BALTIMORE (WJZ) — ACell, Inc. (ACell) a Maryland-based medical device manufacturer, pleaded guilty to charges relating to its MicroMatrix powder wound-dressing product.
ACell entered a guilty plea 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). ACell has also 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 the matters.
As charged in a criminal information unsealed on Tuesday, ACell removed MicroMatrix from its point of use to reduce a risk to health posed by the device, but failed to report the removal to the Food and Drug Administration (FDA).
The United States alleges that in 2012, ACell clandestinely removed its MicroMatrix devices from sales representative inventories, hospitals and other healthcare centers due to a risk to patient health posed by endotoxin contamination of those devices.
Endotoxin exposure on the human body can cause fever, infection, septic shock and death.
ACell admitted that it learned in January 2012 that more than 30,000 MicroMatrix devices were contaminated with endotoxin levels that posed a risk to patient health. Due to that health risk, ACell initiated removal of certain sizes of MicroMatrix devices from the market.
ACell admitted that it did not report the removal of these devices from the market to 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.
Under the terms of the plea agreement, ACell agreed to pay a criminal fine of $3 million. ACell must also abide by an agreement with the Department of Justice requiring ACell to enact extensive compliance reforms.