Informed Consent
Psychiatrists such as Dr. Bursztajn may have expertise in consulting
across a spectrum of medical specialties regarding the quality of the
informed consent process. They may also be asked to serve as consultants
for guidelines regarding the informed consent process by peer review
boards, institutions, state and federal agencies, the courts, or by plaintiffs'
or defendants' attorneys to offer expert opinions as to whether meaningful
informed consent has occurred. Dr Bursztajn consults and teaches physicians,
including psychiatrists, regarding the fundamentals of informed consent.
Some of Dr. Bursztajn's articles in this area include:
A wealth of information on Informed Consent within a case study framework
can be found in Dr. Bursztajn's book Psychiatric
Ethics and Rights of Persons with Disabilities in Institutions and the
Community.
Failure to engage in a meaningful informed consent process can motivate
successful plaintiff lawsuits in even defense oriented venues. On the
other hand, even in challenging circumstances, successful defenses can
be developed based on the presence of a meaningful informed consent process:
Some states have expended the circle of liability for negligent informed
consent as to prescribed medications to include third parties injured
in automobile accidents by prescription impaired but uninformed drivers.
Informed consent regarding prescription medication is the key to preventing
liability in "driving while impaired by prescription medication" cases.
It is important for the individual patient to be involved in the decision-making
process of choosing appropriate treatment. Informed consent can not only
help the patient maintain control over his or her health care; it can
help to prevent medical malpractice litigation. Lack of adequate information
or influence over one's treatment can result in a lawsuit.
Several articles on the Importance of Meaningful Informed Consent for
Protecting Patients
& Clinical Research Subjects:
- Nuremberg Code. The ten
principles of ethics governing the use of human subjects.
- Protection
of Human Subjects in Research. Home Page of the US Air Force
Academy's Institutional Review Board.
- Human Research Questions &
Answers from the Office for Human Research Protections.
- United States Holocaust
Memorial Museum. The Official Trial Record at Nuremberg.
- Science (296:5575,
p 1953, Jun 14, 2002) reports that the FDA has proposed that researchers
(specifically those whose work involves human subjects) be required
to tell their IRBs (Internal Review Boards) about prior IRB reviews.
This is not so much a problem with academic researchers who have
to use their home IRBs. However pharmaceutical companies sponsoring
multisite trials can do "IRB shopping", can submit research
plans to multiple IRBs and to private "super IRBs" to which
individual institutions have ceded authority. These latter IRBs might
be "more agreeable" and might lean toward sacrificing caution
re patient safety. The FDA's proposal has been opposed by various
pharmaceutical companies.
Malpractice
Health services often involve an element of risk and consequently decision-making
on the part of the provider/practitioner. Whether a treating physician
could and should reasonably have made a more informed decision can be
addressed by consultation with a physician with a special interest in
medical decision-making and the informed consent process. Forensic psychiatric
experts include physicians with training and expertise who consult regularly
to physicians in other specialties regarding standards for informed clinical
decision making. The following cases illustrate how forensic psychiatric
and medical expertise can be useful in objectively evaluating malpractice
claims.
- Case: Morgan v. Gosney. In a case with significant implications for malpractice law, disability law, and therapeutic jurisprudence, a plaintiff won a seven-figure damage award against a pharmacy that had mistakenly dispensed the wrong psychiatric medication.
- Article: Direct-to-Patient Laboratory Test Reporting: Balancing Access With Effective Clinical Communication. Dr. Bursztajn's article in JAMA on informing the patient directly about medical laboratory test results and its implications for the informed consent process, public and professional education, and medical malpractice prevention.
- Article: Managing
Risks When Practicing in Three-Party Care Settings. Psychiatric
Times February 3, 2009.
- Case: Heisch
V. Morton, et al. A
lack of response to parents' concerns that an infant in respiratory
distress be transferred to intensive care can result in lifelong
neuropsychiatric impairment.
- Case: Patient
overdoses on an antidepressant prescribed by a psychiatrist,
lack of an informed consent process, failure to prevent suicide;
family wins $1.38m verdict.
- Case: Meador
v. Sidney Stahler, M.D. and Ruben Gheridian, M.D. Failure
of informed consent process.
- Case: Jamie
Claborn Drewry v. Phillip Harwell, M.D.. Dr. Bursztajn
testified for the defense in this case involving the informed consent
process.
- Case: Kennedy
v. United States of America. Judges gatekeeping post-Daubert:
Dismissal of a plaintiff's suicide claim. Dr. Bursztajn retained
as an expert by defense in support of a successful dismissal.
- Case: Monahan
v. Commonwealth of MA Department of Mental Health and New England
Fellowship for Rehabilitation Alternatives, Inc.
- Case: Deasy
v. US
- Case: Plaintiff
v. Doctor
Medical Malpractice
Dr Bursztajn has over the years been a leader
in educational activities focused on
enhancing patient safety and clinical and institutional risk management.
Among his special areas of interest has been standards for distinguishing
merited from unmerited psychiatric medical malpractice claims: Some psychiatric
and medical malpractice suits are merited and some are not. The following
case is illustrative of Dr. Bursztajn's concerns for maintaining standards
for patient safety in this meritorious case:
Dr Bursztajn has over the years been a leader
in educational activities focused on enhancing
patient safety and clinical and institutional risk management: Among
his special areas of interest has been standards for distinguishing merited
from unmerited psychiatric medical malpractice claims: Some psychiatric
and medical malpractice suits are merited and some are not. Lake
v. WVUH, et al. is illustrative of Dr. Bursztajn's concerns for maintaining
standards for patient safety in this meritorious case.
