Intuitive Surgical Inc. (ISRG) acted like a “car dealership” in training doctors to use its robotic surgery system and should pay more than $8 million in damages to the estate of a man who lost his life because of the company’s practices, a lawyer for the estate said.
The attorney, Richard Friedman, in closing arguments yesterday in state court in Port Orchard, Washington, said Intuitive wanted to retain hospitals as customers and increase the number of robotic surgeries using its da Vinci system. It’s the first case to go to trial of at least 26 lawsuits against Intuitive alleging injuries tied to the system. The robots were used in more than 300,000 U.S. operations last year.
Intuitive acted “just like a car dealership” attempting to tie auto sales and service for its customers, Friedman said. Intuitive “wanted to do all the training to keep control of surgeons, to keep control of hospitals and keep control of surgeries,” he said.
The Sunnyvale, California-based company knew it wasn’t providing adequate instruction to doctors after 2006 when it simplified the training program requirements it had committed to in 2000 to win U.S. Food and Drug Administration clearance of the da Vinci system, he said.
Fred Taylor, who experienced multiple medical complications following his September 2008 robotic-assisted surgery to remove his cancerous prostate gland and died four years later, should be awarded $4 million for his four years of “pain, suffering, anxiety, depression and humiliation,” Friedman told the jury. That money would go to his estate.
His widow, Josette Taylor, who cared for her husband around-the-clock for those four years, is entitled to $4 million, Friedman said. Taylor’s son and two stepdaughters should be awarded $150,000 each, the lawyer told the jury.
The urologist who operated on Taylor, Scott Bildsten, had performed 100 successful prostatectomies using traditional methods. Taylor was Bildsten’s 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.
Intuitive has denied the allegations, arguing that it maintained the integrity of its training program and that it met all the objectives submitted to federal regulators to win approval to market the da Vinci system. Lawyers for the company are scheduled to present closing arguments tomorrow.
In robotic surgery, a doctor sits at 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.
Friedman cited 10 ways in which Intuitive was negligent, telling jurors that the most egregious of these was recommending that a surgeon needs only two supervised robotic surgeries following a one-day session at company headquarters before being ready to perform the procedure alone.
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.
“That recommendation was absolutely the worst,” Friedman said. “There’s absolutely no support for that.”
Friedman also told jurors to consider the actions of Damon Daniels, a former sales representative who was in the operating room during Taylor’s surgery.
Daniels testified that while he didn’t remember the Sept. 8, 2008, procedure, Intuitive told surgeons to select simple cases for their first four to six operations, meaning patients with a low body-mass index and no previous surgeries. Taylor weighed 280 pounds and had a body-mass index of 39, which Intuitive has said made him obese.
Daniels testified he didn’t see Taylor’s body because the patient was draped for surgery, Friedman said. When Bildsten couldn’t position the robotic arms around Taylor, however, Daniels moved underneath the surgical table, lowering it so the robot fit over him, Friedman said.
“He helps them dock an inappropriate patient,” Friedman said. The failed operation “might never have happened if Mr. Daniels had not rolled up his sleeve and helped dock the table. Is that reasonable conduct?” he asked. “That’s the question for you.”
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).
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