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.
If you suffered an injury due to the defective medical device in Florida,
contact David C. Rash P.A. and schedule a
case evaluation today.