Food and Drug Administration

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FDA

Food and Drug Administration v. Alliance for Hippocratic Medicine

Issues

Should the Court uphold the FDA’s modifications to the usage conditions of the drug mifepristone and defer to the FDA’s expertise before issuing preliminary relief, and do associations of doctors or medical groups have Article III legal standing to challenge the FDA's modifications due to safety concerns?

This case presents the Supreme Court with the issue of whether the Food and Drug Administration (“FDA”) can uphold its modifications to the usage guidelines of the drug mifepristone despite challenges from the Alliance for Hippocratic Medicine, who assert that these changes are capricious and unnecessarily elevate patient risk. Petitioner, the FDA, argues that Respondent, the Alliance for Hippocratic Medicine, lacks standing and that the FDA’s mifepristone-related decisions were based on solid clinical data and expert evaluations affirming the drug's safety and effectiveness. Respondent, the Alliance for Hippocratic Medicine, contends that it has standing and that the FDA's actions in 2016 and 2021 lack adequate safety studies and do not provide a cogent rationale for the modifications, thereby jeopardizing patient and healthcare provider safety. The Court's decision will determine whether mifepristone will stay subject to the lower court's injunction or if the FDA's decision to relax usage guidelines in 2016 and 2021 stands as justified.

Questions as Framed for the Court by the Parties

(1) Whether respondents have Article III standing to challenge the Food and Drug Administration’s 2016 and 2021 actions with respect to mifepristone’s approved conditions of use; (2) whether the FDA’s 2016 and 2021 actions were arbitrary and capricious; and (3) whether the district court properly granted preliminary relief.

In 1996, the United States Food and Drug Administration (“FDA”) received a new drug application (“NDA”) for the drug mifepristone from the Population Council.

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Wyeth v. Levine

Issues

Whether a drug manufacturer that has complied with the Food and Drug Administration’s labeling requirements can still be liable under state product liability laws on grounds that the label was inadequate.

Court below

 

In 2000, Diana Levine was treated with Phenergan to relieve nausea caused by a migraine headache.  The drug was incorrectly administered into Levine’s vein, causing gangrene that ultimately led to the amputation of part of her arm. Levine sued Wyeth, Phenergan’s manufacturer, in Vermont Superior Court and the Supreme Court of Vermont on claims of negligence and products liability, arguing that Phenergan’s label was inadequate in warning consumers about its possible risks. Wyeth, on the other hand, argued that federal law preempted Levine’s state law claims, as state law directly conflicted with the requirements of the Federal Food, Drug and Cosmetic Act. With both lower courts ruling in favor of Levine, this case gives the Supreme Court an opportunity to further define the federal preemption doctrine by clarifying whether a drug manufacturer can be liable under state law after complying with the labeling requirements of the Food and Drug Administration. Stakeholders on both sides argue that the outcome of this case will have a direct impact on the kind of information included on drug labels and as such, has serious implications for patient safety and public health.

Questions as Framed for the Court by the Parties

Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration ("FDA") pursuant to FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.

In April of 2000, Diana Levine sought medical treatment for symptoms, such as pain and nausea, caused by a migraine headache. See Levine v. Wyeth, 944 A.2d 179, 182 (Vt.

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Additional Resources

·   Drug and Device Law Blog:  Views on issues related to pharmaceutical and medical device product liability litigation.

·   Pharmaceutical and Medical Devices:  Fulbright & Jaworski L.L.P. Briefing on Wyeth v. Levine.

·   Drug Injury Watch Blog:. Information about prescription drug side effects.

·   Mass Tort Litigation Blog

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