Applying consumer protection rules for deficient risk warnings in medicine's package insert

Abstract

The Court of Appeals of the second turn, confirmed the first instance sentence, which, through the application of the consumer protection rules to the field of Health Law, condemned a pharmaceutical company that manufactures a medicine used to treat a patient with acne who developed aplastic anemia. Despite the relationship of causality between the intake of the medicine and the damage suffered by the patient was not demonstrated, the lack of warning in the package insert about other cases, also not proven, that might be associated with this disease, causes the pharmaceutical laboratory incurs in objective responsibility.