Amarin Pharma, Inc. et al v. United States Food & Drug Administration et al
||Amarin Pharma, Inc., Jonathan Herbst, Eric Rishe, Peter Gottesfeld and Ralph Yung
||United States Food & Drug Administration, United States Of America, Stephen Ostroff and Sylvia Mathews Burwell
||May 7, 2015
||US District Court for the Southern District of New York
||Foley Square Office
||XX Out of State
||Paul A. Engelmayer
|Nature of Suit:
||Other Statutory Actions
|Cause of Action:
|Jury Demanded By:
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|August 7, 2015
OPINION & ORDER re: 5 MOTION for Preliminary Injunction filed by Peter Gottesfeld, Amarin Pharma, Inc., Eric Rishe, Ralph Yung, Jonathan Herbst. For the foregoing reasons, the Court grants Amarin's application for prelimin ary relief. Specifically the Court declares that: (1) Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides, and under Caronia, such speech may not form the basis of a prosecution for misbranding; and (2) Based on the information presently known, the combination of statements and disclosures that Amarin proposes to make to doctors relating to the use of Vascepa to treat persons with persistentl y high triglycerides, as such communications have been modified herein, is truthful and non-misleading. The Clerk of Court is respectfully directed to terminate the motion pending at docket number 5. An order will follow shortly as to the next steps in this litigation. (As further set forth in this Opinion and Order.) (Signed by Judge Paul A. Engelmayer on 8/7/2015) (tro)
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