Welcome to our Spring edition of Clinical Law Insight. It has a new section dedicated to safety and learning issues which we hope readers will find helpful. Safety and learning were featured in several recommendations made in the Paterson Inquiry report: multi-disciplinary working (in both the independent and wider healthcare sectors), complaints handling and patient recall (ongoing care and procedures generally). All three areas contain common themes around the need for hospital providers to review their policies and processes to ensure they are robust and where appropriate meet with national guidance. It is clear that challenges remain for providers to embed an effective safety and learning culture which is patient-centred and which has the duty of candour at its heart.

Safety and Learning

Paterson Report: mending a dysfunctional healthcare system

The long-awaited Paterson Inquiry report has been published.  Bishop Graham James the report’s author describes a ‘healthcare system which proved itself dysfunctional at almost every level.’ The recommendations made are wide-ranging and include: a single, mandatory,  publicly accessible database of consultants across England setting out their practising privileges and other performance data; difference between the organisation of the NHS and independent sector to be explained to patients (including those treated in the latter but funded by the NHS); mandatory independent review of any complaint from a private patient; national framework of guidance on recall communication and management;  review of the independent sector indemnity gap/ reform of discretionary indemnity; review of system for collaboration between regulators; suspension of a healthcare professional if internal investigation reveals any perceived risk to patient safety.

Comment: Although many healthcare organisations have been working to improve practices since Paterson’s criminal activities came to light, the report reveals a clear concern that ‘it remains possible for poor or unsafe practice to be undetected today’. The report raises many questions about how the recommendations could be best implemented and it remains to be seen how the government intends to proceed.  Read our Insight on the report and its recommendations and our in-depth Insight on safety & learning. 

Safety and learning in maternity: NHS Resolution’s Early Notification Scheme progress report

NHS Resolution’s Early Notification Scheme for potential severe brain injury following term labour has been running since 1 April 2017 and requires NHS Trusts in England to report within 30 days, for investigation, all births which meet the qualifying criteria.

A total of 746 cases were reported to the scheme between 1 April 2017 and 31 March 2018. The report contains an analysis of 96 out of a total of 197 cases where NHS Resolution panel firms were instructed to investigate liability. Recommendations are made for improvement around the involvement of families; staff support; duty of candour; issues with fetal monitoring; issues with delivery of the head at caesarean section; concurrent maternal medical emergencies and the need for immediate neonatal care and resuscitation.

Comment: Trusts should review their procedures and policies on family involvement, staff support and the duty of candour and staff competencies and training on the midwifery, obstetric and neonatal issues identified. NHS Resolution has produced some helpful guidance on 'Saying Sorry' which includes the duty of candour.  Read our in-depth Insighton how to get the duty of candour right.

GIRFT: lessons from ophthalmology

The GIRFT Ophthalmology Specialty Report highlights the ever increasing challenges for the speciality around soaring demand, workforce issues, variations in eligibility for and delivery of care and patients being lost to follow-up. Clinical negligence claims in ophthalmology were estimated to have cost between £25.3 and £52.1 million over the past 5 years. Improving the quality and use of data to learn from adverse events is identified as a cross-speciality need and a 5-point plan is proposed to reduce clinical negligence costs:

1. Benchmark estimated litigation costs per activity against national average.
2. Ensure data sets are correctly coded.
3. Review claims in detail to determine whether patient care or documentation could be improved.
4. Triangulate claims with learning themes from complaints; and
5. Trusts outside the top quartile for litigation costs per activity will be followed-up to support learning from claims.

Comment: Although claims numbers in ophthalmology are relatively modest, there is significant potential for high value claims given the impact of loss / impairment of vision.  With regard to the 5-point plan, Trusts will need to ensure their data sets are of the best quality possible, that they have good documentation and a seamless learning opportunity across complaints and claims.

Learning from complaints: more work to be done

According to the Healthwatch England report Shifting the mind-set: a closer look at NHS complaints there is too much focus on process; hospitals need to do more to show patients how the NHS is learning from complaints.  Key findings include:

• Local reporting is inconsistent and inaccessible. 
• Numbers of complaints are reported via NHS Digital, but only a minority report on anything more meaningful at local level.
• Staff are not empowered to communicate with the public on complaints
• Statutory complaints reports are only made available to the public on request
• Reporting focuses on counting complaints rather than demonstrating changes.

