Systems Agrees, Resolve False Claims Act, Allegations Related — Aesculap Implant Systems Agrees to Pay $38.5M to Resolve False Claims Act Allegations Related to Knee Implant Failures and Enters into a Non-Prosecution Agreement Related to the Introduction of Two Adulterated Medical Devices into Interstate Commerce | United States Justice Department.
The employee previously pleaded guilty to violating the FDCA and was sentenced to prison.The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by John Marien and Michael McGee, who served as third-party distributors for Aesculap. “The Department will hold accountable medical device companies that knowingly sell products prone to failure that present risks to patients and waste taxpayer dollars.”“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,” said U.S. 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.”“Transparency in medical device marketing is essential to safeguarding patient care,” said Deputy Inspector General for Investigations Christian J. HHS-OIG will continue to work with our law enforcement partners to uncover and dismantle illegal arrangements that exploit the Medicare system for financial gain at the expense of patients.”“Certain medical devices require FDA notification and clearance before distribution to the public,” said
Acting Special Agent in Charge Ronald Dawkins of the FDA Metro Washington Field Office. Marien and McGee will receive a share totaling $4,475,000 in connection with the settlement.The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section; the Civil Division’s Enforcement and Affirmative Litigation Branch; and the U.S. Attorney’s Office for the Eastern District of Pennsylvania with assistance from HHS-OIG and FDA’s Office of the Chief Counsel and FDA-OCI.The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare