Creators of Bair Hugger face lawsuit over alleged defect that allows contamination

By Hoang Tran | Feb 12, 2016

NEW ORLEANS – A man has filed a lawsuit against the manufacturers of medical device used to keep patients warm during surgery claiming that the device caused bodily harm to him.

Richard Smith filed a lawsuit Feb. 1 in the U.S. District Court for the Eastern District Court of Louisiana against 3M Co. and Arizant Healthcare Inc., citing negligence, misrepresentation, fraud and deceit, breach of express warranty, breach of implied warranty and violations of the Louisiana Products Liability Act.

Smith asserts that a defect in the design of defendant’s product, the Bair Hugger, caused contaminants to be blown into his open surgical wound during a right knee surgery on December 2011 and resulted in the contamination and infection of the wound site. Smith claims to have undergone additional surgical procedures because of the incident.

The Bair Hugger, according to the suit, consists of a disposable blanket that is connected to a portable heater/blower by a flexible hose. The device is allegedly positioned over or under patients during surgery, and supposedly keeps the patients warm by blowing hot air on the patient’s exposed skin. However, plaintiff insists that between 2002 and 2009, defendants redesigned the device to reduce the efficiency of its air filtration blowers, which resulted in pathogens incubating and spreading in the internal airflow pathway. The pathogens are then allegedly expelled when it’s used upon patients.

Smith claims that defendants have known about this defect in the Bair Hugger and yet negligently and deceitfully continued to market and sell the device, even after defendants allegedly admitted that the device was prone to pathogens in 1997. Plaintiff also claims that defendants willfully deceived the Food and Drug Administration about the efficiency of its air flow system in 2009.

As a result of defendants unlawful act, Smith claims to have suffered permanent personal injuries which included impaired mobility, medical expenses, economic loss, emotional distress, loss of enjoyment of life and pain.

A spokesperson for 3M provided this statement regarding the lawsuit:

"3M wants patients, surgeons and hospitals to know that there is absolutely no merit to these claims. In over 25 years and more than 200 million patients warmed successfully by 3M’s patient warming products, there is not a single confirmed incident of infection caused by the Bair Hugger system. 3M is sympathetic to patients who experience surgical site infections.

"There are many factors that are known to increase the risk of surgical site infections, some of which include having other medical problems or diseases such as diabetes, high blood pressure or heart disease, being elderly or overweight , and smoking. There is absolutely no evidence that Bair Hugger warming therapy causes or increases the risk of surgical site infections. Patient warming is a recommended practice by leading health care institutions and professional societies  - and the Bair Hugger system is a safe, effective and efficient method of doing so. It is unfortunate that plaintiff attorneys are using bad science to blame their clients’ infections on a warming device that has helped millions of people during surgery."

He is suing for compensatory damages, economic damages, punitive and exemplary damages, pre- and post-judgment interests, attorney fees, cost of suit and any other relief deemed just by the court. He is seeking a jury trial and is represented by Michael Hingle, Byran A. Pfleeger and Julie M. Jochum of Michael Hingle & Associates in Slidell.

U.S. District Court for the Eastern District Court of Louisiana Case number 2:16-cv-00886

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