Seth Roberts Joseph Drysdale, R (on the application of) v His Majesty's Area Coroner for Greater Manchester (South)

The Claimant is the brother of Sasha Drysdale, who died aged 52 on 28 March 2023 at Beckett Place, an inpatient psychiatric unit operated by the First Interested Party, Pennine Care NHS Foundation Trust.

Ms Drysdale had a history of involvement with mental health services and latterly had been diagnosed with a schizoaffective disorder for which she had been prescribed a drug called clozapine, an antipsychotic drug. At the time of her death, she was detained under Section 3 of the Mental Health Act 1983. It is not disputed that the medical cause of death was acute myeloid leukaemia (“AML”) transformed from myelodysplastic syndrome (“MDS”).

An inquest was held into Ms Drysdale’s death from 8 to 12 July 2024. The Claimant and the Fourth Interested Party, Ms Drysdale’s daughter, were active participants. The inquest investigated amongst other things the interrelationship between her taking clozapine and her death.

By Claim Form issued on 22 October 2024, the Claimant sought permission to bring judicial review proceedings relating to the conduct of the inquest by the coroner. The Claim Form names four interested parties, three health trusts and the deceased’s daughter. Only the First Interested Party (whom I shall call “Pennine Care”) has engaged with the judicial review claim and I do not further need to record the position of the other three Interested Parties.

The Claimant has acted throughout as a Litigant in Person. His documents have been well ordered and he has taken his responsibility seriously. Nevertheless, there are certain points at which his lack of legal knowledge and experience become apparent.

One of these is the failure to identify numbered grounds of challenge within the Statement of Facts and Grounds in the Claim Form. It is clear from the Claim Form and the skeleton argument for the hearing before me that the Claimant is concerned in particular with the coroner’s refusal to allow him to put certain questions to a medical witness and the coroner’s decision not to leave the possibility of a neglect verdict to the jury.

Within her skeleton argument, counsel for the Defendant identifies three issues in the case, the first two of which can properly be described as grounds for bringing the claim.

I am satisfied that the analysis in the previous paragraph fairly sets out the Claimant’s case. However, as will be seen in my examination of the issues below, I consider the issue as to whether an option of a finding that the deceased died of “natural causes contributed to by neglect” to be intimately connected with the question as to whether the Defendant’s decision to prevent the Claimant asking the questions referred to in Ground 1 was lawful and so in reality the two grounds have to be considered together.

The Claimant’s application for permission was granted by His Honour Judge Stephen Davies on 11 February 2025. In granting permission, he noted that no summary grounds of resistance had then been filed. The order that he made required the Claimant to file and serve replacement grounds with page references to the transcript and an associated bundle of documents. The order also imposed case management directions upon the Defendant and any other person served with the Claim Form who wish to contest the claim or supported on additional grounds. They were obliged to serve detailed grounds for contesting or supporting the claim and any written evidence relied on within 35 days of service of the order upon them and to file a skeleton argument no less than 14 days before the date of the hearing.

In the event, Pennine Care filed an acknowledgement of service on or around 18 June 2025. Its skeleton argument was served after that date. Given that the Claimant’s application was listed on 26 June 2025, the skeleton argument was served late. I dealt with this point, and the associated issue of whether the Acknowledgement of Service was out of time at the beginning of the hearing on 26 June 2025. In essence, it would seem that, although Pennine Care received various communications about the claim, it was not served with the order of 11 February 2025 by which permission was granted. Since the order says at its foot that it will be served by the court on the Interested Parties, it is not any fault of the Claimant that the order was not served. Mr Simkin KC told me during submissions that Pennine Care in fact received a copy of the order on 16 April 2025 from the coroner’s office.

The Claimant sought an order striking out the Acknowledgment of Service and the skeleton argument filed on behalf of Pennine Care. I refuse that application for reasons given at the beginning of the hearing on 26 June 2025. However, I am conscious that the late service of documents on a Litigant in Person, whether or not the lateness is due to the fault of the party serving the documents, is liable to affect the litigant’s ability to prepare and to present their case effectively. I have endeavoured to ensure that no irremediable prejudice is caused to the Claimant, though, as he told me during oral submissions, if nothing else, the late service of documents caused him sleepless nights.

