FORCED ARGUMENT? Many disagree with the assertion that the forced-air design of the Bair Hugger is inherently dangerous.

The Bair Hugger forced-air warmer is being blamed for the death of a Louisiana man in what is at least the third suit brought over allegations that a patient death was caused by the popular warming system. Hundreds of lawsuits alleging that warmed air can spread bacteria associated with hospital-acquired infections have been filed, especially on behalf of surgical patients who've contracted infections after receiving implants like artificial heart valves and joints.

Family members say Edgar C. Woodyear Jr. developed an infection in May of 2014 after undergoing cardiac mitral valve replacement surgery, and died 4 months later. The infection that ultimately killed him, they say, was a direct result of the Bair Hugger.

In other pending cases, a California resident has alleged that the Bair Hugger caused his father to suffer a MRSA infection, which led to additional surgical procedures, and ultimately to his death; and a Texas widower has claimed that the Bair Hugger caused his wife to contract an SSI during cardiac surgery, which ultimately led to her death.

Meanwhile, 3M insists that it's being targeted both by opportunistic lawyers who are "concocting claims based on junk science," and by anesthesiologist Scott Augustine, MD, who invented the Bair Hugger, but no longer has a financial stake in it. Dr. Augustine left 3M in 2002 and now markets another warming device he invented: the HotDog warming system, which works more like an electric blanket and does not use forced air.

At the heart of the controversy is considerable disagreement about whether the forced-air design of the Bair Hugger is inherently dangerous. Dr. Augustine and others argue that because warm air from the Bair Hugger is exhausted below the operating table, it can contact the floor, mingle with contaminants and then rise above the operating table, where it can enter open surgical wounds and cause infections. Hip- and knee-replacement patients, they say, are especially vulnerable.

In 2011, the Bone and Joint Journal published a study that suggested that forced-air warming created a "significant" increased risk for deep-joint infection compared with the conductive fabric-warming design used by the HotDog.

But many insist that there's no scientific basis for blaming SSIs on the Bair Hugger, and 3M says the Bair Hugger's safety has been supported by 60 randomized controlled clinical trials since 1987. The company points to what it calls "false claims and conjecture, supported by deeply flawed and competitor-sponsored studies [that] have been reviewed and rejected by multiple independent organizations."

Meanwhile, the lawsuits continue to pile up. In December, the Judicial Panel on Multidistrict Litigation centralized 14 federal lawsuits alleging that Bair Hugger caused patients to develop infections. Judge Joan N. Ericksen, of the U.S. District Court for the District of Minnesota, recently announced that the first bellwether trial, which will likely have a significant impact on future cases, will take place in November 2017.

"3M wants patients, surgeons and hospitals to know that there is absolutely no merit to these claims," says 3M spokeswoman Donna L. Fleming Runyon. "In over 25 years and more than 200 million patients there is not a single confirmed incident of infection caused by the Bair Hugger system."

Jim Burger