Kimberly-Clark Corporation (Kimberly-Clark), a US-based multinational consumer goods and personal care company, has agreed to pay up to $40.4 million to resolve a criminal charge relating to the company’s sale of adulterated MicroCool surgical gowns. A criminal information filed in US District Court in the Northern District of Texas charges Kimberly-Clark with one count of introducing adulterated surgical gowns into interstate commerce with an intent to defraud and mislead. According to court filings, a Kimberly-Clark employee conducted fraudulent testing on Kimberly-Clark’s MicroCool gowns to avoid having to submit a premarket notification to the US Food and Drug Administration (FDA) after Kimberly-Clark made a change to the gowns. A premarket notification is meant to show FDA that a medical device is as safe and effective as an already legally marketed device. Based on the fraudulent testing, Kimberly-Clark sold the gowns after the change without a new premarket notification, marketing the gowns as providing the highest level of protection against fluid and viruses.
Under the terms of a deferred prosecution agreement filed with the criminal information, Kimberly-Clark will pay up to $40,400,000, which consists of a monetary penalty of $24,500,000, a forfeiture of profits of $3,900,000, and up to $12,000,000 in victim compensation. The deferred prosecution agreement resolves a criminal investigation into Kimberly-Clark’s sale of its adulterated MicroCool surgical gowns under the Federal Food, Drug, and Cosmetic Act (FDCA).