Deep Joint Infection Lawsuit Filed Over Bair Hugger Knee Surgery Warmer

According to allegations raised in a product liability lawsuit filed this week against 3M Company and its Arizant Healthcare subsidiary, a Texas woman suffered a severe deep joint infection following knee surgery where the 3M Bair Hugger surgical warmer was used to control body temperature. 

The complaint (PDF) was filed by Mary Lewis-Mosqueda in the U.S. District Court for the District of Minnesota on November 18, indicating that the design of the hip and knee surgery warming blanket was the cause of her deep joint knee infection, which led to the need for revision surgery to remove the implant.

The 3M Bair Hugger is a surgical warmer commonly used during most orthopedic joint 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 surgical outcomes. However, a growing number of patients now indicate that they developed deep joint infections following surgery where a Bair Hugger warmer was used.

According to allegations raised in a growing number of similar knee surgery infection lawsuits and hip surgery infection lawsuits filed in recent months, the forced air system used by the Bair Hugger surgical warmer 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 particles in the air near a surgical wound, and some surgeons have reported higher rates of deep joint infections following hip or knee surgery where forced air warming was used.

According to the lawsuit, Lewis-Mosqueda underwent knee replacement surgery on November 23, 2009, during which a Bair Hugger warmer was used. Following the procedure, she soon began showing signs of a deep infection and had to undergo several surgeries and weeks of antibiotic therapy.

In May 2010, she had to have the artificial knee joint removed and replaced with an antibiotic spacer. She then had to undergo another surgery in June 2010 to remove the spacer, and again in July 2010 to have a new knee implanted.

The lawsuit indicates that the manufacturers knew as early as June 1997 that the Bair Hugger could blow contaminants onto a surgical wound, and said as much in a letter that month to the FDA.

“The Defendant addressed this flaw in their products by making further misrepresentations to the FDA when they stated that the risk of contamination by air flow is obviated because all ‘Bair Hugger Blankets designed for use in the operating room feature a tape barrier which prevent [sic] air from migrating toward the surgical site.’ That statement by the Defendants was and is patently false,” the lawsuit states. “A number of Bair Hugger blankets marketed as safe for use in surgeries do not utilize a taped edge at all. Instead, those blankets blow contaminated air directly toward the surgical field.”

Lewis-Mosqueda is pursuing claims against 3M and Arizant for negligence, violations of Minnesota’s deceptive trade practice laws, failure to warn, designing and manufacturing a defective medical device, breach of implied warranty, negligent misrepresentation, fraudulent misrepresentation, and fraudulent concealment, seeking both compensatory and punitive damages.

Hip and Knee Surgery Warmer Litigation

Amid the growing number of cases filed over the Bair Hugger surgical warmer, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation in August, seeking to centralize all deep joint infection lawsuits pending throughout the federal court system before one judge for coordinated pretrial proceedings.

Each of the complaints 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, including MRSA (methicillin-resistant staphylococcus aureus), sepsis or other deep joint infections, often resulting in the need for additional surgery.

A group of plaintiffs have requested that the cases be centralized before one judge in the District of Minnesota, as part of a federal MDL, or multidistrict litigation. The process is designed to reduce duplicative discovery into common issues in the lawsuits, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

3M and Arizant have opposed the establishment of a Bair Hugger infection lawsuit MDL, claiming that there’s no basis in science for the claims and that the cases are too individualized to justify centralized pretrial proceedings.

In a response in support (PDF) filed late last month by one of the many plaintiffs who have brought cases, it is noted that there is a high probability that “hundreds of cases” will be filed in the future, as hip and knee infection lawyers continue to review and file claims on behalf of individuals nationwide.

The U.S JPML is scheduled to consider oral arguments on the motion during an upcoming hearing in New Orleans on December 3.