2 COUNTY OF HENNEPIN FOURTH JUDICIAL DISTRICT Wrongful Death 3 -------------------------4 Court File No. Mary Weiss, on her own behalf 27CV07-1679 5 and as next of kin and trustee of of the Estate of Dan Markingson, 6 deceased, 7 8 -vsPlaintiff,

9 Board of Regents for the University of Minnesota; Dr. Stephen Olson; 10 Dr. Charles Schulz; Institutional Review Board for the University of Minnesota; 11 Astrazeneca Pharmaceuticals, LP; Astrazeneca LP and Zeneca, Inc., 12 Defendants/Respondent 13 - - - - - - - - - - - - - - - - - - - - - - - - - 14 15 16 17 18 19 20 21 22 23 24 By MARTHA M. FIER, COURT REPORTER 12151 Gantry Lane Deposition of: JEANNE KENNEY Taken at: Geraghty, O'Loughlin & Kenney 386 North Wabasha Street Suite 1400 St. Paul, Minnesota Date: May 8, 2007

Commencing at: 12:30 p.m.

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Apple Valley, Minnesota 55124 800-844-6420 * 952-431-1252

2 1 Deposition of JEANNE KENNEY, taken pursuant to Notice to Take Oral Deposition, under the Rules of 2 Civil Procedure, for the District Courts of Minnesota, at Geraghty, O'Loughlin & Kenney, 386 3 North Wabasha Street, Suite 1400, Ecolab University Center, St. Paul, Minnesota, commencing at 4 approximately 12:30 p.m., on the 8th day of May, 2007, before Martha M. Fier, Notary Public, in and 5 for the State of Minnesota. 6 * -

7 APPEARANCES: GALE D. PEARSON, Esq., of the law firm of Pearson, Randall & Schumacher, Suite 1025 Fifth 9 Street Towers, 100 South Fifth Street, Minneapolis, Minnesota 55402 appeared for and on behalf of 10 Plaintiff. 11 DAVID P. ALSOP, Esq., of the law firm of Gislason & Hunter, 701 Xenia Avenue South, Suite 500, 12 Minneapolis, Minnesota 55416 appeared for and on behalf of Defendants Olson and Schulz. 13 DAVID C. HUTCHINSON, Geraghty, O'Loughlin & 14 Kenney, 386 North Wabasha Street, Suite 1400 Ecolab University Center, St. Paul, Minnesota 55102-1308 15 appeared for and on behalf of Defendant Board of Regents of the University of Minnesota. 16 LINDA S. SVITAK, Esq., of the law firm of 17 Faegre & Benson, 2200 Wells Fargo Center, 90 South Seventh Street, Minneapolis, Minnesota 55402-3901 18 appeared for and on behalf of Defendants Astrazeneca and Zeneca. 19 - * 20 Examination: 21 By Ms. Pearson ........... 3 22 23 8

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24 25

3 1 Exhibits: No. 36 - Progress note 2 No. 37 - Progress note No. 38 - Drug bottle IDs 3 No. 39 - 12/05/03 Drug Accountability Log No. 40 - 12/11/03 Med. Adherence Form 4 No. 41 - 12/19/03 Med Adherence Form No. 42 - 12/24/03 Med Adherence Form 5 No. 43 - 12/31/03 Med Adherence Form No. 44 - 1/8/04 Med Adherence Form 6 No. 45 - 01/16/04 Med Adherence Form No. 46 - 01/30/04 Med Adherence Form 7 No. 47 - Theo report No. 48 - 02/13/04 Med. Adherence Form 8 No. 49 - 03/02/04 Med. Adherence Form No. 50 - 03/31/04 Med. Adherence Form 9 No. 51 - Not marked No. 52 - 4/28/04 Med. Adherence Form 10 No. 53 - Progress note No. 54 - Clinical Global Impressions 11 No. 55 - Abnormal Invol. Movement Scale 12 13 14 15 16 17 18 19 20 21 22 23
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24 25

4 1 2 3 4 5 6 7 8 (WHEREUPON, Deposition Exhibit No. 35 was marked for identification by the Reporter.) JEANNE KENNEY, called as a witness, having been duly sworn, was examined and testified as follows: EXAMINATION

9 BY MS. PEARSON: 10 Q. Good morning. How are you doing this

11 morning? 12 13 A. Q. Well, I'm okay. Good, good. My name is Gale Pearson and

14 I'm here on behalf of Mary Weiss in her wrongful 15 death action against the University of Minnesota, Dr. 16 Olson, Dr. Schulz and Astrazeneca. Is that your 17 understanding of why we're here today? 18 19 A. Q. Yes. And you also understand, Ms. Kenney, that

20 you are not a party to this action. 21 22 A. Q. Yes. We have not sued you either in your

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23 capacity as a social worker or employee of the 24 University of Minnesota. Do you understand that? 25 A. Yes.

5 1 Q. Okay. Thank you. I'm going to have marked

2 the Subpoena and the Deposition Notice marked as 3 Exhibit Kenney 35. I'm going to put that in front of 4 you and ask you to look at it briefly. And have you 5 seen a copy of this? 6 7 A. Q. Yes. And if you look at the actual notice

8 itself, there will be -9 (Brief interruption.)

10 BY MS. PEARSON: 11 Q. If you will notice, there's an Attachment A

12 to the notice. Do you see that attachment? 13 14 15 16 A. Q. A. Q. And it is Exhibit A? Correct. Okay. And in this Exhibit A, do you understand

17 what this is requesting of you? 18 19 MR. HUTCHINSON: Go ahead. THE WITNESS: Yes, it's asking for

20 treatment-related records. 21 BY MS. PEARSON: 22 Q. And did you have any records pursuant to

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23 this request to bring to us today? 24 A. I don't have records, other than copies of

25 -- I don't know how to answer. I don't have any

6 1 records that I received from the University. In 2 other words -3 Q. Okay. Do you have any copies or personal

4 records you might have kept while you were an 5 employee at the University? 6 7 A. Q. No, no. Have you ever had your deposition taken

8 before? 9 10 A. Q. Not a deposition, no. The process in place right now is we've got

11 a court reporter that is taking down everything that 12 we say, so when I ask questions, she'll be writing 13 that down and as you're answering those questions 14 she'll also be writing those things down. She cannot 15 hear and type two conversations at the same time, so 16 I'm going to do my best to wait for you to finish 17 your answers, and if you would do your best to wait 18 until I finish my questions, that will allow the 19 court reporter to take down our entire conversation. 20 And I understand she's going to remind us of that 21 from time to time, as well.

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In addition, your attorneys may choose to

23 register objections to my questions. And so if they 24 do, just wait until they are finished with their 25 objections and then you can answer the question as

7 1 well. All right? 2 3 A. Q. All right. Any of the questions that I ask you, if you

4 don't understand them, please ask me and I will try 5 to ask them in a way that you understand the 6 questions. If you need to take a break, let me know. 7 This is not a marathon session, and you're welcome to 8 take a break. If you have any other questions let me 9 know. And you understand that you're under oath. 10 11 A. Q. Yes, I do. Ms. Kenney, how is it that you learned of

12 this lawsuit? 13 A. The first time I learned of it was an

14 e-mail from Dr. Olson just saying, "You may be 15 contacted by the University attorneys," and I think 16 that might have been, oh, early in the year. And 17 then I was contacted by Chuck Grose probably 18 February, March. 19 Q. Do you carry liability insurance on you as

20 a professional social worker? 21 A. Not in the capacity I'm working now, no.

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Did you while you were at the University of

23 Minnesota? 24 A. I'm not 100 percent sure. I believe that

25 in my capacity as a therapist in the clinic, I think

8 1 I was under the, you know, University of Minnesota. 2 But I didn't purchase it by myself. I believe it was 3 covered for me, in my best of recollection. 4 Q. Prior to Mr. Grose contacting you, have you

5 ever spoken to or met with Mr. Grose? 6 7 A. Q. No. Do you have an understanding of who was

8 paying for Mr. Grose's and Mr. Hutchinson's 9 appearance on your behalf today? 10 A. I don't have a complete factual

11 understanding. My assumption is the University of 12 Minnesota. 13 Q. Okay. Thank you. Do you currently have a

14 contract between Mr. Hutchinson's law firm and 15 yourself with regard to representation in this case? 16 17 A. Q. Yes, I believe I do. Okay. Thank you. Okay. I'm going to go

18 to your educational background, and could you tell me 19 where you graduated from high school, please? 20 A. Yes, Seton High School in Cincinnati, Ohio.

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21 22 23

Q. A. Q.

What year was that? That was in 1985. All right. And then where did you attend

24 college? 25 A. I first went to Ball State University for

9 1 one year, so that would have been '85, '86. Then 2 went to the University of Cincinnati that next year 3 where I -- yeah. I'll just answer your questions. 4 Sorry. 5 Q. That's all right. That's all right. And

6 you graduated, then, from the University of 7 Cincinnati? 8 9 A. Q. Yes. And could you tell me what your degree was

10 in? 11 12 A. Q. A Bachelor of Arts in psychology. Did you have any other areas of study that

13 you were working on while you were working on your 14 psychology degree? 15 A. No, that was the only -- I took some

16 women's study courses, but that was the only degree, 17 yeah. 18 Q. And I apologize. What year did you

19 graduate from University of Cincinnati? 20 A. 1991.

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While you were at the University of

22 Cincinnati and working on your degree in psychology, 23 did you take any courses that might be related to a 24 premed degree such as pharmacology? 25 A. No.

10 1 2 3 4 5 6 7 Q. A. Q. A. Q. A. Q. Immunohematology? No. Hematology? No. Toxicology? No. Any other courses, other than what

8 generally is required for a college graduate in the 9 science arenas that might be considered a premed? 10 11 A. Q. No. Did you take any courses that might be

12 related to clinical laboratory scientist, or clinical 13 chemistry studies? 14 15 A. Q. No, no sciences like that. After you graduated from the University of

16 Ohio, did you go on to graduate school? 17 MR. HUTCHINSON: University of

18 Cincinnati. 19 BY MS. PEARSON:

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20 21 22

Q. A. Q.

I'm sorry, I apologize. Not immediately. You eventually did go on to graduate

23 school? 24 25 A. Q. Yes. Did you work in between the time you

11 1 graduated from the University of Cincinnati and 2 attending graduate school? 3 4 5 A. Q. A. Yes. What did you do? I worked at a psychiatric hospital called

6 Emerson North Hospital in Cincinnati and I was there 7 from, while I was working on my undergraduate degree 8 and I was there, also overlapped with NIOSH, National 9 Institute of Occupation Safety and Health. And I 10 worked at both of those places until 1991 when I 11 moved to Minnesota. 12 Q. All right. When you were working at the

13 Emerson Hospital, what were your duties there? 14 A. I was considered a mental health worker or

15 specialist and was considered part of the nursing 16 staff. I would be assigned to a particular unit, 17 inpatient unit, either adult or child or adolescent, 18 would be assigned a patient for the shift. Would 19 just basically, you know, have a one to one with
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20 them, make sure they got to their groups, answered 21 requests. You know, millimanagement is basically the 22 term I would use for that. 23 Q. Did you ever do any patient intake as far

24 as the medical history for these patients? 25 A. Not at that time, no.

12 1 Q. Did you ever draw blood or collect any

2 specimens for the laboratory? 3 4 A. Q. No. When you were working at NIOSH -- did I

5 pronounce it correctly? 6 7 8 A. Q. A. NIOSH, yes. Could you tell me what your duties were? Yes. I was a research assistant. It was

9 an occupational research in, I believe it was called 10 human factors, and so we did studies on different 11 workplace kind of issues. The particular unit I was 12 in was called "Motivation and Stress Research." 13 Q. In your role as a research scientist at

14 NIOSH, did you have an opportunity to collect any 15 clinical data with regard to the physical health of 16 the patients? 17 18 A. Q. I'm not sure I understand the question. Okay. I don't either. Did you have any

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19 opportunity to, say, collect urine samples, blood 20 specimens and analyze those samples? 21 A. I did have the opportunity to collect urine

22 samples because they did a few pregnancy tests. But 23 I just collected the samples. 24 Q. So in your capacity as a research

25 assistant, it basically involved maybe more of the

13 1 social work aspect of it rather than the medical 2 aspect. 3 A. I don't think -- I don't think I can answer

4 either way. I'm not sure exactly what you're asking. 5 Q. What type of studies did you do while you

6 were -- as a research assistant? Can you give me a 7 general idea of those types of studies? 8 A. Sure. For example, one study they did on

9 rest breaks and they had people enter data from, 10 actually what they used was tax forms and what -- I 11 know -- and what we did was, basically, I just would 12 get them set up and then monitor the computer and 13 what they would do, as they were entering data 14 periodic rest breaks would come up and then they were 15 directed to do, like, exercises and that sort of 16 thing. 17 18 Q. A. And you monitored the results of those. I just collected the data. At that point,

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19 I was pretty green, so I was just -20 Q. And then you went on to graduate school,

21 correct? 22 23 A. Q. Not right away. We moved to Minnesota. And then what happened when you moved to

24 Minnesota? 25 A. After I got set up, did a few temp jobs,

14 1 and then procured a job at the U.S. Bureau of Mines, 2 mines meaning mining industry, and was again a 3 research assistant there, and primarily they did 4 studies on the mining industry in Minnesota and 5 Michigan and again it was a matter of collecting data 6 on different mining jobs, looking at records of -7 this is real exciting, haulage truck accidents. 8 9 10 11 Q. A. Q. A. I'm sorry. What type of truck? Haulage truck. College? Haulage, h-a-u-l-a-g-e those big trucks

12 that move the -- for the quarry mining and stuff. 13 Q. What was the objective of these studies?

14 To study human response? 15 A. I worked with a lot of engineers, and so I

16 don't have a complete understanding of their world, 17 but they were looking at accidents, and, you know,

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18 one study was on back function. The data I analyzed 19 was haulage truck fatalities and what circumstances 20 those things happened. 21 Q. Did you ever have occasion to take medical

22 histories of the individuals you were collecting data 23 on? 24 25 A. Q. I did not. And why don't you take us from this job and

15 1 go to the next one. 2 A. Okay. I was at the Bureau of Mines until

3 1994, and then had my first child. I worked just for 4 a few months temporarily at a, it was called 5 Cooperating Community. I can't even remember; I was 6 there for such a brief time. It was working with 7 developmentally disabled. It wasn't a job I enjoyed. 8 And then I got a job at Hennepin County Medical 9 Center as a mental health worker, so very similar to 10 that job I had at Emerson North. 11 Q. Could you tell me the year that you began

12 at Hennepin County Medical, then? 13 14 15 16 17 A. Q. A. Q. A. That was the summer of 1995. As a, you said a mental -Health worker. And what did that duty entail? Again, that was part of the nursing staff.

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18 I would be assigned particular patients, and this was 19 in the in-patient psychiatry unit. My job would be 20 to, you know, get their vital signs, blood pressure, 21 pulse, that sort of thing, help the nursing staff get 22 them up to get their medications, get them to groups, 23 oftentimes answering requests for cigarettes. 24 Sometimes I would be part of the group process, 25 whether it be occupational group therapy or talk

16 1 therapy group. I might sit in on those. 2 Q. Did you have an opportunity to do a medical

3 history on the patients? 4 5 A. Q. Not in that capacity, no. Collect data on their mental health

6 symptoms? 7 8 9 A. Q. A. Yes. What type of -So that would be from observation that I

10 had during that time with the person. 11 Q. All right. And as far as training for this

12 type of position, you had a degree in -- a BA in 13 psychology from the University of Cincinnati, 14 correct? 15 16 A. Q. Yes. Any additional training that you were

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17 required to have before you held this position? 18 A. We were trained in, like, I don't remember

19 the exact terminology, but basic safety sort of 20 things to keep yourself safe, as well as the patient. 21 We learned, you know, it would be a situation in 22 which they needed a restraint, learned techniques and 23 ways to do that. 24 Q. And how long did you work at the Hennepin

25 County Medical Center?

17 1 A. I was there in a full-time capacity from

2 '95 through mid '98, and then worked just part-time 3 from '98 to 2001 while I was working full-time 4 elsewhere. 5 Q. While you were at Hennepin County Medical

6 Center, did your job description change over the time 7 that you were there? 8 A. At one point, while I was pregnant, I was

9 helping one of the nursing case managers. They were 10 monitoring commitments, and I basically would help 11 type up the provisional discharges. It was a brief 12 time while somebody was on vacation that they had me 13 in. They figured that since I was pregnant, it was 14 probably a safe thing for me to do, and so it was 15 just more kind of administrative clerical kinds of 16 things at that time. But primarily it was on the
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17 nursing staff. 18 Q. Okay. And so up until -- you had mentioned

19 in '98 you went part-time at Hennepin County Medical 20 Center and you were working at another job. What was 21 that other job that you were working at? 22 A. I got a job at, it was through the State of

23 Minnesota working in Washington County as the case 24 manager. I was employed by the State of Minnesota, 25 but was in one of their mental health initiatives it

18 1 was considered. 2 Q. Can you describe for me what a case manager

3 at Washington County does? 4 5 6 A. Q. A. I can do my best. Or what you did as a case manager. Again, we had clients that were on our

7 caseload. The way Washington County worked was as a 8 metal health initiative, it was a team approach, so I 9 never had one patient to myself. We shared them as a 10 team. We would do visits, see how they were doing, 11 make sure, you know, find out if they got to their 12 appointments on time. Sometimes it was just as 13 simple as taking them grocery shopping. 14 Q. And when you mention visits, are these

15 visits to their homes or where they were living?

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Sometimes to their homes, sometimes it

17 would be meeting them at a coffee shop. Sometimes, 18 very rarely, they would come to the office, but 19 primarily it would be meeting in the community in 20 some capacity. 21 Q. Would the caseworker ever go in a hospital

22 and meet? 23 24 A. Q. Yes. Did you ever have the opportunity to take

25 medical histories of these individuals that were part

19 1 of your case load? 2 A. Could you describe more what you mean by

3 "medical history"? 4 Q. Sure. Perhaps their history with regard to

5 heart disease, you know, blood pressure, cancer, 6 family history and things of that nature. 7 8 A. Q. No. So that was not part of your job

9 description as a case manager -10 11 12 13 A. Q. A. Q. No. -- at Washington County. No. And then how long did you stay at

14 Washington County as a case manager? 15 A. Well, I was there for nine months. I

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16 stayed as an employee of the State of Minnesota and 17 then I was transferred and actually took a new 18 position as a social worker specialist at the Anoka 19 Metro Regional Treatment Center, which is the state 20 hospital. 21 Q. And you said social worker specialist or

22 social work specialist? 23 24 A. Q. I believe it was social work specialist. And what does that job entail? What did it

25 entail for you?

20 1 A. There's, well, a lot. I worked on the

2 units. I would again have a case load of patients 3 and I was part of a treatment team, so would often 4 get social histories, have communication with 5 families, have communications with their county case 6 managers, discharge planning, helping work towards 7 when they would be discharged and where they would 8 go. 9 I would also help the team determine what,

10 you know, and discuss with the case manager what the 11 provisional discharge would be. So in other words, 12 what their follow-up would be, I would work on making 13 sure they have appointments in a timely fashion to 14 continue med management. Again, it's difficult to

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15 say all of the duties of a social worker. 16 Q. That's all right. Did you ever, while you

17 were an associate worker at Anoka, dispense 18 medication to any of your patients? 19 20 A. No. MR. HUTCHINSON: You need to let her

21 finish. She does what I do towards the end of the 22 sentence, she slows down a bit and you start 23 answering a little early. 24 THE WITNESS: I apologize.


21 1 Q. I think I was just analyzed. I'm just

2 teasing. That's fine. You're doing fine. So you 3 never dispensed medication. Did you ever perform any 4 clinical studies while you were at Anoka? 5 6 A. Q. No. Did you ever take any medical histories,

7 similar to what I had defined before, for your 8 patients -9 10 11 12 A. Q. A. Q. No. -- at Anoka? I'm sorry. That's all right. And you're right, I do

13 slow down. And you said you were here for a period 14 of nine months; is that correct, or did I get that
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15 incorrect? 16 A. That was the previous position as a case

17 manager in Washington County. 18 Q. All right. All right. And then how long

19 were you working at Anoka? 20 21 A. Q. Through June of 2002. And then during this time frame, were you

22 also in college to get -- I'm sorry. I did not ask 23 that. Do you have a Master's in social work? Is 24 that required for your profession? 25 A. Yes.

22 1 Q. All right. Break any time, as we're

2 talking about employment history, when you went to 3 college during this time. What happened after 2002? 4 A. Okay. We would have to back up to get to

5 that. 6 Q. All right. Let's get that, and I

7 apologize. Let's get to the college real quickly. 8 A. I attended an MSW program at the University

9 of St. Thomas, College of St. Catherine. It was a 10 joint program, it was a part-time program and I was 11 in that from 1993 and I graduated with my Master's in 12 social work in 1997. 13 Q. Thank you. Does your particular profession

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14 have specialties in social work? 15 16 A. Q. Could you explain that a little bit more? Well, perhaps you don't and that's why the

17 question isn't clear. For instance, attorneys may 18 have a, you know, tax specialist or real estate 19 specialist or medical malpractice specialist. Is 20 there a formal education for a specialist program in 21 your field or profession? 22 23 A. Q. Not that I was a part of. Okay. All right. And then what happened

24 after June 2002, as far as your employment history? 25 A. Then I got my job at the University of

23 1 Minnesota Department of Psychiatry. 2 Q. Did you have any part-time work outside of

3 your job at the University of Minnesota? 4 5 A. Q. No. So you came to the University of Minnesota

6 in 1997; is that correct? 7 8 9 10 A. Q. A. Q. No. All right. June of 2002. Okay. You're right. When you went to work

11 for the University of Minnesota, did you understand 12 that you were an employee of the University of 13 Minnesota?
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14 15

A. Q.

Yes. Was there any other entity at the

16 University of Minnesota that you were also an 17 employee of? And I'm thinking specifically of the 18 University of Minnesota physicians? 19 MR. HUTCHINSON: You can answer. I'm

20 just going to object to that part of the question 21 that may be seeking a legal opinion or some legal 22 status. But go ahead and explain what your 23 understanding was. 24 THE WITNESS: What my understanding

25 was, and hopefully this is answering your question, I

24 1 know that my duties were to be 60 percent working in 2 the research area and 40 percent was working in the 3 outpatient clinic. I do not remember specifically. 4 I just know that I got a paycheck from the University 5 of Minnesota, and I know that there were different 6 funding sources. I don't know, specifically, how 7 each was paid to me. 8 BY MS. PEARSON: 9 Q. So you're not sure how the University of

10 Minnesota got the money to pay you, but you received 11 a check from the University of Minnesota, correct? 12 A. What I understand is that in my role as the

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13 study coordinator, that there were different studies 14 that we took that we were part of and there were 15 monies that came from that, but to the specifics and 16 how much I got from each one, I do not know. 17 MR. HUTCHINSON: Her question was,

18 did you get one check. 19 THE WITNESS: I got one check.

20 BY MS. PEARSON: 21 22 Q. A. From the University of Minnesota? One check from the University of Minnesota,

23 yes. 24 Q. And actually, I should have asked this

25 first, what was your job title when you went to the

25 1 University of Minnesota? 2 A. I -- study coordinator slash, I believe

3 psychiatric social worker. And I don't know 4 specifically. I just know those were the roles. 5 Q. When you first applied for your position at

6 the University of Minnesota in 2002, did you submit a 7 resumé? 8 9 A. Q. I believe I did. Do you have a copy -- I'm sorry, do you

10 have a resumé today? 11 12 A. Q. With me today? Well, either with you or in existence.

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13 14

A. Q.

Yes, I do. Would you mind if I get a copy of that

15 resumé, if it's current? 16 17 A. Q. Okay. Thank you. So your job title was study

18 coordinator and social worker, and can you tell me a 19 little bit about who you worked under while you were 20 at the University of Minnesota, and let's start in 21 2002. 22 23 A. Q. I worked under Dr. Stephen Olson. During the entire time you were at the

24 University of Minnesota? 25 A. Yes.

26 1 Q. So Dr. Olson was the individual at the

2 University of Minnesota who decided what tasks you 3 were to perform. 4 5 A. Q. Yes. As far as I understand, Dr. Olson was

6 involved in many studies at the University of 7 Minnesota. Can you tell me how many studies you 8 worked with Dr. Olson on? 9 10 A. Q. The number? Yes, and then I'll ask about them, so you

11 can break that down however you'd like.

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Okay. We worked on the Cafe Study, the

13 Catie Study, C-a-t-i-e. My memory fails me on the 14 names of the studies. There was another, the Clear 15 Study. I'm sorry. I'm remembering. And there was 16 another one I had very minimal involvement in, and I 17 don't think we even got any patients. I'm not 18 remembering the other one. I'm sorry. 19 Q. Do you remember what drugs were studied in

20 this study that you can't recall the name of? 21 A. I think it was -- you know, no, I can't

22 remember with certainty. I'm sorry. 23 Q. Do you remember the drugs that you were

24 studying with the Cafe Study? 25 A. Yes, I do.

27 1 2 Q. A. And what were those drugs. They were Risperdal, Seroquel and

3 Xyproxine. 4 Q. Do you recall what you were evaluating

5 under the Catie study? 6 7 8 A. Q. A. I can do my best to remember. All right. It was also those three medications. It

9 was also, I believe, Trilafon, which is an older 10 medication, and I believe Geodon was also -11 Q. Is Geodon also an older medication?

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No. Geodon is a newer atypical

13 antipsychotic. 14 Q. And Trilafon, then, is an older atypical

15 psychotic? 16 17 A. Q. Yes, as I understand it. And what medications did you study under

18 the Clear Study, evaluate under the Clear Study? I 19 apologize. 20 21 A. Q. I believe it was Seroquel and Risperdal. Did any of these studies have a placebo arm

22 to them? 23 24 A. Q. None of those studies did, no. If you, during our conversation, recall the

25 types of medications or name of this last study, go

28 1 ahead and speak up. 2 3 A. Q. I will. All right. Were these studies all going on

4 at the same time while you were at the University of 5 Minnesota? 6 A. They were -- I'm not sure how to answer the

7 that because they staggered in different ways, start 8 and stop. So whether or not they all were at the 9 same time, all four of them, I'm not sure. 10 Q. All right. As you were working under Dr.

