A woman has filed a Bair Hugger joint infection lawsuit that joins an MDL against 3M Company and Arizant Healthcare, Inc.

Plaintiff Joyce S. alleges she underwent a right knee total replacement surgery in November 2015. She says that during the surgery, a Bair Hugger was used to keep her body warm.

A Bair Hugger is a portable heater/blower connected by a hose to a disposable blanket that covers surgical patients. The machine takes air from the surrounding area, including near the floor of the operating room, to create warm air that exits the blanket through several holes to warm the patient’s skin.

According to the Bair Hugger joint infection lawsuit now consolidated into an MDL, “Scientific studies have shown that this warmed air rises against the downward airflow  in the operating room, it deposits bacteria from the non-sterile portions of the operating theater to the surgical site.”

Joyce says she developed a periprosthetic joint infection, also known as a deep joint infection, from a bacteria identified as rare streptococcus mitis/oralis. As a result of the alleged Bair Hugger joint infection, Joyce underwent irrigation and the removal of infected tissue in addition to removal of the infected right knee total hardware in April 2016. Her surgeon implanted antibiotic spacers to further treat the infection.

Bair Hugger Joint Infection Predicted

According to Joyce and other plaintiffs, in June 1997, Bair Hugger admitted in a sworn statement to the FDA that airborne contaminants could be blown into an open surgical site by the action of the machine collecting bacteria. Plaintiffs claim that even after admitting this flaw, Bair Hugger continued to market the machine as safe to use during general and orthopedic surgeries.

The Bair Hugger joint infection lawsuit also alleges the company misrepresented the air filtration as satisfying HEPA standards, but Bair Hugger allegedly has never met that standard of filtration. In fact, Bair Hugger is accused of reducing the air filtration system’s efficiency at some time between 2002 and 2009.

As a result of that redesign, plaintiffs claim, Bair Hugger’s internal airflow pathways become contaminated with mold, bacteria, and pathogens. The design allegedly does not provide an adequate way to clean or sanitize the internal parts, which leads to the incubation and proliferation of these contaminants. Because the Bair Hugger does not include a HEPA-compliant filter – nor does it include an outlet filter – these contaminants are released into the air of the operating room where they can land on the surgical site, according to several plaintiffs’ complaints.

According to the Bair Hugger joint infection MDL, the company allegedly knew of the contamination issues as early as 2009 but neglected to redesign the machine or to warn doctors about the problems. Despite criticism from the surgical community, plaintiffs say the defendants “callously and with conscious disregard of patient safety chose to amplify their efforts to champion the device and silence critics.”

Despite reports of myriad Bair Hugger joint infection occurrences, Bair Hugger allegedly has attempted to hide and discredit scientific studies that would hinder sales of the dangerous device.

The Bair Hugger Joint Infection Lawsuit is Case No. 0:18-cv-00705-JNE-FLN and is part of the Bair Hugger MDL, In re: Bair Hugger Forced Air Warming Products Liability Litigation, MDL No. 15-2666, in the U.S. District Court for the District of Minnesota.