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...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!