| 23-1016 |
William Facteau and Patrick Fabian v. United States |
First Circuit |
2024-03-15 |
Denied |
Amici (1) |
arbitrary-enforcement fda-regulations fifth-amendment first-amendment interstate-commerce medical-device off-label-use truthful-speech |
Whether FDA's intended use' regulations violate the First Amendment and Fifth Amendment |
| 23-235 |
Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine, et al. |
Fifth Circuit |
2023-09-12 |
Judgment Issued |
Amici (3)Relisted (2) |
abortion abortion-medication administrative-law agency-action article-iii-standing civil-procedure fda fda-regulations mifepristone preliminary-relief standing |
Whether respondents have Article III standing to challenge FDA's 2016 and 2021 actions |
| 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… |
| 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… |
| 19-1276 |
Michael B. White, Individually and as Personal Representative of the Estate of Darla K. White, Deceased v. Medtronic, Inc., et al. |
Sixth Circuit |
2020-05-12 |
Denied |
|
21-usc-360 adulteration buckman diversity-of-jurisdiction fda-regulations medical-device-preemption off-label off-label-use pleading pleading-standard private-causes-of-action riegel state-court-jurisdiction summary-disposition |
Whether the 6th Circuit Court of Appeals incorrectly affirmed the U.S. District Court's grant of summary disposition due to an incorrect application o… |
| 19-1246 |
Rita McDaniel, Individually and as Personal Representative of the Estate of Johnny F. McDaniel, Deceased v. Upsher-Smith Laboratories, Inc. |
Sixth Circuit |
2020-04-26 |
Denied |
|
failure-to-warn fda-labeling fda-regulations federal-regulations implied-preemption medication-guide parallel-federal-regulations preemption state-law tort-claim |
Whether a state-law, failure-to-warn claim that parallels a defendant's failure to follow FDA labeling regulations is impliedly preempted? |
| 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 … |