Liability of Vaccine Manufacturers in ECJ Practice Cover Image

Одговорност произвођача вакцине у пракси Европског суда правде
Liability of Vaccine Manufacturers in ECJ Practice

Author(s): Marija Karanikić Mirić
Subject(s): Health and medicine and law
Published by: Институт за политичке студије
Keywords: Directive 85/374/EEC; defective product; vaccine against hepatitis B; multiple sclerosis; causation; burden of proof

Summary/Abstract: The main focus of this paper lies with the June 2017 European Court of Justice (ECJ) decision on vaccine manufacturers’ liability in case C–621/15 (N.W. et al. v Sanofi Pasteur et al.). The ruling caused a great deal of negative press and was inaccurately described in the media as allowing compensation for the alleged vaccine injuries, even without any scientific evidence of a causal link. The author examines the facts, the ruling, and the reasoning in the ECJ case, draws attention to the differences between legal and scientific notions of causation, and points out that the ECJ delivered the opinion on the matter of law, without reexamination of the facts of the case, holding that in absence of scientific consensus, national courts may allow plaintiffs to use circumstantial evidence to prove vaccine harms. However, the courts cannot reverse the burden of proof under Article 4 of the Product Liability Directive of 1985, nor can they introduce irrebuttable presumption at the expense of vaccine producers.

  • Issue Year: 2017
  • Issue No: 4
  • Page Range: 137-159
  • Page Count: 23
  • Language: Serbian
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