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No science needed to blame vaccines for illness, EU court rules
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The European Union Court of Justice has ruled that illnesses can be attributed to vaccines during litigation without scientific proof.
The judges decided that factors falling short of scientific research, but that may suggest a link, can be enough to rule against a vaccine manufacturer. In particular, they said prior rulings on similar cases allow courts to lay blame on a vaccine if the illness occurred near the time of vaccination, the plaintiff was healthy before vaccination and there is no history of the illness in the plaintiff’s family.
Such factors, the judges wrote, “constitute serious, specific and consistent presumptions capable of proving the defect in the vaccine and the existence of a causal relationship between it and the disease in question, notwithstanding the finding that medical research does not establish a relationship between the vaccine and the occurrence of the disease.”
The case stems from a lawsuit brought against Sanofi Pasteur by the family of a man diagnosed with multiple sclerosis about a year and a half after finishing a hepatitis B virus vaccine regimen.
The man, referred to as “Mr. W” in court records, received three injections of the vaccine between December 1998 and July 1999. He allegedly began having health problems the month after the final injection and was diagnosed with MS in November 2000. Mr. W’s health deteriorated until his death in October 2011.
Family members sued Sanofi Pasteur in 2006, implicating the vaccine in the man’s illness and seeking compensation.
The case eventually made its way in the appeals process to the Court of Appeal in Paris. That court ruled against Mr. W’s family, concluding there was no proven link between the vaccine and his disease. The judges in part cited a study showing that the early symptoms of MS likely start many months or years after the disease process actually begins, and that other studies showed 92% to 95% of patients with MS have no family history of the disease. The case was appealed to the EU Court of Justice, which overturned the Paris court’s ruling.
The hurdles for plaintiffs to establish a link between illnesses and vaccines in the United States are no higher than in the EU, although there is a rationale behind that, according to Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
He said plaintiffs bringing cases against vaccine manufacturers are compensated through the U.S. Vaccine Injury Compensation Program, a mechanism under HHS and created to prevent vaccine manufacturers from being overwhelmed by lawsuits.
A plaintiff can file a petition with the U.S. Court of Federal Claims, which appoints a special master to decide on possible compensation, often following a hearing. Compensation comes from a pool of funds collected through an excise tax on vaccines. Even if the court does not find that a vaccine truly caused harm, settlements can be made, HHS acknowledges on its website.
Offit said the burden of proof is not particularly heavy.
“One, as a plaintiff, you have to show that there was a temporal association within a reasonable period of time … and that you developed signs and symptoms of a particular disease,” he told Infectious Disease News. “Number two is you have to provide a reasonable explanation for how those two things could have been causally associated. You don’t have to have any epidemiological proof.”
Offit explained that even Mr. W’s case would seem familiar in a U.S. court.
“The Vaccine Injury Compensation Program has compensated people who have received the hepatitis B vaccine and claimed it caused multiple sclerosis when there are data showing that the vaccine neither causes nor exacerbates symptoms of multiple sclerosis,” he said.
Although it may sidestep science, Offit said, the program has shielded a vital industry that was once in peril.
“The reason for the program is that we almost lost vaccines in the early and mid-1980s,” he said. “Then, we didn’t have the program, and you could go right to civil court and make your claim. It got to the point where we almost lost vaccine manufacturing. The vaccine court stopped the bleeding.”
Nonetheless, Offit acknowledged that cases like those in U.S. and EU courts can embolden vaccine opponents.
“Will it do harm?” he mused. “I think the antivaccine people can use this to say, ‘Look, billions of dollars have been awarded for harm caused by vaccines. Why would they do that unless the vaccines really caused harm?’ The answer is that courts are not a place to determine scientific truths. The courts are a place to settle disputes.” – by Joe Green
Disclosure: Offit reports no relevant financial disclosures.