“Do We Have to Wait Until He Kills Himself or Someone Else Before Anyone Else Does Anything?”

Carl Elliott, M.D., Ph.D.

November 14, 2012

In the “agreement for corrective action” against CAFE study coordinator Jean Kenney last week, the Board of Social Work cited Kenney’s failure to respond to “alarming voicemail messages” from family members of Dan Markingson. Presumably, the Board is referring to a message left by his mother, Mary Weiss, which warned, “Do we have to wait until he kills himself or someone else before anyone else does anything?”  The failure of Kenney and Stephen Olson to take the warnings of Mary Weiss seriously has been one of the most disturbing aspects of this case.  In a deposition for the lawsuit filed by Weiss, Kenney was questioned about her response.  Here is an excerpt.  (The initial questions come from Gale Pearson, an attorney for Mary Weiss.)

BY MS. PEARSON:

Q. What was your first impression after you heard this telephone message from Mrs. Weiss?

A. I remember her — she’s obviously very upset, I guess. You know, I didn’t have any details about why she thought his meds weren’t working. The statement, “Are you asking me or telling me,” didn’t really tell me much. I didn’t quite understand that. And when she said, “Do we have to wait until he kills himself or someone else?” I guess I really wanted to know more about why she was making that — why she was so concerned about that, because I just remember thinking at the time, you know, we weren’t seeing anything like that, and the group home wasn’t seeing anything like that and his case manager wasn’t seeing anything like that and the treatment program wasn’t seeing anything like that, so I wanted to know more from her because she was obviously very concerned.

Q. What did you do to find out more from her?

A. I remember there was a series of phone calls and that we really wanted Mary to come in to talk about that, because certainly her concerns needed to be heard.

Q. Who were those series of phone calls to?

A. Back and forth to Mary, I guess.

Q. Between — I’m sorry, I didn’t mean to interrupt you. Between who and who?

A. Myself and Mary, that I’m aware.

Q. Did you notify Dr. Olson about this statement in the record?

A. Sure.

Q. What did Dr. Olson say?

A. I don’t remember specifically what he said. I do know anytime I ever expressed concerns, he wanted me to follow up on it, and I think, if I remember correctly, at that time we wanted to, you know, find out from Dan what was going on and also to check out from the other places what they were seeing as well, too, and we have to kind of gather information from everybody.

Q. What did Dr. Olson do after he heard this report from you that his mother was concerned that her son might kill himself?

MR. HUTCHINSON: Objection, lack of foundation, but go ahead.

THE WITNESS: You know, I don’t remember specifically what he did.

BY MS. PEARSON:

Q. Did he do nothing?

A. No. I mean, we talked about things. I think we probably talked about when would Dan’s next visit be, when — you know, I should probably call the group home and find out what’s going on, which I believe I did.

Q. Did you report this complaint to the IRB?

A. No, I don’t believe I did report that mom said that, no.

Q. Why?

A. I don’t know. I don’t think I had any indication that that was something that I needed to report. It wasn’t a — I’m not seeing that that would be like an adverse event to report.

Q. Do you know whether or not the IRB is interested in hearing complaints regarding their clinical subjects in the trials that they’re overseeing?

MR. ALSOP: That’s a misstatement of the evidence here. I’ll object, but go ahead.

MR. HUTCHINSON: Same. Lack of foundation, but go ahead.

THE WITNESS: I guess I don’t know the answer if I would be the one responsible to report complaints to IRB.

BY MS. PEARSON:

Q. So you’re saying there is no policy in place from the University of Minnesota’s IRB that would direct a response from you after hearing something like this from the mother of a clinical trial subject?

A. I don’t know if there’s a policy or not on that. I really don’t.

Q. But you don’t know of one, as you sit here today, correct?

A. I don’t know. I would be making a guess if I said that I know with certainty. I don’t know.

Q. But you can’t recall at this moment that there is a policy that would direct you to report this type of  complaint to the IRB?

MR. ALSOP: Same objection.

A.I don’t know if there is a policy like that to report this.

Q. Do you know whether or not Dr. Olson reported this complaint –

A. I don’t know if he did.

Q. — to the IRB?

A. I don’t know that he did report this specific complaint to the IRB.

Q. Would there have been anything that would have prevented you from going to the IRB with this clinical trial subject’s concern?

A. No. Like being told, “Don’t tell IRB this” or –

Q. Uh-huh.

A. No.

Q. So it would have been something you could have easily gotten on the phone and told the IRB and said, “Guess what? We’ve got some concerns here. We don’t know what to do. We just wanted to notify you just to alert you there are some concerns.”

MR. HUTCHINSON: Just a second, the “we don’t know what to do” part of that is assuming facts not in evidence, lacking foundation, calling for speculation and conjecture. Go ahead.

