Sodium valproate, widely known by the brand name Epilim, has been prescribed in Ireland for decades to treat epilepsy, bipolar disorder and other neurological conditions. It remains a clinically important medicine for many patients.
However, exposure to sodium valproate during pregnancy has been associated with a range of birth defects and neurodevelopmental conditions in children. As understanding of these risks has grown, many families across Ireland are now seeking clarity about what happened, what medical records may be relevant and whether legal advice is appropriate to their individual circumstances.
Michael Boylan Litigation advises families in complex medical negligence and pharmaceutical-related injury matters, including cases involving sodium valproate. The firm brought the first ever legal action in Ireland for a child wrongfully exposed to the toxic effects of this drug during pregnancy, resulting in a successful outcome in McGillin v Casey and ors.
People currently taking sodium valproate should not stop or change their medication without first speaking to their doctor or specialist.
What Is Sodium Valproate?
Sodium valproate is an anticonvulsant medicine used primarily in the treatment of epilepsy. It is also prescribed for bipolar disorder and, in some cases, for migraine prevention. The most recognised brand name in Ireland is Epilim, though the drug may be dispensed under other names.
For many patients, sodium valproate is the most effective treatment available. It may still be clinically necessary, and any decision about medication should always be made with a treating doctor or specialist.
Why sodium valproate became a legal and patient safety issue
Since approximately the late 1990s, there was increasing evidence of the toxic effects of sodium valproate on the developing baby when taken during pregnancy. Initially, it was believed that the harmful effects were confined to neural tube defects such as spina bifida, for which folic acid might offer some protection.
In the years that followed, emerging evidence established that the adverse effects were considerably more widespread. By 2008, it became clearer that the drug might also be responsible for causing cognitive difficulties, developmental delay and autism in affected children.
Central concerns include whether adequate warnings were provided to patients, whether prescribing practices reflected the known risks, whether informed consent was obtained and whether appropriate specialist review took place before and during pregnancy.
Sodium Valproate, Pregnancy and Foetal Valproate Spectrum Disorder
What is foetal valproate spectrum disorder?
Foetal valproate spectrum disorder (FVSD) is the term used to describe a pattern of physical, developmental and learning difficulties that may occur in children whose mothers took sodium valproate during pregnancy. The effects vary from child to child. Some children are mildly affected, while others face significant and lifelong challenges.
Conditions and difficulties reported in children exposed to sodium valproate
Children diagnosed with FVSD may experience a combination of the following:
- Neural tube defects: Abnormalities affecting the brain or spinal cord that develop early in pregnancy.
- Spina bifida: A specific neural tube defect where the spine does not close properly before birth.
- Heart defects: Structural problems with the heart present from birth.
- Limb differences: Differences in the formation of hands, fingers, toes or feet.
- Facial differences: Characteristic features affecting the eyes, ears, lips or facial structure.
- Developmental delay: Slower progress in reaching physical or cognitive milestones.
- Speech and language difficulties: Delayed or disordered speech and difficulty with communication.
- Autism spectrum disorder: A neurodevelopmental condition affecting social interaction and communication.
- ADHD-type difficulties: Challenges with attention, concentration and impulse control.
- Learning difficulties: Ongoing problems with reading, writing, numeracy or general academic progress.
Many affected children require ongoing therapies, educational supports and specialist care throughout their lives. The practical impact on families can be substantial.
Why each family's circumstances need individual review
A diagnosis of FVSD does not automatically mean that a legal claim exists. Each case depends on the specific facts, including the mother's medical records, the advice given at the time, the timing and dosage of the medication, whether alternative treatments were considered and what expert evidence supports.
A solicitor experienced in this area will need to review all relevant records and obtain independent expert opinion before advising whether a legal issue arises.
The Sodium Valproate Inquiry in Ireland
What the Irish inquiry is examining
The Sodium Valproate Inquiry commenced on 22 July 2025. It concerns the historical licensing and use of sodium valproate in women of childbearing potential in Ireland. The Inquiry is chaired by Bríd O'Flaherty BL.
The review phase: regulation, prescribing and safety information
The review phase will examine the full timeline of sodium valproate use in Ireland, including how the drug was regulated, prescribed and dispensed, and what safety information was made available to patients and healthcare professionals at different points in time. This review is relevant to the legal context because it may clarify what was known, when it was known and what steps were or were not taken in response.
Personal statements from families affected by FVSD
The Inquiry allows private oral statements from people diagnosed with FVSD, mothers and other family members. Participation in the Inquiry is a separate process from seeking individual legal advice. One does not automatically lead to the other, and families may wish to consider both independently.
Health service capacity and supports
The Inquiry will also consider the current systems, safety communications and supports available to those affected. Even where the Inquiry addresses broader systemic issues, families may still benefit from obtaining separate legal advice about their own individual position and circumstances.
When Might a Sodium Valproate Legal Issue Arise?
