Please note that we are no longer accepting Bair Hugger cases.
The FDA first approved the Bair Hugger warming system in 1987 by way of a premarket clearance program, 510(k), which allows a device to hit the market without clinical proof that it is safe as long as it is similar enough to a device already on the market. Originally developed by Dr. Scott D. Augustine and sold by his company Augustine Biomedical and Design, which later changed its name to Arizant and was later purchased by 3M, Bair Hugger Therapy, has been used on more than 180 million patients and is employed by and estimated 80 percent of hospitals in the U.S.
Bair Hugger Therapy uses forced air warming to prevent and or treat hypothermia in patients during surgery. Hypothermia occurs when the body is losing heat faster than it can produce it. Almost all surgical patients become hypothermic during surgery, which can lead to blood loss and infections. The Bair Hugger units filter the air and then force warm air through disposable blankets that are covering the patients. In addition to warming the body through the use of warm air, they are designed to help prevent heat loss from evaporation by wicking moisture from the body. In order to reduce patient to patient infection risk, the blankets are disposable.
While Dr. Augustine is proud of his products, he has recently become outspoken regarding the risk of infection resulting from the use of the Bair Hugger system, particularly during implant surgeries such as artificial hips, knees or heart valves. A viewpoint which is supported by several studies in recent years.
Bair Hugger Can Increase Infection Risks
Despite its popularity as a warming device during surgery, numerous studies have recently explored the link between forced air warming units like Bair Hugger and increased risk of infection including deep joint infections. Even the creator of Bair Hugger, Dr. Scott D. Augustine, has come out against its use in certain surgical procedures such as hip, knee and heart valve replacements.
In November of 2011, a study was published in The Bone & Joint Journal which showed a significant increase in deep joint infections when force air warming systems were used as opposed to other warming devices during simulated hip replacements and lumbar spinal procedures. In February of 2013, another study published in The Bone & Joint Journal showed that researchers found the use of forced air warming devices caused contaminated air to be sucked up from the operating room floor and deposited over the surgical wound. According to the study 2,000 more contaminated particles were found in the air over the wound with Bair Hugger than with the conductive warming device.
More recently in the August 2013 issue of Anesthesia & Analgesia another study was published concerning the increased contamination in the surgical field from the use of forced air warming. The study showed that the forced air warming devices caused a disruption in the ventilation air flows of the surgical site leading to added contamination.
Deep joint infections can lead to multiple to severe complications. Patients who suffer from deep joint infections may endure extreme pain and suffering, additional revision surgeries, permanent disability and treatment costs in excess of $100,000.
There are several signs that may indicate a possible infected joint replacement:
- Wound drainage
- Fever or chills
- Warmth or redness around the surgical wound
- Increased pain or stiffness in the joint
If you or a loved one are suffering from these symptoms and have recently had a joint replacement or heart valve replacement surgery with a Bair Hugger warming system, you may have a claim.
Lawsuits are Being Filed All Over the Country
Some victims of these severe post-operative infections have started to take legal action against Arizant and 3M. Various lawsuits have been filed across the country claiming that 3M and Arizant knew of the infection risks, but failed to warn about the risk of infection involved with the use of their product. Many of the plaintiffs in these lawsuits claim to have suffered serious deep joint infections after the Bair Hugger was used during their hip or knee replacement surgeries; often times requiring additional surgeries and leading to a prolonged and painful recovery.
One such lawsuit was filed against 3M and Arizant in the U.S. District Court, District of Kansas. The plaintiff in this litigation is claiming the use of the Bair hugger caused him to develop a deep joint infection after undergoing a knee replacement. The infection was so severe that it required several revision surgeries before eventually requiring an amputation.
The number of lawsuits being filed against 3M and Arizant continues to grow. Currently, there has been a request made to consolidate all the lawsuits filed in federal court under one federal multidistrict litigation (MDL). The step to consolidate under an MDL is usually indicative that there will be numerous lawsuits filed.
Do I Have a Case?
You may qualify for financial compensation from the manufacturer if you:
- Have had surgery such as a knee replacement, hip replacement or artificial heart valve replacement
- Suffered from an infection such as a deep joint infection, MRSA or other hospital-acquired infection
- Required additional treatment beyond the normal recovery
We represent our clients on a contingency fee basis. This means that you pay no attorney fees until we win your claim. If we are unable to successfully resolve your claim, you are not obligated to pay attorneys’ fees.
About Sanders Phillips Grossman
Sanders Phillips Grossman has been holding pharmaceutical companies responsible for injuring individuals by their defective drugs and devices for over 30 years. Defective drugs are pharmaceuticals with side effects that potentially harm, injure, or kill the patient to the point that they outweigh the drug’s intended benefits. Defective devices, such as faulty prosthetics, implants, pacemakers or surgical instruments can harm patients when the product is defective in the manufacturing process, design or marketing strategy.
Pharmaceutical companies are some of the largest, wealthiest, and most influential corporate entities in the world. Sanders Phillips Grossman and its predecessors have recovered over one billion dollars for injured consumers. Our firm’s history in dealing with drug and medical device injury claims has allowed us to take leadership roles in many of the national defective drug and device litigations.
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