April 1996 Bulletin

Judge rules informed consent can exclude FDA device status

Judge Louis C. Bechtle of the federal court for the Eastern District of Pennsylvania issued an order on March 8, 1996 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 multidistrict litigation before Judge Bechtle and to state court cases in Pennsylvania.

A number of physician defendants filed this claim. In this case, the patient-plaintiffs allege the physicians performed spinal fusion surgeries which 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 plaintiffs' 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 in favor of the defendant-physicians. He stated 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. That 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. The terms 'Class III,' 'investigational,' and 'significant risk' device are terms adopted by the FDA for administrative or regulatory purposes and cannot be said to be risks of a particular surgical procedure.

"If, however, a physician knows, or should know, of risks, complications or alternatives that directly relate to a medical procedure, the law of informed consent mandates that the physician disclose such information to a patient, regardless of whether the physician learned that information from the FDA or from another source. Further, if certain medical risks or complications are the reasons for the FDA putting a certain label on a device, such risks and complications must be disclosed pursuant to informed consent law."

The plaintiffs in the suit were not part of a clinical investigation, and not subject to the FDA's clinical investigation regulations to inform the patient-participant of the investigational nature of the medical device. Physicians involved in clinical investigations "are required to give the patient-participants such information not because state informed consent law mandates it, but rather in return for the benefit of engaging in a research project that has received the FDA's 'stamp' of approval," according to Judge Bechtle's order.

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