Clinical Law Insight: Autumn 202115/11/21
Press reports suggest that hospital-acquired Covid may have been a more significant cause of death than had been appreciated previously. A study conducted by the Health Service Journal suggested that 1 in 5 deaths at several Trusts where Covid was acquired in hospital and featured on the death certificate were probably caused by the virus. Any claims relating to hospital-acquired Covid are likely to involve similar issues to those for any hospital-acquired infection, but with the additional issue of PPE. What should healthcare organisations do to prepare for claims and the Public Inquiry?
Comment: Decision making, process and documentation will be central issues. The following will be key not only in the Public Inquiry but in relation to individual claims:
- a timeline of guidance received from NHS England
- actions taken to implement the guidance (and by whom)
- details of any escalation , as well as
- collating and retaining information and documentation on systems, procedures, protocols and resources.
Resource issues will probably have an impact on claims in relation to the standard of care determined by the courts. It is likely that there will be greater focus on local decision-making over which individual organisations have control, as opposed to macro / governmental decisions (e.g. on PPE procurement). The former are likely to be relevant to the standard of care, whereas the latter will be a matter for the Public Inquiry due in 2022.
How are Coroners dealing with Covid-related inquests?
Analysis of our recent cases reveals the two most common themes to be acquisition of Covid-19 during hospital admission and staffing/ resource issues. To what extent will Coroners take into consideration the extraordinary and difficult circumstances in which healthcare organisations were working, when framing their conclusions?
Comment: We have noticed a definite trend with Coroners being fairly understanding where care was given which, pre-pandemic, might have attracted criticism and/or may have been substandard. In the same way as with claims, decision-making, process and documentation will be key. From our experience, Coroners appear somewhat reluctant to find that Covid was contracted during admission. For example, one Coroner’s view was influenced by the way Covid is transmitted, incubation periods and false negative tests. If this approach of ‘following the science’ is replicated nationally, it may reduce the likelihood of Covid-related claims.
Covid-19 Clinical Negligence Protocol: effective handling and resolution of claims
Launched in December 2020, the protocol outlines a best practice approach to claims handling agreed between the Society of Clinical Injury Lawyers, NHS Resolution and Action against Medical Accidents. The protocol intends to:
- encourage positive behaviours from both claimants and defendant organisations
- ensure consistency of approach in practice across England
- reduce the risk of costs being spent unnecessarily on issuing proceedings and applications to extend time or stay proceedings. The protocol will remain in place until one of the parties gives notice to end its involvement.
Comment: The protocol has increased the co-operation between parties and successfully stopped cases from escalating into unnecessary litigation, minimising legal costs. Higher levels of co-operation during the pandemic delivered better outcomes for everyone involved in clinical negligence claims.
In our experience, the protocol, Early Notification Scheme for brain damaged babies, and use of ADR all assist in the early resolution of claims, producing tangible benefits for all parties.
Courts continue to take hard line on fraudsters
In Dommett v Northern Lincolnshire & Goole NHSFT (2021), the Claimant was given an immediate custodial sentence of 29 weeks for fundamental dishonesty – the longest custodial sentence of its type, to date. The judge found that Mr Dommett had attempted to defraud the NHS of almost £2 million, deliberately and grossly exaggerating the extent of his symptoms following treatment for Cauda Equina Syndrome. We represented the Trust. Read more in NHS Resolution’s case report.
In One Insurance v Beasley (2021), a 76 year old was given an immediate six-month custodial sentence. The Respondent had hired a wheelchair on two occasions to attend medical appointments and the surveillance evidence of the dishonesty was said to be “devastating”.
Comment: The courts’ appetite for cracking down on fraud shows no sign of diminishing. These cases demonstrate the effectiveness of s.57 Criminal Justice and Courts Act 2015 as a remedy for those against whom fraud is perpetrated. The dishonesty must be actual rather than simply potential and go to the root of the claim, as confirmed in the case of Elgamat (2021).
