“The negligence of the Defendant caused the death of the deceased. Had the Defendant discharged his duty of care to the Deceased, the Deceased would have attended hospital on 25th April where a diagnosis of pulmonary embolism would have been made. The Deceased would have been given anticoagulation treatment so that the massive pulmonary embolism that caused her death would have been avoided. Although unlikely after anticoagulation treatment, if a massive or sub-massive pulmonary embolism did occur whilst in hospital thrombolysis and full supportive treatment would have been available and on a balance of probabilities she would have survived.”
“(8) Mrs Marshall would therefore have had less than 12 hours of full anticoagulation before she suffered a massive PE at 08.00 hours on26 April 2014 . (9) Failure to achieve stable full heparinisation within 24 hours of venous thromboembolism is associated with a 4 to 12 fold increased risk of recurrent pulmonary embolism. (10) Heparin works by interfering with the clotting mechanism in such a way that the clot stops growing and spreading up the leg into the pelvis. New clot is more fragile and probably embolises more readily. It is likely the clot which embolised on the morning of26 April 2014 would already have been present on25 April 2014 and anticoagulation would not have dispersed it overnight. Heparin does not operate to dissolve blood clots. When the clot stops growing, the fibrinolytic enzymes in the blood will slowly dissolve the clot and thereby gradually reduce the risk of part of the clot detaching and causing a pulmonary embolism. Accordingly, the risk of recurrent VTE reduces progressively the longer a patient is anticoagulated. (11) Studies suggest that delay in achieving adequate anticoagulation by as little as 24 hours can increase the risks of recurrent VTE 4 to 12 fold. (12) On the balance of probabilities, had Mrs Marshall been anticoagulated at, or around, 21.00 to 22.00 hours on25 April 2014 , she would still have suffered the massive PE which killed her at 08.00 hours on26 April 2014 .”
“This question needs to be considered in conjunction with the medical literature. Although I will not at this stage draw conclusions from overall mortality of patients with PE who are treated in hospital. I will deal with that more fully in answering question 4.”
“Thrombolytic therapy compared with heparin was associated with a significant reduction in recurrent pulmonary embolism or death in trials that also enrolled patients with major (haemodynamically unstable) pulmonary embolism…but not in trials that excluded these patients…”
“101. Doctor Gomez was of the opinion that the study assisted in showing that, if alteplase had been given three hours prior to death, the deceased would have survived. Further, the deceased just had PE. Otherwise she was healthy. She had nothing wrong with her heart or blood. 102. Professor Hay made a number of qualifications as to what can be drawn from Goldhaber. He agreed that typically nowadays alteplase is given by way of a 50mg bolus at the onset, followed by two hours infusion. Although he said it was difficult to be certain, he said that had Mrs Marshall developed shock and massive PE sometime in the night with enough time for alteplase to work, then it may well have been lifesaving.” 21.On the basis of this material, the judge found: “104. … a number of points can be made about statistics. Nevertheless, broadly speaking, had alteplase been prescribed, say, 3 hours earlier than 8.30 a.m., Mrs Marshall would probably have survived. 105. That said, I have already found that it cannot be shown, the balance of probabilities, that Mrs Marshall would have reached the threshold for prescription of alteplase at any stage prior to her going into cardiogenic shock.”
“112. It is to be recalled that there is a broad similarity of the figures in Sekhri and Casazza. Thus in Casazza 64% of these in cardiogenic shock survived and 37% of those in cardiac arrest survived. In the Claimant's favour: a) These figures include people who were in cardiogenic shock or with arrest on presentation at hospital. b) 43% of those in the Casazza study were over 75. The deceased was not in that category. Nor was she suffering from co-morbidity.” a) These figures include people who were in cardiogenic shock or with arrest on presentation at hospital. b) 43% of those in the Casazza study were over 75. The deceased was not in that category. Nor was she suffering from co-morbidity.”
“115. Looking at the evidence on cardiogenic shock in isolation, I find that: i) The Claimant cannot prove on the balance of probabilities that the deceased would have been in the 64-75% who would have survived; she may or may not have been. ii) Nevertheless, her chances of survival would have been significantly increased had she been in hospital overnight and at the time she became haemodynamically unstable. 116. As to the position with cardiac arrest, the Claimant submits that, because of the fact that she was relatively young and had no comorbidity, she probably would have survived with high quality CPR in hospital, and therefore have been in the group of 35% (Sekhri) – 37% (Casazza) who do not die. In my judgment, whilst this is a possibility, it is less likely than her chances of surviving cardiogenic shock – itself not a probability.”
