A lawsuit alleges that a patient’s death was quickened due to a robotic-assisted prostate operation. The surgical robot—the da Vinci—is manufactured by Intuitive Surgical Inc.
According to physician testimony, the complications and stress from the long surgery, brought about the man’s death, said Bloomberg News. He might have lived another five years and had a significantly improved quality of life had he never been harmed by botched robotic surgery in 2008, said John S. MacGregor, a cardiologist and professor of medicine at University of California, San Francisco, told a jury. The state court trial is in its third week in Port Orchard, Washington.
“A number of complications put stress on his heart and his body in general,” MacGregor said. “I think the prostatectomy and the aftermath of his prostatectomy accelerated his cardiovascular disease and hastened his death.” The case was brought by the man’s widow against Intuitive, said Bloomberg News.
Heavily marketed and used in some 400,000 surgeries in 2012 alone, the da Vinci robotic surgery system has been associated with a number of deaths, serious injuries, and odd accidents. For instance, said the Associated Press (AP) previously, in one case, a da Vinci robotic hand gripped and would not release a patient’s bodily tissue during surgery. In another, the da Vinci’s robotic arm repeatedly hit a patient in her face as she was prone on the operating table.
Personal injury lawsuits allege the da Vinci has caused severe internal injuries, including burns, tears, and other complications, some of which resulted in death or chronic pain and disability. da Vinci lawsuits fault aggressive marketing tactics used by Intuitive to convince hospitals to purchase the expensive surgical robot, and allege that a combination of design flaws inherent in the robot, coupled with poor physician training on the device, have resulted in serious injuries. Some 70 deaths have been linked to robotic surgical systems since 2009.
In this case, the widow’s allegations include that training was simplified so that more da Vinci’s could be sold and which led to errors in her husband’s prostate surgery, said Bloomberg News. He died of heart disease at age 71 in 2012.
Hospitals set credentialing, or training, requirements for doctors who will operate the da Vinci system; however, Intuitive documents reveal that its sales reps were very close to the process, presenting themselves as da Vinci experts, and working toward reduced standards so that training could be eased for busy surgeons, all to increase use of the da Vinci and its sales, said The New York Times recently.
Intuitive blames the plaintiff’s husband’s prior health, and that he should never have been a robotic surgery candidate. Meanwhile, urologist Scott Bildsten and other doctors, had to switch to traditional surgery and, then, emergency care to replace a rectal tear, following seven hours of problematic robotic surgery in September 2008, said Bloomberg News. Bildsten performed 100 successful prostatectomies using traditional surgery, but never operated unassisted on a patient with the da Vinci system. Bildsten testified that Intuitive deemed him ready to operate on the da Vinci after just one day of Intuitive training and two supervised surgeries. He said, according to Bloomberg News, that he now realizes he needed to receive more training to perform the unassisted robotic surgery.
In a recent regulatory filing, Intuitive said it faces 26 lawsuits from people alleging injuries associated with its da Vinci surgical system; that it has entered into agreements with some plaintiffs’ attorneys to temporarily suspend the statutory deadline for filing suits alleging injury due to da Vinci surgery; and acknowledged it has seen a “substantial increase” these types of claims, said Bloomberg News.
In robotic-assisted surgery, a surgeon sits at a console operating three or four robotic arms. Those arms manipulate small tools that are inserted into the patient’s body via tiny incisions. The system also utilizes a small, lighted camera that displays the surgical area in 3-D video. The da Vinci is, noted the AP, the only robotic surgery approved by the U.S. Food and Drug Administration (FDA) for soft tissue surgeries such as prostate and gallbladder removal, hysterectomies, heart repair, stomach reduction, and organ transplantation. Other, similar devices have been approved for neurosurgery and orthopedics. The FDA is now seeking information from surgeons at key hospitals regarding complications seen with the da Vinci and the surgeries robotic surgery devices are best and least suited for.
The state-of-the-art system has been the focus of an increasing number of lawsuits and death and injury reports and is at the center of a growing dispute over the technology and how it is marketed and used.