Clinical Law Insight: Spring 2023
30/03/23Author: Cheryl Blundell, Consultant at Capsticks
COVID-19
Latest on the Covid-19 public inquiry
The first preliminary hearing for module 3 took place on 28 February. The module covers the impact on health systems of Covid-19 and of government and societal responses to it (patients, hospitals and other healthcare workers and staff). There are currently 36 core participants for the module. Somewhat surprisingly NHS England (NHSE) is the only NHS core participant (CP) in England. The position is different in Wales and Scotland.
NHSE have sent out questionnaires to over 200 non-NHS organisations and over 300 NHS organisations. The questionnaire themes include:
- consequences of cancelling elective care
- the pandemic’s impact on the mental health of staff and patients
- access to and suitability of PPE (but not procurement issues).
Other CPs include government bodies (e.g. Department of Health and Social Care (DHSC), HM Treasury), organisations such as National Institute for Health and Care Excellence (NICE), MIND and the British Medical Association (BMA), plus many victims’ organisations. Rule 9 requests (for documents and/or statements) are being made to all 13 UK Ambulance Trusts covering capacity, response times and prioritisation of patients.
What this means for you
Ambulance Trusts should be ready to respond to the Rule 9 requests. They carry legal weight; non-compliance can lead to an enforcement notice and ultimately a fine or even imprisonment. The recipient of a Rule 9 should first consider whether they / the organisation are the right entity to response.
When preparing draft responses to the Rule 9 requests, great care should be taken to ensure that the question has been fully and accurately answered and that supporting evidence is referred to and supplied where appropriate. Indeed, recipients may be asked for documentation, requiring explanations of what organisations do and do not have, and what searches have been carried out.
Acute Trusts should be ready for any future Rule 9 requests generally, but also because answers provided by Ambulance Trusts may raise acute issues e.g. patient drop off times.
There will be a further module 3 preliminary hearing later in 2023 with the substantive hearing in 2024 (dates to be confirmed).
For further insight into the preliminary hearing on 28 February listen to our podcast and if you would like any support, please do contact us.
SAFETY & LEARNING
Are you ready for PSIRF?
The new Patient Safety Incident Response Framework (PSIRF) represents a ‘sea change’ in how the NHS responds to patient safety incidents (PSIs), to achieve learning and improvement. All Trusts (but not primary care providers) should be ready to ‘go live’ with a fully embedded system by autumn 2023.
What this means for you
PSIRF requires organisations to use a planning exercise to inform what their proportionate response to PSIs should be. As the PSIRF approach is flexible it will adapt as organisations learn and improve. There is plenty of guidance accompanying PSIRF, including a helpful preparation guide which sets out suggested tasks and timeframes.
Healthcare organisations will need to review their current PSI profile plus their policies, procedures and plans. With only around six months left to embed PSIRF, any organisations who have not commenced the PSI response planning exercise and scoping of recruitment, training and skills requirements should do so as a matter of urgency.
Further information on PSIRF and suggestions on how to prepare can be found in our insight and webinar. If your organisation needs advice or support on how to implement PSIRF or its implications, please do get in touch.
Government response to the investigation into maternity services at East Kent
The investigation into maternity services at East Kent Hospitals University NHS Foundation Trust (led by Dr. Bill Kirkup) revealed a ‘clear pattern’ of suboptimal clinical care leading to significant harm. In its recommendations the report focused on national themes rather than limiting itself to local issues. Recommendations spanned team working, better identification of poorly performing units and clinical and organisational behaviour. The ministerial statement re-iterates the report’s reference to ‘relevant bodies’ (e.g. Royal Colleges) finding solutions to some of the problems identified. It is also clear that the response to other recommendations will be subsumed into other work already planned or underway (e.g. mandatory national maternal and neonatal outcome measures). However, Trusts will be required to review their approach to reputation management - described by the inquiry report as often the ‘default position’ when things go wrong.
What this means for you
Reputation management can be achieved alongside transparency, openness and compliance with the duty of candour. It is vital that all staff understand and accept that the duty of candour is a statutory one which must be complied with and a breach can lead to the organisation being prosecuted and fined.
Dealing with patient safety issues is part and parcel of good reputation management e.g. ensuring that patient safety incidents are well-managed and where investigation is appropriate under PSIRF, it is timely and thorough and all learning arising from it is implemented to ensure it delivers on preventing future harm.
Launch of new Health Services Safety Investigations Body and Maternity and Newborn Safety Investigations Special Health Authority delayed
The Health Services Safety Investigations Body (HSSIB) and the Maternity and Newborn Safety Investigations Special Health Authority (MNSI) were due to be operational in April 2023. A DHSC statement has revealed that they will not be established until October 2023 to enable all the necessary work to be completed to ensure a smooth transition to these investigation programmes. The new HSSIB will be a fully independent public body with enhanced powers compared with the current Healthcare Safety Investigation Branch (HSIB) – for example, the power to require people/ organisations to co-operate with an investigation, and the ability to protect information obtained during an investigation from disclosure, unless subject to a court order. HSIB’s maternity investigation function will transfer to MNSI, a Special Health Authority.
