Intuitive Surgical Inc. (ISRG), the maker of robots used in 367,000 U.S. operations last year, is facing accusations in lawsuits that it put patients at risk by marketing the machinery to doctors without providing adequate training.
Company e-mails introduced in a lawsuit filed against Intuitive in Kitsap County, Washington, suggest salesmen lobbied hospitals to scale back doctor training. One manager’s e-mail lauded a salesman for persuading a hospital that five supervised operations were too many. In another, a manager told a sales team not to “let proctoring or credentialing get in the way” of meeting goals on the number of robot surgeries.
Intuitive’s robots, which cost about $1.5 million each, are used in 1,371 U.S. hospitals. No universally accepted guidelines exist on how to train people to use them, unlike the standards for many other sophisticated surgical procedures. That’s left some hospitals dependent on guidance from Sunnyvale, California- based Intuitive, which has faced criticism it rushes training to speed revenue growth.
“Sales reps should have nothing to do with credentialing,” said David Penson, a urologist at Vanderbilt University Medical Center in Nashville, Tennessee, in a telephone interview. “Of course they are going to do whatever they can to get that guy out there and using their equipment.”
At least 10 lawsuits have been filed over the last 15 months alleging injuries from robot surgery, and almost all cite Intuitive’s training regimen.
Robotic surgery training has become a growing concern among physicians. This spring, the AAGL, formerly known as the American Association of Gynecologic Laparoscopists, is expected to offer its first robot training guidelines for hospitals, said Michael Pitter, a surgeon who uses the machines at Hackensack University Medical Center in New Jersey.
The 6,000-member organization will likely urge hospitals to mandate physicians perform at least 10 surgeries in the company of a more experienced doctor before being cleared to perform surgeries on their own, said Pitter, who sits on the AAGL task force working on the recommendations.
Myriam Curet, Intuitive’s chief medical adviser, defended the company’s current protocols. “The training we do is quite extensive,” she said in a telephone interview.
Training includes an online quiz, practice simulators and a one-day training course offered at Intuitive’s headquarters in Sunnyvale and 14 hospitals across the country, according to Curet. New doctors are also supposed to observe at least one robot operation, perform dry runs of operations with their team, and most hospitals require the first few operations be supervised by an expert proctor, she said.
Ultimately it’s up to doctors to decide how much training they need, Curet said. “We cannot require anything,” she said.
On Feb. 28, Bloomberg News reported that U.S. regulators were surveying surgeons about the robots following a rise in adverse event reports that include as many as 70 deaths since 2009. The reports, from doctors, patients and companies, don’t necessarily mean the robots caused any deaths, only that they were involved in procedures in which deaths occur.
The Massachusetts Board of Registration in Medicine said March 19 that it had received a rising number of reports on injuries linked to the robots. The board called for better oversight on training and more disclosure to patients on potential risks.
Some doctors also question the robots’ cost-efficiency, pointing to the lack of large, randomized trials showing significant health gains and data in hysterectomies showing they don’t cut complications compared with less-invasive procedures.
The robots and related products generated most of the company’s $2.2 billion revenue in 2012.
Intuitive shares fell 1.8 percent to $486.79 at the close in New York. The company said yesterday that its board authorized the repurchase of an additional $1 billion of Intuitive’s stock outstanding. The share has sunk 15 percent from Feb. 27, the day before the FDA survey was made public.
In robot surgery, a doctor sits at a video-game style 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 3-D camera that shows the work as it is done inside a patient.
It sounds foolproof, but critics say the robots can deprive surgeons of the tactile feel of doing hands-on operations that helps them avoid slip ups. A debate is burgeoning among doctors and in the courts over the cost, usefulness and safety of Intuitive’s da Vinci robotic surgery system.
For Josette Taylor, that debate is more than academic. In a lawsuit filed against Intuitive in Kitsap County, Washington, she alleges that complications suffered by her husband after prostate surgery, and his death four years later, partly resulted from “woefully inadequate” company training “designed to give surgeons a false sense of confidence.”
