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50 results for “Food and Drug Administration”

Case Title Lower Court Docketed Status Tags Question Presented
25A472 Takeda Pharmaceutical Company Limited, a Japanese Corporation, et al. v. Painters & Allied Trades District Council 82 Health Care Fund, third-party healthcare payor fund, et al. Ninth Circuit 2025-10-24 Application causation class-certification individualized-damages injury-requirement rico-claim third-party-payor Whether a class action under Rule 23(b)(3) can be certified for a RICO claim when individual plaintiffs cannot demonstrate uniform injury or causation…
25-440 Thomas Anderson, et al. v. United Airlines, Inc., et al. Seventh Circuit 2025-10-10 Denied None Section 564 of the Food , Drug, and Cosmetics Act ("FDCA") provides that the Food and Drug Administration 's ("FDA") standard process for approving …
25-257 Wells Pharma of Houston, L.L.C. v. Zyla Life Sciences, L.L.C. Fifth Circuit 2025-09-04 Pending consumer-protection drug-marketing fdca-preemption outsourcing-facilities premarket-approval state-law-claims Whether the FDCA preempts private state-law unfair competition and consumer protection claims premised on the marketing of compounded drugs without pr…
25-141 Arnold G. Phillips v. Cecilia Abundis, et al. Seventh Circuit 2025-08-06 Denied administrative-hearing atomic-energy-act due-process medical-license nuclear-medicine settlement-agreement Whether the United States District Court for the Northern District of Illinois improperly suspended a medical license without notice or hearing in vio…
24-1187 Vanda Pharmaceuticals, Inc. v. Food and Drug Administration, et al. District of Columbia 2025-05-21 Denied 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…
24A871 Vanda Pharmaceuticals, Inc. v. Food and Drug Administration, et al. District of Columbia 2025-03-12 Presumed Complete None
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…
24-474 Food and Drug Administration v. SWT Global Supply, Inc., et al. Fifth Circuit 2024-10-29 GVR administrative-law arbitrary-and-capricious-standard e-cigarette-products fda-authorization public-health tobacco-control-act Whether the court of appeals erred in setting aside FDA's denial orders as arbitrary and capricious
24-239 Kenneth Chloe v. George Washington University District of Columbia 2024-09-03 Denied administrative-procedure chevron-doctrine constitutional-rights due-process judicial-review separation-of-powers Whether the United States District Court and Court of Appeals violated constitutional rights through administrative rulemaking and potential breach of…
24-189 R.J. Reynolds Tobacco Company, et al. v. Food and Drug Administration, et al. Fifth Circuit 2024-08-21 Denied commercial-speech first-amendment government-mandated-warnings graphic-warnings tobacco-regulation zauderer-standard Whether provocative and misleading government-mandated graphic warnings on cigarette packaging are 'purely factual and uncontroversial' under Zauderer…
23-1187 Food and Drug Administration, et al. v. R.J. Reynolds Vapor Co., et al. Fifth Circuit 2024-05-02 Judgment Issued administrative-law circuit-court civil-procedure fda fda-authorization federal-courts judicial-review product-distribution standing statutory-interpretation tobacco-regulation Whether a manufacturer may file a petition for review in a circuit (other than the D.C. Circuit) where it neither resides nor has its principal place …
23-1161 Children’s Health Defense, et al. v. Food and Drug Administration, et al. Fifth Circuit 2024-04-26 Denied agency-action article-iii case-or-controversy constitutional-standing injury-in-fact resource-diversion standing vaccine-safety Whether a Constitutionally cognizable case or controversy exists under Article III
23-1125 Logic Technology Development LLC v. Food and Drug Administration Third Circuit 2024-04-17 Denied 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 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) …
23-871 Lotus Vaping Technologies, LLC v. Food and Drug Administration Ninth Circuit 2024-02-13 Denied administrative-procedure-act arbitrary-and-capricious circuit-split comparative-efficacy electronic-nicotine-delivery-systems fair-warning flavored-products food-and-drug-administration marketing-applications Whether FDA's denial of Petitioner's marketing applications for flavored ENDS was arbitrary and capricious
23-799 Magellan Technology, Inc. v. Food and Drug Administration Second Circuit 2024-01-24 Denied 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
