Clinical Law Insight: Spring 202210/03/22
The latest on the Covid-19 Public Inquiry
Since the Prime Minister’s May 2021 announcement of a Public Inquiry, there has been little progress towards it occurring as expected in Spring 2022, save for the appointment of Baroness Heather Hallett DBE as its Chair. Terms of Reference (ToR) were expected early in the New Year, but they are still awaited. Health system leaders have been asked by NHS England (NHSE) to appoint a named inquiry lead and to start preparations around records management, contact and tracing systems for leavers and wellbeing support for staff likely to be involved. NHSE has also issued a stop notice regarding retention of documents.
We may be able to glean something of the ToR from the Scottish draft which was circulated in December – twelve terms with the objective of investigating the strategic elements of the handling of the pandemic. Five of the terms are of particular relevance to healthcare providers:
- Supply, distribution and use of PPE
- Transfer of residents to and from care / nursing homes
- Provision of healthcare services, including management and support of staff
- Delivery of end of life care and use of DNACPR
- (Design and) delivery of a vaccination strategy
What this means for you: In a public inquiry process, individuals and organisations can be compelled to provide documentation, a witness statement and oral evidence under oath. In our experience, early preparation is crucial. How relevant evidence is captured to enable organisations to have an accurate timeline of events and certainty as to information available at the time decisions were made will be vital. Read our insight on preparation for the Inquiry.
Coroners ‘following the science’ on causation
The vast majority of the inquest cases we have been involved in relate to acquisition of Covid-19 during hospital admission and staffing/ resource issues. We have noticed a definite trend whereby Coroners are broadly understanding of the circumstances in which care was given. However, in a recent case a Coroner was critical of a decision not to escalate a patient’s care to ICU. Whether this is an isolated case or is the start of a wider trend, remains to be seen.
Comment: Even if failures of care during the pandemic are scrutinised more closely by Coroners, there appears to be an established trend of reluctance to determine that Covid-19 was contracted during hospital 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.
Procedures and policies, including national policy decisions, will be central to the defence of Covid-related claims
Analysis of the Covid related claims we are handling reveals a slightly different picture to our inquest work. Delays to non-Covid treatment is the leading type, followed by Hospital-Acquired Covid (HAC) / failure to treat Covid-19 appropriately. NHSE’s policy decision to suspend all non-urgent elective surgery in March 2020 had a significant knock-on effect on treatment delays. Claimants are likely to find it difficult to prove a claim based on treatment delays if this decision was implemented by Trusts. The central issue in claims for HAC (and to a significant extent failure to treat) is likely to be one of causation. We understand that ATE insurers are grappling with this issue when deciding whether to offer cover for Covid-19 claims.
What this means for you: If NHSE guidance on ceasing electives was followed in part with elements of local decision-making added, proof that the latter was in line with other similar sized local trusts is likely to be important. Local infection control policies and procedures and Covid-19 treatment pathways with be at the crux of HAC/ failure to treat” cases. Evidence of decision-making will be vital to defending claims. Some evidence will be common to every case of its type. Healthcare organisations should already be preserving and collating this core evidence for the Public Inquiry.
Good news for Defendants on secondary victim claims – but watch this space!
In Paul & Paul v Royal Wolverhampton NHS Trust (2022), the key issue for the Court of Appeal was whether the gap in time between the late Mr Paul’s negligent cardiac treatment and the ‘horrifying event’ (his death from a heart attack witnessed by his daughters 14 ½ months later), meant that ‘proximity’ between the two was not established in law. The appeals (which included two conjoined cases of Polmear and Purchase) were dismissed, based on the Court being bound by its earlier decision in Taylor v A Novo Ltd (2013). In the case of Paul, the negligence was not sufficiently proximate to the heart attack.
Comment: In an obiter comment Underhill LJ went so far as to say that “if the point were free from authority I would be minded to hold that, on the pleaded facts, the Claimants in all three cases should be entitled to recover.” Permission has been granted to appeal to the Supreme Court. A hearing date is awaited.
Vicarious liability: Court of Appeal re-affirms Barclays decision
In Hughes (Respondent) v Rattan (Appellant) (2022), the Court of Appeal was asked to determine whether the Defendant (the former owner of a dental practice and GDS contract holder) was liable for the treatment provided to the Claimant (a patient) by three self-employed dental associates. The High Court had determined that the Claimant was a patient of the practice and that the Defendant was liable on the basis that he owed the Claimant a non-delegable duty of care and that he was vicariously liable for the associates. The Defendant appealed.
