Products Liability
The Bair Hugger Forced Air Warming system has been used for decades to regulate the body temperature of patients during surgery. Bair Hugger lawsuits claim that the device has been linked to severe infections and complications, particularly in hip and knee replacement surgeries.
These sometimes awful infections can cause long-term damage and require additional surgeries, leading to more pain and suffering for a patient already enduring surgery. As a result, over 5000 lawsuits have been filed against the manufacturer, 3M Company, alleging negligence and failure to warn about the potential dangers of using the Bair Hugger. After eight years of trials and tribulations, this class action lawsuit is still pending in 2024 in Minnesota.
This page aims to provide information on the Bair Hugger class action lawsuits and the legal actions being taken by affected patients.
Bair Hugger Warming Blanket Lawsuit Update
January 15, 2024 Update: There are 6,228 Bair Hugger lawsuits in the MDL class action. So the litigation continues to grow.
This litigation is moving slowly. Last week, 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. Two weeks ago, 3M proposed a trial schedule for these cases.
Our law firm is not taking these cases. We are just providing updates because no one else is. If we learn of more developments, we will report them to you here.
October 19, 2023: The MDL Panel transferred three cases to the MDL earlier this month over the plaintiffs’ objections.
September 1, 2023 Update: 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,” the judge’s decision-making process, and hiring a law clerk, among other issues.
Judge Ericksen methodically addressed each point raised by the plaintiffs, refuting the claims of bias or misconduct. She emphasized that the law clerk was not a secret and that their hiring did not necessitate recusal. Further, she clarified 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.
This denial should hardly come as a surprise. Judges do not often rule on a motion to recuse themselves. Plaintiffs can appeal to the 8th Circuit, but that appeal will go nowhere.
August 16, 2023 Update: 5,250 Bair Hugger lawsuits are pending in the MDL.
July 14, 2023 Update: 3M has requested a Minnesota federal magistrate judge to retain his position in a multidistrict litigation (MDL) related to the company’s post-operative warming device. 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. The defendants, however, brushed off these concerns as mere “gamesmanship,” stating that the judge had not erred in refusing to step down. Furthermore, they pointed out that the judge had already divested his 3M shares, attributing the delay to an oversight.
In addition to the presiding judge, the plaintiffs had also tried to disqualify the MDL judge, although the reasons for this remain confidential. Nonetheless, this motion was also rejected.
The plaintiffs’ call for the judges’ disqualification, made in April, revolved around the current judge’s financial connection to 3M and concerns of impartiality arising from his wife’s role in a healthcare organization linked to 3M.
May 30, 2023 Update: 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.
Despite the ruling, there is not widespread excitement about these lawsuits. But there is still hope of settlement. A few months ago, the MDL judge appointed retired Magistrate Judge Arthur Boylan was appointed as a mediator by the MDL judge. Arthur Boylan is known for his experience and expertise in resolving complex legal disputes through mediation. With his appointment, he hopes to facilitate negotiations and discussions between the involved parties to reach a mutually satisfactory resolution.
April 19, 2023 Update: As of April 17, 2023, there are 5,173 plaintiffs with pending lawsuits in the Bair Hugger class action MDL. This MDL was recently reopened after more than a year on hold pending the outcome of appeals. At its peak, there were around 6,000 plaintiffs in the Bair Hugger MDL.
April 17, 2023 Update: A disqualification motion was filed in the Bair Hugger class action claiming that Judge Joan Ericksen of Minneapolis secretly engaged a retired products liability defense attorney as an adviser while considering a critical 3M motion to exclude opinions from plaintiffs’ expert witnesses. The motion alleges that Ericksen didn’t disclose the retired lawyer’s involvement. Yet when she decided in 2019 to bar plaintiffs’ experts and dismiss all cases in the MDL, she relied on legal theories previously put forth by the retired defense attorney Frederick Morris. The 8th US Circuit Court of Appeals later overturned the decision in 2021. But she is still the MDL judge, which is a problem for plaintiffs. It is not ideal to have the trial judge be the same judge who dismissed all your cases in the first place.
