Medical Negligence and Informed Consent in the Managed-Care Era
Harold J. Bursztajn, MD
Linda Stout Saunders, JD
Archie Brodsky
Dr. Harold J. Bursztajn, Associate Clinical
Professor and Co-Director, Program in Psychiatry and the Law, Harvard
Medical School, is in clinical practice in Cambridge, Mass., and
consults nationally as a forensic psychiatrist and expert in medical
decision making and informed consent in primary medical care. Linda
Stout Saunders is President of the New Hampshire Trial Lawyers Association.
Archie Brodsky is Senior Research Associate, Program in Psychiatry
and the Law, Harvard Medical School.
Introduction
In January of 1996, a Manhattan jury awarded $43 million in damages to
the mother of a developmentally impaired 7-year-old son. [l]
Physicians at New York's Beth Israel Medical Center had advised Jan Goldberg
to have a cesarean section at least three weeks before her due date so
that her cervix, which was suspected of being cancerous, could be removed
along with her uterus and ovaries. The verdict made headlines because
of the size of the award. But another aspect of the case could have more
lasting significance. Mrs. Goldberg claimed that her physician not only
delivered the baby too early, but removed her ovaries without properly
obtaining her informed consent. As in this case, the courts increasingly
are scrutinizing the process as well as the content of medical decision
makingnot only what the decision was, but who made it and how it
was made.
Informed consent has long been recognized to be an essential component
of good medical careso much so that its ethical and legal implications
were examined in 1982 by a presidential commission. [2]
As a rule, however, informed consent and negligence have been treated
as separate causes of action, derived from different legal theories.
Nonetheless, whether overtly or covertly, informed consent has been making
itself felt as a factor in determinations of medical negligence. For
both plaintiffs' and defense attorneys, this is a trend worth noting.
Malpractice Broadly Construed
Medical malpractice litigation hinges on more than just the standard of
care in a particular medical specialty. This article takes both a legal
and forensic psychiatric look at examples of nonpsychiatric medical malpractice
cases with a classical psychiatric subtext, or a subtext in the area
of informed consent and the decision-making process. While most medical
malpractice cases are the "hard" technical cases which involve
essentially the brute fact of, say, a sponge or clamp left in the body
after surgery, oftentimes the psychiatric or emotional subtext of such
cases can have a significant tie-in with informed consent and can constitute
a key element of both liability and damages.
When a medical malpractice plaintiff claims emotional damages, most commonly
as a complication of physical injury, Rule 35 of the Federal Rules of
Civil Procedure permits the defense to conduct a forensic psychiatric
examination of the plaintiff. Such an examination makes it possible to
reconstruct the medical decision-making process and relate it to the
patient's emotional condition both before and after the treatment. Even
when the plaintiff cannot be examinedfor example, when a psychological
autopsy must be performed in the case of a patient who has dieda
forensic psychiatric consultation can aid not only in delineating the
nature and extent of damages, but also in understanding the dynamics
of the doctor-patient relationship and their influence on the medical
outcome. The following two cases illustrate how informed consent, interwoven
with psychological issues, can become a significant aspect of the standard
of care.
A Plaintiff's Verdict: Meador v. Stahler and Gheridian
The $1.5 million award to a Massachusetts woman and her family in Meador
v. Stahler and Gheridian [3] made news as
a rare instance of a malpractice judgment based on an allegedly unwanted
and unnecessary cesarean section rather than a failure to perform
such an operation. The plaintiff, Mary Meador, did not claim that
the procedure was negligently performed or that the rare and disabling
physical complications that resulted from it (which left her largely
bedridden and unable to work or meet her family responsibilities
for several years) were foreseeable. Instead, she claimed that the
defendant obstetricians had misrepresented the risks of the alternative
procedure (vaginal birth after prior cesarean) and ignored her persistent
pleas for this alternative. Moreover, she alleged, they compelled
her passive assent to the surgery in an emotionally coercive manner
while she was progressing normally in labor, despite their having
previously agreed to such a trial of labor.
Because the consequences of the cesarean were unforeseeable, and because
Meador had signed a consent form for the surgery (to be used in case
of emergency), this case did not meet the technical requirements specified
under Massachusetts law [4] for an action based on informed
consent. Instead, the case was brought on the theory that the physicians'
failure to obtain the patient's informed consent constituted substandard,
negligent medical care. The forensic psychiatrist's expert testimony
emphasized that the pro forma signing of a consent form did
not constitute true informed consent, especially in light of the physicians'
alleged disregard of the patient's expressed wishes and their inaccurate
representation of the risks and benefits of the approach she preferred.
The psychiatrist also explained to the jury how Meador's life history
left her vulnerable to experiencing the denial of informed consent as
a highly traumatic event. Having coped since childhood with serious illnesses
in her family, Meador had viewed doctors and nurses as nurturing figures
who helped her gain control of potentially tragic situations. She had
learned that choice was still possible even amidst illness and death.
