Thousands of people who developed serious infections have filed lawsuits over Bair Hugger warming blankets. The devices play a critical role in keeping patients’ body temperature stable during surgery, but a design flaw may allow the blankets to spread hard to treat bacteria.
If you or a loved one suffered complications or injury after surgery with a Bair Hugger warming device, you may have legal options.
The Bair Hugger Normothermia System uses forced-air to keep patients warm during orthopedic surgery. But studies have found the devices may lift bacteria or other debris from below operating tables and carry these contaminants into open surgical wounds, increasing the risk of infections.
Some patients have suffered serious infections leading to complications including amputation and death following surgeries using the devices. The first of more than 4,200 lawsuits against Bair Hugger’s manufacturers was filed in 2011.
As of March 2018, there were 4,308 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.
The cases in the Bair Hugger MDL are from across the U.S. and were first combined in a Minnesota federal court in December 2015. New lawsuits have been added since then.
The MDL court has selected five cases to serve as bellwether trials. Bellwethers are “test cases” that are tried before juries. The 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 or the amount of settlements.
The first Bair Hugger trial is scheduled to begin in 2018.
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.
Infections following use of Bair Hugger devices have included MRSA, methicillin-resistant Staphylococcus aureus, an antibiotic-resistant infection that can cause severe complications.
Many of the people who have filed lawsuits against 3M claim that the airflow from Bair Hugger products led to their infections during surgery.
Lawsuits against 3M Company and Arizant Healthcare, Bair Hugger’s manufacturers, claim 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.
There have been no verdicts and 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 at least 11 reports relating to patient deaths, relating to Bair Hugger devices since 2013.
Neither 3M nor Arizant has issued a recall of the devices over reported infections related to the Bair Hugger units.
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.
Please seek the advice of a medical professional before making health care decisions.
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