“Ms Drysdale's physical and mental health. The diagnosis of schizoaffective disorder and what that meant for Ms Drysdale. The different types of treatments she received, and the extent to which these were effective. The prescription, monitoring and ongoing use of a medicine called clozapine. How Ms Drysdale's condition changed when she was not taking clozapine. The development of myelodysplastic syndrome, and its transformation into acute myeloid leukaemia, and whether or not there is any causal relationship between clozapine and the development of either myelodysplastic syndrome and/or acute myeloid leukaemia.”
“It's very different from other cancers in that we don't stage it in the same way as, say, much more common, well known, solid cancers. If you have a lung cancer, for example, catching it at an early stage before it's spread means a completely different treatment plan, and a much better chance of eradicating it. Once it's spread, it becomes difficult or impossible. So, in most cancers, catching it early makes a huge difference. In something like MDS or acute myeloid leukaemia, it's not quite the same, because by definition this is a liquid tumour that's spread through the body at the beginning. So there isn't a concept of the disease having spread or catching it when it's still limited and it can be chopped out, for example, or radiotherapy. So, you know, where there are MDS subtypes and there are treatments available, catching it early, before... while someone is still well and fit enough to, say, tolerate the available treatments can certainly help. So I wouldn't say there's no benefit to picking it up early.”
“I don't think there is sufficient evidence known in the medical literature to make that link. So I don't think we can say that it had that type of link, and that it contributed in any of those ways. I can't say for certain that that's the case. It may be that more evidence comes to light and we view clozapine in a different way in future, but I think it would be over-interpreting a very speculative dataset at the moment, as it is, to say that it contributed in a more [inaudible].”
“are those earlier instances where there have been abnormalities on the basic blood results, neutropenia, low white cells, on occasion, evidence of anaemia… in retrospect, are those most likely to be down to the clozapine, as was suspected? Or, in retrospect, could those be suggestive of, actually, her previously having developed, but not being diagnosed with MDS? Or the third possibility, which we need to put to you to be entirely fair, don't you know? Can't you tell?”
“without seeing the series of results and the dosing alongside and, you know, it's impossible to say with certainty. I think, at that time, in... I think you said early 2022, did you? I think at that time, in retrospect, it's reasonable to imagine this was the MDS starting to show itself. I think you've also mentioned about red flags and amber flags, um, going back to 2013, which, again, I'm not familiar with myself. I think that's almost certainly not related. So I think what that shows is that antipsychotic medications over the years have, on occasion, suppressed the blood counts, which may influence, when it happens again, that the psychiatrist may have assumed the more likely explanation that this was, again, the same thing happening. If the question is whether, in retrospect, that could have been the MDS showing itself, I think that's very likely. I'd have to know much more detail to know whether that was something that ought to have been handled differently. I think there's always, in medicine, an element of clinical judgement, coming up with a list of likely diagnoses and being pragmatic, not doing a bone marrow on everybody every time they have a low blood count. Um, but, yeah, it could have been the MDS at that stage.”
“So, given that you say that, er, and given your evidence on the early detection of MDS, although not conclusive as such, and the evidence you give about the disease evolving, especially with the TP53 genes, etc, do you now believe that the Pennine Care Trust's previous reliance, prior to April 2022, er, as clozapine as the primary cause of... of low white blood cells and low platelets and haemoglobin levels, and their lack of haematological referral or investigation… do you believe this would have likely contributed to Sasha's death, or at least the shortening of it?”
“First of all, your characterisation of the evidence, as you put it in phrasing that question, was highly selective and incomplete. We've heard a range of evidence on those points, er, some of which is that, er, clinicians treat on basis of a range of factors. You'll recall Ms Morgan's evidence about it being relatively common to need to go off licence, for instance, and Dr Lodhi talking about treatment of the patient as a whole, something Mrs Harris talked about. More fundamentally, however, this is not a clinical negligence trial. It is not of assistance to the jury to have a view, er, on... from somebody who, with the greatest respect, is probably not qualified to give it on the reasonableness or otherwise of continuing to give clozapine to a patient with a very complex mental illness. It doesn't assist the jury in answering their questions.”
“if clozapine has contributed to Ms... Ms Sasha Drysdale's death in a way which is material, so their reliance on blood tests and their thought that, well, these particular blood tests were indicative of clozapine toxicity, rather than any other underlying malignancies is, I think, a very fair question to ask.”