Only 38% of Trusts make public any information on actual changes made in response to complaints.  Often the only information given is ‘improvements were made’

Comment: While the report acknowledges that a system wide approach is needed, there are things that can be done at a local level. Trust Boards should ensure that their complaints reports are published regularly and that they contain details on learning and improvement.  In addition, thought should be given to how learning can be communicated to patients in a more accessible way. The report mentions leaflets and display of ‘you said, we did’ information on hospital notice boards.

The ambitions set out in the new NHS Patient Safety Strategy have the potential to enhance learning.  A shared taxonomy is proposed for complaints, incidents and claims, with patients, carers and members of the public being able to upload data to the new single portal.  Read our in-depth Insight on the new NHS Patient Safety Strategy

All change with Health Service Safety Investigations

Last year the government announced its intention to create a new Health Service Safety Investigations Body (HSSIB), a more powerful version of the current Healthcare Safety Investigation Branch (HSIB).  The Health Service Safety Investigations Bill was intended to cover services in both the NHS and independent sector (but in the latter case only those provided under NHS contracts). The Bill proposed the creation of a ‘safe space’ for HSSIB investigations prohibiting HSSIB from disclosing any information it holds except in very limited circumstances and gave it greater ‘teeth’ regarding powers of entry and seizure. Failure to co-operate will be a criminal offence.  The Bill ‘died’ when Parliament was prorogued for the General Election and has not yet been re-introduced. It was also announced that HSSIB will stop carrying out external maternity investigations by 2021.

Following publication of the Paterson Inquiry report, the Under Secretary of State for Health and Social Care has called for the Bill to be extended to the independent sector.

Comment:  The concept of ‘safe space’ should make a significant contribution to ensuring that incidents are fully investigated. However, it is unlikely that information provided to HSSIB by a healthcare organisation which forms, for example, part of its own serious incident investigation, will 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).

Commentators expressed serious concern about the end of the HSSIB’s role in maternity investigations, given the number of neonatal deaths in the NHS and the lost opportunity for learning together with the significant contribution of maternity errors to annual litigation costs. It will be interesting to see if the new Bill also curtails HSSIB’s role in this area.

Liability

NICE guidelines ‘not a complete compendium of clinical definitions or management options’

The case of Ashley Paige Sanderson (by her litigation friend Beverly Sanderson) v Guys & St Thomas’ NHSFT (2020) involved a claim on behalf of a brain damaged baby which centred on interpretation of fetal heart rate decelerations in labour and the NICE Guidelines on electronic fetal heart rate monitoring. Lambert J noted that on their face, the Guidelines appeared to advocate two contradictory options for managing the presence of fetal heart decelerations of greater than 3 minutes duration. They recommended conservative measures (expressly including a fetal blood sample) and also urgent delivery (without taking a blood sample). Lambert J rejected the Claimant’s interpretation of the Guidelines as indicating that the presence of a single prolonged deceleration was evidence of acute fetal compromise mandating nothing other than urgent delivery as ‘highly selective’. She considered that the only way in which the Guidelines were intelligible and workable was for the reasonable obstetrician to use them as a practical tool alongside the exercise of their judgement, assessing the appropriate response by reference to the CTG trace as a whole. The obstetrician's decision to take a fetal blood sample instead of performing immediate delivery had been an appropriate and reasonable response to the CTG trace. The claim was dismissed.

Comment:  NICE guidelines are an important tool for the safe delivery of care.  If they are not followed it is often the case that defending the claim becomes more challenging. This highly practical decision makes it clear that the Guidelines do not override clinical judgment.  If a Guideline is departed from clinicians should make a detailed note of the circumstances and reasons.

Pre-action dishonesty is now actionable

Pre-action dishonesty is not covered by s.57 Criminal Justice and Courts Act 2015 which has been the basis for the courts’ landmark decisions in Calderdale & Huddersfield NHS Foundation Trust v Atwal (2018) - a 3 month immediate custodial sentence for attempting to defraud the NHS out of c. £800,000 and George Eliot Hospitals NHS Trust v Elder (2019) - a 5 month immediate custodial sentence for an attempt to defraud the NHS of over £2million

In Jet2 Holidays Ltd v Hughes & another (2019), the Court of Appeal determined that the High Court had jurisdiction to commit for contempt following dishonesty at the Pre Action Protocol stage which was an ‘integral and important part of the litigation process.’

