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Informed Consent

Albany Urology v. Cleveland, 528 S.E.2d 777 (Ga. 2000)

Also under Abusive litigation against physicians and Professional liability

Outcome:    Very favorable

Issue
The issue in this case was whether a physician was required to disclose his cocaine usage to a patient in order to obtain the patient's informed consent to surgery, even though the cocaine usage did not bear on the physician's surgical skills.

AMA interest

The AMA encourages physician self-reporting of substance abuse in order to obtain proper treatment. Furthermore, it strives to avoid the expansion of liability theories against physicians, which can lead to abusive litigation.

Case summary

This case arose from allegedly unnecessary surgery performed by a physician who occasionally used cocaine.  The surgeon had been using cocaine approximately once a month at the time of the diagnosis and of the surgery, although he had not been using cocaine on days he saw patients.  He did not reveal his cocaine usage to his patients, including the patient in this case.  The operation was unsuccessful and exacerbated a condition that might have resolved itself and could have been treated with Vitamin E.

The trial court found that the failure to disclose the cocaine use had not been a material concealment and entered judgment for the physician and his employer.  The plaintiff appealed.

The Georgia Court of Appeals found that the failure to disclose the cocaine use had been a material concealment and reversed the trial court.  The court also found the defendants liable for battery.  The defendants appealed to the Georgia Supreme Court.

The Georgia Supreme Court reversed the judgment of the court of appeals holding that, without a specific patient inquiry, a physician had no duty to disclose to patients “unspecified life factors” that did not objectively affect the physician’s performance.

Litigation Center involvement

The Medical Association of Georgia, supported by the Litigation Center, filed an amicus curiae brief in the Georgia Supreme Court to support the defendants. While deploring illegal use of drugs, the brief argued that a physician's obligation to disclose the medical risks associated with surgery should not be extended to the disclosure of personal issues that do not affect the patient's well being. The patient's right to recover for professional negligence affords him or her adequate redress for any injuries. A requirement that a physician disclose his or her occasional cocaine usage might prejudice the jury and could chill the physician's voluntary efforts to obtain appropriate medical treatment for an unlawful drug habit.

Heinrich v. Sweet, 308 F.3d 48 (1 Cir. 2002)

Also under Abusive litigation against physicians, Clinical trials, and Professional Liability

Outcome:     Very favorable

Issues
The primary issues in this case were (a) whether the district court correctly applied the Massachusetts statute of limitations to uphold a jury's finding of liability against Dr. William Sweet based on actions that occurred almost forty years prior to trial, and (b) whether a jury's finding of informed consent should have precluded a simultaneous verdict of fraudulent concealment.

AMA interest
The AMA strives to avoid the expansion of liability theories against physicians, which can lead to abusive malpractice litigation.

Case summary

Dr. Sweet, a world famous physician, was the chief neurosurgeon at Massachusetts General Hospital ("MGH"). In the late 1950's and the early 1960's, he conducted a medical experiment, known as boron neutron capture therapy. The experiment was approved in advance by the Executive Committee of the MGH Medical Staff, the MGH Board of Trustees, and the Biomedical Advisory Committee at Massachusetts Institute of Technology ("MIT") (composed of representatives of MIT and seven other prestigious institutions, including three Boston area medical schools). Candidates for the experiment were terminally ill patients with fast growing brain tumors. After their injection with boron, a neutron beam, derived from an MIT nuclear reactor irradiated these patients. Both MGH and MIT closely supervised the clinical trials, which the federal government partially funded and also monitored.

Unfortunately, the procedure was, at least at times, painful. Moreover, the radiation damaged healthy brain tissue as well as the tumors. Ultimately, the experiment was unsuccessful, and all of the patients died.

In 1995, the President's Advisory Committee on Human Radiation Experiments issued an analysis of human radiation testing commencing in the 1940's. When the study was reported in the media, Evelyn Heinrich, the widow of George Heinrich, remembered that Dr. Sweet had conducted radiation treatments on her husband in 1961. She sued Dr. Sweet, MGH, MIT, the United States of America, and several other defendants. After she filed suit, she was joined by Henry M. Sienkewicz, the son of another of Dr. Sweet's patients, Eileen Sienkewicz. The plaintiffs contended that, although Dr. Sweet may have advised his patients of the risks of the procedure, he did not tell them that the experiment was unproven and had no reasonable probability of success. Thus, the plaintiffs alleged that either the procedure itself or the manner in which it was performed was negligent. Dr. Sweet was 89 years old and suffering from Parkinson's Disease at the time of trial, so he did not testify in his own behalf. He died shortly thereafter.

