Taking a generic drug and think those manufacturers are held to the same liability standard as the brand name manufacturer? Here's what a court says:
"'Impossibility' preemption issues arise with some regularity in litigation asserting state-law tort claims against prescription-drug manufacturers. In Wyeth v. Levine 555 U.S. 555 (2009), the Court held that a state-law failure-to-warn claim against a brand-name drug manufacturer was not preempted because FDA regulations allow those manufacturers to change labels without immediate agency approval. Wyeth, 555 U.S. at 568. Wyeth, which involved a branded drug, left unaddressed the case of a generic drug, which is subject to a different regulatory regime. 'Under federal law, a generic drug manufacturer may produce a drug that is identical to one made by a brand-name manufacturer, but when it receives permission to do so, it must use the same FDA-approved design and warning labels as the brand-name manufacturer.' Sikkelee, 907 F.3d at 712. Unlike brand-name manufacturers, then, a generic manufacturer cannot unilaterally change its label consistent with federal law. Id. In PLIVA, Inc. v. Mensing, which dealt with a generic pharmaceutical, the Court distinguished Wyeth and explained that '[t]he question for `impossibility' is whether the private party could independently do under federal law what state law requires of it.' PLIVA, Inc. v. Mensing, 564 U.S. 604, 620 (2011) (emphasis added). '[W]hen a party cannot satisfy its state duties without the Federal Government's special permission and assistance, ... that party cannot independently satisfy those state duties for pre-emption purposes.' Id. at 623-24."
From: Hankowski v. Zydus Pharmaceuticals USA, Inc., case no. 20-2458 (MAS)(TJB), U.S. Dist. Ct., Dist. of NJ (May 28, 2021)
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