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3M Bair Hugger Lawsuit
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By Jane Mundy
A Forced-Air Warming blanket is a medical device designed to keep patients warm during orthopedic surgery and reduce the risk of infections. But these warming blankets, including the 3M Bair Hugger Warming System, may actually be causing infections. A number of 3M Bair Hugger injury lawsuits have been filed by patients who had hip or knee replacements and allege they developed Deep Joint Infections due to forced air warming blanket use. One patient who filed a Bair Hugger defective medical device lawsuit needed his leg amputated after developing infection following surgery.
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3M Forced-Air Warming Blanket
The Bair Hugger was invented by Dr Scott Augustine, an anesthesiologist, and the FDA approved the device in 1988. But Augustine in 2010 asserted that his device is a danger to surgical patients because the forced air can spread bacteria associated with hospital-acquired infections. (He has since designed and promoted another FAW.)
Complications stemming from infection allegedly brought on by use of forced air warming blankets can require the following treatment:
- Additional revision surgeries and longer hospitalization
- Joint implant removal and revision
- Physical therapy
- Placement of an antibiotic spacer in the infected joint
- Intravenous antibiotic treatment
- Amputation
Bair Hugger Studies
The JBJS in December 2014 reviewed current literature involving Forced-air warming devices such as the Bair Hugger. The authors looked at many other studies and a Continuing Education statement by the Association of periOperative Registered Nurses (AORN) and "suggest that proper use of the forced air warming devices mitigates or eliminates this risk while maximizing the benefits of patient warming."
Bair Hugger Lawsuits
The lawsuit further states that Bair Hugger FAW was defective due to inadequate post-marketing warnings and/or instructions because Defendants failed to provide adequate warnings...and continue to aggressively promote Bair Hugger FAW.
3M Company and Arizant Healthcare, Inc.. have also been accused of negligence by:
- Failing to properly and thoroughly test Bair Hugger FAW before releasing the device to market;
- Failing to properly and thoroughly analyze the data resulting from the pre-market tests of the Bair Hugger FAW;
- Failing to conduct sufficient post-market testing and surveillance of the Bair Hugger FAW
Walton is seeking more than $1 million in damages.
March 2014: Timothy Johnson had knee replacement surgery at the University of Kansas Hospital in September 2010 and subsequently developed the antibiotic-resistant infection MRSA. His leg needed to be amputated. Johnson's lawsuit claims that air from the Bair Hugger system "creates warm, rising, airflow currents that deposit bacteria from the floor of the surgical room into the surgical site."
Rosie Bartel also developed a MRSA infection after knee replacement surgery. She is now in a wheelchair after enduring 11 more surgeries and having part of her leg amputated. According to her lawsuit, Bartel also lost her home and her job.
The single-use Bair Hugger blankets and gowns were used in 22 million surgeries in 2012. Arizant Healthcare Inc. was bought by 3M in 2010 for $810 million.
3M Bair Hugger Warming Blanket Legal Help
If you or a loved one has suffered similar damages or injuries, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
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BAIR HUGGER LEGAL ARTICLES AND INTERVIEWS
Filing a Bair Hugger Lawsuit: Attorney Weighs In
Last-Ditch Effort for 3M Bair Hugger Appeal
FDA Clears Bair Hugger for Post-Surgical Use
January 3, 2023
Gabriel Assaad has filed lawsuits against 3M and Arizant Healthcare (3M acquired Arizant in 2010) on behalf of patients who developed periprosthetic joint infections (PJI) after undergoing joint replacement surgery where a Bair Hugger warming blanket was used. If you had a knee or hip replacement surgery, suffered an infection and required additional surgery on your implant, you may be entitled to compensation. READ MORE
Last-Ditch Effort for 3M Bair Hugger Appeal
October 4, 2022
3M has asked the U.S. Supreme Court to grant a review of the U.S. appeals court decision to reinstate close to 6,000 Bair Hugger lawsuits claiming the warming blanket used in surgery results in knee and hip infections. In August 2021, the US Court of Appeals for the Eighth Circuit revived the lawsuits. READ MORE
FDA Clears Bair Hugger for Post-Surgical Use
September 12, 2017
Washington, DC: 3M’s , Bair Hugger, the subject of some 2600 defective products lawsuits across the US, has received clearance for use from the US Food and Drug Administration (FDA). According to a spokesperson for the FDA, the agency has no conclusive evidence to establish an association between use of a forced air thermal regulating systems and an increased risk of surgical-site infections. READ MORE
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READER COMMENTS
Herbert Cox
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Beverly Holm Jarshaw
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Tom Sweesy
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Herbert Cox
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Jonathan Hurley
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So, 3 prior surgeries of hip reduction in the same area had a successful outcome. Introduce the Bair and an infection occurred. And these statistics do not lie. I drove my surgeon crazy just asking "Why?" The INVENTOR of the device is on record and says it causes infection.
