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Lawsuit Against 3M Claims Bair Hugger Surgical Warming Device Caused Devastating Infection

Filed December 16th, 2015 Fran Kelley

A Texas woman has filed suit against 3M, alleging the company’s Bair Hugger surgical warming blanket was responsible for a drug-resistant infection that led to her leg amputation.

This case is one among dozens of cases claiming the Bair Hugger’s defective design leads to dangerous infections, Law360 reports. The Texas woman contracted the devastating infection after knee-replacement surgery during which the Bair Hugger was used.The lawsuit was filed on December 9, 2015 in Harris County court. The lawsuit seeks more than $1 million from 3M Co. and three other defendants who sold and used the Bair Hugger, according to Law360. More than fifty lawsuits have been brought against the Bair Hugger; 3M has asked to have the lawsuits transferred to Minnesota for multidistrict litigation (MDL).

The Bair Hugger is meant to aid in recovery from surgery by trapping a layer of warm air around the surgical site. But the lawsuit claims that the device blew bacteria into the implant site, causing infection. In addition to 3M, the lawsuit names the Houston medical center where the surgery was performed, the doctor who allegedly conducted surgery in the presence of bacteria, and Arizant Healthcare Inc., which created the Bair Hugger. Bair Hugger was sold to 3M in 2010.

The Bair Hugger and similar forced-air warmers are intended to increase the patient’s comfort, reduce bleeding, and reduce the risk of infection and post-operative heart attack, Law360 reports. But 43 federal and 12 state cases against 3M claim the device increases infections, according to a document the company filed last month with the Joint Panel on Multidistrict Litigation. The (Minneapolis) StarTribune explains the warming unit can disrupt the flow of sterile air inside an operating room. Waste heat from the unit can build up under the operating table, creating convection currents that stir up contaminants from the floor and blow them onto the surface of a knee or hip implant.

The Texas woman suffered a drug-resistant infection after knee replacement surgery in December 2013. As a result of the infection, the affected leg was amputated above the knee. The lawsuit alleges that the Bair Hugger’s design was changed in a way that increased the risk of bacteria being blown into the implant site. According to legal documents, a “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,” according to Law360. The lawsuit claims 3M misrepresented the Bair Hugger to “the public, the medical community, and the FDA,” and “actively and knowingly concealed the propensity of these devices to cause infection in orthopedic implant surgeries.”

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