Patient Suing 3M for Bair Hugger InjuryApr 10, 2013
The Bair Hugger, a device used to warm hospital patients following surgery, is at the center of a lawsuit involving allegations of serious infection.
The Bair Hugger carries warmed air through a hose to a special blanket that is draped over a patient. Studies have shown that keeping patients warm during surgical produces benefits such as less blood loss and a faster recovery.
According to the civil lawsuit, the airflow from the Bair Hugger caused the plaintiff, a 70-year-old man, to develop a serious infection, said TwinCities.com/Pioneer Press. Following that procedure in March 2011, the plaintiff required 14 surgeries, including one to remove his artificial hip, according to the lawsuit, said Pioneer Press. According to the lawsuit, the Bair Hugger pulled in air from under the surgical table, also picking up germs, which then rose with the heat and were re-circulated into the hip replacement device the surgeons were implanting, said Pioneer Press.
The defendants are 3M; Arizant Heathcare Inc., which manufactures the Bair Hugger; and a sales representative who works for 3M and Arizant, according to Pioneer Press. Spokesman Stephen Sanchez said 3M "is very confident about the safety and efficacy of the Bair Hugger," according to Pioneer Press. The single-use Bair Hugger was employed in about 22 million surgeries in 2012, according to Sanchez.
Although the lawsuit is new, issues surrounding the Bair Hugger are not. In fact, we previously wrote that Dr. Scott Augustine—who helped develop the Bair Hugger about 20 years ago—was advising hospitals to avoid using the device for certain surgical procedures as far back as 2010. According to a prior New York Times report, Augustine said that the Bair Hugger poses a danger of bacterial infection in people receiving implant devices, such as artificial heart valves and joints.
Although he made a fortune from the Bair Hugger, Augustine has since said that the device can spread bacteria related to hospital-acquired infections in patients undergoing certain procedures. Augustine told the Times that he has a safer alternative that works more like an electric blanket, and doesn’t use forced air, called the HotDog.
Augustine notes that five peer-reviewed studies conducted over the past couple of years confirm the so-called “contamination phenomenon" seen in the Bair Hugger's air flow, linking the device to an increased risk of deep joint infections. Augustine pointed out that this lawsuit is unique in that the plaintiff’s injuries are permanently disabling, said Pioneer Press.
Augustine, an anesthesiologist, brought the Bair Hugger to market in 1988, said Pioneer Press. He has spoken against the Bair Hugger at professional medical meetings; has underwritten studies meant to show the Bair Hugger may pose bacterial threats; and has accused Arizant, the marketer of the Bair Hugger, of covering up its problems.
Critics have asserted that Augustine does not have any definitive evidence to back up his safety claims about the Bair Hugger; however, an independent testing laboratory sought out by Augustine reached similar conclusions, according to a prior Times report. One infectious disease expert interviewed by the Times said that he considered Augustine’s data “compelling,” but that proving a link between a bacterial threat and the Bair Hugger device would require implementing a huge clinical study.
Following a dispute with other board members, Augustine resigned from Arizant in 2002 as chairman and chief executive of the company, which was previously known as Augustine Medical. Also, after a 2004 guilty plea to a misdemeanor charge stemming from a Medicare fraud investigation, Augustine sued Arizant over allegations that the company was required to indemnify him. Augustine received some $5 million in the settlement, the Times said.