The Defense’s Case
In the Bair Hugger cases, the defense is arguing—so far successfully—that there has actually been no determination of what caused the patients’ infections.
Experts for the defense have argued a wholly independent and intervening incident likely occurred following any act or omission by the physician which breaks any “causal link.” Another line of defense is to argue that patient injuries resulted from pre-existing medical conditions or disabilities, for which they exercised no control.
Finally, the defense is also claiming that the patients assumed any and all risks associated with the Bair Hugger device, barring them from recovery.
Plaintiff patients, therefore, have had no choice but to dismiss doctors from their lawsuits. Orthopedic physicians that followed medical professional standards but still found themselves tangled up in Bair Hugger litigation, probably don’t have much to fret about.
Did Bair Hugger Cause Infections?
The core complaint is that Bair Hugger injured patients. The warming system, it is alleged, contracted dirty air particles and forced them into the surgical site causing an infection. Patients’ attorneys have relied on computer animations and simulations to show forced-air warming techniques can circulate air full of bacteria and other contaminants into the surgical site. The use of computer-generated animations and simulations are increasingly common in product liability cases in today’s courtrooms since they help jurors understand complex issues and provide a visual explanation of the product’s malfunctions or defects.
One of the plaintiff’s in the Bair Hugger case also offered a study published in the Journal of Bone and Joint Surgery showing the blanket system created a “significant” increased risk for deep-joint infections due to forced-air warming based upon an experiment with a mannequin.
3M, however, pointed out that the same study examined 1,400 real-world patients with not a shred of evidence the Bair Hugger system harmed any of them.
Enter the Food and Drug Administration
With Bair Hugger lawsuits piling up, the FDA attempted to “clear the air” with healthcare providers in 2017 and recommended patient warming devices, including forced-air warming systems, for surgical procedures when clinically warranted.
The FDA realized some providers and patients discontinued forced-air warming tactics, including the Bair Hugger device, in surgeries due to the mounting lawsuits. The FDA proclaimed that after a review of available data, it was unable to find a consistently reported association between forced-air warming and infections. Scientific research also defended forced-air warming techniques. A review of past studies published in the Journal of Bone and Joint Surgery reiterated, “forced air warming can impact [air] flow under certain very specific conditions, but any actual clinical impact on surgical site infections must be considered unproven at this time.”
One thing is increasingly clear: injured patients are relying on the possibility that the Bair Hugger blanket can infiltrate contaminated air.
However, this “possible effects” theory is largely insufficient in showing the Bair Hugger warming device is hazardous to surgical patients.
The true test of underlying medical product liability has been whether the Bair Hugger blanket “more likely than not” caused the patient’s exacerbated injuries following his or her use of the device.
So far, however, the plaintiff’s attorneys have not been able to meet this standard.
