Case C-621/15, W and heirs – seeking to prove a defective vaccine

Behind this case is a human tragedy. Soon after a person was vaccinated against Hepatitis B, he began to show the initial symptoms of MS. Prior to the vaccination he had shown no signs of MS nor was there any trace of the disease in his family. Unfortunately for the victim, and now his heirs, there is no consensus of opinion in the scientific community about the link between the vaccine and MS. Consequently, can the victim’s heirs rely on the law to make that link? In some circumstances, French law will allow a judge to make the link, even without a consensus of opinion in the scientific community. However, the issue is now whether the French law on this point is compatible with the EU’s ‘defective products’ Directive 85/374 because the Directive actually requires a claimant to prove that there is a causal link between a defect in a product and the harm suffered.

Background
During a period of 7 months, Mr W was vaccinated against Hepatitis B. The final Hepatitis B injection was administered in July 1999. However, in the month that followed Mr W began to suffer from various ailments.

In the November of the following year, he was diagnosed with MS. Yet MS was not in his family and he had shown no signs of the disease prior to the vaccination.

Believing the vaccine to have caused the MS, Mr W brought an action against the manufacturer of the vaccine, Sanofi Pasteur. The company denied liability.

The success of Mr W’s claim, now being continued by Mr W’s heirs on his passing away, turns on the correct interpretation being given to the EU’s ‘defective products’ Directive 85/374 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ [1985] L210/29).

The case has been litigated up to the French Court of Cassation.

At the French Court of Cassation
The judges in the First Chamber noted that vaccines come within the definition of a ‘product’ for the purposes of Article 2 of the Directive, when that Article is read together with Recital 13 of the Directive and the CJEU’s judgments in Case C-127/04 O’Byrne, and C-358/08, Aventis.

However, the legal difficulty in this case stems from the wording of Article 4, which provides:

The injured person shall be required to prove the damage, the defect and the causal relationship between defect and damage.

Although the provision has been implemented into French legislation, that legislation has been interpreted by case law emanating from France’s highest court, the Cour de Cassation.

Under that case law, a causal relationship can be established between a vaccine and harm by using specific legal presumptions. That is to say, French law allows a trial judge unfettered discretion to consider evidence that has been adduced by the claimant to establish the link between the defect and the harm suffered. Such evidence can include the gap in time between the vaccine being administered and the occurrence a disease, or where there is no history of the disease in the family or the patient concerned.

If such indications are present in the case, then a trial judge can find that the claimant has proved that there is a defect in the vaccine and a causal link with the disease. The judge can make that finding even in the absence of medical research establishing a link between vaccination and the disease.

Defendant manufacturers can also rely on presumptions to refute the existence of a causal relationship between the vaccine and the harm suffered.

In that context, the French Cour de Cassation recalled that the appellate court had noted that there was no consensus of opinion in the scientific community as to a link between the Hepatitis B vaccination and MS.

Consequently, the legal issue in this case is whether French case law, and the legal presumptions contained within it, is compatible with Article 4 of the Directive because that provision requires a claimant to prove a causal link between the defect in a product and the harm suffered.

Questions Referred
My unofficial translation of the questions asked by the French Cour de Cassation reads:

1. In respect of a pharmaceutical company’s liability for the vaccines they make, does Article 4 of Directive 85/374 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ [1985] L210/29) preclude a form proof according to which a trial judge, exercising his unfettered discretion, may assess the elements of fact relied on by the claimant and hold that they constitute serious, precise and corresponding presumptions such as to establish the defect in the vaccine and the existence of a causal link with the disease, notwithstanding that medical research has not established such a link between the vaccination and the occurrence of the disease?

2. If the answer to Question 1 is no, then does Article 4 of the Directive preclude a system of presumptions according to which the existence of a causal link between the defect attributed to a vaccine and the harm suffered would still be regarded as established when there are some specific indicators of causality?

3. If the answer to Question 1 is yes, then is Article 4 of Directive 85/374 to be interpreted as meaning that the burden of proof on the victim to establish a causal link between the defect attributed to the vaccine and the harm suffered is only discharged when that link has been established scientifically?

Comment
The EU’s ‘defective products’ Directive was interpreted by the CJEU a couple of times last year in respect of silicone breast implants, and defective pacemakers; see further, Case C-503/13, Boston Scientific Medizintechnik GmbH – are pacemakers with a significantly increased risk of failure defective?

Unfortunately, the French court of cassation has neither explained what gave rise to the French case law nor indicated whether it was in response to there having been too close a proximity between industry on the one hand, and research on the other.

Parallel to this, there is a preliminary reference currently pending before the CJEU which is about health claims that the pharmaceutical industry makes about its products but which they direct at doctors; see further, Case C-19/15, Verband Sozialer Wettbewerb – stopping a company making health claims to doctors.

There is also a preliminary reference about a biocide that has already been licensed by a public body but which is now believed by a campaign group to have an effect on bee deaths; see Case C-442/14, Bayer CropScience – Bee deaths? Buzz Off! The data requested is confidential. The case was heard by the Fifth Chamber last week.

Update – 3 February 2017
The Second Chamber heard this dispute on 23 November 2016, and Advocate General Bobek is due to give his Opinion on 7 March 2017.