Critical care and the law – pertinent cases from 2024

Abstract

This review by the Legal and Ethical Advisory Group (LEAG) follows the 2023 summary, reviewing the important legal cases and Prevention of Future Deaths reports (PFDs) ruled or issued in 2024 that are pertinent to Intensive Care Medicine. The legal cases include Human Rights cases, Clinical Negligence cases, and rulings of the Court of Protection. Not all of the cases relate to events which have occurred in Intensive Care, however the rulings will have a bearing on Intensive Care practice.

Introduction

This article is the 2024 edition of the Legal and Ethical Advisory Group’s (LEAG) summary of legal cases relevant to practice in the Intensive Care Unit (ICU).

As with the 2023 summary, four types of legal cases and reports are included in this summary. The first are cases relating to human rights. These cases cut across traditional legal boundaries, and pertain to subjects such as consent, capacity, autonomy and privacy. The second type relates to the law of negligence, that is the legal mechanism by which patients are compensated for harm caused by a breach of a duty of care. The third relates to the Court of Protection, which is responsible for a final decision on a patient’s capacity, and for determining a patient’s best interests in the event of a disagreement. Finally, Prevention of Future-Deaths (PFD) reports highlight issues arising in the Coroner’s Court which may relate to ICU practice.

Human rights

Pindo Mulla v Spain ¹ concerns the refusal of blood transfusions by a Jehovah’s Witness. The case is brought to the attention of the ICU community to highlight three points; the international context of Human Rights Law, the way in which Articles 2, 8 and 9 of the European Convention interact, and the application of these rights to patients being transferred between hospitals.

Clinicians should be familiar with the content of the European Convention on Human Rights and Fundamental Freedoms (ECHR). ² The ECHR is short and accessible to non-lawyers, and familiarity is best achieved by reading the Convention itself. The Human Rights Act 1998 ³ incorporates ECHR rights into UK law, and cases can be appealed through the national court system and subsequently to the European Court of Human Rights in Strasbourg. Cases which reach the Strasbourg court, of which Pindo Mulla v Spain is one, concern important points of interpretation of the ECHR, or its application to difficult circumstances. Although the events of Pindo Mulla occurred in Spain, the principles of interpretation of the Convention apply in the UK.

Pindo Mulla was due to have surgery for a uterine fibroid, and drew up documents setting out her refusal of a blood transfusion. After surgery she was anaemic, and was transferred to a different institution with expertise in avoiding blood transfusions. Concerned about the patient’s unstable condition, anaesthetists at the receiving institution – prior to the patient’s arrival – requested direction from the duty judge as to how to proceed. The judge was informed of the patient’s verbal refusal of transfusions, but not of the existence of the written documentation. The judge granted authorisation to treat the patient with measures necessary to safeguard her life.

The patient was conscious on arrival, but the receiving clinicians felt the situation was emergent and proceeded to surgery without adhering to the usual process for informed consent. Three units of packed red cells were transfused during the case.

Three articles were relevant to the case: Article 2 (Right to life), Article 8 (Right to respect for private and family life) and Article 9 (Freedom of thought, conscience and religion). The court emphasised that Article 8 confers on adult patients the right to refuse medical treatment notwithstanding serious or even fatal consequences. Article 8, read considering Article 9, confers autonomy in relation to the treatment of her illness, allowing her to make decisions rooted in religious teachings. Article 2, in protecting the right to life, requires a refusal of life-saving treatment to be clear, specific and unambiguous. Some countries, including the UK, achieve compliance with Article 2 by requiring a refusal of life-sustaining treatment to be documented, signed and witnessed, with a statement confirming an understanding that the refusal might result in death. If after reasonable efforts the patient’s refusal cannot be established, the duty to provide care which protects life must prevail.

The Court found that the overall framework for protecting the autonomy of patients was appropriate. However the proceedings before the duty judge were in this instance inadequate, and ambiguities as to the patient’s wishes ought to have been resolved by discussion with the patient on arrival at the receiving institution. The patient had not been made aware of the duty judge’s decision, which made challenge and correction impossible. It should be noted that the judge was not criticised for ordering the blood transfusion, because the information given by the clinical team who had received the patient from the referring hospital was inaccurate.

