A pair of recent lawsuits have been filed in courts nationwide alleging that a device frequently used during surgery may lead to life-threatening hip and knee infections.
The Bair Hugger Forced Air Warming system is often used to keep patients warm in the operating room, but according to paperwork filed in litigation against device manufacturer 3M Infection Prevention Solutions, it also greatly increases a patient’s risk of developing MRSA, sepsis and other potentially deadly deep joint infections.
Study Shows Risks
The Bair Hugger is a blanket that functions similarly to a forced-air heating system. Warm air is sucked through a hose and into the blanket, and pushed out vents on the other side. They are most commonly used to warm patients who are under anesthesia during a surgical procedure to keep them at ‘normalthermia’ (optimal temperature equilibrium).
Surgeons know, a sterile environment free of germs and bacteria is vital to a successful surgical procedure where the fight against infections can mean the difference between life and death. Onsite in the hospital environment, despite best efforts to ensure a sterile operating site, bacterium and microorganisms may be present on some surfaces.
According to the lawsuit complaint filed in Kansas City against 3M Infection Prevention Solutions , hot air warming devices can force bacteria that would otherwise remain on the floor undisturbed to become airborne and possibly infect the patient (Case 2:14-cv-02044).
The lawsuits allege contamination of wounds and implants can happens due to the design of the blanket itself. Bair Huggers discharge the heated air under the operating table, disrupting microorganisms on the floor.
The contaminated hot air naturally rises, and is sucked back into the machine for reuse and in the process exposing the surgical wounds and artificial implants to bacterium and infection causing pathogens.
Recent research by the Bone and Joint Journal found intraoperative forced air warming systems to increase airborne contaminants by as much as 1000-fold, with up to 2000x the airborne contaminant particles when used (Bone & Joint Journal Study).
Initially, patients did not link the infections to the blankets but the study on the devices published in The Bone and Joint Journal, however, showed that patients whose surgeons utilized the forced-air warming devices like Bair Hugger may have increased the likelihood of unwanted pathogen exposure during the procedure.
The researchers compared the contaminants present near the surgical site of patients who were warmed with air-free systems against those who were treated with the Bair Hugger type forced-air system. Measuring the particles, there were 2,000 times more infection-causing microorganisms on the patients warmed using forced-air warmers.
The Dangers of Hospital-Acquired Infections
Hospital-acquired infections are actually more common than many people realize. In fact, they are the fourth leading cause of illness in the United States according the National Institute of Health in a study on infections related to implantable biomaterials (NIH).
In fact, a survey of U.S. hospitals shows that one out of every 25 patients has a hospital-acquired infection at any given time (Center for Disease Control). The study also found that in 2011 alone, more than 722,000 patients contracted an infection while in the hospital. About 75,000 of these patients died before they could be released.
The National Institute of Health study relates how patients who have undergone procedures that require implants or other foreign material to be placed within the body are at a very specific risk. Many of these devices are easily colonized if they are exposed to bacteria. In some cases, infections or fungi can spread across these implants at a rate of a half centimeter per hour.
Within 24 hours, the microorganisms can completely cover the surface of the device and infiltrate nearby tissues.
In some cases, these infections can be treated with antibiotics. Many, however, such as the much-feared MRSA, are resistant to antibiotics.
If they cannot be treated with medication, surgery may be required to repair the damage. This often involves removing the infected knee or hip implant and affected surrounding tissues; amputation is not uncommon when fighting these infections. Deep joint infections can present symptoms many months after the artificial joint was implanted.
Even if amputation isn’t necessary, this type of infection can quickly lead to lasting permanent disabilities. This means the patient must spend more time hospitalized.
Complications can mean disability, prolonged hospitalization, ex-plant / revision surgeries, amputation and other very serious health problems.
The cost of their care may skyrocket, and months of rehabilitation may be required. Without excellent insurance, these patients can quickly owe hundreds of thousands of dollars, may be be too ill to return to work for months if at all, and could possibly face permanent mobility issues.
If you had an infected joint replacement, to find out if you qualify to file a lawsuit, share what happened with an attorney here.
One of the first landmark lawsuits against the 3M device was filed in 2013, in Harris County Texas, plaintiff represented by Houston based law firm Kennedy Hodges (Cause Number 2013-13032). Tommy Walton underwent hip replacement surgery in 2011, and a Bair Hugger system was used to warm him during the procedure. According to the court documents, as a result of the operation, he contracted a serious infection at the site of the surgery.
In order to save his life, the artificial hip had to be removed, and he underwent 15 additional surgeries. Walton is now permanently disabled as a result of the infection. His suit, filed in state court, requests more than $1 million. It names not only 3M but its subsidiary Arizant Healthcare Inc. and an employee working for the companies. (h/t TwinCities)
Another lawsuit, this one filed by a Kansas City personal injury attorney on behalf of a local man, alleges that the plaintiff had to have his leg amputated due to complications caused by the Bair Hugger system (Case 2:14-cv-02044). Timothy Johnson underwent a September 2010 knee replacement procedure that utilized the device at the University of Kansas Hospital.
As a result of the procedure, the complaint alleges he was infected with Methicillin-resistant Staphylococcus aureus, better known as MRSA. This required the patient’s leg to be amputated in order to prevent spread of the infection to the rest of his body.
According to this suit, Johnson believes that 3M knew about the increased risk of infections before he underwent the procedure.
However, no attempt was made to warn hospitals or patients of the risks. The suit also alleges that the company and employees of its subsidiaries actually went out of their way to attempt to “conceal and discredit” any studies that demonstrated an increased risk of infection. You can read more about the basics of product liability litigation here.
Looking Toward The Future
In 2010, the inventor of the Bair Hugger urged surgeons to stop using the device (NY Times). Many healthcare professionals shrugged off this advice, pointing out that Dr. Scott D. Augustine had recently released a new warming product that directly competed against the Hugger.
Meanwhile, a number of leading attorneys believe the claims justified and have begun reviewing hip and knee deep joint infection claims (Newswire).
According to Arizant Healthcare, the Bair Hugger has been used on more than 160 million patients, and is still in use in more than 80 percent of hospitals in the United States (Anesthesiology News). This means the number of lawsuits could skyrocket in the coming years as awareness grows and potential claimants come forward in growing numbers.