Surgical robots have progressed from being new to being considered standard technology in medicine today. Learning to perform surgery through a virtual medium takes time. Learning how to coordinate one's fingers, hands and feet to control a robot's arms and “fingers” takes time. Robotic surgeons do not reach the cutting-edge of competency until performing enough procedures to learn the technique sufficiently well to have an acceptable complication rate, with each procedure having its own learning curve. To twist a phrase from the Wizard of Oz, patients need to know “Who is that man behind the robot?”

In Howard v. University of Medicine and Dentistry of New Jersey, 172 N.J. 537 (2002), the court considered whether a surgeon's misrepresentation of experience can affect the validity of the consent obtained and negate informed consent. The court noted that New Jersey law had never previously held that doctors have a duty to detail their background and experience as a part of the required informed consent disclosure. A physician's experience is generally not information that directly relates to the procedure itself or the known risks for complications and alternative treatments that must be disclosed. Although the court did not decide that question in Howard, it noted that a physician's misrepresentation of qualifications could be a basis for lack of informed consent. A physician's experience may be a material fact that a reasonably prudent person would want to know, if that actual level of experience has the capacity to directly increase the risk of harm from the procedure.

Misrepresented physician experience would have to significantly increase the risk of a procedure in order for it to affect the judgment of a reasonably prudent patient in an informed consent case. The court articulated a two-step proximate cause analysis for determining the facts under which a claim of lack of informed consent can be brought when physicians misrepresent qualifications: First, expert testimony must establish that the more limited experience or credentials could have substantially increased the patient's risk of harm; second, the substantially increased risk would could cause a reasonably prudent person not to consent to the surgery. Id. at 556-59.

Case law is sparse and is only starting to catch up with the new technology. There is only one decision discussing informed consent and a surgeon's experience in performing a robotic hysterectomy. See Forrest v. Bonifield, 2017 N.J. Super. Unpub. LEXIS 103 (Jan. 19, 2017). Defendants brought a motion on summary judgment to dismiss a claim for lack of informed consent in a case concerning injuries during a robotic surgery. The plaintiff alleged that the surgeon did not obtain her informed consent for the DaVinci robotic hysterectomy he performed, because he failed to disclose the increased risk of intra-operative injuries caused by his lack of experience doing the procedure. During the operation, she suffered a ureteral injury, which is a known complication of the procedure. However, the plaintiff learned during discovery that the surgeon had only done three such procedures at the time consent was obtained; that he had only done 10 such procedures by the time he operated on her; and that performing at least 20 procedures is required to obtain sufficient competence to be able to perform the surgery with an acceptable complication rate. These facts formed the basis for the lack of informed consent claim.

The first prong of the Howard proximate cause test was satisfied because plaintiff's expert surgeon established that more limited experience substantially increased the risk of injury:

Studies have clearly shown looking at robotic hysterectomies that it takes generally 20 procedures at least to attain a level of proficiency and to reduce your complication rates to what will ultimately be your standard, and even after that the more you do the more proficient I think you become at the procedure, but studies would indicate that it takes at least 20 procedures of a particular type of procedure to become proficient in that procedure.

Id. at 20. Of course, there is no hard data showing that this is true. Studies have not shown that “20 procedures” is the magic number but it is often suggested at surgical meetings and in articles. The time between operations has to be considered, as well as the type of operation, its complexity and variability. The plaintiff argued that, if she knew the increased risk caused by his inexperience she would have opted for a conventional abdominal hysterectomy rather than the robotic procedure. The court denied summary judgment finding that a reasonable jury could find on the issue of lack of informed consent, because the increased risk could cause a reasonably prudent patient to decline the robotic procedure. Id. at 28.