“…neglect is not a freestanding conclusion, so you don't record a simple conclusion of neglect. You would record a conclusion of, er, natural causes contributed to by neglect, suicide contributed to by neglect, accident contributed to by neglect. You could also use the word neglect in a narrative conclusion. You might say, to give that example, "Mr Smith died as a result of complications arising from major surgery. Mr Smith's death was contributed to by neglect." So it's not a conclusion in its own right. What it used to be called was a rider. In other words, it's something that's used in addition to one of the other conclusions. Now, it has got a very stringent test associated with it. Neglect has been described by one case as a term of art in the law ofinquest. It is nothing to do with negligence. It is a completely separate animal, and it is not to be equated with it. The leading case is a case from the Court of Appeal called Jamieson from 1994, and that was about the death of a person in prison. And I'm paraphrasing the test. I can find the precise words of the judgment, and actually, one of you might have a book with you. Um, neglect is essentially about a gross failure to provide or procure basic medical attention to a person in a dependent position who obviously needs it in circumstances where there is a clear and direct causal connection between the gross failure and the death. And what the Chief Coroner's guidance says about this is this. It's all online, free to look it up. "Neglect has a restricted meaning according to the case law, and should not be considered as a primary cause of death," as I've said to you. A finding of neglect is not in itself a conclusion, but may form part of the conclusion in box 4, either as words added to a short-form conclusion or part of a narrative conclusion. Neglect is narrower in meaning than the duty of care in the law of negligence. It is not to be equated with negligence or gross negligence. It is limited in a medical context to cases where there has been a gross failure to provide basic medical attention to someone in a dependent position." In broad terms, there must be, to use the words in one case, a sufficient level of fault to justify a finding of neglect. It then goes on to make a point, does the guidance, which I've mentioned to the jury already. In a medical context, it is not the role of the inquest to criticise every twist and turn of a patient's treatment. Neglect is not concerned with the correctness of complex and sophisticated medical procedures, but rather the consequences of, for example, failing to make basic checks. There's then some lines about prison death specifically, because it quite often arises as a concern in relation to people that have tragically taken their own life in prison where there has been thought to be maybe a risk that they might do so, and it becomes about things like the observation regime and checks and the like. It then goes on to deal with the issue of causation, which I've mentioned to you. There must be a clear and direct causal connection between the conduct described as neglect and the cause of death. The conduct must have caused the death in the sense that it more than minimally, negligibly or trivially contributed to the death. The touchstone is the opportunity of rendering care which would have prevented the death. It is not enough to show that there was a missed opportunity to ender care which might have made a difference. It must be shown that care should have been rendered, and that it would have saved or prolonged life, not hastened death, and neglect needs to be shown, like everything we consider here, on the balance of probabilities. That's to say what is more likely than not. The guidance goes on to say a real possibility is not enough. So my initial thoughts, um, Mr Drysdale, is that neglect would not pass that Galbraith plus test, unless there's anything you want to say to dissuade me of that view.”
“No…it's because of the very... very high level of... I mean, the reason the questions were disallowed were, they more go to that negligence reasonableness. This is not a court that is entitled to make a decision or go behind the reasonableness of clinical judgment or otherwise. That's very much more what a high court trial is for. Um, no, this is about a gross failure to provide or procure basic medical attention.”
“the application in essential terms was that, contrary to the provisional view I set out and indeed the submissions of the three legal representatives, the possibility of adding the words "contributed to by neglect" should be left to the jury as a possibility for them to consider. I confirm I've very carefully considered all of the evidence heard and read over the course of the hearing in the light of his helpful submissions. Mr Drysdale's submissions were neatly and concisely expressed, and as such, I do not intend to rehearse them here. I start by reminding myself of the key legal principles engaged by Mr Drysdale's submission. First, there must always be sufficient evidence to support a potential conclusion before a Coroner decides to leave it to a jury. That involves, of course, considering all of the evidence heard and read, rather than isolated or individual aspects of it. It is the balance of the evidence that is important. The legal test I must apply is the so-called Galbraith Plus Test. This was drawn initially from a well-known criminal law case, but has been amplified with approval of the senior courts for use in the context of inquests. See, for example, the case from 2012 of our (sic – this should read “R”) ex-parte Secretary of State for Justice and HM Deputy Coroner for the Eastern District of Western Yorkshire. The relevant test, therefore, is a dual test comprising the following limbs. First of all, is there evidence on which a jury, properly directed, could properly record the conclusion under consideration? And secondly, would it be safe for the jury to record that particular conclusion on the evidence before it? In order to apply that test, I need to move on to consider the legal test for neglect in the context of an inquest. Now, I remind myself that neglect is a term of art in the law of inquests. It must not be confused with, or conflated in any way, with the civil law concept of negligence. Negligence, as I've referred to a number of times during these proceedings, is something which the jury is precluded as a matter of law from even purporting or appearing to make any finding in respect of. The leading case in this sphere remains the Court of Appeal's decision in the case of Jamieson. In that case, the court defined neglect, coronial neglect, neglect for the concept of inquests, in the following terms. Neglect in this context means a gross failure to provide adequate nourishment or liquid or provide or procure basic medical attention or shelter or warmth for someone in a dependent position because of youth, age, illness or incarceration who cannot provide it for himself. Failure to provide medical attention for a dependent person whose physical condition is such as to show that he obviously needs it may amount to neglect. Now, applying this test to the present facts under consideration by this court, the first important point to make is that there can be no doubt whatsoever that Ms Drysdale was in a dependent position as far as medical attention is concerned. In my judgement, this is both because of her underlying ill health, but also as a consequence of her detention under theMental Health Act 1983 , as amended. In the light of Mr Drysdale's submissions, I also remind myself that, notwithstanding the wording of the test, the exercise of some degree of clinical judgment does not, of itself, preclude a finding of neglect being made according to the Court of Appeal case of Davis and HM Deputy Coroner for Birmingham and Solihull. However, for the word to be properly and lawfully used by an inquest jury, there needs to be a gross failure to provide basic medical attention to a dependent person whose physical condition is such as to show it is obviously needed. And I reflect on the fact for a moment that the acid test is not one of a simple failing, but a gross failing. The Court of Appeal in Jamieson has not chosen to define the word gross, and as such, I treat it as an ordinary English word, and I apply what I regard as its ordinary English meaning, which is to say something which is total or complete, flagrant or extreme. I've reviewed and considered all of the evidence with the utmost care in the light of the points Mr Drysdale has drawn out when asking questions and addressing the court, and I'm bound to say that in the context of finely balanced decisions arising from monitoring and treatment a patient... treating a patient with treatment-resistant schizoaffective disorder, in circumstances where stopping medication tend to be associated with a profound and distressing deterioration of Ms Drysdale's condition, in circumstances where, on the evidence of Dr Wiseman, she has tragically developed a rare and probably naturally occurring or evolving incurable cancer, on the basis of Dr Wiseman's clear and cogent evidence, this test does not even come close to being met. For these reasons, it would be manifestly unlawful under Galbraith Plus principles to leave the issue of neglect to the jury in this case, and as such, I will not be doing so.”
