The First Amendment Does Not Undermine the Preemption of Medical-Device Failure-To-Warn Suits

As the U.S. Supreme Court confirmed in 2008, federal law expressly preempts most failure-to-warn claims arising from injuries allegedly caused by medical devices that have received premarket approval (PMA) from the Food and Drug Administration (FDA). Since that decision, Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the plaintiffs’ bar has been working to chip away at the preemption defense.

The bar’s most recent effort argues that recent decisions expanding First Amendment protection for commercial speech have undermined the basis for federal preemption. The plaintiffs’ bar is wrong. Even if manufacturers have constitutional right to truthfully promote off-label uses of their products, as certain courts have lately held, federal law still expressly preempts most failure-to-warn claims involve PMA devices.

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