A Missouri couple has filed a Bair Hugger lawsuit against Arizant Healthcare and 3M Company, alleging a warming blanket caused the wife to develop a deep joint infection.

The claim alleges that during knee replacement surgery a forced air warming device blew bacteria on Plaintiff Deborah K.’s open surgical wound, allowing for the infection to develop.

Deborah K. and her husband Timothy jointly filed the Bair Hugger lawsuit, claiming the defective nature of the forced air warming device caused severe long-term health complications that Deborah continues to contend with.

According to the suit, Deborah underwent total left knee replacement on March 25, 2014, during which a Bair Hugger warming blanket was used.

The disposable warming blanket is connected to a portable heater, which blows hot air onto the patient’s skin while they are under anesthesia. This helps regulate body temperature, which has been shown to improve hospital recovery rates and reduce bleeding, according to the complaint.

The Bair Hugger warming blanket has been on the market since 1988 but has recently been associated with serious post-surgical complications.

This was reportedly the case with Deborah, who developed a serious deep joint infection 16 months following her surgery, according to the Bair Hugger lawsuit, which states that she required at least two revision surgeries — surgical irrigation and debridement as well a polyethylene implant exchange — to prevent further infection.

Deborah and Timothy took legal action against 3M and Arizant after discovering the companies knew or should have known about the potentially devastating complications associated with its products, according to their lawsuit.

Overview of Bair Hugger Complications

They allege that Bair Huggers have been connected with serious joint infections due to how the device collects air from the surrounding areas, which may not be sterile.

Several studies have indicated that Bair Huggers and other forced air warmers may cause infections in the surgical area following the procedure, raising serious concerns about the blanket’s potential risks.

At least one study has indicated that forced air warming devices may collect air from non-sterile areas through convection currents, spreading bacteria throughout the surgical site. A 2011 study published in the Journal of Bone & Joint Surgery states that these devices could compromise the sterile environment of the surgical site.

Another 2011 study, published in the American Journal of Infection Control, found that 58 percent of forced-air warmers observed, including the Bair Hugger, produced airborne contaminants. While this study did not determine whether the contaminants were viable, researchers noted that high levels of bacteria were not necessary to cause an infection.

Even though deep joint infection can be devastating to patients, 3M and Arizant allegedly failed to disclose this information to the public, the lawsuit claims.

Deborah and her doctors relied on the Bair Huggers marketing materials and product information, provided by the manufacturers, and had no reason to believe Deborah was at risk for deep joint infection, the suit continues.

The Bair Hugger Lawsuit is Case No. 4:19-cv-00889-RLW, in the Circuit Court of St. Louis, Missouri.