Exactech Inc. agreed to pay $8 million to resolve allegations that the company violated the federal False Claims Act. A medical device company based in Gainesville, Florida, Exactech allegedly violated the False Claims Act by knowingly submitting or causing the submission of false claims for payment to Medicare, Medicaid, and the United States Department of Veterans Affairs (VA) in connection with defective knee-replacement devices. This settlement relates to two separate components of Exactech’s total-knee replacement systems. First, the settlement resolves allegations that as early as January 2008, Exactech knew that its finned tibial tray — a metal component of its knee replacement system that fits into a patient’s tibia — failed prematurely at a higher than acceptable rate. Therefore, it was not reasonable and necessary for use during total-knee replacement surgeries performed on Medicare, Medicaid, and VA beneficiaries. But Exactech continued to market and sell the component for surgeries between January 1, 2008, and December 31, 2018.
Additionally, the settlement resolves allegations that as early as January 2019, Exactech knew that the polyethylene component in certain Logic and Truliant knee-replacement systems failed prematurely at a higher than acceptable rate. Therefore, it was not reasonable and necessary for use during total-knee replacement surgeries performed on government beneficiaries. But Exactech continued to market and sell the Logic and Truliant knee systems with defective polyethylene components for use during total-knee replacement surgeries between January 1, 2019, and February 7, 2022.