I consider it inappropriate that a court document says that the court will serve the document upon and Interested Party but in fact it appears to be the policy of the court not to serve Interested Parties who have not filed an Acknowledgement of Service before the question of permission is dealt with.

In his opening to the jury, the Defendant stated that the evidence in the inquest was likely to cover the following topics:

“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.”

During the inquest, the jury heard evidence from Dr Lodhi, a psychiatrist. He told the jury that clozapine is a drug which is used in cases of treatment-resistant schizophrenia. It has the potential risk to affect the blood count especially of white blood cells, so it is only administered to patients who have blood tests. Dr Lodhi said that the blood tests, “initially are every week, and then after a couple of months, the frequency increases to every fortnight, and then once a month, unless and until the blood count is in a satisfactory range, and we call that blood result as a green result. Unless the blood result is green, the clozapine cannot be prescribed. If we get an amber or a red result, we need to stop it, particularly after the red result, there's no way we can continue with clozapine. It must be stopped immediately.”

The statement of Dr Lodhi prepared for the purpose of the inquest included reference to occasions on which Ms Drysdale’s blood count had been abnormal leading to clozapine being stopped but later restarted. Both the Claimant and the Defendant questioned Dr Lodhi about the sequence of blood results in Ms Drysdale’s case. Dr Lodhi was also asked about the risk benefit balance of prescribing clozapine, particularly where there are abnormal blood test results. I note that the Claimant does not seek to argue that he was prevented from investigating the case as to the risk-benefit analysis nor that an issue should have been left to the jury as to whether the prescription of clozapine was in fact justified or appropriate.

The Defendant asked Dr Lodhi whether there was any known link between clozapine and myelodysplastic syndrome or leukaemia. He replied, “I have worked as a psychiatrist for, I think, over 33 years now, and I have never come across this situation before.” Later he added, “It's difficult for me to say that the clozapine caused the MDS, or was it a coincidence that MDS was diagnosed in a patient who is a psychiatric... who was a psychiatric patient. And that is a question that will be most suitable or more suitable for Dr Wiseman to answer.”

Two treating haematologists were called to give evidence, Dr Punekar and Dr Wiseman. They gave their evidence simultaneously. Dr Wiseman gave important evidence to the jury on the condition of Ms Drysdale. He explained the nature of myelodysplastic syndrome, describing it as “a range of conditions, and what they share in common, effectively, is that the stem cells in the bone marrow undergo genetic changes that stops them from functioning properly.” He stated that Ms Drysdale’s subtype was “MDS with biallelic TP53 inactivation. That is a subtype in which you have mutations involving a gene called TP53, which is a really important gene in how our DNA repairs itself when it undergoes damage. It happens to be the single most commonly mutated, or gene that becomes faulty, across all cancers. And when it happens in bone marrow stem cells like this, it causes a type of MDS that sadly is well recognised to be, er, the worst risk, the poorest prognosis, and hardest to treat of all the subtypes, and effectively renders it incurable … In most cases of MDS, there is no obvious cause. We think it's because of random faults that develop in our bodies, typically as we get older. All of our cells in our body undergo mutations randomly, and if that occurs in the wrong gene in the wrong cell at the wrong time, it can turn a cell from a healthy one into a cancerous cell. That's basically the principle of most cancers.”

As to the development of MDS, Dr Wiseman said that it “is a chronic condition, and it takes time to evolve and develop. So it will have been there for some period of time leading up to the diagnosis. Almost certainly for months, possibly longer. It isn't possible to go back and say exactly when it initiated, but it won't have been something that just triggered rapidly overnight…” Dr Wiseman commented further on this issue in answer to a question from the Claimant:

“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.”

