Country:

France

Court:

Cour de Cassation, 1re civ., 23 September 2003, pourvoi n° 01-13063, Bull. civ. 2003 I, nº188; Gaz Pal 2003 Jurisprudence 3084.

Topics:

Vaccinatation

Causal link

Hepatitis B

Articles:

Art. 1147 Code civil

Art. 1382 Code civil

Previous Articles interpreted "in light of" the Product Liability Directive.

Facts:

The claimant underwent a series of vaccinations for Hepatitis B on 22 July 1994, 3 September 1994 and 7 October 1994. In November 1994, the claimant was diagnosed as suffering from multiple sclerosis. Considering that the vaccinations were the cause of her illness, the claimant sued the defendant, a pharmaceutical company which was the producer of the vaccination in question.

The Court of Appeal found the pharmaceutical company liable. The Court of Appeal held that the existence of a link between multiple sclerosis and the vaccinations could not be entirely excluded even though the aetiology of multiple sclerosis was unknown and no study or expert report had concluded in favour of such a link. The Court held that the claimant was in good health until she had had the first vaccination, and in respect of other patients, there had been a "concordance" between the vaccination and the illness. In the case of the claimant, there was no other cause of the illness. The Court of Appeal thereby deduced that the vaccination had been the "activating factor" of the illness, and that the injury she had sustained showed that the product did not meet the standard "of security which a consumer was legitimately entitled to expect", which proved the defective nature of the product.

Legal questions:

Was the Court of Appeal justified in finding that the vaccinations were defective and that the causal link was made out?

Decision:

The Court de cassation overturned the lower court's decision. In a sibylline, one sentence response, it held that neither the defect of the pharmaceutical nor the link between the product and the loss had been proven.

Comments:

It is dangerous to draw a great deal from such a short judgment. However, this decision of the Cour de Cassation does indicate a shift away from a series of very liberal product liability decisions, and a reaffirmation of the need to prove all the elements of a claim.

The Court of Appeal had adopted a very broad notion of causation. Admitting that there was no scientific consensus as to the causes of multiple sclerosis, the Court of Appeal nonetheless upheld liability on the basis that a link between the illness and the vaccinations could not be entirely excluded. Relying on some limited empirical similarities with other cases, the Court of Appeal deduced that the "activating factor" had been the vaccination. In effect, a quasi-presumption of causation had been applied by the Court of Appeal, which in circumstances where the causes of a disease were scientifically uncertain, was impossible to disprove by the defendant (cf L. Pitet, Gazette du Palais, 4-6 April 2004, page 2)

Such a liberal position in respect of causation is not entirely unknown in French law: a very broad notion of causation has been adopted in contaminated blood cases (case law and statutory scheme). Nonetheless, the Cour de Cassation disapproved of the reasoning of the lower court, no doubt taking account of the

drastic effect the Court of Appeal's approach would have had on claims in relation to pharmaceutical product.

The decision of the Cour de Cassation has already given rise to a series of more restrictive decisions (concerning vaccination) by first instance courts.