A reminder from the Court of Appeal of the principles needed to establish vicarious liability
In Blackpool FC v DSN (2021), the Respondent had been sexually abused by Mr Roper (R), a volunteer football coach at the club. The abuse had taken place on an overseas tour organised and almost wholly funded by R. He had his own club Nova Juniors from which he referred talented young players to the Blackpool FC and other clubs. The club appealed against a High Court decision that it was liable for R’s abuse. The Court of Appeal considered the components required to establish vicarious liability, including:the relationship between the R and the organisation, which needs to be akin to employment, with the degree of control exercised by the latter over the former being particularly crucial. The Court of Appeal determined that there was a complete lack of even a vestigial degree of control by the club over R. The appeal was allowed.
Comment: The decision is perhaps not surprising as the High Court decision pre-dated the 2020 Supreme Court judgments in Barclays Bank (sexual assault by self-employed OH doctor) and Morrisons (data breach by rogue employee). Both judgments found the organisations not to have been vicariously liable. Nevertheless, it remains imperative that employers should fully assess organisational risks in the context of the environment in which they and third party contractors work. This includes situations which at first sight appear to fall outside the scope of the duty of care. Specifically in relation to data security, organisations still need to ensure that they have appropriate data security provisions and governance structures in place. Where employees are processing data solely on behalf of their employer (as distinct from being ‘rogue’), the employer will be directly liable for any data breach. All healthcare organisations should check that they have appropriate cyber risk cover in place. Read our in-depth Insight on the Morrisons decision.
Safety and Learning
Government response to the Independent Medicines and Medical Devices Safety Review (IMMDSR)
The government has responded to the report's nine strategic recommendations and 50 "actions for improvement”. The IMMDSR’s central recommendation - the creation of a new role of Patient Safety Commissioner - has been enshrined in The Medicines and Medical Devices Act 2021. Progress has been made in relation to:
- The call for networks of specialist treatment centres – eight have been set up.
- Improvement of pathways for those adversely affected by medicines in pregnancy and to ensure that sodium valproate is only prescribed where clinically appropriate.
- How the Medicines and Healthcare products Regulatory Agency (MHRA) listens and responds to patients and the public, including the development of a more responsive adverse incident reporting system.
- The establishment of a UK-wide Medical Device Information System.
Some recommendations have been rejected or not fully accepted:
- Transparency of payments made to clinicians has been accepted in principle, in the form of publicly available lists of doctors’ interests. This will be part of professional regulation, but published at the local level, rather than via the GMC.
- A Patient Reference Group rather than an Independent Task Force has been set up to develop and implement government response.
- There will be no independent Redress Agency.
Comment: The IMMDSR identified systemic failings, spanning the breadth of the healthcare system described as ‘institutional resistance to patient safety’. The report notes that ‘Culture in the health sector has changed in recent years, but it appears that there is still some way to go. Healthcare organisations need to ensure that they are complying with the duty of candour and that their governance processes are robust. Read our Insight into the report and its recommendations.
The new role of Patient Safety Commissioner is one of the central planks of the report. Healthcare organisations should be ready to respond to information requests from the PSC with as much care as they give to their responses to PFD reports. For further information on the PSC see Clinical Law Insight: Summer 2021.
Learning from maternity errors and ensuring equality of access to services
The CQC publication Safety, equity and engagement in maternity services addresses concerns about variation in quality and safety of maternity services across the country. Two key issues were considered:
- identifying the barriers that prevent some services from providing consistently good, safe care; and
- how to better understand disparities in outcomes that exist for women and babies from Black and Minority Ethnic groups
Key themes identified in nine inspections and from talking to organisations representing women include:
- Quality of staff training
- Poor working relationships (between obstetrics and maternity services as well as hospital and community teams)
- Lack of robust risk assessment
- Failure to engage with, learn from and listen to the needs of local women
The CQC identified the need for an open system that recognises, investigates and learns when things go wrong, as well as honesty about inequalities that exist for some maternity service users. Addressing inequalities in access and tailoring services to best meet needs of the local population is considered a critical area for action. The report notes that the Chief Midwifery Officer's 4 actions to support maternity equity for women from Black and Minority Ethnic communities, had been interpreted quite narrowly.
