When university attorneys play hardball with patients

Everyone knows that some attorneys have a reputation for playing hardball.  In fact, many of us even seek out attorneys who play hardball. But sometimes “playing hardball” becomes something entirely more disturbing, like a deranged major league pitcher hurling a 90 mile-an-hour fastball at the head of a Little Leaguer.   What would you do if you discovered this was the behavior of attorneys representing your university?

This was the question I asked myself in 2008, when my employer, the University of Minnesota, sought $56,000 from a retired St. Paul woman named Mary Weiss.  Why?  Her mentally ill son had committed suicide in what many observers considered to be a stunningly corrupt, exploitative research study at the university, and Ms. Weiss had the audacity to sue.  When her lawsuit was dismissed on statutory grounds, the University of Minnesota apparently decided to send a message to her and other potential litigants: It notified her that she would be asked to pay $56,535 to the university for its court fees.   Yes, you read that correctly.   A young man killed himself in a research study at the University of Minnesota, and the university demanded $56,535 from the dead man’s mother.

Here is a short version of the story (which I wound up writing about in much greater detail for Mother Jones in 2010 and later in the Bioethics Forum).  On November 12, 2003, Mary Weiss’ 26 year-old son, Dan Markingson, was admitted to Fairview Hospital in Minneapolis after having a psychotic break.  Dan believed that other people could read minds, that he was being visited by aliens, and that a Satanic cult that was calling on him to kill people, including his mother.  At Fairview Dan was evaluated by Dr. Stephen Olson, the head of the schizophrenia program at the University of Minnesota, who thought that Dan was psychotic, dangerous, and incompetent to make his own medical decisions.  Olson recommended involuntary committal to a state institution.  Several days later a second clinician agreed.

In Minnesota, however, patients who have been involuntarily committed are given an option called a “stay of commitment,” which means they can avoid being locked up as long as they agree to comply with the treatment recommendations of their psychiatrist.  On November 20, Olson recommended that Dan be given a stay, and the court agreed.  But the next day, instead of simply treating Dan, Olson enrolled him in a pharmaceutical company-sponsored research study.  Dan signed the consent form for the study while his mother was not present – even though he had been judged incompetent to make his own medical decisions only two days earlier.  When Mary Weiss protested, she was told that the enrollment decision was not hers to make.

The research study – which the sponsor, AstraZeneca, had titled the “CAFÉ study” – was aimed at schizophrenic patients experiencing their first psychotic break.  It was a year-long, 26-site, double-blind comparison of three different atypical antipsychotic drugs: Zyprexa, Risperdal, and Seroquel.   AstraZeneca paid the University of Minnesota approximately $15,600 for each subject who completed the study; the longer the subject stayed in the study, the more money the university received.  In addition, both Dan’s psychiatrist, Stephen Olson – the principal investigator for the CAFÉ study – and his department chair, Charles Schulz – a co-investigator – had significant personal financial relationships with many manufacturers of the atypical antipsychotics, including AstraZeneca.

Dan was eventually discharged to a halfway house in St. Paul.  Worried about his deteriorating condition, especially his anger and agitation, Mary tried repeatedly to get Dan out of the CAFE study, but she could not get anyone to pay attention to her concerns.  Finally, in April of 2004, she left a voice message with the study coordinator, asking, “Do we have to wait until he kills himself or someone else before anyone does anything?”  Three weeks later, in the middle of the night, Dan stabbed himself to death in the shower with a box cutter.  He left a note that said, “I went through this experience smiling.”  Lab tests revealed that he had been taking Seroquel.

In the years since the suicide, many legitimate questions have been raised about the ethics of this dubious study.   How could Dan Markingson give genuine informed consent while under a commitment order?   As an acutely psychotic patient, was he mentally capable of consenting?  Why did the sponsor – and the Institutional Review Board – permit investigators to recruit a patient who was threatening homicide?  Did the AstraZeneca payment scheme give Olson inappropriate financial incentives to keep Dan in the study as long as possible?   Why were the desperate warnings of Mary Weiss ignored?

