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 serious 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 patients already enduring a 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. This class action lawsuit, after eight years of trials and tribulations, is still pending in 2023 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
The Bair Hugger lawsuits are still alive.
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 which would 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 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 would need to 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 Appeal’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, the blankets now are 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 back in the 80s.
The Bair Hugger is a heater and blower connected by a flexible hose to a disposable blanket. The Bair Hugger keeps the patient warm by blowing hot air on the patient, allowing their body temperature to remain at a constant 98.6 degrees Fahrenheit.
The device has become extremely popular across the USA, considering that 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 finding their way into an open incision and causing an infection.
Because the air exhaust from the Bair Hugger blanket is warmer than the operating room temperature, a strong natural convection fluid flow current will be established. This causes the warmer air to move upwards past and perhaps through the operating field. This disrupts 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 bacteria and carry them 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 biggest risk of infection given how difficult deep joint infections are to treat.
The most common type of injury our lawyers saw back when we were looking 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 extremely painful. 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 that the company would not survive. His old company was hardly pleased and sued him for slandering the product. They insisted that he was merely trying to disparage his old company in the name of promoting his new surgical-warming product, the Hot Dog.
Despite the inventor’s warnings, medical journals dispelled them as myths. However, more and more complications are being reported from patients who received infections after undergoing 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 had the opportunity to make an informed call on whether to use a Bair Hugger? That is the key 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 we leave this topic, let’s dig a little deeper into exactly what the problem is 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 long 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 still be encouraged. [Update: not really.] Mass tort cases usually begin with defense verdicts. The bar to bring a medical/scientific case is must stricter in Minnesota state court (Fyre-Mack test) than it is 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 and resulted in a serious infection after hip-replacement surgery in South Carolina. The plaintiff argued that 3M was aware of the potential risks associated with the device 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 as a result of the infection. He is seeking damages for the harm they have suffered, including economic loss, and have listed a range of causes of action against the defendants, including negligence, breach of warranty, and fraud.
Contact Us to File Your Bair Hugger Infection Lawsuit
Our national product liability lawyers are now accepting new Bair Hugger surgical infection cases from qualified plaintiffs. If you underwent a joint replacement surgery (e.g., knee or hip replacement) during which a Bair Hugger warming device was used and you subsequently developed a post-surgical infection, you may qualify for a Bair Hugger lawsuit. Contact our office today at 800-553-8082 for a free consultation.