Affiliations: University of Granada, Granada, Spain. E-mail: mcabezas@ugr.es
Abstract: 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.
Keywords: Defective medicinal products, civil liability, liability for defective products