According to a Reuters analysis of data from the US Judicial Panel on Multidistrict Litigation, a growing number of lawsuits have been filed over the Bair Hugger forced-air warming blanket. Although court documents have not indicated the number of lawsuits pending, 3M said more than 260 lawsuits have been filed as of March 31, 2016. Plaintiffs in the litigation allege that the surgical blanket caused a surgical site infection; most underwent a knee or hip replacement surgery or cardiovascular surgery.
Most of the lawsuits are pending in federal or state court in Minnesota. According to court documents, a lawsuit was filed on behalf of a man who died following a serious surgical site infection. The lawsuit states that the Bair Hugger was used during his cardiac mitral valve replacement surgery, and allegedly caused the infection. The suit alleges that 3M failed to disclose information about its risks and holds the company responsible for the man’s death.
3M denies the claims in the lawsuit, and states that there are many factors that are known to increase the risk of surgical site infection.
It is alleged that the forced-air warming blankets cause infection by picking up bacteria from the operating room floor and re-circulating it to the surgical site. Most plaintiffs were knee and hip replacement patients. Reportedly, the bacteria that formed around these implants during surgery can be resistant to the body’s immune response and made antibiotics ineffective. Lawsuits allege that plaintiffs underwent additional surgeries and sometimes amputation to treat the infection.