fda-regulation

15 cases — ← All topics

Case Title Lower Court Docketed Status Flags Tags Question Presented
25A304 Jazz Pharmaceuticals, Inc. v. Robert F. Kennedy, Secretary of Health and Human Services, et al. District of Columbia 2025-09-16 Presumed Complete administrative-law chevron-deference fda-regulation market-exclusivity orphan-drug-act statutory-interpretation Whether Congress implicitly ratified an FDA regulatory interpretation of the Orphan Drug Act's market exclusivity provision when it amended the statut…
24-1187 Vanda Pharmaceuticals, Inc. v. Food and Drug Administration, et al. District of Columbia 2025-05-21 Denied Response RequestedResponse WaivedRelisted (2) administrative-law agency-discretion drug-approval fda-regulation medical-innovation statutory-interpretation Whether FDA has acted contrary to its statutory mandate by substituting an evaluation of a drug development program's potential for assessing a new dr…
24-1189 California Stem Cell Treatment Center, Inc., a California Corporation, et al. v. United States Ninth Circuit 2025-05-21 Denied Amici (3)Response WaivedRelisted (2) drug-classification enforcement-action fda-regulation medical-law stem-cells surgical-procedure Whether stem cells used in surgical procedures are 'drugs' subject to FDA regulation under the FDCA and whether the FDA had a lawful basis for its enf…
24-977 Merck Sharp & Dohme Corporation v. Doris Albrecht, et al. Third Circuit 2025-03-12 Denied Amici (4) administrative-law drug-preemption fda-regulation pharmaceutical-liability state-law-liability warning-label Whether a pharmaceutical manufacturer can be held liable under state law for failure to warn when the FDA formally denies a proposed warning label cha…
24A724 Johnny Copper, LLC v. Food and Drug Administration, et al. Eleventh Circuit 2025-01-23 Presumed Complete administrative-law agency-overreach fda-regulation procedural-due-process regulatory-burden statutory-interpretation Whether the FDA exceeded its statutory authority in issuing a regulatory order that imposes substantial burdens on a regulated entity without providin…
23-1125 Logic Technology Development LLC v. Food and Drug Administration Third Circuit 2024-04-17 Denied Relisted (3) administrative-law agency-action arbitrary-and-capricious electronic-nicotine-delivery-system electronic-nicotine-delivery-systems fda-regulation menthol-flavoring premarket-tobacco-application premarket-tobacco-product-application retroactive-rulemaking retroactive-standard Whether the FDA's creation of a new, heightened standard for evaluating already-pending PMTAs for certain ENDS products was arbitrary and capricious
23-1038 Food and Drug Administration v. Wages and White Lion Investments, L.L.C., dba Triton Distribution, et al. Fifth Circuit 2024-03-19 Judgment Issued Amici (17)Relisted (2) administrative-law agency-decision agency-deference arbitrary-and-capricious e-cigarettes fda-regulation interstate-commerce public-health tobacco-control tobacco-regulation Whether the court of appeals erred in setting aside FDA's denial orders as arbitrary and capricious
23A779 Logic Technology Development LLC v. Food and Drug Administration Third Circuit 2024-02-26 Presumed Complete administrative-law agency-rulemaking arbitrary-capricious electronic-nicotine fda-regulation marketing-application Whether the FDA improperly adopted a new and heightened evidentiary burden for marketing applications for electronic nicotine delivery systems (ENDS) …
23-799 Magellan Technology, Inc. v. Food and Drug Administration Second Circuit 2024-01-24 Denied Amici (1)Relisted (4) administrative-procedure-act agency-rulemaking arbitrary-and-capricious circuit-split comparative-efficacy electronic-nicotine-delivery-systems ends-products fda-regulation marketing-authorization reliance-interests youth-access Whether FDA's denial of Petitioner's marketing applications for flavored ENDS was arbitrary and capricious
23A421 Magellan Technology, Inc. v. Food and Drug Administration Second Circuit 2023-11-15 Presumed Complete administrative-law arbitrary-and-capricious circuit-split evidentiary-standards fair-notice fda-regulation Whether the FDA's marketing denial order for electronic nicotine delivery system (ENDS) products was arbitrary and capricious by changing evidentiary …
22-1112 Avail Vapor, LLC, et al. v. Food and Drug Administration Fourth Circuit 2023-05-15 Denied Amici (3)Relisted (2) administrative-law administrative-procedure-act arbitrary-and-capricious evidence-standard evidentiary-standard fda fda-regulation marketing-authorization premarket-applications tobacco-product-regulation tobacco-products Whether FDA's marketing denial order was arbitrary and capricious
21-1342 Jacobus Pharmaceutical Company, Inc. v. Catalyst Pharmaceuticals, Inc., et al. Eleventh Circuit 2022-04-11 Dismissed administrative-law circuit-split drug-exclusivity fda fda-regulation lambert-eaton-myasthenic-syndrome orphan-drug-act rare-disease statutory-interpretation Does the Orphan Drug Act unambiguously foreclose FDA's interpretation that the scope of orphan-drug exclusivity is tied to a drug's approved use?
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,…
20-451 Jane Doe, Individually and as Parent and Guardian of Baby Doe, et al. v. Merck & Co., Inc., et al. Second Circuit 2020-10-08 Denied Response Waived citizens-action civil-rights due-process fda-licensing fda-regulation primary-jurisdiction standing thimerosal vaccine-act vaccine-injury vaccine-mandate Whether courts should extend the precedent of Jacobson v. Massachusetts to require that a mandated vaccine be necessary, harm-avoidant, proportional a…
23A712 Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine, et al. Fifth Circuit Presumed Complete administrative-law chemical-abortion drug-safety fda-regulation medical-procedure reproductive-rights Whether the FDA's regulatory framework for chemical abortion drugs satisfies the requirements of the Food, Drug, and Cosmetic Act and does not pose un…