Last year, Denver’s Porter Adventist Hospital announced that Warren Kortz, a general surgeon on staff, was the first in the Rocky Mountain region to use a technique known as robotic surgery to remove gall bladders through one incision in the belly button.
The operation, performed while the doctor sits at a videogame-like console, was “taking advantage of another breakthrough in robotic surgery” and is “easier on the patient,” the hospital said in a press release.
“It’s Star Wars stuff,” Kortz was quoted as saying in another article put out by the hospital touting a 2010 robot-assisted parathyroid surgery. “My prediction is it will eventually replace everything else.”
What the hospital and Kortz didn’t reveal was the risk. Even as Kortz promoted robotic surgery, 10 patients he treated suffered injuries or complications between 2008 and 2011, according to an April complaint by the Colorado Medical Board. Five had arteries punctured or torn. Objects were temporarily left inside two, and others had nerve damage. One died and another needed cardiopulmonary resuscitation. The complaint charges Kortz with 14 counts of unprofessional conduct, including sometimes not advising patients on alternatives to the robot.
Robotic surgeries are on the rise, fueled by aggressive marketing by doctors, hospitals and Intuitive Surgical Inc., which makes the $1.5 million robot. Advertising on hospital and doctor websites, YouTube videos, billboards, and on radio and television has hyped robotic surgeries, often claimed fewer complications without proof, and sometimes ignored contradictory studies finding no advantage.
Robot operations haven’t been proven in randomized trials to offer significant health benefits compared to standard, less-invasive surgery and multiple studies show they can cost thousands of dollars more.
Last year, U.S. hospitals used robot-assisted surgery in more than 350,000 operations — a 60 percent jump since 2010.
Robotic surgery is used to perform hysterectomies, gall bladder removals, prostate cancer treatment, heart valve operations and many other soft tissue operations. Half of general surgeons plan to add robotic systems within two years in response to general demand, according to a JPMorgan Chase & Co. survey reported Oct. 3.
The rise of Intuitive’s robot surgery highlights flaws in FDA regulation of the marketing of medical devices. Only two full-time employees evaluate ads for such devices, which include radiation therapy machines, implanted devices such as artificial hips and cardiac defibrillators, drug infusion pumps, surgical instruments and surgical robots.
By comparison, the FDA has more than 60 people watching over prescription drug promotion.
The complexity of medical devices makes it hard to evaluate safety and efficacy claims, said Robert Steinbuch, a law professor at the University of Arkansas at Little Rock.
“Hospital advertising is essentially a free-for- all,” Steinbuch said.
John Mulhall is a urologist at Memorial Sloan-Kettering Cancer Center in New York, where prostate cancer surgery is performed with and without the robot. Mulhall said, “If there was a Nobel Prize for marketing, it would go to Intuitive Surgical.”
70 deaths since 2009
In February, Bloomberg News reported that the FDA was surveying surgeons about the robots after an increase in reported adverse events, including 70 deaths since 2009. Reports of injuries linked to robotic surgery have more than doubled in the first eight months of this year, based on when the reports were received by the FDA, compared with the same period last year.
In July, the FDA issued a warning to Intuitive Surgical after an inspection found the company inadequately reported device corrections and some poor outcomes.
Sales growth slowed in the second quarter on a decline in robot system sales. Since the first Bloomberg report in February, Intuitive Surgical’s shares have fallen 34 percent to $380.99.
The company says looking at reporting dates, rather than the dates the incidents occurred, “is likely to seriously misrepresent the true performance of a device.”
Spokeswoman Angela Wonson said Intuitive follows regulatory guidance in every market in which it operates and continually updates the information it provides to medical professionals and the public.
Intuitive cannot control how hospitals market the device, Wonson said. “Ultimately, decisions about treatment must be made between the surgeon and the patient.”
“The marketing material that Intuitive puts out is fair and balanced,” said Myriam Curet, the company’s chief medical adviser, noting its “robust program where we review all of the marketing material that goes out.”
“We make sure that discussions of alternative procedures are on the marketing materials as well as discussions about risks,” Curet said. She “would never expect a patient to depend on marketing material in terms of making their informed consent.”
Porter Adventist Hospital cannot comment on the Kortz cases due to privacy laws, Thomas Drake, the hospital’s chief medical officer for the hospital, said in a statement.
