http://bmj.com/cgi/content/full/324/7335/444/c
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News roundup
22 year old damaged by aspirin loses compensation claim
Clare Dyer legal correspondent, BMJ
The High Court last week cleared the UK government of negligence in not
giving a speedier warning 16 years ago about the link between aspirin and
Reye’s syndrome.
Mr Justice Morland rejected a compensation claim on behalf of Amanda Smith,
now aged 22, who had been healthy until as a 6 year old she contracted
chickenpox in May 1986 and was given adult aspirin by her mother. Her condition
deteriorated into Reye’s syndrome, leaving her with brain damage, spastic
quadriplegia, epilepsy, and a life expectancy of 40 years or less.
Through her mother, she sued the health secretary, to whom the Committee on
Safety of Medicines is answerable. The committee had determined in March 1986
that aspirin was a contributing factor in the development of the acute
childhood syndrome, which can be fatal.
But the judge said: "I have reached the clear conclusion that no fault
is established against the secretary of state, the secretariat of the medicines
division of the Department of Health, or the Committee on Safety of Medicines,
who in my judgment acted throughout rationally and in good faith reaching
decisions and implementing them carefully and expeditiously in the interest of
the public at large and children in particular, having regard to the risk of
very serious injury to young children from taking aspirin when feverish."
He said that the postponement of a public warning until June 1986 was
"reasonably justifiable," adding that "the risk was that without
that postponement the prospect of full positive cooperation from the industry,
which in the event achieved so much, might be lost."
It was right to delay until the drug industry was fully on board to ensure
the right message got home, he said.
The fact that the Aspirin Foundation, representing manufacturers, was an
integral part of the campaign in June 1986 was what made it so successful, the
judge said. A decision had to be taken that balanced the real risk of grave or
fatal injury to two or three children as the result of the delay against the
reasonable expectation of the undoubted benefit of a "coherent,
coordinated, comprehensive campaign."
The campaign included the withdrawal of paediatric aspirin with the full
weight of the Department of Health, the Committee on Safety of Medicines, and the
industry behind it, thus giving a clear, definitive, unambiguous message to
both professionals and the general public.
"In my judgement it would be unfair and unreasonable to condemn the
decision, essentially a discretionary/policy one, as faulty or negligent,"
said the judge.
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