Medico-legal aspects of bile duct injury

Gall stone disease is common all over the world; gall stones are very common in northern India. Cholecystectomy, open or laparoscopic, is one of the commonest operations performed by a general, gastrointestinal/hepatobiliary (GI/HPB) or laparoscopic surgeon. It is now well-established that laparoscopic cholecystectomy is associated with a two to three times higher (about 0.5%) risk of bile duct injury (BDI) than open cholecystectomy. BDI can cause severe morbidity and even mortality; moreover, BDI during cholecystectomy is a common cause of medico-legal suits filed by the patient against the surgeon.

An average of 50,000 cholecystectomies is performed in the UK every year. Between 1995 and 2008, a total of 300 claims were filed — an incidence of 0.4 per 1,000 cholecystectomies.[1] The National Health Service (NHS) Litigation Authority's data on clinical negligence over 15 years between 1995 and 2009 revealed 418 claims — an incidence of 0.6 per 1,000 cholecystectomies.[2] The incidence increased to 0.7 per 1,000 between 2000 and 2005 when 208 claims were filed.[3] The incidence of BDI-related litigation after laparoscopic cholecystectomy was higher, 0.8 per 1,000 in the Netherlands.[4] In contrast, Kern[5] found only 49 litigation cases over 20 years between 1970 and 1991 in the USA during the open cholecystectomy era.

BDI is the most frequent complication of cholecystectomy resulting in a claim.[2] BDI was responsible for 27 (61%) out of 44 litigations in one report.[6] BDI accounted for 72% of 208 claims in the NHS Litigation Authority between 2000 and 2005.[3] Common bile duct (CBD) injury (41%) and bile leak (12%) were the commonest causes of malpractice litigation in the UK.[1] The severity of BDI is also related to the chances of claims being filed — one-third of the patients with a major BDI are likely to resort to litigation.[7] Complete transection of the CBD was the only independent predicting factor for starting a claim procedure.[8] Delay in recognition of post cholecystectomy complications is one of the most common causes of a claim. In 46 cases of BDI involving malpractice litigation, 80% of the injuries were not detected at the time of cholecystectomy; the average delay in diagnosis was 10 days.[9] In another report, BDI was missed during cholecystectomy in 86% of cases involving litigation.[10] The files of 23 legal cases with BDI that were referred by the Turkish courts to the Istanbul Forensic Medicine Institute for expert opinion were analysed — late recognition of injury and late transfer of patient (to a higher centre) was found in 20 (45%) files.[11] Immediate non-specialist repair is also an independent predictor for possible litigation.[12] In Germany, four out of 44 cases where BDI was recognized intraoperatively and immediate repair was performed by a biliary surgeon were not considered as malpractice.[13]

Poor communication of the adverse event (BDI) to the patient/relatives may also be responsible for litigation. Insufficient information to the patient/relatives was considered as malpractice in one case in Germany.[13] Barrios et al.[14] conducted a very interesting study; general surgery residents were asked to perform mock laparoscopic cholecystectomy on a surgical simulation device — half were presented with a BDI and half with an incidental finding of metastatic gall bladder cancer. They were then asked to disclose the event to a sculpted family member. It was found that they were ill-prepared to deliver the bad news — disclosing iatrogenic BDI was found to be more challenging than disclosing an incidental finding of cancer. This was a mock scenario; the results are likely to be worse in real life scenarios where emotions of ego, guilt, fear, and worry are involved.

Medical (surgical) experts should be called to assist the lay jury;[15] de Reuver et al.[16] conducted an interesting study — 13 experts were asked to review 10 closed cases of litigation for BDI after cholecystectomy. Full agreement among the experts was observed in only one case; in seven out of 10 cases, only half of the experts agreed. As many as eight out of 13 experts suggested that more than one expert should be asked to review and comment on a litigation case. Fellmer et al.[17] observed that as laparoscopic cholecystectomy is becoming more popular and acceptable, more and more expert witnesses are judging a BDI to be predominantly inherent in the procedure itself.