Comment: This holiday sickness case brings the position of Defendants facing unscrupulous Claimants in pre-action matters into line with those where proceedings are issued. Increases in the number of challenges to dishonest claims and committals for contempt are likely to follow.

Clinicians must satisfy themselves that informed consent has been obtained and should not assume it has been obtained by others

In Edyta Mordel v Royal Berkshire Hospitals NHS Foundation Trust (2019)the Defendant was found liable to the Claimant for her baby being born with Down's Syndrome. A sonographer had failed to check that there had been a discussion about screening between a midwife and the Claimant and that the latter understood the essential elements and purpose of screening for Down’s. When the Claimant attended for an ultra-sound scan, the sonographer recorded that she had declined screening. The Clamant alleged that at all times she had indicated that she wished to have screening. Had she known of the high risk of Down’s she would have chosen to undergo invasive testing and if necessary a termination.

Comment: The Claimant had accepted all of the standard screening tests at the prior appointment with the community midwife.  Six weeks after the appointment with the sonographer, she attended a further appointment with the midwife who did not discuss Down’s screening with her.  Although Jay J considered it was not incumbent on the midwife to undertake a lengthy enquiry, where a patient was booked for screening and did not have it (as here), the midwife’s failure to enquire was substandard care. Interestingly, Jay J found that the sonographer would have asked the Claimant whether she wanted screening, but that her refusal was not ‘informed’.   He considered it unnecessary for a clinician to unravel a patient’s reasons for acceptance or rejection, but that it was necessary to gently probe her to ensure that she had understood.  What was reasonable was not dependent on the attributes of any particular patient.

This decision highlights the risks around obtaining consent where patient care is an ongoing process involving a number of different individuals.  Members of a clinical team should not assume that informed consent has been obtained by the person who suggested a particular investigation. Informing the patient is not the same as obtaining informed consent.

Evidence

Covert recording of medical examination not unlawful

Mustard v Flower (2019) involved an appeal against Master Davison’s decision to allow in evidence a covert recording of an examination and testing of the Claimant by the Defendant’s neuropsychologist. The claim involved a rear-impact RTA alleged to be so severe that the Claimant sustained a sub-arachnoid haemorrhage and brain injury.  Her experts considered the injury to be serious but with subtle presentation; the Defendant did not agree. The Claimant’s solicitors advised her to record the examinations with the Defendant’s experts.  The Claimant covertly recorded both the Defendant’s neuropsychologist’s examination and testing, despite the expert having consented only to the former. The neuropsychologist’s conduct was brought into doubt and the Claimant applied to rely on the covert recording.  It was held that the recording was neither unlawful nor unfair and the contents were probative and highly relevant to the matters in issue. 

Comment: Although Master Davison considered the process of covert recording to be ‘reprehensible’, it had been done on the advice of the Claimant’s solicitor and her motives were understandable.  In this case once the recordings had been considered it was difficult to ignore the evidence.  He suggested an industry-wide agreed model on how meetings with expert evidence could be recorded would be helpful. This decision does not detract from the fact that covert recordings of medical examinations (whether for the purposes of care and treatment or a medico-legal report) are not permitted without consent. This applies to both recordings by patients and by doctors. Healthcare organisations should ensure that they have a policy on recording of consultations and that this is regularly reviewed.  Capsticks has produced an in-depth Insight on the relevant considerations.

Late service of witness statement – a narrow escape

In Dootson v Newhouse (2019)relief from sanctions was granted to a GP in a cauda equina syndrome case, who had served a witness statement from a medical student present at the Claimant’s consultation, 5 ½ months late and only 3 months before trial.  Although the breach was significant and there was no good reason why the student had not been traced sooner, relief was granted as the student had a good recollection of the consultation and the evidence was relevant and independent. Preventing the Defendant from relying on the evidence would penalise him and be disproportionate.