“The court heard evidence as to a small number of studies conducted internationally which, whilst having small sample sizes, could be read as suggesting an increased incidence of certain forms of blood cancer amongst those taking Clozapine. I am concerned that further research is needed to either refute or confirm whether or not taking Clozapine materially increases the risk of a patient developing certain blood cancers.”
“an event or conduct said to have caused the death, must have contributed more than minimally, negligibly or trivially to the death. The conduct or event must make an actual and material contribution to the death of the deceased.”
“A coroner must disallow any question put to the witness which the coroner considers irrelevant.”
“(i) The scope of the investigation and inquest comprises those lines of inquiry or topics which the coroner considers to be relevant to answering the four statutory questions; in Coroner for the Birmingham Inquests v Hambleton[2018] EWCA Civ 2801 , at para, 48, the Court of Appeal noted, “A decision on scope represents a coroner's view about what is necessary, desirable and proportionate by way of investigation to enable the statutory functions to be discharged. These are not hard-edged questions. The decision on scope, just as a decision on which witnesses to call, and the breadth of evidence adduced, is for the coroner. A court exercising supervisory jurisdiction can interfere with such a decision only if it is infected with a public law failing. It has long been the case that a court exercising supervisory jurisdiction will be slow to disturb a decision of this sort (see Simon Brown LJ in Dallaglio at [155] cited in [21] above) and will do so only on what is described in omnibus terms as Wednesbury grounds. That envisages the supervisory jurisdiction of the High Court being exercised when the decision of the coroner can be demonstrated to disable him from performing his statutory function, when the decision is one which no reasonable coroner could have come to on the basis of the information available, involves a material error of law or on a number of other well-established public law failings”, (ii) A coroner must investigate factors that probably caused or contributed to the death and has a discretion to consider matters which possibly contributed to the death. However, coroners are entitled to exclude from their inquiry any issues they consider to be so remote from the cause of death that they could not even arguably be said to have contributed (R (Speck) v Coroner for the District of York[2016] EWHC 6 (Admin) ), (iii) Even if the procedural obligation under Article 2 of the EHCR is engaged, the question of the proper scope of the inquest remains a discretionary matter for the Coroner and, as in non-Article 2 inquests, it must be a fact specific decision (Coroner for the Birmingham Inquests v Hambleton[2018] EWCA Civ 2801 , at para 47)… (iv) Nor is the issue of scope linked to or affected by the decision as to whether or not a jury should be summoned … the need for a jury is a separate and unconnected issue governed by s. 7 of the CJA, and (v) In an inquest in which the issues arising are concerned with the provision of clinical treatment and care, a coroner should be careful not to allow the investigation of the factual cause or causes of the death to slip into a general review of the adequacy or standard of the care provided, as the inquest is, expressly, not concerned with issues of negligence; this is so even if the clinical care was provided whilst the Deceased person was in state detention.”
“Neglect in this context means a gross failure to provide adequate nourishment or liquid, or provide or procure basic medical attention or shelter or warmth for someone in a dependent position (because of youth, age, illness or incarceration) who cannot provide it for himself. Failure to provide medical attention for a dependent person whose physical condition is such as to show that he obviously needs it may amount to neglect.”
“…when coroners are deciding whether or not to leave a particular verdict to a jury, they should apply a dual test comprising both limbs or ‘schools of thought’, i.e. coroners should (a) ask the classic pure Galbraith question “Is there evidence on which a jury properly directed could properly convict etc.?” (see above) plus (b) also ask the question “Would it be safe for the jury to convict on the evidence before it?”