23-788 Hope Medical Enterprises, Inc., dba Hope Pharmaceuticals v. Fagron Compounding Services, LLC, et al. Ninth Circuit 2024-01-22 Denied circuit-split drug-regulation federal-law federal-preemption food-and-drug-administration preemption state-law state-rights statutory-interpretation Whether the FDCA preempts state laws prohibiting the in-state sale of unapproved drugs whose sale is also prohibited as a matter of federal law by the…
23A530 Hope Medical Enterprises, Inc. v. Fagron Compounding Services, LLC, et al. Ninth Circuit 2023-12-12 Presumed Complete drug-approval enforcement fdca preemption private-litigation state-law Whether the Food, Drug, and Cosmetic Act's enforcement provision preempts state-law claims that mirror federal drug approval requirements
23A507 Lotus Vaping Technologies, LLC v. Food and Drug Administration Ninth Circuit 2023-12-05 Presumed Complete administrative-procedure agency-discretion evidentiary-standards fair-notice marketing-denial regulatory-review Whether the Administrative Procedure Act permits a federal agency to change its evidentiary standards for regulatory approval without providing fair n…
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 …
23A344 Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., et al. Federal Circuit 2023-10-17 Presumed Complete KSR-standard obviousness patent-law pharmaceutical-patents predictable-result prior-art Whether the Federal Circuit's obviousness analysis complies with the Supreme Court's standard in KSR International Co. v. Teleflex Inc. by requiring t…
23-395 Alliance for Hippocratic Medicine, et al. v. Food and Drug Administration, et al. Fifth Circuit 2023-10-16 Denied abortion abortion-medication administrative-procedure-act drug-regulation fda fda-approval generic-drugs medical-safety mifepristone subpart-h Whether Cross-Petitioners' challenge to FDA's 2000 mifepristone approval is timely
23-236 Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, et al. Fifth Circuit 2023-09-12 Judgment Issued administrative-procedure-act administrative-record agency-deference article-iii-standing circuit-split fda-drug-approval judicial-review national-scope preliminary-injunction Whether an association can demonstrate Article III standing to enjoin a government action
23-235 Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine, et al. Fifth Circuit 2023-09-12 Judgment Issued 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
23A181 Joseph R. Biden, Jr., President of the United States, et al. v. Greg Abbott, Governor of Texas, et al. Fifth Circuit 2023-08-28 Presumed Complete constitutional-separation-of-powers covid-19-vaccination federal-authority militia-clauses national-guard state-militia-capacity Whether the Militia Clauses of the Constitution, Article I, Sections 8, Clauses 15 and 16, prohibit the federal government from imposing a COVID-19 va…
22-1180 Shire U.S., Inc., et al. v. Mark Blackburn Eleventh Circuit 2023-06-07 Denied 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…
22-1121 Kamaladoss Selvam v. United States, et al. Second Circuit 2023-05-17 Denied administrative-law administrative-warrant civil-procedure drug-enforcement fda-jurisdiction federal-agencies law-enforcement search-and-seizure search-warrant statutory-interpretation subpoena-power Whether the FDA has jurisdiction to enforce the Drug Abuse Prevention and Control Act
22-1112 Avail Vapor, LLC, et al. v. Food and Drug Administration Fourth Circuit 2023-05-15 Denied 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
22A902 Food and Drug Administration, et al. v. Alliance For Hippocratic Medicine, et al. Fifth Circuit 2023-04-14 Presumed Complete None
22A777 Avail Vapor, LLC, et al. v. Food and Drug Administration Fourth Circuit 2023-03-03 Presumed Complete None
22-757 Jonathan Roberts, et al. v. James V. McDonald, Commissioner, New York State Department of Health, et al. Second Circuit 2023-02-10 Denied civil-rights defendant-conduct due-process emergency-approval equal-protection injury-in-fact legal-standing predictable-events racial-discrimination standing Whether plaintiffs' injury is imminent where it flows from a predictable course of events that results from the defendant's conduct
22-708 Gripum, LLC v. Food and Drug Administration Seventh Circuit 2023-01-30 Denied administrative-agencies administrative-law administrative-procedure-act agency-deference conflicts-of-interest evidentiary-requirements fda-guidance judicial-deference judicial-review regulatory-conflict tobacco-control-act What level of judicial deference is afforded to administrative agencies with conflicts of interest?
