Lawsuit says protective medical gowns failed safety tests, don’t protect against Ebola
A class action lawsuit was filed in October alleging that Kimberly-Clark Corp. has committed fraud in the marketing and selling of certain protective medical gowns.
The lawsuit states that the Kimberly-Clark Corp. falsely represented that the Microcool Breathable High Performance Surgical Gowns are impermeable and provide protection against Ebola. The company has known since 2013 that these gowns failed industry tests and don’t meet relevant standards, the suit says, and it claims the gowns placed healthcare professionals and patients at considerable risk for infection and serious bodily harm.
"These are extremely serious allegations and ones that we do not make lightly," said lead attorney Michael Avenatti of Eagan Avenatti, a law firm with offices in Los Angeles that filed the lawsuit. "Kimberly-Clark needs to immediately recall these gowns and come clean with the FDA, CDC, healthcare professionals, and the general public. The risks associated with continued concealment of the truth are far too great."
Avenatti’s firm is aware of persons who have contracted various diseases while wearing the gown, according to a story from The Associated Press (AP).1 The AP story also quoted Avenatti as saying that Texas Health Presbyterian Hospital in Dallas, where two nurses contracted Ebola, once stocked the Kimberly-Clark gowns, but he said he didn’t know whether the infected nurses or an infected nursing assistant in Spain had worn them.
Kimberly-Clark said in a statement that it doesn’t comment on ongoing litigation but that it stands behind the safety and efficacy of its products.
LA surgeon filed suit
The lawsuit was filed by Hrayr Shahinian, a Los Angeles surgeon who specializes in skull base and brain tumor operations, AP said. Shahinian said he had used the gowns and thus potentially was exposed to harm, the story said.
According to the lawsuit, Kimberly-Clark has knowingly misled the medical community, regulators, and members of the general public about the safety of the surgical gowns. Even after learning of multiple test failures, the company failed to alert the Food and Drug Administration, healthcare professionals, and patients, the suit says.
Suit: Gowns failed tests
As stated in the complaint, tests of numerous random samples from separate manufacturing lots showed that the gowns failed to meet the Association for the Advancement of Medical Instrumentation (AAMI) Level 4 standards, with many of the gowns experiencing catastrophic failures that allowed liquid, bacterial, and viral pathogens to penetrate the gowns.
"Instead of recalling the gowns and disclosing the truth, the company concealed what it knew and continued promoting, marketing and selling the gowns by stating they were impermeable, even going so far as to recommend that the gowns be used when treating patients with serious infectious diseases, including Ebola," the law firm stated in a released statement.
The lawsuit seeks damages in excess of $500 million.
"Kimberly-Clark’s actions of concealing the truth about their surgical gowns and continuing to market them as impermeable is unconscionable," said Shahinian. "This conduct has placed physicians, healthcare workers, and patients at risk of being unknowingly exposed to harmful bacteria, viruses, and illness, including Ebola. This is a very serious matter and deserves the immediate attention of regulators and the medical community."
1. Jablon R. Lawsuit: Surgical gowns let diseases pass through. Oct. 30, 2014. Accessed at http://apne.ws/1G28AmW.