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11 Olson in these studies, was it ever your job, within 12 your job description, to recruit new patients for 13 these studies? 14 15 16 A. Q. A. Yes. How would you go about doing that? We had opportunity to go speak at different

17 agencies. 18 19 20 21 Q. A. Q. A. What type of agencies? Social service agencies. Could you give me an example? Uh-huh. Let's see. I'm trying to think of

22 some specific ones. Well, we spoke, for example, at 23 Hennepin County in their -- with their crisis 24 department. 25 Q. Do you recall if you were a paid speaker at

29 1 these events? 2 3 4 5 6 A. Q. A. Q. A. No. No meaning no, we were not paid. And when you said "we" who is "we"? Usually it was Dr. Olson -All right. -- myself and one of the other study

7 coordinators or assistants. 8 Q. And can you tell me what percentage of your

9 time was spent recruiting patients as you were 10 working under Dr. Olson?
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11 12 13

A. Q.

It would be a guess. Do your best, and that's all you can do. MR. HUTCHINSON: I assume, counsel,

14 when you say recruiting patients, you are meaning the 15 kind of activity she just described, speaking to 16 different agencies? 17 BY MS. PEARSON: 18 Q. I do. And if I need to clarify it, I'll

19 give you an opportunity to clarify your answer, also. 20 A. Okay. It certainly varied. I'd say, this

21 is my guess, maybe five percent. 22 Q. So you would go to these different

23 agencies, such as Hennepin County Medical Center 24 Crisis Center. 25 A. We also -- oh, gosh, I'm so sorry. I'm

30 1 having a hard time remembering. 2 3 Q. A. That's fine. Because we went to several places, and I

4 helped -- because I have a lot of community 5 connections. I just want to be specific. I mean, I 6 want to make sure I say the correct thing. 7 8 out loud. 9 THE WITNESS: I'm sorry. MR. HUTCHINSON: Okay. Don't think

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MR. HUTCHINSON: I'm not sure what

11 question you're answering or you're trying to 12 supplement, what answer you're trying to supplement 13 now. 14 THE WITNESS: What I'm trying to do

15 is answer the question about what specific agencies 16 we went to. 17 BY MS. PEARSON: 18 19 Q. Correct. MR. HUTCHINSON: So if you have

20 something to add to that, go ahead. 21 THE WITNESS: I'm not remembering

22 right now. 23 BY MS. PEARSON: 24 Q. That's all right. That's all right. You

25 let me know if you need to take a break, okay?

31 1 2 A. Q. Thank you. You can't take a break in between my

3 question and your answer, but you can take a break 4 once you finish answering my question. 5 So you spent about five percent of your

6 time going out into the community using your 7 community connections. I suppose they were very 8 useful for Dr. Olson because I understand it's pretty 9 difficult to recruit patients for some of these
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10 clinical studies? 11 12 A. Q. It is. So were you involved at all in the

13 recruitment of medical subjects for the Cafe Study? 14 15 A. Q. Yes. Can you tell me more specifically about the

16 type of things you did in that regard. 17 A. For example, we had study fliers that would

18 give the specifics of the study, and we had mailings 19 to different agencies. I had a list of community 20 service agencies that we would mail these to. We 21 would have them posted in different community support 22 programs in the community, so the Minneapolis and St. 23 Paul area. 24 Q. Would these fliers need to be first

25 approved by the University of Minnesota Institutional

32 1 Review Board before you distributed them? 2 3 A. Q. Yes, they were. Do you remember what requirements -- I'm

4 just going to just call them the IRB. Is that all 5 right? 6 7 A. Q. That's fine. Do you recall what type of requirements the

8 IRB had over the context of these fliers that were

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9 disseminated? 10 A. I don't remember specifically what those

11 requirements where. 12 Q. Is Dr. Olson mainly the individual that

13 worked on the details to assure that your fliers 14 complied with the IRB requirements or was that 15 somebody elses duty? 16 17 A. Q. Could you -- say that again. I'll say it in a different way: Whose job

18 was it to make sure that the fliers you disseminated 19 complied with the IRB requirements, or who took on 20 that task? 21 A. Myself and the co-coordinator would type

22 them up. They would meet with Dr. Olson's approval 23 and then they would be sent to the IRB for final 24 approval. 25 Q. Did Dr. Olson or the IRB have guidelines

33 1 for you to follow so that your fliers would comply 2 with whatever standards the University has with 3 regard to these types of fliers? 4 A. I'm sure they had standards and I'm sure

5 that we would do those, based on what those were. 6 Q. Do you recall if they were written

7 standards or just a conversation between -8 A. No.

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9 10 11

Q. A. Q.

Okay. I believe they were written standards. Okay. Off the top of your head, do you

12 recall ever looking at some of those written 13 standards? 14 15 A. Q. I don't remember specifically, I'm sorry. All right. That's all right. If I were to

16 ask your attorneys to get copies of those standards, 17 who would I ask them to direct that request to? Who 18 do you think would have a copy of those standards or 19 guidelines? 20 A. I'm sure Dr. Olson could direct them to the

21 right person for that. 22 Q. Okay. I was going to say, if I ask Dr.

23 Olson's attorney to request that, who would I have 24 him direct that request to. Okay. So then you 25 disseminated the fliers and hopefully recruited

34 1 patients for your studies, and as they were 2 responding to the fliers, did you have a database 3 that collected the inquiries? How did you collect 4 the inquiries as they were coming into your facility 5 in response to those fliers? 6 A. Could you say that another way, because I'm

7 not sure I can answer.

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Absolutely. Absolutely. There must have

9 been someone who was in charge -- there must have 10 been a telephone number on the flier, correct? 11 12 A. Q. Yes. Who did that telephone get directed to so

13 that folks calling in would be talking to a person? 14 A. Okay. I can answer that. It would come to

15 myself or the other study coordinator. 16 Q. Do you recall the name of the other study

17 coordinator? 18 19 A. Q. Yes. Elizabeth Lemke, L-e-m-k-e. Do you know whether or not Ms. Lemke is

20 still at the University of Minnesota? 21 22 23 24 A. Q. A. Q. The last I heard she was. So you don't keep in touch with her. No. All right. So you would get a telephone

25 call, and then, you know, we don't need to go into

35 1 too many details, but you would collect that data and 2 then what would you do with that data? You would 3 pass it on to someone else to evaluate whether or not 4 to contact these people? 5 A. Typically, would follow up myself with a

6 phone call. There would be some screening questions. 7 Q. Do you recall who would -- you were the

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8 person that asked those screening questions, then? 9 10 A. Q. Myself or Elizabeth. Okay. All right. And then if they

11 answered those screening questions in a way that 12 still qualified them as a participant, what would be 13 the next step? 14 A. Typically I would give Dr. Olson a call and

15 say we had a lead. 16 Q. And would Dr. Olson then follow up with

17 that lead? 18 19 20 21 A. Q. A. Q. No, I would. All right. Or Elizabeth would. All right. Then when you follow up with

22 the lead, what type of collection -- what type of 23 data do you collect during that follow-up process? 24 A. I don't remember specifically, because it's

25 been a while, and I've done a lot of things since

36 1 then. So we would ask them just some general 2 questions: Why they were interested and if they 3 already had a diagnosis, maybe, that made them think 4 that they were eligible for this. But primarily what 5 we would do is schedule a time for them to come in 6 and have the study explained to them.

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7 8

Q. A.

Who would they meet with at that time? It could be myself, typically. They would

9 also get an opportunity to meet Dr. Olson. It was 10 very much a team sort of thing. 11 Q. Okay. All right. I got a little bit off

12 my plan here. I apologize. I just have one copy of 13 that. Okay. So you were working with Dr. Olson on 14 the Cafe Study, and we talked a little bit about your 15 duties. One of the roles working with Dr. Olson is 16 recruiting patients and we talked a little bit about 17 that process, the flier IRB approval and who goes 18 about approving it. 19 Now, how did you transition from recruiting

20 patients in the Cafe Study to actually being one of 21 the folks that is taking medical data in? Because I 22 see your initials a lot all over the Cafe Study. 23 Tell me about that process and how it occurred. And 24 give some time to this and we'll go back and reask 25 questions. So if you forget things, we'll go back.

37 1 A. Okay. Typically, when we had a potential

2 person interested, they would come in and meet with 3 myself and/or -- usually not or, but Dr. Olson would 4 be there for the first time or sometimes not. And 5 what was most beneficial was for them to go through 6 the consent form, because it outlined everything that
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7 was part of the study, what was entailed in it. 8 Q. At this stage of the game, you would go

9 over the consent form. Was your objective to have 10 them sign it at this point or just to teach them 11 about the study? 12 A. To teach them about the study, give them an

13 opportunity to ask questions about it, and then, yes, 14 if they were interested, they could then sign the 15 consent form. 16 Q. All right. And did you use the same

17 consent form at any given time for every single 18 patient in the Cafe Study? 19 20 A. Q. Yes. In the Cafe Study, yes. All right. When did the Cafe Study

21 first -- I guess I don't know how to ask this 22 question. The Cafe Study began on what date? And 23 I'm not counting the recruiting process of it. When 24 is the first time that Dr. Olson and you began 25 collecting baseline information or screening

38 1 information on a patient in the Cafe Study? 2 3 4 A. Q. I don't remember an exact date. Okay. MR. HUTCHINSON: I'm still back on

5 the last question.

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MS. PEARSON: Would you fill this in

7 for me, that question? 8 MR. HUTCHINSON: I think you asked

9 was the same consent form used throughout the entire 10 Cafe Study, and I guess I thought there was a change 11 in the consent form. 12 MS. PEARSON: At any given time I

13 asked. I knew there was a change, but for a 14 particular time, any given time, every clinical trial 15 subject would be given the same form. 16 MR. HUTCHINSON: Yeah, because your

17 question could have been taken a couple different 18 ways. Okay. So you were saying on February -- on 19 February 1 did you give the same consent form to all 20 patients. 21 22 MS. PEARSON: Correct. MR. HUTCHINSON: All right. You two

23 were communicating, I wasn't. 24 MS. PEARSON: She understands my

25 questions.

39 1 MR. HUTCHINSON: All right.

2 BY MS. PEARSON: 3 Q. All right. And I guess what I don't -- I'm

4 not clear about in the Cafe Study is if it started 5 all on the same date and ended at the same time. I
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6 understand that it was a 52-week trial. Did folks 7 start at different times in this trial? 8 9 A. Q. Yes. All right. Do you recall the date you

10 first started to recruit patients for the Cafe Study? 11 12 A. Q. I don't recall a date. Was it going on before you came to the

13 University of Minnesota? 14 15 A. Q. The process was going on before I came. Do you recall, when you first came to the

16 University of Minnesota, how many patients had been 17 recruited for the Cafe Study? 18 A. I don't believe there were any in the Cafe

19 Study yet. 20 Q. Okay. So when you came in -- what month in

21 2002 did you come in? 22 23 A. Q. June. So as far as you recall, June 2002 there

24 were no individuals in the Cafe Study? 25 A. I don't believe there was.

40 1 Q. All right. And then was there a point in

2 time that you stopped recruiting patients for the 3 Cafe Study? 4 A. There was.

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5 6 7

Q. A. Q.

And do you recall that? I don't recall the date. Was it before Dan Markingson died, which

8 would be May 8th? Actually, that's today, the 9 three-year anniversary. 10 11 A. Q. Yes. I don't remember. All right. Do you recall how many patients

12 you recruited for the Cafe Study, or how many 13 patients were recruited at the University of 14 Minnesota site for this Cafe Study? 15 A. I do not remember the exact number. I know

16 it was in the twenties. 17 Q. Okay. And with regard to those 20 patients

18 -- let me ask this first: Do you understand the term 19 "intend to treat?" If you don't, that's okay. 20 21 A. Q. I don't. All right. With regard to these 20

22 patients that were initially enrolled, are you 23 considering that these are all folks who have passed 24 the screening, who have passed baseline, signing the 25 consent form and now have been given the medication,

41 1 a medication? Or what is your definition of 20 2 patients that were recruited? 3 A. All may not have passed the screening or

4 the baseline.
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All right. And so of those 20, you're not

6 certain how many might not have passed the screening 7 or the baseline. 8 9 A. Q. No, I'm not remembering. All right. That's fine. I mentioned

10 before, I've noticed your initials on a lot of the 11 documents in the Cafe Study. When did you get 12 assigned the duty to collect data in the Cafe Study? 13 In other words, when did your duties switch from 14 recruiting patients in the Cafe Study to now being 15 one of the persons who collect data within the study? 16 A. They didn't switch. They were both ongoing

17 duties. 18 Q. All right. When you first began collecting

19 -- I'm sorry. Prior to the time you first started 20 collecting data on the first patient, first subject, 21 what training did you have from Dr. Olson in order to 22 take on this role? 23 A. Primarily the training for the specific

24 study came from an agency call Quintiles. And there 25 were written protocols to read, there was a lot of

42 1 on-line learning, there were rater reliability tests 2 that we were given the assessments and needed to pass 3 the test.

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Do you remember how long this training

5 process was before you first collected the first 6 piece of data on a clinical subject? 7 A. I don't know specifically, but it was

8 several -- it took a while. It was at least a -9 several months. It wasn't just right away. 10 Q. Do you have any documents related to the

11 training process or the scores you received during 12 that training process? 13 14 15 A. Q. A. I do not have them. Who would have that information? They would be at the research center at the

16 University of Minnesota. 17 Q. Would it be under your name or would it be

18 under Cafe Study? Do you know? 19 A. There would be -- the tests that I did

20 would be under the Cafe Study. 21 Q. So if I were to request all of the medical

22 records related to the Cafe Study, the information on 23 the training that folks went through as they were 24 collecting data should be in that batch of documents? 25 A. There is actually a separate -- they're

43 1 called -- and I don't remember the terminology now. 2 It's like I'm -3 Q. That's all right.

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Okay. I'm thinking. There is a separate,

5 like, file that has the documents that, for example, 6 would go to the IRB, documents that would -7 correspondence with Quintiles, and it would be in 8 that. So it would not be in where the specific 9 subject study information would be. It's a separate 10 filing system. 11 Q. So I would request all the correspondence

12 between Quintiles and the University of Minnesota 13 related to the Cafe Study? 14 15 A. Q. That would make sense, yes. All right. What about the training from

16 the IRB? Did you interact with the Institutional 17 Review Board at all in preparation for your training 18 to collect data from these clinical trial subjects? 19 A. The only interaction I had with them was

20 any required documents for the study. So it was not 21 a training situation. 22 Q. Did the IRB have a written standard

23 operating procedure that you -- that they required 24 you to follow to insure the safety of your clinical 25 subjects?

44 1 MR. HUTCHINSON: By "you" are you

2 referring to her?

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3 BY MS. PEARSON: 4 5 Q. A. Specifically, yes. I do remember when I first started there,

6 there were, and I don't know if it came specifically 7 from the IRB, but it was big binders of information 8 about doing clinical research that I had to read 9 through and be familiar with, and I don't remember if 10 it came specifically from the IRB, but it was part of 11 my learning and training process. 12 Q. If you can recall specifically what you

13 remember reading related to reports of adverse events 14 on clinical subjects, could you tell me what the 15 standard operating procedure would be? 16 MR. HUTCHINSON: So can you either

17 read that back or restate it, please? 18 BY MS. PEARSON: 19 Q. Was there a standard operating procedure

20 that directed your activities in the event you 21 received a report of an adverse event from a clinical 22 trial subject? 23 24 25 A. Q. A. There was a standard operating procedure. What was that? I do not remember the specific details at

45 1 this time. 2 Q. Do you remember any general details -- and

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3 let me give you a little bit of guidance. I'm 4 looking to see what the chain of command or reporting 5 protocol would be. Who would you tell if you 6 received that information about an adverse event? 7 MR. HUTCHINSON: So the hypothetical

8 is she somehow becomes aware of some adverse event 9 and then what's the question? 10 BY MS. PEARSON: 11 Q. And then what are you supposed to do as far

12 as the guidance that the IRB had given you? 13 A. There were people that -- well, the IRB

14 needed to be notified. 15 16 17 18 Q. A. Q. A. So you would notify the IRB directly. Yes. I would notify the study. The study. I'm sorry. Meaning the Cafe. So Quintiles, the people

19 we worked through. 20 21 Q. A. All right. Anyone else? Of course Dr. Olson was, of course, the

22 first person. 23 Q. Okay. Anyone else you would be required to

24 notify? 25 A. Not that I'm remembering.

46 1 Q. Okay. Do you know who sponsored the Cafe

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2 Study? 3 4 5 6 A. Q. A. Q. Yes, I do. And who was that? Astrazeneca. Did you ever meet with anyone from

7 Astrazeneca any time during your involvement with the 8 Cafe Study? 9 10 A. Q. In my capacity working in the Cafe Study? At any time during your employment at the

11 University of Minnesota. 12 A. Yes, there were often, in the clinic, drug

13 reps that would come through, and they were from all 14 of the drug companies. So I'm sure I met with drug 15 reps from Astrazeneca. 16 Q. Do you remember ever discussing the drug

17 Seroquel with any of the drug reps from Astrazeneca? 18 A. Yeah, in general terms. I mean, that's

19 what they would do is come and give presentations on 20 the new medications. 21 Q. They would give presentations to you and

22 Dr. Olson or a group of folks at your university? 23 A. A group, yeah. Typically, it would be just

24 being available to answer questions. It wasn't a 25 huge presentation. Just, you know.

47 1 Q. They weren't selling stuff?

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2 3

A. Q.

No, not to me. Did they ever tell you about or ever warn

4 you about concerns with their medication? 5 A. That information was always available in

6 pamphlets and I know on the drug labels there was 7 always side effects, and I was aware of various side 8 effects with all of the medications. And I knew -9 yes. 10 11 12 Q. A. Q. I'm sorry. Go ahead. There was, yeah, documents on those things. Do you remember specifically with regard to

13 Seroquel what you were told by Astrazeneca about the 14 adverse effects or side effects of medication? 15 MS. SVITAK: Object as vague.

16 BY MS. PEARSON: 17 18 Q. A. Go ahead. I don't -- I can't answer because I would

19 hear from different, you know, "these types of drugs 20 cause things." And I don't remember specifically, 21 "Seroquel causes this." 22 Q. When you say "these types of drugs," are

23 you talking about antipsychotics or neuroleptics or 24 what are you talking about? 25 A. In this case, I was thinking of


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1 antipsychotics. 2 Q. And what do you recall, generally, this

3 group of drugs or antipsychotics, the warnings about 4 these types of drugs and their adverse events, or 5 effects? 6 MS. SVITAK: Object as vague.

7 BY MS. PEARSON: 8 9 10 Q. A. Q. Go ahead. Could you ask the question again, then. With regard to this group of drugs, what do

11 you recall hearing about their warnings or their side 12 effects or adverse events. 13 14 MS. SVITAK: Same objection. MR. HUTCHINSON: This is

15 antipsychotic? 16 17 MS. PEARSON: Correct. MR. HUTCHINSON: I'll just object on

18 grounds of Lack of foundation, but go ahead. 19 THE WITNESS: Okay. This is what I

20 read were a whole array of things, anywhere from 21 dizziness, sometimes sexual dysfunction. I know in 22 some cases, and I don't remember the medical 23 terminology, where there can be, you know, issues 24 with white blood cell count, insomnia, sedation, 25 stomach problems such as constipation or diarrhea.


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1 Later on, especially with Zyprexa, I remember hearing 2 there was potential for you know, higher, I don't 3 know if it cholesterol or, you know, blood sugar 4 types of things that could be linked to diabetes. I 5 remember that coming out. And I remember it being, 6 in my recollection, a memory of Zyprexa, primarily. 7 There were questions about vision and, you know, 8 changes in vision. And that's about all I can 9 recall. 10 BY MS. PEARSON: 11 Q. The things you have identified, although

12 they can be serious, seem somewhat mild. Do you 13 recall any serious, what I would call serious adverse 14 events, such as death, and those types of warnings 15 that specifically were told to you by representatives 16 from drug companies such as Astrazeneca related to 17 antipsychotics? 18 MR. HUTCHINSON: I'm just going to

19 ask you to rephrase that without the editorial, but 20 we don't know what you mean by "serious." 21 MS. PEARSON: Yeah, and I understand

22 that and it really is a term of art, and that is 23 really how I was using it, not as an editorial. So I 24 apologize. 25 MR. HUTCHINSON: It sounds like you

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1 were asking about a risk of death. 2 MS. PEARSON: That would be a serious

3 adverse effect. 4 MR. HUTCHINSON: Maybe there's more

5 to it than that. 6 BY MS. PEARSON: 7 Q. I guess that I did not mean to

8 editorialize. It really was a term of art, "serious 9 adverse events," which would trigger a different type 10 of reporting requirement than, say, dizziness. Do 11 you recall any type of serious adverse event that 12 could trigger an immediate reporting requirement? 13 14 A. There was -MS. SVITAK: Excuse me. I'm going to

15 object as vague. And foundation, as well. 16 MR. HUTCHINSON: Yeah, I'll join.

17 But go ahead. 18 BY MS. PEARSON: 19 20 Q. A. That's okay. And I'm really, there is a condition that

21 they -- it was discussed, that can be associated with 22 medications, that I remember it being said it was 23 very rare and it was a medical terminology, and I 24 don't remember what it was called. 25 Q. Okay.

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51 1 A. It was a specific kind of medical thing

2 that could happen sometimes, and I don't remember it. 3 I just don't. 4 5 the tape. 6 7 (A brief recess took place.) TAPE 2 MS. PEARSON: And we need to change

8 BY MS. PEARSON: 9 Q. Ms. Kenny, before we went on break, we were

10 talking about those types of adverse events that the 11 manufacturers of medications such as Astrazeneca and 12 Seroquel told you were related to antipsychotics. Do 13 you recall whether or not Dr. Olson told you 14 information regarding the adverse effects of 15 medications such as Seroquel? 16 17 vague. 18 19 specific? 20 BY MS. PEARSON: 21 Q. What types of things did Dr. Olson tell you THE WITNESS: Could you be more MS. SVITAK: I'm going to object as

22 about, for instance, that you might have to look out 23 for in the patients that are getting treated with 24 medications in the antipsychotics -- or I'm sorry, in 25 the Cafe Study?

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52 1 A. I remember learning about different side

2 effects in terms of movement disorders. So 3 stiffness. That was primarily stiffness, shakiness. 4 It's referred to as akathisia, a slow-down sort of 5 movement. 6 Q. Could we go back a moment to akathisia?

7 Akathisia is, you said, simply shakiness? 8 A. As I understand it and have learned about

9 it akathisia is a sense of inner restlessness. 10 Oftentimes it can be manifested. Visually you can 11 see a person's legs shaking. 12 Q. And that would be an adverse event that

13 would be related, for instance, to the neuroleptics 14 you were studying in the Cafe Study; is that correct? 15 16 17 18 A. Q. A. Q. It could be. And Seroquel is one of those -That was one of the medications. -- medications in the Cafe Study. I

19 understand, I think I understand what akathisia is 20 and I understand it more than just simply shakiness. 21 Is there more to it than that? And more 22 specifically, did Dr. Olson teach you about the 23 entire syndrome of akathisia as related to 24 neuroleptics such as Seroquel. 25 MS. SVITAK: I'm going to object on

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53 1 foundation. I'm sorry. Go ahead. 2 3 question. 4 5 again? 6 BY MS. PEARSON: 7 Q. What did Dr. Olson -- my understanding of THE WITNESS: Could you repeat that MR. HUTCHINSON: Just answer the last

8 akathisia is it involves -9 MR. HUTCHINSON: We don't need to

10 know that. 11 MS. PEARSON: Yeah, I know that, but

12 I'm explaining to her a little bit better what I'm 13 looking for to see if Dr. Olson explained to you the 14 full complement of the disease or the condition known 15 as akathisia as it's related to in neuroleptic 16 medications, and I'm trying to understand your full 17 knowledge of this disorder as to what he told to you 18 related to these types of medications? 19 MR. HUTCHINSON: So the question

20 is -- that's what you're trying to understand. 21 MS. PEARSON: That's what I'm trying

22 to understand. 23 24 question? 25 BY MS. PEARSON:
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MR. HUTCHINSON: So what's your

54 1 Q. Is that all that Dr. Olson told you related

2 to the condition known as akathisia, or do you recall 3 anything else? 4 A. I don't recall anything else, other than it

5 is a feeling of inner restlessness. 6 7 8 Q. A. Did he tell you it could lead to suicide? Never, no. MR. HUTCHINSON: Akathisia could lead

9 to suicide? 10 11 12 question? 13 MS. PEARSON: Yes, I asked her if Dr. MS. PEARSON: Akathisia. MR. HUTCHINSON: But that was your

14 Olson had told her that piece of information and the 15 answer was no. 16 THE WITNESS: No.

17 BY MS. PEARSON: 18 Q. Thank you. Anything else that Dr. Olson

19 told you specifically and even if it's a repeat of 20 the things that you learned from the pharmaceutical 21 companies, I want to know everything that Dr. Olson 22 told you related to adverse events for the drugs you 23 that were studying in the Cafe Study. 24 MR. HUTCHINSON: And you can answer.

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25 I'm going to object on grounds of lack of foundation,

55 1 vague. 2 MS. SVITAK: I'm also confused. Are

3 you talking about adverse drugs or side effects? 4 5 6 7 MS. PEARSON: Either. MS. SVITAK: Okay. THE WITNESS: And -MS. SVITAK: What is the question in

8 front of her, then? 9 BY MS. PEARSON: 10 Q. What did Dr. Olson tell you related to

11 adverse events and side effects of the medications 12 that you studied in the Cafe Study? 13 14 15 MR. HUTCHINSON: Same objection. MS. SVITAK: Same objection. MR. HUTCHINSON: Part of my problem

16 with the question is she worked there for three years 17 and it sounds like you're asking her about three 18 years' worth of communications. That's what it 19 sounds like. And maybe that's what you're doing. 20 BY MS. PEARSON: 21 22 Q. A. Do your best. I mean, do your best. I can't recall, specifically, what Dr.

23 Olson told me, because I learned about side effects 24 just in different capacities. So it's hard to
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25 isolate. And I don't know that I have anything to

56 1 add to what I have already said. 2 Q. Okay. Do you recall whether or not Dr.

