June 27, 2016
A doctor who helps oversee approval of medical devices for the U.S. Food and Drug Administration told a federal jury in Boston on Monday that within months of an Acclarent device's approval in 2006, the company came back to expand on its use — raising concerns among regulators in Washington.
June 20, 2016
Two former Acclarent executives on Monday asked the federal judge overseeing their off-label promotion fraud trial in Boston to "admonish" government lawyers "with increasing sternness" about what they view as hearsay testimony and forays into areas previously ruled out of bounds.
June 13, 2016
Acclarent Inc. employees developed plans to tell doctors about the benefits of a sinus-clearing device, even after the company agreed to stop promoting it amid questions about its safety and efficacy, a company sales representative testified Monday in Massachusetts federal court in the fraud trial of two former executives.
June 09, 2016
A former Acclarent sales representative testified Thursday that when she started working there in 2008, the focus of her training and her sales pitch was on the off-label use of a new device that is now the focus of the fraud trial of two company executives in Massachusetts federal court.
June 08, 2016
An ear, nose and throat specialist told a Massachusetts federal jury Wednesday at the fraud trial of two Acclarent Inc. executives that he repeatedly raised concerns about the company's marketing of a new medical device, saying it differed from its FDA-approved label.
June 07, 2016
Former executives of Johnson & Johnson subsidiary Acclarent Inc. told a Massachusetts federal jury Tuesday that the real impetus for their trial on fraud charges is a government desire to crack down on off-label promotion, saying opaque and contradictory rules on off-label medical devices combined with bureaucratic infighting to hinder innovation.
June 01, 2016
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.
April 13, 2015
The former CEO and vice president of sales of Acclarent Inc., a company sold to Johnson & Johnson in 2010, were charged with securities fraud in connection with the allegedly illegal marketing of a medical device in order to drive up the company's valuation ahead of a buyout, federal prosecutors said Friday.