The case highlights the risk to patient autonomy of inter-hospital transfers. Despite the transferring team’s best efforts, the handover of a patient’s wishes may not receive the same priority as handover of treatments, observations and clinical status. Documentation is liable to become misplaced, misfiled or lost within the overall bundle of paperwork. A specific handover prompt for important patient decisions or refusals may be considered by teams involved in patient transfers. Of note, in Spain advance decisions are copied onto a national register which makes them available to healthcare providers throughout the region.

For a further analysis of the judgement, and the relationship with the Oviedo Convention ⁴ (an international bioethics convention to which the UK is not a signatory), the interested reader is referred to the excellent case report by 39 Essex Chambers. ⁵

Negligence

Paul v Royal Wolverhampton NHS Trust ⁶ concerns family members who witness traumatic medical events, or their aftermath, where the illness in question is caused by the negligence of a healthcare provider.

Witnessing the death of a close family member can have a powerful psychological impact. However the court explained that society is not at a stage where witnessing death of a family member from disease is something from which a person can reasonably expect to be shielded by the medical profession.

our opinion that the persons whom doctors ought reasonably to have in contemplation when directing their minds to the care of a patient do not include members of the patient’s close family who might be psychologically affected by witnessing the effects of a disease which the doctor ought to have diagnosed and treated. Hence there does not exist the proximity in the relationship between the parties necessary to give rise to a duty of care. – para 142

The case is pertinent to ICU practice as relatives are often present at the bedside, and the acuity of the patients and invasiveness of available techniques increase the risk that relatives witness a traumatic and unforeseen event. Where negligence causes the patient harm, the patient may be awarded compensation for injuries sustained to themselves, but family members cannot claim for the psychiatric injury of witnessing the patient’s injuries, or the patient’s subsequent death.

In Winterbotham v Shahrak ⁷ a patient claimed against their dentist for failure to adequately obtain consent for an invasive procedure. The procedure itself was performed adequately, and the patient was informed of relevant risks, including those of lingual nerve damage which in fact materialised. The claim was founded on the failure of the dentist to explain the availability of an alternative treatment which did not have this risk.

The case is brought to the reader’s attention to emphasise that it is not sufficient to explain the benefits and risks of a proposed procedure. The relevance of those risks can only be fully appreciated, and so the patient’s autonomy only fully respected, if the patient is also aware of the alternative options and their associated risks, including the option of not receiving treatment. Clinicians may also be aware that standardised consent forms do not always prompt the documentation of this aspect of the discussion, or provide space for its record.

Jessica Tuffin v University Hospitals Coventry ⁸ pertains to a failure to prescribe low molecular weight heparin after spinal surgery. The patient developed a deep vein thrombosis, as well as developing Complex Regional Pain Syndrome (CRPS) which ultimately required an above knee amputation. The case turned on the legal test for causation, and the court relied on the Court of Appeal judgement Bailey v Ministry of Defence ⁹ ;

In a case where medical science cannot establish the probability that ‘but for’ an act of negligence the injury would not have happened but can establish that the contribution of the negligent cause was more than negligible, the ‘but for’ test is modified, and the claimant will succeed. – para 46

In this case the patient was not able to convince the court that a DVT can cause CRPS, so that the patient was only able to claim for the injury relating to the DVT. The case illustrates the application of two legal tests of causation, in a post-operative context that will be common in ICU. The first is the but-for rule, in which but-for the negligent act the harm would not have occurred. Where this test is not satisfied but medical science can establish that the negligent act made a material contribution to the harm, the patient can still claim. Where the failure of an ICU to administer thromboprophylaxis falls below the relevant standard of care, the trust will be liable for those consequences which can be established by medical science to have been caused, or been materially contributed to, by that failure.

