled by your question. I don't understand what you 11:15:45 19 mean by something wrong with their body. 11:15:47 20 Q. I'm talking about something organically wrong, like a 11:15:50 21 brain tumor, for example? 11:15:53 22 A. No, that's not correct. If you look at -- and I'm sure 11:15:57 23 you've discussed this with Dr. Tardiff at some length, but if 11:16:01 24 you look at the kinds of psychiatric diagnoses which are 11:16:04 25 associated with the compounded tragedy of suicide/homicide, 1680 11:16:11 1 you will see that the most -- the diagnosis that comes up 11:16:19 2 commonly, at least -- for example, there are two studies, in 11:16:23 3 one 3 out of 4 individuals had a major depression and in the 11:16:28 4 other study 4 out of 4 had a mood disorder. 11:16:33 5 So a male who is depressed is, in a sense, one of the 11:16:38 6 prototypical groups that are at risk for this terrible 11:16:42 7 consequence. 11:16:43 8 Q. Maybe my question wasn't clear. No one disputes that. 11:16:47 9 My question was that in addition to depression, have 11:16:52 10 you ever seen a person who with no history of violence or 11:16:57 11 suicidal behavior did something like this and there wasn't 11:17:01 12 some additional biological factor at work? Ever seen one? 11:17:09 13 A. Well, first of all, you have to remember that the way in 11:17:13 14 which we can study individuals who commit suicide is by doing 11:17:20 15 an analysis, biochemical analysis of brain tissue. 11:17:28 16 In most of the patients that we do these analyses in 11:17:30 17 we find evidence of these kinds of biological abnormalities. 11:17:34 18 In other words, we've got an indication biologically anyway 11:17:37 19 of this kind of predisposition that exists prior to the 11:17:42 20 development of, say, depression or whatever the illness is 11:17:46 21 that caused them to feel suicidal. 11:17:48 22 Q. I appreciate that information, but I would appreciate your 11:17:52 23 direct answer to my question. 11:17:55 24 Have you ever seen an instance where someone with no 11:17:57 25 history of violence or suicide attempt did something like 1681 11:18:00 1 this and there was not something physically wrong with them? 11:18:09 2 A. You mean specifically suicide/homicide or suicide? 11:18:13 3 Q. Either. 11:18:15 4 A. All right. Let's stick to suicide since I believe 11:18:18 5 Dr. Tardiff is the expert testifying in suicide/homicide and 11:18:22 6 my expertise is in suicides more specifically. 11:18:29 7 We don't systematically go around testing all of the 11:18:32 8 suicides to try and see whether there is this biochemical 11:18:36 9 abnormality in all of the cases of suicide that I may have 11:18:40 10 ever seen. 11:18:41 11 So I can't answer your question that way. What I can 11:18:43 12 say is in those situations where the family has given us 11:18:49 13 permission to do the analysis on the brain, the vast majority 11:18:53 14 of those cases have evidence of these kinds of biochemical 11:18:56 15 abnormalities indicating that the person had a predisposition 11:19:00 16 to suicidal behavior that was there all -- 11:19:03 17 Q. Let me cut to the chase why I asked this. Dr. Maltsberger 11:19:11 18 testified the other day he's been reading and studying about 11:19:12 19 suicide for 41 years and he's never seen any instance where 11:19:16 20 someone with no history of violence or suicidal behavior did 11:19:21 21 something like this unless there was something organic, 11:19:25 22 something biological present. 11:19:27 23 Do you have any reason to disagree with him on that 11:19:29 24 point? 11:19:30 25 A. I certainly don't have any reason to disagree with 1682 11:19:34 1 Dr. Maltsberger's experience clinically. It is obviously 11:19:38 2 vast. I'm just saying that when you look at the literature 11:19:41 3 systematically as to what was the problem in individuals who 11:19:48 4 perpetrated a suicide/homicide, you find that the commonest 11:19:52 5 thing is they tend to be men and psychiatrically the 11:19:59 6 diagnosis that stands out is that they suffer from a mood 11:20:01 7 disorder. 11:20:02 8 Now, do they have other abnormalities in addition to 11:20:05 9 that? There isn't a systematic set of reports in the 11:20:09 10 literature indicating that they have brain tumors or head 11:20:11 11 injury or, I don't know, things wrong with the rest of their 11:20:16 12 bodies. 11:20:17 13 Q. Okay. Let's follow up on that. Do the brain stems of 11:20:34 14 people who have completed suicide have low 5HIAA? 11:20:44 15 A. Is that a yes or no question? 11:20:45 16 Q. Yes, sir, it is. 11:20:49 17 A. Most studies have found that there are lower levels of 11:20:54 18 5HIAA in the brain stems of people who commit suicide. 11:21:22 19 Q. And we have been talking about 5HT. That's serotonin. 11:21:28 20 We've been talking about that for weeks now. 11:21:31 21 Will you tell the jury what 5HIAA is? 11:21:34 22 A. 5HIAA is the breakdown product of serotonin. So every 11:21:38 23 time a bit of serotonin is released, a small fraction of that 11:21:41 24 doesn't make it back safely into the cell for recycling and 11:21:45 25 reuse. Some of it is broken down. 1683 11:21:47 1 And what is it broken down to? It is broken down to 11:21:51 2 this stuff 5HIAA. So you can get a sense of how much 11:21:55 3 serotonin is being released and how active the serotonin 11:21:57 4 system is by measuring, if you like, sort of the waste 11:22:02 5 production of the breakdown product of 5HIAA. 11:22:05 6 I want to point out, because we're in a court of law 11:22:10 7 and not having a chummy talk with each other, but that 11:22:14 8 statement isn't exactly what I said. What I said was that 11:22:17 9 most studies find that in a group of people that commit 11:22:20 10 suicide that they have lower levels of 5HIAA in the brain 11:22:23 11 stem. But everybody finds this and it doesn't seem to 11:22:26 12 necessarily apply to every case. 11:22:28 13 Q. Should I put the word "most" in front of it? 11:22:31 14 A. You can write whatever you like. 11:22:34 15 Q. Well, I want to be accurate here. 11:22:36 16 Now, I'm not doing real well with yes or no questions 11:22:40 17 so I'm going to try multiple choice, okay? 11:23:21 18 Sir, would you be so kind to step to the board and 11:23:24 19 fill out the answer to the question I've wrote? 11:23:27 20 A. This is about the most misleading piece of information 11:23:30 21 you've heard this morning. I can explain why. 11:23:33 22 Q. I'm going to ask you to do that. If you will just answer 11:23:37 23 my question, we will do just fine. 11:23:40 24 A. Okay. 11:23:41 25 Q. What you have checked is the box that says, "Paxil lowers 1684 11:23:46 1 5HIAA," correct? 11:23:47 2 A. Correct. 11:23:48 3 Q. And so what -- our starting point for this discussion is 11:23:53 4 that most suicide victims have low 5HIAA, and that Paxil 11:24:00 5 lowers 5HIAA, right? 11:24:04 6 A. Correct. 11:24:04 7 Q. Now, you have already told us today that your knowledge 11:24:11 8 about the -- or your belief about the bioneurological means 11:24:21 9 whereby SSRI drugs might have caused suicide -- what you 11:24:25 10 thought back in 1991 turned out not to be true, correct? 11:24:32 11 A. That's correct. 11:24:32 12 Q. And tell the ladies and gentlemen of the jury, if you 11:24:38 13 would, Doctor, of the 12 or so receptors for 5HT, how many 11:24:45 14 have been discovered in the last five years? 11:24:50 15 A. Probably a third of them. 11:24:51 16 Q. So we're discovering things all of the time about the 11:24:54 17 serotonin system, aren't we? 11:24:56 18 A. That's correct. 11:24:57 19 Q. Okay. I know you would like to explain to us why it is 11:25:00 20 misleading to point out that suicide victims have low 5HIAA 11:25:05 21 and Paxil lowers 5HIAA, so have at it. 11:25:10 22 A. The reason is as follows: The reason -- when you find -- 11:25:18 23 when you measure serotonin function in the brain stem of 11:25:22 24 individuals who have committed suicide, you find 5HT is low 11:25:31 25 and 5HIAA is low. Both of them are low. 1685 11:25:35 1 And then when you look at different types of 11:25:37 2 receptors, the whole clinical picture that emerges -- and 11:25:42 3 we've measured lots of these receptors. We've measured lots 11:25:46 4 of these receptors than any other place -- is of a serotonin 11:25:51 5 deficiency. There's not enough activity in the system. It 11:25:55 6 is reduced in activity. 11:26:00 7 Paxil and other medications that increase serotonin 11:26:04 8 function by blocking the transporter, I repeat, increase 11:26:09 9 serotonin function. They don't decrease it as this would 11:26:13 10 suggest. I mean, if you took the real simple-minded view, 11:26:20 11 5HIAA is low in suicide, 5HIAA is lowered in people taking 11:26:25 12 these types of antidepressants like Paxil, therefore the 11:26:29 13 antidepressant is making people look biologically like 11:26:33 14 somebody who commits suicide, it is exactly the opposite. 11:26:37 15 The only reason the 5HIAA level drops in people 11:26:44 16 taking these types of antidepressants is that they are so 11:26:48 17 effective at cranking up the amount of serotonin available 11:26:53 18 and improving serotonin transmission that the brain actually 11:26:59 19 slows down the production of serotonin. It doesn't even need 11:27:03 20 as much. And the amount of 5HIAA that's produced actually 11:27:08 21 begins to go down. It is only because these drugs are so 11:27:12 22 good at increasing serotonin function that the 5HIAA begins 11:27:16 23 to drop. So it is exactly the opposite. 11:27:21 24 In the suicide victims, number one, you have low 11:27:25 25 5HIAA because you have low serotonin function. In the people 1686 11:27:28 1 who are being treated with Paxil, you have enhanced serotonin 11:27:34 2 function, better serotonin function, so good, as a matter of 11:27:37 3 fact, the brain begins to sort of try and produce less 11:27:41 4 serotonin because it doesn't need as much anymore. 11:27:43 5 Q. Okay. Thank you. 11:27:46 6 I thought you said earlier that it is not possible to 11:27:48 7 measure the amount of serotonin in the synaptic cleft. True 11:27:54 8 or not true? 11:27:55 9 A. That's correct. 11:27:56 10 Q. Now, Dr. Wheadon when he was here on Friday drew us this 11:28:07 11 little diagram. It is in evidence as SB-II. And he said 11:28:13 12 that Paxil doesn't really cause more production of serotonin, 11:28:18 13 he just -- it keeps it in this space right here longer. 11:28:22 14 Are you saying now he's wrong and that really does 11:28:25 15 affect the production and the metabolization of serotonin? 11:28:33 16 A. No. And actually yesterday I spoke about this subject as 11:28:36 17 well. I don't disagree with that at all. What I'm saying 11:28:40 18 simply is that these medications like Paxil block that little 11:28:47 19 pump or transporter over there and that leaves the serotonin 11:28:51 20 around for a lot longer. 11:28:54 21 While the serotonin is sitting in that intrasynaptic 11:28:58 22 cleft, it is sending a signal, it is firing and transmitting, 11:29:05 23 if you like. So it is so good at doing that, that even 11:29:09 24 though the patient may have started out with less serotonin 11:29:12 25 than they needed, these medications make even the reduced 1687 11:29:15 1 amount of serotonin work so well that the brain begins to 11:29:21 2 crank back on the amount of serotonin that's there, and 11:29:25 3 that's why the 5HIAA begins to drop. 11:29:29 4 And you can measure the 5HIAA, and we don't stick a 11:29:33 5 needle in people's brains. We take some spinal fluid which 11:29:38 6 has all of the 5HIAA coming from the brain and we measure the 11:29:42 7 5HIAA in that. That's what counsel is referring to. 11:29:45 8 We can see that over a period of weeks, because it 11:29:51 9 doesn't happen the first day -- over a period of weeks the 11:29:55 10 5HIAA in the patients treated with these kinds of medications 11:29:58 11 begins to gradually decline, but the serotonin function is 11:30:01 12 actually increasing. 11:30:05 13 Q. Okay. How much serotonin is in the body? 11:30:15 14 A. In what sense? 11:30:16 15 Q. I mean, how much? All of us in this courtroom, how much 11:30:20 16 serotonin do we have, on average, in our bodies? 11:30:24 17 A. Well, serotonin is in the brain, it is in the gut and it 11:30:27 18 is in the platelets which circulate in the blood and plug 11:30:31 19 holes in blood vessels. I guess is there a pound, a 11:30:35 20 kilogram, is there 20 pounds? No, it is a very tiny amount. 11:30:39 21 Q. Like then 20 grams? 11:30:41 22 A. Yes. 11:30:41 23 Q. Less than 20 milligrams? 11:30:45 24 A. Well, the whole body? I'm not sure about that. 11:30:50 25 Q. About 20 milligrams? 1688 11:30:55 1 A. The total amount in the body, 20 milligrams? I think 11:30:59 2 that's a little high, but it might be that far off. Might be 11:31:04 3 the right order of magnitude. 11:31:07 4 Q. So we're going to take a 20-milligram pill every day to 11:31:10 5 regulate the amount of a substance in the body, and there's 11:31:15 6 only 20 milligrams of that whole substance in the whole body, 11:31:18 7 right? 11:31:19 8 A. The amount of the pill has nothing to do with the amount 11:31:21 9 of serotonin. They're completely unrelated. 11:31:24 10 Q. Okay. I want to talk about warnings for a minute. What 11:31:42 11 are the role of warnings or package inserts? 11:31:43 12 A. Well, the role is to provide information about medication 11:31:46 13 that's being used in terms of some information about its 11:31:52 14 pharmacology, its metabolism, its half-life, the doses that 11:32:05 15 ought to be used, its indications, side effects and reports 11:32:14 16 of things that have happened when people have taken the 11:32:14 17 medication, whether we know it is because of the medication 11:32:16 18 or not, and a lot of other information. There's a lot of 11:32:19 19 detail in there. 11:32:21 20 Q. Is it designed to help the physician do his job? 11:32:26 21 A. Of course I'm testifying from the point of view of the 11:32:29 22 physician, not the person at FDA or the regulator or the 11:32:33 23 pharmaceutical company. I'm sure Dr. Wheadon would be much 11:32:36 24 better placed to discuss those aspects. 11:32:39 25 From the point of view of a physician prescribing 1689 11:32:42 1 medication, they're supposed to help us do a better job in 11:32:46 2 terms of deciding what dose to use in the patients and what 11:32:48 3 side effects to look out for. 11:32:50 4 Q. I want to look at a paragraph of your report. It is 11:32:52 5 paragraph 22. You're talking here about the physician's 11:33:17 6 role, right, and you say, "It is up to the physician to make 11:33:20 7 a reasonable clinical judgment as to how the management of 11:33:23 8 the patient should be modified in light of the patient's 11:33:26 9 evolving clinical picture. Such actions may include 11:33:30 10 increasing or decreasing the dose of the medication, adding 11:33:35 11 adjunctive medications or perhaps for some patients 11:33:39 12 hospitalization." 11:33:42 13 Now, I want to ask you about each of those things. 11:33:45 14 With respect to the dose, when you start a patient that has a 11:33:51 15 depression but with an anxiety component to it on Paxil do 11:33:59 16 you tell them to cut that pill in half for the first few 11:34:01 17 days? 11:34:02 18 A. The interesting thing about that question is that when you 11:34:05 19 look at the control clinical trials that have looked at the 11:34:11 20 effect of Paxil and the overwhelming prescription practice in 11:34:20 21 the U.S. and overseas -- actually, you start people off on 20 11:34:24 22 milligrams, but if you look at the control clinical trials, 11:34:29 23 in depression you find that -- and those trials used 20 11:34:35 24 milligrams as a starting dose, that whether the patient was 11:34:39 25 anxious to begin with or whether the patient became anxious 1690 11:34:42 1 or even if they're an older patient that tends to have more 11:34:47 2 anxiety with their depression, the efficacy of Paxil in those 11:34:52 3 trials was unquestionably present. 11:34:56 4 Not only that, in several clinical trials Paxil was 11:35:00 5 superior to Prozac and to fluvoxamine, which is another 11:35:10 6 antidepressant, SSRI, in terms of the antianxiety effect. 11:35:14 7 So it is not clear that the -- Paxil actually seems 11:35:18 8 to be one of the antidepressants, in fact, one of the SSRIs 11:35:25 9 that is both best tolerated in the anxious depressed patient 11:35:30 10 and also the most beneficial for the anxiety component of the 11 depression. 11:35:36 12 Q. I appreciate all of that information about the clinical 11:35:39 13 trials, but I wasn't asking about the clinical trials. I was 11:35:42 14 asking about what you do when you start a patient on Paxil 11:35:45 15 and that patient has an anxious component to their 11:35:48 16 depression. 11:35:49 17 Do you tell them to cut the pill in half for the 11:35:53 18 first few days? 11:35:54 19 A. No, I tell them to start with 20 milligrams. 11:35:57 20 Q. Are you aware of the fact that SmithKline Beecham trains 11:36:00 21 its salespeople to recommend to doctors that they do titrate 11:36:05 22 the dose or cut it in half for anxious depressed people? 11:36:09 23 A. I appreciate the question, but I think that most people 11:36:13 24 here would appreciate I'm not an expert on SmithKline 11:36:15 25 Beecham's training practices for their sales force. And 1691 11:36:19 1 Dr. Wheadon would be the logical person to have responded to 11:36:23 2 that. 11:36:23 3 Q. Actually, we've heard testimony from the salesman himself 11:36:26 4 that says that's how he was trained. The fellow that called 11:36:30 5 on the doctor that prescribed the Paxil for Dr. Schell said 11:36:34 6 that's how he was trained. 11:36:35 7 MR. PREUSS: I'll object to the mischaracterization 11:36:37 8 of the testimony of our representative. The testimony is 11:36:43 9 what it is. It mischaracterizes it. 11:36:46 10 THE COURT: Rephrase the question, if you would, 11:36:48 11 please. 11:36:48 12 MR. VICKERY: Let me pass on that. I'm sure the jury 11:36:51 13 will remember that much better than I will, Your Honor. 11:36:53 14 Q. (BY MR. VICKERY) How about adding adjunctive medications? 11:36:56 15 You're talking about benzos, aren't you? 11:37:00 16 A. Not necessarily. 11:37:02 17 Q. Let me be -- let me ask you a very specific question, and 11:37:06 18 please try to answer it very specifically. 11:37:09 19 Have you ever prescribed a benzodiazepine to be taken 11:37:14 20 conjunctively or at the same time with a SSRI drug when you 11:37:18 21 were starting the patient on that SSRI drug? 11:37:22 22 A. Almost never. 11:37:23 23 Q. Almost never? All right. 11:37:27 24 Do you prescribe some other type of sedative 11:37:32 25 medication with SSRI drugs when people start on them? 1692 11:37:36 1 A. No, that's not my practice. And that's in agreement, 11:37:40 2 actually, with the massive study that I mentioned yesterday, 11:37:43 3 the Inman study with 13,000 patients receiving Paxil where I 11:37:48 4 think it was 8 or 9 percent of those patients had received 11:37:52 5 concomitant benzodiazepines. 11:37:54 6 Q. Have you seen the German warning for Paxil -- the German 11:37:59 7 label -- it is not really a warning -- the German label for 11:38:02 8 Paxil? 11:38:07 9 A. As I said, no. 11:38:07 10 Q. Let me show it to you. 11:38:39 11 We will find it and come back to it. 11:38:42 12 How important is a history of prior violent acts in 11:38:46 13 predicting suicide or violence? 