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.


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.


  1. Goldberg V. Wallach, N.Y.L.J. Jan. 16, 1996, at 2 (col. 6).
  2. 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).
  3. Meador v. Stahler and Gheridian ( Middlesex Superior Court C.A. No. 88- 6450, Mass. 1993)
  4. See Harnish v. Children's Hospital Medical Center, 387 Mass. 152 (1982).
  5. Drewry v. Harwell, et al., No. CIV-94-1600-T USDC WD (Okla., 1995).
  6. 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).
  7. See Andreas Teuber, Justifying Risk, Daedalus, Fall 1990, at 235.
  8. See Sheila Jasanoff, Science at the Bar: Law, Science, and Technology in America (1995).
  9. See Allan M. Brandt, The Cigarette, Risk, and American Culture, Daedalus, Fall 1990, at 155.
  10. Neil Vidmar, Medical Malpractice and the American Jury: Confronting the Myths About Jury Incompetence, Deep Pockets, and Outrageous Damage Awards (1995).
  11. Id. at 142.
  12. Steve Cohen, Malpractice: Behind a $26-million Award to a Boy Injured in Surgery, in Vidmar, supra note 12, at 95.
  13. 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).
  14. See Robert Pear, Doctors Say H.M.O.'s Limit What They Can Tell Patients, N.Y. Times, Dec. 21, 1995, at A1.
  15. Shea v. Esensten No-95-4029MN
  16. Alan A. Stone, Psychotherapy and Managed Care: The Bigger Picture, Harvard Mental Health Letter, Feb. 1995, at 5, 7.
  17. Ralph Crawshaw et al., Patient-Physician Covenant, Psychiat. News, Oct. 20, 1995, at 6.
  18. See Harold J. Bursztajn and Archie Brodsky., A New Resource for Managing Malpractice Risks in Managed Care, 156 Arch Intern Med., 2057 (1996).