The first lawsuit to be decided involving the da Vinci surgical robot suggests that hospitals are going to be held responsible if they do not properly credential physicians on emerging technology. The company making the device may be in the clear.
The da Vinci system was widely adopted after its 2000 FDA approval, and in 2013 the first of at least 26 lawsuits went to trial alleging death or injury from the use of the device. In Taylor v. Intuitive, the patient had undergone a robotic-assisted radical prostatectomy and suffered a rectal laceration among other complications. The patient died four years later and the plaintiffs contend that the injury contributed to his death.
The surgeon in that case was a board-certified urologist who had performed more than 100 open prostatectomies with good outcomes over a decade. He had one day of hands-on training at the company headquarters of Intuitive Surgical, the company that makes the da Vinci robot, and he had proctored on two cases with a more experienced surgeon. The Taylor case was the surgeon’s third robotic procedure and the first in which he was not supervised by a more experienced surgeon.
Court documents indicate that the hospital’s new robotics committee included Intuitive consultants and the credentialing requirements were based solely on the company’s training program.
The hospital and surgeon acknowledged responsibility for the patient harm and settled malpractice lawsuits for undisclosed amounts. The case against Intuitive proceeded and a Washington state jury found in favor of the company, saying it was not responsible for the negligence that led to the patient’s injury.
In particular, the court said that the company did not have an obligation to warn the hospital of the hazards associated with an insufficiently skilled surgeon using the device. The company must warn the physician, which it did, but determining the physician’s competency was the hospital’s responsibility.
The plaintiffs appealed, but the Court of Appeals of Washington, Division 2, affirmed the trial court’s decision. The appeals court decision is available online at http://tinyurl.com/qcx6fqs.