11:38:49 14 A. Prior behavior is very valuable as a predictor of future 11:38:53 15 behavior, and that's true of suicide or serious violence. 11:38:56 16 Q. So a prior suicide attempt would be a strong predictor of 11:38:59 17 suicide? 11:39:00 18 A. Yes. 11:39:00 19 Q. And a prior violent action would be a strong predictor of 11:39:06 20 future violence or suicide? 11:39:07 21 A. It would be a predictor, yes. 11:39:21 22 Q. Did you write your report yourself? 11:39:24 23 A. Every word. 11:39:25 24 Q. I just wondered why you used the word "we" in paragraph 11:39:29 25 18. Is that kind of the royal we or -- 1693 11:39:34 1 A. I sometimes use terminology like that when I feel that the 11:39:38 2 scientific information that has contributed to the point of 11:39:43 3 view was generated by, you know, other investigators. I 11:39:49 4 don't want to create the impression that it is all my own 11:39:52 5 work and ideas and so on and so forth. 11:40:01 6 Q. This is Plaintiff's Exhibit 1 and this is the label for 11:40:10 7 Paxil, and actually they call it something else, Seroxat, in 11:40:17 8 the Federal Republic of Germany. You see the paragraph where 11:40:21 9 "Paroxetine does not have a generally sedative effect. 11:40:24 10 Occasionally in patients with acute suicidal tendencies and 11:40:28 11 in patients who suffer from marked restlessness and insomnia 11:40:32 12 adjuvant sedative therapy may be necessary"? Have you ever 11:40:36 13 seen that before? 11:40:39 14 A. I'm not sure -- I mean, I don't know what document this 11:40:42 15 is. I can read the sentence like anybody else. What would 11:40:45 16 you like me to comment on? 11:40:47 17 Q. Were you aware that the parallel provision for Prozac 11:40:52 18 actually says in big capital letters, "Risk of suicide"? 11:40:58 19 A. What are you referring to? 11:40:59 20 Q. I'm talking about the German label for Prozac. 11:41:01 21 A. You know, I don't have the German labels in front of me. 11:41:04 22 I really can't comment on them. I don't know who produces 11:41:07 23 the German label. I don't know what the regulatory 11:41:11 24 requirements are for the German label. I don't know who 11:41:14 25 decides what goes in it or doesn't go in it, what the basis 1694 11:41:18 1 for those decisions are, so on and so forth. I can comment 11:41:23 2 on the U.S. a lot better. 11:41:28 3 Q. Would you agree with me that the biological response of 11:41:33 4 people in the Federal Republic of Germany to psychoactive 11:41:39 5 drugs is probably going to be about the same as the 11:41:41 6 biological response of people in this country to those drugs? 11:41:44 7 A. You would certainly think so. And in that regard, of 11:41:47 8 course, to respond to your question I would just like to 11:41:50 9 mention the survey of the use of paroxetine in Germany by the 11:41:57 10 Zanelli study which you may have read. 11:42:03 11 And that was a survey, again, a bit like the Inman 11:42:07 12 study I mentioned yesterday, of 500 plus psychiatrists in 11:42:11 13 Germany and about 3,000 patients getting paroxetine. And 11:42:15 14 each of these patients, they asked the question what happened 11:42:19 15 in the first six weeks and what happened after that, and the 11:42:22 16 patients had to be treated for a certain minimum period of 11:42:25 17 time. So it really goes directly to the heart of your 11:42:28 18 question, do things in Germany look like things in the U.S. 11:42:33 19 And the answer is only 40 percent of the people 11:42:35 20 getting paroxetine were receiving adjunctive medications and 11:42:38 21 those adjunctive medications included a whole slew of things. 11:42:43 22 So it is obvious if somebody here is recommending that 11:42:45 23 benzodiazepines be used in conjunction with paroxetine for 11:42:50 24 this kind of depression indication, it is not clear that that 11:42:55 25 is something that physicians in Germany are automatically 1695 11:42:58 1 doing. So physicians have quite a degree of latitude about 11:43:04 2 this. 11:43:04 3 The other study was from the U.K. where it was only 8 11:43:07 4 or 9 percent of prescriptions in 13,000 patients who got 11:43:11 5 paroxetine for depression that required or were given 11:43:14 6 adjunctive benzodiazepines. 11:43:16 7 So I think that those data which are concrete and in 11:43:22 8 massive groups are far more consistent with the results of 11:43:27 9 the double-blind clinical control studies that I've been 11:43:31 10 quoting over and over where paroxetine seems to have a 11:43:34 11 remarkably beneficial effect on anxiety relative to other 11:43:43 12 SSRIs and relative to other antidepressants. 11:43:48 13 Q. Finished with the explanation? 11:43:50 14 A. Yes. 11:43:51 15 Q. My question was do psychoactive drugs affect human beings 11:43:56 16 in Germany the same as they do in this country? Now, do you 11:44:00 17 really think that answer got to the heart of the question? 11:44:03 18 A. The answer is yes. 11:44:05 19 Q. Thank you. 11:44:06 20 Until 1991 you recommended in your article with 11:44:10 21 Dr. Kapur specific future prospective tests, true or false? 11:44:19 22 A. Can you be more specific? 11:44:24 23 Q. Did you recommend that testing be done in a prospective 11:44:27 24 fashion in your 1991 article with Dr. Kapur? 11:44:30 25 A. Yes, we indicated that double-blind, prospective, 1696 11:44:34 1 randomized, control clinical trials are the best way to try 11:44:37 2 and determine the answer to the question as to the efficacy 11:44:42 3 and safety of medications. 11:44:44 4 Q. Did you recommend that in the future tests, the 11:44:47 5 prospective tests, that instead of using a HAM-D, that they 11:44:52 6 should use the Beck Suicidal Ideation Scale? 11:44:57 7 A. We indicated that the Beck Suicidal Ideation Scale has an 11:45:02 8 advantage in sensitivity which may allow one to get more 11:45:08 9 precise measures of changes in suicidal ideation. 11:45:13 10 And I discussed that yesterday. First of all, with 11:45:15 11 those thousands of patients in those databases it turns out 11:45:20 12 that the HAM-D Item 3 is sufficiently sensitive because there 11:45:24 13 are thousands of patients. In fact, in Montgomery he went 11:45:30 14 further because he used the Item 10, as you know, of his 11:45:33 15 rating scale which tested with significantly more sensitivity 11:45:38 16 than the HAM-D and it showed even more striking positive 11:45:41 17 therapeutic effects for paroxetine. 11:45:45 18 Q. My question was did you recommend the Beck scale? Could I 11:45:47 19 have an answer to that question, please? 11:45:49 20 A. We did. 11:45:52 21 Q. And is the Beck scale more sensitive and refined than the 11:45:56 22 single question on the Montgomery-Asburg scale? 11:45:59 23 A. It is not a single question. It is an item that can be 11:46:03 24 scored from zero to 7. So -- with anchor points telling you 11:46:08 25 if it is this level of severity, it is a 2; if it is this 1697 11:46:12 1 level of severity, it is a 4; if it is this level, it is a 6; 11:46:13 2 if nothing is there it is a zero. And you sort of get the 11:46:18 3 idea. 11:46:18 4 Q. We've all seen it. It is in evidence. 11:46:21 5 A. Fine. 11:46:21 6 Q. The thing that it has that the HAM-D doesn't have is a 11:46:24 7 place to focus on whether the person has a plan to commit 11:46:27 8 suicide, right? 11:46:29 9 A. No, that's not correct. 11:46:31 10 Q. Let's look at it, then. Let's just look. This is 11:47:15 11 Plaintiff's Exhibit 8. Let me see if I can zoom in on that 11:47:18 12 for us. Item 10 -- 11:47:24 13 THE COURT: Tell us what Plaintiff's Exhibit 8 is. 11:47:28 14 MR. VICKERY: The MADRS scale, Your Honor, the 11:47:30 15 Montgomery-Asburg Depression Rating Scale. 11:47:33 16 Q. (BY MR. VICKERY) Item 10 is the question on suicidal 11:47:36 17 thoughts, right? 11:47:37 18 A. Yes. 11:47:41 19 Q. What does number 6 say? 11:47:45 20 A. "Explicit plans for suicide when there is an opportunity, 11:47:49 21 active preparations for suicide." 11:47:52 22 Q. Does that refresh your recollection about whether the 11:47:55 23 Montgomery-Asburg scale has a place to rate for a plan for 11:47:58 24 suicide? 11:47:59 25 A. I said that all along. You asked me about the HAM-D. 1698 11:48:04 1 Q. The HAM-D doesn't have one for a plan, does it? 11:48:06 2 A. Let's put the HAM-D up. 11:48:08 3 Q. I will in a minute. But does it have one for a plan? 11:48:12 4 A. You mean this? It definitely distinguishes between plan 11:48:15 5 and no plan, that's correct. 11:48:18 6 Q. Now, a few minutes ago, Dr. Mann, you testified that a 11:48:20 7 prior history of suicide attempts is a strong predictor of 11:48:26 8 future suicide risk, right? 11:48:29 9 A. We don't have strong predictors of anything, but it is 11:48:34 10 amongst the predictors that we have one of the strongest. 11:48:38 11 Q. Look at what is on this scale. Suicide attempts should 11:48:42 12 not in themselves influence this rating, do you agree with 11:48:47 13 that? 11:48:47 14 A. There's a specific reason that that's in there, and that 11:48:50 15 is that the assumption of the individuals who constructed 11:48:53 16 this scale is that suicide attempts would be recorded 11:48:58 17 separately. You don't need a rating scale to record a 11:49:00 18 suicide attempt. You can record there is or isn't a suicide 11:49:07 19 attempt. 11:49:08 20 This instrument item here is designed to determine 11:49:11 21 how severe is the suicidal ideation. 11:49:14 22 Q. Okay. We were talking about your '91 paper with 11:49:17 23 Dr. Kapur, and in addition to the Beck scale, you recommended 11:49:24 24 that they use a scale to measure akathisia, did you not, sir? 11:49:38 25 A. Where are you referring to now? 1699 11:49:40 1 Q. Sorry. I didn't think I would have to show you. Let me 11:49:43 2 get it. 11:49:58 3 MR. VICKERY: This is Plaintiff's Exhibit 51 for the 11:50:00 4 record, Your Honor. It is 803(18) material. 11:50:23 5 Q. (BY MR. VICKERY) Bear with me, Doctor, for a minute. It 11:50:26 6 is going to take me a minute to find it. 11:50:52 7 Do you have the article there, footnote 58 where you 11:50:55 8 cite Barnes? 11:50:58 9 A. I'm looking at it. What page is that? 11:51:02 10 Q. There it is. Okay. 11:51:20 11 "Future studies should incorporate ratings for 11:51:22 12 akathisia, anxiety, agitation, insomnia and other side 11:51:26 13 effects to analyze the potential contribution of these 11:51:30 14 factors to the emergence of suicidality in patients receiving 11:51:38 15 antidepressant therapy." 11:51:38 16 And the footnote 58 is to the Barnes Akathisia Scale, 11:51:39 17 isn't it, that footnote right there? 11:51:48 18 A. Yes, that was one of the scales that we suggested. And 11:51:50 19 I'm glad you brought that up because somebody actually read 11:51:53 20 this article and took our advice and did the exact study 11:51:56 21 pretty much that we recommended. I can tell you about the 11:51:59 22 results of that, if you would like. 11:52:01 23 Q. We may get to that. 11:52:03 24 The people you cite here, King and Colleagues, that's 11:52:05 25 Dr. Robert King at Yale, isn't it? 1700 11:52:09 1 A. Robert King? I don't know. It might be. 11:52:12 2 Q. And even though you're at Columbia and there's maybe a 11:52:16 3 little Ivy League rivalry there, those are pretty respectable 11:52:22 4 folks down at Yale, aren't they? 11:52:24 5 A. Yes. We beat them in football all the time, but that has 11:52:26 6 nothing to do with our view of their science. 11:52:26 7 Q. Are they good scientists and doctors? 11:52:29 8 A. Some are, some aren't. This study was not a particularly 11:52:32 9 good study. 11:52:35 10 Q. It was a study involving children that became suicidal on 11:52:37 11 SSRI drugs, wasn't it? 11:52:40 12 A. It was a set of case reports in young people who had 11:52:43 13 obsessive-compulsive disorder and started off on very high 11:52:48 14 doses of Prozac. 11:52:50 15 Q. Now, one of the ways that you suggested -- maybe I better 11:53:01 16 put this back up. 11:53:02 17 One of the things you suggested for a study design 11:53:05 18 included something called an A-B-A design, right? 11:53:25 19 A. Where we looking now? Same article? 11:53:25 20 Q. Same article, page 1031. 11:53:27 21 A. Give me a second while I find the place. 11:53:45 22 Q. Are you with me now? You see where it says, "Because a 11:54:03 23 paradoxical increase..."? 11:54:19 24 Do you need my help? 11:54:22 25 A. No, I have the place. 1701 11:54:25 1 Q. Read with me: "Because a paradoxical increase in 11:54:28 2 suicidality is reportedly an uncommon event occurring in 11:54:33 3 fewer than 5 percent of patients exposed to 11:54:36 4 antidepressants..." 11:54:38 5 Now, 5 percent of 70 million prescriptions is 3 and a 11:54:46 6 half people, isn't it -- 3 and a half million people? 11:54:53 7 A. Let's just slow down here and do this arithmetic 11:54:57 8 carefully. 11:54:58 9 5 percent of -- 11:55:01 10 Q. 70 million prescriptions that you testified yesterday that 11:55:04 11 we have each year for SSRI drugs in this country, 5 percent 11:55:09 12 of that number is 3 and a half million people, isn't it? 11:55:14 13 A. 5 percent of -- yeah, right, okay. 11:55:18 14 Q. So that's a pretty large small, vulnerable subpopulation, 11:55:25 15 isn't it? 11:55:26 16 A. I think that's a point I've been trying to make when I 11:55:30 17 mentioned that. If -- and we spent the last day trying to 11:55:34 18 point out that all of the control clinical scientific 11:55:39 19 evidence does not support this assertion at all. 11:55:42 20 And if you take the assumption that maybe it is 11:55:45 21 right, 3 and a half million people, and the national suicide 11:55:53 22 rate is 31,000 people and the country has so many people 11:55:57 23 taking these medications, and if this assertion is correct, 11:56:01 24 then why is the suicide rate dropping? Why is the suicide 11:56:05 25 rate dropping when the numbers of prescriptions in ten years 1702 11:56:09 1 go up 30-fold? Why does it go down by 10 percent? 11:56:15 2 It doesn't make any sense. And we went through 11:56:18 3 yesterday all of those control clinical study methodologies, 11:56:23 4 and each of those methodologies draws a blank in terms of 11:56:28 5 this assertion that there's a relationship between this 11:56:31 6 medication causing suicide, but affirms over and over that 11:56:36 7 there's an absence of certain associations. 11:56:40 8 On the contrary, the medication does a lot of good 11:56:45 9 and that's why so many people are using it. 11:56:47 10 Q. Let me follow up on that. Do you believe that this 11:56:49 11 medication reduces the suicidal thinking for some of those 70 11:56:53 12 million people? 11:56:56 13 A. There is no question from the double-blind control 11:57:00 14 clinical studies that are out there that Paxil reduces the 11:57:05 15 suicidal thinking in most of the patients that receive it, 11:57:09 16 and it does a better job of doing that than tricyclic 11:57:15 17 antidepressants. And, as a matter of fact, if they start the 11:57:18 18 treatment and they don't have suicidality, it does a better 11:57:21 19 job of preventing the suicidality emerging. And it doesn't 11:57:28 20 matter whether they're inpatients or outpatients. 11:57:32 21 And, by the way, that's also confirmed by the 11:57:34 22 independent analysis of the FDA data by Kahn who looked at 11:57:40 23 suicide and suicide attempts and showed no evidence of an 11:57:44 24 increase in suicide or suicide attempts in SSRIs, including 11:57:48 25 Paxil. 1703 11:57:49 1 And he did that in the FDA studies which you so 11:57:53 2 correctly point out are mostly outpatients. But he did one 11:57:56 3 more thing that wasn't mentioned. He analyzed the suicide 11:58:01 4 rates in that very outpatient population which you say is so 11:58:08 5 low and, in fact, the suicide rates in that outpatient 11:58:08 6 population when he calculates it out comes to something 11:58:10 7 between 40 and 80 times the expected rate in the general 11:58:17 8 population. 11:58:18 9 So there is no doubt that the very patients in all of 11:58:24 10 those FDA studies were at risk for suicide. 11:58:27 11 Q. And you're aware that Dr. Healy said just the same thing, 11:58:31 12 that if you look at it globally, it probably helps more than 11:58:35 13 it hurts? You're aware that that has been his testimony in 11:58:42 14 his report, aren't you? 11:58:43 15 A. I'm not here to comment on Dr. Healy's -- you know, what 11:58:47 16 you say he said. I can -- I just want to say this is my 11:58:50 17 view. This is how I read the literature. That's how the FDA 11:58:55 18 read the literature. That's how the ACNP reads the 11:59:00 19 literature. And that's how the physicians all over the 11:59:02 20 country and overseas are reading the literature. 11:59:05 21 Q. Dr. Healy is not alone in that. Drs. Teicher and Cole in 11:59:09 22 the article I showed you yesterday said yes, this drug helps 11:59:12 23 people but it hurts others, redistributes the risk? That's 11:59:16 24 what they said, isn't it? 11:59:18 25 A. That was the question they raised and that's why we've 1704 11:59:20 1 been going through all of these double-blind control clinical 11:59:25 2 trials and these surveys of 13,000 people taking Paxil and 11:59:28 3 all of that stuff, because if they were right, that's a very 11:59:31 4 serious concern. It turns out they're wrong. 11:59:34 5 Q. They're not the only people that said it. You know 11:59:37 6 Worshing and Van Putton? Of course Van Putton is dead but 11:59:42 7 you knew him before he died, didn't you, Theodore Van Putton? 11:59:47 8 A. How is that relevant? 11:59:49 9 Q. Wasn't he an expert on akathisia? 11:59:52 10 A. He was an expert on akathisia. We were just discussing 11:59:59 11 something else. 12:00:00 12 Q. Didn't Dr. Worshing and Van Putton also in the scientific 12:00:03 13 literature write essentially the same thing, this drug helps 12:00:06 14 some people but it hurts other people and as long as it helps 12:00:10 15 more than it hurts you're never going to even find them if 12:00:12 16 you look at statistical significance in randomized clinical 12:00:16 17 trials? Haven't you seen their writings to that effect? 12:00:20 18 A. Dr. Van Putton was an expert in the side effects of 12:00:28 19 antipsychotic medications, a completely different class of 12:00:32 20 medications to the SSRIs, totally different class of 12:00:37 21 medications. 12:00:38 22 Q. Have you seen -- 12:00:39 23 A. He did not ever address the issue of suicidality and 12:00:45 24 SSRIs. 12:00:46 25 Q. I will show you in a few minutes where he did. 1705 12:00:52 1 The A-B-A design that you suggested is 12:00:56 2 challenge/dechallenge/rechallenge, isn't it, Doctor? 12:01:02 3 A. That's correct, double blind. 12:01:04 4 Q. When you were doing this free work for Eli Lilly in 1990 12:01:08 5 or 1991 was one of the things you did help Dr. Charles 12:01:11 6 Beasley and Dr. David Wheadon design a 12:01:15 7 challenge/dechallenge/rechallenge or A-B-A design study? Did 12:01:21 8 you do that? 12:01:22 9 A. No, I didn't. 12:01:23 10 Q. I've asked you before in depositions about the Beasley 12:01:26 11 rechallenge protocol. Do you recall that? 12:01:30 12 A. It is conceivable, but you've asked me whether I helped in 12:01:33 13 the design of such a study with Dr. Beasley and the answer is 12:01:37 14 I did not. 12:01:38 15 Q. I have a different question. 12:01:40 16 A. Uh-huh. 12:01:40 17 Q. Have you taken the time to read his study, his protocol? 12:01:43 18 A. I've never read it. 12:01:45 19 Q. Okay. 12:01:48 20 THE COURT: Well, since we're not finishing with this 12:01:50 21 witness, we will break for lunch. 