failure to warn – Duane Morris Products Liability

On August 15, 2024, the United States Court of Appeals for the Third Circuit held in Schaffner v. Monsanto that the plaintiff’s Pennsylvania state-law claims, which asserted that Monsanto failed to warn about alleged cancer risks presented by glyphosate (the active ingredient in the weed killer Roundup), were expressly preempted by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). In so holding, the Third Circuit disagreed with earlier decisions issued by the Ninth Circuit (Hardeman v. Monsanto) and the Eleventh Circuit (Carson v. Monsanto), both of which held that FIFRA did not preempt state failure-to-warn claims regarding glyphosate product labeling. This circuit split makes it more likely that the Supreme Court of the United States will ultimately take up the issue―and its eventual ruling will have significant implications on the scope of FIFRA preemption nationwide.

Read the full Alert on the Duane Morris LLP website.

On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries, must decide whether state law failure-to-warn claims against brand-name drug manufacturers are preempted by the FDA’s labeling regulations. In so holding, the Court further clarified the preemption standard set forth in an earlier decision, Wyeth v. Levine, concluding that such claims are preempted where a drug manufacturer can show “that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”

View the full Alert on the Duane Morris LLP website.