When 67-year-old Fred E. Taylor had his cancerous prostate gland removed in September 2008, it was his doctor’s first unsupervised surgery using Intuitive’s system, according to a lawsuit filed for Josette Taylor by Richard Friedman, of the Bremerton, Washington-based Friedman Rubin law firm.
Taylor lost 15 cups of blood during his 13-hour procedure, and suffered complications that included kidney failure, brain damage, permanent incontinence, and a 1-inch tear in his rectum, according to papers filed in the case, scheduled for trial in April.
Taylor died from heart failure last year as a consequence of the injuries, the lawsuit alleges.
The doctor who performed the surgery, Scott Bildsten, had done about 100 prostate removals in his career using the standard method, according to court documents. Before Bildsten operated on Taylor, he did two supervised robotic prostate removals. Intuitive provided the overseeing physician for those surgeries and the hospital paid the fees, documents show.
Bildsten has been employed by Franciscan Medical Group since July 1, 2010. A spokeswoman for Franciscan, Sheila Hanson, said neither Bildsten nor the group “choose to comment on a case that is still in litigation.”
Before the robot device was cleared in 2000, Intuitive told the U.S. Food and Drug Administration that the company would create a 70-question quiz and a three-day training course that all operating-room personnel would attend, according to FDA documents gained by Friedman and filed in the Taylor case.
Just months after the robot hit the market, Intuitive put a marketing official in charge of training who reduced the off- site training to one day and cut the test to 10 questions that was difficult for doctors to fail, according to the suit.
Documents released by Intuitive in response to the Taylor complaint also include company e-mails on training from marketing officials and sales personnel.
A December 2009 e-mail from Michael Rose, identified as a clinical sales representative for the company, advises a Montana hospital that its suggestion that new robot surgeons have a minimum of five proctored cases “is on the high side” and might have “some unintended consequences.”
The requirement would cost $15,000 per urologist and a similar requirement “slowed down” development of robotic surgery at another hospital, according to the e-mail, which also said the company wants “quality patient outcomes.”
After the hospital indicated it would “most likely” lower its requirement, Rose was congratulated in a company e-mail: “Mike, nice job on taking charge and ownership of your programs,” wrote Jeff Gillam, a clinical sales manager.
In May 2011, another sales manager advised his team on how to meet a quarterly goal of 31 operations on the robot from newly trained surgeons, providing a chart with specific targets for how many robot operations each surgeon should perform. That e-mail advised salesmen they shouldn’t “let proctoring or credentialing get in the way” of meeting company goals.
Angela Wonson, an Intuitive spokeswoman, said the company doesn’t comment on specific allegations in pending litigation. Generally, she said, “robotic surgery has been shown to be safer than the open surgery alternatives in numerous independent large scale, peer reviewed studies.”
In legal papers, Intuitive argues the Taylor case should be dismissed because “credentialing and privileging for performing surgery at a hospital is solely the responsibility of the hospital. It is not the responsibility of a medical device manufacturer like Intuitive.”
According to court papers, Intuitive’s sales representatives helped guide the hospital’s decisions on training, attending meetings of the hospital’s robotics steering committee, providing timelines of how quickly surgeons could be up and running on the robot and marketing brochures for patients touting the process.
Rando Wick, the attorney representing the hospital in the case, said Harrison Medical Center “counts on training being provided by other companies such as Intuitive, and so far we have had very happy patients with this one exception.”
The center, which offers 297 patient beds in two facilities, doesn’t dispute that Taylor suffered complications and settled with Taylor and his wife in 2012 for an undisclosed amount, said Wick, of the Seattle-based legal firm Johnson, Graffe, Keay, Moniz and Wick.
On the issue of mandated training, Wonson referred to a statement filed in the Taylor case by a former FDA official, Philip J. Phillips.
Phillips was deputy director for science and regulatory policy at the FDA’s office of device evaluation when the da Vinci system was being evaluated for approval by the agency and is now an industry consultant, according to the sworn statement.
