This blog began covering Intuitive Surgical’s da Vinci robot in July of 2012, but we have not followed up on the outcomes of lawsuits against the manufacturer since last year. A year ago, we reported on the first case to result in a verdict. The plaintiff, 67-year-old Fred Taylor, died four years after his robot-assisted prostate surgery, which stretched a routine five-hour surgery into a thirteen-hour ordeal and resulted in Mr. Taylor’s incontinence, damage to his lung and kidney, sepsis, and eventually a stroke. Despite having performed this same procedure hundreds of times manually, Taylor’s surgeon opted for the da Vinci system despite never having used it on an actual patient before. In spite of the evidence, the Washington State jury found 10 — 2 in favor of Intuitive Surgical, but new findings may serve to alert others to the dangers such technology presents.
The American Association for Justice (AAJ) recently released a report on the da Vinci system explaining that the FDA has recalled two components of the robot and issued new training and credentialing standards for those using it. There have been more than 70 products liability cases filed against Intuitive Surgical in federal courts, and, in 2013 alone, 3,697 reports involving “death, injury, or malfunction” in robot-assisted surgeries. This figure is up from about 1,600 in 2012, and may be due to the fact that more and more, patients are turning to this flashy new technology for their hysterectomies, prostatectomies, gastric bypasses, and heart surgeries.
The AAJ report also details cases in which the da Vinci’s parts have stalled, causing electrical arcing and burns, and even detached from the main unit and fallen into patients’ bodies (at least one such case required a second surgery to remove the robotic component). They also point out that several surgeons have had to abort robot-assisted surgeries due to complications and resume with time-tested manual procedures.
Even though there has been a large jump in reports of adverse surgical events using the da Vinci system, researchers from the Johns Hopkins University School of Medicine (in an article published in the Journal for Healthcare Quality) argue that the prevalence of these events is still under reported. They estimate that in the 12 years since its introduction, there have been about 174 injuries and 71 deaths related to the da Vinci robot being used during surgeries.
Critics of existing surveys have pointed to their small sample sizes. For example, one FDA report surveyed 11 surgeons despite the fact that there were over 400,000 robot-assisted surgeries performed in the U.S. in 2012. Still, an overwhelming 10 of the 11 doctors asked about their experiences reported problems with the unit’s arms.
Dr. Marty Makary, a Johns Hopkins professor of surgery and longtime skeptic of robot-assisted procedures, explains in a statement to the New York Times, “This whole issue is symbolic of a larger problem in American healthcare, which is the lack of proper evaluation of what we do. We adopt expensive new technologies, but we don’t even know what we’re getting for our money–if it’s of good value or harmful. […] We have this haphazard smattering of reports that relies on voluntary self-reporting with no oversight, no enforcement, and no consequences.”
Tragically, it seems the real cost of advances in medical technology is the health of innocent victims.