The Bair Hugger warming blanket comprises a portable heater/blower connected by a flexible hose to a blanket. It warms patients by blowing heated air through the blanket onto their exposed skin.
3M Bair Hugger lawsuits claim the forced-air system, which maintains patient temperature during surgical procedures, caused infections in the affected joints in one of two ways. The “airflow disruption” theory claims that heat from the Bair Hugger creates currents that carry ambient bacteria to the surgical site. The second, “dirty machine” theory, says that the Bair Hugger is internally contaminated with bacteria, which become ambient and reach the surgical site. The Appeals Court said there are shortcomings in the supports for both theories.
In May 2022, the U.S. Supreme Court let stand an appellate ruling that revived nearly 6,000 lawsuits over 3M’s Bair Hugger surgical warming device, which are slated for trials to resume this fall, according to Reuters. The American multinational conglomerate claimed that a federal judge in Minnesota had properly dismissed all claims from the multidistrict litigation (MDL) in 2019 after finding testimony from the plaintiffs’ key expert witnesses inadmissible because they had offered “no scientific support for concluding that the device caused surgical-site infections”.
But the 8th U.S. Circuit Court of Appeals disagreed, and reversed the ruling based on the experts’ testimony having “weaknesses” but not “so fundamentally unsupported” that it had to be excluded. Reuters further reported that “3M’s certiorari petition derided the 8th Circuit’s analysis as “unique” and “erroneously lax.” It drew amicus support from the Product Liability Advisory Council, the National Association of Manufacturers, the U.S. Chamber of Commerce and other pro-business groups.”
Expert Witnesses Barred
Plaintiffs’ lawsuits were combined in multidistrict litigation in the U.S. District Court for the District of Minnesota, which dismissed them in 2019.
The MDL court barred epidemiologist Jonathan M. Samet, infectious disease specialist William Jarvis, and orthopedic surgeon Michael J. Stonnington after finding too great an analytical gap between their opinions and the information on which they relied, reported Bloomberg Law. Also barred was engineering expert Said Elghobashi, who developed a model showing how bacteria-tainted particles could reach a patient’s surgical site. The appeals court upheld the exclusion of some of Elghobashi’s testimony but said his model may be considered as part of the factual basis for the airflow-disruption theory.
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To date, one bellwether trial, which was held in 2018, was a win for 3M. The case is 3M Company et al v. George Amador, U.S. Supreme Court, No. 21-1100.