Following a periprosthetic joint infection, 3M faces a new lawsuit regarding their Bair Hugger product.

Plaintiff Kimberly M. and her husband George M. recently filed a periprosthetic joint infection lawsuit against 3M Company and Arizant Healthcare Inc, alleging that the use of 3M’s Bair Hugger product during Kimberly’s surgery resulted in a serious infection.

In July 2011, Kimberly underwent a left total knee arthroplasty. Allegedly, contaminants were introduced to her open surgical wound by the Bair Hugger which resulted in a periprosthetic joint infection. As a result of the periprosthetic joint infection, Kimberly says, she had to have multiple implant removals, multiple reimplantations, long-term IV antibiotics courses, and other medical treatments. She says she received treatment from June to August 2012.

The Bair Hugger is a portable heater connected by a flexible hose to a disposable blank placed over surgical patients. The device intakes air from the surrounding area and passes it through a filter into an outlet hose. The warm air travels through the hose into the blanket which exits onto the patient’s skin, keeping the patient warm during surgery.

Despite being an effective way to keep patients warm in a cold operating theater, there are allegedly multiple design defects which can lead to contamination. The lawsuit argues that air can escape from under the blanket and create airflow currents that can deposit bacteria from non-sterile portions of the room onto the surgical site. Scientific studies have allegedly found that the air filter in the device, which intakes air from the non-sterile floor, cannot adequately filter out pathogens and bacteria.

“Because the internal air path surfaces of the device cannot be easily cleaned or decontaminated, and the operating instructions for the device do not provide a method for cleaning or decontaminating the inside of the device, microorganisms build up and colonize therein. Without an adequate filtration system at the distal hose outlet, the device releases contaminants into the operating theater and directly onto the surgical site itself,” alleges the complaint.

One possible outcome of this contamination is a periprosthetic joint infection. Although the exact definition of a prosthetic joint infection is a source of contention in the medical community, the condition includes an infection of a prosthetic implant site following a joint replacement.

Symptoms of a periprosthetic joint infection include persistent pain and stiffness at the implant site, swelling, tenderness, drainage, and decreased function. A periprosthetic joint infection can sometimes be treated with long-term antibiotics but often requires a revision surgery. If an infection is allowed to progress for too long, amputation may be necessary.

Kimberly and George accuse the defendants of negligence, strict liability (failure to warn and defective design/manufacture), breach of warranty, violation of state business laws, negligent misrepresentation, fraudulent misrepresentation, fraudulent concealment, loss of consortium, and unjust enrichment. The lawsuit seeks a trial by jury, damages (compensatory and statutory), restitution, court costs, and attorneys’ fees.

The Bair Hugger Lawsuit is Case No. 0:18-cv-00740-JNE-FLN and is a part of the Bair Hugger MDL, Case No. 0:15-md-02666-JNE-FLN, in the U.S. District Court for the District of Minnesota.