Courts are relegating failure-to-warn claims, the decades-old staple of medical products liability, to the trash bin of tort jurisprudence. But a new and more potent approach is poised to emerge: the doctrine of parallel claims. Lawyers need to know what these claims involve, where they came from, why they emerged and which courts are making the law.

Mass tort litigation involving products approved by the Food and Drug Administration (FDA) began in the 1980s. Since then, the defensive doctrine of federal preemption has emerged in fits and starts. Since the mid 1990s, the doctrine of federal preemption gradually has swung the pendulum toward dismissal of claims. This relegates claimants to the few venues where jurists, flummoxed by plaintiffs’ lack of a remedy, forged a tenuous path forward.

This path is emerging in the context of Congressional silence. It’s unclear whether Congress intentionally has refused to provide a private remedy for tort claimants or simply has neglected to do so. What is increasingly clear is that courts are finding room in U.S. Supreme Court rulings for a creative new theory to permit tort claims to proceed: parallel claims.

The same triumvirate of Supreme Court cases that form the foundation for the defensive doctrine of federal preemption is allowing development of the plaintiffs-side doctrine of parallel claims. The three cases address medical devices under the Food, Drug, and Cosmetic Act (FDCA): Medtronic Inc. v. Lohr (1996), Buckman Co. v. Plaintiffs Legal Committee (2001)and Reigel v. Medtronic Inc. (2008).

These three cases gave birth, in turn, to another trio of U.S. Supreme Court cases addressing preemption in the context of approved drugs: Wyeth v. Levine (2009), PLIVA v. Mensing (2011)and Mutual Pharmacy Co. v. Bartlett (2013).

The Supreme Court’s language can help lawyers see how the preemption and parallel-claims doctrines intersect. 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.” Buckman purportstoallow tort claims where the plaintiff is “relying on traditional state tort law” but not where the FDCA “is a critical element in their case.”

Most recently, in Riegel, the high court established a two-prong test for determining if a state-law tort claim could proceed. First, has the FDA established applicable requirements? Second, does the state law at issue create a requirement related to safety or effectiveness that is “different from or in addition to the federal requirement”? While the precise contour of purported parallel claims is uncertain, no court allows claims that purport to impose liability despite compliance with the applicable FDCA.

Out of the shadows of Supreme Court opinions emerged a trilogy of opinions by federal circuit courts of appeals that threaten to up-end medical products liability. These are Bausch v Stryker Corp., decided by the U.S. Court of Appeals for the Seventh Circuit in 2010; Hughes v Boston Scientific, decided by the U.S. Court of Appeals for the Fifth Circuit in 2011; and Stengel v. Medtronic Inc., decided by the en banc U.S. Court of Appeals for the Ninth Circuit in 2013.

In Bausch v. Stryker Corp., the 7th Circuit noted, “The idea that Congress would have granted civil immunity to medical device manufacturers for their violations of federal law that hurt patients is, to say the least, counter-intuitive.” The court continues, “That protection does not apply where the patient can prove that she was hurt by the manufacturer’s violation of federal law.

The Fifth Circuit echoed this sentiment Hughes v. Boston Scientific Corp., writing that the U.S. Supreme Court’s decisions in Riegel and Lohr “make clear” that a manufacturer is not protected from state tort liability when the claim is based on the manufacturer’s violation of applicable federal requirements. The Fifth Circuit further observed, “We are persuaded that any additional ‘formal’ finding or enforcement action by the FDA is not an ‘implicit precondition’ to suit under the facts of this case.”

Cert Petition Pending

In Stengel v. Medtronic, a significant stepchild could join the triumvirate of Supreme Court cases that gave birth to the emerging doctrine of parallel claims. While prior Supreme Court cases created the framework for permitting claims based on parallel state law theories, Stengel stands either to tighten the reins on such claims or release them. Either way, it’s likely that medical products liability will change in significant ways.

The Ninth Circuit had reinstated purported state-law failure-to-warn claims, stating that the Medical Device “Amendments do not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty.”

Citing Lohr the Ninth Circuit wrote, “Given the ambiguities in the statute and the scope of the preclusion that would occur otherwise, we cannot accept [the manufacturer's] argument that by using the term ‘requirement,’ Congress clearly signaled its intent to deprive the States of any role in protecting consumers from the dangers inherent in many medical devices.”

Manufacturers of FDA-regulated products have enjoyed a decade of rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction, with courts limiting or dismissing claims. But the political climate and emerging new approaches by the courts threaten to reshape the litigation landscape.

While it is unclear how the Supreme Court will rule, what is clear is that if the court denies the petition for writ of certiorari or affirms the Ninth Circuit, the medical products liability pendulum will have gained significant momentum in its turn towards allowing tort cases to proceed.

Michael Walsh, a partner in Strasburger & Price in Dallas, leads the firm’s food and drug law industry team. He serves as national coordinating counsel and Texas trial counsel in a wide variety of tort and product liability ligation matters. He is a member of the Federation of Defense and Corporate Counsel, DRI Drug and Device Committee, and the ABA Section of Litigation.