Case Detail

Amarin Pharma, Inc. v. FDA
On August 7, 2015, the U.S. District Court for the Southern District of New York preliminarily enjoined the Food and Drug Administration’s efforts to prevent a drug manufacturer from providing doctors with truthful information about one of its FDA-approved drugs. The decision is a major milestone in WLF’s two-decades-long effort to require FDA to abide by the First Amendment. The district court agreed with WLF’s arguments, set forth in a brief it filed in the case, that the First Amendment prohibits the government from restricting truthful speech, subject only to very rare exceptions. On March 8, 2016, Amarin and FDA entered into a settlement under which Amarin would be able to market its product in a manner consistent with the federal court ruling. The settlement left the court decision, and thus WLF's victory, intact.
Case Status:
Victory. Case favorably settled.
More Information and Downloads:
8/7/2015: Download Opinion
6/12/2015: Download the Brief

Medical Marketing and Media: Amicus briefs pile up in Amarin lawsuit

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