More on the ECJ Vaccine Liability Decision

By Alex Stein

My friend and mentor, the former Israeli Chief Justice Aharon Barak, used to say that when neither side likes the court’s decision, chances are that the court was right. This is likely to be the case with the European Court of Justice (ECJ) decision on vaccine manufacturers’ liability, N.W. et al. v. Sanofi Pasteur MSD, C‑621/15. Popular press reacted to this decision with sharp criticism that included unsubstantiated assertions about the European law of products liability, about what the Court did and did not say, and about the economics of vaccines. My short blog-post, which appeared here, offered a more positive (and hopefully more informative) assessment of this decision and its implications. I argued that the decision was balanced and well grounded in the principles of evidence and products liability. The follow-ups and subsequent analyses that appeared in Nature, Science and Hipertextual (in Spanish) have largely vindicated the decision (while citing some of its critics alongside the decision’s supporters such as myself).

To remove any remaining confusion about the implications of the ECJ decision, I thought I should clarify the Court’s statement that a vaccine liability suit can only succeed when the plaintiff proves that the vaccine complained against was “defective” within the meaning of Article 6(1) of the European Council Directive on products liability (85/374/EEC) (the Directive). Critics of the Court’s decision have uniformly missed this important proviso.

The Article 6(1) test for “defectiveness” incorporates the totality of factors that need to be taken into account to secure the key goal stated in the Directive’s Preamble: “a fair apportionment of the risks inherent in modern technological production.” The Preamble also clarifies that “the defectiveness of the product should be determined by reference not to its fitness for use but to the lack of the safety which the public at large is entitled to expect” (emphasis added).

The ECJ’s earlier decision, Boston Scientific Medizintechnik GmbH, et al., C‑503/13 & C‑504/13, which the Court quoted in N.W. v. Sanofi Pasteur, interpreted those provisions to incorporate a cost-benefit analysis that juxtaposes the product’s risks against its social utility. The Boston Scientific ruling also included a statement that “assessment [of product defects] must be carried out having regard to the reasonable expectations of the public at large” and that “the safety which the public at large is entitled to expect … must therefore be assessed by taking into account, inter alia, the [product’s] intended purpose” (emphasis added).

All this is consequential for future vaccine liability decisions in Europe because vaccine products embody the risk-benefit calculation in their very design. Vaccines are designed to save many by risking just a few, and they therefore cannot be identified as defective when they bring about this social consequence. As a corollary, plaintiffs suing vaccine manufacturers in Europe will always need credible expert testimony in order to prove that the vaccine product fails the cost-benefit analysis and hence was defective. Absent such testimony, their suits will be doomed to failure.

For that reason, the Court’s decision to allow the plaintiffs in N.W. v. Sanofi Pasteur 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” will hardly give those plaintiffs an upper hand in the proceeding that will now resume in France. Vaccine manufacturers may well be unhappy about that decision, but the Court’s Article 6(1) ruling gives them every reason to suppress that feeling. In fact, it is vaccine plaintiffs who should feel lukewarm, if not unhappy, about the Court’s decision. For them, proving that a vaccine product was defective because it fails the cost-benefit analysis within the meaning of Article 6(1) will remain an uphill battle. Add to this the Court’s ruling that plaintiffs should bear the burden of proof on every products liability issue—defect, damage, and causation—and that member states cannot shift this burden to the defendant, and you will get the full picture. Cf. Alex Stein, The Domain of Torts, 117 Colum. L. Rev. 535, 561-63; 589-93 (2017) (outlining and rationalizing common law rules that relieve plaintiffs from the burden of proving causation following the defendant’s violation of a safety standard).

Contrary to what the doomsayers say, the ECJ’s decision is many miles away from imposing “crashing liability” on vaccine manufacturers.

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