The Bair Hugger forced-air warming blanket originally seemed like a great idea. Developed by an anesthesiologist, Dr. Scott Augustine, Bair Hugger was a forced-air warming blanket that is draped across a patient during and after surgery. The theory is that warm air against the body stimulates faster recovery and reduces bleeding. I believe the results have shown that Bair Hugger has sped recoveries for patients. Unfortunately, patients also began to suffer from infections. Some of these infections have been significant and caused serious injury in patients.
In fact, Dr. Augustine has reversed field on his invention and now believes it should no longer be used during and after surgeries. He believes it is particularly dangerous for patients receiving medical device implants like artificial hips and knees, according to an article in The New York Times. The risk of infection is allegedly caused by the forced-air within the blanket which can spread bacteria often found in hospitals. Consumer advocates allege that the forced air pushes bacteria and other contaminants into open wounds of patients during and after surgery, which can increase risk of infections. Some individuals have suffered from very serious or even life-threatening infections. The scientific theory suggests that in artificial joint surgeries the immune system is not triggered as readily, such that bacteria introduced into the body is much more dangerous to the patient than under normal conditions. As a result, the bacteria in the patient’s body can cause much more damage and be life-threatening. In some cases, patients have had to undergo revision surgeries at the site of the artificial joint implantation; in rare cases, amputation was necessary because of the severe infection.
However, as I discuss below, Arizant Healthcare, Inc., the manufacturer of the Bair Hugger blanket, disputes that any increased risk of infection occurs with Bair Hugger. The medical device is still on the market and is still used in many surgeries.
Despite Arizant’s denials, people have suffered bad infections and have sued because of those injuries. Currently more than seven hundred (700) lawsuits have been filed against Arizant Healthcare and its parent company, 3M Company. These lawsuits allege injury from infection caused by the Bair Hugger blanket.
Bair Hugger MDL Formed
In August 2015, the Judicial Panel on Multidistrict Litigation (JPML) formed a multi-district litigation site for Bair Hugger lawsuits. The MDL is situated in the United States District Court in Minnesota. The JPML chose Minnesota in large part because “3M and Arizant defendants are headquartered in Minnesota, and many witnesses and relevant documents are likely to be found there.” In addition, the December 11, 2015 JPML Order, which transferred the first Bair Hugger cases across the country to the Minnesota MDL, stated:
“[W]e find that these actions involve common questions of fact, and that centralization will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. The actions share factual issues arising from allegations that plaintiffs developed serious infections during their orthopedic surgeries due to the introduction of contaminants into their open wounds as a result of the use of a Bair Hugger Forced Air Warming system (Bair FAW). Specifically, plaintiffs allege that the device is defective in at least two respects: (1) the device affects airflow in the operating room, causing bacteria from the operating room floor to be deposited into the surgical site; and (2) the internal airflow paths of the device’s blower can become contaminated with pathogens that can then be expelled into the operating room. The actions thus present common issues concerning the development, manufacture, testing, regulatory approval process, and marketing of the Bair FAW. Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings on Daubert and other issues, and conserve the resources of the parties, their counsel, and the judiciary.”
On September 27, 2016, the Bair Hugger MDL issued a pretrial order approving a “Plaintiff Fact Sheet” (PFS) for all cases in the MDL. The Order requires all Plaintiffs to serve a completed Fact Sheet within ninety (90) days of filing a lawsuit in the MDL or transferring a lawsuit to the MDL. The PFS will essentially set out the essential facts of the specific case: complete contact information, the type of surgery, the dates of surgery and later infection, a description of the infection, the treatment required, the injuries that occurred, whether temporary or permanent, and other key information. The PFS is used often in MDLs to streamline discovery and to make review of each individual case more efficient.
Bair Hugger Dangers Disputed by Manufacturer
It is important for me to note again that Arizant Healthcare, the Bair Hugger blanket manufacturer, disputes reports that Bair Hugger poses an increased risk of infection to patients. In fact, Arizant and Dr. Augustine, the original inventor, have been engaged in bitter litigation over the years, both for monies owed and for alleged defamatory statements about the Bair Hugger.
3M Corporation purchased Arizant in 2010. So now the Bair Hugger blanket is 3M’s blessing and its curse. 3M released a statement years ago about the company’s disagreements with the inventor: “We believe Mr. Augustine’s allegations against forced-air warming stem from a personal vendetta and are baseless.”
At this point, it appears Arizant and 3M will vigorously defend themselves against the lawsuits filed over the Bair Hugger blanket. This hard line may soften, however, if more reports of serious infection occur, and if the medical research community determines an increased risk for infection after careful scientific study. If you suffered a serious infection after artificial hip or knee surgery which utilized the Bair Hugger blanket, you should probably have your case reviewed by a competent products liability attorney. Feel free to call me for more information: (919) 546-8788.
In re Bair Hugger Forced Air Warming Products Liability Litigation, MDL No. 2666