Abstract
When the claimant was aged 9 she suffered a fibrosarcoma in her right foot and was treated successfully for the malignancy, but over the following years she suffered from increasingly severe symptoms of pain and discomfort in the foot. By 2005, when she was aged over 40, she sought medical advice about the possibility of a below-knee amputation.
The first surgeon she consulted cautioned her against such an approach, but the second (Mr Royston) agreed to carry out the operation, although he was less than encouraging as to its prospects. Accordingly, on the 3 January 2006 he undertook a trans-tibial amputation of the Claimant's right leg.
Post-operatively, symptoms consistent with an infection around the area of the wound developed. These were initially treated by antibiotics, but on the 13 January there was radiological evidence of the development of gas gangrene, such that a decision was made to carry out an emergency above-knee amputation.
It was alleged that Mr Royston had undertaken the initial procedure negligently and specifically that all non-vital tissue had not been removed, allowing bacteria to germinate.
Several points were not in dispute between the parties:
Development of gas gangrene was caused as a result of the limb having become infected with a bacterium known as Clostridium perfringens (CP) during the course of the surgery. If spores of the bacterium come into contact with unhealthy non-vital tissue, in a situation devoid of oxygen, the spores can germinate and proliferate. They then release toxins which are lethal to vital tissue and may in turn lead to the development of gas gangrene. The natural habitat of CP is the large bowel of humans. It may be deposited on the surface of the skin, usually by faecal soiling. Although thorough cleansing of the surface of the skin will remove the vast majority of CP spores, some may remain despite the highest standards of pre-operative skin preparation. As the claimant's right leg was, apart from the symptoms of pain and discomfort, an otherwise healthy limb, the only way in which an anaerobic environment could have arisen within it was by tissue or other material de-vitalised by the surgery remaining within the surgical wound after its closure. Ever since the 19th century the importance of careful checking for the presence of non-vital tissue within a surgical wound, and its removal, has been a central tenet of safe surgical procedure. Gas gangrene is a potentially fatal condition which requires removal of all the affected tissue. This was achieved by the mid-thigh amputation.
It was argued on behalf of the claimant that although there was no direct evidence that non-vital tissue remained within the closed surgical wound, there was a clear inference that this had occurred, since without its presence the CP spores would not have been able to proliferate.
This was accepted on behalf of the defendant, but the trust maintained that there was no prima facie evidence of negligence because it was an inevitable consequence of safe surgery that some non-vital tissue remained, and that this would be enough to provide a sufficiently hypoxic environment for the proliferation of CP.
The claimant argued that the lack of a similar case within the medical literature supported her claim that the development of gas gangrene reflected negligence on the part of the surgeon.
Mr Royston had been a consultant orthopaedic surgeon for 12 years. He stated that he was well aware of the necessity for careful checking for and the removal of non-vital tissue prior to closure of the surgical wound. It was his invariable practice. Checking involved an assessment of the colour of the tissues, their consistency, contractility and their capacity to bleed. Even non-vital tissue might continue to bleed for up to 5 min. Surgery itself inevitably caused some degree of trauma to the body tissues. Diathermy caused freckle-sized pieces of non-vital tissue to be created, which remained within the surgical wound after closure.
Mr Mathews, the claimant's surgical expert, said that gas gangrene was a very rare complication of elective amputation. He was not prepared to accept that it gave rise to an inference of bad surgery, but rather he thought that pre-surgical cleansing may have caused the infection. Neither he nor the trust's orthopaedic expert had been able to locate any medical literature in which gas gangrene after elective surgery was described as having occurred.
Professor Briggs was the trust's orthopaedic expert. He described the occurrence of this infection as a rare but non-negligent complication, and considered that Mr Royston's surgical procedures were appropriate. He agreed that diathermy inevitably leaves some small areas of non-vital tissue at the site of the operative wound.
Dr Gant, a microbiology expert called by the claimant, considered that as the CP had been introduced during the course of clean elective surgery, there had been a breach of proper pre-operative cleansing.
By contrast, the trust's expert microbiologist, Professor French, took the view that gas gangrene was a rare but recognised complication of surgery and that its occurrence was not necessarily indicative of negligence. The trauma of amputation inevitably resulted in the existence of conditions of relative hypoxia, and he believed that infection occurred more frequently than it was detected. He agreed that non-vital tissue inevitably remained after appropriate diathermy, but did not consider that any detrimental significance arose from the lack of detailed examples in the medical literature.
Held: In Ratcliffe v Plymouth and Torbay Health Authority and Exeter and North Devon Health Authority (1998) PIQR 170, Lord Justice Brooke stated that where the claimant was arguing that the facts of the case spoke for themselves, as here, the judge is entitled to infer negligence on the defendant's part unless the defendant adduces evidence which discharges that inference. The explanation must be a plausible one and not a theoretically or remotely possible one, but the defendant certainly does not have to prove that his explanation is more likely to be correct than any other. If the claimant has no other evidence of negligence to rely on, his claim will fail. Alternatively, the defendant must satisfy the judge on the balance of probabilities that he did exercise proper care.
The court was satisfied that the occurrence of gas gangrene in the circumstances in which it developed in this case was a rare event. No previous detailed example of its occurrence in the medical literature had been brought to the court's attention. However that in itself, in the absence of expert medical opinion, was not sufficient to establish that the development in this case was such that an inference of negligence was thereby established. As Professor French had pointed out, there may be valid reasons as to why its prior occurrence had not been described in detail in the literature. None of the experts, including Dr Gant, stated that in their opinion the rarity of the risk was sufficient in itself to raise an inference of negligence.
The court should approach any non-negligent explanation for this occurrence with particular care and circumspection. However, it was acknowledged by several of the experts that safe surgery would inevitably leave some non-vital tissue within the closed surgical wound. The question therefore was whether the development of gas gangrene within the claimant's right leg gave rise to an inference that non-vital tissue or other material over and above that resulting from safe surgery had been left in the closed wound in this case.
Professor French was an individual of particular renown within his profession, and the court was impressed with the careful way in which he provided his evidence, giving reasoned responses to explain his conclusions. His evidence that the amount of non-vital tissue remaining after safe surgery was sufficient to provide a nidus for CP spores was to be accepted. This gave rise to a sufficiently plausible non-negligent explanation for what had occurred. Accordingly, even if the development of gas gangrene in this case had been sufficient in itself to raise an inference of negligence, the non-negligent explanation provided by Professor French was sufficiently plausible to have discharged the inference.
On the balance of probabilities, appropriate pre-operative cleansing took place, and Mr Royston and his team carried out appropriate surgical procedures. The development of gas gangrene was a rare but non-negligent event which occurred in the manner described by Professor French. Although the court had nothing but sympathy for the position in which the claimant found herself, liability for that position did not rest with the defendants.
Simon King (instructed by Howells) appeared for the claimant. Charlotte Jones (instructed by DAC Beachcroft) appeared for the Trust.
Comment
This was an extremely unusual case. In essence, the claimant was arguing the facts spoke for themselves. However, following guidance issued by the Court of Appeal in 1998, the judge accepted that the explanation provided by the trust's microbiologist was plausible. In other words, the bacteria may well have developed from non-vital tissue left within the closed surgical wound non-negligently. This reasoned explanation defeated the claimant's argument.