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

ACell Inc., a Maryland-based medical device manufacturer, pleaded guilty to charges relating to its MicroMatrix powder wound dressing product, the Department of Justice announced today. 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 . 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 civil settlement resolves a lawsuit filed by John Murtaugh, a former employee of ACell, under the qui tam or whistleblower provisions of the False Claims Act, which permit private individuals, known as relators, to sue on behalf of the government for false claims and to share in any recovery. read more »

FAA says has no timetable for Boeing 737 MAX's return to service

The Federal Aviation Administration said on Wednesday it does not have a specific timetable on when Boeing Co’s troubled 737 MAX jet would return to service after two fatal crashes led to the airplane’s worldwide grounding in March.

FAA spokesman Greg Martin said the agency has “no timetable” for allowing the 737 MAX to resume flying and will act “only when it is safe to return to service”. read more »

The opioid tracking group with Big Pharma ties

A small yet influential group called Researched Abuse, Diversion and Addiction-Related Surveillance, or RADARS, monitors how opioids are misused across the nation. It also accepts money from the companies that make those opioids.

Why it matters: Health care experts view RADARS as a credible, independent resource, but its ties to the pharmaceutical industry raise questions about how the group operates. read more »

Former Co-Owner of L.A. Home Health Agency Gets 10 Years for Medicare Scam

The former co-owner of a Los Angeles home health agency was sentenced Monday to 10 years behind bars for participating in a $22 million Medicare fraud scheme. read more »