3 Olson, and here's where I'm going with this: As I 4 recall, during the Cafe Study, or I should ask this: 5 Were you the person that would distribute the bottles 6 of pills to the clinical subjects as they came in for 7 their visits? 8 9 A. Q. I would distribute them. So you would collect them from the patients

10 and then distribute them. 11 12 13 A. Q. Yes. Okay. MR. HUTCHINSON: Can I just clarify,

14 you said "was she the person." 15 16 17 was? 18 BY MS. PEARSON: 19 20 21 Q. A. Q. Were you one of the individuals? I was one of the individuals. And are you aware that Minnesota law and MS. PEARSON: A person. MR. HUTCHINSON: Could you ask if she

22 the University of Minnesota has a policy that only a 23 physician can distribute prescription drugs?

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MR. ALSOP: Object as a multiple

25 question. Calls for a legal conclusion.

57 1 MR. HUTCHINSON: That's not what

2 happens when I go to the drugstore. 3 BY MS. PEARSON: 4 Q. Let me read this from the University of

5 Minnesota Web site and it may clarify some questions. 6 "According to the Minnesota Statute and rules, only a 7 licensed practitioner or pharmacist is authorized to 8 compound or dispense legend drugs. This applies to 9 legend drugs used in research projects and those 10 drugs not yet a by the Food & Drug Administration. A 11 practitioner is defined as a licensed doctor, doctor 12 of osteopathy, doctor of dentistry, doctor of 13 ophthalmology podiatrist or veterinarian. A 14 physician's assistant and advanced practice 15 registered nurses are authorized to prescribe, 16 dispense and administer drugs within his or her scope 17 of practice." 18 And as I understand your representation

19 today, your qualifications do not fit into anyone of 20 these categories that the Minnesota statutes permit 21 to dispense medication; is that correct? 22 23 A. Correct. MR. HUTCHINSON: And which statute

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24 did you just read? 25 MS. PEARSON: I'm reading from the

58 1 Minnesota -- University of Minnesota web site, and I 2 did not make a copy for everyone, but I certainly 3 can. It says "Conducting outpatient clinical 4 research using legend or investigational drugs" and 5 it's got the University -6 MR. HUTCHINSON: Can I ask about the

7 statutory cite? 8 MS. PEARSON: They didn't cite it

9 here, but I presume there is a statute that 10 identifies it. 11 BY MS. PEARSON: 12 Q. They go on to say "Administering the drugs

13 can be delegated by a principal investigator as long 14 as, and only after, the designee has given and has 15 demonstrated an understanding of basic pharmacology 16 and information about the drug." And what I was 17 looking to see specifically if that process went on. 18 Did Dr. Olson take the time to teach you and document 19 that process about the drugs that you were dispensing 20 in the Cafe Study? 21 22 MS. SVITAK: Object to form. MR. ALSOP: Join. It's a multiple

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23 question. 24 MR. HUTCHINSON: Same, and lacking

25 foundation. Go ahead.

59 1 THE WITNESS: I'm still not

2 understanding the question. 3 BY MS. PEARSON: 4 Q. Did Dr. Olson take the time to train you on

5 the pharmacological information about the drug and 6 adverse events and did he document that training 7 session? 8 9 10 MS. SVITAK: Object to form. MR. ALSOP: Join. MR. HUTCHINSON: And it's multiple

11 and it lacks foundation. Which of those questions do 12 you want her to answer? The one about documentation 13 or how much time or -14 BY MS. PEARSON: 15 Q. Well, did Dr. Olson take the time to teach

16 you about the pharmacological aspects of the drugs 17 that you were dispensing in the Cafe Study? 18 A. I recall discussions about medications in

19 general, and side effects; and also from what I read, 20 as I said before, in the different documents. 21 Q. Do you recall Dr. Olson specifically

22 teaching you about the particular drugs you were
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23 dispensing in the Cafe Study? 24 MR. HUTCHINSON: Objection,

25 repetitive. She just answered that. Go ahead.

60 1 THE WITNESS: The drugs in the study

2 were part of what I understood to be antipsychotic 3 medications that had these types of side effects. 4 BY MS. PEARSON: 5 Q. Do you remember whether or not that

6 training session or this information that was passed 7 from Dr. Olson to you was documented any place? 8 9 A. Q. I don't remember. Do you have any records of documentation of

10 a training session from Dr. Olson informing you about 11 the pharmacological aspects of the drugs you were 12 dispensing in the Cafe Study? 13 14 A. Q. I do not. Let's go back a little bit to talk about

15 your training that you received as a study 16 coordinator. It seems like there was some -- you do 17 certainly have some background information about 18 mental health, which helped Dr. Olson recruit the 19 patients because of your contacts. What type of 20 training, additional training or additional steps 21 were taken to train you as a study coordinator for

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22 the Cafe Study? 23 MR. HUTCHINSON: Are you asking what

24 training she got on the Cafe Study once she started 25 at the U of M?

61 1 BY MS. PEARSON: 2 Q. Any time. Anything that would document

3 that you are trained and qualified to collect data 4 and interact with patients in this clinical study. 5 6 7 A. Q. Again, the -Aside from the Quintiles. MR. HUTCHINSON: Aside from the

8 Quintiles? 9 BY MS. PEARSON: 10 11 Q. A. Uh-huh. Aside from the Quintiles, there were, when

12 I first started, as part of the training, there were, 13 again, these, and again, I don't know if they were 14 from the IRB or not, but it was about conducting 15 clinical research studies, and it was a lot of 16 documentation that I remember reading through. 17 Q. Do you remember any generalizations about

18 the information that you gleaned after reading 19 through those documents? 20 MR. HUTCHINSON: Object to that as

21 vague, lacking foundation. Go ahead.
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THE WITNESS: I really don't remember

23 any specifics that I can say with certainty. 24 BY MS. PEARSON: 25 Q. Prior to you being involved with the Cafe

62 1 Study, have you ever had a job where you intake 2 medical history of patients? 3 A. I do not remember any of my positions where

4 I took a medical history. 5 Q. In any of your prior positions in research,

6 did you ever take information related to adverse 7 events of a drug? 8 9 A. Q. No. Is the Cafe Study the first study that you

10 have been involved with that you were taking 11 information relating to adverse events of a drug? 12 13 A. Q. The Catie Study also. But prior to that, you had never been

14 charged with the responsibility of intaking 15 information relating to adverse events of a drug. 16 17 18 19 A. Q. A. Q. Prior to the University of Minnesota, no. Who delegated that responsibility to you? Dr. Olson. Okay. Did he ever ask you whether you had

20 any experience doing this type of work?

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21 22

A. Q.

I'm sure he did in our interview, yes. You understood that Astrazeneca was the

23 sponsor of the Cafe Study, if I understand that 24 correctly. 25 A. Yes.

63 1 Q. And you also talked about there are times

2 that drug reps would go to the University of 3 Minnesota and talk about their drugs and you kind of 4 remember there was a lot of drug reps that would come 5 and do this sort of thing. Do you ever remember, 6 specifically, related to the Cafe Study speaking to 7 any individual from Astrazeneca? 8 MS. SVITAK: First of all, I'm going

9 to object to the form. 10 THE WITNESS: In relation to the Cafe

11 Study, I did not speak to any Astrazeneca 12 representative. 13 BY MS. PEARSON: 14 Q. What about in relationship to the Catie

15 Study? 16 17 18 A. Q. A. No. In relationship to the Clear Study? In relationship to the Clear Study, I did

19 go to the investigators meeting which was the 20 preliminary, the training, and the -- I do not know
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21 if it was Astrazeneca representatives that did the 22 training there, but we did learn about medications 23 and there was information on side effects. But I do 24 not know if it was specifically an Astrazeneca person 25 there.

64 1 Q. And I'm sorry. Would you remind me again

2 what medications you studied in the Clear Study? 3 4 A. Q. Seroquel and Risperdal, as I remember it. Do you remember at that time what type of

5 information they shared with you about the 6 medications? 7 A. I am remembering specifically discussion

8 about -- because there was also a ophthalmology piece 9 to this, and they were discussing -- I think, part of 10 the study was to see whether or not one drug versus 11 another caused, I think it's cataracts. And so 12 that's my primary recollection about that. 13 Q. Okay. Other than cataracts, anything more

14 serious, other than cataracts, that you remember 15 discussing? 16 17 A. Q. I don't remember the focus being on that. Okay. When looking through the Cafe

18 documents, there are a lot of documents and I'm 19 trying to get a handle on all of the places that

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20 records were kept from either Dr. Olson, from you, 21 from the University of Minnesota. If I understand 22 correctly, there are a set of source documents, 23 correct? 24 25 A. Q. Yes. And a source of clinical documents that

65 1 would also be related to the Cafe Study. 2 3 A. Q. Yes. Then with specificity to Dan Markingson,

4 there would be records at the Fairview Hospital? 5 A. I'm sure there were, because he was

6 in-patient there. 7 8 9 Q. A. Q. Fairview Day Treatment Center? Yes. Okay. Did Dr. Olson and Dr. Schulz keep

10 separate notes related to their patients? 11 12 A. Q. Not that I'm aware. Did you keep separate notes related to the

13 patients? 14 MR. HUTCHINSON: Separate from those

15 three you just listed? 16 BY MS. PEARSON: 17 18 19 Q. A. Q. Uh-huh. I'm not sure how broad you mean by "notes." Any notes. In fact, let me back up one

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20 moment. Strike that question. 21 When you were training for and reviewing

22 the information from Quintiles and also reviewing the 23 information, I think you had mentioned from the IRB 24 and reviewing the information related to the study 25 itself, did you ever take notes about those things

66 1 you learned. 2 3 4 A. Q. A. I'm sure I did. And where did you keep those notes? I believe I had like a legal pad that I

5 used. 6 7 8 Q. A. Q. Do you still have that? No. And there also are, and we'll go back to

9 this, there are also records in the Department of 10 Psychiatry in the University of Minnesota also 11 related to Dan Markingson and the study, correct? 12 13 A. Q. I'm sorry. Could you say that again? There are also records at the University of

14 Minnesota Department of Psychiatry related to Dan 15 Markingson and his participation in the Cafe Study, 16 correct? 17 MR. ALSOP: Object on the basis of

18 foundation. Go ahead.

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THE WITNESS: I'm not sure I

20 understand, other than the records you've already 21 talked about with the Cafe Study. I don't think 22 there were any separate -23 BY MS. PEARSON: 24 Q. Well, I think I have -- in fact, I don't

25 have it with me now, but actually I have a document

67 1 signed by you that certifies all the records from the 2 Department of Psychiatry were responding to a 3 request, I believe, by Mary Weiss. And where is 4 that? I guess I'm really not clear where all those 5 records are kept and I'm really trying to get help to 6 figure that out. 7 8 A. Q. Sure. So if you recall collecting those records

9 and recall putting a letter saying you're certifying 10 that all these records are complete in the entire 11 file, where did that come from? 12 A. Those records came from the source

13 documents and the clinical binder. I don't know that 14 there were any other ones I had access to. 15 Q. Okay. When -- okay. Do you know if there

16 would be any other location, other than what we just 17 talked about, that records related to either Dan 18 Markingson or Dan Markingson in his participation of
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19 the Cafe Study may exist? 20 21 22 A. Q. If I'm understanding the question, no. Okay. Did doctor -MR. HUTCHINSON: I think you're

23 talking about geographic location, and you're also 24 talking about a description of documents, and the two 25 are getting --

68 1 MS. PEARSON: Yeah, and it's been a

2 tough battle trying to figure out if I've got 3 everything. And so please be patient with me as I'm 4 trying to struggle with this. Typically you send 5 medical records to the doctor's office and you get 6 all of the records back. That hasn't been as smooth 7 with the University of Minnesota. 8 MR. HUTCHINSON: Just ask her where

9 the records are kept, regardless of what they're 10 called. Maybe that would be -11 BY MS. PEARSON: 12 13 14 15 Q. A. Q. A. Okay. Would that be helpful to you? Yeah. All right. Why don't you -Yeah, at the University of Minnesota in the

16 research center there is a room that all the study 17 binders are kept for all the studies, regardless if

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18 it's Cafe or one of the eating disorder studies or 19 what have you. And anything related specifically to 20 each subject is in the source binder or in the 21 clinical binder. 22 Any other kind of, like, just general

23 things about the study was in that cabinet I told you 24 about, the things that we reported to IRB, but then 25 that was just not on specific patients, it was more a

69 1 general things. 2 3 cabinet? 4 THE WITNESS: The cabinet was in MR. HUTCHINSON: So where is the

5 Elizabeth Lemke's office. 6 BY MS. PEARSON: 7 Q. Do you know what the cabinet is called

8 besides "the cabinet"? 9 A. You know, there is a term that we called

10 that and I do not remember what it's called. 11 12 13 14 15 Q. A. Q. A. Do you know who would know? Elizabeth would know. Okay. All right. Yeah. MR. HUTCHINSON: And in addition to

16 that, you asked about the Fairview in-patient 17 records, which presumably are at Fairview, and
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18 then -19 20 MS. PEARSON: And we've got those. MR. HUTCHINSON: And the Day

21 Treatment Center, I don't know where those are. 22 MS. PEARSON: I think we have those

23 also. It's just the University of Minnesota that was 24 kind of unknown. 25 THE WITNESS: And I'm not aware of

70 1 any other records like that that Dr. Olson would keep 2 in his office. Not at all. 3 BY MS. PEARSON: 4 5 Q. A. Did Dr. Olson use a laptop? We -- I had the laptop and we didn't keep

6 any personal information of patients on that, that 7 I'm remembering. You know, Dr. Olson didn't -- I 8 don't know what his computer was. So -9 10 Q. A. But he did not use a laptop? I don't remember -- I remember he just had

11 a computer in his office and I had a laptop. Boy, he 12 might have, but I don't remember specifically for 13 sure. 14 Q. So if someone saw him using his laptop, it

15 may be something that, since you left, that he was 16 using.

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Could have, and did he have a laptop then?

18 I don't know. 19 20 21 Q. A. Q. Did he drive a BMW? No. I'm just kidding. Strike that question.

22 Do you remember Dan Markingson? 23 24 25 A. Q. A. I do. Do you remember his mother Mary Weiss? Yes, I do.

71 1 Q. Do you recall -- did you ever take a family

2 history of Dan Markingson in your capacity as a study 3 coordinator or in any other capacity? 4 A. I asked Dan questions about his family

5 history. I don't remember the answers, though. 6 Q. Do you remember anything about the family

7 dynamics between Mrs. Markingson and her son? 8 9 A. Q. What do you mean by "family dynamics"? Just the relationship and the observations.

10 If they were close, they were distant, they fought 11 all the time, they were best of friends? 12 13 14 15 16 A. Q. A. Q. A. I can -And these are your impressions. My impressions? Right. I know that Dan did not live with his mom

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17 for several years, he was living in California. I 18 know that he had come home at one point at which time 19 mom became very concerned with him. I remember her 20 telling me that she had to do whatever it took to get 21 him to come home. I remember that there was some 22 discussion of these e-mails that she sent to him, 23 what she said to lure him home. 24 Q. And she lured him home because she was

25 concerned for his mental health, correct?

72 1 MR. HUTCHINSON: Just so the record

2 is clear, I think you're interrupting her answer, 3 which is fine. I just want the record to reflect she 4 had not completed her answer to the prior question. 5 6 question. 7 8 MR. ALSOP: I'll join in that also. MR. HUTCHINSON: So where are we? MS. SVITAK: I object as to the last

9 BY MS. PEARSON: 10 Q. And I apologize. I thought there was a

11 pause. And it may be just like when I ask questions 12 when I put a pause in between words and it sounds 13 like we're done with the answers to the question. 14 But one of the things I was curious about is your 15 understanding of why she wanted him back in Minnesota

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16 and why she tried so desperately to get him back 17 here. And do you have any understanding or knowledge 18 of why that was so? 19 A. I remember her talking to me about her

20 concern about having him home, because if I remember 21 correctly, she had a hard time staying in touch with 22 him. And I don't know how it all came about, but she 23 somehow got ahold of his e-mail and wanted him to 24 come back. And I know she said she pretended to be 25 an angel or something and was -- there was some event

73 1 that was going to take place. And again, I believe 2 this was part of his delusional thing he was talking 3 to her about, and she had -- she told me she had to 4 do whatever it took to get him home. And so -5 Q. Do you recall coming to any understanding

6 as to why she thought it was so important to get him 7 home? 8 9 10 A. Q. A. She was worried about him. Do you know why? What I remember her telling me was that she

11 was concerned about him not paying for his bills, he 12 was exhibiting symptoms of psychosis. He, I remember 13 reading in the records when he was in patient that, 14 you know, he at one point thought his mother was a 15 lizard, he wanted to kill her. There was an array of
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16 lots of different things. 17 Q. And just so I'm understanding, it was your

18 belief that she was getting him home because she was 19 concerned that he was -- had a mental illness; is 20 that correct? And if it's not your understanding, 21 then tell me. But that's what I'm gathering. 22 A. I don't remember her saying that, "I think

23 my son has mental illness," I just remember her 24 saying, "I'm really worried about him," and he needed 25 to be home. And this, again, is in context of he was

74 1 already in the hospital or, actually, was already in 2 the study. So I'm assuming that because this was 3 someone with a mental illness. 4 Q. And she may not have used the term "mental

5 illness." That might have been my term. But I think 6 the general -7 8 9 A. Q. She felt he was sick. I can say that. Okay. Do you think she was right? MR. HUTCHINSON: Objection, lack of

10 foundation, vague and ambiguous. But go ahead. 11 12 MS. SVITAK: Same objection. THE WITNESS: I believe Dan

13 Markingson had a mental illness. 14 BY MS. PEARSON:

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Do you think Mrs. Markingson was right

16 that, in her assessment, of her son having a mental 17 illness? 18 A. Which, of that, could be very broad. I'm

19 not sure what -- was she right that he had a mental 20 illness? 21 22 Q. Yes. MS. SVITAK: I'm going to object as

23 to foundation. 24 THE WITNESS: Well, considering that

25 he has had a mental illness and she was concerned

75 1 that he was sick, that piece, yes, she was right that 2 he was sick, yes. 3 BY MS. PEARSON: 4 Q. Were you aware that Mrs. Markingson raised

5 Dan as a single parent? 6 MS. SVITAK: Object as to her name.

7 You said Mrs. Markingson. 8 MS. PEARSON: I'm sorry. You're

9 right. Thank you. 10 BY MS. PEARSON: 11 Q. Were you aware that Mrs. Weiss raised

12 Daniel at that time as a single parent? 13 A. I did not know what the length of -- you

14 know, I know that I had no information about Dan's
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15 father and he did not give any information on that. 16 So I don't know -- I knew that she was a mother, 17 single mother at the time, but I did not know where 18 dad was in the picture or if he was in the picture at 19 all. 20 So I don't know, like, in other words, I

21 can't say with certainty that I knew she raised him 22 from birth throughout as a single mom. I don't know 23 that for sure. 24 Q. Did you, in your evaluation or in any of

25 your family history of questioning Dan ever come to

76 1 learn about the close relationship that Mrs. Weiss 2 had with her son, Daniel Markingson? 3 MS. SVITAK: I'm going to object as

4 to foundation. 5 THE WITNESS: I don't know how to

6 answer that in terms of what -7 8 evidence. 9 MR. HUTCHINSON: Same. MS. SVITAK: Assumes facts not in

10 BY MS. PEARSON: 11 Q. I'm just asking, as you do a patient

12 intake, I assume especially with regard to patients 13 who have mental illness, it is very important to get

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14 an understanding of their family history; is that 15 correct? 16 17 A. Q. Yeah. And get an understanding of their family

18 dynamics; is that correct? 19 20 21 A. Q. A. Yes. Okay. I know that -- I know that mom, that Mary

22 was very involved, and I also know that Dan was 23 cooperative and that, you know, we could speak to 24 mom, and he signed a release that we could, which 25 allowed me to talk to her. And I just knew that she

77 1 was, now that he was back in Minnesota, she was very 2 involved in his life, because she would come in to, 3 you know, the visits at times and called me several 4 times. 5 So, yeah, but he never described their

6 relationship as close. In fact, he didn't talk a lot 7 about those personal things. That was one of the 8 things that -- and I think in my notes probably 9 reflect that he was, what we call guarded when it 10 came to a lot of personal. He will not answer 11 several things about personal things. 12 Q. But you had an opportunity to talk to

13 Mrs. Weiss about these items also. You could have.
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14 15

A. Q.

Yes. And you did. Did you ever talk to Mrs.

16 Weiss about these things? 17 MR. HUTCHINSON: About?

18 BY MS. PEARSON: 19 Q. About the relationship as it relates to

20 importance of the mental illness to understand the 21 family dynamics as they were growing up. And I'm 22 asking whether you ever went to Mrs. Weiss to ask 23 about those types of things that might be relevant to 24 the care of Daniel Markingson? 25 MS. SVITAK: Object as vague.

78 1 2 MR. HUTCHINSON: Same. THE WITNESS: It would have been

3 common practice to ask questions about, you know. 4 Did you live together, closeness. I'm not exactly 5 sure, you know, I would have asked her if she was 6 supportive, or if mom is supportive. Those are the 7 kinds of questions I would ask and, yes, she said 8 that she was supportive, meaning -- and I also know 9 that she was trying to help him financially and 10 things like that. So I could assume that was the 11 support. 12 BY MS. PEARSON:

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So you have no -- there is nothing in your

14 medical records as you're collecting data on 15 Mr. Markingson about his family history, about mother 16 and son traveling around the world together and being 17 very close their entire life. There was nothing in 18 your records that documents any inquiries into the 19 nature of their relationship. 20 MR. ALSOP: Object, that's a multiple

21 question. Object to form. 22 23 question. 24 BY MS. PEARSON: 25 Q. Well, answer my question to the best you MR. HUTCHINSON: Just answer the last

79 1 can. They've registered their objections and they're 2 allowed to, but answer the question as best you can. 3 MR. HUTCHINSON: And I'm advising you

4 to answer the last question. There were several 5 questions there. She'll ask them individually if she 6 wants to pursue that. 7 THE WITNESS: Yeah, now I'm not sure

8 what the questions are. Could you ask that again? 9 BY MS. PEARSON: 10 Q. Was there any documentation in the records

11 that reflected your inquiries into how close 12 Mr. Markingson and his mother were growing up,
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13 traveling around the world together, very close 14 relationship, very, very best of friends all through 15 growing up? Any type of documentation of that type 16 of investigation, as you were trying to find out the 17 history of this individual and his mental illness. 18 19 A. I don't remember -MS. SVITAK: Excuse me, just a

20 second. Object to the form, please, and multiple. 21 22 MR. ALSOP: I'll join. MR. HUTCHINSON: Same.

23 BY MS. PEARSON: 24 25 Q. A. And I'm sorry. You said you don't recall? I don't recall the specific information

80 1 you're telling me about traveling around the world. 2 I do not have recollection, nor do I believe that I 3 documented anything like that. 4 Q. All right. You had said that

5 Mr. Markingson was, in fact, in Fairview Hospital, 6 correct, when he was first hospitalized? 7 8 A. Q. Uh-huh. And do you recall when he was first

9 admitted to the hospital because of his illness? And 10 this is not a memory test, and general is all right. 11 A. It might have been November.

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12 13 14

Q. A. Q.

November of 2003? I believe it was 2003, yeah. And I think you had told me that you

15 observed him as being guarded. What does that mean? 16 A. My definition of guarded would be not

17 wanting to answer questions fully. If I would ask 18 him, just as an example, if I would ask him, you 19 know, one of the things, "How is your financial 20 situation?" He would say, "Oh, that's really not any 21 of your business." Another example of guarded would 22 be, you know, "Are you having any problems in the 23 group home? Are you getting along with everybody?" 24 And he would give very general answers such as, 25 "Everything is fine." And I would say, "Well, tell

81 1 me more about that." And he would not expound on his 2 answers. 3 Q. I have -- I'm going to have this marked as

4 Exhibit 36. 5 6 7 (WHEREUPON, Deposition Exhibit No. 36 was marked for identification by the Reporter.)

8 BY MS. PEARSON: 9 Q. And it is a page out of the progress notes,

10 and I'll wait until you get one, if you could mark 11 this. These are the progress notes at Fairview
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12 Hospital. And what I'd like to draw your attention 13 to is the entry -- and I'm sorry. We've got this 14 Bates stamped as FH-000152, and just marked 15 11/17/2003, and -16 MR. HUTCHINSON: Do you have enough

17 copies to give her that one? 18 BY MS. PEARSON: 19 Q. Yes, absolutely. Yes, I do. And if I were

20 to have you look at that entry, could you tell 21 immediately -- and it's hard for me to read this 22 writing -- if you go down to the bottom of the page 23 and see who signed that? Do you recognize that 24 signature at all? 25 MR. HUTCHINSON: This is the note at

82 1 2300 hours? 2 3 MR. ALSOP: The last one? MS. PEARSON: Well, it seems like it

4 goes all the way down, doesn't it? I thought at 5 first, but it doesn't seem -- seems like we've got -6 oh, I'm sorry. 7 8 at 2300. 9 BY MS. PEARSON: 10 Q. The 1520. Do you recognize that name at MR. ALSOP: One is at 1520 and one is

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11 all? 12 13 A. Q. No. And part of this process is just trying to

14 figure out who was involved. Would you mind reading 15 this to me, because I want to -- I really want this 16 to be clear? 17 18 19 20 A. Q. A. Okay. If you can read it. I'll try my best. MR. HUTCHINSON: First of all, you're

21 not the author of this? 22 MS. PEARSON: No, she's not, and I'm

23 not assuming she is and I don't think, as she reads 24 it, you'll think it's a problem. 25 MR. HUTCHINSON: Have you seen this

83 1 either in original form or photocopy before today, or 2 do you remember? 3 THE WITNESS: I don't remember. I

4 may have when I was looking at records, but I do not 5 remember. 6 MR. HUTCHINSON: So for the court

7 reporter, read this slowly, whatever you can read. 8 THE WITNESS: "Patient attended

9 community meeting. Patient answered special question 10 at community meeting, which was, 'What is the'" -file:///C|/Users/ellio023/Desktop/Rothenberg%20letter%20to%20Mike/kenny%20depo%20(2).txt[11/10/2012 11:01:28 AM]

11 BY MS. PEARSON: 12 13 Q. A. Nicest? I'm not sure, something, "'that someone has

14 done in the past month that you have seen.'" "My 15 mother bringing me to the hospital to get help." It 16 looks like end quote. 17 Q. And I guess I just wanted to get the

18 clarification. 19 20 note. 21 BY MS. PEARSON: 22 23 Q. A. You can go ahead. "Patient spent most of shift in room. MR. HUTCHINSON: There's more to the

24 Observed." 25 MR. HUTCHINSON: Observed?

84 1 THE WITNESS: Looks like observed.

