Kimberly-Clark settles $40 million dispute over allegations involving the sale of surgical gowns.
Kimberly-Clark Corp. has agreed to pay up to $40.4 million to resolve a criminal charge related to the sale of adulterated MicroCool surgical gowns. The U.S. Department of Justice (DOJ) announced the settlement on Tuesday.
The charge against Kimberly-Clark is one count of introducing adulterated medical gowns into interstate commerce with the intent to defraud and mislead. The adulteration of the MicroCool gowns occurred after a change was made to the product, resulting in fraudulent testing to avoid submitting a premarket notification to the U.S. Food and Drug Administration (FDA).
The MicroCool gowns, intended for use in surgeries and other high-risk medical procedures, were marketed by Kimberly-Clark as providing the highest level of protection against fluid and viruses. However, the company failed to submit a premarket notification for the modified MicroCool gowns, a violation of the FDA's regulations.
According to the DOJ, a Kimberly-Clark employee conducted fraudulent testing on the MicroCool gowns to meet the ANSI/AAMI PB70 standard, the system of classification recognized by the FDA for medical gowns. The standard reserves the highest protection level (AAMI Level 4) for medical gowns used in high-risk medical procedures on patients suspected of having infectious diseases.
Under the deferred prosecution agreement, Kimberly-Clark will forfeit profits of $3.9 million and pay a monetary penalty of $24.5 million. The agreement also allows for up to $12 million in victim compensation.
The case is being handled by the U.S. District Court in the Northern District of Texas. Kimberly-Clark has neither admitted nor denied the charges but has agreed to cooperate with the DOJ's ongoing investigation.
This is not the first time Kimberly-Clark has faced scrutiny over its products. In 2017, the company agreed to pay $2.3 million to settle allegations that it violated the False Claims Act by selling food products that did not meet contractual specifications to the U.S. government.
The settlement serves as a reminder to companies to prioritize the safety and integrity of their products, especially when dealing with medical devices intended for high-risk procedures. The FDA encourages healthcare providers and consumers to report any concerns about the safety and efficacy of medical devices to the agency.
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