Back on April 1st, we published a litigation guide on the da Vinci Robot Surgical System (produced by Intuitive Surgical, Inc.). It details the different litigation issues, medical summaries, and robotic surgery expert witnesses used in those types of cases. Since that time, a number of items have come up regarding how the claims are being litigated and what issues are being discussed. Subsequently, we compiled this update to provide insight on these new developments and highlight some recent cases we worked on which involved robotic surgery expert witnesses.
FDA error reports…and lack thereof
Perhaps the most startling bit of news was detailed in a study done for The Journal for Healthcare Quality. In the study, as detailed by the New York Times Blog, the researchers found that many reports of errors with the da Vinci system went unreported. Further, they state that the ultimate conclusion of the study was that, “adverse events associated with the da Vinci were ‘vastly underreported.’” One of the researchers on the project, Dr. Martin A. Makary, attributed the recent issues to, “expansion…without proper evaluation and monitoring of the benefits.” This has led to widespread issues, with Dr. Makary noting a 2010 study that found 56.8 percent of urologists surveyed anonymously stated that they had experienced irrecoverable operative malfunctions while using the da Vinci system.
Moreover, this issue is compounded by the fact that, in terms of reporting to the FDA, most complaints are registered through self-regulation. Ultimately, Intuitive Surgical is responsible for reporting error claims to the FDA. This creates a conflict of interest. Which could further lead to false statistics on the actual error rate of using the surgical system.
How good is it?
In our litigation guide, we discussed the success rates of robotic surgery and the overall benefit to the patient in utilizing the surgical system.
As more and more da Vinci cases begin to go through pre-trial proceedings, various robotic surgery expert witnesses are employed, different items are highlighted and new issues emerge. Here are a few cases we’ve worked on and feedback provided by robotic surgery expert witnesses.
1.) Robotic surgery for total proctocolectomy results in serious complications
In a case, the patient underwent a total proctocolectomy, which was robot-assisted and laparoscopic. While in recovery, it was revealed that the patient suffered from IV infiltration, amongst other postoperative complications. A general surgery expert witness was brought in to discuss the accepted complications of the procedure. Specifically how specific complications should be treated once they are discovered.
2.) Nerve damage alleged caused by physician’s inexperience with robotic surgery
A subsequent case we saw involved a laparoscopic prostatectomy. The procedure, which was performed with the da Vinci Surgical System, lasted for six hours. Of course, this is a vastly excessive amount of time for the given procedure. Due to the extended amount of time in the Trendelenburg position, the patient required several surgeries to repair the nerve damage to his hand (with minimal improvement). Consequently, a urology expert witness was brought in to discuss the relationship between appropriate training with a surgical robot and extended procedural times.
3.) Robotic surgery contributes to error in treating prostate cancer
Lastly, in a very recent case, an elderly male was being treated for prostate cancer, and underwent a prostatectomy, which was robot-assisted. Due to the robotic surgery, the patient suffered from complications caused by a surgical wound. Similar to the previous case, a urology expert witness was brought in to discuss the complications of a laparoscopic prostatectomy. Specifically how the robotic surgery may have contributed to the complications that the plaintiff experienced.