2 And it's after an I. I'm not sure what the -- and 3 then A is probably assessment; "polite, respectful, 4 isolative," and P is plan. "Continue with treatment 5 plan," and then whoever signed that. 6 BY MS. PEARSON: 7 Q. Had you ever seen this or have you not seen

8 this? 9 A. Not that I'm remembering, no.

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Does it help you understand the

11 relationship between Dan and his mother? 12 MR. ALSOP: Object on the basis of

13 foundation, vague. 14 MS. SVITAK: Same objection.

15 BY MS. PEARSON: 16 17 Q. A. Well, we'll get there. That's a really hard question to answer,

18 because how can anyone completely understand a 19 relationship, you know. I guess I'm not really 20 understanding what you're asking me. 21 Q. Part of what I'm asking, of course, part of

22 what we're concerned about is the lack of 23 understanding of Dan -- that the University of 24 Minnesota, Dr. Olson Dr. Schulz and his entire staff 25 had on the family relationship between his mother and

85 1 himself and how important these two people were to 2 each other, and how important the things that 3 Mrs. Weiss might say and report to you folks of her 4 concerns, and part of, and I'll be blunt, we're 5 wondering why her concerns weren't listened to. And 6 that's not a question. Don't answer. 7 8 MR. ALSOP: Object on form. MS. PEARSON: All right. But that's

9 somewhat of a mystery, quite frankly.
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MS. SVITAK: I apologize, but I

11 really do object to the speeches. This is a 12 deposition regardless, and I think we need questions 13 and answers, not speeches. 14 15 THE WITNESS: Sure. MS. PEARSON: And I agree and,

16 really, the reason that I cannot have a visit with 17 Mrs. Kenney is because she is now represented by 18 attorneys, by a group of individuals that we are 19 suing here, and otherwise, I would have a 20 conversation with you and we would not have to have 21 this structured environment and we could have a frank 22 conversation. It is very difficult to ask the 23 questions that I wanted to ask of a witness while 24 you're being represented by attorneys who are 25 representing folks we're suing.

86 1 MR. HUTCHINSON: You ask however

2 frank you want to get. You go right ahead, and 3 she'll be frank in response. 4 BY MS. PEARSON: 5 Q. All right. So let's go on, and I'm just

6 going to continue and we can set that aside. I'm 7 going to have you mark this as 37. 8 (WHEREUPON, Deposition

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9 10

Exhibit No. 37 was marked for identification by the Reporter.)

11 BY MS. PEARSON: 12 Q. Okay. I have placed in front of you what I

13 understand are progress notes from the records that 14 Jeanne Kenney has produced to us pursuant to our 15 request from the psychiatric department at the 16 University of Minnesota. And there are five sheets 17 of paper in this, and I'm going to identify the 18 numbers for those sheets of paper. The first one is 19 PSY-00147, the second is PSY-000021, the third is 20 PSY-000022 and -21 22 A. Q. Wait a second. Okay. The next is PSY-000023, the last is

23 DC-000042. 24 25 MR. ALSOP: There's one more. MR. HUTCHINSON: I have one more.

87 1 2 MR. ALSOP: There's six pages. MS. PEARSON: You're right. And

3 PSY-000145. 4 MR. ALSOP: Six pages.

5 BY MS. PEARSON: 6 Q. All right. And Jeanne, can you go

7 through -8 MR. HUTCHINSON: No, it's Ms. Kenney.

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9 BY MS. PEARSON: 10 Q. I'm sorry. I apologize. I apologize. Ms.

11 Kenney, could you please go through these documents 12 and let me know if you recognize the handwriting on 13 each of those pages? 14 A. Yes. Page 1, PSY-00147, I recognize it.

15 This is Julie Pearson's handwriting. Her signature 16 and my co-signature. 17 Q. Will you explain that again? I see your

18 signature at the bottom of this. 19 MR. HUTCHINSON: The line above,

20 right above her signature. 21 THE WITNESS: The line above is Julie

22 Pearson. She wrote the note. 23 BY MS. PEARSON: 24 25 Q. A. And you -Co-signed the note because she was an

88 1 social work student I was supervising. 2 Q. But you reviewed this note and agreed with

3 its contents, correct? 4 A. Yes. I read the note based on the

5 information she gleaned and signed it saying that 6 yes, I have read it. 7 Q. Okay. Go to the next page, please.

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8 9 0021?

MR. HUTCHINSON: So now we're on

10 BY MS. PEARSON: 11 Q. Right. You know what, you can do it all at

12 once. And I assume that you had signed each of these 13 pages, and if that is incorrect, just point it out to 14 me. 15 A. Sure. This one is my note and my

16 signature. 17 18 19 signature. 20 21 22 23 MR. HUTCHINSON: 23? THE WITNESS: My note and -MR. HUTCHINSON: 42? THE WITNESS: My note. Yep, and my MR. HUTCHINSON: 22? THE WITNESS: Is my note and my

24 signature. And -25 MR. HUTCHINSON: 145.

89 1 THE WITNESS: Yes, all me.

2 BY MS. PEARSON: 3 Q. If we go to page 000147, and I guess this

4 is the first time I appreciated that you co-signed 5 this note, and if you go up to the top, it says, 6 "DRM," which I assume is Dan Markingson, "is here for 7 visit 10. Returned med. bottles" and identifies, it
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8 looks like lot number for each of those bottles. 9 10 A. Q. Uh-huh. Are you saying that Ms. Pearson is who

11 received those bottles from Dan? 12 A. You know, she assisted us in doing things,

13 so she probably got the bottles, yeah. I don't know 14 if I was there sitting with her or if I was with 15 another patient. I don't recall if I was there, but 16 she would have, yeah, she would have taken the 17 bottles. 18 Q. And she wrote down, "Med. compliance very

19 good"? 20 21 22 A. Uh-huh. MR. ALSOP: Is that a yes? THE WITNESS: Yes.

23 BY MS. PEARSON: 24 Q. Do you know what she based that statement

25 on?

90 1 A. Yes. We would get the returned medication

2 bottles and we would count how many pills were 3 returned. And based, you know, on how many he was 4 supposed to take, and how many were returned to us. 5 6 Q. Uh-huh. Who did that process? MR. HUTCHINSON: Counting pills?

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7 BY MS. PEARSON: 8 Q. Any way, you know, from the moment that

9 those bottles of pills left Dan's hands, who was 10 involved? 11 12 13 A. Q. A. When he brought them back to us? Uh-huh. It could be myself, it could be Elizabeth,

14 or one of our assistants could help with the counting 15 of the pills. 16 17 Q. Who would dispense those pills? MR. HUTCHINSON: Now, by "dispense,"

18 you mean actually puts them in the patient's hand? 19 BY MS. PEARSON: 20 21 22 Q. A. Q. Correct. Typically it would be me or Elizabeth. Okay. And it would never be your

23 assistant. 24 A. I don't believe she ever did that because

25 she didn't have a code to call in and get, you know,

91 1 what bottle number, et cetera. So it would be either 2 myself or Elizabeth that would do that. 3 Q. So this writing is really information that

4 Ms. Pearson collected during an interview with Dan? 5 A. Based on the visit that he was there, she

6 would have written a summary of what happened at the
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7 visit. 8 Q. Could you tell me what her qualifications

9 were? 10 A. She was studying -- I believe she had -- I

11 don't know if she had a Bachelor's in psychology or 12 not, but she was in a Master's of social work 13 program. 14 Q. Do you know whether or not she went through

15 any training with Quintiles? 16 A. She also had to go through, again, the

17 study to learn how to do the assessment and 18 everything and take the test and to pass those tests 19 in order to be able to do those. 20 Q. Do you know whether or not she was trained

21 to recognize adverse events in patients that were 22 taking study medication? 23 A. I know she was trained on how to do the

24 form that we ask those questions when we would do an 25 assessment of side effects.

92 1 Q. I'm sorry. You said she was trained to

2 fill out the form? 3 A. And to ask those questions, yeah, about

4 side effects. 5 Q. Do you know whether or not she was trained

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6 to recognize side effects in patients? 7 A. I guess I'm not sure. Like formal training

8 or -9 10 Q. A. Yeah. Okay. I don't remember if she did that.

11 I'm sorry. 12 Q. That's all right. That's all right. Let's

13 go to the next -- I'm sorry. Let's go back. And you 14 said you read this information and signed off on it? 15 16 A. Q. Uh-huh. And about three-quarters of the way down

17 the page, there's an entry that says, "His plan seems 18 unrealistic." 19 20 21 or no. 22 THE WITNESS: Yes. A. Uh-huh. MR. HUTCHINSON: You need to say yes

23 BY MS. PEARSON: 24 25 Q. A. That's all right. Yes.

93 1 Q. And do you recall the plan she was talking

2 about? Do you recall your understanding of what 3 plans he was talking about? 4 A. If I remember correctly, his plan to return

5 to California and start a job doing tours and not
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6 really having specifics about how he would go about 7 doing that. 8 Q. And then in this note, as far as I

9 understand, it says, "He admits being overwhelmed 10 with the steps to return to California and wants to 11 recharge his batteries before moving." So you 12 remember reading this before you signed this, and so 13 this is part of your understanding of Dan's concerns, 14 correct? 15 A. The best I can interpret what he meant by

16 that. 17 18 Q. A. What do you think he meant by that? In my opinion, if somebody says they need

19 to recharge their batteries, I think that he probably 20 wanted to get -- I hate to use another idiom, but get 21 his ducks in a row, you know, probably have the 22 finances to do so. 23 24 Q. A. He wasn't ready to go quite yet, correct? No. I'm thinking by saying that, he's

25 saying, "No, I need to do a little bit more before I

94 1 go." 2 Q. The next page, 000021 date 3/25/04, and do

3 you recall this -- writing this note or what went on 4 during the time you put these notes together?

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5 6 7

A. Q.

Uh-huh. Tell me your impressions. MR. HUTCHINSON: Could you restate

8 that, please? 9 BY MS. PEARSON: 10 Q. Why don't you tell me what you recall about

11 this event. What are your impressions? I guess 12 that's the best I can do. What are your impressions 13 after reading this of the event? What do you recall 14 thinking at the time? 15 A. Boy. I recall that it was a phone

16 conversation with his mom, and now I'm remembering 17 that her friend, boyfriend was also in the 18 conversation, although I don't remember that exactly. 19 And what I do remember is she was very concerned that 20 he was just going to get up and leave for California, 21 and I remember her saying if he did that, then he'd 22 be kind of lost after he returned to California. And 23 what she meant by "lost" is just her inability to 24 have close contact with him. 25 Q. That's your interpretation of what she --

95 1 A. That she was very concerned that he would

2 leave for California. I remember her feeling -- or 3 saying that she was very concerned that he was going 4 to just leave.
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You don't remember her telling you she was

6 concerned and he still was ill? 7 A. Oh, yeah. Now that I am reading more down

8 there. I remember she would say that it was based on 9 what the boyfriend would say. They would have, you 10 know, they would talk, have conversations, and he 11 would make a statement such as -- and what's written 12 here, "you and I are perfect" and she related he said 13 that with a cold stare, and then also, and I didn't 14 understand this, but he would ask "How are you?" And 15 she had concerns about the way he asked that 16 question. 17 18 19 20 21 22 Q. A. Q. A. Q. A. What does NOC stand for? Night. Night? Yeah. So what does that sentence mean? Oh, that he spent the night with them and

23 didn't have his meds with him to take them in the 24 morning, and she -- he didn't even seem concerned 25 that he wasn't taking his medications.

96 1 Q. So at this point, he was non-compliant,

2 correct? 3 A. Well, with that particular morning, I'm

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4 assuming, he could have very well returned to the 5 group home and have taken them. I mean -6 Q. But at this point he's not compliant,

7 correct? 8 9 A. I don't know. MR. HUTCHINSON: Object, that's

10 argumentative and she just answered it. 11 12 MR. ALSOP: I'll join. MR. HUTCHINSON: Lacking in

13 foundation. 14 BY MS. PEARSON: 15 Q. If you go up a little bit earlier, was

16 there anything she was reporting to you that made you 17 concerned that maybe Dan is not doing so well right 18 now, and if so, what is it? 19 A. Okay. Again, when she was expressing it --

20 if he, in fact, was going to just get up and return 21 to California, I would be very concerned about that, 22 because, you know, he wouldn't have anything in place 23 to follow up to take medications, to see somebody, 24 to, you know, I mean, this is a young man who just 25 was hospitalized and sick, and so that doesn't just

97 1 go away over night. 2 Q. She was justified in her concerns, wasn't

3 she.
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4 5

A. Q.

I don't know how to answer that. That's fine. That's fine. Was there

6 anything else, and I can't tell if this was you 7 reporting this or if this was Mrs. Weiss reporting 8 this. 9 10 11 "this" is. 12 BY MS. PEARSON: 13 Q. Apparently he has canceled medical A. Oh, I can -MR. HUTCHINSON: I'm not sure what

14 appointments? 15 16 A. Q. That's what she reported to me. And why don't you go ahead and read that

17 and tell me what concerns triggered in your mind due 18 to this report. 19 MR. HUTCHINSON: Just a second now.

20 Read what? 21 BY MS. PEARSON: 22 23 24 got it? 25 THE WITNESS: I got it. Q. Starting at "Apparently." You see -MR. HUTCHINSON: I don't see it. You

98 1 MR. HUTCHINSON: And how much do you

2 want her to read? To the end of the page or what?

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3 BY MS. PEARSON: 4 Q. No, why don't you read to the end of the

5 therapist. 6 A. Okay. "Apparently he has canceled medical

7 appointments for thyroid and hyperlipoidemia, which 8 we have been advising for months now," and the "we" 9 is meaning us, Dr. Olson, "Therapist reports he's 10 not" -- I'm sorry. I skipped something. "He has 11 canceled several therapy appointments and therapist 12 reports he's not talking in sessions," and this was 13 based on her information. 14 Q. Did this trigger any concerns in your mind

15 that perhaps Dan, Mr. Markingson was not doing well? 16 A. Well, it certainly would trigger some

17 concerns, in general, because, yeah, all of -- it 18 would for any patient in terms of, you know, what's 19 going on with them. 20 Q. So you believed Mrs. Markingson in her

21 report right here, correct? I'm sorry, Mrs. Weiss in 22 her report right there, correct? 23 MR. ALSOP: Object to a misstatement,

24 assumes facts not in evidence. 25 MS. SVITAK: Same.

99 1 MR. HUTCHINSON: Same. Lacking

2 foundation.
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3 4

MS. SVITAK: Same objection. MR. HUTCHINSON: And I'm not sure

5 what you're referring to. 6 THE WITNESS: I guess I would have no

7 reason not to believe her. 8 9 break. 10 11 (A brief recess took place.) TAPE 3 MS. PEARSON: And we need to take a

12 BY MS. PEARSON: 13 Q. Now, if I recall what we were talking

14 about, basically, and I'm just summarizing a moment 15 here, we were looking at page 000021 date 3/25/04, 16 and Mrs. Kenney, you just read to me a portion of 17 your recorded medical record discussing the fact that 18 Mr. Markingson apparently, according to his mother's 19 report, is cancelling medical appointments, has 20 cancelled appointments with the therapist and the 21 therapist reports he is not talking in sessions, and 22 if I understand you correctly, you said that you did 23 believe Mrs. Markingson when she reported this 24 information to you, correct? 25 A. Yeah.

100 1 Q. Did you do anything in response to this

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2 report? 3 A. I'm sure I did. I'm sure that because I

4 had daily contact with Dr. Olson, would let him know 5 how all of my patients, or all of the client subjects 6 were doing. So, yes. And would also probably speak 7 to Dan about it as well in our next visit. 8 Q. You mentioned you had daily contact with

9 Dr. Olson. Did you ever record those conversations 10 or the results of that contact? 11 A. Not always. Just what would be in the

12 notes, but I wouldn't have, every time we talked or 13 discussed things, no, unless he gave me a specific 14 directive or something. 15 16 17 Q. A. Q. Specific directive to write this down? Yeah. Otherwise, there might be a lot of

18 conversations between you and Dr. Olson that would 19 not get recorded; is that correct? 20 21 A. Q. That's correct. Do you recall whether or not you had a

22 specific conversation with Dr. Olson after you got 23 this report from Mrs. Weiss on 3/25? 24 A. I don't remember specifically, but I know

25 that I always -- any concerns of any of the study

101 1 subjects, would let Dr. Olson know, because sometimes
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2 it would involve, you know, increasing medications or 3 whatever. So, I mean, because it was out of my 4 capacity, I would tell Dr. Olson just about 5 everything. 6 Q. Do you remember whether Dr. Olson wrote

7 down these conversations that you would have with 8 him? 9 10 A. Q. I don't know if he did. Okay. You can turn the page, and now we're

11 on 000022. 12 13 A. Q. Uh-huh. If you go to the top of the page and the

14 date is 4/15/04. 15 16 A. Q. Uh-huh. And why don't you take a moment to look

17 over these notes just to refresh your memory about 18 what was going on. 19 MR. HUTCHINSON: Does it matter to

20 you if you're out of order or not? 21 22 23 pages. 24 MS. PEARSON: Well, this really MS. PEARSON: As far as the dates. MR. HUTCHINSON: Well, just the

25 resulted from getting information kind of in bits and


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1 pieces and I had to put them in as far as how we were 2 getting them, and I think it triggers, perhaps, you 3 know, really, the need to, when we have all of the 4 records collected, have one system to Bates stamp 5 them all. 6 MR. HUTCHINSON: Well, I just suggest

7 that you might want to ask her, of these three pages 8 having the date April 15th, which is the first one 9 she wrote first, which is the one she wrote second, 10 and which is the one she wrote third. Just a 11 suggestion. You can do what you want. It might help 12 speed things up here. 13 BY MS. PEARSON: 14 Q. And I thought they were in order, I guess,

15 is what I had thought. Which page did you write 16 first, which page did you write second, and which 17 page did you write third, Mrs. Kenney? 18 A. Starting with 22 -- I guess I'm not really

19 sure -- because they all were on 4/15. I -20 MR. HUTCHINSON: Just look at the

21 part that's crossed out on the bottom. 22 THE WITNESS: Yeah. Oh, yeah. I'm

23 not seeing that in my part, though. 24 25 MR. HUTCHINSON: Page 23. THE WITNESS: Oh, okay. Right.


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1 BY MS. PEARSON: 2 Q. Why don't we get there, because I'm not

3 sure that, you know, the information that is in here, 4 and this is actually a continuation of this page. 5 Okay? I don't want to spend too much time on this, 6 but this came after this. This is not a late entry. 7 This says late entry for 4/9. The assumption is this 8 was written afterwards. 9 MS. SVITAK: We're not going to be

10 able to follow any of this -11 12 13 14 15 16 MR. HUTCHINSON: That's okay. MS. SVITAK: -- on the -MS. PEARSON: On the transcript? MS. SVITAK: Uh-huh. MS. PEARSON: Yeah, I know. THE WITNESS: I think this page --

17 BY MS. PEARSON: 18 Q. Let's just go through it because, I mean,

19 let's just go through and get through this part. At 20 any rate, you did read your entry dated 4/15 on 21 000022? 22 23 A. Q. Yes. Okay. And -I'm sorry. Go ahead, you were going to say

24 something? 25 MR. HUTCHINSON: I'm not sure what

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1 the question is. 2 BY MS. PEARSON: 3 4 Q. A. Did you want to say something about this? I was going to respond to, well, I think

5 you asked the question about what I remember about 6 that. 7 MR. HUTCHINSON: No, she didn't ask

8 anything. She said please read it, please look it 9 over. 10 11 12 hint. 13 14 THE WITNESS: I'm so sorry. MR. HUTCHINSON: She said please. THE WITNESS: All right. MS. PEARSON: You're not supposed to

15 BY MS. PEARSON: 16 Q. You're doing fine. You're doing just fine.

17 Why don't you let me know -- why don't you tell me, 18 and I'm a little bit confused because you have a date 19 4/15/04, and if I'm looking at this first page here, 20 I'm reading, "Received two phone calls one from Mary, 21 one from her boyfriend Mike, on Sunday 4/18/04," and 22 I was wanting to clarify what that was. 23 A. I think what I did is probably that was

24 like a Monday and I was retrieving my voice mail 25 messages, and you know, I knew the call came on

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105 1 Sunday so what I probably did was like okay, what was 2 Sunday's date and I probably just, you know, not at 3 all thinking. So, because, yeah, it would have been 4 -- so that's inaccurate, the 4/18. It would have 5 been whatever -6 Q. And then, again, we've got a report I want

7 you to read right after 4/18. Why don't you go ahead 8 and read that next six lines. 9 A. Okay. "Mary again reiterated D," meaning

10 Dan's "meds are not working. He is totally out of 11 control. He says such things as, 'are you asking me 12 or telling me?'" 13 MR. HUTCHINSON: Can you put in the

14 quote marks for the reporter. 15 16 17 says." 18 THE WITNESS: "He says such things THE WITNESS: Okay. MR. HUTCHINSON: Start with "He

19 as, 'are you asking me or telling me?' She also 20 stated, 'Do we have to wait until he kills himself or 21 someone else before anyone else does anything?'" 22 BY MS. PEARSON: 23 Q. What was your first impression after you

24 heard this telephone message from Mrs. Weiss? 25 A. I remember her -- she's obviously very

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106 1 upset, I guess. You know, I didn't have any details 2 about why she thought his meds weren't working. The 3 statement, "Are you asking me or telling me," didn't 4 really tell me much. I didn't quite understand that. 5 And when she said, "Do we have to wait until he kills 6 himself or someone else?" I guess I really wanted to 7 know more about why she was making that -- why she 8 was so concerned about that, because I just remember 9 thinking at the time, you know, we weren't seeing 10 anything like that, and the group home wasn't seeing 11 anything like that and his case manager wasn't seeing 12 anything like that and the treatment program wasn't 13 seeing anything like that, so I wanted to know more 14 from her because she was obviously very concerned. 15 16 Q. A. What did you do to find out more from her? I remember there was a series of phone

17 calls and that we really wanted Mary to come in to 18 talk about that, because certainly her concerns 19 needed to be heard. 20 21 22 Q. A. Q. Who were those series of phone calls to? Back and forth to Mary, I guess. Between -- I'm sorry, I didn't mean to

23 interrupt you. Between who and who? 24 25 A. Q. Myself and Mary, that I'm aware. Did you notify Dr. Olson about this

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107 1 statement in the record? 2 3 4 A. Q. A. Sure. What did Dr. Olson say? I don't remember specifically what he said.

5 I do know anytime I ever expressed concerns, he 6 wanted me to follow up on it, and I think, if I 7 remember correctly, at that time we wanted to, you 8 know, find out from Dan what was going on and also to 9 check out from the other places what they were seeing 10 as well, too, and we have to kind of gather 11 information from everybody. 12 Q. What did Dr. Olson do after he heard this

13 report from you that his mother was concerned that 14 her son might kill himself? 15 MR. HUTCHINSON: Objection, lack of

16 foundation, but go ahead. 17 THE WITNESS: You know, I don't

18 remember specifically what he did. 19 BY MS. PEARSON: 20 21 Q. A. Did he do nothing? No. I mean, we talked about things. I

22 think we probably talked about when would Dan's next 23 visit be, when -- you know, I should probably call 24 the group home and find out what's going on, which I 25 believe I did.
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108 1 2 Q. A. Did you report this complaint to the IRB? No, I don't believe I did report that mom

3 said that, no. 4 5 Q. A. Why? I don't know. I don't think I had any

6 indication that that was something that I needed to 7 report. It wasn't a -- I'm not seeing that that 8 would be like an adverse event to report. 9 Q. Do you know whether or not the IRB is

10 interested in hearing complaints regarding their 11 clinical subjects in the trials that they're 12 overseeing? 13 MR. ALSOP: That's a misstatement of

14 the evidence here. I'll object, but go ahead. 15 MR. HUTCHINSON: Same. Lack of

16 foundation, but go ahead. 17 THE WITNESS: I guess I don't know

18 the answer if I would be the one responsible to 19 report complaints to IRB. 20 BY MS. PEARSON: 21 Q. So you're saying there is no policy in

22 place from the University of Minnesota's IRB that 23 would direct a response from you after hearing 24 something like this from the mother of a clinical

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25 trial subject?

109 1 A. I don't know if there's a policy or not on

2 that. I really don't. 3 Q. But you don't know of one, as you sit here

4 today, correct? 5 A. I don't know. I would be making a guess if

6 I said that I know with certainty. I don't know. 7 Q. But you can't recall at this moment that

8 there is a policy that would direct you to report 9 this type of complaint to the IRB? 10 11 A. MR. ALSOP: Same objections. I don't know if there is a policy like that

12 to report this. 13 Q. Do you know whether or not Dr. Olson

14 reported this complaint -15 16 17 A. Q. A. I don't know if he did. -- to the IRB? I don't know that he did report this

18 specific complaint to the IRB. 19 Q. Would there have been anything that would

20 have prevented you from going to the IRB with this 21 clinical trial subject's concern? 22 A. No. Like being told, "Don't tell IRB this"

23 or -24 Q. Uh-huh.

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110 1 Q. So it would have been something you could

2 have easily gotten on the phone and told the IRB and 3 said, "Guess what? We've got some concerns here. We 4 don't know what to do. We just wanted to notify you 5 just to alert you there are some concerns." 6 MR. HUTCHINSON: Just a second, the

7 "we don't know what to do" part of that is assuming 8 facts not in evidence, lacking foundation, calling 9 for speculation and conjecture. Go ahead. 10 THE WITNESS: Could you ask the

11 question again. 12 BY MS. PEARSON: 13 Q. It could have been something you could have

14 done. You could have gotten on the phone and said, 15 "Look, we've got a complaint regarding one of our 16 vulnerable adults" and you know, setting aside, I 17 just want to clarify an understanding: You do 18 understand that Daniel Markingson, under law, 19 Minnesota law, is designated as a vulnerable adult. 20 You do know that, correct? 21 MR. HUTCHINSON: Objection, lack of

22 foundation. Go ahead. 23 THE WITNESS: I believe he would be

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24 considered a vulnerable adult. 25 BY MS. PEARSON:

111 1 Q. We've got a vulnerable adult whose mother

2 is contacting the study coordinator complaining that 3 the medications in the study are not working and that 4 she has concerns about the lack of response and she 5 says to you, "Do we have to wait until he kills 6 himself or someone else before anyone else does a 7 thing?" 8 9 10 A. Uh-huh. Okay. MR. HUTCHINSON: So -THE WITNESS: Say the question again.

