Apter v. Department of Health and Human Services — S.D. Tex., Galveston

Case summary

Three physicians, Robert L. Apter, Mary Talley Bowden and Paul E. Marik, filed a complaint for vacatur, declaratory and injunctive relief on June 2, 2022 in the U.S. District Court for the Southern District of Texas, Galveston Division, No. 3:22-cv-00184, against the Department of Health and Human Services, its Secretary, the Food and Drug Administration and its Commissioner. The complaint concerns FDA statements about the off-label use of ivermectin for COVID-19 and argues that the FDA cannot ban particular uses of approved human drugs or advise whether a patient should take one. The district court's judgment was reversed and the case remanded by the Fifth Circuit on October 24, 2023. The parties settled and stipulated to dismissal with prejudice on March 21, 2024.

Case at a glance

What did the Fifth Circuit decide?

It ordered that the judgment of the district court be reversed and the cause remanded for further proceedings in accordance with its opinion, each party to bear its own costs on appeal; the judgment was issued as the mandate on October 24, 2023.

What did the settlement provide?

That within 21 calendar days the defendants would retire the FDA Consumer Update "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19", while retaining the right to post a revised Consumer Update, and delete and not republish named FDA social media posts from August 21, 2021 and April 26, 2022 and other posts linking to that update, with all materials archived as required by federal law.

Did anyone admit liability?

No. The stipulation states that neither it nor the actions described in it constitute an admission or evidence of any issue of fact or law, wrongdoing, misconduct or liability on the part of any party.

Summary written from the documents on this page; every sentence is sourced.