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Bair Hugger Investigated As a Defective Product

Over two decades ago, Dr. Scott D. Augustine, an anesthesiologist in Minnesota, helped pioneer the idea of keeping a patient warm during surgical procedures. Studies have shown that in doing so, it benefits such as less bleeding and a quicker recovery. The Bair Hugger is a device that works like a forced-air heater as it carries warmed air through a hose to a special blanket that is draped over the patient. Since its inception in 1987, the device has been used to safely warm more than 200 million patients in hospitals around the world, says 3M, the company that bought the product after Dr. Augustine, the inventor, resigned in 2002 as chairmen and CEO of the former company Augustine Medical.

However, Dr. Augustine has since contended that the device is faulty as the old technology actually may spread infectious diseases produced at hospitals to patients, causing dangerous contaminations. He suggests that the heat generated by Bair Hugger can redirect circulation in specialized rooms where joint implant surgeries are performed and consequently, that change in air flow can bring airborne contaminants in contact with patients.  Some doctors also agree and are concerned about using the Bair Hugger therapy during orthopedic surgery or surgeries involving implants, because these surgeries often carry a high risk of infection. The device’s current manufacturer points to about 170 studies that have found forced-air warming to be beneficial to maintaining normal body temperature. However, just as the doctors above argue, Augustine says that none of those studies analyzed forced-air warming during orthopedic surgery. Continually, the inventor also claims that the investors knew of the problems and has even gone so far as to accuse the company of a covering it up.

In a letter sent to the New York Times, Dr. Augustine states, “The questions for you to answer is the following; is Bair Hugger going to be replaced quickly and catastrophically by a mandatory recall, or do you survive a voluntary recall and live to fight another day?”

However, 3M refuted all of what Dr. Augustine has said in a statement to media; “We believe Mr. Augustine’s allegations against forced-air warming stem from a personal vendetta and are baseless.” [1]

Several independent researchers, including the Association of PeriOperative Registered Nurses (AORN) note that studies showing evidence of a link are limited or use flawed methodologies. In a 2013 review, AORN says that “given the efficacy of these devices in preventing inadvertent perioperative hypothermia” facilities can continue using forced-air warming “until well-conducted, large scale trails can further examine the issue. Also, Augustine has also recently invented a new warmer called the HotDog which acts like an electric blanket rather than an air blower and appears to work as well as the Bair Hugger. Many feel as though he inventor is trying to discredit the old device in efforts to promote his new product [2].

The Current State of Facts

Regardless of the bickering back and forth, there has been studies and MAUDE adverse reports documented on the FDA website, as well as claims reported in the media from patients who have experienced the detrimental effects that allegedly Bair Hugger purported. A list on drugwatch chronicles the current state of facts.

  • 2011: Deep Joint Infection- A study concluded that there was a significant increase in deep joint infection when using forced-air warming compared to conductive fabric warming (the HotDog) during orthopedic procedures.
  • 2012: Convection- A study concluded forced-air warming created convection current activity near the surgical site. This activity could disrupt ventilation airflows which are supposed to dispose of airborne contaminants.
  • 2012: Forced-Air Warming- A study found forced-air warming resulted in a significant increase in the number of particles near the surgical site compared to radiant warming devices.
  • 2013: Ventilation- A study concluded that excess heat from forced air warming disrupted the ventilation of air low. Comparatively, conductive patient warming had no effect on ventilation air flow.
  • 2013: Increased Air Temperature- A study found that waste heat from a forced-air warming blanket increased temperature of a surgical drape, creating convection currents that produced turbulence over the patient. This turbulence over the patient could draw damaging particles from below the operating table to the surgical site [3].

