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Practice Management

Lessons Learned from a Medical Malpractice Lawsuit: Laparoscopic Cholecystectomy Complication

Ross F. Goldberg, MD, FACS, and David L. Feldman, MD, MBA, CPE, FAAPL, FACS

A patient over 50 years of age with known gallstones underwent a laparoscopic cholecystectomy. The surgeon noted dense adhesions to the gallbladder, and dissection was encumbered by bogginess of the gallbladder. Also noted was a small posterior secondary duct that was clipped in the course of dissection. complications were noted. According to the operating surgeon, the surgery was “uneventful.” Later, the surgeon testified that the critical view of safety with identification of the common bile duct was achieved—although there was no mention of it in the operative report and the surgeon said it was customary to note it only if the critical view could not be achieved.

The patient left the hospital the next day. The surgeon’s office staff tried unsuccessfully to reach the patient at home later that day. This attempt at contact was not noted in the patient’s record. The patient described calling the office the next morning and telling the surgeon about having dark-colored urine and itching of the abdominal wall. The surgeon told the patient that because some bile had passed through the system, the patient would “pee it out” and not worry about it. No notes in the surgeon’s chart documented this call.

The patient came to the office one week later complaining of nausea and bright yellow urine. The surgeon’s impression was “possible ductal problem/obstruction.” Labs were ordered and the bilirubin was 9.9 mg/dL. The next day the patient was seen in the office by a nurse practitioner (NP), who ordered a magnetic resonance cholangiopancreatography (MRCP). The surgeon saw the lab results and called the patient, noting that the patient “sounded upset.” The MRCP was done the following day. The results showed dilated bile ducts with an abrupt change in caliber, suggesting stricture or stone and the need for an endoscopic retrograde cholangiopancreatography (ERCP). Later that day, the patient was seen by the NP in the surgeon’s office. The NP noted jaundice and dark urine and referred the patient to a gastroenterologist for an ERCP. The surgeon stated that this information was not passed along by the NP or the patient.

The patient underwent an ERCP 2 days later, but the gastroenterologist was unable to cannulate the common bile duct and could not perform a cholangiogram due to what was noted as a “misplaced surgical clip.” The patient was referred to an interventional radiologist. The patient was admitted overnight and complained of pain and nausea. Labs showed a bilirubin of 13.5 mg/dL and WBC of 16,400. Liver enzymes were elevated.

An interventional radiologist placed a transhepatic biliary drain. The patient subsequently had a complicated course due to an occluded bile duct, necrotizing pancreatitis, and sepsis and ultimately underwent corrective surgery by another surgeon in which a transected common bile duct was noted and reconstructed. After that operation, the patient fully recovered.

Experts were critical about not mentioning the critical view in the operative note and not performing an intraoperative cholangiogram in the event of any uncertainty. Other experts thought the common bile duct injury was a known complication and that the patient had an atypical gallbladder duct configuration. They felt it was likely that the pancreatitis was due to the failed ERCP and not to the common bile duct injury.

The lawsuit went to trial, and the jury returned a verdict in favor of the plaintiff.

“Three P” Analysis

The “Three Ps” refer to “prevent, preclude, and prevail"—the three key elements to reduce practitioner risk related to malpractice litigation.1

Prevent Adverse Events

  • When dissecting the cystic structures during a laparoscopic cholecystectomy, all efforts should be made to identify and confirm the anatomy prior to clipping or dividing any structures.
  • It is suggested that surgeons use the critical view of safety (CVS) for anatomic identification of the cystic duct and artery during a laparoscopic cholecystectomy.2
  • The three elements of the CVS are: (1) the hepatocystic triangle is cleared of fat and fibrous tissue; (2) the lower one-third of the gallbladder is separated from the liver to expose the cystic plate; and (3) two, and only two, structures should be seen entering the gallbladder—the cystic duct and cystic artery. Also, the CVS should be described in the operative report.3
  • When the CVS cannot be achieved and the biliary anatomy cannot be clearly defined by other methods (like imaging), consider options such as subtotal cholecystectomy over total cholecystectomy.4

Preclude a Malpractice Case Despite an Adverse Event

  • It is imperative to clearly document the steps of an operation and define terms (such as CVS). The rationale for why certain actions were taken should also be part of the operative report.
  • While it is common for surgeons to collaborate with advanced practice clinicians (APCs), it is critical that any unexpected outcomes be addressed directly by the surgeon or in close collaboration with the APC. Be honest and direct with the patient, acknowledge the complication, and either actively monitor it or treat it. Never ignore the complication and hope that the patient does not bring it up.
  • Conflicting information—either from different healthcare practitioners or from the same individual at different times—can be extremely confusing and distressing for the patient. Giving the patient conflicting information erodes trust and raises questions of intent, integrity, and competence. It can also increase the likelihood of a complaint or suit.

Prevail in Lawsuits When a Claim Is Made

  • This case example included many opportunities to improve documentation—from the operative report to the communication between the surgeon and patient and the decision-making process regarding the most appropriate treatment for this patient’s postoperative complications. It is essential to clearly document the events and thought processes before, during, and after a procedure. Taking these steps can increase your chance of success in a malpractice lawsuit.

Disclaimer

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

References

  1. Feldman DL. Prevent, communicate, document: Medical malpractice data help us manage risk. The Doctor’s Advocate. Available at: https://www.thedoctors.com/the-doctors-advocate/second-quarter-2021/prevent-communicate-document-medical-malpractice-data-help-us-manage-risk/
  2. Brunt LM, Deziel DJ, Telem DA, et al. Safe cholecystectomy multi-society practice guideline and state of the art consensus conference on prevention of bile duct injury during cholecystectomy. Surg Endosc. 2020 Jul;34(7):2827-2855.
  3. Conrad C, Wakabayashi G, Asbun HJ, et al. IRCAD recommendation on safe laparoscopic cholecystectomy. J Hepatobiliary Pancreat Sci. 2017 Nov;24(11):603-615.
  4. Brunt LM, Deziel DJ, Telem DA, et al. Safe cholecystectomy multi-society practice guideline and state of the art consensus conference on prevention of bile duct injury during cholecystectomy. Surg Endosc. 2020 Jul;34(7):2827-2855.