Third Circuit: Hybrid Device Rules Apply to Individual Components

In a precedent-setting decision, a federal appeals court ruled that federal statutes on hybrid medical devices — products including components with different regulatory classifications — supersede state laws.

In a 2013 lawsuit, plaintiff Walter Shuker, who was implanted with components from Smith & Nephew’s 510(k)-cleared R3 hip replacement system and an R3 metal liner in 2009, sued for negligence, fraud, and strict product liability, blaming the product for complications that eventually required further surgeries.

The suit was dismissed in September 2016, after which Shuker launched an appeal. Last September, the FDA filed an amicus brief with the Court of Appeals for the Third Circuit siding with the company. “Because the component is subject to device-specific federal requirements, [the FD&C Act] expressly preempts any state requirements ‘with respect to’ the component that are ‘different from, or in addition to,’ those device-specific federal requirements,” the FDA wrote.

In its March 1 opinion, the court ruled that the District Court was correct in dismissing the preempted claims of negligence, strict liability and breach of implied warranty. However, the court wrote, the FD&C Act’s medical device amendments’ preemption provision does not cover “parallel” claims, or those that hinge on state laws incorporating federal requirements.

The plaintiffs, in their appeal, claimed that the device at issue is the entire hybrid system, but the company and the FDA argued that “analysis at the component level is the only way to harmonize various provisions of the statute.”

The court found in favor of the company for three reasons:

• The FD&C Act does not define devices as finished products and statutory precedent has always defined it to include components;
• The FD&C Act’s provision for off-label use supports component-level analysis, as such uses are “an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine”; and
• FDA enforcement of such issues has historically favored the component argument over the full-system argument.

“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,” the ruling states. However, the court overturned the district court’s dismissal of negligence based on off-label promotion claim but affirmed its dismissal of the fraud claim.

Read the ruling here: www.fdanews.com/03-08-18-Smith.pdf. — Zack Budryk