Litigation & Robotic Surgery: Product Liability or Medical Malpractice?

By Libby Rozbruch 
Libby Rozbruch is a junior at the University of Pennsylvania studying Psychology. 

The rapid introduction of advanced technology in surgery has had a significant impact on clinical practice. With its growing application, the robotic surgery device has had to meet new demands of different types of surgery, and this transition has not been entirely trouble-free. Specifically, malfunction of the robotic device in surgery presents an issue regarding the complicated legal roles and responsibilities of the various involved parties.

​The principles of law that are binding upon professional liability in medicine are exactly the same for robotic surgery. The complexity of litigation associated with it stems from the difficulty of determining liability given that an integral part of a patient’s treatment is the use of a sophisticated medical device. [1] Therefore, in the case of an undesirable outcome, liability can fall on either the surgeon performing the surgery or on the manufacturer of the robotic device, or both. As a result, litigation associated with robotic surgery often combines medical malpractice law and products liability law, though the two are completely separate.[2]

The liability rule applied to malpractice cases is negligence. This means that a doctor’s breach of duty to practice the best standard of care based on customary practice must be a proximate cause of substantial injury to a patient. [3] A doctor is liable for all aspects of his or her own practice, including “indications for a diagnostic or therapeutic procedure, making comprehensive explanations to his [or her] patients, taking decisions and proceeding to actions, [and] to up-to-date instrumentation and maintenance of the highest level of competence through continuous education and training.” [4] If a doctor proves that he or she acted as a reasonably prudent person who performed a method or technique that is acceptable within the medical society, the adverse outcome will not be associated with malpractice. The problem is that robotic surgery is still in its infancy, making it hard to judge whether a certain method or technique is acceptable within the medical society and validated in clinical practice.

In robotic surgery, the doctor operating the device is still obligated to provide the best standard of care and thus has the responsibility to correctly use the instrument. If he or she incorrectly operates the device, then the patient must prove that the robotic malfunction risk would have been lower had the procedure been performed at a different hospital or with a different surgeon. [5] This alone would be difficult to prove since each robotic device, by nature, has a potential risk of malfunctioning. Therefore, it is especially important for doctors to take all reasonable precautions prior to and during robotic surgery given the inherent risk and uncertainty associated with the procedure.         

The Food and Drug Administration requires doctors who perform robotic surgery to have special training, experience, and high-quality assessment. This means they must have specific training in laparoscopic techniques and must be versatile with use of the robotic system. There also must be at least one other surgeon at the operating table who is equally as trained as the surgeon operating the device. Interestingly, the FDA requires the manufacturer of the device to provide surgeons with hands-on training courses and to adequately warn them about device hazards. [6]

This is where litigation starts to become complex, because patients can raise claims that a surgeon’s training provided by the manufacturer was not enough for him or her to operate the device and perform the surgery efficiently. Unfortunately, there is actually no consensus as to how much training is sufficient to accredit a surgeon to operate the robotic surgery device; each institution determines its own credentialing process. As a result, it is difficult to identify the distinct duties and responsibilities of the various parties involved.

Traditionally, hospitals and surgeons are seen as providing services rather than products, which is why they are typically not associated with product liability. When a doctor uses or implants a medical device during surgery, he or she is not held liable for product malfunction, as the device is often deemed incidental to the service provided by the doctor. [7] Doctors are nonetheless required to provide patients with very comprehensive information on the treatment itself, the risk associated with the treatment, and what will be done in the case of technical malfunction. [8]

As mentioned earlier, the manufacturer has the duty to provide warnings to consumers about the risks of their products, of which the doctors also inform their patients. If the manufacturer provides adequate educational instructions and warnings to the physician, then the Learned Intermediary (LI) doctrine “absolves the manufacturer from the obligation of providing further warning to the patient; and shifts the duty to warn patients about device hazards to the physician." [9] Thus, if a doctor fails to provide an adequate warning to the patient about the limitations and risks of the device, then he or she can be found liable for medical malpractice while the manufacturer would escape liability. Overall, litigation associated with robotic surgery is extremely complex due to the intermingled relationship between the manufacturer’s duty and the surgeon’s duty. [10]

​Robotic surgery technology undoubtedly has and has had a significant impact on surgical practice. Nevertheless, its widespread use presents a challenge for the legal system in addressing unprecedented and complex claims under the existing system of liability and regulation. On the one hand, manufacturers should not be discouraged from developing innovative technology, especially because the robotic surgery device has been used in a large number of cases without any problems. On the other hand, manufacturers and doctors using the device have a responsibility to undertake all reasonable means of minimizing the risks associated with its technology. In practice, the legal standards associated with robotic surgery have combined products liability and medical malpractice law to cope with this unique area of conflict, but this is not entirely uncomplicated. This is just one example of how many different fields are now facing the issue of having to adapt to advancing society in an unprecedented way.

[1] McLean, T. R. “The complexity of litigation associated with robotic surgery and cybersurgery.” The International Journal of Medical Robotics Assisted Surgery, February 23, 2007. Accessed February 23, 2018. http://onlinelibrary.wiley.com/resolve/doi?DOI=10.1002/rcs.121
[2] Ibid.
[3] Mavroforou, A; Michalodimitrakis, E; Hatzitheofilou, C; Giannoukas, A. “Legal and ethical issues in robotic surgery.” International Angiology, Feb 2010. Accessed February 23, 2018. https://www.minervamedica.it/en/journals/international-angiology/article.php?cod=R34Y2010N01A0075
[4] Ibid.
[5] Ferrarese, Alessia, Giada Pozzi, Felice Borghi, et al. “Malfunctions of robotic system in surgery: role and responsibility of surgeon in legal point of view.” Open Medicine, August 2, 2016. Accessed February 23, 2018. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5329842/pdf/med-2016-0055.pdf
[6] Ibid.
[7] Saceanu SM, Angelescu C, Valeriu S, Patrascu A. “Telesurgery and Robotic Surgery: Ethical and Legal Aspect.” Journal of Community Medicine & Health Education, July 7, 2015. Accessed February 23, 2018. https://www.omicsonline.org/open-access/telesurgery-and-robotic-surgery-ethical-and-legal-aspect-2376-0214-1000355.php?aid=54752
[8] Ibid.
[9] Ibid.
[10] Ibid.
Photo Credit: https://www.law.com/njlawjournal/sites/njlawjournal/2018/01/15/surgical-robots-are-all-the-same-but-robotic-surgeons-arent/?slreturn=20180123121127

The opinions and views expressed through this publication are the opinions of the designated authors and do not reflect the opinions or views of the Penn Undergraduate Law Journal, our staff, or our clients.