Lehigh Valley medical device maker settles lawsuit over faulty equipment for nearly $40 million

An Upper Saucon Township company that specializes in surgical equipment will pay $38. 5 million to settle allegations under the False Claims Act, U. S. Attorney David Metcalf and the Justice Department announced Monday. Aesculap Implant Systems LLC, a subsidiary of B. Braun, allegedly sold knee replacement devices that it knew would fail prematurely at a higher-than-acceptable rate, resulting in false claims to Medicare and Medicaid. “Doctors who implant medical devices need complete and accurate information about those devices to ensure they choose the best and safest options for their patients,” Metcalf said. “A company that knows its product has a propensity to prematurely fail must not mislead doctors or government regulators or conceal material information about those known issues. Medicare and other federal programs should not be required to pay charges for devices that are unduly risky, and that may require painful and expensive surgeries to fix.” In its own news release, Aesculap said it “is grateful to the DOJ’s Civil Division leadership and the United States Attorney’s Office for the Eastern District of Pennsylvania for bringing closure to these long-pending matters.” The U. S. attorney also said the settlement further resolves allegations that the company paid unlawful remuneration to a physician to induce him to use the Vega System knee implants. The government alleged that Vega was prone to becoming loose from a patient’s bone prematurely, often shortly after surgery. Patients experiencing loosening could have pain, instability and difficulty walking, and such patients required a revision surgery to remove and replace the Vega implant. The United States alleged that Aesculap knew shortly after Vega was released in the United States that bone cement did not properly adhere to the implant. In addition to the civil settlement, Aesculap agreed to enter into a nonprosecution agreement related to the introduction of two medical devices into interstate commerce in violation of the Food, Drug and Cosmetic Act from March 2017 until August 2017. The two devices were the ELAN-4 Air Drill, a high-speed surgical drill used for bone cutting, sawing and drilling, and the JS Series SterilContainer S2, a reusable sterilization container for medical instruments. According to the agreement, Aesculap tasked an employee with shepherding both medical devices through the FDA clearance process, but the employee never submitted any documentation to FDA. Aesculap said it promptly notified the FDA, terminated the employee, initiated a recall and fully reimbursed all purchasers. AIS subsequently obtained FDA clearance for both devices. No patient harm was reported. The company was recognized by the court as the victim of the fraud.
https://www.mcall.com/2025/11/17/lehigh-valley-medical-device-maker-settles-lawsuit-over-faulty-equipment-for-nearly-40-million/