The plaintiffs’ motion comes on strong. Morris was the “man behind the curtain,” and it claims that Ericksen concealed his involvement to avoid revealing her bias. This is a full-throated argument directed at a federal judge.
The plaintiffs also moved to disqualify the federal magistrate, Judge David Schultz, alleging that his financial adviser bought and sold a small number of 3M shares for his account while the MDL was in progress. This is an issue but much smaller potatoes compared to the no-turning-back attack on the MDL judge. Ironically, the roles are reversed in the 3M earplug litigation, where 3M has made several no-holds-barred attacks on the judge overseeing that litigation.
March 24, 2023 Update: New Bair Hugger lawsuits continue to be filed. A patient has filed a lawsuit claiming that the Bair Hugger Forced Air Warming system caused him to develop a periprosthetic joint infection during his left total knee arthroplasty surgery at Sarasota Memorial Hospital in 2021.
The lawsuit, filed on March 22, 2023, alleges that contaminants introduced into the patient’s surgical wound during the use of the Bair Hugger system led to the infection. The patient has since undergone four additional procedures and treatments, including irrigation and debridement, synovectomy, single-stage revision, two-stage revision, wound treatment, and intravenous antibiotics at Doctor’s Hospital of Sarasota and Sarasota Memorial Hospital between August 2021 and August 2022.
The lawsuit further claims that 3M has been aware of the contamination problem associated with the Bair Hugger system since 2009.
The case has been assigned to U.S. District Judge Joan Ericksen as part of a multidistrict litigation proceeding.
February 10, 2023 Update: Judge Ericksen held the first status conference in the Bair Hugger class action MDL since it was reactivated following the plaintiffs’ victory on appeal.
December 16, 2022 Update: the Bair Hugger plaintiffs sent a letter of their own to MDL Judge Ericksen objecting to 3M’s proposed schedule for the MDL moving forward and highlighting new scientific evidence. The plaintiffs argue that the new, recent evidence strengthens their causation argument.
December 14, 2022 Update: the Bair Hugger class action MDL was officially resumed today after 3M sent a letter to MDL Judge Joan Ericksen formally requesting a resumption of the MDL proceedings following the conclusion of the appellate court battle. In the letter, 3M asked Judge Erikison to adopt a new schedule to wave further discovery and schedule 3 new bellwether test trials for the beginning of 2024.
June 1, 2022 Update: The Supreme Court rejected 3M’s appeal. This effectively ends the appellate court battle and clears the way for the Bair Hugger class action MDL to resume.
February 11, 2022 Update: 3M and its subsidiary, Arizant Healthcare, filed a writ of certiorari petition with the Supreme Court. The petition sought to have the court evaluate whether the Court of Appeals’ August 2021 ruling was too lenient in allowing plaintiffs’ expert witness testimony. It argued that the plaintiff’s expert witness testimony was unreliable. The petition also argued that the Appeals Court’s decision to exclude some plaintiff testimony showed that it acknowledged the testimony’s flaws.
February 3, 2022 Update: U.S. District Judge Joan N. Ericksen announced that she appointed retired Magistrate Judge Arthur Boylan to mediate the Bair Hugger lawsuits. The involved parties will correspond with Judge Boylan to schedule and attend mediation sessions he considers appropriate in these cases. Hopefully, this also means that over 5,200 active lawsuits involving the Bair Hugger blanket may potentially settle.
The lawyers certainly differ on how the Bair Hugger bellwether trials should proceed. The plaintiffs’ lawyers suggested that the parties and the Court should plan to remand significant waves of cases for discovery and trial in several transferee courts. 3M disagreed, arguing that remanding these cases would be “premature.” It indicated that additional bellwether trials were “warranted.” However, it argued that the parties must carefully select sets of cases to ensure they are ready for trial by early 2023.