The Defendant asked Dr Wiseman about the relevant literature on the connection between clozapine and leukaemia. Dr Wiseman replied:

“I think the starting point is that clozapine is not a drug that any haematologists would instantly have in their head as linked to acute leukaemia development. It's not a chemotherapy drug. It's not one that would be known to cause genetic damage. It's not something that commonly we see causing this. I've never seen another case in which that's been a possible thing. Um, that said, as you say, there is a small body of literature. At the time, I think one of... I'm aware of three studies, the first from 2010 which is a Danish study, that looked at a large number of people with schizophrenia or similar conditions, and they just looked back and looked at those who'd been treated with clozapine, those who hadn't, and they looked at who went on to develop blood cancers, particularly in that study, MDS or acute leukaemia. And as I recall, out of about 33,000 patients, something like 3,700 had received clozapine, the others hadn't, and there were a total of eight cases of acute myeloid leukaemia, four from those who'd had clozapine, four from those who hadn't. So when you do the statistics, that suggests the possibility that perhaps there is a link, and you're more likely to have developed acute leukaemia if you've had clozapine. I would say that's not definitive. That's certainly not a conclusive result. The numbers are very, very small. The absolute risk is clearly very low.

At one point, the coroner asked of Dr Wiseman,

“…one of the things, and one of the tests this court considers, and this isn't about whether it was right or wrong to give clozapine - that's not something this court is here to determine - is whether the fact that Ms Drysdale had been treated with it has contributed to the development of the MDS, and therefore the AML, in a way that is more than minimal, more than negligible, or more than trivial. The senior courts give us those very specific words. Is that something you have a view on?”

Dr Wiseman replied:

“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].”

These answers as to the possible causative link between clozapine and lymphoma and other haematological cancers was consistent with evidence that had earlier been given by a pharmacist, Ms Morgan.

The Claimant asked Dr Wiseman about the various blood test that have been carried out. This led to the first question that the Defendant ruled to be one that should not be answered which was in these terms:

“As a haematologist, if you were presented with these results on a blood test from an ordinary person, and by that, I mean a patient that's not detained in a psychiatric hospital and not being prescribed medicine such as clozapine, would you have thought further investigations and tests were required as to rule out potential bone marrow malignancies?

At that stage the Defendant did not give reasons for preventing the question being asked.

A little later the Defendant himself asked a question of the haematologists as to the abnormal blood results:

“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?”

Dr Wiseman responded:

“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.”

This answer was immediately followed by the second question that the Defendant prevented the Claimant from asking:

“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?”

In ruling that this question could not be asked, the Defendant said:

“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.”

The Claimant explained further his reasoning in asking the question:

“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.”

At the conclusion of the evidence, the Defendant ruled that the issue of neglect should not be left to the jury. The Defendant had explained his reasoning for his provisional view that neglect should not be left to the jury in an exchange with the Claimant at the end of the third day of the inquest:

“…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.”

The Claimant asked whether, if the questions that he had sought to ask but had been prevented from pursuing had been answered in the positive, the coroner would have considered the threshold for a neglect finding to be made out. The coroner replied:

“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.”

His final ruling on this issue was in these terms at the beginning of the fourth day of the inquest:

“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 the Mental 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 inquest concluded that Ms Drysdale died as a consequence of Acute Myeloid Leukaemia transformed from myelodysplastic syndrome and that her death was due to natural causes.

The coroner exercised his powers under the 2009 Act and Regulations 28 and 29 of the Coroner’s (Investigations) Regulations 2013 to raise a concern as to the potential connection between clozapine and blood cancer. The report puts the matter of concern this way:

“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.”

The purpose of an inquest is set out at section 5 of the Coroners and Justice Act 2009:

“(1)

The purpose of an investigation under this Part into a person’s death is to ascertain—

(a)

who the deceased was;

(b)

how, when and where the deceased came by his or her death;

(c)

the particulars (if any) required by the 1953 Act to be registered concerning the death.

(2)

Where necessary in order to avoid a breach of any Convention rights (within the meaning of the Human Rights Act 1998), the purpose mentioned in subsection (1)(b) is to be read as including the purpose of ascertaining in what circumstances the deceased came by his or her death.

(3)

Neither the senior coroner conducting an investigation under this Part into a person’s death nor the jury (if there is one) may express any opinion on any matter other than—

(a)

the questions mentioned in subsection (1)(a) and (b) (read with subsection (2) where applicable);

(b)

the particulars mentioned in subsection (1)(c).

This is subject to paragraph 7 of Schedule 5.”

Section 10 of the 2009 Act deals with the determinations and findings to be made following an inquest:

“(1)

After considering the evidence given to an inquest into a death, the senior coroner (if there is no jury) or the jury (if there is one) must -

(a)

make a determination as to the questions mentioned in section 5(1)(a) and (b) (read with section 5(2) where applicable), and

(b)

if particulars are required by the 1953 Act to be registered concerning the death, make a finding as to those particulars.

