State ‘not liable’ for narcolepsy after swine f lu vaccine
THE State bears no responsibility for injuries to a schoolgirl who developed narcolepsy after having the swine flu vaccine, the High Court has heard.
In the major test case, the court heard Aoife Bennett’s life had been changed forever, after developing the incurable sleep disorder and sporadic bouts of muscle collapse.
Now 26, she was 16 in December 2009, when she was given the swine flu vaccine Pandemrix at her school in Naas, Co. Kildare.
Paul Gallagher SC, for the Health Minister and the HSE, expressed ‘the greatest of sympathy for Ms Bennett’ but added: that the State had no liability.
He said the case was a collateral challenge on the decision of the European Medicine Agency to licence the vaccine.
Judge Michael McGrath heard that Ms Bennett and her parents said they were never warned the vaccine had not been tested on children aged between ten and 18, whose immune responses had not yet fully developed.
Neither were they told that other countries had stopped vaccinating a month earlier, as the pandemic had turned out not to be as serious as first feared, they said.
Ms Bennett has taken her case against the minister and the HSE, who recommended and administered the ‘defective’ vaccine, Parents: Pat and Mary Bennett and against its manufacturer GlaxoSmithKline Biologicals, and the Health Products Regulatory Authority, which regulates medicines in Ireland.
Mr Gallagher said all appropriate information was disclosed by the State to recipients, via a public campaign.
He said criticism of public servants, who had spent their lives working to improve public health, and who bought and rolled out the vaccine, was ‘unjustified’, and that the effect of the anticipated pandemic on young people was of major concern in 2009, so schools were a priority for vaccination.
He said narcolepsy, as a side effect, could not have been predicted and that 30million doses of the vaccine were given out worldwide after Ms Bennett was given her injection, and the World Health Organisation did not lift its pandemic warning until the following August.
Ms Bennett’s senior counsel Dermot Gleeson said Ireland had competed for its share of Glaxo’s vaccine, which cost the State €100million, but that the Government was under pressure to get it after pandemic warnings of potential loss of life by WHO.
However, he said the Germanmade vaccine, which generated US$26billion of profits for Glaxo, had only been tested in ‘mock up’ form, and some elements had not been tested at all, particularly on adolescents.
He said Glaxo knew this and demanded immunity from the Government if any recipient should sue.
Glaxo was concerned the HSE would not give sufficient warning about the risks, yet it took no steps to rectify this through its own labelling, he said.
He said around a thousand children in Europe, including 75 to 100 in Ireland, developed narcolepsy, characterised by poor sleep at night and sudden bouts of uncontrollable sleep during the day.
Around two months after the vaccination, he said Ms Bennett developed symptoms, as well as a muscle condition called cataplexy, which caused her knees to buckle suddenly, her head to nod, or her jaw to fall open.
He said Ms Bennett had developed narcolepsy because she had a particular gene variant which had been affected by an untested ‘booster’ part of the vaccine.
He added: ‘This was a de facto clinical trial on a whole population. It was being tested out by being used.
‘Maybe that was justified. Maybe that’s what you have to do when there’s a pandemic.
‘But what is certainly not, is keeping that fact from the recipients.’
The case continues.
Greatest of sympathy
Uncontrollable sleep at daytime