Bair Hugger Class Action Litigation
Thousands of individuals who suffered severe infections after surgeries involving defective Bair Hugger devices have filed lawsuits against 3M and Arizant Healthcare.
Products Liability Claims
The class plaintiffs allege that the manufacturers knew the device's risks but failed to warn patients and healthcare providers adequately.
In 2015, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federally filed Bair Hugger lawsuits into a multidistrict litigation (MDL) in the District of Minnesota. At its peak, the MDL included over 5,000 cases.
Lawsuit Reactivated
Although the lower courts initially dismissed the MDL in 2019, the 8th Circuit Court of Appeals reinstated the litigation in August 2021, finding that the plaintiffs' scientific evidence was sufficient to proceed.
The U.S. Supreme Court denied 3M's appeal, allowing the lawsuits to proceed. As of 2024, plaintiffs continue to file new cases as affected patients seek justice.
Did The Manufacturer Know About This Problem?
Plaintiffs in the Bair Hugger litigation allege causation and liability by pointing to multiple studies and expert opinions that support the link between Bair Hugger use and increased infection risk.
A key piece of evidence arises in a 2009 internal email from the Bair Hugger's inventor, Dr. Scott Augustine, warning 3M about the device's potential to spread bacteria. Plaintiffs argue that 3M disregarded these concerns and continued to market the device as safe.
3M has countered allegations by maintaining that the Bair Hugger is safe and effective, citing numerous studies that found no increased risk of infection. The company claims that Dr. Augustine's warnings were baseless and motivated by a desire to promote his competing device.
FDA Involvement and 3M's Response
The U.S. Food and Drug Administration (FDA) has been aware of the potential link between Bair Hugger devices and surgical site infections since at least 2013. The Agency received hundreds of adverse event reports, including some describing patient deaths related to the use of Bair Hugger.
Affirmation and Warning
In August 2017, the FDA issued a letter to healthcare providers acknowledging the infection concerns but ultimately recommending the continued use of Bair Hugger devices. The Agency stated that it had reviewed available data and concluded that the benefits of patient warming devices outweighed the potential risks.
Rebuttal Arguments
3M has used the FDA's position to support its defense, arguing that the Agency's findings validate the safety of Bair Hugger. However, critics argue that the FDA's review was inadequate and relied heavily on studies funded by 3M.
Manufacturer Recall
In January 2018, 3M recalled 165,000 Bair Hugger blankets due to a design defect that could prevent proper warming. However, this recall was unrelated to the alleged infection risks at the center of the lawsuits.
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