When Dr. Scott Augustine realized his invention was causing more problems than it was solving, he began spreading the word to his colleagues in the medical community. Unfortunately, by the time he became aware of the dangers of the device, he no longer had control over its sales and distribution. The rights to Dr. Augustine’s invention now belong to corporate giant 3M – and they aren’t about to let go of their profitable product without a fight.
Dr. Augustine developed the Bair Hugger in the late 1980s. An experienced anesthesiologist himself, Dr. Augustine understood how a patient’s body temperature falls under anesthesia, and realized that maintaining normal body temperature could reduce bleeding and speed up post-operative recovery. The Bair Hugger uses heated forced air, which circulates around the patient’s body as well as under the surgical table. What Dr. Augustine failed to take into account at the time was the presence of bacteria under the table – which can spread to patients’ incisions, causing serious infections.
Dr. Augustine started his own company, Augustine Medical. For many years, he was the head of the company that manufactured and marketed his invention. Then, in 2002, he wound up in a serious dispute with the Board of Directors. Dr. Augustine was ultimately forced to resign as CEO and walk away from the company he founded. That company eventually changed its name to Arizant Healthcare, Inc. In 2010, Arizant was acquired by 3M for $810 million. The old Arizant company website proudly proclaims: “Our solutions are now part of 3M Infection Prevention Solutions!”
Therein lies the irony. Dr. Augustine became aware of reports that his invention was actually increasing the risk of infection for surgical patients. This was due to the air circulation under the table. The underside of a surgical table is often a breeding ground for bacteria, which can be carried into patient incisions along the air current. Dr. Augustine became aware of the risks while testing a different invention, a type of pillowcase. However, actually proving his allegations at that time would have required lengthy and expensive testing by the Food and Drug Administration. Instead, Dr. Augustine produced a video presentation of a simulated surgical procedure, demonstrating how the forced air circulation is able to pull bacterial contamination from under the table and into the room.
Dr. Augustine went to work on a new, and safer solution. After a few years and a $23 million investment, he introduced the “Hot Dog,” a specialized electrical blanket using high-tech materials originally developed for military use in “stealth” aircraft. In 2011, Dr. Augustine told the Minneapolis Star Tribune: “Forced air is my baby, and I love my baby…but I believe it’s the introduction of forced-air warming that has led to the increase in infections.”
3M management disagrees. Robert Buehler, vice-president of 3M’s patient warming products division, says that Augustine’s allegations have no basis. He stated: “The science is clear that forced-air warming is safe and effective.” He added, “We believe Mr. Augustine’s allegations against forced-air warming stem from a personal vendetta and are baseless.”
Since that time, there have been five studies supporting Dr. Augustine’s concerns. Three of the studies showed that forced-air technology can carry bacteria into the ventilation stream surrounding the incision, increasing the risk of bacterial infections. An earlier study found elevated levels of particulates around incisions when forced-air devices were employed.
The stakes are high for 3M. Bair Huggers are used in 90 percent of hospitals across the U.S., and were employed in 22 million surgeries in 2010 alone. Last year, Bair Hugger sales generated more than $31 billion in sales. Meanwhile, an increasing number of plaintiffs have been coming forward, claiming that infections and post-surgical complications – some of which have resulted in the loss of limbs – were caused by infections spread by the Bair Hugger. The lawsuits, being handled by mass torts law firm such as Levin Papantonio, allege that 3M and subsidiary Arizant were aware of the dangers and withheld this information from the public.