CONTRACTUAL INFORMATION AND PROPERTIES OF PHARMACEUTICAL PRODUCTS: PHARMACEUTICAL LIABILITY AND MODIFICATION OF THE PRODUCT INFORMATION IN SOME DISTRIBUTIONAL AREAS

Abstract

This paper studies the recent jurisprudence relating to information that has to be provided to the consumer. Our Supreme Court has analyzed and reviewed the content of the patient information leaflet of a medicine used to treat hot flushes associated with menopause in women, containing veralipride as a neuroleptic, as well as the liability of the pharmaceutical Company. Many of the patients suffered damages and serious side effects affecting the nervous system not mentioned in the product information, and not known by the prescribers. Therefore, we will analyze the notions of defective product, medicine and burden of proof in Consumer Law.