Federal Law Preempts State Law Product Liability Claims Involving “Hybrid” Medical Devices
On an issue of first impression in the federal Circuit Courts of Appeals, the Third Circuit held that federal law preempts state law claims involving hybrid medical devices where any part of the device requires FDA pre-approval of the device’s safety and effectiveness.
The 1976 Medical Device Amendments to the Food, Drug and Cosmetics Act brought medical devices under the regulatory authority of the Food and Drug Administration. The Amendments established a system whereby certain types of devices, termed Class 3 devices, require approval by the FDA prior to being brought to market after a finding of the device’s safety and effectiveness. The Amendments also prescribe labeling requirements, but permit off-label uses. Class 1 and 2 devices do not require pre-approval or a finding as to their safety or effectiveness, but only a limited review and finding that the device is substantially equivalent to a preexisting approved device. The Amendments also expressly preempt state law claims that relate to the safety or effectiveness of Class 3 devices and that impose any such requirement that is different from or in addition to the federal requirements.
The plaintiff in Shuker v. Smith & Nephew, PLLC (No. 16-2785, 2018 WL 1096185 (3d Cir., Mar. 1, 2018)) had hip replacement surgery involving a hip replacement system with multiple components, all but one of which were Class 1 and 2 devices. The Class 3 component, a metal liner that sat on top of the hip socket component and mediated the connection between the hip socket and thigh bone, was approved for use in a hip resurfacing system, but not the hip replacement system. The approved label noted the use for which the FDA approved the liner, and the parties agreed that the use in this case was off-label. The plaintiff suffered complications from the hip replacement attributed to the use of the Class 3 metal liner in conjunction with the Class 2 components of the hip replacement device.
The plaintiff asserted an assortment of state and federal claims, including negligence, strict liability and breach of implied warranty. He argued that these claims are not preempted by the Amendments’ preemption provisions because the device at issue is the entire hip replacement system which is not a Class 3 device. Defendant and the FDA argued that the Amendments operate at the component level, with Class 3 components entitled to preemption from relevant state claims if that component is implicated in the injury. The court sided with the defendant and the FDA, holding that because the negligence, strict liability and breach of warranty claims concerned the Class 3 component, the preemption provisions of the Amendments applied to those claims despite the injury arising from the interaction between the Class 2 and 3 components.
This decision should provide some comfort to medical device manufacturers in an increasingly complex medical environment. Because doctors can and do prescribe off-label uses for Class 3 medical devices, manufacturers have a risk that the use of their devices will lead to unforeseen complications and liability. This ruling, predicted by several district courts, but adopted for the first time by an appellate court, goes a long way toward mitigating that risk.