drug-labeling
7 cases — ← All topics
| Case | Title | Lower Court | Docketed | Status | Flags | Tags | Question Presented |
|---|---|---|---|---|---|---|---|
| 24A720 | Merck Sharp & Dohme Corporation v. Doris Albrecht, et al. | Third Circuit | 2025-01-22 | Presumed Complete | drug-labeling failure-to-warn federal-regulations pharmaceutical-liability preemption product-liability | Whether federal preemption principles under the Wyeth v. Levine framework preclude state law failure-to-warn claims against pharmaceutical manufacture… | |
| 24-5593 | Otis Brandon v. Janssen Pharmaceuticals, et al. | Fourth Circuit | 2024-09-20 | Denied | IFP | drug-labeling fda-citations judicial-review medical-liability mental-capacity pharmaceutical-misconduct | Did the lower courts fail to properly consider evidence of pharmaceutical misconduct and misrepresentation in cases against Janssen and Johnson & John… |
| 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… |
| 21-1238 | Ina Ann Rodman v. Otsuka America Pharmaceutical, Inc. | Ninth Circuit | 2022-03-11 | Denied | Response Waived | 21-cfr-314-80 design-defect drug-labeling expert-testimony failure-to-warn misbranding pharmaceutical-liability post-marketing-surveillance summary-judgment wyeth-v-levine | Whether Ms. Rodman presented admissible evidence of Otsuka's failure to follow post-marketing surveillance and label revision requirements, and whethe… |
| 20-1069 | Janssen Pharmaceuticals, Inc., et al. v. A. Y., et al. | Pennsylvania | 2021-02-05 | Denied | Amici (4) | civil-liability drug-labeling fda-regulation federal-preemption impossibility-preemption off-label-use preemption state-tort-law | Whether federal law preempts state-law claims that a manufacturer failed to provide adequate warnings relating to the off-label use of their products,… |
| 19-1444 | GlaxoSmithKline LLC v. United Food and Commercial Workers Local 1776 and Participating Employers Health and Welfare Fund, et al. | Third Circuit | 2020-07-01 | Denied | Amici (1)Response Waived | avandia brand-name-drug brand-name-drugs conflict-preemption drug-labeling drug-manufacturer fda-preemption fda-regulations label-change material-information regulatory-compliance tort-claims | Whether federal law preempts state-law tort claims where a brand-name drug's manufacturer provides the FDA with all material information in its posses… |
| 18-803 | Wendy B. Dolin v. GlaxoSmithKline, LLC, fka SmithKline Beecham Corporation | Seventh Circuit | 2018-12-21 | Denied | Relisted (2) | clinical-trials drug-labeling drug-manufacturer fda-regulations impossibility-preemption labeling-changes preemption truthful-risks unilateral-labeling-changes unilateral-warning wyeth-v-levine | Does federal law prevent a drug manufacturer from enhancing its label to reflect truthful risks revealed in its clinical trials when the relevant FDA … |