How comfy can a bear hug be? Very cozy and warm, right? But a tight hug can crush your bones and be fatal. The topic of our blog, the Bair Hugger air-warming blanket, has proved to be a bear’s hug.
The Bair Hugger air-warming blanket is a patient-warming device intended to protect patients from hypothermia. However, it is alleged to cause fatal surgical site infections and deep joint infections in patients.
The pernicious side effects have led thousands of plaintiffs to demand justice in the form of Bair Hugger lawsuits.
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Before digging deep into the details of the Bair hugger warming blanket lawsuits, let’s try to deskin the truth behind the evolution of Bair Hugger lawsuits.
What is Bair Hugger Air-Warming Blanket?
The Bair Hugger is a mechanism for forced air warming. During a surgical procedure, this medical device blows warm air into a blanket that is draped over a sedated patient. When patients are under anesthesia, their body temperature may drop. Bair Hugger forced air-warming blankets is used to prevent hypothermia (a medical condition of dangerous reduction in body temperature). Let’s see how.
In hospitals, the 3M Bair Hugger forced-air warmer blanket is frequently used to regulate the body temperature of patients undergoing hip or knee replacement surgery to prevent hypothermia and help in faster recuperation too.
Two main parts of the system are a warming unit and a single-use disposable blanket. The single-use blanket is connected to the warming device by a flexible hose. The flexible hose allows warm air from the warming device to enter the blanket. As soon as the heated air enters the blanket, it escapes through a number of tiny holes on the underside, warming the patient’s skin in the regions unrelated to the surgery.
More than 80 percent of hospitals across the U.S. rely on this medical device to keep their patients warm.
3M claims that their device filters air and then forces warm air through it. Using pressure points on the patient’s body, Bair Hugger blankets are intended to keep heat from accumulating in areas, but that could burn or develop pressure sores.
The disposable Bair Hugger blankets reduce the possibility of infection transmission from one patient to the next. They are not intended for use in sterile areas of the human body during surgery.
Background History of Bair Hugger Blankets
Let’s scoop out the history of Bair Hugger.
Bair Hugger air-warming blanket was first developed by an anesthesiologist named Dr. Scott D. Augustine. He was the founder of two trailblazing medical device companies, Augustine Medical, Inc. (1987) and Augustine Biomedical + Design (2003). He manufactured the blankets in Augustine Medical, INC., after getting approval from the Food and Drugs Administration in 1987. It is said that the FDA approved it under 510(K) pre-market programs without any clinical trial to prove its safety.
That was not a single incident. Augustine Medical Devices received 12 more clearances under the 510(k) pre-market programs in the period of 1990 to 2002.
When the company came under new management, it was renamed Arizant. In 2002, Augustine left Arizant and started Augustine Biomedical + Design. From 2002 to 2004, Arizant products were cleared twice under the same pre-market program.
In 2010, Augustine invented a different type of patient-warming device named HotDog and sold it through his new company.
In the meantime, in 2009, Arizant was purchased by 3M for $810 million and became a subsidiary of 3M. Since then, Bair Hugger has been produced and marketed by 3M.
In 2010, Dr. Scott reported to the New York Times that the epic product he had invented could pose serious Hospital Acquired Infections (HAI) to patients.
Complications of Bair Hugger
The elevated temperature over the surgical site causes convection currents that move air from non-sterile places into the surgical site, such as the floor and under the anesthetic surgery drape. Convection currents transport possibly contaminated particles from beneath the operating table into the surgical site, raising the risk of serious infection substantially.
The immune system has a more difficult time attacking microorganisms on foreign things, such as metal and plastic hip or knee implants. An infection that gets within an implant can quickly grow and produce symptoms like pain, swelling, fever, and exhaustion. If left untreated, deep joint infections can result in amputation, permanent disability, hospitalization, implant revision surgery, and even death.
The Bair Hugger blankets can cause hospital-acquired infections like Methicillin-resistant Staphylococcus aureus (MRSA), sepsis, etc. MRSA mostly affects an individual’s heart, lungs, bones, and joints. These infections can resist antibiotics and other medications to restrain the infection and cause a big hindrance in the course of treatments.
Many patients have come forward complaining that the use of Bair Hugger blankets during their hip or knee joint surgeries has acquired infections. These infections damage the tissues in the joints and lead to more risky revision surgeries.
