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# Plaintiffs Bar Seeks to Weaken Device Preemption: WLF
- URL: https://www.fdaweb.com/plaintiffs-bar-seeks-to-weaken-device-preemption-wlf/
- Published: 2016-02-29T12:00:00.000Z
- Updated: 2026-09-15T02:39:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134906

> A Washington Legal Foundation [backgrounder](http://www.wlf.org/upload/legalstudies/legalbackgrounder/022616LB%5FTauber2.pdf?ref=fdaweb.com) dismisses plaintiffs’ bar actions to weaken medical device preemption. Authored by Mayer Brown partner **Andrew Tauber**, the backgrounder notes that the bar’s most recent effort argues that recent decisions involving First Amendment protection for commercial speech have undermined the basis for federal preemption. “The plaintiffs’ bar is wrong,” Tauber writes. “Even if manufacturers have a 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 involving PMA devices.”  
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> Tauber contends that some members of the plaintiffs’ bar have argued that recent First Amendment cases (Caronia and Amarin) have undermined the Supreme Court’s *Riegel* decision that interpreted device preemption. “Plaintiffs cite *Caronia* and *Amarin* when arguing that if a manufacturer has a constitutional right to engage in truthful speech regarding a device, then nothing can prevent the manufacturer from issuing truthful warnings, even if they are different from or in addition to those approved by the FDA,” he writes. “Consequently, plaintiffs have reasoned, failure-to-warn claims brought in connection with medical devices that have received premarket approval from the FDA are no longer preempted.”  
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> That suggestion, Tauber says, which ignores the plain text of § 360k(a) of the Food, Drug & Cosmetic Act, has no merit. “The mere fact that the manufacturer of a PMA medical device might have a First Amendment right to issue warnings beyond those that the FDA requires does not mean that the manufacturer is under a federal obligation to do so,” he writes. “The manufacturer’s only duty under federal law is to distribute the FDA-mandated warnings. Thus, any state-law requirement that the manufacturer issue other warnings would be a requirement “different from, or in addition to,” the federal requirement — and therefore squarely foreclosed by § 360k(a).”  
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> Tauber notes that off-label uses of PMA devices are frequently the accepted standard of treatment. “If device manufacturers must fear criminal or regulatory enforcement actions when discussing off-label uses, they will avoid discussing such uses,” he contends. “As a result, doctors will be without the benefit of relevant information and patients will suffer accordingly. The courts’ recent recognition of expanded commercial-speech rights under the First Amendment reduces the threat of such pernicious results. It would be paradoxical if the recognition of those same rights were used by the plaintiffs’ bar to undermine the protection afforded manufacturers by § 360k(a)—protection that spurs the development of innovative medical devices and patients’ access to such devices. Fortunately, the statutory text and the case law interpreting it preclude such a negative outcome.”