United States v. Jackson: Clarifying the Scope of the Off-Label Use Privilege as Applied to the Reuse of Single-Use Medical Devices

Marissa Lawson

In United States v. Jackson, the United States Court of Appeals for the Fourth Circuit sought to strike a balance between (1) the U.S. Food and Drug Administration’s (“FDA”) regulatory authority under the Federal Food, Drug, and Cosmetic Act (“FDCA”) to protect patients from unnecessary risks injurious to health, and (2) the “off-label use” privilege afforded to health care providers to use their expertise to engage in the off-label use of a medical device. More specifically, the court set out to clarify the scope of the off-label use privilege as applied to single-use medical devices. The court upheld Jackson’s criminal conviction under the FDCA, holding that, where the reuse of single-use medical devices in the course of treating patients constitutes holding an adulterated device for sale in violation of the Act, the physician’s conduct necessarily falls outside the scope of the off-label use privilege. Though a novel issue for the Fourth Circuit, the court properly aligned its analysis with the present FDCA legal framework Congress established and sister courts have interpreted. Declining to establish a standard that the reuse of single-use medical devices constitutes per se adulteration, the court correctly preserved the off-label use privilege. Despite a well-reasoned analysis, the desperate need for congressional or agency clarification of the scope of the FDCA permeates the Fourth Circuit decision.