Clinical Law Insight: Summer 202102/07/21
In May the Prime Minister announced that he “expected the right moment” for the Public Inquiry into the government’s response to the pandemic “to begin” would be spring 2022. In NHSE’s Healthcare Leaders’ Update of 8 June 2021 health system leaders are asked to start preparations by considering four key areas of action:
- ensuring robust and comprehensive records management.
- embedding systematic approaches to log key leavers, carry out exit processes and retain contact details.
- considering wellbeing support for staff who may have to provide evidence.
- appointing a named inquiry lead.
NHSE will be issuing a stop notice internally regarding retention of documents.
Comment: In our experience, early preparation will be crucial. As a matter of urgency, NHS organisations will need to decide who is going to lead the response within their organisation. How relevant evidence is captured to enable organisations to have an accurate time line of events and certainty as to information available at the time decisions were made will be vital. Read our Insight on what NHS organisations need to consider when preparing for the Inquiry.
Inquests where Covid-19 is a factor
The vast majority of deaths from Covid-19 are due to the progression of a naturally occurring disease and will not require investigation by a Coroner. What about those which are indirectly attributable? These are likely to form a far wider pool encompassing:
- patients who were seriously unwell but did not seek treatment and died at home (e.g. of heart attack);
- those with life threatening treatable illnesses where diagnosis was too late;
- cerebral blood clots from vaccines.
When deciding whether to hold an inquest, a Coroner must decide first whether there is a suspicion that the death was “violent or unnatural”. This is a fairly low threshold; Guidance Note 37 makes it clear (para.12) that, provided there is an element of unexpectedness and culpable human failure, a death is plainly unnatural even if it arose from a natural cause. The Senior Coroner for London North has determined that an inquest into the death of railway worker Belly Mujinga will be held as there is reason to suspect that she ‘died a violent or natural death’. Ms Mujinga was working at Victoria Station when coughed on by a passenger who said he had Covid. She had been given no PPE and subsequently died of Covid-related complications of a pre-existing respiratory condition
Comment: The number of Covid-19 related inquests is likely to rise. Healthcare organisations’ policies and procedures will be crucial to demonstrating a safe system of working. These documents should be gathered together as soon as possible. Being ‘ahead of the curve’ is likely to reduce the burden on legal services resource further down the line as many of these documents will be common to all inquests of a particular type. With regard to PPE, local decision making on availability will be relevant, but national availability falls outside the remit of the coronial process and will be considered by the Public Inquiry in 2022.
Handling Covid-19 claims and managing ongoing risk
Covid-19 claims against health and social care providers are likely to fall into two broad categories – acquiring Covid-19 in hospital or a care home, or arising from the delay in providing non-Covid treatment during the pandemic. The former are likely to feature similar issues to any other Hospital Acquired Infection, but with the additional issue of PPE.
As the NHS begins to restore elective work and prioritise cancer care and management, the risk shifts back to the one faced in summer 2020 – managing the backlog of patients.
NHSE guidance sets out priorities and emphasises collaborative working.
Comment: Resource issues are likely to be a significant feature when determining the standard of care in relation to historical claims, particularly in relation to PPE. A distinction is likely to be drawn between macro (governmental/ economic) and micro (local/ medical) decisions. For further information see ‘Resource issues are likely to be a significant feature in determining the standard of care in non-Covid claims’ in the CLI Winter 2020/2021. Resource issues are also likely to feature in claims arising from ongoing delay to both treatment planned pre-pandemic and delays in treating new referrals. A patient-centred approach with clear communication between the treating clinician, hospital and patient will be key to minimising these risks. For further information see ‘Impact on future claims’ in the CLI Summer 2020. As with inquests, early collation and review of core documents is likely to reap benefits.
Safety and Learning
Learning from litigation claims
Getting It Right First Time’s 'Learning from litigation claims' highlights the importance of capturing key claims data and engaging in claims analysis, to help implement learning from claims. GIRFT’s litigation work stream has collaborated with NHS Resolution to engage with NHS Trusts and share data regarding their own claims on a speciality specific basis.
Comment: Traditionally, claims are seen as representing the ‘tip of the iceberg’ compared to incidents and complaints. But when a forensic analysis is undertaken, they are an invaluable source of learning to help prevent future harm and claims. Read our Insight on the report.
New Patient Safety Commissioner
The Medicines and Medical Devices Act 2021 has created a new role of Patient Safety Commissioner. The role will span both the NHS and independent sectors. Although funded by the DHSC and appointed by the Secretary of State, the PSC will be an independent, neutral office holder with statutory powers to make reports/ recommendations to the Secretary of State and any relevant person/ organisation, and to request information. The PSC will be under an obligation to publish a set of principles to govern the way in which they carry out their core duties. A consultation has been launched regarding the appointment and operation of the PSC. It closes on 5 August 2021.
