R (Drysdale) v HMAC Manchester (South) [2025] EWHC 1850 (Admin) 18 July 2025, judgment here
To what extent an inquest must investigate possible causes of death is often a perplexing question. Until oral evidence is explored in a hearing it may not be known whether a possibility will crystallise into probability and so lend itself to a meaningful inquest conclusion. In this case the criticism levelled at the coroner was that he had prevented some questioning of an expert and so not permitted relevant possibilities to be explored.
Although there was some limited research evidence supporting a possible correlation between the prescription of an anti-psychotic drug and the development of fatal leukaemia, the judge was not persuaded the coroner had been wrong when he exercised his r.19(2) power.
Once the expert had confirmed the evidence of a causative association was scant, the Area Coroner had been correct to prevent additional questioning on the issue. There could not have been any meaningful inquest conclusion based on the expert evidence, since it revealed no more than a theoretical possibility which could not support factual or legal causation.
Background
The Claimant’s sister, Sasha Drysdale, had been prescribed clozapine, an antipsychotic drug that can potentially affect white blood cells. Consequently blood tests are required before its prescription can safely continue. On some occasions Ms Drysdale’s blood count had been abnormal, leading to clozapine being stopped but later restarted. When his sister died from acute myeloid leukaemia (‘AML’) the Claimant questioned a possible link between the prescription of clozapine and the development of Ms Drysdale’s AML.
At the inquest the treating psychiatrist’s evidence was that he had worked as a psychiatrist for over 33 years and had never come across this suggested link before. The expert haematology evidence was that Ms Drysdale had gene mutations that caused a sub-type of AML that was hard to treat, was well recognised to have poor prognosis, and was effectively incurable. The expert haematologist stated that “clozapine was not a drug that any haematologist would instantly have in their head as linked to acute leukaemia development” and that clozapine was not known to cause genetic damage. However he also cited a study from 2010 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.”
“Over-interpreting a very speculative dataset”
When then asked by the coroner whether he thought Ms Drysdale’s treatment with clozapine had more than minimally contributed to the development of the AML, the expert’s view was that it would be “over-interpreting a very speculative dataset” as there was insufficient evidence in the medical literature to make such a link.
When the claimant also sought to ask the expert whether, if results similar to his sister’s blood tests were obtained from a person who was not prescribed clozapine, this would have suggested further investigations were required to rule out potential bone marrow malignancies the coroner disallowed that question. The claimant was also stopped from asking whether there had been a causatively relevant lack of haematological referral or investigation. At the end of the inquest the jury returned a conclusion of death from natural causes.
The JR claim
Judicial review proceedings were brought with two grounds relied upon:
- the coroner wrongly refused to allow the claimant to put his questions to a medical expert
- the coroner wrongly decided not to leave a conclusion of neglect to the jury.
During the hearing, as it was clear that the medical evidence could not demonstrate a causative link between the prescription of clozapine and the development of AML, the Claimant dropped a major plank of his argument that neglect should have been available. The Claimant still asserted that there was a credible basis for believing that a failure to attribute the abnormal blood tests to developing AML might have contributed to death, and so the coroner should have permitted that issue to be explored during the evidence. He argued that even if the evidence was not sufficient to justify a finding of neglect, the issues merited investigation so that the coroner might consider the exercise of the power under regulation 28 Coroner’s (Investigations) Regulations 2013 to raise a concern about future deaths possibly related to the misdiagnosis of haematological conditions where a patient was taking clozapine.
The judge’s decision
The judge remarked upon “the self-evident proposition that a coroner should not leave to the jury a conclusion that could not be supported by the evidence that has been adduced before the jury”
A conclusion of neglect required a gross failure of basic care that was a direct cause of the death. It was a prerequisite to an issue being left for the jury to determine that the material available includes evidence that is capable of supporting that conclusion as well as whether it would be safe for the jury to reach that conclusion.[1] That could not 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 also no evidence to support probable causation
As there was not any reasonable basis to believe that the arguably causative factor here could ever reach the threshold of being held to be actually causative the coroner had been correct to refuse to leave the possibility of neglect to the jury.
Theoretical possibilities do not require exploration
Furthermore, the only narrative conclusion that could have been arrived at on the evidence was along the lines that it might be the case that, had Ms Drysdale’s blood test results been recognised as potentially showing developing AML 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, said the judge, was simply not meaningful conclusion since it stated no more than theoretical possibilities rather than engaging with actual causation and it was not a conclusion which an Article 2 compliant inquest could properly have reached.
