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

By Lori G. Cohen and Sara K. Thompson

Plaintiffs' attorneys continually seek new and novel ways to circumvent the defenses afforded to manufacturers of FDA-approved medical products, such as federal preemption and the learned intermediary doctrine. At the same time, “it is undisputed that the prescription of drugs [and devices] for unapproved uses is commonplace in modern medical practice and ubiquitous in certain specialties.” Washington Legal Foundation v. Henney, 202 F.3d 331, 333 (D.C. Cir. 2000) (internal citations omitted.) The increased level of enforcement activity by the United States Food and Drug Administration (FDA) has focused the attention of consumers and the plaintiffs' bar on the increased frequency with which physicians prescribe FDA-approved drugs and medical devices for unapproved uses. Plaintiffs' attorneys increasingly choose to name prescribing physicians in their products liability suits as co-defendants, pleading both medical malpractice and other associated tort claims against these physicians, and often premising such claims upon the decision to prescribe for a so-called “off-label” or unapproved use. Thus, the continuing expansion of off-label uses of drugs and devices has led to numerous potential legal minefields for the prescribing physicians.

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.

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