Acclarent, a subsidiary of giant corporation Johnson & Johnson, paid out $18 million to settle complaints that the company sold a medical device without approval from the US Food and Drugs Administration (FDA), which then led health care providers to submit dishonest claims to Medicare and other government healthcare programs.
According to a statement from the federal Justice Government, a saleswoman for Acclarent named Melayna Lokosky, filed a whistleblower lawsuit against Acclarent and two of its senior executives, UPI reports.
Court documents demonstrate that managers at Acclarent ordered the sales staff to market the company’s Stratus device as a drug delivery system. The FDA had only approved the device for use in keeping an opening in the sinus open immediately after surgery.
Acclarent had initially asked for FDA approval in 2007 to expand uses for the Stratus, but was denied. According to the court documents, the company went on to market the device despite not having been approved. Its FDA-approved technology includes the Relieva Balloon Sinuplasty systems, which are used by otalaryngologists to dilate sinuses.
Lokosky is set to receive $3.5 million, plus legal expenses and interest.
Johnson & Johnson acquired Acclarent in 2010. A spokesperson for the corporation said that since the suit, tighter compliance rules have been enacted and said that the allegation took place before Johnson & Johnson took over the company.
The Silicon Valley-based Acclarent is a company that manufactures medical devices, particularly for the Ear, Nose and Throat field. Founded in 2004, it has more than 300 employees and operates in about 45 countries worldwide, and is funded by several venture partners. Its mission is to create “minimally invasive ENT technologies that relieve suffering as effectively and painlessly as possible.” It partners with physicians and experts in producing advanced medical devices, conducting research and development programs towards this goal.