Bair Hugger lawsuit claimed due to complications by patients who used the warming blankets during surgery, led to serious life-threatening infections, such as Methicillin-Resistant Staphylococcus Aureus (MRSA), particularly in hip and knee replacement surgeries. Due to the infection, patients led to an additional surgery, accumulation or death. Below article will provide you detailed information on Bair Hugger Lawsuit and its latest updates.
What Is Bair Hugger?
what is bair hugger
Bair Hugger is a forced air warming system used for patients during surgery to regulate the body temperature. It was a well-intended invention an idea by an anesthesiologist in 80s. During the surgery, when body temperature drops bleeding and recovery time increase. Here Bair Hugger act as a heater to keep the body temperature remain at 98.6-degree Fahrenheit.
It was manufactured by Arizant Healthcare since 1987, and acquired by 3M for $810 million in 2010. The device was designed to prevent hypothermia by keeping the patient’s core body temperature normal during surgery. Although 3M is known for facing many lawsuits by patients due to complications in Bair Hugger Warming Blanket. In January 2018, 3M recalled about 165,000 Bair Hugger warming blankets for a design defect. 3M warned in its recall letter that partial inflation could prevent proper warming.
Potential Risk Associate With Bair Hugger
Potential Risk Associate With Bair Hugger
Bair Hugger exhaust warmer air then the operating room temperature. This warmer air moves upward, pass through operating room, disrupt the laminar air flow protection system of operating room, contaminate the air by bacteria into the surroundings of operating room. The bacteria infected the operating table, which has potential to enter into the body as the infected instrument gets in contact with the body.
The bacteria enter the patient’s body by opening of surgical wounds and infect one or more joints like knee, hip or shoulder, thus commonly Bair Hunger Lawsuits seen were deep joint infections. In some cases, people lose their loved ones due to Bair Hugger infection. Patients point out the development of methicillin-resistant Staphylococcus aureus (MRSA), which is an antibiotic-resistant infection.
In December 2010, Dr. Scott Augustine, the inventor of Bair Hugger devices, published an article in The New York Times, claimed that the device poses a danger to patients. He warned the company about the potential risks associated with the device, insisted to recall the device. Although the company blamed that he was trying to counter his own surgical-warming product, the Hot Dog over the Bair Hugger products.
“We believe Mr. Augustine’s allegations against forced-air warming stem from a personal vendetta and are baseless.”
In 2010, 3M said in a statement.
Consequences Of Infection
Patients claimed that deep infections can result in several long-lasting medical complications like additional surgeries, hospitalization, extensive physical therapy and amputations while some face death by using the device.
Some common signs of infections included:
- Swelling
- Warmth or redness around the wound
- Fatigue
- Increased pain
- Inability to move the limb
- Stiffness in the affected area
- Bloodstream infections
- Wound drainage
- Fevers, chills and night sweats
Role of FDA Concern To Infection
FDA received thousands of reports including patient deaths since 2013. FDA said that they were well aware of infection concern with the device but the company recommended to continues use it. Since after the first approval of Bair Hugger in 1987, FDA issued at least 14 additional clearances for changes in the device. On the other hand, they describe the benefits (to healthcare providers) of using blankets during surgery that included less loss of blood and fast recovery.
Bair Hugger Lawsuit
Bair Hugger Lawsuit
The use of Bair Hugger warming blanket after surgery found linked to an infection, complications and often deaths that led to seek a legal case on the manufacturer 3M causing Bair Hugger Lawsuit. Models named in Bair Hugger lawsuits included Model 500, Model 505, Model 750 and Model 775. The device causes long-term damage, required additional surgeries that led to more pain and suffering for patient.
There are over 7500 Lawsuits filed in multidistrict against 3M company which allegiants negligence and failure to warn about any potential damage caused by using this device. The lawsuit is still pending in Minnesota under U.S. District Judge Joan Eriksen of the District of Minnesota, after long eight years of trials. While 3M company won the first bellwether trail in May 2018, and July 31, 2019 where a judge dismissed all 6618 cases federal lawsuits.
