A landmark High Court action being taken by Aoife Bennett (27) from Kildare is expected to become a test case for Ireland’s vaccination programmes.
More than 100 children and young adults allege they contracted a sleeping illness, narcolepsy, after receiving the swine-flu vaccine Pandemrix.
Ms Bennett is seeking damages from both the State and the drugs giant GlaxoSmithKline (GSK), who developed and patented the drug. She alleges that she contracted narcolepsy after receiving Pandemrix in 2009.
Approved for use
The vaccine was rushed into service in 2009 due to fears of a global swine flu pandemic.
Because clinical trials had not been fully completed, the Government agreed to indemnify GSK, which would not otherwise have agreed to supply the vaccine.
The vaccine is one of the H1N1 vaccines approved for use by the European Commission in September 2009, upon the recommendations of the European Medicines Agency (EMEA).
Such vaccines are only approved for use when an H1N1 influenza pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU).
In August 2010, the Swedish Medical Products Agency and the Finnish National Institute for Health and Welfare launched investigations into the development of narcolepsy as a possible side effect to Pandemrix flu vaccination in children.
They discovered a minimum 6.6-fold increased risk among children and youths, resulting in a minimum of 3.6 additional cases of narcolepsy per 100,000 vaccinated subjects.
Pandemrix was finally withdrawn on 28 March 2011, after studies overseas indicated a link to spiralling cases of narcolepsy.
Duty of care
The action is due to open before the High Court tomorrow and is expected to take up to 12 weeks at hearing. Among the issues likely to be addressed will be whether a duty of care is owed to those allegedly injured – and whether informed consent should be required warning of the risks of a new vaccine that has had limited clinical trials.
The outcome of the Bennett case could have significant implications, with almost 100 other narcolepsy damages claims pending against the State.
The Bennett action is being handled by Michael Boylan and Gillian O’Connor (Michael Boylan, Litigation Law Firm, Dublin). It will be opened by former attorney general Dermot Gleeson SC (for the plaintiff), with Denis McCullough SC and Jonathan Kilfeather SC.
The Government and GSK have denied liability.