unilateral-label-changes

1 cases — ← All topics

Case Title Lower Court Docketed Status Flags Tags Question Presented
22-1180 Shire U.S., Inc., et al. v. Mark Blackburn Eleventh Circuit 2023-06-07 Denied Amici (1) drug-labeling fda-preapproval FDA-regulations federal-preemption pliva-v-mensing preemption prescription-drugs state-law-claim state-law-claims unilateral-change unilateral-label-changes Whether a state-law claim is preempted if it places a duty on a drug manufacturer to unilaterally change FDA-approved language that appears in the Hig…