Minimally invasive robotic-assisted surgery has increased in the last few years. In fact there is one specific surgical robot that has had a predominant position in this field, kind of a “monopoly”: the da Vinci, a master-slave system manufactured by Intuitive Surgical. Its practical application raises liability issues for hospitals using it.
The increase of the da Vinci surgical robot worldwide
As of March 31, 2019, 5,114 da Vinci robots were installed around the world: 3,283 of them in the United States, 893 in Europe, 661 in Asia, and 277 in the rest of the world.
Just to compare, we can see the following evolution on the installed base of da Vinci robots since the fourth quarter of 2018.
|September 30, 2018||March 31, 2019||Change|
|Overall installed base||4,814||5,114||▲ 300 (6,23%)|
|US||3,110||3,283||▲ 173 (5,56%)|
|Europe||821||893||▲ 72 (8,77%)|
|Asia||629||661||▲ 32 (5,09%)|
|Rest of the world||254||277||▲ 23 (9,06%)|
The first cases of liability reported in the United States: McCalla, Taylor and O’Brien
Along with the increase on the number of da Vinci installed in the last six months, in the U.S. there have been already cases involving the use of surgical robots (Taylor v. Intuitive Surgical or O’Brien v. Intuitive Surgical). In the most recent case, Taylor, the Supreme Court of Washington dealt with the appeal of the Taylor’s estate against the jury’s defense verdict and vacates it.
In summary, in Taylor v. Intuitive Surgical, the Supreme Court of Washington reminds a doctrine that is not provided in the Spanish legal framework: the learned intermediary doctrine, according to which the manufacturer may be free of liability if it proves that he fulfilled its information duties towards the hospital or the doctor, who is in a better position to inform the patient about the risks and benefits of the product. In this case, the Court found that such duties were not fulfilled at all by Intuitive Surgical, and that the applicable standard was one of strict liability, considering that the lower court erred to instructing the jury.
The search for potential solutions, aside of litigation: is personhood necessary?
Aside from what has been told previously, my research also encompasses an analysis on which solutions may be brought to our legal frameworks to solve such litigation in a more efficient way. Initially, the focus of analysis is the project, pending of further development by the EU Commission, on Civil Law Rules on Robotics which started back in 2016 by Mady Delvaux, a member of the European Parliament. In that proposal, among other solutions, the European Parliament proposed the creation of specific status for autonomous robots, a tertium genus between natural personhood and legal personhood: electronic personhood.
A critical analysis of this solution was presented in my paper, but my opinion was, and is, quite clear: granting personhood to autonomous robots is currently unnecessary, there are better potential solutions that may solve litigation involving autonomous robots. Also, granting personhood to robots as a way of making them potentially liable would require answering questions such as: can robots be owners of assets? May robots have rights? Shall robots pay taxes? Personhood is not only a prerequisite for liability but is a complex legal construct that requires further development, not limited to liability or accountability.
Regarding autonomous surgical robots, we are yet far (not much) from the point in which we shall ask ourselves: the da Vinci has been qualified as a master-slave surgical robot, so is the interaction between the surgeon and the robot necessary for the latter to work and function? But there are new initiatives of robots, such as the Smart Tissue Autonomous Robot (STAR), which level of autonomy is under dispute, some say that is robot with autonomous features, while others say that it is a semi-autonomous robot.
In my paper, I further analyze the necessity of such a solution, given that the proposal of the European Parliament linked personhood with liability, but disregarding other issues such as rights and obligations, assets, taxation, etc.
For this reason, in my paper, I propose that the solution of granting this tertium genus was not necessary, as well as too much fictional, but that efficient solutions shall be envisaged. Solutions that ease the path for potential claimants of liability in case of harms suffered while undergoing a surgical procedure with a robot like the da Vinci and, at the same time, preserve the procedural rights of those who produce the robots, and the hospital or medical team who used the robot.
One of the solutions is the creation of compensation funds specifically for harms caused in robotically assisted surgeries. There are examples of both medical (the Patienterstatningen in Denmark, or the patient compensation funds in several U.S. States) and non-medical funds (the U.S. 9/11 Fund and Superfund, among others); or even, the creation of a legally mandatory insurance scheme for manufacturers of robots.
So, in summary, my research is intended to develop a comprehensive frame of study of liability (not only civil but also administrative) of every potentially liable subject (the regulatory agency, the producer, the coder, the public or private hospital using the robot, etc.), and evaluate how a future case of liability for robots could be solved using the current legal framework in Spain (and, regarding product liability law, in the European Union), as well as providing with the pros and cons of every potential solution envisaged to solve such situations.
Tomás Gabriel García Micó (08.10.1992, Barcelona) is a practicing lawyer registered before the Barcelona Bar Association (Num 43,200). Since October 2018 he is taking the Ph.D. in Private Law at the Pompeu Fabra University (Barcelona, Spain) about “Surgical robots and tort law”. His dissertation deals with an area of special interest: whether law and new technologies are synchronized or not, and how a real case of harms caused by a surgical robot could be solved according to the current legal framework. Then, the solutions that have been proposed by legislators or the scholarship will be critically appraised, as well as, new potential solutions will be provided to promote a legal framework applicable to surgical robots. In doing this, it will be especially relevant to take into consideration the regulatory specificities, both at the EU and US level, for these robots. In September 2019, he will do one-month research stay at the China-EU School of Law (Beijing, China).
Published under licence CC BY-NC-ND.