After a twenty-day trial, most of the defendants were either dismissed on motion or found not liable. However, the jury found in favor of the plaintiffs and against Dr. Sweet for $4,750,000. A portion of this sum was compensatory damages, and a portion was punitive damages. The jury did find, though, that the patients' consent to the procedure had been informed. The trial court upheld the finding of liability against Dr. Sweet, summing up the case against him as follows:

"In short, Sweet well knew during his care of these patients that his [boron neutron capture therapy] treatments were not helping them, and, in fact, were causing severe side effects unrelated to the progressive effect of the fatal brain tumors. He pressed ahead anyway, believing in complete good faith that such experimentation on dying patients held out hope for other cancer victims."

Due to certain statutory limitations, the court reduced the award against Dr. Sweet to $830,000. Judgment was also entered against MGH. Both sides appealed.

The United States Court of Appeals for the First Circuit reversed. It held, primarily, that the evidence against the defendants was insufficient to prove negligence or damages for wrongful death. The plaintiffs' case was built upon the conclusions that they reached in hindsight, rather than the state of medical science available at the time of the experiments. The court also agreed with the argument, raised in the amicus brief, that the jury verdicts for the defendants on the informed consent count precluded liability on the other counts.

Litigation Center involvement
The Litigation Center and the Massachusetts Medical Society filed an amicus curiae brief on Dr. Sweet's behalf in the First Circuit.

United States Court of Appeals for the First Circuit.

Osburn v. Danek Medical, 530 S.E.2d 54 (N.C. S. Ct. 2000)

Also under Professional liability

Outcome:     Very favorable

Issue
The issue in this case was whether a physician was required to disclose, in addition to the medical risks, that medical devices to be surgically implanted in a patient's spine had not received FDA approval for such use.

AMA interest
The AMA supports a reasonable interpretation of a physician's obligation to obtain a patient's informed consent.

Case summary
The patient claimed that, because his surgeon had not explained that the FDA had not granted approval for the surgically implanted device, the surgery was performed without the patient's informed consent. Both the trial court and the North Carolina Court of Appeals held that informed consent only requires disclosure of medical risks: physicians need not discuss the actions or inactions of a government agency or the implications of such actions or inactions.

The case was appealed to the North Carolina Supreme Court, which affirmed.

Litigation Center involvement

The Litigation Center and the North Carolina Medical Society filed an amicus brief, joined by the American Academy of Orthopedic Surgeons, in support of the physician.

Southard v. Temple University Hospital, 781 A.2d 101 (Pa. S. Ct. 2001)

Also under Professional liability

Outcome:     Very favorable

Issue

The issue in this case was whether physicians should be required to disclose, in addition to the medical risks, that medical devices to be surgically implanted in a patient's spine had not received FDA approval for such use.

AMA interest

The AMA supports a reasonable interpretation of a physician’s obligation to obtain a patient’s informed consent.

Case summary

Southard, a former patient, along with his wife, sued Temple University Hospital and his physicians. He alleged that the defendants, during spinal surgery, implanted pedicle bone screws in his spine without obtaining his consent to the procedure. His basic argument was that he was not advised that the United States Food & Drug Administration had not approved pedicle bone screws for such use, and this omission was material. The trial court entered partial summary judgment against the Southards on this issue, and they appealed.

The appellate court noted that the Food and Drug Act specifically states that it is not intended to limit a physician's right to use non-FDA approved medical devices in their practices. Moreover, the FDA had formally acknowledged that the use of bone screws in the pedicles of the spine is "considered to be the standard of care by the surgical community." Furthermore, the court observed that in other cases physicians had not been required to inform their patients of the FDA's non-approval of pedicle screws for use in spinal surgery. Nevertheless, the court felt that the jury should have been allowed to decide whether, by not disclosing to Southard the FDA's position on pedicle screws, the physicians had committed a material omission. It therefore reversed the order of summary judgment and remanded the case.

The Pennsylvania Supreme court accepted the physicians' argument and reversed the intermediate appellate court decision.

Litigation Center involvement

The Pennsylvania Supreme Court granted allocatur on the issue of informed consent. PMS and the Litigation Center filed an amicus brief in support of the physicians.

The PMS/Litigation Center brief argued that the physicians were only obliged to warn Southard of the medical risks of the surgery, which they had done. However, physicians are not lawyers, and Southard had not come to the defendants for legal advice. A bare statement that the FDA had not approved pedicle screws for use in spinal surgery would, standing alone, probably have been misleading and would certainly not have helped reach an understanding of the medical risks of the surgery. Physicians lack the expertise to provide a meaningful explanation of the FDA position or of FDA procedures. A ruling against the physicians would have impaired the general quality of health care, because it would, in some instances, induce physicians to be unduly conservative in their recommendations.