The Health Products Regulatory Authority (formerly the Irish Medicines Board) has been joined as a defendant in a personal injury case by a Kildare woman who claims she suffered narcolepsy after receiving a vaccine for the swine flu virus.
The application was brought on behalf of Aoife Bennett, who is among an estimated 70 people who have brought cases against the Minister for Health, the HSE and Glaxosmithkline (GSK) Biologicals S.A over being given the Pandemrix vaccine against "human swine flu" in 2009-10.
Ms Bennett, originally from Naas in Co Kildare, claims she suffered injuries including narcolepsy and cataplexy disorder, and fainting fits, as a result of being given Pandemrix in 2009.
The application to join the HPRA came after Ms Bennett's lawyers discovered information about the vaccine's safety records that were furnished to the then Irish Medicines Board in 2009 -2010 by GSK.
The IMB which became the Health Products Regulatory Authority in 2014, is a state body whose role is to protect and enhance public health by regulating medical products.
The safety reports allegedly show what is claimed to be "a particularly striking" difference between the number of adverse effects in those given Pandemrix and a similar vaccine also made by GSK.
It is claimed that had parents been aware of the "vast difference" in the numbers of people who had adverse effects from the respective vaccines they would not have given their consent to the administration of Pandemrix to their children.
As a result of the documents Ms Bennett claims the HPRA owes her a duty of care to persons given Pandemrix, including how the safety and appropriateness of the vaccine was monitored.
She alleges the manner in which the HPRA performed its functions breached those duties.
On Thursday, October 5, Ms Bennett, represented by William Binchy Bl and instructed by solicitor Gillian O'Connor, secured permission from the Master of the High Court Mr Edmund Honohan SC to add the HPRA to the case.
In a sworn statement seeking to have the authority joined, Ms O'Connor said the application came following the examination of some 4,500 documents discovered to the plaintiff by GSK.
The HPRA was not represented at Thursday's hearing before the Master, but Ms O'Connor said in her sworn statement that in correspondence the board said it will not be admitting any culpability in the matter.
Ms O'Connor said that the discovery process had revealed that the authority had data concerning the safety records of Pandemrix which is made in Dresden, Germany and a very similar vaccine also used to treat swine flu is made in Quebec, Canada called Arepanrix.
There are some differences in the manufacturing processes between Quebec and Dresden, Ms O'Connor said.
The safety records shows that the level of adverse effects in those administered Pandemrix ranged between 10 and 7 times higher than the Canadian made product.
One report from late 2009 states that of the tens of millions of vaccines administered there was a serious adverse effect rate of 75.9 per million for Pandemrix compared to 7.9 per million for Arepanrix.
The type of adverse effects listed in the reports range from conditions such as convulsions, facial palsy, to still birth and fatal outcomes in those who got the vaccines.
Ms O'Connor said the discovered material does not indicate that the Irish Medicines Board made the information it received available to the Minister or the HSE immediately after it was received or at all.
A representative of the board attended all meetings of the National Public Health Emergency Team, which was set up by the Dept of Health to oversee the administration of pandemic vaccines, she said.
While discovery is being awaited on those meetings Ms O'Connor said no minutes were recorded regarding adverse effects of Pandemrix at meetings to monitor and oversee the swine flue virus.
Ms O Connor added that a HSE brochure issued to the public in 2009 about swine flu contained information to the effect that it was safe to use Pandemrix and that it had been appropriately tested, and that side effects were rare.
Mrs O'Connor said the reality, which known to the Irish Medicines Board, was that not all the conclusions as contained in the brochure were warranted.
Pandemrix was not adequately test on children young people before it was licensed, she said adding that if parents were aware of the facts regarding the lack of testing they would have likely refused to allow the vaccine be administered on their children.