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.
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