Author: Joe Carlson
Minnesota Star Tribune
3M Co. declared legal victory Thursday after a federal judge dismissed lawsuits from more than 5,000 plaintiffs who said 3M’s Bair Hugger patient-warming device caused their post-surgical infections.
“There is no legitimate scientific support for the plaintiffs’ theory,” Dr. Todd Fruchterman, general manager at 3M’s medical solutions business, said in a statement. “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.”
The Bair Hugger, invented by Minnesota anesthesiologist and entrepreneur Dr. Scott Augustine, is used in more than 80% of U.S. hospitals. It includes a mechanical unit that blows warm air and an array of inflatable plastic “blankets” that are draped over a patient before, during and after surgery and filled with warm air. The goal is to keep the patient’s body from entering hypothermia during surgery, which causes vessels to constrict and can delay healing.
The plaintiffs alleged that the device could actually increase the risk of infection in several ways. The blower could be colonized with bacteria, they said; it could suck bacteria-laden particles from the operating-room floor and deposit them in the air over a surgical wound; and it could disrupt the normal ceiling-to-floor airflow in an operating room that is designed to remove the skin particles that all patients and doctors shed during surgeries.
However, U.S. District Judge Joan Ericksen in Minneapolis ruled late Monday that none of the plaintiffs’ experts could prove these theories. She placed her full ruling under seal until Aug. 6 to give the parties time to redact sensitive information.
“The federal court granted 3M’s request to exclude the plaintiffs’ general causation experts, leaving the plaintiffs with no scientific support for their claims,” 3M’s statement said. “The court previously had 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.”