Surgical robot’s maker sued over business practices — but not patients’ care?

davincirobot-300x176Hospitals finally are saying bull feathers to the leading maker of surgical robots that cost institutions millions of dollars annually to buy and maintain. New lawsuits against Intuitive Surgical dispute the company’s business practices, including the exclusivity it demands for its costly services and products.

But will the civil claims also crack open the door to bigger questions about daVinci robots and other such medical devices and whether they benefit patients or just add backbreaking costs to their hospital bills?

Intuitive has declined to comment on the suits filed against it in federal courts in California by the Franciscan and Kaleida health systems. The company has denied one aspect of the media reports about the suits — that it shut down its robots remotely in the middle of a patient’s operation, forcing a surgeon and his team to improvise and finish the procedure (without problems) using standard techniques.

Such hardball tactics — including purportedly telling hospitals that their multimillion-dollar machinery would be turned into giant “paperweights,” if they did not adhere to exclusive dealings with the makers — would seem ill-advised, undercutting a pillar of support for Intuitive: surgeons’ wishes.

But how do robots benefit patients?

Despite a sizable body of rigorous research and a growing number of damning media investigations into problems with daVinci robots and the scant evidence of their improving patients’ outcomes, doctors seem smitten by the devices. Surgeons say the robots allow them to be more precise and to avoid fatigue during longer procedures, arguing these and other attributes benefit patients.

But researchers disagree, finding that robot surgeries often last longer, produce no measurably better outcomes, and definitely cost more, especially as hospitals seek to recoup the costs of daVinci devices, costing anywhere from $500,000 to $2.5 million, reported the Axios news site, adding:

“[A] majority of Intuitive Surgical’s $4 billion of annual revenue comes from instruments, accessories, and service contracts that are needed to keep the robots operating.”

Indeed, the hospitals assert in their suits that Intuitive limits who may service the devices and the replacement life of key components of the machines, forcing institutions to buy pricey parts long before they would get close to losing their usefulness.

Still, surgeons keep pushing the robots’ use, prompting the federal Food and Drug Administration in 2019 to warn doctors against deploying the devices in mastectomies and other cancer-related surgeries. Such uses were an unproven and unwelcome experimentation, with the FDA acting after studies showed that minimally invasive procedures for early-stage cervical cancer, many robot-aided, were more likely than standard, large-incision surgeries to result in recurrences of the disease and deaths.

It is sadly common, however, to see paid, informercials for surgeons and hospitals advocating robot-assisted procedures, and gullible broadcasters still air fawning stories about gee-whiz technologies such as these devices.

Dissenting points of view

Savvy and skeptical consumers may wish, instead, to view The Bleeding Edge, an HBO documentary on the surgical robot system. They also may wish to review an NBC News investigation of harms tied to daVinci devices.

Dr. Robert Poston, chief of cardiothoracic surgery at SUNY Downstate Medical Center, told NBC he has concerns about how ill-trained many surgeons may be with the device. He said he has performed 1,200 or so da Vinci procedures, before he did his first with two hours of training on it — less time than most of us would expend on planning and preparing a weekend meal for guests. Intuitive, the da Vinci’s maker, says it has a “four-level training program.”

But the company emphasized that it “cannot legally require surgeons to complete it and cannot train surgeons on patients.” The federal Food and Drug Administration also told NBC it lacks authority to oversee device training and education.

Broadcast journalists found that in the last decade, the FDA has tallied more than 20,000 reports of “adverse events” related to the da Vinci.  More than 2,000 of these involved injuries, 274 were deaths, and nearly 17,000 device malfunctions — some minor, others more serious, including robotic arms uncontrollably going in the wrong direction and insulation cracking off and dropping inside patients’ bodies. To be fair, with more than 3,000 of the devices in use since 2000, the number of da Vinci surgeries performed in the United States has “increased by 52% since 2013, to nearly 700,000 procedures in 2017.”

In my practice, I see not only the harms that patients suffer while seeking medical services but also their struggles to access and afford safe, effective, and even excellent medical care, especially when they are injured by defective and dangerous products, notably medical devices.

Jeanne Lenzer, a seasoned medical investigative reporter, has found that 32 million Americans — about one in 10 of us — have at least one medical device implanted in our bodies. These include artificial joints, cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices. Most patients — indeed most of the public — may think federal regulators subject all this hardware to rigorous quality and safety testing.

That’s a wrong assumption. And though medical devices may be helping change and save many lives, Lenzer also warns they are harming and even killing too many patients. Under pressure from pro-business, anti-regulatory politicians and lawmakers, federal regulators have allowed a “Wild, Wild West” to flourish in the medical device business, she has argued.

It is worth noting two points about this view and surgical robots.

As Axios reported:

“Intuitive Surgical has a market cap of $113 billion — higher than companies like CVS Health or Lockheed Martin — and its executives are among the highest-paid in health care. Wall Street has loved Intuitive Surgical for years because of the company’s competitive moat and the high profit margins that result. Last year, while discussing a possible surgical robot competitor from Johnson & Johnson that remains years away from federal approval, bankers at SVB Leerink told investors this market “has essentially been a monopoly for da Vinci over the past two decades.”

And as NBC reported:

“[A recent] medical study found that payments from Intuitive appeared to “influence” doctors when they conducted research on the robot. The study found that if there was a financial relationship between the doctors in each study and Intuitive, there was a higher likelihood of studies reporting a benefit of robotic surgery. Public records show that since 2013, Intuitive has paid over $144 million to doctors and hospitals, for education, research, and travel. The company says that the majority of the payments made to doctors were for education, such as paying doctors to train other doctors.”

We have a lot of work to do to ensure that huge medical spending, especially for fancy hardware, produces equally positive outcomes for patients — and not just to enrich surgeons, device makers, and hospitals.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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