A settlement reached to resolve False Claims Act Allegations against Johnson & Johnson Subsidiary Acclarent Inc.
The whistleblowers' share of the settlement will be approximately $3.5 million.
The allegations arose by a lawsuit claiming Acclarent Inc, caused health care providers to submit false claims to Medicare and other federal health care programs by marketing and distributing its sinus spacer product for use as a drug delivery device without U.S. Food and Drug Administration approval of that use.
On July 22, 2016, the Justice Department announced, that Acclarent sold a variety of medical devices used in sinus surgeries, including a device known as the Relieva Stratus MicroFlow Spacer (Stratus). In 2006, Acclarent received FDA clearance to market the Stratus as a spacer to be used only with saline to maintain sinus openings following surgery. Allegedly, Acclarent intended for the Stratus to be used instead as a drug-delivery device for prescription corticosteroids, including Kenalog-40, and that the device was specifically designed and engineered for this use.
Also, Acclarent allegedly marketed the Stratus as a drug delivery device even after the FDA rejected the company’s 2007 request to expand the approved uses for the Stratus.
Acclarent added a warning to its label regarding use of active drug substances in the Stratus in 2010, but continued to market the Stratus for drug delivery. By May 2013, Acclarent discontinued all sales of the Stratus and the company agreed to withdraw all FDA marketing clearances for the device.
On July 20th 2016, Acclarent’s former CEO and former Vice President of Sales were convicted of 10 misdemeanor counts of introducing adulterated and misbranded medical devices into interstate commerce.