Failure to warn about the risks during pregnancy
A legal issue may arise where a patient was not informed of the known risks of taking sodium valproate during pregnancy, where those risks were not discussed clearly, where no written warnings or patient information were provided, or where the patient's consent was not properly informed.
Prescribing sodium valproate to women of childbearing potential
Questions may also arise about whether treatment was reviewed before a planned or known pregnancy, whether alternative medications were considered, whether risk minimisation steps were discussed and whether the patient's personal medical history justified continued use of the drug.
Failure to review medication before or during pregnancy
Proper care requires that medication is reviewed at appropriate stages. This includes GP review, neurology review, obstetric care and careful medication management both before conception and throughout pregnancy.
Pharmacy, product information and system-level issues
In some cases, issues may relate to dispensing information, patient information leaflets or regulatory communications. The relevant question is whether warnings about the risks of sodium valproate reached patients in a meaningful and timely way.
Evidence That May Be Relevant in a Sodium Valproate Matter
Medical and maternity records
Important records include GP notes, neurology notes, hospital records, antenatal and maternity records, prescription records, pharmacy records and details of medication dosage and dates.
Records relating to the child's diagnosis and needs
Relevant records may include paediatric records, genetic testing (where carried out), developmental assessments, autism or ADHD assessments, speech and language therapy reports, occupational therapy reports, educational psychology reports and school support plans.
Family and care records
Documents relating to care needs, medical appointments, out-of-pocket costs, lost work time and the practical impact on family life may all be relevant. Records of support services accessed can also assist in building a clear picture of the family's circumstances.
How a Sodium Valproate Claim Is Assessed in Ireland
Each case is assessed on its own facts. A solicitor will review the mother's medical history, the prescribing and dispensing records, the advice given at the time, the child's diagnosis and needs and the available expert medical evidence. Only after this review can a solicitor advise whether there are grounds to pursue a claim.
Time Limits and Capacity Issues
Limitation periods for sodium valproate claims can be complex. Time limits may depend on factors including the age of the child, whether a disability is present, the date on which the connection between the drug and the harm was known or ought to have been known, and whether there has been delayed diagnosis.
Because time limits can depend on individual facts, families should obtain advice specific to their circumstances. Early engagement with a solicitor can help ensure that important rights are not lost through delay.
Cases of Note
In 2010, Michael Boylan (then head of the medical negligence department at his previous firm) successfully brought the first ever legal action in Ireland for a child who was wrongfully exposed to the toxic effects of sodium valproate during pregnancy and who suffered damage as a result. This groundbreaking case, McGillin v Casey and Ors, established an important precedent.
The High Court has also approved disability settlements in cases involving the misuse of Epilim during pregnancy, reflecting the seriousness with which the courts treat these matters.
Frequently Asked Questions
Is sodium valproate the same as Epilim?
Yes. Epilim is the most common brand name for sodium valproate in Ireland. The same drug may also be dispensed under other names.
What is foetal valproate spectrum disorder?
FVSD is the term for a range of physical, developmental and learning difficulties that may occur in children whose mothers took sodium valproate during pregnancy. The effects vary widely from child to child.
Does a diagnosis of FVSD mean there is a legal claim?
Not automatically. A solicitor must review medical records, the advice given, the exposure history and expert evidence before advising whether a legal issue arises in any particular case.
What is the sodium valproate inquiry in Ireland?
The Inquiry, which commenced on 22 July 2025, is examining the historical licensing and use of sodium valproate in women of childbearing potential. It is a separate process from individual legal advice or claims.
Can a parent seek legal advice on behalf of a child?
In general, a parent or guardian may seek legal advice on behalf of a child. The specific position depends on the child's age, circumstances and capacity, and a solicitor can advise on this.
What records are useful in a sodium valproate case?
Relevant records typically include GP notes, neurology records, hospital and maternity records, prescription and pharmacy records, paediatric and developmental assessments, therapy reports and educational records.
Are there time limits for sodium valproate claims in Ireland?
Yes, but the applicable time limits can be complex and fact-specific. Factors such as age, disability and date of knowledge all play a role. Families should seek legal advice about their own circumstances.
Should I stop taking sodium valproate if I am concerned?
No one should stop taking prescribed medication without first consulting their doctor or specialist. Medical advice should always be sought before making any changes to treatment.
Can Michael Boylan Litigation advise families outside Dublin?
Michael Boylan Litigation is based at 97 Saint Stephen's Green, Dublin, but the firm can advise families across Ireland where appropriate.
Speak with Michael Boylan Litigation About Sodium Valproate
If your family has been affected by sodium valproate exposure during pregnancy, Michael Boylan Litigation can review your circumstances and advise on whether a legal issue may arise. The firm has particular experience in this area.
To discuss your situation, contact Michael Boylan Litigation to arrange an initial consultation. Each matter is considered on its own facts, and early advice can help clarify your position.
*In contentious business, a solicitor may not calculate fees or other charges as a percentage or proportion of any award or settlement.
