Ex-Execs Say 1st Amendment Protects Off-Label Promotion

By Brian Amaral (June 1, 2016, 4:49 PM EDT) -- Attorneys for two medical device executives told a Massachusetts federal judge at a pretrial hearing Wednesday that true statements promoting medical devices off-label can't be used to prove violations of federal law because they're protected by the First Amendment.

Former Acclarent CEO William Facteau and former company vice president Patrick Fabian are set to go on trial next week on charges of conspiracy, securities fraud, wire fraud and introducing adulterated or misbranded medical devices into interstate commerce. Prosecutors said they got Food and Drug Administration approval of a device called Stratus to be used as a sinus spacer, but then mostly...

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