“28. In the absence of any positive evidence of breach of duty, merely to show that a claimant's loss was consistent with breach of duty by the defendant would not prove breach of duty if it would also be consistent with a credible non-negligent explanation. But where a claimant proves both that a defendant was negligent and that loss ensued which was of a kind likely to have resulted from such negligence, this will ordinarily be enough to enable a court to infer that it was probably so caused, even if the claimant is unable to prove positively the precise mechanism. That is not a principle of law nor does it involve an alteration in the burden of proof; rather, it is a matter of applying common sense. The court must consider any alternative theories of causation advanced by the defendant before reaching its conclusion about where the probability lies. If it concludes that the only alternative suggestions put forward by the defendant are on balance improbable, that is likely to fortify the court's conclusion that it is legitimate to infer that the loss was caused by the proven negligence.”
“128. … As is accepted, the Claimant has the burden of proving causation. Yet the Claimant needs to prove no more than that Mrs Marshall would have probably have survived had she been admitted to hospital. The Claimant does not need to prove the precise mechanism by which her survival would have been achieved. 129. There has been very detailed evidence from four experts dealing with the probabilities of what did happen and what would have happened, absent the negligence. I must deal with causation on the facts of the case and analysis of the expert evidence in conjunction with the medical literature.”
“139. There cannot be an inference, much less a finding, merely on the basis that a number of possibilities amount to a probability that death would have been avoided. That said, this concentration on each possible stage of what would have happened where much is uncertain and difficult to resolve, must be considered against some important overall evidence.”
“140. Overall most people do not die of PE when they are in hospital. The deceased was not very elderly and had no comorbidity. In addition, Professor Empey said that his experience and that of many of his colleagues is that once a patient is admitted to hospital, properly assessed and given the appropriate treatment: heparin, oxygen, monitoring and other observations they do not die. It is very, very unusual. Similarly, Doctor Gomez said that he would have fully expected the deceased to survive because of the package of care that would be given to her. “140. Overall most people do not die of PE when they are in hospital. The deceased was not very elderly and had no comorbidity. In addition, Professor Empey said that his experience and that of many of his colleagues is that once a patient is admitted to hospital, properly assessed and given the appropriate treatment: heparin, oxygen, monitoring and other observations they do not die. It is very, very unusual. Similarly, Doctor Gomez said that he would have fully expected the deceased to survive because of the package of care that would be given to her. 141. The Claimant's case was that despite the statistics in the literature, to find for the Defendant, the court would need to accept the scenario that Mrs Marshall, having initially presented as normotensive with a diagnosis of PE, would have gone on to develop a massive PE whose onset and progress would have been so sudden as to be undetectable and irreversible. In other words that what did happen would have probably happened in any event. It was said that such counterfactual scenario is not described anywhere in the literature adduced at trial. Also, that it is statistically unlikely and based on the factual fallacy that the embolus or emboli would have been as big – or almost as big – as the embolus or emboli that did in fact embolise at home in the absence of treatment.”
“145. Thus the expert medical evidence to which I have referred and the statistical evidence demonstrate that at the time when Mrs Marshall should have presented at hospital, anybody rating her chances of survival would have put them at being very high. Tragically, she did in fact die out of hospital. In the situation which occurred, detailed analysis of such evidence as we have cannot lead the court to find that by such and such a mechanism, or at any particular stage, the course of events would probably have been different. This is overwhelmingly because of a large number of unknowns. 146. The court, in looking at the evidence as a whole, must take a common sense and pragmatic approach to that evidence, in circumstances where it is equivocal. The court must also be wary of relying on the statistical evidence in the literature which has a number of variables. Had the statistical evidence, in conjunction with the expert evidence, have led to the conclusion that Mrs Marshall's chances of dying would have been assessed on presentation as only slightly better than 50-50, I would have found for the Defendant. However, the above evidence of Professor Empey and Doctor Gomez, in conjunction with the medical literature, drives me to the conclusion that on the clear balance of probabilities she would have survived.”
“1. The Judge’s conclusion was wrong in that: (i) Having found that the Claimant had not proven that the Deceased would have survived had she been admitted to hospital on the basis of detailed analysis of the particular circumstances (Question 1 to 3), he should have concluded that the claim must fail. (ii) He should not have posed a separate overriding question (Question 4) based on general survival rates of patients with pulmonary embolisms in hospital. (iii) He should not have based a finding in favour of the Claimant on a general analysis that most people do not die from pulmonary embolisms in hospital. (iv) In answering question 4, in any event a. the Judge failed to consider or give any or any adequate weight to the evidence of Professors Hay and Davies whose evidence he had largely preferred when answering Questions 1 to 3. b. the Judge wrongly applied general propositions to the Deceased’s individual case in circumstances where there was sufficient evidence for him to consider the individual case, as he correctly done.”
