A Dangerous Method: Correlations and proof of causation in vaccine related injuries

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In June 2017 the Court of Justice of the European Union (CJEU) handed down a complex decision on the liability of vaccine producers. The reference for a preliminary ruling stemmed from a French case in which a hepatitis B vaccine manufactured by Sanofi Pasteur allegedly caused personal injury to Mr W in the form of multiple sclerosis, a disease that ultimately led to his death.
The case is of particular significance as it presented the Court with an opportunity to clarify aspects of the causal link that a plaintiff needs to establish in order to be successful in a claim under the European Product Liability Directive (the Directive). This is the third decision in a series of recent judgments of the Court on the interpretation of several grey areas of the original text of the Directive. Sanofi comes after a clarification of the material scope of the Directive and its relationship to special liability systems provided under national laws in Novo Nordisk Pharma, and a revision of the concept of defect and defectiveness in cases involving complex technological products in Boston Scientific. This article contends that the decision in Sanofi endorses a dangerous method for the determination of a causal link between the administration of a vaccine and subsequent personal injury, whereby factual causation can effectively be reduced to speculative correlation.While there is undeniable value in vindicating the autonomy of legal reasoning in cases involving uncertain scientific issues, this should not result in arbitrariness.
Original languageEnglish
Pages (from-to)289-307
JournalJournal of European Tort Law
Issue number3
Publication statusPublished - 21 Dec 2018


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