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 making—not 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 care—so 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 examined—for example, when a psychological autopsy must be performed
in the case of a patient who has died—a 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 consideration—which 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).
