Professor Graeme Poston
Professor of Surgery, University of Liverpool
Consultant Hepatobiliary Surgeon, Aintree University Hospital, Liverpool
The Respondent was diagnosed in 2005 as suffering from a symptomatic gallstone in her gallbladder and was referred to the Appellant, a consultant general and vascular surgeon, who advised her that she would benefit from a laparoscopic cholecystectomy. As he Respondent had the benefit of private health insurance, the Appellant offered to undertake this operation at the private hospital to which he had admitting privileges.
At surgery on the 10th October 2005, the Appellant found a non-inflamed gallbladder containing a single gallstone. He documented that the Respondent’s biliary anatomy was such that the cystic duct (which would need to be clipped and divided in order to facilitate the procedure to remove the gallbladder) connecting the gallbladder to the biliary ductal system entered the right hepatic duct, which in turn joined with the left hepatic duct to form the common bile duct, the Respondent therefore having no common hepatic duct (see Figures 1 and 2). The Appellant applied two clips to the cystic duct, one proximally, close to the right hepatic duct, and the other distally towards the gallbladder, and then divided the cystic duct between these two clips. He then repeated this procedure on the cystic artery (blood supply to the gallbladder) before removing the gallbladder. The Respondent was the discharged from hospital the following day.
The Respondent was readmitted to hospital on the 14th October with sudden onset severe abdominal pain, and the working differential diagnosis was between non-specific abdominal pain, a postoperative bile leak, and acute pancreatitis. A CT scan shortly after readmission did not demonstrate any free fluid in the abdomen at that time, pointing away from a bile leak. Following admission the Respondent’s blood liver function tests deteriorated and the Appellant arranged for an ERCP (endoscopic retrograde cholangio pancreatogram, an X-ray examination of the bile ducts performed through an endoscope under sedation) which was attempted, but abandoned on the 18th October. A further ERCP on the 20th October was interpreted by the Appellant as showing a leak from the cystic duct stump and a biliary stent was placed in order to decompress the biliary ductal system.
Thereafter, the Respondent’s condition continued to deteriorate, with increasingly abnormal liver function tests, and the onset of acute renal failure. She was therefore transferred to the regional hepatobiliary centre where she underwent a further laparoscopy on the 26th October at which several litres of bile were extracted from the abdominal cavity, and following conversion to an open laparotomy, the operating surgeon identified bile leaking from a hole in the bile duct through which the stent placed at the ERCP of the 20th was visible, and not due to a failure of the clip on the cystic duct. Surgical drains were placed against the hole and following completion of the operation the Respondent was transferred to the Intensive Care Unit. The biliary stent was removed the following February, but the Respondent subsequently developed an incisional hernia in the scar of the operation of the 26th October.
Issues of Liability
Bile duct injury is a well-recognised complication of cholecystectomy, regardless of whether it is carried out laparoscopically or as an open procedure1. The Respondent developed biliary peritonitis 4 days after her laparoscopic cholecystectomy which was not identified until 6 days later, and was inadequately managed at the ERCP of the 20th since the bile was allowed to continue to drain into abdominal cavity causing her to develop renal failure. Although it was possible that the bile leak was due to the failure of the clip on the cystic duct, the operative findings of the 26th were otherwise, that the bile was leaking directly from a hole in the common bile duct. There were only 2 mechanisms for this injury, a full thickness puncture due to direct trauma during the cholecystectomy, or a subsequent hole developing as a consequence of a full thickness burn to the bile duct wall, due to inappropriate use of diathermy cautery during the dissection of the gallbladder away from the bile ducts. In this case, although all possible mechanisms were discussed in Court, it was almost certainly the latter since the Respondent was well for 3 days after the index cholecystectomy, indicating that the hole (and thus the biliary peritonitis) did not develop until the 14th when the bile duct wall disintegrated.
Injudicious use of diathermy during surgery in general 2, and laparoscopic cholecystectomy in particular, is well described in the literature, especially as a cause of iatrogenic bile duct injury 3, 4, 5. While I have not had sight of the Appellant’s operation notes of the index cholecystectomy, surgeons have a duty of care when performing a cholecystectomy to avoid the use of diathermy cautery in the region of Calot’s Triangle (see Figure 1, between the gallbladder and bile ducts, bordered inferiorly by cystic duct and gallbladder, medially by common hepatic duct, and superiorly by the undersurface of the liver), and the bile duct in general, as diathermy is well-recognised to arc unintentionally and uncontrollably over distances >1 cm to adjacent organs, thereby causing damage, in this case to the common bile duct. Even if diathermy cautery is used at some distance from the bile ducts to dissect the gallbladder from the liver, only the lowest power settings should be employed, and documented as such 3.
