Pharmaceuticals liability for defective products in Spain

The medicinal product set of rules in the European Union includes a full regulation of the required conditions for its marketing that provide the highest levels of safety that should be expected from this kind of consumption products. However,^1 sometimes the failure by the manufacturer to comply with this requirements or the innovative nature of the product lead to cases of defective medicinal products in the market, which generates a civil liability of the manufacturer with the consumer. The legal framework of the medicinal product does not include a civil liability regime of its own, but rather it should be applied the general regime of civil liability for defective products established in the EU Directive for the harmonisation of the national regulations regarding the liability for damages caused by defective consumption products in general, which defines a direct and objective liability of the manufacturer. In terms of civil liability, the Spanish legislation has incorporated the European criteria, but due to the characteristics of the medicinal product, those general European criteria need to be adapted to the singularities of the product and to be interpreted by the courts to which the liability is demanded.

The court decisions from the Spanish courts of justice regarding defective medicinal products cases occurred in the last decade are gathered, analysed and systematized in this work. We distinguish between the jurisprudence based on the defect in manufacturing, the defect in the design and the defect in the information, which are the three different kinds of civil liability considered in the application of the European regulation regarding the concept of defective product. The interpretation that each court makes results in contradictory decisions, and hence, the determination of the liability is not made in a direct way, as the community regulation intends, which leads to conclude that it is necessary a more detailed regulation for the medicinal products sector.