On the issue of non-delegable duty, the Court of Appeal agreed that the Claimant was a patient of the practice and that she was in the Defendant’s actual care as owner of the practice. The Claimant had no control over how the Defendant chose to perform his obligations, whether personally, through employees or third parties. The appeal on this ground was dismissed. On the issue of vicarious liability, applying the “critical question” from the Supreme Court decision in Barclays Bank (2020) of whether the relationship between the Defendant and associates was “sufficiently akin to employment”, the Court determined that it was not and the appeal was allowed.
What this means for you: The decision may have ramifications for providers in the wider healthcare sector. We could see more of these cases as the private sector plays a role in ‘Covid recovery’, but the outcome is likely to depend on the precise structure of the relationship. Healthcare organisations engaged in this work (on either side of the contract) will need to consider contract terms and indemnity provision carefully, in particular any variation to the NHS standard contract. Read our insight on the decision.
Safety and Learning
Government response to Paterson Inquiry Report
The government has published its long-awaited response to the Paterson Inquiry Report. Much of the response deals with work that is already in progress, for example: the work of the Acute Data Alignment Programme in respect of collection of consultant performance data, and CQC inspection framework updates on multi-disciplinary team (MDT) working. In addition, the government has committed to various recommendations which impact the independent sector; for example, extending its 2018 consultation on appropriate clinical negligence cover. Draft legislation will be brought forward on regulation and in particular the duty of regulators to co-operate.
The government has not accepted / is keeping under review:
- Automatic suspension of any healthcare practitioner perceived to be a risk following a hospital investigation; and
- The need for agreed recommendations to be implemented across the entire independent sector (private, insured and NHS funded) for providers to qualify for NHS contracts.
What this means for you: The crimes of Ian Paterson highlighted deficiencies in patient safety regimes across the independent sector and the NHS. In both sectors, the key to learning from Paterson as an organisation is increased governance from ‘Ward to Board’ and addressing organisational culture to encourage open discussion of concerns and ensure accountability. Read our insight on learning from the Paterson Inquiry.
All change with maternity safety investigations
The government will create a new Special Health Authority to take over maternity investigations currently handled by the Healthcare Safety Investigation Branch (HSIB). Concerns around the creation of a ‘safe space’ for the new Health Service Safety Investigations Body (HSSIB) proposed by the Health and Care Bill (2021) appears to be the driving force behind the proposal. ‘Safe space’ will prohibit HSSIB from disclosing any information it holds, except in very limited circumstances. This is now considered to be inappropriate for maternity investigations.
Comment: There was a clear tension between ‘safe space’ on the one hand, encouraging those aware of patient safety incidents to come forward, and on the other, ensuring that incidents are rigorously investigated and seen to be transparent. It was always possible that information provided to HSSIB by a healthcare organisation which forms, for example, part of its own serious incident investigation, would not be privileged from disclosure in any subsequent legal proceedings against it. This includes not only reports, statements and the like, but internal communications relating to them (including drafts).
Major expansion of virtual wards – balancing the risk and benefits
Improving the responsiveness of urgent and emergency care and building community care capacity is a 'top 10' priority for NHSE in 2022. This will be delivered in part by the expansion of ‘virtual ward models’. It is easy to see how such models free up Emergency Department (ED) beds, minimise ambulance handover delays and potentially provide a more congenial experience for patients at home or in a more relaxed care setting out of hospital. However, recent reports of allegedly inadequate care and support in a ‘care hotel’ are a salutary tale of potential pitfalls.
What this means for you: risk issues for NHS trusts are likely to centre on patient selection for ‘virtual wards’, ensuring that appropriate systems are in place for monitoring patient progress / deterioration and, above all, a robust system for transfer to a hospital setting. These policies and care pathways will be crucial to the defence of any clinical negligence claim. Likewise, decision-making with regard to selection should be clearly documented.
Managing risk at handover between ambulance and acute trusts
A local investigation pilot by HSIB has identified safety issues around processes and systems for patient identification at handover. One case involved a 76 year old lady taken by ambulance to the local trust following a 999 call. The Emergency Operations Centre used an incorrect NHS number which in fact related to another person with the same date of birth and similar name. This number was used to book the patient in the ED and continued to be used. When medication was reviewed by the pharmacy, she was prescribed medication for the individual with the other NHS number. She refused to take the medication and the error was revealed. Safety recommendations were made by HSIB on a regional basis and included development and implementation by the Trusts of a standardised approach to patient identification and exploration of barriers to checking patient identifiers.
