Medical Device Maker ACell, Inc. Pleads Guilty And Will Pay $15 Million To Resolve Criminal Charges

[TexasTowelie]

Medical Device Maker ACell, Inc. Pleads Guilty And Will Pay $15 Million To Resolve Criminal Charges And Civil False Claims Allegations


Baltimore, Maryland – ACell, Inc. (ACell), a Maryland-based medical device manufacturer, pleaded guilty to charges relating to its MicroMatrix powder wound-dressing product (MicroMatrix). ACell entered a guilty plea before U.S. District Court Judge Ellen L. Hollander in the District of Maryland 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). In addition, ACell has 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 these matters.

The guilty plea and settlement were announced by United States Attorney for the District of Robert K. Hur; Assistant Attorney General Joseph H. Hunt of the Justice Department’s Civil Division; Special Agent in Charge Maureen Dixon, Office of Investigations, Office of Inspector General of the Department of Health and Human Services; Special Agent in Charge Mark S. McCormack of the U.S. Food & Drug Administration, Office of Criminal Investigations’ Metro Washington Field Office; Special Agent in Charge Jennifer C. Boone of the Federal Bureau of Investigation, Baltimore Field Office; and Special Agent in Charge Robert E. Craig, Jr. of the Defense Criminal Investigative Service - Mid-Atlantic Field Office.

“When companies use contaminated materials to manufacture devices and fail to notify the FDA of recalls of their products due to concerns of patient safety, they undermine the integrity of the FDA recall process and may cause patients to receive devices that are not safe,” said U.S. Attorney for the District of Maryland Robert K. Hur. “This joint criminal and civil resolution holds ACell accountable for this violation while returning dollars back to the Medicare program for false claims.”

“Today’s settlement underscores the Department’s commitment to holding device manufacturers accountable for ensuring that their products are safe, which includes making timely notifications to the FDA when a product recall is required,” said Assistant Attorney General Joseph H. Hunt of the Department of Justice.

Read more: https://www.justice.gov/usao-md/pr/medical-device-maker-acell-inc-pleads-guilty-and-will-pay-15-million-resolve-criminal