Patient Dies in Clinical Drug Trial: Menninger Clinic Found Negligent by Jury
In mid-December 2001, a jury found the Menninger Clinic (then of Topeka, KS, now relocated to Houston, TX) negligent in the treatment of an individual who was placed in a clinical trial in which he received an experimental neuroleptic (antipsychotic drug). Psychiatrist Peter R. Breggin, M.D. was the only medical expert for the plaintiffs.
A man diagnosed with chronic schizophrenia went to the Menninger Clinic for long-term residential treatment in an off-campus non-hospital setting. However, at the urging of the Menninger Clinic, he was later hospitalized as an inpatient at Menninger in order to be placed into a clinical trial for the FDA approval of a new antipsychotic drug. The drug company paid Menninger for each patient that was entered into the trial. The amount was considerably more than the patient was paying for his treatment before being ushered into the clinical trial.
The patient received the experimental drug during the clinical trial and was then continued on it for a brief time following the conclusion of the clinical trial. While being treated with the drug, he wandered off or eloped from the hospital grounds and died of exposure. The drug was never approved by the FDA and was withdrawn by the manufacturer.
Dr. Breggin testified concerning standards of care in a residential treatment center and a mental hospital ward. He testified on informed consent and the standards for the conduct of controlled clinical trials. He gave the opinion that the patient did not meet the criteria established for the trial and therefore should not have been included. He testified that the patient was not properly monitored, and that more appropriate treatment was withheld from the patient in order to maintain him in the clinical trial. He testified that the hospitalization and the drug treatment further impaired the patient’s condition. He described the adverse effects of neuroleptic drugs that contributed to the man’s elopement, including worsening depression and akathisia. Akathisia is drug-induced internal agitation and anxiety that drives the person to move about and often to resist treatment.
The jury found the Menninger Clinic negligent and gave an award to the deceased patient’s family. (Kernke v. The Menninger Clinic, U.S. District Court for the District of Kansas, Case No. 00-22630GTV). Attorneys for the plaintiff were Murray Abowitz and Kayce Gisinger, Oklahoma City, Oklahoma, and Stephen G. Dickerson, Kansas City, Kansas.
See additional information on this website concerning neuroleptic drugs .
(1) Peter Breggin, M.D. Brain-Disabling Treatments in Psychiatry (Springer Publishing Company, 1997, revised and updated 2008) for extensive scientific analyses of neuroleptic drug effects and also standards concerning clinical trials for the FDA approval of drugs.
(2) Peter Breggin, M.D. and David Cohen, Ph.D., Your Drug May Be Your Problem: How and Why to Stop Taking Psychiatric Medication (Perseus Books, 1999) for a more popular, abbreviated discussion of neuroleptic drug effects.
Also see Dr. Breggin’s peer-reviewed articles related to neuroleptic drug effects and to clinical trials for the FDA approval of drugs.