Patients, Adverse Reports & Recent Proceedings

The FDA and several media sources have also received damaging reports of personal issues with the Bair Hugger. One story in particular is from a man in Columbia, South Carolina who underwent surgery to amputate his foot due to a past diving injury. It was such a bad break that orthopedic surgeons figured Patrick would be better off with a prosthetic, and there was nothing more they could do to save his foot. After surgery concluded and he was sent home, his fever spiked to life-threatening levels that prompted his doctor to send him to the hospital. His wife is the one who first saw that his stump had an odd discoloration which led the doctors to do a CT scan that showed a “pocket of infection bigger than a golf ball at the end of [his] leg, almost on the bone.” Patrick said “They opened and drained it, pumped me with heavy-duty antibiotics and put me in a wound-vac, essentially a torture chamber, for several weeks. It was the most painful things I have ever experienced.”

Infections can occur near incision sites due to a multitude of factors such as hospital staff, a variety of medical equipment and even bad linens could be the culprit. However, this particular case revealed that this infection was deep and nowhere near the incision site. This infection was so damning that the doctors had to remove another four inches of Patrick’s lower leg to prevent the spread of infection [4].

Another story posted on the FDA MAUDE report website is described by a patient—no name provided–who also suffered the consequences of an infection after the Bair Hugger was used. The patient described the event in which the device was used during their hip replacement surgery. They developed a postoperative infection due to corynebacterium which further led to an exchange/washout procedure in the same month. Unfortunately the infection reoccurred and the patient needed an antibiotic loaded spacer that was placed this year. In about six weeks from that surgery, the patient states that surgery will be needed to “either [place] a new antibiotic spacer of a new hip prosthesis or [one for] hip revision.” The patient is wheelchair bound and apparently has been deathly ill for over a year. They also claim that they do not know if they will be able to walk again. All of these issues has led the patient to warn the public and state, “The Bair Hugger warmer has been used on me with each of the three surgeries I have already had. Please take this warmer off the market before it injures someone else!”

As a number of hip and knew infection lawsuits filed against 3M continue to increase, plaintiffs have filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to have the cases centralized in a single jurisdiction for pretrial handling. In a motion to transfer filed on August 21, plaintiffs stated that given the similarities between the cases, they should be transferred to a Multidistrict Litigation (MDL) in the District of Minnesota. The JPML is expected to be decided on the proposed Bair Hugger MDL after hearing oral arguments on December 3 [5].

Sibley Dolman Gipe Accident Injury Lawyers, PA

While the evidence is mounting against the manufacturer of Bair Hugger alleging that forced-air heating from the blanket caused surgery patients to contract infections from germs picked up in the hospital and circulated by the device, patients also claim—with the help of Dr. Augustine’s accusations—that 3M was aware of the risk of dangerous complications associated with the device for almost a decade. Furthermore, Plaintiffs have had to undergo multiple surgeries to further evade dangerous complications associated with the device. The money spent, along with the pain and suffering, are just some of the civil claims that about 50 lawsuits are alleging.

If you or a loved one has experienced Bair Hugger complications such as deep joint infections after the forced-air warming blanket was used during surgery, you may be entitled to take legal action against 3M and its subsidiaries. To deal wtih such a powerful firm, it is essential that you obtain experienced legal professionals who know how to get fair judgement when it comes to defective devices. Call Sibley Dolman Gipe Accident Injury Lawyers, PA to be on your side. We won’t collect a dime until you get what you deserve for your suffering. The number to call is (833) 606-DRUG [3784]. Call today.

Sibley Dolman Gipe Accident Injury Lawyers, PA
800 North Belcher Road
Clearwater, FL 33765
(833) 606-DRUG [3784]

https://www.dolmanlaw.com/legal-services/defective-medication-attorneys/

References:

[1] https://www.nytimes.com/2010/12/25/business/25invent.html?_r=0
[2] https://www.outpatientsurgery.net/outpatient-surgery-news-and-trends/general-surgical-news-and-reports/what-to-make-of-these-bair-hugger-lawsuits–09-23-15
[3] https://www.drugwatch.com/bair-hugger/
[4] https://www.lawyersandsettlements.com/articles/bair-hugger-warming-blanket/interview-bair-hugger-lawsuit-warming-blanket-2-21087.html#.Vl2y9r9J29Y
[5] https://topclassactions.com/lawsuit-settlements/lawsuit-news/234406-bair-hugger-inventor-says-device-poses-infection-risk/