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CJEU: Clear evidence is sufficient in the event of vaccination damage
Luxembourg (jur). Product liability for pharmaceuticals is not limited to cases where there is clear medical evidence of consequential damage to health. "In the absence of scientific consensus", "clear and consistent evidence" may be sufficient, specifically the accumulation of damage after vaccination, judged on Wednesday, June 21, 2017, the European Court of Justice (ECJ) in Luxembourg (file number: C-62 / 15).
The verdict had been eagerly awaited by drug manufacturers across the EU in particular. With regard to vaccines, however, it can only be transferred to Germany to a limited extent because there is a liability regulated by social law for all publicly recommended vaccinations.
A patient in France had sued here. In 1998 and 1999 he received a total of three hepatitis B vaccinations. Symptoms appeared shortly after the last vaccination; it turned out to be multiple sclerosis. The man's health deteriorated rapidly, he died in 2011.
Family members continued the lawsuit against the vaccine manufacturer, Sanofi Pasteur MSD. They claim that multiple sclerosis was caused by the vaccine. The French courts initially dismissed the complaint. There is no scientific evidence for a link between vaccination and the disease.
In front of the Cassation Court in Paris, relatives claimed that vaccination should be assumed to be the cause of damage under French law if there is a close temporal connection and there is no family history. The deceased himself was completely healthy before the vaccination.
The Court of Cassation submitted the dispute to the CJEU.
He now confirmed that product defects "can be proven in the absence of scientific consensus 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 initially sufficient for the injured party. However, the manufacturer still has the opportunity to prove that the vaccine was not the cause of the secondary disease.
As justification, the ECJ referred to the aim of EU product liability law "a fair distribution of the risks associated with modern technical production between the injured party and the manufacturer". If only "reliable evidence based on medical research" would be allowed for medicinal products, this goal would be undermined and "claiming the manufacturer's liability would be overly difficult" or even completely excluded.
However, the CJEU emphasized that the evidence presented must be "sufficiently serious, clear and consistent" so that "the existence of a defect in the product, taking into account the evidence and arguments put forward by the manufacturer in its defense, is the most plausible explanation for the occurrence of the Damage appears ”.
In the specific case, there was no previous exposure in the victim's family, but there was a "significant number" of comparable illnesses after the vaccination. This could be sufficient as evidence. Finally, the French courts have to decide on this again.
In Germany, the Luxembourg judgment is mainly of interest for travel vaccinations, and it is also applicable to other medicinal products.
Vaccine damage after a generally recommended vaccination is compensated in Germany from a fund managed by the federal states, into which the manufacturers also pay. According to the case law of the Federal Social Court (BSG) in Kassel, the causal link between vaccination and harm also applies here to the “measure of probability”; waterproof medical and scientific evidence is not required (see BSG judgment of April 7, 2011, file number: B 9 VJ 1/10 R). mwo / fle