Johns Hopkins Researchers Say da Vinci Robotic Surgery Lawsuit Complications Only Partially Reported to FDA
Complications similar to those alleged in dozens of da Vinci robotic surgery lawsuit filings may have been underreported to the U.S. Food and Drug Administration, according to a recent study published in the Journal of Healthcare Quality.
A report published in September 2013 revealed that only 245 adverse event reports, which included 71 patient deaths stemming from use of the da Vinci Surgical System, were logged by the agency since the device was approved in 2000.
400 Percent Increase in da Vinci Procedures over 3-Year Period, May Give Way to da Vinci Lawsuit Filings
Researchers at Johns Hopkins Medicine, who conducted the study, found this information hard to believe given the 400 percent increase in robot-assisted procedures between 2007 and 2011.
“The number reported is very low for any complex technology used over a million times,” said an associate professor of surgery at Johns Hopkins University School of Medicine. “Doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent. There may be some complications specific to the use of this device, but we can only learn about them if we accurately track outcomes.”
There were also 1,400 da Vinci Surgical Systems installed in U.S. hospitals by 2011. Three years earlier, there were 800.
Researchers at Johns Hopkins also highlighted in their study that FDA-filed adverse events associated with the da Vinci may not serve as an accurate indicator of complications, since they are only reported when they are a direct result of the device. The associate professor of surgery said surgeon error during a robot-assisted procedure should be noted as well.
Since the remote-controlled surgery robot was approved in 2000, the Intuitive Surgical-manufactured device has been used in gynecologic, urologic and laparoscopic procedures. Additionally, the da Vinci is now aided to perform a myriad of hysterectomies, prostatectomies, thyroid surgeries and even heart-related procedures.
When researchers analyzed data from the FDA, gynecologic, urologic and cardiothoracic procedures were most commonly linked to death by excessive bleeding. Gynecologic procedures made up 22 of the 71 deaths, cardiothoracic surgeries resulted in 12 deaths, and urologic had 15 deaths, according to the study.
Researchers noted 43 percent of the da Vinci complications reported to the FDA involved hysterectomies. In those cases, the patients survived.
According to a regulatory filing from July 2013, Intuitive Surgical revealed it had been named in 33 lawsuits involving the da Vinci Surgical System in federal and state jurisdictions throughout the U.S. These cases allege injuries stemming from the remote-controlled robot, which plaintiffs say was designed defectively by the manufacturer.
How to File a da Vinci Robot Lawsuit
To learn more about da Vinci robot lawsuits, contact the lawyers at Bernstein Liebhard LLP at (877) 779-1414.