NY TIMES - Salesmen in the Surgical Suite
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 operation, on Sept. 9, 2008, 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 Mr. 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.
Mr. 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 Mrs. 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 in April, is unusual. Internal company e-mails, provided to The New York Times 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 that its robotic equipment results in 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 hospitals in the United States have purchased a da Vinci system, and many have purchased two. 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 e-mails 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 e-mail 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 upcoming cases to robotic ones.
“Don’t let proctoring or credentialing” — shorthand for supervised surgery and hospital certification — “get in our way,” the e-mail said.
In December 2009, a sales representative urged a hospital in Billings, Mont., to ease up on its credentialing requirement, saying in an e-mail 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.”
Ms. Wonson, the Intuitive spokeswoman, said the company does not get involved in determining who is qualified to operate its robotic equipment, which is the responsibility of the hospitals. “We do not make recommendations,” she said in an e-mail.
Dr. 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 Mr. Taylor, he said in a legal deposition. Still, he said, no one warned him that a patient like Mr. Taylor, who weighed nearly 300 pounds, was not a good candidate for robotic surgery.
He did not respond to telephone messages requesting comment.
Company e-mails submitted in the Taylor case also suggest that members of the sales staff at Intuitive worked diligently to persuade surgeons to choose the da Vinci procedure for patients even when they were planning to use a different method.
In one e-mail 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 moved up by a few days in order to make the quarterly goal. “Let’s bring it home!” she wrote. “Be sure you scrub all schedules, identify cases on Thursday and Friday that can be moved up.”
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 legal 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.
On March 3, 2011, a sales representative wrote in an e-mail to his team that he had met with a gynecologic surgeon in Utah who was trained a year earlier but had stopped doing robotic cases. The surgeon subsequently “agreed to convert the next two to da Vinci.”
In depositions, some Intuitive sales representatives defended their involvement, saying that it was important for surgeons to use the robotic system frequently in order to maintain and 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 of safety and efficacy typically required of new drugs. Manufacturers are able to exempt devices from the rigorous trials by claiming they are similar to existing devices already on the market.
When devices are brought to market this way, the F.D.A. “cannot require training programs as a condition of clearance,” said Synim Rivers, an agency spokeswoman.
Before allowing this type of market clearance, the agency twice asked Intuitive for more information about how doctors would be trained to use company equipment. Intuitive provided details of a 70-item exam for surgeons and a three-day hands-on training protocol.
By 2002, however, the company had revamped its training program, replacing the 70-item exam with a 10-question online quiz and reducing the time spent in hands-on training at Intuitive’s facility to one day.
The largest study to date of robotic hysterectomies has questioned the use of robot-assisted surgery over more conventional forms of minimally invasive surgery. A study published in February in The Journal of the American Medical Association evaluated outcomes in 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 robotically assisted surgery for hysterectomy costs on average about one-third more than laparoscopic surgery.
Last week, Dr. James T. Breeden, the president of the American Congress of Obstetricians and Gynecologists, publicly urged patients “to separate the marketing hype from the reality” when considering a surgical method for hysterectomy. “Just because it’s newer and higher technology,” he said, “doesn’t mean it’s better.”
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