Da Vinci Robot Lawsuit Filed over Prostatectomy Injuries
A Kentucky man has filed a Da Vinci robot lawsuit over serious injuries sustained during a prostatectomy that was performed using the surgical system. Russell W. Fryman vs. Intuitive Surgical Inc. alleges that Mr. Fryman suffered injuries during his surgery that were the result of flaws in the Da Vinci system and that Intuitive Surgical did not provide adequate warning about potential complications. The complaint was filed on March 16 in the US District Court, Eastern District of Kentucky, Lexington Division.
The complaint states that on March 18, 2014, Fryman, who was 65 at the time, underwent a prostatectomy utilizing the da Vinci robot at Baptist Health Lexington in Lexington, Fayette County, Kentucky. As a result of what the lawsuit alleges were the system’s technical malfunctions, including the tendency to cause burns, Mr. Fryman “sustained and will continue to suffer from physical and emotional injuries, including rectal injury, fistulas, infections, and blood clots, causing serious permanent physical and mental pain and suffering; the need for multiple surgeries and other procedures and treatment; performance of an ileostomy; loss of enjoyment of life; medical, hospital, surgical, and related expenses; lost wages; and impairment of the ability to work and earn money.”
Lawsuit alleges flawed equipment, misleading promotional information
Fryman vs. Intuitive Surgical states that the plaintiff agreed to the use of the Da Vinci Surgical System during his surgery because he had been exposed to promotional information touting the benefits of this system, including faster healing, better outcomes, and less pain. At no time did he hear about potential complications resulting from defects in this system.
The lawsuit alleges that “the da Vinci Surgical System can cause thermal injury burns to the rectum and bowels, post-surgical abscesses, tears, dehiscences, bleeding, hematomas, sepsis, fistulas, and other injuries” and that the defendant did not provide adequate warning for doctors and patients about such possible risks even though information about the risks was available prior to the time of Mr. Fryman’s surgery.
The complaint also makes several additional allegations, including that the defendant did not test the system sufficiently before or after marketing it, that they had not inadequate post-marketing surveillance regarding injuries, malfunctions, and complications reported in connection to the Da Vinci system, and that they did not train surgeons properly in the use of the equipment.
Criticisms of da Vinci surgical system
The Da Vinci “robot” is used in hundreds of thousands of surgeries in the U.S., including operations to remove the prostate, gall bladder, and uterus, to repair the heart valve, and in order transplants. It has been heavily marketed to doctors and hospitals who, in turn, often showcase the system as one of the benefits that they offer potential patients. Proponents of the surgical tool contend that it allows surgeons to operate with less fatigue, less blood loss, and faster healing.
However, critics contend that the surgical system was inadequately vetted as a tool and has caused many injuries, including burns and lacerations, related to technical malfunctions. Hundreds of reports have been filed with the FDA concerning complications during Da Vinci surgeries, though there is some debate about whether all such injuries relate to problems with the device itself.
Some early lawsuits filed against the makers of the device have been successful for plaintiffs. These include a lawsuit filed by the family of a Chicago man who died after his intestines were punctured during spleen surgery and he contracted a fatal infection. The jury awarded the family $7.5 million.
- New York Times, New Concerns on Robotic Surgeries http://well.blogs.nytimes.com/2013/09/09/new-concerns-on-robotic-surgeries/
- New York Daily News, Surgical robot da Vinci scrutinized by FDA after deaths, other surgical nightmares http://www.nydailynews.com/life-style/health/surgical-robot-scrutinized-fda-deaths-nightmares-article-1.1311447
- NBC News, Electrical Burns May Burst Surgical Robot's Bubble http://www.nbcnews.com/health/electrical-burns-may-burst-surgical-robots-bubble-6C10321766