“1. The judge was addressing a counter-factual question (as the deceased had not, due to the defendant’s breach of duty, in fact been admitted to hospital). Had the deceased been admitted to hospital, she would have been monitored throughout, her clot would have been smaller (para 114), she would have been provided with support including oxygen, electrolyte and fluid balance (para 110) and she would have had almost instantaneous treatment from trained staff when she would have gone into cardiogenic shock (para 114). Although the deceased did, as a matter of fact, go into cardiogenic shock for a short period of time only, there is no knowing the duration of cardiogenic shock on the counter-factual basis (para 114). 2. In those circumstances, the judge’s assessment was/should have been guided by a combination of statistical evidence, known evidence about the deceased and by taking a robust approach to causation drawing inferences in favour of the claimant. …”
“46. Having performed that exercise, the Judge concluded in relation to Questions 1 to 3 (which correctly identified the controversial issues which remained between the parties) that: i) the Claimant had not established that on a balance of probabilities that there were continuing emboli forming during the night. ii) Accordingly, the Claimant had not established that on a balance of probabilities thrombolysis would have been administered overnight. iii) The Claimant had not established that thrombolysis undertaken when she was in cardiogenic shock or in cardiac arrest would have allowed her to survive. iv) In so finding, the Judge had appropriately considered the causation issues between the parties and had concluded that the Claimant’s case could not be established. The only proper consequence of this analysis was that the claim should be dismissed. 47. The Judge’s decision to ignore his own (detailed) analysis of the evidence and to revert to ‘general’ statistics and some general observations from some of the medical experts was wrong. His apparent belief that these were a valid substitute for the analysis which he had already undertaken was wrong.”
“48. … In short, the analysis undertaken in respect of Questions 1 to 3 explains why the Deceased would have died if in hospital, notwithstanding that most people do not, e.g. she would not have displayed signs that would have prompted the treatment which might have saved her and the treatment which she would have received would have been inadequate to change the outcome.”
“35. When the judge had to consider, on the balance of probabilities, whether Dr Farrar's negligence (and the consequent delay in her admission to hospital) was causative of Mrs Wardlaw's death the judge had to take into account all the relevant evidence, and the rival cases that were being put forward at the trial in relation to this evidence. The failure of anti-coagulant therapy, when it was tried, to prevent the formation of a massive pulmonary embolism (which had not been present on 22nd September) was inevitably a material piece of evidence. While judges are of course entitled to place such weight on statistical evidence as is appropriate, they must not blind themselves to the effect of other evidence which might put a particular patient in a particular category, regardless of the general probabilities.”
“On the other hand, care should be taken not to take the logic of this reasoning too far in the opposite direction. If the evidence is that, say, 80 per cent of patients survive with prompt treatment, but 20 per cent die even with prompt treatment, the fact that the patient died following delayed treatment does not establish that he probably fell into the 20 per cent category at the outset and therefore the delay did not contribute to the death. The assessment of causation would turn upon the detailed medical evidence, both as to the overall statistical chances of survival and the particular condition and circumstances of the patient.”
“27. … In cases of medical negligence assessment of a patient's loss may be hampered, to greater or lesser extent, by one crucial fact being unknown and unknowable: how the particular patient would have responded to proper treatment at the right time. The patient's previous or subsequent history may assist. No doubt other indications may be available. But at times, perhaps often, statistical evidence will be the main evidential aid. 28. Statistical evidence, however, is not strictly a guide to what would have happened in one particular case. Statistics record retrospectively what happened to other patients in more or less comparable situations. They reveal trends of outcome. They are general in nature. The different way other patients responded in a similar position says nothing about how the claimant would have responded. Statistics do not show whether the claimant patient would have conformed to the trend or been an exception from it. They are an imperfect means of assessing outcomes even of groups of patients undergoing treatment, let alone a means of providing an accurate assessment of the position of one individual patient.”
“32. The value of the statistics will of course depend upon their quality: the methodology used in their compilation, how up to date they are, the number of patients involved in the statistics, the closeness of their position to that of the claimant, the clarity of the trend revealed by the figures, and so on. But to reject all statistical evidence out of hand would not be acceptable. This argument, if accepted, would effectually nullify the use of statistics in all cases of delayed treatment save perhaps where the figures approached 0% or 100%. Despite its imperfection, in practice statistical evidence of a diminution in perceived prospects will often be the nearest one can get to evidence of diminution of actual prospects in a particular case. When there is nothing better courts should be able to use these figures and give them such weight as is appropriate in the circumstances. This conclusion is the more compelling when it is recalled that the reason why the actual outcome for the claimant patient if treated promptly is not known is that the defendant by his negligence prevented that outcome becoming known.”
“Proof of causation is almost inevitably about a burden of persuasion and sometimes statistics can be highly persuasive.”