Medicolegal Issues in Robotic Surgery
The da Vinci® Surgical System is designed to improve minimally invasive surgeries by providing surgeons with enhanced precision and visualization and by enabling procedures that were otherwise considered too challenging without a robotic instrument. When expertly performed, these robotic minimally invasive procedures can help provide patients optimized recoveries when compared to traditional open surgeries. Robotic surgery, specifically with devices like the da Vinci® Surgical System, has seen rapid expansion and growth since the early 2000s. However, as the frequency of robotic procedures grows, so do complaints of system malfunctions and reports of patient injuries that may lead to lawsuits against stakeholders which include the device manufacturer, the hospital or institutions and their staff, as well as the surgeons and their associates. Each of these stakeholders involved in robotic surgery is responsible to uphold the highest level of training and care available to help a patient achieve a good outcome. This chapter aims to provide an overview of these stakeholder responsibilities, as well as to attempt to differentiate what each stakeholder is and is not responsible for when it comes to a legal complaint.
KeywordsRobotic surgery Adverse events MAUDE database Device malfunctions Operator errors Product liability Medical malpractice
- 4.Intuitive Surgical. Clinical evidence: level of evidence of peer-reviewed publications [Internet]. 2014 [cited 2018 Apr 28]; Available from: https://www.davincisurgerycommunity.com/evidence.
- 5.Herron DM, Marohn M, The SAGES-MIRA Robotic Surgery Consensus Group. A consensus document on robotic surgery [Internet]. 2007; Available from: https://www.sages.org/publications/guidelines/consensus-document-robotic-surgery/.
- 8.Reportlinker. Global surgical robotics market to reach $12.6 billion 2025 [Internet]. 2018 [cited 2018 Apr 28]; Available from: https://www.prnewswire.com/news-releases/global-surgical-robotics-market-to-reach-126-billion-2025-300587080.html.
- 9.Intuitive Surgical. Intuitive Surgical announces preliminary fourth quarter and full year 2017 results [Internet]. 2018 [cited 2018 Apr 24]; Available from: http://investor.intuitivesurgical.com/mobile.view?c=122359&v=203&d=1&id=2325993.
- 10.Greenberg H. Robotic surgery: growing sales, but growing concerns [Internet]. 2013 [cited 2018 Apr 27]; Available from: https://www.cnbc.com/id/100564517.
- 13.Justia. Taylor v. Intuitive Surgical Inc. (Majority and Dissent) [Internet]. 2017 [cited 2018 May 27]; Available from: https://law.justia.com/cases/washington/supreme-court/2017/92210-1.html.
- 14.Intuitive Surgical. Annual report 2017 [Internet]. 2018; Available from: http://phx.corporate-ir.net/phoenix.zhtml?c=122359&p=irol-sec.
- 17.Intuitive Surgical. Annual report 2004 [Internet]. 2005; Available from: http://www.annualreports.com/HostedData/AnnualReportArchive/i/NASDAQ_ISRG_2004.pdf.
- 18.FindLaw. Da Vinci robot surgery lawsuits [Internet]. 2017 [cited 2018 Apr 29]; Available from: https://injury.findlaw.com/product-liability/da-vinci-robot-surgery-lawsuits.html.
- 20.Rozbruch L. Litigation and robotic surgery: product liability or medical malpractice? [Internet]. 2018 [cited 2018 Apr 28]; Available from: https://www.pulj.org/the-roundtable/litigation-robotic-surgery-product-liability-or-medical-malpractice.
- 23.U.S. Food & Drug Administration. MAUDE – manufacturer and user facility device experience [Internet]. 2018 [cited 2018 May 10]; Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm#fn1.
- 24.U.S. Food & Drug Administration. Intuitive Surgical, Inc. 7/16/13 [Internet]. 2014 [cited 2018 May 10]; Available from: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm363260.htm.
- 25.Greenberg H. FDA: Intuitive Surgical failed to report warning [Internet]. 2013 [cited 2018 Apr 30]; Available from: https://www.cnbc.com/id/100843549.
- 26.Centers for Medicare & Medicaid Services. Open payments search tool [Internet]. 2018 [cited 2018 May 27]; Available from: https://openpaymentsdata.cms.gov.
- 28.Schiavone MB, Kuo EC, Naumann RW, et al. The commercialization of robotic surgery: unsubstantiated marketing of gynecologic surgery by hospitals. Am J Obstet Gynecol. 2012;207(174):e1–7.Google Scholar