The federal judge overseeing thousands of hip and knee replacement infection lawsuits involving the 3M Company’s Bair Hugger forced air warmer blanket has denied a defense motion seeking to dismiss a design defect claim from the case selected for the litigation’s first bellwether trial.
According to court documents pending in the U.S. District Court, District of Minnesota, the case was filed on behalf of South Carolina resident Louis Gareis, who underwent right total knee replacement surgery in November 2010. The Bair Hugger Forced Air Warming System was used to help Gareis maintain an optimal body temperature during the procedure.
Gareis went on to develop a post-operative deep joint infection and alleges that the Bair Hugger system allowed contaminants to come into contact with his open wound during while he was undergoing surgery. As a result, he has undergone cleaning procedures, intravenous antibiotic treatment, insertion of antibiotic spacer, and the removal and revision of his knee replacement.
According to HarrisMartin.com, U.S. District Judge Joan N. Ericksen denied a defense motion seeking dismissal of Gareis’s design defect claim in an order dated April 13th, holding that he could present the Berchtold TableGard Warming Mattress as an alternative design to support the allegation.
“By warming patients conductively, the TableGard does not spread squames by disrupting operating-room airflow like Elghobashi describes,” she noted. “As of 2008, the TableGard was feasible. The FDA cleared it then as substantially equivalent to the Bair Hugger based on performance and safety testing. Weighing its utility and risk as compared to the Bair Hugger, the jury may decide whether the TableGard embodies a reasonable alternative design.
Judge Erickson also denied defense bids seeking to exclude Gareis’s expert witnesses. However, she did grant the defendants’ motion that sought to dismiss his failure to warn claims, finding that the available data would not have alerted a reasonable manufacturer that the Bair Hugger could cause a post-operative deep joint infection.
The decision clears the way for the case to head to trial on May 14th.
The Bair Hugger Forced Air Warming System was brought to market by Arizant Healthcare in 1987. 3M acquired Arizant in 2010.
The Bair Hugger apparatus consists of a portable heater that is connected via flexible plastic tubing to a disposable, inflatable blanket designed to be draped over or placed under patients undergoing surgery. Ambient air is drawn in and warmed by the heater, then forced through the tube into the blanket.
Plaintiffs pursing Bair Hugger warming blanket lawsuits claim that the design of the system disrupts the airflow in the operating room, allowing potentially-contaminated air from the floor to come into contact with the surgical site. They also allege that the Bair Hugger’s central unit can house bacteria that may be forced out and transferred to the patient during normal use. The complaints further charge that either occurrence greatly increases the likelihood that patients undergoing hip or knee replacement surgery will develop a post-operative infection at the site of their implant.
More than 4,300 Bair Hugger lawsuits are currently pending before Judge Erikson in the District of Minnesota. Verdicts in the litigation’s bellwether trials could provide insights into how juries might rule in similar cases involving the forced air warming system.