On March 1, the U.S. Court of Appeals for the Third Circuit addressed an issue of first impression: how courts should apply an express pre-emption provision to state law tort claims challenging the design and manufacture of a hybrid medical device, defined as a medical device comprised of differently classified components.

In Shuker v. Smith & Nephew, the Third Circuit affirmed a district court's ruling that common law claims against a medical device manufacturer are expressly pre-empted by the Medical Device Amendments of 1976. At its essence, the Third Circuit's holding finds that when dealing with a multicomponent medical device, pre-emption must be addressed on a component-by-component basis.

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (FDCA) 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. Class I devices, such as surgical instruments, pose the least amount of risk. Class II devices, such as contact lenses and ultrasound scanners, are “more harmful,” and Class III devices, such as hemodialysis machines and orthopedic implants, pose the greatest risk and receive the most federal oversight. Class I and Class II devices are subject to a limited review. However, a Class III device requires rigorous pre-market approval by the Food and Drug Administration (FDA) before becoming available to the public. In exchange for completing pre-market approval, Class III device manufacturers are afforded express pre-emption protections.

In 2009, the plaintiff in Shuker had total hip replacement surgery. The plaintiff's surgeon chose to use a Smith & Nephew device that consisted of several component parts, a hybrid system, all manufactured by the same company.The system included a metal head, metal sleeve, stem and metal liner. The components that replaced the plaintiff's thighbone were Class II. However, the R3 metal liner that mediated the connection between the plaintiff's hip socket and thigh bone was a Class III component and thus had undergone FDA pre-market approval. Within two years following the surgery, the plaintiff began experiencing pain due to metallic debris. As a result, the plaintiff underwent multiple revision surgeries to remediate the issues he was experiencing.

Ultimately, the plaintiff brought suit against the manufacturer for various state law claims including claims for negligence, strict liability, and breach of implied warranty, as well as violations of federal law.

The question before the Third Circuit, then, was how and whether to apply the express preemption provision of the Medical Device Amendments of 1976 to a hip replacement system with multiple components with different classifications.

The plaintiff argued that the hip replacement system should be viewed as a whole, single device, and therefore not subject to pre-emption. Conversely, the manufacturer asserted that each component of the hip replacement system was a separate device, and that the proper focus was on the component of the device which caused an injury to the plaintiff, in this case the R3 metal liner, a Class III component.

The Third Circuit ultimately agreed with the manufacturer and concluded that the plaintiff's negligence, strict liability and breach of implied warranty claims were all pre-empted under Riegel v. Medtronic.

The Third Circuit based its holding on three findings. First, the FDCA defines a “device” to include not just a finished “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,” but also “components, parts and accessories.” Next, the FDCA's regulations of off-label provisions acknowledge that a third party can use components separately from the system for which the FDA approved use. Thus, regardless of the use to which the component is put, the FDA's PMA-regulations for the component follow it. To this end, the Third Circuit stated “pre-market approval requirements apply equally to the components, as manufacturers generally may not deviate from the requirements imposed through pre-market approval regardless of how [a component] is used.” Lastly, the Third Circuit relied on the FDA's position that a device is not limited to the device as a whole but includes components, and that the FDA endorses preemption analysis at the component level. Further, the FDA is charged with assuring the safety and effectiveness of components as well as finished devices. The Third Circuit stated, “taken together, the statutory definition of 'device,' the treatment of off-label uses, and the guidance of the FDA all counsel in favor of scrutinizing hybrid systems at the component-level … And the Riegel test is properly framed at Step One as 'whether the federal government has established requirements applicable' to a component of the hybrid system.”

The Third Circuit then analyzed the various components of plaintiff's medical device separately, including the metal head, metal sleeve, stem, and metal liner. The Third Circuit concluded that the plaintiff's common law claims challenged the safety and effectiveness of the R3 metal liner, a Class III device. Since the plaintiff's common law claims attempted to impose nonparallel state law requirements that were different from or additional to federal requirements, they were pre-empted. The Third Circuit affirmed the district court's ruling that plaintiff's negligence, strict liability, and breach of implied warranty claims were expressly preempted by the Medical Device Amendments of 1976.

This Third Circuit is the first U.S. Court of Appeals to deal with the application of express preemption to medical devices that contain components of various different classifications, also known as “hybrid” devices. When analyzing a hybrid medical device case, a party must now consider if the hybrid device contains at least one Class III component and whether that particular component makes up the majority of the potential state law claims involved in the litigation. If so, there is a strong argument that the negligence, strict liability, and breach of implied warranty claims are preempted by federal law.

Megan E. Grossman is a shareholder at Segal McCambridge Singer & Mahoney in its Philadelphia office. She is the chair of the firm's life sciences practice group and she focuses her practice on the defense of pharmaceutical and medical device companies in products liability lawsuits. 

Asher A. Block is an associate in the firm's Philadelphia office. He focuses his practice on the defense of products liability, medical device, and pharmaceutical actions, including those associated with defect and misrepresentation claims.