Tipp FM Legal Slot – 24th April 2012
Gillian O’Mahony on Narcolepsy and the Swine Flu Vaccine[soundcloud id=’167084325′]
Download Narcolepsy Notes
In the last week narcolepsy and the swine flu vaccine has been very topical – what is this about?
In August 2010 the European Medicines Agency began to investigate a possible link between the swine flu vaccine and narcolepsy, following an increased number of reported cases of narcolepsy among children and adolescents in Finland and Sweden.
The Irish Department of Health also commissioned a study and this report was published last week. The study found that there was a 13 fold risk of narcolepsy in vaccinated compared to unvaccinated individuals.
Is there a name for this vaccine?
Pandemrix® is the name for the vaccine. It was used against the (2009) (swine flu) virus during the H1N1 influenza pandemic. Over 900,000 doses were used in Ireland.
What is narcolepsy?
Narcolepsy following the swine flu vaccination is more prone in children and adolescents. It is a sleep disorder that causes overwhelming and severe daytime sleepiness. People with narcolepsy fall asleep at inappropriate times and places. These daytime sleep attacks may occur with or without warning, and can occur repeatedly in a single day.
What are the main symptoms of narcolepsy?
Narcolepsy is typically characterized by the following four symptoms with varying frequencies:
(i) Excessive daytime sleepiness,
(ii) Cataplexy (sudden and temporary loss of muscle tone often triggered by emotions such as laughter),
(iii) Hallucinations (intense, vivid and sometimes terrifying hallucinations at the beginning and ending of a sleep period),
(iv) Sleep paralysis (paralysis that occurs most often upon falling asleep or waking up; the person is unable to move for a few minutes).
How common is narcolepsy?
International evidence indicates that around one in 100,000 people per year develop narcolepsy. However, most experts would agree that the condition is under diagnosed. The recent study by the Department of health showed nearly 6 people per 100,000 who received the vaccination.
Can narcolepsy be treated?
It can be managed through the use of medicines.
Is Pandemrix® still in use in Ireland?
No. Pandemrix® has not been recommended in Ireland since January 2011. Doctors were requested to return all stocks of Pandemrix® for disposal.
How many affected/cases in Ireland?
To date, the Irish Medicines Board has received 32 reports with confirmation of narcolepsy in individuals who were vaccinated with this vaccine. The IMB is continuing to follow up with specialists where a diagnosis of narcolepsy is considered possible.
What impacts can narcolepsy have on those affected?
The impacts on those affected by narcolepsy may vary from person to person and may include medical, educational and social impacts.
What is happening in other countries in Europe?
A fund of 30 million Euros has been set aside in Finland to pay for medical care, medication and travel costs for treatment, As narcolepsy is a life-long condition, and can be passed down to later generations. The Finnish Government has acknowledged that the fund is unlikely to sufficient to cover the claims and that the State may have to substantially increase the amount available to cover claims of medical negligence.
What will happen in Ireland?
The Irish Government entered into an arrangement with the manufacturers of this vaccine and under the agreement they agreed to indemnify them if there were any claims arising out of this vaccine. The Government has not indicated yet whether they will or will not set up a similar fund like in Finland.
Under Irish Law those who manufacture or medical products have clear responsibilities to patients – including a duty to ensure that their products will be effective and have as few side-effects as possible. We are currently investigating claims for compensation for children who have been diagnosed with narcolepsy. It will be necessary to engage expert witnesses who will prove to the Court that the vaccination is causally related to these children and adolescents developing narcolepsy. If this is proven each of those affected will be entitled to recover damages under the Liability for Defective Products Act, 1991
What could a person who is affected by narcolepsy from the vaccine recover?
Someone who is affected by this would be entitled to damages for loss of opportunity into the future, loss of earnings as no doubt a disorder like this will effect career opportunities, the injury itself and any other expenses and outlay incurred by the claimant.