Written evidence submitted by The Independent Fetal Anticonvulsant Trust (NLR0006)
Introduction
The Independent Fetal Anticonvulsant Trust works as a registered charity and Trust supporting over 2000 people affected by the Epilepsy drug Sodium Valproate while in the womb since licensing in 1973, and due to failure of the litigation system for those families INFACT started a parliamentary campaign which continues to date.
Over the years since 1991 to 2010 there were litigation cases for clinical negligence against the NHS and a product liability case against the Pharmaceutical company Sanofi, of which many of our members were involved.
Valproate families were exposed to an emotional rollercoaster, unbearable stress and experienced unforgiving questions over a period of 10 years for the Clinical Negligence and another 5 years for Product Liability.
As a charity and trust we watched families as they suffered the overwhelming stress while dealing with the disabilities suffered by their children at the hands of the drug. Yet 30 years on, and still families continue to be failed by the NHS system with Valproate still given on prescription with information not reaching them via their GP or specialist, and have not received any recognition or compensation via litigation for the damages caused.
The devastation caused by Valproate taken in pregnancy has been allowed to continue even though we are all aware, due to national archive documents found by INFACT, of how long the Dept of Health and NHS Drs, through Dear Dr Letters have been aware of the dangers.
The ‘Blame Culture’ is spoke about continuously nowadays, yet it’s a culture of responsibility which is most needed to ensure Clinicians and the like are empowered to giving the full honest and open information instead of cowering behind the policies and protocols.
NHS litigation Reform is welcomed to ensure families like those touched by Valproate receive closure and the financial support needed which is failed to be given through the DWP and the benefit system.
Litigation never worked for those harmed by Valproate and therefore nothing was learned by the 15 years of fighting carried out by the parents, we hope, with reform to the NHS Litigation that those lessons can be learned, understood and corrected.
While working for almost 30 years with children and their families affected by Sodium Valproate prescribed in pregnancy with no information on the toll it would have, hundreds of those affected have attempted litigation ranging from Clinical negligence cases from 1991 to product liability which ended in 2003.
The clinical negligence cases went on for over 10 years costing millions of pounds in legal aid and private consultations, all of which came to a wasteful end when, in some circumstances, Drs withdrew their support or legal aid funding was withdrawn, leaving families with no answers and still without support. From that point valproate continued to seek health and care support through the NHS bearing in mind, at this point the majority of those affected by Valproate were still children under the age of 16yrs.
Since then the NHS cost for those harmed by Valproate have been staggering with the constant use of services such as Occupational Therapy, Physiotherapy, speech and language, audiology, regular appointments with Ear, Nose and Throat specialists, Ophthalmology, orthopedics, neurology etc., not forgetting the majority needing support in school in the form of an educational statement now known as EHCP Plan.
The cost, due to the failure of the clinical negligence cases has fell into the arms of the NHS and Education costing the Government around 10 times more it would have cost in Care Plans for those involved. The cost alone at present for the NHS for those harmed by Valproate is calculated at over £1 billion a year.
This does not consider the cost of the Product Liability case FACLit which began in 2005 covering around 180 cases, the cost alone over a 5-year period cost approx. £3.7million with legal aid funding withdrawn in summer of 2010, only 18weeks before the case reached court. The withdrawal alone only saves the Government £300,00 with another £3.7million of tax payers money wasted with no gain whatso ever for those harmed.
Since the end of clinical negligence in 2003 the cost of patient care for those harmed by Valproate in pregnancy has been astronomical, where so much could have been saved in the long term.
Our experience of clinical negligence can only be described as traumatic and unbearably long. Over 10 years of constant solicitor and Barrister meetings, Dr consultations and hospital examinations, endless reports and legal aid forms. process of legal aid back then was a confusing system however the no win no fee process now can be just as prolonged as claimants still go through the same consultations with solicitors, barrister and the medical profession only to find that once the calculations have been done the case isn’t worth its weight to continue. The amount of stress this brings is just a traumatic and takes just as long, so nothing has really changed and neither has the cost.
The NHS costs were £2.4bn in clinical negligence claims in 2018-19 which only equated to 2% of the entire budget for NHS England, with NHS Resolutions accounting for claims likely to be received in the future accounting to £83.4billion which is set aside and is among the most substantial public sector financial liabilities faced by the UK Government.
The experience of Clinical negligence in 1991 compared to today has not changed in cost or experience and therefore there needs to be shift in court procedures, the amount of paperwork and evidence required to have any effect or the system being simpler in order for the patient to receive the redress required more quickly.
The ENS is vital to ensure ‘Each Baby Counts’ and aims to
The Each Bay Counts programme was set up the Royal College of Obstetricians and Gynaecologists and is applied to all babies born at term (>37 weeks) following labour that had a potentially severe brain injury diagnosed within the first 7 days of life. It includes those who
However, it fails to cover those babies exposed to medications in utero such as anticonvulsants and/or antidepressants. The majority of these babies go on to have a brain injury which is diagnosed in later life as Fetal Anti-Convulsant Spectrum Disorder, Fetal Valproate Spectrum Disorder, and/or Autistic Spectrum Disorder which is life changing for the parents and if a life long condition for the children.
These conditions in a large number of cases can be and are diagnosed at birth due to their facial features, anomalies of the fingers, toes and ears and major malformations such as Spina Bifida, Cleft lip & Palate and heart and kidney malformations.