She had even been inspired to become a nurse herself and to teach this
discipline to others. Thus, when she experienced a sudden loss of choice
and control during childbirth, she reacted with intense fear and horror
and felt she had been betrayed by health professionals, whom she now
feared and mistrusted. In this way she lost her accustomed strategy for
coping with life. Moreover, having helped hold her original family together
in the face of tragic illness, Meador saw the family she had created
torn apart by her sudden and devastating loss of control in a medical
situation. The jury's recognition of the importance of the emotional
facts of the case was highlighted by its awarding almost one-third of
the total damages for loss of consortium.
Thus, it was not simply the physically disabling consequences of the surgery,
but the loss of personal decision-making power concerning her body, her
health, and the birth of her child, that caused Meador to suffer from
Post-Traumatic Stress Disorder. Similarly, her husband's experience of
loss of consortium was exacerbated by the physicians' failure to consult
him to interpret his wife's wishes during labor. Instead of having participated
in a true informed-consent process, he was left to feel powerless and
helpless. In this way, forensic psychiatric testimony established a persuasive
causal link between the lack of informed consent and the physical and
emotional damages suffered by the patient and her family.
A Defendant's Verdict: Drewry v. Harwell
The jury verdict in
Drewry v. Harwell [
5] may
be seen as the mirror-image of
Meador in the medical negligence/informed
consent nexus. The plaintiff was a young woman who had suffered chronic pelvic
pain. After unsuccessful attempts to control the pain with medications, the
defendant obstetrician/gynecologist performed a hysterectomy. In the course
of the surgery an embryo of one month's gestation was discovered and, as
a necessary consequence of the surgery, aborted. The plaintiff subsequently
brought an action for medical malpractice, alleging that the defendants had
performed an unwanted procedure, caused an unwanted abortion, and engaged
in sexual misconduct.
The plaintiff's claims had the ingredients of a major damage award: a
woman who had lost her baby and could never have another, and on top
of that an accusation of sexual misconduct. Subsequent to the forensic
examination, however, the allegation of sexual misconduct was dropped.
The case did go to trial on the two other claims. A unanimous jury verdict
for the defendants was returned on both counts.
The key to this verdict appears to have been a forensic analysis of the
informed-consent process engaged in by the physician and patient, which
provided a psychological autopsy of the decision. In an unusual move,
the forensic psychiatrist originally retained by the defense to evaluate
the sexual misconduct charge testified as an expert witness as to the
elements of medical decision-making and informed consent.
In the course of his direct examination, the psychiatrist used a decision
tree to represent the choices made by the physician and patient at each
stage of the process. He was thus able to help the jury move from a "hot" (emotional)
to a "cool" (reflective) consideration of the issues in the
case. He emphasized the need to understand the decisions from the perspective
of foresight (what the doctor and patient knew or did not know at the
time) rather than hindsight (what was known after the fact). Having established
that framework, the psychiatrist testified that the physician and patient
had appropriately considered the risks and benefits of four possible
courses of action: medical treatment, psychiatric treatment, surgery,
or no treatment. The patient had been competent to give informed consent
and had in fact done so. On the basis of these facts, the psychiatrist
concluded that the physician's actions met the standard of care in the
areas of medical decision making and informed consent and were responsive
to the patient's wishes as expressed at the time.
This testimony was reinforced by a psychological analysis of the plaintiff's
retrospective distortion of the choices she had made. As a result of
traumatic experiences early in life, the patient had grown up feeling
victimized. Consequently, she had difficulty taking responsibility for
her actions, which she equated with taking blame. There was evidence
that having an early hysterectomy (as a close relative had done) had
presented itself as an attractive option to her, and that she had even "shopped" for
a physician to perform the procedure. Subsequently, however, she seemed
to have felt considerable emotional pressure to disavow responsibility
for the outcomes of the surgery, which included losing her boyfriend.
It is understandable if, feeling that pressure, she revised her memory
of the decision-making process.
In both Meador and Drewry, expertise in medical
decision making was deployed to determine whether the defendant physicians
met the standard of care for engaging the patient in making an informed
decision. In both cases, there were unwanted outcomes, so that the decisions
made might be questioned from hindsight. In Meador, however,
there was an uninformed decision, so that, from the perspective of "retrospective
foresight," the physicians were found negligent in their duty to
obtain the patient's informed consent.
Informed Consent as an Evolving Concept
The growing importance of informed consent in medical malpractice litigation
is in part a function of developments outside the courtroom. In the field
of medicine itself, the old assumption that the effects of "hard" medical
procedures can be neatly separated from those of the doctor-patient relationship
is giving way to an understanding that the manner in which treatment
is conducted materially affects its outcome. The universe of uncomplicated "technical" cases
of medical malpractice is shrinking as physicians, attorneys, and the
public come to realize that the relationships the patient, family, and
physician form around an illness contribute to the effectiveness with
which they address it. The kinds of questions asked about the illness
and the participants' ability to work together to answer those questions
will influence the patient's feelings, moods, and motivation to get better.