THE WITNESS: Could you ask the question again.

BY MS. PEARSON:

Q. It could have been something you could have done. You could have gotten on the phone and said, “Look, we’ve got a complaint regarding one of our vulnerable adults” and you know, setting aside, I just want to clarify an understanding: You do understand that Daniel Markingson, under law, Minnesota law, is designated as a vulnerable adult. You do know that, correct?

MR. HUTCHINSON: Objection, lack of foundation. Go ahead.

THE WITNESS: I believe he would be considered a vulnerable adult.

BY MS. PEARSON:

Q. We’ve got a vulnerable adult whose mother is contacting the study coordinator complaining that  the medications in the study are not working and that she has concerns about the lack of response and she says to you, “Do we have to wait until he kills himself or someone else before anyone else does a thing?”
A. Uh-huh. Okay.

MR. HUTCHINSON: So –

THE WITNESS: Say the question again.

BY MS. PEARSON:

Q. So that’s not something that you think ought to be reported to the IRB?

A. At that time, I did not think that was something I had to report to the IRB. I felt that that was something I had to report to Dr. Olson.

Q. And you did report it to Dr. Olson.

A. Yes.

Q. Did you report it to anybody else?

A. I don’t remember.

Q. What else did you do in response to this concern expressed by Mrs. Weiss?

A. I remember –

MR. HUTCHINSON: You want her to — other than what she wrote in her note, or you want her to repeat what’s in the note or -

MS. PEARSON: I want to know if she did anything other than write it down and tell Dr. Olson.

MR. HUTCHINSON: Well, the writing described some of the things she did. That’s why I’m asking the question. Do you want her to –

BY MS. PEARSON:

Q. Well, go ahead. You know, what else did you do?

A. I called the group home to find out what it was she was talking about.

Q. And what was that?

A. Oh, there was something about — what I remember was that they went to pick him up for Easter and he didn’t want to come or something like that and that’s when he made the comment to, I believe it was the boyfriend, that, his fists were doubled and he said something about “I’m invisible.” And then I called the group home to see what happened and they remembered saying well, they thought there was some kind of miscommunication about what time he was being picked up, et cetera, and I said to her, you know, “Are you having any concerns about Dan?” And she said, “No, he’s fine here.”

BY MS. PEARSON:

Q. And that satisfied you that you did not have to account any further on Mrs. Weiss’ concerns that her son may kill himself.

MR. HUTCHINSON: That’s not what she said. That’s not what mom is reported to have said. I think she’s asking if you did anything else after hearing that. Apparently that’s what you’re asking.

THE WITNESS: I don’t remember what else I did.

BY MS. PEARSON:

Q. I guess I’m asking if the explanation from the Theo House satisfied you that there is nothing further to be concerned about after his mother calls and says, “Do we have to wait to kill himself or someone else before anyone does anything?”

A. No, I don’t think that would satisfy me, because I believe that, you know, we have to listen to everything and continue. But in terms of making any decisions, I mean, we have to take it from everybody. How do I decide who to believe, one person over another? I mean –

Q. Who is right here, Jeanne — Mrs. Kenney? I apologize. I apologize. Who was right here?

MR. HUTCHINSON: Well –

MS. SVITAK: I’m going to object, argumentative.

MR. HUTCHINSON: Just a second.

BY MS. PEARSON:

Q. What happened to Mr. Markingson before this study was completed?

A. I know what happened to him, but I don’t know –

Q. I’m sorry. What happened to Mr. Markingson? Please answer the question.

A. Mr. Markingson killed himself.

Carl Elliott, M.D., Ph.D.

Enemy of the People: Carl Elliott  is a professor at the Center for Bioethics at the University of Minnesota.  He writes on the medical-industrial complex, and is the author of Better Than Well and and White Coat, Black Hat.  

“Do We Have to Wait Until He Kills Himself or Someone Else Before Anyone Else Does Anything?” Comments RSS

2 thoughts on ““Do We Have to Wait Until He Kills Himself or Someone Else Before Anyone Else Does Anything?”

  1. I used to work for a public university as a mental health study coordinator (not a drug trial, though). EVERYONE involved in the project knew that any and all concerns about a participant committing suicide HAD TO BE REPORTED TO THE IRB IMMEDIATELY, no matter how likely or unlikely they were (one part of my job was to make certain everyone knew that). The pretense that she “had no indication that this was something she needed to report” is laughable. She literally couldn’t have been given IRB approval to do her job without affirming in writing that a.) she knew these events MUST be reported TO THE IRB b.) there was a specific procedure in place for reporting these events.

    How is it she’s not being sued??

Leave a Reply