US giant Kimberly-Clark has to pay up to $40.4m to resolve a criminal charge relating to its sale of adulterated MicroCool surgical gowns, with the Justice Department saying it betrayed the trust of consumers and healthcare providers “when it chose to defraud the FDA and bring adulterated surgical gowns to market for its own financial gain”.
According to court filings, a company employee had conducted fraudulent testing on the company’s MicroCool gowns to avoid having to submit a pre-market notification to the US Food and Drug Administration (FDA) after Kimberly-Clark made a change to the garments.
A pre-market notification is meant to show the FDA that a medical device/product is as safe and effective as an already legally marketed device.
But based on the fraudulent testing, Kimberly-Clark sold the gowns after the change without a new pre-market notification, marketing them as providing the highest level of protection against fluid and viruses.
Surgical gowns sold in the US are subject to regulation by the FDA that recognises 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 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.
To establish compliance, the gown needs to demonstrate blood-borne pathogen resistance in each of several critical zones, including the sleeve, by preventing fluids from penetrating the gown.
Kimberly-Clark admitted that between late 2013 and late 2014, it sold millions of adulterated MicroCool surgical gowns labelled as AAMI Level 4 after the fraudulent testing and without a new 510(k) FDA premarket notification. In total, Kimberly-Clark sold $49 000 000 worth of these to customers in the United States and abroad.
The deferred prosecution agreement requires Kimberly-Clark to, among other obligations, provide ongoing cooperation with and disclosures to the Justice Department, implement a compliance and ethics programme, and report to the Justice Department regarding remediation and implementation of these compliance measures.
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