Dive Brief:

• Orthopedics firm Exactech has agreed to pay an $8 million settlement to resolve allegations that the company violated the federal False Claims Act by knowingly selling defective knee implants, the U.S. Attorney’s Office for the District of Maryland said Tuesday.
• The settlement addresses allegations that Exactech knew two components of its total knee replacement systems failed prematurely at a higher than acceptable rate, yet the company still sold the devices. Exactech submitted claims for payment to Medicare, Medicaid and the U.S. Department of Veterans Affairs in connection with the defective implants, according to the allegations.
• The settlement follows several other regulatory actions related to Exactech’s implants. Exactech received a warning letter from the Food and Drug Administration last year due to packaging problems with shoulder implants. The company filed for Chapter 11 bankruptcy, facing product liability claims brought by around 2,600 patients, and is in the process of selling to an investor group.

Dive Insight:

The U.S. Bankruptcy Court for the District of Delaware approved the settlement as part of Exactech’s Chapter 11 bankruptcy proceedings. Kelly Hayes, U.S. attorney for the District of Maryland, and Prim Escalona, U.S. attorney for the Northern District of Alabama, announced the settlement.

“Patients who need a medical device to enjoy their lives rely on device manufacturers to put patient safety first. When a manufacturer learns that...

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