The surgical site infections can spread through the bloodstream to other joints like the hip, shoulder, spine, arms, and leg joints. This may lead to permanent bone or cartilage damage to the victim. Some of these infections can be capable of causing multiple organ damage too.
Studies on Bair Hugger Adverse Effects
A 2011 study done by McGovern et al. found that using air-forced warming instead of conductive warming cloth resulted in a significant rise in deep joint infections.
According to a 2012 study by Legg et al., published in the Journal of Bone & Joint Surgery, and two 2013 studies published in the Bone & Joint Journal (February 2013) and Anesthesia & Analgesia (August 20), excess heat from forced-air warming devices affected ventilation airflow over the surgical site. This forced-air warming increased the number of airborne particles around the surgery site significantly. The tests did not uncover any germs in the extra particles, but they did find the increased particles to be alarming.
In November 2014, a study based on clinical research on the health hazards caused by forced-air warming devices was published.
Bair Hugger Complications Derail Lives
The already ailing patients’ lives are put at risk by the surgical site infections caused by Bair Huggers. They are forced to encounter unpleasant outcomes such as:
- Additional surgeries
- Joint implant removal and revision
- Insertion of an antibiotic spacer in the infected joint
- Intravenous antibiotic therapy
- Physical therapy
- Prolonged hospitalization
- Pain and suffering
- Mental agony
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Adverse Event Report to the FDA and Bair Hugger Recalls
At the start of 2018, one of the patients who used the Bair Hugger blanket experienced hypothermia while using the air-warming blanket. The dip in his body temperature led him to be kept under anesthesia for a prolonged period and treated in the Intensive Care Unit. He had reported the event to the FDA’s adverse events.
Following the incident, the manufacturers went with a recall notice in January, recalling around 160,000 Bair Hugger air warming blankets due to the design defect. In February 2018, the FDA reported the Bair Hugger recall. It is said that this recall impacted more than 33,000 Bair Hugger blanket boxes containing five blankets in each.
The recalled batches were meant to be used under the body of patients and not the ones to cover the upper body. It included a series from R10359 to R10366.
The overwhelming early adverse event reports included burns caused by extended heat exposure during surgery or equipment problems that resulted in cold air circulating under the blanket.
Many more adverse events were reported from the marketing of the blanket until 2017. The usage of forced air thermal regulating systems and surgical site infection has not been consistently linked, according to the FDA, despite a thorough evaluation of the evidence that was available. Therefore, the FDA continues to recommend the use of thermoregulating devices for surgical procedures when clinically warranted. However, they assured to continuously monitor the adverse effects of the blankets on the patients.
When we look back into the history of Bair Hugger devices, we can find that the FDA issued a warning in 2010 against the manufacturers for violating the regulations of the Federal Food, Drug, and Cosmetic Act.
The Bair Hugger makers were warned for failing to:
- Notify a device malfunction that caused serious injury
- Create, maintain, and implement FDA reporting processes.
- Create and maintain adequate adverse event files.
Two Sides of the Story
The heated debates over the efficacy of the medical gadget between the manufacturer and the inventor, Augustine, had ramped up the heat in the Bair Hugger blankets.
Dr. Augustine warned that the Bair Hugger blankets could pose a serious threat of infections and sent a warning letter to Arizant about the same. He quoted many studies that supported his warning.
On the other hand, many physicians have come up against the inventor blaming that in order to promote the sales of his new product, the HotDog, Dr. Augustine has been defaming his own prime invention. They say that all the studies that proved the inefficacy of the Bair Hugger blankets have one or the other connections with Dr. Augustine. At least one of the researchers in each study was a former assistant or employee of Dr. Augustine’s former company.
While there are ongoing discussions about who is lying, the injuries of the plaintiffs cannot be nullified as insignificant. We are not here to dig into the feud between Dr. Augustine and Arizant. These arguments, too, can have great impacts on the ongoing Bair Hugger warming blanket infection lawsuits.
Progression of Bair Hugger Lawsuits
The first Bair Hugger blanket lawsuit was filed in 2013 by a 70-year-old patient named Tommy Walton in Texas. He alleged that the use of a Bair Hugger blanket during his hip replacement surgery in 2022 caused a joint infection. He blamed the infection led him to undergo around 15 surgeries and finally got his artificial hip joint removed. He demanded $1 million in compensation for his pain and suffering and the negligence of the manufacturers.
