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In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the U.S. Supreme Court held that most product liability claims against manufacturers of the riskiest, most critical, and most extensively regulated medical devices are preempted by federal law. The Court left open a small window for state law claims premised on violations of FDA regulations ' known as “parallel claims” ' but did not define the contours of such claims. After Riegel, the federal appellate and district courts have reached divergent conclusions regarding the level of specificity required to plead a parallel claim that survives a motion to dismiss. This article provides an overview of the case law on the topic.
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