The Eighth Circuit revived thousands of suits in multidistrict litigation against 3M over injuries caused by a surgical warming device, finding that the lower court erred by excluding expert witnesses’ opinions on the cause of the patients’ infections.
A three-judge panel said the lower court in July 2019 made an error in judgment by barring three medical experts’ opinions that 3M’s Bair Hugger forced-air warming device caused bacterial infections by circulating bacteria from non sterile areas of the operating room to the surgical site. The experts all relied on a 2011 study that found that patients who were warmed with a convection device — which is what the Bair Hugger system is — were four times as likely to develop an infection than patients who used a different device, the panel said. But the study fell short of finding that the devices caused the infections.
The panel disagreed with the lower court’s conclusion that it’s unreliable for an expert to infer causation from an epidemiological study that disclaimed proving causation.
The MDL was first consolidated in 2015, and patients in the litigation alleged that they developed infections from the warming system, which is designed to prevent and treat unintended hypothermia in people undergoing surgery.
Specifically, the device, which blows hot air into a specially designed blanket covering a patient, spreads bacteria from the hospital floor or the inside of the device.
In 2017, the parties selected 31 bellwether cases, which are still being litigated. 3M won the first case, while several others have been dismissed before trial.
When the cases were first consolidated, 3M painted the suits as a smear campaign by Bair Hugger inventor Scott Augustine. Augustine founded Augustine Medical Inc., which eventually became 3M subsidiary Arizant Healthcare Inc. and also manufactures the device.
Augustine left the company in 2003 when he and his company were being investigated for Medicare fraud.