extraordinary safety record and an incredibly
low complaint history."
More than just gowns?
According to the testimony of Messrs.
Edgett and Vezeau, the high-performance
gowns were not the only problems. The
company also allegedly experienced per-
sistent, unresolved seaming problems with its drapes, seaming and
pinhole problems with its sterile wraps, and pinholes in its masks. It
experienced problems with other gowns as well.
"It was not just limited to gowns, it was on every business that we
had," testified Mr. Vezeau. "We had a problem with our surgical wrap
having pinholes. … When you have pinholes, that allows bacteria to set-
tle on the instruments. Face masks also had pinholes, which would
enable bacteria to flow through the mask when the surgeon wore them.
Exam gloves, pinholes." Mr. Vezeau died of a heart attack in 2016.
In his deposition, Mr. Edgett expressed frustration that the products
were not removed from the market until the problems could be solved.
"The organizational behavior was not consistent with what I would con-
sider to be an ethical organization," he testified. "I was … shocked
when I learned about the extent of the issues. … I believe (the compa-
ny's leaders) were putting customers in harm's way. … We were track-
ing HAIs as well as new viruses globally … and I felt we were mislead-
ing our customers."
OSM
S E P T E M B E R 2 0 1 6 • O U T PA T I E N TS U R G E R Y. N E T • 2 9
A lawsuit claims that
Halyard Health experienced
serious, persistent quality
issues in all of its barrier
protection products for as
long as a decade.
