The Preemption Pendulum: The Supreme Court Punts Stengel V. Medtronic

Drug and Medical Device Manufacturers Beware; State-law Parallel Claims Threaten

As failure-to-warn claims, the decades-old staple of medical products liability, are relegated to the trash bin of tort jurisprudence, a new and more potent approach—parallel claims—has emerged. What are parallel claims, where did they come from, why did they emerge, and when will the Supreme Court clear up the issue?

With the advent of mass tort litigation for claims involving Food and Drug Administration (FDA) approved products in the 1980's, the defensive doctrine of federal preemption emerged in fits and starts and, since the mid 1990's, has gradually swung the pendulum toward dismissal of claims, relegating claimants to those few venues where jurists, flummoxed by the lack of a remedy, forged a tenuous path forward. Whether Congress has intentionally refused, or simply neglected to provide a private remedy for tort claimants is unclear. What is increasingly clear is that trial courts are finding room in Supreme Court rulings to permit state-law tort claims to proceed. Claimants are also finding a willing advocate in the FDA itself, which has flip-flopped from its prior view favoring preemption to its position that now assists private litigants in pursuing private tort and Lanham Act "labeling" claims under the Food Drug and Cosmetic Act (FDCA).

Parallel Claims: What Are They And Where Did They Come From?

A triumvirate of Supreme Court cases forms the foundation for federal preemption and parallel claims for medical devices under the FDCA (See Medtronic, Inc. v. Lohr,518 U.S.470 (1996), Buckman v. Plaintiffs' Legal Comm.,531 U.S. 341 (2001)and Reigel v. Medtronic, Inc.,552 U.S. 312 (2008)). These opinions gave birth to another trio of Supreme Court cases addressing preemption in the context of approved drugs (See Wyeth v. Levine, 555 U.S. 555 (2009), Pliva v. Mensing, 131 S. Ct. 2567 (2011)and Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013)).

In Lohr, the Supreme Court stated that the FDCA does not preempt "a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements." Lohr, 518 U.S. at 495. Buckman purports to allow tort claims where the plaintiff is "relying on traditional state tort law" but not where the FDCA "is a critical element in their case." Buckman, 531 U.S. at 353. In Riegel, the Court established a two-prong test for determining if a state-law tort claim could proceed: 1) has the FDA...