A woman from Alabama has filed a claim alleging the Bair Hugger warming system caused her to develop an infection after her orthopedic surgery.

The plaintiff, Barbara L. of Ozark, Ala., underwent hip replacement surgery in November 2010. During surgery, she was kept warm by a Bair Hugger, a system used to keep surgical patients warm by warming air and driving it through a blanket, the Bair Hugger lawsuit says.

Following the surgery, Barbara says, she developed a serious infection and had to undergo at least seven additional surgeries to remove the implant and eliminate the Bair Hugger infection.

Barbara says she continues to endure residual effects of that infection and has to use a cane to walk. She argues the infection was caused by the Bair Hugger system.

Barbara filed the Bair Hugger lawsuit  against 3M Company and its subsidiary, Arizant Healthcare, Inc., both of whom manufacture and sell the Bair Hugger.

The Bair Hugger Warming System

Keeping a patient warm during surgery offers a few distinct benefits. Under general anesthesia, a patient’s body can’t regulate its own temperature. The lack of temperature regulation puts the patient at risk for hypothermia, infections, and longer recovery time.

The Bair Hugger system was created to resolve those problems by keeping the patient warm. The system consists of a warmer and blower unit attached to a hose that directs the warmed air under a blanket that drapes over the patient.

The apparent problem comes from the system’s ability to move air from near the floor of the operating room up to the site of the surgery. According to Barbara’s Bair Hugger lawsuit, contaminants from the floor catch a ride on the air that the Bair Hugger drives up to the operating table and into the open surgical site on the patient’s body.

This action works contrary to what Barbara says is the standard downward air flow usually implemented in operating rooms. She cites six different scientific publications supporting this theory, all published from 2009 through 2013.

Barbara also alleges several false representations on the part of 3M and Arizant. She says the defendants falsely represented in a 2009 communication to the FDA that the Bair Hugger met HEPA standards.

HEPA requires a system to remove 99.97 percent of all particles 0.3 microns or larger, but the Bair Hugger removes less than 65 percent of those particles, she says. In her lawsuit, Barbara alleges the defendants knew their statement was false when they made it.

She also says defendants falsely described the Bair Hugger as using a taped edge to prevent warmed air from flowing toward the surgical site, when in fact some Bair Hugger blankets have no taped edge.

Barbara’s Bair Hugger lawsuit is raising claims based on theories of negligence, misrepresentation, fraudulent concealment, failure to warn, breach of warranty, defective design and manufacture, and violation of Minnesota consumer protection and deceptive trade practice laws. She seeks compensatory damages, punitive damages, and reimbursement of her attorneys’ fees and costs of litigation.

Barbara’s Bair Hugger Lawsuit is filed in the U.S. District Court for the District of Minnesota. Barbara is represented by attorneys from Meshbesher & Spence, Ltd. and Levin Papantonio, P.A.