A recent study and a growing number of lawsuits would have us believe that injuries and deaths during robotic surgery are due to failures with the robotic devices. But there is much more to those claims than meets the eye.
According to researchers at the University of Illinois at Urbana-Champaign, Massachusetts Institute of Technology and Chicago’s Rush University Medical Center, robotic surgery has been linked to at least 144 patient deaths and over 1,000 injuries. The study analyzed the adverse events data related to robotic systems and instruments used in minimally invasive surgery, reported to the U.S. FDA MAUDE database from January 2000 to December 2013. To put these numbers in perspective, according to this same study, “[b]etween 2007 and 2013, over 1.74 million robotic procedures were performed in the U.S., of which over 1.5 million (86%) were performed in gynecology and urology, while the number of procedures in other surgical specialties altogether was less than 250,000 (14%).”
As one would expect, many of these purported incidents have already lead to numerous lawsuits, with plaintiffs’ lawyers blaming the devices themselves. Websites that solicit plaintiffs list several of the potential device-specific failure modes identified in the study as “common causes” of patient injuries. Some of those alleged “common causes” include:
- Broken or burned robotic parts falling into patients’ bodies;
- Uncontrolled movements and spontaneous powering on/off of the machines;
- Electrical sparks, unintended charring, and damaged accessory covers; and
- Loss of quality video feeds and/or reports of system error codes.
Yet relatively little attention is being paid to the ever-present human element, and the significant impact that a surgeon’s lack of experience can have on patient outcomes.
Enter Dr. David Samadi, Chairman of Urology, Chief of Robotic Surgery at Lenox Hill Hospital, and Professor of Urology at Hofstra School of Medicine. In a recent article, Dr. Samadi questions whether surgeon inexperience is being overlooked. According to Dr. Samadi, “in the hands of experienced surgeons, robotic surgery is safe.” In the article, Dr. Samadi goes on to note that the above-referenced device-specific failure modes “could also mean that the robot wasn’t set up correctly prior to the surgery” and that even the study’s authors “admitted their uncertainty regarding the root cause of these problems and whether it’s the fault of the robot or the surgery team.”
It remains to be seen what impact this latest study will have on ongoing litigation. One thing is for sure, however. Surgeon training is an important part of increasing the chances of successful patient outcomes and fighting claims in court. Therefore, robotic device manufacturers should give serious consideration to identifying and addressing existing physician training needs. Doing so will benefit not only patients, but the companies themselves when they are faced with litigation.