January 3, 2022 Update: A trial judge had dismissed nearly 6,000 federal lawsuits because it did not believe the plaintiffs’ lawyers had produced experts that could bring a viable claim in court. But, yesterday, the 8th U.S. Circuit Court of Appeals said the MDL judge overseeing the warming blanket lawsuits wrongly excluded testimony from medical experts supporting the plaintiffs’ claims. The appeals court found that the Plaintiffs’ medical engineering expert opinions on causation could be derived from models and epidemiological that suggest a causal connection between infection and the Bair Hugger. This is a tough blow for 3M, who is also the defendant in the defective earplug lawsuit that is the biggest mass tort in U.S. history.
On November 9, 2021, the U.S. Court of Appeals for the Eighth Circuit rejected 3M’s request to review the Court of Appeals’s August 2021 decision. This meant that the cases remained reinstated and returned to the lower court. The only path for 3M now is the Supreme Court. It is a long shot that the Supreme Court would even hear the case, much less overrule the 8th Circuit.
The Bair Hugger lawsuits involved infections from Bair Hugger surgical warming blankets. The blankets are designed to maintain a surgical patient’s body temperature. However, they are now allegedly causing bacterial infections in cases involving joint replacement.
What Does A Bair Hugger Do?
The Bair Hugger warming blanket is a well-intended invention. During surgery, the body temperature drops as a result of anesthesia. When the body temperature drops, both bleeding and recovery time are increased. Knowing this reality of surgery, an anesthesiologist came up with the idea of the Bair Hugger warming blanket in the 80s.
The Bair Hugger is a heater and blower connected by a flexible hose to a disposable blanket. It keeps the patient warm by blowing hot air on them, allowing their body temperature to remain at a constant 98.6 degrees Fahrenheit.
The device has become extremely popular across the USA, considering it is used in nearly 90% of all major surgeries. It has also been effective in treating hypothermia and exposure. More than 50,000 Bair Hugger units are currently in use across the country.
So Why Is This Device Potentially Dangerous?
Operating rooms use Laminar Air Flow Systems, which constantly circulate filtered air throughout the operating facility. These systems prevent airborne contaminants from entering an open incision and causing an infection.
A strong natural convection fluid flow current will be established because the air exhaust from the Bair Hugger blanket is warmer than the operating room temperature. This causes the warmer air to move upwards past and perhaps through the operating field, disrupting the flow protection against the entrainment of contaminating bacteria from the surrounding uncontrolled air volume.
So the Bair Hugger system has the potential to disrupt air systems by allowing some of the warm air emitted from the machine to cycle below the operating table. Once there, it can collect and carry bacteria to the operating table. Bacteria then has the potential to enter incisions, which could obviously lead to infection. Joint replacement surgeries involving the Bair Hugger seem to produce the most significant risk of infection, given how difficult deep joint infections are to treat.
The most common type of injury our lawyers saw when we looked at these lawsuits was a deep joint infection. This infection occurs when bacteria enter the patient’s body and infect one or more of their joints, such as the knee, hip, or shoulder. Deep joint infections can be excruciating. Many of the Bair Hugger lawsuits involve claims that an infection caused long-term damage to the affected joint.
Did The Manufacturer Know About This Problem?
There is an interesting story behind this device. Its inventor sold his stake in the company and the invention back in 2002 after a dispute with his board of directors. They soon changed their name and became a subsidiary of 3M. In 2010, the inventor wrote to the company warning them about the dangers of the Bair Hugger. He insisted that a mandatory recall was imminent and the company would not survive. His old company was hardly pleased and sued him for slandering the product. They insisted he was merely trying to disparage his old company to promote his new surgical-warming product, the Hot Dog.
Despite the inventor’s warnings, medical journals dispelled them as myths. However, more complications are reported from patients who received infections after surgery involving the Bair Hugger.
The defects in the Bair Hugger forced-air warming system relating to bacterial contamination during surgery have long been acknowledged. 3M, in their own literature, addresses the issue. But 3M has failed to modify the design of Bair Hugger to fix the airflow pattern in the surgical field that can cause bacterial contamination.
