ALA OCTA: Spain’s Supreme Court ruling on product and public healthcare liability

Supreme Court, Third Chamber, Contentious Administrative, Section 5, Judgment 1806/2020 of 21 December 2020, Appeal 803/2019

Data de publicação

26 abr 2021

Serviços

Localizações

In this case Spain’s Supreme Court declined to impose liability where the cause of loss is a defect and the claim properly lies against the manufacturer (or a supplier). Subject to any referral to the European Court of Justice, the practical implication is that injured patients may be denied a private law remedy if the manufacturer is insolvent and its insurance cover is subject to a territorial limitation.

Background

On 26 June 2015, the Spanish Agency of Medicines and Medical Devices (AEMPS) issued a health alert to recall and for use to cease of ALA OCTA (Perfluorooctane), a product used in retinal surgeries.

The alert was issued due to the detection of a toxic substance that contaminated the product and caused the loss of visual acuity and in some patients, blindness. The manufacturer, a German company, supplied this product to a Spanish distributor that distributed it in various public and private hospitals and medical centres.

In Spain, more than a hundred patients of 28 medical centres in 13 different regions have been affected. This is in addition to patients in several other countries. In Spain, legal proceedings were brought by those affected against, among others, the medical centres that performed vitrectomy procedures where the product was used. The outcome of those claims varied. The Superior Courts of Justice of the Canary Islands and Cantabria issued contradictory judgments.

In December 2020, the Supreme Court provided its ruling, thereby clarifying the position and setting legal precedent.

Decision of the Superior Court of Justice of the Canary Islands

The Superior Court of Justice dismissed the €571,157 public liability claim against the Canary Health Services due to deficient health assistance.

The Court found that the cause of the loss was clear: the toxicity of the medical product. As such, the Canary Health Service did not have the requisite power of inspection and control. This instead belongs to the Spanish Agency of Medicines and Medical Devices.

With regard to liability arising from the Consumer and User Protection Act approved by Royal Legislative Decree 1/2007 of 16 November, the Court concluded that, according to the cause of the damage, it is the manufacturer who has to respond to the claim. Finally the Court did not find any infraction of the lex artis (law of skill) principle that could lead to disproportionate harm.

Decision of the Superior Court of Justice of Cantabria

In contrast, the Superior Court of Justice of Cantabria ordered the Cantabrian Health Service to compensate a patient 25.000 € in damages (against a claim of 150.000 €).

In reaching its conclusion, the Court took into consideration the personal circumstances of the patient and that the injury scale for motor accidents has a mere orientating nature. With regards to the ratio decidendi, the Court justified the “objective liability from the sued administration for the risk created by the use of the gas that has resulted toxic, without prejudice to the right of this Health Service to recover from the product’s distributor or the manufacturer, who are not defendants”.*1

Decision of the Supreme Court

The Supreme Court recently ruled on this matter (21 December 2020), establishing that liability must rest with the manufacturer, the distributor, or, when applicable, the Spanish Agency of Medicines and Medical Devices.

The Court assessed whether:

the Administration that performs correctly and adequately a health act shall be liable for the losses caused to a patient as a consequence of the use of a defective medical product, which toxicity is revealed and alerted subsequently to its use and has been authorized by the competent administration (AEMPS) or if, in the contrary, the liability shall lie on the manufacturer or, in the Administration with power to authorize and monitor the medicines and medical products”.*2

Supreme Court legal reasoning

The Supreme Court carried out an exhaustive analysis of the liability of the public administrations, specifically in relation to health liability. The Court observed that when medical assistance has been performed in accordance with the current state of science and adopting all reasonable means, the resulting loss cannot be considered wrongful.

The Supreme Court stated that public health services malpractice liability cannot be deemed merely from the use of a defective medical product, in circumstance in which the Administration is subsequently alerted to its toxicity.

Further, in this respect, the Supreme Court dismissed the assertion that the public health service should be held liable for the risk arising from the use of the toxic gas for two reasons:

(i) “the power of authorizing, homologating and controlling medicines and health products corresponds solely to the Spanish Agency of Medicines and Medical Devices”;*3 and

(2) the risk does not arise from the use of the defective product – this is, the medical act – but from the manufacture of the said product as well as a lack of control by the competent Administration. It was not the use of the product that was duly authorized that created any risk whatsoever, but its defective manufacturing.

Comment

This decision leaves patients in a potentially difficult situation in instances when, for example, the manufacturer of the product is declared bankrupt or has an insurance policy with an insured sum that is insufficient to cover the losses suffered by all of the patients. The outcome of this case thereby demonstrates the limitations of Spain’s health liability system in respect of claims for compensation by patients affected by a defective medical product. The mechanisms of the liability system place liability on those directly causing the damage - in this case, a foreign manufacturer, that became bankrupt and a Spanish distributor. It would appear however that a Spanish distributor would only be held liable under Spanish consumer protection legislation in circumstances where the manufacturer can not be identified.

Another potential challenge for claimants to overcome is that the manufacturer’s policy may limit the territorial scope of the coverage to losses occurring in a particular country (as was the case in RB v TÜV Rheinland LGA Products and Allianz IARD [Case C-581/18] see here). In that case, the Court held that the general prohibition of discrimination on the reason of nationality cannot be invoked to dispute a clause, established in a contract between a medical product manufacturer and an insurance company, that limits the territorial scope of the liability coverage.

Please note this is our translation.

Original Spanish judgment text:

*1 responsabilidad patrimonial objetiva del servicio sanitario demandado por el riesgo creado por la utilización del gas que ha resultado tóxico, sin perjuicio de que este servicio sanitario pueda repetir de la distribuidora del producto o de la fabricante, contra las que no se ha dirigido la reclamación patrimonial”.

*2 la Administración sanitaria que realiza correcta y adecuadamente un acto sanitario debe responder de las lesiones causadas a un paciente como consecuencia de la utilización de un producto sanitario defectuoso, cuya toxicidad se descubre y alerta con posterioridad a su utilización previamente autorizada por la Administración competente (Agencia Española de Medicamentos y Productos Sanitarios) o si por el contrario, la responsabilidad deber recaer en el productor o, en su caso, en la Administración con competencias para autorizar y vigilar los medicamentos y productos sanitarios”.

*3 la competencia para la autorización, homologación y control de los medicamentos y productos sanitarios corresponde, única y exclusivamente, a la Agencia Española del Medicamento y Productos Sanitarios” (AEMPS).

Read other items in London Market Brief - May 2021