London: The highest court of the European Union ruled that courts can consider whether a vaccination led to someone developing an illness even when there is no scientific proof.
The decision was issued in relation to the case of a Frenchman known as J W, who was immunised against hepatitis B in late 1998-99.
After the case went to France’s Court of Cassation, it was brought to the European Union.
The EU’s top court said that despite the lack of scientific consensus on the issue, a vaccine could be considered defective if there is “specific and consistent evidence,” including the time between a vaccine’s administration, the 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.
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 rule on the specific French case.
Sanofi Pasteur did not immediately respond to requests for comment.
Some vaccine experts slammed the ruling, saying the court’s threshold for linking a vaccine to side effects is too low.
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 leukemia after eating a peanut butter sandwich,” he said.