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. — Tamra Sami