Criminal Law

Wound Care Co. Pays $15M, Admits Contamination Cover-Up

ACell, Inc., a Maryland-based medical device manufacturer, pleaded guilty to charges relating to its MicroMatrix powder wound-dressing product.

The company 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 . 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).

Read the source article at U.S. Department of Justice

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