Analysis of 59 ERCP lawsuits; mainly about indications

Background: This study reports the analysis of a personal series of 59 cases in which ERCP malpractice was alleged. Methods: Half of the cases involved pancreatitis; 16 suffered perforation after sphincterotomy (8 of which involved pre-cutting), and 10 had severe biliary infection. There were 2 esophageal perforations. Fifteen of the patients died. The most common allegation (54% of cases) was that the ERCP, or the therapeutic procedure, was not indicated. Most of these patients had pain only, usually after cholecystectomy, Negligent performance was alleged in 19 cases, with corroborating evidence in 8. Inadequate postprocedure care was alleged in 5 cases, including 3 with a delayed diagnosis of perforation. Disputes about the extent of the education and consent process were common. Results: The final outcome was available in 40 cases. Sixteen were withdrawn, and 14 were settled. Of the 10 that came to trial, half were defense verdicts. Conclusions: The lessons are clear. ERCP should be done for good indications, by trained endoscopists with standard techniques, with good documented patient informed consent and communication before and after the procedure. Speculative ERCP, sphincterotomy, and pre-cuts are high-risk for patients and for practitioners.