A FRENCH COURT has allowed families to join a class action against the manufacturer of an epilepsy drug, sodium valproate, that caused birth defects and learning difficulties to babies when taken by their mothers during pregnancy.

Manufacturer Sanofi sold the drug in France under the brand name Depakine, which French health authorities estimate was responsible for deformities in between 2,150 and 4,100 children and neuro-developmental defects in up to 30,400 children.

In Ireland, the same manufacturer distributed the drug under the brand name Epilim. As in France and other countries in Europe, Irish mothers were prescribed the drug – an epilepsy treatment – during pregnancy without being made aware of the risk it posed to the foetus. 

An investigation by Noteworthy last year found that around 3,000 Irish children were potentially harmed by exposure to the drug in the womb. 

The French court yesterday ruled that the manufacturer “was at fault because it failed to meet the obligation for vigilance and the obligation to inform” concerning the risks of the drug for the foetus.

Victims’ association APESAC, which represents 7,500 families, launched the class action in September 2021 against Sanofi, which was placed under formal investigation in 2020 on charges of manslaughter over the drug.

In a statement to The Journal, Sanofi said it will file an appeal against the court decision “based on the objectionable conclusions of an expert report filed in the context of the criminal proceedings”.

“There are various reasons why a class action is not admissible: variety of individual situations; multiplicity of stakeholders in the chain of information on the possible risks linked to medicines; respective role of these stakeholders; and developments in scientific knowledge,” the manufacturer said.

“Sanofi has always been transparent by alerting the health authorities and by repeatedly requesting changes to Depakine’s product information documents, intended for patients and healthcare professionals. Product information documents have been modified in accordance with the evolution of scientific knowledge and the decisions of the health authorities of the time,” it added.

The ruling comes as families affected by the drug in Ireland continue to wait for an inquiry into the historical licensing and use of the drug, which was promised by the Health Minister Stephen Donnelly over a year ago.

Chairperson of the Organisation for Anticonvulsant Syndromes (OACS) Ireland Karen Keely welcomed the announcement in France.

In a statement to The Journal, she said: “OACS Ireland very much welcomes this recent ruling in Paris. Our families are elated for our French counterparts and send our congratulations to our French colleagues.”

We believe that for justice to prevail the truth must come to the forefront of any investigation. Both France and the UK have now had their investigations. It is now the turn of Irish families to have their say and for this dreadful injustice to be corrected.

Peter Murphy, CEO of Epilepsy Ireland, also welcomed the ruling, calling it “great news and vindication of what the families in France been trying to achieve for the last number of years”.

He said the ruling shows “the importance of understanding the issue better in an Irish context.”

“We know what that’s supposed to be. Over a year ago now, the Health Minister promised an inquiry and announced his intention to have an inquiry. We still don’t have that inquiry, unfortunately. It hasn’t been established yet,” he said.

“We have been talking to the Department for the last three or four months about getting an inquiry set up in Ireland that works for the families and works for the State, and I would be hopeful that we’ll get a sign off on that in the next number of weeks if not months.”

The French situation has just shown the importance of that and the importance of getting it set up in a meaningful way and ensuring that the Irish inquiry will look at the issue as thoroughly as possible, leave no stone unturned and try and deliver for the Irish families what is being delivered in other countries.

The ruling is further justification that there are families in Ireland who have been affected and who require answers like what their colleagues and friends have gotten.

The Journal sought a comment on the court ruling and an update on the inquiry from the Department of Health. In response, a spokesperson for the department said: “Department officials are engaging with relevant patient groups regarding the terms of reference for the proposed inquiry into sodium valproate.”

It was known since its availability in Ireland in the 1970s that valproate may cause birth defects if used in pregnancy. Yet, for decades many women across the world were prescribed this drug without being warned of the different risks by their doctors.

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Valproate scandal: Parents feel failed by State over drug that harmed their children

When Noteworthy published its report into the valproate scandal in April of last year, reporter Maria Delaney found that pleas for help from women whose children were impacted by valproate continue to be dismissed.

It found that the recommended ‘full suite of services’ for affected children is non-existent, resulting in families paying thousands for therapies and other costs.

This ‘suite of services’ was one of the key recommendations of an Oireachtas Joint Committee on Health report over three years ago. 

A key measure – the Programme for Women’s Health in Epilepsy – identified by a HSE report to “greatly enhance our ability to reduce harm in the future” has yet to be fully implemented.

This programme is needed in order to fulfil both the European and Irish regulators’ requirements that women taking valproate are required to have yearly follow-ups and be kept up to date with developments of the drug. 

In Ireland, a HSE report estimated that between 153 and 341 children will have experienced a major congenital malformation and up to 1,250 children will have experienced a neurodevelopmental delay from exposure to valproate between 1975 and 2015.

Children exposed to the drug while in the womb are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases), according to Epilepsy Ireland.

The Journal contacted the HSE for comment. 

Additional reporting by Maria Delaney of Noteworthy and AFP.