Odds are if you have ever been through a surgery then chances are you have been exposed to a Bair Hugger warming blanket. Bair Hugger systems are forced-air warming devices designed to keep patients warm before, during and immediately after surgery. The device works by filtering air and then forcing that warm air into disposable blankets used to cover patients. Its original developer now says the device can spread bacteria during surgery, causing infections. Though the FDA hasn’t recalled Bair Hugger systems, maker 3M is fighting lawsuits from patients who allege the systems were responsible for their deep-joint infections.
Bair Hugger History
In 1987, Dr. Scott D. Augustine invented the Bair Hugger in order to keep patients warm during surgery. Almost all patients become hypothermic – a condition causing the body to lose heat faster than it can produce heat – during surgery. Even mild hypothermia during surgery can lead to a myriad of different complications including blood loss, infections, and prolonged hospital stays. The Bair Hugger equipment includes blankets, warming units, and accessories.
Augustine began selling Bair Huggers through his company, Augustine Medical, 30 years ago. The company reorganized under new owners in 2003 and was renamed Arizant. In 2010 3M paid about $810 million to buy Arizant, and 3M still manufactures and markets Bair Hugger systems to this day. More than 50 orthopedic surgery patients have sued the cooperate giant 3M, alleging Bair Hugger was responsible for infections they encountered during surgery. Bacterial joint infection can cause septic arthritis, which can cause sudden pain and swelling and can destroy a joint if not treated promptly with antibiotics.
Bair Hugger & the FDA
In 1987 the U.S. Food and Drug Administration (FDA) cleared the first Bair Hugger warming system through the 510(k) premarket clearance program as a “substantially equivalent device”. This 510(k) program says the FDA is allowed to clear a medical device without clinical proof that it is safe if it is similar to a previous device already on the market. The FDA went on to issued 12 additional clearances for Augustine Medical devices through the 510(k) premarket program from the years 1990 through 2002. After Arizant took over the Bair Hugger product line, the FDA issued two more clearances for medical devices through the 510(k) program from the years 2004 through 06. With over 30 years on the market, there have been numerous adverse events have been reported to the FDA. The majority of early adverse event reports involved burns from prolonged exposure to heat during surgery or equipment malfunctions that resulted in a cold air circulating under the blanket instead of a warm air. To this day the FDA has not issued a recall of Bair Hugger devices and they continue to be used in hospitals and clinics.
Bair Hugger Infection Risks
Patients can and have developed serious deep joint infections during surgery. Surgeries involving implants, including knee, hip, and other joint implants, have a higher risk for contamination than other surgeries. Beginning in 2011, some studies claimed to have found forced-air warming could increase the risk of infection during high-risk orthopedic surgeries. However, some researchers say these studies have flaws that make them inconclusive, unreliable and unable to prove that forced-air warming actually increases infection risk. 3M and Bair Hugger both maintain that the systems are safe and effective in all surgeries, including orthopedic surgeries.
Bair Hugger Lawsuits
Medical device manufacturers have a duty to develop, promote, and market safe products to health-care professionals and consumers. When said manufacturers fail to do so, people who are harmed can turn to the courts for relief. As a result, hundreds of people have and are filing lawsuits accusing 3M of failing to properly and thoroughly test their Bair Huggers product, failing to conduct sufficient post-market testing and surveillance of Bair Huggers and continuing to market Bair Huggers after the manufacturer should have known of adverse effects.
One of the key components to Bair Hugger lawsuits is the alleged manufactures failure to warn. When medical devices carry a risk, manufacturers have a duty to inform both health-care professionals and the public of that risk. Patient, through their lawsuits, has accused Bair Hugger’s maker, 3M, of failing to adequately warn health-care professionals and the public of the risk of circulating air in operating rooms, which they say could lead to infections.
Another key component to legal action against 3M and the Bair hugger line is the misrepresentation. Device manufacturers have an obligation to represent their products accurately and truthfully. Patient lawsuits have claimed 3M not only knowingly, but also recklessly disregarded that obligation, misrepresenting Bair Huggers as safe, but also that Bair Huggers are safer than alternative patient warming devices that are available.
Status of Bair Hugger Lawsuits
To date, no lawsuits filed over Bair Hugger have settled or gone to trial, but as of November 2017, more than 4,000 have been filed in federal court. The first such case likely to go to trial is in re: Bair Hugger Forced Air Warming Devices Products Liability Litigation in the U.S. District Court, District of Minnesota, which the courts refer to as MDL No. 15-2666. This will result in a bellwether trial – a representative case that allows all parties to test their arguments and allows other potential plaintiffs to consider whether they wish to continue to litigate or attempt to settle.
Ahead of any trials, there is the possibility that 3M could settle with some or all of the plaintiffs. If that doesn’t happen, the results of the first trial may make other plaintiffs think about withdrawing their suits, if the verdict goes against the injured patients, or encourage other patients who feel their injuries were caused by Bair Hugger warming units to file their own suits should the jury decide for the plaintiffs.
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If you or a loved one underwent joint replacement surgery that used a Bair Hugger warming system and subsequently developed a serious deep joint infection, you may be eligible to file a lawsuit and recover compensation. Jones Brown is currently accepting clients who have suffered due to 3M Bair Hugger Warming Blankets. To help the Jones Brown Team get started on you possible claim, please fill out our Jones Brown Defective Drug Evaluation by clicking HERE.