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A federal appeals court reinstated a state product liability claim against a medical device manufacturer that charges it falsely promised its spinal cord stimulator had a nine-year life.
A patient, Ray Wildman, had a RestoreUltra neurostimulator manufactured by Minneapolis-based Medtronic Inc. surgically implanted in his back to manage chronic back and life pain, according to Tuesday’s ruling by the 5th U.S. Circuit Court of Appeals in New Orleans in Ray Wildman v. Medtronic, Incorporated; Medtronic USA, Incorporated.
The device malfunctioned about a year-and-a half after it was implanted. Mr. Wildman required multiple surgeries to remove the device and address the resulting infection, according to the ruling.
He sued Medtronic in state court, alleging breach of express warranty. The case was removed to U.S. District Court in San Antonio, Texas, which dismissed the case.
The case was unanimously reinstated by a three-judge appeals court panel on appeal. If a state-law claim imposes a requirement that is “different from, or in addition to” those imposed by the Food and Drug Administration when it approved the medical device, then federal law preempts the claim, the court ruled. But if the claim parallels federal requirements, “that is, if it would enforce a duty also imposed by federal law,” it is not pre-empted, according to the ruling.
The court held the latter was the case. When a claim “challenges a warranty that goes above and beyond any guarantee the FDA expressly or implicitly approved, it’s a parallel one,” the ruling stated.
The warranty in this case goes beyond what the FDA considered, the ruling stated. As part of its “rigorous premarket approval process,” the FDA approved a statement that the device’s battery life was nine years, according to the ruling.
But Medtronic’s warranty goes beyond what the FDA considered. “It repeatedly makes a ‘distinction’ between the battery and the ‘many components’ and focuses on guaranteeing the reliability of the latter,” it states.
Medtronic “has not identified anything in the administrative record showing that the FDA evaluated the longevity of the other components,” the ruling stated.
“A verdict finding that Medtronic misled consumers like Wildman in making this representation – something Wildman is a long way from proving as this case is just at the pleading stage - would not undermine any FDA finding concerning the safety of the device. It would instead be enforcing a duty that also exists under federal law: to not make misleading presentations about the Device,” the court ruled in reversing the lower court’s ruling and remanding the case to the lower court.