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Women sue over epilepsy drug risks

BMJ 2004; 329 doi: (Published 07 October 2004) Cite this as: BMJ 2004;329:820
  1. Clare Dyer, legal correspondent
  1. BMJ

    Families whose children were born with fetal anti-convulsant syndrome are suing the makers of anti-convulsant drugs taken by mothers during pregnancy, in what could become a substantial group action.

    Three claims have been lodged at the High Court in London on behalf of four children, and nearly 30 more claims, one involving a mother who works as a general practitioner, are being prepared.

    The claims are being brought under the Consumer Protection Act 1987, which creates a strict liability regime under which claimants alleging injury by defective products need not prove fault on the part of the manufacturer, but merely that the product has a defect.

    Lawyers for the families say the drugs have a “defect in use” because mothers with epilepsy faced the “impossible dilemma” of risking their unborn child's health by not taking anti-convulsant drugs to prevent epileptic fits while knowing the medicine itself posed risks.

    The effects of the drugs vary but include facial and limb abnormalities, learning difficulties, speech problems, and developmental delays.

    The drug companies sued so far are Sanofi-Synthelabo, CP Pharmaceuticals, and Aventis Pharma, but other companies are expected to be named in the pending actions.

    David Body, of the law firm Irwin Mitchell, said, “We are hoping to prove that, under the Consumer Protection Act 1987, the drugs are defective because either before these mothers became pregnant or once they were pregnant, they were faced with an impossible dilemma.

    “Should they stop taking anti-convulsant medicine and risk having an epileptic fit, so endangering their unborn child? Or should they continue to take the drugs knowing that there was a risk of damage to the child from the drugs?”

    He added, “From the mother's perspective, anti-convulsant drugs are necessary and therapeutic; from her baby's viewpoint those drugs are harmful and have no therapeutic effect.

    “As these children require special and costly care, and will often need care and equipment throughout their lives, we are asking the drug manufacturers to take responsibility for the damage their products caused in the unborn children and to meet the high cost of caring for these children by compensating the families.”

    Sanofi-Synthelabo said in a statement, “Anti-epileptic drugs are crucial to the health of those prescribed them and have passed stringent medical tests. Sanofi-Synthelabo Ltd has every sympathy for people born with congenital abnormality and would advise women with epilepsy who may become pregnant to speak to their doctor.”

    The company added that the regulatory authorities had decided, having considered the risk-benefit analysis that anti-epileptic drugs “satisfied the requirements of safety, quality and efficacy, having regard to the prevailing state of scientific knowledge.”

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