Vaccines can be deemed defective without scientific proof, EU court rules

The Court of Justice of the European Union ruled that EU national courts may link health problems with vaccines without scientific evidence.

The medical world has found no causal relationship between hepatitis B vaccines and nervous system diseases such as multiple sclerosis, but the Court of Justice of the European Union (CJEU) just rendered such scientific evidence unnecessary in confirming a link for EU courts.

The ruling (PDF) says that if a disease occurrence follows shortly after the vaccination in a patient with no personal and familial history of the condition, and if there exists “a significant number of reported cases,” EU national courts can consider it sufficient evidence to determine a vaccine defect.

The decision came from a French case involving Sanofi Pasteur’s HBV vaccine. A man identified as Mr. J.W. received the vaccine between late 1998 and mid-1999 and was diagnosed with multiple sclerosis in 2000. In 2006, he and his family brought lawsuits against the French vaccine maker, which were dismissed by France’s Court for Appeal based on the reasoning that there was no scientific consensus supporting the relationship.

After receiving an appeal, the French Court of Cassation sought CJEU’s interpretation of EU law.

In a statement, Sanofi Pasteur said “it is not our role to comment on this legal decision,” but did add that its HBV vaccines are safe and effective and have been marketed for more than three decades.

The CJEU decision only acts as a guidance for EU national courts instead of a ruling on this particular case, and leaves “freedom of assessment” to national courts on a case by case basis. Nonetheless, it received plenty of backlash from medical professionals.

“Using those criteria, you could reasonably make the case that someone should be compensated for developing leukemia after eating a peanut butter sandwich,” Paul Offit, M.D., a pediatrician and vaccine expert, chief of the infectious diseases at Children’s Hospital of Philadelphia, told the Associated Press.

The court also stressed that “national courts must ensure that the evidence adduced is sufficiently serious, specific and consistent to warrant the conclusion.” However, the ruling does lower the bar so a court won't have to rely on scientific analysis to rule a vaccine flawed.

While some vaccine naysayers cheered the CJEU decision on social media, many studies have debunked the theory of a link between HBV vaccination and nervous system diseases since it emerged in late 20th century, including those published in renowned scientific journals like the New England Journal of Medicine, Lancet, and the Journal of Neurology.

The CDC also makes it clear on its online vaccine safety page that hepatitis B vaccination doesn’t cause MS. “Hundreds of millions of people worldwide have received hepatitis B vaccine without developing MS or any other autoimmune disease,” the agency says, adding that with that large number of vaccinations, it does expect reports of MS happening after vaccination “by chance alone.”

Both the EMA and the U.S. FDA have systems where patients can directly report suspected adverse drug reactions. But only when those assertions are examined by clinical reviewers and a link is drawn will regulatory agencies take action, which is in very rare cases.