The questionable financial relationships between AstraZeneca and the University of Minnesota psychiatrists became even more acute when AstraZeneca was forced to defend itself against federal charges that the company had marketed Seroquel illegally.  The U.S government argued that AstraZeneca had paid doctors to sign ghostwritten journal articles and give promotional talks about unapproved uses of Seroquel.   Documents unsealed during litigation strongly suggested that Dr. Charles Schulz – the CAFÉ study co-investigator – had been involved in spinning research studies in a way that made Seroquel appear to be a far better drug than the data warranted.   (See this article, and also this one.)  AstraZeneca eventually settled the federal charges for $520-million.  Many observers, myself included, believe that the CAFÉ study was rigged to produce positive results for AstraZeneca.

Mary Weiss filed suit against the University of Minnesota, but her lawsuit was dismissed in 2008.  A judge ruled that as a state agency, the University of Minnesota was statutorily immune from her claims.  That judgment was shocking, but even more shocking was the next move by attorneys representing the university, who notified Mary Weiss of their intention to force her to pay $56,000 in court costs.

This tactic is perfectly legal.  In corporate litigation, I am told, it is not even that uncommon.   The demand for costs is a way of discouraging frivolous lawsuits.  But should such tactics be deployed by a university against a woman who has just lost her only child to suicide?  In a just world, I believe, the University of Minnesota would have investigated the suicide, apologized to Mary Weiss, paid her an enormous settlement, and fired everyone involved in the CAFÉ study.   Instead, it tried to punish Ms. Weiss even further.

The university eventually dropped the demand, but it is unlikely that collecting the money was ever really the point.  Some commentators, such as Howard Brody of the University of Texas Medical Branch, have compared the tactic to a SLAPP, or Strategic Lawsuit Against Public Participation.  SLAPP’s are lawsuits which the plaintiff typically does not really expect to win, but which are used as way of intimidating critics and preventing other potential critics from speaking out.   They are typically used by large, well-funded organizations – often corporations – to frighten people who do not have the funds to fight back.  Often, just the threat of a lawsuit is enough to do the job.  Many states have enacted anti-SLAPP legislation to prevent this kind of bullying.

The demand for court costs is somewhat different, but it can be deployed for similar purposes, and the University of Minnesota is not the only academic health center to use it.  In 2004, surgeons at two Duke University hospitals inadvertently operated on thousands of patients with surgical instruments that had been washed in used hydraulic elevator fluid.  According to the Durham News, repair crews had drained elevator fluid into used detergent barrels, and the fluid was later mistaken for the detergent used in machines to clean surgical instruments.  Surgeons complained that their instruments felt greasy for nearly a month before the mistake was detected.

A group of patients sued Duke in 2010, contending that Duke had manipulated studies to show that the elevator fluid had caused no harm.  For years the patients had received letters from Duke explaining the incident and telling them that they were part of a study tracking the possible effects of exposure.  When Duke later determined that some of these patients hadn’t been exposed to the elevator fluid after all, those patients were dismissed from the lawsuit.  Then Duke put the screws to the dismissed patients by demanding that they pay Duke’s costs.  Attorneys for the patients said that their clients had no way of knowing they were not exposed until they filed suit.

At the University of Minnesota, matters have been complicated even further by the fact that virtually every question about the Markingson case has been handled by the Office of the General Counsel.  When I wrote about the case for Mother Jones, the university’s (misleading) response came from the General Counsel, Mark Rotenberg.  When a group of faculty members asked the Board of Regents to appoint an external panel to investigate the suicide, the refusal came from Rotenberg.  When the press started looking into the case, the comments to reporters came from Rotenberg.  And when the Committee on Academic Freedom and Tenure began looking into so-called “factually incorrect attacks on particular University faculty research activities” – that is to say, the ethical questions being raised about the case –  the point man for the inquiry was, once again, Mark Rotenberg.

As Stanford’s Matt Lamkin has written, “When patients and research participants raise serious and legitimate concerns about the hospitals and research centers in whom they have entrusted their medical care, it’s wrong to use the same bare-knuckled tactics that are common in corporate litigation.”  Exactly right.  But it was also a mistake for University of Minnesota administrators to put Rotenberg in charge of adjudicating ethical questions about the CAFÉ study.   As the attorney in charge of defending the university, he is hardly an impartial judge – especially if there had been genuine wrongdoing in the case and he had used hardball tactics to prevent that wrongdoing from being dealt with fairly.  By making Rotenberg the public relations spokesman and de facto administrator in charge of the case, the University of Minnesota took a significant step towards preventing hard questions about Dan Markingson’s suicide from being answered.

(This was originally posted on the Chronicle of Higher Education Brainstorm blog.)