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Florida Second DCA rules that plaintiff was barred from asserting a parallel state law claim against manufacturer of medical device approved through Premarket Approval Process (PMA)

On February 15, 2017, in Wolicki-Gables v. Doctors Same Day Surgery, No. 2D15-2495, the Florida Second DCA affirmed a trial court’s dismissal of a plaintiff’s first party spoliation lawsuit against the defendant medical facility. The plaintiff had alleged that the medical facility had failed to preserve an allegedly defective pain-pump connector, and if they had done so, the plaintiff could have maintained an action against the medical device manufacturer. However, both the trial court and the Second DCA concluded that any such claim would be preempted by federal law because the components were Class III medical devices approved through the Premarket Approval Process (PMA) of the FDA. See 21 U.S.C. Sections 360k(a) and 337(a). The Court noted that virtually all state-based claims, such as claims for negligent manufacturer, are expressly preempted by Section 360k(a), and that claims specifically asserting a violation of the Medical Device Amendment Acts of 1976 (MDA) are expressly prohibited by Section 337. The plaintiff had tried to circumvent PMA preemption by asserting a “parallel claim” against the manufacturer, essentially requesting damages in state court for the failure to comply with the PMA requirements. Although the Second DCA recognized that states may in fact pass laws which create a private cause of action for “failure to comply with the federal standards which were established [for a medical device] through the PMA process,” the Court noted that Florida has no such law and that under Florida law, a statutory violation does not give rise to a private cause of action absent a clear legislative intent to do so.

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