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Case Detail


Medtronic, Inc. v. Stengel
On June 23, 2014, the Supreme Court declined to review an appeals court ruling that federal law does not preempts state-law product liability suits challenging the design or labeling of medical devices that FDA has determined to be safe and effective. The decision was a setback for WLF, which filed a brief urging the Court to grant review. WLF argued that Congress mandated preemption when in 1976 it adopted the medical device law, which established a rigorous Pre-Market Approval process (PMA) for all new medical devices. WLF argued that judgments against a device manufacturer based on a determination that the device is deficiently designed or labeled would undermine the PMA process by calling into question FDA’s decisions mandating specific product designs and labels. In its 2008 Riegel decision, the Court held that most product liability claims against device manufacturers are, indeed, preempted. But some lower courts—including the appeals court here–have not followed that decision.
Case Status:
Supreme Court review denied.
More Information and Downloads:
6/13/2013: Download the Brief

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