The manufacturer of the surgical robot sued for commercial practices – but not for patient care? | Patrick Malone & Associés PC | DC Personal Injury Lawyers


Hospitals are finally saying bull feathers to the leading manufacturer of surgical robots that cost institutions millions of dollars per year to purchase and maintain. New lawsuits against Intuitive Surgical challenge the the company’s business practices, including the the exclusivity it demands for its expensive products and services.

But will civil lawsuits also open the door to bigger questions about daVinci robots and other medical devices and whether they benefit patients or simply add grinding costs to their hospital bills?

Intuitive declined to comment on lawsuits brought against her in federal courts in California by the Franciscan and Kaleida health systems. The company denied one aspect of media reports on 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 complete the procedure (no problem ) using standard techniques.

Such harsh tactics – including allegedly telling hospitals that their multi-million dollar machines would be turned into giant “paperweights” if they didn’t adhere to exclusive deals with manufacturers – would seem ill-advised, undermining a pillar of support for Intuitive: the surgeons’ vows.

But how do robots benefit patients?

Despite a considerable amount of rigorous research and a growing number of damning media investigations into the problems with daVinci robots and the sparse evidence of improved patient outcomes, doctors appear to be won over by the devices. Surgeons say robots allow them to be more precise and avoid fatigue during longer procedures, arguing that these and other attributes benefit patients.

Corn researchers disagree, finding that robotic surgeries often last longer, do not produce better measurable results, and certainly cost more, especially as hospitals seek to recoup the costs of daVinci devices, which cost between $ 500,000 and $ 2.5 million. dollars, news site Axios reported, adding:

“[A] majority of Intuitive Surgical $ 4 billion of the annual turnover comes from instruments, accessories and service contracts necessary for the operation of the robots.

Indeed, hospitals say in their lawsuits that intuition limits who can service devices and the replacement life of key machine components, forcing institutions to purchase expensive parts long before they are on the job. point of losing their usefulness.

Yet surgeons continue to push the use of robots, prompting the Federal Food and Drug Administration in 2019 to warn doctors against the deployment of devices in mastectomies and other cancer-related surgeries. Such uses were unproven and unwanted experimentation, with the FDA acting after Studies have shown that minimally invasive procedures for early-stage cervical cancer, many robot-assisted surgeries were more likely than standard large-incision surgeries to result in disease recurrence and death.

However, it’s sadly common to see paid news aimed at surgeons and hospitals advocating robot-assisted procedures, and gullible broadcasters still spread obscene stories about gee-whiz technologies like these devices.

Divergent views

Savvy and skeptical consumers may want to consult instead The bleeding edge, an HBO documentary on the surgical robot system. They can also want to review an NBC News investigation of harm linked to daVinci devices.

Dr Robert Poston, chief of cardiothoracic surgery at SUNY Downstate Medical Center, told NBC he is concerned about the lack of training many surgeons have with the device. He said he performed around 1,200 da Vinci procedures, before doing his first with two o’clock training on it – less time than most of us would spend planning and preparing a weekend meal for guests. Intuitive, the creator of da Vinci, says he has a “four-level training program.”

But the company stressed that it “cannot legally force surgeons to complete it and cannot train surgeons on patients.” The Federal Food and Drug Administration also told NBC it does not have the authority to oversee the training and education of the devices.

Broadcast journalists have found that over the past decade, the FDA has documented more than 20,000 reports of “adverse events” related to da Vinci. More than 2,000 of these involved injuries, 274 fatalities and nearly 17,000 device malfunctions – some minor, others more serious, including robotic arms going uncontrollably in the wrong direction and isolators. that crack and fall inside the patient’s body. To be fair, with more than 3,000 devices in use since 2000, the number of da Vinci surgeries performed in the United States has “increased by 52% since 2013, reaching almost 700,000 procedures in 2017”.

In my practice, I not only see the harm suffered by patients when 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, in particular medical devices.

Jeanne Lenzer, seasoned medical investigative journalist, 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, heart stents, surgical nets, pacemakers, defibrillators, nerve stimulators, replacement lenses in the eyes, heart valves, and birth control devices. Most patients – indeed most of the public – may think that federal regulators are subjecting all of this material to rigorous quality and safety testing.

This is a false assumption. And while medical devices can help change and save many lives, Lenzer also warns that 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 thrive in the medical device industry, she argued.

Two points should be noted regarding this point of view and surgical robots.

As Axios reported:

“Intuitive Surgical has a market capitalization of $ 113 billion – more 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 gap and the resulting high profit margins. Last year, in discussing a possible surgical robot competitor to Johnson & johnson still years away from federal approval, SVB Leerink bankers told investors that this market “has been essentially a monopoly for da Vinci for the past two decades.”

And as NBC reported:

“[A recent] A medical study found that Intuitive’s payments seemed “Influence” doctors when they researched the robot. The study found that if there was a financial relationship between the physicians in each study and Intuitive, there was a higher likelihood of studies reporting a benefit from robotic surgery. Public records show that since 2013, Intuitive has paid more than $ 144 million to doctors and hospitals, for education, research and travel. The company says the majority of payments to doctors were for education, like paying doctors to train other doctors. “

We have a lot of work to do to ensure that huge medical expenses, especially for sophisticated equipment, produce equally positive outcomes for patients – and not just to enrich surgeons, device makers and hospitals.

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