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:
Protection of human research subjects and patient and public safety
Informed consent processes
Effects of marketing and publicity on physician and patient decision-making
Evaluation of claims of neuropsychiatric impairment
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.
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:
M. Jones v. MetroWest Medical, Inc. In dismissing a claim
of a diagnosis of multiple chemical sensitivity disorder, the judge
cited favorably Dr Bursztajn's forensic neuropsychiatric testimony
regarding the unreliability of the plaintiff's medical expert's diagnostic
and causation evaluation and opinion formulation methodology.
v. Doe. In the case of a plaintiff who claimed neurotoxicity
from worksite exposure to a pesticide, although the impairments he
alleged may have been caused by steroids he was taking, Dr. Bursztajn
was retained by the defense to evaluate the reliability of the plaintiff's
medical experts' causation analysis. On voir dire the judge disqualified
each of the plaintiff's experts, citing Dr. Bursztajn's report as
to the lack of methodological reliability and relevance in their
Clinical Expertise in Medical Product Litigation or "Experts--What You Don't Know Can
Hurt You." [Text
only version] Dr. Bursztajn's presentation slides from the Drug & Medical
Device Conference on December 14, 2004 in New York City. Topics discussed
are how to find the medical expert for your case; how to best work
with the expert; what should I do to prep for screening my expert
and how to question certain experts.
Other News, Articles and Cases of Interest
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.