Drug & Device Law

Bonjour à tous.

Now that we have completely exhausted our entire high school French vocabulary, for today's blog post we are traveling back across the Atlantic to France and Luxembourg. Today, we examine a recent judgment of the Court of Justice of the European Union relating to the evidentiary requirements for finding a causal link between a vaccine and an unrelated disease where there is no medical proof to support the existence of such a causal link. For our American readers who are familiar with the way vaccine cases used to be litigated, one may get a feeling of "déja vu," and not in a good way.

If we cast our minds back to the 1980s scare over the DPT vaccine, large jury awards were given to plaintiffs despite the fact that most public health officials did not believe that there was a link between the vaccine and certain autism spectrum disorders. As a result of these cases, a number of vaccine makers decided to cease production. For the United States government, this development was worrying and threatened a drop in important childhood vaccinations. In order to encourage the continued production of vaccines, Congress passed the National Childhood Vaccine Injury Act, which set up the National Vaccine Injury Compensation Program (NVICP) in 1988 to compensate individuals (or their families) allegedly injured by certain covered childhood vaccines. The compensation scheme is funded by a tax on vaccines purchased. The scheme applies only to conditions that have already been determined administratively to be associated with the vaccine, therefore relieving (i) the plaintiff of the burden of proving a general causal link between the vaccine and the injury; and (ii) the vaccine producer of the cost of defending or settling expensive civil liability cases. The plaintiff is still required to prove that, on balance, a specific causal link between the vaccine and the injury. Although this scheme is limited to certain injuries caused by certain vaccines, it significantly reduced the number of product liability claims against manufacturers for vaccines. See generally Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226-30 (2011) (describing NVICP and reasons for its enactment).

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