Medical device manufacturer 3M has been hit with another Bair Hugger lawsuit over allegations that the use of the forced air warming blanket used during hip surgery caused a surgical infection that created further complications.

Plaintiff James H. claims he underwent total right hip arthoplastic surgery in November 2011, during which the Bair Hugger device was used.

These warming blankets are placed over patients during surgical procedures in order to keep the patient’s body temperature stabilized.

According to the 3M Bair Hugger lawsuit, James developed a post surgical hospital infection soon after his procedure, reportedly due to bacteria that was blown directly into the surgical sight.

The plaintiff alleges that he was diagnosed with a periprosthetic infections that contained Methicillin-Resistant Staphylococcus Aureus (MRSA).

However, the Bair Hugger lawsuit states that it was not until recently that James discovered that the medical device may have been the reason why he suffered a serious hospital infection.

James states that Bair Hugger manufacturers have been aware of this tendency since 1997. The 3M lawsuit points a letter the defendants wrote to the FDA, where they admitted that “air blown intraoperatively across the surgical wound may result in airborne contamination.”

Bair Hugger Complications

The Bair Hugger is composed of a portable heater that is connected to a flexible hose and disposable blanket, which is placed over the patients undergoing surgery.

The blankets blow hot air onto the patient to prevent lowering body temperatures but as as the temperature of the air rises, the Bair Hugger lawsuit alleges that it collects bacterial from the floor that are then deposited onto the patient.

According to the lawsuit, 3M had reduced the efficiency and safety of the Bair Huggers between 2002 and 2009. In 2000, the companies stated that the Bair Hugger met federal High Efficiency Particulate Air (HEPA) standards, which was later proven to be false.

HEPA requires all air filter devices to be able to remove at least 99.97 percent of all bacterial particles in the surrounding air, the plaintiff claims that Bair Hugger’s removed less than 65 percent.

Over 50,000 Bair Huggers are used in hospitals across the country, each of which were allegedly sold under the false marketing statements of 3M and Arizant of meeting HEPA standard.

James states that the defendants’ either knew or should have known the risks their device imposed on him, and should have notified him or his physicians of these complications.

Patients who suffer hospital infections after using the Bair Hugger, often have to undergo additional surgeries to correct the problem. James states that he never would have used the Bair Hugger device, if he had known the risk of bacterial infections.

For being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous product, James is suing 3M Company and Arizant Healthcare. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.

The Bair Hugger Lawsuit is Case No. 2:15-cv-08835-BRO-JC, in the U.S. District Court of Central California.