Da Vinci Robot Lawsuits Mount: Questions Raised Regarding Intuitive's Training Process for SurgeonsMar 22, 2013
Dr. Scott Bildsten had performed about 100 prostate removals during his career. Then, in September 2008, he removed a cancerous prostate gland from 67-year-old Fred E. Taylor.
During the 13-hour surgery, Taylor lost the equivalent of nearly 15 cups of blood. For the rest of his days following the procedure, Taylor suffered from a range of complications – including kidney failure, brain damage and permanent incontinence – until he died last year of heart failure brought on as a consequence of his various ailments, according to papers filed in a lawsuit on his behalf.
Although Dr. Bildsten had performed enough prostate removals during his medical career for the procedure to likely become somewhat routine, the operation on Mr. Taylor represented the doctor’s first solo attempt at performing the procedure using Intuitive Surgical Inc.’s robotic surgical system, according to a Bloomberg News report.
Previously, Dr. Bildsten had completed two supervised robotic prostate removals, with Intuitive providing the overseeing physician for those surgeries, and the hospital paying the related fees, Bloomberg News reported.
The story of Mr. Taylor helps crystallize why the robot manufacturer is presently facing an accumulation of lawsuits that specifically charge it with putting patients at risk by failing to provide sufficient training for the doctors who use the robotic systems.
Bloomberg News reported that the robots were used in 367,000 operations in the United States last year and that, according to “informal incident reports” sent to U.S. regulators since 2009, they are linked to 70 deaths.
Despite such risks, Intuitive’s surgical robots, which are under the da Vinci brand, are increasingly used by hospitals to perform prostate removal, hysterectomies and other surgeries, and was even cleared by U.S. regulators in 2011 for use in gall bladder removal surgery.
The U.S. Food and Drug Administration cleared Intuitive’s robotic surgical devices in 2000, at which time the company had informed the regulator of its intentions to create a 70-question quiz and a three-day training course for its target audience, the operating-room personnel, according to FDA documents reported on by Bloomberg News.
In the face of that stated intent, company salesmen worked at getting hospitals to reduce doctor training on the devices, according to emails introduced in one of the lawsuits filed against the manufacturer and included in the Bloomberg News report.
How hard did the salesmen work to deemphasize training? “One manager’s email lauded a salesman for persuading a hospital that five supervised operations were too many. In another, 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,” Bloomberg News reported.
Intuitive’s robots cost about $1.5 million or more each and are used in 1,371 hospitals in the United States. At the same time, “no universally accepted guidelines exist on how to train people to use them, unlike the standards for many other sophisticated surgical procedures,” Bloomberg News reported. “That’s left some hospitals dependent on guidance from Sunnyvale, California- based Intuitive, which has faced criticism it rushes training to speed revenue growth.”
Lawsuits against the company have been piling up over the past 15 months, alleging that Intuitive’s devices caused injuries. Nearly all cite the training regimen, according to Bloomberg News