Kimberly-Clark Agrees to Settle $40 Million Over Allegations Concerning Surgical Gown Sales
In a significant development, the U.S. District Court in the Northern District of Texas is hearing a case against Kimberly-Clark Corporation. The charge is related to the sale of adulterated MicroCool surgical gowns, a product marketed for providing the highest level of protection against fluid and viruses.
According to the U.S. Department of Justice, Kimberly-Clark Corporation is charged with one count of introducing adulterated surgical gowns into interstate commerce. The alleged offense involves a change made to the MicroCool gowns, which were sold in the U.S., a market regulated by the FDA, and subject to the ANSI/AAMI PB70 standard.
The ANSI/AAMI PB70 standard reserves the highest protection level for surgical gowns - AAMI Level 4 - for gowns used in high-risk medical procedures on patients suspected of having infectious diseases. However, the DOJ alleges that Kimberly-Clark Corporation sold the MicroCool gowns without a new premarket notification after the change, and fraudulent testing was conducted to avoid having to submit a premarket notification to the FDA.
As part of a deferred prosecution agreement, Kimberly-Clark Corporation has agreed to pay up to $40.4 million to resolve the criminal charge. The deferred prosecution agreement requires the company to pay a monetary penalty of $24.5 million and forfeit profits of $3.9 million. Additionally, up to $12 million is stipulated for victim compensation.
The deferred prosecution agreement follows allegations that a Kimberly-Clark Corporation employee conducted fraudulent testing on MicroCool gowns. The aim of this activity was to defraud and mislead customers, potentially putting patient safety at risk.
This case highlights the importance of adhering to regulatory standards in the sale of medical products, particularly those intended for use in high-risk procedures. Kimberly-Clark Corporation has acknowledged the seriousness of the allegations and is working to address the issues raised by the U.S. Department of Justice.
Read also:
- Top-Notch Home and Expert Age Spot Remedies
- 'Starting today, registration for the Ayushman Bharat Scheme is available'; announced Delhi's Health Minister, Pankaj Kumar Singh
- Apparition's Significance and its Delivered Messages - as discussed by Sensenmann
- Explored the Popular Health Assessment with a Queue of 100,000 Aspiring Participants - Here's My Unadulterated Opinion
