The Bair Hugger is a widely used device in operating rooms to keep patients warm during surgery. Surgical theaters are historically kept cool to aid in the alertness of the surgical team and to maximize the sterile environment. A patient is draped with a disposable warming blanket, which is then attached via a plastic hose to a unit stationed at the floor that produces heat and blows warm air up from the floor, through the hose to the warming blanket to benefit the patient.
The product was developed to aid the patient in many ways, including the reduction of cardiovascular incidents resulting from the cold and to speed healing after the fact. The problem, according to various reports, is that the sterile envelope is usually maintained between the ceiling and the patient in the operating theater. Various remote bacteria and pathogens that may gather at the floor are not normally considered a threat to the patient as they are below and well away from the surgical site.
However, it is alleged that use of a fan unit at the floor, combined with the heater, results in the transference of pathogens from the floor area up through the hose carried by the warm air to the surgical site, compromising the sterile environment.
“Any reasonable and competent physician would not use a Bair Hugger in an orthopedic implant surgery if they were fully apprised of the dangers and risks associated with doing so,” the Childers Bair Hugger Warming Blanket lawsuit said.
“However, through misrepresentations to the public, the medical community, and the [US Food and Drug Administration] the defendants actively and knowingly concealed the propensity of these devices to cause infection in orthopedic implant surgeries.”According to her complaint, Childers underwent knee replacement surgery in December 2013. Following surgery, it was revealed she had incurred a drug-resistant infection in the joint. Her knee was subsequently amputated above the knee.
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Childers is seeking in excess of $1 million for her pain and suffering.
On the Bair Hugger deep joint infection lawsuit front there have been 43 cases filed in federal court, with 12 in state court. There are reports that 3M is lobbying to have the lawsuits transferred to the jurisdiction of Minnesota for multidistrict litigation.
Childers filed her Bair Hugger Warming Blanket lawsuit December 9 in Harris County court. The case is Ruth E. Childers v. 3M Company et al, case number 2015-73957 in the District Court of Harris County, Texas.