The agency first required that Intuitive submit the robot for approval in the FDA’s most rigorous device review category as it had “new technological characteristics” and hadn’t been proven equivalent to existing surgery equipment.
Around May 2000, Phillips reversed that decision and placed the robot into a less stringent category, paving the way for the device to be cleared for marketing in July 2000, he said. The earlier promise to create a three-day training program “was never required,” he said in the court papers.
While the agency expected the company to provide doctor training, the details “were left to the discretion of Intuitive Surgical.” Phillips doesn’t say in his court statement why he changed the reviewing category for the robotic system. A telephone call to a number listed for his consulting business wasn’t returned.
Jim Hu, director of Urologic Robotic and Minimally Invasive Surgery at the David Geffen School of Medicine at the University of California, Los Angeles, said he believes any safety issues involving the robot today, a dozen years after they were first approved for surgery in the U.S., have a lot to do with experience and training of the doctors using it.
“A lot of people have not had the most optimal outcomes” after robotic surgery due to limited training, Hu said in a telephone interview, speaking generally. “The robot surgery requires a long learning curve to become good at it.”
In prostate cancer surgery, it can take 200 or more operations to get proficient at using the robot, according to Hu. While market pressure has driven numerous hospitals to buy the robot, patients may have been better served if the robot had been introduced more gradually at top hospitals that could become expert at it, Hu said.
“If you know what you are doing these things just don’t happen,” Hu said. The robot “doesn’t just harm people.”
In gynecology surgery, Mayo Clinic researchers found it takes 90 operations to become proficient on the robot, according to study results published in January in the medical journal Obstetrics & Gynecology. Before that level is reached, there may be a higher rate of certain complications including injuries to the bowel, bladder or blood vessels, the study found.
Intuitive’s Wonson said previous studies showed robotic surgery was easier to learn than standard less-invasive surgery for gynecology.
Memorial Sloan-Kettering Cancer Center, requires that surgeons learning the robot have at least their first 10 operations supervised by expert robot surgeons to insure safety, said Peter Scardino, chairman of surgery for the hospital. The proctor must sign off that there were no unexpected complications during those operations, he said.
Marketing of the robots to patients “put huge pressure” on hospitals to buy the surgery systems “and grossly overstate claims for the safety” of the instruments, lest they lose business to rivals, Scardino said in a telephone interview.
“Patients were over promised” that robot surgery is risk- free, he said. In reality, the skill of the surgeon matters far more than whether a robot is used or not, he said.
“An inexperienced surgeon with a robot in his hands is going to do a very bad operation,” Scardino said.
Pitter, the New Jersey surgeon working with an AAGL committee on proposed training guidelines, said they group also is likely to recommend airline-style simulator training.
“In the same way that airline pilots are credentialed to fly 787s, we want to make sure that before surgeons get in cockpit that they have seen all scenarios they could possibly see” with the robots, Pitter said in a telephone interview. Patient safety is the main goal, he said.
“If you are not a skilled surgeon no matter what tools you are using you are going to have some problem with complication rate,” said Pitter, who defends use of the machines.
The question of training has often come up since the robots were first cleared by the FDA for use in the U.S. in 2000 after a trial on 233 patients, done at a hospital in Mexico City.
The 1998 trial compared robotic surgery in 113 patients with conventional operations for removing gall bladder and treating heartburn. The study found no advantage for robotics. To the contrary, the robot surgery took longer to perform and there was slightly more blood loss, a statistician reviewing the data told an advisory panel.
Equivalence to standard surgery, the main goal of the study, “was not demonstrated,” the official told doctors at an agency hearing on June 16, 1999. FDA advisers, though, voted to recommend approving the robot system, concluding it was safe and effective, and citing the technical capability and potential of the robot, according to a hearing transcript.
Several of the panel members, though, suggested it was crucial that Intuitive devise a detailed training program for its use, and a company founder assured them the company would do that. The company providing detailed plans for surgeon training as a condition of the approval vote, according to the meeting minutes.
The robot “is doing surgery in a completely different way,” UCLA’s Hu said. “It is a lot to bite off after a two-day course.”
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