Safety and Learning

‘First Do No Harm’

First Do No Harm’ the long-awaited report of the Independent Medicines and Medical Devices Safety Review has been published. The Review considered safety issues arising from the use of Primodos, Sodium Valproate and vaginal mesh surgery for pelvic organ prolapse and urinary incontinence. Failings are identified in all three areas and described as systemic, spanning the breadth of the healthcare system and as ‘institutional resistance to patient safety’.

Comment: 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.

Paterson Inquiry Report latest

The government’s response to the Inquiry Report has been delayed due to COVID-19, but an indication was given in April 2020 of its intention to respond as soon as practicable and a commitment to ‘implementing considered and effective improvements in the areas set out in the Inquiry’s recommendations.’

Comment: The similarities between the Inquiry Report and ‘First Do No Harm’ are noteworthy.  Both identify issues around governance, accountability and culture spanning both the NHS and private sectors. It will be interesting to see how the government approaches these recurrent themes.  Read what we said about the report in Clinical Law Insight, Spring 2020 and our Insights on safety and learning and engaging with patients.


Impact on future claims

Although speculative at this stage, it seems likely that clinical negligence claims will be brought both by COVID-19 patients (or their families) and non-COVID patients whose outcome has been affected by the pandemic. As lockdown ends, healthcare providers are faced with an additional risk: appropriately managing the prioritisation of patients for treatment, given the significant backlog that has built up. Delays to treatment may increase the risk of a future clinical negligence claim. New ways of working such as remote consultation will also need to be risk-managed appropriately

Comment: Whilst the risk from having to prioritise due to restricted resources cannot be eliminated, healthcare organisations should review their triaging policies. Clinicians should ensure that informed consent is obtained from the patient to any delay in treatment or change of treatment plan. Communication between the treating clinician, the hospital and the patient will be key to minimising risk. The discussion should cover reasons and treatment options, material risks and impact on likely outcome, and be fully documented. Assessment of a patient’s suitability for remote consultation, consent to it and any treatment decisions, plus the context and content of the consultation will be relevant to liability. All of these issues should be documented in the patient record.

Face-to face trials can take place although remote trials not unfair

SC v University Hospitals Southampton NHSFT [2020] EWHC 1445 was a clinical negligence claim arising from the management of a child with suspected meningitis, with a trial due to take place during lockdown. The Defendant sought an adjournment on the basis that the default form of remote hearing during the pandemic was unfair. The judge determined that although a fair hearing could take place remotely, there was no legal or practical impediment to the hearing taking place in court. The overriding objective militated against an adjournment which was refused.

Comment: Although remote hearings are likely to be around for a while yet, given the capacity issues caused by social distancing, it is clear that where possible a face-to-face hearing will take place. Adjournments will not be granted simply because the hearing has to be a remote one.

New Chief Coroner Guidance on remote hearings

    As courts slowly get back to business following the lockdown, the Chief Coroner has issued new guidance (no. 38) regarding remote participation in inquests via video and audio broadcast.  Inquests had in the main stalled for the 3 months of lockdown. It remains a requirement for the Coroner to be physically present in the court room. As such, the terminology used is that the hearings are ‘partially remote’.  There are clear benefits: reducing the risk of infection and maximising the chances of the current backlog of hearings increasing.

    Comment: There are likely to be significant regional differences in approach and we are already seeing this across the country. The suitability of hearings to be remote should be considered on a case by case basis, some may simply be inappropriate for remote hearing.  However, healthcare providers should expect to see an increase in their number and prepare to participate in them. Read our Insight and 'top tips' for remote hearings.

    Chief Coroner Guidance on death in the workplace

    Updated guidance (no. 37) on reporting deaths in the workplace emphasises the discretion of individual coroners in individual cases.  The original guidance stated that an inquests would not be the right forum to consider whether general arrangements in place for provision of PPE were adequate. This was incorrectly interpreted by some commentators are meaning that the death of healthcare workers should not be reported to Coroners.

    Comment: Healthcare worker deaths in the workplace involving COVID-19 need to be reported to Coroners. Healthcare providers should be ready for Coroners to investigate such deaths, although the Coroner will exercise discretion. The Coroner, in any event, may suspend the investigation if consideration of policy or resource issues are necessary for a full investigation until there is clarity about how these enquiries can be taken forward. As per previous guidance, if the medical cause of death is COVID-19 and there is no reason to suspect any culpable human failure as a contributory factor, there will usually be no requirement for an inquest to be opened. All deaths in state detention (e.g. prison or a secure mental health unit) will still require an inquest to be held. 

