Clinical Law Insight: Winter 2020/202104/02/21
Prioritisation of patients for life-saving treatment
A coalition of healthcare organisations has written to the Health and Social Care Secretary requesting immediate legal protection for doctors if they are forced to choose between patients when demand for life saving treatment is at capacity. How should clinicians approach what are likely to be the most challenging decisions of their professional lives?
Comment: The BMA has issued guidance which includes the circumstances in which it considers it would be lawful and ethical to refuse potentially life-saving treatment. The guidance makes it clear that doctors should follow accepted local guidance and protocols. Trusts should review these against the criteria set out by the BMA.
New GMC fitness to practise guidelines
The GMC has published new guidelines to be used by its assessors when investigating complaints and fitness to practise issues. Context/ environmental factors will be taken into consideration, in particular the resources, guidelines and protocols in place at the time. The guidelines re-iterate the primary requirement for all doctors to react responsibly and reasonably to the situations that they face based on the circumstances at the time. The GMC’s ethical guidance will continue to apply as far as is practical in the circumstances.
Comment: The guidelines will have come as a relief to medical practitioners who have expressed concern about how they will be judged on treatment decisions in the pandemic, given that some of them have been re-deployed to unfamiliar areas, returned from retirement, started working whilst still a student or are simply faced with working with a lack of resource. However, what we have said about this and the legal and ethical issues around prioritisation of patients for life-saving treatment should be read in the context of the Supreme Court decision in Maughan. See ‘Inquests’ below
Resource issues are likely to be a significant feature in determining the standard of care in non-Covid claims arising during the pandemic
Commentators have predicted that delay in treating non-Covid-19 medical conditions during the pandemic is likely to be the basis for the majority of Covid-19 claims. Oncologists have expressed particular concerns about delays in cancer diagnosis and treatment, given the impact of the first lockdown on cancer services. Poorer outcomes associated with delay in diagnosis could lead to a significant increase in the number of cancer and other clinical negligence claims. The interface between finite healthcare resources and the standard of care is likely to be under close scrutiny.
Comment: Whether the alleged breach of duty involved a decision at a macro or micro level, is likely to be key to establishing the standard of care. Existing caselaw shows the courts unwilling to impose liability where there is a macro / economic decision is made (e.g. in Hardaker v Newcastle Health Authority (2001) a hospital was not liable for failing to have a decompression chamber available for a diver suffering the bends. On the other hand where the decision is a micro / medical one, they have been more ready to impose liability (e.g. Bull v Devon Area Health Authority (1993), where there was a one hour delay securing the attendance of a suitably qualified doctor. The Court of Appeal determined that a system in place to secure prompt attendance was a bottom-line which had to be met.
The decision in Maughan may have wider consequences than intended
The Supreme Court decision in R (Maughan) v HM Senior Coroner for Oxfordshire & others  UKSC Civ 809 means that all inquest conclusions (including suicide and unlawful killing) should now be decided on the balance of probabilities, rather than the criminal standard of proof which applied previously.
Comment: A trend is already emerging of families raising the issue of unlawful killing at inquest, either by way of gross negligence manslaughter by the clinicians involved or corporate manslaughter by the organisation. With the change following Maughan and as an unintended consequence of that decision, it will be necessary to consider the potential for personal criticism and possibly criminal investigation/liability. Inevitably, that will result in more complexity and separate representation for clinicians and organisations at inquests with a potentially significant impact on cost. Read our Insight for more information on the impact of the decision.
Inquests costs recovered by family where Defendant failed to make appropriate admission
In Greater Manchester Fire & Rescue Service v Veevers  EWHC 2550 (comm) the Claimant’s costs of attending an inquest were determined to be recoverable costs in a subsequent action for damages under the Fatal Accidents Act 1975. The Defendant had stated in open correspondence that it was “willing to compensate the estate and dependants” and “deal with the claims on a full basis.” However, it was also stated that the Defendant was “not in a position to consider an admission of liability.” These words were not considered to amount to an appropriate admission within the meaning of the CPR. This meant it was reasonable for the Claimant’s lawyers to attend the inquest and seek to recover costs.
