An Ohio man filed a lawsuit against 3M Company and Arizant Healthcare Inc., saying their Bair Hugger warming system caused his surgical infection.

Plaintiff Gerald N. underwent right knee replacement surgery in November 2010, during which he was kept warm with a Bair Hugger warming system.

He claims that after surgery he developed a staph infection. That infection was allegedly severe enough to require removal of the knee implant and cleaning of the affected area.

Gerald says he continues to suffer impaired mobility as a result of these complications. He attributes the infection and resulting injury to the use of the Bair Hugger warming system, which he says directed contaminants into his open incision during surgery.

He says manufacturers 3M Company and Arizant Healthcare knew about hazards associated with the device but failed to disclose that information. He also says the manufacturers failed to conduct adequate post-marketing surveillance after putting the Bair Hugger on the market.

The Bair Hugger is a device used to keep patients warm during surgery. It consists of a unit that heats air and drives it through a hose onto the patient’s skin, which is covered by a disposable blanket.

Gerald’s Bair Hugger lawsuit says there are now over 50,000 Bair Hugger units being used in the United States.

Gerald argues that 3M and Arizant have not kept their story straight about the risk of infection associated with the Bair Hugger. He cites a 1997 letter to the FDA in which the defendants stated that air blown across the surgical site may cause infection.

They also stated that the blankets designed for use with the Bair Hugger system use a taped edge to prevent contaminated air from reaching the surgical site. Gerald says that statement is false, however, because several types of Bair Hugger blankets do not use a taped edge. And those that do use a taped edge fails to prevent heated air from rising against the general downward air flow of the operating room.

The Bair Hugger lawsuit also lists several statements from the defendants’ website that Gerald says are “intentionally false and misleading.” The site says, for example, that the downward air flow standard in operating rooms is much stronger than that of the forced air warming system, and that the air emerging from the blanket is directed down from the operating table and into the room’s return inlets.

Gerald says these statements mask the true problem, namely that warm air from the blower unit rises past the cold air of the operating room and enters the surgical site.

Gerald also says that sometime between 2002 and 2009, the defendants increased the risk of infection even more by reducing the efficiency of the air filtration systems inside the blower unit. That causes pathogens to get trapped inside the blower unit and incubate there, he says.

For compensation, Gerald is seeking an award of damages for his injuries as well as an award of punitive damages large enough to deter any future similar conduct by the defendants.

Gerald’s Bair Hugger Lawsuit is Case No. 0:15-cv-03141, in the U.S. District Court for the District of Minnesota.