California-based medical device manufacturer Acclarent Inc., a subsidiary of Johnson & Johnson, agreed to pay $18 million to resolve allegations it violated the False Claims Act by causing health care providers to submit false claims to Medicare and other federal health care programs by marketing and distributing its sinus spacer product known as the Relieva Stratus MicroFlow Spacer (Stratus) for use as a drug delivery device without FDA approval of that use. The government further alleged that Acclarent 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. On July 20, Acclarent’s former CEO William Facteau and former VP of Sales Patrick Fabian were convicted of introducing adulterated and misbranded medical devices into interstate commerce. The allegations originated in a whistleblower lawsuit filed by Melayna Lokosky under the qui tam provisions of the False Claims Act. The whistleblower will receive an award of roughly $3.5 million from the proceeds of the government’s recovery. DOJ
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