Otis-Wisher v. Medtronic, Inc. (Second Circuit)
The plaintiff in this case alleges that she was injured by her physicians’ off-label use of a Class III medical device and that the device manufacturer improperly promoted off-label uses. On behalf of the manufacturer, we argue that the plaintiff’s claims are both expressly and impliedly preempted by federal law. The Medical Device Amendments to the federal Food, Drug, and Cosmetic Act expressly preempt any state-law claim that would impose safety or effectiveness requirements that are “different from, or in addition to” the federal requirements imposed through the FDA’s premarket approval process, and allegations of off-label promotion do not transform a plaintiff’s state-law tort claims into “parallel” claims that escape express preemption. In addition, the FDCA’s no-private-right-of-action clause impliedly preempts any private tort action seeking to enforce the federal medical-device regulations; instead, Congress granted the FDA exclusive power to decide how and when to enforce these requirements. Congress thus determined that complex, life-sustaining medical devices should be regulated exclusively by an expert federal agency rather than private plaintiffs and lay juries across 50 states.