The U.S. Justice Dept. (DOJ) announced that B. Braun subsidiary Aesculap agreed to pay $38.5 million to resolve allegations under the False Claims Act.
Aesculap faced allegations that it sold knee replacement devices that it new would fail prematurely at a higher-than-acceptable rate. This resulted in false claims to Medicare and Medicaid, the DOJ said. According to the DOJ, the settlement also resolves allegations that the company paid unlawful remuneration to a physician to induce him to use the implants.
Finally, Aesculap agreed to a non-prosecution agreement with the U.S. This relates to its distribution of two medical devices without the required FDA clearance.
The DOJ said the settlement resolves allegations that span from July 30, 2010, to June 17, 2023. It alleges that Aesculap sold the VEGA knee system, a line of prosthetic knee implants, “while knowing that it would fail prematurely at a higher than acceptable rate.” This rendered the device “not reasonable and necessary” for use in these procedures.
“Medical device failures — and their potential to harm patients — are of paramount concern to the Department of Justice,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “The Department will hold accountable medical device companies that knowingly sell products prone to failure that present risks to patients and waste taxpayer dollars.”
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