Settlement reached in swine flu vaccine case
A High Court action for damages by a student who claimed she developed the sleep disorder narcolepsy after receiving the swine flu vaccine has been settled.
Details of the settlement in the case of Aoife Bennett from Naas, Co Kildare, have not been made public.
However, she is to receive compensation and the High Court was told all her costs are to be paid by the Minister for Health and the Health Service Executive.
Mr Justice Michael McGrath said he was delighted the case had gone to mediation and praised all sides for their handling of the case.
The case began on 8 October and was expected to last ten weeks and cost millions of euro.
It was seen as a test case for up to 100 more and the court had been asked to determine if any or all of the defendants, including the vaccine maker and the State, were liable for damages.
The defendants in the case were GlaxoSmithKline Biologicals, the Health Service Executive, the Minister for Health and the Health Products Regulatory Authority, formerly the Irish Medicines Board.
All claims made in the case were denied and the settlement was made without admission of liability.
No orders were made against the HPRA or GSK.
Ms Bennett was 16 when she was given the Pandemrix vaccine at school as part of a vaccination programme administered by the HSE.
The court heard she was later diagnosed with an incurable, life-changing sleep disorder narcolepsy, excessive daytime sleepiness and episodes of sudden weakness known as cataplexy.
At the opening of the case, lawyers for Ms Bennett said it was not an anti-vaccine case, but was about a once off badly managed vaccine, which had not been properly tested on teenagers.
Senior Counsel Dermot Gleeson said the rare autoimmune disease can be caused when those with a certain genetic variant receive a new adjuvant or booster contained in a vaccine.
Because narcolepsy was an auto immune disease, the vaccine affected children and teenagers in a different way because their immune systems were not fully developed, he said.
Mr Gleeson said the narcoleptic effect of the vaccine was located in about 1,000 children across Europe and a public inquiry set up in Ireland concluded that there was a 12 to 14 fold increase in the chance of becoming narcoleptic in those with a certain gene variant who were given the vaccine.
He said there were 75 to 100 children identified with the condition in Ireland, 350 in Sweden, up to 200 in Finland, 100 in France and in the UK and a handful in Denmark and the Netherlands.
It was claimed during the case adverse reactions from Pandemrix were ten times greater than seen with another swine flu vaccine administered in Canada.
All claims were denied and the defendants argued the Pandemrix vaccine was properly authorised by the European Commission for use in all EU member states and was required to address the swine flu pandemic.
Lawyers for the vaccine maker GSK said no causal link had been established between the Pandemrix swine flu vaccine and the sleep disorder narcolepsy despite ten years of research.
Afterwards, Ms Bennett's mother Mary thanked her daughter for having the courage to take the case.
She described it as a "landmark" case and said it was extremely difficult for a 26-year-old "to take on the might of the State and a large multinational company GSK" while also coping with her illness.
She added: "Today, Aoife has succeeded in recovering compensation and her case has been vindicated.
"However, no money will ever compensate Aoife for a lifetime of living with the incurable disability of narcolepsy and cataplexy."
She said she hoped the settlement would pave the way for the 100 other people to receive proper compensation.
"Hopefully, this can be achieved without the need to go through a protracted trial like Aoife has," she said.
She also criticised what she described as "the adversarial approach" taken by the defendants in the case, adding: "I hope will not be replicated for other families. Aoife had no State legal aid, whilst the defendants had access to unlimited taxpayers' monies."
During the case, the Bennetts had claimed the State was aware of the safety concerns and the lack of proper testing of this particular vaccine and that a new adjuvant (booster) had been used in the vaccine and that they had failed to properly inform them and the public about these concerns.
These claims had been denied.
Ms Bennett also said the State authorities continue to deny that they owe her and the public any duty of care with regard to administering vaccines.
They continue to deny that the vaccine caused narcolepsy.
She said evidence during the case showed that GSK had been settling similar claims in the UK for the past three years, adding: "This begs the question why Ireland didn't follow a similar approach which would have been less onerous on the victims and the families."
She called for a review of HSE/Department of Health communication policies with the public to ensure all relevant information is given to the patient, so they can give proper "informed consent".
She said: "It is a national scandal that millions of taxpayers' money has been wasted in defending my case and other similar cases against children and young people who do not have any right to legal aid.
"In this regard I would to express my thanks to my legal team for their help and support throughout the years and all the experts who gave evidence to support my case."
Narcolepsy group expresses disappointment with State for fighting case
The narcolepsy group SOUND (Sufferers Of Unique Narcolepsy Disorder) has expressed disappointment with the State for 'fighting the case' with Ms Bennett.
In a statement released after today's settlement, Sound Secretary Tadgh Kennedy said: "We thank Aoife and the Bennett family for taking the first landmark case.
"However, we are disappointed that the State saw fit to fight the case in court.
"Approximately 100 other children and young adults must now await the outcome of their own legal cases, which the State insists must be taken on an individual basis.
"The State should ensure that this is not a long, drawn-out legal process, causing further hardship.
"From the start, the State's response to what transpired has been painfully slow, and this remains a difficult and protracted process for the families involved.
"Sound wants the State to fulfill the duty of care it is morally bound to provide to children and young adults who now have to move through life with narcolepsy.
"The cost to the State of this action alone can be measured in millions," said Mr Kennedy.
19th November 2019