In Southard v. Temple Univ. Hosp., 566 Pa. 335, 781 A.2d 101, 102 (Pa. 2001), the Pennsylvania Supreme Court determined whether the doctrine of informed consent required surgeons to advise their patients of the FDA regulatory status of a medical device.
The court concluded that there was no such requirement. Id. at 102-03. The plaintiffs filed a complaint against the defendants, alleging that the defendants failed to obtain informed consent because they were not advised of the FDA regulatory status of the bone screws used in the surgery. Id. at 103.
The jury returned a verdict in favor of the defendants, but the appellate court reversed. Id. at 105. On appeal, Pennsylvania's highest court concluded that:
The category into which the FDA placed the device for marketing and labeling purposes simply did not enlighten the patient as to the nature or seriousness of the proposed operation, the organs of the body involved, the disease sought to be cured, or the possible results. The FDA administrative label did not constitute a material fact, risk, complication or alternative to a surgical procedure. It followed that a physician need not disclose a device's FDA classification to the patient in order to ensure that the patient has been fully informed regarding the procedure. Id. at 107.