When Fred E. Taylor arrived at Harrison Medical Center in Silverdale, Wash., for a routine prostatectomy, he expected the best medical care new technology had to offer: robotic surgery, billed as safer, less painful and easier on the body than traditional surgery.
The 2008 operation was supposed to take five hours. But it was marred by a remarkable cascade of complications and dragged on for more than 13 hours, leaving Taylor, who had been an active 67-year-old retiree, incontinent and with a colostomy bag, and leading to kidney and lung damage, sepsis and a stroke.
Taylor survived his injuries but died last year. Now his wife, Josette, is suing Intuitive Surgical Inc., the company that makes the equipment and trained the surgeon to use it. As it turned out, the surgeon, Dr. Scott Bildsten, had never before used the robotic equipment without supervision.
“We are the old school, where you trust the doctor,” said Josette Taylor, who noted that her husband’s life was so limited after the operation that he used to cry about being “trapped in this body.”
It is not the first time patients have claimed they were harmed by Intuitive’s robotic surgical equipment, called the da Vinci Surgical System. But the Taylor case, set for trial this month, is unusual. Internal company emails, provided by lawyers for the Taylor estate, offer a glimpse into the aggressive tactics used to market high-tech medical devices and raise questions about the quality of training provided to doctors before they use new equipment on patients.
Intuitive, based in Sunnyvale, Calif., declined to comment on the lawsuit but said studies showed the company’s robotic equipment produces better outcomes than conventional open surgery.
“The most objective and therefore best measure of efficacy for all of those involved in training — from Intuitive Surgical, the hospitals, the proctors and the surgeons themselves — is represented in the comparative clinical outcomes of da Vinci surgery,” said Angela Wonson, the company’s vice president for communications.
According to Intuitive, 1,371 U.S. hospitals have purchased a da Vinci system. Nearly half a million procedures worldwide were performed robotically last year, including prostatectomies and hysterectomies, among other operations.
A surgeon using the da Vinci system sits at a console with a camera that provides a high-definition, three-dimensional image of the surgical site. He or she manipulates miniaturized instruments; computer and robotic technology translates and scales the surgeon’s hand movements.
Hospitals are responsible for setting the credentialing standards, or training requirements, for physicians who will use the equipment on patients. But internal company emails suggest that Intuitive’s sales representatives were intimately involved in the process, presenting themselves as experts and pressing for lower standards in order to ease the training path for busy surgeons, to increase use of the equipment and to drive sales.
In an email dated May 31, 2011, a Western regional sales manager for Intuitive noted that area surgeons had used robotic equipment only five times, although the company’s goal was to see 36 robotic operations performed by the end of June. He urged sales staff to persuade surgeons to switch coming cases to robotic ones.
“Don’t let proctoring or credentialing” — shorthand for supervised surgery and hospital certification — “get in our way,” the email said.
In Dec. 2009, a sales representative urged a hospital in Billings, Mont., to ease up on its credentialing requirement, saying in an email that requiring surgeons to do five supervised operations using the robot before going solo was “on the high side” and could have “unintended consequences.”
Hospital officials replied, saying, “We will review and most likely will decrease the 5 down to 3.”
Wonson, the Intuitive spokeswoman, said the company does not get involved in determining who is qualified to operate its robotic equipment.
Bildsten was one of six doctors given free training by Intuitive, including one day of hands-on training at the company’s facility in California. He also had done two practice runs on the equipment with a more experienced surgeon before operating on Taylor, he said in a legal deposition.
Still, he said, no one warned him that a patient like Taylor, who weighed nearly 300 pounds, was not a good candidate for robotic surgery. He did not respond to requests for comment.
Company emails submitted in the Taylor case also suggest that members of the Intuitive sales staff worked diligently to persuade surgeons to choose the da Vinci procedure for patients, even if a different method was planned.
In one email on June 28, 2010, a clinical sales director urged the sales team — whose compensation was linked to filling a quarterly quota of operations — to “scrub” doctors’ schedules and get procedures advanced a few days in order to make the quarterly goal.
On Aug. 9, 2010, a clinical sales director wrote to his team: “Be proactive in finding cases to convert. Be prepared to challenge each trained surgeon every time you see a lap or open case. Be unsatisfied with the thought of ending a day without a converted case.” (“Lap” refers to laparoscopic procedures, an alternate form of minimally invasive surgery.)
The sales representatives were often in the operating rooms, where they offered advice to newly trained surgeons who were having technical difficulties with the robot, according to depositions in the Taylor case. The representatives also appear to have had access to the operating room schedules and were urged to “partner” with surgical teams “to review and select appropriate cases,” according to court documents.
In depositions, some Intuitive sales representatives defended their involvement, saying it was important for surgeons to use the robotic system frequently in order to improve their skills.
The Food and Drug Administration allowed the sale of the da Vinci system in 2000 under a controversial process called “premarket notification,” often used to bring medical devices to market without the rigorous trials typically required of new drugs.
The largest study to date of robotic hysterectomies has questioned the use of robot-assisted surgery over more conventional forms. A study published in February in The Journal of the American Medical Association evaluated 264,758 women who had laparoscopic or robotically assisted hysterectomy and found no overall difference in complication rates between the two groups.
But the researchers did find that the robot surgeries cost an average of one-third more.