• Informed Consent &
  Malpractice
• Employment Litigation
  ADA - Disability - Sexual Misconduct
  Discrimination - Worker's Compensation
• Emotional &
  Physical Damages
  Conscious Pain & Suffering
  Post-Traumatic Stress Disorder (PTSD)
  Neuropsychiatric Autopsy
• Standards for Experts
• Product Liability
  Medical Devices & Pharmaceuticals
  Toxic Tort
• Criminal Justice &
  Public Safety
  Diminished Capacity - Drug Addiction
  Competency to Confess
  Death Penalty Mitigation
  Workplace Safety
• Family & Custody Issues
• Testamentary &
  Contractual Capacity
• Professional &
  Organizational Ethics
  Patient Care - Managed Care - Privacy
• Psychoanalysis &
  Cultural Perspectives

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:

• 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.

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:

• Article: Popping Xanax is more harmful than you think. Dr. bursztajn is quoted in Self magazine on alternatives to prescription medications for anxiety.
• Article: Children on psych meds raise these ethical concerns. Dr. Bursztajn is quoted in the Medical Ethics Advisor, January 2013.
• Article: Undue Pharmaceutical Influence on Psychiatric Practice: Steps That Can Reduce the Ethical Risk. Dr. Bursztajn and Lisa Cosgrove's latest article in the Psychiatric Times regarding increasing concerns arising about the ways in which corporate sponsorship of clinical trials and continuing medical education activities may bias the information that is published and disseminated about the benefits and risks of medications.
• Article: Conflicts of interest bedevil psychiatric drug research. Dr. Bursztajn is mentioned along with his colleague and frequent co-author in USA Today.
• Article: Firms tied to some MDs who set policy. Dr. Bursztajn along with his colleagues Lisa Cosgrove and Sheldon Krimsky is mentioned in a Boston Globe article examining his latest paper on the writers of psychiatric clinical guidelines and their financial ties with pharmaceutical companies, published in the journal of Psychotherapy and Psychosomatics.
• Article: Informed consent in neuropsychosocialpharmacology.
• Article: Ethical and legal dimensions of benzodiazepine prescription. Dr. Bursztajn's article providing a new resource for managing malpractice risks in managed care.
• Article: Melatonin Therapy: From Benzodiazepine-Dependent Insomnia to Authenticity and Autonomy. Dr. Bursztajn's article on the accounting for the risks of Melatonin therapy.
• Article: Avoiding Ipse Dixit Mislabeling: Post-Daubert Approaches to Expert Clinical Opinions Dr. Bursztajn's article on how experts can reduce the likelihood that their conclusions will be mislabeled.
• Article: The Grand Inquisitor’s Choice: Comment on the CEJA Report on Withholding Information from Patients. Dr. Bursztajn's recent article with Darlyn Pirakitikulr published in The Journal of Clinical Ethics (Winter 2006).
• Article: Beyond cognition: the role of disordered affective states in impairing competence to consent to treatment.
• Article: Daubert Without Prejudice: Achieving Relevance and Reliability Without Randomness.
• The importance of the wording of warning labels on pharmaceuticals is addressed in the following articles by Dr. Bursztajn:
  • Article: Medical and judicial perceptions of the risks associated with use of antipsychotic medication.
  • Article: Micro-effects of language on risk perception in drug prescribing behavior.

Selected Cases

• Case: Mayotte 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.
• Case:  Doe 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 opinions.

Presentations

• 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

• Case: Matrixx Initiatives, Inc. et al., v. James Siracusano, et al. This vital recent Supreme Court decision reflects an understanding of the fundamentals of medical decision-making first articulated by Dr. Bursztajn in Medical Choices, Medical Chances.
• Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. The Food and Drug Administration (FDA) will hold a public hearing to provide an opportunity for broad public participation and comment on promotion of FDA-regulated medical products using the Internet and social media tools.
• Article: Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration. A new study taking into account all studies submitted to the FDA comparing antidepressants and placebo concludes that antidepressant efficacy increases compared to placebo as the severity of the depression increases, but such increases are relatively small even for severely depressed patients. This increase can also be attributed to a decreased response in severely depressed patients to placebo rather than an increase in response to antidepressants.
• Article: Duluth-based health system bans pharmaceutical logos. A Duluth-based health system is declaring a ban on drug-logo freebies, no matter how small.
• F.D.A. Rule Limits Role of Advisers Tied to Industry

  The new rules would bar government advisers who receive money from a drug or device maker from voting on that company’s products.

• Article: After Sanctions, Doctors Get Drug Company Pay. Many doctors who were sanctioned by a medical board were later paid for research by drug makers. New York Times, June 3, 2007.
• Article: Gimme an Rx! Cheerleaders Pep Up Drug Sales. Pharmaceutical Marketing to Doctors: Issues in pharmaceutical sales representative influence on prescribing patterns. New York Times, November 29, 2005.

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.

• See Dr. Bursztajn's article "Daubert Without Prejudice: Achieving Relevance and Reliability Without Randomness"
• Case: McBarron v. Arena

  Specific fact patterns matter. In this case Dr. Bursztajn testified that the plaintiffs, as reasonable persons, knew or should have known about the toxic leak on their land and assumed the risk in question.

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