Devices

Exactech Pays $8 Million in Whistleblower Cases

The Justice Department says that Exactech, a Gainesville, FL, medical device company, has agreed to pay $8 million to resolve allegations brought by four whistleblowers that the company violated the False Claims Act in connection with defective knee replacement devices. A department statement says the settlement relates to two separate components of the company’s total knee replacement systems.

First, it says, the settlement resolves allegations that as early as 1/2008, the company knew that its finned tibia tray failed prematurely at a higher than expected rate and thus was not reasonable and necessary for use during total knee replacement surgeries performed on Medicare, Medicaid, and Veterans Administration beneficiaries. The department says Exactech continued to sell the component for another 10 years.

Second, it says, the settlement resolves allegations that as early as 1/2019, the company knew that the polyethylene component in certain Logic and Truliant knee replacement systems failed prematurely at a higher than accepted rate and thus also was not reasonable and necessary for use during total knee replacement surgeries performed on government beneficiaries. The government says the company continued to sell the component for three years.

Of the $8 million settlement, $7,640,000 is the federal share, and $360,000 is the share for states (Alabama and Maryland) that are entering into separate agreements with the company.

The False Claims Act action was filed by three whistleblowers in Alabama and one in Maryland. The Alabama whistleblowers will receive a $1,329,360 share of the settlement, and the Maryland whistleblower will receive $565,360.

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