The last week in February, Michael Walsh published an article in the New Jersey Law Journal claiming that courts are “relegating failure-to-warn claims, the decades-old staple of medical products liability, to the trash bin of tort jurisprudence” in favor of parallel claims. Walsh points to three Supreme Court cases that established a basis for the federal preemption, which exists when a state law conflicts with a federal law. Under the Supremacy Clause of the Constitution, the federal law preempts, or overrides, the state law. But many critics have also claimed that this in turn conflicts with the Tenth Amendment, which states that any powers not delegated to the federal government (or prohibited by it) are to be left to individual states to decide.
What has been particularly contentious in personal injury law is FDA preemption under the Food, Drug, and Cosmetic Act, which states that the manufacturers of products approved by the FDA are exempt from tort claims.
The case that changed the landscape of medical products liability suits on the plaintiffs’ side,Reigel v. Medtronic Inc in 2008, established a two-prong test for deciding whether a tort claim could proceed under state law: “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?” Walsh adds that though the “precise contour” of parallel claims is nebulous, “no court allows claims that purport to impose liability despite compliance with the applicable [Food, Drug, and Cosmetic Act].”
After a string of Supreme Court cases had dealt extensively and complexly with preemption, three opinions came out of various circuit courts of appeals which were vocal in their support for plaintiffs harmed by dangerous medical devices. For example, in Bausch v. Stryker Corp, the Seventh Circuit stated, “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 […] That protection does not apply where the patient can prove that she was hurt by the manufacturer’s violation of federal law.” Similarly, the Fifth Circuit noted that under the Supreme Court’s past decisions, it is 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.”
Walsh then discusses the Ninth Circuit court, which has again begun hearing failure-to-warn claims under state law, claiming that laws like the Food, Drug, and Cosmetics Act “do not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty.” The court went on to state, in its Stengel v. Medtronic decision, that it cannot accept the argument presented by Medtronic that by using the word “‘requirement,’ Congress clearly signaled its intent to deprive the States of any role in protecting consumers from the dangers inherent in many medical devices.”
Walsh concludes by explaining that in the past decade courts have limited or outright dismissed claims against FDA-approved medical products manufacturers. For ten years these companies received preferential treatment compared with the individuals who were harmed using their products. But perhaps the metaphorical pendulum is beginning to swing in the opposite direction.