The decision was issued in relation to the case of a Frenchman known as Mr J.W., who was immunised against hepatitis B in late 1998 – 99 and developed multiple sclerosis a year later. In 2006, he and his family sued vaccine-maker Sanofi Pasteur in an attempt to be compensated for the damages they claim he suffered due to the vaccine. In 2011, Mr J. W. passed away.
France's Court of Appeal ruled there was no causal link between the hepatitis B vaccine and multiple sclerosis, dismissing the case. Numerous studies also found no relationship between the hepatitis B shot and multiple sclerosis (MS).
The case then went on to France's Court of Cassation before it was brought to the European Union.
Sanofi ensures that its vaccines are safe and effective
The EU's top court explained its decision that despite the lack of scientific consensus on the issue, a vaccine could be considered defective if there was "specific and consistent evidence," including the time between a vaccine's administration and the onset of a disease, an individual's prior 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 ̶ Mr J.W.'s case referred to the first three criteria.
In a statement, the court said that such factors could lead a national court to conclude that "the administering of the vaccine is the most plausible explanation" for the disease and that "the vaccine therefore does not offer the safety that one is entitled to expect." It did not provide verdict on the specific French case.
Sanofi Pasteur responded that its vaccines are "safe and effective and protect against infectious diseases," noting that the company's hepatitis B vaccines were well-tolerated.
"They have been approved by health authorities and (have been) marketed for more than 30 years," it said.
Vaccine experts slam ruling and criticise court's reasoning
Some vaccine experts have slammed the ruling, saying the court's reasoning for associating a vaccine to side effects was unreasonable.
Professor Tony Fox from the pharmaceutical medicine group at King's College London said that the EU court is authorising national court to make such judgments about causality themselves; based on evidence they are presented with, without reliance on expert opinion.
Drawing Mr J.W.'s case as an example, Keith Neal, emeritus professor in the epidemiology of infectious diseases at the University of Nottingham said, "What they are saying is, the vaccine is responsible for the patient's MS if it can't be proved it isn't, and that is virtually impossible given what is worded. Potentially, this ruling affects all drugs and threatens the development of new drugs."
Peter Openshaw, president of the British Society for Immunology and professor of experimental medicine at Imperial College London supported Neal, saying that it is illogical and confusing to the public to state that there is a link between any vaccine and multiple sclerosis and at the same time admit that there is no scientific evidence of such link.
Anti-vaccination supporters can bolster their campaign again
Dr. Paul Offit, a paediatrician and vaccines expert at the University of Pennsylvania, said the criteria used by the court made no sense — and are similar to those used by vaccine injury compensation programs in the United States.
“Using those criteria, you could reasonably make the case that someone should be compensated for developing leukaemia after eating a peanut butter sandwich,” he said. He further added that courts should not be trusted to make rulings about scientific evidence.
"The only alleged evidence that would be worth taking seriously is the alleged numbers of other similar cases," Fox said. "Those data should be capable of detailed case comparisons for consistency, and probably also orthodox epidemiological study."
But without such a study, Fox added, "one might just as well say, 'if this vaccine causes MS, then why is it that millions of people have been vaccinated and did not get MS? And why are there so many people with MS who have never had this vaccination?' "
Anti-vaccination supporters now have another court judgment to bolster their campaign against vaccines. Offit said the court's decision was extremely concerning and hoped it wouldn't spur more people to reject vaccines.
“Vaccines save lives and people who choose not to vaccinate their children are putting those children at risk,” he said. “To prove whether one thing causes another has to happen in a scientific venue, and the courts are not a scientific venue,” he added. MIMS
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