Ninth Circuit Affirms Conviction in Harkonen, Rejects the Defendant’s “Off-Label” First Amendment Challenge

March 12, 2013

On March 4, 2013, a panel of the United States Court of Appeals for the Ninth Circuit issued its opinion in United States v. Harkonen, a case in which the CEO of a pharmaceutical company was prosecuted for transmitting allegedly false and misleading information about the effectiveness of one of the company’s products as an “off-label” treatment. The Ninth Circuit case attracted attention because one of the CEO’s defenses to the criminal charges was a First Amendment challenge – namely, that the statements that served as the factual basis for the charges brought against him were constitutionally protected speech about the off-label uses of a prescription medication. Oral argument in the case took place only days after a divided panel of the United States Court of Appeals for the Second Circuit issued its dramatic decision in United States v. Caronia, where that court held that neither drug companies nor their representatives could be criminally prosecuted for the truthful promotion of off-label uses. The Harkonen trial court had rejected the defendant’s First Amendment challenges to the legal sufficiency of the charges and a jury ultimately found him guilty of wire fraud. The Ninth Circuit affirmed the conviction in an unpublished per curiam opinion, and in the process also rejected the defendant’s First Amendment arguments. This Dechert OnPoint focuses on the Ninth Circuit’s First Amendment reasoning and on what, if anything, this new appellate decision adds to the continuing debate over whether, and how much the First Amendment protects the marketing and promotion of prescription drugs for “off-label” uses.

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