A company accused of supplying faulty protective equipment to hospitals during the most recent Ebola outbreak also sold the equipment to the U.S. government's Strategic National Stockpile for use in future outbreaks and emergencies, Anderson Cooper reports this week on 60 Minutes. The story airs this Sunday, May 1 at 7 p.m. ET/PT.
Cooper's investigation focuses on Halyard Health's MICROCOOL Surgical Gown, which is supposed to meet a rigorous industry standard known as AAMI Level 4, meaning it is impermeable, so that blood and body fluids containing dangerous viruses like Ebola can't get through. The Centers for Disease Control and Prevention (CDC) recommended AAMI Level 4 gowns for use during the Ebola outbreak.
But 60 Minutes reports that when the government's National Institute for Occupational Safety and Health commissioned tests of MICROCOOL gowns produced in 2014 for the national stockpile, there were some sleeve seam failures in three out of four batches tested.
Bernard Vezeau, Halyard's former global strategic marketing director for MICROCOOL, tells Anderson Cooper the MICROCOOL gowns didn't consistently meet industry standards.
"They would leak when we pressure tested them," Vezeau says, "especially in the seams."
California attorney Michael Avenatti shows Cooper a December 2012 laboratory test report of MICROCOOL gowns, commissioned by one of Halyard's competitors, Cardinal Health. According to the report, 77 percent of the gowns tested failed the industry-recognized test on one or both sleeves.
Avenatti represents hospitals that are suing Halyard Health in civil court for fraud. "Forget about the civil liability," he tells 60 Minutes. "This is criminal conduct."
But Chris Lowery, the Chief Operating Officer of Halyard Health, tells Cooper the test commissioned by Cardinal Health is an "extreme outlier" that is not consistent with the company's own laboratory tests.
Lowery says the allegations against the company "aren't based in the facts...We get less than one complaint for every million gowns sold. And... we've never received even one report of a health care professional contracting an infection as a result of a flaw in our product."
Halyard Health was a division of the Kimberly-Clark Corporation until it was spun off into a separate company in November 2014. The government's Strategic National Stockpile of medical supplies is maintained by the CDC.
Anderson Cooper's investigation was produced by Andy Court and Sarah Fitzpatrick.