Some indicia vaccine damage for the first time recognized by the European Court of Justice

ECJ: Clear evidence is sufficient for a vaccine damage
Luxembourg (jur). Product liability for medicinal products is not limited to cases where there is clear medical evidence of consequential harm. "In the absence of scientific consensus" can also be "clear and consistent evidence" sufficient, such as the accumulation of damage after vaccination, judged on Wednesday, June 21, 2017, the European Court of Justice (ECJ) in Luxembourg (Ref .: C-62 / 15).

The verdict was particularly eagerly awaited by drug manufacturers across the EU. With regard to vaccines, however, it is only limitedly transferable to Germany, because there is a socially regulated liability for all publicly recommended vaccinations.

(Image: Richard Villalon / fotolia.com)

Here a patient in France had sued. In 1998 and 1999 he had received a total of three vaccinations against hepatitis B. Shortly after the last vaccination, complaints occurred; it turned out to be multiple sclerosis. The health of the man deteriorated rapidly, he died in 2011.

Family members continued the case against the manufacturer of the vaccine, Sanofi Pasteur MSD. They claim that multiple sclerosis was caused by the vaccine. The French courts initially dismissed the lawsuit. There is no scientific evidence for a link between the vaccine and the disease.

Before the Court of Cassation in Paris, the relatives claimed that, under French law, vaccination should be the cause of harm if there is a close temporal relationship and there is no family history. The deceased himself had been completely healthy before the vaccination.

The Court of Cassation submitted the dispute to the ECJ.

He now confirmed that product defects "in the absence of scientific consensus can be proved by a bundle of serious, clear and consistent evidence". The French rule of proof is therefore admissible in principle.

According to the Luxembourg judgment, such evidence leads to a reversal of the burden of proof. This means that the evidence is sufficient for the injured party first. For the manufacturer, however, there is still the possibility of own proof that here the vaccine could not have been the cause of the secondary disease.

In support of this, the ECJ referred to the objective of the EU product liability law "a fair distribution of the risks associated with modern technical production between the injured party and the manufacturer". If only medicinal proof based on medical research were allowed for medicinal products, that would undermine that aim and render 'the use of the manufacturer's liability excessively difficult' or even completely ruled out.

However, the ECJ underlined that the evidence provided must be "sufficiently serious, clear and consistent" that "the existence of a defect in the product, taking into account also the evidence and arguments put forward by the manufacturer in its defense, is the most plausible explanation for the occurrence of the product Damage appears ".

In the specific case, there had been no bias in the family of the victim, but there was a "significant number" of comparable diseases after vaccination. This could be sufficient as proof of circumstantial evidence. Finally, the French courts have to decide on that again.

In Germany, the Luxembourg judgment is mainly interesting for travel vaccinations, in addition, it is also transferable to other medicines.

In Germany, vaccine damage following a generally recommended vaccine is compensated by a fund managed by the countries in which the manufacturers also contribute. According to the case law of the Federal Social Court (BSG) in Kassel, the causal relationship between vaccination and harm is also the "yardstick of probability"; a watertight medical-scientific proof is not required (so BSG judgment of 7 April 2011, Az .: B 9 VJ 1/10 R). mwo / fle