Johnson & Johnson subsidiary Acclarent will pay $18 million to resolve false claims allegations related to its sinus spacer product.
The DOJ alleged that the company caused healthcare providers to submit false claims to Medicare by marketing and distributing the drug-delivery device without FDA approval.
Acclarent markets devices used in sinus surgeries, including the Relieva Sratus MicroFlow Spacer. The FDA cleared the company to market the device with saline to keep sinuses open following surgery.
But the DOJ alleged that Acclarent used the product as a drug-delivery device for corticosteroids.
Moreover, Acclarent marketed the Stratus as a drug-delivery device even after the FDA rejected the company’s 2007 request to expand the approved uses, the DOJ said, noting that “Acclarent employees trained physicians using a video that demonstrated the Stratus being used with prescription corticosteroid Kenalog-40.”
In May 2013, Acclarent discontinued all sales of the Stratus in the U.S., and the company agreed to withdraw FDA marketing clearances.
Former Acclarent CEO William Facteau and former sales VP Patrick Fabian were convicted of 10 misdemeanor counts of introducing adulterated and misbranded devices into interstate commerce, the DOJ said.
The civil settlement resolves a lawsuit filed under the whistleblower provision of the False Claims Act filed in the District of Massachusetts.
J&J told IDDM that this was a civil-only resolution, “with no admission of any liability, or wrongdoing. The alleged conduct took place almost entirely prior to the acquisition of Acclarent in 2010 and immediately after the acquisition, Johnson & Johnson introduced numerous compliance changes to Acclarent.” — Tamra Sami