Bair Hugger Lawsuit Alleges Infection Risk from Warming Blanket Known For Years

According to allegations raised in a Bair Hugger warming blanket lawsuit filed last week by a California man, 3M Company and it’s Arizant Healthcare subsidiary have known for years about the infection risk from the forced-air warming blanket commonly used during knee and hip replacement surgery.

The complaint (PDF) was filed by Manuel Griego in the U.S. District Court for the District of Minnesota on October 9, alleging that a Bair Hugger warming blanket used during his knee replacement surgery caused the development of a severe infection, which required extensive treatments and revision surgery.

Griego underwent left knee arthroplasty on March 4, 2014, during which a Bair Hugger was used to control body temperature, which has been an increasingly common practice during artificial hip and knee implant procedures in recent years. However, the complaint alleges that the forced-air system used by the Bair Hugger caused bacteria and other pathogens to be blown into the sterile surgical site, resulting in a coagulese-negative staphylococci infection.

As a result of the knee infection, the original implant had to be removed and replaced with an antibiotic spacer for three months in order to eliminate the infection. Griego then had to undergo additional surgery to have a new knee implant installed.

The complaint alleges that 3M and Arizant have been aware of the increased infection risk with Bair Hugger warming blankets since at least 2009, yet continued to provide false and misleading information to the public and the medical community, instead of fixing the problems.

Griego’s case joins a growing number of hip infection lawsuits and knee infection lawsuits filed in recent weeks over the Bair Hugger, each raising similar allegations that the device disrupts the laminar air-flow used in the operating room to keep bacteria away from the open surgical wound.

Plaintiffs allege that they have suffered various complications due to the Bair Hugger infections, including methicillin-resistant staphylococcus aureus (MRSA), sepsis, amputations and even wrongful death.

Bair Hugger Infection Risks

In recent years, the Bair Hugger warming blanket has been found in most operating rooms throughout the U.S. during orthopedic joint replacements, providing forced air warming to help control body temperature during surgery. This is designed to reduce the risk of bleeding and improve outcomes. However, many patients indicate that they developed severe infections that may have been avoided if alternative designs had been used.

According to allegations raised in the lawsuits, the forced air system disrupts the laminar flow of the operating room, allowing bacteria and other contaminants from the floor to enter the surgical site. Plaintiffs point to studies that indicate use of forced air warming blankets cause substantial increases in the number of contaminant particles in the air near a surgical wound and higher rates of knee or hip sepsis infections following joint replacement surgery.

There are more than 50,000 Bair Hugger warming blankets in hospitals nationwide, and the devices have been used on millions of patients. The lawsuits 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.

As hip and knee infection lawyers continue to review cases for individuals who have experienced problems following surgery where a Bair Hugger was used, it is ultimately expected that several hundred cases will be filed against 3M in courts throughout the country.

In August, a  motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to consolidate all Bair Hugger lawsuits pending throughout the federal court system, indicating that centralized management before one judge is necessary to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the courts.