Settlement without admission of liability of vaccine damage case
THE family of a young woman who sued the State and drugs giant GSK over her contracting the sleep disorder narcolepsy following receipt of the Pandemrix vaccine has slated as "a national scandal" the millions of Euro in taxpayers money spent defending the case.
The Department of Health and Health Service Executive (HSE) dramatically settled the High Court action taken by Aoife Bennett (27) who received the controversial vaccine as a child at the height of the Swine Flu pandemic fears in 2009.
The settlement, the details of which remain confidential, is without an admission of liability.
In 2009, the State had agreed to indemnify GSK to allow the vaccine to be fast-tracked into service.
In the High Court today Mr Justice Michael McGrath was told by Ms Bennett’s counsel Denis McCullough SC the case had been settled.
The settlement came just days after one of the world's leading experts on narcolepsy revealed GSK and the UK Government were engaged in a confidential mediation process with those in the UK who contracted narcolepsy after receiving Pandemrix.
Further, the High Court action - slated to be one of the longest running civil claims in the history of the State - last week heard that key data on the vaccine was not included in Irish medication reports because it was considered to be "useless."
However, that data indicated that Pandemrix had a ten times greater risk for serious side effects than a sister vaccine manufactured by the same company.
Ms Bennett and her family said they now hope that the State decision to settle their action will pave the way for 100 other pending claims over narcolepsy to be settled with proper compensation being paid to claimants.
The settlement for the student teacher was against the Department of Health and the HSE.
GSK and the Health Products Regulatory Authority (HPRA) were not party to the settlement and will not pay anything in costs or compensation.
"It is a national disgrace 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," the Kildare woman's mother, Mary Bennett said.
She said the public was not made aware that there were safety issues over the vaccine - and she called for a full review of the drug regulatory system in Ireland.
The Bennett family also hit out at the way they were treated over the past decade by the State.
Ms Bennett had broken down while giving evidence in the High Court.
"The behaviour of the defendants prior to and during the trial has been exceptionally hostile," her parents Pat and Mary said.
"Further, the State Claims Agency have taken a very adversarial approach in dealing with Aoife's case."
"The aggressive cross examination of Aoife, and us as parents, over four days is something I hope will not be replicated for other families."
"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."
The case opened before the High Court last month - and was expected to continue for several more months as the State fought the action. Millions of Euro has been spend defending the action.
It had been 21 days at hearing.
A further 100 cases pending from Irish children and young adults who claimed they contracted the debilitating sleep disorder having received Pandemrix are also being contested.
In the case of one child, she received two doses of Pandemrix in 2009 and 2011.
The Bennett action, being handled by Michael Boylan and Gillian O'Connor of Michael Boylan Litigation in Dublin, was led by former Attorney-General Dermot Gleeson SC who acted for the plaintiff along with Denis McCullough SC and Jonathan Kilfeather SC.
The vaccine was rushed into service because of fears in 2009 of a global Swine Flu pandemic.
However, it had not fully completed clinical trials and, to get it into service, the Government agreed to indemnify GSK who would not otherwise have agreed to supply the vaccine.
Last week, Prof Paul Gringras of the Evelina London Children's Hospital and King's College London, one of the world's leading experts on sleep disorders, revealed to the High Court he has assisted the UK process to resolve and settle UK claims.
While Ireland vehemently contested the actions, other EU countries including those in Scandinavia worked with narcolepsy victims to put support systems in place.
"I just assisted the now confidential mediation process, that is, that are how I believe ongoing claims were sorted in the UK which involved me acting as expert witness, producing reports on some people who are not under my clinical care," Prof Gringras said.
He confirmed that the confidential mediation process to resolve claims is between the UK Government, GSK and the various claimants.
He also told the court that he believed the vaccine was involved in a 'spike' of narcolepsy cases across European countries which had introduced Pandemrix because of Swine Flu fears.
"I concluded that, in my opinion, it's more likely than not that the Pandemrix vaccine acted as a trigger, increasing her (Ms Bennett's) risk of developing narcolepsy," he said.
"There were four or five European countries that had found actually remarkably similar increased risks of narcolepsy in children vaccinated compared to those who were not vaccinated. One thing worth saying is these were completely independent research groups. It is quite rare for people across Europe to agree on things."
The studies referred to were conducted in Ireland, the UK, Sweden and Finland - all countries where Pandemrix was deployed.
A Swedish study, started in 2010, found a 13 times greater risk of getting narcolepsy amongst teens who received the Pandemrix vaccine.
An Irish study indicated a 13 times greater risk while a study in the UK indicated a 14.5 time greater risk.
The Bennett action is set to prove a test case for Ireland's vaccine programmes and more than 100 children and young adults who claim they contracted the sleeping illness after getting a Pandemrix jab.
Experts believe the action will determine how future Irish vaccine programmes are operated, implemented and what the public are told. Pandemrix was rolled-out for a national immunisation programme from November 2009.
Monitoring of the vaccine was done after-sale.
It was finally withdrawn on March 28 2011 after studies in various Scandinavian countries indicated a link to a spiraling number of cases of narcolepsy.
Pandemrix is now at the centre of a global narcolepsy controversy amid claims the vaccine, developed by GSK in Germany, tricks the human immune system into mistaking the neuropeptide Orexin, a vital regulator of sleep, for the Swine Flu virus.
The reported consequences for sufferers is catastrophic - they are unable to enjoy normal sleep routines.
Sufferers collapse into deep sleep without warning, often in the middle of daily tasks - some can even fall asleep while eating and with their mouths full of food.
Many will suffer from narcolepsy and its symptoms such as nighttime sleep paralysis and even horrific hallucinations for the rest of their lives.
The Government and GSK denied liability in High Court actions lodged over Pandemrix. Campaign group, SOUND (Sufferers Of Unique Narcolepsy Disorder), hopes the High Court action will reveal how the roll-out of the vaccine was handled.
Irish Independent Nov 2019