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Bair Hugger: Complications & Lawsuits

The Bair Hugger is a forced-air warming blanket system used to keep patients warm and maintain body temperature during surgery. The U.S. Food and Drug Administration (FDA) approved the first Bair Hugger system in 1987. Currently, 3M owns the Bair Hugger brand of forced-air warming systems.

And while studies have found benefits to keeping patients warm during surgery, the creator of the Bair Hugger now suggests that the forced-air blankets could increase risk of infection.

Why is hypothermia during surgery risky?

Anesthesia used during surgery may increase the risk of hypothermia. Perioperative hypothermia can increase the risk of surgical site infection, cardiac events, and other complications. Preventing hypothermia during surgery may also reduce the length of the hospital stay.

Forced air warming blankets like Bair Hugger may reduce these and other risks by keeping the patient warmer during surgery. But, as some evidence suggests, these devices are not without risk.

How do hospitals use the Bair Hugger system?

Surgical teams use the Bair Hugger forced-air warming system to prevent perioperative hypothermia. The manufacturer has revised the original system to become a three-stage hypothermia solution. Hospitals can use Bair Hugger devices in three situations:

  • Pre-operative warming with blankets or gowns.
  • Operative warming with drapes and blankets.
  • Temperature monitoring during pre-operative, operative, and post-operative phases.

The blankets, drapes, and gowns connect to an air hose that pumps heated air into the blanket and around the patient. It is this forced-air system, though, that may increase infection risk during surgery.

Bair Hugger May Increase Infection Risk

In 2010, the inventor of the Bair Hugger, Dr. Scott Augustine, publicly cautioned of the risk of surgical site infection associated with these devices, particularly during implant surgeries such as:

  • Knee implants
  • Hip implants
  • Artificial heart valves

Dr. Augustine claims that the device could disrupt circulating air in the operating room. The device may create a convection current that brings contaminants on the operating room floor up to the patient. This may increase the risk of surgical site infection.

Plaintiffs have cited a 2011 study published in the Journal of Bone & Joint Surgery, which found an increased risk of infection associated with the Bair Hugger device. In the study, the researchers conducted experiments with mannequins and reviewed patient records, finding a 3.1 percent rate of infection with the Bair Hugger system compared to 0.8 percent with conductive fabrics, such as the new HotDog device that Dr. Augustine developed.

(3M claims Dr. Augustine biased this study to promote his new device, and that the data is not h3 enough to support the claims of increased risk of infection. 3M has cited other studies and clinical trials to argue the safety of the Bair Hugger devices.)

The Dangers of Surgical Site Infections

Surgical site infections can result in longer hospital stays to treat the infection. Depending on the nature and severity of the infection, some patients require additional surgeries.

For example, one current lawsuit claims the plaintiff required 15 revision surgeries, including removal of the original hip implant that became infected because of use of the Bair Hugger device, the lawsuit claims. Another plaintiff says that she underwent seven surgeries after developing a joint infection following a surgery that used the Bair Hugger.

Bair Hugger Lawsuits

Numerous lawsuits are currently active against 3M, Arizant (the former manufacturer of Bair Hugger), and several other third parties. These claims include allegations that 3M and Arizant knew of the risks of contaminated airflow and was not forthcoming about the air quality associated with the system.

In 2015, the Judicial Panel on Multidistrict Litigation designated Minnesota as the central district for a multidistrict litigation (MDL). The MDL consolidated the individual lawsuits against Bair Hugger therapy to combine resources. This MDL now contains over 200 individual plaintiffs seeking damages from 3M and Arizant. Some of the accusations include:

  • Deceptive marketing
  • Covering up study data
  • Undisclosed knowledge of dangers
  • Falsifying air quality data

The MDL has yet to go to trial, and the Minnesota court system expects more plaintiffs to add cases.

Recoverable Damages in Bair Hugger Lawsuits

If successful, plaintiffs who file a lawsuit against 3M, Arizant, or other parties may recover compensation for the damages associated with infections and other complications associated with the Bair Hugger.

Recoverable damages in these cases may include:

  • Additional medical expenses, such as the costs of subsequent surgeries
  • Lost wages while recovering from infections associated with Bair Hugger devices
  • Lost earning potential if an infection affects a plaintiff’s ability to work (at least one patient required amputation after developing an infection)
  • Pain and suffering to cover the physical and emotional pain that the plaintiff experiences
  • Punitive damages, which punish the defendant for its grossly negligent behavior

These are just a few examples. The value of your case depends on the effects of the infection or other condition related to the Bair Hugger device, and the severity of your injuries. Review your case with a lawyer for a personalized case evaluation.

Am I eligible to file a claim against Bair Hugger therapy?

There is significant evidence about the safety of Bair Hugger warming blankets, some favoring plaintiffs arguing that their injuries are the result of the device. It is in a patient’s best interest to talk to an attorney to discuss their options.

You might be eligible to join the MDL if you had a surgical operation that used a Bair Hugger device and developed a surgical site infection after the operation. Learning about your legal rights starts with finding the right attorney. For help finding a lawyer who can help you, call 1-800-DRUG-411.

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