What is Sodium Valproate?
Sodium Valproate, commonly known by brand names including Epilim, Episenta and Depakote is licensed in the UK to treat epilepsy and bipolar disorder. It is also occasionally used to treat migraines. Sodium Valproate is an essential medicine for men and women who suffer from epilepsy and for whom other treatments might not be effective.
When was it used to treat Epilepsy?
It was first licensed to treat epilepsy in the UK in 1972. At that time it was known to be teratogenic (harmful to a developing fetus) in animals. There were also concerns about the teratogenicity of other anti-epileptic drugs during this period. .
For some women, including those of childbearing potential, Sodium Valproate may be the only effective treatment for their epilepsy. Sodium Valproate is very strongly contra-indicated for women of childbearing potential and they must only be prescribed valproate if a Pregnancy Prevention Programme (PPP) is in place. The PPP includes the use of a highly effective contraception and an annual review by a specialist, ensuring that the patient is fully advised of the risks to their unborn child should they become pregnant.
What can go wrong?
Understanding the impact of Sodium Valproate on the fetus developing in utero has however developed over time. When SV was first prescribed to girls and women during their reproductive years, the risks associated with in utero exposure to all anti-convulsant drugs were much more poorly defined than they are now. There was no “ideal” drug for women considering pregnancy. Seizures pose a significant risk to health and in certain circumstances can even cause death. In pregnant women, seizures also pose a serious risk to the unborn baby, including intracranial haemorrhage and heart rate abnormalities potentially leading to permanent and irreversible brain damage. The British Medical Journal (Clinical Research ed.) 1981 advised doctors that the risks did not justify “discouraging a woman who needs anticonvulsant treatment from having a child or changing a satisfactory drug regimen when the epilepsy is well controlled”.
Information in the data sheet for Sodium Valproate continued to evolve with advice on monitoring and breast feeding in 1984, advice on the risks of neural tube defects in 1990 and further associations with congenital malformations such as cleft palate being added as the risks became better understood. From the early 2000s evidence started to emerge of neurodevelopmental effects of Sodium Valproate on the developing fetus during pregnancy, an association with verbal IQ and autism spectrum disorders. This group of features is referred to as Fetal Valproate Spectrum Disorder.
Advice to doctors also developed over this time period. Best Practice guidelines for Women with Epilepsy (Seizure 1999) stated “Women should enter pregnancy having complete seizure control or as few seizures as possible”. The aim was to balance achieving good seizure control with the lowest therapeutic dose of anti-convulsant medication possible.
In 2004 the National Institute for Health and Care Excellence (NICE) guidance stated it was the responsibility of the treating clinician to give accurate information and advice to girls and women and to enable them to make informed decisions which best met their individual needs.
“First do no harm” – The Independent Medicines and Medical Devices Safety Review
As a result of concerns raised by a number of women and children who were concerned that exposure to Sodium Valproate in utero had caused damage and that there had been no or an inadequate warning of the associated risks, the (then) Secretary of State for Health and Social Care, Jeremy Hunt MP, announced a review into Sodium Valproate. The review was led by Baroness Julia Cumberlege and the report of the Independent Medicines and Medical Devices Safety (IMMDS) “First Do No Harm” can be read here.
The Government published its response to the IMMDS Review in July 2021.
How do you know if you can make a Sodium Valproate claim?
If you were prescribed Sodium Valproate and you took it prior to and during a pregnancy with the result that you believe your child suffered damage in utero, you or your child may be able to make a claim against the NHS. A typical scenario may have been that you were diagnosed with epilepsy, often in adolescence, and referred by your GP to a neurologist or a general physician at a hospital. If you were prescribed Sodium Valproate it is likely that the treating clinician will have monitored and reviewed you over a period of time (possibly including the time you became pregnant) and then, may have discharged you back to the care of your GP who may have continued to prescribe Sodium Valproate (again possibly covering the period of your pregnancy). Every situation will be different and personal to you.
You may be able to claim if you consider that you were given the wrong information or advice, the wrong medication or dose; and that if you had been given different medication/dose or additional information, you would have chosen to do something differently, e.g. you would have taken a different medication or dose; and the injury or damage to you/your child, on the balance of probabilities, would not have occurred. Please see below for more details about the legal test and the claims process.
Claims of this nature are often very complex and difficult to investigate involving the gathering of your neurology records, your obstetric records, your GP records and the records relating to the damage suffered by your child. This is particularly so where they relate to events and treatment many years ago where your medical records may be difficult to locate and the doctors who treated you may have moved on. You may require the help of a specialist medical negligence solicitor who can guide you through the process. Please see below details of organisations that can help you find a medical negligence solicitor.