11 BY MS. PEARSON: 12 Q. So that's not something that you think

13 ought to be reported to the IRB? 14 A. At that time, I did not think that was

15 something I had to report to the IRB. I felt that 16 that was something I had to report to Dr. Olson. 17 18 19 20 21 Q. A. Q. A. Q. And you did report it to Dr. Olson. Yes. Did you report it to anybody else? I don't remember. What else did you do in response to this

22 concern expressed by Mrs. Weiss? 23 A. I remember --

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MR. HUTCHINSON: You want her to --

25 other than what she wrote in her note, or you want

112 1 her to repeat what's in the note or -2 MS. PEARSON: I want to know if she

3 did anything other than write it down and tell Dr. 4 Olson. 5 MR. HUTCHINSON: Well, the writing

6 described some of the things she did. That's why I'm 7 asking the question. Do you want her to -8 BY MS. PEARSON: 9 Q. Well, go ahead. You know, what else did

10 you do? 11 A. I called the group home to find out what it

12 was she was talking about. 13 14 Q. A. And what was that? Oh, there was something about -- what I

15 remember was that they went to pick him up for Easter 16 and he didn't want to come or something like that and 17 that's when he made the comment to, I believe it was 18 the boyfriend, that, his fists were doubled and he 19 said something about "I'm invisible." And then I 20 called the group home to see what happened and they 21 remembered saying well, they thought there was some 22 kind of miscommunication about what time he was being

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23 picked up, et cetera, and I said to her, you know, 24 "Are you having any concerns about Dan?" And she 25 said, "No, he's fine here."

113 1 BY MS. PEARSON: 2 Q. And that satisfied you that you did not

3 have to account any further on Mrs. Weiss' concerns 4 that her son may kill himself. 5 MR. HUTCHINSON: That's not what she

6 said. That's not what mom is reported to have said. 7 I think she's asking if you did anything else after 8 hearing that. Apparently that's what you're asking. 9 THE WITNESS: I don't remember what

10 else I did. 11 BY MS. PEARSON: 12 Q. I guess I'm asking if the explanation from

13 the Theo House satisfied you that there is nothing 14 further to be concerned about after his mother calls 15 and says, "Do we have to wait to kill himself or 16 someone else before anyone does anything?" 17 A. No, I don't think that would satisfy me,

18 because I believe that, you know, we have to listen 19 to everything and continue. But in terms of making 20 any decisions, I mean, we have to take it from 21 everybody. How do I decide who to believe, one 22 person over another? I mean -file:///C|/Users/ellio023/Desktop/Rothenberg%20letter%20to%20Mike/kenny%20depo%20(2).txt[11/10/2012 11:01:28 AM]



Who is right here, Jeanne -- Mrs. Kenney?

24 I apologize. I apologize. Who was right here? 25 MR. HUTCHINSON: Well --

114 1 MS. SVITAK: I'm going to object,

2 argumentative. 3 MR. HUTCHINSON: Just a second.

4 BY MS. PEARSON: 5 Q. What happened to Mr. Markingson before this

6 study was completed? 7 A. I know what happened to him, but I don't

8 know -9 Q. I'm sorry. What happened to Mr.

10 Markingson? Please answer the question. 11 12 13 14 A. Mr. Markingson killed himself. (WHEREUPON, Deposition Exhibit No. 38 was marked for identification by the Reporter.)

15 BY MS. PEARSON: 16 Q. Okay. I have marked a series of documents

17 here that I'm going to pass out, and to save time, 18 I'm going to give everyone their copies, and we can 19 just go through it. Otherwise, it will take quite a 20 bit of time. The first one is -21 A. Is this for me?

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22 23 24

(WHEREUPON, Deposition Exhibit No. 39 was marked for identification by the Reporter.)


115 1 Q. Yes, it is. Mrs. Kenney, Deposition 38,

2 and as you can see, it is a collection of copies of 3 the labels. The next document here is entitled a 4 Drug Accountability Log. And it's marked Kenney 39. 5 MR. ALSOP: I have two pages. One is

6 stapled together and one is not. 7 MS. PEARSON: Okay. The Drug

8 Accountability Log -9 MR. HUTCHINSON: Is that a one-page

10 document? 11 MS. PEARSON: No, it's several pages.

12 It should start with the page that looks like this. 13 14 15 MR. ALSOP: 12/05/03. MS. PEARSON: Correct. MR. HUTCHINSON: 171.

16 BY MS. PEARSON: 17 Q. Correct. And the next page is PSY-000159,

18 the next page is PSY-000196. And the next page is 19 PSY-000197, and PSY-000198, and PSY-000199. 20 21 A. Q. Okay. And I think for the next, what we'll do is

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22 go through a few visits at a time, because otherwise, 23 we'll have too many documents in front of the 24 witness, and I don't do well with that. 25 (WHEREUPON, Deposition

116 1 2 Exhibit No. 40 was marked for identification by the Reporter.)

3 BY MS. PEARSON: 4 Q. Okay. And the last one that I'll pass out,

5 Kenney 40, and this is Medication Adherence Form for 6 visit one of the Cafe Study. 7 Ms. Kenney, I've got three categories of

8 documents set in front of you. The first one, as 9 we've identified, beginning with PSY-000148 is a 10 series of it looks like images from the label of 11 bottles that were dispensed to Daniel Markingson. Do 12 you see that document? 13 14 A. Q. Yes. And at the top of the page we've got

15 initials DRM? 16 17 18 19 A. Q. A. Q. Yes. And the site patient number is 00100013? Yes. And do you recollect that being Dan

20 Markingson's designation during the clinical trial?

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21 22

A. Q.

Yes. Can you explain what this document entails

23 and what is in front of us here? 24 A. Okay. These are copies of the labels that

25 were originally attached to the study med bottles.

117 1 There would be a duplicate form on the bottle, 2 duplicate meaning just the written part. So when 3 myself or someone else would give the bottle, we 4 would fill out the information. And so he would have 5 on the bottle the information on his bottle and then 6 the same information is here in our record. 7 Q. And then to the very far right, there looks

8 like little boxes with notations in them, and it 9 looks like visit number and starts with BL. Is that 10 baseline? 11 12 A. Q. Yes. And then there is visit number three.

13 Visit number five. And I'm reading down the page. 14 On the next page we have visit number six, visit 15 number seven, eight, interim, it looks like. 16 17 A. Q. Uh-huh. On the third page visit nine, visit 10,

18 another visit 10, and on the last page, we have two 19 visit 11s referenced by the labels; is that correct? 20 A. Yes.

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Or the copies of the labels. Then the next

22 category of documents I have in front of you, Ms. 23 Kenney, is it looks like a Drug Accountability Form? 24 25 A. Q. Yes. And they start with, I'm not going to give

118 1 the Bates range, but the first page is 000171. 2 3 A. Q. Okay. And -- well, we'll go through the rest.

4 The next PSY-000195. 5 6 7 8 A. Q. A. Q. Yes. Through 199. Yes, I have those. And on the top of the Drug Accountability

9 Log each page is initials DRM. 10 11 12 13 A. Q. A. Q. Okay. And site patient number 00100013? Yes. And again, that references Mr. Markingson's

14 designation in the clinical trial? 15 16 A. Q. Yes. And on the upper right-hand corner of each

17 of these pages it looks like we've got a different 18 date and a different visit designation; is that 19 correct?

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20 21

A. Q.

Yes. And we can go over in detail as we move

22 along through these documents what those are. The 23 third set of documents that I've got in front of you, 24 Ms. Kenney, is what's called the Medication Adherence 25 Form?

119 1 2 3 4 5 6 A. Q. A. Q. A. Q. Yes. Again, it starts CS000285? Yes. And it goes to 000288; is that correct? Yes. And, again, at the top of this set of

7 documents are the initials DRM and site patient 8 number 00100013, and again, that designates 9 Mr. Markingson's identification in this clinical 10 trial; is that correct? 11 12 A. Q. Yes. And on the upper right-hand corner of this

13 page we've got the date 12/11/2003 visit 1; is that 14 correct? 15 16 A. Q. Yes. And the rater's initials are on this page,

17 and do you recognize those initials? 18 19 A. Q. Those are my initials JMK. And I'm going to walk through what I think

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20 I understand these documents, and I'll have to say, I 21 did not find these documents in one place. I had to 22 go to three different sources to find these 23 documents. And we can talk about that later. 24 Okay. What I want to first do is track

25 down every single bottle between the page that has

120 1 copies of the labels and the drug accountability log 2 so we know every single bottle is accounted for in 3 the drug accountability log? 4 5 A. Q. Okay. We're going to start with the first entry

6 and that -- I'm going to use bottle I.D. number to 7 identify these. That bottle I.D. is number 505561, 8 and if I go over to the drug accountability log, I 9 see two entries for that number. 10 11 A. Q. Yes. And I look at the date bottle dispensed and

12 the date bottle returned. And it looks like this 13 first entry is a fairly clear record of the bottles 14 and were dispensed to Mr. Markingson, actually one 15 bottle, on December 5, 2003. It looks like you gave 16 this bottle to Mr. Markingson; is that correct? 17 18 A. Q. Yes. Okay. And then he returned that bottle on

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19 December 11, 2003; is that correct? 20 21 22 23 A. Q. A. Q. Yes. And then you've got the pill counts here? Yes. Let's go through, first of all, and make

24 sure we have all of the bottles accounted for him and 25 then we'll go through all of the specific entries.

121 1 The copies of the labels we've got on PSY-000148 is 2 bottle ID number 507182? 3 4 A. Q. Yes. And if we go to the next page of the drug

5 accountability log, we see two entries for that 6 number? 7 8 A. Q. Yes. And the first entry is the bottle was

9 dispensed on 12/24/2003. 10 11 A. Q. Okay. And the second entry, that bottle again was

12 dispensed on 12/31/2003; is that correct? 13 14 A. Q. Yes. The next labeling, the next copy of the

15 label is bottle I.D. number 502154? 16 17 A. Q. Yes. And if we look to the drug accountability

18 log, we see an entry for that bottle 502154 dispensed
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19 on January 8, 2004; is that correct? 20 21 A. Q. Yes. Okay. The next page we have labeled --

22 copy of a label identified as bottle 505609. 23 24 A. Q. Okay. And if we go over to the drug

25 accountability log, we see an entry for that labeled

122 1 bottle 505609 on page 000196, bottle dispensed 2 1/16/2004; is that correct? 3 4 A. Q. Uh-huh. The next bottle is a bottle identified as

5 506843. 6 7 A. Q. Okay. And we go to the drug accountability log

8 and see an entry for this bottle, 506843, bottle 9 dispensed 1/30/2004. And if we go on the next page, 10 we again see another entry for that bottle, and the 5 11 is cut off here, but it is 506843. 12 13 14 15 A. Q. A. Q. Okay. You see that? Yes, I see it. With your initials crossing through the

16 incorrect information. 17 A. Uh-huh.

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Speaking of which, when you're dealing with

19 medical records, what is the appropriate way to make 20 a change, correct an error? 21 A. How I understand it to be is to put a line

22 through it and initial and date it. 23 Q. And you never would white out any entry in

24 a medical record. 25 A. No.

123 1 2 3 Q. A. Q. Correct? Next entry is 504391. Okay. And if we go to the next page, we see an

4 entry for this bottle on page PSY-000197 and 504391 5 was dispensed both on 2/27/2004 and 3/2/2004; is that 6 correct? 7 8 A. Q. Yes. And then we go to the next page of the

9 copies of the bottle label, and the first entry is 10 bottle number 503735. Look at the copy of the 11 labels. 12 13 A. Q. Yep. The very top. Okay. Yes. Go to the Drug Accountability Form. Again,

14 you see an entry for that 503735? 15 16 A. Q. Yes. Next label, copy of the label bottle we

17 have is 501173?
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18 19

A. Q.

Yes. And if we go to the drug accountability log

20 page 000198 we see an entry for this bottle; is that 21 correct? 22 23 A. Q. Uh-huh. Yes. And then at the bottom of the same page, we

24 see a bottle number 505546? 25 A. Yes.

124 1 Q. And go to our drug accountability log and

2 we see an entry for that bottle? 3 4 A. Q. Yes. For the last page of our copies of your

5 labels, we see a bottle number 501250. 6 7 A. Q. Yes. And go over to our drug accountability log

8 and we see a dispensing on this date 4/28/2004, 9 correct? 10 11 12 13 A. Q. A. Q. Yes. And our last entry on this page is 506804? Yes. And then we go to the drug accountability

14 log and we see an entry for that bottle also. 15 16 A. Q. Yes. So up to this point, every single bottle is

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17 accounted for on the drug accountability log that was 18 dispensed in Daniel Markingson's case, correct? 19 20 A. Q. As far as I can see, yes. Are you aware of any bottles outside of

21 this recorded sheet that existed in Mr. Markingson's 22 case? 23 24 25 A. Q. A. "Bottles" meaning Cafe Study bottles? Correct. Not that I'm aware, no.

125 1 2 3 Q. A. Q. So they all should be here. They should be. Okay. Let's go to the Medication Adherence

4 Form, CS 000285, and you had testified that you 5 recognize this and these are your initials, correct? 6 7 A. Q. Yeah. Go to the last page of this document and we

8 see recorded weight for Daniel Markingson 181, 181 9 pounds, correct? 10 11 A. Q. Yes. On the second page of this document which

12 is 000286 we look at the box identified as 5 entitled 13 "Pill Count," correct? And is this where you recall 14 -- actually, tell me how this worked. 15 16 A. Q. Okay. Tell me what was done first and tell me how

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17 that information got into box number 5. And just use 18 this one as an example. 19 A. Okay. I would write down the number of --

20 for that particular visit, how many pills were 21 dispensed, and then what the count of how many he 22 returned. 23 Q. Would you first record that in the drug

24 accountability log? 25 A. I don't remember if I would do one versus

126 1 the other, you know. 2 Q. How were you instructed to complete this

3 collection of data? 4 A. I don't remember being instructed in terms

5 of which form went first or which form was second. 6 7 Q. A. So you basically just filled in the blanks? That we would need to count the meds and

8 then record it. 9 Q. Okay. So if we're looking at this first --

10 so you don't know if you first collected the data in 11 the drug accountability form and then transferred it 12 to the Medication Adherence Form. 13 14 15 A. Q. A. Right. Or vise versa. Or vise versa. I can say likely that I did

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16 the Medication Adherence Form because that was 17 probably -- because it's part of the assessment I was 18 doing while I was meeting with the patient. 19 Q. So for this very first visit, we've got --

20 why don't you explain to me why we've got one bottle 21 dispensed three times? 22 A. We would have redispensed it because there

23 were pills left in there. So we would have 24 redispensed the bottle. 25 Q. So you would issue, for instance, 505561

127 1 you would dispense that to Mr. Markingson and you 2 would hand him the bottle; is that correct? 3 4 5 6 7 A. Q. A. Q. Yep. And he would be on his way with it. And he would be on his way with it. What did he do with it after he left you? MR. HUTCHINSON: Objection, lack of

8 foundation, go ahead. 9 THE WITNESS: What I understand he

10 would do, because he was at Theo residence, he would 11 give it to them, because I do know that they were 12 supposed to dispense the pills there. 13 BY MS. PEARSON: 14 Q. Did you ever follow up after you dispensed

15 it to see whether or not they received a bottle of
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16 pills from Mr. Markingson? 17 A. Only in that they would send paperwork back

18 saying -- you know, we communicated with what pills 19 he was supposed to have and what he didn't have. So 20 I didn't call each time and say, "Hey, did Dan give 21 you this today?" 22 Q. But otherwise, you're just handing a bottle

23 of these pills to the clinical study subjects, right? 24 25 A. Q. Yes. These mentally ill subjects, right?

128 1 2 A. Q. Yes. So on the first date, then, it looks like

3 Mr. Markingson returned the bottle on 12/11/2003 and 4 you did a pill count and 124 pills were dispensed and 5 as we look over to the entry of the bottle on the 6 copies of the label, we find out there's 124 capsules 7 in each label and in fact this bottle initially was 8 dispensed 12/5/03, correct? 9 10 A. Q. Which one are we looking at? Go back and look at the label, a copy of

11 the label of the pills. I think you've got it in 12 your right hand. You've got it in your right hand. 13 14 A. Q. Okay. So just to cross-check, we know that this

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15 bottle was in fact dispensed on that day, it had 124 16 capsules if that's what the bottle described. You 17 expected 112 to return and the actual pills returned 18 were 112. 19 20 A. Q. (Witness nodded head in the affirmative.) When did you fill in the expected number of

21 pills returned? Can you tell me -- you filled it in 22 after you completed the medication return form or you 23 filled it in beforehand? 24 A. Like I said before, I'm not sure which one

25 I did first. I would have likely done the Medication

129 1 Adherence Form first. 2 Q. So when we look at expected number of pills

3 returned, that number actually was completed after 4 you counted the number of pills that were returned? 5 That box was completed after you actually counted the 6 number of pills returned? 7 A. It could have been, or I could have written

8 it, you know, after we dispensed it and, you know, 9 figured it out when he came back. But it was hard to 10 know because I wouldn't know exactly what date he 11 would be returning on, so I would have to count the 12 number of days that he was away. So -13 Q. Well, certainly on the day he returned the

14 bottle back you would know how many pills he should
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15 have returned on that day, correct, without counting 16 them first? You could calculate that amount, 17 correct? 18 19 A. Q. I could yeah. And you could fill that in to the expected

20 number of pills returned, correct? 21 22 A. Q. Uh-huh. And we know how many pills Mr. Markingson

23 took on each day because the dose changed, tracking 24 right underneath the Drug Accountability Log box 25 identifying how many pills he was to take during a

130 1 visit, times between visits, correct? 2 3 A. Q. Yes. So on this first visit on 12/5 he was to

4 take two pills a day. 5 6 A. Q. Yes. And then I'm trying to figure out when,

7 exactly, you calculated the expected number of pills 8 returned, whether it was after you did the math of 9 counting the pills coming back or whether it was 10 something you calculated when you received the 11 bottle. 12 13 A. Q. I'm sorry. Say that again. I'm trying to figure out, when you

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14 calculated the expected number of pills returned, 15 whether it was based on the date that the bottle was 16 returned and number of pills taken per day or was it 17 a number you obtained after you subtracted the number 18 of pills returned. 19 A. The number expected to be returned would be

20 based on the day he returned. It would be calculated 21 on that, not based on how many pills were returned. 22 Q. So you would multiply the number of days he

23 was out and then just by the number of pills he took 24 today and fill in this box, correct? 25 A. Yes.

131 1 Q. And then it looks like you redispensed the

2 medication. Are you the one that redispenced this 3 medication on 12/11, then? 4 A. I don't remember if it was redispensed or

5 if it was instructions to change it at that time. 6 Oh, okay. That was back when he returned it, yeah. 7 So say the question again. I'm sorry. 8 Q. I'm just asking, you've got your rater's

9 initials after the 12/11 start date and I'm wondering 10 if that indicates you were the person who gave these 11 pills to Dan Markingson. 12 13 A. Q. Yes. On 12/11. And similarly, on 12/15 -- or

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14 wait. I can't read that. Someone wrote over this 15 date. Can you read what that date says? 16 17 18 19 20 21 A. Q. A. Q. A. Q. 12/14. Is it 12/14? Yes. And that's the start date? Yes. How does that match up to your drug

22 accountability log? 23 A. Could you repeat the question? I'm not

24 sure what -25 Q. I'm trying to figure out how you calculated

132 1 the next set of expected number of pills to return. 2 It looks like, in your dose tracking changes, you've 3 got four pills per day starting 12/11/2003 and the 4 stop date of four pills per day is 12/13/2003; is 5 that correct? 6 A. Yes, because it looks like he was to start

7 two pills per day on the 11th and we had to do that 8 for two days, and then was increased to two and 9 three. 10 Q. Okay. Do you know whose writing that is

11 that wrote over that date instead of drawing a line 12 through it and putting their initials next to it?

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13 14

A. Q.

That was probably me. Okay. And the fact that your initials are

15 at the end, does that indicate that you're the person 16 who collected these pills as well as gave them out? 17 A. Well, in terms of handing him the bottle,

18 because oftentimes Dr. Olson was in on the visits 19 because he would have to say how many he was supposed 20 to take. 21 22 Q. A. He was sitting in on the visits? Dr. Olson sat in on the visits, yeah. Not

23 every, but any time we made a medication change, yes. 24 Q. And that would be recorded in the medical

25 records, correct?

133 1 2 3 A. Q. A. Whether or not he sat there or not? Whether or not he was part of the visit. Not always. I mean, I don't know if I'd

4 say specifically Elizabeth was sitting here, Jeanne 5 was sitting, you know. 6 Q. Okay. So on 12/14, then, it looks like he

7 was to take five pills a day; is that correct? 8 9 A. Q. Yes. And again, there's someone that wrote over

10 the date rather than drawing a line through it with 11 their initials, correct? 12 A. Yes.

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So on 12/14, somehow communication got to

14 Mr. Markingson that he needed to take five pills a 15 day and then stopping on 12/19 and you have, going 16 back to the drug accountability log, 12/19 was the 17 date that the bottle came back and you've got the 18 number of pills dispensed 112 and expected number of 19 pills returned. And again, did you calculate that 20 after you counted the actual number of pills returned 21 or how did you come up with that number? 22 A. Again, it would be based on the number of

23 days he was to take the pills. Again, I don't know 24 if I -- which I did first or second. 25 Q. All right. Would it be appropriate,

134 1 though, most appropriate to calculate the expected 2 number of pills returned first, correct? 3 A. Well, yes, because then I would know if he

4 took the appropriate amount. 5 Q. All right. And then we see, then, on 12/19

6 the same bottle, 505561 was dispensed on 12/19/2003, 7 correct? And returned on 12/24/2003. 8 9 A. Q. Yes. And that number of pills dispensed was 76

10 and the number returned was 41. We go to visit one, 11 we see that it was accurately reflected in the drug

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12 accountability log. Is that correct? Is that's how 13 you see the information? 14 15 A. Q. Yeah, I see that as being accurate. Okay. Let's go to visit two. And now for

16 each entry, is that a new visit? So 12/05 to 12/11 17 is visit one and 12/11 to 12/19 is visit two? 18 19 20 A. Q. A. Not always necessarily. Okay. You know, we could have made a change based

21 over the phone or if he, you know, if we knew that 22 one bottle would end and, you know, he might take the 23 remainder of one bottle and then get a new bottle to 24 start when the other one completed. 25 (WHEREUPON, Deposition

135 1 2 Exhibit No. 41 was marked for identification by the Reporter.)

3 BY MS. PEARSON: 4 Q. All right. So we're looking at the next

5 visit, Kenney 41, and it looks like it's a visit, the 6 date on the upper right-hand corner is 12/19/2003, 7 visit starting with CS 000887. 8 9 A. Q. Yep. And do you recognize the initials under

10 rater's initials? 11 A. Yes.

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And if we turn the page to medications

13 given on this form we are looking at a pill count. 14 15 A. Q. Yes. All right. And 12/19 as we see, go to the

16 drug accountability log, we see 12/19. You issued a 17 bottle -- well, can you explain to me why it looks 18 like on 12/19 a bottle was dispensed with 76 pills in 19 it, but in visit two you've got recorded 112 number 20 of pills dispensed under 5A? 21 22 23 A. Q. A. He returned 112 on the 19th. Okay. Or, no. I'm sorry. 112 were dispensed on

24 the 19th and then he returned -- I'm sorry. I'm 25 getting confused.

136 1 Q. No, you're not. You're not confused.

2 You're reading what's in front of you. 3 4 MR. HUTCHINSON: Well, just a second. MS. PEARSON: No, no. I tell you --

5 and I understand. I will be very patient, because 6 this took me a long time and several places to find 7 these documents to put this together so -8 MR. HUTCHINSON: Yeah, but you don't

9 tell her if she's confused. 10 MS. PEARSON: Oh, did I say that?

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11 I'm sorry. I did not -- I meant to say I understand. 12 MR. HUTCHINSON: You don't tell her

13 you're not confused. 14 MS. PEARSON: Oh, I didn't think she

15 was confused. I don't think it plays out. 16 MR. HUTCHINSON: So where do you

17 think there is an error? 18 MS. PEARSON: No, I'm asking Ms.

19 Kenney if she can explain to me why there is -- why 20 do we have 112 pills dispensed on 12/19 -21 MR. ALSOP: No, you're misreading the

22 document. 23 MR. HUTCHINSON: Originally

24 dispensed. 25 MR. ALSOP: 112 dispensed on

137 1 12/11/03. 2 3 THE WITNESS: Yes. MS. PEARSON: Okay. Number

4 dispensed, so that's 112. 5 6 7 8 MR. ALSOP: On the 11th. MS. PEARSON: On the 11th. MR. ALSOP: Yes. THE WITNESS: Yes.

9 BY MS. PEARSON: 10 Q. And then it was returned and then we have

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11 76? 12 13 A. That he actually returned. MR. HUTCHINSON: Actually returns.

14 BY MS. PEARSON: 15 Q. And expected number of pills returned

16 was -17 18 A. Q. 75. So he brought back one too many. And then -- so then you have -- wait a

19 minute. I've got expected number of pills, number 20 returned was 76? 21 22 23 24 25 A. Q. A. Q. A. Yes. And expected was 75? Yes. What is this number 36 here? How many he took.

138 1 MR. HUTCHINSON: It's the difference

2 between 112 and -3 BY MS. PEARSON: 4 Q. So that's 90 percent, 99 percent. Okay. I

5 didn't think there was an error on this one. I was 6 surprised. 7 8 9 A. No. (WHEREUPON, Deposition Exhibit No. 42 was marked for

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identification by the Reporter.)

