Surgical Robots: Are Batteries Included?
With robotic surgery now capable of being performed on a patient in one part of the world, by a surgeon on the other side of the world, this creates its own legal issues, particularly in relation to common law negligence and battery, informed consent, and product liability.

 

One of the main ideas behind digitalisation is the dissolution of the dividing line which bifurcates the real world from the online world. Technologies such as 5G, Internet of Things, Augmented Reality (AR) and Virtual Reality (VR) allows the digital realm to bleed into the physical world, and visa versa. With the ability to now undertake activities in the digital world which were once only possible in the physical world, we must ask ourselves, are our laws capable of dealing with the melding of these two realms. A prime example of this is remote robotic surgery, where, using technologies such as 5G, AR and VR a surgeon on one side of the world can operate on a patient at the other side of the world. 

Remote Robotic Surgery

In 2019, with the use of surgical robots and 5G technology, 12 patients in six hospitals in six different cities in China had an orthopaedic spinal surgery performed on them. The patient was anaesthetised, and then three-dimensional images of the patient were obtained by a motorised robotic arm. The images were then transmitted to the master control room in Beijing Jishuitan Hospital Remote Surgery Centre. From Jishuitan Hospital, the surgeon could control the surgical robot remotely and insert orthopaedic screws into the patients' spines. Advances in robotics technologies, minimal latency, high bandwidth and reliable communication have enabled such surgical developments.  

Surgical Robots: Are Batteries Included?

Battery in the law of torts can be defined generally as wrongful or harmful unwanted physical contact on another.  It protects people against contact which they have not consented to. It is part of the broader category of trespass to the person, which includes assault.  Any medical procedure could be held to be  a battery unless there is  written or oral consent or other lawful reason, such as an emergency where the patient is unconscious. 

The onus of showing that consent has been provided rests with the doctor. O'Leary v HSE and ors [2016] IECA 25 established that even where it was alleged that informed consent had not been provided (and thus it was alleged that the procedure was a battery) as there was no evidence that the patient would not have consented if such a warning was given then the case must fail on a causation point.  

Proceedings arising out of a failure to provide informed consent are not usually based on the tort of battery but rather arise under the tort of negligence. A failure to ensure that proper and adequate warnings are given as to all material  risks involved with a surgical procedure or other intervention, could give rise to an action in negligence. In Geoghegan v Harris [2000] 3 I.R. 536 , Kearns J pointed out that the requirement was to give a warning of any material risk that was a "known complication". He said that mere coincidental and unrelated risks, for example, could not properly fall within the compass of any duty, any more than consequences that might flow from a practitioner’s negligence. Kearns J continued that it is the court that ultimately decides what is material. ‘Materiality’ includes consideration of both (a) the severity of the consequences and (b) the statistical frequency of the risk.

Where robotic surgery gets legally complex is, if a surgeon in New York is operating on a patient in Paris, and there was a slip of a scalpel which nicked an artery, causing significant medical complications, is the surgeon causing harmful physical contact on the patient, despite the distance of some 6,000 kilometres? This issue will become more prevalent as virtual reality and metaverse technology become  more popular. 

The issue becomes more complicated if the matter is considered from a medical negligence perspective. Was the errant scalpel a result of the human surgeon's negligence in operating the robotic surgeon control system, or was it a product liability defect that caused the machine to misinterpret the surgeon's inputs? We have all experienced a video call dropping due to connection issues – but what if those connection issues were quite literally a matter of life and death? Is the surgeon liable for a connection dropping, the hospital, the robot manufacturer, or even the telecoms provider?

In terms of the liability of manufacturers of robotic surgical devices, cases concerning the technology have been instituted already. One lawsuit in the USA against a robotic surgical system manufacturer involved a woman who died after a hysterectomy. The family claimed that a product defect allowed an electric current to jump to healthy tissue and cause burns. 

Conclusion

The development of remote surgery and the advent of the Metaverse and other frontier technologies are putting a strain on traditional legal frameworks. With the common law tort of battery requiring "contact", it is not clear if new forms of contact facilitated by technology will be captured by existing law, or if new legislation  is necessary for the new virtual world. It is also possible in common law systems that the courts will provide a solution to this issue, by either confirming, that this situation could constitute a battery, or by broadening the definition of battery. 

This will be an issue that manufacturers of medical devices will need to consider from a liability perspective as technology moves increasingly into digital and virtual formats. 

 

 

Key Contacts

Barry Scannell Consultant

Mary Cooney Partner

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