His lawsuit alleged that 3M failed to do the following and became solely responsible for his damages and suffering. They are as follows:
- Failed to conduct enough testing and preserve follow-up data after the device was made available to the consumer market.
- Failed to properly and thoroughly assess pre-market testing data.
- Failed to properly and thoroughly test the Bair Hugger warming device.
Timothy Johnson filed a Bair Hugger lawsuit in Kansas in March 2014. He had acquired MRSA during his knee replacement surgery in 2010, which led to the amputation of his leg. His lawsuit alleged that the air-warming blanket circulated the contaminated air down the floor into the surgical site.
Rosie had undergone a knee replacement and got infected after the use of the air-warming blanket and contracted MRSA. She had to undergo 11 more additional surgeries to recover from the infection. Finally, she had to undergo a partial amputation of her leg. She filed a Bair Hugger lawsuit in 2014 against the makers of the blanket. Her lawsuit alleged that 3M marketed a defective product knowing the risk of surgical site infection. She claimed that her amputation led her to lose her job and abode.
Tawas Reed encountered an MRSA infection during his hip replacement surgery in 2014. It led to 15 further consecutive surgeries to recover from the infection. He had to face lifelong mobility issues due to the negligence of the Bair Hugger manufacturers. He had filed his Bair Hugger lawsuit in the District Court for the District of Minnesota on July 25, 2015, claiming damages for his infection, revision surgeries, and disability.
Bair Hugger Lawsuits MDL
All the 3M Bair Hugger lawsuits filed in the federal courts were consolidated as MDL no. 2666 in the district court of Minnesota under Judge Joan Erickson in December 2015. The court’s first pre-trial order, issued in January 2016, said that regular status conferences would start in February 2016.
Five cases were chosen for bellwether trials in August 2017 to be scheduled in 2018, and the first bellwether trial of Louis Gareis vs. 3M went in favor of 3M.
In 2019, 3M moved a motion for summary judgment to exclude the plaintiff’s experts in the case of Louis Gareis and his wife, Lillian Gareis. The lawsuit alleged that Louis Gareis got an MRSA infection after his hip replacement surgery in 2010.
After considering their arguments, U.S. District Judge Joan Eriksen granted the motion in favor of the manufacturer, stating that the plaintiff’s side failed to prove the link between the infection and the Bair Hugger device.
Judge Joan Erickson ordered the cancellation of all the active cases in the MDL 2666 on July 31, 2019. There had been more than 5,000 individual Bair Hugger lawsuits in the MDL at the time of the dismissal.
The judge stated that the plaintiff’s expert testimonies were unreliable and failed to scientifically prove that the device caused the infections and the alleged damages claimed in the Bair Hugger lawsuits.
This happened alongside John Petitta’s claim against 3M. He had undergone knee replacement surgery in Texas. He alleged that his development of a periprosthetic joint infection was due to the use of the Bair Hugger blanket.
The plaintiff John Petitta filed his lawsuit in the MDL on November 10, 2016. Later, he also pursued an individual product liability lawsuit in Hidalgo County against 3M for its negligence, warranty breach, and strict product liability.
3M filed a motion for an injunction against Petitta’s claim, saying that his MDL claim and the individual claim had contradictions. After going through their arguments, the court allowed 3M’s motion preventing Petitta permanently from moving lawsuits against 3M in August 2019.
In a statement, Dr. Todd Fruchterman, general manager of 3M’s medical solutions business, said, “There is no real scientific foundation for the plaintiffs’ argument.”
Bair Hugger Lawsuits Got Rejuvenated
Though the MDL 2666 was closed in 2019, there was no stop in the inflow of the Bair Hugger lawsuits.
In August 2021, an Eighth Circuit Court of Appeals breathed life into the dying hopes of the Bair Hugger victims, stating that the barring of the plaintiffs’ expert testimonies in the Bair Hugger MDL was wrong. It reinstated all the dormant Bair Hugger lawsuits.
Earlier in 2019, Judge Joan Erickson barred the expert testimonies of an engineering expert, an epidemiologist, and an orthopedic surgeon. She stated that there was a great gap between their expert opinions and the sources they relied upon to prove their statements and considered them unreliable.
In February 2022, Judge Joan Erickson appointed retired judge Arthur Boylan to handle the Bair Hugger mediation talks. This mediation process brings hope of a settlement in all the remaining claims.