11 BY MS. PEARSON: 12 Q. Okay. Then let's go to visit number 42.

13 I'm sorry. Exhibit No. 42, visit number three. And 14 we're going to be doing this exercise with each 15 visit. 16 17 it? 18 MS. PEARSON: Yes, there is. MR. HUTCHINSON: Is there a point to

19 BY MS. PEARSON: 20 Q. Next we have -- okay on the upper

21 right-hand corner of document 000352 I have the date 22 of 12/24/2003 visit number three. Do you have that 23 in front of you? 24 25 A. Q. Yes. Let's go to the pill count box number five

139 1 and see if we can track this one. And the date this 2 bottle was returned was 12/24/2003? 3 4 A. Q. Yes. And that would match up with 5A where there

5 was 76 pills dispensed, correct, and 41 returned. 6 I'm sorry. Do you follow where I'm going? 7 8 A. Q. I think so. Okay. All right. Do you want to take a

9 moment to look at it?
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10 11 12 13 14 15 16 17

A. Q. A. Q. A. Q. A. Q.

76 returned. And then -Uh-huh. -- number of pills returned 41. Yes. And actual pills returned 41. Yes. So we've got number taken 35 and we've got

18 100 percent compliance on this, correct? 19 20 A. Q. Yes. And then again under six, you correct an

21 error there? 22 23 A. Q. Yes. By drawing a line through the error and

24 putting your initials and the date, correct? 25 A. Yes.

140 1 2 3 (WHEREUPON, Deposition Exhibit No. 43 - 50 was marked for identification by the Reporter.)

4 BY MS. PEARSON: 5 Q. Okay. Visit four is 43, Kenney 43. And it

6 looks like visit four, I've got 000424, upper 7 right-hand corner is the date 12/31/2003, visit 8 number four.

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9 10

A. Q.

Yes. And now on this date, it looks like we've

11 got somewhat of a division of the number of pills he 12 should be taking per day, or is it -- for this entire 13 visit should he have taken seven pills a day or can 14 you tell by looking at the dose tracking change? 15 A. Okay. So we're talking from the period of

16 12/24 to 12/31 of '03? 17 Q. Well, the period of time that would

18 represent between visit three and visit four. 19 20 21 A. Okay. So actually the next -MR. HUTCHINSON: It's the next page. THE WITNESS: This one?

22 BY MS. PEARSON: 23 24 25 Q. A. Q. So we're now on to a new bottle, correct? Can you tell me which bottle you're -I'm looking at -- well, it seems like a

141 1 bottle was dispensed on 12/24/2003 and that bottle 2 number was 507182? 3 4 A. Q. Yes. And that bottle, it looks like from that

5 bottle, seven pills a day should be taken; is that 6 correct? 7 8 A. Q. Yes. All right. Then the bottle was returned on

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9 12/31/2003; is that correct? 10 11 A. Q. Uh-huh. And if we look at box five on the

12 Medication Adherence Form, the pill count, I'm going 13 to see if we can line this up again. And there's -14 15 A. Q. 124 and 75. 124 pills and expected pills returned would

16 be 75, actual pills returned was 75, and so that 17 lines up with 100 percent compliance, correct? 18 19 A. Q. Yes. Visit five, and we have in front of you a

20 document that is marked CS 000458. 21 22 A. Q. Yes. Upper right-hand corner, the date is

23 January 8, 2004. 24 25 A. Q. Yes. And can you tell me whose initials are the

142 1 rater's initials? 2 3 4 5 A. Q. A. Q. Those are Tanya Addelman's. Who is Tanya Addelman? Tanya was also one of our assistants there. What qualifications did Tanya Addleman

6 have? 7 A. I believe she had a Bachelor's degree. I'm

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8 not sure in what. I guess I don't know what her 9 qualifications are. 10 Q. From looking at this document, does it look

11 like Ms. Addelman was the person who took the pills 12 from Mr. Markingson and also dispensed them? 13 A. I can't say if she dispensed them. I can

14 say she took them and counted them. 15 Q. How would we track who dispensed these

16 pills to Mr. Markingson on this visit? 17 A. I don't -- I'm trying to remember how we

18 did that. It could have been Dr. Olson, could have 19 been me, could have been Elizabeth. 20 Q. But that's something you would keep track

21 of, wouldn't you, keeping a record of who is 22 dispensing pills? 23 24 A. Q. We could look at the notes for that day. Okay. And on this particular date, January

25 8, 2004, visit five, let's see if we can track that

143 1 with the drug accountability log. 2 3 A. Q. Okay. And if we look to see on the accountability

4 log, we've got a date bottle dispensed was 1/8/2004. 5 6 A. Q. Okay. And -- I'm sorry. Going back to date

7 bottle returned, it looks like bottle 507182 was
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8 returned on this date. Is that how you interpret the 9 data? 10 11 12 13 A. Q. A. Yes. 75 pills were returned? No. MR. ALSOP: No, no.

14 BY MS. PEARSON: 15 16 17 18 19 Q. A. Q. A. Q. I'm sorry, dispensed. Yes. And 15 were returned? Yes. That's what you expected. What is "E dose

20 taken"? 21 A. Oh, that probably means in terms of my

22 trying to figure out how many pills came back, 23 whether or not he took -- if he took his morning dose 24 yet or had just taken the evening dose. 25 Q. And you're saying that's -- this is your

144 1 writing here? 2 3 A. Q. Yes, it looks like mine. Okay. So then we see that on this

4 particular visit five, it looks like we've got 100 5 percent compliance, correct? 6 A. Yes.

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MS. PEARSON: Okay. We're going to

8 change the tape. 9 10 (Brief interruption.) TAPE 4

11 BY MS. PEARSON: 12 Q. All right, Ms. Kenney, I put in front of

13 you Exhibit No. 45 and in the upper right-hand corner 14 we see a date of January 16, 2004, visit number six. 15 Again, patient's initials DRM for document CS 000524. 16 Do you see that? 17 18 19 20 A. Q. A. Q. 000524, yes. Who are the rater's initials? Those are my initials, Jeanne Kenney. And I'm trying to make sure that we're

21 tracking the correct bottles here, because I think 22 that's real important, and it looks like from the 23 last visit -- did we finish with bottle 507182? 24 25 A. Q. Yes. So bottle 507182 is now empty and gone and

145 1 no longer part of your data collecting. 2 3 A. Q. Uh-huh. All right. So we're looking at -- and on

4 that date it looks like bottle -- I'm sorry, on that 5 last visit, on visit number five, it looks like 6 bottle 502154 was dispensed; is that correct.
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7 8

A. Q.

Yes, that's what it looks like. Begin 1/9/2004 and I take it even though

9 the date the bottle was dispensed was January 8th, it 10 was actually -- dosages began removing from it 11 January 9th; is that correct? 12 13 A. Q. That's what it would indicate to me, yes. So this, on January 16, 2004, visit six,

14 pills from this bottle were returned and if we go to 15 pill count number five we look at 124 pills that were 16 dispensed, and again, we know that that's the amount 17 of pills that each bottle contained. Then if I look 18 at the drug accountability log, it looks like a 19 little math calculation going on here. 20 21 A. Q. That's what it looks like. But it looks like 52 pills, which, as we

22 look over in 5C, that was the number taken. That 23 number was subtracted from 124 and then we've got the 24 figure, is it 92 or 72? 25 A. 72.

146 1 Q. Okay. Now again, is this how you

2 calculated the expected number of pills returned? 3 Because that number then was put into -4 A. Yeah. I would have counted how many he was

5 taking each day with the amount of days and

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6 subtracted it from the number of pills dispensed, 7 which should be the expected number returned. 8 Q. And I guess my question to you is, did the

9 number 52 come from after you finished counting the 10 pills or -11 12 13 A. Q. A. No. Okay. Where did that 52 come from? The 52 would come from the amount of days

14 he was taking the medications with the number of 15 pills he should take each day. 16 Q. But if we look over at the -- okay. The

17 number taken was 52, and the number -- okay. If we 18 look for the number taken is 52 and the number he 19 should have taken was 52, I guess I'm wondering what 20 came first, the chicken or the egg. You calculate 21 the amount that they should have -- expected pills to 22 return, so you -- and that's how you got the 72. 23 There's two separate processes going on here, 24 correct? 25 A. Yeah, yeah. I would count the number of

147 1 pills he returns, and then at some point, regardless 2 of how many he returns or not, I'm still counting the 3 same number he should have taken. It doesn't have a 4 bearing. 5 MR. HUTCHINSON: That was a partial

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6 sentence. 7 8 THE WITNESS: I'm sorry. MR. HUTCHINSON: I understood it when

9 she said it three times ago. 10 BY MS. PEARSON: 11 Q. Okay. Then let's go to the next visit,

12 visit number seven. And this is Kenney -13 MR. HUTCHINSON: Can I clarify? 52

14 is an odd number. If he was taking seven pills a day 15 for seven days or eight days, you'd come up with a 16 different number. So is there a partial day in there 17 somewhere? 18 THE WITNESS: Well, I'm wondering,

19 yeah, like it would be counted like depending if he 20 started in the morning or evening. 21 MR. HUTCHINSON: Seven pills a day

22 for seven days is 49, seven pills for eight days is 23 56. 52 is in between those two. 24 THE WITNESS: That would probably be

25 because of morning or evening time.

148 1 BY MS. PEARSON: 2 Q. And in fact, you had documented that on one

3 of the visits when you said "evening dose taken," 4 correct?

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6 BY MS. PEARSON: 7 Q. But you did not document this, on this

8 particular date, that the evening dose was taken. 9 A. Yeah, I think that was just a note to

10 myself. 11 MR. HUTCHINSON: That is the

12 documentation. 13 14 Q. Well -MR. HUTCHINSON: The evening dose

15 taken means -16 BY MS. PEARSON: 17 Q. Again, on 1/9/2004. Actually, these were

18 not ones I was having problems with, so I was hoping 19 we could whip through these quickly. Anyway, okay. 20 The next visit, and it looks like on the 16th we 21 dispensed pill bottle number 502154. 22 23 24 A. Again. MR. HUTCHINSON: Containing 72 pills. THE WITNESS: Uh-huh.


149 1 Q. And if we go over to Exhibit 46, do you

2 have 46 in front of you? 3 4 A. Q. Yes. Which is visit seven?

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5 6


Yes. MR. HUTCHINSON: Looks like they gave

7 him two bottles that day, correct? 8 THE WITNESS: Yes.

9 BY MS. PEARSON: 10 Q. On this particular day, we've got recorded

11 two bottles being dispensed, 502154 and 505609; is 12 that correct? 13 14 A. Q. Yes. And number of pills dispensed from 502154,

15 72, and the number of pills dispensed from 505609 is 16 the full bottle, 124 pills, correct? 17 18 A. Q. Yes. So if we were to go to the Medication

19 Adherence Form box five, and that looks like 5A, the 20 number of pills dispensed is 196, which that's 21 correct? 22 23 A. Q. Yes. The number returned, which actually you

24 completed, was 92, correct? Number returned was 92? 25 A. (Witness nodded head in the affirmative.)

150 1 Q. Number taken was 104, number should have

2 taken was 98, and we've got 106 percent compliance. 3 How does that work?

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I think I remember writing a note because

5 sometimes that would happen where a patient would 6 take more than they were supposed to, and I think 7 with Dan, there was some question because he, when 8 they were dispensing them, whether or not it was in a 9 -- they were already maybe dispensed in his drug -10 like they probably gave him a medication box or 11 something. I don't know exactly why it turned out 12 that way, but I certainly have seen that before where 13 they returned, you know, less than they should have. 14 15 Q. A. What's a medication box? A medication box would be something that a

16 person would use, like they would set up their pills 17 for them, probably would put for each day of the week 18 for that particular patient. Again, I'm just 19 assuming that's something they could have done at 20 Theo, because they had to dispense pills to him. 21 Q. Did you contact Theo and find out why we

22 have 106 percent compliance? 23 A. I don't remember if I contacted them or if

24 I just, you know, had asked Dan, "Well, what do you 25 think happened in this case?"

151 1 Q. Do you have a documentation of tracking why

2 they have 106 percent compliance? 3 A. You could look in the clinical notes and

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4 see if I wrote anything to that account. 5 Q. I think I recall seeing your postulation,

6 but I didn't see anything that documented a 7 follow-up, and I'm wondering if you recall anything 8 other than what is in your clinical note. 9 10 A. Q. I don't recall. Did you typically call to follow up to see

11 why there's 106 percent compliance in a clinical 12 study subject? 13 A. I oftentimes, if it were someone else, I

14 could only go by what they told me. 15 16 17 Q. A. Q. What the clinical subject told you? Yes. There's no other way to track compliance in

18 this clinical study? 19 A. I guess I could have called and asked the

20 group home. I don't remember if I did or not. 21 Q. Six pills is almost an entire dosage, isn't

22 it? If we go back to see how many pills he was 23 assigned that day, it's seven pills a day, and that's 24 almost an entire day's medication. Did that concern 25 you that this person is getting overmedicated?

152 1 2 A. Q. Not for one day, no. Not for one day. Because why?

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I just -- kind of based on our own

4 experience of, you know, my own medications or 5 something, if I took one, I don't think that would be 6 anything to scare me, and I'd never heard that taking 7 one too many pills would hurt anyone. So -8 9 Q. A. But this was six too many pills. Six too many pills was, really, they were

10 all small doses, so it really only would have been 11 like one pill possibly. 12 13 Q. A. Possibly. But you don't know that. Well, I don't -- at the time, I didn't know

14 which medication. All I knew is that they would get 15 lots of pills, based -- which could have been really 16 like, if it was an over-the-counter dispensed, it 17 would have only been maybe one pill. It's based on 18 the dosage, I would think, versus the number of 19 pills. 20 Q. Were all the pills -- were you the person

21 that counted all of the pills for a large part of the 22 clinical subjects when they came back? 23 24 25 A. Q. A. I did a lot of the time, not always. What did they look like? They were big gray pills.

153 1 2 Q. A. All of them were the same? All of them were the same.

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Did you notify Dr. Olson about this breach

4 in protocol? 5 MR. HUTCHINSON: I'm going to object

6 to the characterization. I think you're asking her 7 if she notified Dr. Olson that the patient took six 8 pills more than he should have. I think that's the 9 question, right? 10 MS. PEARSON: I think I characterized

11 it as a breach of protocol. 12 13 14 THE WITNESS: Yeah. MS. SVITAK: Object as argumentative. THE WITNESS: I don't remember if I

15 told him or not. 16 BY MS. PEARSON: 17 Q. Okay. You had mentioned to me a few

18 minutes ago that there was correspondence going from 19 the Theo House to you. Would this correspondence be 20 traveling with Dan and he would hand you a paper? 21 22 A. Q. Yep. Okay. And I'm going to put in front of you

23 Kenney No. 47 and ask if this document looks familiar 24 to you. 25 A. Uh-huh.

154 1 Q. What is this?

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2 3


4 BY MS. PEARSON: 5 6 Q. A. And what is this document? This was a communication from Theo

7 residence about what they knew he was taking for 8 medications, up at the top, diagnosis, their comments 9 and then if I wrote anything, any response. 10 Q. And so this is a document generated from

11 the Theo House, correct? 12 13 A. Q. Yes. They would send a document like this each

14 time with Dan to the clinical study visit? 15 16 A. Q. Usually. Okay. And this, the date on this document

17 is January 30, 2004, and I apologize, it's 18 BHC-000147. 19 20 A. Q. Yes. And on -- could you read for me, please,

21 the staff comment that came from Theo House to you on 22 this visit? 23 A. "We have started to," I think, "put Dan's

24 meds into his hand - have him take the meds and show 25 us his empty hand - a couple staff members were

155 1 questioning his med compliance - there have been no
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2 problems since we have been double-checking." 3 Q. And why would something like this be

4 significant to you as a person collecting data on a 5 clinical trial? 6 A. To see if he was really taking the

7 medications or not. 8 Q. When you received this information, what

9 did you do with it? 10 A. Well, I don't remember at the time,

11 specifically, what I did. But I may have very well 12 told Dr. Olson about it. I would have possibly wrote 13 a note about it in my clinical notes. I don't 14 remember, specifically, what I did at that time. I 15 remember remembering like, "Oh, he might not be 16 taking his medications." 17 Q. Okay. And how does this fit with a

18 compliance data for that day for that visit? 19 20 21 22 A. Q. A. Well -- okay. It doesn't jibe, does it? I don't understand the question. MR. HUTCHINSON: Nor do I.

23 BY MS. PEARSON: 24 Q. Is it consistent with the fact that Daniel

25 might be not taking medications when we have a 106


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1 compliance report on January 30, 2004 for visit 2 seven? 3 MR. ALSOP: Object as vague,

4 ambiguous. I don't know what you're asking. 5 MR. HUTCHINSON: Same.

6 BY MS. PEARSON: 7 Q. Well, I guess for a person who is

8 collecting data in a clinical study, it's very, very 9 important to make sure that the data you're 10 collecting is accurate, correct? 11 12 A. Q. To the best I can. And when a person is being -- when a

13 clinical study is involving testing medication, it's 14 very, very important to get an accurate report on 15 compliance of a patient taking that medication, 16 correct? 17 A. Yes, based on -- but we're limited on just

18 being able to count. I could never go home with each 19 and every patient to make sure they were -- I mean, 20 they could count out the pills and make it look like 21 they took them. I would never know if they did or 22 not. 23 24 25 Q. A. Q. Do you draw blood tests? I wouldn't do a blood test, no. Could a blood test be done to check whether


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1 or not the patient is compliant with their medication 2 regimen? 3 A. That would be a question for a doctor. I'm

4 not qualified to tell you how that would be measured. 5 I know some medications can be measured, like 6 Lithium, but I don't know the answer to that. 7 Q. When Dr. Olson was explaining to you the

8 pharmacological properties of Seroquel, he did not 9 give you any indication whether or not this is a 10 medication that can be detected in your blood? 11 12 A. Q. I don't remember specifically. Do you believe that this information is

13 consistent: That we've got a report from the Theo 14 House that the clinical trial patient possibly is 15 cheeking or not taking his medication and you've got 16 data that comes back to you in the form of pill 17 counts that's saying there's a 106 percent 18 compliance? Do you think that -- for the very same 19 visit. Do you think that those two pieces of 20 information are consistent or should they have 21 triggered a flag in your head that something is going 22 on and needs to be investigated? 23 MR. ALSOP: Object to the form of the

24 question. It's multiple. 25 MR. HUTCHINSON: Same. Lacking in

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1 foundation. 2 3 4 MS. SVITAK: Same objection. MR. HUTCHINSON: Go ahead. THE WITNESS: I know it would

5 certainly raise a flag to me to question and, you 6 know, to make sure and to check next time, you know, 7 what the situation is. I don't know what I would 8 have done at that time to do anything differently, me 9 myself. 10 BY MS. PEARSON: 11 12 Q. Do you think this is a breach of protocol? MR. HUTCHINSON: Which? What is a

13 breach of protocol? 14 15 16 MR. ALSOP: It's vague. THE WITNESS: A breach of protocol? MS. SVITAK: Object to lack of

17 foundation. 18 BY MS. PEARSON: 19 Q. Do you understand -- when I'm asking you a

20 breach of protocol, do you understand what I'm 21 asking? 22 A. Well, I think that what you're saying is

23 that what was supposed to happen didn't happen in 24 terms of how many pills he was supposed to take, and 25 I think that that's part of what we look at, because

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159 1 people are human, make errors, and so he could have 2 had them dispensed incorrectly, he could have taken 3 them incorrectly. So part of what we were looking at 4 was compliance. So whether that was -- like, when I 5 hear "breach of protocol" it's like, I guess I'm not 6 -- I'm not -- I mean, that's part of what they were 7 looking at was were people compliant or not. 8 Q. You never have been trained as a clinical

9 laboratory scientist, correct? 10 11 A. Q. No. All right. Would this -- do you think this

12 should have triggered some further investigation to 13 see about what is going on with the medication 14 dispensement of Mr. Markingson? 15 16 MS. SVITAK: Object as speculative. MR. HUTCHINSON: Same. And lacking

17 foundation. "This" being he took too many pills? 18 19 MR. ALSOP: Or took too few, I guess. MS. PEARSON: We don't know. We

20 don't know what "this" is because we don't have 21 tracking of what's going on here. 22 MR. HUTCHINSON: I think we know what

23 it is. What don't we understand? 24 BY MS. PEARSON: 25 Q. I'm just asking you if you think this

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160 1 should have triggered a notification to Dr. Olson or 2 perhaps a study sponsor that there's a problem with 3 compliance, either on your part, the part of the 4 folks taking their data from the clinical trial, or 5 on your system of dispensing the medication to the 6 clinical subjects. 7 MR. HUTCHINSON: Objection, lack of

8 foundation. Also speculation. 9 10 11 MR. ALSOP: I'll join. MS. SVITAK: Same objection. THE WITNESS: I'm not sure what I'm

12 being asked to answer. 13 BY MS. PEARSON: 14 Q. Okay. That is all right. Okay. I've got

15 Kenny 48. And don't let the last visit go too far. 16 I might need it again. This is visit -- and again, I 17 have CS 000648, and the date of this visit is 18 12/13/04. 19 20 A. Q. Yes. And again, patient's initials, DRM,

21 indicating this is Daniel Markingson's record, 22 correct? 23 24 A. Q. Yes. Rater's initials are JMK, which is you, Ms.

25 Kenney, correct?

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161 1 2 A. Q. Yes. And the last page of this document, look at

3 the weight, 186. 4 5 A. Q. Yes. I'm just going to ask you to remember that

6 for later on. Now, for you to look again at our drug 7 accountability log to see what's going on with the 8 bottles -- oh, excuse me. I'm going back for the 9 moment. On the last visit, you have reported that, 10 "bottle was thrown away." 11 12 13 14 A. Q. A. Q. That 502154. And "forgot bottles" on 1/30/04, correct? Yes. I guess I'm curious, how did you presume

15 that all of these pills were missing when the bottle 16 was gone? And, you know, you didn't enter anything 17 in there, but I do think I recall on visit number 18 seven that there was an entry of pills dispensed was 19 72 plus 124, which includes both bottles. So I guess 20 you presume here that the entire bottle of pills were 21 dispensed because the bottle was never returned to 22 you; is that correct? 23 A. Okay. Whether or not the 502154 was

24 redispensed? 25 Q. No, whether or not you correctly recorded

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162 1 accurate information. The bottle was thrown away, 2 and I don't understand how you were able to make the 3 presumption that all of the pills were dispensed if 4 you never -- well, I'm sorry. The bottle was never 5 returned to you. And is that permissible, under the 6 protocol, to make a presumption that those pills were 7 all taken? 8 A. It would have been just the same as if he'd

9 of returned it empty. 10 11 Q. A. Does the protocol permit that? I don't know. I don't think there was any

12 specific thing that said yes or no to that. I think 13 I just made a decision and -14 Q. Wouldn't you think that compliance with

15 taking the medication is a key ingredient into the 16 accuracy of the data generated by this clinical 17 trial? 18 19 A. Q. Yes. Did you notify anybody that the bottle was

20 thrown away and you could not make any conclusions 21 about whether or not these pills were ingested? 22 A. Well, just like I wouldn't know for sure if

23 they were ingested for anybody returning them. With 24 him, I had a little bit more ability to think that it

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25 did because he had people monitoring his medication

163 1 compliance. 2 Q. But they were telling you that he is

3 cheeking the medication. 4 5 A. They didn't say he was cheeking them. MR. ALSOP: Misstatement of the

6 evidence here. 7 8 9 10 here. 11 BY MS. PEARSON: 12 Q. They gave you indication that he might be MR. HUTCHINSON: Just -THE WITNESS: I'm sorry. MR. HUTCHINSON: We're overlapping

13 not taking his medication, so how did you interpret 14 that information by the fact he didn't return one of 15 the bottles to you? 16 MR. HUTCHINSON: Well, object to that

17 as a misstatement of the evidence. It's 18 argumentative and lacks foundation. 19 BY MS. PEARSON: 20 Q. That's fine, but I'm asking you, how did

21 you -- you know, how were you permitted to make that 22 presumption when you've got evidence that perhaps 23 there may be an issue with his compliance? 24 MR. HUTCHINSON: Well, what date are

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25 we talking about here?

164 1 THE WITNESS: I believe the last

2 visit was January 30, 2004. "We have started to pour 3 Dan's meds into his hand - have him take the meds and 4 show us his empty hand." 5 MR. HUTCHINSON: "There have been no

6 problems since we have been double checking." 7 BY MS. PEARSON: 8 Q. "Since we have been double checking," but

9 this covers a time period that his bottle was never 10 returned to you. 11 A. And it wasn't returned because they're the

12 ones that threw it away. 13 14 Q. A. Where is that documentation? I remember him telling me that and I might

15 have actually been -- I remember there was a note 16 saying to remind him that we needed to have those 17 study bottles returned to us. 18 Q. Did you call Theo house to verify whether

19 or not they, in fact, threw it away? 20 A. I don't remember if I called or not. I

21 could have very well had. 22 23 Q. A. But you don't know. I don't know for sure to be factual. I

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24 don't want to say I did. 25 Q. Okay. So were you're presented with a

165 1 patient who's returned a bottle that contains 108 2 pills only, not a second bottle, and you have a 3 report from the Theo house there is concern about 4 whether or not he's compliant with his medications; 5 is that correct? 6 MR. HUTCHINSON: That's a

7 misstatement of the evidence again. 8 9 MR. ALSOP: Argumentative also. MR. HUTCHINSON: And argumentative.

10 BY MS. PEARSON: 11 Q. Is that the information you received on

12 this particular visit? 13 MR. HUTCHINSON: Exhibit 47 speaks

14 for itself. Go ahead. 15 THE WITNESS: I guess, again, I don't

16 know how to answer the question because I don't know 17 for sure if he was cheeking the medications and I 18 didn't -- again, I would never know if anyone was or 19 not. And I know they had some suspicion of that, but 20 they were checking it out. They were having him look 21 at it. And, too, it's the best anybody can do. It's 22 the best I can do to be able to figure out how many 23 pills were supposed to be returned.
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24 BY MS. PEARSON: 25 Q. So we don't know if this information is 100

166 1 percent accurate, do we? 2 3 A. Q. I don't think we can ever know. Okay. Thank you. Going to visit eight,

4 and we're -- we don't know where bottle 520154 is. 5 That bottle is gone. 6 7 A. Q. Right. And it looks like bottle -- wait a minute.