12:01:51 22 MR. VICKERY: Very well. 12:01:53 23 THE COURT: I understand, ladies and gentlemen, 12:01:55 24 you're going to go to lunch, so we will recess until 1:30 12:01:58 25 p.m. and again, as usual, it is very important that you 1706 12:02:01 1 remember the admonition of the Court. 12:02:02 2 And we will stand in recess until 1:30 p.m. 12:02:07 3 (Trial proceedings recessed 12:00 p.m. 12:02:11 4 and reconvened 1:35 p.m., June 1, 2001.) 13:37:27 5 MR. GORMAN: Your Honor, on agreement of counsel and 13:37:27 6 with the Court's permission we would ask to interrupt 13:37:27 7 Dr. Mann and put on Mrs. Powers so that she can get home. 13:37:27 8 THE COURT: That's fine. 13:37:27 9 MR. GORMAN: We would call Dee Powers to the stand. 13:37:52 10 (Witness sworn.) 13:37:54 11 THE CLERK: State your name and spell it for the 13:37:56 12 record. 13:37:57 13 THE WITNESS: The name is Deanna Powers, D E A N N A, 13:38:01 14 P O W E R S. 15 16 DEANNA POWERS, 17 called as a witness on behalf of the Defendant, being first 18 duly sworn, testified as follows: 19 DIRECT EXAMINATION 13:38:05 20 Q. (BY MR. GORMAN) Good afternoon, Mrs. Powers. 13:38:10 21 A. Hi. 13:38:11 22 Q. Where do you live, ma'am? 13:38:13 23 A. I live in Gillette, Wyoming. 13:38:15 24 Q. And how long have you lived in Gillette? 13:38:19 25 A. About 20 years. 1707 13:38:20 1 Q. And you came to Gillette, Wyoming from where? 13:38:25 2 A. From Rapid City, to Gillette from Rapid City but that's 13:38:28 3 not our original home. 13:38:30 4 Q. What did you do when you came to Gillette 20 years ago? 13:38:34 5 A. As far as a business or work? 13:38:36 6 Q. Yes, ma'am. 13:38:36 7 A. We came to build and open a Tower West Lodge. 13:38:42 8 Q. And that's a motel? 13:38:43 9 A. Uh-huh, a Best Western. 13:38:46 10 Q. There in Gillette? 13:38:46 11 A. Uh-huh. 13:38:50 12 Q. And how long did you operate the Tower West Lodge? 13:38:54 13 A. Until 1988. 13:38:55 14 Q. And you currently work where? 13:38:57 15 A. At Powder River Coal. 13:38:59 16 Q. You do -- what are your job tasks at Powder River Coal? 13:39:04 17 A. I'm an executive admin assistant to the general manager. 13:39:09 18 Q. And how long have you been in that position? 13:39:12 19 A. Eleven years. 13:39:12 20 Q. You are a single mother, is that true? 13:39:15 21 A. Yes. 13:39:16 22 Q. You have children that are currently how old? 13:39:21 23 A. 29, 30, 31 and 32. 13:39:25 24 Q. Now, when you first came to Gillette did you buy a home 13:39:31 25 that was near the home of Don and Rita Schell? 1708 13:39:36 1 A. Yes, we did. 13:39:38 2 Q. And could you tell the jury -- give them an example or an 13:39:43 3 idea of how close your residence was to Mr. and Mrs. Schell's 13:39:48 4 home? 13:39:49 5 A. We were the second house in on Hunt Street and on the 13:39:56 6 alley, so you go two doors down to hit the main street and 13:39:59 7 the Schells lived on Fourth, on the main street -- or on 13:40:05 8 Fifth. They looked into our backyard from their front door. 13:40:08 9 Q. That's what I wanted to ask you. Could -- if you were at 13:40:11 10 the front door of the Schell residence you could see into 13:40:14 11 your backyard? 13:40:16 12 A. Yes, because it is elevated. 13:40:18 13 Q. And likewise, if you looked out your back door, you could 13:40:21 14 see the front door of the Schells' home? 13:40:26 15 A. Uh-huh. 13:40:27 16 Q. Yes? 13:40:27 17 A. Yes. 13:40:27 18 Q. You also, I understand, had a dog when you lived in this 13:40:33 19 house? 13:40:33 20 A. Yes. 13:40:34 21 Q. And what type of dog did you have? 13:40:36 22 A. Black Labrador. 13:40:37 23 Q. And was the black lab that you had, I will call it a 13:40:42 24 barker-nuisance dog? 13:40:46 25 A. No, or we wouldn't have kept her. She would bark if there 1709 13:40:49 1 was somebody near, a stranger. She wouldn't bark at friends. 13:40:53 2 Cats and birds would sit on the fence and taunt her, and she 13:40:58 3 would never bark, but she would bark if there was someone in 13:41:03 4 the alley. And that's why we had her. 13:41:05 5 Q. Because she would alert you that somebody was in the 13:41:08 6 alley? 13:41:09 7 A. Uh-huh. 13:41:10 8 Q. Did there come a time after -- let me back up. 13:41:13 9 Your children when you moved into the house in 1981 13:41:15 10 were how old? 13:41:22 11 A. 10, 11, 12 and 13, approximately. 13:41:25 12 Q. Did there come a time after you moved into the house where 13:41:30 13 you started getting anonymous phone calls in the evening? 13:41:36 14 A. Yes. 13:41:38 15 Q. Can you tell the ladies and gentlemen of the jury about 13:41:41 16 how long you had lived in this home when you started getting 13:41:45 17 anonymous phone calls? 13:41:49 18 A. A few months after we moved in, the phone would ring at 13:41:54 19 night and an older man -- my age or older, I knew it wasn't a 13:42:00 20 young person -- would say, "Shut that damned dog up." That 13:42:05 21 was originally. 13:42:06 22 Q. And I'm going to get into that. The person that was 13:42:09 23 calling, you could tell it was an older adult male? 13:42:12 24 A. Uh-huh. 13:42:13 25 Q. And did the older adult male who called you ever identify 1710 13:42:16 1 himself? 13:42:17 2 A. No. 13:42:19 3 Q. Tell the ladies and gentlemen of the jury about -- your 13:42:23 4 first phone call was, again, what? 13:42:30 5 A. "Shut the damned dog up," and hang up. 13:42:33 6 Q. Did the phone calls continue over a period of time? 13:42:37 7 A. Yes. I don't know how long it was, two or three weeks, 13:42:42 8 until I finally was frightened. 13:42:46 9 Q. Okay. And what happened during the course of the 13:42:49 10 anonymous phone calls that started to frighten you? Did they 13:42:54 11 get more threatening in their content? 13:42:59 12 A. Yes. 13:43:00 13 Q. Tell the ladies and gentlemen of the jury what these phone 13:43:04 14 calls became over this period of time. What did the caller 13:43:09 15 say to you? 13:43:16 16 A. "Either shut the dog up or I will take care of your kids. 13:43:21 17 I will throw something through the front window and I will 13:43:24 18 take care of your kids," and by then I was scared to death to 13:43:27 19 leave the kids in the house alone. 13:43:39 20 Q. Did you then contact the telephone company about the 13:43:44 21 calls? 13:43:44 22 A. Yes. 13:43:44 23 Q. Did you then contact the police department about the phone 13:43:47 24 calls? 13:43:48 25 A. That's what the telephone company had me do. 1711 13:43:50 1 Q. And was a trace device put on your phone? 13:43:53 2 A. Yes. 13:44:01 3 Q. What were you supposed to do in relation to the trace 13:44:03 4 device if more calls continued? 13:44:05 5 A. I was told the next time I got a call was to look at the 13:44:09 6 clock and get the exact moment that the phone call came 13:44:12 7 through and call the phone company immediately and they would 13:44:15 8 trace it and take care of it. 13:44:17 9 Q. Did you get another phone call? 13:44:20 10 A. After that? 13:44:21 11 Q. Yes, after the trace was put on your phone? 13:44:26 12 A. No, not after the trace. 13:44:28 13 Q. Well, after the trace device was put on your phone -- 13:44:33 14 A. Oh, yes. 13:44:34 15 Q. -- did you get another call? 13:44:35 16 A. Oh, yes. 13:44:36 17 Q. And can you recall, was it the same older adult male that 13:44:39 18 had been calling you all along? 13:44:42 19 A. Uh-huh. Every call was from the same person. 13:44:45 20 Q. Was the voice angry on the other end, or could you tell? 13:44:50 21 A. Angry and threatening, just -- 13:44:54 22 Q. Why would the person be calling? What was precipitating 13:44:57 23 the calls, if you know? 13:44:59 24 A. The minute the dog would bark. 13:45:01 25 Q. Can you tell the ladies and gentlemen of the jury 1712 13:45:03 1 generally what time of the day these calls took place. 13:45:09 2 A. Usually late evening, but there were some in the middle of 13:45:14 3 the night. It got to where I would lay awake and not sleep. 13:45:19 4 The minute Pepper would bark, I would be at the window to get 13:45:22 5 her to come because I knew I would get a phone call. And I 13:45:26 6 got some phone calls in the middle of the night, but usually 13:45:30 7 they were late evening. 13:45:32 8 Q. Now, after the tap was put on your phone and the other -- 13:45:36 9 another call was made to you, did you do as you were 13:45:39 10 instructed and call the phone company with the exact time? 13:45:44 11 A. Yes, I did. 13:45:47 12 Q. And do you know whether or not -- and you can answer this 13:45:50 13 question yes or no. 13:45:52 14 Do you know whether or not the phone company and the 13:45:55 15 police were able to trace that call from where -- from its 13:46:01 16 origination? 13:46:02 17 A. Yes. 13:46:05 18 Q. And again, you can answer this question yes or no. Do you 13:46:09 19 know who -- 13:46:10 20 MR. FITZGERALD: Excuse me, Your Honor. The Court 13:46:12 21 has prescribed the method by which these questions are to 13:46:15 22 proceed. You entered an order about it and it is time to 13:46:18 23 enforce the order, if you would, please. 13:46:21 24 MR. GORMAN: I'm not asking about what was said. I'm 13:46:23 25 to the point where we will then ask for the -- I just want to 1713 13:46:27 1 know yes or no. 13:46:29 2 Q. (BY MR. GORMAN) Do you know who was making the calls? 13:46:31 3 A. Yes. 13:46:37 4 Q. As a result of these calls, did you develop a fear of Don 13:46:43 5 Schell? 13:46:44 6 MR. FITZGERALD: Excuse me, Your Honor. This is -- 13:46:48 7 this is not according to what was prescribed. It is in the 13:46:52 8 area of hearsay. It is asking what did you learn. That's 13:46:57 9 hearsay. And I understood -- 13:47:00 10 THE COURT: I'm going to sustain the objection. 13:47:02 11 MR. GORMAN: I did not ask that, Judge. 13:47:05 12 THE COURT: I'm going to sustain the objection. 13:47:07 13 MR. GORMAN: Then we would like at this point to make 13:47:09 14 the record, Your Honor. 13:47:10 15 THE COURT: Very well. In order to do that I'm going 13:47:12 16 to ask the clerk to escort the ladies and gentlemen of the 13:47:14 17 jury to the jury room for a moment so we can have the 13:47:19 18 proceeding. 13:47:21 19 (Following out of the presence of the jury.) 13:47:42 20 THE COURT: All right. 13:47:43 21 MR. GORMAN: Thank you, Your Honor. We would at this 13:47:44 22 point like to then continue with the -- Mrs. Powers' 13:47:50 23 testimony with an offer of proof. 13:47:56 24 Q. (BY MR. GORMAN) Mrs. Powers, do you know who made the 13:47:58 25 telephone calls? 1714 13:47:59 1 A. Yes. 13:48:01 2 Q. Who was it that made the telephone calls? 13:48:04 3 A. Don Schell. 13:48:10 4 Q. As a result of those telephone calls did you develop a 13:48:12 5 fear of Mr. Schell? 13:48:14 6 A. Yes. 13:48:17 7 Q. You learned Mr. Schell made the telephone calls how? 13:48:22 8 A. A policemen came to our door and said that they had traced 13:48:28 9 the calls and that he would go over to visit the person and 13:48:34 10 they would stop. And I said, "Would you be willing to tell 13:48:38 11 me whose number that was, who is making the calls?" And he 13:48:43 12 said, "It is Don Schell." 13:48:45 13 Q. And do you have an understanding about whether or not the 13:48:47 14 police, in fact, went to Mr. Schell's residence and talked to 13:48:51 15 him? 13:48:51 16 A. I saw them pull out and get out and go in. 13:48:54 17 Q. As a result of that contact with the police did the calls 13:48:58 18 stop? 13:48:58 19 A. Yes. 13:49:02 20 MR. GORMAN: Your Honor, at this point I think it is 13:49:05 21 fairly clear, certainly, that Mr. Schell's comment is not 13:49:12 22 hearsay. His comments certainly are not hearsay because 13:49:18 23 they're certainly not offered to prove the truth of the 13:49:23 24 matter asserted. Obviously Mr. Schell did not harm 13:49:27 25 physically Mrs. Powers and her children. 1715 13:49:32 1 The comment, then, from the officer to -- and even if 13:49:41 2 it were hearsay, we believe it would come under the exception 13:49:44 3 803(3) which is a then-existing mental, emotional or physical 13:49:50 4 condition. 13:49:51 5 The comment from the officer to Mrs. Powers is not -- 13:50:00 6 is an exception to the hearsay, we think, 803(8), public 13:50:09 7 records and reports setting forth, A, activities of the 13:50:13 8 office; or B, matters observed pursuant to a duty to report 13:50:18 9 (excluding in criminal cases observation by the police); or 13:50:26 10 C, in civil cases and against the government in criminal 13:50:29 11 cases, facts from an investigation pursuant to authority 13:50:35 12 granted by law if it is not untrustworthy. 13:50:44 13 It is our position that certainly the tap was placed 13:50:46 14 on Mrs. Powers' phones pursuant to law. The officer was 13:50:50 15 investigating the threatening phone calls pursuant to law, 13:50:54 16 and his comments about who was making the calls comes under 13:50:58 17 an exception, we think, 803(8), and in those instances the 13:51:07 18 availability of the declarant is immaterial. 13:51:12 19 We also believe 804(b)(3) applies and the declarant 13:51:22 20 there must be unavailable because certainly the statement 13:51:25 21 by -- the statements by Mr. Schell were statements against 13:51:28 22 pecuniary, proprietary or penal interest at the time of their 13:51:33 23 making. 13:51:34 24 In addition, if the Court believes that we have 13:51:37 25 hearsay within hearsay, I think 805 applies to allow the 1716 13:51:44 1 evidence in because hearsay within hearsay is not excluded if 13:51:50 2 each part of the combined statement is a valid exception. 13:51:57 3 We believe Mr. Schell's comments certainly are not 13:52:01 4 hearsay, but if the Court deems they are hearsay, we believe 13:52:04 5 the 803(3) exception applies. And then we believe to the 13:52:08 6 officer's statement the 803(8) exception applies, and then, 13:52:17 7 lastly, I think the evidence could come in through the 13:52:21 8 residual hearsay exception, 807. 13:52:28 9 Certainly also we think that Mrs. Powers should be 13:52:31 10 allowed to testify that she, in fact, saw the police pull up 13:52:36 11 to the Schell house and the calls stopped, which certainly is 13:52:42 12 not hearsay. 13:52:43 13 So I think the questions that I asked Mrs. Powers 13:52:48 14 were clearly within the guidelines the Court established 13:52:50 15 earlier today. I merely asked her if she knew who was making 13:52:56 16 the calls and then I asked her as a result of those calls did 13:53:00 17 she develop a fear of Don Schell. 13:53:04 18 That certainly is not hearsay and certainly is 13:53:08 19 probative and relevant evidence. I did not ask, according to 13:53:15 20 the Court's instructions would not ask unless authorized what 13:53:19 21 she was told. 13:53:20 22 So I think the objection being hearsay is an improper 13:53:23 23 objection and I think the testimony should be allowed to be 13:53:27 24 presented to the jury. 13:53:30 25 THE COURT: Thank you. 1717 13:53:31 1 Mr. Fitzgerald. 13:53:33 2 MR. FITZGERALD: Yes, Your Honor. It is true, 13:53:36 3 Counsel didn't ask directly what she was told, but he did ask 13:53:39 4 what she learned and the way he asked it was did you develop 13:53:42 5 a fear here and that's based upon hearsay. The hearsay link 13:53:47 6 is the officer coming to her home and talking to her about 13:53:51 7 this. There's no state of mind exception for him. 13:53:56 8 The exception for hearsay coming in is when the 13:53:59 9 declarant's state of mind is at issue or the statement 13:54:03 10 reveals the declarant's state of mind. And the declarant in 13:54:07 11 this case is the officer, not Mr. Schell. 13:54:11 12 Second, let me address the 807 issue. First of all, 13:54:15 13 it makes it clear that we have to be informed sufficiently in 13:54:19 14 advance of the trial pursuant to the words I just quoted, 13:54:25 15 advance of the trial. We have to be notified sufficiently in 13:54:29 16 advance of the trial to provide us with a fair opportunity to 13:54:33 17 prepare to meet it. And we haven't had that. 13:54:37 18 Now, the reason I want to mention this is because it 13:54:40 19 has been suggested on this record that somehow we knew this 13:54:43 20 information was out there and that we discouraged 13:54:47 21 Mrs. Lafferty from coming to the trial. 13:54:50 22 I have before me an e-mail dated May 10th in which 13:54:54 23 Mr. Vickery told Mrs. Lafferty, among other things, "I 13:54:58 24 appreciate your willingness to consider coming to testify. 13:55:01 25 We will work with you as much as possible regarding 1718 13:55:04 1 scheduling." That was on May 10th. 13:55:07 2 On May 17th -- excuse me. On -- just before May 13:55:15 3 17th, May 10th there was a message from Mrs. Lafferty, "When 13:55:21 4 we returned from our trip I found that I had been subpoenaed 13:55:24 5 by the attorney for the defendant to appear for them." 13:55:27 6 Now, she lives in Colorado Springs. I had advised 13:55:30 7 Mr. Vickery that you cannot in this district subpoena someone 13:55:33 8 from Colorado Springs. It is more than a hundred miles away. 13:55:36 9 If she lived in Denver the court will honor those subpoenas. 13:55:39 10 And then Andy wrote back to her and told her on May 13:55:43 11 17th, "We could accommodate you earlier and frankly would 13:55:48 12 like the jury to hear from you during our case. I will call 13:55:50 13 tomorrow afternoon when we hit Cheyenne to coordinate the 13:55:57 14 best time." 13:55:57 15 On the next day, May the 18th, Mrs. Lafferty writes, 13:55:58 16 "You need to know after giving the whole thing a lot of 13:56:02 17 thought I don't want to testify for the family because I 13:56:06 18 don't believe the meds are what caused Don to do what he did. 13:56:11 19 I can't believe what little I know is important, so I will be 13:56:14 20 at the trial since I was subpoenaed so the jury will know 13:56:17 21 what little I know." 13:56:18 22 THE COURT: Read that slowly, please. 13:56:21 23 MR. FITZGERALD: I'm paraphrasing these. "All I want 13:56:23 24 from you or any other witness is the truth." He explained to 13:56:27 25 her, "We're not asking you to testify for the family or 1719 13:56:29 1 against the family. Just come and testify to the truth." 13:56:32 2 And he said that "We" -- the plaintiffs -- "were concerned 13:56:35 3 that the other side will subpoena you but then decide not to 13:56:38 4 call you as a witness and in that way the jury, you know, 13:56:42 5 wouldn't wind up hearing your testimony," quote, "so I hope 13:56:45 6 you will still honor the subpoena and be here on the 30th 13:56:48 7 regardless," end quotes. 13:56:50 8 So I say all of this because there's no suggestion 13:56:53 9 here that we did anything, except defense counsel suggested, 13:56:59 10 to keep Mrs. Lafferty from coming to the trial. 13:57:02 11 Now, Counsel represents that after she got off the 13:57:05 12 witness stand, she talked with counsel about this dog 13:57:08 13 incident and that has led us here today to having Mrs. Powers 13:57:13 14 on the stand. 13:57:14 15 But it doesn't come close to meeting the requirement 13:57:17 16 of Rule 807 for the residual exception. So it doesn't meet 13:57:21 17 807. 13:57:21 18 It doesn't meet 803(8) for the hearsay exception. 13:57:26 19 The issue of whether it meets 803(8) -- it doesn't 13:57:35 20 come close to 803(3). 13:57:38 21 As to 803(8), there is no public record and report 13:57:42 22 that we've been able to find. After I had my opportunity to 13:57:46 23 interview this witness earlier this morning, we made an 13:57:49 24 effort, contacted an attorney up in Gillette to see if there 13:57:53 25 were a police record about this. There is no police record 1720 13:57:56 1 or report about this that we have been able to locate. 