Robotic urologic surgery: trends in litigation over the last decade

Abstract

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.