Defectiveness and Causation in Vaccine Liability Cases – the Jurisprudence of the Supreme Court of the United States and the Court of Justice of the European Union

Abstract

The reflection we undertake is two-pronged. We analyse the policy arguments put forth in crucial decisions by the European and American highest courts to sanction vaccine-related injuries. In parallel, we investigate the place and role of scientific evidence in the legal framework disciplining liability of vaccine manufacturers. In doing so, we will identify convergence and discrepancies in respect to policy, regulatory and legal approaches in Europe and the United States. Admittedly, this analysis is limited to EU and US federal laws, regulations, and case law. We acknowledge that internal divergences exist (between States in the US and Member States in the EU), and these will be referred to when appropriate, but the focus is on the overarching approach that the two principal markets adopt in the face of alleged vaccine-related injuries.

There are two fundamental questions for us to consider. The first is whether the SCOTUS's jurisprudence is excessively rigid in an ambit characterised by rapid scientific developments and discoveries that should warrant more open-textured readings of legislative texts. The second question is whether the CJEU has conceded too wide a margin of manoeuvre for national courts when it opened the door to a system of presumptions for vaccine liability and, by the same token, whether it has endorsed a ‘dangerous method’ for determining defectiveness and causation, which has the potential to elevate illogical reasoning to the status of legal proof. The point of interest is identifying which option achieves a better balance between public health concerns and individual rights, or whether a balancing act between the two approaches would be desirable.

Keywords: vaccine, defectiveness, causation, product liability, tort, comparative matrix

JEL Classification: k13, k23, k32