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Date: 06-13-2024
Case Style:
Case Number: 2:22-cv-223
Judge: Matthew J. Kacsmaryk
Court: United States District Court for the Western District of Texas (Potter County)
Plaintiff's Attorney:
Defendant's Attorney: Noah T. Katzen, et al.
Description:
Amarillo, Texas civil litigation lawyers represented the Plaintiffs who sued the Defendants seeking a declaratory judgement.
In 2000, the Food and Drug Administration approved a new drug application for mifepristone tablets marketed under the brand nameMifeprex for use in terminating pregnancies up to seven weeks. To help ensure that Mifeprex would be used safely and effectively, FDA placed additional restrictions on the drug’s use and distribution, for example requiring doctors to prescribe or to supervise prescription ofMifeprex, and requiring patients to have three in-person visits with the doctor to receive the drug. In 2016, FDA relaxed some of these restrictions: deeming Mifeprex safe to terminate pregnancies up to 10 weeks; allowing healthcare providers, such as nurse practitioners, toprescribe Mifeprex; and approving a dosing regimen that required justone in-person visit to receive the drug. In 2019, FDA approved an application for generic mifepristone. In 2021, FDA announced that it would no longer enforce the initial in-person visit requirement. Four pro-life medical associations and several individual doctors moved for a preliminary injunction that would require FDA either to rescind approval of mifepristone or to rescind FDA’s 2016 and 2021 regulator yactions. Danco Laboratories, which sponsors Mifeprex, intervened to defend FDA’s actions.
Outcome: Judgment in favor of the Plaintiffs.
Affirmed by the 5th Circuit Court of Appeals.
Reversed and dismissed by the United States Supreme Court because the Plaintiffs lacked standing under Article II to challenge the FDA's actin regarding the regulation of mifepristone.
Plaintiff's Experts:
Defendant's Experts:
Comments: