Amarin's Off-Label Victory Opens Door To More Injury Claims

Law360, New York (August 10, 2015, 9:26 PM EDT) -- Amarin Pharma Inc.'s landmark win in its New York federal suit against the U.S. Food and Drug Administration upholds drugmakers' right to truthfully promote their products' unapproved uses, but attorneys say this expanded marketing can inadvertently supply more fodder — without the FDA's imprimatur — for failure-to-warn lawsuits.

Amarin won a preliminary injunction Friday against the agency's increasingly controversial ban on drugmakers' ability to promote their drugs for unapproved, or off-label, uses. The Ireland-based drugmaker sought to promote its fish oil-based omega-3 drug Vascepa for patients with lower levels of triglycerides, fatty molecules linked to heart problems, than the group for...

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