Legal aid withdrawn from epilepsy drug families

Families who blame an epilepsy drug for causing defects in their children are to have legal aid to sue its maker withdrawn, it was confirmed today.

The Legal Services Commission (LSC) said it was no longer funding an action against the makers of sodium valproate, a drug used to prevent epileptic seizures.

About 80 families claim the drug, also known as epilim, caused a range of birth defects, including spina bifida, damage to the heart, learning difficulties, cleft palate and deformities of the hands and feet.

They have been pursuing a legal action for damages against manufacturer sanofi-aventis, claiming that there were inadequate warnings about the possible harm in the 1990s.

The firm has denied the claims, saying that it has always provided appropriate precautions and warnings on the risks associated with possible side-effects of the medicine.

David Body, head of medical law at solicitors Irwin Mitchell, representing the families, urged the LSC to rethink its "bitterly disappointing" decision.

He said the action was an important test case and without legal aid it was very likely that it would have to be discontinued.

"The withdrawal of public funding by the LSC is bitterly disappointing for our clients who have waited a long time for the trial of this claim," he said.

"Without public funding to support the case against this multi-national pharmaceutical company, then it seems very likely that this claim will have to be discontinued.

"This is a case which we were ready to fight, in which there were real clinical and legal issues at stake - both for our injured clients and for consumers generally - so far as prescription drugs are concerned."

Dr Ian Weatherhead, communications director for sanofi-aventis, said: "We have sympathy for the claimants but we have always believed that their case would be unsuccessful.

"Sodium valproate remains the most effective treatment of generalised epilepsy and for many patients it is the only medicine that will effect adequate seizure control.

"sanofi-aventis has always provided appropriate precautions and warnings on the risks associated with possible side-effects of this medicine, including possible risks to the unborn child, in line with developing scientific knowledge."

A spokesman for the LSC said: "Legal aid is no longer funding an action against the makers of the drug epilim.

"However, because proceedings are still ongoing we are unable to comment further."

The National Society for Epilepsy, (NSE) warned women taking the drug not to panic.

"It is essential that women don't panic and don't stop taking their medication as prescribed," a statement said.

"They should seek advice from an epilepsy specialist as soon as possible and together they should consider the options.

"Women who are considering becoming pregnant should also discuss their treatment options in advance of becoming pregnant.

"Sodium valproate is extremely effective in controlling seizures. A sudden cessation of treatment can lead to the woman experiencing renewed or additional seizures. Seizures themselves may be life-threatening for the woman and, significantly, the new research also shows that seizures themselves may lead to the baby having developmental delay.

"But it should be recognised that most women with epilepsy, including those taking sodium valproate, will deliver normal babies.

"Although the risks of problems in the baby are greater with sodium valproate than with other anti-epileptic drugs, it may be that, in consultation, the woman and her epilepsy specialist may decide that sodium valproate remains the most appropriate drug."