Safety is the top priority of the hospital, which responds “with swift and immediate action” to clinical concerns, Drake said. “Our approach to robotic surgery marketing is focused on consumer awareness.”
Military origins
Robotic surgery grew out of the U.S. military’s attempts in the late 1980s to design remote-control devices that would enable surgeons at military bases far from the battlefield to treat wounded soldiers. The FDA cleared Intuitive Surgical’s robot for use in 2000.
In robot-assisted surgery, a physician looks into a high-definition display at a console several feet from the patient. Foot pedals and hand controls maneuver mechanical arms equipped with tools, guided by a 3-D camera that shows the work as it is done inside a patient.
This differs from other minimally invasive operations in which doctors stand over the patient and manipulate instruments and a tiny camera through multiple small incisions.
Teresa Hershey, 41, of Bermuda Dunes, Calif., said she knew nothing about robotic surgery when her doctor proposed it as an alternative to standard hysterectomy.
“It sounded good. She sold me on it,” Hershey recalled.
But during her 2010 operation at Desert Regional Medical Center, doctors punctured her bowel, a problem that wasn’t discovered until she had been hospitalized in severe pain for nine days, Hershey said. It took nine operations to fix the problem, racking up almost $1 million in medical bills that were paid by her insurance.
A brochure her doctor gave her didn’t mention that the same less-invasive hysterectomy can be done through small incisions without the robot, said Hershey, who plans to sue Intuitive Surgical.
“They are deceiving people,” Hershey said of doctors and Intuitive Surgical. “People don’t hear the cons. They only hear the pros.”
Desert Regional spokesman Richard Ramhoff said the center puts its marketing materials “through a stringent marketing and advertising review process prior to publication.”
“Our website, where we feature our robotic surgery offerings, explains that all surgical procedures, including those with robotic options, have risks and benefits,” Ramhoff said in an email.
Aggressive marketing
Doctors and hospital officials say Intuitive Surgical is particularly aggressive in marketing to hospitals.
In gynecology, the company “came in and convinced surgeons this new technology is going to take over the market,” said Wendel Naumann, a gynecologic surgeon at Levine Cancer Institute in Charlotte, N.C. “Learn to do this or you can get left behind.” He no longer uses the robot because “it really didn’t add anything.”
Paul MacKoul, director of minimally invasive gynecology surgery at Holy Cross Hospital in Silver Spring, Md., has done thousands of the standard operations and can perform a hysterectomy through two small incisions in just 45 minutes.
In 2011, he said, he started losing business to gynecologists with less experience in the operations who had previously referred patients to him. They were instead keeping the patients by adopting the robot, even though the robot operations had more incisions than his method, he said.
“The marketing has been genius,” MacKoul said. “You’d be surprised how many patients think the robot operates on the patient, not the doctor, and it is very sophisticated and precise and that is why it is better.”
While Intuitive’s marketing tactics are aggressive, “there is nothing ethically wrong with what they have done when you look at it from a business perspective,” said Peter Carnegie, a former Intuitive cardiothoracic program development manager who left in 2010. Carnegie said he remains “very positive on the technology,” which is “a monstrous leap” over what was available before.
When a hospital bought a robot, Intuitive Surgical provided an extensive marketing kit with everything from material for radio spots to television clips to Web pages the hospital could use for marketing, Carnegie said.
The sales reps were “masterful at being very aggressive” in playing a hospital off its local rivals to get it to buy a robot, said Carnegie, now a consultant for hospitals on complex robotic surgery. “They used every ounce of leverage they had in that monopoly to pressure hospitals into purchasing.”
Once a hospital had one robot, sales people were “trained to drive conflicts” between surgeons so they would squabble over who got to use the robot at popular times, Carnegie said. If enough prominent doctors started complaining, hospital administrators might buy another.
Peter Dunn, executive medical director for perioperative services at Massachusetts General Hospital in Boston, described similar tactics.
Dunn recalled a sales manager visiting his hospital saying that a senior gynecologist couldn’t get enough operating time on the robot, a claim that turned out to be false.
Another sales representative told a staff surgeon that training on the robot was worthwhile only if the doctor performed a certain number of cases, Dunn said. Sales representatives “were constantly coming in” with suggestions for how the hospital could form a partnership with the company.
