Vaccination claims: Has Europe opened the floodgates?

The European Court of Justice’s judgment in W v Sanofi Pasteur MSD caused an outcry in certain sections of the media. It was claimed the CJEU had “opened the floodgates for spurious vaccination claims”. But what is the legal significance of the decision?

W had been given three doses of Sanofi’s hepatitis B vaccine between December 1998 and July 1999. Shortly after, W’s health deteriorated, he became incapacitated, and needed substantial care. He was diagnosed with multiple sclerosis and died on 30 October 2011. An action was brought by his family after his death seeking damages on the basis the vaccine was the cause of his illness and death. Causation was vigorously disputed. The referring court said that the scientific evidence neither proved nor ruled out a causal link.

The CJEU decided that the EU Product Liability Directive did not contain any definition of what is a “causal relationship”, and that while the directive aims to harmonise laws on product liability, it does not seek to harmonise the entire legal regimen around defective products. It was for the national courts to decide on the ways in which evidence was to be elicited, admitted, and assessed, and the level of proof required. The court therefore decided the French evidential rules were not ousted by the directive.

Implications for the UK

The government’s view is that the CJEU’s decision would have little impact on the UK. On 6 July 2017 the parliamentary under-secretary of state for health, Lord O’Shaughnessy, said the court’s decision “does not impact on the UK. This case relates to specific circumstances and law in France.” As such, the media talk about “floodgates being opened” was (unless you are French) overblown.

The history of vaccine litigation in the UK is a sorry tale where many attempts at claims have failed. In Loveday v Renton & Wellcome Foundation [1986] the claims regarding the old whole-cell whooping cough vaccine failed to demonstrate generic causation and were dismissed. The MMR vaccine litigation of 1998-2003 was a notable disaster.

In O’Byrne v Aventis Pasteur (2001-10) the claim had two visits to the House of Lords and to the CJEU before failing on a limitation point. And in Thompson v Bradford a GP escaped liability for clinical negligence on a successful appeal to the Court of Appeal against a High Court decision that had found negligence in the administration of a live polio vaccine to a sick child which resulted in poliomyelitis. Successful claims are few and far between indeed.

However, a careful reading of the CJEU’s decision might give grounds for some more optimism for claimants. The requirements of the directive are that consumers are to have rights of redress where they have been injured by products which are “defective” – i.e. where the products are not as safe as they are reasonably entitled to expect. Given that a vaccine is administered to a healthy individual as a prophylactic, it is arguable any serious adverse reaction resulting in permanent disablement renders the vaccine “defective” as consumers reasonably expect absolute safety.

So the court’s decision could perhaps be read as a warning that the purpose of the directive would be undermined if evidential rules are set too high, preventing consumers from obtaining redress. This possibly has implications for the UK, where so many claims have foundered because the courts expect a high level of scientific and epidemiological proof as to causation in vaccine cases. It will be interesting to see whether this decision is cited in future UK cases as authority that standards of proof must not be set too high, or will be struck down by the application of the directive.

Peter Todd is a partner at Hodge Jones & Allen

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