The federal Judicial Panel on Multidistrict Litigation is considering consolidating a number of Bair Hugger lawsuits into a single multidistrict litigation (MDL).

In August 2015 a plaintiff in a Bair Hugger lawsuit petitioned the federal Judicial Panel on Multidistrict Litigation to consolidate several federal Bair Hugger lawsuits into a single multidistrict litigation in a federal court in Minnesota.

The creation of a multidistrict litigation would direct current and future Bair Hugger lawsuits to that court for coordinated pretrial procedures.

Defendants 3M and Arizant, the manufacturers of the Bair Hugger, oppose the motion for consolidation. Oral arguments on the motion are now scheduled for Dec. 3, 2015.

What is the Bair Hugger Warming System?

The Bair Hugger is a device used to keep surgical patients warm while under general anesthesia. It has been the subject of a growing number of Bair Hugger lawsuits alleging the device drives contaminated air from near the floor of the operating room up to the surgical site. The plaintiffs say this disrupts the downward flow of air that is standard in operating rooms.

Plaintiffs generally allege the Bair Hugger’s design increases the risk of infection, particularly in hip replacement surgery and knee replacement surgery. They allege that alternative designs are available that would not similarly increase the risk of infection.

FDA Bair Hugger Warning

Similar concerns about the risk of hospital infections have been raised in relation to the use of warming and cooling systems that use circulated water instead of air. In October 2015, the FDA issued a warning that certain devices used to keep patients warm or cool during surgery may increase those patients’ risk of infection.

The warning applies to devices that supply heated or cooled water to oxygenator heat exchangers, cardioplegia heat exchangers, or warming and cooling blankets. By controlling the patient’s temperature while under general anesthesia, these devices are used to optimize the patient’s care and improve the outcomes of surgery.

However, the federal agency says that use of these devices to regulate patient temperature has been associated with nontuberculous mycobacteria infections, or NTM infections.

The organisms that cause NTM infections are found throughout nature, and their presence typically does not lead to infection. However, for patients who are seriously ill or who have compromised immune systems, NTM infection can be a serious problem.

The FDA’s concern is that NTM organisms may find their way from the water used in these devices to the patient. Although the patient does not come into contact with the water used in these devices, it’s possible that the devices’ exhaust systems can release bacteria from the water into the air of the operating room, increasing the risk of infection.

The FDA cites 32 Medical Device Reports received from January 2010 to August 2015 describing patient infections associated with these devices and cases in which bacterial contamination was discovered in the device. The agency also noted the possibility that other cases of infection and contamination may have gone unreported.

The FDA recommends surgical staff take certain precautions in addition to following the instructions from the device’s manufacturer. These include directing the device’s exhaust stream away from the surgical field, monitoring the environment for signs of contamination, and immediately removing from service devices that show possible evidence of contamination.