Harm caused during robotic surgery has led to numerous malpractice lawsuits against surgeons who use the high-tech devices and product liability actions against manufacturers who make them. Last week we wrote about the statement from the American College of Obstetricians and Gynecologists advising caution in robotic use for hysterectomies.
Intuitive Surgical Inc., according to a story on Bloomberg.com, manufactured robots used in 367,000 U.S. operations last year. The company has been sued for putting patients at risk because it allegedly sold the devices to doctors without training them sufficiently in their use.
“At least 10 lawsuits have been filed over the last 15 months,” says the Bloomberg story, “alleging injuries from robot surgery, and almost all cite Intuitive’s training regimen.”
Among the adverse outcomes resulting from robotic surgery are tearing internal tissue and burning internal organs.
One patient at the wrong end of the robotic knife was Fred E. Taylor. His widow, Josette Taylor, sued Intuitive for complications Fred suffered after prostate surgery. He died four years later, partly, she claims, from “woefully inadequate” company training “designed to give surgeons a false sense of confidence.”
Taylor’s cancerous prostate gland was removed in 2008. It was his doctor’s first unsupervised surgery using the Intuitive device, according to the lawsuit. He lost 15 cups of blood during the 13-hour procedure. He suffered kidney failure, brain damage, permanent incontinence and a 1-inch tear in his rectum, the suit charges.
As Bloomberg reports, Scott Bildsten, the doctor who performed the surgery, had done about 100 prostate removals via the standard method, without any complications. Bildsten had done only two supervised robotic prostate removals before Taylor’s. Intuitive provided the overseeing physician and the hospital paid the fees.
The robots, called the Da Vinci system, cost about $1.5 million each, says Bloomberg, and nearly 1,400 U.S. hospitals have them. Remarkably, there is no universal, prescribed guideline for training the people who use them, unlike the standards for many other sophisticated surgical procedures. Many hospitals depend Intuitive for this instruction. But its priority, of course, is selling, not teaching.
“Sales reps should have nothing to do with credentialing,” Dr. David Penson, a urologist, told Bloomberg. “Of course they are going to do whatever they can to get that guy out there and using their equipment.”
Last year, says Bloomberg, robots and related products generated most of Intuitive’s $2.2 billion in revenue.
The FDA approved the robotic device in 2000. Documents obtained by Rick Friedman, Taylor’s attorney, showed that Intuitive told the agency then that it would design a 70-question quiz and a three-day training course for all operating-room personnel. But only months after the robot hit the market, Intuitive put a marketing official-not a medical professional-in charge of training. Off- site training was cut to one day and the test questions were cut to 10.
Documents from the Taylor complaint include Intuitive emails about training from marketing officials and sales personnel. One, from 2009, was by a company clinical sales representative. It told one hospital that had suggested that new robot surgeons have at least five supervised procedures was “on the high side” and might have “some unintended consequences.”
What the rep might have meant, it seems, is that such careful oversight would cost $15,000 per urologist. The email said a similar requirement “slowed down” development of robotic surgery at another hospital. When the first hospital indicated it would “most likely” lower its requirement, the rep was congratulated in another company email, Bloomberg reports: “… [N]ice job on taking charge and ownership of your programs.”
Another company email by a manager told a sales team not to “let proctoring or credentialing get in the way” of meeting goals on the number of robot surgeries. Translation: We’re about numbers, not safety. We’re about sales, not outcomes.
Myriam Curet, Intuitive’s chief medical advisor, told Bloomberg that company training includes an online quiz, practice simulators and a one-day course at Intuitive’s headquarters in Northern California and 14 hospitals across the country. Doctors new to the procedure are supposed to observe at least one robot operation and perform mock operations with their team. Most hospitals require the first few operations be supervised by an expert, Curet said.
But there’s no credentialing, there’s no regulated oversight; it’s up to doctors to decide how much training they need, Curet said. “We cannot require anything.”
Which is why several parties might share responsibility for a tragedy like Taylor’s. People, like institutions, don’t always do the right thing without being required to do so. We’re not moved by Intuitive’s argument to have the Taylor lawsuit dismissed: “…[C]redentialing and privileging for performing surgery at a hospital is solely the responsibility of the hospital. It is not the responsibility of a medical device manufacturer like Intuitive.”
Tellingly, the hospital where Taylor underwent surgery didn’t dispute that Taylor suffered complications. It settled the case for an undisclosed amount.
The FDA shares responsibility for robotic device misuse and poor patient outcomes-it first required that Intuitive submit the Da Vinci for approval in its most rigorous device review category. That’s reserved for products that aren’t seen as equivalent to anything already on the market (otherwise, devices can qualify for a faster approval).
But in spring 2000, the FDA reversed that decision and moved the robot into a less stringent category. By July 2000, it was approved for marketing. The earlier three-day training program simply wasn’t required. The agency left the training the details “to the discretion of Intuitive Surgical,” said one official in a statement.
Like Josette Taylor, we are left to wonder-who guards the guards?
If you or a loved one is scheduled for surgery your doctor wants to perform robotically, ask:
- Why is a robotic procedure preferable to traditional surgery?
- What are the risks of each approach?
- How many robotic surgeries have you performed with this device? (One expert told Bloomberg that it can take 200 operations to be proficient at robotic prostate cancer surgery; the Mayo Clinic says it can 90 procedures to be proficient in gynecological surgery.)
- Ask how long the hospital has had the robotic equipment-some hospitals feel pressured to use expensive technology as much as possible to recoup costs, even if their staffs haven’t been adequately trained.
To see what reports and warnings the FDA has about medical devices and their safety, link here.