Kimberly-Clark sold surgical gowns marketed as offering the highest level of protection against infectious diseases when in reality the company knew the gowns were unsafe for healthcare providers to wear, according to a class action lawsuit that seeks more than $500 million in damages.

In the lawsuit, lead plaintiff Hrayr Shahinian, MD, FACS, director of the Skull Base Institute in Los Angeles, Calif., says he uses Kimberly-Clark's line of Microcool Breathable High Performance Surgical Gowns, which the company claims offer level 4 protection designated by the Association for the Advancement of Medical Instrumentation (AAMI). It's the highest level of liquid barrier protection possible that helps prevent blood and other bodily fluids from penetrating through to the wearer's skin.

According to court documents, Kimberly-Clark has known since 2013 that the gowns failed industry standard tests, which showed the personal protective equipment allowed liquid and bacterial and viral pathogens to penetrate the outer material, which meant the gowns could not longer be classified as AAMI Level 4 protection.

The lawsuit accuses Kimberly-Clark of concealing and delaying disclosure of the problems with the gowns and suggesting the gowns could be used to treat patients infected with Ebola.

"These are extremely serious allegations and ones that we do not make lightly," says Michael Avenatti, lead attorney for the plaintiffs. "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."

A Kimberly-Clark spokesman would not comment on ongoing litigation. "However," he says, "the company stands behind the safety and efficacy of its products."

Daniel Cook