These factors also help determine what resources can be mobilized to
overcome the illness and residual disability.
This interconnectedness of content and process in medical treatment has
prompted a reconsideration of what adequate informed consent really is.
A perfunctory, pro forma signing of a consent form elicits mere
passive assent, not active consent. It neither enhances patient understanding
nor helps the patient take responsibility for his or her choices. Indeed,
the dry recitation of possible complications may only heighten unrealistic
feelings of certainty and control, on the one hand, or of helplessness
and fatalism, on the other.
Instead, to involve the patient fully and meaningfully in decision-making,
informed consent must be carried out not just at the outset of treatment,
but as an ongoing dialogue around the need to confront uncertainty and
risk. [6] Such a dialogue enables the physician to monitor
whether the patient is competent to give consent, whether the patient
understands the changing clinical situation, and whether the patient
is choosing voluntarily, knowingly, and with an appreciation of the benefits
and risks of the relevant alternatives. This informed-consent dialogue
has by now become one of the accepted standards of direct patient care.
Knowing Assumption of Risk
There is a substantial consensus in our society that it is unethical to impose
risks on people without their consent. [
7] In medicine,
informed consent has been associated historically with participation in medical
research and, in clinical practice, with treatments regarded as experimental
or non-standard. [
8] By now, however, informed consent as
an ethical and legal requirement extends to well-established, mainstream
medical procedures. The issue is whether or not the use of a given treatment
was negligent in the particular case at issue. Practically speaking, this
determination in turn often hinges on whether the patient knowingly and competently
assumed the risks of that treatment.
In cases in which tobacco companies have been charged with liability
for damage to smokers, juries have shown a remarkable tendency to set
aside sympathy and hold people responsible for their personal choices;
at the same time, the tobacco industry's alleged negligence in informing
the public about the risks of smoking may loom larger in future cases.
[9] The same dynamic is observable in medical malpractice
verdicts. Contrary to popular critiques of the irresponsibility of juries,
newly published research shows that juries do not regularly give large
awards for damages in medical malpractice cases. When they do, they often
do so on the basis of at least an implicit consideration of informed
consent. [10]
In other words, although attorneys and judges think of negligence and
informed consent as separate legal doctrines, there seems to be an informal
community standard by which the lack of truly informed consent is an
important element in a finding of medical negligence. This standard has
a rational basis, since personal choice becomes paramount in those difficult "threshold
cases" where the risks are on the margins of acceptability. In one
such case, in which failure to obtain informed consent was not a cause
of action, interviews with jurors revealed that their favorable verdict
for the defendant was based on their belief that the patient understood,
or should have understood, the risks of surgery. [11]
As per the Meador case, the size of damage awards, too, can
be influenced by this considerationwhich again makes sense, since
people's response to physical impairment depends on how well prepared
they are for the possibility of that outcome and whether they have taken
the risk knowingly. Moreover, where relatively large amounts have been
awarded for pain and suffering on an implicitly punitive basis, the impetus
can come from the jury's belief that the treating physicians failed to
inform the patient and family not only before the fact, about the risks
of an untoward outcome, but also after the fact, about the negligent
acts. [l2] What is communicated may be very different
from what is heard or remembered. Moreover, a person's competence to
assume risks may vary with time and circumstance and may be impaired
at an emotional as well as a cognitive level. [13]
Informed Consent and Managed Care
As informed consent becomes an increasingly prominent factor in medical
malpractice litigation, all of the considerations discussed thus far
are likely to be magnified in the managed care environment. More and
more, the financial arrangements under which physicians must practice
are narrowing the range of choices available to physicians and patients.
This problem becomes a defense attorney's nightmare when the plaintiff
did not know the extent to which choices were limited because physicians
were being instructed by insurers not to tell patients about benefits
denied, treatments disallowed, or potential conflicts of interest. [l4]
Such "gag rules" now seem on their way out by virtue of a combination
of legislation, government administrative rulings regarding Medicare
and Medicaid recipients' rights to be informed, progressive managed care
leadership (as on the part of Humana), and recent case law developments,
such as an Eighth Circuit ruling that seems to require an HMO to disclose
financial incentives. [15] Ruling out explicit prohibitions
against full disclosure to patients still leaves the room for critics
to focus note that managed care already has made physician-patient communication
more difficult by reducing the reimbursable time available for such communication.
Representative of such criticisms is the opinion of Harvard professor
Alan A. Stone, an eminent scholar in law and psychiatry, that managed
care is denying many patients the benefits of a therapeutic alliance,
a cornerstone of mental health care and of much medical care as well.
