Following close behind the rapid adoption of the da Vinci surgical robot in hospitals across the country is a rising tide of lawsuits challenging the device's safety, the aggressiveness of its corporate marketers and the adequacy of training for the surgeons who use it.
This past week, reports critical of California's high-flying Intuitive Surgical, the maker of da Vinci robotic surgery systems, have appeared on CNBC, in Bloomberg News coverage and other media outlets. With a price tag of $1.5 million apiece, da Vinci robots already are used in the operating rooms of nearly 1,400 U.S. hospitals.
In the past 15 months, at least 10 lawsuits claim Intuitive Surgical put patients at risk, and in some cases caused injuries, by marketing the robotic systems to doctors and hospitals without providing sufficient training.
In Tampa, this growing controversy is both a concern and possible public relations gift for one young symbol of innovation in the city's downtown. The 1-year-old Center for Advanced Medical Learning and Simulation — best known locally as CAMLS (pronounced "Camels") — was opened initially as a "partnership" with Intuitive Surgical, in part to provide national and international training to surgical teams using da Vinci robots in their hospital operating rooms.
CAMLS is part of the University of South Florida health system and is not part of the recent flurry of lawsuits aimed at Intuitive Surgical. CAMLS leaders say there are no lawsuits against CAMLS or its robotic training programs.
In short order, CAMLS has become a key sign of downtown Tampa's resurgence and growing sophistication. The medical facility's proximity to the Tampa Bay Times Forum put it in the spotlight during last summer's Republican National Convention, when the city was eager to show off its best assets.
But USF medical leaders are eager to distance themselves from Intuitive Surgical. In interviews, they differentiated what CAMLS does to minimize any potential blowback from the current spurt of litigation that claims da Vinci's maker urged training shortcuts at some hospitals, reportedly in the name of faster sales. Stories by CNBC and Bloomberg, for example, suggest the manufacturer's aggressive marketing of robotic surgery's capabilities excited the public, motivated hospitals to invest in the devices, then pressed some hospitals to shortcut the time spent by surgeons training on the devices.
"It's just the opposite in the CAMLS program," says Stephen Klasko, CEO of USF Health and dean of USF's Morsani College of Medicine. CAMLS provides independent training and sets more demanding standards that test the proficiency of surgeons and their surgical teams in new technologies, he said. And that happens to include da Vinci robotic surgery systems.
Klasko is big on measuring medical proficiency, which could prove an appealing message to da Vinci users confronted with training questions. The ability to assess and certify technical and teamwork competence, Klasko often tells medical audiences, "is one of the most striking examples of where health care has fallen behind other high-reliability fields."
At CAMLS, the most basic training on the facility's four da Vinci robots is taught by technicians who are employees of Intuitive Surgical Inc. But the higher-level training, from handling complications to advanced surgical team performance, is done by USF physicians, says CAMLS CEO Deborah Sutherland. More than a thousand surgeons and their teams have been trained so far by USF and CAMLS.
In fact, Sutherland says her team is working with other medical schools to come up with a set of robotic surgery standards to be used by all residency programs.
Are these recent lawsuits the unfortunate but hardly unusual path of any new technology that goes through rough spots after introduction? Obviously, the stakes are higher and more personal in the case of robotic surgery where human life can be on the line.
And Intuitive Surgical is not your average medical device maker.
One analyst calls the company the "Apple of the med-tech sector" with a recent stock price hovering near $500 a share and a $20 billion market value. The da Vinci devices assist surgeons who use minimally invasive techniques while sitting at a console, remotely handling surgical tools via joysticks and viewing a screen that displays the surgical site much more clearly than traditional methods. In theory, such procedures are supposed to decrease a patient's bleeding, pain and recovery time.
Last month, the U.S. Food and Drug Administration began asking doctors to provide information about their training on, and the safety and performance of, the widely used da Vinci robots after noticing an uptick in reports of adverse events.
"FDA wants to better understand users' perspectives on the different challenges raised when using the da Vinci Surgical System interface for performing surgery versus using conventional surgical procedures," the agency said in its letter to physicians. The letter indicated that agency officials would speak with surgeons for up to an hour as part of a survey.
Klasko calls CAMLS training on robotic systems "agnostic" — meaning the center is not committed to the da Vinci system if a superior surgical tool reaches the market.
Says the USF medical dean: "Tomorrow, if a new thing we've never heard of comes out that's better, it will be in CAMLS."
Robert Trigaux can be reached at [email protected]