MJF v University Hospitals Birmingham ¹⁰ is relevant to all healthcare staff, but particularly those who – due to the time-sensitivity of their work – will need to write notes retrospectively. The case relates to the reliability of healthcare records made contemporaneously, and relied on two Court of Appeal judgements, useful excerpts of which are quoted below:

Synclair v East Lancashire ¹¹ ;

. . .it is too obvious to need stating that simply because a document is apparently contemporary does not absolve the court of deciding whether it is a reliable record and what weight can be given to it. Some documents are by their nature likely to be reliable, and medical records ordinarily fall into that category. . . para 12

And Manzi v Kings College Hospital ¹²

Clinical records are made pursuant to a clear professional duty, serious failure in which could put at risk a practitioner’s registration. Moreover, they are not compiled simply as a historical record, they fulfill an essential and ongoing purpose in informing the care and treatment of a patient. Contemporaneous records are for these reasons alone inherently likely to be accurate. – para 18

In summary contemporaneous medical notes will ordinarily be considered accurate because they are made for an important purpose by registered practitioners. However, the court retains the discretion to find that medical notes are inaccurate, whether made contemporaneously or retrospectively.

In Spellman v Portsmouth Hospitals University NHS Trust ¹³ the court considered whether a radiologist had been negligent in the interpretation of an MRI study, which had been performed to exclude cauda equina syndrome. The specific details of the case are not material, however the court’s approach to clinicians who interpret images is instructive. Firstly the court will determine, using expert evidence, what the relevant imaging or study demonstrates. The court will then determine whether a clinician exercising reasonable skill and care would be able to identify this. If relevant, the court will then consider whether the clinician acted reasonably on the scan, given what they were able to identify. ICU clinicians will frequently rely on their own interpretation of medical imaging, using that interpretation to make clinical decisions sometimes before a formal report of the imaging is issued. There are therefore two separate processes of interpretation and then action – albeit likely conducted in close succession – each of which may separately fall below the appropriate standard of care.

Court of protection

Hemachandran & Anor v Thirumalesh & Anor ¹⁴ arises from the same clinical case discussed in the 2023 LEAG summary, relating to freedom to publish information about clinicians. This legal case relates to the interpretation of section 3(1) of the Mental Capacity Act 2005. ¹⁵

Section 3(1):

Inability to make decisions

• (1) For the purposes of section 2, a person is unable to make a decision for himself if he is unable—

• (b) To retain that information,

• (c) To use or weigh that information as part of the process of making the decision, or

• (d) To communicate his decision (whether by talking, using sign language or any other means).

The patient in this case did not believe their diagnosis or their prognosis. However the court held that this did not inevitably undermine their capacity; a failure to believe a diagnosis or prognosis does not necessarily mean that a patient does not understand relevant information. This is particularly important in the ICU, where prognostication is complex, diagnosis may not be established, and decisions will often pertain to life-sustaining treatments.

Whittington Health NHS Trust v XY ¹⁶ recognised the established trends of the ICU community in relation to prolonged disorders of consciousness (PDOC).

These days, the consensus amongst the medical profession is that prolonged disorder of consciousness is a continuum which it is unnecessary, artificially, to demarcate by labels. XY, in the view of all the doctors involved in his treatment, is at the lowest point on the spectrum of prolonged disorders of consciousness. That is all they are required to say on this point. Given the wide medical consensus that I have referred to, the time has surely come to consign the phrase, ‘persistent vegetative state’ to the past.

Similarly Northumbria Healthcare v HX ¹⁷ involved the withdrawal of life-sustaining treatment, and reaffirmed the trend away from requiring a specific diagnosis. The judge instead emphasised the importance of the patient’s current clinical state, and the certainty around the prognosis.