(2)

A determination under subsection (1)(a) may not be framed in such a way as to appear to determine any question of -

(a)

criminal liability on the part of a named person, or

(b)

civil liability.

Where an inquest is concerned with whether a particular factor caused death, the test to be applied is conveniently set out inTaintonv HM Senior Coroner for Preston and West Lancashire [2016] EWHC 1396 (Admin) at [62]: “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.”

Rule 19(2) of the Coroners (Inquests) Rules 2013 deals with the scope of questions that may be put to a witness in an inquest:

“A coroner must disallow any question put to the witness which the coroner considers irrelevant.”

The principles to be applied in determining the scope of an inquest are accurately and conveniently set out in the Defendant’s skeleton argument at [8] and I can do no better than quote what is said there (omitting those parts that comment on the case being advanced by the Claimant):

“(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.”

I would add to these principles the self-evident proposition that a coroner should not leave to the jury a verdict that could not be supported by the evidence that has been adduced before the jury a point explored further below on the issue of neglect.

Where it is contended that a finding of neglect should be included in a short-form conclusion or a narrative conclusion in the record of inquest, the Coroner must bear in mind the specific meaning of that word in this context. In R (Jamieson) v HM Coroner for North Humberside and Scunthorpe [1995] QB 1, the Court of Appeal held:

“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.”

Further, for such a finding to be made, the neglect must be shown to be a direct cause of death. As Richards J as he then was said inR (Khan) v Chief Constable of Hertfordshire Constabulary [2002] EWHC 302 at [43], “This must mean an opportunity of doing something that would probably have been effective, rather than the opportunity of doing something which simply might have made a difference.”

I bear in mind that whether an issue such as a neglect finding should be left to the jury is governed by the two limb test summarised by Haddon-Cave J as he then was inR (Secretary of State for Justice) v HM Deputy Coroner for the Eastern District of West Yorkshire [2012] EWHC 1634 (Admin) at [23]:

“…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?”. The second limb, arguably, provides a wider and more subjective filter than the first in certain cases. In my view, this extra layer of protection makes sense in the context of a coronial inquiry where the process is inquisitorial rather than adversarial, the rights of interested parties to engage in the proceedings are necessarily curtailed and coronial verdicts are at large.”

The Claimant accepts that a coroner has a wide discretion as to the scope of an inquest, including which witnesses should be called and what evidence they can give, and has a duty to disallow questions which considered to be irrelevant. However it was necessary to carry out a proper enquiry into how Ms Drysdale met her death. The link between the prescription of clozapine and Ms Drysdale’s development of AML was part of the broader circumstances of her death and should have fallen with within the ambit of that which was examined in the inquest. In particular, following R (Jamieson) v HM Coroner for North Humberside and Scunthorpe, it was incumbent on the Defendant to investigate all arguably causative issues, such that the inquiry should have investigated whether the side effects of clozapine masked symptoms of MDS, leading to delay in diagnosis of the MDS and, causing or contributing to Ms Drysdale’s death and whether the prescription of clozapine aggravated her condition or caused her death.

It is the Claimant’s case that there is no bar on an inquest investigating matters that might overlap with questions of clinical negligence and the standard of care provided to a patient so long as the material is relevant to the statutory task of the jury. The Claimant contends that the coroner unreasonably restricted the questioning and therefore the material that went before the jury, by applying tests of relevance to the questioning of witnesses when those tests were more relevant to what issues were left to the jury.

During oral submissions, the Claimant contends that the arguments advanced by Pennine Care conflate “actual” causation with “arguable causation” – if there was a credible basis for believing that certain acts or omissions might have contributed to death, the coroner should permit that to be explored in evidence. He accepted however that such arguable causation would have to be more than merely speculative or fanciful, such that there was reasonable basis to believe that the arguable causative factor could reach the threshold of being held to be actually causative applying the test as set out in Tainton above and that the coroner had a power to exclude questions that pointed to a causation argument that was simply too remote.

