Product Liability

Product liability cases often raise issues of informed consent processes, assumption of risk, professional and organizational ethics, complex neuropsychiatric causation of claimed injuries, and the validity and reliability of expert methodology and opinion formulation. There can also an issue of distinguishing medical product liability from the physician's or patient's knowing assumption of risk. Here the level of informed consent available may be crucial.

Dr Bursztajn consults and teaches physicians, including psychiatrists, regarding the fundamentals of informed consent processes. "Informed Consent in Neuropsychosocialpharmacology," Psychiatric Times, 2005; 22(13):59-63. His long standing interest in the ethical foundations of pharmaceutical and medical device research led to his serving on the National Committee for Quality Assurance (NCQA) under contract to the U.S. Department of Veterans Affairs (VA) in developing standards for the accreditation of programs for the protection of human subjects. These standards served as a basis for field testing and adoption nationally by the Institute of Medicine.

Areas of special interest include:

A forensic neuropsychiatric examination can also be useful in checking for publicity as a factor in suggestible individuals presenting with an impairment in highly publicized cases. In the forensic neuropsychiatric evaluation of medical product liability causation issues, when there is widespread publicity regarding a newly discovered side effect of a medication, the possibility of a "nocebo" effect - i.e., a "me, too" response by placebo-sensitive individuals -- has to be ruled out prior to attributing causation of a presenting impairment to the medical product in question. Similar considerations apply in highly publicized toxic tort cases. A forensic neuropsychiatric evaluation to rule out suggestibility and "bandwagon" effects" is very helpful, from either the plaintiff's or defense attorney's viewpoint, both in the initial examination and in the kind of "expert on expert" analysis of methodology described in the next paragraph.

Cases involving the causation of medical or mental-health impairments may also call for an "expert on experts," whose analyses can be relied on by the finder of fact to determine whether experts' opinions are admissible under the U.S. Supreme Court's Daubert, Kumho, and Joiner decisions.

Dr. Bursztajn has also had a career long interest in the clinical and forensic analysis of causation including how psychotropics can precipitate suicidal ideation and psychosis in some vulnerable individuals even while they may relieve it in others; and thus the importance of clinicians and patients having accurate information. In cases of disputed psychiatric causation he is often retained as an expert on experts whereby an analysis is conducted of the reports of the experts retained by the opposing sides.

Selected Articles

Some of Dr. Bursztajn's articles on the importance of the informed consent process in neuropsychopharmacology and the ongoing debate on conflicts of interest in medicine and psychiatry:

Selected Cases


Other News, Articles and Cases of Interest

Toxic Tort

In toxic tort cases, the plaintiff sometimes claims new neuropsychiatric damages. In determining the merits of such claims, the testimony of a forensic psychiatrist can shed light on the reasonableness of risk perception and the influence of pre-existing conditions on the alleged impairments as well as on the person's capacity to give informed consent or assume risk. The forensic psychiatrist may also serve as an "expert on experts," evaluating the validity and reliability of expert methodology and opinion formulation so that the finder of fact can determine whether the experts' opinions are admissible under the U.S. Supreme Court's Daubert, Kumho, and Joiner decisions.

Dr. Bursztajn has an active patient care practice and consults to physicians, institutions, judges, and plaintiff and defense counsel nationally.