Comment: This case serves as a reminder that an early decision should be made on whether an admission of liability is necessary and care taken in how this is expressed. Otherwise the risk is run that inquest costs will be recoverable from the Interested Party if it becomes a Defendant in a subsequent clinical negligence claim.
Safety and Learning
The Elizabeth Dixon Investigation – learning from clinical error
In his investigation report Dr Bill Kirkup describes the life and death in 2001 of 11-month old Elizabeth Dixon as a “catalyst for change”. The report identifies multi-agency system failures in Elizabeth’s short life and the investigation of the circumstances of her death. Twelve recommendations are made, which span NHS and private healthcare, regulators, Royal Colleges, police and the justice system itself
Comment: The events surrounding the tragedy of Elizabeth Dixon predate the Francis Inquiry Report (2013) which led to the statutory duty of candour. However, the report echoes concerns around transparency and openness, governance and learning identified in the Paterson Inquiry Report and the Independent Medicines and Medical Devices Safety Review earlier in 2020. There is still work to be done to embed the duty of candour in the health service and learn from clinical error. Although the report’s remit is historic, it highlights the need to seize every opportunity for learning and that this should not be restricted to current incidents, complaints and claims. Read our Insight into the report and its recommendations
Initial learning from the Ockenden review into maternity services at The Shrewsbury & Telford Hospitals NHS Trust
The interim report identifies emerging findings and makes recommendations following review of 250 of 1,862 cases of “alleged avoidable neonatal and maternal deaths and harm” at SaTH between 2000 and 2019. Seven of the 34 recommendations relate to learning to be shared and acted upon by maternity services across England and are described as Immediate and Essential Actions. They span the need for increased collaboration between Trusts and partnership working across local networks to enhance patient safety, ensuring the voices of women and families are heard, multi-disciplinary training and working, managing complex pregnancy, risk assessment throughout pregnancy, fetal monitoring and ensuring informed consent is obtained about place and mode of birth.
Comment: The report shows what can happen when governance processes are inconsistent or fail, leading to loss of valuable learning opportunities to prevent future harm. NHSEI has driven forward the recommendations with its letter of 14 December 2020 (updated 11 January 2021) . Trusts were required not only to implement and certify compliance with 12 urgent clinical priorities spanning the 7 recommendations by 21 December 2020, but to complete an assurance assessment tool by 15 February and confirm that they have a plan in place to Birthrate Plus standard by 31 January 2021 and their timescales for implementation.
MBRRACE report into neonatal deaths & twin pregnancies
The inquiry looked at 50 twin pregnancies in 2017 where one or both of the babies died. It found that in 1 in 5 baby deaths the care was good, in 1 in 2 deaths it was poor. Had it been better, the death may have been prevented. For around 3 in 5 mothers care after their baby/babies died was poor.
Comment: The report echoes some of the concerns raised in other inquiry reports, particularly Ockenden. For example: the need for multi-disciplinary ante-natal and intrapartum care; lack of ante-natal discussion of individual risks; lack of regular scanning and referral to highest level fetal medicine centres for monochorionic pregnancies; lack of support following births/bereavement; and issues around the number and quality of hospital reviews of deaths. Trusts should review their policies and guidelines on the issues identified by the report.
ICO data protection audit reports highlight learning from assessments
The ICO considers that “audits play a key role in assisting organisations in understanding and meeting their data protection obligations”. It has reported on its findings from 12 consensual audits of NHS organisations between 2018 and 2019. The report
highlights headline areas of concern which include: documenting personal data processing; the role of the Data Protection Officer; requests for access to personal data; privacy information; training and awareness; and data processor contacts.
Comment: Devising and implementing an information governance strategy presents a significant challenge for NHS organisations. Learning extracted from these reports could assist them in doing this. Conversely, a failure to take account of ICO guidance and their previous regulatory activities increases the risk of a more serious sanction from them in the event of a major data breach. A similar review carried out by Capsticks of 13 recent reports for NHS organisations used the data to highlight some of the key ingredients of an effective strategy and also considered the particular challenge of cyber security.
