In an en banc ruling released today, the U.S. Court of Appeals for the Ninth Circuit held that the federal Medical Device Amendments do not preempt a patient's tort claim alleging that that manufacturer violated its state-law duty to warn of dangers when it did not report "adverse events" to the FDA, as required by federal law. The en banc court's unanimous opinion in Stengel v. Medtronic overturned a panel opinion holding the claim preempted. The opinion follows an earlier decision of the Fifth Circuit, Hughes v. Boston Scientific, in holding that plaintiffs can go forward with failure to warn claims when a manufacturer has failed to inform the FDA of newly discovered dangers posed by its devices after they have received FDA approval.
The plaintiff, Stengel, alleges he was rendered a paraplegic when a Medtronic pain-medication pump and catheter that had been surgically implanted in him malfunctioned. The device was a Class III device that had received premarket approval from the FDA under the Medical Device Amendments. After receiving approval, however, Medtronic failed to inform the FDA of information it received about incidents in which the device failed, as manufacturers are required to do by regulation and under the terms of their premarket approvals. The FDA later learned of the adverse events, and the device was recalled, but too late to protect Stengel.
Stengel sued, claiming among other things that in failing to report adverse events to the FDA, Medtronic had also violated its Arizona common-law duty to warn users of its products by providing information to third parties who can be relied on to pass the warnings on to affected users. Relying on the Supreme Court's decision in Riegel v. Medtronic, which held many claims directed at Class III devices to be preempted by the FDA's premarket approval, Medtronic contended that the claim was preempted.
The Ninth Circuit, however, held that under both Riegel and the Supreme Court's earlier decision in Medtronic v. Lohr, the claim was not preempted because the state-law requirement at issue "paralleled" federal requirements and thus was not different from or in addition to any federal requirement. The Ninth Circuit also rejected Medtronic's argument that another Supreme Court decision, Buckman v. Plaintiffs' Legal Committee, which held claims based on "fraud on the FDA" to be preempted, applied to the plaintiff's claims. The court ruled that Buckman does not apply where an established common-law duty parallels federal requirements under the Medical Device Amendments.
Medical device manufacturers have been arguing that failure-to-warn claims are either barred by Riegel or Buckman, with little or no space between the two for claims to avoid preemption. The Ninth Circuit's decision, like the earlier decision of the Fifth Circuit in Hughes, is a welcome refutation of that theory, and enables plaintiffs who suffer as a result of manufacturers' concealment of adverse events the possibility of a remedy.