ACell Inc. Silently Recalled Contaminated Wound Dressing Product

ACell Inc. pleaded guilty last year to charges the company conducted a silent recall of its MicroMatrix wound dressing powder that surgeons use to help heal external wounds.

The Department of Justice said ACell admitted to one misdemeanor count of failure to and refusal to report a medical device removal in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). ACell also agreed to pay $15 million to resolve criminal and civil liability it faced regarding allegations the company caused health care providers to submit false claims to federal health agencies for MicroMatrix.

ACell MicroMatrix Powder Contamination

ACell purportedly knew the MicroMatrix product was contaminated in 2011, but instead of notifying the U.S. Food and Drug Administration, the company quietly removed the affected wound dressing material from the market in 2012, a move known as a “silent recall,” which is against FDA regulations. Packages of the 500mg and 1,000mg MicroMatrix wound dressing powders were removed from the market even though consumers allege many of the 100mg and 200mg packages were also contaminated, yet left on the shelves.

The MicroMatrix wound dressings were a problem because they were contaminated with high levels of endotoxins, which are large molecules found within the membrane of Gram-negative bacterial cells. Of course any material that comes into contact with the human body should be sterilized first, but endotoxins can remain even when the bacteria itself has been eradicated.

Some of the MicroMatrix samples were found to contain as much as 31 times higher endotoxin levels than is deemed safe by the FDA.

Secrecy Regarding ACell MicroMatrix Powder

ACell Inc. admitted hiding the removal of the affected 30,000 MicroMatrix devices from the FDA. In addition, the company never shared with physicians, hospitals or even its own sales force that the reason the product was taken off the shelves was due to endotoxin contamination. As a result of the secrecy, doctors who had used contaminated containers of MicroMatrix powder to dress wounds were not told that their patients could have suffered a high amount of exposure to dangerous endotoxins.

“Neglecting to provide vital medical device information to the FDA, medical professionals, and even the company’s own sales force, posed a significant threat to the lives of patients across the country,” said Maureen Dixon, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services region including ACell Inc.’s home base, Maryland. “Compounding that crime, the government contended the company paid thinly-veiled bribes to health providers and stuck taxpayers with inflated bills.”

ACell was accused of convincing health care workers to use MicroMatrix by providing them with free products, entertainment, and financial rewards for speaking positively about the product to cohorts.

ACell MicroMatrix Powder Whistleblower Award

Former ACell employee John Murtaugh received $2,366,004 of the civil settlement under the qui tam or whistleblower provisions of the False Claims Act. The provisions allow an individual with information regarding Medicare fraud, waste or abuse to sue on behalf of the government for false claims by filing a complaint with the U.S. Attorney’s office, and to share in any resulting recovery.

The government has the option of intervening in the action or declining to take over the lawsuit, which then means the whistleblower may proceed with the action on their own. Whistleblower awards generally range from 10% to 30% of the money collected when monetary sanctions are greater than $1 million.

Should I File an ACell Lawsuit?

Exposure to endotoxins may result in a severe inflammatory response that gives rise to fever, infection, septic shock, and sometimes, death.

At least one woman has filed an ACell Inc. lawsuit after the wound dressing was placed internally in her fingers to encourage bone growth. The FDA has not approved the use of MicroMatrix as an internal medical device, but ACell is accused of marketing the material for such use, as it was allegedly used in the plaintiff’s hand.

Her lawsuit alleges the use of contaminated MicroMatrix led to her developing an infection, which then required additional surgeries that her health insurance would not cover. She further alleges that MicroMatrix was used improperly on her for internal purposes despite the fact that the FDA had not approved it for such reasons.

Because the contaminated lots of MicroMatrix wound dressing powder allegedly contained endotoxin levels at least 4.5 times higher than the FDA’s safety standards, patients who incurred injuries from the medical device are able to take legal action.

If you file a lawsuit, you could receive financial compensation for pain and suffering, medical expenses, lost wages and other losses that are connected to the defective MicroMatrix wound dressing powder.