The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, has published its report “First Do No Harm” today. In a letter to the Secretary of State dated 8 July 2020, Baroness Julia Cumberlege acknowledges that this report is being published at a time when the NHS are facing “enormous challenges” arising from the Covid-19 pandemic.
The Report runs to 277 pages and is accompanied by additional documentation which is downloadable. The Terms of Reference outlined how the Review would engage with patient campaign groups and other stakeholders. The Review’s approach was to “listen, learn and recommend” stating that they would listen to those who had suffered harm.
The three areas we were asked to explore, primodos, sodium valproate and pelvic mesh, were new to us so we travelled the country, not only England but Scotland, Wales and Northern Ireland. We met and listened to over 700 people, mostly women, often accompanied by their partners, other family members and sometimes their children. We are indebted to all of them. Their dignity and courage in telling us intimate and harrowing details of their damaged lives has made a great and lasting impression on us.”
An immediate and fulsome apology should be issued by the Government on behalf of the healthcare system to the families affected by primodos, sodium valproate and pelvic mesh.
A Patient Safety Commissioner should be appointed who would be an independent public leader with a statutory responsibility. The Patient Safety Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.
Creation of a new independent Redress Agency for those harmed by medicines and medical devices based on models operating effectively in other countries. Administration of decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.
Setting up of “cost of care” schemes for each intervention – HPTs, valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
Setting up of networks of specialist centres to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.
Substantial revision of the MHRA particularly in relation to adverse event reporting and medical device regulation. More engagement with patients and their outcomes required and ensure patients have an integral role in its work.
A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation.
Improvement of transparency of payments made to clinicians. The General Medical Council (GMC) register needs to be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests and their recognised and accredited specialisms. Mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.
Task force to be established by the Government to implement this Review’s recommendations.
“The pandemic is not a licence to act negligently, but the standards to be expected reflect the realities on the front line of healthcare. What would be negligent at any other time, might not be during this crisis – the pandemic may render reasonable what would usually be unreasonable.“
(Mr Nigel Poole QC, 2020)
Welcome to my round up of must-read articles recently published on COVID-19, clinical negligence and patient safety. Here, I provide a round up of some of the key themes, information and opinions which are emerging online. This blog post does not constitute legal advice and should not be relied on or treated as a substitute for specific advice relevant to particular circumstances.
I will be putting the lens on articles and blog posts from Mr John Tingle, Lecturer in Law at Birmingham Law School, University of Birmingham (UK), Mr Nigel Poole,Clinical Negligence QC, Head of Kings Chambers, Dr Daniel Sokol, clinical negligence barrister at 12KBW, medical ethicist and award winning medical journalist, Mr Isaac Hogarth, specialist clinical negligence barrister at 12KBW and Mr Peter Walsh, CEO of AvMA (with their kind permission).
I am acutely aware that this blog post is being published during a pandemic and at a time when many healthcare professionals are doing phenomenal work. I am a MSc Student in Public Relations and Communication (Healthcare Communication) specialism and am sharing my research and learning which I have collected and organised. This may be of value to fellow healthcare communication students, law students, lawyers, patients and healthcare professionals.
How will COVID-19 affect clinical negligence litigation in England and Wales?
Mr Poole QC has opined that “context is all” ie., the present context will be of great significance when the courts weigh up whether a Trust or a professional has acted negligently during this period. Mr Poole QC in his blog draws a distinction between patients who do not present to a GP or A & E because of the pandemic and patients affected by delay in diagnosis. For further information, read the full blog post here.
Mr Poole QC states that “the resource implications of the pandemic would…be taken into account by the Court. What would have previously been an inexcusable delay in the system, might be regarded as acceptable in the current circumstances.”
Significantly, Mr Poole QC stated that “an expert that has no direct experience of working in the circumstances that currently prevail, will not be able to assist the court as well as another expert who does have that information and experience.”
However, it would be a mistake for doctors to think that working in a stressful covid ward in and of itself provides immunity against negligence claims. Even in challenging circumstances, there are mistakes that no reasonably competent doctor would make.”
“The BMA has advised its members not to accept redeployment outside their competence, although in the real world (and where doctors are trying their best to cover rota gaps), it is probably unrealistic to expect all redeployed doctors to have the relevant up-to-date training. It is inevitable that this will lead to challenges in patient safety, and it is probable that some patients will suffer harm.” (Isaac Hogarth, 2020)
Mr Isaac Hogarth, specialist clinical negligence and personal injury barrister discusses “the issue of the standard of care to be applied to redeployed doctors in a Covid-19 setting. He suggests that legislation would be required to lay down any proposed modifications to the standard of care” in his recent blog post. Mr Hogarth suggests that any such legislation should be narrow in its terms so as not to curtail important patient rights.
The blog post entitled “Standard of care in a clinical setting during the Covid-19 crisis”published on 1 June 2020 sets out the law on standard of care and a detailed consideration of established principles in the context of Covid-19. Mr Hogarth clarifies that “whilst the Coronavirus Act contains provisions to ensure that redeployed health workers are indemnified (see section 11(3)(b)), it does nothing to alter the standard of care under which they are required to operate. ”
We need to resist calls to give legal immunity from clinical negligence claims to doctors and others during the COVID-19 pandemic. The courts and judges should be trusted to deal with such claims fairly and patients’ rights to claim for negligence respected. Faith in our civil justice compensation system should be maintained during COVID-19. (John Tingle, 2020)
Dr Sokol raised a question: “Would an orthopaedic or ophthalmic surgeon on the medical ward, fulfilling the role of a medical registrar, be given some slack by the courts? In other words, is the standard of care expected of these doctors lower than it would otherwise be?” The short answer is no. The expected standard of care and skill will be based on the post that the doctor is fulfilling at the time of the alleged breach,” Dr Sokol said.
Mr Tingle discusses multiple issues to include (i) legal, ethical and patient safety issues (ii) restriction of patient choice in a crisis (ii) responsibilities of employers, employees, PPE, staff safety and the employment relationship (iii) refusal to treat where PPE is inadequate (iv) the role of tort law (v) indemnity issues (vi) legal immunity (vii) moral and legal rights to sue for negligence (viii) risk areas such as equipment and pharmaceutical manufacture (ix) the US perspective (x) clinical guidelines and the law.
Mr Tingle is also a guest blogger on the Harvard Law School blog and a new post COVID-19 Clinical Negligence and Patient Safety Update was published on 17 June 2020. Mr Tingle highlights that a key issue will be whether medical practitioners followed relevant clinical guidelines.
Call for urgent action on non COVID-19 diagnostics and treatment
Whilst the drastic action taken at the start of the current pandemic to protect patients, staff and the NHS by closing down many NHS services other than those treating COVID-19 patients was understandable, AvMA is increasingly concerned about the consequences for patients with other conditions which need urgent treatment or diagnostic procedures.We have already been receiving enquiries from patients or their families where the unavailability of such services appears to have resulted in avoidable harm or even death. Solicitors around the country tell us that they have also.”
AvMA have called on the UK Government to address the unavailability of urgent diagnostics and treatment for thousands of non COVID-19 patients and will be creating a petition on the UK Government website.
(Not the) Annual Clinical Negligence Conference -AvMA 25 June 2020
Action against Medical Accidents (AvMA) held the (Not the) Annual Clinical Negligence Conference on 25 June 2020. My own best moments as a remote follower of the online conference are contained in the tweet below.
This blog post does not constitute legal advice and should not be relied on or treated as a substitute for specific advice relevant to particular circumstances.