Spain: public bodies in product liability litigation

23 April 2010

Raquel Ballesteros, Lola Canalejo

As a result of the public nature of the Spanish healthcare system, as well as of the principle of strict liability of Spanish public bodies for damages, in Spain judicial claims concerning defective medicines tend to be brought directly against the public bodies whose professionals prescribed or administered the defective product (the so called “servicios regionales de salud” or “regional health providers”).

In addition to this “traditional” title of liability as “healthcare providers”, public bodies have recently started to face a new type of claim, based on their role as regulators or supervisors of healthcare and, in particular, of pharmaceutical assistance.

There is no doubt that the relevant public bodies (the Ministry of Health and the Spanish Agency of Medicines attached to the former) should be held liable in the case of improper authorisation or supervision (pharmacovigilance) of medicines (i.e. breach of the procedural steps or the improper assessment of safety, efficacy, quality or information requirements). Once the product is on the market, they can also be liable in case of a failure in taking post-authorisation control measures (as provided in Spanish Royal Decree 1344/2007 of 11 October, on pharmacovigilance of medical products for human use).

Recent cases: much ado about nothing

Despite the dramatic increase of litigation against Spanish public bodies as regulators and/or supervisors in the health sector, no unfavourable judgments for those public bodies have yet been made.

By way of example, 25 claims were filed in the last year against the Spanish Ministry of Health in the AGREAL case (a medicine marketed by Sanofi Aventis for menopause treatment that resulted in certain psychiatric and neurological adverse effects). Until now, all of these claims have been dismissed on the grounds that, until 2005 (the year in which the marketing authorisation for that medicine was suspended and then subsequently revoked) there was insufficient evidence to prove that in the risk-benefit balance, the safety and efficacy of the medicine was not guaranteed (Judgments of the National Court “Audiencia Nacional” of 29 December 29, 2009, and 17 and 24 February 17 and 24, 2010 ... etc).

Procedural issues in the involvement of public bodies in product liability litigation in the health sector

The involvement of a single public body in a product liability case has procedural consequences, since claims brought at the same time against both public bodies and private companies (e.g. manufacturers, suppliers and insurers) cannot be heard by the Civil Courts but must instead be heard by the Contentious Administrative Courts.

This is due to the so called “vis atractiva” (“attraction power”) of the contentious jurisdiction over the civil jurisdiction, introduced by Organic Law 19/2003 of 23 December, which amended article 2 e) of the Law 29/1998, of 13 July on the Administrative-Contentious Jurisdiction which provides that where proceedings are brought against a public body and a private company together, the case must be heard by the Contentious Administrative Courts, which have jurisdiction over the Civil Courts as soon as a public body becomes involved. This amendment was introduced following a long debate as to which court was competent to hear cases for damages involving both public bodies and private companies (in this case, pharmaceutical or insurance companies”).

Different position of public bodies and pharmaceutical companies in product liability litigation: the development risks defence

According to Article 141.1 of Law 30/1992, related to the Public Administration liability, "Damages arising from facts or circumstances that could not have been foreseen or prevented according to the state of scientific or technical  knowledge at the time of production shall not be compensated (...).

The quoted article refers to the “development risk” defence which can be used to exonerate public bodies from liability and has been successfuly argued in a number of cases:

  • The Cerivastatin case: a medicine manufactured by Bayer for cholesterol disorders was withdrawn by the Spanish Agency of Medicines due to certain serious adverse effects. In a Judgement of 23 July, 2008 the Spanish National Court understood that the Agency fulfilled its pharmacovigilance duties by conducting  several statements and precautionary actions between April and August 2001 in response to the high number of reports of rhabdomyolysis (damage to muscle tissue). According to the National Court "actions developed and launched since 9.4.2001 can be considered to have been taken quickly and appropriately... according to Pharmacological State of science at that time and the provisions of art.141.1 of Law 30/92 on Public Administration."

  • The cases related to blood products contaminated with HIV and HCV when the discovery of the viruses was impossible due to the scientific knowledge by the time the product was placed into circulation. In particular, it is worth noting that the Judgement of 5 October 1999 delivered by the Spanish Supreme Court, which exonerated the public bodies involved from development risk damages, but not the pharmaceutical company which was ordered to pay €300,506 in damages.

This different treatment received by public bodies and private companies, producers or suppliers, results from the specific implementation in Spain of Directive 85/374, on Product Liability by means of a Consumers Code compiled by Royal Decree 1/2007. Article 140.3 of this Code expressly states that producers and suppliers shall not be entitled to invoke the development risk defence in the case of medicinal products, food or food products intended for human use.

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