13:57:59 2 And so the 803(8), public records and reports, 13:58:08 3 connection here is extremely tenuous. They don't have the 13:58:13 4 police officer here to testify to what he said. It is just 13:58:15 5 too attenuated, Your Honor. 13:58:17 6 Under Rule 403, which is a substantial part of the 13:58:21 7 problem here, where it says that evidence may be excluded if 13:58:26 8 its probative value is substantially outweighed by the danger 13:58:31 9 of unfair prejudice, and I think that's already happened by 13:58:35 10 the way the question was asked. 13:58:36 11 I understood clearly from the Court that there would 13:58:39 12 be no effort to get this information out in a way that called 13:58:43 13 for hearsay. But, in fact, it came out, so we've already 13:58:46 14 been prejudiced. 13:58:47 15 And to do more would prejudice us more, confuse the 13:58:51 16 issues and it is -- it is a matter where it is already 13:59:00 17 tenuously relevant and to go further with this witness than 13:59:09 18 he's already gone in answering these questions would 13:59:13 19 hopelessly prejudice us that we have no hope of a fair trial. 13:59:17 20 I'm quite convinced that the jury hearing that Don Schell 13:59:21 21 threatened her children is such a volatile and negative thing 13:59:25 22 against us that we have seriously been damaged. 13:59:29 23 THE COURT: I don't believe she answered the 13:59:30 24 question. You were saying it was suggested through the 13:59:33 25 question. 1721 13:59:33 1 MR. FITZGERALD: Yes, the question said -- what I'm 13:59:36 2 saying is she said -- the question was did you come to fear 13:59:40 3 Don Schell as a result of this? The only way that that 13:59:43 4 evidence would ever come in is if the hearsay came in. 13:59:48 5 THE COURT: I'm saying she didn't answer that 13:59:50 6 question. 13:59:50 7 MR. FITZGERALD: She did. That's why I stood up and 13:59:54 8 said we have prescribed a method by which this should proceed 13:59:57 9 and I asked that it be invoked. It was asked. 14:00:00 10 THE COURT: Last comment, Mr. Gorman. 14:00:02 11 MR. GORMAN: You bet, Your Honor. 14:00:04 12 807 says advance notice is required with name and 14:00:10 13 address of declarant, which was given. I do know 14:00:15 14 Mr. Fitzgerald had the opportunity to interview Mrs. Powers 14:00:21 15 this morning, just like I did, the opportunity to interview 14:00:25 16 her this morning. 14:00:27 17 We have heard now with Dr. Mann -- and I don't 14:00:30 18 know -- I don't know how many references we have now heard 14:00:36 19 from Dr. Mann in questioning by Mr. Vickery, isn't it true 14:00:39 20 you need an act of violence or a suicide, and there's no 14:00:44 21 violence in this man's life, there's no -- never a threat 14:00:48 22 made by this man over and over and over again. And that is 14:00:52 23 not the truth. 14:00:55 24 And I think the questions I asked were proper. They 14:00:59 25 did not ask for a hearsay response. They asked for relevant 1722 14:01:08 1 evidence, and I think the rules that I quoted apply. 14:01:10 2 THE COURT: Thank you very much. 14:01:11 3 For the record, it should reflect that Mr. Gorman and 14:01:14 4 Mr. Fitzgerald met with the Court this morning outside of the 14:01:17 5 presence of the court reporter and we discussed these 14:01:21 6 matters. 14:01:22 7 We planned on allowing Mr. Gorman to lay an offer of 14:01:28 8 proof and that was to be done and we were going to excuse the 14:01:31 9 jury on this. I've pretty well explained my position this 14:01:35 10 morning. I will explain it now on the record. 14:01:38 11 First of all, I am convinced beyond doubt that there 14:01:43 12 is no hearsay exception to allow this witness to testify 14:01:48 13 directly or indirectly to what she learned from a law 14:01:52 14 enforcement officer 17 years ago. That is clearly hearsay 14:01:56 15 and it does not fit any of the exceptions that have been 14:02:00 16 brought, and especially the magnificent stretch to say that 14:02:05 17 somehow what she's going to testify to is in the public 14:02:08 18 record. It is not in the public record as that exception is 14:02:11 19 directed. And so I'm not convinced at all that that covers 14:02:15 20 the matter. 14:02:17 21 The Court also agrees with the argument of 14:02:22 22 Mr. Fitzgerald that to go to the matter of saying that we 14:02:29 23 could call upon this witness to then say, "I am afraid or I 14:02:33 24 was afraid back in 1981 of Mr. Schell," it begs the issue of 14:02:38 25 why she was afraid of him. 1723 14:02:40 1 She's afraid of him because she found out he was the 14:02:43 2 one that made the phone calls and she drew that impression as 14:02:47 3 of today, anyway, testified to it, on improper, inadmissible 14:02:51 4 testimony. That's the only way -- the only place it would 14:02:55 5 come from. 14:02:56 6 With regard to 807, there are three criteria, it 14:03:00 7 appears to me, that you have to meet in order to come up with 14:03:04 8 the residual exception and the defendant has failed to 14:03:07 9 establish that the general purposes of these rules in the 14:03:13 10 interests of justice will best be served by admission of this 14:03:17 11 statement or statements into evidence. 14:03:20 12 That is not the situation. I agree that under 14:03:22 13 Rule 403 also that this hearsay, and it is hearsay, is 14:03:29 14 inadmissible, at least the hearsay declarations of this 14:03:34 15 witness are inadmissible because their probative value is far 14:03:39 16 outweighed by the prejudice of the testimony of an incident 14:03:43 17 that allegedly occurred 17 years ago, 17 years before the 14:03:47 18 events which are the gravamen of this action in this 14:03:51 19 courtroom these last two weeks, notwithstanding the fact, and 14:03:55 20 the Court recognizes, that the plaintiffs have put Mr. Don 14:03:59 21 Schell's character into question throughout this entire 14:04:03 22 matter. 14:04:05 23 But this is not the proper way to challenge that 14:04:08 24 character and I'm not going to allow this kind of hearsay 14:04:11 25 evidence into this matter. And I missed it, that the witness 1724 14:04:17 1 answered the question. That bothers me a whole lot. 14:04:22 2 If we want to create reversible error, this is the 14:04:25 3 way to do it. I cautioned counsel about that this morning. 14:04:30 4 I caution you about it now. The last question that can be 14:04:35 5 asked of this witness -- and you can argue about this. I'm 14:04:40 6 going to let him ask this question, Mr. Fitzgerald -- and 14:04:43 7 that is "When the police came to your house, Mrs. Powers, 14:04:47 8 what did you see thereafter?" I don't think I can disallow 14:04:51 9 that. The jury can draw their own inferences. But we will 14:04:57 10 not have any more suggestive questions and we will be done 14:05:00 11 with this witness. 14:05:01 12 MR. FITZGERALD: May I just get a clarification 14:05:03 13 here, Your Honor? When you say, "...what did you see 14:05:05 14 thereafter" -- 14:05:07 15 THE COURT: What I'm getting at is the defense 14:05:09 16 counsel can ask this witness -- she basically -- and he's 14:05:13 17 made a proffer or she's stated she saw the police officer go 14:05:17 18 to the Schell home. I think she's privileged to say that. 14:05:20 19 That's something she saw 17 -- a lot longer ago than that. 14:05:26 20 MR. FITZGERALD: I don't think she saw him go to the 14:05:28 21 Schell home. He reported to her that he had been to the 14:05:30 22 Schell home and that the -- 14:05:32 23 THE COURT: That's not what I understood. 14:05:33 24 MR. GORMAN: That's not what I understand. I 14:05:34 25 understand that she saw the police officer pull up to the 1725 14:05:37 1 Schell house and after that the calls stopped. 14:05:43 2 MR. FITZGERALD: May we ask is that so? 14:05:45 3 THE COURT: Absolutely. You may voir dire the 14:05:47 4 witness. 14:05:47 5 Q. (BY MR. FITZGERALD) Is that so? 14:05:48 6 A. That's what I said. 14:05:49 7 MR. FITZGERALD: Your Honor, we do not in any way 14:05:52 8 fault the Court for, as you put it, missing this. I think 14:05:54 9 your order in limine this morning was very clear. I think 14:06:01 10 the way the question was asked perhaps lulled the Court into 14:06:05 11 a false sense of security. But the question has been asked 14:06:09 12 based on hearsay. This is no reflection on the Court at all. 14:06:12 13 I would ask the Court to strike the testimony that 14:06:17 14 she developed a fear of Don Schell and ask that the jury 14:06:20 15 disregard. 14:06:25 16 THE COURT: Mr. Gorman. 14:06:28 17 MR. GORMAN: Well, I -- you know, I certainly am not 14:06:32 18 one and never have been one to step on the rulings of these 14:06:36 19 Courts. My questions were framed very specifically to stay 14:06:43 20 away from the hearsay issue that we talked about this 14:06:45 21 morning, and I think the question as phrased was proper. 14:06:50 22 If the Court feels otherwise, I apologize because it 14:06:54 23 certainly was not my intent to step on the Court's rulings. 14:06:59 24 I would like a clarification, so that when the jury 14:07:02 25 does come back I will be allowed to ask, "After the police 1726 14:07:09 1 left your home, did you see what happened next?" 14:07:17 2 And your response would be you saw the police pull up 14:07:19 3 to the Schell house. 14:07:21 4 Can I then ask Mrs. Powers, "After that did the calls 14:07:26 5 stop?" Those are permissible, Your Honor? 14:07:30 6 THE COURT: They're permissible. 14:07:32 7 MR. GORMAN: Okay. Thank you. 14:07:33 8 THE COURT: Very well. The clerk will bring back the 14:07:35 9 jury. 14:07:35 10 MR. FITZGERALD: Excuse me, Your Honor. Did you rule 14:07:37 11 on the motion to strike? 14:07:39 12 THE COURT: I'm going to grant that, absolutely. I 14:07:42 13 will instruct the jury. 14:07:44 14 MR. FITZGERALD: And although Mr. Gorman may have 14:07:47 15 inadvertently asked these questions, but the way it came out, 14:07:51 16 it was -- it elicited hearsay inadvertently perhaps. 14:07:56 17 MR. GORMAN: Could we ask the court reporter to 14:07:59 18 double-check? I'm not so sure the question was answered. 14:08:03 19 THE COURT: Sure, let's take an opportunity to do 14:08:04 20 that. I don't want to strike something and raise the issue 14:08:09 21 even more. I think that's more to your benefit. 14:08:12 22 MR. FITZGERALD: Yes, Your Honor, I appreciate that. 14:08:13 23 THE COURT: I missed it. I thought the objection was 14:08:15 24 made before the answer. 14:08:39 25 (Previous question and answer read.) 1727 1 (Following in the presence but out 14:17:30 2 of the hearing of the jury.) 14:17:30 3 THE COURT: For the record, the court reporter drew 14:17:30 4 to the Court's attention that the statement that she read 14:17:30 5 back as requested by the Court and counsel as to whether or 14:17:30 6 not the witness answered the question whether she was in fear 14:17:30 7 of Mr. Schell, she read back -- the court reporter read back 14:17:30 8 that portion where Mr. Gorman made the statement as a proffer 14:17:30 9 outside of the presence of the jury when we were discussing 14:17:30 10 this particular matter. 14:17:30 11 It came to the court reporter's attention that she 14:17:30 12 needed to look back further, she keyed the word fear and that 14:17:30 13 was the first one that came up. She looked back further and 14:17:30 14 showed the Court, and that's why I'm bringing to you the 14:17:30 15 side-bar, to demonstrate that during the direct examination 14:17:30 16 of Mrs. Powers by Mr. Gorman he did ask the question whether 14:17:30 17 or not she was in fear of Mr. Schell, and Mr. Fitzgerald, the 14:17:30 18 record reflects, raised an objection and the answer was never 14:17:30 19 given in the presence of the jury. 14:17:30 20 Therefore, I'm not going to instruct the jury on the 14:17:30 21 matter of any response or lack of response to that question 14:17:30 22 because it hasn't been before the jury. 14:17:30 23 MR. FITZGERALD: I recall it being and maybe my 14:17:30 24 recollection is faulty. I recall it being answered before 14:17:30 25 the objection because there was a -- and the reason it was 1728 14:17:30 1 timed that way, because of the Court's order in limine, and I 14:17:30 2 thought that it would be offered pursuant to the order in 14:17:30 3 limine that at that point counsel would say, "Your Honor, may 14:17:30 4 we excuse the jury?" and then get into the hearsay. 14:17:30 5 But I don't know whether it is appropriate for me to 14:17:30 6 ask the court reporter is that the first time the word "fear" 14:17:30 7 popped up? If it is not the first time the word "fear" 14:17:30 8 popped up, I would like to ask if it be looked for for the 14:17:30 9 first time it popped up. 14:17:30 10 (Discussion held.) 14:17:30 11 MR. FITZGERALD: I just wanted to say that when she 14:17:30 12 was asked, "Do you know who made the phone call?" and she 14:17:30 13 answered yeah, that's the hearsay because there is no way she 14:17:30 14 would know that without hearsay. That's why it is hearsay. 14:17:30 15 MR. GORMAN: But I did not ask her who made the call. 14:17:30 16 I asked her do you know if the call was traced to its 14:17:30 17 origination. That's exactly what we asked the Court if I 14:17:30 18 could ask. 14:17:30 19 MR. FITZGERALD: And the only way she knows that is 14:17:30 20 by hearsay, based on hearsay, because they told her that they 14:17:44 21 had traced it. That's the whole point. 14:17:44 22 MR. GORMAN: That doesn't even point to the Schells. 14:17:44 23 MR. FITZGERALD: But she has no personal knowledge of 14:17:44 24 how it was traced except but by hearsay. 14:17:44 25 MR. GORMAN: I didn't ask her that. 1729 14:17:44 1 MR. FITZGERALD: You said, "Do you know whether the 14:17:44 2 phone company was able to trace it from its origination?" 14:17:44 3 The answer is yes. 14:17:44 4 MR. GORMAN: I don't think that's hearsay and that's 14:17:44 5 within the guidelines. 14:17:44 6 THE COURT: I will agree with Mr. Gorman. 14:17:44 7 MR. FITZGERALD: What the next question -- okay. 14:17:44 8 THE COURT: We're going to let it stand. 14:17:44 9 MR. GORMAN: Now, can I ask these questions? 14:17:44 10 THE COURT: Yes. 14:17:44 11 MR. GORMAN: I wanted to make sure so I don't get in 14:17:44 12 trouble or do you -- where do you want me to start, after -- 14:17:44 13 THE COURT: No, I want you to ask the last two 14:17:44 14 questions. 14:17:44 15 MR. GORMAN: "Did you see the police pull up to the 14:17:44 16 Schell" -- 14:17:44 17 THE COURT: No, that's leading. 14:17:44 18 MR. GORMAN: I know that, I'm trying to get the 14:17:44 19 subject. "You saw them pull up to the Schell house and saw 14:17:44 20 them -- 14:17:44 21 THE COURT: That's her expected testimony. 14:17:44 22 MR. GORMAN: Okay. Thank you, Judge. 14:17:44 23 (Following in the hearing of the jury.) 14:17:44 24 THE COURT: Counsel reminded me this is the second 14:17:44 25 side-bar in a two-week trial and they're taking a lot of 1730 14:17:44 1 pride in that and as I am as well. We're doing pretty good. 14:17:51 2 Mr. Gorman, you may proceed. 14:17:53 3 MR. GORMAN: Thank you, Your Honor. 14:17:57 4 Q. (BY MR. GORMAN) After you learned what you did -- you've 14:17:59 5 told the jury about, what did you see next happen? 14:18:03 6 A. After the policemen left our house? 14:18:05 7 Q. Yes. 14:18:06 8 A. He went directly to the Schells' house, pulled into their 14:18:09 9 driveway and -- 14:18:13 10 Q. And you saw that? 14:18:14 11 A. I saw that. -- and went in. I could see that from my 14:18:20 12 patio. 14:18:21 13 Q. After you saw the police pull up to the Schell house, did 14:18:23 14 the anonymous phone calls stop? 14:18:25 15 A. Yes, they did. 14:18:27 16 MR. GORMAN: Thank you, Your Honor. Nothing further. 14:18:29 17 THE COURT: Cross-examination. 18 CROSS-EXAMINATION 14:18:30 19 Q. (BY MR. FITZGERALD) This all happened 20 years ago now? 14:18:33 20 A. Approximately. 14:18:34 21 Q. It was 1981? 14:18:35 22 A. Uh-huh, '81 to '82. 14:18:37 23 MR. FITZGERALD: Okay. Thank you. 14:18:40 24 THE COURT: Anything else from Mrs. Powers? 14:18:43 25 MR. GORMAN: No, Your Honor. We would ask that 1731 14:18:45 1 Mrs. Powers be excused. 14:18:49 2 THE COURT: Any objection? 14:18:49 3 MR. FITZGERALD: No, Your Honor. 14:18:50 4 THE COURT: Thank you very much, Mrs. Powers. You're 14:18:52 5 permanently excused from further attendance at this trial. 14:18:57 6 Counsel may recall Dr. Mann. 14:19:26 7 And you know you're still under oath? 14:19:28 8 THE WITNESS: Yes, sir. 14:19:28 9 THE COURT: Very well. 10 CONTINUED CROSS-EXAMINATION 14:19:29 11 Q. (BY MR. VICKERY) Over the lunch hour, Dr. Mann, did you 14:19:36 12 find that you were indeed in error with respect to Worshing 14:19:40 13 and Van Putton writing in the scientific literature on the 14:19:44 14 issue of distribution of risk and the appropriate way to 14:19:48 15 study these matters? 14:19:52 16 A. We were discussing their comments on akathisia, I think is 14:19:55 17 what you're referring to. 14:19:57 18 Q. Right. And you said before lunch that you -- that they 14:20:00 19 never wrote anything about that. Did you discover over the 14:20:04 20 lunch hour that you were, in fact, wrong? 14:20:06 21 A. What I did say was that Dr. Van Putton had written a great 14:20:14 22 deal about akathisia and that the focus of his attention had 14:20:18 23 been the akathisia due to antipsychotic medications. 14:20:25 24 Q. Did you discover anything over the lunch hour about 14:20:28 25 Worshing and Van Putton's writing? 1732 14:20:31 1 A. You may be referring to the case report. Is that what 14:20:34 2 you're talking about? 14:20:36 3 Q. I just want to know if you learned anything over the lunch 14:20:38 4 hour about Worshing and Van Putton, and if so, what did you 14:20:43 5 learn? 14:20:44 6 A. Lunch hour? Nothing. 14:20:46 7 Q. No one, even someone like you who studies in this area has 14:20:50 8 a full recall of all the scientific literature, do they? 14:20:55 9 A. I certainly can speak for myself. I don't have perfect 14:20:58 10 recall. 14:20:59 11 Q. All right. And I know you've published yourself 200 14:21:03 12 articles. Is it customary when someone publishes in a 14:21:07 13 peer-reviewed journal and someone else writes a letter to the 14:21:10 14 editor like the one of yours that we looked at yesterday, for 14:21:14 15 the editor to call that to the attention of the author of the 14:21:17 16 first article? 14:21:18 17 A. Yes, that's proper. 14:21:22 18 Q. Every time you have published something and someone wrote 14:21:25 19 a letter to the editor about your work, the editor would call 14:21:28 20 it to your attention? 14:21:31 21 A. Not necessarily. 14:21:33 22 Q. Isn't that customary? 14:21:34 23 A. It is very common. 14:21:35 24 Q. Have you ever seen what Worshing and Van Putton wrote in 14:21:39 25 response to your article with Dr. Kapur? 1733 14:21:47 1 A. Yes, I have read that. 14:21:49 2 Q. Recently? 14:21:51 3 A. I'm not sure how recently, but at some point. 14:21:54 4 Q. During this trial? 14:21:55 5 A. No. 14:21:56 6 MR. VICKERY: This is Plaintiff's Exhibit 46, for the 14:21:58 7 record, Your Honor. It is 803 material and comes from the 14:22:01 8 July 1992 Archives of General Psychiatry. And I seem to have 14:22:09 9 lost my light saber here. 14:22:53 10 Q. (BY MR. VICKERY) "Fluoxetine, akathisia and 14:22:53 11 suicidality" -- fluoxetine is Prozac, right? 