Home Opinion Vaccine Liability And Causation: Has Europe Gone Overboard?
Vaccine Liability And Causation: Has Europe Gone Overboard?

Vaccine Liability And Causation: Has Europe Gone Overboard?


My son and I are avid baseball fans (though we support different teams — he the O’s and I the Nats).  Sometimes we turn on a game in progress on TV, while our favorite team is in the lead.  It often seems that, invariably, the opponent scores as soon as we start watching.  We feel we have jinxed our team — in extreme cases we resolve not to watch the next game in order to allow our team to win.

This attitude (believing irrationally that we are “the grim”) is, of course, a superstitious application of the logical fallacy of post hoc, ergo propter hoc.  The mere fact that an act precedes another is no proof at all that the first act caused the second. Say my Washington Nationals triumph tonight against the Atlanta Braves (or, G-d forbid, suppose they lose).  I know deep in my heart that writing this column didn’t cause that happy (or sad) outcome.

Causation is really important in Tort law.  The defendant must have wrongfully caused harm to the plaintiff in order for the latter to recover damages from the former.  If I drive drunkenly and erratically on Main Street tonight, and one hour later you keel over from a heart attack a mile away, I may be guilty of a crime but I sure don’t owe your estate any money in tort.  Your death coincidentally followed my wrongful behavior.  Correlation does not imply causation, as we all are supposed to have learned in high school.

Courts are supposed to enforce the causation requirement rigorously.  In the USA, where juries usually decide tort suits, judges are supposed to take a case from the jury if the plaintiff merely establishes coincidence and offers no theory of causation.  In Europe, where judges decide cases alone, they must have evidence of causation (not merely correlation in time) in order to find for the plaintiff.  A recent referral from France’s highest civil court to the European Court of Justice, however, may be stretching this fundamental legal principle beyond recognition.

The case involved one W,  who received a series of three vaccinations against Hepatitis B, in December 1998, January 1999 and July 1999.  One month later (in August 1999) he began to feel ill.  Various tests were performed, and three months later (in November 1999) W was diagnosed with multiple sclerosis, even though no one in his family had ever contracted the disease.  W’s condition gradually deteriorated, and he tragically died 12 years later.  In 2006 he sued Sanofi Pasteur, the manufacturer of the Hepatitis B vaccine, for the damages he suffered.  [The suit was continued by his estate after his death.]

W’s legal theory was that a defect in the vaccine caused him to get MS.  Under European (and American) products liability law, a manufacturer of a product is liable if a defect in its product causes harm to a consumer.  But the plaintiff’s legal theory had several problems, among them the following non-contested facts (adduced from the decision by Paris’s Cour d’Appel):

  1. No scientific link between Sanofi’s (or anyone else’s) Hepatitis B vaccine and MS has ever been established or accepted.  Indeed, all national and international health authorities who have examined the question reject any link between a likelihood of developing central or peripheral demyelinating disease (characteristic of MS) and the vaccination against hepatitis B.
  2. According to multiple medical studies, the etiology (cause) of MS is currently unknown.
  3. A recent medical publication concluded that, by the time the first symptoms of MS appear, the pathological process has probably been going on for many months or even years.
  4. Epidemiological studies show that only 5 to 8% of persons with MS have a family member with the disease.

The trial court held Sanofi liable for W’s MS, but on appeal the Cour d’appel insisted that the burden of providing persuasive evidence of causation (burden borne by the plaintiff, in Europe as here) had not been met.  France’s Cour de cassation (that country’s highest civil court) quashed the Appeal Court decision and remanded the case back to a different division of that court, on the grounds that the first division had not adequately considered the fact that W had been in excellent health, had had no MS family history, and had contracted his disease so soon after finishing the series of vaccinations.  On remand, however, a different Appeal Court repeated the reasons given earlier for denying any recovery to the plaintiff.  W’s estate appealed again, and this time the Cour de cassation referred the whole case to the European Court of Justice, in order to determine what Europe’s treaty had to say about the matter.

In a decision rendered on June 21, 2017, the European court seemed to side with the Cour de cassation and against the Courts of Appeal.  It noted that the European treaty doesn’t define “causal relationship,” and therefore that each country’s court system can develop its own reasonable theory of causation.   The European court asserted that modern science doesn’t have anything to say, positive or negative, about the link between the Hep B vaccine and MS.  Therefore, it concluded, the French high court was totally within its rights to conclude that the temporal link (post hoc) satisfied plaintiff’s burden of proof of causation (propter hoc). [Note:  it’s easier to read the European Court decision in the (obviously original) French version than in the very awkwardly translated English version.]

It’s very hard to know what to make of the European Court decision.  No study has linked any Hep B vaccine to MS — does that mean that science is silent on the matter?  No scientific study has proven that Michael Krauss’s watching the Washington Nationals has no effect on their success rate, for that matter  The European Court seems to imply that science is agnostic about this causal relationship, but is that an accurate reading?  If there is no theoretical reason to believe that the Hep B vaccine causes MS, and no studies causally linking the two, is it true that the science is “agnostic?”

A decade ago most researchers agreed that we needed to study vaccines in relation to autism. Some children apparently became autistic very soon after receiving the measles, mumps, and rubella (MMR) vaccine.  And generally, the number of vaccines children were receiving was increasing while at the same time the number of children who were being diagnosed with autism also was on the rise. Studies were conducted of children who received vaccines and those who didn’t, or who received them on a different, slower schedule. There was no difference in neurological outcomes. Researchers have also studied thimerosal, a mercury-based preservative, to see if it had any relation to autism. The results of studies are clear; the data show no relationship between vaccines and autism. After years of investigation, Dr. Andrew Wakefield, the London-based author of a highly publicized 1998 report that did connect autism and vaccines, was found to have acted unethically in the reporting of his results. Because of his report, fear had spread across the world, and many parents stopped vaccinating their children. At the same time, measles and other diseases such as mumps and pertussis (whooping cough), which were once on the decline, began to increase. In 2010, the General Medical Council in England declared that Wakefield’s paper that linked the MMR vaccine and autism, was not only based on bad science, but on deliberate fraud (immunize.org). Wakefield  lost his medical license.  How many unvaccinated children died?

It’s doubtful that the European Court of Justice’s decision will have any similar effect on administration of the Hep B vaccine.  Still, it is unsettling to see the burden of proof essentially reversed by the court.  I know parents who are convinced their child contracted autism from the MMR vaccine based solely on post hoc, ergo propter hoc.  And yet every single person who becomes autistic, or who contracts MS, likely had some unusual event happen to him or her shortly beforehand.  Unusual events happen every day.  That does not establish causation.

Remember my drunken and erratic driving?  How do we KNOW that you didn’t hear my tires squealing a mile away, and that those squeals didn’t trigger a panic attack that killed you?  We don’t, do we?  Science didn’t PROVE that my driving didn’t kill you, did it?  If we allow tort recovery in such cases, we essentially throw out the causation requirement in tort law.  Purchasers of the Sanofi vaccine have every reason to hope that Europe doesn’t go down that road.


This article was written by Michael I. Krauss from Forbes and was legally licensed through the NewsCred publisher network. Please direct all licensing questions to legal@newscred.com.

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