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Pandemrix

In 2009, the Irish Government, like the governments of other states, formed a policy to offer a vaccine to counteract the onset of the H1N1 2009 flu pandemic, colloquially called the swine flu.

The vaccine was offered through HSE clinics and general medical practitioners and was promoted by the state for the particular protection of young people. The state chose the vaccine brands to implement the policy. One vaccine chosen was Pandemrix, a vaccine licensed by the European Medicines Agency.

HSE clinics administered more than 900,000 doses of Pandemrix in 2009 and 2010 and the young people affected ranged in age from 5 to 21 years of age.

Not everyone was happy with Pandemrix; the German Medical Association, in October 2009, opposed the vaccine’s use in young people and pregnant women, saying that, since the risks of swine flu were lower than feared, it would be unwise to rely exclusively on new vaccines containing adjuvants if alternatives were available (they were).

It appears there was another very notable sceptic concerning Pandemrix; its manufacturer, GlaxoSmithKline.

In 2009, it said it hadn’t had the opportunity to collect a significant amount of data on the use of Pandemrix, but that it had experience with similar vaccines for seasonal flu, bird flu, as well as data on the use of adjuvants.

It now claims the Irish state furnished GlaxoSmithKline with an indemnity against any claims arising from adverse reactions to the use of Pandemrix. Such an arrangement, effective or not, is powerful evidence of the skepticism of GlaxoSmithKline about the safety of Pandemrix.

Sure enough, there was an unintended consequence of the vaccine programme; an increase in the incidence of narcolepsy appeared. The parents of affected Irish children associated it with the administration of Pandemrix. They were not alone. Finnish authorities also noted this consequence, following the delivery, by the state of Finland, of Pandemrix to the young people of Finland, also to counteract the H1N1 flu.

Those Finnish authorities launched an investigation.

Eventually, so too did the Irish authorities. Two reports, Finnish and Irish, now conclude that the explanation for the incidents of narcolepsy appearing after the vaccine programmes lies with Pandemrix.

Narcolepsy is a serious neurological sleep disorder. It is life-long and there is no known cure. It will affect the course of a person’s future life and occupational chances.

Lawyers are familiar with situations such as this. It is one where a problem is recognised or experienced by one or more private persons. They have sustained a loss or injury but it has followed from the actions or inactions of others.. Under the Irish constitution, the state is obliged to vindicate the … person… of its citizens. This means that a personal injury, inflicted by one person on another, demands a constitutionally mandated resolution.

Was narcolepsy inflicted on some young Irish persons?

An answer lies in the concept of “cause”, as understood by scientists. Another answer, perhaps the same one, lies in the same concept, as understood by lawyers.

We see this in the terms of the Irish report; it purportedly identifies a genetic element in the incidence of narcolepsy. Be that right or wrong, there must be some additional element besides Pandemrix, to explain these cases of narcolepsy. We know this from the fact that not every young person receiving Pandemrix developed narcolepsy. This implies a vulnerability on the part of those “unlucky” persons.

Lawyers refer to such cases as “egg-shell skull” cases; that is, a person might possess a vulnerability where a blow to the head, say, causes injury that a “normal” person would not suffer.

In law, a vulnerability like that is not a bar to recovery of compensation. As lawyers say, “you must take your victim as you find him/her”.

This is where scientists and lawyers go their separate ways on the considerations of “cause”. A scientist is reluctant to attribute the word cause to one element in a chain of events; a lawyer is often and habitually not so reluctant if that element is proximate to the injury.

We see this in every personal injury civil action. The burden of proof on a plaintiff is to prove the case on the balance of probabilities. If the plaintiff proves that it is more probable than not that something done by the defendant has injured the plaintiff, he or she will succeed in the claim.

This is exactly what has been determined by the Irish and Finnish reports; it is probable that Pandemrix caused the cases of narcolepsy appearing in young people who got the vaccine.