There are a number of further clinical issues that are pertinent to this case. The first of these addressed by Mr Justice Griffith Williams at the original trial relates to variation in biliary anatomy (Para. 20 of the Trial Judge’s judgment). The ‘usual’ disposition of biliary anatomy referred to by Mr Justice Griffith Williams, of the right and left hepatic ducts joining to form the common hepatic duct, which in turn is joined by the cystic duct to form the common bile duct (see Figure 1) is found in less than 50% of people. The Respondent’s anatomical variant (cystic duct joining the right hepatic duct which in turn joined the left hepatic duct to form the common bile duct, in which case there can be no common hepatic duct, see Figure 2) is found in 4- 5% of people, and is therefore a common anatomical variant. Any surgeon performing a cholecystectomy has a duty of care to be aware of the commonly occurring anatomical variants and take steps to establish the biliary anatomy beyond doubt before clipping and dividing any structure. The most frequently seen iatrogenic bile duct injury occurs when the surgeon mistakenly identifies the common bile duct as the cystic duct, clipping and dividing it. While this injury has never been successfully defended in any English Court, some American courts have been persuaded that such an mistake is an excusable error of misperception,6 and therefore successfully defended. However, there is an alternative view in the US that holds that such an opinion reduces surgery to a mindless game of chance, and that patients should expect more from their surgeons 7. However, the Appellant correctly identified the Respondent’s biliary anatomy, and in this case, no bile duct structures were inappropriately divided.
Figure 1. The ‘conventional’ biliary anatomy seen in just under 50% of people.
Figure 2. The Respondent’s biliary anatomy in which the cystic duct connecting the gallbladder to the biliary ductal system enters the right hepatic duct. This is seen in 4-5% of people.
With regard to the views of the two Expert Witnesses, Professor Parks and Mr McDonald disagreed as to the site and mechanism of the injury, I agree with Professor Parks’s view that the injury arose because of injudicious use of diathermy during the dissection of the gallbladder. Mr McDonald argued that the bile leak came from a failed clip on the cystic duct (as interpreted by the Appellant at the ERCP of the 20th), but he did not appear to have a grasp of the anatomy of the injury. It wasn’t helpful to the Court that neither side had sought a witness statement from Mr Prasad, the surgeon who operated on the 26th, to determine exactly what he meant by ‘loss of bile duct wall anteriorly’, which at face value places the injury below the confluence of right and left hepatic ducts, as the form the start of the common bile duct. It is not uncommon with this particular anatomical variant for the Hartmann’s pouch of the gallbladder (where the cystic duct meets the gallbladder) to abut the common bile duct, and be attached by folds of peritoneal membrane which will need to be divided in order to access the anatomy of Calot’s Triangle, and complete the operation. If the Appellant had used diathermy cautery to assist such a dissection, then on balance, the bile duct was going to be inadvertently burnt (resulting in the observed injury), and such an action would not be supported by any responsible body of surgical opinion. In my opinion, it would have been extremely helpful for the Court to have had the opportunity to examine Mr Prasad (an experienced biliary surgeon) and ascertain his exact findings and his thoughts on the mechanism of injury. As I state above, the only possible mechanism in these circumstances of an injury to the anterior wall of the bile duct that resulted in the development of a hole in the bile duct 3 days later was a full thickness diathermy cautery burn to the wall of the bile duct, which can only occur if the surgeon employs diathermy cautery too close to the bile duct, which would constitute substandard care.
Issues of Causation
While the Appellant appears to have considered biliary peritonitis within the differential diagnosis following readmission, the delay of 6 days in confirming the diagnosis at the ERCP of the 20th, and simply placing a biliary stent and taking no other action, cannot be supported by a responsible body of surgical opinion. During that time the Respondent was developing biliary peritonitis and renal failure. There was a duty of care to laparoscope the Respondent at the earliest opportunity, which would have identified the hole in the common bile duct, allowed evacuation of the bile in the abdomen, and facilitated the placing of surgical drains (as Mr Prasad did on the 26th), followed by an ERCP and biliary stent. Therefore, on balance, appropriate early action would have prevented the onset of renal failure, the laparotomy of the 26th, the period in intensive care, and the subsequent incisional hernia.
With regard to the other rejected grounds for appeal on causation, there is considerable literature demonstrating that this injury is associated with loss of life expectancy 8,9, and if survived, long-term loss of quality of life 10, and exposure to further chronic life-long and life-threatening complications 11, 12.
In conclusion, I am surprised that this case ever made it to Court, for which, in my opinion, the responsibility in part remains with Mr McDonald’s opinion on the site and mechanism of the injury.
Wendy J Owen- Barrister, St John’s Buildings
The case is a good example of how a case for clinical negligence can develop over the course of time and how, by the time of the trial itself, the issues have often narrowed quite considerably.
At first instance, the trial judge, whose judgment was subsequently upheld by the Court of Appeal, noted that the issues had narrowed from 5 allegations of negligence to just two, namely:
- damaging the claimant’s common bile duct during laparoscopic surgery to remove the claimant’s gallbladder; and
- failing to ensure adequate monitoring of the claimant for two days post operatively by failing to arrange for her fluid balance and renal function to be monitored.
