Bair Hugger Warming Blanket Lawsuits

Drugwatch is unaware of any attorneys currently taking Bair Hugger lawsuits.

U.S. District Judge Joan Ericksen of the District of Minnesota presided over federal lawsuits in the Bair Hugger Forced Air Warming Devices Products Liability Litigation. There had been 7,563 lawsuits filed in multidistrict litigation (MDL) No. 2666 until, in July 2019, Judge Eriksen excluded plaintiffs’ general causation experts and granted summary judgment to 3M as to all of Plaintiffs’ claims. Several days later, the court issued a final judgment dismissing all suits in the MDL.

However, plaintiffs appealed, and in August 2021, in a case styled Amador v. 3M Co., Inc. et al, the Eight Circuit Court of Appeals reversed Judge Eriksen’s ruling on plaintiffs’ general causation experts. Because the summary judgment order was based on those exclusions, the Eighth Circuit also reversed that order, reviving the MDL. 3M appealed to the U.S. Supreme Court, but that Court declined to hear the case, according to Reuters.

As of May 2024, 6,618 cases were listed in the MDL report.

In a Joint Status Update filed January 27, 2025, lead counsel for both sides reported that as of January 22, 2025, there were 7920 active cases pending in the MDL. Counsel also reported that in late 2024, the parties agreed to 34 trial candidate cases (bellwether cases) two of which were voluntarily dismissed and 26 of which were transferred to the districts plaintiffs listed in their short form complaints, leaving 18 pending trial candidate cases as of January 23, 2025, with some ready for trial in 2025 in federal courts in Minnesota and a number of other states. Counsel also reported seven pending state court cases in Texas, Missouri, Minnesota, Pennsylvania, New Mexico, and Montana, some with trial dates in 2025 or 2026.

Counsel stated that since 2019, general discovery has mostly occurred in the state court cases, and that the “parties have begun discussion on what additional supplementation of discovery responses and document production should occur in the MDL.” Additionally, counsel reported that the parties have been working to select cases to serve additional trial candidates.

According to the Joint Status Update, there is debate between the parties over whether, as a result of the Eighth Circuit’s ruling in Amador, general causation should be deemed established for the entire MDL (plaintiffs’ position), or whether each transferee court should consider the issue on its own (defendants’ position).

The parties also reported that defendants’ motion to dismiss relating to deceased plaintiffs is pending, and that an Eighth Circuit appeal brought by a number of dismissed plaintiffs was dismissed in November 2024.

In February 2025, Judge Ericksen ordered that expert testimony on general causation will will be permitted, a ruling that could significantly help plaintiffs.

As of April 1, 2025, the number of pending cases had grown to 8,084. According to the parties’ January 2025 Joint Status Report, 18 Bellwether cases are set for trial in the federal MDL, with some ready for trial in 2025.

Product 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 focused 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 who sued had knee and/or hip replacement surgeries resulting in deep-joint infections that were difficult to treat. Patients said 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 went to trial. 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 filed suit asked for as much as $1 million in damages from 3M and Arizant.

The U.S. Food and Drug Administration (FDA) 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.”