The Claimant contended that the material before the court was capable of supporting the conclusion that:

Even if the evidence on these issue was not sufficient to justify a finding of neglect or otherwise to lead to a narrative conclusion that dealt in greater detail with the significance of the clozapine prescription, these issues merited investigation in order for the coroner to consider the exercise of the power under regulation 28 of the Coroner’s (Investigations) Regulations 2013 to raise a concern about the possible misdiagnosis of haematological conditions where a patient is taking clozapine.

Further, the Claimant contends that the Defendant erred in not leaving the possibility of a finding of neglect to the jury. Whilst he accepts that such neglect would have to be “gross” to be capable of giving rise to such a conclusion, he cites the judgment of Davis J in R (Commissioner of Police for the Metropolis) v HM Coroner District of Greater London [2003] EWHC 1829 at [60] in support of the proposition that whether neglect can be described as “gross” is “a value judgment which ordinarily is to be assessed by the jury.” For the coroner to withdraw this issue from the jury was an unreasonable trespass on the jury’s functions.

The Claimant points out that additional information is available that was not before the original inquest, namely a full set of blood results Ms Drysdale during the period 28 March 2021 to 28 March 2023. The Claimant criticises Pennine Care for not disclosing this material earlier and contends that it should be before a new inquest.

The Defendant confined his written and oral submissions to setting out relevant principles of law without taking a stance on the conclusion that the Court should reach. To that extent his position was neutral and it is not necessary to summarise his submissions here, beyond noting the legal position as set out above.

During oral submission, Ms Hewitt for the Defendant emphasised the need for an inquest to focus on identified specific issues that were capable of being causative of (in the sense of materially contributing to) the death. The coroner needs to be alert not to permit the inquest to become a general review of the adequacy of the treatment of cared that has been given, so as to avoid offending Section 10 of the 2009 Act. The case that the Claimant was advancing would have involved detailed consideration of the treatment and decision-making process in 2022 when abnormal blood test results were arising. But this was not how the scope of the inquest had been set, nor should it have been, given the tenuous argument of a link between delayed treatment and death.

The Defendant made the point that, even if these questions had been put to the witnesses, it is difficult to see how a different result would have been achieved given the tenuous nature of the causation argument being advanced. I note that in responsive submissions, the Claimant did not accept this argument, saying that the new medical evidence now available by way of additional blood test results might lead to a different conclusion on causation. To this argument, the Defendant pointed out the statutory route to a new inquest if the Claimant sought to rely on additional material that was not before the first inquest.

Pennine Care adopts the Defendant’s analysis of the law. It contends that the Defendant is not to be criticised for preventing the Claimant asking either of the disputed questions. Neither would have assisted the jury in their deliberations as to “how” it was that Ms Drysdale died. The medical evidence before the jury was clear that there is no identified link between the prescription of clozapine and the development of leukaemia. To this extent it could not be argued that clozapine was a cause or contributory factor in Ms Drysdale’s death.

Insofar as the Claimant sought to argue that there was a delay in diagnosis of MDS/AML, Pennine Care contends that there is no material from which the jury could reach a conclusion that “neglect” played a part in the death of Ms Drysdale. The Defendant correctly directly directed himself on the test to be applied for such a finding and correctly reach the conclusion that it was simply not open to a jury to make that finding.

Ground 1 applies to each of the two questions in respect of which the Claimant complains that he was not permitted to raise.

It is clear from the Defendant’s summary to the jury of the issues that evidence was likely to address, as set out at paragraph 13 above, focused on questions as to whether the prescription of clozapine was justified and whether it in some way contributed to Ms Drysdale’s death. Indeed, the Claimant’s argument is advanced in his skeleton argument continues to contend that there is evidence to support the conclusion that the clozapine caused or contributed directly to the development of MDS and/or ADL. In light of the evidence from Dr Wiseman set out at paragraphs 19 and 20 above, there was simply no material from which a jury properly directed could conclude that such a contributory link could be made out so as to meet the test for causation set out in Tainton. The Claimant has not sort to pursue an argument that the coroner erred in this respect.

