Vaccine Liability in Europe: A New Development

By Alex Stein

Yesterday, the European Court of Justice has issued an important ruling on vaccine manufacturers liability. N.W. et al. v. Sanofi Pasteur MSD, C‑621/15. This ruling triggered a hailstorm of criticism from different media outlets, including CNN. These outlets, however, have largely misreported the ruling and its underlying reasons, partly because of this misleading Press Release issued on behalf of the Court itself. In this post, I analyze the Court’s actual decision and briefly compare it with the American law.

The case at bar was about an adult patient who developed multiple sclerosis shortly after being vaccinated against Hepatitis B. The vaccination he received was manufactured by Sanofi Pasteur. Following the patient’s death from multiple sclerosis, his family filed a products liability suit against the company. The suit was filed in a French court, whose decision on evidentiary matters triggered a series of appeals that brought the case before the European Court of Justice. The Court was asked to determine whether the French evidentiary rule which allows plaintiffs to prove the vaccine’s defect and causation by “serious, specific and consistent evidence” in the absence of medical research in either direction aligns with the European law of products liability. The Court ruled that it does while making a number of clarifications and setting up conditions for such rules being valid under Article 4 of the European Council Directive 85/374/EEC of 25 July 1985.

Specifically, the Court decided that European law precludes evidentiary presumptions with mandatory inferences with regard to a product’s defect. European law, the Court held, also precludes any presumption with a mandatory inference as to whether the manufacturer caused or did not cause the victim’s injury. Such factual issues need to be determined on a case-by-case basis when the plaintiff bears the burden of proof with regard to defect, damage and causation.

According to the Court, it should be permissible for the plaintiff to rely on evidence showing “the temporal proximity between the administering of a vaccine and the occurrence of a disease and the lack of personal and familial history of that disease, together with the existence of a significant number of reported cases of the disease occurring following such vaccines being administered.” This means that plaintiffs in vaccine injury or other products liability cases can prove causation as more probable than not based upon any relevant evidence—including differential etiology and naked statistics—even when there is no medical proof linking a vaccine product to, say, multiple sclerosis (as in the case at bar) or autism. Making medical proof a prerequisite for establishing products’ defects and causation would unduly deny plaintiffs access to justice as well as create unfairness in the “apportionment the risks inherent in modern technological production.”

Based on the same principles, the Court also decided that member states can have no mandatory presumptions with regard to manufacturers’ liability. The Court clarified in connection with this ruling that “even if the presumption … were to be refutable, the fact remains that, since the facts preidentified by the legislature or supreme judicial body would be proven, the existence of a causal link would be automatically presumed, with the result that the producer could then find itself, even before the courts ruling on the merits of the case had the opportunity to familiarise themselves with the producer’s evidence and arguments, in the position of having to rebut that presumption in order to defend itself successfully against the claim,” and that “such a situation would lead to the burden of proof provided for in Article 4 of Directive 85/374 being disregarded.”

Our system of vaccine liability is set up by the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa-1. This system differs from the European system, as interpreted in the Court’s present decision, in four fundamental respects. First and most important, our system relies on the special Vaccine Court (the Office of Special Masters of the U.S. Court of Federal Claims) while effectively denying plaintiffs access to the general courts system. Second, our system favors vaccine manufacturers in that it makes medical proof of causation a prerequisite for prosecuting a suit against the manufacturer—a requirement that the European Court of Justice has ruled invalid. On the other hand, our system also helps plaintiffs by establishing presumptions of liability that appear in special tables. When a plaintiff proves that she sustained an on-table injury following her immunization, the Vaccine Court must presume the vaccine to be the cause of the injury. See Lauren L. Haertlein, Immunizing Against Bad Science: The Vaccine Court and the Autism Test Cases, 75 Law & Contemp. Probs. 211, 213–17 (2012). Such mandatory pro-plaintiff presumptions also run afoul Article 4 of the European Council Directive 85/374/EEC, as interpreted by the Court. Finally, under the European system, a vaccine victim can only be awarded compensation when s/he proves that the vaccine s/he took fails the risk-utility test. If the vaccine protects millions against serious illness while injuring or even causing death to a single person, it will satisfy the test and will be deemed non-defective. This critical component of the European Court of Justice decision (and the bar it raises for the plaintiffs’ suit) was missed by many of the decision’s critics. In the United States, on the other hand, the victim would still be able to recover compensation if s/he has medical proof of causation or shows the presence of an on-table injury.

The two systems of vaccine liability—ours and the European—strike different tradeoffs between victims’ rights and society’s need to secure adequate supply of safe vaccines. Both tradeoffs are prima facie plausible. Which of them is better than the other is a separate question, too big to be discussed here.

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About Alex Stein

Alex Stein is a Professor of Law at Brooklyn Law School. Before joining Brooklyn, Alex was a Professor of Law at Cardozo Law School (2004-2016) and served for more than a decade at the Hebrew University of Jerusalem Faculty of Law (1991-2004). He also held visiting professorial appointments at Alabama, Columbia, Miami, and Yale Law Schools. In Fall 2016, he visited Harvard Law School, where he taught Torts and a seminar on Medical Malpractice. Alex's specialty areas include Torts, Medical Malpractice, Evidence, as well as general legal theory and economic analysis of law. He authors three books, An Analytical Approach to Evidence (with Ronald J. Allen et al.) (6th ed. 2016); Foundations of Evidence Law (2005) and Tort Liability under Uncertainty (2001, with Ariel Porat), and over sixty articles of which many have appeared in leading journals. Alex was one of the founding editors of Theoretical Inquiries in Law and is on the editorial board of the International Journal of Evidence & Proof. In 2013, he launched an e-journal STEIN on Medical Malpractice, http://www.steinmedicalmalpractice.com, that covers all significant developments in medical malpractice laws across the United States. He graduated from the Hebrew University of Jerusalem and earned a Ph.D. from the University of London.

One thought on “Vaccine Liability in Europe: A New Development

  1. “ In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual’s informed consent.”

    Universal Declaration on Bioethics and Human Rights

    19 October 2005 UNESCO

    Article 6 – Consent

    1. Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.

    2. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. Consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice. Exceptions to this principle should be made only in accordance with ethical and legal standards adopted by States, consistent with the principles and provisions set out in this Declaration, in particular in Article 27, and international human rights law.

    3. In appropriate cases of research carried out on a group of persons or a community, additional agreement of the legal representatives of the group or community concerned may be sought. In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual’s informed consent.

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