As of 2019, 4000 federal lawsuits have been filed alleging that 3M knew that the design increased the risk of joint infections yet neglected to redesign the product. But the biggest issue is going to be the failure to warn. Did 3M step up when they knew there was a problem so doctors and patients could make an informed call on whether to use a Bair Hugger? That is the critical issue in these lawsuits.
Plaintiffs’ lawyers contend that 3M knew about the risks of the Bair Hugger, at least since 2011. Despite this knowledge, there was never an attempt to redesign their product or simply warn surgeons of the risks. That is what these cases will ultimately be about. Maybe they should have fixed the Bair Hugger. Maybe it was not possible. But the key claim is that healthcare providers should have been warned about the true risks of the Bair Hugger, including that the Bair Hugger might be circulating contaminated air that could cause infections.
Before leaving this topic, let’s dig a little deeper into the problem with the Bair Hugger. The most likely theory that will work for plaintiffs is the “Reservoir of Infection” theory. This theory, postulated by plaintiffs’ experts, contends that Bair Hugger pulls the bacteria from the operating room floor and puts it back into the air without an adequate filter. This escaped air creates airflow currents that flow against the downward air flow of the operating room. So as warm air rises, bacteria are transported from the floor of the surgical room into the patient’s surgical wound. This theory has been around long before the lawsuits began to fly in this litigation. Specifically, one expert contends that the “air velocity at the floor under the Bair Hugger is sufficient to entrain particles from the floor.”
- 3M has its hands full with 270,000 earplug lawsuits
Should I Seek Legal Representation?
Chances are, if you received a knee or hip implant, a Bair Hugger was used during your surgery. The device is used in approximately 80% of all implant procedures. Why are we focused on the hip and knee? Patients undergoing hip and knee joint replacement procedures are especially at risk for infection because the procedure is lengthy and invasive.
If you received an infection and had to undergo subsequent surgery, you should discuss your options with an attorney. Some of the key signs of infection in these cases would include: fatigue, fever, pain, stiffness, swelling, redness around the incision, and wound drainage. If you have experienced these side effects and required revision surgery, discussing your case with an attorney is necessary.
Is There a Class Action?
There are now over 5000 surgical infection victims with cases pending. There has been one bellwether trial that resulted in a verdict for the defendant. The lawsuits in state court in Minnesota — only about 60 or so — have been dismissed.
The result? Many Bair Hugger victims’ lawyers have run for the hills. Google “Bair Hugger Lawsuit,” and you no longer see a long stream of paid ads (bizarrely, you see ads for another 3M product, Combat Arms earplugs).
But there is a reason to be still encouraged. [Update: not really.] Mass tort cases usually begin with defense verdicts. The bar to bring a medical/scientific case is much stricter in Minnesota state court (Fyre-Mack test) than in federal court. Just one victory in court — just one — would change the landscape of this litigation. We hope to update this page soon with news of a plaintiffs’ victory.
Gareis v. 3M Bair Hugger
In Gareis v. 3M Bair Hugger, the first trial, the plaintiff claimed that the warming blanket caused contaminated air to enter his surgical wound, resulting in a severe infection after hip-replacement surgery in South Carolina. The plaintiff argued that 3M was aware of the device’s potential risks but failed to adequately warn patients and healthcare providers.
After a two-week trial, the plaintiff lost, and this case has been affirmed on appeal.
Example 2023 3M Bair Hugger Lawsuit
In Goff v. 3M, a newly filed Bair Hugger lawsuit, the plaintiff alleges he suffered an infection after undergoing a knee replacement surgery at Plainview Hospital in 2019. During the surgery, the Bair Hugger Forced Air Warming system was used, which the plaintiff alleges introduced contaminants into his surgical wound, leading to a periprosthetic joint infection (PJI) and subsequent complications. The plaintiff has undergone six additional medical procedures and treatments due to the infection. He is seeking damages for the harm they have suffered, including economic loss, and has listed various causes of action against the defendants, including negligence, breach of warranty, and fraud.