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.
The Third Circuit agreed with Smith & Nephew. The Court reasoned that the FDCA defines “device” to mean not just a finished “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,” but also “any component, part, or accessory” of that article. In addition, FDA regulations regarding off-label use of devices contemplate that devices may be broken down into component parts and used separately by third parties. Finally, the Court looked favorably on the FDA’s endorsement of preemption analysis at the component level in its amicus brief.
The Third Circuit proceeded to analyze the metal head, metal sleeve, stem, and metal liner as individual devices. It concluded that the Shuker’s common law claims only challenged the safety and effectiveness of the metal liner. Since the metal liner was a Class III device, the Shuker’s common law claims imposed non-parallel state law requirements and were therefore preempted. As a result, the Third Circuit affirmed the District Court’s ruling that the Shuker’s negligence, strict liability, and breach of implied warranty claims were expressly preempted by the Medical Device Amendments of 1976.
The Shuker decision is expected to play a significant role in the analysis of hybrid medical device litigation going forward. If you are a manufacturer or distributor of hybrid medical devices facing device related litigation, the viability of a preemption defense may very well turn on the allegedly defective component(s) instead of the system as a whole.
- Do the plaintiff’s claims concern individual component(s)?
- How is that subject individual component(s) classified? Class I, II, or III?
- Has the plaintiff asserted state law claims? Are those state requirements “different from, or in addition to” federal requirements?
Preemption is a defense that can limit the scope of, if not eliminate, product liability in medical device cases early. Shuker is a decision to keep in mind when developing your next hybrid medical device litigation strategy.