God forbid you find yourself harmed and need to resort to tort law. I was healthy and in great shape. Really looked forward to enjoying my retirement. Swimming, sailing, scuba diving, traveling, bike riding and golf were on my daily agenda. Now, I can't even walk. I aged 25 years in 6 months. I would have happily endured the cold of the OR to be healthy today. I did well the first 3 times.
Barbara
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Catherine Felix
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Doreen phillips Atkinson
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Wayne Wedgeworth
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Tony Friday
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Walter
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Ronald F.Williams
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Jayne Scheets
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The Bair Hugger was used in my surgery's. After the first surgery I had suffered and contracted a vicious MRSA infection. The Bair Hugger was used during my surgery and also in the recovery room in fact I was admitted into my hospital bed with the Bair Hugger still on me. I believe that this caused my infection and thus needed several rounds of heavy antibiotics such as Vancomycin IV for over 2 ½ years and being on a would vac for months every time I came home from the hospital. The embarrassment of being wheeled around in my wheel chair having a tube running out of my body with blood and puss and was just horrible. I only went out of the house for doctor visits and blood work. My husband lost his job because he had to take so many days off work to take me to all of my appointments. My hip surgeon gave up on me and sent me to another hip surgeon that was able to get my infection under control. The emotional, physical, unbearable pain, constant digging with needles sticking into me and the humiliation of being exposed and finally being labeled someone with a contagious infection was indescribably emotionally unbearable. I could not go near my grandchildren because of the fear of infecting them with this airborne incurable MRSA infection I did not want to cause them any harm of being infected. I only hope that this miserable infection (that has no real cure) has not harmed my husband in any way. He is my main care giver. The emotional strain of these 3 hip implants, one medicated hip and 3 cleanouts and 6 months with no hip at all until the infection was totally undetected. Because of this I have to be on low does antibiotics the rest of my life. I have the most horrible scar that is over 9 ½ inches and the bone, and muscle tissue loss that I may never get back.
After my original surgery from Dr. Z (who dumped me because he could not figure out what to do) I was at a total loss and thought I was going to die. He made some phone calls because of my very active infection was so bad it needed to be treated. He referred me to Dr. M that took one look at my infection, that had turned into three bulbous green areas on my incision had needed immediate surgical removal. I was admitted into the hospital and Dr. M took out the hip replacement and did not put anything back so the area would begin to heal with no foreign parts in my hip. After 6 long months the infection cleared and Dr. M has put the hip appliance in this past October 6th. I show no elevated white cell at this time. I am holding my breath because this has been a long road that has not ended yet. I stand the risk of reinfection and a lifelong scar. I am now trying to walk again. I have to use a cane and a walker. I have a lot of pain and have phantom feeling of blood and puss running down my leg all the time. What a horrible continuing nightmare I have had to endure that I have gone through and it may not be over yet.
kathy meacham
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C.R.
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Otis. Young
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Linda C. Miller
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