The father of a 24-year-old woman who died 2 weeks after undergoing a hysterectomy with the da Vinci surgical robot filed a lawsuit against device maker Intuitive Surgical (NSDQ:ISRG) on the grounds that the system led to her death.
Gilmore McCalla also claims that Intuitive Surgical "has suppressed reports of complications, and has oversold the merits of its da Vinci robot to hospitals considering buying it."
The news has yet to slow the ever-increasing value of ISRG stock, which was up about 0.3% to $545.55 around 3 p.m. today, but the lawsuit may represent a hurdle for the company moving forward.
In a lawsuit filed in a New York court, McCalla said that the da Vinci system burned an artery and intestines during his daughter’s surgery, further accusing the surgeon and the hospital of carelessness for not discovering the damage.
McCalla claimed that the surgical robot contains dangerous design flaws, including un-insulated surgical arms that may allow electrical currents to jump to healthy internal organs and tissue. He also said that Intuitive didn’t properly train physicians to use the device, according to a press release.
The Sunnyvale, Calif.-based device maker has a corner on the robot-assisted surgery market, recently adding gall bladder surgery to its list of FDA-approved indications. The machine, which features a console through which a physician can manipulate robotic arms with surgical tools, has become the preferred option in prostatectomy and is gaining ground in hysterectomies.
"The cost for performing robotic surgery greatly exceeds the type of laparoscopic or open surgery it replaces, and there has been debate in the medical literature whether the extra costs – whether paid by insurance companies, the government or patients – is justified because of claimed better outcomes with the device," according the lawsuit, which alleges that "Intuitive Surgery has not sponsored any comparative safety tests where patients are selected prospectively as compared to just looking at results."
According to a study published in the Journal of Clinical Oncology in January, complication rates for women with endometrial cancer were roughly the same after standard laparoscopy and robot-assisted surgery, although the robotic procedures each cost about $1,300 more.
"It turns out that the paper actually entirely misses the point, in that it compares laparoscopic to robotics, but the reality is that what’s happening in the market is robotics are converting open procedures to robotic procedures," Intuitive CEO Gary Guthart told MassDevice in an exclusive interview last month. "If you look at that comparison, which is what’s really happening, the economics are easy to describe."
"For the patient, it’s pretty straightforward," he added. "The return to full function versus an open procedure is faster with robotics, the complication rate is lower with robotics versus open and the patient doesn’t pay any more out of pocket, because it is typically a covered benefit."