Ordinarily, the Product Liability Directive 85/374/EEC (the Directive) recognises the manufacturer/producer as liable for any damage caused by a defect in a product, one exception being that if products are imported into the European Union, the importer of the equipment into the EU is instead treated as the manufacturer/producer.

In the case of Besancon v Thomas Dutrueux (Case C-495/10), a patient in a French hospital suffered burns caused by a defective heated mattress. At first instance the hospital was ordered, under French law, to pay compensation to the patient. However, on appeal the hospital argued that only the manufacturer of the mattress, once identified, was to be held liable as stated in the Directive. The European Court of Justice had to decide whether the French law on no-fault liability in public hospitals could exist alongside the system of product liability outlined in the Directive.

The court ruled that the system of product liability established by the Directive could co-exist with the no-fault liability principle of a service provider, as long as national rules did not impair the effectiveness of the Directive. The Directive only imposed a liability on the producer of the defective product, therefore anything outside of this sphere could be subject to national law. In this case, the hospital was not considered an operator in the production line therefore French law was not undermining the effectiveness of the producer liability principle, and so could be applied.

In such instances, the Directive would not stop Member States from implementing rules dictating that a service provider must pay compensation for injury suffered by a patient as a consequence of a defective product used in treating him, even when it was not at fault. The Directive only sought to impose no-fault producer liability. The service provider would, however, retain the right to put the producer’s liability in issue on the basis of the Directive.