What this means for you: Had the patient not refused the medication, she could have suffered significant harm. All healthcare organisations should check the robustness of their systems for patient identification. If data is stored in different parts of a patient records system, it is essential to ensure that there is consistency of approach.
Update on the new role of Patient Safety Commissioner
The creation of this role was a central plank of the Independent Medicines and Medical Devices Safety review report. Scoping of the role has been completed and the job advertised – the interview date is 23 March 2022. The PSC will have statutory powers to report and make recommendations to the Secretary of State and any relevant person or organisation and to request information.
What this means for you: Although the PSC will not be under a statutory duty (unlike a Coroner considering Prevention of Future Death), the PSC’s power is likely to highlight patient safety issues to a wider audience and further enable learning from error to prevent harm. 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. They should also be mindful of the possibility of reputational damage
Exceptional case funding for inquests no longer means tested
From 12 January 2022, bereaved families facing an inquest into a death under article 2 of the European Convention on Human Rights are no longer required to pass a means test to secure public funding for legal representation. An ‘article 2’ inquest will be triggered if the death took place in police custody or while the deceased was detained in a mental health facility.
Comment: Although ‘article 2’ inquests represent a small proportion of healthcare inquests, we are likely to see more families being represented and possibly an increase in the overall number of such inquests.
The latest approach to CQC inspections
The CQC continues to flex its approach to inspection to allow for the pressures caused by the pandemic. It is clear from its February 2022 update that the CQC does not currently plan to return to routine, frequency-based, inspections. The current approach is a blend of focused inspection activity and regular remote monitoring. In terms of ‘boots on the ground’ inspections, these will only be undertaken where there is evidence that people are at risk of harm. In terms of NHS providers, the CQC will also focus on urgent and emergency care pathways to determine how well services across a system are working together.
From July 2021, some providers have been subject to regular monitoring calls from the CQC. Initially, NHS trusts were not included in this, but this is likely to change. The monitoring calls are more formal than the relationship meetings trusts have with the CQC as they are based on a slimmed down version of the Key Lines of Enquiry (KLOE). The CQC is using these calls to determine whether a more formal inspection might be needed. It has published a number of different versions of the monitoring questions (slimmed down KLOE) which will be asked during these monitoring calls. These are the relevant versions for NHS trusts and Mental health services (NHS and independent).
What this means for you: NHS trusts will need to be familiar with the monitoring questions so that they are prepared for this development in the CQC’s inspection methodology.
Digital technology to transform care delivery and outcomes – take care with data protection
The use of digital technology to achieve a “core level of digitisation in every service across systems” is a 'top 10' priority for NHSE in 2022. The pandemic has accelerated the pace at which new technology is being introduced into the NHS – for example, remote GP consultations. NHSE intends that technology is used not only to support the Shared Care Record collaborative, but that an NHS e-referral service should span ‘any-to-any’ health sector triage, referral and e-booking systems by 2025. Both initiatives contain the common thread of processing sensitive personal data. As use of technology in the health sector expands further, legal issues are likely to centre on information governance.
What this means for you: When processing personal data, healthcare organisations need to demonstrate compliance with data protection law. Data must be kept confidential, safe and securely stored in compliance with cyber security regulations. The development and deployment of technology should take account of internal NHS requirements (e.g. the ‘DTAC’ toolkit) as well as broader legal obligations, such as undertaking data protection impact assessments and being able to explain to service users how their information is used and shared.
Fixed recoverable costs – consultation
The government has opened a consultation on fixed recoverable costs (FRCs) in low value clinical negligence claims. FRCs for these cases were first suggested by Sir Rupert Jackson in his 2017 review of civil litigation costs. The current proposal does not prevent parties from pursuing claims in the courts if agreement cannot be reached, although it is intended that litigation can be avoided. The scheme aims for a rapid exchange of evidence for faster agreement on liability, causation and quantum. Claims would be assigned either to a light track or standard track according to their complexity. Two resolution stages would be built in: a ‘stocktake’ meeting between parties and a neutral evaluation by a barrister to resolve as many cases as possible. Costs would be limited to £6,000 for standard track claims plus 20% of damages agreed. For claims in the so-called ‘light’ track, proposed recoverable costs are no more than £1,500 plus 10% of damages.
Comment: Claimant representatives have argued that the proposals would stop patients securing the representation and compensation they deserve, while some defendants feel the proposals do not go far enough. Whoever is right, it appears inevitable that some change will occur regarding this long-standing problem of how to deal proportionately with low value claims. The consultation closes on 24 April 2022 and all interested parties are encouraged to respond.