Hip, Knee Replacement Infection Lawsuits Over 3M Bair Hugger Claim HEPA Non-Compliance

3M and their Arizant Healthcare subsidiary face a growing number of product liability lawsuits over hip and knee replacement infections caused by Bair Hugger warming blankets, which allege that the manufacturers lied to the FDA about how effective the forced air warming device is at filtering out contaminants.

The Bair Hugger has been commonly used during most orthopedic joint replacement procedures in recent years, providing forced air warming (FAW) to help control the patient’s body temperature during surgery. However, many patients are now pursuing hip replacement infection lawsuits and knee replacement infection lawsuits, claiming that the device caused bacteria and contaminants from the operating room floor to enter the sterile surgical field.

More than 50,000 Bair Hugger units are in hospitals nationwide, and the warming blankets have been used on millions of patients. The lawsuits claim that the manufacturer has known about the infection risk for years, yet failed to make design changes or provide warnings to the medical community.

At least four Bair Hugger lawsuits were filed this week, alleging that Arizant, the original creator of the forced air warming blanket that was later acquired by 3M, provided false and misleading information to the FDA in 2000 about the effectiveness of the device in filtering air particles.

High Efficiency Particulate Air (HEPA) standards require that an air filter be capable of removing 99.97% of all particles 0.3 microns or larger. However, plaintiffs allege that the manufacturer told the FDA that the Bair Hugger meets this standard, when it does not, causing hip and knee replacement patients to face a risk of serious infection during the procedure.

According to allegations raised in one complaint (PDF) filed in the U.S. District Court for the District of Minnesota on August 19, the Bair Hugger blanket caused an Alabama woman, Barbara Libby, to suffer a severe infection following a right hip replacement procedure in November 2010.

“The filter of the Bair Hugger, which is marketed as HEPA compliant, is only capable of removing less than 65% of all such particles,” according to the lawsuit filed by Libby. “When the Defendants made these representations, they had actual knowledge of their falsity.”

The lawsuit also notes that as early as 1997, the manufacturer admitted to the FDA that “air blown intraoperatively across the surgical wound may result in airborne contamination.” They told the FDA that was prevented in the case of the Bair Hugger by a tape barrier, which plaintiffs say does not work

Libby claims that the forced air warmer introduced contaminants into her surgical wound, resulting in the need for seven additional surgeries, including one to remove the implant. She has now been left with permanent injuries and impaired mobility, requiring use of a cane or walker to walk.

Similar allegations were raised in another complaint (PDF) filed the same day in the District of Minnesota, where Michael Williams claims that he experienced an infection following a right knee replacement surgery in February 2013, where a Bair Hugger warming blanket was used. Due to the infection, Williams required two additional surgeries within less than nine months of the implant, the first to remove the artificial knee and place a temporary antibiotic spacer. Months later, he underwent a second procedure to remove the spacer and place another knee implant.

“The Defendants concealed and continue to conceal their knowledge of the Bair Hugger’s unreasonably dangerous risks from Plaintiff, other consumers, and the medical community,” according to the lawsuit filed by Williams. “The defendants failed to conduct adequate and sufficient post-marketing surveillance after they began marketing, advertising, distributing and selling the Bair Hugger.”

As more individuals discover the potential link between their knee or hip replacement infection and the Bair Hugger warming blanket, it is expected that the number of complaints will continue to increase over the coming months or years.

Plaintiffs are pursuing claims for failure to warn, designing and manufacturing a defective product, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, and fraudulent concealment, seeking both punitive and compensatory damages.