Bair Hugger lawsuits claim the operating room warming blankets circulate microbes from the floor throughout the OR, allowing them to contaminate surgical instruments and open wounds. Plaintiffs say this contamination caused serious infections and even amputations. Trials thus far have been dismissed, withdrawn, or judged in favor of the manufacturer, 3M.
Why People Were Filing Bair Hugger Lawsuits
The Bair Hugger patient warming system circulates warm air through a sterile, disposable blanket used to cover and regulate a patient's body temperature during surgery. The air goes through a filter small enough to remove any microbes before flowing through the channels in the blanket. According to several medical publications, the Bair Hugger is the most clinically effective patient warming device currently available.
The patient warming blanket was originally developed by Scott Augustine, MD and sold by Arizant, formerly known as Augustine Medical. Dr. Augustine designed the device to keep patients more comfortable during long procedures like joint replacement surgery. Augustine resigned from Arizant in 2002, and 3M acquired the company and the warming system in 2009.
Design Flaws Lead to Lawsuit Claims
Despite the Bair Hugger's widespread use for nearly 40 years, some critics have blamed the technologically advanced blanket for surgical site infections. In fact, Dr. Augustine stands prominently among those pointing the finger at the device. And his accusations may have inspired the many related lawsuits currently making their way through the court system.
Lawsuits claim the patient warming device:
- Disrupted airflow around sterile operating surfaces
- Compromised efficacy of the operating room's air filtration system
- Increased the number of airborne particles on sterile surfaces and the patient's open surgical site
- Caused or contributed to surgical site and deep joint infections
Plaintiffs say the Bair Hugger warming blanket compromised the sterile environment of their surgical procedures, leading to serious infections. According to court records, those infections caused plaintiffs to endure further invasive medical procedures, some requiring complete removal of joint replacement implants.
Most filings accuse 3M of negligence, failure to warn, breach of express and implied warranty, and multiple consumer fraud violations. Plaintiffs hoped to claim damages to help cover the costs of their resultant and unexpected medical treatments.
Despite these accusations, multiple peer-reviewed scientific publications affirm the safety and utility of the Bair Hugger medical device. In addition, the FDA released a statement in 2017 notifying healthcare providers that their investigation found no association between forced-air warming blanket systems like Bair Hugger and increased risk of infection.
Bair Hugger Inventor's Questionable Assertions
During a 2016 court hearing, lawyers shared evidence calling the entire premise of these lawsuits into question. They disclosed deposition testimony from the anesthesiologist credited with filing one of the earliest and most consequential adverse event reports with the FDA. As part of his testimony, the anesthesiologist Dr. Robert Gauthier said he did not file or author the report in question.
Dr. Gauthier further clarified that he had received a version of the report from Dr. Augustine, the inventor of Bair Hugger, and Mr. Benham. Augustine had founded a company whose device competed directly with the Bair Hugger, and Mr. Benham was the company's general counsel at the time. Gauthier "toned down" the language in the report but did not submit it to the FDA, suggesting that either Dr. Augustine or Mr. Benham did.
This instance of subterfuge seems to have been just the tip of the iceberg when it comes to Augustine's questionable actions regarding Bair Hugger. Court documents accuse him of manipulating research, attacking other physicians who would not make negative statements about Bair Hugger, and repeatedly sabotaging the reputation of the warming blanket in an attempt to gain additional market share for his own product.
Bair Hugger Litigation
In December 2015, the United States Judicial Panel for Multidistrict Litigation consolidated more than 200 Bair Hugger lawsuits under MDL 2666 in the District of Minnesota. Of the 5,000 or so inactive cases, most have been dismissed or withdrawn, but a handful have been tried and found in favor of 3M.
There are no class action lawsuits related to the Bair Hugger at this time.
MDL 2666 Bair Hugger Forced Air Warming Devices Products Liability Litigation
Bellwether trials for MDL 2666 began in February 2018, but most cases were dismissed or dropped before going to trial. Of the 12 cases originally transferred to the MDL, only one remains active as of March 2019. The rest have been withdrawn, dismissed or tried and found in favor of 3M. The next trial, and last remaining of the original bellwether trials, is scheduled for May 2019.