As the adult American population ages, it has become much more frequent that modern and innovative orthopedic device implants and joint replacement surgeries have become the norm. Hip replacement surgeries, knee replacement surgeries and orthopedic injuries to the young and aging adults have become prevalent.
During and after orthopedic surgeries, hospitals have been using Bair Hugger Therapy devices. Recent studies have indicated that the use of the Bair Hugger during the orthopedic joint replacement surgery such as hip replacement and knee replacement surgeries, may lead to serious infections. The inventor of Bair Hugger products has claimed that the product was faulty and some people who had developed infections have filed suit against the manufacturers of the device.
Bair Hugger Therapy is used to force warm air to a blanket-like system that is designed to prevent and treat hypothermia in patients during surgery. Dr. Scott D. Augustine invented Bair Hugger surgical equipment. The equipment includes blankets, warming units and accessories. The products were sold through his company originally named Augustine Biomedical and Design.
Many American patients have been exposed to the use of Bair Hugger Therapy since its introduction in1988. More than 80% of the hospitals in the United States use this therapy today.
Dr. Augustine was one of the first to recognize that patients develop hypothermia during orthopedic surgeries or other surgeries which are a condition that causes the body to lose heat faster than it can produce heat during the surgery. Even mild hypothermia during surgery can result in blood loss, infections and prolonged hospital stays.
But Dr. Augustine, the medical device designer of the Bair Hugger now says that hospitals should not be using it when patients receive undergo knee implants, hip implants and artificial heart valves because the heating device can spread bacteria and cause serious injury or death.
The Bair Hugger warmer units filter air through the Bair Hugger disposable blankets which cover the patients before, during and after surgery. The warming unit is supposed to force the air gently and evenly through the Bair Hugger blanket. The Bair Hugger blankets are disposable in order to reduce the chance of infection transmitted from one patient to another. They are not designed to enter sterile fields during surgery. There are several warming units, some of which are distributed and sold by 3M which markets a Bair Hugger 241 Blood Fluid Warming set, which is connected to the warming units.
The Bair Hugger warming units are even used in pediatric size. There are outpatient cardiac blankets and accessories.
The U.S. Food and Drug Administration (FDA) cleared the first Bair Hugger warming system in 1987 through the 510(k) premarket clearance program as a substantially equivalent device. Even though the FDA has not issued a recall of Bair Hugger devices, there has been numerous adverse events that have been reported to the FDA. Most of these adverse events include burns from prolonged exposure to heat during surgery or equipment malfunctions. The Augustine medical device name was changed to Arizant.
In 2010, 3M formerly known as Minnesota Mining and Manufacturing Co. bought Arizant for $810 million.
There are many lawsuits that have been filed against 3M and Arizant claiming that the Bair Hugger Therapy has caused infections after surgery. The lawsuits claim that 3M knew about the risks of infections, but did not warn healthcare providers about those risks. The lawsuits also claim that 3M and Arizant attempted to conceal and discredit scientific data that could be associated with the risk of infection.
In one lawsuit, a man claimed to have lost his leg to amputation after developing an antibiotic-resistant infection following a knee replacement surgery. Another lawsuit was filed by a man who claimed to have had 15 surgeries after developing an infection following a hip replacement surgery using the Bair Hugger device. In another lawsuit against the makers of Bair Hugger Therapy blankets, a lawsuit was filed when an individual developed MRSA after a hip implant infection.
Currently a class action is being considered against the Bair Hugger manufacturers and distributors for persons who have been exposed to injury, infection or burns because of a defect in the Bair Hugger Therapy device.
Medical device makers have a duty to develop and promote safe products for use in hospitals and clinics. In the current wave of Bair Hugger lawsuits, it is claimed that 3M and Arizant chose not to properly and thoroughly test the Bair Huggers before introducing them to the medical providers and hospitals. It is also claimed that Bair Hugger’s makers chose not to conduct sufficient post-market testing and surveillance of Bair Huggers, but instead continued to market Bair Huggers after the manufacturer should have known of the adverse effects and injuries to patients.
When medical devices increase the risk of injury, they have a duty to inform the medical providers, the physicians, the hospitals, clinics and the public of those risks. Lawsuits that have been filed accuse 3M and Arizant for choosing not to adequately warn healthcare professionals and the public of the risk where circulating air in operating rooms in the use of Bair Hugger devices can lead to serious infections, amputations and death. There are pending cases in federal courts in Texas and Kansas, as well as many other states and federal courts. It seems possible that after many more cases are filed, they may form a multidistrict litigation (MDL) or class action lawsuit. The more patients that file claims, the more likely such a scenario would take place.
If you or someone you love, has been seriously injured or died because of a defective medical device, you may be entitled to compensation from the company who manufactured this product as well as from the sales companies, end sellers, doctors or even hospitals who introduced the dangerous product.
Kreisman Law Offices, located in the heart of Chicago’s Loop, has been helping individuals receive justice because of injury or death by defective medical devices for over 40 years. Our personal injury attorneys assist individuals who have been injured by defective medical devices such as the Bair Hugger, pacemakers, defibrillators, defective stents, pharmaceutical products and many other medical devices causing infections and death. These products could be the Bair Hugger Therapy used in orthopedic surgery, the Morcellator device, or it could be a defective or dangerous drug or supplement such as Zoloft, Topamax, Xarelto, Meridia, Paxil, Hydroxycut, Yas/Yazmine, or Propecia.
If you would like to speak to attorney Robert Kreisman regarding health problems caused by a defective medical device like a Bair Hugger, an implanted pacemaker, defibrillator or other medical devices, please do not hesitate to call us 24 hours a day at 312.346.0045 or toll free 800.583.8002 for a free and immediate consultation, or complete a contact form online.