Comment: As well as being both a professional and statutory requirement, candour is a vital part of any system that seeks to identify and learn from safety issues and error. Openness and transparency are key; the incident investigation should seeks to establish what happened and the action that needs to be taken to prevent recurrence. Trusts should review the actions they have taken on the four pledges against the criteria set out in the Chief Medical Information Officer’s (CMiO) letter.
Government’s response to Justice Committee’s proposals for the Coroner Service
When the Committee’s report was published in May 2021, the headline recommendation was that all bereaved families receive public funding for inquests where a public body is represented. The government has said it will consider the proposal when it responds to the Bishop James Jones’ report into the Hillsborough tragedy and inquests. In the meantime, it will legislate to remove the means test for both current and future cases funded by the Exceptional Case Funding (ECF) Scheme. The response to several other recommendations are also deferred to be considered with the response to the Jones’ report. The following recommendations have been agreed:
- The MoJ will revive its 2019 consultation on the investigation by Coroners of stillbirths and to publish proposals for reform.
- The High Court has power to direct that the particulars of the Record of an Inquest are amended without ordering a fresh inquest.
The recommendation for a National Coroner Service has been firmly rejected on a cost - benefit analysis. It seems clear that the government sees continued mergers of Coroners’ areas as a way to achieve consistency in service standards.
Comment: Removing the ECF means test will likely cause higher numbers ofinquests where families are represented. This will probably be dwarfed by the increase in inquests if coroners are given the power to investigate all stillbirths. The High Court’s ability to amend the inquest record will be of real practical use as, in those rare cases where this is necessary, witnesses will no longer have to face the prospect of giving their evidence again.
The latest on the Liberty Protection Safeguards (LPS)
The LPS are due to be implemented in Spring 2022 and will replace the Deprivation of Liberty Safeguards (DoLS). We still await the draft Code of Practice and Regulations (originally due Spring 2021). A further delay in implementation looks likely. The DHSC has published a series of LPS factsheets which summarise the various aspects of the regime and the roles of those involved.
Comment: There will be a lot to get to grips with when the new regime is implemented. Forward planning regarding personnel and procedures should help ensure a smooth transition further down the line. Read our Insight on the key issues for organisations to start work now.
CQC’s scope to be widened
The Health and Care Bill 2021 proposes several new powers and duties for the CQC, including the:
- power to require NHS England (NHSE) to appoint a special administrator for both Foundation Trusts (FTs) and non-FTs
- duty to assess the performance of local authorities in relation to the discharge of their adult social care functions
- power to police new hospital food standards (to be set by the Secretary of State)
- duty to co-operate with the Health Services Safety Investigations Body in relation to its investigations
Comment: The special administrator role is consistent with the proposals for NHSE becoming the regulator of FTs and non-FTs, a power currently enjoyed only by the CQC. The devil will be in the detail regarding local authority performance, but the regime is likely to mirror the present form of inspections and ratings, warning notices and ‘special measures’. The food safety changes are likely to bring hospital food standards in line with other CQC standards, for example safe care and duty of candour. Read our Insight on what the Bill means for CQC regulation
The future of data protection law
The government’s wide-ranging consultation on the future of data protection law and regulation may lead to significant changes in how health and social care organisations comply with the law. The most radical reform proposed is to the ‘accountability’ requirements in the UK GDPR, replacing the current regime with a ‘risk-based privacy management programme’. Whilst the government has suggested that the approach should be flexible, the proposed framework looks similar to the ICO’s recent accountability framework and quite prescriptive in in nature.
Comment: The online consultation runs until 19 November 2021. Read our Insight on the proposals and find out how you can have your say.