The privileging process for robotic surgery, and other new technologies, is an undefined path. Medical societies are struggling to set standards for credentialing surgeons and have refused to set a minimum number of required procedures to be performed because of the complexities described above. The Society of Thoracic Surgeons (STS) looked at the privileging process for new technological procedures, including robotic surgery. See Blackmon SH et al., The Society of Thoracic Surgeons Expert Consensus Statement: A Tool Kit to Assist Thoracic Surgeons Seeking Privileging to Use New Technology and Perform Advanced Procedures in General Thoracic Surgery. Am Thorac Surg 2016; 101:1230-7 (Elsevier 2016). The purpose of privileging is to ensure that surgeons provide high quality care in accordance with accepted standards of care and legal requirements. Unfortunately, there is no standardized process for credentialing robotic surgeons. Each hospital determines its own criteria for granting privileges, and this results in a wide variability in the competency of robotic surgeons. The patient does not know what criteria were used to grant privileges to her surgeon: this information is not a matter of public record. Although the hospital has a duty to terminate privileges once it is made aware of incompetence, that approach is “a day late and a dollar short.” A reasonable patient would want to know the surgeon's experience before consenting to a robotic procedure.

The STS refused to mandate strict criteria and felt that credentialing should not be based on the numbers of procedures performed but rather on evaluation of knowledge, skills and outcomes. Even though, Forrest, supra, suggested that the number of robotic procedures done by a surgeon correlates with competence, there is institutional resistance to doing so. Critics of using metrics for credentialing claim that the number of times a surgeon performs a robotic procedure, alone, does not tell enough of the story. A surgeon who has done two robotic procedures annually for 10 years does not have the same “skill readiness” as a surgeon who has done 10 robotic procedures a month for the last two months. While absolute numbers may be misleading, the frequency of procedures recently performed is a good indicator of the surgeon's proficiency as are their outcomes.

There are economic reasons why surgical societies, hospitals and out-patient facilities refuse to use metrics for privileging robotic surgeons. Robotic surgery is a major marketing tool and revenue source for medical centers. It attracts the best surgeons and patients who are looking for cutting-edge healthcare. Surgical robots are expensive, and hospitals need to make sure they get a sufficient return on investment. Supply-side demand creates extreme pressure on hospitals and societies to get as many surgeons using the robots as possible. This creates a direct conflict between the medical institution and patient safety. The only solution offered by STS is patient-centered transparency. The STS recommends that the surgeon give the patient information on the surgeon's training and experience to date as part of obtaining informed consent. Even with full transparency, most patients are not able to properly use this information when making informed consent decisions. Surgical societies and medical institutions need to do more to protect patients from the bleeding-edge surgeons, and they have. The American Association of Thoracic Surgery started a course four years ago to mandate credentialing pathways for trainees and for attendings. It has been very successful.

Measuring competence using a surgical robot can be done with precision. The robot is a computerized slave that faithfully translates the movements of the surgeon into actions of its operating arms. All the data is digital and recordable: the exact view of the surgical field during the operation is reviewable; each movement of the surgeon's fingers can be documented; each twist of each robotic arm is recordable; and the time to do standard tasks is measurable. A surgeon's performance can be measured against peers, as well as against her own past performance. Even though robotic surgery data allows assessment of a surgeon's technical skills better than ever before, it is not used to measure surgical competence. Yet, when robotic operations are performed by experts, the results can set new highs. One recent study by Cerfolio and colleagues (Long-term Survival of Robotic Lobectomy for Non-small Cell Lung Cancer; a Multi Institutional Study. J. Thorac. Cardiovasc. Surg. 2017, Sep. 18) showed some of the highest stage specific survival rates ever reported in over 1,300 patients with lung cancer who had robotic lobectomy. Moreover, these patients had some of the lowest complication rates ever reported.

Society and patients want improved care and outcomes through technological innovation to continue, and patients rely on their physicians' training and experience when seeking treatment. Honesty and transparency by surgeons about their experience when obtaining consent for new procedures are needed for informed decisions by patients and for new technologies to be realized.

Leone is co-founder and a partner in Britcher Leone, a law firm based in Glen Rock. Cerfolio is a professor in the Department of Cardiothoracic Surgery and a director of Clinical Thoracic Surgery at NYU Langone Lung Cancer Center.