This story has been updated with a comment from Augustine Surgical and the plaintiffs’ attorneys.
The decision follows six years of litigation over claims that the warming system was responsible for infections suffered by patients during surgery. The lawsuits were consolidated in a multidistrict litigation in federal court in Minnesota. In her order, U.S. District Court Judge Joan Ericksen rejected four of the plaintiffs’ expert witnesses and granted Maplewood, Minn.-based 3M summary judgment in all of the cases. Ericksen’s order does not dismiss two similar cases filed in state courts in Missouri and Texas.
Ericksen had previously agreed to allow the plaintiffs’ experts to testify in court. After those experts testified in the first Bair Hugger system trial in 2018 and after the publication of a new study on surgical site infections, 3M asked the court to revisit its earlier decision. 3M argued that the new evidence further proved that the plaintiffs’ experts lacked scientific support for their claims.
The company said the plaintiffs’ infection theory was invented by 3M competitor Augustine Temperature Management (now Augustine Surgical) and its founder Dr. Scott Augustine — whom 3M claimed has waged a decade-long campaign to malign the Bair Hugger system as part of an effort to market his own competing product, the HotDog patient warming system.
“Our hearts go out to the horribly injured patients who may not get their day in court. Of course, the ruling will likely be appealed, so this may just be a pause in the litigation,” Augustine, an anesthesiologist and serial medtech entrepreneur, said in an email to MassDevice. “No matter what happens with the litigation against Bair Hugger, one key fact remains: Forced-air warming increases contamination in the sterile field and increases the risk of infection… I didn’t invent physics: hot air rises and forced hot air contaminates the sterile field.”
The plaintiffs’ attorneys told MassDevice in an email that they are disappointed and disagree strongly with the judge’s decision, but are not surprised. “We will continue to digest the order, and anticipate our appeal will follow shortly,” they said.
Ericksen sealed her memorandum explaining the order, giving both sides until August 6 to propose redactions. In the weeks before Ericksen’s order, 3M filed a motion for contempt and sanctions against the plaintiffs’ attorneys, claimed they had disclosed sealed documents. The plaintiffs’ attorneys fired back, asking for sanctions against 3M’s attorneys as well.
The decision in favor of 3M comes six months after the Minnesota Court of Appeals upheld a Minnesota state court order dismissing 61 similar cases filed by lawyers on behalf of Minnesota plaintiffs.
“There is no legitimate scientific support for the plaintiffs’ theory. We are pleased that the court has dismissed all of the cases in the multidistrict litigation,” said Dr. Todd Fruchterman, general manager, 3M Medical Solutions Business, in a news release. “Most importantly, we want physicians and patients to understand that the practice of patient warming is supported by leading health care institutions, professional societies and the U.S. Food and Drug Administration. Our industry-leading 3M Bair Hugger system has been proven to be a safe, effective and efficient method of delivering patient warming therapy.”
In August 2017, the FDA sent a letter to health care providers saying that it “has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.” The agency recommended continued use of the devices when clinically warranted.