FDA chimes in on off-label use, preemption in Smith & Nephew hip suit

The FDA last week chimed in on a lawsuit brought against Smith & Nephew (NYSE:SNN) by a patient whose surgeon used the company’s hip implants off label, arguing that federal law preempts most tort claims even when medical devices are used outside of their indications.

Plaintiff Walter Shuker was implanted with components from Smith & Nephew’s 510(k)-cleared R3 acetabular system and an R3 metal liner in April 2009 (confusingly, the R3 liner was granted pre-market approval as part of the company’s Birmingham hip resurfacing system and was not intended or approved for use with the R3 acetabular system; Smith & Nephew pulled the R3 metal liner from the market in June 2012). Within two years complications emerged that eventually led to more surgeries; Shuker and his wife sued in September 2013, alleging negligence, strict products liability, breach of express and implied warranties, fraud, and loss of consortium.

Smith & Nephew, in motions to dismiss and for summary judgment, argued that most of the Shukers’ claims were preempted and the rest inadequately pleaded. The court largely agreed in March 2015, ruling that the plaintiffs failed to plead sufficient facts, and in September 2016 dismissed the case altogether, prompting an appeal.

In an amicus brief filed last week with the U.S. Court of Appeals for the 3rd Circuit, the FDA said that all components of a pre-market-approved device are PMA devices when it comes to preemption, regardless of any off-label use. That would limit the Shukers’ claims to the non-PMA portions of the implant, but implied preemption could apply there on a case-by-case basis, according to the federal safety watchdog.

“The component of the premarket-approved device is itself a ‘device’ under the [Food, Drug & Cosmetics Act], and FDA’s approval imposes device-specific requirements with respect to that component. The manufacturer generally may not deviate from those requirements without prior approval from FDA, regardless of the uses to which the component may be put by third parties. Because the component is subject to device-specific federal requirements, [the MDAFDCA] 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.

“Defendants do not appear to have raised an implied-preemption defense before the district court, and this court ordinarily does not reach claims or defenses on appeal that were not presented or passed on below. If the court nonetheless deems the issue to be properly before it, medical-device tort claims that are not expressly preempted remain subject to implied-preemption principles,” the agency wrote.

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