Johnson & Johnson’s subsidiary Acclarent, paid $18 million to resolve allegations the company marketed a medical device without FDA approval, which led health care providers to submit false claims to Medicare and other federal healthcare programs.
According to a statement from the Justice Department, Melayna Lokosky, a saleswoman for Acclarent, filed a whistleblower suit against the company and two if its senior executives.
Court documents show managers at Acclarent directed the sales staff to market the company’s Stratus device as a drug delivery device. The Food and Drug Administration had only cleared the device to maintain an opening to the sinus immediately after surgery.
Acclarent had first sought approval to expand approved uses for the Stratus in 2007, but was denied by the FDA. Court documents show Acclarent continued to market the device despite it not being regulated.
For her role in the suit, Lokosky will receive $3.5 million, plus legal expenses and interest.
Johnson & Johnson acquired Acclarent in 2010. A spokeswoman for the company said tighter compliance controls have since been put in place and noted the alleged misconduct took place before the acquisition.