14:22:53 12 A. Yes. 14:22:53 13 Q. -- "is there a causal connection? To the editor: We 14:22:53 14 thank Drs. Mann and Kapur for their thoughtful and cogent 14:22:53 15 treatment of the antidepressant and the suicidality 14:22:53 16 question." That's referring to the 1991 Mann and Kapur 14:22:53 17 article, correct? 14:22:53 18 A. How can you tell that from that? 14:22:53 19 Q. Real easily. I will show you. Do you see where it says 14:22:55 20 footnote 1 there, right there? 14:22:59 21 A. Yes. 14:23:00 22 Q. Drs. Mann and Kapur, footnote 1? 14:23:03 23 A. Sure. 14:23:03 24 Q. Footnote 1 would cite the article, wouldn't it? 14:23:10 25 A. It does. Yes, that's correct. 1734 14:23:14 1 Q. Okay. Thank you. And you see where it is Worshing and 14:23:21 2 Van Putton and several other people out at West Los Angeles 14:23:22 3 Veterans Affairs Medical Center. Were you acquainted with 14:23:25 4 any of those gentlemen, or Dr. Aims or Dr. Hicks-Gray -- or 14:23:34 5 Nurse Hicks-Gray? 14:23:38 6 A. The only person I know from that list apart from 14:23:40 7 Dr. Van Putten is Dr. Marder. 14:23:55 8 Q. Let's read together what they say. 14:23:57 9 "As Drs. Mann and Kapur noted, akathisia has been 14:24:02 10 reported to occur during treatment with fluoxetine and other 14:24:06 11 typical tricyclic antidepressants." 14:24:09 12 And at the time they're writing, neither Paxil or 14:24:12 13 Zoloft were on the market in the United States, correct? 14:24:14 14 A. Yes. 14:24:15 15 Q. "Our cases appear to confirm that certain subjects 14:24:17 16 experience akathisia while taking fluoxetine and that this 14:24:21 17 effect is dose related in the individual patient," and they 14:24:24 18 refer to three of the five case reports that they submitted 14:24:27 19 with their letter to the editor, right? Is that right, 14:24:35 20 Dr. Mann? 14:24:36 21 A. Yes, they talk about cases 1, 4 and 5. 14:24:38 22 Q. It says, "Further, like the akathisia in the 14:24:40 23 neuroleptic-treated schizophrenic population" -- that's what 14:24:46 24 you're saying Dr. Van Putten had written so much about? 14:24:51 25 A. Correct. 1735 14:24:51 1 Q. And are neuroleptics antipsychotic medications? 14:24:55 2 A. They are. 14:24:55 3 Q. He said, "Like the akathisia in the neuroleptic-treated 14:24:58 4 schizophrenic population, fluoxetine akathisia can apparently 14:25:02 5 be associated with suicidal ideation, sometimes of ruminative 14:25:07 6 intensity." What does ruminative intensity mean? 14:25:13 7 A. That means the patient obsesses over and over about 14:25:16 8 feeling suicidal. 14:25:18 9 Q. It says, "Cases 2 and 3 seem to indicate that conventional 14:25:22 10 antiakathisic treatments, in these cases benzodiazepines, may 14:25:26 11 be of benefit in this subpopulation." 14:25:29 12 Is it true that benzodiazepines were conventional 14:25:33 13 antiakathisic treatments? 14:25:36 14 A. That's one of the treatments for akathisia, that's 14:25:38 15 correct. 14:25:38 16 Q. And are you aware of the fact that in this case, in 1990 14:25:45 17 when Dr. Suhany gave Prozac to Mr. Schell, he gave him a 14:25:49 18 benzodiazepine with it? 14:25:51 19 A. Yes. 14:25:52 20 Q. And if that Prozac were likely to trigger akathisia in 14:25:57 21 Mr. Schell, then the antiakathisic medicine that was given to 14:26:03 22 him by Dr. Suhany would have protected him to some degree 14:26:08 23 against that, wouldn't it? 14:26:10 24 A. If, if, if. If it would have produced that, if, 14:26:14 25 et cetera, et cetera. I mean, that's highly speculative. 1736 14:26:22 1 Of course, this falls into the category of case 14:26:25 2 reports which I thought we discussed at some length. 14:26:32 3 Q. What we were discussing this morning is whether examining 14:26:35 4 a large placebo-controlled database of patients is a good way 14:26:39 5 to find the problem if it helps some and hurts others. Do 14:26:43 6 you remember that discussion? 14:26:46 7 A. Yes, I remember you raising the point. 14:26:48 8 Q. Well, let's see what these gentlemen said about it. 14:26:51 9 "Examining large placebo-controlled databases for 14:26:55 10 treatment-emergent suicidal ideation is not likely to be 14:26:59 11 instructive because the active treatment, even if it causes 14:27:02 12 suicidal ideation in a subgroup, also suppresses it. As long 14:27:08 13 as the treatment fluoxetine suppresses more suicidal ideation 14:27:13 14 than it induces, it will compare favorably with the placebo 14:27:28 15 group." 14:27:30 16 Isn't that the same point that Teicher and Cole at 14:27:33 17 Harvard were making, that Dr. Healy has made here, that these 14:27:38 18 gentlemen were making there? 14:27:40 19 A. Actually, that's the point that I keep trying to make, and 14:27:44 20 my point is that these medications clearly suppress suicidal 14:27:52 21 ideation in patients who have it and clearly prevent or 14:27:56 22 reduce the probability of suicidal ideation emerging in 14:28:01 23 people who take it. That's what Prozac -- that's what Paxil 14:28:05 24 does. We're talking about Paxil. 14:28:07 25 It prevents suicidal ideation appearing if you 1737 14:28:12 1 haven't got it when you start treatment and it reduces it if 14:28:15 2 you have got it when you start treatment. The fact that it 14:28:18 3 may, this is a completely hypothetical, unproven suggestion 14:28:22 4 in this letter that if it helps some and it helps more than 14:28:29 5 it harms, you end up with no help and you don't know that it 14:28:35 6 did a bit of harm. 14:28:37 7 That's kind of a nonsensical, argumentative approach 14:28:42 8 which doesn't get us anywhere. Medicine is all about does 14:28:46 9 the medication help? And in this case the answer is yes. 14:28:49 10 Q. Can you point me to your letter to the editor responding 14:28:54 11 to Worshing and Van Putten when they wrote that? I mean, 14:28:59 12 surely if you felt as strongly about it as you just said now, 14:29:02 13 you must have written a letter to the editor and said, "Boy, 14:29:05 14 those guys are way off base." Did you? 14:29:10 15 A. I'm not sure that we were aware of this letter, and I 14:29:13 16 don't know what the situation was in terms of response. But 14:29:18 17 I'm on the record as giving you my opinion. 14:29:23 18 Q. Ten years later, right? 14:29:25 19 A. That's not true. I've been consistent about this all 14:29:27 20 along. This was in response to the 1991 article. Then there 14:29:32 21 was the ACNP statement, et cetera. 14:29:40 22 Q. Okay. Bear with me. 14:30:16 23 MR. VICKERY: I'm sorry, Your Honor. I thought I had 14:30:18 24 all of these things right here. 14:30:19 25 THE COURT: That's all right. 1738 14:31:30 1 Q. (BY MR. VICKERY) Let's cover some of the things from 14:31:30 2 yesterday. You said 60 percent of the suicides committed in 14:31:30 3 this country are committed by depressed people? 14:31:30 4 A. That seems to be true for the U.S. and for other countries 14:31:30 5 as well. 14:31:30 6 Q. Who commits the other 40 percent? 14:31:30 7 A. People with a variety of other psychiatric diagnoses. 14:31:30 8 Q. With biological problems? 14:31:30 9 A. Psychiatric illnesses by and large always involve some 14:31:30 10 biological abnormality in the brain. 14:31:33 11 Q. Now, you mentioned also I think in your direct examination 14:31:35 12 with Mr. Preuss that all of the SSRIs seem to have sexual 14:31:38 13 dysfunction problems; is that right? 14:31:44 14 A. Say that again. 14:31:46 15 Q. Unless I just took it down wrong, in your direct 14:31:49 16 examination you were talking about the side effects of the 14:31:52 17 SSRIs as a class and you said they all have sexual 14:31:54 18 dysfunction problems? 14:31:57 19 A. I'm not sure what I said precisely in that way, but it 14:32:02 20 is -- it is certainly reported that with all of the SSRIs 14:32:07 21 there is an incident of sexual dysfunction, that is correct. 14:32:10 22 Q. What kind of sexual dysfunction? 14:32:12 23 A. I believe I mentioned that when I was giving the brief 14:32:17 24 history of antidepressants. 14:32:19 25 People have difficulties in terms of sustaining 1739 14:32:22 1 erections, delays in ejaculation. Women have a potential 14:32:27 2 delay to orgasm. 14:32:29 3 Q. How long does it take for the drug to have that effect on 14:32:32 4 somebody? 14:32:33 5 A. It is -- first of all, it is fairly common. Estimates 14:33:03 6 range as high as anywhere from 15 to 50 percent. It is 14:33:03 7 probably dependent. It may appear within the first few days 14:33:03 8 or the first few weeks. It usually does not appear if the 14:33:03 9 person has been taking the same dose for a long time. 14:33:05 10 Q. Can it appear within 30 minutes or an hour after taking 14:33:07 11 the pill? 14:33:07 12 A. That would be an interesting experiment to try and carry 14:33:10 13 out. I'm not sure that anybody has ever done that. 14:33:13 14 Q. Is there a market there? Can they market it for that? 14:33:18 15 Maybe some people might like that side effect? 14:33:21 16 A. I think your point is that people don't like that side 14:33:24 17 effect. I would agree with that. 14:33:27 18 Q. Don't you know that they've tried clinical trials to see 14:33:31 19 if it would work to help people with premature ejaculation 14:33:36 20 problems? 14:33:36 21 A. Oh, that is your point? 14:33:38 22 Q. Yeah. It is just another something to sell the pill for, 14:33:43 23 isn't it? 14:33:44 24 A. It is not -- I mean, that's your characterization. I 14:33:48 25 think people that have premature ejaculation and are bothered 1740 14:33:52 1 by it would like to find treatments that might be helpful. 14:34:19 2 Q. You said something interesting this morning. People 14:34:21 3 having a very wide difference in the way they react to the 14:34:24 4 drugs and the concentration levels being as much as 20 times 14:34:29 5 different depending on body chemistry -- true? 14:34:32 6 A. Yes, the body chemistry varies quite a bit from person to 14:34:36 7 person. 14:34:36 8 Q. Is this analogous to an allergic kind of reaction? 14:34:41 9 A. Unrelated. 14:34:42 10 Q. Unrelated? You know, for example, from the medical 14:34:46 11 records Mr. Schell was allergic to codeine, don't you? 14:34:49 12 A. Irrelevant. 14:34:51 13 Q. But you do know that, don't you? 14:34:53 14 A. I don't recall it. 14:34:55 15 Q. And codeine is something that works fine for lots of folks 14:34:59 16 but just didn't work well for him? 14:35:01 17 A. Well, an allergic reaction is something different. 14:35:24 18 Q. What is mania? 14:35:27 19 A. Mania is excessive mood elevation accompanied by other 14:35:31 20 sorts of symptoms such as racing thoughts, grandiosity, maybe 14:35:36 21 delusions that the -- of grandeur, that the person is 14:35:41 22 unusually capable, talking very fast, high energy, sleeping 14:35:45 23 less, impulsive sometimes aggressive behaviors. 14:35:48 24 Q. Is mania the kind of thing that can lead to suicide and 14:35:51 25 violence? 1741 14:35:52 1 A. As a matter of fact, mania is the period of time -- people 14:35:56 2 that have manic depression, bipolar disorder, highs and 14:36:03 3 lows -- when they're at least risk for suicide. 14:36:06 4 Q. Oh, really? What is psychosis? 14:36:09 5 A. Psychosis is where a person has symptoms that involve 14:36:16 6 delusions which are false beliefs that you can't talk a 14:36:20 7 person out of; for example, someone is threatening them, 14:36:27 8 someone is trying to poison them, someone is trying to harm 14:36:30 9 them or they believe they're some kind of deity or important 14:36:34 10 politician or something like that, some false belief you 14:36:37 11 can't talk them out of. 14:36:45 12 And the second major component of psychoses are 14:36:45 13 hallucinations where people see, hear, smell or feel things 14:36:47 14 that aren't there at all. There's no sensation there. There 14:36:51 15 are other features I can go into if you want. 14:36:53 16 Q. Do the SSRI drugs like Paxil produce mania and psychosis 14:36:58 17 in some vulnerable individuals? 14:37:01 18 A. All of the antidepressants have the thought to -- are 14:37:08 19 thought to have the potential for triggering mania according 14:37:18 20 to some researchers. According to others, it is not so 14:37:21 21 clear. There's some debate about the matter. 14:37:24 22 Q. How about psychosis? 14:37:25 23 A. There's also a widely held belief that some 14:37:32 24 antidepressants can trigger a psychotic symptomatology in 14:37:40 25 patients who may have some predisposition to that. That's 1742 14:37:43 1 pretty unusual. 14:37:48 2 Q. Is the Journal of Clinical Psychiatry a peer-reviewed, 14:37:52 3 respectable journal? 14:37:53 4 A. I believe it is peer reviewed, yes. 14:37:55 5 Q. Do you take it? 14:37:56 6 A. Do I what? 14:37:57 7 Q. Take the journal. 14:37:59 8 A. I think the Journal of Clinical Psychiatry is given free 14:38:03 9 to psychiatrists throughout the country, so you don't have to 14:38:06 10 pay for it. 14:38:07 11 Q. Do you receive it? 14:38:07 12 A. Yes, I do. 14:38:08 13 Q. And when there are articles that are in your field of 14:38:11 14 interest do you have a look at them? 14:38:13 15 A. Generally. 14:38:14 16 Q. Did you see the article by Dr. Preda and colleagues from 14:38:21 17 Yale earlier this year on antidepressant associated mania and 14:38:26 18 psychosis resulting in psychiatric admissions to the 14:38:30 19 hospital? 14:38:31 20 A. I have not read it. 14:38:32 21 Q. Let me show you parts of it. Do you know any of these 14:38:46 22 doctors: Adrian Preda, Rebecca MacLean -- 14:38:51 23 A. The only doctor I know there is Dr. Bowers. 14:38:56 24 Q. Who? 14:38:57 25 A. At the end. 1743 14:38:57 1 Q. Who is Malcom B. Bowers, Junior? 14:39:00 2 A. He's a psychiatrist at Yale. 14:39:04 3 Q. Respectable psychiatrist? 14:39:05 4 A. Yes. 14:39:06 5 Q. Okay. Let's look at what they say here. Well, let's try. 14:39:52 6 It starts out, "Antidepressants have been recognized as 14:39:52 7 potential inducers of psychosis since their introduction in 14:39:52 8 the 1950s." Would you agree with that? 14:39:53 9 A. Would I agree with the wording that reports suggest, that 14:40:02 10 antidepressants appear capable? That's a hypothesis. Are 14:40:09 11 you asking whether I think the evidence supports that 14:40:11 12 hypothesis, or what? 14:40:12 13 Q. That's a great question. Do you think the evidence 14:40:15 14 supports that hypothesis? 14:40:18 15 A. Not at this stage. I think -- 14:40:21 16 Q. Do you agree or disagree with this statement from these 14:40:23 17 Yale physicians: "Subsequent reports suggest that all 14:40:26 18 antidepressants, including selective serotonin reuptake 14:40:30 19 inhibitors and the newer non-SSRI antidepressants, are 14:40:37 20 capable of producing mania and psychosis in vulnerable 14:40:40 21 individuals." 14:40:44 22 A. I think there's a good volume of opinion that thinks that 14:40:49 23 may be the case and I have another mind on the matter. 14:40:54 24 Q. What these doctors were doing was looking at hospital 14:40:58 25 admissions into psychiatric hospitals and this is the second 1744 14:41:01 1 in a series of papers they published on it. Did you read the 14:41:05 2 first one? 14:41:06 3 A. Well, you know, I guess I thought I was here as an expert 14:41:09 4 witness, but if you present me with papers I haven't read and 14:41:13 5 select little bits and pieces from them, it is very hard to 14:41:16 6 comment in an intelligent fashion. 14:41:18 7 MR. PREUSS: Your Honor, in addition I would like to 14:41:21 8 object to the whole line of questioning. There's no claim of 14:41:23 9 mania or psychosis in this case. Never has been. 14:41:29 10 MR. VICKERY: Yes, there is. It has been 14:41:30 11 Dr. Maltsberger's and Dr. Healy's testimony. 14:41:34 12 THE COURT: Go ahead. 14:41:36 13 Q. (BY MR. VICKERY: In the Table 1, antidepressants prior to 14:41:40 14 admission, paroxetine, there were 9 and 21 of these 14:41:45 15 psychiatric admissions. 14:41:47 16 What I really wanted to show you and ask your opinion 14:41:50 17 about was something right at the end. 14:42:08 18 Another area of research that may be relevant to this 14:42:10 19 issue is the work of Winter and colleagues showing that 14:42:13 20 "Fluoxetine and other SSRIs can simulate the effects of 14:42:17 21 lysergic acid diethylamine" -- I probably didn't say that 14:42:22 22 right, that's LSD -- "and phenethylamine hallucinogens in an 14:42:32 23 operant discriminative stimulus paradigm. These 14:42:36 24 investigators have shown that this effect is quite likely 14:42:39 25 mediated by serotonin 2 receptors." 1745 14:42:42 1 Those are the 5HT2 receptors that the people were 14:42:45 2 talking about in the Textbook of Suicidology, correct? 14:42:50 3 A. That's correct. 14:42:50 4 Q. "To the extent that LSD and phenethylamine hallucinogens 14:42:57 5 are seen as psychotogenic in humans" -- what's psychotogenic? 14:43:02 6 A. Makes or creates psychosis, from genesis. 14:43:06 7 Q. -- "then the SSRIs may facilitate the emergence of some 14:43:09 8 forms of psychosis." Do you agree with these folks or 14:43:13 9 disagree? 14:43:13 10 A. I only agree with a small part of what is being said 14:43:17 11 there. This is highly hypothetical. Perhaps I can explain 14:43:20 12 how I arrived at that conclusion. 14:43:23 13 As we discussed before, there are a lot of serotonin 14:43:25 14 receptors. Some actually work to offset the action of others 14:43:29 15 so there isn't too much activity in the wrong place. They 14:43:33 16 kind of act as a system of checks and balances. 14:43:36 17 What is misleading about this line of thinking here 14:43:38 18 is that agents like LSD -- which by the way we do know 14:43:43 19 produce hallucinogenic effects through the 5HT2 receptor, 14:43:50 20 that is correct -- distinguish in a fundamental fashion from 14:43:53 21 SSRIs. 14:43:54 22 So when you lop them together, you know, it is just 14:43:57 23 confusing and the reason it is confusing is that what do 14:44:01 24 SSRIs do? They don't do what LSD does which is directly go 14:44:05 25 and stimulate just that receptor and make people psychotic. 1746 14:44:10 1 They release serotonin which stimulates a whole range of 14:44:13 2 receptors. 14:44:14 3 Some of those receptors are designed to offset too 14:44:18 4 much stimulation of other receptors so that when you have -- 14:44:21 5 and that's why with a huge number of people taking these 14:44:26 6 kinds of medications all over the country for a whole variety 14:44:29 7 of indications you don't see every second person running 14:44:32 8 around hallucinating. 14:44:34 9 But let me assure you, if you gave 100 people LSD, 14:44:38 10 the number of individuals who are going to hallucinate are 14:44:42 11 going to be tremendous. You give 100 people Paxil and the 14:44:45 12 number of individuals hallucinating, as we discussed earlier 14:44:50 13 using Mr. Vickery's chart, will be less than 1 percent. 14:44:59 14 We will round it to zero, but of course if you look 14:45:02 15 in the package insert, all of those pharmaceutical companies 14:45:05 16 are telling you how many cases there were and what the 14:45:07 17 percentages are. 14:45:12 18 Q. Are those 8 people important, those 8 people that 14:45:18 19 experienced hallucinogenic reactions as of 1989, the 8 out of 14:45:24 20 2964? 14:45:35 21 A. Absolutely, but your question is did they experience those 14:45:37 22 kinds of hallucinations as a result of the kind of medication 14:45:40 23 they're receiving or because of their illness. 14:45:43 24 A perfect example to show you why it is easy to draw 14:45:46 25 the wrong conclusion is the question you raised before about 1747 14:45:48 1 mania. When people looked at the depressed patients coming 14:45:53 2 into a hospital and getting treated for depression and the 14:45:56 3 rate at which they develop mania, in other words, the 14:46:01 4 implication that the suggestion is here might be related to 14:46:04 5 the antidepressant treatment. 