Bair Hugger Bears The Heat (MDL 2666)

 
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Defective Medical Devices
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Bair Hugger

Bair Hugger, world’s first surgical warming blanket, feels the heat as more than 1,300 litigations have been grouped in a multidistrict litigation: MDL NO. 2666, by Judge Joan N. Ericksen of the District of Minnesota. Launched in late 80’s as an FDA approved medical device through a 510 (k) pre-market approval, this product is designed to maintain the temperature of the patient during a surgery, preventing unintended hypothermia and other related complications.

This surgical blanket came under the scanner when the first Bair Hugger lawsuit was filed by a Texas man, who claimed he had been infected by the device during his hip replacement surgery in 2011. A research study indicated that the forced-air surgical variety of Bair Hugger was responsible for creating a convection current may have resulted in carrying the contaminated air off the ground with higher chances of contaminants, in some cases infectious bacteria such as Methicillin-resistant Staphylococcus aureus (MRSA), settling at the incision site. Resulting infections have required further hospitalization, surgeries, or removal of the implant itself. In the worst case scenario, an amputation of the affected limb was the only cure, although the deep joint infections caused by MRSA may be fatal. This set the ball rolling and a number of affected recipients of hip and knee implants came forward and joined the litigation.

The plaintiffs further allege that in spite of knowing about the increased risk of infection, the company not only failed to redesign the product but also failed to warn the medical fraternity about the potential risks. Matters complicated in 2002, when Dr. Scott Augustine, the inventor of the Bair Hugger system, resigned from the company. He is now a forerunner and an active participant in the litigation against the Bair Hugger device. Allegations also claim that the company attempted to hide and discredit any scientific research that found an increased risk of hip and knee infections with the use of its products. Despite these shocking allegations, there has been no recall of the device linked to the alleged injuries either from the FDA or from the manufacturer itself.

The courtroom battle is going to be intense as the plaintiffs are prepared with numerous arguments backed by peer-reviewed research data to prove their allegations. On the other hand, the defendants continue to claim that it can never be proven that the infections caused were due to their product. More than 30 Bair Hugger lawsuits have been nominated as potential Bellwether trial nominees. Once case specific discovery selection gets completed no later than July 1, 2017, a pool for the final Bellwether Trial will be ready. Bellwether trials are planned to begin from November 2017. This is a warning bell for the Bair Hugger Lawsuit lawyers to prep up cases.

What a Bair Hugger Lawsuit lawyer should keep in mind while intaking clients is whether the client, during his or her orthopedic surgery, such as a hip or a knee replacement surgery, faced any subsequent serious joint infections. The client’s anesthesia records of the surgery, perioperative temperature management records, surgical care improvement project data (SCIP), and even the operative report to treat the postoperative infections could rightly link the usage with the injury caused.

This article was submitted by Neural IT. Neural IT provides cost effective and timely medical reviews for screening potential mass tort cases. For more information, please visit www.neuralit.com. You may email us at [email protected] or call +1-844-NIT-TEAM (648-8326).

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