Lofton v. McNeil Consumer & Specialty Pharmaceuticals presented a failure-to-warn claim based on a severe reaction to a common pain medicine. No. 10-10956 (Feb. 22, 2012). The Court concluded that the specific claim at issue, based on Tex. Civ. Prac. & Rem. Code § 82.007, required litigation about whether “fraud on the FDA” had occurred and was thus preempted. Op. at 13-14. The Court acknowledged a circuit split on this preemption issue, and also noted that it was not addressing an issue about the severability of the Texas statute because that issue was raised for the first time on appeal.
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