A medical equipment manufacturer is being sued by a grieving widower after claiming that the surgical robot 'Da Vinci Surgical System’ burned a hole in his wife’s organs during a colon cancer treatment procedure.
Sandra Sultzer underwent surgery at Baptist Health Boca Raton Regional Hospital in September of 2021 for her colon cancer treatment. The surgery involved the use of the Da Vinci robot, a remote-controlled, multi-armed surgical device, which is famous for the 2018 viral video "They did surgery on a grape." The manufacturer, Intuitive Surgical (IS), advertises the device as “designed to provide surgeons with natural dexterity while operating through small incisions” with “precision beyond the limits of the human hand.”
The lawsuit by husband Harvey Sultzer claims that the robot burned a hole in his wife’s small intestines, which required additional surgery. After the procedure, the patient continued to experience abdominal pain and fever until she ultimately succumbed to her injuries in February 2022 “as a direct and proximate result of the injuries she suffered.”
The lawsuit also alleges that IS knew, but did not disclose to the Sultzer Family or the public that the robot had issues with insulation that could cause the device to burn internal organs.
This was according to numerous reports by an investigation by the Food and Drug Administration (FDA) between 2009 and 2011. The suit further claims that IS had been engaged in “systemic underreporting” of the thousands of reports about defects and injuries associated with the Da Vinci robot.
A financial report filed by IS in 2014 with the Securities and Exchange Commission (SEC) reveals that the company was a defendant in more than 90 lawsuits at the time, which allege that "they or a family member underwent surgical procedures that utilized the da Vinci Surgical System and sustained a variety of personal injuries and, in some cases, death as a result of such surgery." In 2023, the company also told the SEC that it was a defendant in many individual product liability lawsuits that involved the same allegations in their annual report.
Another lawsuit also alleges that the company sold surgical robots to hospitals that have no experience in robotic surgery and did not properly train surgeons in the use of the Da Vinci. In 2018, an NBC news investigation found that while the company offers training programs, it could not legally mandate surgeons to complete them.
Now, Harvey Sultzer is suing IS for over $75,000 for design defects and failure to warn, negligence, product liability, loss of consortium, and punitive damages.
Robotic-Assisted Surgery
Robots have been utilized in surgical procedures for decades. The first successful robot-assisted surgery was in 1985, with the PUMA 200 by Westinghouse Electric. It was used for needle placement in a CT-guided brain biopsy. Since then, robotic surgery technology has developed further and has been used in other operations, including endocrine surgery, neurosurgery, spine surgery, gynecology, and many more.
Robotic-assisted surgery has many advantages over conventional surgery, including improved precision and accuracy, virtual mapping, lack of fatigue, and consistency, among others. It has allowed for less-invasive surgery, which improves patient outcomes. However, it lacks the haptic feedback or ‘touch feedback’ of the human hand, which is a limiting factor. There is also the risk of malfunction, albeit rarely fatal. But when a malfunction does prove fatal, we are left with the question. Who is to blame?
Robotic surgery faces some medicolegal issues. A study published in the National Center for Biotechnology Information delves into these underexplored problems. First is the lack of standardized training and credentialing for surgeons. As in this current case, IS was unable to legally mandate the training and certification of surgeons before selling the Da Vinci.
It is unclear what type of training the hospital required its surgeons to undergo as well. This undermines surgeon competence and, potentially, patient safety. The second issue is the informed consent process, which requires additional considerations to make patients fully aware of the risks and capabilities of the technology. While it is already mandated by law to inform the patient of the process and the potential risks, it is not required to disclose the prior experience and training of the surgeon who will operate the robot. The third issue is the legal liability. There are multiple stakeholders in the use of robotic systems for surgery. If an unfortunate incident were to take place and result in harm to the patient, who should be blamed? Is it the product manufacturer, the surgeon, or the medical institution?
Legal Liability In Robot-Assisted Surgery
For this particular case, should it be proven that Intuitive Surgical was indeed guilty of failure to warn their customers of potential hazards and releasing a faulty product, they could very well be held liable.
But in general, there is no clear-cut answer for cases of medical negligence and malpractice involving robot-assisted surgery. Cases need to be evaluated individually, and the laws and guidelines continue to evolve with the technology. The issue of legal standing in cases of robotic-assisted surgery is still up for debate.
The surgeon, the hospital, and the device manufacturer all share some legal responsibility. Using a robot does not give surgeons immunity from suit. At the end of the day, the robot is merely a tool, and the doctor is still expected not to commit malpractice (i.e., deviate from the applicable standards of care) while performing the surgery.
There are limited verdicts and legal literature for cases of robotic-assisted surgery, but the closest example we can liken them to right now is the case of self-driving cars, where shared liability exists. For self-driving cars or 'autonomous vehicles,' a legal analysis has shown that culpability varies for every case. But if the car crash involved fully automated vehicles, the user was often held less liable and a majority of the blame was put on the manufacturer and the government agency that issued the certifications and manufacturing licenses. However, in cases of partially automated vehicles, there are instances of drivers being held liable for crashes they cannot reasonably avoid.
As you can see, even the closest examples are not quite clear. And this is not a 1:1 application either. Guidelines and laws are still being drafted since the technology is relatively new, and the availability of these devices is also limited by the high cost of acquisition, making it difficult to study for a comprehensive enough sample size.
Ultimately, what we have here is unexplored territory, a developing legal field where the next decisions could set precedents for future laws and restrictions regarding the use of robots in medicine.
In times of uncertainty like these, what you want is an experienced team of lawyers who can navigate the legal field with confidence and the willingness to go above and beyond in terms of research and investigation to secure for you and your family the compensation you deserve.
The lawyers at Porter Law Group have an extensive track record of exceptional service for victims of medical malpractice and negligence. Our dedicated team of lawyers and partners in the medical field have worked for years to ensure that victims get what they justly deserve. Porter Law Group has secured millions of dollars* in compensation for numerous medical malpractice victims and personal injury claims.
If you or a loved one have been harmed in a robot-assisted or other medical surgery in New York, call the Porter Law Group today for a free, no-obligation consultation.
*Prior results do not guarantee similar outcomes