    COVID-19 and the Mental Capacity Act 2005

    COVID-19 poses significant resource and logistical challenges for all those who work with, for or alongside protected parties who lack capacity under the MCA. Read our Insight to see how the principles of the Act are to apply in a COVID-19 environment and the DHSC’s guidance on COVID-19 testing of those without capacity, life-saving treatment for COVID patients (including reference to Advanced Decisions) and a Deprivation of Liberty Safeguards Q&A.

    COVID-19: CQC and the Emergency Support Framework

    Having suspended its inspection regime in March following the COVID-19 outbreak, the CQC launched a new Emergency Support Framework. Under the Framework inspectors will set up a one hour online meeting with managers / nominated individuals, to discuss the stresses and challenges services are experiencing during the pandemic

    Comment: Whilst the CQC is presenting the ESF as somewhat informal, it is important that the discussion is treated as a formal CQC process. Providers should ensure they are prepared for the discussion and are prepared to provide documentary evidence if necessary. Read our Insight on the ESF.


    Covert recordings by patients

    In Rory MacDonald (by his litigation friend Lindsay MacDonald) v Simon Burton [2020] EWHC 906, a motor claim involving catastrophic injuries, the Claimant’s solicitor wanted the examination of the Defendant’s neuropsychologist to be recorded. He refused.  The judge held that it was appropriate to await imminent guidance from the British Psychological Society, following the case of Mustard v Flower (2019), rather than to lay down any in the instant case.  To ensure a level playing field the Defendant’s expert’s testing should not be recorded as the Claimant’s expert had not recorded his.

    Comment: The technology to make recordings is readily available on smartphones, and if a patient wishes to record a consultation, in practical terms, it is going to be difficult to stop them. However, healthcare organisations may wish to consider whether they should have a policy on the circumstances in which making recordings are less appropriate (e.g. where consultations touch on third parties).  Staff training on communicating with patients about and facilitating recordings is likely to be important as is the creation of signage, leaflets and guidance for patients on making recordings and protecting confidentiality. Read our Insight on the impact of the Mustard decision.


    Defendant penalised for refusing to mediate

    In DSN v Blackpool FC Ltd [2020] EWHC 670, the Claimant made a Part 36 offer of £10,000 to settle his sexual abuse claim. It was rejected. The matter went to trial and the football club was found vicariously liable and the Claimant was awarded £17,000. Due to its conduct, the Defendant was ordered to pay indemnity costs but for a longer period than would otherwise have been the case. The Defendant had refused to mediate repeatedly stating that it ‘continues to believe it has a strong defence’.  In making the order the judge commented that no defence however strong justifies a failure to engage in mediation.

    Comment: This case illustrates a continuing move towards claims being resolved without the need for proceedings / trial. Failure to engage in mediation is likely to be seen as conduct which save in exceptional circumstances is likely to lead to a (costs) penalty being imposed on the party refusing. A strong defence may inform what offer a Defendant might make at mediation, but should not be a reason to refuse to engage.


    Independent contractors: ‘employer’ not vicariously liable for sexual assault

    The Supreme Court decision in Barclays Bank plc v Various Claimants [2020] UKSC 13 involved a self-employed contractor of the bank who had committed sexual assaults on staff undergoing OH assessments.  The Court decided that the key question to determine whether vicarious liability should apply, was whether the tortfeasor was in business on his own account or in a relationship akin to employment. They found the bank not to be vicariously liable for the doctor’s actions as he was in business on his own account with a portfolio of patients and clients.

      Comment: The decision is good news for all organisations using independent contractors. However, the Court did not rule out the possibility of vicarious liability being imposed in relation to the actions of self-employed or agency workers. Therefore, it remains imperative that healthcare organisations 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.

        Employer not liable for data breach by rogue employee

        In WM Morrison Supermarkets Plc v Various Claimants [2020] UKSC 12, the Supreme Court has determined that an otherwise blameless employer should not be vicariously liable where a rogue employee stole HR information relating to colleagues, as part of a vendetta against his employer. The data breach had been committed at home using a memory stick.

        The Court determined that the employee’s actions were not so closely connected to those which he was authorised to do as part of his job that they could fairly and properly be regarded as done while acting in the ordinary course of his employment.

        Comment: Whilst welcome news for employers, all 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, the latter will be directly liable for any data breach. Healthcare organisations should check that they have appropriate cyber risk cover in place. Read our in-depth Insight on the decision.

        A wider pool of secondary victims?

        Mr Paul sadly died of a fatal MI when out shopping 14 months after an admission to the Defendant hospital with chest pain.  His daughters (age 12 and 9) witnessed his collapse and the subsequent distressing scenes, which led to them suffering psychiatric harm. In Paul & Paul v Royal Wolverhampton NHS Trust [2020] EWHC 1415, the Claimants alleged that the treatment he received during the admission was negligent. The court held that the 14 ½ month period between the negligent omission and the collapse which had been caused by it, did not in itself, preclude liability.

