Intuitive Lawyer Says Warnings in Robot Surgery Ignored

A lawyer for Intuitive Surgical Inc. told jurors that a doctor who used the company’s robot in surgery on a morbidly obese patient who later died ignored warnings that the operation shouldn’t be performed.

Allen Ruby, in his opening statement today to jurors in state court in Port Orchard, Washington, defended Intuitive against a lawsuit claiming that the company’s robotic da Vinci surgical system training was compromised by aggressive marketing, and led to errors in removing a patient’s prostate gland, and eventually caused his death four years later.

Fred Taylor was five-feet, 11-inches tall, and weighed 280 pounds, giving him a body mass index of 39 -- a measurement that should have precluded robotic surgery according to the training Intuitive provided to the doctor, Scott Bildsten, Ruby said.

“Morbid obesity is not a criticism, it is a medical fact,” Ruby told jurors. Bildsten was asked in a deposition what Intuitive taught him “in regards to the physical size of the patient relative to using the da Vinci.”

“Yes, there were suggestions not to do overly obese patients in your initial procedures,” Bildsten said, according to Ruby.

Early Procedures

Bildsten, who is expected to testify as a witness at trial, was warned by Intuitive 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, Ruby said. “He was taught not to do this in his early cases,” Ruby said.

The case, brought by Taylor’s 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.

Richard Friedman, a lawyer for Josette Taylor who finished his opening arguments yesterday, claimed Taylor was a victim of training Intuitive provided for the robotic surgery. After Intuitive won regulatory approval for its daVinci robot the training was diluted in an aggressive marketing campaign to increase sales, Friedman claimed.

Intuitive designed a training program to get U.S. Food and Drug Administration approval for its robot that, starting in 2000, was simplified and “watered down so much that nobody’s ever failed -- ever,” Friedman said yesterday.

Seven Hours

After seven hours of robotic surgery on Taylor in September 2008, complications developed and 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, according to Friedman.

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.

Bildsten had performed 100 successful prostatectomies using a traditional procedure and hadn’t used the da Vinci system on a patient without being supervised. He 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.

Watertight Seal

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.

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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