Intuitive Wins Trial, Beats Negligence Claims (Corrected)

Intuitive Surgical Inc. convinced a Washington state jury that it wasn’t negligent in its training of a doctor who performed a robot-assisted surgery on a patient who later died.

Jurors in Port Orchard, Washington, reached their verdict yesterday by a 10-2 vote after a five-week trial. Intuitive owes no damages based on claims that the patient, Fred Taylor, and his family suffered due to the company’s inadequate training of the doctor who removed his prostate gland in 2008, according to the verdict.

The case was the first to go to trial of at least 26 lawsuits against Intuitive alleging injuries tied to its da Vinci robotic system, which was used in more than 300,000 U.S. operations last year.

Robots and related products generated most of Intuitive’s $2.2 billion in revenue in 2012. The robots, which are in more than 1,300 U.S. hospitals, cost $1.5 million each and were used in 367,000 U.S. procedures in 2012. Operations done using the robot include prostate cancer surgery, hysterectomy and gall bladder removals.

“A win is a clear net positive as it may eliminate some of the overhang associated with pending litigation,” Andrew S. Zamfotis, an analyst at evaDimensions in New York, said in an e-mail. “The market’s expectations for future profit are very low and perhaps partially due to legal risks but there have been ongoing concerns for a while with respect to margin sustainability.”

Stock Jump

Intuitive jumped as much as 5.5 percent after the close of trading yesterday on the Nasdaq Stock Market. Shares had closed at $478.46 in New York before the verdict was announced.

Richard Friedman, who represented the plaintiffs in the case, said evidence at the trial shows how Intuitive encourages sales representatives to “manipulate surgeons” by “insinuating themselves into the operating room” and “overcoming physicians’ resistance” to traditional surgery to convert them into robotic procedures.

‘Steer Clear’

Patients contemplating robotic surgery need to ask their surgeons: “How many operations have you done?” Friedman said. “If it’s not in the hundreds, steer clear.” Friedman said he hasn’t decided if he’ll appeal the verdict.

Friedman argued at trial that Intuitive’s most egregious negligence was its recommendation that surgeons are prepared to perform robotic procedures alone after just two supervised robotic surgeries following a one-day session at company headquarters in Sunnyvale, California.

That recommendation, which appears in company documents describing “best practices,” was the idea of Gene Nagel, who was an executive in charge of training and development and “a former wine salesman with no prior training” in medicine or medical devices, Friedman said in his closing arguments.

Morbidly Obese

Intuitive’s lawyer, Allen Ruby, told jurors that Taylor was morbidly obese, and that his urologist, Scott Bildsten, ignored specific instructions that for his first several procedures with the da Vinci, he should choose simple cases and patients with a low body-mass index.

Taylor was five-feet, 11-inches tall (180 centimeters), and weighed 280 pounds (127 kilograms), giving him a body mass index of 39 -- a measurement that should have precluded robotic surgery, Ruby argued.

Taylor experienced multiple medical complications following the surgery and died last year. Friedman sought $8.45 million in damages based on claims that Intuitive streamlined and compromised its training in a push to sell its robots.

Bildsten settled claims against him by Taylor’s estate, according to court documents, which didn’t provide specifics.

Bildsten had performed 100 successful prostatectomies using traditional methods. Taylor was his first patient using the da Vinci unassisted. After seven hours of difficulty, Bildsten and other doctors turned to traditional surgery and then emergency care to repair a rectal laceration.

‘Highest Standards’

“We are pleased with the jury’s verdict,” Angela Wonson, a spokeswoman for Intuitive, said in an e-mail statement. “Intuitive Surgical’s technologies have extended the benefits of minimally invasive surgery to over 1.5 million patients around the world. We will continue our commitment to patients, surgeons and hospitals to uphold the highest standards of safety.”

In robotic surgery, a doctor sits at a console several feet from the patient and peers into a high-definition display. Foot pedals and hand controls maneuver mechanical arms equipped with surgical tools, guided by a 3D camera that shows the work as it is done inside a patient.

The case is Estate of Fred E. Taylor v. Intuitive Surgical Inc., 09-2-03136-5, Superior Court, State of Washington, Kitsap County (Port Orchard).

(Corrects to remove lawyer’s unsubstantiated comment about the number of cases in seventh paragraph of story published May 24, 2013.)
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