        Comment: This case marks a departure from earlier caselaw on the need for proximity in time and space between the negligence and the event which causes the Claimant’s psychiatric damage. It is not known whether the decision is to be appealed or whether it will progress to trial. Although each secondary victim case will turn on its own facts and the decision related to an appeal against Master Cook’s strike out of the secondary victim claims, the decision means that the pool of potential Claimants in clinical negligence cases could be widened.


        Changes to bereavement damages

        The bereavement award under The Fatal Accidents Act increased to £15,120 for deaths occurring on or after 1 May 2020. Following a Report from the Parliamentary Human Rights Committee, the draft Fatal Accidents Act 1976 (Remedial) Order 2020 provides that co-habiting couples (previously excluded from the award) will be able to claim bereavement damages if they have lived together for at least two years.

        Comment: These changes are likely to produce a modest increase in the value of individual claims. The extension of the category of Claimants to cohabitees may have a more significant overall impact on the total value of fatal claims in England and Wales, given the popularity of cohabitation as a mode of long-term relationship.

        Resolving future accommodation claims in the era of negative discount rates

        Since the advent of negative discount rates in 2017 (current rate minus 0.25%) the traditional Roberts & Johnstone approach has rendered the value of claims for the capital cost future accommodation, zero. The Claimant’s appeal in Swift v Carpenter [2018] EWHC 2060, against a zero award for house purchase, was heard by the Court of Appeal in June 2020.  Judgment is awaited.

        Comment: Several possible solutions were proposed by the Claimant in this and other post-2017 cases.  All were rejected by the courts because of the practical difficulties which arose. The Court of Appeal will need to find a workable solution which provides fair and appropriate resolution for Claimants and Defendants.

        Commercial surrogacy now a recoverable head of loss

        The Supreme Court decision in XX v Whittington Hospital NHS Trust [2020] UKSC 14 is a watershed case. Changing social and legal attitudes to surrogacy and what constitutes a family, were key to the Court’s decision to overturn the Court of Appeal decision in Briody (2001) which dismissed a claim for commercial surrogacy on public policy grounds. Although donor egg surrogacy in the USA did not directly replace XX’s own fertility, it was considered the best that medical science can offer.

        Comment: The decision is likely to increase the cost of claims where a Claimant’s fertility has been compromised as a result of negligence and she elects for surrogacy. Nevertheless, a Claimant will still need to prove that the claims for such treatment are reasonable.  The Court decision in XX related to principles alone – quantum was not the issue. Read NHS Resolution’s case note.


          Article 2 inquest not required simply because deceased deprived of liberty

          Ms Morgan, (aged 52) had Down’s syndrome and moderate learning difficulties. She lived in a care home under a the Mental Capacity Act 2005 Sch.A1 standard authorisation, but died in hospital as a result of a perforated gastric ulcer, peritonitis and pneumonia, having fallen ill some days before her death. Failures were identified in the response of the care home, GPs, NHS111 and paramedics. In R (on the application of Maguire) v HM Senior Coroner for Blackpool [2020] EWCA Civ 738 the Court of Appeal upheld the decision of the Coroner and Divisional Court that the state’s obligations under article 2 were not triggered by the mere fact of Ms Morgan’s vulnerability and deprivation of liberty. There was no systemic or structural failure in the medical services provided to her.

          Comment: The crucial distinction in determining whether article 2 is engaged is between a breach of duty which is a systemic error and one which is due to ‘ordinary’ clinical negligence. In some cases there will be an element of both and the risk of an article 2 inquiry remains.  The position in Morgan where the DoL was pursuant to MCA authorisation, should be contrasted with that where the deceased is under a DoL due to state detention (e.g. under the MHA 1983). In the latter scenario an article 2 inquest will always be required.


          Court authorises dialysis to be provided without consent under s.63 Mental Health Act 1983

          In A Healthcare & B NHS Trust v CC [2020] EWHC 574, Capsticks advised both the NHS Trust and the independent mental health service provider. The Applicants sought confirmation that dialysis could be provided to a patient with psychotic depression and mixed personality disorder under the MHA, under which regime he was detained. CC suffered from type 1 diabetes and renal failure associated with poor compliance with diabetic treatment and was often non-compliant with dialysis.  The latter was thought to be a manifestation of his mental disorder. Continued non-compliance would lead to death. CC was assessed as lacking capacity to make decisions about dialysis or the conduct of proceedings, but his capacity fluctuated. The court determined that dialysis was treatment for a manifestation of CC’s mental disorder as the need for it stemmed from his self-neglect (itself a consequence of his mental disorder), which had led to his kidney failure. CC’s dialysis could be provided as treatment within the scope of s.63 MHA, rather than requiring an application under the MCA.  Arguments on the use of the MCA were also canvassed in the Court but the argument of ‘A Healthcare’ that it could rely on the MHA was accepted.