What this means for you
PSIRF gives Trusts a lot of flexibility about whether to carry out a patient safety investigation and what form it should take. An exception is where an external body such as HSSIB or MNSI requires an investigation to be carried out. The issue of documents provided to HSSIB (but not MNSI) being privileged from disclosure (unless the court otherwise orders) is unlikely to change the law on legal privilege. A court is unlikely to consider that any documents created for a purpose other than actual or anticipated litigation are privileged from disclosure in subsequent litigation. However, the sheer existence of that ‘safe space’ will hopefully provide reassurance to those involved in patient safety incidents that information provided will not be used for other purposes (e.g. a disciplinary process) and foster a culture of openness and transparency within the organisation.
Assessment of risk during the maternity pathway
This HSIB report draws on findings from its maternity investigation programme to identify key issues associated with assessing risk during pregnancy, labour and birth. It is a thematic review of all HSIB maternity reports from April 2019 to January 2022. The need to facilitate and support individualised risk assessments for pregnant women to improve maternity safety is the overarching theme. Specific themes include:
- The language used to discuss and document risk to ensure it is continually assessed and all relevant factors are considered.
- Use of triage – issues around telephone, face to face, access, staff competence and the need for a structured approach.
- Place of labour care and birth.
- Assisting pregnant women to understand individualised risk.
- Where induction is required, the need for clinical oversight and individual care plan for fetal and maternal monitoring.
What this means for you
The report includes 13 prompts for Trusts to consider how these risks might be mitigated. They include:
- documentation
- training
- opportunities to review decision-making as pregnancy progresses
- use of structured tools to facilitate individualised care planning
- systems for prioritising those requiring induction.
LIABILITY
Pre inquest admissions fatal to defendant’s case
In Somoye v NW Anglia NHSFT [2023] EWHC 191 (KB), the Defendant made admissions on breach and causation before an inquest which was adjourned in 2020 and again at a pre-inquest hearing in 2021. Later it sought to withdraw the admission on causation on the basis that its expert’s opinion had changed at the inquest.
Master Sullivan refused the application. The decision was based on the prejudice to the Claimant in allowing the withdrawal being greater than that to the Defendant in refusing it.
Factors included the theory not being ‘new’. It had been canvassed by the expert in a 2018 report. His opinion had simply changed as to which theory was the most like on balance of probabilities. The Claimant’s opportunity to investigate a civil claim fully had been affected as the admission led to an agreement that factual witnesses would not be called at inquest.
What this means for you
The court has a discretion under Practice Direction 14 to permit an admission to be withdrawn. However, in this case the Master considered the balance of prejudice was in the Claimant’s favour. Whether evidence is ‘new’ is likely to be interpreted strictly and defendants will need to demonstrate more than an expert favouring a new theory in order to have a reasonable prospect of the discretion being exercised in their favour.
COSTS
Defendants’ ability to recover their costs from claimants extended from 6 April 2023
For proceedings issued on or after 6 April, CPR 44 will be amended to permit a defendant to enforce an order for costs in its favour “up to the aggregate amount in money terms of any orders for or agreement to pay or settle a claim for damages, costs and interest.” Previously enforcement could take place in only limited circumstances which effectively excluded settlements, including a claimant accepting a Part 36 offer.
What this means for you
The change will affect the way claimants’ solicitors approach settlement and what offers they accept or reject; for example, defendants’ Part 36 offers will need to be considered more carefully. There will also be an impact on interim payment applications. In costs disputes, a successful defendant will now be able to recover its costs. As the change is not retrospective, defendants may see a surge in claims being issued before 6 April.
Read more about the changes in our insight.
ON THE HORIZON…
Liability: Supreme Court to consider proximity test in psychiatric damage/ secondary victim claims
The Supreme Court is due to hear the Claimants’ appeal in Paul & Paul v Royal Wolverhampton NHS Trust (2021) in May 2023. Last year the Court of Appeal determined that a 14 month gap in time between the negligent treatment (for the late Mr Paul’s cardiac problems) and the horrifying event (his death from a heart attack witnessed by his daughters), meant that ‘proximity’ between the two was not established in law.
Interestingly, Underhill LJ (obiter) would have been minded to find for the Claimants on the facts if not bound by existing law.
More on the Court of Appeal decision can be found in Clinical Law Insight: Spring 2022.
Quantum: will dementia risk be considered in future awards for provisional damages?
In May 2023, the Claimant’s appeal in Mathieu v Hinds (2022) will be heard by the Court of Appeal. The High Court awarded provisional damages for the epilepsy risk from a traumatic brain injury, but the claim for the dementia risk was rejected as the judge considered the evidence base to be insufficient. The need to ‘buy off’ the risk of a provisional damages award for epilepsy risk is fairly common in brain injury cases. Claims for dementia risk are a newer phenomenon, but are becoming more common. We understand that Mathieu is the first case where the issue was litigated.
Our analysis of the High Court decision can be found in Insurance review summer 2022.
Quantum: government prepares for Personal Injury Discount Rate (PIDR) review
The Ministry of Justice has issued a call for evidence to inform the decision-making process for its next PIDR review (due to be completed by July 2024). When launching the call for evidence the Ministry of Justice (MOJ) described the case for setting different rates as ‘interesting’ – a higher rate for longer awards where expected returns are greater. The call for evidence closes on 11 April 2023.
Further information on the PIDR review can be found in Medical Malpractice and Casualty Forward View 2023.