On March 1, the U.S. Court of Appeals for the Third Circuit, in Shuker et al. v. Smith & Nephew PLC, affirmed a District Court’s ruling that claims against a medical device manufacturer are expressly preempted by federal law. In doing so, the Third Circuit addressed an issue of first impression: how courts should apply an express preemption provision to state law tort claims challenging the design and manufacture of a medical device comprised of multiple components with different classifications.
The Third Circuit’s analysis focused largely on the federal regulatory scheme applicable to medical devices. The Medical Device Amendments of 1976 assign approval procedures to new medical devices based upon a device’s class designation. The Medical Device Amendments divide devices into three classes based on the risk posed to the public, with Class III devices receiving the most federal oversight. Unlike the rigorous premarket approval process for Class III devices, Class I and Class II devices are subject to a limited review. In exchange for completing the rigorous premarket approval, Class III device manufacturers get the benefit of express preemption protections.
The plaintiff had total hip replacement surgery in 2009. The hip replacement system implanted was a hybrid system comprising multiple components manufactured by the same company. The components that replaced the plaintiff’s thighbone were Class II devices, while another component that mediated the connection between plaintiff’s hip socket and thighbone was Class III. Nearly two years after the surgery, plaintiff began experiencing pain due to metallic debris. As a result, plaintiff underwent multiple surgeries to remove and replace his hip replacement system. Plaintiff brought claims against the manufacturer alleging various state law claims, including negligence, strict liability, and breach of warranty. The manufacturer asserted that the claims were expressly preempted by federal law.
The Third Circuit was faced with the issue of how to apply the Medical Device Amendments’ express preemption provision to this hybrid system. Plaintiff argued that the device at issue was the entire hybrid hip-replacement system. The Third Circuit disagreed and held that express preemption must be analyzed at the component level based on three grounds.
First, the Food, Drug, and Cosmetic Act (FDCA) defines a device not just as a finished product, but any component, part, or accessory of that product. Second, the FDCA provision for off-label use supports a component-level analysis because it contemplates that devices might be broken down into parts and used separately by third parties. Finally, FDA took the position, in its amicus brief, that the preemption analysis must be evaluated at the component level.
The Third Circuit agreed with the District Court’s observations that the heart of plaintiff’s claims challenged the safety and efficacy of the Class III component. Because the claims would impose requirements that are different from or additional to the federal ones, the Third Circuit held those claims were preempted.
The Third Circuit has now become the first U.S. Court of Appeals to address how to apply express preemption to medical devices that contain components of different classifications. The Third Circuit’s decision establishes that, when a “hybrid” device contains at least one Class III component and that component makes up the bulk of plaintiff’s state law claims, those claims are preempted by federal law.