Maryland – ACell Inc. (ACell), a Maryland-based medical device manufacturer, pleaded guilty to charges relating to its MicroMatrix powder wound dressing product (MicroMatrix), the Department of Justice announced today. ACell entered a guilty plea before U.S. District Court Judge Ellen L. Hollander in the District of Maryland to one misdemeanor count of failure and refusal to report a medical device removal in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). In addition, ACell has agreed to settle allegations that it caused false claims to be submitted to federal health care programs for MicroMatrix, and to pay $15 million to resolve its criminal and civil liability arising from these matters.
“Today’s settlement underscores the Department of Justice’s commitment to holding device manufacturers accountable for ensuring that their products are safe, which includes making timely notifications to the FDA when a product recall is required,” said Assistant Attorney General Jody Hunt of the Civil Division.
“When companies use contaminated materials to manufacture devices and fail to notify the FDA of recalls of their products due to concerns of patient safety, they undermine the integrity of the FDA recall process and may cause patients to receive devices that are not safe,” said U.S. Attorney for the District of Maryland Robert K. Hur. “This joint criminal and civil resolution holds ACell accountable for this violation while returning dollars back to the Medicare program for false claims.”
“The FDA will not tolerate the actions of companies that put patients at risk by failing to report the market withdrawal of their medical devices to the FDA,” said Acting FDA Commissioner Ned Sharpless, M.D. “By not notifying the FDA nor being forthcoming about their reasons for the product removal, ACell executives placed profit above patient safety. They risked that doctors would use the devices in procedures that could jeopardize patient health, and violated both the trust of patients and the medical community in their medical device. We will continue to investigate and bring to justice companies that do not follow FDA’s postmarket compliance requirements, which are important to ensure the protection of the public health.”
Along with the civil settlement, ACell entered into a Corporate Integrity Agreement (CIA) with the HHS-OIG. The five-year CIA requires, among other things, the implementation of a risk assessment and internal review process designed to identify and address evolving compliance risks on an ongoing basis. In addition, the CIA enhances individual accountability by requiring sign-off certifications from the ACell Board of Directors and specified executives. The CIA requires training, auditing, and monitoring designed to address the range of activities (promotional and otherwise) at issue in the case.
Access full press release.