The Legal Test
In order for a claim to succeed, the party bringing the claim (you or your child) must prove, on the balance of probabilities:
- That there was a breach of duty – that those treating you acted in a way that was contrary to a practice accepted as proper by a responsible body of Neurologists/ General Physicians/GPs at the time. It is not sufficient to prove that another medical professional or even a body of medical professionals would have acted differently – you must prove that no reasonable body of medical professionals operating in the same field would have supported the decisions made in your/your child’s case. This is sometimes referred to as the ‘Bolam’ test. In the event court proceedings are issued, independent expert evidence from a consultant in the relevant field is required, supporting your/your child’s allegations. You/your child’s case may concern a failure to obtain informed consent (also sometimes referred to as a ‘Montgomery’ case). You may allege that you were not adequately warned of the known material risks of the medication you were prescribed and/or that you were not offered reasonable alternative treatments. It is important to note that the test relating to risks requires consideration of which risks were known to the profession at the time of your treatment (i.e. a doctor cannot be held liable for failing to warn of a risk which was not reasonably known to the medical profession at the time your medication was being discussed).
and
- That if you had been given additional or different information, you would have chosen to do something different. You must be able to satisfy the Court on the balance of probabilities that ‘but for’ the Defendant’s breach of duty, you would have opted for a different course. This is known as ‘factual causation’.
and
- That you/your child suffered an injury (damage) resulting from the breach of duty of care (medical causation). To establish causation, there must be a link between the breach of duty and the injury suffered, and the test for causation is the ‘on balance of probabilities’, which means more than a 50% chance. As above – if court proceedings are issued you will require independent expert evidence detailing the injury or damage.
You must be able to satisfy both the breach of duty and causation limbs of the legal test if you/your child are to be successful in recovering damages.
Once the legal test is satisfied, the claim will move to ‘Quantification/Assessment of damages’ – this is sometimes referred to as ‘quantum’. It is split into two categories:
- General damages (the compensation for your/your child’s injury; pain, suffering and loss of amenity)
- Special damages (the losses and expense you/your child has incurred/will incur as a result of the injury)
Expert evidence is usually required to assess condition and prognosis. It will be necessary to provide evidence of losses and expenses (for example through receipts/invoices).
The Claim Process
Ordinarily, all claims against hospitals, GPs, dentists and other healthcare providers are initially managed by a “pre-action protocol”. The protocol can be read in full here.
The protocol outlines the process for parties to share sufficient information to be able to understand, investigate and respond to a claim without the need for litigation. An overview of the process is outlined here. You may wish to follow that process and if so, a precedent ‘Letter of Claim’ is attached here for you to use. You will note, as mentioned above, and from the protocol that it is necessary to obtain copies of your medical records and a form of authority is attached here for your use.
Outlined below is an alternative claims process which you may choose to use. It is entirely up to you which process you select and you may wish to obtain independent legal advice. Whether you submit a Letter of Claim or questionnaire, your claim will be dealt with in the same way and a full investigation will take place and a response will be provided.
Alternative process for Sodium Valproate claims:
- You will need to complete the questionnaire. We ask that you fill this in and provide as much information as possible. Please remember to sign and date the questionnaire. You will also need to complete the Forms of Authority so that we can gain access to your GP (Mother) and GP (Child) and Hospital (Mother) and Hospital (Child) records to allow us to investigate your claim.
- Please send your completed questionnaire and Forms of Authority to: nhsr.sodiumvalproate@nhs.net. We recommend that you add a password, for security, and e-mail that password separately to the same address.
Once we receive all the documents, we will send these to our solicitors who will be tasked to investigate your claim. If we require further information from you, the case manager at NHS Resolution or one of the solicitors will contact you to explain what further information is needed.
Our solicitors will then obtain copies of your medical records and begin their investigations. They will be looking to see if there was a ‘breach of duty’ and will also investigate ‘causation’. They will need to obtain expert evidence. This process can be lengthy particularly where the events were many years ago as those involved in your treatment may have moved on or retired and your records may be hard to find, but they will endeavour to keep you updated on the progress of the investigation and inform you of any unexpected delays.
At the conclusion of their investigations, our solicitors will give us a report and at that stage two things can happen:
- (i) If the report concludes that the hospital was at fault and that as a result you/your child suffered an injury, the solicitors will be instructed to admit liability which means that we then accept that you are entitled to compensation. In some cases it may be possible to make an offer of compensation to you/your child as soon as we have admitted liability. The offer will be based on the injury suffered and whether you/your child have any financial losses have been suffered as a result of the injury. It may not be possible in all cases to settle your claim immediately as it may be necessary to undertake further investigations to establish the value of your claim. Depending on the value, this further investigation can be lengthy and require further expert evidence. Sometimes we are required to obtain an order from the Court to confirm that the settlement is fair/appropriate.
- (ii) If the investigations reveal that the hospital was not at fault, the solicitors will inform you of their findings explaining why we do not believe you have a claim.
In either situation, unfortunately we will not be able to release the solicitors’ report to you.
We would like to emphasise that at any point during this process, you have the right to seek independent legal advice. Details of organisations which can help you find a medical negligence solicitor are provided below.
- The Law Society-Find a Solicitor
- Association of Personal Injury Lawyers (APIL)
- Action Against Medical Accidents (AVMA)
The Citizens Advice Bureau may also be able to assist you.
You may also find the ‘Litigant in Person’ guidance sheet produced by The Law Society helpful.
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