Why Did ACell Inc. Conceal the MicroMatrix Recall from the FDA?

As part of a 2019 settlement agreement with the U.S. Department of Justice, medical device manufacturer ACell Inc. pleaded guilty to both criminal and civil charges for “clandestinely removing” its ACell MicroMatrix wound healing powder from the market due to concerns of contamination with a potentially deadly bacteria, but failing to notify the U.S. Food and Drug Administration (FDA), a violation of the federal Food, Drug, and Cosmetic Act (FDCA).

In addition to pleading guilty to a misdemeanor count of failure and refusal to report a medical device removal, the terms of the deal call for Maryland-based ACell to pay $15 million to resolve both its criminal and civil liability and “enact extensive compliance reforms.” ACell’s actions “caused false claims to be submitted to federal health care programs for MicroMatrix,” according to the Justice Department.

In January 2012, ACell learned that more than 30,000 of its MicroMatrix products were contaminated with endotoxin levels that posed a risk to patient health and took them off the market without notifying anyone – not federal regulators, hospitals, doctors who had used the potentially dangerous wound-healing product, or even the company’s own salespeople, the Justice Department’s news release stated.

ACell must pay $12 million over five years for causing false claims for MicroMatrix to be submitted to government health care programs plus the $3 million fine. The Justice Department says that starting in 2011, ACell engaged in false and misleading marketing by having its sales reps tell physicians that it was safe and effective to use MicroMatrix powder internally despite there being no clinical data to back up the claim and the powder only having FDA-approval for external use. Whistleblower John M., a former ACell employee, will receive $2.4 million of the civil settlement under the whistleblower provision of the False Claims Act, which permits private individuals to sue on behalf of the government for false claims and to share in any recovery.

In March 2012, according to the Justice Department, ACell representatives provided healthcare providers incorrect and improperly inflated coding recommendations for Medicare reimbursement. Despite two different coding consultants telling ACell about the error, the company continued this practice. The Justice Department further alleged that ACell reps improperly provided “entertainment and payments for being part of ACell’s speaker program, and free product, designed to encourage orders from the recipients of those inducements.”

What Is ACell Inc.?

ACell characterizes itself as a leader in regenerative medicine. The biotech company creates medical technologies used to repair wounds and soft tissue. Their products come in sheet or powder form and are made of animal bladder tissue, rather than synthetic materials. ACell’s Cytal Wound Matrix aids in the healing of open wounds and its Gentrix Surgical Matrix reinforces damaged soft tissue, such as hernias. The MicroMatrix is used in conjunction with the Cytal Wound Matrix to treat diabetic foot ulcers, traumatic wounds, and necrotizing soft tissue infections.

What is the ACell MicroMatrix?

The MicroMatrix, approved by the FDA for topical use, is a powdery substance that’s applied to open wounds. The powder is made up of porcine (pig) bladder tissue that has been ground into fine particles.

The MicroMatrix label states that the surgical powder has been approved to treat wounds, several types of ulcers, including diabetic ulcers, surgical openings or incisions, abrasions or skin tears, and second-degree burns.

Why Was ACell MicroMatrix Recalled?

The lawsuit against the biotech company claimed that ACell recalled some of its products due to a risk of endotoxin contamination. Endotoxins are found in bacteria and may cause the body to launch an inflammatory response. In addition to potentially causing autoimmune flare-ups, where the body’s immune system turns against itself, endotoxins may also cause septic shock. Septic shock occurs when the body activates an inflammatory response that leads to blood vessel dilation and decreased heart function. The condition can be fatal. Exposure to endotoxins may also result in damage to the internal organs, including the kidneys, lungs, and adrenal glands, and in some cases can result in the development of gangrene on the extremities.

However, according to the FDA, ACell did not notify the agency that these products were potentially dangerous and were being removed from the market. Medical device manufacturers are required to inform the FDA of any product safety concerns and alert them to any recalls. ACell’s alleged failure to do so may have put many patients at risk of endotoxin exposure, as the company was not upfront that these products may be dangerous.

Rather than following the procedure to recall its products, ACell reportedly removed from the marketplace certain sizes of the MicroMatrix. The company did not give a clear reason for doing so and did not contact medical professionals who had already used these products in the course of patient care.

How Many ACell MicroMatrix Lawsuits Have Been Filed?

In addition to the whistleblower lawsuit, a class action lawsuit was also filed against the company in May 2020 by a woman who claimed to have been harmed by MicroMatrix products. According to her lawsuit, the product was used internally, despite only being approved for external use. She claims that ACell markets its products for internal use and other uses that have not been approved by the FDA, resulting in potentially bad outcomes for patients.

If you have received ACell products for wound care or surgical healing, you may be eligible to join or file a class action lawsuit against ACell Inc. Speaking with an experienced attorney about your legal options may be the first step towards pursuing compensation for injuries sustained due to ACell products.

Join a MicroMatrix Class Action Lawsuit Investigation

If you or a loved one underwent surgery to treat internal wounds with MicroMatrix, you may qualify to join a class action lawsuit investigation.

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This article is not legal advice. It is presented
for informational purposes only.