A hip-implant device with component parts that were subject to different regulatory classifications should be pre-empted by federal law, the U.S. Court of Appeals for the Third Circuit has ruled in an issue of apparent first impression.

A three-judge panel ruled Thursday in Shuker v. Smith & Nephew that, when considering pre-emption issues, courts should look to the premarket approval classification for each individual component, rather than consider the multicomponent device as a whole. The ruling sided with hip implant maker Smith & Nephew as well as the U.S. Food and Drug Administration, which handles the premarket approval of medical devices.

The plaintiff, Walter Shuker, had argued that not treating the entire hybrid device he alleged was defective as a single device would produce “unfairness and incongruity” since one of the components had been used in an off-label manner.

However, Third Circuit Judge Cheryl Ann Krause said the statutory definition of device, the treatment of off-label uses, and FDA guidance all warranted an approach examining hybrid devices on a component level.

“The regulatory landscape contemplates that devices may be broken down into component parts and individual components used separately by third parties,” Krause said. “It is not surprising, then, that several courts have held that when a single component of a Class III device is used on its own, rather than in the premarket-approved system, express pre-emption adheres to the individual premarket-approved component.”

Shuker's case stemmed from a hip replacement that involved implanting a multicomponent device. Most of the components were Class II devices, but one of the components, which was referred to as an “R3 metal liner,” was a Class III device, which received a greater level of premarket approval scrutiny. Complicating matters was the fact that the R3 liner only received premarket approval to be used in the “Birmingham Hip Resurfacing System,” and the Class II components used in the rest of Shuker's hip implant were from a different system.

The use of the R3 system created a “metal-on-metal articulation,” Krause said, and eventually Shuker had to have a revision surgery.

Shuker sued and contended, among other things, that because the R3 liner had not been approved for use outside the Birmingham system the entire hybrid device constituted off-label use for which pre-emption would not apply.

Although Krause rejected that argument, her analysis did not end with whether the claims were pre-empted, and she eventually reversed the lower court's decision to dismiss some of Shuker's parallel claims.

Attorney Eric Zajac of Zajac & Arias, who is representing Shuker, said the panel appeared to be concerned with how the R3 liner was marketed, noting that, despite its name, the liner component had not been approved for use in the “R3 Acetabular System,” which is where the other components used in Shuker's hip replacement came from. The Third Circuit's ruling revived the negligence, loss of consortium and fraud claims premised on those marketing-related arguments.

“The analysis did not simply end [with pre-emption],” he said. “Pre-emption will not close the courthouse doors.”

Zajac & Arias attorney Robert Astrachan, who argued the case before the Third Circuit panel, also said district courts in New York, Connecticut and West Virginia have split on the first-impression issue, and the Third Circuit's ruling is the first statement by a federal appeals court about how to handle pre-emption for devices that have multiple components.

Sara Gourley of Sidley Austin, who argued the case for Smith & Nephew, did not return a call seeking comment.