North Central London ICB v Royal Hospital for Neurodisability ¹⁸ highlighted how difficult it can be even for specialist centres to have effective processes in place for best interests decision-making.

even a specialist facility remained drifting in a vacuum of ineffective best interests decision-making – para 88

The Court of Appeal emphasised that any institution responsible for caring for patients with PDOC should pro-actively consider the 2020 RCP Guidelines ¹⁹ and the Vice President’s Guidance, ²⁰ have clarity about who is responsible for making enquiries about a patient’s best interests, and ensure there is a rigorous process for making best interests decisions,

King’s College Hospital v XY ²¹ related to a withdrawal of life-sustaining treatment, including Clinical Assisted Nutrition and Hydration (CANH). The case provides an accessible and useful summary of relevant principles that the court will apply to best interests proceedings. Although some of these principles are covered in the 2023 LEAG summary, ²² we include a condensed restatement here for our readers’ reference.

1. Treatment includes CANH.

2. Neither the patient nor family nor court can force a doctor to give a particular treatment.

3. The court considers matters from the patient’s point of view, and in so far as the patient’s wishes feelings beliefs or values can be found out, the court should take them into account.

4. The nature of the patient’s condition and likelihood of regaining capacity and the timescale should be considered.

5. The importance of an actual diagnosis has reduced over time, it is the information relating to their condition and prospect of recovery that matters.

6. Strong but rebuttable presumption that it is in the patients best interest to stay alive.

XY (Withdrawal of Treatment). ²³ It will be familiar to the ICU clinician that a dispute as to the patient’s capacity or best interests should be referred to the Court of Protection. The subsequent route by which such a decision may be challenged may be less familiar. This case is included to draw the reader’s attention to the ability of any party to apply for permission to appeal the decision of the Court of Protection. This will only be granted if the Court of Protection’s decision is likely to be wrong, or unjust because of procedural irregularity, neither of which was applicable here.

Prevention of future deaths

Strictly these are not court rulings, as they arise from a statutory duty to issue reports where issues highlighted in a coronial inquest have the potential to cause further loss of life if not corrected. The reports are issued under Regulation 28 of The Coroners (Investigations) Regulations 2013, ²⁴ and so are sometimes referred to as Regulation 28 Reports.

Ref 2024-0696 deceased name: Anne Leake

This PFD highlighted the risks associated with using different electronic patient records in different departments of the same hospital. An MDT decision was made to insert an ICD, and the decision was stored on a centralised record accessible to all teams. Each team also had its own separate electronic patient record, available only within that team. As the centralised record was not checked, the patient was discharged without the device being implanted, and unfortunately suffered a fatal cardiac arrhythmia.

Ref 2024-0695 deceased name: Eleanor Aldred-Owen

This case concerned a chest radiograph demonstrating a tension pneumothorax. The standard operating procedure in the clinical area did not contain a provision for radiographers to escalate care or put out a peri-arrest call, and in the event the radiographer did not raise an alert in person with the patient’s clinical team. The events did not occur in intensive care, but the use of portable chest X-rays in levels 2 and 3 units is commonplace, and patients receiving level 2 care may not always have a bedside nurse immediately available.

Ref 2024-0517 deceased name: Sophie Dean

Key consultation and discussion details were omitted by very junior doctors scribing, and the notes did not reflect important details of consent discussions. The use of doctors in training to scribe is commonplace and not objectionable per se, however whatever practice is used should ensure the notes accurately reflect the contents of the important and technical discussions which can occur in Intensive Care.

Ref 2024-0389 deceased name: Joseph Parker

This case concerned an intensive care doctor attending the emergency department for an emergent intubation. The endotracheal tube was discovered to have been placed in the oesophagus. The risk of oesophageal intubation is well-recognised. The case highlighted that although the use of capnography is standard practice, there is currently no guidance on what capnography measures constitute confirmation that the endotracheal tube is correctly placed. Guidance would be particularly helpful to standardise decision-making for intensivists working with other teams, and in other departments.

Ref 2024-0342 deceased name: Brian Colby

The clinical status of the patient deteriorated whilst admitted to the ICU. No adequate protocols for escalation to the on-call consultant were available, and the escalation in this instance was via text message. This raises the risk of the communication not being sent, not being noticed and not being auditable.

There were also no clear policies for recording clinical information, with the unit in question using a hybrid approach which included paper notes and an electronic patient record.

