Around 900 lawsuits have been filed by people who developed deep joint infections after surgeries involving 3M’s Bair Hugger forced-air warming device.
UPDATE: Bair Hugger MDL Judge Sets Trial Schedule
In November 2016, the federal judge overseeing nearly 900 lawsuits involving 3M’s Bair Hugger Forced-Air Warming Blanket set a deadline of March 8, 2017 for lawyers to agree upon one case for the first “bellwether” trial.
What is the Bair Hugger?
The Bair Hugger is a forced-air warming blanket for patients undergoing surgery. It helps anesthetized patients regulate their body temperature and prevent hypothermia. It works by forcing hot air through a hose into a special disposable blanket that is draped over the patient.
What is the problem?
The Bair Hugger is supposed to reduce health risks for patients during major surgeries, but critics say it can potentially blow non-sterile air into sterile surgical sites. The risk is especially serious for patients undergoing heart surgery to implant artificial valves, or joint replacement surgery to implant prosthetic hips and knees.
How Could Forced-Air Warming Contribute to Infections?
- Convection Currents: “[F]orced air warming was found to establish convection currents that mobilized resident air from nonsterile areas (under the anesthesia drape) upward and into the surgical site. The clinical concern is that convection currents may mobilize underdrape contaminants into the surgical site and/or impede the ventilation systems’ ability to clear contaminants from the surgical site.” (Source)
- Internal Contamination: “The design of FAW blowers was found to be questionable for preventing the build-up of internal contamination and the emission of airborne contamination into the operating room. Although we did not evaluate the link between FAW and surgical site infection rates, a significant percentage of FAW blowers with positive microbial cultures were emitting internally generated airborne contamination within the size range of free floating bacteria and fungi (<4 µm) that could, conceivably, settle onto the surgical site.” (Source)
- Mobilizing Skin Organisms: “Prolonged exposure of the patient to the exhaust of the warming blanket could potentially mobilize their resident skin organisms into the theatre atmosphere, and thence into the surgical field, possibly increasing the risk for prosthetic material infection. This has not previously been investigated.” (Source)
March 2014 — A federal lawsuit has been filed in Kansas alleging that the Bair Hugger caused a man to become infected with Methicillin-resistant Staphylococcus aureus (MRSA), leading to the amputation of his leg.
The man, Timothy Johnson, developed the antibiotic-resistant infection after knee replacement surgery at the University of Kansas Hospital in September 2010. According to the lawsuit, air from the Bair Hugger system “creates warm, rising, airflow currents that deposit bacteria from the floor of the surgical room into the surgical site.”
Another victims is Rosie Bartel, a woman who developed a MRSA infection after a routine knee replacement. She had to have 11 surgeries, part of her leg amputated, and now must use a wheelchair.
Bair Hugger MDL
All of the lawsuits are consolidated into Multi-District Litigation (MDL No. 2666) in the U.S. District Court for the District of Minnesota under Judge Joan N. Ericksen. The MDL was created in December 2015 and mostly involves orthopedic surgery infections.
Antibiotic-Resistant MRSA Infections
Lawsuits have been filed by people who developed antibiotic-resistant MRSA infections after undergoing hip or knee replacements in which the Bair Hugger was used.
Bair Hugger Lawsuits
- A man from Michigan who developed a severe infection after a hip replacement has filed a lawsuit (PDF) claiming the Bair Hugger blew bacteria onto his body. Click here to read more.
- A federal lawsuit (PDF) has been filed by a Texan who blames the Bair Hugger for an antibiotic-resistant MRSA infection after routine hip replacement surgery. Click here to read more.
- A lawsuit (PDF) has been filed against 3M by a man who blames the Bair Hugger for his severe joint infection. Click here to read more.
Hip Replacement Infections
About 1% of hip or knee replacement patients develop a deep joint infection. This serious complication often must be treated with multiple surgeries to replace the implant, wash out the joint and tissues, and administer intravenous antibiotics.
Symptoms of a Deep Joint Infection
- Increased pain or stiffness in a previously well-functioning joint
- Warmth and redness around the wound
- Wound drainage
- Fevers, chills, and night sweats