Comment: When a trial date is potentially threatened the courts tend to take a dim view of late service of evidence.  The importance of identifying and tracing witnesses as early as possible after a claim has been notified cannot be over-emphasised, not only to avoid the risk of key evidence not being admissible, but to obtain the best evidence when matters are still reasonably fresh in the mind of the witness.

Quantum

Court of Appeal adopts ‘Blamire’ broad-brush approach to future loss of earnings

In Irani v Duchon (2019), the Claimant appealed against a decision to base an award for future loss of earnings on a broad-brush approach rather than the multiplier/ multiplicand.  The Claimant’s injuries had led to his redundancy and loss of his immigration status in the UK. The appeal was dismissed on the basis that to calculate a multiplicand it was necessary for a claimant to establish on the balance of probabilities (a) the earnings he would have had but for the accident, and (b) his residual earning capacity.  This required evidence of the type of work and the level of remuneration over time. In the Claimant’s case the only evidence of residual earnings was a letter from a friend, a snapshot of unsuitable jobs currently available from one Indian website and various assertions made by him, a number of which were specifically rejected. 

Comment:  This is a useful case for Defendants where there is any uncertainty about the ‘but for’ or residual earning capacity of a Claimant.  The ‘Blamire’ award made a significant difference to the value of the loss of earnings claim: £150,000 as against a potential value of c. £1.2 million. An example of a case where the multiplier/ multiplicand approach was adopted is Inglis v MOD (2019), reported in Clinical Law Insight, Autumn 2019.

Inquests

Updated Guide to Coroner Services

The MOJ has published an updated guide intended for the bereaved and others who may be affected by a Coroner’s investigation or are attending a Coroner’s inquest.  It forms part of the government’s work to make inquests more sympathetic to the needs of the bereaved.  It contains a protocol of key principles applicable when a government department has Interested Person status in an inquest.  These include: supporting the inquisitorial nature of the process; being open and honest; effective and empathetic communication with the bereaved; and acting with sensitivity at the hearing

Comment:  The keystone of the Protocol is placing the bereaved at the heart of the process. Trusts and clinicians should familiarise themselves with the Protocol and ensure compliance in both letter and spirit when dealing with bereaved people following a death in hospital which is referred to the Coroner.

Notification of Death Regulations 2019 Guidance

The Guidance covers the notification requirements, circumstances in which a notification should be made under regulation 3 and information to be provided to the Senior Coroner.

Comment:  A death must be reported to the Senior Coroner for the area where the deceased’s body lies if the Registered Medical Practitioner has reasonable cause to suspect that it was due to (more than minimally, negligibly or trivially), caused or contributed to by the relevant circumstance. The Guidance provides examples of what is covered by the various circumstances. Read our in-depth Insight on the Regulations and Guidance

Advisory/ Regulatory

High Court determines it is not in child’s best interests for life-sustaining treatment to be withdrawn

Tragically, 5 year-old Tafida Raqeeb had suffered extensive and irreversible brain damage and was being kept alive by a ventilator. Her treating clinicians considered that she was unlikely to recover and that it was not in her best interests for life-sustaining treatment to continue. The Trust made an application for a declaration to that effect.  Her parents refused to consent and wished to take her to Italy for palliative treatment.   In Raqeeb v Barts NHS Foundation Trust [2019] EWHC 2531 (Admin) and [2019] EWHC 2530 (Fam), the High Court determined that it was in the Tafida’s best interests for life-sustaining treatment to continue and there was no continued justification for her doctors to refuse to agree to her being transferred to the Italian hospital. Guidance was given by the court on the proper course to be taken by doctors in England and Wales when faced with a best interests’ dispute and request by parents for the transfer of their child for medical treatment under the Treaty on the Functioning of the EU art. 56 (the right to receive healthcare services in another EU member state)

Comment: The fact that the Claimant was unlikely to perceive pain (and thus the burden on her of continued treatment was low), plus the continuance of treatment being consistent with the religion (Islam) and culture in which she was being raised, appear to have been significant issues in the court’s decision.    The guidance for doctors in Raqeeb deals with the proper course of action when faced with a best interests’ dispute.  This complements guidance given by the Supreme Court in re Y (2018) on the circumstances in which there is no requirement for court approval to withdraw treatment in agreed prolonged disorder of consciousness cases.  Art.56 will apply until the end of the Brexit transition period (currently 31 December 2020), but the extent of any ‘reciprocal’ arrangements for healthcare will depend on the final deal secured between the UK and the EU. Read our in-depth Insight on re Y.

