The trial for the class action surrounding Kimberly-Clark’s MicroCool surgical gowns progressed in favor of the plaintiffs this week as expert witness Jeffrey Stull of International Personnel Protection testified that after defendant Kimberly-Clark Corporation and its subsidy and co-defendant Halyard Health Inc. were informed of the product’s failure during industry standard testing, it should have been recalled. Stull ascertained that “at the very least notification should have been provided to the customers” that the product no longer met safety standards for protection against pathogen and liquids.
The suit, originally filed in October 2014 by California-based Bahamas Surgery Center, claimed that the defendants fraudulent failed to disclose and also concealed information from consumers pertaining to the fact that the MicroCool surgical gowns had failed industry safety tests and therefore put wearers in serious risk of exposure to pathogens and liquids. The class, which includes all California purchasers of the MicroCool gowns between February 2012 and January 2015, pointed to internal communication from March 2012 between a company scientist and manager wherein the pair discussed a batch of gowns that failed safety tests.
The standard in question is procured by the Association for the Advancement of Medical Instrumentation (“AAMI”). The MicroCool gowns were advertised by the defendants as having achieved the highest level of safety by the AAMI and marketed as providing protection against dangerous pathogens such as Ebola. However, an industry competitor put the gowns through a similar battery of tests in January 2013 and reported that out of 96 samples, 46 failed to pass the safety tests.
Kimberly-Clark argues that the MicroCool surgical gowns were approved for use by the FDA in 2010, while abiding by the then-current 2003 standards for safety. The company further claimed that the new industry standard that has since been introduced is merely an aspirational standard for the product to meet and not in fact a requirement.
The case is: Shahinian v. Kimberly-Clark et al., case number 2:14-cv-08390, in the U.S. District Court for the Central District of California.
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