22-584 Children’s Health Defense, et al. v. Food and Drug Administration, et al. Sixth Circuit 2022-12-23 Denied agency-action article-iii case-or-controversy constitutional-standing injury resource-diversion risk-of-injury standing third-party third-party-injury Whether a Constitutionally cognizable case or controversy exists under Article III
22A482 Gripum, LLC v. Food and Drug Administration Seventh Circuit 2022-12-01 Presumed Complete None
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?
21A176 Breeze Smoke, LLC v. Food and Drug Administration Sixth Circuit 2021-11-23 Presumed Complete None
20-1203 Moose Jooce, et al. v. Food and Drug Administration, et al. District of Columbia 2021-03-03 Denied administrative-procedure-act agency agency-law appointments-clause due-process government-action ratification ratification-doctrine rulemaking-authority standing Whether a government official has the power to validate the unauthorized actions of other officials is presumptively determined by the law of agency, …
20-1069 Janssen Pharmaceuticals, Inc., et al. v. A. Y., et al. Pennsylvania 2021-02-05 Denied 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,…
20-850 Big Time Vapes, Incorporated, et al. v. Food and Drug Administration, et al. Fifth Circuit 2020-12-28 Denied administrative-discretion administrative-law constitutional-limits executive-authority executive-power legislative-authority legislative-delegation non-delegation-doctrine separation-of-powers tobacco-control-act tobacco-product-regulation Whether Petitioners have stated a claim that § 387a(b) grants excessive policymaking discretion to the executive branch to determine which tobacco pro…
20-779 Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corporation Federal Circuit 2020-12-08 Denied administrative-proceeding article-iii-standing article-three-standing fda-approval inter-partes-review joint-venture leahy-smith-america-invents-act patent-challenge patent-validity pharmaceutical-industry pharmaceutical-patent Did the Federal Circuit categorically and erroneously preclude redress for injured members of joint ventures in the pharmaceutical industry by only re…
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 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…
20-295 Hi-Tech Pharmaceuticals, Inc., et al. v. Food and Drug Administration, et al. Eleventh Circuit 2020-09-08 Denied botanical-ingredients constituent-definition dietary-supplements dmaa DSHEA FDA-approval federal-food-drug-and-cosmetic-act geranium-plants prior-history-of-use trace-quantities Whether a substance that naturally occurs in a plant is a 'constituent' of an 'herb or other botanical' under the Dietary Supplement Health and Educat…
20A34 Food and Drug Administration, et al. v. American College of Obstetricians and Gynecologists, et al. Fourth Circuit 2020-08-26 Presumed Complete None
19-1038 Department of Health and Human Services, et al. v. California, et al. Ninth Circuit 2020-02-19 GVR administrative-law affordable-care-act conscience-exemption contraceptive-coverage contraceptive-mandate health-insurance preventive-services religious-freedom-restoration-act Whether the agencies had statutory authority under the ACA and the Religious Freedom Restoration Act of 1993 to expand the conscience exemption to the…
19-454 Donald J. Trump, President of the United States, et al. v. Pennsylvania, et al. Third Circuit 2019-10-07 Judgment Issued administrative-procedure-act affordable-care-act agency-rulemaking conscience-exemption contraceptive-coverage contraceptive-mandate healthcare-mandate nationwide-injunction religious-freedom-restoration-act standing statutory-authority Whether the agencies had statutory authority to expand the conscience exemption to the contraceptive-coverage mandate
18-182 AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc., et al. Federal Circuit 2018-08-09 Denied actual-controversy article-iii declaratory-judgment drug-exclusivity fda-approval generic-drugs patent-invalidity pharmaceutical pharmaceutical-patents standing Whether the 'actual controversy' requirement of the Declaratory Judgment Act requires a party seeking to introduce a generic drug product to file an a…
23A301 Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, et al. Fifth Circuit Presumed Complete None Question not identified.
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…
23A300 Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine, et al. Fifth Circuit Presumed Complete None Question not identified.