As of September 2018, there are over 1,500 Bair Hugger warming blanket lawsuits pending in the MDL in Minnesota.
In one typical case, a New York couple claims that a surgical warming blanket used after the husband’s hip replacement operation caused severe infections, resulting in four additional surgeries. A man and his wife filed a lawsuit in New York on Nov. 25, 2015, against 3M, the manufacturer of the Bair Hugger forced-air warming system. Medical facilities commonly use this blanket during knee and hip replacement operations. In addition to 3M, the lawsuit lists the Arizant Healthcare, Inc. and its subsidiaries as Defendants.
During the surgery on Oct. 24, 2012, medical personnel used a Bair Hugger on the man’s left hip, supposedly to help regulate body temperature. However, the warming blanket might have introduced bacteria into the surgical site, resulting in infection. The Plaintiff received five surgeries within 16 months, including the original surgery, and he now struggles with mobility and needs crutches to walk.
Per the lawsuit: “Due to the infection, Plaintiff needed four additional surgical procedures to remove the implant and clean the infected area within sixteen months from the original implant surgery, and he continues to suffer limited mobility, requiring crutches to ambulate.”
According to diverse news reports, this Plaintiff is far from alone; many consumers across the nation have taken legal action after illnesses they’ve acquired after using the Bair Hugger, following hip and knee surgeries.
The Plaintiffs noted that 3M sent a letter to the FDA way back in June 1997, that warned of possible contamination issues with this product.
How Bair Hugger Works and Why It Might Lead to Infection
During and after surgery, doctors place a disposable blanket on the patient, while the 3M Bair Hugger warmer blows hot air. Plaintiffs assert that the blanket’s design increases bacteria in the air around the surgery site, encouraging infection.
In 2000, 3M claimed that the product’s air filter complied with High-Efficiency Particulate Air (HEPA) standards, removing 99.97 percent of the possible infectors. However, the lawsuit states that the filter only removes 65 percent of contaminants. Plaintiffs insist that the use of the product increases the risk of introducing pathogens into the surgical site.
Some surgeons have expressed significant concerns about the 3M product, and they have argued that other warming devices might be safer for patients. The plaintiffs allege that, instead of addressing safety concerns, the manufacturer minimized the Bair Hugger’s risk, which led to the injuries.
This New York lawsuit lists the following claims: negligence, negligent misrepresentation, strict liability, failure to warn, defective design and manufacture, fraudulent misrepresentation and concealment, breach of express and implied warranty, and violations of New York consumer protection laws. Plaintiffs further alleged loss of consortium and they are requesting punitive sanctions and compensatory damages.
Plaintiffs’ Experts Specific Claim of Negligence
How exactly does the Bair Hugger cause harm? Plaintiffs’ engineers, very qualified and well-respected experts, have engaged in a number of experiments to count the particles emitted from the Bair Hugger warming blanket. They have developed a computer simulation that explains how the bacteria is spread with the Bair Hugger. Two mutually consistent theories have emerged of how this device impacts operating room airflow and causes surgical infections:
- Reservoir of Infection: Bair Hugger vacuums the bacteria off the operating room floor and then spins it around in filter that does not eliminate the bacteria inadequate filter, and then circulates that bacteria in the air which can cause a surgical infection.
- Airflow Disruption: The hot air that comes out of the Bair Hugger disrupts operating room airflow, stirs up bacteria, and pushes it out which causes bacteria to get into the patient open wound.
What’s Next in the MDL? 2018 Update
In December 2017, the MDL judge shot down 3M’s incredibly annoying strategy of attacking the credibility of plaintiffs’ scientific case. U.S. District Judge Joan Ericksen ruled that the plaintiffs’ science is credible. Hopefully, these cases continue to move forward towards an eventual out of court class action settlement.
Unfortunately, there was a defense verdict in May 2018. But these cases are just getting started.
The Bair Hugger cases really never got off the ground. Our lawyers are no longer investigating these cases.
Important Bair Hugger Studies
- Belani KG, Albrecht M, McGovern PD, Reed M, Nachsheim C, 2013, Patient warming excess heat: the effects on orthopedic operating room ventilation performance, Anesthesia & Analgesia 117, 406-411.
- Reed M, Kimberger O, McGovern PD, Albrecht MC, 2013, Forced-air warming design: evaluation of intake filtration, internal microbial buildup, and airborne-contamination emissions, AANA Journal 81(4), 1-6.
- Albrecht M, Gauthler R, Leper D, 2009, Forced-air warming: a source of airborne contamination in the operating room? Orthopedic Reviews, 1e28, 85-88.
These studies contend that bacteria swabbed or rinsed from the interior surfaces of Bair Hugger warming units and hoses are emitted into the air.