Medical Malpractice Case of the Month
August 2002

A Pennsylvania appellate court has approved a cause of action for lack of informed consent against a physician who fails to advise a patient that a medical device he plans to use in a surgical procedure has not been approved by the FDA.
A patient underwent spinal fusion surgery to alleviate severe back pain. During the surgery, the operating physicians implanted orthopedic bone screws in the patient's spine to aid in the fusion process. Following the procedure, the patient suffered complications and sued the physicians for, inter alia, failure to obtain his informed consent to the surgery. The patient asserted that the physicians failed to inform him that the FDA had classified the bone screws as a "Class III" medical device when used in the spine, which meant that the manufacturers of the screws had not provided sufficient Information to provide reasonable assurance that the screws were safe and effective for that purpose. (The FDA had approved the screws for use in long bones but not for use in the spine.) The patient's case was consolidated with numerous other cases arising out of similar surgery using these bone screws. The state and federal courts that were overseeing the consolidated actions jointly ruled that the physicians who performed the operations had no duty to disclose the FDA's classification of the bone screws and, accordingly, rendered partial summary judgment in favor of the physicians on that issue. The patient in the instant The appellate court reversed, holding that the patient had stated a viable claim under Pennsylvania's informed consent doctrine. In so ruling, the court observed that Pennsylvania has adopted the "prudent patient" standard of disclosure, which obligates a physician to disclose all risks of and alternatives to a proposed surgical procedure that a reasonable person in the patient's position would consider material to his decision whether to undergo the procedure. The physicians argued that the FDA's classification of a medical device is an administrative matter, and not a risk of surgery, and that it is proper for a physician to use a medical device for a purpose for which it has not been approved by the FDA. The Court acknowledged that using a medical device for an "off-label" purpose may be consistent with the applicable medical standard of care, but concluded that the FDA's classification of the device could still constitute a risk which a reasonable person would want to know about before consenting to such a procedure. The court reasoned that a reasonable patient might place importance on the fact that the FDA-the government agency charged with overseeing medical devices-has not approved a device for the use proposed by the treating physician. The court therefore concluded that a jury question existed as to whether the physicians had a duty to disclose the bone screw's FDA classification - Southard v. Temple University Hospital, No. 3660 Philadelphia 1997 (Pa. Super. Ct. April 27, 1999).

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