A Bair Hugger lawsuit has alleged that the medical device contributed to complications from a knee replacement surgery.

In her Bair Hugger lawsuit, plaintiff Mary L.-M. of Houston, Texas states that she had a knee surgery in November of 2009. During this surgery, her knee was replaced with an artificial knee joint. During her knee surgery, a Bair Hugger device was allegedly used.

What is a Bair Hugger?

The Bair Hugger is a medical device used to keep patients warm during surgery to improve surgical outcomes.

However, the Bair Hugger lawsuit states that Mary L.-M. developed an infection after the surgery, which the Bair Hugger lawsuit alleges was caused by the Bair Hugger: “because the Bair Hugger was used, contaminants were introduced to the Plaintiff’s open surgical wound, resulting in a deep joint infection, multiple surgeries, permanent and ongoing injuries.”

Bair Hugger Complications

According to the Bair Hugger lawsuit, Mary L.-M. required a series of surgeries to deal with the infection. First, her brand new knee joint was removed due to the infection in May of 2010. The knee joint was replaced with an antibiotic spacer until a surgery in June of 2010 implanted a new knee joint.

Mary L.-M’s Bair Hugger lawsuit holds that this series of surgeries was all caused by the Bair Hugger. In fact, the Bair Hugger lawsuit quotes a letter to the FDA from the makers of the Bair hugger in saying that “air blown intraoperatively across the surgical wound may result in airborne contamination.” The FDA letter was dated to June of 1997, more than a decade before Mary L.-M’s knee surgery and infection.

The Bair Hugger lawsuit further states that: “the publication of numerous peer-reviewed studies identifying and documenting the critical safety shortcomings of the Bair Hugger should have prompted the Defendants to redesign or discontinue their product.”

In fact, the Bair Hugger lawsuit cites no less than six studies that looked into the effects of the Bair Hugger on the quality of air in a surgical bay.

The Bair Hugger lawsuit alleges that the medical device alters air flow in surgical bays in such a way that the warmed air produced by the Bair Hugger can change the air flow in the surgical bay to rise from the ground: “as this warmed air rises, it can deposit bacteria from the floor of the surgical room into the surgical site.” The Bair Hugger lawsuit holds that this caused the infections Marry L.-M. suffered.

The Bair Hugger lawsuit further alleges that in spite of allegations that the Bair Hugger could allegedly promote surgical infections: “the Defendants have actively and aggressively marketed the Bair Hugger as safe in both general and orthopedic surgeries despite their knowledge to the contrary,” per the text of the Bair Hugger lawsuit.

Bair Hugger Lawsuits

At present, there are efforts to group various Bair Hugger lawsuits together into a coordinated group called a multidistrict litigation or MDL. The makers of the Bair Hugger have argued against this, stating that the cases are without merit, and that their specifics vary too much to warrant inclusion in a single MDL.

However, a response from attorneys representing plaintiffs in Bair Hugger lawsuits have argued that “there is a high probability that hundreds of cases will be filed in the future” and further argues that consolidating cases will save resources for the courts and the parties involved.

The Bair Hugger Lawsuit is Case No. 0:15-cv-04161, in the U.S. District Court for the District of Minnesota.

The proposed Bair Hugger Lawsuit MDL is In Re: Bair Hugger Forced Air Warming Devices Product Liability Litigation, MDL No. 2666, before the U.S. Judicial Panel on Multidistrict Litigation.