Country:
France
Court:
Topics:
Notion of defect
Causal link
Statutes:
Facts
The claimant had been prescribed two drugs as a treatment for gout. Whilst taking the prescribed treatment in October 1994 he began suffering from Lyell syndrome, which caused erythema (a form of dermatitis), and skin peeling. He sued the two producers of the drugs, Glaxo Smithkline and Aventis, claiming that the products were defective and had caused his skin problems. The Rennes appeal court found both producers liable on the basis of article 1147 of the Civil code, which provides for damages to be paid in the event of a breach of contract.
The laboratories appealed to the Cour de cassation. Aventis argued that the claimant had failed to establish a causal link between their product and the harm suffered since the appeal court had only stated that the existence of a causal link "could not be excluded" rather than concluding that it had been a certain cause of the claimant's injury. For their part, GlaxoSmithkline argued and their product was not defective within the meaning of the 1985 directive.
Decision
The Cour de cassation rejected the Aventis appeal but accepted Glaxo's application.
On the Aventis appeal, the court concluded that there was sufficient proof of a causal link in this case. The link between the taking of the drug and the occurrence of Lyell syndrome was recognised scientifically and the claimant here had developed the syndrome in the time that would have been expected. Also, the symptoms had disappeared once the patient stopped taking the drug. There were also no other apparent causes of the illness.
However, concerning the appeal by Glaxo, the court concluded that the claimant had not established the defective nature of their product. It was not sufficient to show that some of the features of the drug were dangerous. The Court held that the appeal court should not have concluded that the product was defective simply on that basis, without considering all the circumstances, and in particular the presentation of the product, the use which the public was entitled to expect, the time when the product was put on the market and the seriousness of the harmful effects.
Commentary
The case is decided on the basis of article 1147 of the civil code rather than on the 1998 Law which implements the Product liability directive. This is because both products were put into circulation well before the 1998 Law came into force. Article 1147 has been used as a means of implementing the 1985 directive in the absence of applicable transposing legislation. It is employed to impose liability on producers of defective products in terms identical to those contained in the directive.
The main significance of this case is the approach of the court to the interpretation of the concept of defect. Here the Court shows that it intends to closely follow the wording of the directive. Certain previous decisions of the lower courts had implied that it was sufficient for a product to be defective to show that the product was dangerous. The Cour de cassation here confirms that the dangerous nature of the product on its own is not sufficient, and follows the criteria provided in the directive. Serious side effects will therefore not necessarily render the product defective. It can be noted however that the court refers to the use of the product which the public is entitled to expect whereas the directive refers to the use which the producer is entitled to expect. It would seem unlikely that this signifies an intentional divergence in approach with respect to the provisions of the directive since everything tends to indicate that the Cour de cassation intends to interpret its law in conformity with the European legislation.
On the causation issue, the conclusion of the Cour de cassation that there was in this case sufficient evidence of a causal link appears logical on the facts. In theory, French law insists on the proof of the certainty of a causal link, but in practice the court will accept, as here, a number of concordant circumstances to create a presumption of causation. Here, the proof of a causal link was much stronger than in the Cour de cassation's decision of 23 September 2003, where the link between hepatitis B vaccinations and multiple sclerosis was rejected by the court. However, one major commentator (G. Viney) sees a further significance in this decision. She argues that it demonstrates a specific approach by the court to health products, where, once scientific evidence of a possible link between the use of the product and the victim's harm has been shown, causation will be presumed unless the defendant can provide an alternative explanation for the damage.
