In truth, the FDA was responding to a growing number of joint
replacement surgeons who have discontinued warming their hip and
knee implant patients over concerns about the risks of infection due
to airborne contamination from FAW.
2. About those forced-air lawsuits
3M is facing more than 4,000 product liability claims that it knew
about the potential increased risk of joint infections linked with the
use of Bair Hugger during hip and knee replacement surgeries. The
plaintiffs claim that the forced-air system circulated airborne contami-
nation around the surgical field, thus causing their deep-joint infec-
tions.
The federal court overseeing the lawsuits has ordered 2 knee
replacement infection lawsuits prepared for a bellwether trial that
could begin as early as April 30, 2018. (A bellwether trial is a small
consolidation of lawsuits, taken from a larger group of similar cases,
to be tried first. The bellwether trial is like a practice run to help
anticipate the results of the future similar cases.) The 2 cases were
filed on behalf of individuals who developed deep-joint infections
allegedly related to the use of the Bair Hugger during their total knee
replacements.
3M denies that the Bair Hugger is a vector for transporting germs,
noting that its warming blanket machine has been used in more than
200 million surgeries since 1987. The plaintiffs could have a hard time
linking FAW to SSIs because none of them has definitive physical proof
that the blower swept bacteria-laden particles off of the floor and
deposited them into their wounds during surgery. Instead, they hope to
rely on expert testimony and computer simulations to try to prove that
the Bair Hugger disrupts an operating room's normal downward air-
flow that's meant to keep bacteria on the floor.
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