New Guidance on reflective practice

The GMC has published bespoke guidance for medical students.  Reflective practice became a significant concern for doctors following the case of Dr Bawa-Garba, convicted of gross negligence manslaughter in connection with the sad death of Jack Adcock and erased from the Register of Medical Practitioners (although later reinstated after a further hearing before the Medical Practitioner’s Tribunal following a decision by the Court of Appeal).  There were concerns in the medical profession that Dr Bawa-Garba’s reflective journal had been used in Crown Court proceedings and doctors became worried that their reflections could be used against them in civil or criminal proceedings.

Comment:  The bespoke guidance for medical students sits alongside The Reflective Practitioner  guidance, published following the Bawa-Garba case.  The guidance makes it clear that anonymising the journal entry is the key to appropriate and effective reflection. This involves more than removing the patient’s personal identifiers and according to the Information Commissioner’s Office should neither identify any individual nor allow any individual to be identified through its combination with other data.    In civil proceedings reflections are disclosable if they are ‘relevant’ and either support or adversely affect a party’s case.   Therefore care needs to be taken when writing in a reflective journal.  Anonymisation can assist provided it complies with the ICO’s definition. The focus should be on learning rather than writing at length about the incident or what has gone wrong

Following Bawa-Garba the GMC has confirmed that it does not request reflective notes. However doctors do submit them to show insight.  The CPS has confirmed that reflective notes did not form part of the criminal case against Dr Bawa-Garba. 

Policy/News

Civil Justice Council publishes report on Fixed Recoverable Costs

The new scheme of FRCs will apply to ‘lower value clinical negligence’ claims (value up to £25,000 – complex or sensitive cases will be excluded). Claimants and Defendants representatives have agreed on the shape of the scheme. However, there was no consensus on the level of fixed fees, the report containing proposals from both.  Changes are proposed to pre-action procedures with the emphasis on trying to resolve claims at the earliest opportunity. There are some innovative features such as a mandatory ‘stock-take’ if the matter cannot be settled at Letter of Response stage and mandatory Neutral Evaluation if the impasse still cannot be broken.

Comment:  Parties and their legal representatives will need to be ready for changes to the claims process given the proposal for Claimants making settlement offers with the Letter of Claim. Although the timescale proposed for the ‘new’ Letter of Response is 6 rather than the current 4 months, Defendants will need to either admit or deny liability and accept the Claimant’s offer or make a counter–offer.  Any denial (on liability or quantum) must be reasoned. It is reported that the government may decide to hold a further consultation to iron out some of the continuing disagreements, for example whether fatal claims should be excluded from the scheme.

Indemnity issues in integrated healthcare

With reports of Acute NHS Trust expanding into the primary care market, indemnity for these new areas of service delivery has come under the spotlight. Cover under the Clinical Negligence Scheme for General Practice will be available if  the service is commissioned under a Primary Care Contract (GMS, PMS or APMS contract or as enhanced primary care elements under Schedule 2L of the NHS Standard Contract), including a direct sub-contract to a PCC or as an Ancillary Health Service.  In those circumstances, cover will extend to all those involved in the delivery of the service.  There may be some overlap with CNST, for example a GP working in a Trust Minor Injuries Unit or A&E may be covered under the Trust’s CNST arrangements

Comment:  Any provider working in the primary care market should check that they have adequate indemnity cover for all services they are providing whether primary, secondary or community. If CNSGP cover is available, the provider should be aware that it only covers incidents on or after 1 April 2019 and that cover relates only to clinical negligence liabilities. Alternative indemnity arrangements will be required in relation to other risks or liabilities which may arise, e.g. fitness to practise investigations, and inquests.  Further information on the scope of cover of CNSGP can be found on NHS Resolution's webpage. Read our in-depth Insights on the CNSGP Scheme: The new CNSGP scheme, Locum and OOH work, Immunisations and Cover in urgent care scenarios.