ACell to pay $15 million to resolve US allegations over MicroMatrix powder wound dressing product

ACell announced that it reached final settlement agreements with the US Attorney's Office for the District of Maryland and three US states to resolve all civil and criminal allegations relating to the sales and marketing of the company's MicroMatrix powder wound dressing product. Under the agreements, ACell will pay $3 million to resolve the criminal allegations and $12 million to resolve the civil claims, over the course of five years, to the US Department of Justice and the states.  

Under the criminal case, ACell pleaded guilty to one misdemeanor count of failure to report a medical device removal in 2012 in violation of the Federal Food, Drug, and Cosmetic Act. According to the Department of Justice, while ACell removed MicroMatrix from its point of use in 2012 to reduce a risk to health posed by endotoxin contamination of the product, the company failed to report the removal to the FDA. "ACell also admitted that it concealed the reason for the product removal from doctors, hospitals, and the company’s own sales force, and did not notify doctors who had already used MicroMatrix devices from the lots subject to removal of the elevated endotoxin levels," the Department of Justice said. 

In addition, ACell agreed to settle allegations that it caused false claims to be submitted to federal health care programmes for MicroMatrix. According to the Department of Justice, from 2011, ACell's marketing of MicroMatrix was "false and misleading" as sales representatives stated to physicians that the use of MicroMatrix powder, which is indicated for the treatment of topical wounds, non-topically and internally was safe and effective, "when the sales representatives knew that no such clinical data existed." Additionally, the Department of Justice alleged that from March 2012, the company provided coding recommendations to healthcare providers for its devices that were "incorrect and improperly inflated reimbursement from Medicare," and continued to provide this misinformation after two separate coding consultants advised ACell that it was incorrect. Finally, ACell induced prescribers to order ACell products by providing improper inducements, the Department of Justice contended.

In response to the settlements, Patrick McBrayer, ACell's CEO, remarked that "we look forward to putting this matter behind us. We are focused on moving forward with positive momentum and growth." The company noted that the activities investigated "occurred many years ago, when ACell was headed by a different management team," adding that "except to the extent admitted in ACell's guilty plea, ACell does not admit liability or wrongdoing."