Legal regulation mechanisms in the control of medicines.
In 2002, a case was brought against the Secretary of State--sued on behalf of the Committee for the Safety of Medicine (CSM)--by a mother who in May 1986 gave aspirin to her 6-year-old daughter who was suffering from chickenpox (Smith vs. Secretary of State for Health, [2002]). The child deteriorated and following admission to hospital she was diagnosed as suffering from Reye's syndrome. As a consequence, the girl was left with a serious neurological handicap and was totally dependent on others for her care. In June 1986, the government issued a general public warning advising parents not to give aspirin in any form to children under 12 years old and told chemists to take all junior aspirin preparations off their shelves. This followed advice from the CSM that in this age group aspirin could trigger the fatal disease Reye's syndrome. The CSM had been aware of this danger in September 1982 following evidence in the USA. Further evidence was produced in 1985 and the CSM continued to monitor the situation. In April 1986, a meeting was held between the Department of Health (DoH) and members of the aspirin industry. It was subsequently agreed that the producers would withdraw stocks and there would be cooperation between the industry and the DoH rather than a public warning. In May 1986, the CSM recommended that the DoH should give a general public warning, which was made on 10 June 1986. The mother's case was that there was an unreasonable delay in publishing a warning following the CSM meeting on 26 March 1986. It was accepted that the administration of aspirin was a contributory factor in the development of the girl's neurological condition and that had her mother been aware of the warnings before May 1986 she would not have given her aspirin. Were the Secretary of State and CSM liable?
University of Glamorgan.
Bridgit
B
Dimond
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D001241:Aspirin / Q000009:adverse effects; D002644:Chickenpox / Q000188:drug therapy; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D006266:Health Education / Q000331:legislation & jurisprudence; D006801:Humans; D016365:Liability, Legal; D010290:Parents / Q000193:education; D011634:Public Health / Q000331:legislation & jurisprudence; D012202:Reye Syndrome / Q000139:chemically induced; D012957:Societies, Pharmaceutical / Q000331:legislation & jurisprudence; D013222:State Medicine / Q000331:legislation & jurisprudence*; D006113:United Kingdom
D001241:Aspirin