Comment: The PSC’s ability to report / recommend is similar to the concept of Coroners’ Prevention of Future Death reports, albeit the PSC has a power rather than a duty (Coroner). Nevertheless, the power is likely to highlight patient safety issues to a wider audience and further enable learning from error to prevent harm. There is also scope for reputational damage. Healthcare organisations should be ready to respond to requests from the PSC with as much care as they give to their responses to PFD reports.
The Paterson Inquiry Report - latest
In March 2021, the government published a partial response to the Inquiry Report (4 of the 13 recommendations)
- Recommendation 2 (information to patients): Academy of Medical Royal Colleges (AoMRC) guidance to be incorporated into the NHS standard contract;
- Recommendation 4 (consent): GMC to work with providers to embed revised good practice guidance on consent;
- Recommendation 5 (MDTs): CQC to ensure existing questions about MDT in appropriate CQC frameworks become mandatory elements of its assessment and inspection approaches;
- Recommendation 7 and 8 (patient recall and ongoing care): The response confirmed the efforts made to date to contact patients and review their continuing care.
As well as confirming that it will respond in full to the inquiry during 2021, the proposed Health and Care Bill includes extension of the remit of the Health Service Safety Investigation branch to private providers. The Medical and Medical Devices Act 2021 provides for the establishment of a UK-wide medical device information system to allow the government to routinely collect medical device, procedure and outcome data across both NHS and independent providers and a Patient Safety Commissioner, as discussed above.
Comment: All the above initiatives should assist in meeting the concerns raised in the report, but the challenge of learning to prevent future harm is one that individual healthcare organisations need to grapple with. The key to learning from Paterson is the need for increased governance from ‘Ward to Board’ and addressing organisational culture to encourage open discussion of concerns and ensure accountability. Read our Insight into the Inquiry Report ‘one year on’.
GIRFT – pilot review in independent sector highlights cross sector issues
GIRFT has piloted a report on the independent sector, focusing on acute providers of orthopaedic and spinal services. The report highlights good practice as well as examples of variations/ areas for improvement. Variation in performance and quality of monitoring of independent sector hospitals by CCGs and NHS Trusts were identified as an area for improvement.
Comment: this is an interesting and maybe unsurprising finding as cross sector governance was an area of concern highlighted in the Paterson Inquiry report. The government’s formal response to these proposals (no.11 and no. 13) is awaited. Read our Insight on the 13 recommendations made by the Inquiry Report.
Ockenden Report - latest
It has been reported that NHSE ‘maternity improvement advisers’ will undertake Quality Assurance visits to evaluate progress regarding the immediate safety actions recommended by the Ockenden report, and support improvement. Evidence submitted by Trusts to NHSE on their compliance with the report’s recommendations will be used to inform the visits. No start date for the QA visits has been specified.
Comment: this is a follow-up to the immediate actions required by NHSE in late 2020 in the aftermath of the Report’s publication. Although some of the Ockenden recommendations will require change at a national or regional level, the QA visits should help strengthen governance in maternity units. Good governance particularly around incident reporting, investigation of adverse outcomes, learning lessons and implementing effective change is an ongoing process. Trusts need to ensure that they have a robust system for regular review of governance policies and procedures. For further information on the Ockenden report see @initial learning from the Ockenden review’ CLI Winter 2020/21.
Extent of causation in clinical negligence claim limited by the scope of the duty
The case of Khan v Meadows  UKSC 21 involved failures in testing /advice regarding haemophilia given by Dr Khan (GP) to Ms Meadows, prior to pregnancy. Her son was born with haemophilia and autism. A claim was made for losses arising from both conditions. The Appellant admitted liability only in relation to the consequences of the haemophilia. The Supreme Court determined that Dr Khan’s duty was limited to advising on the specific question of haemophilia and as such the losses arising from the autism diagnosis did not have sufficient nexus to that scope of duty.
Comment: The outcome of the decision will likely have far-reaching consequences for clinical negligence claims and marks a shift away from the traditional ‘but-for’ test. Whilst it remains to be seen how far the principle is developed in practice, the decision is favourable to those defending claims, creating legal precedence for limiting damages to those which fall within the scope of the initial advice or treatment sought and excluding any damages for incidental losses. Read our Insight on the decision.
