At present, there are have been over 40 lawsuits filed against 3M over the Bair Hugger warming blanket, and I expect that number to grow. All of the complaints share similar allegations that after joint replacement surgery in which the device was used, patients developed catastrophic injuries, including infections, repeated joint surgeries, immobility and in severe cases amputations of knees and legs. According to the lawsuits, 3M knew about the hip and knee surgical infection risk for many years, but failed to make design changes or warn the doctors and hospitals.
Currently there is an application to The U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate and centralize all Bair Hugger infection lawsuits nationwide against 3M Corporation. Centralization. This is a common practice in pharmaceutical and medical device litigation, and is often done in anticipation of a large number of lawsuits.
The Bair Hugger warming blanket was approved by the FDA in 1988 and has been in widespread use ever since. It consists of a perforated blanket connected to a forced-air heating unit that rests on the floor near the operating table. The unit carries heat via forced air to the blanket, with the warm air transferred to the patient through the blanket.
During hip and knee replacement surgeries it is a common practice for doctors to use warming devices on patients to guard against the risk of hypothermia and to ensure normal blood flow during the operation. The 3M Bair Hugger forced air-warming blanket is one of the most popular devices, and has been in common use for over 25 years. The company claims that close to 180 million operations have been carried out using the device.
Over the years there have been reports of infections in surgeries that used the Bair Hugger device, especially in invasive joint replacement surgeries where the introduction of any infectious germs can have devastating consequences.
The configuration of the floor-situated Bair Hugger has been suspected of compromising the carefully controlled ventilation systems common in operating theaters that help maintain the sterile environment. In a recent report in the Journal of Hospital Infection, no fewer than 10 peer-reviewed studies were referenced that suggested use of forced-air warming systems such as the Bair Hugger succeeded in the introduction of contamination to the operating field.
An estimated 50,000 Bair Hugger devices are currently in use across the U.S. Patients need to be aware of the suspected risks associated with this device, especially if they are undergoing hip or knee replacement surgery. Our firm is accepting cases for surgical infections that may have been caused by the Bair Hugger blankets.