“They would go to any avenue they could to infiltrate Mass General,” said Dunn, who said the hospital uses the robot sparingly for urology and gynecology procedures. “We absolutely refused.”
The company’s marketing “has pushed the limits of truth,” Dunn said.
Risks ignored
Marketing materials for robotic hysterectomy often has contained “cherry-picked and very misleading information,” said Barbara Levy, vice president for health policy at the American Congress of Obstetricians and Gynecologists.
The FDA is “especially weak when it comes to regulating ads for medical devices,” said Diana Zuckerman, president of the National Research Center for Women & Families in Washington. FDA spokeswoman Synim Rivers said the agency is working on increasing the staff working on device promotion.
A September 2012 study by researchers at Columbia University revealed that 44 percent of hospital websites touted robot gynecology surgery, yet only 1.6 percent of the sites mentioned its potential complications.
Websites for hospitals doing robotic prostate surgery often have contained unproven claims of superiority in erectile dysfunction, a 2010 study by researchers at Memorial Sloan-Kettering found. Many sites had “generic information copied directly from the website of Intuitive Surgical.”
A 2011 study by doctors at Johns Hopkins School of Medicine found that 164 hospital robot-surgery websites surveyed “overestimate benefits, largely ignore risks and are strongly influenced by the manufacturer,” according to research in the Journal for Healthcare Quality.
But Intuitive’s Curet said many studies have found that surgeons using the robot are less likely to run into difficulties that would require them to convert to traditional large incisions, compared with surgeons using less invasive methods.
“Where the robot brings value is when you get into more complex procedures” that cannot be done with standard, less invasive methods, Curet said. “You are taking a patient who would otherwise have a large incision and now operating minimally invasively.”
Curet said that while randomized, controlled trials comparing surgical techniques are infrequently done, analyses of large patient databases “have shown a definitive advantage” to robotic prostate surgery compared with traditional large- incision prostate removal, including fewer operative complications.
A Stanford University study in the September issue of Urology found that men who received robotic prostate operations had shorter hospital stays, needed fewer blood transfusions, and had fewer complications and deaths in the 30 days after surgery.
Complaints against doctor
Kortz, a summa cum laude Dartmouth graduate, started performing robotic operations in 2005 and by 2012 had done 350 to 400 such operations, according to a court deposition.
In October 2009, Porter Adventist Hospital issued a press statement on Kortz’s prowess, saying he was “the first surgeon in the Rocky Mountain region” to remove the parathyroid gland with the robot.
On May 21, 2010, Shanti Lechuga, 22, was to have her kidney removed for a donation. Kortz pierced her aorta at the beginning of the robotic surgery, necessitating an immediate operation to fix the problem, according to a malpractice lawsuit against Kortz.
A sponge was left inside her body that had to be removed during a second surgery, and Lechuga suffered a nerve injury. Court documents show the litigation was resolved last month.
Kortz’s robotic operating room privileges were suspended at Porter Adventist around August 2010. He got them back early in 2011, he said in the 2012 deposition in the Lechuga case.
A few months later, Kortz, several other surgeons and the hospital created the Porter Robotics Institute. The parties involved signed “a joint marketing agreement” agreeing to split costs of promoting the institute, Kortz said in the deposition.
A local television station filmed a segment about new institute. The robot is “decreasing the trauma even further to the patient,” Kortz said in a May 2011 web article accompanying the video on www.thedenverchannel.com.
Two months later, another Kortz patient died after his condition worsened following a robotic operation and a second non-robotic operation did not solve the problem, according to a wrongful death lawsuit by the patient’s widow.
Drake, Porter Adventist’s chief medical officer, said that “our marketing efforts are never meant to interfere with this physician-patient relationship or to supersede a physician’s clinical judgment.” Hospital spokesman Tim Shonsey said that while Kortz is on the hospital’s medical staff, he is not an employee.
Kortz “strongly denies” unprofessional conduct and his complication rate “is not out of line with those of other experienced general surgeons,” said Lisanne Leasure, a lawyer for Kortz, in an email. “To suggest or imply that it was somehow improper for Dr. Kortz to speak publicly about the proven benefits of robotic surgery even though a very small number of his patients had experienced complications is irresponsible and false.”
The medical board complaint against Kortz is scheduled to be heard in February.
By Robert Langreth, Bloomberg
Posted Oct. 21, 2013, at 7:12 a.m.
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