As per the update on Bair hugger lawsuit in November 2022, after the rejuvenation of the Bair Hugger lawsuits, there are around 6,000 active Bair Hugger lawsuits in the courts.
In the second week of December 2022, 3M requested MDL Judge Joan Ericksen to reopen the Bair Hugger class action lawsuit MDL proceedings and urged to start a new phase of bellwether trials in 2024.
The plaintiffs on their part claimed that a new study report was ready to bolster their claim.
Follow our blog to get the latest Bair hugger bellwether trials updates and Bair hugger recent news.
Latest Bair Hugger Litigation Update 2023
March 2023 Update
New Bair Hugger lawsuits are still being filed by the victims. An Alabama resident, Cheryl Jones filed a lawsuit District of Minnesota on March 13, 2023 against Bair Hugger.
She developed a knee joint infection from the use of Bair Hugger blanket during her knee replacement surgery in April 2021. The infection necessitated her to undergo multiple knee surgeries and prolonged suffering. Her lawsuit was added to the MDL.
Another Bair Hugger litigation filed on March 22, 2023 claimed that the use of Bair Hugger blanket in 2021 during his arthroplasty surgery led to the plaintiff’s periprosthetic joint infection.
The infection resulted in more surgeries and additional treatment comprising of synovectomy (surgical removal of the joint lining), lavage (cleaning the organ with fluids) and debridement of contaminated tissues, single-stage and two-stage revisions, wound care, and more intravenous antibiotics.
April 2023 Update
As per the update in April 2023, there are more than 5,000 Biar Hugger lawsuits in the MDL. After many years of trials and controversies, still these lawsuits are pending in the court of Minnesota, giving hope to the plaintiffs.
May 2023 Update
In a stunning turn of events, 3M’s plea for a Supreme Court review has been ruthlessly denied, leaving the fate of the consolidated litigation surrounding Bair Hugger surgical warming blankets hanging in the balance. The company, known for its influential presence in the medical industry, argued passionately that the esteemed Eighth Circuit had committed a grave error by adopting an excessively lenient standard when permitting expert witnesses for joint-replacement patients.
With bated breath, 3M had hoped that the Supreme Court would intervene, shedding light on what they believed to be an unjust ruling. However, their hopes were dashed as the highest court in the land turned a deaf ear to their pleas, leaving the issue unresolved and the consolidated litigation looming like a dark cloud over the horizon.
In July 2023, Plaintiffs raised their concerns over a judge presiding over lawsuits. The judge and his wife had connections with 3M in the past, which made the plaintiffs worried. However, 3M wanted the judge to continue.
As of August 16, 2023, there are 5,250 Bair Hugger lawsuits in the MDL.
As the battle rages on, the question remains: will justice prevail for the joint-replacement patients affected by the Bair Hugger surgical warming blankets. Only time will reveal the answers as this high-stakes legal drama unfolds.
Let’s wait and see how the mediation talks progress and if it will lead to a global settlement in the pending Bair Hugger lawsuits. To know the Bair Hugger lawsuit update 2023 and the expected Bair Hugger settlements, keep in touch with us. Whenewver we get any bair hugger settlement news, we will update it here.
In case of acquiring a deadly infection after the use of the Bair Hugger air-warming blanket, you can definitely proceed with a claim. Medical records can come to your aid in proving your injuries and the cause.
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To wrap up,
In the case of the Bair Hugger air warming blankets, medical equipment intended to aid in the patient’s health and recovery time proved otherwise.
Patients undergo surgery in the hope of getting a resolution to their pain and agony. When that hope becomes a void ending up in permanent disability and prolonged pain and suffering, they have all the rights to demand justice for their damages.
The rejuvenation of the Bair Hugger lawsuits has revived the expectation of the plaintiffs to get the deserving reparation sky-high. We will be updating all the significant progress in Bair Hugger 3m lawsuit here. Check in to get the details on Bair Hugger lawsuit update 2022, latest bair hugger lawsuit 2023 updates, and when the Bair Hugger lawsuit settlements will be paid.
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1/6 What is Bair Hugger Air-Warming Blanket?
The Bair Hugger is a mechanism for forced air warming.
During a surgical procedure, this medical device blows warm air into a blanket that is draped over a sedated patient.#bairhuggerlawsuits #lezdomedlegal #productliability pic.twitter.com/eQiPZ8czoT
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