Belgian Waffles and Post Hoc Ergo Propter Hoc

In language that could well be a Sokol hoax on the vacuousness of post-modernist non-thinking, the Court of Justice of the European Union issued a press release to announce its judgment in N.W. v. Sanofi Pasteur MSD, Case C-621/15 (Luxembourg, 21 June 2017). With European hypersensitivity to public disclosure, and in recognition of the right to be forgotten, the plaintiffs are known only as the “W” family. Mr. J. W. received Sanofi’s hepatitis B vaccine between late 1998 and the middle of 1999. In the summer of 1999, Mr. W. began to experience symptoms, which led to a diagnosis of multiple sclerosis over a year later, in November 2000. J.W. and his family sued Sanofi Pasteur in 2006. J.W. died in 2012.

The Ws filed their case in Paris, where the courts found for Sanofi Pasteur. The Cour d’Appel de Paris, impressed by the lack of scientific consensus to support W’s causal claim, held that the plaintiffs had failed to demonstrate causality. The Cour d’Appel de Paris court dismissed the W’s case. The dismissal was remarkable in the context of credulous French courts that had routinely recognized such claims. See C. Rougé-Maillart, N. Guillaume, N. Jousset, and M, Penneau, “Recognition by French courts of compensation for post-vaccination multiple sclerosis: the consequences with regard to expert practice,”47 Med. Sci. Law 185 (2007) (summarizing the course of M.S. and hepatitis B vaccination litigation in France). The Ws appealed further to the French Cour de Cassation (Court of Cassation), which punted to the EU Court of Justice, to ask whether the EU directive on liability for defective products required a different result than handed down by the Cour d’Appel.

The “Court of Justice” stated that the claimants had the burden of proof, but dubiously framed the causation issue as a choice between “certain and irrefutable evidence” and evidence of a “sufficiently high degree of probability.” What gives rise to sufficiently high degree of probability? In bold type, the EU press release announces that:

Where there is a lack of scientific consensus, the proof of the defect of the vaccine and of a causal link between the defect and the damage suffered may be made out by serious, specific and consistent evidence.”

But what is “serious, specific, and consistent evidence”? Scouring both the press release and the full decision of the Court provides one answer:

Anecdotes. Unspecified number of case reports of multiple sclerosis occurring in patients after vaccination, without regard to an anticipated or expected incidence of the disease in the vaccinated population suffices. The Court of Justice sums up the Ws’ case as a showing that:

The temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of the person vaccinated and the existence of a significant number of reported cases of the disease occurring following such vaccines being administered may, where applicable, constitute sufficient evidence to make out such proof.”

The significant number of cases is never quantified or even described. The “sufficiently high probability” is never quantified or described. Presumably, the judges in Brussels can count, and the probability is some number greater than zero, but less than 1. The Court of Justice follows many other lay courts in falsely dichotomizing scientific disputes as involving either “certain, irrefutable” evidence or something less, and good enough for government (judicial) work. Even its representation of the Ws’ evidence as “serious, specific and consistent” and its suggestion of a “sufficiently high” probability are false, at least without spelling out the evidentiary base of the anecdotal evidence that is elevated to legally sufficient in the eyes of the Court of Justice. The Court fails to acknowledge, as a Court of Justice should, that large, high quality epidemiologic studies fail to find associations between hepatitis B vaccination and multiple sclerosis. See, e.g., Annette Langer-Gould, Lei Qian, Sara Y. Tartof, PhD; Sonu M. Brara, Steve J. Jacobsen, Brandon E. Beaber, Lina S. Sy, Chun Chao, Rulin Hechter, Hung Fu Tseng, “Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases,” 71 J. Am. Med. Ass’n Neurol. 1506 (2014); Miguel A. Hernán & Susan S. Jick, “Hepatitis B vaccination and multiple sclerosis: the jury is still out,” 15 Pharmacoepidemiology & Drug Safety 653 (2006).

The European right to be forgotten has apparently been extended to scientific evidence. There may be reasons more legitimate than racist xenophobia to exit the European Union.

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