The maker of a "defective" flu shot that left a Perth girl with brain damage knew before its release there was a high risk it may cause fevers in children, lawyers for the girl and her family have claimed while launching a potentially massive lawsuit.
A civil action, which could be one of Australia's biggest medical compensation cases, has been lodged against manufacturer CSL in the Federal Court on behalf of four-year-old Saba Button.
Saba had fever and febrile convulsions caused by an alleged defect in the Fluvax shot she was given in April 2010.
She suffered a severe hypoxic brain injury and was left a quadriplegic with epilepsy and limited vision.
In a statement of claim, lawyer Julian Johnson said "in testing performed by (CSL) prior to April 2010, it was apparent and identified by it that fever was a recognised side effect of the CSL 2010 Fluvax which occurred at a relatively high rate and higher incidence than in previous years".
Mr Johnson said Fluvax caused reported febrile convulsions in 0.09 per cent of patients in 2010 and a febrile reaction in 57 per cent of children aged six to 59 months who received it in WA.
The incidence of febrile convulsions in WA patients vaccinated with Fluvax in 2010 was one for every 100 doses administered for children under four, three times higher for all patients compared with non-CSL-made vaccines and 200 times higher than the only published population-based estimate.
The document says Saba's parents, who received a Health Department letter encouraging them to vaccinate her, had no warning. The product packaging and labelling contained no mention of any possible risk of febrile convulsions and other serious complications.
Fluvax was recalled on April 22, 2010, three days after Saba's shot.
Saba's medical expenses, the need for aids and equipment, damages for pain, suffering and loss of enjoyment of life and the need for supervised care will be included in the compensation case.
Mr Johnson told _The Weekend West _yesterday: "In my view, Saba has a compelling case against CSL that the vaccination was defective."
Saba's mother Kirsten Button declined to comment.
She said last month she and her husband would never have had Saba given the vaccination if they had all the information.
The Health Department's Paul Effler wrote in the Medical Journal of Australia last month there had been insufficient studies into Fluvax's safety before it was rolled out in 2010. The shot resulted in serious reactions in 250 other WA children.It was revealed last month the vaccine, banned for under-fives since 2010, was recently used on two WA children.