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LSC stops funding epilepsy drug group action

9 November 2010

The LSC has decided to cease funding a group action by epileptic mothers who claim that taking the drug Epilim while pregnant caused birth defects in their children.

David Body, head of medical law at Irwin Mitchell, said the withdrawal of funding was “bitterly disappointing” for his clients, who had waited a long time for the trial.

The case, brought by the parents of 100 children, is reported to have taken six years to prepare and cost the LSC £3m.

“Without public funding to support the case against this multinational pharmaceutical company, it seems very likely that this claim will have to be discontinued,” Body said.

“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.”

Body said the medical and scientific community first identified and reported in 1980 on the side effects of sodium valproate, the active ingredient in Epilim.

“Thirty years on from that first report, it now seems that this case cannot go ahead to explore the reasons why these children have been injured.”

Hugh Barrett, executive director for commissioning at the LSC, said that “following advice from counsel” the LSC had withdrawn funding.

“Before making the decision the LSC had to await the exchange of evidence and the provision of comprehensive opinions from counsel – this process has only just been completed,” he said.

“The LSC can only spend taxpayers money where we believe there is a reasonable prospect of success.”

A spokesman for sanofi-aventis said: “The impact of the LSC decision means that the trial can no longer start on 15 November as scheduled. We are considering our position in the light of that decision and await the claimants’ proposals as to next steps.

“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.”

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