Bair Hugger Lawsuit Timeline
In 2013, first case was found on 3M when Patient Tommy Walton filed the first Bair Hugger lawsuit, asked for $1 million. He had hip replacement surgery in March 2011, but Walton developed a deep-joint infection after his surgery and required 15 follow-up surgeries to remove the infection. From 2013 – 2015 dozen of other patients had filed lawsuits in federal courts against Bair Hugger.
In December 2015, A federal panel combined the first 14 Bair Hugger lawsuits into a multidistrict litigation. In August 2017, Multidistrict litigation (MDL) judge selected five cases for bellwether trials. In May 2018, the company 3M won the first bellwether trial in Minneapolis. While in April 2019, 5,659 Bair Hugger lawsuits had been filed and 5,036 remained pending in the MDL. In August 2019, U.S. District Judge Joan Ericksen dismissed all remaining cases in the MDL.
January 3rd, 2022
The 8th U.S. Circuit Court of Appeals ruled that the MDL judge overseeing the warming blanket lawsuits wrongly excluded testimony from medical experts supporting the plaintiffs’ claims. They approved the expert opinion and make them a part of case.
February 3, 2022
Retired Judge Magistrate Judge Arthur Boylan were appointed by U.S. District Judge Joan N. Ericksen on Bair Hugger Lawsuit. Judge Boylan had to schedule and attend mediation sessions for the case in correspondence with the involved parties. This will open the potential settlement of over 5200 active Bair Hugger Blanket Lawsuit.
February 11, 2022
The company filed a petition in Supreme Court against Appeal Court’s decision argued that the witness testimony of plaintiff’s was unrealistic and exclude those testimony from the case.
June 1st, 2022
The Supreme Court has rejected 3M’s appeal, and has upheld the Appeals Court’s decision.
December 14, 2022
The Bair Hugger class action MDL was officially resumed after Supreme Court decision, a letter sent to MDL Judge Joan Ericksen formally requesting a resumption of the MDL proceedings by adopting new schedule for further discovery.
December 16, 2022
The Bair Hugger plaintiffs sent a letter of their own to MDL Judge Ericksen proposed schedule moving forward and highlighting new scientific evidence. The plaintiffs argue that the new, recent evidence strengthens their causation argument.
February 10, 2023
Judge Ericksen held the first status conference in the Bair Hugger class action.
March 17th, 2023
With the rejection of the petition, 3M is expected to face thousands of infection lawsuits.
If a settlement agreement isn’t reached, the court will decide whether to proceed with bellwether trials or to remand the cases to their original courts for trials, which plaintiffs requested.
March 24, 2023
A new Bair Hugger Lawsuit was filled that allegations that the device cause infection to patient who then led to further surgeries at Sarasota Memorial Hospital between August 2021-2022.
April 17th, 2023
The plaintiffs have filed a disqualification motion against US District Judge Joan Ericksen and federal magistrate Judge David Schultz. The motion alleges that Ericksen didn’t disclose the retired lawyer’s involvement. Also, she tried to dismiss all cases in MDL, which is a problem for plaintiffs. While Schultz’s financial adviser bought and sold 3M shares during the multidistrict litigation. The plaintiffs claim that these actions caused bias in the case.
May 30, 2023
3M was denied a request for review by the Supreme Court regarding the reinstatement of consolidated litigation over Bair Hugger surgical warming blankets. The company claimed that the Eighth Circuit applied an erroneously permissive standard in allowing expert witnesses for joint-replacement patients.
July 14, 2023
3M has requested a Minnesota federal magistrate judge to retain his position in a multidistrict litigation (MDL). The plaintiffs had raised objections about a potential conflict of interest, as the judge had previously owned 3M shares and his wife had an association with the company.
July 2023
As thousands of patients pursue compensation, the Bair Hugger Warming Blanket case remain unsolved. Patients who have undergone a procedure utilizing Bair Hugger may qualify for significant financial compensation. However, their motion to disqualify the judge was ultimately rejected.
September 1st, 2023
U.S. District Judge Joan N. Ericksen firmly denied a motion filed by plaintiffs seeking her disqualification and the reassignment of their motion. The plaintiffs had raised concerns about bias, citing a “pattern of conduct and rulings,”.
