Eight Circuit Court revives About 6000 Lawsuits Against 3M Surgical Warming Device
On August 16, 2021, over 6,000 lawsuits were revived by the 8th U.S. Circuit Court of Appeals, which alleged that the device produced by 3M co (Multinational conglomerate company) – causes the development of infections. Gareis v. 3M Co, No. 18-3553 (8th Cir. 2021). The device- Bair Hugger helps clinicians keep a patient’s core body temperature within the normothermic temperature zone and safeguard patients while improving outcomes. The plaintiffs claimed that the device was defective because it transferred antibiotic-resistant bacteria into open surgical wounds, either by disrupting airflow in the operating room or through contamination of the device itself.
However, this is not the first time. Plenty of lawsuits focused on far more serious Bair Hugger complications. The lawsuits claimed that people developed serious infections after surgeries wherein the impugned devices were used. Some people lost limbs to infection or had a loved one die. Many of the patients suing had knee and/or hip replacement surgeries resulting in deep-joint infections that were difficult to treat. Some also developed MRSA (methicillin-resistant Staphylococcus aureus), which is an antibiotic-resistant infection that can lead to skin infection, sepsis, pneumonia, and bloodstream infections. Similarly, FDA received hundreds of adverse event reports, including multiple reports about patient deaths, relating to Bair Hugger devices since 2013. Since 1987, the FDA has issued at least 14 additional clearances for changes or new versions of the devices.
Moreover, after 3M won the first bellwether trial in 2018, the company released a statement saying it was “grateful the jury put science first.” Yet, the company failed to redesign the product to make it safer and chose not to warn of the danger.
U.S. District Judge Joan Ericksen in Minneapolis had found in 2019 that the allegations lacked scientific support, leading her to toss all of the lawsuits. But the 8th Circuit observed that while there were “weaknesses” in the opinions of the plaintiffs’ experts, they were not “so fundamentally unsupported that they had to be excluded.”
Given the recent ruling in the Bair Hugger lawsuit, plaintiffs may request to see documents from the manufacturer regarding the design of the device, any reports of adverse effects, or any studies that were done regarding the safety of the device. Plaintiffs should also have access to depose key figures from the defendant companies, as well as any expert witnesses that the defendants may call upon to testify during the trial. In order to prevail in a Bair Hugger claim, a plaintiff would need to show evidence proving that 1) The plaintiff was injured or suffered a loss; 2) The Bair Hugger device is defective; 3) The defect in the Bair Hugger device caused the plaintiff’s injury or loss, and 4) The device was being used as intended by the manufacturer.
It is quite evident that proving each of these different elements would be extraordinarily difficult and overwhelming for individual plaintiffs. But once it is consolidated before a judge each individual can claim benefit from it.