Getting It Right First Time diabetes report emphasises the importance of a multi-disciplinary approach
The report focuses on type 1 diabetes, inpatient care and diabetic footcare. GIRFT’s analysis revealed that several of the most common causes of claims are patient safety issues that can be reduced through measures such as safer administration and management of insulin and effective footcare to prevent ulceration. Recommendations include:
- the need for better insulin safety training; and
- a dedicated multi-disciplinary footcare service well integrated with the community footcare protection service and with hospital renal wards and dialysis units given the increased risk of amputation for diabetic patients in these areas.
Comment: Trusts need to ensure that they implement a programme of training and competency assessment appropriate to the level of responsibility of any staff involved in prescribing, dispensing or administering insulin. In relation to footcare, Trusts and commissioners are requested to action the ’10 steps to effective diabetic footcare services’ developed in the southwest. These include root cause analysis of all amputations. Trusts will need to ensure that their SII action plans are robust and kept under review for effectiveness in preventing future harm. Skill-mix of the investigation team is likely to be important.
Government response to Independent Medicines and Medical Devices Safety Review
Creation of a new role of Patient Safety Commissioner was the central plank of the recommendations. This was tabled on 14 December 2020 as an amendment to the Medicines & Medical Devices Bill 2019-21, which is due for its 3rd reading in the House of Lords on 21 January 2021.
Comment: The PSC’s core duties are described as promoting the safety of patients and the importance of their views in relation to medicines and medical devices. It is proposed that the PSC will have a number of powers and functions (to be set out in regulations), including the ability to make reports and recommendations to the NHS and independent sector, and to request and share information with these bodies. The new role is likely to mean that healthcare organisations will need to review their policies around governance and accountability, but the devil is likely to be in the detail. We will continue to monitor the Bill’s progress.
Identifying and tracing key witnesses central to trial success
In Hewes v West Hertfordshire Hospitals NHS Trust & others  EWCA Civ 1523, the Court of Appeal upheld the trial judge’s decision that the Defendants were not liable for the injuries suffered by the Claimant as a result of an alleged delay in diagnosis and treatment of cauda equina syndrome. The central issues in the liability only trial were: when an MRI scan could have been done; whether surgery could have been performed without tertiary referral; and whether the Claimant’s condition was already permanent by the time of his presentation to hospital. Capsticks represented the two Trust Defendants.
Comment: As part of our case preparation, we spent a significant amount of time undertaking detailed factual investigations from pre-action to trial to locate multiple witnesses some of whom had moved to Australia. This case demonstrates how factual evidence regarding timings (of MRI and surgery) is pivotal to a cauda equina case and the importance of locating and gaining the co-operation of clinicians who may no longer work at the Trust or live in the UK.
Supreme Court reaffirms illegality doctrine in negligence claims
In Henderson v Dorset Healthcare University NHS Foundation Trust  UKSC 43 the Supreme Court reaffirmed that compensation cannot be awarded for negligence where the losses result from the Claimant’s subsequent illegal act. The Claimant killed her mother during a psychotic episode due to the Defendant’s negligence. In the Crown Court she had been convicted of manslaughter by diminished responsibility, psychiatry experts having agreed that she had some responsibility.
Comment: This decision is welcome news to Defendants. If the claimant had succeeded it would in effect be inviting the civil courts to look behind a conviction and review the penalty imposed by the criminal law. Read our Insight on the decision.
Resolving future accommodation claims in the era of negative discount rates
In the case of Swift v Carpenter  EWCA Civ 1295 the long-established Roberts v Johnstone approach to valuing future accommodation produced a nil award. The Claimant appealed to the Court of Appeal. The Court determined that the formula no longer provided “fair and reasonable compensation” and that an approach based on assessing the market value of reversionary interests in property should be substituted. It adopted a discount rate of 5% over the Claimant’s lifetime.
Comment: The Court accepted the approach in Swift might not be the appropriate one in all cases, but that the methodology should apply in the majority of cases, particularly if the Claimant had a long life expectancy. The decision will result in increased awards for compensation in cases where future accommodation costs are claimed. In cases of a short life expectancy, thought will still need to be given to the most appropriate approach to valuation. Read our Insight on the decision.
Bereavement award extended to cohabitees of 2 years’ standing
For deaths occurring on or after 6 October 2020, cohabitees of at least 2 years’ standing will be able to recover the bereavement award. The award is set at £15,120 for deaths occurring on or after 1 May 2020.
