3M Claims False Bair Hugger Recall Rumors Being Spread By Competitor

Amid continuing concerns about the risk of hip and knee infections from the Bair Hugger forced-air warming system, 3M Company is refuting claims that it issued a “silent” recall for the controversial warming blanket, indicating that false rumors are being spread by a competitor and that 3M continues to stand behind the safety of their product.

The 3M Bair Hugger is a surgical warming system commonly used during many hip replacement and knee replacement procedures in recent years, which involves hot air forced into a blanket that is placed over a patient during surgery to control body temperature. However, a growing number of hip infection lawsuits and knee infection lawsuits have been filed against 3M in recent months, alleging that the product contains dangerous design defects, which may cause bacteria and contaminants from the operating room floor to enter the sterile surgical site.

In a statement (PDF) issued last week, 3M indicates that there is no truth to claims that a Bair Hugger recall has been issued, or that the manufacturer is “silently” replacing the forced-air warming system with an alternative product.

3M indicates that Augustine Temperature Management sent out mass e-mails about a “silent recall of Bair Hugger” through its OrthopedicinfectionAdvisory.org website, suggesting that the false claims were made to “incite more litigation and unease” about their widely used warming blanket. While the Augustine Temperature Management website itself appears to make no mention of a Bair Hugger recall currently, 3M claims that this competitor has previously made “spurious claims” and run into trouble with the FDA for making false statements.

“Augustine sells a competing product that is not widely used nor accepted in the marketplace,” according to the 3M statement. “The company’s founder, Scott Augustine, has pursued a deliberate business strategy of disparaging and instigating litigation against the 3M Bair Hugger system in an attempt to promote his own competing product. He has a history of making false and misleading claims and has been warned by the FDA to stop.”

There are currently more than 900 product liability lawsuits over Bair Hugger infections pending throughout the federal court system against 3M Company and its Arizant Healthcare subsidiary, alleging that the manufacturers failed to warn that the forced-air system may disrupt the laminar air flow in operating rooms, increasing the risk of painful and debilitating deep joint infections.

Given the similar questions or fact and law raised in the litigation, including allegations that 3M should have recalled Bair Hugger warming blankets after discovering a high rate of infections among hip and knee replacement patients, the federal cases have been centralized before U.S. District Judge Joan Ericksen in the District of Minnesota, as part of an MDL, or multidistrict litigation.

The first Bair Hugger trial dates are expected to begin in February 2018, which are designed to help the parties gauge the relative strengths and weaknesses of the claims, and gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

As hip and knee infection lawyers continue to review and file additional cases in the coming months and years, it is ultimately expected that several thousand claims involving severe and debilitating deep tissue infections may be brought on behalf of individuals throughout the United States.