[16]
This gathering crisis in medical ethics has enormous ramifications for
malpractice litigation. Indeed, the disruptive effect of managed care
on the doctor-patient relationship may already be fueling the rash of
litigation involving informed consent. More and more patients who, if
fully informed, would not have consented to treatments that had negative
outcomes or would have been better prepared for those outcomes will now
be seeking legal recourse. If juries are giving the benefit of the doubt
to patients who have not been fully informed about the risks and benefits
of different procedures, they are likely to do so whether the failure
to inform has resulted from physician negligence or managed care restrictions.
Moreover, in addition to withholding medical information per se,
physicians may also be held liable for failing to inform patients about
the conflict of interest they experience between their duties to patients
and the dictates of managed care.
Physician response to this conundrum includes such documents as the "Patient-Physician
Covenant" drafted by a group of physicians and published by the
American Medical Association, which reasserts that medicine is "a
moral enterprise grounded in a covenant of trust" and that physicians
must serve their patients' best interests regardless of financial incentives.
[17] Open disclosure of such incentives by doctors
to patients enters into the clinical standard of care to the extent that
a doctor-patient therapeutic alliance is considered part of that standard
in the direct-care medical specialties. For their part, risk-proactive
managed care organizations and physician groups, especially when self-insured,
are taking steps to encourage physician-patient communication and documentation
of informed consent. Modeled after such employment law practices as sexual
harassment prevention training by corporations at risk for litigation
for supervisory negligence, an effective malpractice prevention risk-management
program includes physician and staff continuing education, in-service
training programs, and best- practice guidelines. The goal of such a
program is to the identify, anticipate, and respond to patients, situations,
and physician communication styles at high risk for a lack of an informed
consent process and an atmosphere of alienation rather than alliance,
resulting in dissatisfaction even in the best of times and a high likelihood
of litigation after a tragic outcome. [18] Even though
they sometimes have conflicting interests, physicians, patients, hospital
and managed care executives and attorneys together can work to restore
meaning to the ethical and legal concept of informed consent, especially
now that the latter is taking on greater prominence in medical malpractice
litigation.
Endnotes
-
Goldberg V. Wallach, N.Y.L.J. Jan. 16, 1996, at 2 (col.
6).
-
President's Commission for the Study of Ethical Problems in Medicine
and Biomedical and Behavioral Research, Making Health Care Decisions:
A Report on the Ethical and Legal Implications of Informed Consent
in the Patient-Practitioner Relationship (1982).
-
Meador v. Stahler and Gheridian (
Middlesex Superior Court C.A. No. 88- 6450, Mass. 1993)
-
See Harnish v. Children's Hospital Medical Center, 387
Mass. 152 (1982).
-
Drewry v. Harwell, et al., No. CIV-94-1600-T USDC WD
(Okla., 1995).
-
See Harold J. Bursztajn et al., Legal Issues in Inpatient Psychiatry,
in Inpatient Psychiatry: Diagnosis and Treatment 379 (Lloyd I.
Sederer ed., 3rd ed. 1991); Harold J. Bursztajn et al., Medical
Choices, Medical Chances: How Patients, Families, and Physicians
Can Cope with Uncertainty (1990).
-
See Andreas Teuber, Justifying Risk, Daedalus, Fall 1990, at 235.
-
See Sheila Jasanoff, Science at the Bar: Law, Science, and Technology
in America (1995).
-
See Allan M. Brandt, The Cigarette, Risk, and American Culture, Daedalus,
Fall 1990, at 155.
-
Neil Vidmar, Medical Malpractice and the American Jury: Confronting
the Myths About Jury Incompetence, Deep Pockets, and Outrageous
Damage Awards (1995).
-
Id. at 142.
-
Steve Cohen, Malpractice: Behind a $26-million Award to a Boy Injured
in Surgery, in Vidmar, supra note 12, at 95.
-
See Harold J. Bursztajn et al., The Rebirth
of Forensic Psychiatry in Light of Recent Historical Trends in Criminal
Responsibility, 17 Psychiat. Clin. N. Am. 611, 623-624 (1994).
-
See Robert Pear, Doctors Say H.M.O.'s Limit What They Can Tell Patients,
N.Y. Times, Dec. 21, 1995, at A1.
-
Shea v. Esensten No-95-4029MN
-
Alan A. Stone, Psychotherapy and Managed Care: The Bigger Picture,
Harvard Mental Health Letter, Feb. 1995, at 5, 7.
-
Ralph Crawshaw et al., Patient-Physician Covenant, Psychiat. News,
Oct. 20, 1995, at 6.
-
See Harold J. Bursztajn and Archie Brodsky., A
New Resource for Managing Malpractice Risks in Managed Care,
156 Arch Intern Med., 2057 (1996).