However, as the evidence developed during the inquest, the Claimant’s questioning began to address another argument – whether abnormal blood results obtained because of the monitoring of clozapine in fact were caused by the MDS that mutated into leukaemia or, at the very least, side effects of the clozapine masked signs or symptoms that could have led to a diagnosis of MDS. In particular, the response of Dr Wiseman set out at paragraph 24 above supports the conclusion that, whilst historic abnormal blood tests (going back to 2013) were unlikely to be connected to the MDS, the more recent abnormalities observed in 2022 might have been a consequence of the MDS. The very question that led to Dr Wiseman’s answer had been asked by the Defendant himself, so he was clearly alert to the possibility of the suggestion that abnormalities were misattributed to the clozapine.

The Claimant’s question referred to at paragraph 22 above that shortly preceded the exchange between Dr Wiseman and the coroner appears to have been prompted by the same line of thinking. Had Ms Drysdale not been prescribed clozapine (because she was not somebody who had treatment resistant schizophrenia), that drug obviously could not have been the cause of any abnormalities. In those circumstances, one might think that a treating doctor would have investigated the abnormal results further; the question then arises as to whether a doctor treating somebody who was taking clozapine should equally have been alert to the possibility that the abnormal results had a different cause.

Insofar as the Defendant prevented the question being asked because it potentially raised the alternative argument that clozapine should not have been prescribed, as I have indicated that was not in fact an argument that the Claimant pursued during the inquest, nor is it one pursued before me. The evidence is simply not capable of supporting a causative link between clozapine and the development of Ms Drysdale’s cancer, albeit that the possibility of such a connection is understandably thought to merit further investigation, as demonstrated by the Coroner’s Regulation 28 letter to NICE and various pharmaceutical companies.

But the question asked by the Claimant at paragraph 22 above was a perfectly proper question insofar as it was legitimate to investigate the treatment that Ms Drysdale had received. The question then arises as to whether the investigation of that treatment properly fell within the scope of the inquest. As I have identified above, the coroner does not appear to have been alert to this particular line of argument when he summarised the case to the jury at the outset. He is not to be criticised for that, since I cannot see any material that would have put him on notice that this was a probable argument to be investigated, prior to Dr Wiseman’s acceptance of a possible link between the MDS and the abnormal blood results. A coroner cannot be expected to examine the medical records with the acute scrutiny in which, for example, a clinical negligence lawyer instructed to advise the Claimant on whether a damages claim could be brought arising from his sister’s death might have been expected to engage.

Nevertheless, once an issue is raised, even if it has not been anticipated at the beginning of an inquest, it is accepted both by the Defendant and Pennine that the coroner is under a duty to review the scope of an inquest in the light of emerging evidence. Were this not to be the case, one would clearly risk an inquest failing properly to achieve its statutory purpose. Accordingly, I am satisfied that the coroner was bound to consider the implications of the point that lay behind the Claimant’s first disputed question to Dr Wiseman. The fact that he raised a question about the same issue, albeit wording it somewhat differently, indicates that he did so. Accordingly, the Defendant cannot be criticised for closing down the enquiry in this respect.

But the Claimant’s question went further than the Defendants insofar as it suggested that, had it been appreciated that the abnormalities in blood testing related to something other than the prescription of clozapine, the relevant health providers should have investigated matters further. The difficulty with this line of questioning is that it risks offending the prohibition in section 10 (2) of the 2009 Act, by raising questions that are only likely to assist in determining a forbidden issue of civil liability. The failure to investigate matters further is clearly capable of being a breach of the duty of care owed to Ms Drysdale which might be actionable in civil proceedings. If that was the only matter to which the question was relevant, the coroner would have been obliged under Rule 19(2) of the Coroners (Inquests) Rules 2013 to disallow the question on the grounds that it was not capable of leading to an answer which might be relevant and correspondingly the question would have fallen outside of the proper scope of the inquest.

It is only if the Claimant could show that the question either went to the possibility of a finding of neglect or could properly be said to be relevant to the circumstances of how Ms Drysdale came by her death that the question could potentially have been relevant. In the latter case, that itself would have involved consideration of whether there was any arguable breach of Ms Drysdale’s Convention rights within the meaning of the Human Rights Act 1998.

