Have You Been Subject to MicroMatrix Endotoxin Exposure?

Maryland-based pharmaceutical company ACell allegedly conducted a silent recall of its MicroMatrix Powder Wound Dressing after learning the material was contaminated with high levels of endotoxins.

The company also purportedly promoted the topical powder as a suitable treatment for internal wounds, a use that the Food and Drug Administration (FDA) never approved. Some similar medical devices are approved for internal use—even some of the ones from ACell Inc.—but MicroMatrix is not one of them. The use of MicroMatrix internally has reportedly led to serious adverse health effects after use during surgery, sparking litigation.

ACell’s MicroMatrix Powder Wound Dressing consists of made from porcine (pig) urinary bladder.

What Is Endotoxin?

Endotoxins are large molecules located in the outer membrane of Gram-negative bacterial cells.

An endotoxin is known as a lipopolysaccharide, which consists of a lipid A layer that contains materials that can prompt the human body’s immune system to interpret the endotoxin as a bacterial infection.

When any type of injection is given or any type of material is implanted into the human body, such material must be sterilized to prevent any type of bacteria from entering the body. However, according to science website HorseshoeCrab.org, the process used to eradicate the bacteria may inadvertently cause the endotoxins to flow from the bacteria’s cells. The bacteria may be gone, but dangerous endotoxins remain.

Because bacterial or endotoxin contamination can make a patient very ill or even prove fatal, products that are meant to be implanted are tested for both bacterial contamination and endotoxins prior to their use.

What Endotoxin Symptoms Can Patients Have?

The release of endotoxins causes an inflammatory response that can prompt a fever, infection, septic shock and in some cases, death. Even at lower doses, endotoxin exposure can lead to toxic pneumonitis, lung function decrements, and respiratory symptoms. Another concern is chronic exposure to endotoxin, which has been linked with an increased risk of developing nonatopic chronic obstructive pulmonary diseases and can worsen the severity of asthma.

According to at least one MicroMatrix lawsuit, the wound dressing placed internally in a woman’s hand to encourage bone growth in her fingers caused her to develop an infection, which led to the need of additional surgeries. Her health insurance provider did not cover the costs of the subsequent surgeries because MicroMax allegedly was used improperly on her internal wounds when the product was only approved for topical use.

The patient said her hand was unable to properly heal because of MicroMatrix, which she alleged hindered the healing of her wounds and the onset of infection because of the high level of endotoxin exposure.

“Despite the FDA warning concerning internal use, and ACell’s decision not to submit a premarket application for MicroMatrix concerning any internal use, ACell chose to market MicroMatrix for internal use,” the MicroMatrix class action lawsuit claims.

“ACell management not only directed but also incentivized its sales force to sell MicroMatrix for a variety of internal uses that the FDA had not cleared.”

How Could MicroMatrix Cause Endotoxin Exposure?

Contaminated MicroMatrix wound dressing purportedly contained endotoxin levels that measured 4.5 to 13.5 times greater than safety standards set by the FDA. ACell allegedly discovered this contamination in 2011, but when an independent third-party lab tested the samples, they found levels of endotoxins that were more than 31 times greater than the FDA’s safety standards.

Despite ACell knowing the dangers of these contaminated wound dressings, the company did not notify the FDA. Instead, ACell quietly removed more than 30,000 500mg and 1,000mg MicroMatrix wound dressings from the market, which is often known as a “silent recall,” which is against the law.

At least one lawsuit claims the company failed to remove its 100mg and 200mg wound dressings despite knowing those devices also contained high levels that could dangerously make patients suffer endotoxin exposure, especially if the wound powder was improperly used on internal wounds.

Has ACell Faced Charges?

In the summer of 2019, ACell pleaded guilty to charges in relationship to its MicroMatrix powder wound dressing product. The company pleaded guilty to one misdemeanor count of failure and refusal to report a medical device removal in violation of the Federal Food, Drug, and Cosmetic Act, according to a press release from the U.S. Department of Justice.

At the same time, ACell agreed to pay $15 million to resolve criminal and civil liability in regards to violating the False Claims Act by submitting claims to federal health care programs such as Medicare for the defective MicroMatrix products.

ACell not only admitted hiding the removal of MicroMatrix from the FDA, but also kept secret the reason for the removal from health care workers, hospitals and ACell’s own sales people. The company also admitted it never notified physicians who had used contaminated MicroMatrix prior to the wound powder’s removal from market that patients who had been treated with the material had a likelihood of high endotoxin exposure.

“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 Maryland. “Compounding that crime, the government contended the company paid thinly-veiled bribes to health providers and stuck taxpayers with inflated bills.”

ACell also agreed to pay a $3 million fine and to enact extensive compliance reforms within the company. Medicare and Medicaid fraud costs American taxpayers billions of dollars each year.

Does ACell Still Sell MicroMatrix?

Yes, the wound management powder is promoted on ACell’s website as an appropriate treatment for acute wounds, chronic wounds and irregularly shaped wounds that may arise from diabetic foot ulcers, trauma or necrotizing soft tissue infections. The powder’s product page (as of November 2020) does not note that it is intended for topical use.

Filing an ACell Micro Matrix Lawsuit

If you or someone you love has suffered from side effects after ACell MicroMatrix was used during surgery, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by these kinds of complications, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

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.

Submit your information now for a free case evaluation.

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