The Da Vinci System: A Feat in Medicine, a Newfound Dilemma in the Legal Field
By L. Michelle Ugalde
The da Vinci Robotic Surgical System is said to be catalytic in the advancement of modern medicine since its inception by Silicon Valley’s Intuitive Surgical. [1] While the machine itself is exceedingly complex, a major design component of the da Vinci system is that the system is used and overall conducted by a human surgeon.[2] As it turns out, this is exactly where a vast amount of the recent litigation surrounding the system stems from.[3] This litigation poses some crucial concerns.[4] As errors with using the system increase, so does the amount of litigation discussing whether those mistakes should be attributed to the system, or to the surgeon leading the system.[5] As a result, it appears that many are beginning to question if this new abundance of legal troubles, along with other issues revolving the system, are detrimental to the point where the da Vinci system is exceeding its worth.[6]
The da Vinci system itself is comprised of three essential structures: The Surgeon Console, the Patient Cart, and the Vision Cart.[7] The Surgeon Console is the part of the machine that the (human) surgeon controls, guiding the system to perform the functions that the surgeon desires.[8] The Patient Cart then constitutes several “arms” of the machine, that vary in functionality.[9] The main objectives of the arms are to facilitate the surgery by ensuring proper lighting, providing video footage to the surgeon, and holding the necessary surgical instruments that are to be piloted by the human surgeon.[10] Finally, the Vision Console provides the necessary equipment to assure that the surgeon is able to see the footage that is being recorded by the Patient Cart, on their respective Surgeon Console.[11]
The system is regularly being introduced to new hospitals, with the system often being referenced as a “breakthrough” in the medical field.[12] In the United states alone, over 3,000 of these systems have already integrated into various locations.[13] This choice ideology surrounding the da Vinci system finds a source in the benefits of using the da Vinci system in surgical procedures.[14] In short, the claimed benefits to a successful surgery using the da Vinci system include “surgeries . . . performed through smaller incisions, meaning faster healing and less blood loss,” with overall “a quicker return to normal daily activities.”[15] It is no surprise that a considerable amount of hospitals, doctors, and patients are opting to use the da Vinci system in their surgical procedures.[16]
But nothing comes without its imperfections. Since the creation of the da Vinci system in 2000, there have been several reports and lawsuits discussing the errors in procedures stemming from the system.[17] Several of these reports include reports filed by the founders, Intuitive Surgical themselves, in which they state there have been varying device malfunctions.[18] These errors have included incidents where the system’s arms being to spasm, and are thus contradicting the surgeon’s overall control.[19] Alongside these reports, there has been litigation including claims filed by patents who state they have been “burned or otherwise injured” in surgical procedures using the da Vinci system.[20] There have also been class actions filed by the shareholders of Surgical Intuitive, alleging that there were incorrect representations of the troubles the company was facing with the da Vinci System.[21]
To focus in on the litigation, a significant proportion of these legal issues specifically involve patients suing for complications in surgical procedures performed using the da Vinci system.[22] In one instance, Laurie Featherstone filed suit against both her doctors and Intuitive Surgical, when her ureter duct and colon were damaged in a hysterectomy performed using the da Vinci system.[23] These types of injuries have attorneys aruging all sorts of legal theories.[24] For instance, James Blumstein, a legal professor at Vanderbilt, poses the question: “if it’s a mechanical malfunction, would the professional standard of care apply to a robot?”[25] As the inclusion of such integrated technology in the surgical field is new, these types of developing concerns come in company with that inclusion.[26]
Subsequently, investigations are becoming more frequent, in order to find the source of these errors, and thus, the litigation circulating around those errors is also becoming more frequent.[27] There are several theories as to what is causing the rising trend in litigation surrounding the da Vinci system.[28] These theories begin by pondering if there is a lack of training for the medical professionals that are using the system.[29] This thought also contributes to another overarching theory that discusses the “gray area when it comes to assessing the difference between doctor and device error.”[30] Other theories merely dote on the idea that there are always unavoidable defects in any invention.[31] Some examples of the defects for the da Vinci system include defects that lead to issues in both spasming of the arms and leaks during procedures.[32]
Yet, we must remember that every problem has a solution. While these theories are seemingly overwhelming, each of them has a foreseeable fix. For example, the lack of training in using the da Vinci system can be solved by implementing a standard level of training before professionals can begin using Intuitive Surgical’s device.[33] As with the defect theory, any machine is bound to face a few defects here and there.[34] The simple solution here is to send the machines back to their original manufacturers for repairs, and also making sure to keep up to date with the latest software updates.[35] Finally, we discuss the legal claims that arise with these concerns, as they are the trickiest to tackle. However, these lawsuits are bound to decrease in number over time, as the issues surrounding the da Vinci system get solved.[36] Training standards and regular device inspections will unquestionably reduce those issues with the robotic system.[37] In turn, legal confusion over which party is to hold liable, alongside concerns over which parties should hold certain standards of care, will also diminish.[38] And while they may not diminish permanently, who is to say they should? As medical technology advances, robotic systems are bound to find a more permanent place in the healthcare field, and these legal concerns are sure to be encountered then.[39] Consequently, these concerns are better off being addressed now, rather than later.
