In the last week narcolepsy and the swine flu vaccine has been very topical, but you may be wondering what it is all 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.
The Pandemrix Vaccine and Narcolepsy
Pandemrix®, the name of the swine flu vaccine was used against the (2009) (swine flu) virus during the H1N1 influenza pandemic. Over 900,000 doses were used in Ireland. Narcolepsy 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. Narcolepsy following the swine flu vaccination is more prone in children and adolescents.
Main Symptoms of Narcolepsy
Narcolepsy is typically characterized by the following four symptoms with varying frequencies:
- Excessive daytime sleepiness
- Cataplexy (sudden and temporary loss of muscle tone often triggered by emotions such as laughter)
- Hallucinations (intense, vivid and sometimes terrifying hallucinations at the beginning and ending of a sleep period)
- Sleep paralysis (paralysis that occurs most often upon falling asleep or waking up; the person is unable to move for a few minutes)
The impacts on those affected by narcolepsy may vary from person to person and may include medical, educational and social impacts.
How common is Narcolepsy?
International evidence shows 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. Narcolepsy can be treated through the use of medicines.
Use of Pandemrix® in Ireland
Pandemrix® has not been recommended in Ireland since January 2011. Doctors were requested to return all stocks of Pandemrix® for disposal. 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.
Reaction 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. 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 be sufficient to cover the claims and that the State may have to substantially increase the amount available to cover claims of medical negligence.
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.
Someone who is effected by this may 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.