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The introduction of laparoscopic cholecystectomy (LC) in the U.S. as a viable and indeed the preferred alternative to the "gold standard" open cholecystectomy (OC) has brought forth a new sphere of medical negligence litigation.

By far the most common source of these claims is related to injuries of the extrahepatic (outside of the liver) biliary tree, the common hepatic duct (CHD) and the common bile duct (CBD). These injuries include excision, division, narrowing and occlusion of these structures.

Generations of surgeons performing biliary tract surgery (removal of gallbladder, common bile duct explorations, etc.) have known very well that significant injury to either one of these structures (CHD, CBD) may, and frequently does, represent a very serious complication. These injuries often require frequent reoperation or necessitate the use of various other invasive techniques to repair them and are thus a source of significant morbidity and on occasion mortality, not to mention the very great monetary expense to both patient, hospital and insurance companies. These patients frequently experience significant time away from work, loss of income, loss of employment. Also on occasion they may develop long-term medical problems related to these injuries. Two of the most serious medical problems being liver damage and the possibility of narrowing (stricture) of the repaired bile duct, especially if the injury is not managed correctly the first time. (See below.)

Due to this, it is obvious that the incidence of malpractice claims related to this problem and associated complications are very significant.

The incidence of bile duct injury associated with laparoscopic cholecystectomy is reported to be twice that of open cholecystectomy (0-0.4% for OC and 0-0.7% for LC). As experience with laparoscopic cholecystectomy increases it is the impression of many authors that the incidence of common duct injuries associated with this technique is going down. Other experts dispute this and feel that the incidence of complications is still higher with the laparoscopic technique and in fact shows no signs of decreasing.

Because complications related to either technique are so serious and because the incidence is almost certainly higher with the laparoscopic technique than with the open technique. The potential for litigation related to this problem (especially for the laparoscopic technique) is a very real concern to the surgeon, patient and insurance carriers.

As with all medical negligence claims associated with complications (surgical or otherwise) the issue is "are these complications examples of self-evident negligence?" I would submit that in the cases of ductal injuries by either technique the answer is frequently no. Common duct (CBD or CHD) injury is an "acknowledged complication" of gallbladder and biliary tract surgery whether it is the open technique (OC) or the closed technique (LC).

The consensus of opinion seems to be that what does constitute negligence in this clinical setting is the management of these complications once they have been recognized. If they are recognized at the time of the initial surgery and depending on the nature of the injury it may be appropriate for the initial operating surgeon to repair it then and there. Otherwise, transfer of the patient (following an initial period of stabilization) to a referral center that has experience with repair of these ductal injuries is frequently necessary and indeed is within the best interest of the patient. To be emphasized is the fact that since the introduction of laparoscopic cholecystectomy these injuries seem to be more frequent and referrals to specialized centers for the management of these problems have risen dramatically.

The correct treatment of these injuries by surgeons experienced with this problem will ensure a successful long-term outcome of this reparative surgery in over 90% of these patients. On the other hand, attempted correction of this very serious problem by the initial operating surgeon who probably has limited or no experience with this situation has been associated with a very high failure rate (over 50% in most series) and repeated hospitalizations, operations, etc. have thus been necessary.

In summary, injury to the extrahepatic biliary tract is a very serious problem and is almost certainly more common in the new era of the laparoscopic approach to removal of the gallbladder. Injury to these ductal structures is an acknowledged complication and does not necessarily represent medical negligence. In my opinion what does constitute medical negligence in many of these cases is the inappropriate treatment of these injuries once they are recognized.

* The above work by Herbert Rubin, M.D. was provided by the Technical Assistance Bureau.