Lawsuit Alleges Surgical Infection Following Leg Fracture Repair Was Caused by Bair Hugger Warming Blanket

A recently filed product liability lawsuit alleges that side effects of a Bair Hugger surgical warming blanket, which was used during a leg fracture open reduction internal fixation, caused an Illinois man to suffer a deep infection that required two-stage revision surgery.

The complaint (PDF) was filed by Larry Young in the U.S. District Court for the Northern District of Illinois on January 27, naming 3M Company and its Arizant Healthcare subsidiary as defendants.

Young indicates that he underwent a leg fracture repair in June 2013, known as an open reduction internal fixation (ORIF), which involves realigning a fractured leg bone with steel rods. During the procedure, the anesthesiologist used a 3M Bair Hugger warming blanket to help control body temperature. However, the lawsuit claims that problems with the design of the forced air warming system caused contaminants to enter the sterile surgical field, leading to a devastating perisprothetic infection.

As a result of the leg fracture surgical infection, Young indicates that he suffered persistent pain and required multiple additional surgeries to remove the hardware and treat the deep infection. However, because the doctors were unaware of the link between the 3M Bair Hugger and infections, the waring blanket was also used during the first stage revision in November 2013.

“The Defendants concealed and continue to conceal their knowledge of the Bair Hugger’s unreasonably dangerous risks from Plaintiff, other consumers, and the medical community,” this complaint states. “The Defendants failed to conduct adequate and sufficient post-marketing surveillance after they began marketing, advertising, distributing and selling the Bair Hugger.”

Similar allegations have been raised in other Bair Hugger infection lawsuits filed over use of the forced air warming blanket. Most of the complaints involve deep infections following hip replacements or knee replacements, as the device is commonly used in an estimated 80% of all orthopedic joint surgeries.

The complaints allege that the design of the Bair Hugger allows bacteria and contaminants from the operating room floor to be blown in the surgical wound, increasing the risk of infection. Although several experts indicate that safer alternative designs are available, plaintiffs allege that 3M Company has continued to defend the safety of their warming blanket and provided false and misleading information to the medical community.

“Rather than alter the design of their product or warn physicians of the dangers associated with the Bair Hugger, as numerous studies confirm, the Defendants have chosen to ‘double down’ on their efforts to promote their defective product,” according the lawsuit filed by Young.

Amid the growing number of lawsuits filed over the device throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings for the cases last month, centralizing all federal Bair Hugger lawsuits before U.S. District Judge Joan Ericksen in the District of Minnesota, as part of an MDL, or Multi-District Litigation.

There are currently about 100 knee replacement infection lawsuits and hip replacement infection lawsuits pending in the MDL, with additional cases expected as lawyers continue to review and file claims for individuals diagnosed with MRSA, sepsis or other deep joint infections following use of the surgical warming blanket.

As part of any coordinated pretrial proceedings before Judge Ericksen, it is expected that a small group of cases will be prepared for early trial dates. Known as “bellwether” cases, the outcomes are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation, potentially promoting settlement negotiations to resolve cases brought by individuals who have experienced problems.