Woman (26) sues State claiming she developed narcolepsy from Pandemrix swine flu vaccine
Aoife Bennett was 16 when she got the vaccine as part of a mass vaccination programme as the country braced itself for a human swine flu pandemic ten years ago.
This is the first case over an alleged link between the human swine flu vaccine and narcolepsy and is regarded as a test case for as many as one hundred other cases due before the High Court.
Ms Bennett, Lakelands, Naas, Co Kildare, a third level student has sued the Minister for Health, the HSE, the vaccine producer Glaxosmithkline Biologicals S.A. and the Health Products Regulatory Authority.
Opening the case in the High Court today her counsel Dermot Gleeson SC instructed by Michael Boylan solicitor told Mr Justice Michael McGrath the case will last over ten weeks .
The opening of the case will take several days. The defendants will then have a day to reply and put forward their points before any evidence is heard.
The judge was also told there are as many as 60,000 documents in the case.
Counsel stressed it was not an anti vaccination case and he said the Bennett's are a pro vaccination family.
He said Ms Bennett got the vaccine in December 2009 just a few days before her seventeen birthday. He said narcolepsy was not diagnosed until almost two years later.
He said narcolepsy is an auto immune disease which is incurable where Aoife suffers uncontrollable bouts of sleep during the day. . He said the disease affects those with a genetic variant. He said Aoife can be “ like a puppet collapsing during the day” and she once collapsed in the shower breaking her teeth.
Counsel said 1000 children in Europe suffered narcolepsy in countries where the Pandemrix vaccine was administered but in Germany there weren’t any cases where the vaccine was not used.
He said it was their case the situation in relation to the swine flu vaccine was “badly managed “ by Glaxosmithkline and the State agencies in Ireland.
The truth, counsel said was the Pandemrix vaccine was never tested on teenagers .
The focus of the hearing is to decide whether the defendants, or any of them, are liable, arising from Ms Bennett having narcolepsy. If liability is established, a separate hearing will be held later to assess damages.
In the midst of concern as to the health risks posed by human swine flu in 2009 and 2010, the Pandemrix vaccine was purchased, approved and administered by the State. The HSE ran a a Pandemrix vaccine programme and the vaccine was administered in local hospitals, clinics and schools.
HSE brochures on the vaccine it is claimed had the foreseeable effect of allegedly misleading those who read them as to the safety of the Pandemrix vaccine and the alleged risk associated with its use. It is claimed the brochures contained purported advice which it is claimed was not consistent with the the actual facts.
One brochure it is claimed was written in a manner that most reading it would believe that everybody except those with a confirmed lab test for swine flu needed to get the vaccine and that it was safe to use the Pandemrix and that it and another vaccine were equally safe.
It is further claimed the Health Minister and HSE ought to have known that those who read the brochures were likely to come to an alleged erroneous conclusion as to the safety of Pandemrix vaccine and whether it had been adequately tested at all on children and adolescents prior to its release to the public.
Glaxosmithkline it is claimed demanded an indemnity from liability from the State before it would agree to supply the vaccine.
Parents, it is claimed if they had known all this would be likely not to have consented to the administration of Pandemrix to their children.
Public assurances given in the media and to the Oireachtas that the Pandemrix vaccine was safe it is alleged further prevented the users of Pandemrix or parents from giving their informed consent.
The Health Products Regulation Authority it is alleged was well aware there was an alternative vaccine which had more clinical data available in relation to its safety and efficacy.
All the defendants deny the claims and deny liability. Among various pleas, they contend the Pandemrix vaccine was properly and validly authorised by the European Commission for use in all EU member states and was required to address the pandemic H1N1 2009 virus, as confirmed by the World Health Organisation, in 2009.
Ms Bennett was 16 years old when she was vaccinated with the Pandemrix vaccine in December 2009.
It is claimed she suffered a narcolepsy and cataplexy disorder.
Ms Bennett following vaccination it is claimed developed excessive daytime sleepiness, disruption to her night sleep and had episodes of sudden weakness which it is claimed+was highly disruptive to her daily life.
She had to attend numerous doctors until in 2011 she was diagnosed with narcolepsy.
Her quality of life it is claimed has been seriously curtailed and she had also suffered significant mental distress, anxiety and worry arising from her condition.
She had always been a high achiever at school and it is claimed throughout 2010, she was observed by teachers to zone out in class and missed school and also had to shorten her class times.
The case before Mr Justice McGrath continues.