April 1996 AAOS Report

Informed consent need not include FDA classification

Judge Louis C. Bechtle of the federal court for the Eastern District of Pennsylvania issued an order on March 8, stating that the doctrine of informed consent does not require a physician to disclose to a patient the Food and Drug Administration's regulatory status of a medical device such as the pedicle screw. This order applies to all pedicle screw cases that have been joined in the pedicle screw multi-district litigation before Judge Bechtle and to state cases in Pennsylvania. In the case, the patient-plaintiffs alleged the physicians performed spinal fusion surgeries that involved the implantation of pedicle screws, but did not inform the plaintiffs that the FDA had not approved pedicle screw manufacturers to label such devices for use in the human spine. The plaintiffs also contend that the physicians should be held liable under the law of informed consent for failing to disclose the FDA regulatory status of the pedicle screw devices before implanting them in the plaintiff's spines. The physician-defendants argued that the doctrine of informed consent does not require a physician to inform his or her patient of the regulatory status assigned to a medical device by the FDA and that the physicians are entitled to use medical devices for off-label purposes. Judge Bechtle ruled that "a physician is free to use a medical device for an off-label purpose, if, in the physician's best medical judgment, he or she believes that use of the device will benefit the patient. Because the off-label use of a medical device is a matter of medical judgment, a physician may be subject to medical malpractice liability for the exercise of that judgment. The physician cannot, however, be held liable under the doctrine of informed consent for failing to advise a patient that a particular device has been given an administrative or regulatory label by the FDA. The law of informed consent obligates a physician to advise a patient of the medical risks, benefits and alternatives directly related to the patient's operative procedure." Additional comments on the ruling can be found on the Academy's home page - http://www.aaos.org.


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