Medical Device MDL Status: Bair Hugger

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The following is the status of the pending multidistrict litigation (MDL) involving the Bair Hugger warming blanket manufactured by 3M:


2666 IN RE: Bair Hugger Forced Air Warming Products Liability Litigation
District of Minnesota (Hon. Joan N. Erickson)

In a pretrial order issued on May 30th, Judge Ericksen identified eight representative cases that will be part of the final bellwether trial pool, which will be eligible to be the first to go before juries. The final list includes at least three cases that the sides disagreed about, arguing that they were not representative of the larger body of the litigation.

Judge Erickson recently has held that the plaintiffs are not entitled to documents concerning another patient-warming system because it uses a different type of heating technology than the Bair Hugger and is therefore a “substantially different product”. As such, the documents sought by plaintiffs are not relevant to their allegations that a safer alternative design existed for the Bair Hugger. The next monthly Status Conference will be convened on June 13, 2017 at 9:30 AM CST.

Following the completion of bellwether case discovery, challenges to the admissibility of expert witness testimony and any dispositive motions, Judge Ericksen has indicated that the first trial will commence on February 8, 2018.

Given the need to keep surgical theatres cool to aid in reducing the spread of bacteria and to contribute to the alertness of surgical staff, it has been determined that warming the patient during surgery aids in healing and promotes blood flow. The Bair Hugger was developed and first introduced in 1987 as a way to warm a patient’s body during surgery. The Bair Hugger, which transfers warmed ambient air from a unit on the floor through a conduit of forced air to a disposable warming blanket draped over the patient during surgery, has since been adopted by thousands of hospitals in the United States and Canada and is considered standard procedure for long surgeries. Originally manufactured and marketed by Arizant Healthcare Inc., the 3M Bair Hugger is now in the 3M stable of products after the latter acquired Arizant in 2006, and has generated over $31 billion in sales. In recent years, the Bair Hugger blanket has been used in more than 80% of all hip replacement surgical procedures, with more than 50,000 of the devices in hospitals throughout the United States.

Plaintiffs’ primary allegation is that Arizant knew or should have known that the design may cause bacteria, pathogens and other contaminants lingering at the floor level is transferred up to the patient with the warm air and risks infection, specifically at the surgical site, including deep joint infection. Various lawsuits assert that the risk of infection is worse for joint replacement procedures, such as for hips and knees. Research has also suggested that the device is linked to higher rates of hip sepsis, MRSA or other infections.

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