Bair Hugger Lawsuits Update: 800 Cases Filed, Conference on Nov. 17, 2016. Lawsuits alleging deep joint infections from the Bair Hugger forced-air warming blanket are consolidated into a federal multidistrict litigation (MDL) in the U.S. District Court, District of Minnesota. The next status conference in the Bair-Hugger MDL is scheduled for Nov. 17, 2016 at 10:00 a.m. CST. The litigation continues to move forward, as cases continue to mount.
According to an update issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML), the Bair Hugger MDL contained 809 lawsuits as of Oct. 17, 2016. The personal injury lawyers at Parker Waichman LLP note that the number of filings has increased by 116 cases since September 15th, when the JPML reported 693 lawsuits in the Bair MDL.
An MDL is a proceeding that consolidates similar lawsuits to one court before one judge. Centralizing cases with common questions of fact helps make legal proceedings more efficient by avoiding duplicate discovery and conserving court resources. In the Bair Hugger MDL, plaintiffs similarly allege that the Bair Hugger surgical warming blanket introduced contaminants into the surgical site and led to a serious infection. The lawsuits allege that Arizant Healthcare and parent company 3M failed to warn patients and the medical community about these risks.
The JPML established the Bair Hugger MDL in December 2015. The litigation initially contained only 14 Bair Hugger lawsuits.
“Bellwether cases” are the first lawsuits in an MDL to go to trial. Since these are the first lawsuits in a mass tort to be considered by a jury, their outcome can have a large impact on how the remaining litigation will be handled. For instance, if the first few bellwether trials yield large verdicts for the plaintiff, it could fuel settlement talks. The cases chosen for bellwether trials are lawsuits that represent most of the litigation. According to a Mar. 24, 2016 Pretrial Order, bellwether cases are to be chosen by Mar. 1, 2017. The first bellwether trial is expected to begin in November 2017.
Bair Hugger Forced-Air Warming Blanket Background
The Bair Hugger forced-air surgical warming blanket was introduced in 1987. It was initially developed and marketed by Arizant Healthcare, Inc., which is now a subsidiary of 3M Company. The single-use device is used to maintain a patient’s body temperature during surgery, as the body temperature falls due to anesthesia. The surgical blanket is connected to a portable heating unit through a flexible hose, which pumps warm air into the blanket.
Lawsuits filed over the Bair Hugger allege that the surgical blanket has a design defect that circulates contaminants from the operating room floor and deposits them into the surgical site, causing serious, deep joint infections. Most plaintiffs in the Bair Hugger MDL underwent a knee or hip replacement when the device was used, and allege deep joint infections. The lawsuits allege that 3M and Arizant was aware of this risk but failed to implement design changes or warn the medical community.
The Bair Hugger was invented by Dr. Scott Augustine, who is expected to testify on behalf of the plaintiffs in the litigation, Star Tribune reported in November 2015. Dr. Augustine is now against using the device, saying it presents an infection risk. He runs a company that sells a competing device called the HotDog that uses conductive heat rather than forced air. “There is no question that it’s a true phenomenon. It’s happening. And it’s easy to show,” he said. “With regard to orthopedic infections, a scare is what’s needed. This product should never be on another orthopedic patient.”
Augustine argues that the Bair Hugger can disrupt the flow of sterile air in the operating room and that heat from the unit creates convection currents that can pick up contaminants from the OR floor, introducing them into the surgical site of a knee or hip replacement patient. “We studied this extensively for about 18 months. I can tell you with 100 percent certainty that the waste heat rises every single time. This was reported before 3M even bought the company,” he said, according to Star Tribune. “3M can say that it doesn’t happen. … But when you are going against a basic law of physics, it’s kind of an absurd thing to say.”
In 2011, the Bone and Joint Journal in the United Kingdom published a paper suggesting that the Bair Hugger had a “significant” increased risk for deep joint infection compared to the HotDog. After conducting statistical analysis from experiments with mannequins, authors said that the Bair Hugger infection rate was 3.1 percent compared to 0.8 percent with the HotDog.