Courts continue to clamp down on dishonest claims
In Calderdale & Huddersfield NHS Foundation Trust v Metcalf (2021) the Claimant served a Schedule of Loss of c. £5.7million in her claim arising from late diagnosis of cauda equina syndrome. She dishonestly and falsely claimed that she could not walk unaided and needed a wheelchair, walking frame or sticks. She also claimed that she was only able to go out socially to places with which she was comfortable and familiar, and took relatively few holidays, restricting herself to travel which was appropriate to her allegedly reduced mobility. In fact she was regularly taking holidays to a variety of places in the UK and abroad, in none of which she appeared to have any difficulties with her mobility or to be failing to enjoy herself fully. Following committal for contempt of court she received an immediate custodial sentence of 6 months.
Comment: This is the longest custodial sentence for fraudulent dishonesty to date. Fraudulent misrepresentations spanned her pleadings, witness statements and presentation to experts and others. Defendants are bringing these cases more frequently now and are getting results. The courts take a particularly dim view of public money being targeted in this way.
Status quo maintained in valuation of sleeping night care
The Supreme Court decision in the employment law case Royal Mencap Society v Tomlinson-Blake and others (2021) had the potential to affect the way that sleeping night care is valued and increase the cost of this head of claim in clinical negligence cases. The central issue was whether for the purposes of payment of the National Minimum Wage ‘sleeping night care’ workers were working when asleep. The Court determined that they were only working when awake.
Comment: Had the decision gone the other way, it could have increased the value of care claims in catastrophic injury cases. The case demonstrates the potential inter-relationship between employment and clinical negligence cases. For further information on the decision read our employment team’s Insight.
Data security – take care when redacting documents
The case of London Borough of Lambeth v AM (no.2) (2021) serves as a salutary reminder of the care that needs to be taken when redacting documents. HJ, the aunt of a child known as LM, had made a confidential report to social services regarding welfare / development concerns. The child’s father (AM) declined to engage, but subsequently made a Subject Access Request to the Council who disclosed the file with HJ’s name redacted using Adobe. It was possible to ‘undo’ the redactions using the Adobe software and AM issued proceedings against HJ for malicious prosecution.
Comment: Although the Council successfully obtained an injunction against AM’s use of the material, the risk created by the underlying problem with the means of redaction is an important point for organisations to be aware of. When faced with a Subject Access Request, it is essential that redactions are made in way that is permanent. Otherwise, healthcare organisations handling the most sensitive of data could not only face the time and expense of obtaining an injunction against the use of the material, but also a potential claim from any person identifiable in the failed redaction who has suffered harm / loss.
CQC: updated guidance on the duty of candour
The guidance gives a more specific explanation of what is defined as a notifiable safety incident (NSI) and examples covering a range of scenarios. In addition, it provides clarification that the apology required to fulfil the duty of candour does not equate to an acceptance of liability and will not affect a provider’s indemnity cover.
Comment: It is crucial that all healthcare staff understand that the general duty of candour applies at all times and the circumstances in which the statutory duty applies. The updated guidance should assist with the latter, in particular identifying what is an NSI. It should also be borne in mind that the CQC will investigate breaches of regulation 20 and, if appropriate, prosecute. Read our Insight on the guidance and a Trust fined for failure to comply with duty of candour’ CLI Winter 2020/21.
CQC: first prosecution of NHS Trust for failing to provide safe care
East Kent Hospitals University Foundation Trust pleaded guilty to a charge under regulation 12 of the Health and Social Care Act 2008. The Trust was accused of causing harm by failing to provide safe care and treatment to baby Harry Richford and his mother Sarah in 2017. Sadly, Harry died aged 7 days – a delay in resuscitation at birth had caused irreversible brain damage. The Trust was fined £733,000 and ordered to pay over £28,000 in costs and a victim surcharge.
Comment: This is the first prosecution of an NHS Trust under regulation 12. Providers need to ensure that they have effective systems in place in investigate serious incidents and ensure learning takes place to prevent future harm and ensure delivery of safe care. When things do go wrong, openness and transparency will be key in order to meet the duty of candour. The Kirkup investigation into the management, delivery and outcomes of care provided by the maternity and neonatal services at East Kent University Hospitals NHS Foundation Trust during the period since 2009, is due to report next year.
DNA CPR decision-making “a worrying picture”
The CQC has published its final report on their special review into ‘Do Not Attempt Cardiopulmonary Resuscitation’ (DNACPR) decisions taken during the COVID-19 pandemic. The report concludes that, whilst it did not find that there had been a national ‘blanket approach’ to DNACPR, it did find a “worrying variation in people’s experiences of … DNACPR decisions during the pandemic” and in some cases, patients and their families did not understand what a DNACPR was, or were not aware that a DNACPR decision was in place.
Comment: Care providers must assure themselves that any DNACPR decisions have been made appropriately, in discussion with the person and in line with legal requirements and best practice. Commissioners also have responsibilities to plan for prevention of discrimination, monitor and assure themselves of the quality and safety of DNACPR decisions and ensure system compatibility between providers. Read our Insight on the CQC report.