Are Current Tort Liability Doctrines Adequate for Addressing Injury Caused by AI?

As capabilities of predictive algorithms improve, machine learning will become an important element of physician practice and patient care. Implementation of artificial intelligence (AI) raises complex legal questions regarding health care professionals' and technology manufacturers' liability, particularly if they cannot explain recommendations generated by AI technology. The limited literature on liability for innovation provides opportunities to consider possible implications of AI for medical malpractice and products liability and new legal solutions for addressing liability issues surrounding "black-box" medicine.

Robotic urologic surgery: trends in litigation over the last decade.

There is a lack of information regarding malpractice claims and indemnity payments associated with robotic cases in surgery. Malpractice claims and indemnity payouts will elucidate and mitigate harms of future adoption of new technology into surgery. We analyzed claims filed against Intuitive Surgical, Inc. from 2000 to 2017. A law librarian identified product liability claims from 2000 to 2017 with the defendant "Intuitive Surgical, Inc." using the Bloomberg Law database. We reviewed all available legal documents pertaining to identified claims, and extracted data points including filing date, surgery date, surgery type, robot type, instrument type, complications, and case outcomes. Since 2000, 123 claims were filed; 108 met criteria for inclusion. Gynecologic surgeries comprised the majority of claims (62%, 67 claims), followed by urologic surgeries (20%, 22 claims). Number of claims filed peaked in 2013 (30%, 32 claims) and then decreased each year, with 6% (7 claims) filed in 2016, and only 1% (1 claim) filed in 2017. Of the 22 claims regarding robotic urologic surgeries, 19 claims (86%) pertained to prostatectomy. Commonly alleged injuries in urologic cases were bowel injury (8 claims), erectile dysfunction (5 claims), bowel fistulas (4 claims), and incontinence (4 claims). Device failure was cited in only 2 claims. Early adopters of robotic surgery were at highest risk of litigation. This risk subsequently decreased despite the wide spread adoption of this technology. Almost all claims were secondary to surgical complications and not device failure, thus demonstrating a need for more systematic training for novel devices and early adopters.

Legal, regulatory, and ethical frameworks for development of standards in artificial intelligence (AI) and autonomous robotic surgery.

BACKGROUND: This paper aims to move the debate forward regarding the potential for artificial intelligence (AI) and autonomous robotic surgery with a particular focus on ethics, regulation and legal aspects (such as civil law, international law, tort law, liability, medical malpractice, privacy and product/device legislation, among other aspects). METHODS: We conducted an intensive literature search on current or emerging AI and autonomous technologies (eg, vehicles), military and medical technologies (eg, surgical robots), relevant frameworks and standards, cyber security/safety- and legal-systems worldwide. We provide a discussion on unique challenges for robotic surgery faced by proposals made for AI more generally (eg, Explainable AI) and machine learning more specifically (eg, black box), as well as recommendations for developing and improving relevant frameworks or standards. CONCLUSION: We classify responsibility into the following: (1) Accountability; (2) Liability; and (3) Culpability. All three aspects were addressed when discussing responsibility for AI and autonomous surgical robots, be these civil or military patients (however, these aspects may require revision in cases where robots become citizens). The component which produces the least clarity is Culpability, since it is unthinkable in the current state of technology. We envision that in the near future a surgical robot can learn and perform routine operative tasks that can then be supervised by a human surgeon. This represents a surgical parallel to autonomously driven vehicles. Here a human remains in the 'driving seat' as a 'doctor-in-the-loop' thereby safeguarding patients undergoing operations that are supported by surgical machines with autonomous capabilities.

What robot for tomorrow and what improvement can we expect?

PURPOSE OF REVIEW: The purpose of this review is to summarize the status of robotic surgery currently, contextualizing the advances and improvements we can expect in the immediate future. Robotics continues to demonstrate increased utility and expansion in medicine, particularly surgery. When coupled with the imminent expiry of Intuitive patents in the next few years, it is timely to consider what we can expect to see from new platforms; what new features might we anticipate and what technology will be available to enhance and improve patient care. RECENT FINDINGS: There really are no limits with the anticipated developments in the field of medical robotics. Multiple large companies and academic institutions continue to invest in design and production with the release of a number of platforms already having occurred, whereas others are to come in the near future. The main anticipated advances will be haptic feedback, decreased cost, improved theatre assimilation with open consoles permitting free communication and lower theatre footprint. The robot patient interface is to be enhanced with single port platforms in production with a better interface including haptic feedback. The addition of NOTES and smarter flexible robotics is the next key area of interest, whereas the introduction of technology with image guidance and networking where large data sets or connectivity permit increased clinical acumen to enhance decision making. SUMMARY: We are at the cusp of a tipping point as the intellectual property for the first major robotic system in surgery comes to an end. It is likely to be a period of great opportunity with enhanced surgery and patient outcomes through significant innovation, multiple platforms nearing dissemination, with various technological advances. We anticipate this will yield a great period of innovation and diversity. Will we see a truly automated robot soon; the Smart Tissue Autonomous Robots are the limit.

Medical malpractice and transoral robotic surgery: Evaluation and some preemptive thoughts.

Medical malpractice is costly and disruptive, and it is important to prevent. We conducted a study with the objective to look at medical malpractice in robotic surgery overall, to evaluate reasons for litigation, and to comment on possible strategies to avoid litigation with transoral robotic surgery. We used the Westlaw computerized database to identify all state and federal verdict summaries in medical malpractice cases. We found 17 cases alleging malpractice that involved the use of robotic surgery. In all, the plaintiffs in 6 cases (35%) contended that an open rather than a robotic approach should have been used, 5 (29%) alleged negligent credentialing, 4 (24%) alleged training deficiencies, 2 (12%) alleged manufacturing problems, and 1 (6%) charged that robotic surgery should have been performed instead of open surgery (1 case involved two of these allegations). In 11 cases (65%), plaintiffs charged that robotic surgery contributed to an undesirable outcome, and in 6 cases (35%) they raised concerns about informed consent. In all, only 5 of the 17 lawsuits (29%) resulted in plaintiff verdicts or settlements; damages ranged from $95,000 to $7.5 million. We believe the courts should not play a major role in establishing safety guidelines for the introduction of new technology such as robotic surgery. Instead, training and credentialing guidelines should be established by appropriate national associations and societies to assist hospitals in doing so.