A Bair Hugger Blanket is a medical device used to keep patients warm during surgery. Major surgery is always risky and by keeping a patient’s body temperature up, certain risks, like infections, can be lessened. The Bair Hugger was invented by an anesthesiologist and first came into use in 1987. Since then 3M has bought rights to the device, but is facing some controversial issues and lawsuits. Although the device is supposed to protect patients, evidence is growing that it may be doing more harm than good in some cases.

The Bair Hugger Blanket

There are many risks during surgery and keeping patients warm helps to mitigate those risks. An operating room is a chilly place, kept at a temperature to make surgeons comfortable. The patient is covered only in surgical paper and has open incisions that cause them to lose heat. It is typical for the body temperature of a patient in surgery to drop by a few degrees. This loss of heat can increase the risk that a patient will experience heart complications, excessive bleeding, and infections.

Dr. Scott D. Augustine, an anesthesiologist in Minnesota saw that there was a need for a medical device that could keep patients warm during surgery and he invented the Bair Hugger. Early tests with the device showed that patients were warmer, bled less, and recovered more quickly after surgery with the device. Dr. Augustine started his own company, which eventually was named Arizant, to sell the Bair Hugger, but sold the rights to the device for about $800 million to 3M in 2010.

3M now makes the Bair Hugger in 25 different shapes, sizes, and designs to meet the needs of most patients and surgeries. Each blanket is designed to be disposable and to be used just once for one patient. The blanket is attached to a temperature management unit. This uses a hose to circulate warm air through the blanket. The blanket is perforated with small holes on the side that faces the patient’s body so that warm air circulates over the skin throughout the surgery.

Burns and Equipment Failure

Bair Hugger Blanket lawsuits have been filed since the device has been in use because of accidents that have harmed patients during surgery. The U.S. Food and Drug Administration (FDA) keeps a record of adverse events experienced with medications and devices and has collected numerous reports related to fires, burns, and failures with the Bair Hugger.

There were enough such issues that before the sale to 3M the FDA sent a warning letter to the company that sold the Bair Hugger. The letter included a warning about adverse events occurring with the device. The FDA stated that the company was at fault because it did not report the events, which was required. Instead the reports came only from patients and doctors.

Some of the problems to which the FDA referred included serious burns. The equipment used to force the warm air through the blanket failed in several instances and caused second and even third degree burns to patients undergoing surgery. Some of the failures in the equipment were short circuits, loose screws, and loose heater wires that caused fires.

In some cases the machine had been turned off, but continued to produce heat and burned patients. There were even situations in which the machine failed and did not produce heat as it should have. In one particular case this caused a serious complication for a patient who lost significant body heat during a procedure.

An Increase in Infections

The Bair Hugger Blanket is supposed to protect patients by reducing the risks of surgical complications, including infections. Evidence has shown, though, that the device may actually increase the risk of infections in patients. The problem may be the circulating air in the blanket. The warm air is circulated and re-circulated, which critics say can pick up contaminants and cause infections in the surgical incisions.

The inventor of the device, Dr. Augustine, who no longer has rights to it, has been one of the loudest recent critics of the blanket. He has publicly stated that the device should no longer be in use and that it is causing infections and harm to patients. He has even accused Arizant, bought by 3M, of covering up evidence of these problems.

Arizant and 3M Negligence

Accusations have been made by Dr. Augustine, plaintiffs in lawsuits, and others that Arizant and 3M both have been negligent in some of the accidents and infections blamed on the Bair Hugger Blanket. Current lawsuits state that the companies failed to warn patients and doctors about the potential risks of using the device. They also state that the companies did not accurately represent the safety and effectiveness of the Bair Hugger. Plaintiffs claim that both 3M and Arizant marketed the Bair Hugger as safe and as a better alternative to other devices used to warm surgical patients.

Bair Hugger Blanket Lawsuits

There have been several individual Bair Hugger Blanket lawsuits filed, including one in which the plaintiff accuses 3M and Arizant of being negligent in his infection. The man developed an infection deep in his knee joint after a replacement surgery with the Bair Hugger. After multiple surgeries in an attempt to contain the infection, he had to have his leg amputated.

Another plaintiff has made a similar claim, stating that he developed a deep joint infection because of the blanket used during hip replacement surgery. This man had to have 15 more surgeries after the initial surgery and now lives with permanent damage to his hip joint and leg.

3M’s Reactions to Lawsuits

Lawsuits against 3M and Arizant have not been resolved, but 3M is battling hard to make sure they don’t have to pay or admit any negligence. The company claims that the Bair Hugger is safe and effective and continues to market it as such. 3M also says that Dr. Augustine has a personal vendetta against the company and the Bair Hugger and is trying to blame it for injuries and infections as a way to promote his most recent invention, a new surgical warming device.

The Future of Bair Hugger Lawsuits

Despite 3M’s stance, lawsuits are moving forward and they may even be consolidated into a multidistrict litigation, or MDL. An MDL is a way to expedite lawsuits and save on costs by grouping together similar cases. The MDL may come together in Minnesota and lawyers and their clients are currently moving forward to make their cases in the court system there. If you have been hurt by the Bair Hugger device, you can start your own lawsuit against 3M or join the current ongoing cases. Contact a lawyer to find out what your options are and how to take the next step.