A Texas woman has filed a Bair Hugger lawsuit, alleging the device caused an infection that led to the amputation of her leg.

Plaintiff Ruth C. says she underwent a total left knee replacement surgery in December 2013, during which she was kept warm using a Bair Hugger warming system.

After that surgery, she allegedly developed a MRSA infection in her knee.

Multiple surgical efforts to clean the infected area were unsuccessful, and she ultimately had to have the infected leg amputated above the knee, according to the Bair Hugger lawsuit.

Ruth claims the Bair Hugger warming system caused her infection by introducing contaminants into her surgical wound.

She is suing Bair Hugger’s manufacturers 3M Company and Arizant Healthcare, Inc. Arizant developed the Bair Hugger on its own and has been owned by 3M since 2010

What is a Bair Hugger?

The Bair Hugger warming system is used to prevent hypothermia in patients undergoing anesthesia for surgery.

General anesthesia causes the patient’s body temperature to drop, which itself can increase the need for blood transfusion, lengthen the recovery time, and increase the risk of mortality.

The Bair Hugger is intended to prevent these complications by keeping the patient warm.

According to Ruth’s Bair Hugger lawsuit, the system consists of a heater and blower unit connected to a disposable blanket by a flexible hose. This set-up keeps surgical patients warm by warming air and directing it over the patient’s skin.

Ruth alleges that flaws in the Bair Hugger’s design cause it to blow contaminated air towards the open surgical wound, increasing the chance of infection.

The 3M Bair Hugger lawsuit cites scientific studies that report that the Bair Hugger disrupts the normal downward air flow present in operating rooms, driving contaminated air from near the floor up to the surgical site on the patient’s body.

Ruth further argues that sometime between 2002 and 2009, the defendants reduced the efficiency of the air filtration used in the Bair Hugger, causing the forced air warmer blanket itself to become internally contaminated with pathogens, according to her lawsuit.

In a statement, 3M denied that the Bair Hugger warming system causes infections.

The company said that claims implicating the Bair Hugger are based on “junk science” sponsored by a competitor. They state that there is no single confirmed case of a Bair Hugger causing an infection.

Bair Hugger Lawsuits

A few dozen Bair Hugger lawsuits like Ruth’s are now pending in both state and federal courts. Several federal claims have already been consolidated into a single multidistrict litigation to be conducted in a Minnesota federal court.

These claims were consolidated there following a December 2015 order of the federal Judicial Panel on Multidistrict Litigation establishing the Bair Hugger multidistrict litigation, or MDL.

In addition to the fourteen Bair Hugger lawsuits transferred, the panel also noted the existence of 51 other similar federal lawsuits already pending in federal courts. These and future Bair Hugger lawsuits could eventually be transferred into the MDL in Minnesota.

Ruth’s Bair Hugger Lawsuit is Case No. 2015-73957, in the District Court of Harris County, Texas. The Bair Hugger MDL will be conducted in the U.S. District Court for the District of Minnesota under MDL No. 2666.