HSE rejects claim of liability over alleged swine flu vaccine effects

The State has told the High Court it has the “greatest sympathy” for a 26-year-old woman who claims she developed narcolepsy after getting a human swine flu vaccine but neither it nor the HSE has any liability in the matter.

The allegation that Irish children had been vaccinated because the State was not prepared to dump vaccines was of no substance, Paul Gallagher SC said on Friday.

Counsel also said there was “absolute disclosure of all appropriate information” and the public campaign for the vaccination programme was “unprecedented and extensive”.

Mr Gallagher, for the Minister for Health and the HSE, was outlining his side's defence to the continuing action by Aoife Bennett arising from receiving the vaccine Pandemrix in 2009.

The action by Ms Bennett (26), from Naas, Co Kildare, is considered a test case for as many as one hundred other cases relating to the Pandemrix vaccine.

The focus of the hearing before Mr Justice Michael McGrath is to decide the issue of liability.

Pandemic

During the three-day opening of the case on behalf of Ms Bennett, the judge was told she was aged 16 years when she got the vaccine as part of a mass vaccination programme as the country braced itself for a threatened human swine flu pandemic 10 years ago.

She has sued the Minister for Health, the HSE, the vaccine producer GlaxoSmithKline Biologicals SA and the Health Products Regulatory Authority.

Among her claims is that HSE brochures concerning the vaccine had the 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 advice which was not consistent with the facts.

One brochure, it is alleged, 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 Pandemrix.

Erroneous conclusion

It is further claimed the Minister and HSE ought to have known 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 also claimed, demanded an indemnity from liability from the State before it would agree to supply the vaccine. Parents, if they had known all this, would be likely to have not consented to the administration of Pandemrix to their children, it is claimed.

The HPRA, 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.

The case continues on Tuesday.