Surgical Warming Blanket Lawsuit Filed Over Cellulitis, Propionbacterium Infections Following Hip Replacement

A New York couple has filed a product liability lawsuit that alleges side effects of a surgical warming blanket used during a hip replacement caused a number of severe and debilitating infections.

The complaint (PDF) was filed in the U.S. District Court for the Eastern District of New York on November 25, by Peter Ciappa and his wife, Tanya, over the design of the 3M Bair Hugger forced-air warming system, which is used during most hip and knee replacement procedures in hospitals throughout the country.

The surgical warming blanket lawsuit indicates that a Bair Hugger was used during Peter Ciappa’s left hip replacement surgery on October 24, 2012, providing forced-air warming during the procedure to help doctors control body temperature. However, Ciappa indicates that the design of the warming blanket may have caused bateria and other contaminants from the operating room floor to enter the sterile surgical site.

“Because the Bair Hugger was used, contaminants were introduced to Plaintiff’s open surgical wound, thereafter resulting in infection, including but not limited to Cellulitis and Propionbacterium acnes,” the lawsuit indicates. “Due to the infection, Plaintiff needed four additional surgical procedures to remove the implant and clean the infected area within sixteen months from the original implant surgery, and he continues to suffer limited mobility, requiring crutches to ambulate.”

The complaint includes 3M Company and its Arizant Healthcare, Inc. subsidiary as defendants, indicating that Ciappa suffered and continues to suffer from permanent injuries as a result of the Bair Hugger hip infection.

Hip and Knee Surgery Warmer Litigation

The Ciappas join a growing number of other individuals now pursuing a hip surgical infection lawsuit or knee surgical infection lawsuit after experiencing similar problems with a Bair Hugger was used during their procedure.

The 3M Bair Hugger warmer works by blowing hot air into a disposable blanket that is placed over the patient during surgery. However, plaintiffs allege that this design disrupts the sterile air flow in an operating room, causing substantial increases in the number of particles in the air near a surgical wound.

As early as June 1997, Ciappa points out that a letter sent by the manufacturer to the FDA acknowledged that “air blown intraoperatively across the surgical wound may result in airborne contamination.” However, in 2000, the manufacturer told the FDA that the Bair Hugger’s filtration system met High Efficiency Particulate Air (HEPA) standards, which require that an air filter remove 99.97% of all particles 0.3 microns or larger. The lawsuit claims that the filter was only capable of removing 65% of such particles. Then, the lawsuit claims, the company made changes to the Bair Hugger that increased the risk of infection even more.

“At some point between 2002 and 2009 the Defendants reduced the efficiency of the air filtration of Bair Hugger blowers. This action reduced the safety of such blowers,” the latest lawsuit states. “As a result of these actions by the Defendants, the internal airflow paths of Bair Hugger blowers become contaminated with pathogens.”

Ciappa is pursuing causes of action against 3M and Arizant for negligence, violations of New York consumer protection laws, strict liability, failure to warn, defective design and manufacture, breach of express and implied warranty, negligent misrepresentation, fraudulent misrepresentation and concealment, as well as loss of consortium, seeking both compensatory and punitive damages.