Jury deliberations are scheduled in the first of some 26 lawsuits brought over Intuitive’s da Vinci robotic surgical system and involve allegations of injuries associated with the controversial robotic system.
Kitsap County Superior Court Judge Jay Roof (Port Orchard, Washington), just handed the case to the 12-member jury after a five-week trial, according to Bloomberg News. Deliberations being this week.
Personal injury lawsuits have alleged that the da Vinci system has caused patients to suffer from a variety of adverse events, including internal injuries. Many of these injuries are the result of burns, tears, and other complications. In some cases, patients have died or suffer from chronic pain, even disability. da Vinci lawsuits fault aggressive Intuitive marketing positioned to induce hospitals to buy the costly system. Lawsuits also allege that a collaboration of design flaws and poor physician training on the da Vinci led to the injuries alleged in the litigation. At last count, some 70 deaths have been tied to the system since 2009.
This lawsuit involves allegations that a patient’s death—Fred Taylor—was accelerated because of prostate surgery conducted with the da Vinci system. Recent physician testimony indicated that the stress of the long surgery and the complications the patient suffered from that surgery brought about his death, Bloomberg News previously reported. John S. MacGregor, a cardiologist and professor of medicine at University of California, San Francisco, told the jury that the man might have lived five more years, and with a better quality of life, had he not been harmed in the botched 2008 robotic surgery.
Intuitive’s attorney told the jury in closing arguments that Taylor’s urologist, Scott Bildsten, ignored Intuitive’s warnings and that the urologist is to blame for the plaintiff’s injuries, according to Bloomberg News. “Dr. Bildsten knew the path he was on was unduly risky, and he still proceeded,” the attorney said.
The man’s widow alleges that da Vinci training was simplified to better enable Intuitive to sell more of the systems, which she claims led to errors during her husband’s prostate surgery. He died of heart disease at age 71 in 2012. Intuitive disagrees with the allegations, according to Bloomberg News, arguing that Bildsten performed 100 successful prostatectomies via traditional surgery.
Bildsten testified that Intuitive deemed him sufficiently ready to operate on the da Vinci after receiving just one day of Intuitive training and two supervised surgeries. Bildsten never operated unassisted on a patient using the da Vinci prior to this surgery, according to a Bloomberg News report. He says he now realizes he should have received additional training before performing the unassisted robotic surgery.
In closing arguments, the plaintiff’s attorney cited 10 ways in which, he said, Intuitive was negligent, including that Intuitive recommends that only two supervised robotic surgeries are needed in addition to a one-day session at the device maker’s headquarters, according to Bloomberg News. Intuitive’s training recommendation is described in its literature as its “best practices,” the brainchild of Gene Nagel, an executive in charge of training and development and “a former wine salesman with no prior training,” said Taylor’s attorney, in either medicine or medical devices, according to Bloomberg News.
The attorney also noted that Intuitive simplified its training program requirements after 2006; those requirements were part of the data submitted to the U.S. Food and Drug Administration (FDA) in 2000 when Intuitive sought approval of the system. A sign, he says, that Intuitive knew it was providing inadequate instruction to physicians.
The heavily marketed da Vinci was used in hundreds of thousands of surgeries in just 2012 alone.