As 2021 draws to a close, we review some of the key decisions over the last eleven months which impact healthcare and those who provide indemnity to this sector. From considering issues around causation and vicarious liability through to the announcement of a public inquiry on COVID-19 and greater regulation of the aesthetic industry, many important decisions and changes have come about. In our annual Forward View in the New Year we will consider what lies ahead but this overview recaps what has happened since the lockdown of January 2021.

Spotlight on key decisions

Extent of causation in clinical negligence claim limited by the scope of the duty

The case of Khan v Meadows [2021] UKSC 21 involved failures in haemophilia testing /advice provided 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. Dr Khan admitted liability only in relation to the consequences of the haemophilia. The Supreme Court determined that his 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 connection to that scope of duty.

What this means for you:  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.

Proximity between negligent act and causative event in secondary victim claims damage

The appeal in Paul & Paul v Royal Wolverhampton NHS Trust is in the Court of Appeal floating list for 14 or 15 December 2021. The issue to be determined is the need for proximity in time and space between the negligent act and the event which causes a secondary victim Claimant’s psychiatric damage. The High Court held that a 14 ½ month period between negligent cardiac treatment and Mr Paul’s collapse and sad death which had been caused by it, did not in itself preclude liability to his young daughter who witnessed the collapse. The decision marked a departure from earlier case law on the need for proximity in time and space between the negligence and the event which causes a claimant’s psychiatric damage. If the decision is upheld the pool of potential claimants in clinical negligence cases is likely to become wider.

Claimant succeeds in claim for “wrongful life” 

The case of Toombes v Dr Mitchell concerned the concept of “wrongful life” - as opposed to “wrongful birth” where the parents of a child bring the claim. The claimant alleged that her mother had not been given appropriate advice in relation to when she should attempt to conceive after being on the contraceptive pill and furthermore had not been told by the Defendant to take a folic acid supplement during her pregnancy. The Defendant, accepting he had no clear recollection of the consultation, agreed that if he had told her that there was no need to delay conceiving, then this would have been negligent advice. He argued that although his note simply said “folate if desired” his standard practice was to advise prospective mothers of the link between folic acid supplements and the prevention of spina bifida. The claimant was born in 2001 with a form of spina bifida.  

It was decided as a preliminary issue in 2020 that if – which was yet to be tried – the claimant’s factual assertion as to the advice her mother was given was correct, then the claimant was not precluded from bringing her claim for “wrongful life”. This was because with the correct advice regarding folic acid, the mother’s pregnancy would have been delayed and a different child without spina bifida would have been born. In December this year, after hearing evidence from both sides on the factual matrix,  HH Judge Coe QC found in favour of the claimant thus ratifying the facts on which the preliminary legal issue was based; i.e. if the correct advice had been given, the claimant’s mother would have delayed conception while she took a course of folic acid rather than attempting to conceive in a folic acid deprived state.  

What this means for you: The case is important because the preliminary issue in 2020 established that if there is a causative connection between negligent advice or treatment and the occurrence of sexual intercourse which would not otherwise have happened and this results in a child with a disability being born, then a claim for “wrongful life” can be made. It also highlights the importance yet again of the need for adequate note taking as to what advice is given rather than relying on what the usual course of practice would have been.

Vicarious liability continues to extend its reach

2020 saw the Supreme Court handing down two key judgments on vicarious liability: W M Morrison Supermarkets Plc v Various Claimants [2020] UKSC 12 and Barclays Bank v  Various Claimant [2020] UKSC 13. See Medical Malpractice Review 2020 for our insight on the decisions. This year has seen a number of significant decisions.

In The Trustees of the Barry Congregation of Jehovah’s Witnesses v BXB [2021] EWCA Civ 356, the issue to be determined by the Court of Appeal was whether the Trustees were vicariously liable for the rape of congregation member BXB by congregation member Mark Sewell (S), at his home. BXB reported the rape to the elders and S was convicted.

The Court upheld the High Court decision that the relationship between the Defendant and S was capable of giving rise to vicarious liability. The key components were: S’s role as an elder was integral to the business of a Jehovah’s Witness congregation; his status provided him with the opportunity for physical proximity with congregation members; and S’s father (a senior elder) had out BXB and her husband in a position which made it difficult for them to terminate the association even after S’s behaviour had become seriously concerning. The decision demonstrates that a religious organisation will be liable for the abuse of one of its members by a leader, irrespective of setting and whether the victim is an adult or a child.

The Court of Appeal in Blackpool Football Club Ltd v DSN [2021] EWCA Civ 1352 found in the Appellant’s favour. The Respondent had been sexually abused on an overseas tour by Mr Roper (R), a volunteer football coach at the club. In allowing the appeal, the Court determined that there was a complete lack of even a vestigial degree of control by the club over R; for example the tour had been organised and almost entirely funded by R who had his own juniors club which referred players to other clubs as well as Blackpool. The decision may be explained by the fact it pre-dates the Supreme Court decisions in Morrisons and Barclays.

