Whistleblower Suit Triggered Years-Long Investigation
The dispute traces back to 2017, when two distributors of Aesculap orthopedic devices filed a whistleblower suit on behalf of federal and state governments. Their complaint alleged that as early as December 2013, the company knew the VEGA System implant was failing to properly adhere to bone cement, causing hardware to loosen and forcing patients into revision surgeries.
The relators reported receiving surgeon complaints, but say Aesculap either failed to submit adverse event reports to the FDA or sent reports containing incorrect information. According to the suit, Aesculap sought permission from B. Braun to modify the implant to fix the problem but was denied.
B. Braun did not immediately respond Monday to questions regarding those allegations.
Federal Intervention: False Claims and Kickback Concerns
Upon stepping into the case, the U.S. government alleged that from 2010 to 2023, Aesculap continued marketing and selling implants it knew would fail at higher-than-acceptable rates — rendering them neither “reasonable nor necessary” for knee replacement surgeries and thus producing false claims to federal healthcare programs.
Prosecutors also claim the subsidiary violated the Anti-Kickback Statute, alleging it provided an orthopedic surgeon experiencing complications with the implant free international travel and other improper benefits to encourage continued recommendations.