Comment: This change will produce a modest increase in the value of a fatal claim based on a relationship of cohabitation. However, the change will have a more significant overall impact on the total value of fatal claims in England and Wales given the preponderance of cohabitation as a long-term relationship.
Decision making and the under-18s
In the recent case of An NHS Trust v X  EWHC 65 (Fam) a teenage Jehovah’s witness requiring on-going blood transfusions refused to receive them. The case follows on from the case of Bell v Tavistock & Portman NHS Trust  EWHC 3274 (admin) which considered whether children had Gillick competence to make decisions about puberty blockers. In X the teenager’s refusal was overridden by the court. In Bell the claim was for judicial review of the Defendant’s practice of prescribing puberty blockers to under 18s experiencing gender dysphoria. It was held that in respect of children aged 16 and above there was a rebuttable presumption that they had capacity to consent. However, the court doubted that a 14 or 15 year old would be able to understand, retain and weigh up the relevant information and that 13 year olds would be highly unlikely to be able to do so.
Comment: The central point in both cases is that in relation to medical treatment, neither the decision of a Gillick competent child nor that of a young person over 16 is determinative in all circumstances. A refusal can be overridden by the courts, albeit that the refusal should be taken into account as part of the court’s decision making. There remains a distinction between children under the age of 16 and those aged between 17 and 18 years. Read our Insight on the Bell decision and our Insight on X, both of which are being appealed.
Trust fined for failure to comply with duty of candour
Elsie Woodfield (aged 91) died at Derriford Hospital in December 2017 following an endoscopy which was abandoned 5 minutes after it began, due to an issue with her trachea. An internal investigation concluded that the incident should not be categorised as a Serious Incident in accordance with the Trust’s policy. This was due to the fact that the incident was a recognised complication of the procedure. This mistake meant that the Trust did not follow the process for Duty of Candour. The Trust apologised to the family for this. On 23 September 2020 the Trust pleaded guilty to breaching regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, the duty of candour. It was fined £1600 (max. fine £2500) and ordered to pay costs of £10,845 and a victim surcharge of £120.
Comment: This was the first prosecution of its type by the CQC (although fixed penalties have been issued for similar breaches). The real learning to be taken from this case is that Trusts should review their Serious Incident Policies to ensure they are properly aligned with the associated Duty of Candour Policies. Gaps, such as the one which occurred here, should be filled as recognised complications which lead to moderate harm and above must be classified as ‘candour cases’ even if they are not classed as Serious Incidents. All staff should be trained on what is required – openness and transparency when things go wrong – and reassured that an apology is not the same as an admission of liability. Read our Insight on the duty of candour and NHS Resolution’s guidance on ‘Saying Sorry’.
New GMC guidance on decision making and consent
The GMC has updated its guidance on decision making and consent to make it easier to apply in everyday practice. New features include a focus on taking a proportionate approach, acknowledging not every paragraph of the guidance will be relevant to every decision. There is a new section to help doctors find out what matters to patients to facilitate shared decision making
Comment: Patients should be supported to make decisions before determining that they lack capacity. Patients who are likely to lack capacity over time as their condition progresses or who have fluctuating capacity should be encouraged to think about what they might want to do if they become unable to make a healthcare decision. The timing of any decision, the need to keep capacity under review and fully documenting discussions and decisions continue to be important. If a patient may lack capacity a capacity assessment should be carried out.
Reform of the Mental Health Act 1983
The government’s white paper was published on 13 January, accepting the vast majority of the recommendations of Sir Simon Wessley who led the independent review. Four guiding principles of choice and autonomy: least restriction; therapeutic benefit; and the person as an individual will shape the approach. Key areas include: clearer, stronger detention criteria; changes to the treatment of patients with autism or learning difficulty; improving support for children and young people; changes to the treatment of patients from ethnic minorities; increased involvement of the patient and a focus on capacity. There will also be changes to some of the ‘nuts and bolts’ of mental health work e.g. in relation to Community Treatment Orders.
Comment: The white paper describes the significant changes proposed to the current system as “the most ambitious programme to transform mental health care that England has ever known.” With such wide-ranges changes proposed, contributions from all those working with the MHA are encouraged. A public consultation is open until 21 April 2021. Read our Insight on the proposed reforms.