A widely used brand of surgical gown manufactured by Kimberly-Clark Corp. exhibited “catastrophic failures” in product safety tests, according to a $500 million class-action lawsuit filed this week in Los Angeles. The suit claims the company’s Microcool Breathable High Performance Surgical Gown is not protecting surgeons and other health care workers from Ebola and other infectious diseases.
The Dallas-based multinational continues to market and sell the gowns “represented to be impermeable and to provide the highest level of protection from the transfer of bodily fluids, bacteria and infection (i.e. Ebola) between patient and health care professional,” said a complaint filed Wednesday at the U.S. District Court of the Central District of California in Los Angeles. “In reality, Kimberly-Clark has known since at least as early as 2013 that these gowns failed industry tests and do not meet relevant standards.”
Kimberly-Clark spokesman Robert Brand issued the following statement by email on Friday: “As a matter of policy, Kimberly-Clark does not comment regarding ongoing litigation. However, the company stands behind the safety and efficacy of our products.”
The company is the largest supplier of hospital protective wear worldwide, so the allegations have far-reaching implications for health care workers, including those treating people in the underdeveloped world. Guinea, Liberia and Sierra Leone are grappling with major outbreaks of Ebola, and the virus has jumped to North America and Europe. The virus has killed nearly 5,000 people, but only about 10 individuals outside of those three countries and only one outside of Africa.
Michael Avenatti, the lead attorney in the case, says his firm is aware of individuals who have contracted diseases while wearing the gown. The named plaintiff in the case is Los Angeles-based surgeon Hrayr Shahinian, who claims he was potentially exposed to harm with misleading information about the gowns.
The suit seeks class action status and alleges the maker of Huggies diapers and Kleenex tissues continues to falsely advertise the efficacy of its product. The company advertises the gown as breathable, meaning that unlike plastic or rubber protection, the gowns allow vapors from perspiring health care workers to pass outward through the material, but block liquids from entering.
Kimberly-Clark maintains that the Microcool gowns meet the so-called AAMI Level 4 Liquid Barrier Standard, the highest protective rating by the Association for the Advancement of Medical Instrumentation. This means the gowns should provide the highest protection, especially in the critical areas of the upper torso and forearms most likely to be spattered with bodily fluids.
Read the full complaint here:
Read the exhibit documentation here. The suit is using these exhibits as evidence of Kimberly-Clark's alleged false advertising.