The case below is illustrative of how Dr. Bursztajn's work can also be
helpful for physician and institutional risk management in defending
good clinical practices from those malpractice claims which lack merit:
Elizabeth Marie Kennedy, et al. v. United States of America
Judge rules in favor of defense.
Defense retained expert: Dr. Harold J. Bursztajn
Excerpt:
"None of the facts known (or that should have been know) by Dr.
Diebold and the other medical personnel at the V.A. held any clue that
Kennedy would take his own life on February 22, 1994. Unlike the cases
cited by the plaintiffs in which the decedent's suicide was found to
be foreseeable, see, e.g., Dinnerstein v. United States, 486 F. 2d 34
(2nd Cir. 1973)(decedent's extensive history of mental depression and
suicidal tendencies provided notice of need for heightened supervision);
Lucy Webb Hayes National Training School for Deaconesses and Missionaries
v. Perotti, 419 F. 2d 704 (D.D.C. 1969) (suicide of psychiatric patient
who had previously been diagnosed as suicidal and who suffered from 'paranoid
depression,' apathy, slowness of speech, delusions of persecution, and
depression on day of suicide was foreseeable), nothing known or that
should have been known by Dr. Diebold or the other VA personnel should
have sent up a red flag that Kennedy posed a danger to himself. As the
defendant's reply suggests, Dr. Diebold did not have a crystal ball to
foresee that sending Kennedy home (as he insisted) would result in his
act of suicide.
Because Kennedy's suicide was not a foreseeable consequence of the defendant's
employees' acts, the court grants the defendant's motion for summary
judgment." [Case No. 96-4032-SAC, In the United States District
Court for the District of Kansas]
Psychiatric Malpractice
- Case: Doe v. Roe Hospital. Dr. Bursztajn's expert evaluation helps to resolve a claim that clinical and institutional malpractice caused a patient's suicide.
- The importance of providing patients with informed and meaningful
choices as to treatment modalities is underscored by this article. Like
Drugs, Talk Therapy Can Change Brain Chemistry by Richard
A Friedman, M.D., The New York Times, August 27,
2002.
- Article: Captive
Patients, Captive Doctors: Clinical Dilemmas and Intervention in
Caring for Patients in Managed Health Care by Harold J. Bursztajn,
M.D. and Archie Brodsky, B.A.
- Article: Report of the Council on Scientific Affairs: Use
of Restraints for Patients in Nursing Homes. Archives of
Family Medicine, March/April 1999
- Case: Behn
v. Tufo, Patient overdoses on antidepressant prescribed
by psychiatrist: Improper treatment: Failure to prevent suicide:
Post verdict settlement. [Professional Negligence Law Reporter]
- Article: Behn
v. Tufo [Boston Globe article]
- Case: Nowak
v. Tak How, Conscious Pain and Suffering and the Psychological
Autopsy of the Deceased in Negligent Death Cases
- Article: Medical
and Judicial Perceptions of the Risks Associated with Use of Antipsychotic
Medication. Evaluation of risk differs from medical evaluation.
- Article: Attacks
Spur Call to Force Medications. Chicago Tribune article
quoting Dr. Bursztajn.
- Article: Mismanaged
Care & Suicide. CNN program which aired June 20 & 21,
1999.
- Article: Don't
Give in to Demands of Managed Health Care, Says Panel Dr. Bursztajn's
presentation at APA's 1999 Annual Meeting commented in the A.P.A. Psychiatric
News.
- Article: When
Health Care Goes Lacking Dr. Bursztajn on consequences of managed
health care denial in The New York Times, 8-4-99.
- Case: Kennedy
v. United States of America. Judges gatekeeping post-Daubert:
Dismissal of a plaintiff's a suicide claim. Dr. Bursztajn retained
as an expert by defense in support of a successful dismissal. See
also:
- Article: Daubert
Without Prejudice: Achieving Relevance and Reliability Without Randomness
- Article: Medical
Directors Are Physicians First
- Article: Melatonin
Therapy: From Benzodiazepine-Dependent Insomnia to Authenticity
and Autonomy
- Article: Mental
Health of Students Gets New Push at Harvard College Mental Health
Services Risk Management
- Excerpt: Suitable
Behavior: What to Do When Being Sued
- Article: Ethical
and Legal Dimensions of Benzodiazepine Prescription
- Article: Under
Legal Attack, H.M.O.s Face a Supreme Court Test
- Article: Uses
and Abuses of Prescription Drug Information in Pharmacy Benefits
Management Programs
- Report: Kids Using
More Psych Drugs ADD and the need for a comprehensive psychiatric
evaluation
- Article: Trends
in the Prescribing of Psychotropic Medications to Preschoolers.
Overmedication of preschoolers?
- Case: Wendell
Williamson v. Myron Liptzin, MD. A young UNC-Chapel Hill Law
Student who was diagnosed with schizophrenia went on a killing spree
in Downtown Chapel Hill after being "abandoned" by his
psychiatrist.
EMTLA
Dr. Bursztajn has an active patient care practice and consults to physicians,
institutions, judges, and plaintiff and defense counsel nationally.