Bair Hugger Warming Blanket Lawsuits

U.S. District Judge Joan Eriksen of the District of Minnesota presided over federal lawsuits in the Bair Hugger Forced Air Warming Devices Products Liability Litigation. There had been 5,846 active cases in multidistrict litigation No. 2666 until Eriksen granted 3M’s motion for summary judgement to exclude plaintiff’s experts.

The judge gave orders to the clerk of the court to close all cases on July 31, 2019. But as of October 2022, 5,234 cases were still listed in the MDL report.

Models named in Bair Hugger lawsuits included Model 500, Model 505, Model 750 and Model 775. Companies being sued were Arizant Healthcare, which has produced Bair Hugger warming blankets since 1987, and 3M Company, which acquired Arizant for $810 million in 2010.

The lawsuits focus on the most serious Bair Hugger complications. They claim people developed serious infections after surgeries involving the devices.

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. Patients say they developed MRSA (methicillin-resistant Staphylococcus aureus), which is an antibiotic-resistant infection that can lead to skin infection, sepsis, pneumonia and bloodstream infections.

One Bair Hugger lawsuit has gone to trial so far. It ended in May 2018 with a verdict in favor of 3M.

Louis Gareis filed the lawsuit. His lawyers sought more than $200,000 in damages. They promised to appeal the verdict.

Gareis underwent hip replacement surgery in which doctors used a Bair Hugger device. Gareis blamed the device for infections.

There have been no publicized settlements. People who have filed suit have asked for as much as $1 million in damages from 3M and Arizant.

The U.S. Food and Drug Administration (FDA) has received hundreds of adverse event reports, including multiple reports about patient deaths, relating to Bair Hugger devices since 2013.

In August 2017, the FDA said it was aware of infection concerns with the blankets. But the agency recommended that health care providers continue using them.

The FDA sent a letter to health care providers highlighting the benefits of patient warming devices during surgery. These included less blood loss, faster recovery and decreased infection risk.

The letter said the agency reviewed medical research and data. The FDA also pledged to “actively monitor this situation.”

Since approving the first Bair Hugger warming device in 1987, the FDA has issued at least 14 additional clearances for changes or new versions of the devices.

In January 2018, 3M recalled 165,000 Bair Hugger warming blankets for a design defect. Some blankets failed to fully inflate after the company redesigned the system’s underbody blankets. 3M warned in its recall letter that partial inflation could prevent proper warming.

An adverse event report to the FDA claimed a patient suffered hypothermia during surgery in which a blanket failed to fully inflate. The device was among the lots later recalled. The patient required intensive care unit treatment to regain normal body temperature.

Neither 3M nor Arizant has issued a recall of the blankets due to reported infections.

After 3M won the first bellwether trial in 2018, the company released a statement saying it was “grateful the jury put science first.”

“This verdict affirms the science behind the 3M Bair Hugger system, which has been proven to be a safe and effective way to warm patients during surgery,” the statement said.

3M and Arizant continue to advertise the blankets as safe and effective in all surgeries, including orthopedic procedures. The manufacturers contend that 170 studies have found forced-air warming to be safe.

However, Dr. Scott Augustine — the inventor of Bair Hugger products — claims those studies are misleading and measured the wrong things. He has urged 3M and Arizant to recall the devices.

Augustine designed and sells a competing medical device called the HotDog. In 2010, 3M said in a statement: “We believe Mr. Augustine’s allegations against forced-air warming stem from a personal vendetta and are baseless.”