Not only is the da Vinci system advancing the precision and accuracy of surgical techniques, but it is aiding the challenges that the healthcare field is currently facing.[40] As previously discussed, the benefits to using the da Vinci system (and similar robotic systems) come in multitudes.[41] Most importantly, a huge benefit of these systems is that they contribute to a faster healing time for patients after a surgical procedure.[42] This quality is sure to benefit healthcare in a major way, as one source estimates that the use of robotic surgical systems is expected to grow 10.5% between 2020 and 2030.[43] That same source states that “robotic surgical procedures will stand to outpace other procedure types.”[44] This will be crucial to quicker turnaround times for hospital stays, allowing for a greater influx of patients.[45] As previously discussed, the use of these systems in procedures also greatly assist the surgeons performing these surgeries in both dexterity and visual aspects. In combining these benefits, healthcare workers can plan on seeing major perks as consistent use of robotic systems is implemented into the healthcare field.[46]
As the use of the da Vinci system diffuses throughout the globe, it is safe to infer that the litigation surrounding this medical system will continue. Nonetheless, the da Vinci system is a revolutionary idea, even if it encounters a range of issues.[47] The leading question is whether those issues are worth the troubles it causes, such as errors that result in medical malpractice lawsuits .[48] In analyzing the statistics and consequences of frequenting the da Vinci system in the healthcare field, it seems that this device will bring a wide range of benefits.[49] We can expect great advances in the technology of the healthcare field, and while they may bring legal claims here and there, they are absolutely worth the trouble.[50]
[1] See Emily R. Siegel et al, The da Vinci Surgical Robot: A Medical Breakthrough With Risks for Patients, NBC News (Dec. 19, 2018, 6:59 PM), https://www.nbcnews.com/health/health-news/da-vinci-surgical-robot-medical-breakthrough-risks-patients-n949341.
[2] See id.
[3] See id.
[4] See id.
[5] See Kaiser Health News, Mishaps and Deaths Caused by Surgical Robots Going Underreported to FDA, PBS (Nov. 11, 2013, 11:31 AM) https://www.pbs.org/newshour/health/mishaps-and-deaths-caused-by-surgical-robots-going-underreported-to-fda.
[6] See id.
[7] About da Vinci Systems, Intuitive, https://www.intuitive.com/en-us/patients/da-vinci-robotic-surgery/about-the-systems (last visited Nov. 8, 2023, 11:43 PM)
[8] Id.
[9] About the da Vinci Surgical System, Roswell Park, https://www.roswellpark.org/cancer-care/treatments/robotics/about/da-vinci-surgical-system (last visited Nov. 8, 2023, 11:52 PM).
[10] What Surgeries Does the da Vinci Robot Do?, Advanced Womens Healthcare, https://www.awhcare.com/blog/908577-what-surgeries-does-the-da-vinci-robot-do/ (last visited Nov. 8, 2023, 11:53 PM);
[11] Intuitive, supra note 7.
[12] Siegel, supra note 1.
[13] Siegel, supra note 1.
[14] Kristen Compton, da Vinci Robotic Surgery Lawsuits, Drugwatch (Sep. 5, 2023) https://www.drugwatch.com/davinci-surgery/lawsuits/.
[15] Compton, supra note 14; Kim Evans, Q&A With a Surgeon: daVinci Surgical Robot, Tahoe Daily Trib. (Sep. 2, 2023) https://www.tahoedailytribune.com/news/qa-with-a-surgeon-davinci-surgical-robot/.
[16] See Compton, supra note 14; Evans, supra note 15.
[17] Compton, supra note 14.
[18] Siegel, supra note 1.
[19] Id.
[20] Id.
[21] Id.
[22] Id.
[23] Emily R. Siegel et al, The da Vinci Surgical Robot: A Medical Breakthrough with Risks for Patients, NBC News (Dec. 19, 2018, 6:59 PM), https://www.nbcnews.com/health/health-news/da-vinci-surgical-robot-medical-breakthrough-risks-patients-n949341.
[24] See Kaiser Health News, supra note 5.
[25] Id.
[26] See Siegel, supra note 1.
[27] See id.
[28] Ronald V. Miller, Jr., Surgical Checklist May Reduce Robotic Surgery Complications, Miller & Zois, LLC (June 6, 2013), https://www.lawsuit-information-center.com/surgical_checklist_may_reduce_1.html.
[29] See id.
[30] Kaiser Health News, supra note 5.
[31] See Siegel, supra note 1.
[32] Id.
[33] See Miller, supra note 28.
[34] See Siegel, supra note 1.
[35] See id.
[36] See id.
[37] See Miller, supra note 28; Siegel, supra note 1.
[38] See Kaiser Health News, supra note 5.
[39] See id.
[40]Nikki Thompson, Robotic Surgery Stands to Outpace all Other Procedure Types, Med. Device Network (May 24, 2023), https://www.medicaldevice-network.com/sponsored/robotic-surgery-stands-to-outpace-all-other-procedure-types/.
[41] Compton, supra note 14.
[42] See Compton, supra note 14.
[43] Thompson, supra note 40.
[44] Id.
[45] Thompson, supra note 40.
[46] See id.
[47] See Siegel, supra note 1.
[48] See id; Thompson, supra note 40.
[49] See Thompson, supra note 40.
[50] See id.’
Image Source: https://blog.sciencemuseum.org.uk/wp-content/uploads/2017/03/Robot-Surgery-e1488553792377.jpg