A transfer order filed on December 11, 2015 has consolidated fourteen actions against 3M Company and Arizant Healthcare Inc. in the District of Minnesota for their patient warming product the Bair Hugger. There are fifty-one additional related federal cases that may eventually be “tag along cases” to this action.
The Bair Hugger system has been used on more than 180 million patients since 1988. It is a box-like warming unit which is connected to a hose. This pumps warm air into the Bair Hugger disposable blanket. Using forced air warming, the product is supposed to prevent and treat hypothermia during surgery. This is helpful because anesthetized patients cannot regulate their own body temperature.
Operating rooms typically have airflow systems that push cool air down and draw it away through air inlets in order to keep bacteria or air contaminants out of the surgical area. Patients undergoing hip implants, knee implants, and artificial heart valve surgeries are especially at risk for infection. The implants are made of metal and plastic, which the human body is not equipped to attack once infection occurs. Therefore, many patients have required additional surgery to fight the infections after these procedures.
The plaintiffs in this suit allege that the Bair Hugger device affects airflow in the operating room, causing bacteria from the floor to be deposited into the surgical site. They also allege that the internal airflow paths of the device’s blower can become contaminated with pathogens, which are then expelled into the surgical site. Air inside an operating room is supposed to be sterile. However, clinical studies support the theory that heat waste from the warming unit builds up under the operating table. Convection currents stir up contaminants from the floor which can then be embedded in the implants, causing infections.
The plaintiffs are seeking damages from 3M and Arizant for failure to warn, misrepresentation, and punitive damages for knowingly marketing a dangerous product. One plaintiff, Timothy Johnson, claims he needed multiple revision surgeries after the infection. It ultimately resulted in the amputation of his leg. Another plaintiff claims to suffer from permanent disability and decreased mobility.
Dr. Scott Augustine, the inventor of the product, resigned from his position as chairman and chief executive of Arizant in 2002. He has since advised against the use of his own invention. He now promotes another device of his own design called the Hotdog. This product serves the same function as the Bair Hugger system, but without the use of the forced air system. Instead, it works more like an electric blanket through use of conductive fabric warming.
A technology assessment done in 2014 by medical evidence organization, the ECRI Institute, indicated there is not enough evidence to determine which of the two products was better at reducing surgery-related infections. Contrary evidence from the Bone & Joint Journal, however, show 2,000 times more contaminants present in the air when the Bair Hugger was used compared to when the Hotdog was used. Other studies concluded that there is absolutely no scientific evidence that the forced air warming system leads to an increase in infection, regardless of the type of procedure being performed.
Lawyers for 3M stand by the safety of the Bair Hugger device. They claim that the plaintiff’s allegations are “junk science.” They state that Dr. Augustine is simply trying to further his own agenda by discouraging the use of the Bair Hugger system and promoting the use of his new product instead.