Hypothermia, which is when the body's core temperature drops below 96.8 degrees Fahrenheit, is a common occurrence when a patient undergoes a surgical operation. When the body temperature drops, the heart and nervous system cannot properly function. To remedy this problem, the Food and Drug Administration approved medical equipment known as the Bair Hugger warming system, created by Dr. Scott Augustine, in 1987.
The Bair Hugger manages temperature during surgery by using blankets and warming units to surround patients – effectively preventing dramatic drops in temperature. The system is based on forced air warming that delivers controlled temperatures to the patients by way of the blankets. Each warming unit has four temperature settings and are capable of being mounted on the hospital bed rail or floor.
The Bair Hugger system has been wildly popular in the medical community with over 180 million patients having used the system. In fact, over 80% of hospitals in the United States use the therapy today. 3M, the company formerly known as the Minnesota Mining and Manufacturing Company, purchased the Bair Hugger system in 2010 for $800 million. With the acquisition, 3M became the systems maker and marketer.
After the sale of the system, Dr. Scott Augustine criticized his invention by claiming that the equipment can spread infectious bacteria during surgery. Studies have been performed to test the theory but the results have been inconclusive. 3M, who has made over $31 billion since 2014 on the sales of the Bair Hugger system, have vehemently denied the claims that the equipment spreads bacteria. The company pointed to 170 studies that failed to validate Dr. Scott Augustine's claims. 3M's attorney has stated that not one hospital, doctor, or medical provider has confirmed a single incidence of infection that has been caused by forced air warming.
Despite the claims made by 3M, many patients have filed lawsuits against the company. The litigation is based upon the claims that 3M knew about the risks of the Bair Hugger system but did not warn health care providers about those risks, in addition to attempting to conceal scientific data that would point to the devices dangers. More specifically, plaintiffs are claiming that the Bair Hugger system has a propensity to spread infection during knee, hip and heart valve surgeries.
To date, the Food and Drug Administration has not issued a recall.
Medical malpractice can have devastating effects that last a lifetime. If you have been injured by a physician's neglect, attorneys Charles Gilman and Briggs Bedigian will work to get you the full compensation to which you are entitled. Call 800-529-6162 today or contact them online for a free case evaluation. They handle cases in Maryland, Pennsylvania, and Washington, D.C.