ACell Pays $15M to Resolve Probe Into Failing to Notify FDA of a Market Withdrawal

Regulatory NewsRegulatory News | 12 June 2019 |  By 

The US Department of Justice (DOJ) closed its probe into a devicemaker’s failure to inform the US Food and Drug Administration (FDA) it had withdrawn its powder wound dressing product from the market.

ACell pleaded guilty to charges related to its MicroMatrix device and will pay $15 million. The guilty plea charges the Maryland-based devicemaker with one misdemeanor count of failure and refusal to report its 2012 medical device removal, court filings show.

A separate settlement resolves the allegation that ACell submitted false claims to federal health care programs for MicroMatrix, beginning in 2011. ACell also entered into a five-year Corporate Integrity Agreement with the US Department of Health and Human Services’ Office of Inspector General.

The agreement “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 FDA when a product recall is required,” said Assistant Attorney General Jody Hunt at the DOJ’s Civil Division.

The case was brought against ACell by a former employee who alleged that the company acted in violation of the law when it pulled MicroMatrix from the market in 2012 over a health risk and failed to report the removal to FDA.

Acting FDA Commissioner Ned Sharpless said: “FDA will not tolerate the actions of companies that put patients at risk by failing to report the market withdrawal. By not notifying the FDA nor being forthcoming about their reasons for the product removal, ACell executives placed profit above patient safety.”

ACell issued a statement Wednesday saying that the activities at issue in the DOJ’s investigation “occurred many years ago, when ACell was headed by a different management team.”



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