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ARTICLE · 16 JANUARY 2020

Causation-Related Factual Evidence: ECJ Judgment Interpreted By Spanish National Court

A large number of clinical trials, studies and papers by worldwide health authorities evidencing the safety and positive risk-benefit profile of the vaccine were filed in support of the lack of causal relationship.

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Introduction

Until recently, the Spanish courts had neither applied nor referenced the 21 June 2017 ruling by the European Court of Justice (ECJ) on the Hepatitis B vaccine. However, that changed in June and July 2019 when the Spanish National Court handed down judgments in two separate cases (for alleged damages following administration of an HPV vaccine), both of which referred to and interpreted the ECJ ruling. This article provides an overview of the conclusions reached by the National Court, as well as the potential implications of its interpretations of the 2017 ECJ judgment.

The 2017 ECJ judgment summarised

By way of background, the European Court of Justice concluded in 2017 that when medical evidence neither establishes nor rules out the existence of a link between a vaccine's administration and the occurrence of a disease, the existence of a causal link between the defect attributed to the vaccine and the damage suffered by the victim could be

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