A woman in Texas has filed a lawsuit alleging that the Bair Hugger, a surgical blanket used to maintain a patient’s body temperature in the operating room, caused an infection that ultimately led to the loss of her leg. The suit names 3M and Arizant Healthcare as defendants. The Bair Hugger was developed by Arizant, which was bought by 3M in 2010.
According to the complaint, the plaintiff underwent a knee replacement surgery in 2013. During the operation, the Bair Hugger surgical blanket was used to keep her body warm. After the operation, she developed a Methicillin-resistant Staphylococcus aureus (MRSA) infection in her knee. MRSA is difficult to treat because it is resistant to many different antibiotics. The lawsuit alleges that multiple surgeries were performed in an effort to fight the infection, but ultimately physicians were forced to amputate her leg above the knee.
The lawsuit alleges that the forced-air design of the Bair Hugger caused the infection. Allegedly, the blanket circulates air from the OR floor and deposits contaminants into the surgical site. The suit alleges that the manufacturers were aware of this risk, but failed to warn the medical community.
The lawsuit cites research findings to support the plaintiff’s allegations. In particular, the complaint notes studies suggesting that the Bair Hugger disrupts the normal downward air flow present in operating rooms. This disturbance, the suit alleges, causes contaminants from the floor to enter the surgical site.
The suit also alleges that the blanket itself becomes internally contaminated with pathogens because manufacturers reduced the efficiency of the air filter sometime between 2002 and 2009.
3M issued a statement denying these types of allegations. The company said the blanket does not cause infections, referring to the studies cited by plaintiffs as “junk science” sponsored by their competitors. 3M asserts that there have not been any infection cases definitively caused by Bair Hugger.
A multidistrict litigation (MDL) has been established for Bair Hugger lawsuits. The Judicial Panel on Multidistrict Litigation created the MDL in December 2015, transferring 14 cases. Additionally, another 51 similar lawsuits were already pending in federal courts at the time.