14:46:06 6 Sure enough, the longer in the hospital and the 14:46:09 7 longer they were treated, more and more developed mania. It 14:46:12 8 was a small group. Not everybody developed it, but the curve 14:46:16 9 would go up. 14:46:18 10 So everyone thought it was clear, no question about 14:46:20 11 it, until somebody pulled out a curve on onset of mania of 14:46:25 12 patients admitted to the hospital before 1958, before we had 14:46:29 13 any antidepressants. The curve was exactly the same. So if 14:46:34 14 you didn't know that, you could think these people are 14:46:37 15 getting manic because the antidepressant is making them 14:46:42 16 manic. 14:46:44 17 Once you realize there's a spontaneous rate of things 14:46:47 18 going wrong in people who are sick, and if you don't know 14:46:50 19 what the rate is because of the illness, you make the mistake 14:46:54 20 of blaming the treatment. And the whole discussion here 14:46:56 21 today is to avoid that mistake. 14:46:58 22 Q. Would you mind telling me what question you were just 14:47:01 23 answering? 14:47:02 24 A. Sure. I was talking about the eight individuals that you 14:47:07 25 mentioned, the other eight reporting this effect because it 1748 14:47:16 1 is part of their illness or is it part of the treatment. 14:47:19 2 Q. You're right about one thing. My real question is did 14:47:21 3 this drug cause these people to have the hallucinations. And 14:47:26 4 what I want to ask you, sir, is would it be all right with 14:47:28 5 you if in making that determination the jury simply relied on 14:47:35 6 SmithKline Beecham's own determination when they prepared 14:47:39 7 that information in November of '89? 14:47:42 8 MR. PREUSS: Objection, argumentative, Your Honor. 14:47:45 9 THE COURT: Sustained. 14:47:55 10 MR. VICKERY: May I check with counsel, Your Honor? 14:47:57 11 THE COURT: Yes. 14:48:38 12 MR. VICKERY: I think I'm almost done. 14:48:39 13 Q. (BY MR. VICKERY) What are Kraepilian mixed states? 14:48:47 14 A. I think you're referring to mixed mood states where the 14:48:47 15 person has both features of mania and depression? 14:48:49 16 Q. Right. Are people in those states prone to suicide? 14:48:54 17 A. Yes, there is an increased risk of suicide during that 14:48:57 18 state, that is correct. 14:49:08 19 Q. Dr. Mann, in your own mind how many cases of confirmed 14:49:14 20 suicide or attempted suicide or homicide -- and when I say 14:49:23 21 confirmed, I mean confirmed as being caused by Paxil -- how 14:49:28 22 many such cases would it take before you would recommend that 14:49:34 23 a warning like the one drafted by Dr. Maltsberger or some 14:49:42 24 similar warning be put on the Paxil label in a black box? 14:49:47 25 MR. PREUSS: Objection, argumentative. 1749 14:49:48 1 THE COURT: That's kind of compound. If you could 14:49:50 2 break it down a little bit, that's a tough one. 14:49:54 3 MR. VICKERY: It did get long. 14:49:55 4 THE COURT: And you put the warning in there, too. 14:49:58 5 Q. (BY MR. VICKERY) How many cases confirmed to be caused by 14:50:00 6 Paxil by competent authority would it take -- and the cases 14:50:07 7 being either attempted suicides, completed suicides or 14:50:10 8 homicides -- before you would change your opinion about the 14:50:17 9 adequacy of the Paxil label? 14:50:19 10 MR. PREUSS: Objection, argumentative and 14:50:20 11 speculative, hypothetical with no facts established. 14:50:23 12 THE COURT: Overruled. I will let the witness answer 14:50:25 13 if he has an opinion. 14:50:30 14 A. That's not how we determine whether or not an agent causes 14:50:38 15 suicide. Because if you knew in some magical way that the 14:50:46 16 drug really did what Mr. Vickery suggests it does, then you 14:50:52 17 don't need any signs, then you don't need any clinical 14:50:56 18 trials. You can't even get to case number one without having 14:51:02 19 the principle of causality established. 14:51:15 20 In other words, when you have a patient that you're 14:51:15 21 treating with any antidepressant and they commit suicide, 14:51:16 22 suicide, unfortunately and tragically is a complication of 14:51:21 23 depression. So there are always going to be some suicides in 14:51:24 24 people who have depression and people being treated for 14:51:27 25 depression. 1750 14:51:28 1 To suggest that anybody can say this case was due to 14:51:32 2 the medication and when there are three, four, five, a 14:51:37 3 hundred, a thousand, what's the threshold for changing the 14:51:41 4 label, that's simply not how we arrive at that decision. 14:51:45 5 What we do is we look at the control clinical data 14:51:50 6 where neither the patient nor the doctor knows what they're 14:51:53 7 taking and we ask the question, are more people getting 14:51:56 8 better with the medicine than with placebo. 14:52:00 9 But in this particular set of cases we've asked the 14:52:04 10 question in a far more elaborate and extended fashion. We 14:52:08 11 already know that there is an antisocially thinking, 14:52:12 12 suicidality effect of this medication. We already know that 14:52:15 13 it works to stop suicidality developing. 14:52:19 14 But we've actually gone beyond that because people 14:52:22 15 have analyzed patients who don't suffer from depression and 14:52:24 16 looked at emergent suicidality regarding those patients. I 14:52:28 17 can only speak to Prozac. I believe that Dr. Wheadon spoke 14:52:34 18 to Paxil. And in patients who don't suffer from conditions 14:52:38 19 complicated by suicidality, there is no evidence that these 14:52:41 20 drugs produce suicidality. 14:52:43 21 Q. (BY MR. VICKERY) Over and above the rates, isn't it, 14:52:45 22 Doctor? Every time you've written in the published 14:52:49 23 literature when you've made that statement, you've said no 14:52:52 24 evidence over and above the rates normally occurring; isn't 14:52:56 25 that true? 1751 14:52:58 1 A. That's correct. And that's precisely why I'm making the 14:53:01 2 additional point right now that when you take conditions that 14:53:06 3 are associated with a much lower problem in terms of 14:53:09 4 suicidality like obesity, like smoking cessation and so on 14:53:14 5 and so forth, you take these much lower risk patients and you 14:53:18 6 say since there's much lower risk, there's much less 14:53:22 7 confusion with the illness itself, can you see any of those 14:53:25 8 folks suddenly becoming suicidal. And double-blind control 14:53:29 9 clinical trials say no, you don't. So where is the evidence? 14:53:34 10 Q. My question was how many cases of confirmed causal 14:53:40 11 relationship, confirmed causal relationship by competent 14:53:45 12 authority would it take before you would change your opinion 14:53:50 13 about the adequacy of the Paxil label? 14:53:53 14 MR. PREUSS: Objection, asked and answered, Your 14:53:55 15 Honor. 14:53:56 16 MR. VICKERY: If it had been answered, I wouldn't 14:53:57 17 have asked it again, Your Honor. It wasn't. There was a 14:54:00 18 long speech, but he did not answer my question. 14:54:03 19 THE COURT: Ask it one more time. We've had a lot of 14:54:06 20 the same questions and answers for about two weeks so I'll 14:54:09 21 tolerate one more. Ask the question again. 14:54:13 22 Q. (BY MR. VICKERY) How many cases confirmed by competent 14:54:18 23 authority to be causally related to Paxil would it take 14:54:22 24 before you, sir, would change your opinion about the adequacy 14:54:29 25 of the Paxil label which contains no warning about iatrogenic 1752 14:54:31 1 suicide? 14:54:34 2 A. Beyond these methods of counting people in double-blind, 14:54:38 3 placebo-controlled trials, without any data suggesting such a 14:54:43 4 connection, the only person who knows if drug X for treatment 14:54:49 5 Y does something that we can't see doesn't walk on earth 14:54:55 6 today. 14:54:57 7 In other words, maybe God can figure out the answer 14:54:59 8 to your question. We don't have a way without double-blind 14:55:04 9 controlled trials of finding patients, individual, single 14:55:09 10 patients and saying yes, the drug caused this particular 14:55:13 11 pathology in this patient without -- of this nature, this 14:55:18 12 suicidality question. 14:55:20 13 We have no way of doing that without going through 14:55:23 14 double-blind control trials, and the double-blind control 14:55:28 15 trials say there is no such association. So to suggest that 14:55:31 16 you can get individual cases and say yes, there is such a 14:55:35 17 case and the other one is such a case and so on and so forth 14:55:38 18 is complete speculation and flies in the face of all of the 14:55:42 19 control scientific data. 14:55:45 20 Q. You took the Hippocratic oath when you became a doctor, 14:55:50 21 didn't you? 14:55:50 22 A. Yes, I did. 14:55:51 23 Q. Isn't the first tenet of the Hippocratic oath first do no 14:55:56 24 harm? 14:55:56 25 A. I think that's fundamental. 1753 14:56:00 1 Q. And is it not true, sir, that if you believed that even 14:56:04 2 one person had killed themself or someone else because of 14:56:09 3 Paxil, that you would be on the bandwagon saying doctors need 14:56:16 4 to be alerted about this possibility? 14:56:19 5 MR. PREUSS: Objection, argumentative. 14:56:20 6 THE COURT: And asked and answered. Sustained. 14:56:23 7 MR. VICKERY: Thank you, Dr. Mann. 14:56:25 8 THE WITNESS: Thank you. 9 REDIRECT EXAMINATION 14:56:33 10 Q. (BY MR. PREUSS) Dr. Mann, you have that book on 14:56:35 11 suicidology that was there? 14:56:38 12 MR. VICKERY: It is right here. 14:56:39 13 A. That's Mr. Vickery's book. 14:56:43 14 Q. (BY MR. PREUSS) Just one quick question. Doctor, would 14:56:46 15 you turn to 294 which you were asked to read there? Do you 14:57:05 16 see that, page 294 -- I think it had a magic marker on it 14:57:13 17 there. 14:57:14 18 A. It is definitely not 294 -- here, I've got it. 394. 14:57:20 19 Q. I'm sorry, 394. And you were asked to read that? 14:57:25 20 A. Yes, I was. 14:57:25 21 Q. And that talks in terms of possibility, does it not, 14:57:30 22 causality; is that correct? 14:57:32 23 A. Yes, it describes a biological mechanism involving SSRIs 14:57:42 24 and it says leads to possible -- I assume that's what you 14:57:47 25 mean -- possible adverse effects. I guess what you're 1754 14:57:52 1 suggesting is it is not definite adverse effects, it is 14:57:55 2 possible adverse effects. 14:57:59 3 Q. Right. 14:57:59 4 A. You know, as I said before, endorsing this book, I don't 14:58:04 5 endorse all of the wording, but possible leaves open more 14:58:09 6 than one point of view. 14:58:11 7 Q. Right. All right. Now, earlier, I think right before the 14:58:14 8 lunch hour, you mentioned a study that you referred to in 14:58:19 9 responding to some questions with respect to ratings for 14:58:21 10 akathisia and anxiety. What study was that that you were 14:58:24 11 referring to, sir? 14:58:26 12 A. Yes, I thought Mr. Vickery was going to return to this 14:58:31 13 subject. It was in regards to the fact we had recommended 14:58:34 14 that if people thought SSRIs caused akathisia, that they 14:58:40 15 should employ a rating scale that can measure it in a 14:58:43 16 double-blind, placebo-controlled trial where nobody is 14:58:46 17 biased; the doctor is not biased because they can't tell what 14:58:50 18 the patient is on, patient is not biased. 14:58:53 19 And that study is being done, in fact. Chouinard in 14:58:55 20 Canada where they compared Paxil to Prozac, they administered 14:58:59 21 a scale which included objective measurements related to 14:59:03 22 akathisia. The scores were so low on the scale in both 14:59:07 23 groups from the beginning of treatment all the way through to 14:59:09 24 the end that there was really no meaningfully detectable 14:59:14 25 effect. So that was in the context of a controlled clinical 1755 14:59:18 1 trial. It shows the value of doing these kinds of controlled 14:59:25 2 clinical trials. 14:59:26 3 Q. Dr. Mann, has anything with regard to your discussion with 14:59:28 4 Mr. Vickery today changed your opinion with respect to 14:59:31 5 whether Paxil can cause suicide or murder/suicide, sir? 14:59:39 6 A. No. 14:59:40 7 Q. And you believe based on any discussion you had with 14:59:42 8 Mr. Vickery that there's any need to change the Paxil label 14:59:45 9 as it stands right now? 14:59:46 10 A. I do not believe there's any need to change the Paxil 14:59:49 11 label, and I have no qualms for all of those patients of mine 14:59:56 12 that have been depressed and suicidal that I have treated and 15:00:00 13 continue to treat and will continue to treat with medications 15:00:02 14 like Paxil. 15:00:03 15 MR. PREUSS: Thank you, sir. 15:00:07 16 Q. (BY MR. VICKERY) What was the name of that Canadian study 15:00:09 17 on akathisia? 15:00:13 18 A. C H O U I N A R D. 15:00:20 19 Q. I? 15:00:23 20 A. C H O U I N A R D. 15:00:30 21 Q. How many patients in it? 15:00:31 22 A. Over 200. 15:00:32 23 Q. Who sponsored it? 15:00:34 24 A. What it was funded by? I'm not sure. I can't remember. 15:00:42 25 Q. And when was it published? 1756 15:00:45 1 A. I always love to see how good doctors' memories are. My 15:00:50 2 best recollection is 1998. 15:00:51 3 Q. And one more question. Was it listed in your Rule 26 15:00:55 4 bibliography? 15:00:57 5 A. Yes. 15:00:58 6 MR. VICKERY: Okay. I can find it that way. Thank 15:01:00 7 you. 15:01:01 8 THE COURT: Anything else, Mr. Preuss? 15:01:02 9 MR. PREUSS: No, Your Honor. 15:01:03 10 THE COURT: May Dr. Mann be permanently excused? 15:01:06 11 MR. PREUSS: I hope so. 15:01:09 12 MR. VICKERY: Yes, Your Honor. 15:01:09 13 THE COURT: Thank you very much, Dr. Mann. You're 15:01:11 14 permanently excused from further attendance at this trial. 15:01:14 15 THE WITNESS: Thank you. 15:01:16 16 THE COURT: We're right at 3:00. I don't know if 15:01:17 17 that was planned or not. Let's take our afternoon recess and 15:01:21 18 we'll stand in recess for 15 minutes. 15:01:25 19 (Recess taken 3:00 p.m. until 3:20 p.m.) 15:24:24 20 THE COURT: Call your next witness. 15:24:26 21 MR. GORMAN: Your Honor, we're pleased to call 15:24:28 22 Dr. Arthur Merrell to the stand, please. 15:24:32 23 (Witness sworn.) 15:24:59 24 THE CLERK: Please state your name and spell it for 15:25:00 25 the record. 1757 15:25:01 1 THE WITNESS: It is Arthur Nelson Merrell, 15:25:05 2 M E R R E L L. 3 4 ARTHUR MERRELL, M.D., 5 called as a witness on behalf of the Defendant, being first 6 duly sworn, testified as follows: 7 DIRECT EXAMINATION 15:25:17 8 Q. (BY MR. GORMAN) Dr. Merrell, you've been sitting for a 15:25:20 9 long time. Tell the ladies and gentlemen of the jury where 15:25:22 10 you're from. 15:25:25 11 A. I'm from Cheyenne. I was sitting here for four hours this 15:25:28 12 morning. That's a long morning. 15:25:30 13 Q. How long have you lived in Cheyenne? 15:25:32 14 A. Twenty-seven years. 15:25:33 15 Q. And you are a medical doctor? 15:25:35 16 A. Yes. 15:25:35 17 Q. Tell the ladies and gentlemen of the jury and Judge Beaman 15:25:39 18 your educational background, please. 15:25:42 19 A. Actually, I went to college in Colorado Springs and got a 15:25:47 20 BA there, and then I went to the University of Colorado 15:25:51 21 Medical School, and I received my M.D. degree at the 15:25:55 22 University of Colorado Medical School. 15:25:59 23 Subsequent to that -- that was in 19 -- I have to 15:26:02 24 look at this sometimes. It has been a long time -- 1967. 15:26:08 25 Then I did a rotating internship at Good Samaritan in 1758 15:26:14 1 Portland, Oregon for a year, and then went to a psychiatric 15:26:18 2 residency at the University of Colorado. 15:26:22 3 I completed that in 1971. So I guess I've been a 15:26:28 4 psychiatrist for 29 years. 15:26:33 5 Q. And that's the focus of your specialty, is psychiatry? 15:26:37 6 A. That's correct. 15:26:37 7 Q. Are you board certified in any specialties within your 15:26:42 8 field of expertise? 15:26:45 9 A. Yes. Actually, I have three board certifications. One is 15:26:53 10 in general psychiatry and I received that back in 1973. 15:27:02 11 I have another board examination in forensic 15:27:05 12 psychiatry I'm not sure any of the other experts have that. 15:27:11 13 I wasn't sure when I read their CVs. But a forensic board 15:27:16 14 examination is legal psychiatry. It involves the testing of 15:27:25 15 legal principles, the ability to pull together case material 15:27:33 16 to make decisions on a wide variety of criminal and civil 15:27:35 17 matters. 15:27:37 18 Those include things such as not guilty by reason of 15:27:42 19 insanity, competency to stand trial, testamentary capacity 15:27:48 20 which is can a person make a will, all matters of civil 15:27:55 21 litigation that I've been able to testify in terms of 15:27:58 22 forensic matters. 15:28:00 23 Q. And when did you get your forensic certification? 15:28:04 24 A. Actually, that was back in 1986. You might say that that 15:28:10 25 board at the time I took it -- there are only about 20 people 1759 15:28:16 1 in the United States certified by that examination, and I was 15:28:20 2 the only one in Wyoming and there was maybe one or two 15:28:24 3 perhaps in Colorado. Most of the people that got that 15:28:28 4 particular certification were like on the East Coast or they 15:28:32 5 were in teaching hospitals. 15:28:35 6 That board collapsed or changed after the American 15:28:45 7 Psychiatric Association recommended changing this to an added 15:28:49 8 qualifications in forensic psychiatry, and now that's a 15:28:53 9 term -- that was the toughest test I ever went through, 15:28:59 10 though, I have to tell you that, that original test. 15:29:01 11 Q. You have a third certification in what specialty? 15:29:04 12 A. That's in addiction psychiatry. That involves alcohol and 15:29:09 13 drug addictions. 15:29:12 14 Q. Now, tell the ladies and gentlemen of the jury -- you also 15:29:18 15 hold or participated in some fellowships? 15:29:24 16 A. You don't really participate in a fellowship, but you're 15:29:26 17 awarded fellowships. 15:29:29 18 Q. And tell the ladies and gentlemen of the jury what 15:29:30 19 fellowships you hold. 15:29:35 20 A. I'm a fellow of the American Psychiatric Association, and 15:29:41 21 that was done in 1980. I am also a fellow of the American 15:29:45 22 College of Physicians. I am very active as a physician at 15:29:50 23 the hospital and with the other medical doctors. And that's 15:29:55 24 really a medical organization. 15:29:58 25 Q. In terms of your -- do you belong to professional 1760 15:30:02 1 societies and associations? 15:30:03 2 A. Yes. 15:30:04 3 Q. Tell the ladies and gentlemen of the jury some of the 15:30:06 4 professional associations you are affiliated with. 15:30:13 5 A. I don't know how many really to say here. Should I say 15:30:14 6 just a couple? 15:30:16 7 Q. Just give them a flavor of what professional associations 15:30:20 8 you belong to. 15:30:22 9 A. I would say the important ones probably are the American 15:30:27 10 Psychiatric Association. That's a national group of 15:30:28 11 psychiatrists. We have a Wyoming Psychiatric Society. There 15:30:34 12 aren't a lot of Wyoming psychiatrists, but we have an active 15:30:38 13 group of psychiatrists in Wyoming, about 25 right now. 15:30:42 14 I am also a member of the medical society, Wyoming 15:30:44 15 Medical Society, the Laramie County Medical Society. I'm a 15:31:24 16 member of the American College of Physicians which is a small 15:31:24 17 group of psychiatrists that really meet every year. And 15:31:24 18 that's a good group of psychiatrists. 