Judge Ericksen methodically addressed that her judicial decisions, including expert testimony exclusion and summary judgments, were based on a fair assessment of the law and facts, not favoritism or antagonism.
September 2023
The most recent report on the 3M Bair Hugger cases reveals a total of 5,251 pending claims within the multi-district litigation, making it the 8th-largest MDL in the country.
October 19, 2023
The MDL Panel transferred three cases to the MDL earlier this month over the plaintiffs’ objections.
November 1st, 2023
No noteworthy developments, alterations, or additional information concerning the 3M Bair Hugger lawsuit have been made in recent months. The MDL continues to be one of the largest in the country, currently encompassing over 5,000 pending claims.
January 15, 2024
There are 6,228 Bair Hugger lawsuits in the MDL class action. So, the litigation continues to grow. 3M requested a scheduling conference for six specific trial-candidate cases not included in the Court’s suggestion for remand. In these cases, the plaintiffs have chosen the District of Minnesota as their preferred trial venue or did not specify a district court outside this district.
Plaintiffs of Bair Hugger Lawsuit
Tommy Walton, was the first person who claim Bair Hugger Lawsuit, developed a deep-joint infection after his surgery and required 15 follow-up surgeries to remove the infection.
Barbara Libby now suffers permanent disability, claimed that she developed a deep-joint infection and required seven additional surgeries because of a Bair Hugger device.
Rosie Bartel, required 27 additional surgeries following a knee replacement in 2009. Eventually doctors amputated her right leg below the hip.
Timothy Johnson claimed that he developed a deep-joint infection after total knee arthroplasty in 2010. His leg had to be amputated when multiple revision surgeries failed to remove the infection.
Ruth Childers claimed that use of a Bair Hugger device gave her an antibiotic-resistant infection following knee replacement surgery in 2013. She had to have her leg amputated above the knee.
Studies on Bair Hugger Warming Blankets
- In a 2009 study published by Orthopedic Reviews, researchers found the design of forced-air warmers fails to prevent the build-up of internal contamination and may emit airborne contaminates into the operating room.
- Additionally, a 2010 study published in the American Journal of Injection Control concluded that the risk of cross-infection by inadequately preventing the buildup of microbial contaminants in the operating room.
- In November 2011, The Journal of Bone and Joint Surgery published, the researchers found a significant increase in deep joint infection when forced-air warming was used in Bair Hugger compared to favorable fabric warming.
- Another study published in February 2012, in the Journal of the Association of Anesthetists of Great Britain and Ireland. Found forced-air warming technology can form air currents that disrupt airflow that can help clear airborne bacteria from the surgical site. This could increase the risk of infection when devices like the Bair hugger warming system are used.
- One year later, The Bone & Joint Journal published a study revealing that forced-air warming could potentially draw bacteria and other contaminants from surgical site onto the patient.
Conclusion
The Bair Hugger lawsuits highlight serious concerns over the safety of medical devices. While initially designed to prevent hypothermia during surgery, now become a life-threatening infection causing device. More than 7500 cases were filed on the manufacturing company M3. Additionally, the company knew the risk and also many studies shows that the mechanism used in Bair Hugger contaminate the surgery room and thus cause infection. Bair Hugger currently used in many facilities thus it is important to be aware of the risks associated with it.
FAQs
What is the Bair Hugger system used for?
The Bair Hugger system is used to maintain a patient’s body temperature during surgery by providing forced-air warming.
What types of complications have been reported with the Bair Hugger?
Complications reported include infections, particularly deep joint infections following orthopedic surgeries, and other surgical site infections.
Can the Bair Hugger system still be used in surgeries?
Yes, the Bair Hugger system is still in use, though its safety and efficacy continue to be debated. Some hospitals may choose alternative warming methods.
Are there any alternatives to the Bair Hugger system?
Yes, alternatives include conductive warming blankets and other patient warming devices that do not use forced air.
How many lawsuits are currently pending against the Bair Hugger system?
As of January 2024, there are 6,228 lawsuits pending in the multidistrict litigation (MDL) involving the Bair Hugger warming system.
