3M Compiles Bair Hugger Research Compendium To Combat Safety Concerns

Amid mounting concerns about 3M Bair hugger warming blankets causing hip and knee infections following joint replacement surgery, the manufacturer has released what it calls a “compendium” of research that purports to establish that the controversial forced-air warming system is safe.

The move comes as the company faces a growing number of hip infection lawsuits and knee infection lawsuits filed by individuals nationwide, alleging that the use of a Bair Hugger warming blanket during surgery caused contaminants or bacteria from the operating room floor to enter the open surgical wound, often causing a severe and debilitating deep joint infection.

The 3M Bair Hugger is found in most operating rooms throughout the U.S., using forced-air blown into an inflatable blanket placed over a patient during surgery to control body temperature. However, complaints allege that the design of the system disrupts the laminar air flow of the operating room, citing studies that have found substantial increases in the temperature and number of particles over the surgical site when forced-air warming is used. In addition, many of the cases allege that the Bair Hugger filter system is insufficient and unreasonably dangerous.

The 3M research “compendium” was released by the manufacturer of the device late last month, including data on more than 200 studies involving the use of forced air warming blankets conducted since 1987, when the Bair Hugger was first released.

“This compendium represents the largest body of evidence supporting patient warming, specifically the Bair Hugger system,” Dr. Michelle Stevenschief medical officer, 3M Infection Prevention Division, said in a May 24 press release. “Since its inception, the Bair Hugger system has been the gold standard in patient warming devices, and this expertly compiled evidence reaffirms the safety and effectiveness of this system.”

Lawsuits over the warming blanket claim that the manufacturer has known about the hip and knee surgical infection risk for years, yet failed to make design changes or provide warnings to the medical community. In addition, plaintiffs allege that there are safer alternative warming blanket designs that do not carry the same risks.

Given the similar questions of fact and law presented in the cases, the U.S. Judicial Panel on Multidistict Litigation (JPML) established coordinated pretrial proceedings for the federal litigation, centralizing cases brought nationwide before U.S. District Judge Joan Ericksen in the District of Minnesota to reduce duplicative discovery into common issues that will arise in the cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

As hip and knee infection lawyers continue to review and file additional cases in the coming months and years, it is ultimately expected that several thousand claims involving severe and debilitating deep tissue infections may be brought on behalf of individuals throughout the United States.