15:31:24 19 I have some other memberships. I have some 15:31:24 20 memberships through the military that I'm involved with. 15:31:24 21 Q. That's fine. Do you -- what current positions do you 15:31:24 22 hold? First of all, are you affiliated with the hospital 15:31:24 23 here in Cheyenne? 15:31:27 24 A. I actually have -- right now I think it is honorary staff. 15:31:31 25 Q. And what does that mean? 1761 15:31:32 1 A. Well, for 20 years I worked in the hospital. From 1974 15:31:36 2 until about '93 I worked very strongly in the hospital. I 15:31:43 3 admitted patients there. We admitted patients in the days in 15:31:50 4 which there was not a psychiatric unit. We would put people 15:31:53 5 in the hospital in those days in a medical unit and take care 15:31:56 6 of patients and then discharge them back to outpatient 15:32:00 7 follow-up. 15:32:03 8 And I helped create the medical psychiatric unit that 15:32:06 9 is there now. I ended up leaving the hospital several years 15:32:13 10 ago. I had done a lot of work there, and I really wanted to 15:32:16 11 go to outpatient treatment. 15:32:18 12 Q. Okay. In that realm, then, what positions do you hold now 15:32:21 13 currently? 15:32:24 14 A. Currently? I'm the medical director of the mental health 15:32:27 15 center here in Cheyenne. That is a large, four-county mental 15:32:33 16 health center. It actually supplies psychiatric services for 15:32:36 17 the entire southeast part of Wyoming, so it is Wheatland, 15:32:42 18 Laramie and Torrington. 15:32:49 19 That is probably my primary job duty now. I work 15:32:52 20 probably 60 percent of the time there. 15:32:55 21 Q. The other 40 percent time is spent doing clinical 15:32:58 22 practice? 15:32:59 23 A. Basically in a variety of settings. I work at the VA 15:33:03 24 Hospital, for example. I see patients there about a day a 15:33:06 25 week at the current time. I do forensic work. I do legal 1762 15:33:15 1 evaluations in a private practice. I have some patients in 15:33:20 2 my private practice, but I'm getting older and not taking on 15:33:25 3 new patients so I will do evaluations but not do a lot of 15:33:28 4 treatment in a private setting. 15:33:30 5 Q. You are married? 15:33:31 6 A. Married. 15:33:32 7 Q. Children? 15:33:33 8 A. Four children. 15:33:37 9 Q. Now, you mentioned a minute ago that there are 25, did I 15:33:42 10 hear you right, psychiatrists practicing within our great 15:33:47 11 state of Wyoming? 15:33:48 12 A. Roughly that number. It may be slightly higher than 25 15:33:52 13 right now. Certainly under 30. You know, that's surprising 15:33:57 14 enough. That's a low number. But Wyoming has the fewest 15:34:02 15 psychiatrists per capita of any state in the United States. 15:34:05 16 So it is not just the total low number. We also have 15:34:08 17 a low number compared to population. Our population is a 15:34:13 18 very low state, so we deserve to have fewer psychiatrists, 15:34:18 19 but even with that, our numbers per population are very 15:34:22 20 limited. 15:34:24 21 Q. In your background and your practice for all of these 15:34:27 22 years here in Cheyenne as a psychiatrist, for how many of 15:34:32 23 those years were you the only psychiatrist available to the 15:34:35 24 folks here in Cheyenne? 15:34:39 25 A. I'm not sure how long that happened, but there was a 1763 15:34:42 1 period of time when I was the only psychiatrist who would 15:34:46 2 practice and take care of patients here in Cheyenne except I 15:34:51 3 think there was a military psychiatrist at the Air Force base 15:34:55 4 that wasn't allowed really to take care of civilian patients. 15:34:59 5 But there were some years I was here by myself. 15:35:02 6 During that period of time I did a lot of -- a lot of 15:35:05 7 hospital work. Some of those times I would be on call like 15:35:09 8 270 days a year. The only people that would cover for me, 15:35:14 9 since there wasn't a psychiatrist, was another general 15:35:17 10 practitioner, somebody like that. 15:35:20 11 Q. Do you also or have you in your past supplied psychiatric 15:35:27 12 services to the Wyoming Women's Center in Lusk? 15:35:31 13 A. Yes. One of the things I did which was interesting -- one 15:35:35 14 of the nice things about living in Wyoming is that you can 15:35:42 15 experience a lot of different activities and work activities. 15:35:45 16 I've had an interest in prison psychiatry, so for about ten 15:35:49 17 years I went to the women's prison in Lusk and saw patients 15:35:54 18 there, treated patients there. 15:36:00 19 I did the same at Rawlins for a few years, perhaps 15:36:01 20 four years there. 15:36:01 21 Q. At the men's prison? 15:36:03 22 A. At the men's prison as well. 15:36:05 23 Q. Okay. You mentioned the Warren Air Force Base here in 15:36:10 24 Cheyenne. Have you also provided services, psychiatric 15:36:13 25 services, to the mental health clinic at the Air Force base 1764 15:36:17 1 here in Cheyenne? 15:36:18 2 A. Yes. For several years I went to -- particularly if they 15:36:23 3 had trouble having coverage out there. If they didn't have 15:36:25 4 psychiatric coverage, I would go to the Air Force base and 15:36:28 5 see patients at Warren. Did that for several years. 15:36:37 6 Q. In your capacity as a psychiatrist do you have experience 15:36:41 7 working with general practice physicians in Wyoming? 15:36:48 8 A. Yes. And that's another experience that I enjoyed in 15:36:51 9 Wyoming. For, I guess it was, around ten years I was the 15:36:59 10 coordinator of the psychiatric teaching at the family 15:37:02 11 practice residency here. 15:37:04 12 Q. Tell the ladies and gentlemen of the jury a little bit 15:37:05 13 about that program. 15:37:07 14 A. That's a program that trains family practice doctors to -- 15:37:13 15 from Wyoming to go into communities. They train six a year, 15:37:19 16 and it is a three-year program. Pretty good program. I 15:37:26 17 think they get a good education. 15:37:28 18 During those times I would have a family practice 15:37:31 19 resident essentially be at my heels for a month. They would 15:37:34 20 do everything I did. They would accompany and I would teach 15:37:38 21 them during the month. 15:37:40 22 Q. And you have done that for about ten years or you did that 15:37:43 23 for about ten years? 15:37:44 24 A. I did that for about ten years. 15:37:46 25 Q. You mentioned you also have some military experience. 1765 15:37:48 1 Tell the ladies and gentlemen of the jury quickly what your 15:37:51 2 military experience is. 15:37:54 3 A. Okay. I don't know if -- that's as a flight surgeon, as a 15:37:58 4 doctor for the military. I have 20 years with the military 15:38:06 5 total. I was in the Navy for two years. I did psychiatry in 15:38:10 6 the Navy many years ago and went back into the Air National 15:38:15 7 Guard where I've been a flight surgeon, which is a doctor who 15:38:19 8 works with pilots and does basically medicine. 15:38:27 9 For about ten years I was the clinic commander out 15:38:30 10 there of the clinic, so as time went on, I was the commander 15:38:36 11 of the medical detachment here and I'm still the commander. 15:38:41 12 I'm retiring soon, but I'm still the commander of the clinic. 15:38:45 13 Q. Now, one thing that I've been very interested in getting 15:38:48 14 to when learning about you is your involvement as a physician 15:38:53 15 in humanitarian missions. 15:38:57 16 Can you tell the ladies and gentlemen of the jury and 15:38:59 17 Judge Beaman a little bit about your work in humanitarian 15:39:07 18 missions? 15:39:10 19 A. Well, briefly one of the things that the military here 15:39:12 20 does, Air National Guard, is it has summer training. One of 15:39:19 21 the things we did in March of this year is we went to Peru 15:39:23 22 and we treated citizens down there. The Peruvian government 15:39:30 23 had asked for medical assistance. There was 40 of us that 15:39:34 24 went down there to provide medical services. 15:39:39 25 We're proud of that deployment. We saw over 10,000 1766 15:39:43 1 people, over a thousand people a day. 15:39:45 2 Q. Do you practice medicine other than psychiatry on those 15:39:49 3 humanitarian ventures? 15:39:52 4 A. Yes, I would say basically I was doing medicine. And you 15:39:55 5 have to remember, a psychiatrist is a doctor first, 15:39:58 6 psychiatrist second, so I was doing general medicine seeing 15:40:07 7 kids, families. I pulled teeth while I was down there. 15:40:11 8 There was a lot of dental work that needed to be done. 15:40:14 9 Q. Is there a person who organizes those missions? 15:40:17 10 A. I was the person that had to organize the mission. 15:40:19 11 Q. Now, in your years of experience here in Wyoming have you 15:40:27 12 had occasion to treat with antidepressants, including the 15:40:32 13 SSRIs? 15:40:35 14 A. Yes, I would say even before coming to Wyoming I've had, 15:40:42 15 you know, 30 years of experience with these various 15:40:47 16 medications for depression and other problems. 15:40:50 17 Q. Have you had occasion to use the older generation 15:40:54 18 tricyclic medications like imipramine, we have heard? 15:40:58 19 A. Yes, I've used imipramine. I don't know how many hundreds 15:41:02 20 or thousands of times I've used imipramine. Imipramine is 15:41:06 21 still a good medication for the right person, and it goes way 15:41:11 22 back. And I've used all of the MAO inhibitors and used all 15:41:17 23 the SSRIs. 15:41:18 24 Q. Including Paxil? 15:41:19 25 A. Including Paxil. I've used the atypicals and I've used 1767 15:41:26 1 combinations of these various medications. I get a lot of 15:41:29 2 patients referred to me that are called treatment resistant 15:41:32 3 or difficult depressions, and so in those kinds of cases 15:41:35 4 there's very difficult treatment strategies that are 15:41:39 5 required. 15:41:45 6 Q. We have heard -- help yourself to some water there. 15:41:49 7 We have heard a lot about research physicians over 15:42:00 8 the last -- research scientists and doctors over the last 15:42:01 9 couple of weeks. Are you a research physician or are you a 15:42:07 10 treating physician? 15:42:11 11 A. I'm a treating physician. I've done a little bit of 15:42:19 12 interest in a small amount of research, but basically I see 15:42:25 13 myself as a treating physician. 15:42:28 14 Q. Okay. Dr. Merrell, do you believe that Paxil is a safe 15:42:35 15 and effective medicine to treat depression? 15:42:41 16 A. That answer is definitely so. It is a safe and effective 15:42:43 17 medication. There's -- Paxil is a good medication. I have a 15:42:48 18 lot of people on Paxil. In my hands it does fine. 15:42:53 19 Q. Do you believe that Paxil caused Mr. Schell to commit the 15:43:00 20 murder/suicide in this case? 15:43:02 21 MR. VICKERY: Objection. Not a thing in the Rule 26 15:43:04 22 report about that opinion, Your Honor. 15:43:06 23 THE COURT: Besides that, no foundation laid. 15:43:09 24 MR. GORMAN: We will get to that, then, Judge. 15:43:12 25 THE COURT: What about his objection, that it is not 1768 15:43:15 1 part of the 26 designation? 15:43:18 2 MR. GORMAN: Well, I think it is in his 26 15:43:20 3 designation. I will come to it in due time to -- 15:43:25 4 THE COURT: Point it out to Mr. Vickery and myself. 15:43:27 5 MR. GORMAN: I think the ultimate conclusion and 15:43:29 6 opinion is on the last page of the Rule 26. It says that 15:43:35 7 Mr. Schell's ongoing, untreated depression was the cause of 15:43:41 8 his -- was the cause of this tragedy. 15:43:50 9 MR. VICKERY: It does and if he wants to ask him was 15:43:53 10 depression a cause, I have no problem with that. There's 15:43:56 11 nothing in this report saying that Paxil wasn't also a cause. 15:44:00 12 Nothing. 15:44:01 13 MR. GORMAN: Judge, I assumed that's what this case 15:44:04 14 was about. 15:44:06 15 THE COURT: Overruled. Proceed. But you're going to 15:44:08 16 have to lay a foundation. 15:44:10 17 MR. GORMAN: I will, Your Honor. Thank you. 15:44:13 18 Q. (BY MR. GORMAN) Dr. Merrell, we asked you to do a 15:44:16 19 forensic analysis of this case, did we not? 15:44:23 20 A. That is correct. 15:44:23 21 Q. Can you tell the ladies and gentlemen of the jury what 15:44:25 22 materials you have reviewed, you have been provided with that 15:44:29 23 form the bases of your opinions that you will give in this 15:44:32 24 case? And if you need to look at your notes to tell the 15:44:38 25 ladies and gentlemen of the jury about those materials, 1769 15:44:41 1 please feel free to do so. 15:44:43 2 A. Okay. I think I'll lump this by saying that, to my 15:44:48 3 knowledge, there isn't any information that is out there that 15:44:51 4 I haven't read. I have read all of the depositions, all the 15:44:57 5 treating physicians and psychiatrists and the fact witnesses. 15:45:03 6 I have read every medical and psychiatric record that is 15:45:09 7 available, and that's from all of the doctors that I'll 15:45:13 8 mention in a minute. 15:45:14 9 I've read all of the employment and insurance 15:45:16 10 records, pharmacy records, police department records, all the 15:45:24 11 autopsy reports, all of the expert reports from January on. 15:45:32 12 Those were at the base of my opinion. 15:45:35 13 There were a lot of things in addition to that that 15:45:36 14 I've reviewed that I don't need to go into, I guess. 15:45:41 15 Q. Okay. Now, can you estimate for the ladies and gentlemen 15:45:44 16 of the jury the number of patients you have treated for 15:45:48 17 depression in your 30-plus years of practice? 15:45:55 18 A. I'm sorry, I can't, that would be accurate. Let's say it 15:46:03 19 is over thousands, but anything else would be a guess. We're 15:46:06 20 talking 30 years of seeing patients, and I suppose if I 15:46:11 21 see -- I can tell you probably how many patient contacts I 15:46:15 22 might have had over that time. 15:46:17 23 Q. Please, if that will help you quantify this for us. 15:46:24 24 A. And this is just for depression? 15:46:31 25 Q. Yes. 1770 15:46:31 1 A. Well, if I average seeing perhaps somewhere between 40 and 15:46:36 2 50 patients a week, when I was in the hospital sometimes I 15:46:39 3 would have 12 to 14 inpatients at a time, so there were years 15:46:43 4 where I saw more patients per day. 15:46:48 5 If it is 40 a week, major depression or depressions 15:46:51 6 might be 50 percent of that easily, maybe 60 percent; 20 a 15:47:10 7 week times 50 weeks, roughly a thousand, times 30 years. 15:47:10 8 Q. A lot of people? 15:47:15 9 A. A lot of people. 15:47:16 10 Q. And those have been, I believe you said, both inpatients 15:47:18 11 and outpatients? 15:47:20 12 A. That's correct. 15:47:20 13 Q. And you went over the materials that you have reviewed and 15:47:26 14 all of the factual materials that have been provided to you. 15:47:29 15 In a forensic analysis like that which you've performed why 15:47:34 16 is it important for you to review the materials that you did? 15:47:38 17 A. A forensic analysis needs to be reliable, and if there are 15:47:43 18 materials that are not reviewed or examined, the reliability 15:47:53 19 is suspect of the examination. 15:47:55 20 And there's nothing worse than forming an opinion and 15:47:58 21 not having available some fact or information. I have done 15:48:03 22 enough of these evaluations for criminal matters that you 15:48:07 23 really have to review every piece of information that is 15:48:10 24 available. You have to be very thorough to be able to come 15:48:19 25 up with a credible opinion. 1771 15:48:19 1 Q. And do you believe you have done that in this case? 15:48:19 2 A. I believe I have a credible opinion. 15:48:22 3 Q. Now, we have heard a lot about psychiatric autopsies. Is 15:48:31 4 that what you have done in this case? 15:48:39 5 A. I suppose that would be a good word to say what I have 15:48:42 6 done. 15:48:42 7 Q. Or a forensic psychiatric evaluation? 15:48:45 8 A. That would be another term. 15:48:46 9 Q. Now, I want to ask you one other thing. If a person -- if 15:48:54 10 a person who is -- if a person were to make anonymous phone 15:49:06 11 calls, what significance, if any, is that to you in this 15:49:13 12 whole analysis that you've done? What does that mean to you? 15:49:21 13 A. Well, it depends on the context of anonymous phone calls, 15:49:24 14 the content of those communications. It would depend upon 15:49:30 15 more information regarding those phone calls. 15:49:33 16 Q. If they were threatening phone calls? 15:49:35 17 A. That would be significant. 15:49:36 18 Q. If they were phone calls made in response to, for example, 15:49:40 19 a dog barking? 15:49:46 20 A. You know, I think a threat is an index of suspicion. It 15:49:50 21 would require further evaluation to really find out the depth 15:49:56 22 of the threats, the nature of those, and that would be of 15:50:01 23 concern. I mean, that's evidence of a -- threatening 15:50:05 24 behavior is always a concern. 15:50:07 25 Q. There's a term in psychiatry -- is there a term in 1772 15:50:10 1 psychiatry called impulsivity? 15:50:13 2 A. Yes. 15:50:13 3 Q. What does that mean? 15:50:19 4 A. I'm not sure I can define that totally for you. Basically 15:50:25 5 just impulsive behavior, acting without thinking, performing 15:50:34 6 an action before really thinking about the consequences of 15:50:37 7 that action. 15:50:37 8 Q. And is that -- is impulsivity significant to a 15:50:44 9 psychiatrist in evaluating the mental state or frame of mind 15:50:48 10 of a particular patient? 15:50:55 11 A. I think impulsivity are one of those symptoms that you 15:50:59 12 would want to learn more about. It makes people more at 15:51:02 13 risk, let's say, for certain behaviors. To act before 15:51:07 14 thinking is potentially a dangerous behavior. 15:51:11 15 Q. Okay. Have you had the opportunity to evaluate 15:51:18 16 Mr. Schell's history in terms of depressive episodes that he 15:51:25 17 suffered based upon the materials we were able to accumulate? 15:51:32 18 MR. VICKERY: Excuse me, Doctor, before you answer 15:51:34 19 that. 15:51:34 20 Your Honor, I object to the display of the Power 15:51:38 21 Point slides. We discussed this with the Court previously in 15:51:42 22 chambers in connection with Dr. Healy's slides. These 15:51:45 23 slides, like his, were not produced with the Rule 26 report, 15:51:49 24 nor the blowups of them which are at the ready over there. 15:51:53 25 And given the Court's exclusion of all of Dr. Healy's 1773 15:51:56 1 Power Point slides, I object to any of theirs. They were not 15:52:00 2 timely designated with the Rule 26. 15:52:02 3 MR. GORMAN: And, Your Honor, if you will look, the 15:52:04 4 slides have been even designated as exhibits by the defense 15:52:07 5 that have been agreed to and stipulated to by Mr. Vickery. 15:52:14 6 The first exhibit, for example, will be SmithKline's 15:52:19 7 Exhibit DD. That is in the exhibits that are already before 15:52:24 8 the Court. 15:52:25 9 MR. VICKERY: Your Honor, it is true that I made that 15:52:27 10 stipulation, but it was sauce for the goose and the gander. 15:52:33 11 Part of the stipulation was that I share Dr. Healy's slides 15:52:37 12 with them and they share these slides with me. 15:52:41 13 When they said, "Oh, you can't use Dr. Healy's 15:52:45 14 slides," I advised the Court and counsel in chambers if they 15:52:50 15 were going to renege on the stipulation, it would go all the 15:52:52 16 way. 15:52:52 17 So I object to them showing things which were not 15:52:55 18 timely designated, and I move to strike them from the 15:53:00 19 exhibits. 