8 On bottle 1/30/2004, go back to seven, 1/30/2004, it 9 looks like you've dispensed on that day bottle 10 506843, correct? 11 12 13 14 A. Q. A. Q. Yes. Containing 92 pills. Yes. And then bottle 505069 dispensed on that

15 day containing 124 pills? 16 17 A. Q. Yeah. But we have already dispensed bottle 505609

18 on January 16th and on that day, you said it 19 contained 124 pills and only came back with 108 20 pills. Tell me how we have now 124 pills. 21 MR. ALSOP: He came back with 92

22 pills, not 108. You misspoke.

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23 BY MS. PEARSON: 24 Q. Okay, 92. Tell me how 505609 now has 124

25 pills in it. Did you dump pills from one bottle to

167 1 the other? 2 A. We would have given out the two bottles

3 together, and I don't know if -- I wouldn't have 4 dumped them. They could have been dumped together 5 from the group home. 6 Q. But the recording here that talks about

7 number of pills dispensed comes from Cafe Study, 8 correct? 9 10 A. Q. Yeah. So this is information that you have before

11 it gets to the Theo House, correct? 12 13 14 15 A. Q. A. Q. I guess I'm not understanding. Let's go back to the first entry, 505609. Yes. Dispensed 1/16/2004, and on that day, that

16 bottle had 124 pills in it. You expected 108 to be 17 returned, but in fact 92 were returned. So we have 18 bottle 505609 with 92 pills in it, correct? 19 20 A. Q. Yes. So now if we go down again to look at that

21 label? 22 A. Uh-huh.

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505609 dispensed 1/30/2004, we now are

24 going to have 124 pills in it. And tell me how -25 A. I see what you're asking.

168 1 2 Q. A. -- how that can be accurate. Because, when there's more than one bottle

3 dispensed, so perhaps he had not even opened that 4 505609, so I was redispensing it and it still had 124 5 in it, because the one before would have been a 6 combination of the bottles above. 7 Q. Okay. Let's go back, and I suppose that is

8 one explanation. But if we go back and look on 9 January 16,2004, bottle 505609, that bottle was, in 10 fact, opened, wasn't it? Because you've told -- you 11 represented on this document that you signed your 12 initials to that 92 pills in that bottle were 13 returned. 14 MR. HUTCHINSON: So the question is?

15 BY MS. PEARSON: 16 Q. Is that correct that on January 30th you

17 recorded that bottle 505609 has only 92 pills in it? 18 Correct? 19 A. It would not necessarily have been specific

20 to just that bottle. 21 Q. Is that how you record information, that

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22 the information in the last two columns is not 23 specific to the bottle dispensing number? Are you 24 saying there's no connection between our last two 25 columns and the label, the number identifying that

169 1 bottle? 2 A. No. What I am saying is that when two

3 bottles would go out and then they were returned, I 4 mean, I wouldn't have had any way to count how many 5 specifically came from bottle one versus bottle two. 6 Q. You've told us that this label sheet are

7 labels that appear on the bottle, correct? 8 9 A. Q. Uh-huh. So this, I thought the drug accountability

10 log does precisely that, it looks at the label on the 11 bottle. 12 13 A. Q. Yes. And it has you open that bottle, it has you

14 dump out the pills and count the number of pills in 15 that bottle. Isn't that the process you go through? 16 17 18 A. Q. A. Yes. Okay. So -I guess I really don't know how to answer

19 what happened, then. I don't know. 20 21 Q. But it certainly is an error, correct? MR. HUTCHINSON: What is?

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THE WITNESS: I'm not remembering

23 with 100 percent certainty that specific time, so I 24 don't know what happened there. 25 BY MS. PEARSON:

170 1 Q. Okay. But now that's going to kind of

2 throw off our compliance data, isn't it? 3 4 A. Q. I don't know. Okay. Okay. That's fine. Let's look

5 at -6 MR. HUTCHINSON: Do you mind if I ask

7 a question? 8 9 10 11 MS. PEARSON: Of your client? MR. HUTCHINSON: Yes. MS. PEARSON: I don't see why not. MR. HUTCHINSON: I'm wondering if on

12 Exhibit 39. 13 14 MR. ALSOP: 39. MR. HUTCHINSON: I guess in goes with

15 this, PSY-000196. It's possible that the last bottle 16 mentioned, 505609, is actually misnumbered and that 17 number should be on the bottle just above it and the 18 last item should actually be 506843, if those two 19 numbers are just switched. 20 THE WITNESS: Again, I can't say for

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21 certainty. I really don't know. 22 MR. HUTCHINSON: And it looks like on

23 January 30th the bottle containing 92 pills was 24 returned and on that same day a bottle containing 92 25 pills was dispensed.

171 1 2 THE WITNESS: Yes. Yes. MR. HUTCHINSON: Would you think that

3 would be the same bottle returned and dispensed 4 containing 92 pills? 5 THE WITNESS: That would have made

6 more sense. 7 8 9 know. 10 MR. HUTCHINSON: And I understand you MR. HUTCHINSON: Okay. THE WITNESS: I'm sorry. I don't

11 don't remember that from three plus years ago. 12 THE WITNESS: I don't.

13 BY MS. PEARSON: 14 Q. But that information -- but we only have,

15 because you can't recall, we only have the 16 information that you wrote down at the time that you 17 collected the information. 18 19 A. Q. Yes. And that would probably be the most

20 accurate reflection of what was going on at that
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21 time, correct? 22 23 A. Q. Yes. All right. Let's go back to visit number

24 eight, February 13, 2004 and we're going to go back 25 and look to see where we're at in our drug

172 1 accountability log. And if we go to the Medication 2 Adherence Form, box five for this particular date, 3 and we look at, for instance, on -- I'm sorry. 4 February 13, 2004, we have recorded that 124 pills 5 are returned from bottle 505649 and the next page 6 we've got a return -- I can't see where another 7 bottle was reported as returned on February 13, 2004. 8 9 question? 10 BY MS. PEARSON: 11 Q. The question is, how did you come up with a MR. HUTCHINSON: So, what's the

12 number 216 as the number of pills dispensed and the 13 number of capsules returned? How did you complete 14 your Medication Adherence Form box five? 15 16 17 18 19 A. Q. A. Q. A. For the 13th? Bottles returned. These two bottles add up to 216. I'm sorry. Which? 506843 and 505649.

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The date bottle returned 0506843 you have

21 marked as March 2, 2004. 22 23 A. Q. That it was returned. But we're talking about visit February 13,

24 2004 and I'm trying to track what pills were returned 25 on that day that you're able to complete your box

173 1 five Medication Adherence Form from. 2 A. Okay. I'm sorry, I'm just really -- I'm

3 thinking in this context having a hard time how this 4 all worked. 5 6 7 8 Q. A. Q. A. That's all right. That's all right. So I -You don't know. I'm doing okay, I'm just doing my best. I

9 don't want to make up an answer, so I don't know. 10 Okay. 11 Q. Thank you. That's a fair answer. That's a

12 fair answer. All right. Again, the weight on this 13 date was 186 pounds for Mr. Markingson. Was Mr. 14 Markingson a heavy fellow, do you recall? 15 A. I don't remember. I think he was tall. I

16 don't think he was over weight that I remember. 17 Q. I might have lost track of -- you think

18 this is hard for you, you're a lot younger than I am. 19 All right. This is Kenney Deposition Exhibit No. 49.
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MR. HUTCHINSON: Did you want to

21 mention to her that she made the correction on 22 page -23 BY MS. PEARSON: 24 Q. I absolutely will. And I will draw your

25 attention to your correctly made correction that you

174 1 made March 2, 2004. Good job. 2 3 meant? 4 MR. HUTCHINSON: Well, all these MS. PEARSON: Is that what you

5 so-called errors you've been asking about and then 6 you didn't mention she corrected it. 7 MS. PEARSON: And I did, and I told

8 her "good job." 9 10 MR. HUTCHINSON: Thank you. MS. PEARSON: You're welcome. Okay.

11 I'm going to have you mark this. 12 13 14 (WHEREUPON, Deposition Exhibit No. 53 was marked for identification by the Reporter.)

15 BY MS. PEARSON: 16 Q. Okay. I don't remember why I marked this.

17 Okay. We'll go back one more time to visit seven. 18 And Ms. Kenney, if we -- you had mentioned that in

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19 this box to visit number seven, January 30, 2004, you 20 may have made a note into the file regarding the 21 compliance rate that we saw of 106 percent, and if 22 you look at entry dated January 30, 2004 on document 23 PSY-000018, can you tell me whether or not that 24 refreshes your recollection of what you were thinking 25 and what you may or may not have done on that day?

175 1 A. I think that there was a discrepancy in the

2 medications returned and that the group home was 3 wondering if he was taking the medications or not. 4 But also, they were doing something about it to make 5 sure that it didn't continue. 6 Q. Okay. So at this point, I think it's fair

7 to say there was a problem with their finding 8 compliance for clinical drug trial from the Cafe 9 Study? 10 MS. SVITAK: Object as foundation and

11 argumentative. 12 13 MR. ALSOP: It's argumentative. MS. SVITAK: I don't even know if

14 it's a question. 15 MR. HUTCHINSON: It's a gratuitous

16 statement. "Randomized to new bottle 506843 on 17 January 30, 2004." 18 THE WITNESS: That would have been

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19 the new bottle started, bottle 506843. 20 BY MS. PEARSON: 21 Q. It's recorded in the Drug Accountability

22 Log? 23 24 this here. 25 MR. HUTCHINSON: You randomize a new MR. ALSOP: It's recorded as it's on

176 1 bottle. Does a new bottle usually have 124 pills? 2 3 THE WITNESS: Yes. MR. HUTCHINSON: Okay.

4 BY MS. PEARSON: 5 Q. And that's inconsistent with what your

6 record is, correct? 7 MR. HUTCHINSON: Well, which record?

8 We went through that. She corrected that the next 9 visit. 10 BY MS. PEARSON: 11 Q. Oh, yeah. This is corrected. And that was

12 6843. All right. Let's go to visit number nine, and 13 did I give you back -- that's in front of you? 14 15 16 17 A. Yes. MS. PEARSON: Who did not get a copy? MR. ALSOP: -- with all of them. MS. PEARSON: You did not?

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18 19 you.

MR. ALSOP: I don't think so. Thank

20 BY MS. PEARSON: 21 Q. If we look at visit nine on CS-000723, date

22 of visit is 3/2/2004, visit nine. Again, DRM are the 23 patient's initials at the top of the document? 24 25 A. Q. Yes. And your initials are on this page?

177 1 2 A. Q. Yes. And if we look at the compliance

3 information for this particular date, you have, it 4 looks like the number of pills dispensed was 289 5 pills. And what would I have to do? If I'm catching 6 onto this correctly, we have to look at the dates the 7 bottles were returned? 8 9 A. Q. Uh-huh. So we would look at the two returned --

10 well, you actually have three dates that the bottles 11 were returned. It seems like there are three entries 12 for March 2, 2004. And one of those entries is 13 number of pills dispensed was 92; another one of 14 those entries for bottle 504391 was number of pills 15 dispensed 124; another one of the entries, which is 16 unclear, if you're attempting to eliminate the whole 17 entire line of data, or just simply the bottle number
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18 described. 19 20 A. Q. The bottle number described is what I -So as far as the math that I'm seeing here

21 is we've got 124 plus 124 plus 92 pills were recorded 22 as returned -- I'm sorry. 122 plus 92 pills returned 23 on that day. Is that -- except one of the records, 24 bottle 506843, date bottle returned where it 25 indicates 124 pills were dispensed, you don't have

178 1 any information about the amount of pills returned on 2 that day from that bottle. Do you recollect -3 MR. HUTCHINSON: Don't say anything

4 until there's a question. This is all interesting. 5 BY MR. PEARSON: 6 Q. Do you have any recollection as to why the

7 data reflects this information? 8 9 A. Q. I don't have recollection. Okay. But you don't have any recollection

10 of calling Dr. Olson to let him know we might have a 11 compliance problem with Mr. Markingson. 12 13 date? 14 BY MS. PEARSON: 15 16 Q. On this date. MR. HUTCHINSON: March 2nd. MR. HUTCHINSON: On when, now? This

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THE WITNESS: I don't have a specific

18 recollection, but I communicated with Dr. Olson about 19 everything in the studies. 20 BY MS. PEARSON: 21 Q. So this would be one of those things that

22 you would have communicated with Dr. Olson about? 23 24 A. Q. I'm sure I did. So Dr. Olson would have known that we've

25 got a problem with compliance.

179 1 2 MR. HUTCHINSON: When? MR. ALSOP: That's --

3 BY MS. PEARSON: 4 5 Q. On -MR. ALSOP: Go ahead.

6 BY MS. PEARSON: 7 8 Q. On March 2, 2004 for Mr. Markingson. MR. ALSOP: Argumentative and a

9 misstatement of the records and her testimony. 10 MR. HUTCHINSON: The form you gave us

11 as Exhibit 49 says there's 100 percent compliance. 12 So I don't understand your question. 13 MS. PEARSON: Well, I guess that's my

14 concern is that this is where the information is 15 recorded. That's where the information is filled out 16 and there's an inconsistency between the two places.
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17 And I guess my question is, why do we have -- you 18 know, you and I can argue about this outside of the 19 witness. I don't want to sit and coach the witness 20 during our conversation. Why don't we move on and 21 then we can have this conversation afterwards, or you 22 can ask questions of her. 23 MR. HUTCHINSON: My only question is

24 if you look at dates the bottles are returned March 25 2nd, March 2nd, March 2nd, the only place that says

180 1 number of pills returned is 122 and that's the same 2 as it says on this form. There's no inconsistency. 3 MS. PEARSON: You have three bottles

4 that have come back on that particular date. Those 5 bottles dispensed have them recorded as 124, the 6 other is 72, whatever the number is. There's no 7 tracking of the number of pills that came back in 8 that third bottle. 9 MR. HUTCHINSON: Well, there are only

10 two bottles if you look at the bottle numbers. I 11 just think -- I understand your confusion, but what 12 I'm saying is I don't think the documents are 13 inconsistent, nor do I think it's less than 100 14 percent compliance. 15 MS. PEARSON: I appreciate that and I

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16 think we can have this conversation outside of the 17 witness. I would prefer that. 18 MR. HUTCHINSON: Okay.

19 BY MS. PEARSON: 20 Q. I'm going to ask, this is actually marked

21 as Dr. Olson Exhibit No. 19. And this is a document 22 that you may or may not recognize, but it was part of 23 the information collected from Dan Markingson during 24 the participation in the clinical Cafe Study. Does 25 this document look familiar to you?

181 1 A. This specifically, no. I was not -- did

2 not do any of that testing and I wasn't trained on 3 how to do that kind of testing. And I, quite 4 frankly, probably didn't read the information. 5 Q. If you look in the upper left-hand

6 corner -- I'm sorry, document number OM-000584, I 7 believe. 8 9 A. Q. Yes. If you look in the upper left-hand corner,

10 there's a last name and initials DRM. You see that? 11 12 A. Q. Yes. And under client I.D. we also see the

13 number 00100013. 14 15 A. Q. Yes. And again, that's your recollection that

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16 that's how Mr. Markingson is identified in the 17 clinical trial? 18 19 A. Q. Yes. And so all of the age, 27 three months

20 gender, male, that information is consistent with 21 what you just read describing Mr. Markingson, 22 correct? 23 24 A. Q. Yes. Look over to the test date which is the

25 upper right-hand corner, 3/2/2004, and there's also

182 1 an entry that says, "On medication." What is the 2 information completed in that statement there? 3 4 5 6 A. Q. A. Q. Oh, that says "No." Do you have any explanation why? I don't. This particular report would say that Mr.

7 Markingson is not on medications. 8 9 A. Q. No, I don't know why that would say that. So this information was never brought to

10 your attention as the person collecting data on 11 patient compliance? 12 A. No, no. I don't remember anything about

13 this and why it said no. 14 Q. Okay. All right. I have Deposition

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15 Exhibit 50. What is in front of you, then, is the 16 document numbered CS 000700 dated March 31, 2004, 17 Medication Adherence Form. Again, patient's initials 18 DRM. 19 20 A. Q. Yes. And that, to the best of your knowledge,

21 indicates Daniel Markingson, correct? 22 23 A. Q. Yes. Can you identify the rater's initials,

24 please? 25 A. JLP. That would be Julie Pearson.

183 1 Q. And Julie Pearson again was a person that

2 was assisting you -3 4 5 6 A. Q. A. Q. Yes. -- in the data collection, correct? Yes. And you don't recall what specific training

7 she had with regard to the pharmacological attributes 8 of medication that may be dispensed, correct? 9 10 11 recall. 12 13 correct. 14 BY MS. PEARSON:
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No. MR. HUTCHINSON: Yes, she does not

THE WITNESS: Thank you. That's



I added that. Okay. On this particular

16 date, March 31, 2004, and if we look at the dates 17 bottles returned and we're looking at two bottles 18 that were identified as 504391, and 503735 and both 19 those bottles are recorded as being returned 20 3/31/2004; is that correct? 21 22 A. Q. That's what I see, yes. And then for the number of pills dispensed

23 per bottle, 504391, you see 142 and for the second 24 bottle 503735, 124. And so the total of those two 25 bottles dispensed that day looks like 146 -- 246?

184 1 2 A. Q. 246. And that's what we see in the Medication

3 Adherence box five, correct? 4 5 A. Q. Yes. The number returned was 44, although I

6 don't see any indication in the Drug Accountability 7 Form of the amount of pills returned, expected or 8 actually received. And I'm just wondering if you 9 have any understanding why this information is not 10 completed in the Drug Accountability Log. 11 A. Those two came in together, so, I mean, the

12 391 and 735. Because those two bottles came back 13 together and so maybe I should have put zero and zero

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14 there. 15 Q. Did you complete this section? Is that

16 your writing or is that Ms. Pearson's writing? 17 A. Actually, part looks like my writing and

18 the date bottle returned looks like it's somebody 19 elses writing. 20 Q. Okay. And if you were to turn to the next

21 page, we see -- the next bottles were dispensed. And 22 it looks like we've got two bottles dispensed, and 23 let me pull out visit 11. We're looking at Kenney 24 Exhibit No. 52. 25 MR. ALSOP: This is 52 now?

185 1 BY MS. PEARSON: 2 Q. Yes. Kenney Exhibit No. 52. And if you

3 look at CS 000840, date of visit 4/28/2004, visit 11, 4 and again, at the top of the page are the initials 5 DRM, correct? 6 7 A. Q. Yes. And that letter indicates Mr. Daniel

8 Markingson. His initials. JLP and that's Ms. 9 Pearson's initials? 10 11 A. Q. Yes. And let's look at the weight of Mr.

12 Markingson. And can you tell us what, on this visit, 13 Mr. Markingson weighed?
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14 15

A. Q.

171. Do you recall the weight that Mr.

16 Markingson -- or that was reported for Mr. Markingson 17 on his visit number eight? 18 19 20 21 A. Q. A. Q. 185. Pretty good. 186. Okay. And what difference in weight is that?

22 Fifteen-pound difference between visit number eight, 23 it was February 13, 2004. You should have that 24 document. I just want to verify. 25 MR. HUTCHINSON: What's the question?

186 1 What's the difference between 185 and 171? I'll 2 stipulate to that difference. 3 MS. PEARSON: I think I answered it,

4 but you might not have been listening to me. But 5 that's okay. 6 MR. HUTCHINSON: So, what question

7 are we on? 8 MS. PEARSON: I would like her to get

9 that out and verify the date between those two 10 visits. 11 THE WITNESS: On February 13, 2004 he

12 weighed 186 and on April 28th he weighed 171.

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13 BY MS. PEARSON: 14 Q. So that's 15 pounds in a matter of how many

15 weeks is that? Approximately six weeks? 16 17 A. Uh-huh. MR. HUTCHINSON: February 13th to

18 April 28th? 19 20 THE WITNESS: Yes. MR. HUTCHINSON: Is that the

21 question, how many weeks? 22 MS. PEARSON: Approximately. Are you

23 going to tell us? Get your pen out. Get moving. 24 MR. HUTCHINSON: Well, 10 weeks. We

25 should be able to agree.

187 1 BY MS. PEARSON: 2 Q. Ten weeks. Do you recall what

3 Mr. Markingson weighed throughout his Cafe visits 4 prior to this time, the approximate range? 5 A. If I remember correctly -- I could look.

6 It was in the 180 range. 7 Q. Is this drop in weight something that

8 should have been brought to the attention -- Dr. 9 Olson's attention? 10 A. I don't know. Not being a medical person,

11 I don't know the significance of that. I really 12 don't.
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So because you're not a medical person, you

14 don't know the significance of that, it would be 15 really hard for you to decide what type of 16 information probably should get to Dr. Olson, isn't 17 it? 18 A. In terms of weight, I guess I don't know.

19 I don't know how to answer today what -- if that's 20 concerning or not. 21 Q. This is not the only portion of data that

22 you collected for the Cafe Study, is it? 23 24 A. Q. No. What other types of things did you collect

25 data on on the clinical trial subjects that you were

188 1 monitoring in this Cafe Study? 2 A. Symptomatology. We collected information

3 on side effects, we collected information at specific 4 visits on drug and alcohol use, we collected 5 information on community resources they used. So in 6 other words, did they see a case manager, did they 7 see a therapist. That sort of thing. We collected 8 information on a mood scale. It was specifically a 9 depression inventory. That's what I can recall now. 10 Q. Going back to the information you collected

11 on -- I'm sorry. You said on adverse events -- or

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12 what did you say? I don't recall. 13 14 A. Q. Side effects I called it. -- side effects, you have no background as

15 a physician or RN, do you? 16 MR. HUTCHINSON: We've gone over her

17 credentials. 18 19 20 THE WITNESS: No, I don't. (A brief recess took place.) TAPE 5

21 BY MS. PEARSON: 22 Q. Back on the record. Ms. Kenney, you had

23 told us, as your attorney mentioned, about your 24 qualifications and your profession and you also 25 admitted that you did not have training in medicine,

189 1 correct? 2 3 A. Q. Correct. Yet you were asked to collect data on

4 patients in a clinical trial with regard to their 5 medical condition, correct? 6 7 8 as 54. 9 10 11 (WHEREUPON, Deposition Exhibit No. 54 was marked for identification by the Reporter.) A. Yes. MS. PEARSON: I'll have this marked

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12 BY MS. PEARSON: 13 Q. You have in front of you Exhibit No. 54,

14 CS-000250. The date of this document is in the upper 15 right-hand corner, 12/11/2003, and patient's initials 16 also are DRM, which will again indicate this is a 17 record of Daniel Markingson, correct? 18 19 A. Q. Yes. And your initials, rater's initials are on

20 this page? 21 22 A. Q. Yes. And can you tell me what, on this

23 particular page, are you gauging for Mr. Markingson? 24 A. The overall severity of his illness at this

25 time, based on my experience with other people.

190 1 Q. Why don't you go ahead and read number one

2 in this box. 3 A. "Considering your total clinical experience

4 with people with schizophrenia, how mentally ill is 5 the patient at this time?" 6 7 8 Q. A. Q. And what did you mark? "Mildly." Do you recall whether or not there are

9 other documents like this that Dr. Olson would have 10 signed off on?

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Just like this? I'm not sure. Do you have

12 a specific -13 Q. Would Dr. Olson also have submitted

14 information in the Cafe Study record regarding Daniel 15 Markingson on a page just like this that would 16 identify Dr. Olson's impressions, based on his 17 experience as a psychiatrist, with schizophrenia or 18 how mentally ill Mr. Markingson is? 19 A. He may have been the one to fill this form

20 out. He could have been the one to fill out this 21 form, but I did this time. 22 Q. Okay. But from Mr. Markingson, do you know

23 if there would have been any other records that Dr. 24 Olson himself would have assessed how mentally ill 25 Mr. Markingson is with regard to his schizophrenia

191 1 disease? 2 3 any date? 4 BY MS. PEARSON: 5 6 Q. A. I said on this date. On this date? Not using -- not the same MR. ALSOP: Vague. On this date or

7 assessment scale, that I'm aware. 8 Q. Prior to coming to the University of

9 Minnesota and working in the clinical study under Dr. 10 Olson, were you ever asked to assess the degree of
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11 illness for a schizophrenic patient? 12 A. I was never asked specifically to -- not in

13 the way it's asked here in that degree, I was not 14 asked formally to do that, no. 15 Q. Okay. Thank you. Do you recall in the

16 Cafe Study, Ms. Kenney, any other incidents that 17 occurred in the University arm of the Cafe Study? 18 A. Could you define what you mean by

19 "incidents"? 20 21 22 Q. A. Q. Any suicide events? No. Do you know whether or not there was any

23 suicide attempts or suicide ideations at the 24 University of Minnesota arm of the Cafe Study? 25 A. There were no suicide attempts. And I

192 1 think there may have been suicidal ideations. 2 Q. Were you able -- did you ever have access

3 to the information related to the Cafe Study from 4 other sites that the study was conducted at? 5 6 A. Q. No. Is it the policy of the University of

7 Minnesota and/or Dr. Olson that any time a page is 8 completed, that whoever completed that page must 9 initial that page, or sometimes do we notice the

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10 initials are missing and we fill it in for that 11 person that we know completed that? 12 13 14 A. Q. Yes. With this being a -MR. HUTCHINSON: I'm assuming she's

15 answering yes to the question after the word "or." 16 BY MS. PEARSON: 17 Q. Okay. We better clarify that. Does it

18 sometimes occur that one of your colleagues would 19 complete information or collect data on a particular 20 patient in this study and you might go back later and 21 notice that they forgot to complete their initials 22 and you might complete their initials for them? Does 23 that ever happen? 24 25 A. Q. Yes. And we were curious about this particular

193 1 information, abnormal involuntary movement scale. 2 I'll mark as Exhibit No. 55. 3 4 5 (WHEREUPON, Deposition Exhibit No. 55 was marked for identification by the Reporter.)

6 BY MS. PEARSON: 7 Q. And this document, CS-000183 visit looks

8 like BL, that means baseline, correct? 9 A. Yes.

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Day 12/5/2003, this is an abnormal

11 involuntary movement scale rating. And at the top of 12 this first page, it looks like initials that, to us, 13 did not seem like they looked like Dr. Olson's 14 initials, and we were wondering -15 MR. HUTCHINSON: You mean

16 handwriting. Those are his initials, I presume. 17 MS. PEARSON: Yes, you're right.

