Several studies, including one Irish study, have associated an influenza vaccination, Pandemrix, with unusual cases of narcolepsy.
These are statistical studies; the causes of narcolepsy are obscure, but they include infections.
European public health authorities, including in Ireland, worry about seasonal influenza. In 2009 they worried about the variant H1N1. The response was to arrange for mass vaccination of populations.
At that time, Pandemrix, had limited approval for use as a vaccination. The details of the original approval are HERE.
This was described by the European Medicines Agency in these terms;
“Pandemrix was granted Marketing Authorisations in the EU in May 2008, with use being restricted to subjects aged 18-60 years in section 4.2 of the summary of product characteristics (SPC) due to lack of data outside of this age range.”
Despite this, during 2009 it was administered to at least 30.8 million people in Europe. Its history is to be found in this review of Pandemrix “Questions and answers on the review of Pandemrix…”
It received limited approval on 20th May 2008 because of outstanding issues. It was permitted to switch from conditional to full marketing on 24th June 2010 as can be seen in this Procedural History.
Within eight weeks of full authorisation the Swedish national authorities reported cases of juvenile narcolepsy following immunisation with Pandemrix and the Finnish authorities suspended its use, whereupon the European Commission sought, (27th August 2010), the opinion of the EU Committee for Medicinal Products for Human Use on these reports of narcolepsy.
The World Health Organisation’s Global Advisory Committee on Vaccine Safety has remarked of this,
“… an increased risk of narcolepsy had not been observed in association with the use of any vaccines in the past and that it did not appear that narcolepsy following vaccination against pandemic influenza was a general worldwide phenomenon.”
Nonetheless, the facts are now established; Pandemrix is the cause of a number of cases of narcolepsy in Ireland. Narcolepsy is a serious incurable disability. It has occurred in Irish young people and will affect their lives inescapably for the future. It will make the chances of getting and holding employment problematic. It may rule out the driving of motor vehicles. It would certainly rule out the flying of aircraft.
The liability for this, in law, is clear. The Irish state provided Pandemrix to the Irish population. There were various avenues of distribution. Many involved payment of a fee or fees. This implied the delivery of a commercial service. The services delivered to these patients were subject to the implied terms of the Sale of Goods and Supply of Services Act 1980.
GlaxoSmithKline Biologicals S. A. were the defined producer of Pandemrix. In producing Pandemrix GlaxoSmithKline Biologicals S. A. triggered the terms of the Liability for Defective Products Act 1990. Each of these pieces of Irish legislation renders the General Practitioners or HSE clinics and GlaxoSmithKline Biologicals S. A., (the producer), liable for patent and latent defects in the product. It is not necessary to prove negligence to succeed in these claims. It is also not necessary to prove that Pandemrix was the sole cause of these narcolepsy claims. In civil claims for personal injury the burden of proof on a plaintiff is to prove fault on the balance of probability.
The claims are for personal injury. The limitation period for personal injury claims is two years from the date of the accrual of the cause of action (the immunisation) or the date the patient knew or could reasonably know that she had been injured and/or the identity of the person injuring her. Failure to issue proceedings before the limitation period expires will render the claim barred.