Two Texans who are pursuing Bair Hugger lawsuits against the 3M Company and Arizant Healthcae, Inc. recently came forward to discuss their experiences with a Houston media outlet. Both plaintiffs are alleged to have developed deep joint infections after the forced air warming blanket was used in their hip replacement procedures.
“Some of the days, I don’t remember anything,” Tommy Walton told click2houston.com. “Then I would start to be coherent again, and whoops, you got to go to another surgery.”
“I was in bed for six months, you know, and couldn’t get out of bed,” Diane Dunn said. “Then I go from that to a wheelchair, and then you have to maneuver and not be able to use my legs and use my arms.”
Between them, the two retirees have undergone a dozen additional surgeries to treat their infections. Walton now walks with a prosthesis.
They are among nearly 700 plaintiffs who have filed hip and knee infection lawsuits against the manufacturers of the Bair Hugger forced air warming blanket. The disposable, inflatable blanket connects to a portable heater and is used to help surgery patients maintain an optimal body temperature while they are under anesthesia. Introduced in 1987, it is now the standard patient warming system in thousands of hospitals around the world.
According to click2houston.com, the U.S. Food and Drug Administration (FDA) has received 300 reports of adverse reactions involving the Bair Hugger over the past 16 years. However, the article did not specify how many of those might have involved post-operative deep joint infections.
Plaintiffs who have filed joint infection lawsuits claim that the device suffers from a design defect that allows contaminated air from the operating room floor to enter the sterile surgical site, greatly increasing the risk that patients undergoing hip and knee implants will develop an infection in their joint. They further claim that 3M and Arizant have been aware of this problem for years, but have not made any design changes to the Bair Hugger or provided warnings to doctors.
3M and its Arizant Healthcare subsidiary deny these allegations, and maintain that the studies being used by plaintiffs to support their claims do not actually establish that the Bair Hugger causes surgical site infections.
At least 693 forced air warmer lawsuits involving the Bair Hugger have been filed in a centralized litigation now underway in the U.S. District Court, District of Minnesota. The first trials could begin some time next year.