But there was no evidence before the jury from which they could properly have reached a verdict of neglect, even if there had been contradicted evidence the abnormal blood test results. This is because the medical evidence summarised above does not permit a finding that earlier diagnosis of the MDS would have resulted in a different outcome or even might in fact have done so. The passage from Dr Wiseman’s evidence set out at paragraph 18 above includes towards the end an acceptance that earlier recognition of MDS might theoretically affect matters, for example because a patient at an earlier stage of the condition might better tolerate a particular course of treatment. But Dr Wiseman gave no detail that could support the conclusion that was or at least might in fact have been the case for Ms Drysdale. From Dr Wiseman’s evidence, one simply cannot reach the conclusion that this was anything more than a theoretical possibility. In those circumstances, a finding of neglect contributing to Ms Drysdale’s death would have been irrational and itself capable of challenge on public law grounds; or to put the same point the other way round, there was simply no material that could have enabled the jury to reach the conclusion that the alleged failures of care were in fact a factor contributing to Ms Drysdale’s death.

The facts of this case also well demonstrate the very concern summarised by counsel for the Defendant at the fifth point of her summary of the principles of law relating to the scope of an inquest at paragraph 37 above. In order to lay the foundation for a finding that, by reason of the failure to diagnose Ms Drysdale’s MDS at an earlier time, a finding of neglect contributing to the death was available, it would have been necessary to point to evidence showing a gross failure to provide basic medical attention that directly caused the death. This would have required a detailed investigation into the medical issues in the case with an examination of issues of civil liability. The Coroner’s inquest is not established with that purpose in mind and the authorities make clear that a Coroner should not engage in that kind of exercise. The analysis by Richards J in R (Khan) v Chief Constable of Hertfordshire Constabulary at [43] sets out on the facts of that case the kind of evidence that would have needed to be before the jury to support that finding. The evidence in this case comes nowhere near supporting a finding that there was a probable loss of the chance of doing something that would in fact have been effective rather than simply the loss of an opportunity to do something that theoretically might have made a difference.

Insofar as it is contended that the question of neglect is properly to be treated as an issue for the jury (as was stated to be the usual position in R (Commissioner of Police for the Metropolis) v HM Coroner District of Greater London cited above), I accept that, as a general proposition, this is correct. A judgment on whether something is properly described as “gross” involves a value judgment which a jury may be asked to determine. It is however a prerequisite to that issue being left for the jury to determine that the material available to the inquest includes evidence that is capable of supporting that conclusion as well as whether it would be safe for the jury to reach that conclusion (see R (Secretary of State for Justice v HM Deputy Coroner for the Eastern District of West Yorkshire cited above at [23]).). That cannot be said to be the case here. There was simply no material from which the jury could reach the conclusion that the neglect was gross and accordingly it was not appropriate to leave the issue to the jury.

It follows that, even if the coroner may have misunderstood the Claimant’s first question, he put right that omission by himself asking a similar question but correctly did not permit the Claimant further to investigate this issue in the light of the material before the jury.

As with the first question, I see some evidence that the Defendant may have misunderstood the Claimant’s purpose in asking the second question. The question itself, at paragraph 25 above, is unfortunately ambiguously worded, insofar as the word “this” in the phrase “this would have likely contributed to Sasha’s death or at least the shortening of it” might be thought to be a reference to the prescription of clozapine. That seems to be how the Defendant read it in his ruling on this issue, since he responded to the point by referring to evidence that the prescription of clozapine may have been justified by Ms Drysdale’s condition rather than the considering the evidence as to whether the abnormal blood tests may have had a cause other than the prescription of clozapine but that the prescription of clozapine and the expectation of side effects from that drug was blinding the clinicians to the proper investigation of the situation.

The Claimant’s explanation at the inquest of his reason for asking the question, set out at paragraph 27 above, however shows that he was really concerned with the clinicians’ reliance upon clozapine as a probable explanation of the abnormal blood results. Accordingly, his question was actually related to the same issue as the first question, but now looking at it from the point of causation – had the true cause of the abnormal blood results been investigated, might Ms Drysdale have received treatment that would have prolonged her life?

As a question going to causation, this would not necessarily point the jury in the direction of making a determination that offends section 10 of the 2009 Act. But even if causation were made out, the answer to the question would only inform the jury’s verdict if a finding of neglect was open to it. For reasons I have identified above, I do not accept that the evidence here was capable of supporting that finding.

