High Court’s Cert Denial Should Put an End to Novel Anti-Preemption Claim in Medical-Device Suits

ReedGuest Commentary

by Matthew A. Reed, Sedgwick LLP

When plaintiffs bring state tort causes of action against the manufacturers of medical devices that have passed the Food and Drug Administration’s (“FDA”) rigorous pre-market approval (“PMA”) process, they enter a realm highly regulated by the federal government, and thus face a daunting task to avoid dismissal of their claims. They must demonstrate that their state-law claims require nothing more or different of the manufacturer than what the federal Food, Drug, and Cosmetic Act (“FDCA”) already requires, or else their claims are not “parallel” and thus expressly preempted by § 360k of the Medical Device Amendments (“MDA”) to the FDCA. But they also must show that their claims are based on state law distinct from the FDCA, because claims predicated on the FDCA are impliedly preempted as private attempts to enforce federal law. Continue reading “High Court’s Cert Denial Should Put an End to Novel Anti-Preemption Claim in Medical-Device Suits”