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 negligient 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.
The Importance of Meaningful
Informed Consent for Protecting Patients
& Clinical Research Subjects
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Nuremberg Code. The
ten principles of ethics governing the use of human subjects.
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Protection of Human
Subjects in Research. Home Page of the US Air Force Academy's
Institutional Review Board.
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Human Research Questions &
Answers from the Office for Human Research Protections.
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United States Holocaust
Museum. The Official Trial Record at Nuremberg.
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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 houses 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.
FDA's proposal has been opposed by various drug houses. Seems important
in view of developments of significant and relevant prescription
drug cases.
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.
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Case: Skillman,
et al. v. Berlin. Dr. Bursztajn, an expert on the doctor-patient
relationship who consults to physicians in primary-care and other
medical specialties on patient-care issues, opines on the damaging
consequences of a doctor's failure to obtain a specialized second
opinion or encourage the parents to obtain such a consultation and
the damaging consequences of such failure on an infant.
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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.
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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.
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Case: Meador
v. Sidney Stahler, M.D. and Ruben Gheridian, M.D. Failure
of informed consent process.
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Case: Jamie
Claborn Drewry v. Phillip Harwell, M.D.. Informed consent
process.
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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.
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Case: Elaine
Kennedy v. Dr. Ferroll Sams, III. Patient awarded $3.4
million for improper commitment.
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Case: Jones,
estate of Lee Forbes, deceased v. West Oaks Hospital Inc..
Patient flees hospital and commits suicide resulting in a $5 million
verdict.
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Case: Monahan
v. Commonwealth of MA Department of Mental Health and New England
Fellowship for Rehabilitation Alternatives, Inc.
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Case: Edwards,
Executor of the Estate of Agatha M. Edwards, deceased v. Daniel Tardif,
M.D. Woman commits suicide with anti-depressant drugs
prescribed by phone; court upholds $500,000 verdict.
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Case: Deasy
v. US
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Case: Plaintiff
v. Doctor
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Case: Murphy
v. Board of Examiners. MCO Medical director held responsible
for 'medical decision'.
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Case: Self
v. Medical Group Patient care supersedes profits: Physician
wins award after being fired by an HMO for spending too much time
with patients and ordering too many tests.
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Case: Turner
v. Jordan. "Psychiatrist Has Duty to Protect Hospital
Nurse from Violent Patient"
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Case: Plocica
v. NylCare. Under new Texas law, family of a man who committed
suicide, accuses HMO of malpractice.
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Case: Engalla
v. Permanente Medical Group, Inc. "Fraudulent Arbitration
by HMO"
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]
Additionally, the following case summary addresses an additional aspect
of MCO liability:
Malpractice Prevention & Liability
Medical Malpractice & Informed
Consent
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Article: "Informed
Consent as a Dynamic Process"
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Case: Meador
v. Sidney Stahler, MD and Ruben Gheridian, MD, Failure
to Inform as Negligence
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Case: Jamie
Claborn Drewry v. Phillip Harwell, MD, Informing as a
Defense to Negligence
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Case: Cobo
v. Raba, When Informed, Patient is Responsible for Contributory
Negligence
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Article: "New
Report on Doctors & Nurses Experience with Managed Care Denials & Patient
Injury"
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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.
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Article: "Series
of Rulings Eases Constraints on Suing HMO's"
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Article: "Do
No Harm; Breaking Down Medicine's Culture of Silence"
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Article: "Informed
Decision Making in Outpatient Practice"
Emergency Care
Emotional & Physical Damages Post-Medical Malpractice
Psychiatric Malpractice
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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.
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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.
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Article: Report of the Council on Scientific Affairs: Use
of Restraints for Patients in Nursing Homes. Archives of
Family Medicine, March/April 1999
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Article: The
Changing World of Medical and Psychiatric Malpractice from 1985 to
1997
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Case: Behn
v. Tufo, Patient overdoses on antidepressant prescribed
by psychiatrist: Improper treatment: Failure to prevent suicide:
Postverdict settlement. [Professional Negligence Law Reporter]
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Article: Behn
v. Tufo [Boston Globe article]
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Case: Nowak
v. Tak How, Conscious Pain and Suffering and the Psychological
Autopsy of the Deceased in Negligent Death Cases
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Article: Medical
and Judicial Perceptions of the Risks Associated with Use of Antipsychotic
Medication. Evaluation of risk differs from medical evaluation.
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Case: Swift
v. Fitchburg Mut. Ins. Co.: "Insurer's Duty to Insured
Person with Mental Disability"
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Case: Robert
McNemar v. Commonwealth of Massachusetts, Dept. of Mental Health Psychiatric
negligence case.
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Article: "Attacks
Spur Call to Force Medications." Chicago Tribune article
quoting Dr. Bursztajn.
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Article: "Mismanaged
Care & Suicide." CNN program which aired June 20 & 21,
1999.
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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.
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Article: "State's
Assisted Suicide Law Raises Competency, Assessment Issues" On
the need for an expert forensic psychiatrist evaluation for competence
to refuse treatment.
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Article: "Treatment
for the Mentally Ill in Jail"
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Article: "New
Report on Doctors & Nurses Experience with Managed Care Denials & Patient
Injury"
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Article: "When
Health Care Goes Lacking" Dr. Bursztajn on consequences
of managed health care denial in The New York Times,
8-4-99.
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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:
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Article: "Daubert
Without Prejudice: Achieving Relevance and Reliability Without Randomness"
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Article: "Medical
Directors Are Physicians First"
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Article: "MDs'
Success Rate in Lawsuits Is Dropping"
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Article: "The
Last Resort-- The Use of Physical Restraints in Medical Emergencies"
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Article: Melatonin
Therapy: From Benzodiazapine-Dependent Insomnia to Authenticity
and Autonomy
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Article: "Mental
Health of Students Gets New Push at Harvard" College Mental
Health Services Risk Management
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Excerpt: "Suitable
Behavior: What to Do When Being Sued"
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Article: "Ethical
and Legal Dimensions of Benzodiazepine Prescription"
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Article: "Informed
Consent as a Dynamic Process"
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Article: "Under
Legal Attack, H.M.O.s Face a Supreme Court Test"
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Article: "Uses
and Abuses of Prescription Drug Information in Pharmacy Benefits
Management Programs"
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Report: "Kids
Using More Psych Drugs" ADD and the need for a comprehensive
psychiatric evaluation
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Article: "Trends
in the Prescribing of Psychotropic Medications to Preschoolers" Overmedication
of preschoolers?
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Article Summary: "Stress
and Psychiatric Disorder in Healthcare Professionals and Hospital
Staff"
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Case: Court Decision regarding Wendell
Williams case, a young UNC-Chapel Hill Law Student who was diagnosed
with schizophrenia and after being "abandoned" by his psychiatrist,
went a killing spree in Downtown Chapel Hill.
Malpractice Prevention in
Telemedicine
Dr. Bursztajn has an active patient care practice and consults to physicians,
institutions, judges, and plaintiff and defense counsel nationally.