The Third Circuit has become the first U.S. Court of Appeals to address the application of the express preemption provision in the Medical Device Amendments of 1976 to hybrid medical devices. Hybrid medical devices are devices which contain differently classified components.
In Shuker v. Smith & Nephew, PLC, the Third Circuit held that Plaintiff Walter Shuker’s common law claims against medical device manufacturer Smith & Nephew were preempted by the Medical Device Amendments of 1976. There, the plaintiff’s implanted hip replacement system included a metal head, metal sleeve, stem, and metal liner. After the metal on metal system caused degeneration, Walter and his wife brought suit against Smith & Nephew for negligence, strict liability, breach of implied warranty and violations of federal law. The question before the Third Circuit was how to apply the express preemption provision of the Medical Device Amendments of 1976 to a hip replacement system with multiple separately classified components.
The Medical Device Amendments of 1976
The Medical Device Amendments of 1976 added a medical device approval process to the Federal Food, Drug, and Cosmetic Act (“FDCA”). The approval process assigns a Class I, II, or III designation to new medical devices based on public risk. Class I devices pose the least risk, Class II devices are “more harmful,” and Class III devices pose the greatest risk. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). Before becoming available to the public, a Class III device requires premarket approval by the Food and Drug Administration (“FDA”).
A medical device that obtains Class III approval is granted express preemption from state requirements that are “different from, or in addition to” federal requirements. Riegel v. Medtronic, Inc., 552 U.S. 312, 322-23 (2008). However, the express preemption provision does not prevent plaintiffs from filing claims premised on state requirements that incorporate applicable federal requirements and are therefore not “different from, or in addition to” federal requirements. Lohr, 518 U.S. at 494-95.
The Hybrid Medical Device in Shuker
Walter Shuker’s hip replacement system was comprised of Class II and III components, making it a hybrid medical device. The Shukers argued that the Third Circuit should analyze the hip replacement system as a single device. Smith & Nephew conversely asserted that each component of the hip replacement system was a separate device, an opinion supported by the FDA. Read more ›