18 Handwriting. Thank you for that clarification. 19 BY MS. PEARSON: 20 Q. And we're trying to track who signed Dr.

21 Olson's initials to this particular piece of data 22 that was collected. 23 MR. HUTCHINSON: And your question

24 is, does she know whose handwriting that is? 25 BY MS. PEARSON:

194 1 2 3 4 5 Q. A. Q. A. Q. Would this be your handwriting? It looks like my handwriting. Okay. All right. That was an easy one. Yeah. I'm going to have that -- this is Olson

6 Exhibit 26 I put in front of you, a document marked 7 Olson Exhibit No. 26, Bates stamped PSY-000143. Do 8 you recognize what this document is?

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9 10 11

A. Q. A.

Yes. What is it? It's a series of adverse events reports

12 that was submitted to Quintiles. 13 14 Q. A. It was submitted to Quintiles? I would give it -- yes, it would be sent

15 through them because they did all of the coordination 16 of everything. 17 18 Q. A. Okay. Did you complete this form? I remember -- yeah, if I remember

19 correctly, that was me that did that. 20 Q. Do you recall who -- let me go back a

21 little bit. After Mr. Markingson's suicide, was 22 there discussion between you, Dr. Olson and IRB about 23 what needed to be done? 24 MR. ALSOP: Well, I'll object on the

25 basis it's seeking attorney-client peer review

195 1 information and it's privileged. 2 3 4 5 6 7 objection. 8 MR. ALSOP: If he has discussed with MS. PEARSON: Peer review? MR. ALSOP: Peer review. MS. PEARSON: Peer review? MR. ALSOP: Yes. MS. PEARSON: I don't understand that

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9 professionals that are part of the quality assurance 10 in the peer review process, by Statute, they are 11 protected and privileged, and I don't know -12 MS. PEARSON: Well, in the context of

13 a clinical trial? You're saying that conversations 14 in the context of a clinical trial? 15 16 MR. ALSOP: I don't know -MS. PEARSON: What context? We're

17 talking about a clinical trial now. 18 MR. ALSOP: I don't know whether it's

19 a clinical trial or not. They can still have peer 20 review discussions. 21 MS. PEARSON: We're talking clinical

22 trial, and whether or not that is in the malpractice 23 context, I don't know, but I don't know that that 24 exception is in the clinical trial. 25 MR. HUTCHINSON: Let's back up a

196 1 second. I understand the question, it sounds like 2 you were asking if there were discussions, what 3 reports or paperwork had to be completed in light of 4 the data. 5 MS. PEARSON: What steps needed to be

6 taken, what action needs to be taken. 7 MR. HUTCHINSON: Okay.

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8 BY MS. PEARSON: 9 Q. Okay. Did you have discussions about what

10 actions needed to be taken? 11 12 13 A. Q. A. I'm sure I did. Who did you have those discussions with? I would have let what they call the study

14 monitor from Quintiles know. 15 16 17 18 Q. A. Q. A. Who was that? I don't remember the name. Who else would you need to notify? Obviously Dr. Olson. The IRB would need to

19 be notified. 20 Q. Would you do that directly or would Dr.

21 Olson have responsibility for that? 22 MR. HUTCHINSON: This is questions

23 for simply notifying them of the death? 24 25 MS. PEARSON: Correct. MR. HUTCHINSON: Because she said she

197 1 filled out this report. 2 MS. PEARSON: Correct, which I think

3 is a different obligation in completing this adverse 4 event report. 5 6 little -7 BY MS. PEARSON:
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MR. HUTCHINSON: The question was a



I apologize if it was unclear, but

9 notifying the IRB, would that be your duty or would 10 it be Dr. Olson's duty to notify the Institutional 11 Review Board of the death of a clinical trial 12 subject? 13 A. As a study coordinator, I would be

14 responsible to help with the documentation to do so. 15 And I would take direction from him in order to do 16 it. 17 18 19 Q. A. Q. Direction from Dr. Olson? Yes. Anyone else that you would take direction

20 from? 21 A. In terms of reporting to IRB, no. That

22 would be Dr. Olson, in terms of who else needed to be 23 notified. I would have gotten -- I'm sure I would 24 have consulted with the study monitor. 25 Q. Did you ever speak with Dr. Schulz during

198 1 any point of time during the clinical trial in the 2 Cafe Study? 3 A. I talked to Dr. Schulz several times. I

4 mean, he was there and -- could you ask the question 5 specifically what I talked to him about or -6 Q. Well, that's fine. Generally, then. We

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7 can get specifically. During the course of the 8 clinical trial, you had talked to me that oftentimes 9 you would talk with Dr. Olson, you would have 10 conversations about information that you're 11 collecting on the clinical trial subjects, and that's 12 correct. 13 14 A. Q. Yes. Did you have the same types of

15 conversations with Dr. Schulz during the course of 16 the clinical trial regarding information you were 17 collecting on the patients in this clinical trial? 18 A. I don't remember specifically what I talked

19 to Dr. Schulz about, other than in generalities about 20 how the study's going, how many people have been 21 recruited, how's it going. You know. 22 23 Q. A. The Cafe Study? The Cafe Study. We would have meetings in

24 department and we would say and he often would be at 25 those meetings and we would report on the type of

199 1 studies that were going on and how many people were 2 in the study, how many people had completed it, how 3 many people had dropped out or were no longer in it. 4 So he would get that sort of data. 5 Q. Who else would be at these meetings,

6 besides you, Dr. Schulz, sometimes Dr. Schulz, Dr.
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7 Olson? 8 A. Yes. Other study investigators from the

9 department. 10 11 Q. A. Do you recall their names? Yeah, I can give you a few. Dr. John

12 Whinchatoch. 13 MR. HUTCHINSON: Can you spell it?

14 It's in the usual way. 15 BY MS. PEARSON: 16 17 18 Q. A. Q. All right. Dr. Tanya White? Is it -- Tanya White. All right.

19 Physician or Ph.D.? 20 21 22 23 24 25 A. Q. A. Q. A. Q. Physician. Dr. Calvin Lim. Ph.D., M.D.? M.D. Other study coordinators. For the Cafe Study? Not just -- no, not specifically. Were there ever minutes of these meetings

200 1 that were taken by anybody? 2 3 A. Q. I never took minutes, so I don't know. Was there anybody else that you know that

4 might be taking notes of these meetings? 5 A. I don't know that they had meetings or

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6 minutes. I never saw a copy of, "Oh, this is the 7 minutes from the last meeting." So I really don't 8 know. 9 10 11 12 13 14 Q. A. Q. A. Q. A. Who ran these meetings? Do you remember? Oftentimes, Cal Lim. Is it L-i-m-b? I think it's just L-i-m. Do you know what his job title is? He's a psychiatrist and he's part of the

15 Department of Psychiatry, and he's in the 16 schizophrenia program there. 17 18 Q. A. And he kind of ran the meetings? Yeah. When we would meet kind of as a

19 department to talk about what studies are going on. 20 He had a neuroimaging study that he did and we would 21 report on that. 22 Q. Okay. But you don't recall whether or not

23 there had been any notes or someone with a laptop 24 taking information down during these meetings at all? 25 A. No, I don't recall. I think he had a study

201 1 coordinator and I saw her writing notes, but I don't 2 know -- I'm sure it was reported how many people were 3 in each study. So there could very well be 4 documentation on that. I just don't know who would 5 be responsible for that.
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6 7

Q. A.

Were these weekly meetings or -Usually weekly meetings, yes, that I

8 remember. 9 10 11 Q. A. Q. Last about a half hour? Half hour to an hour. All right. Sorry. Again, I got off track.

12 Going back to what happened after Dan Markingson 13 committed suicide, and you said that the 14 conversations about who to report this information to 15 and as part of your duty as a study coordinator your 16 job was to collect information and file the reports 17 with the agencies that required that; is that 18 correct? 19 20 A. Q. Yeah. And you said that you completed this

21 particular report? 22 23 A. Q. Yes, I did. Was there anyone else, Dr. Schulz, anyone

24 that worked with you on choosing what to say in this 25 particular report?

202 1 A. If I remember correctly, I wrote it and ran

2 it by Dr. Olson before I sent it. 3 MR. HUTCHINSON: And he signed it,

4 right, page 3?

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THE WITNESS: Yeah, so he would have

6 looked at it. 7 BY MS. PEARSON: 8 Q. I'm curious, when you drafted the language

9 in this report, and there's a lot of information in 10 this report -11 12 A. Q. Yes. -- what is not in this report is any

13 information that was communicated to you by 14 Mrs. Weiss during the course of Dan's participation 15 in his clinical trial, and I'm wondering why you 16 chose, or you or Dr. Olson chose to leave that 17 information out. 18 A. I don't know that it was a choice. I think

19 that I just answered the brief description, symptoms, 20 course and treatment of SAE, adverse event. 21 Q. You say, "Over the last few months" and I'm

22 reading down a little, halfway down about, 60 percent 23 down, "DRM's ADLs have deteriorated, often with a 24 disheveled appearance and wearing the same clothes as 25 previous visit. These observations were discussed

203 1 with the subject." But there is really no 2 information that said such as, "Three weeks before 3 Mr. Markingson committed suicide, his mother called 4 us and was very, very concerned and asked, 'What does
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5 he have to do, kill himself or somebody else, before 6 you folks do something?'" And I'm wondering why that 7 type of red flag or warning did not show up in this 8 adverse event report or was that information just 9 discounted from Mrs. Weiss? 10 MR. HUTCHINSON: Object to the

11 question and advise her not to answer as framed. 12 It's multiple, multiple, multiple and it's 13 argumentative and assumes facts not in evidence, and 14 please rephrase. I'm not sure which of those 15 questions you want her to answer? 16 BY MS. PEARSON: 17 Q. Why did you decide the information from Ms.

18 Weiss was not relevant in this adverse event report? 19 A. I believe I was writing down the facts that

20 I gathered from the study in terms of, I mean, I 21 didn't put opinions down in terms of outside 22 opinions. I put down what the assessments were. So 23 I don't really know that there was a deliberate, 24 okay, I'm going to leave this in or I'm going to 25 leave this out. I think that I just put down the

204 1 summary of the information. I couldn't put 2 everything in there. 3 Q. Well, that would have just taken a sentence

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4 or two, correct, and you would have had room for that 5 information, correct? 6 MR. HUTCHINSON: Objection,

7 argumentative. You're asking if there was room to 8 put it in there? 9 BY MS. PEARSON: 10 Q. If there was room to put in the information

11 related to Ms. Markingson's complaint like suicide 12 that his mother phoned in and reported to you her 13 concern. 14 15 A. Q. Yeah. And she was very concerned, so much so that

16 she says, "What does he have to do, kill himself or 17 someone else before you folks do something" and I'm 18 wondering, with that heightened concern, why, that 19 was not relevant to be put into an adverse event 20 report that goes to the FDA and the sponsor and is 21 utilized to help them understand the signals that 22 might trigger suicide in a person taking these 23 medications or in a clinical study. 24 MR. HUTCHINSON: Now you're asking

25 the same question again, because she did answer that.

205 1 So you asked that, she answered it. What is the 2 question? 3 MS. PEARSON: I don't know that she

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4 considered the impact of this report and how this 5 report gets used by the sponsor, and that's why I'm 6 asking it quite differently. 7 MR. HUTCHINSON: But this is a

8 lawsuit about a suicide of a young man and you're 9 asking about paperwork prepared after the death. 10 What does that have to do with anything? 11 MS. PEARSON: Well, it's a lawsuit

12 about a group of professionals who completely 13 discounted the family member's repeated request for 14 help to get her son help. 15 MR. HUTCHINSON: But this is after

16 the fact. That should have been included in that 17 information that was part of the medical history. 18 BY MS. PEARSON: 19 Q. Ms. Kenney, is it not important when you're

20 dealing with mental illness subjects to collect 21 information from family members during the course of 22 treatment? 23 24 A. Q. Yes, it's important to collect information. And that information is relevant, isn't it,

25 in the treatment of the mentally ill patient,

206 1 correct? 2 MR. ALSOP: Object, lacking

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3 foundation, vague. 4 MR. HUTCHINSON: Same. She's not a

5 physician. 6 THE WITNESS: I guess I have a hard

7 time determining what's relevant or not relevant. 8 BY MS. PEARSON: 9 Q. Ms. Kenney, you have completed in the

10 clinical trial a form assessing the level of severity 11 of Mr. Markingson's schizophrenia. 12 13 A. Q. Uh-huh. Yes. I think that would be a much more difficult

14 question -- excuse me. Let me stop there. Don't go 15 there. I guess my understanding is -16 MR. HUTCHINSON: Just so, I don't

17 want to interrupt your questioning, but what mom 18 reported is in the record prior to death. It's in 19 there. And now you're asking about a report prepared 20 after the death and you seem to be arguing with her 21 why isn't it there after the death. What my point is 22 it may be relevant pre-death, but it's in the 23 records. 24 25 So I -MS. PEARSON: I understand. MR. HUTCHINSON: I'm confused where

207 1 we're going. 2 MS. PEARSON: I understand you don't

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3 under -- I get that part, that that is clear to me 4 and I'm disagreeing with how you see the purpose of 5 these adverse event reports. 6 MR. HUTCHINSON: But is there some

7 theory of liability against anybody here, based on 8 the way a report was prepared after death? 9 MS. PEARSON: I guess my

10 understanding of what these are used for is different 11 than yours, and I guess my understanding of this case 12 is different than yours, and I think we see this case 13 differently. So we're going to proceed. How we 14 understand this case should be defined and you 15 certainly can object to the question and have it 16 stricken from the deposition if we use it again. And 17 that's your option. 18 BY MS. PEARSON: 19 Q. Ms. Kenney, do you understand how the

20 information that you submit in these serious adverse 21 event reports are utilized by, not only the FDA, but 22 also manufacturers of pharmaceuticals? 23 24 25 MS. SVITAK: Object to foundation. MR. ALSOP: I'll join. THE WITNESS: I don't understand the

208 1 terms. This is a brief description just to let them

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2 know about it. If it would be more investigation, 3 there would be a lot more details they could look 4 into. There's a lot of things you could have put in 5 there. 6 BY MS. PEARSON: 7 Q. You don't -- and I guess this is just my

8 conclusion is that -- I guess I wanted to ask you 9 what your assessment is, what credibility you gave to 10 Mrs. Weiss during the course of Mr. Markingson's 11 involvement in the clinical trial as relates to how 12 Mr. Markingson is treated in this study? 13 MS. SVITAK: Object, asked and

14 answered multiple times. 15 16 17 MR. ALSOP: Also vague and ambiguous. MR. HUTCHINSON: Same. THE WITNESS: I really don't know --

18 I'm not clear on the question to be able to give an 19 accurate answer. 20 BY MS. PEARSON: 21 Q. Okay. If you are -- if your children are

22 in danger -23 24 a second. 25 BY MS. PEARSON: MR. HUTCHINSON: Just a second. Just

209 1 Q. -- and you're calling to request someone to

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2 help, wouldn't you want those folks to listen to you? 3 4 MR. ALSOP: Irrelevant. MR. HUTCHINSON: Object and advise

5 her not to answer. It's highly argumentative and 6 it's -7 MS. PEARSON: Well, I think she's

8 asked to under -9 10 children. 11 MS. PEARSON: And this was not our MR. HUTCHINSON: It's not her

12 child also. 13 MR. HUTCHINSON: And you asked if she

14 believed Ms. Weiss and she said yes. And you asked 15 her to read what she wrote about Mrs. Weiss and 16 complaining. 17 MS. PEARSON: I'm one person, you're

18 four. This is the case that we're bringing forth and 19 we repeatedly claim a serious concern about the 20 amount of information that was discounted from 21 Mrs. Weiss during the whole course of this clinical 22 trial study, and we want to know the depth of the 23 desire to ignore this information. It was very clear 24 to us when we first looked at this case how much 25 Mrs. Weiss tried to notify the medical professionals


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1 about her son's condition and it was ignored. And I 2 don't want an attorney to tell me also that we can't 3 proceed in the same direction, because this is the 4 key to the case. 5 MR. HUTCHINSON: That's not what I'm

6 saying. That's not what I'm saying. All of what you 7 said is pre-death information. And then you're 8 asking about post death, number two. 9 10 sorry. 11 MR. HUTCHINSON: In all honesty, you MS. PEARSON: How does this -- I'm

12 have asked her what Mrs. Weiss reported, how she 13 handled it. You asked if she believed everything Ms. 14 Weiss said, and so I think we're going over plowed 15 ground here, and maybe we're going there because I'm 16 objecting, but -17 MS. PEARSON: Well, I think it's

18 fair, I think the things you're saying are fair. I'm 19 not -- I hear what you're saying and I understand. I 20 guess it's our perspective that the fact that key 21 information was left out of this adverse event 22 demonstrates perhaps a misunderstanding of the role 23 that a family member is reporting in a mental illness 24 case and the use of these very important documents 25 that FDA uses, and I'm trying to exhibit more that


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1 understanding. If there is a complete lack of 2 knowledge with the IRB about what things are 3 important to get to FDA then fine, let's get it out. 4 But we're starting here and we'll go further, but I 5 want to find out, is this a system-wide problem or do 6 we just have pockets of problems? And that's what I 7 want to understand. So I do want to understand. 8 And Ms. Kenney, please, with all due

9 respect, this is a conversation between the 10 attorneys, and please don't take this personally. 11 It's a disagreement here. I do want to understand 12 why we have a system that believes that the 13 information, the signal that Mrs. Weiss gave to the 14 folks taking data in this clinical trial was ignored. 15 16 MR. ALSOP: Argumentative, counsel. MR. HUTCHINSON: That's your theory.

17 Our defense is it was not ignored. They talked to 18 the group home people, they talked to the case 19 manager and they talked to his therapist. They 20 evaluated him themselves. They talked to the 21 patient. Everybody disagreed with mom's statements. 22 And so to say it's ignored is -- if it's a legal 23 theory, you know, we're not going to get anywhere 24 today repeating questions that you've already asked 25 her about that.

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MS. PEARSON: I understand, and this

2 has nothing to do with getting input. This has to do 3 with providing information. 4 MR. HUTCHINSON: After death to FDA

5 or whoever. And she did. 6 7 MS. PEARSON: It's an important form. MR. HUTCHINSON: And she didn't put

8 anything in here about mom's statements, and we agree 9 she said she didn't. She said the reason is she was 10 trying to be factual, not opinions from mom or 11 anybody else. She didn't put anything in here about 12 group home people, I don't think. 13 MS. PEARSON: But you don't

14 understand where our concern is coming from is what 15 you're saying. 16 MR. HUTCHINSON: I understand your

17 concern. I don't understand where it's going to get 18 you legally. I don't think you're going to win this 19 case if somebody would have prevented his death by 20 filling out a report after his death differently. I 21 don't understand that. That's where I'm losing you. 22 MS. PEARSON: If we have an expert

23 that states that a report completed like this -24 25 MR. HUTCHINSON: After death. MS. PEARSON: -- is misrepresenting

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213 1 facts of the case and is purposely designed to avoid 2 liability, would that change your mind? 3 4 5 MR. HUTCHINSON: Not really. MS. PEARSON: Okay. That's fine. MR. ALSOP: I haven't seen that in

6 the complaint. That would surprise me. 7 MS. SVITAK: It's 10 to six. I hate

8 to be a brood, but can we move on and finish up the 9 deposition and let Ms. Kenney go home? 10 MS. PEARSON: And thank you, Linda.

11 BY MS. PEARSON: 12 Q. And so I think the point was made. I think

13 your attorneys will not let you answer anymore 14 questions on that, and we'll see what happens after. 15 I know we have time left. Let me wrap up a couple of 16 things here. Do you know how often Dr. Olson talked 17 with Mrs. Weiss? 18 A. I know that he spoke with her in a meeting

19 that we had together, and I thought that he had a 20 phone conversation with her, but I can't be certain. 21 Q. Okay. Did she only attempt -- okay. Never

22 mind. But she spoke with you several times, correct? 23 24 A. Q. Yes. And each time she spoke with you did you

25 pass the information on to Dr. Olson?

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214 1 A. Yes. That I recall. I can't imagine that

2 I wouldn't. 3 Q. Did she ever ask you to ask Dr. Olson to

4 call her back? 5 A. No, I don't remember she said, "Please have

6 Dr. Olson call me." No. 7 8 9 Q. A. Q. How about anything close to that? No. I'm not remembering such. As far as I understand, other than

10 comitting suicide, there are two other ways that Dan 11 could have been taken out of the study, either his 12 physician could have asked to be removed or he could 13 have chosen to be removed himself. 14 15 A. Q. Yes. Did you have the ability to communicate

16 information to Dr. Olson and urge him to take 17 Mr. Markingson out of the study? 18 A. I guess I'm not fully understanding your

19 question. 20 Q. My understanding is that, and I'll tell you

21 why: Mary Weiss recalls, you tell her that you could 22 take him out of the study if he wasn't doing well on 23 it. 24 25 A. Q. Me personally? I'm just repeating what she told me.

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215 1 2 A. Q. Okay. So I'm asking you whether or not you had

3 the ability to advocate for Dan to be removed from 4 the study if, in fact, you were convinced that the 5 study was harming him. 6 A. I certainly would have had no problem

7 giving my opinion to Dr. Olson. 8 Q. Did you ever give your opinion to Dr. Olson

9 that Mr. Markingson was not meant to be in the study? 10 A. I never made the opinion he should not be

11 in the study. 12 Q. Did you ever give the opinion to Dr. Olson

13 that maybe something further should be investigated 14 as far as his medical condition? 15 A. No, because I felt that he was getting very

16 good care. 17 Q. Did Mrs. Weiss ever report to you that she

18 felt that Dan was hiding his symptoms from you? 19 20 21 A. Q. A. Yes, she did. Is that common in a schizophrenic patient? Yes, that's common. Well, maybe I

22 shouldn't say "common" because I don't know, but I 23 certainly have heard that myself before or have seen 24 evidence of that before. 25 Q. Do you know whether or not the University

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216 1 of Minnesota or IRB has a patient advocate for people 2 in the study, especially vulnerable adults? 3 A. I know that in the Catie Study there were

4 -- I believe that people could have a patient 5 advocate. So I don't know specific policy or not, 6 but I certainly had heard that, I mean, that that 7 could be done. I don't know if I'm answering your 8 question. 9 Q. You are. Do you know whether or not there

10 were patient advocates in the Cafe Study? 11 A. I'm not aware of any patient advocates in

12 the Cafe Study. 13 Q. So if someone from the University of

14 Minnesota told Ms. Weiss that you were the patient 15 advocate, that would be incorrect information, 16 wouldn't it? 17 A. I guess it would depend what the definition

18 of a patient advocate is. I mean -- I guess I'm not 19 understanding the question. 20 Q. What did you understand a patient advocate

21 meant when I asked you and you answered that you 22 understood there were patient advocates in the Catie 23 Study? 24 A. What I understand a patient advocate would

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25 be is somebody else who was maybe a family member or

217 1 friend or someone that the subject identified to know 2 what was going on and to be able to give feedback to 3 us about whether or not, you know, I think this 4 person is still doing well in the study or not. But 5 that was not something that was in the Cafe Study, 6 per se. 7 Q. And certainly not a role you played,

8 correct? 9 10 A. Q. No. Not specifically. And you submitted the SAE report to Dr.

11 Olson. Did he give you feedback on additional things 12 that needed to be in there or things that should be 13 taken out? 14 15 16 17 A. Q. This report here? Correct. MR. HUTCHINSON: Exhibit No. 26. THE WITNESS: I don't remember him

18 saying to add or take anything away. I'm trying to 19 -- I don't remember -- no, I do not remember. 20 BY MS. PEARSON: 21 22 23 Q. A. Q. One way or the other to take out or put in. Exactly. Okay. I'd like to go back quickly to

24 Exhibit 47 which is one of the communication tools
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25 used between the Theo house and the Cafe Study.

218 1 A. Uh-huh. I don't know if I can find it

2 again. 3 4 5 Q. A. Q. You know what it looks like? I know what it looks like, yeah. And if you go to the second page marked BHC

6 000148 and this was a form created by the Theo house, 7 correct? 8 9 A. Q. Yes. And top of this page is written "To be

10 completed by a doctor and returned with consumer." 11 But you're not a physician. Was there any question 12 as to whether or not, or as to why a physician was 13 not completing this page and returning it to the Theo 14 House by the Theo house personnel? 15 A. No, I think it was just a general form that

16 people probably took to doctors in therapy visits. 17 18 Q. A. So no one paid attention to it? No, I didn't really pay attention to that.

19 It said doctor and I would, you know, imagine that I 20 would have hoped that Theo would have told me, "No, 21 you're not supposed to be filling it out," because I 22 signed it. 23 Q. Do you remember, to the best of your

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24 knowledge, how many times Dr. Olson saw Daniel 25 Markingson after he was discharged from the hospital?

219 1 2 3 A. Q. A. I would be guessing, so -Every visit? He would probably not see him every visit.

4 Some visits were shorter than others and there were 5 visits that were, you know, assessments that were 6 being done were ones I could just do alone. 7 8 it. 9 10 11 12 THE WITNESS: Really? Okay. MR. ALSOP: I have no question. MS. SVITAK: No questions. MR. HUTCHINSON: We have no MS. PEARSON: Okay. I think that's

13 questions. We'll read and sign. 14 15 16 17 18 19 20 21 22 23
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24 25


2 COUNTY OF BLUE EARTH) 3 BE IT KNOWN that, I took the foregoing deposition

4 of JEANNE KENNEY, pursuant to Notice; 5 That I was then and there a notary public in and

6 for the County of Blue Earth, State of Minnesota; 7 That said witness before testifying was duly

8 sworn to tell the truth, the whole truth, and nothing 9 but the truth relative to the cause specified in the 10 Notice; 11 That the witness did not waive the reading and

12 signing of said deposition; 13 That I am neither attorney nor counsel for, not

14 related to or employed by any of the parties to the 15 action in which this deposition is taken and, 16 further, that I am not a relative or employee of any 17 attorney or counsel employed by the parties hereto or 18 financially interested in the action; 19 That the testimony was taken down in stenotype by

20 me; then reduced to typewriting under my direction by 21 means of computer-aided transcription, and is a true 22 and correct transcript of my stenotype notes.

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Witness my hand and seal this 20th day of May, ______________________ MARTHA M. FIER

24 2007. 25

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