American Journal of Law & Medicine

Informed consent: physicians need not inform patients of the FDA classification of a medical device - Southard v. Temple University Hospital.(Pennsylvania)

Informed Consent: Physicians Need Not Inform Patients of the FDA Classification of a Medical Device--Southard v. Temple University Hospital (1) --The Supreme Court of Pennsylvania held that the doctrine of informed consent does not require physicians to advise their patients of the federal Food and Drug Administration (FDA) regulatory status of a medical device. In 1992, plaintiff Branes Southard underwent spinal fusion surgery at Temple University Hospital to alleviate his severe back pain. During the surgery, defendant physicians implanted orthopedic bone rods and screws into Southard's spine. Following surgery to remove the screws in 1994, Southard filed suit against Temple University Hospital and defendant physicians, alleging in part that the physicians failed to obtain his informed consent prior to surgery. Southard specifically claimed that his consent was not informed because the defendant physicians did not advise him of the FDA regulatory status of bone screws implanted in his vertebrae. (2)

The court reviewed the FDA's regulation of the marketing, labeling and promotion of medical devices, such as bone screws, pursuant to the Medical Device Amendments of 1976 (MDA) to the federal Food, Drug, and Cosmetic Act. …

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