The first lawsuit alleging links between a Bair Hugger device and infection failed in May 2018. A second trial against Bair Hugger manufacturer 3M is scheduled for December 2018. More than 5,000 people have filed lawsuits over the devices. They claim that Bair Huggers used in surgery led to serious infections. The infections required another surgery or amputations.
As of July 2018, there were 4,623 active lawsuits over Bair Hugger warming blankets in a multidistrict litigation (MDL).
MDLs combine similar lawsuits to move them more quickly and cost-effectively through the legal system.
Bair Hugger’s manufacturer, 3M, won the first bellwether trial in May 2018. Bellwethers are “test cases” that are tried before juries. A second bellwether case is scheduled for trial in December 2018.
Bellwether trial verdicts can help both sides gauge how other lawsuits will do at trial.
The outcome of bellwethers can sometimes help determine if other cases will proceed to court. It can also influence settlements.
The cases in the Bair Hugger MDL are from across the U.S. A federal panel combined them in a Minnesota federal court in December 2015. The court has added new lawsuits since then.
People claim in their lawsuits that they or close relatives developed serious infections after surgeries involving Bair Hugger warming blankets. Many had knee and/or hip replacement surgeries resulting in difficult to treat deep joint infections.
Lawsuits claim infections following use of Bair Hugger devices have included MRSA (methicillin-resistant Staphylococcus aureus). MSRA is an antibiotic-resistant infection that can cause severe complications.
Bair Hugger lawsuits claim that the devices affected the airflow in operating rooms. They allege this allowed contaminants to get into patients’ incisions and cause infections. 3M says Bair Huggers are not responsible for infections. The company claims that more than 200 studies and clinical trials show the devices are safe and effective.
Lawsuits against 3M Company and Arizant Healthcare, Bair Hugger’s manufacturers, claim that the companies marketed an unsafe product and didn’t do enough to warn the public of its dangers.
Arizant, Inc. has produced the Bair Hugger since 1987. In 2010, 3M acquired Arizant for $810 million.
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. Doctors used a Bair Hugger device during the surgery. Gareis blamed the device for infections.
There have been no publicized settlements of Bair Hugger lawsuits yet. People who have filed suit have asked for as much as $1 million in damages from 3M and Arizant.
Any verdicts or settlements in the Bair Hugger lawsuits may depend on the nature of each individual’s injuries or losses.
There are currently no class action lawsuits over Bair Hugger warming blankets. New lawsuits filed over the devices have generally been combined into the MDL currently underway in Minnesota.
Generally, lawsuits over medical devices are better suited to MDLs than to class-action lawsuits. Both combine the resources of several — even thousands — of plaintiffs, but there are important differences. One of the most important is that class actions can only be filed in cases where the damages involved would make an individual lawsuit impractical. The amounts of damages injured people are seeking in the Bair Hugger lawsuits are likely too high to qualify as a class action.
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.
Neither 3M nor Arizant has issued a recall of Bair Hugger due to reported infections.
In August 2017, the FDA said it was aware of infection concerns with Bair Huggers. But the agency recommended that health care providers continue using Bair Huggers. The FDA sent out a letter to health care providers. It highlighted 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 in making its decision. The letter also said that the FDA would continue 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 Bair Hugger 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.
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