February 2024
All birth injuries are distressing, but those caused by medication taken by the mother during pregnancy can take a particularly emotional toll because the mother often (mistakenly) blames themselves. Following the Thalidomide scandal of the late 1950s and early 1960s, the British Government passed the Medicines Act 1968 to strengthen control of the manufacturing and supply of human and animal medicines. Despite this, over half a century on from the Thalidomide catastrophe, the country is in the middle of another prescription drug linked to birth defects scandal, that of the epilepsy drug, Sodium Valproate, which can cause Foetal Valproate Syndrome (FVS) in infants.
What is Sodium Valproate?
Sodium Valproate is a prescription drug used to treat epilepsy, bipolar disorder, and migraines. It is an anticonvulsant drug and has been on the market since the 1970s.
How does Sodium Valproate damage new-borns?
The risks of Sodium Valproate on an unborn baby if a mother takes the drug during pregnancy have been known for decades.
According to Government guidance, women who take the drug while pregnant, around one in ten babies will have a birth defect, and about 30-40% may have developmental problems.
Birth defects include:
- spina bifida
- facial and skull malformations (including cleft lip and palate)
- malformations of the limbs, heart, kidney, urinary tract, and sexual organs.
The effects on development can include:
- being late in learning to walk and talk
- lower intelligence than other children of the same age
- poor speech and language skills
- memory problems.
The Government guidance also states that children exposed to Sodium Valproate in the womb are more likely to have autistic spectrum disorders, and there is some evidence children may be more likely to be at risk of developing symptoms of attention deficit hyperactivity disorder (ADHD).
Are there grounds for compensation claims?
It is thought that since the 1970s, thousands of UK children have suffered FVS. According to recent research by the Epilepsy Society, the lifetime costs of harm caused by exposure to epilepsy medications during pregnancy could be as high as £2.5 million. This includes costs to the NHS, education and welfare systems, the affected individual, their family and broader society.
To bring a birth injury compensation claim, the Claimant must show that the Defendant:
- Owed them a duty of care,
- Breached that duty, and
- Due to the breach, the Claimant suffered harm.
The fact that problems with Sodium Valproate, commonly known by the brand names, Epilim, Episenta, and Depakote, were identified back in the 1970s, but restrictions on its use were only introduced in 2018, means there are grounds for a negligence claim in some cases. Furthermore, according to a recent investigation by the Sunday Times (which also played a leading role in bringing the Thalidomide scandal to light), six babies a month are still being born after exposure to Sodium Valproate, and expectant mothers are receiving their medication without any warnings or safety information provided. NHS data also shows 247 pregnant women were prescribed the medication between April 2018 – September 2021.
In 2004, a claim was brought against Sanofi, the company that manufactures Epilim supplied to the UK; however, the Legal Services Commission pulled its funding for the proceedings three weeks before they were due to begin.
In February 2024, A new report by the Patient Safety Commissioner said the Government should provide financial packages to help victims of the drug. The report states:
“Thousands of women, children, and families have been harmed by these two medical interventions and that there is a compelling case for the government to award them redress.”
This latest call for a redress scheme follows a similar recommendation made in 2020 in a report entitled First Do No Harm. The British Government rejected the recommendations and has thus far refused to set up a programme to compensate victims.
At this point, pursuing a clinical negligence claim is the only way to achieve the compensation many families require to fund the care and treatment their child needs.
How do I make a compensation claim for Sodium Valproate birth injuries?
Given the fact that drug companies and healthcare professionals have known about the danger posed to unborn children by Sodium Valproate for 40 years, it is natural and understandable to feel furious and betrayed if your child has been affected. You may also be confused as to where to start when bringing a birth injury claim. Our Clinical Negligence Solicitors have years of experience advising and supporting parents and children and can provide compassionate, practical help in bringing a claim. Our expertise ensures we can take the worry off your shoulders and do all the fighting for you.
If you are concerned about how you will pay for legal advice and representation, don’t be. Along with most other Medical Negligence Solicitors, we offer our clients no win, no fee arrangements. If your claim is unsuccessful, you will not need to pay any legal fees, only expenses (disbursements) related to your case. We can also arrange After The Event insurance to protect you from paying the other side’s costs if the judgment goes against you.
If you were prescribed Sodium Valproate whilst you were pregnant and your child or children suffered a birth injury, contact us immediately. We can swiftly inform you if you have been a victim of negligence, explain the entire claim process, and protect your best interests.
Our team has decades of combined experience in successfully advising and representing clients in birth injury claims. We are sympathetic, understanding, and are here to help you every step of the way.
If you would like to discuss an issue, please get in touch to arrange a free no obligation consultation. We’re available by email or phone.
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