Intuitive Surgical Inc. designed a training program to win regulatory approval for its surgical robots that was later “watered down” to get them into more hospitals, a lawyer for a woman suing the company told a jury.
The lawyer, Richard Friedman, made his opening statement yesterday to jurors in state court in Port Orchard, Washington, telling them the training Intuitive provided for the robotic surgery was compromised by aggressive marketing, led to errors in removing Fred Taylor’s prostate gland, and eventually caused his death.
The case, brought by his widow, Josette Taylor, is the first to go to trial of at least a dozen lawsuits filed against Sunnyvale, California-based Intuitive since 2011 alleging injuries tied to its da Vinci surgical system. The robots were used in more than 300,000 U.S. operations last year.
Intuitive designed a training program to get U.S. Food and Drug Administration approval for its robot that, starting in 2000, under Gene Nagel, the executive in charge of training and development, was simplified, targeted less-skilled surgeons and was “watered down so much that nobody’s ever failed -- ever,” Friedman said.
This case is “about a medical device company that sought to radically change the way medical devices are marketed to doctors,” Friedman told jurors.
The device was so novel “that no one else knew how to use it,” Friedman said. Doctors, the government and hospitals had to look to Intuitive for expertise, he said. “At bottom this case is about a betrayal of that trust -- and one family that got hurt by that betrayal.”
After seven hours of robotic surgery on Taylor in September 2008, complications developed and the physician, Scott Bildsten, and other doctors turned to traditional surgery and then emergency care to repair a rectal laceration. Taylor died in August of heart failure resulting from injuries caused by Intuitive’s inadequate training of Bildsten, Friedman said.
Intuitive’s robots, which cost about $1.5 million each, are used in 1,371 U.S. hospitals, the company has said. The robots and related products generated most of its $2.2 billion revenue in 2012.
Allen Ruby, a lawyer representing Intuitive, told jurors that on the day of Taylor’s surgery, the “only physical injury that was suffered by Mr. Taylor” occurred after “the da Vinci robotic system was literally unplugged and out of the way and not in use.” The suit is “an attempt to blame Intuitive” and its marketing “for something that happened after the robotic surgery was completed,” Ruby said.
Ruby, who will continue his opening defense arguments today, presented jurors with a timeline, including Taylor’s Sept. 9, 2008, surgery, that he said will be referenced throughout the trial.
“We believe that the way to tell how good Intuitive’s product and training and warnings were, is to look at the surgery that was done on Mr. Taylor,” Ruby said.
If Bildsten was “poorly trained, if he was ignorant, if he was unwarned” then “we would expect to see consequences in the surgery which is the subject of this lawsuit.”
Arguing that Taylor’s death of heart disease four years after the prostate surgery wasn’t caused by the da Vinci, Intuitive said in a court filing that Taylor’s lawyers concede that before the surgery, Taylor had been diagnosed with diabetes, coronary artery disease, hypertension and high cholesterol. His treatment included bypass surgery in 2002.
Taylor weighed 280 pounds and had a body-mass index of 39, which Bildsten said made him obese, according to the filing. Intuitive said it told Bildsten that for his early procedures with the da Vinci -- at least the first four to six surgeries -- he should choose simple cases and patients with a low body-mass index.
“We take legal claims seriously and trust in the legal system as the appropriate place to resolve these disputes,” Angela Wonson, a spokeswoman for Intuitive, said in an e-mailed statement.
Bildsten, who had performed 100 successful prostatectomies using a traditional procedure and hadn’t used the da Vinci system on a patient without being supervised, failed in Taylor’s surgery to create a watertight seal between the bladder and the urethra when the prostate was removed, inflating Taylor’s abdomen with carbon dioxide pressure which led to a stroke, according to court filings.
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.
According to court filings, Bildsten said Intuitive’s training didn’t inform him of the need to create the watertight seal or warn of the risk of abdomen inflation. After reading Food and Drug Administration documents about the “learning curve to obtain basic competency” with the da Vinci system, Bildsten said, “I believe I likely would not have agreed to begin training on the robot had I been given this information,” according to the filing.
Bildsten said Intuitive told him he could achieve “basic competency” after two assisted surgeries, and that the company did not tell him that consultants paid by Intuitive reported that such proficiency couldn’t be reached “until twenty or more operations were complete,” according to the filing.
Bildsten was “led to believe the training program was FDA approved,” Friedman told the jury yesterday.
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).