BDI is the most common complication of cholecystectomy resulting in a successful claim.[2] As many as 40 (86%) out of 46 BDI-related malpractice litigations in the USA were resolved in favour of the plaintiff either by an out-of-the-court settlement or by a court verdict.[9] In the UK too, CBD injury accounted for the highest proportion (86%) of successful claims;[1] in another report from the UK, 198 (65%) out of 303 settled claims were decided in favour of the claimant.[2] In Germany, seven out of 26 cases of BDI were judged as malpractice;[18] another report from Germany reported medical malpractice in 25 (57%) out of 44 cases.[13] The acceptance of liability rate in the Dutch arbitration system was, however, lower — only 16 (18%) out of 88 closed cases were accepted; an additional 11 cases were settled out of court and 61 were rejected.[4]

In the USA, 21 out of 44 cases were settled out of court with mean payment of US$469,711; four out of 23 cases proceeding to trial were decided in favour of the plaintiff with a mean payment of US$188,772.[6] The average award in another report from the USA was US$214,000.[9] The average payment for a successful claim in the UK was British Pound (GBP) 102,827 (US$168,387);[2] average compensation in another report from the UK was in the range of GBP 40,000-90,000.[12] Median compensation in the Dutch arbitration system was much lower at €9,826 (US$11,000 approximately); delay in imaging, delay in diagnosis and reoperation with repair in the same hospital where cholecystectomy was performed were, however, associated with higher compensation.[4]

In the Netherlands, there are multiple tiers of redressal — hospital complaints committee, medical disciplinary board and the court of law. An article from the Netherlands[19] debates as to whether a no-fault compensation system for all BDIs will be better than compensation based on proof of negligence. The author (VKK) does not favour a no-fault compensation system but certainly is in favour of a BDI insurance (’chole beema’) for every patient undergoing cholecystectomy with premium to be paid by the patient as well as surgeon. The extent of the premium to be paid by the patient could be based on the presence or absence of factors predicting difficulty of cholecystectomy, e.g., old age, male gender, long duration of symptoms, attacks of acute cholecystitis or acute pancreatitis, presence of common bile duct stones, prior endoscopic stenting, and thick-walled gall bladder on ultrasonography. Part of the premium to be paid by the surgeon could be decided by the level of training, accreditation and certification of the surgeon, experience (number of years), volume (number of cholecystectomies every year) and results (BDIs caused) of cholecystectomy.

In India, the Consumer Protection Act 1986 lays down the rights of consumers for promotion and protection of their rights and enables them to secure inexpensive and often speedy redressal of their grievances against manufacturers of goods and providers of services including medical treatment. Under the provisions of the Act, District Forums and State Commissions with the National Consumer Disputes Redressal Commission (NCDRC) at the apex have been set up as quasi-judicial bodies. A District Forum is headed by a person who is or has been a District Judge and a State Commission is headed by a person who is or has been a High Court Judge; the NCDRC is headed by a sitting or retired Supreme Court Judge. Complaints for pecuniary value of up to 2 million are filed before the District Forum, for a value of up to 10 million before the State Commission and for a value above 10 million before the NCDRC.

A BDI does increase the financial burden on the patient and his/her family — the median total (direct and indirect) costs of management of a BDI in a paying but subsidized government hospital, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) Lucknow, Uttar Pradesh, India, was 93,046 (22,204-562,790), which was 10 times the median cost of laparoscopic cholecystectomy (9,328) at the same hospital and 8.4 times the median monthly income of the patient's family (11,057).[20] A random search of NCDRC judgments using the term cholecystectomy revealed cases with BDI where compensation of up to 1 million has been awarded.

A structured written consent form detailing all common and significant complications including BDI,[21] lower threshold for conversion in case of a difficult cholecystectomy,[10] proper documentation of operative findings and procedure, a high index of suspicion and low threshold for investigation of a bile leak after cholecystectomy, open and honest communication with the patient/relatives and timely referral of a BDI to a biliary centre with a detailed referral note can prevent/reduce the risk of a medico-legal suit being filed, and even if filed, being decided in the patient's favour.

All surgeons performing cholecystectomy must, in any case, take an adequate indemnity insurance policy even though the high premium may initially appear to be an unnecessary and wasteful annual expenditure.

BDI may be considered by the surgeons to be a complication of cholecystectomy the procedure; most patients may accept it as an accident but some may allege it to be an error on the part of the surgeon and take recourse to legal remedy. The court of law or the NCDRC may, however, decide it to be negligence on the part of the surgeon and award compensation to the patient, more so if there is a delay in diagnosis or if the management is inappropriate (including an attempt to repair by a non-specialist surgeon or even late referral to a biliary centre).

Injury to the bile duct is an accident;
to miss the bile duct injury is a mistake;
to mismanage the injury is negligence.