A precedential case: hybrid medical devices

On March 1, 2018, the U.S. Court of Appeals for the Third Circuit issued a first-of-its-kind decision upholding that federal law can (and does) preempt state law claims in suits brought against medical device manufacturers over medical devices containing components of differing regulatory classifications.

The case, Shuker v. Smith & Nephew, arose when a Mr. Shuker underwent total hip replacement surgery (in 2009). The hip replacement system (a metal head replacing the top of the femur, a metal sleeve, a stem connecting the the head to the thighbone, and another component resting in his hip socket) was a Class II device that went through the relatively lenient 510(k) pathway. A final component, a “R3 metal liner”, that mediated the connection between his hip socket and his thighbone underwent the more rigorous premarket approval (PMA) process as a supplemental component for a separate Class III device. The FDA’s PMA process required that the R3 metal liner only be used with the device for which it was approved. Its use in Mr. Shuker’s case was off-label. About twenty-one months later, Mr. Shuker “began developing increasing pain and discomfort in his buttocks, groin, and thigh, limiting his daily activities.” After an aspiration procedure, metallic debris due to metal-on-metal articulation was found to be the culprit. Mr. Shuker sought to hold Smith & Nephew accountable.

The courts found that “In sum, the negligence, strict liability, and breach of implied warranty claims asserted in the Second Amended Complaint, would impose non-parallel state law requirements and are therefore expressly preempted.” However, because Smith & Nephew specifically advertised the R3 metal liner for use with systems beyond the one for which it was specifically approved, the plaintiffs made their case for negligence based off-label promotion.