3M Opposes Centralization of Bair Hugger Infection Lawsuits

Despite a growing number of hip infection lawsuits and knee infection lawsuits that continue to be filed over the 3M Bair Hugger forced air warming blanket, the manufacturer is opposing the centralized management of the litigation in the federal court system.

Last month, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to consolidate all Bair Hugger infection lawsuits pending throughout the federal court system against 3M Corporation, 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.

There are currently at least 14 product liability lawsuits pending against 3M and their Arizant Healthcare subsidiary, which each raise similar allegations that design problems with the Bair Hugger warming blanket used during hip and knee replacement surgeries caused individuals nationwide to suffer severe and catestrophic infections.

The lawsuits claim that the forced air warming system may cause bacteria and contaminants from the operating room floor to enter the surgical site, causing plaintiffs to suffer MRSA (methicillin-resistant staphylococcus aureus), sepsis or other deep joint infections, often resulting in the need for additional surgery.

In a response (PDF) filed with the U.S. JPML on September 14, 3M indicates that it opposes the creation of a Bair Hugger MDL, suggesting that the claims have no basis in science and that the lawsuits have too many individual characteristics to warrant consolidation for pretrial proceedings before one judge.

3M indicates that the Bair Hugger litigation differs from other mass-tort proceedings, which are typically initiated by an FDA action or independent, peer-reviewed studies that discover a new risk with a medical device. The manufacturer suggests that hip and knee replacement infection lawsuits have been “concocted” by lawyers and are based on claims by the inventor of the Bair Hugger, Dr. Scott Augustine, who now sells a competing surgical warming system.

“The Motion of Plaintiff for Transfer of Actions to the District of Minnesota recites a litany of false claims and conjecture, supported by deeply flawed and competitor-sponsored ‘studies,’ and draws conclusions that the studies themselves do not suggest,” argues 3M in the opposition. “Indeed, these same allegations and alleged ‘studies’ have been reviewed and rejected by multiple independent organizations. Sanctioning this litigation through the creation of an MDL could put countless patients in danger of serious surgical complications by needlessly intimidating medical providers into discontinuing the use of proven and important surgical care. There have been no studies establishing that the use of Bair Hugger FAW causes infections.”

The U.S. JPML is expected to schedule oral arguments on the motion during an upcoming hearing session set for December 3, in New Orleans, Louisiana.

Forced Air Warming Blanket Infection Risks

The Bair Hugger warming blanket is commonly used during most orthopedic joint replacement procedures in hospitals throughout the U.S., 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 joint infections due to the design of the device.

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.

An alternative warming blanket now sold Dr. Augustine, known as the HotDog Warming system, provides an air-free, water-free method of maintaining body temperature during surgery, which many experts indicate is a safer alternative design to the Bair Hugger.

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.