Stumbled into Judge Engelmayer's Courtroom this morning to hear oral arguments. I concur with previous poster that, in my opinion, an injunction will issue. The only question was what the scope of the injunction would be. There was no indication about timing of the opinion, but it is likely to be soon given the nature of the relief requested and showing of irreparable harm.
Oral argument went from 9:00 to 11:45. About an hour each side plus rebuttal time for Amarin. Floyd Abrams argued for Amarin, (assisted ably by another attorney from Cahill) and the Judge was clearly pleased to hear argument from one of the lions of the First Amendment bar. Ellen London for the FDA was somewhat dreadful. She mumbled her way through the argument, making it impossible for the Court reporter to understand her on numerous occasions.
Judge clearly has a different view of Caronia than that of the FDA. Judge also had issue with the FDA's treatment of OTC Omega-3's vs Vascepa. Judge to FDA: 'This is an unusual case in that the most contested disclosure regarding 'supportive but not conclusive evidence supports the fact that EPA may reduce cardiovascular risk' is one that the FDA has otherwise embraced" The Judge did not buy the FDA's attempt to distinguish the "truthful and misleading" nature of each statement based on context. Judge also didn't buy why something stated in a report or scientific paper or print publication was truthful and misleading, but not when discussed or disseminated orally.
Judge said to the FDA,'you have been inviting Amarin to market the drug as OTC, where they could make the claim about "substantial but not conclusive" evidence of reduction in cardio-vascular events. Let's assume that Amarin did that for the Anchor population, but continued to market Vascepa as a prescribed drug for Marine. So you would have the exact same drug for two different indications. Why should the statement be considered truthful and not misleading in one context and not in the other? The FDA didn't have a good answer.
At the end of the day, the Judge wanted to hear specifics about how he could fashion relief. he was particularly focused on other proposed claims and tweaks set forth in the Ketchum Reply Affidavit at paragraphs 22, 25. When the Court spends that much time on those specifics, he is going to issue an injunction and is just considering the wording.
The Judge complemented the parties on their "superb" briefing of the issues, but you had to believe he was mostly congratulating Amarin's team. The Judge was smart as a tack, knew the record and knew his First Amendment law. At the end, Floyd Abrams had more time to argue, but basically said "nothing further." I think he knew there was no need for anything further.
AI
