Kimberly-Clark Paying $40M to Resolve Charge Related to Sale of Surgical Gowns

Kimberly-Clark Corp. agreed to pay up to $40.4 million to resolve a criminal charge relating to the sale of adulterated MicroCool surgical gowns.

A filing in U.S. 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 U.S. Food and Drug Administration after Kimberly-Clark made a change to the gowns, according to the U.S. Department of Justice.

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, according to the DOJ.

The terms of a deferred prosecution agreement stipulate that Kimberly-Clark will pay up to $40.4 million, which consists of a monetary penalty of $24.5 million, a forfeiture of profits of $3.9 million and up to $12 million in victim compensation.

Surgical gowns sold in the U.S. are subject to regulation by the FDA, which recognizes a system of classification set forth by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) — known as the ANSI/AAMI PB70 standard. Under the ANSI/AAMI PB70 standard, the highest protection level for surgical gowns — AAMI Level 4 — is reserved for gowns intended to be used in surgeries and other high-risk medical procedures on patients suspected of having infectious diseases.