ACell Inc. Pays $15 Million for Deadly Device Cover-Up

Baltimore, Maryland – ACell, Inc., a Maryland-based medical device manufacturer, has admitted guilt and will shell out a hefty $15 million to resolve both criminal charges and civil allegations of false claims. The company pleaded guilty to one misdemeanor count of failure to report a medical device removal – a blatant violation of the Federal Food, Drug, and Cosmetic Act (FDCA). This isn’t just about paperwork; it’s about potentially putting patients at risk.

The Justice Department, led by U.S. Attorney for the District of Maryland Robert K. Hur and Assistant Attorney General Joseph H. Hunt, along with a multi-agency task force including the HHS Office of Inspector General, the FDA’s Office of Criminal Investigations, the FBI, and the Defense Criminal Investigative Service, announced the settlement. “When companies use contaminated materials and fail to notify the FDA of recalls due to patient safety concerns, they undermine the integrity of the entire system,” Hur stated bluntly. “This resolution holds ACell accountable and returns money to the Medicare program for false claims.”

The core of the case revolves around ACell’s MicroMatrix powder wound-dressing product. Back in 2012, the company discovered over 30,000 MicroMatrix devices were contaminated with dangerous levels of endotoxin – a substance that can cause fever, infection, septic shock, and even death. Instead of immediately alerting the FDA and healthcare professionals, ACell allegedly launched a clandestine removal of the tainted devices from sales representative inventories, hospitals, and healthcare centers. They didn’t just remove the devices; they actively concealed the reason, keeping doctors, hospitals, and even their own sales force in the dark.

According to the criminal information unsealed today, ACell didn’t report the removal to the FDA, and crucially, failed to notify doctors who had already used the contaminated MicroMatrix devices. This wasn’t a simple mistake; it was a calculated decision to protect the company’s bottom line at the expense of patient safety. Maureen Dixon, Special Agent in Charge for the HHS OIG, put it starkly: “Neglecting to provide vital medical device information…posed a significant threat to the lives of patients across the country.” The government also contends ACell engaged in thinly-veiled bribery and inflated billing practices.

Under the plea agreement, ACell admitted to learning about the endotoxin contamination in January 2012 and initiating the device removal. They admitted to both failing to report the removal and concealing the true reason behind it. This isn’t just about a faulty product; it’s about a deliberate attempt to mislead the public and regulators. The $15 million settlement aims to address both the criminal violation and the resulting false claims submitted to federal healthcare programs.

The investigation underscores the critical importance of transparency and accountability in the medical device industry. Federal officials are sending a clear message: concealing potentially life-threatening information about medical devices will not be tolerated. This case serves as a warning to other manufacturers – prioritize patient safety over profits, or face the consequences.

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