The legal and economic forces that will shape the international market for cybersurgery

Abstract

BACKGROUND: Despite the common use of medical devices most health care providers have little understanding how a device alters medical malpractice litigation. Such knowledge will be increasingly valuable as cybersurgery (i.e. remote robotic surgery) becomes routine. METHODS: Review of the laws governing products and telecommunication liability. RESULTS: Litigation after cybersurgery will be complex. In addition to being able to sue physicians and hospitals, patients who sustain an adverse outcome after cybersurgery will have the potential to sue the robotic manufacturer and telecommunication company. Robotics manufacturers can obtain virtual immunity from liability if they elected to place their devices on the market after obtaining [see text]360 per-market approval from the FDA. However, because [see text]360 pre-market approval is expensive and time consuming most medical devices on the market (including the robotic surgical instruments) do not have immunity to products liability. Consequently, after an adverse cybersurgical outcome a manufacturer of a robotic surgical instrument faces liability for failure to warn, design defects, and failure to properly manufacture. As for telecommunication providers, existing law provides them with immunity from liability. CONCLUSIONS: Litigation following cybersurgery will involve multiple defendants who are likely to use "finger pointing" defenses. Accordingly, there will be liability traps associated with providing cybersurgery.

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