Avoiding Physician Liability for Off-Label Use of Drugs and Devices

Often, physicians do not realize that, to a lay person, the use of a drug or device for an indication that has not been approved by the FDA may sound as though the physicians are somehow “experimenting” on their patients with off-label uses. While “[a] physician is free to use a medical device for an off-label purpose if, in the physician's medical judgment, he or she believes that use of the device will benefit the patient,” it also stands to reason that “[b]ecause the off-label use ' is a matter of medical judgment, a physician may be subject to medical malpractice liability for the exercise of that judgment.” Alvarez v. Smith, 714 So.2d 652, 653 (Fla. App. Ct. 1998). It is important for prescribing and implanting physicians and their counsel to be aware of the murky and shifting arguments plaintiffs may make against decisions to prescribe off-label. This three-part article explores the potential theories of liability for off-label prescriptions that have been employed, with mixed success. It will also discuss strategies for physicians to use to protect their power to prescribe approved drugs and devices in an off-label manner, in their exclusive medical judgment, while protecting themselves from a threat of potential future litigation or liability.