Taken against the background, the Claimant’s suggestion that, had it been appreciated that the abnormalities in Ms Drysdale’s blood tests related to something other than the prescription of clozapine, then relevant health providers should have further investigated matters was not a line of questioning that should have been permitted. This was because such questioning raised matters that could not support any coronial conclusion but were only likely to assist in determining the issue of civil liability, which was prohibited by section 10 (2) of the 2009 Act. In the judge’s view, even if the impugned questions had been put to the witnesses, it was difficult to see how a different result would have been achieved given the tenuous nature of the causation argument being advanced and the tenuous support for any link between allegedly delayed treatment and death.
The claim was therefore dismissed.
Commentary
That the clamant lost his claim will surprise no-one. A Coroner has a wide discretion regarding the scope of an inquest and even in an Art 2 inquest is entitled to exclude questions that point to a causation argument that is simply too remote or too speculative. There was at most only scant evidence from a single study of a statistical association between prescription of clozapine and the development of AML.
With a disease that was hard to treat, had poor prognosis, and was effectively incurable whether any earlier recognition of the blood disorder would have made any difference was also unknown and unknowable. The effect of Galbraith (without any gloss) meant that no conclusion implying causation or possible causation could have been safely left to the jury.
PFD matters
Although not part of the ratio of the case the epilogue to the judgment contains a slightly baffling discussion relating to a report to prevent furture deaths (a ‘PFD’ report) at §76-§77.
On 18 July 2024, after the inquest ended, the Coroner had issued a PFD report (see here) aimed at NICE[2] and three manufacturers of clozapine,[3] in which he set out his concern that further research was needed to refute or confirm whether taking Clozapine materially increased the risk of a patient developing certain blood cancers. The recipients had replied by September 2024, each explaining why none of them perceived any need to take any action.[4]
However during the course of submissions, the judge was invited by the Coroner to consider whether he should now send an additional Regulation 28 report, dealing with the possibility that Ms Drysdale’s abnormal blood tests were misunderstood in light of the fact that she was being prescribed clozapine. It is not clear what prompted the coroner to seek the judge’s opinion about a further PFD report, all that is said is that the suggestion was not resisted by the NHS Trust.
The judge responded saying that he could “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.”
The judge noted that a High Court judge has no power to order the coroner to make such a report in the absence of any identified public law error (of which he found no evidence)
However, the judge was prepared to go as far as saying that he would “give every encouragement” to the coroner to consider whether a PFD report should be sent.
It is not clear why the coroner felt the need to invite a judge to indicate to him whether he should issue a PFD report or not. The relevant law is clear,[5] if in a coroner’s opinion action should be taken to eliminate or reduce the risk of future deaths then that coroner is under a statutory obligation to issue a PFD report. The subjective opinion of the coroner is what is relevant, not anyone else’s view, even if the other person is a High Court Judge. There is no limit of time under Reg 28 for issuing PFD reports, although it must be quite unusual to issue such a report a year after an inquest has ended.
Where the purpose of such a report is to prevent other deaths, then delaying the issuing of a PFD report to seek a High Court judge’s opinion about whether or not to issue a report must be inimical to the statutory objective of saving lives. It is hardly a welcome precedent if coroners should feel they need to first seek the endorsement of a judge before to exercising their PFD powers, or if claimants should now think they can invite a High Court judge to encourage or put some pressure on a coroner to issue a PFD report when one has not been issued.
The judgment does not reveal to whom the putative report is to be sent. The NHS Trust involved have been aware of the issue for over a year. Perhaps all will become clearer once the anticipated report is eventually published.
Footnotes
[1] R (Secretary of State for Justice v HM Deputy Coroner for the Eastern District of West Yorkshire [2012] EWHC 1634 (Admin) at [23].
[2] NICE is not the regulator for medicines and medical devices in the UK nor NICE does it have a direct role in clinical research the UK. The regulatory role falls to the Medicines & Healthcare products Regulatory Agency (MHRA). The MHRA is responsible for issuing the marketing authorisation for medicines (also known as the licence) and has ongoing responsibility for monitoring their safety.
[3] Vitaris UK Healthcare Ltd, Britannia Pharmaceutical Ltd; and Leyden Delta Ltd.
[4] See the responses published here.
[5] Paragraph 7(1) Sched 5 CJA 2009