With an openness given to mother on visiting ante-natal or on the labour ward, and consulting her about her medications taken in pregnancy, a diagnosis and early notification could be given reaching a more efficient level of transparency and knowledge for both medical staff and mother, which in turn would lead to a more efficient system throughout the child’s life.
At present, compared to 30 years ago, there is better knowledge on medications and vaccines in pregnancy, with syndromes and disorder more clearly understood due to the research gathered over the years.
Due to the history of Valproate we have been able to take a look back at advice given in the early 70’s, where in archive documents uncovered by INFACT it stated to “inform Drs in datasheets but not packaging inserts so there would be no danger of the patient themselves seeing it”. Over the years people have become more intrigued as to why medical problems arise and have become good at asking questions or finding the information themselves, until it has become the norm.
People have realised the Drs haven’t always told you everything, and with the arrival of a change in the law and ‘Ambulance chasing’ solicitors in the late 1990’s with the phrase “where’s there’s blame there’s a claim” which stuck with the media, the pressure has been put on the medical profession to ensure they get it write and explain the facts to the patient and their family. However, we know this doesn’t happen all the time, and those who have taken litigation in the past have found where their medical notes don’t always match the advice given.
Therefore, this is very much not a “blame culture” but where patients have learned that Drs haven’t always taken on the responsibilities they should. It is noted clearly by the General Medical Council to all doctors
You must make sure that you communicate relevant information clearly to:
However, due to the re-occurrence of problems where patients have not received information from their Doctor a culture of apprehension has been allowed to form, and lack of trust between Dr and patient has become the norm.
Revisiting history shows that Drs must take more responsibility in informing their patients, open and honestly in order to avoid the apprehension their patient suffers and
A vital point for any Dr must be to learn from their mistakes however, not many of them seem to do so with the constant influx of clinical negligence claims costing the NHS around £2.4 billion per year.
We all know the NHS will never be perfect and free of medical errors however, honesty is the policy when it comes to mistakes being made with policies and protocols in place to deal with those issues. Occasionally attitudes and constant tiredness will play a huge part in the errors made and it is vital to iron out any opportunity for mistakes continuously be made which costs the NHS dearly.
We believe better teaching facilities and funding into those areas for staffing and experience would help support and avoid some problem areas. Everyone has heard of the Thalidomide Scandal, except those who begin their University course today because of their age, without topics like this being visited the educational age group of today cannot learn from it. However, learning how to visit the topic of congenital abnormalities with a patient and its approach requires structure, strategies in place and confidence which can only be taught, once a mistake and a clinical negligence claim is made it’s too late.
A ‘learning culture ‘within the NHS is something which should be constantly ongoing whether it’s because a clinical negligence claims or otherwise. If a clinician, nurse, or doctor has made a mistake which has cost a life or caused injury, then that healthcare professional should be held responsible for their mistakes. It is important that the public feel safe in their hands and if a member of the health profession is allowed to ‘learn’ from their mistakes and not held responsible then that gives the impression that a person’s life stands for nothing and there would be no resistance to avoid mistakes in the first place.
A healthcare professional is aware of their responsibilities when they decided to take that initial step to study medicine. Having experienced a doctor’s mistakes when dealing with a baby’s life, we have been at the forefront of a what is seen as the ‘blame culture’, however the public must be allowed to pursue a clinical negligence claim if they feel a responsibility has been breached and should not feel resistance to do so due to a system which, financially, stops them from doing so. If a child or adult is harmed through medical negligence then that person may need to be looked after for the rest of their life and be allowed the financial support to do so where the benefits system is simply not enough.
The Healthcare Safety Investigation Branch has been in situate for some considerable time however it has never been triggered for use until the Independent Medicines and Medical Devices Safety Review reached their conclusions and released their report.
This must be used alongside the Patient Safety Commissioner; however, we already know that the PSC will not be responsible for dealing with individual cases and so patients still will have nowhere to go for help and support other than a clinical negligence claim. A government should not, at any point be seen to be ignoring individual patients and their complaints, however this policy and protocol change is seen to be doing just that.
In some circumstances such as Valproate, questions must be asked of the Medicines and Healthcare Regulatory Agency (MHRA) and their attention to detail when it comes to warning patients on side effects and teratogenic effects of a medication. INFACT truly believe that everything had been done up until the start of their campaign in 2012 to coverup and ignore the damages caused in pregnancy by Sodium Valproate. The litigation services failed those harmed by the drug over a curse of 20 years because of this internal culture to hid the truth about medicines, an attempt to stop the public seeking the truth and who is responsible would be wrong and unlawful.
Therefore, to avoid litigation the whole health systems ‘patient safety’ culture must change allowing patients the knowledge about their condition and any effects their medications may have on them or their offspring must be given so as to inform them and allow them to make decisions for their own health. Transparency has always been very vague when it comes to the health system, now is time to change to an open and honest society.
At the moment we have the Health and Care bill going through that process where these legislative changes can be made for the better of the patient, ensuring healthcare professionals are open about a patient’s condition and medications, and if this fails to be carried out then that responsibility must be borne by the healthcare professional and/or the health trust who has failed to do so.
We understand policy change isn’t an easy process for those who fight for it following INFACTs exact same fight with Valproate, however, it is vitally important that the MHRA and NHS England work together to ensure changes are made and for the Government to ensure these changes are carried out through legislation in the form of disciplinary action or penalties for those who fail to follow it. The system of the QOF fails so many people in the UK as doctors work to incentives, and therefore not having time for the conditions not on the QOF, this is something which needs to change by working with NHS England on the Statement of Financial Entitlements.
Oct 2021