Exactech has agreed to pay $8 million to resolve allegations that the orthopedic device company violated the federal False Claims Act.
The U.S. Attorney’s Office, District of Maryland, said in a news release that Exactech allegedly violated the False Claims Act by knowingly submitting or causing the submission of false claims for payments to Medicare, Medicaid and the U.S. Dept. of Veterans Affairs (VA) in connection with defective knee replacement devices.
This settlement approval came as part of the company’s Chapter 11 bankruptcy proceedings. Exactech said earlier this week that it received court confirmation of its restructuring plan and approval of the sale of its assets.
Kelly O. Hayes, U.S. Attorney for the District of Maryland, announced the settlement with Prim F. Escalona, U.S. Attorney for the Northern District of Alabama.
The settlement relates to two separate components of Exactech’s total-knee replacement systems. It first resolves allegations of premature failure of the company’s finned fibial tray. The component of the knee replacement system allegedly failed prematurely at a higher-than-acceptable rate. According to the attorneys, the allegations state that Exactech knew of this issue as early as January 2008.
Because of this failure rate, it was deemed not reasonable and necessary for use during surgeries performed on Medicare, Medicaid and VA beneficiaries. However, the attorneys says the company continued to market and sell the component between Jan....
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