Last month, a California OSHA lawsuit – which alleges protective surgical gowns were determined to be “less protective” due to manufacturer’s cost-cutting tactics – made its way through the U.S. District Court for the Central District of California.
Brought by Bahamas Surgery Center (Bakersfield, CA), the suit alleges that Kimberly-Clark Corp. and Halyard Health Inc. fraudulently failed to disclose and also concealed information from buyers which demonstrate that their MicroCool surgical gowns didn’t meet standards for barrier protection against liquids and pathogens. According to a testimony by an expert in personal protective equipment, Kimberly-Clark’s MicroCool surgical gowns should have bene recalled when the product began failing quality-control testing.
The class action is being brought on behalf of individuals and entities in California who bought the gowns between February 2012 and January 2015. The gowns were approved by the U.S. Food and Drug Administration (FDA) through an FDA 510(k) Clearance, which fast-tracks medical products through what is typically a more meticulous testing and clinical trial process. According to the former director of Kimberly-Clark, not only did the manufacturer misled customers and clients regarding the protective capacity of the gowns, but that Kimberly-Clark also gave inaccurate information to the FDA in order to obtain the necessary clearances.
Former executive Keith Edgett testified that design changes were made to the gowns after the FDA approved the design back in 2010. These changes were the result of cost reduction in order to improve the bottom line, but not improve the performance of the gown.
The MicroCool surgical gowns were marketed as providing the greatest level of protection in the surgical room, with the ability to protect a user from robust pathogens (such as Ebola) and liquid. The manufacturer is standing behind its product, as well as its reputation.