The Problem With Proving Vaccine Injury Claims – Lessons From the European Union

By Mark T. Sadaka, Esq., MSPH
ecj-eu-vaccine-rulingThe highest court of the European Union ruled that a court can decide that hepatitis B vaccine caused multiple sclerosis even when scientists disagree that it is possible.

The European Court of Justice’s ruling was related to a case in France, where a man claimed that a hepatitis B vaccine caused him to develop multiple sclerosis. The man’s family claims that after receiving three injections of a hepatitis b vaccine between December 1998 and July 2000, the man was soon after diagnosed with multiple sclerosis. He was then declared unfit to work in 2001 and eventually passed away in 2011.

In 2006, the man’s family filed a suit against the maker of the vaccine, Sanofi-Pasteur, alleging that the vaccine directly contributed to his multiple sclerosis. The family claims that the fact that the MS symptoms began almost immediately following the final booster shot proves that the disease was caused by the vaccine.

A lower French court ruled in the family’s favor in 2009 and it was appealed. France’s Court of Appeal overturned the lower court’s ruling and ruled that there was no causal link between hepatitis B vaccine and multiple sclerosis. The case finally ended up before the French equivalent of the Supreme Court (Court of Cassation) where they asked for the European Union’s guidance on what kind of scientific evidence can be used to show that hepatitis B vaccine can cause multiple sclerosis.

The EU’s top court said that a vaccine could be considered defective despite overwhelming direct scientific evidence showing that hepatitis B vaccine does not cause multiple sclerosis.  A court can also use circumstantial evidence to find that a vaccine can cause a specific injury.

What does it all mean? The example of the exploding T.V.

Imagine you are sitting in front of your brand new T.V. watching Game of Thrones and your T.V. suddenly catches fire. Unfortunately, you were sitting too close to the T.V. and the sudden fire causes severe burns to your popcorn hand.  You decide to sue the T.V. manufacturer because a brand new T.V. is not supposed to burst into flames.

The T.V. was destroyed in the fire so it is impossible for you to use direct evidence to prove that the T.V. was defective.  Under the EU ruling you can now use circumstantial evidence to prove that the T.V. was defective, like the fact it was new and had no problems prior to bursting into flames.

Want more? Circumstantial v. Direct Evidence: The Problem With Proving Vaccine Injury Claims

First a little bit of boring legalese.

All lawsuits are disputes over facts

Whether it is a vaccine injury claim or a contract dispute, all cases come down to a dispute over facts.  It is the job of the fact finder to decide what facts are supported by the evidence.  In the United States the fact finder is typically a judge or a jury.

A judge or a jury will listen to direct and circumstantial evidence presented by both sides and decide who wins.

What is direct evidence

Direct evidence proves a fact directly.  Examples of direct evidence would include the testimony of an expert directly linking a vaccine to the injury or eyewitness testimony where the witness describes what he saw, heard, or experienced.

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What is circumstantial evidence

Circumstantial evidence does not point directly to a fact.  Circumstantial evidence includes the timing between a vaccine’s administration and the onset of a disease, an individual’s previous state of health, the lack of any family history of the disease and a significant number of reported cases of the disease occurring following vaccination.

The issue

Can the French court consider both direct and circumstantial evidence when

deciding the role of the hepatitis B vaccine in causing a man’s multiple sclerosis?

Sanofi-Pasteur wants courts to only consider direct scientific evidence when deciding whether hepatitis B vaccine can cause MS.

Injured people want courts to consider both direct scientific evidence AND circumstantial evidence when deciding whether hepatitis B vaccine can cause MS.

Traditionally, courts in the United States and Europe have required a person claiming that they were injured by a product to provide direct evidence as to how the product injured them. Evidence traditionally used by courts include testimony as to how the product injured them and having an expert testify that a defect in the product caused their injury.

However, courts in European Union have joined some U.S. states by recognizing that a person injured by a product can sometimes use circumstantial evidence when they are unable to identify a specific defect in the product that caused the injury.

Scientists concern over the EU ruling is unwarranted

Scientists are worried that the EU vaccine ruling could open up vaccine manufacturers to more liability lawsuits and could force them to pay compensation despite a lack of direct evidence linking a vaccine to a specific illness.

Point 1: Direct scientific evidence favors vaccine manufacturers like Sanofi-Pasteur   

Courts must still consider all the relevant direct scientific evidence supporting that the vaccine cannot cause a specific injury, such as multiple sclerosis.

There is simply no question that there is a significant amount of direct scientific evidence that supports Sanofi-Pasteur’s claim that hepatitis B DOES NOT cause multiple sclerosis.  The vaccine manufacturer was allowed to present such evidence to the French court to defend itself.

The sheer amount of credible scientific evidence showing that the vaccine is safe will generally always win the case.

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Point 2:  There is direct scientific evidence that supports that hepatitis B can cause multiple sclerosis

The idea that hepatitis B vaccine can cause multiple sclerosis is not crazy or even scientifically unfounded.  It is NOT widely accepted by the medical community, but it has some scientific support that stems from a sharp increase in MS cases in people who received the hepatitis B vaccine.

  • Le Houezec, D. (2014). “Evolution of multiple sclerosis in France since the beginning of hepatitis B vaccination.” Immunol Res 60(2-3): 219-225.
    Since the implementation of the mass vaccination campaign against hepatitis B in France, the appearance of multiple sclerosis, sometimes occurring in the aftermath of vaccinations, led to the publication of epidemiological international studies. This was also justified by the sharp increase in the annual incidence of multiple sclerosis reported to the French health insurance in the mid-1990s. Almost 20 years later, a retrospective reflection can be sketched from these official data and also from the national pharmacovigilance agency. Statistical data from these latter sources seem to show a significant correlation between the number of hepatitis B vaccinations performed and the declaration to the pharmacovigilance of multiple sclerosis occurring between 1 and 2 years later. The application of the Hill’s criteria to these data indicates that the correlation between hepatitis B vaccine and multiple sclerosis may be causal.

Point 3:  Law is not science and science is not law (thank goodness)

No scientific fact is to be considered an absolute truth.  This is the core philosophy of the scientific method. 

The result of this case allows a French judge to weigh all the evidence before deciding whether the vaccine manufacturer or the injured person wins.  What is wrong with that really?  To think otherwise is unscientific.

The French judge who decided that hepatitis B vaccine caused a man’s multiple sclerosis is charged under French law to weigh the evidence and decide the facts.  That judge undoubtedly heard countless experts from Sanofi-Pasteur describe the huge amount of safety data yet still decided that hepatitis B caused multiple sclerosis in this particular case.

Why is that wrong? What do you think?

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