Thursday, February 21, 2008

SCOTUS rules on medical device preemption

The United States Supreme Court, in Riegel v. Medtronic, sided with the majority of the federal circuit courts today, holding that federal law regulating medical devices preempts common law tort actions that would impose different or additional requirements than those approved by the federal Food and Drug Administration (“FDA”). This ruling puts to rest a long running dispute over whether there is federal preemption for medical device product liability lawsuits, but may have opened the way for an even longer dispute on the scope of that preemption.

Affirming the Second Circuit, the Supreme Court held that FDA premarket approval of a medical device under the Medical Device Amendments of 1976, 21 U.S.C. § 360(k), precludes common law claims challenging the safety or effectiveness of the medical device. The Court agreed with Medtronic that obtaining the FDA’s safety and efficacy approval pursuant to stringent premarket approval process established certain federal requirements for the medical device. The Court held that common claims based upon different or additional requirements were preempted by the Medical Device Amendments of 1976.

Justice Scalia, who delivered the opinion of the Court, broadly confirmed federal preemption for any state law requirements different from or additional to those imposed by the FDA on approved medical devices. The Court specifically declined to adopt a more narrow view (once espoused by the FDA but now abandoned) that the statute only preempted requirements specific to medical devices, not requirements of general applicability to all types of products.

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