FCA Free Speech Defense Tested In DOJ-PhRMA Fight

Law360, New York (September 19, 2014, 2:24 PM EDT) -- A fiery feud in California federal court between the U.S. Department of Justice and Pharmaceutical Research and Manufacturers of America shows the gloves are finally off in a fight that will shape the future of False Claims Act litigation, experts say, with opposing sides clashing over whether the First Amendment always shields honest off-label promotion.

The battle playing out in recent weeks in Solis v. Millennium comes almost two years after the Second Circuit’s monumental Caronia ruling, which erased a pharmaceutical salesman’s misbranding conviction after finding he’d been prosecuted for truthful speech, not separate conduct related to his speech.

That decision raised doubts...

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