Blog Economie Numérique - Robotic surgery on trial : Between surgeon and machine, who bears legal responsibility ?

Robotic surgery has developed into one of the most innovative advancements in modern medicine, providing a level of precision never before accessible in surgery, creating large benefits for the patients and physicians alike. However, the advent of robotics and artificial intelligence in the operating room brings complex legal issues : when something goes wrong, or an incident or error results in death, who is liable ? Is it the robot that is at fault, the surgeon, the hospital, or the manufacturer ?

Overview of medical robotics

Medical robots, like the widely recognized Da Vinci system or Rosa robot, were created to support surgeons and improve accuracy of surgical gestures in particular complex or minimally invasive surgeries. These robots are naturally able to minimize incision size and decrease fatigue among human surgical assistants, which typically results in faster recovery and lower complication rates for patients. However, robotic surgical systems require additional training and create new organizational and safety demands for healthcare organizations in order to be used properly.

Integration of robots in the operating room

The increasing use of robotics in medicine goes well beyond urology to include cardiovascular surgery, neurosurgery, and pediatrics. This technology has slowly but surely changed the role of healthcare providers (surgeons) in hospitals, giving them the ability to « robotically » perform some parts of surgery by directing a mechanical arm from a control console. For these positions, the question remains whether the robot is merely a « better tool » or if, because of its autonomy, it also expands the chain of responsibility.

Foundations of traditional medical liability

In traditional medical legislation, legal liability rests on the fault of the healthcare provider. An act that harms a patient gives rise to civil liability, and in some cases even criminal liability, for the healthcare provider, unless the healthcare provider shows absence of fault or demonstrates that the act was a risk of treatment that cannot be avoided. Liability can be joint, particularly with the healthcare organization or with national compensation entities for medical accidents.

Intersection of robotics and liability

The law views the robot in medical procedures as merely another instrument that the surgeon employs, similar to a scalpel or other tools used to deliver care. In theory, the same standards for criminal and civil liability apply if harm occurs through the use of the robot, including in robotic-assisted procedures. The surgeon must remain actively engaged during the robotic procedure, calibrate the robot, and interpret the data generated by the robot.

Fault is no longer exclusively human; if the robot is damaged, malfunctioning, or being operated incorrectly, it can cause injury. In such cases, the fault lies in the product defect or malfunction, which can lead to liability for the manufacturer or supplier of the robot, in addition to or instead of the practitioner’s liability, if it can be shown that the defect existed.

Case law and landmark cases

Multiple instances have already demonstrated the ongoing uncertainties present. For instance, in 2013, the death of a patient after a robotic ablation procedure at a clinic in France resulted in a complex legal case involving the surgeon, the clinic, and the national compensation authority. The courts ruled shared responsibility, holding the compensation authority liable for the medical accident while not completely absolving the professionals involved. The judges notably stressed that while technology is evolving rapidly, this does not negate or diminish the essential responsibility of the care provider, and new standards are not free, whether managed by existing or new care organizations.

What if the robot operated independently ?

The prospect of a fully autonomous robot operating without direct human supervision presents an unparalleled challenge. If the robot were to cause a severe incident, existing law would likely still focus on identifying human fault upstream, such as a calibration defect, lack of maintenance, or a poor decision to delegate an important task to a robot. Nevertheless, some legal scholars argue for the development of an « adapted » legal liability framework, or even a specific legal status for medical robots. Currently, a victim could hold the surgeon accountable, the facility employing the surgeon, or possibly the robot’s manufacturer, but not the robot itself.

When humans operate with robotic assistance

In the majority of current scenarios, humans retain procedural autonomy: robotics is used to enhance human capabilities rather than fully replace them. If something goes horribly wrong or serious harm occurs, the responsibility of the human practitioners will be evaluated first. However, the involvement of robotics or machines may complicate the assessment of potential faults.

A Framework Requiring Clarification

Medical robotics will revolutionize the execution of surgical gestures, but a natural consequence is a more complex liability landscape for both legislation and the courts. Although surgeons remain primarily responsible, the increasing technological complexity calls for legal clarification and uniformity to benefit patients and eliminate grey areas in compensation for damages.

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