15:53:00 20 MR. GORMAN: They were timely designated. 15:53:02 21 Mr. Vickery couldn't put on Dr. Healy's Power Point 15:53:06 22 presentations because he had not identified them as exhibits. 15:53:11 23 These exhibits are in the exhibit book, Defendant's exhibits 15:53:17 24 that Mr. Vickery the other day said he had no objection to. 15:53:21 25 MR. VICKERY: I can't say any more than what I have, 1774 15:53:23 1 Judge. I said I had no objection based on that time because 15:53:27 2 I thought the stipulation was a two-way street and it would 15:53:31 3 be honored two ways. When the defendant reneged on the 15:53:35 4 stipulation, simply for parity I must object. 15:53:40 5 THE COURT: Objection overruled. 15:53:41 6 MR. GORMAN: Thank you, Your Honor. 15:53:44 7 Q. (BY MR. GORMAN) Have you had the opportunity, 15:53:47 8 Dr. Merrell, to analyze based upon the medical information 15:53:53 9 that we were able to gather Mr. Schell's known prior 15:53:59 10 depressive episodes? 15:54:00 11 A. Yes, I've had that opportunity. 15:54:02 12 Q. And I want to -- can you tell the jury just real quickly 15:54:08 13 how many depressive episodes between 1984 until February of 15:54:17 14 1998 that you were able to evaluate? 15:54:26 15 A. Okay. We need to talk about six episodes of depression. 15:54:30 16 Talking about six episodes of depression. 15:54:33 17 Q. All right. I want to take you through those, Dr. Merrell. 15:54:36 18 And we do have a Power Point presentation. You will be able 15:54:43 19 to see the slide on your screen. You also have a pointer 15:54:43 20 there that you can use on the large screen if you -- in 15:54:49 21 discussing these to point out things to the jury, if you can. 15:54:54 22 Tell the ladies and gentlemen of the jury about the 15:54:57 23 first episode of depression that you were able to identify 15:55:02 24 and evaluate. It is hard to read up there. It says -- 15:55:10 25 A. I can read it. 1775 15:55:11 1 Q. Go ahead. 15:55:13 2 A. Back in 1984 appears to be the first episode of a 15:55:16 3 depression for Mr. Schell. Now, the evidence for that 15:55:22 4 particular depression is not noted in any medical records. 15:55:27 5 There are no written medical records to review for that 15:55:31 6 depression. The notation of that depression is in 15:55:35 7 Dr. Hemphill's deposition. Dr. Hemphill. 15:55:40 8 Q. And who was Dr. Hemphill? Who do you understand 15:55:44 9 Dr. Hemphill to have been? 15:55:49 10 A. I understood him to be a general practice or internal 15:55:52 11 medicine physician. 15:55:53 12 Q. In Gillette? 15:55:54 13 A. In Gillette. 15:55:55 14 Q. Based on your review of Dr. Hemphill's material, what was 15:55:59 15 Mr. Schell -- for what conditions was Mr. Schell treated in 15:56:04 16 1984? 15:56:05 17 A. Well, we don't have any details. It is very sketchy. We 15:56:09 18 know he was treated for depression, stress and anger. We do 15:56:13 19 not know the medications he may have received or any other 15:56:16 20 details. 15:56:18 21 Q. Do you know -- 15:56:19 22 A. Very sketchy. 15:56:20 23 Q. Excuse me. Do you have an understanding of what kind of 15:56:26 24 treatment Mr. Schell received for his depression, stress and 15:56:30 25 anger in 1984? 1776 15:56:33 1 A. No, I do not know how that was treated. 15:56:36 2 Q. Now, let me ask you, is this depressive episode, even 15:56:45 3 though we have very little records -- is this depressive 15:56:49 4 episode something that is or should be to you as a 15:56:52 5 psychiatrist significant? 15:56:57 6 A. This episode may or may not be significant. 15:57:01 7 Q. And why is -- 15:57:03 8 A. I think what you're referring to, the first episode of a 15:57:05 9 major depression is very significant, and the reason it is 15:57:10 10 significant is that after a person gets through the first 15:57:16 11 episode of depression and is treated successfully, to come 15:57:19 12 off medications implies a risk of somewhere between 50 and 60 15:57:25 13 percent relapse rate. 15:57:28 14 Q. And what does that mean? 15:57:30 15 A. That means that if I treat a patient with major 15:57:34 16 depression, first episode they've ever had, they're better, I 15:57:40 17 treat them for a year, I get them off of medications, they 15:57:43 18 have a 50 to 60 percent chance of getting a second 15:57:48 19 depression. That's pretty high. 15:57:52 20 Now, the thing you need to realize, I think, is that 15:57:56 21 this type of depression that we see developing here is a 15:57:58 22 chronic, lifelong illness. This is not mild adjustment 15:58:06 23 depression. What we're going to see here is chronic, 15:58:12 24 long-term depression, that is essentially untreated, by the 15:58:18 25 way. 1777 15:58:18 1 Q. Was there a second depressive episode, then? 15:58:21 2 A. Yes. The second depressive episode is more illustrative. 15:58:27 3 Q. The second episode was when? 15:58:30 4 A. What I have been able to determine was that it lasted for 15:58:33 5 about five months or more between December '88 and April 15:58:38 6 of -- actually May of '89. My report says April, but it 15:58:44 7 should be May of '89. 15:58:47 8 Now, Mr. Schell at that time was 51 years old. This 15:58:56 9 information from this episode comes from Dr. Suhany and I 15:58:59 10 believe that that is very reliable information. Later we 15:59:02 11 will see Dr. Suhany treated him for almost a year. 15:59:07 12 Q. Well, it shows, for example, doctors are Dr. Hemphill, an 15:59:11 13 internist, and Dr. Bresnahan, a psychiatrist? 15:59:16 14 A. Yes. 15:59:16 15 Q. Do you understand -- is this obviously the same 15:59:19 16 Dr. Hemphill that treated this patient back in 1984? 15:59:22 17 A. Yes. 15:59:23 18 Q. Who is Dr. Bresnahan? 15:59:25 19 A. Okay. Now, Dr. Bresnahan is a psychiatrist. He is one of 15:59:32 20 the four psychiatrists you will see treated Mr. Schell in 15:59:36 21 Gillette. He apparently worked for the Campbell County 15:59:43 22 Hospital system because his records are in the Campbell 15:59:47 23 County Hospital records. 15:59:49 24 Q. And you see -- 15:59:50 25 A. They're very hard to read. 1778 15:59:51 1 Q. And you say this information was gathered, however, from 15:59:53 2 medical records that were provided to you by Dr. Suhany? 15:59:58 3 A. They weren't provided to me, but there is reference of 16:00:01 4 these -- that depression is referenced reasonably clearly in 16:00:10 5 Dr. Suhany's records. 16:00:11 6 Q. Do you know what -- the second depressive episode what 16:00:15 7 treatment Mr. Schell received for this episode? 16:00:25 8 A. There is one reference he had taken a low dose of Desyrel. 16:00:30 9 Desyrel is this one that's right here. Desyrel. That's 16:00:35 10 trazodone. That was a popular medication years ago for 16:00:39 11 Prozac. We used to use Prozac a lot with trazodone. 16:00:43 12 Trazodone was useful to help sleep, but it was very low-dose 16:00:47 13 medication that he was on on the Desyrel. 16:00:55 14 Now, the other notations really come from 16:00:58 15 Dr. Bresnahan and there's only two notes on that from 16:01:02 16 Dr. Bresnahan. 16:01:05 17 It is significant to note that he took Prozac either 16:01:10 18 one or two tablets a day and he was taking a dosage of Ativan 16:01:16 19 which is a tranquilizer, reasonably high doses. At one point 16:01:27 20 in the record there's an underlined note saying that his 16:01:30 21 response to Prozac is good. You can see the record 16:01:33 22 underlined for emphasis saying his response to Prozac was 16:01:40 23 good. You can look in the record if you would like to see 16:01:42 24 that. 16:01:43 25 There's another note that a higher dose of Prozac 1779 16:01:46 1 levelled him off too much. 16:01:48 2 Q. As a psychiatrist, what does that mean to you? 16:01:51 3 A. My interpretation of that was that it perhaps sedated him, 16:01:58 4 that two tablets of Prozac was rather sedating. 16:02:03 5 The other thing that's significant in this note is 16:02:07 6 that he had been off of work for a period of time and right 16:02:24 7 now I can't remember how long -- 16:02:27 8 Q. I think January of '89 to March of '89. Is that 16:02:31 9 consistent with the records? 16:02:33 10 A. Let me look at my report. 16:02:43 11 Q. Well, it doesn't matter. What significance is it that he 16:02:46 12 was off of work for any period of time? 16:02:51 13 A. Okay. The significance of that is it has to do with the 16:02:54 14 severity. From my reading of Mr. Schell, work is an 16:03:02 15 important element for him and for him to not be able to work 16:03:05 16 is quite disabling. That's significant when he is able to 16:03:11 17 work. That goes to severity of his illness. 16:03:15 18 Q. Now, based upon -- based upon -- strike that. 16:03:19 19 Is this episode -- we have one now in '84, we have 16:03:23 20 one now in '88, '89. Is this second depressive episode a 16:03:32 21 significant event in evaluating Mr. Schell's overall 16:03:35 22 psychiatric history? 16:03:38 23 A. Yes, that second episode actually is an important one 16:03:42 24 because here's a time when he clearly has a major depression, 16:03:45 25 he's being treated with appropriate antidepressant therapy, 1780 16:03:50 1 but for a very short period of time. If you look at the 16:03:54 2 amount of medication he was on or the length of time on the 16:03:59 3 Prozac, it looks like he might have been on this for as long 16:04:05 4 as three months. That's too short of a time for treatment of 16:04:11 5 this type of depression. Most people need to be on treatment 16:04:15 6 for a year, as I mentioned. 16:04:18 7 Q. Is there a significance to the fact that we've had, you 16:04:21 8 know -- we had a depression in 1984 and now all of a sudden 16:04:27 9 we have another major depression in '88 or '89? Is this that 16:04:33 10 60 percent you're talking about? 16:04:35 11 A. Nope, I think the 60 percent starts here. This is where 16:04:38 12 we say we've really made the diagnosis after chemical major 16:04:42 13 depression and from here on the clock is running. And I 16:04:45 14 think that the chances for him to have another one are very 16:04:48 15 high. 16:04:48 16 Q. Now, what do you mean by a first chemical major 16:04:52 17 depression? What do you mean by that term? 16:04:59 18 A. Well, a major depression is not the blues or adjustment 16:05:01 19 disorder. You know, we all get situational depressions, and 16:05:05 20 this is not a situational depression. This episode here is 16:05:11 21 the kind of depression I see regularly in my practice. This 16:05:15 22 is an episode of major chemical depression. This is a very 16:05:20 23 serious illness. This illness at this point is considered 16:05:26 24 severe. 16:05:27 25 Q. Do the records indicate why the medication or treatment on 1781 16:05:30 1 Prozac was ceased after three months? 16:05:39 2 A. No, and I did not include this lack of follow-through here 16:05:43 3 and later in my report because I really wasn't sure how much 16:05:47 4 Mr. Schell had been counseled about continuing on medicine. 16:05:50 5 And the treatment was discontinued. I don't think it was 16:05:53 6 recommended by the doctor. I think it was premature, but I 16:06:00 7 can't say that he went against doctor recommendations, for 16:06:07 8 example. 16:06:07 9 Q. Okay. So now with this episode, then, the second episode, 16:06:11 10 we know now based upon what you've told us earlier this man 16:06:15 11 is at least at a 60 percent risk of suffering another major 16:06:20 12 depression? 16:06:20 13 A. Yes, 50 to 60 percent risk. 16:06:22 14 Q. And did he, in fact, have a third depressive episode that 16:06:26 15 you were able to document and analyze? 16:06:29 16 A. Actually, my report says that this is either a third 16:06:33 17 episode, this one, or a continuing episode that never 16:06:37 18 improved. 16:06:40 19 Q. And why do you say that? 16:06:41 20 A. Well, I don't think there's evidence that we know he went 16:06:43 21 into a total remission. When we're treating these types of 16:06:49 22 patients we want to get a remission. We want to get people 16:06:52 23 totally better and back to work, and I don't know if any of 16:06:58 24 us know if he was in a remission between these two. 16:06:59 25 Q. Well, tell us about the third depressive episode and what 1782 16:07:03 1 information you were able to gather and analyze about this -- 16:07:08 2 first of all, is the third depressive episode another major 16:07:11 3 depression? 16:07:12 4 A. Yes. 16:07:13 5 Q. Okay. Please tell us what information you were able to 16:07:16 6 gather and what significance this episode gives to your 16:07:20 7 analysis. 16:07:23 8 A. Now, the third episode is the best documented episode of 16:07:28 9 depression that we have. 16:07:29 10 Q. And this episode is in 1990? 16:07:32 11 A. 1990. 16:07:34 12 Q. Okay. Go ahead. 16:07:35 13 A. This is the most complete documentation we have about his 16:07:38 14 depression, 1990. This is a depression that began with 16:07:44 15 Dr. Hemphill again treating him with Desyrel at night, and 16:07:52 16 shortly after the treatment he was referred to a psychiatrist 16:07:55 17 by the name of Dr. Suhany. 16:07:58 18 Q. Do you know or did you know Dr. Suhany? 16:08:00 19 A. I knew of him. I never practiced closely with him. I 16:08:05 20 think he had a good reputation and he was one of the 16:08:08 21 psychiatrists in Wyoming at that time, but from -- I might 16:08:14 22 say that from my record review of him, I think he's an 16:08:18 23 excellent psychiatrist. 16:08:20 24 Q. Go ahead. What other information is important to you 16:08:22 25 about the third depressive episode. 1783 16:08:24 1 A. Okay. Dr. Suhany treated Mr. Schell somewhere between 18 16:08:28 2 and 21 sessions. These were sessions that occurred almost 16:08:35 3 every week, sometimes one to two or three weeks, but a large 16:08:40 4 number of sessions. And it lasted for one month short of a 16:08:44 5 year. This went on between January 16, 1990 to December of 16:08:52 6 1990. So the entire year of 1990 he was in psychiatric 16:08:59 7 treatment. 16:09:00 8 Q. And what did -- what did the psychiatric treatment consist 16:09:03 9 of? 16:09:05 10 A. It was very good approach. This was a combination of 16:09:09 11 medication and counseling. 16:09:12 12 Q. And what types of medication was Mr. Schell given for this 16:09:18 13 major depressive episode? 16:09:24 14 A. There's quite an important chain to the kind of medication 16:09:33 15 he used. I wanted to make a point that Mr. Schell was not 16:09:37 16 hard to diagnose, that Dr. Suhany diagnosed a major 16:09:42 17 depression in his first session. There wasn't any question. 16:09:45 18 He made a clear diagnosis of major depression his first 16:09:50 19 visit. 16:09:50 20 And his initial work with medication was to increase 16:09:54 21 the medicine that Dr. Hemphill had given him. He essentially 16:10:05 22 increased his trazodone at night and used this tranquilizer. 16:10:10 23 Q. Trazodone is a tranquilizer? 16:10:13 24 A. No, trazodone is an antidepressant. 16:10:15 25 Q. And he increased the antidepressant? 1784 16:10:17 1 A. He increased that. 16:10:19 2 Q. And trazodone is what type of antidepressant medication? 16:10:23 3 A. It is not really an SSRI. It is rather atypical. And its 16:10:29 4 origin -- I think it is a better sleep medicine than 16:10:32 5 antidepressant. By itself it is not a very good 16:10:36 6 antidepressant to treat people, but as I mentioned before, it 16:10:39 7 was a popular combination with Prozac and also became a 16:10:45 8 popular combination with Paxil. 16:10:47 9 Q. You see the medications listed on the chart there. It has 16:10:49 10 got Desyrel, Prozac, imipramine and Ativan; is that correct? 16:10:55 11 A. That's correct. 16:10:55 12 Q. Would you tell the ladies and gentlemen of the jury the 16:10:56 13 history of the use of those drugs to treat this depression in 16:11:00 14 this episode? 16:11:01 15 A. In this episode? 16:11:02 16 Q. Yes. 16:11:37 17 A. Well, essentially Dr. Suhany tried the increase of 16:11:37 18 trazodone or Desyrel at first, and this caused sedation. 16:11:37 19 This caused him to be sedated. And that's something you 16:11:37 20 don't want to do with somebody that's already depressed. 16:11:37 21 So he lowered the dose of Desyrel and he began 16:11:37 22 Prozac. He began Prozac early January and he continued on 16:11:39 23 the Prozac for about six weeks, as I recall, until that was 16:11:47 24 changed. 16:11:48 25 Q. To what and why? 1785 16:11:49 1 A. Well, his response to Prozac was variable. Initially 16:11:55 2 he -- there is some -- there's actually some information to 16:12:04 3 indicate that he improved on Prozac. In February there's a 16:12:09 4 notation of improvement on Prozac and it is noted again in 16:12:12 5 March. 16:12:13 6 But he did have some ongoing symptoms and although he 16:12:18 7 tried to return to work in February, he had been off work and 16:12:24 8 he was actually off work for about two months between January 16:12:31 9 26th and March 26th, so we see the disability in terms of 16:12:35 10 being off work for a long period of time. For somebody to be 16:12:41 11 off work two months is significant, particularly someone who 16:12:48 12 is proud and work oriented like Mr. Schell. 16:12:57 13 Q. Did this episode in Dr. Suhany's treatment -- did 16:13:01 14 Mr. Schell now begin focusing on losses that were causing his 16:13:09 15 problems? 16:13:10 16 A. The interesting thing in the record is that I think the 16:13:13 17 chronology is better to say he began to focus on his symptoms 16:13:17 18 after he was changed to a new medication. 16:13:20 19 Q. Okay. Tell me when that was and what type of -- what was 16:13:22 20 the change in focus that occurred because of that. 16:13:28 21 A. There was a question whether he developed some hand 16:13:30 22 tremors and anxiety that -- it was a question of whether that 16:13:35 23 was a side effect of Prozac or that was an independent 16:13:38 24 problem due to his depression. 16:13:41 25 In any event, Dr. Suhany, and this is in my report, 1786 16:13:44 1 he tried to control the anxiety with a certain medication, 16:13:47 2 which he couldn't do. 16:13:49 3 Q. And what medication was he using to try to control the 16:13:52 4 anxiety? 16:13:53 5 A. Actually Inderal, but he was also on the tranquilizer, so 16:14:00 6 you could say there might have been two medicines working on 16:14:04 7 the anxiety. 16:14:06 8 Q. What was the tranquilizer he was on? 16:14:10 9 A. It was Ativan. 16:14:10 10 Q. And what class of medication is Ativan? 16:14:13 11 A. A benzodiazepine. It is essentially the tranquilizer 16:14:17 12 family, same family as Valium, Librium and Xanax. 16:14:23 13 Q. You say with the use of Ativan he was unable to control 16:14:26 14 the fluctuating anxiety? 16:14:33 15 A. Apparently the anxiety continued and the nonresponse. He 16:14:36 16 did not appear to get better, so Dr. Suhany changed him to a 16:14:40 17 medication called imipramine. He did that in March. 16:14:43 18 Q. And what kind of drug is imipramine? 16:14:45 19 A. That is called a tricyclic antidepressant. That's the 16:14:49 20 older generation. 16:14:50 21 Q. Okay. Continue on through this -- 16:14:55 22 A. Well, in March he was placed on the imipramine in lower 16:14:58 23 doses and there was some initial improvement. And to be 16:15:06 24 brief, I guess, the dosage was gradually increased until his 16:15:14 25 final dose in about April where he ended up on 150 milligrams 1787 16:15:18