ACell Inc. (ACell), a Maryland medical device manufacturer, has pleaded guilty to charges relating to its MicroMatrix Powder Wound Dressing (MicroMatrix) product, as announced today by the Department of Justice. ACell pleaded guilty to a plea before U.S. District Court Judge Ellen L. Hollander in the Maryland District department on a charge of failure and failure to report a removal of medical equipment in violation of the Federal Food, Drugs and Cosmetics Act (FDCA). In addition, ACell agreed to clarify allegations that it led to false allegations about federal health-related programs for MicroMatrix and to pay $15 million to resolve its criminal and civil liability arising from these cases. BALTIMORE (WJZ) — ACell, Inc. (ACell), a Maryland-based medical device manufacturer, pleaded guilty to pleading guilty to its MicroMatrix powder product. About ACell, Inc. ACell, Inc. is a leading regenerative medicine company focused on the design, manufacture and marketing of medical devices for wound management and surgical soft tissue repair.
ACell`s mission is to become and remain an innovative leader in regenerative medical technology, which offers physicians and patients excellent healing opportunities. ACell is a private company that operates production plants in Columbia, MD and Lafayette, IN. For more information about ACell, see www.acell.com. View original content:www.prnewswire.com/news-releases/acell-reaches-final-agreement-with-us-government-300865932.html A whistleblower action against ACell Inc., Maker of the MicroMatrix Wunddressing product, ended up with an admission of guilt from the company before the U.S. District Court for the District of Maryland, according to the U.S. Department of Justice. The admission of guilt relates to a charge of failure and refusal to report the removal of medical devices in violation of the Federal Food Drug and Cosmetic Act (FDCA). As part of the plea, ACell will pay $3 million and stick to “extensive compliance reforms.” As part of the civil transaction, it will pay US$12 million over five years to resolve civil liability for alleged false claims made to Medicare. As part of the plea, ACell agreed to pay a $3 million fine. ACell must also stick to an agreement with the Department of Justice that commits ACell to undertake comprehensive compliance reforms. As indicated by a woundsource.com, MicroMatrix is ideally an extracellular sterile mixture of collagen derived from pigs and supporting wound healing.
The reasons for the removal of the products, in the case of the contaminated versions, would not have been explained to the doctors, medical centres or even the company`s own sellers. The most important, says the DOJ, is the informal recall and the justification has been hidden from the FDA. ACell will pay a $3 million fine for this alleged covert activity. In addition to the admission of guilt, the whistleblowers` complaint resulted in an agreement to respond to the charges against ACell regarding the filing of false allegations against state medical programs for MicroMatrix. The company will pay $12 million to resolve these criminal and civil charges. Apart from the practices admitted in the context of the admission of guilt, the claims resolved in connection with the civil transaction are merely allegations and no evidence of liability has been taken. ACell agreed to plead guilty because it did not report the removal of medical devices in 2012. ACell also entered into a separate civil settlement False Claims Act that resolves the DOJ`s civil claims and state rights. Under the agreements, ACell will pay a total of $15 million to the Department of Justice and the States over a five-year period. ACell also entered into a company integrity agreement with the Inspector General for a five-year term. ACell fully cooperated with the government in the process that led to the agreement.
The company will continue to cooperate with its regulators.