In any event, on the evidence of Dr Wiseman noted above at paragraph 24, the causation question could only be answered by saying that the putative lost opportunity to treated MDS/AML earlier may have caused the loss of a chance to do something that might have made a difference rather than it led to the loss of a chance to do something that would probably have been effective in prolonging life. Again that would not have been sufficient evidence to permit the finding of neglect to be left to the jury.

The Claimant’s argument (not expressed in the grounds themselves) that, were it legitimate to prevent this questioning the scope of the inquest was too narrow, does not take matters further. Assuming for a moment that the Coroner had found that this was an inquest that engaged wider questions of Convention rights, especially Article 2 rights, the Defendant is not to be criticised for preventing a line of questioning that simply could not inform any valid narrative conclusion that the jury could have reached. The only narrative conclusion that could have been arrived at on the evidence before the jury was along the lines that it might be the case that, had Ms Drysdale’s blood test results been recognised as being the potential consequence of MDS or some other haematological abnormality unrelated to the prescription of clozapine, it is possible that she may have been treated differently and that the outcome may have been different but that it was not possible to say that a different outcome would or indeed could in fact have been achieved by earlier or different treatment. That is not meaningful conclusion since it states no more than theoretical possibilities rather than engaging with actual causation and is not a conclusion which an Article 2 compliant inquest could properly have reached.

The Defendant was entitled to prevent the Claimant from asking both of these questions on the ground that the answers to them were not likely to be able to support the jury in making findings that were open to them. The coroner was therefore not only entitled to prevent the Claimant from asking them on grounds of relevance, he was bound to do so under Rule 19(2) of the Coroners (Inquests) Rules 2013. No public law error arises from the conduct complained of.

I have noted the Claimant’s complaint about the lack of adequate disclosure. This is not a ground on which judicial review has been sought. Given the Defendant’s acceptance that the new material is capable of being the basis of a fresh inquest, I do not consider that the theoretical possibility of fresh evidence on the issue of causation being available justifies the court acceding to an argument that the verdict of the first inquest should be quashed.

For the avoidance of doubt, this is not a decision reached on the basis that a fresh inquest under the statutory procedure gives the Claimant an adequate alternative remedy. I accept that it may be very difficult to obtain an order for a fresh inquest and I should certainly not be taken as suggesting that such an order might be justified. Rather, I consider that, where this ground of challenge has not been put before the court in the application for permission or indeed in the substantive application for judicial review save as a comment in oral submissions, the court should not accede to an implicit application for amendment to the ground, in particular where the causation argument remains speculative and the Claimant may (if able to firm up the causation argument) be able to pursue the matter by another route.

Given my conclusions that a verdict that Ms Drysdale died of “Natural Causes contributed to by Neglect” was not available on the evidence before the jury even if the questions been asked and had been answered in the way that the Claimant argues they may have been, there is no public unlawfulness either in the Defendant having prevented the questions being asked or in the failure to leave the neglect issue to the judgment. Accordingly the claim must fail.

During the course of submissions, I was invited to consider whether the Defendant should send a Regulation 28 report to Pennine Care, dealing with the possibility that Ms Drysdale’s abnormal blood tests were misunderstood in light of the fact that she was being prescribed clozapine. This suggestion was made by counsel for the Defendant and was not resisted by counsel for Pennine Care. Whilst this court is not able to make as close an examination of the issues that arise in respect of the blood tests as was the coroner, I can see considerable force in this proposal, since it must be a matter of concern that a psychiatric patient such as Ms Drysdale, who is being prescribed clozapine and consequently having blood tests, is at risk of abnormal results from those blood tests being misunderstood. I do not however have the power to order the coroner to make such a report in the absence of any identified public law error (of which I find no evidence) and in any event would be unwilling to draft the wording without a closer analysis of the blood tests. However I would give every encouragement to the Defendant to consider whether that course of action should be taken.

I make three final comments:

I invite the parties to seek to agree an order dealing with any matters consequential upon this judgment. In the meantime, I adjourn the question of any application for permission to appeal, requiring any such application to be made in writing within 7 days of service of this order on the party so applying. I extend the time for service of an Appellant’s Notice to the later of 21 days from the date of service of this order or, in the event that an application for permission to appeal is made to me, 14 days of determination of the application for permission by me.