          Comment: In the subsequent case of Warrington & Halton Hospitals NHS FT v GTI [2020] EWCOP 28, (not a Capsticks case) we understand (a) the parties chose not to run the s.63 argument as they wanted a declaration under the MCA and (b) that s.63 was considered in Court despite not being mentioned in the Judgment.  In GTI the Court declared that it was in GTI’s best interests to have a PEG feeding tube inserted in order to provide him with nutrition in order to prevent deterioration and a potentially fatal collapse, despite GTI clearly refusing such treatment.  He had an established history of schizoaffective disorder and in January 2020 he stabbed himself in the neck, causing significant impairment to his swallow reflex.  He was therefore unable to take food or drink orally without significant risks of aspiration. GTI initially agreed to the insertion of a PEG but then refused.  The Court found that the treatment could be given under the MCA as it is was clearly in his best interests, the Judge noting that it seemed inevitable that without the PEG, GTI’s malnutrition would worsen and eventually he would collapse. The insertion of the PEG was a less intrusive and painful means of maintaining nutrition than the alternative. The hope was that when GTI’s condition improved and his mental health stabilised, he would come to accept the need for the PEG.  However CC provides useful confirmation by the Court that an application under the MCA can be avoided altogether when the need for (physical) medical treatment stems from the underlying mental disorder.  In such circumstances the Responsible Clinician can authorise treatment for physical health under section 63 MHA. Early legal advice should be sort in these sorts of cases.

          Court approved withdrawal of life-sustaining treatment for stoma patient

          Barnsley Hospital NHSFT v MSP [2020] EWCOP 26 involved a 34 year old (MSP) who had expressed a strong wish not to live with an irreversible stoma. Sadly, this procedure was necessary when he suffered bowel obstruction and sepsis following a temporary stoma reversal.  Three months prior to the reversal operation MSP had made an Advanced Decision which rejected all life sustaining treatment and any treatment that would result in a permanent stoma.  The AD was procedurally defective and not available to the on-call surgeon, who advised him that a new stoma needed to be formed as his life would otherwise be in danger. MSP consented. Post-operatively MSP was sedated and ventilated and did not have capacity.  The Court came to its decision on the basis that MSP had made a clear and settled decision that he did not wish to live with an irreversible stoma or have treatment which would artificially prolong his life. His wishes were confirmed by his family and three consultants.  Although MSP had capacity when he consented to the stoma, he was unwell and on strong high-dose analgesia. The on-call surgeon had been optimistic that the stoma could be reversed, but he agreed that his conversation with MSP would have been of a different complexion if he has been aware of the AD.  The court considered that M’s consent was not inconsistent with his previous views and granted a declaration that the withdrawal of all treatment except palliative care was in his best interests.

          Comment: This was a desperately sad case and although the AD was procedurally defective it provided crucial information about M’s wishes. Its lack of availability to the on-call surgeon was even more crucial as he considered the conversation with M would have been of a ‘different complexion’, had it been available. It is debateable whether the AD would have covered the situation pertaining then as the surgeon hoped the stoma would be reversible. However, it seems likely that M would have refused the treatment and matters taken their course at that point.  It is vital that clinicians make enquiries about the existence of Advance Decisions in any case where they are discussing with a patient a potentially life changing treatment. However in this case the doctor was not aware of it so could not take it into consideration in discussions with MSP.

          Latest on Liberty Protection Safeguards

          The October 2020 implementation date has been abandoned. Helen Whateley (Minister for Care) provided a written statement on 16 July 2020 that “It is paramount that implementation of LPS is successful so that the new system provides the safeguards needed. The intention to date, subject to the DHSC’s work with stakeholders and delivery partners, was for LPS to come into force on 1 October 2020. It is now clear that successful implementation is not possible by this October. We now aim for full implementation of LPS by April 2022. Some provisions, covering new roles and training, will come into force ahead of that date. I will continue to update the sector and stakeholders on timings”

          Comment: This is not surprising in light of the resources taken up by Brexit and latterly the COVID-19 pandemic and the amount of work that needs to be done to prepare for the implementation of LPS In advance of the April 2022 deadline the government will have to publish and consult on both underpinning regulations and a Code of Practice neither of which have been published yet.  The Government will also need to allow the sector time to consider the final Code and prepare for implementation.

          Capsticks annual seminars on deprivation of liberty under the MHA and MCA will be taking place as webinars in a couple of months’ time and our lawyers are speaking at national events with leading experts.