Government sued for 11 week delay in warning about aspirin

BMJ 2002; 324 doi: (Published 19 January 2002) Cite this as: BMJ 2002;324:134
  1. Clare Dyer, legal correspondent
  1. BMJ

    The UK government is being sued for negligence over an 11 week delay 15 years ago in issuing a warning about links between aspirin and Reye's syndrome.

    In an action that opened in the High Court in London this week, lawyers for Amanda Smith, now aged 22, argued that the Committee on Safety of Medicines, the government's drug watchdog, was negligent in waiting until June 1986 to act after resolving in March that year that a warning was necessary.

    AmandaSmithwasahealthy 6 year old when in May 1986 she con-tracted chickenpox and was given adult aspirin by her mother, Jenny. She developed Reye's syndrome and was left with brain damage, spastic quadriplegia, and epilepsy—and a life expectancy of 40.

    The claim has been launched against the health secretary, Alan Milburn, as the person responsible for the Committee on Safety of Medicines.

    Ms Smith's counsel, Lord Brennan QC, told the court that the committee had decided at its meeting on 26 March 1986 that aspirin might be a contributory factor in causing Reye's syndrome, which can lead to death or severe disability, and that action was needed to prevent children from using it. The syndrome, which is viral in origin, can affect children with chickenpox, influenza, or other viral infections, causing inflammation of the brain and in some cases liver damage, he said.

    “Having decided that action was necessary, the CSM [the Committee on Safety of Medicines] and civil servants then took until June 10—one day short of 11 weeks—to give a public warning,” said Lord Brennan. He argued that the warning should have been given as soon as reasonably possible to avoid the risk of serious injury or death—within two weeks after the meeting or at least no later than mid-May.

    Lord Brennan told the judge, Mr Justice Morland, that he would have to decide whether the Committee on Safety of Medicines owed a duty of care between March and June 1986 to warn that children with chickenpox should not be given aspirin. If so, the judge would have to decide whether it breached that duty by not acting until June.

    A further issue was whether, if the advice had been given earlier, Ms Smith's family would have become aware of it and avoided giving her the aspirin. The defendants deny negligence and liability.

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