The doctrine of vicarious liability has also been considered in a health care context. In Breakingbury v Croad (2021, Cardiff County Court), the Claimant was an NHS patient at a practice owned by the Defendant. Her treatment was provided by several associates at the practice – all self-employed. The judge held that the Defendant was vicariously liable for the dentists. The dentists were given targets, he had to ensure the practice met the necessary standards and he got a financial benefit from their work. The fact that they managed their won tax affairs was irrelevant.

The subsequent High Court decision in Hughes v Rattan also looked at the issue of whether a claimant should sue the owner of a dental practice even when the dentists were “self-employed”. Once satisfied that the relationship between the practice owner and “associate dentists” was sufficiently akin to employment the court went on to find that a sufficiently close connection between the relationship and the tortfeasors wrong doing was also satisfied. In addition it was held the factors needed to establish a non-delegable duty of care were met.

What this means for you:  These decisions could have significant practical implications for health providers. Practice owners should review their Associate contracts and insurance cover and might want to consider pursuing an indemnity from the treating health professional.

Given the importance of this issue of vicarious liability Capsticks hosted a webinar in November, with a panel of speakers to discuss the key points and how they may impact health providers as well as their insurers. A summary from the webinar is available here along with a link to view this and David Myhill’s helpful summary of the developments in the case law dealing with vicarious liability.

COVID-19 Public Inquiry

In May the Prime Minister announced that the Public Inquiry into the government’s response to the pandemic would begin in Spring 2022. As a matter of urgency, health and social care organisations (including those in the private sector) will need to decide who is going to lead the organisation’s response. In NHS England’s (NHSE) 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, and
• appointing a named inquiry lead.

NHSE will be issuing a stop notice internally regarding retention of documents.

Within such 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 will be crucial.  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 particularly important. Read our insight to learn more about how you can prepare for the Inquiry.

The Paterson Inquiry Report – ‘one year on’

In March 2021, the government published a partial response to the Inquiry Report (4 of the 13 recommendations): Recommendation 2 (information to patients); Recommendation 4 (consent); Recommendation 5 (MDTs); and Recommendation 7 and 8 (patient recall and ongoing care).

As well as confirming that it will respond in full to the Inquiry during 2021, the government’s Health and Care Bill includes extension of the remit of the Health Service Safety Investigation branch to private providers. The Medicines 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.

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 latest insight on the Inquiry Report.

New Patient Safety Commissioner

The Medicines and Medical Devices Act 2021 has created a new role of Patient Safety Commissioner, spanning both the NHS and independent sectors. Although funded by the Department of Health and Social Care (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.

What this means for you:  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.

Regulation and patient safety in the non-surgical aesthetic sector

There have been two significant developments in patient safety and regulation of the non-surgical aesthetic sector. Firstly, the long awaited ban on under-18s receiving botox or fillers has been implemented from 1 October 2021 by The Botulinum Toxin & Cosmetic Fillers (Children) Act 2021. The Act makes it a criminal offence for a person to give botulinum toxin or filler injections for cosmetic purposes to a person under the age of 18. Administration by registered medical practitioners or healthcare professionals acting under their direction can be a defence.

Secondly, changes to regulation of the entire non-surgical aesthetic sector look likely, following publication of the All Party Parliamentary Group on Beauty, Aesthetics and Wellbeing (APPG) report. The APPG noted a “complete lack of a legal framework of standards” and makes 17 recommendations spanning minimum standards, qualification/licensing, prescribing, mandatory pre-screening, extension of the under-18s ban to other invasive procedures and advertising / social media restrictions. Read our insight on patient safety, the report and its wider impact.

CQC: updated guidance on the duty of candour

The guidance relates to the statutory duty of candour under regulation 20 in the Health & Social Care Act 2008 (Regulated Activities) Regulations 2014. It gives a more specific explanation of what is defined as a notifiable safety incident (NSI) and examples covering a range of scenarios. The guidance acknowledges that in many cases, lack of a timely apology is the driver for a patient to take legal action. Clarification is provided 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.

The Paterson Inquiry report made it clear that the private sector faces challenges to embed an effective safety and learning culture which is patient-centred and which has the duty of candour at its heart.

What this means for you:  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.

Last year, Plymouth Hospitals NHS Trust pleaded guilty to a breach of regulation 20 and was fined £1600 (maximum £2,500). The Trust’s Duty of Candour Policy was not triggered following the death of an elderly patient following an abandoned endoscopy as it was not aligned with its Serious Incident Policy. Healthcare organisations should review their policies to ensure they are properly aligned and fill any gaps. Read our insight on the guidance.

How Capsticks can help

Aiming to be the firm of choice for medical malpractice insurers and healthcare providers, we advise and support on all aspect of medical law including claims, inquests and regulatory proceedings.

To discuss how any of these issues may affect your organisation, please get in touch with Majid Hassan, Anna Walsh, Sarah Bryant or Ed Mellor.