The coroner also highlighted the risk of uncertainty around authority to request imaging out of hours. On site resident doctors were under the impression that they did not have the authority to request scans, and efforts to convey the actual policy (which did give resident doctors the required authority) had not been effective.

The report is particularly valuable in emphasising that even where a risk within an institution is highlighted publicly, by an external body, as a result of a case in which the patient has died, remedial measures may be ineffective. Organisations should not be complacent when a risk is identified, nor should an organisation be complacent that action taken has necessarily been adequate or effective. That the institution in this case was a private hospital does not preclude the same issues being found in NHS facilities.

Ref 2024-0277 deceased name: Miriam Stone

This case highlighted the risks of admission to a department during handover periods. Admission immediately before or during handover results in ambiguity in relation to task allocation and completion, and ineffective transfer of information to the receiving team. In this case, important clinical and risk assessments were not conducted owing to these ambiguities in responsibility. The events in this case did not occur in Intensive Care, and many units will have protected handover policies; this case serves to emphasise the value of these policies and encourage their universal adoption.

Ref 2024-0256 deceased name: Ben Harrison

The coroner identified that healthcare staff do not always understand that a new CD oxygen cylinder has a tamper-evident cover, under which there is a valve which must be set to open to allow the flow-metered oxygen to flow. The case did not occur in intensive care, where there may be greater familiarity with the features of CD cylinders, however intensivists often work in conjunction with other clinicians.

Ref 2024-0116 deceased name: Jennifer Trigger

The coroner highlighted that the bleep system in use at the hospital did not allow users to convey information. This resulted in a communications system which did not assist resident doctors to prioritise time-critical tasks. The coroner highlighted that alternative systems exist which do allow important information to be conveyed to residents, reducing ambiguity in the importance of the call.

Ref 2024-0082 deceased name: Michael Nye

It is common practice in some institutions to issue a ‘just to let you know’ notification to intensive care. The coroner highlighted (coroner’s emphasis):

The need for training of all Intensive Care Unit clinicians at all levels, both existing Intensive Care Unit clinicians and new joiners, in the policy that a ‘just to let you know’ call should result in an Intensive Care review of the patient.

This PFD report has understandably prompted consideration of the value of ‘just to let you know’ calls. Such calls do not have a standardised purpose across trusts, so that it will not be clear what is to be expected from the recipient of such a call. We suggest that most such calls, when made to the ICU team, might instead be reasonably constituted as a request for advice, a request for practical assistance at the bedside, or a referral for consideration of admission to ICU. This PFD was also the subject of a FICM safety bulletin, ²⁵ which can be found here, recommending that clarification of the requested outcome should be obtained, the call should be documented, and if in doubt an in-person review should take place.

Similarly with other cases described in this series, the coroner was also critical of the absence of out-of-hours escalation policies (in particular where general escalation policies were demonstrably non-functional at night) and the burdensome processes which can be involved in requesting scans out of hours from external providers.

Ref 2024-0011 deceased name: David Moore

The National Tracheostomy Safety Project guidelines ²⁶ provide an algorithm for management of issues with tracheostomies, with separate guidelines depending on whether the patient does or does not have a patent upper airway. The coroner in this case highlighted that national guidelines do not exist which cover regular assessment of flanged tracheostomy tubes. ICU clinicians should be aware of the particular risk of misidentifying correct placement, and difficulties in troubleshooting flanged tracheostomy tubes, especially where these tubes are infrequently encountered.

Conclusions

We hope this summary of legal cases from 2024 is informative for the ICU community. We have outlined important Human Rights considerations for patient transfers, and considered clinical negligence cases relating to consent, post-operative care, the legal test of causation and the way in which courts will assess medical documentation. We have also reviewed Court of Protection cases relating to the withdrawal of life-supporting care, including the Court’s understanding of trends in care of patients with PDOC, and the interpretation of Section 3 of the Mental Capacity Act. Lastly we highlight PFD reports covering commonly used equipment, documentation, procedures and imaging, and clinical communication and escalation pathways. Knowledge of the legal landscape will hopefully complement the medical expertise of ICU clinicians and allow them to practice safely and confidently.