Liability of products in defective drugs.

               Liability Of Products In Defective Drugs

Every year, thousand of people are injured because of defective drugs, but first of all we must determine the liability for a drug that it is defective, if it produces adverse effects that are not included in the product insert. According to art. 3.1 of Law 22/1994, of July 6, on liability for damage caused by defective products (LPD) "means one defective product that does not offer the security that would legitimately expect, considering all the circumstances and, especially its presentation, the reasonably foreseeable use of it and the time of entry into service. " It follows, without doubt, that if the drug causes side effects are not listed in the leaflet, if there isnt collected interactions or contraindications that actually exist, or doesnt report the maximum consumption, as this can result in effects adverse not listed should be considered defective, because it causes not advised or expected by patients, which in turn are consumers,  does not offer the security that would legitimately expect damage in his presentation.

The Spanish Agency for Medicines and Health Products appropriate, when it detects a problem with a drug, as follows, notes the existence of adverse reactions to reconsidered the risk-benefit balance, the study makes a review of the product found to see if it produce an  adverse effects health, analyze what happened, and not only that,  they have to declare that the product is harmful, based on the Royal Decree 711/2002, of 19 July, on the pharmacovigilance of medicinal products for human use. It concluded that the drug's benefits did not outweigh its risks and it is recommended that the product marketing authorizations are withdrawn.