The main issue between the parties at first instance was determination of the location of the bile leak, the parties having agreed that the claimant’s symptoms were consistent with such a leak. The claimant submitted that the leak was from the common bile duct, the defendant submitted that it was a cystic duct stump leak.
The other issue was determining the cause of the leak. The claimant argued that it was caused by an iatrogenic injury to the common bile duct. It was accepted that such injury could be caused by a sharp instrument or diathermy. The defendant submitted that it was due to two clips falling off the cystic duct, either through mechanical failure or ischaemic necrosis. It was accepted that if the latter had occurred, this would not be negligent.
The judge at first instance found that the leak was from the common bile duct and that it was caused by an iatrogenic injury. He concluded that this was a result of a breach of duty on the part of the defendant. He noted the medical literature relied upon and concluded that as the defendant was apparently carrying out an uncomplicated procedure some distance away from the site of the common bile duct injury and that no explanation had been given for how such an injury could be caused by a breach of duty on the defendant’s part, the injury must have been caused by negligence on the defendant’s part.
The defendant had submitted that, in terms of the allegation relating to the bile duct injury, the claimant was trying to run the case on the basis that it was one of res ipsa loquitur, that, in essence, as the bile duct was damaged, the surgeon must have been negligent. The trial judge was well aware that the Court of Appeal had held in Ratcliffe v Plymouth and Torbay Health Authority and others (1998) Lloyd’s Med Rep 162 that res ispa will rarely apply in clinical negligence where medical records and witness statements and expert evidence will normally be available to assist the Court to make a find of negligence where appropriate. In this case, the claimant had never pursued the matter on the basis of res ipsa. It was, however, this point which the defendant pursued, unsuccessfully, before the Court of Appeal. The other grounds of appeal were also dismissed by the Court of Appeal.
At appeal, the negligent surgeon’s barrister argued that in essence the trial judge had erred in not regarding her case as a res ipsa case, as according to him the claimant’s case had been that as there was evidence of bile duct injury this must have been negligent. The Court of Appeal dismissed the appeal.
It is interesting to see how the Court of Appeal dissects the judgment of the trial judge and is particularly impressed with the manner in which the trial judge considered the medical literature relied upon at trial. In terms of the res ipsa argument, the Court of Appeal noted that the trial judge had not erred, finding that “the judge was not drawing an inference of negligence from the mere fact of injury to the common bile duct during an operation. He was addressing the particular circumstances of this particular case in the round, having regard to all the evidence and having assessed its weight. This is apparent from his reference to the fact that this was an uncomplicated procedure some distance removed from the site of the common bile duct injury.”
So what can lawyers involved in clinical negligence cases learn from this case? Firstly, that it is very risky to run a case for a claimant on the basis of res ipsa alone. It is quite common for an expert to say that as certain damage was caused then the surgeon must have been negligent. That is generally not enough. It is important that the expert is specific and that the allegations of negligence are specifically pleaded. Take, for instance, a laporoscopic cholecystectomy, many an expert would criticise the surgeon for damaging the bile duct, but the question the expert should also answer is why he is critical? Has the surgeon failed to identify the Calot’s triangle, for instance? If so, that would be a valid allegation of negligence on his part and would explain why the anatomy has been misidentified. Such a specific allegation of negligence might well prove difficult to defend.
There was much discussion at first instance as to the precise location of the damage. Time was spent trying to interpret the operation note of Mr Prasad, the surgeon who operated on the claimant on the 26th, after the breaches occurred. (No criticism was made of Mr Prasad.) In his medical commentary, Graeme Poston expresses surprise that Mr Prasad was not called as a witness to explain his findings in more detail. I do not know if Mr Prasad was contacted or not. However, it can be very useful to contact the surgeon who essentially “sorts out the mess” to ask for clarification of his operative findings. Even with a good and clear operation note, the evidence of the operating surgeon can carry much more weight with the Court and one then avoids the risk of an expert witness interpreting the operating surgeon’s notes in the wrong way.
The case is also interesting in terms of the manner in which Counsel for the defendant sought to undermine the credibility of the claimant’s expert witness as he criticised him for failing to address the defendant’s case, presented by way of its defence and witness evidence prior to exchange of expert evidence. The judge dismissed this criticism on the basis that the claimant’s expert had subsequently dealt with the defendant’s case in the joint statement. This type of experience is, however, likely to have been unnerving for the claimant’s expert and could have been relatively easily avoided by the claimant’s expert having the opportunity to formally consider, by way of a report, the defendant’s case as it stood prior to the exchange of expert evidence. It essential that parties to litigation consider the other side’s case with its experts prior to exchange of expert evidence with great care. Whilst the expert may find it difficult to work out the pleadings, it is important that the legal team goes through them with the expert as well as the, usually, more easily comprehensible witness statements. The Judge will look at the pleadings first. The importance of ensuring that each party’s case is properly pleaded in the particulars of claim and defence respectively cannot be underestimated.
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