Like the U.S., Italy has a national vaccine injury compensation program to give some financial support to those people who are injured by compulsory and recommended vaccinations. The Italian infant plaintiff received three doses of GlaxoSmithKline’s Infanrix Hexa, a hexavalent vaccine administered in the first year of life. These doses occurred from March to October 2006. The vaccine is to protect children from polio, diphtheria, tetanus, hepatitis B, pertussis and Haemophilus influenza type B. In addition to these antigens, however, the vaccine then contained thimerosal, the mercury-containing preservative, aluminum, an adjuvant, as well as other toxic ingredients. The child regressed into autism shortly after receiving the three doses. When the parents presented their claim for compensation first to the Ministry of Health, as they were required to do, the Ministry rejected it. Therefore, the family sued the Ministry in a court of general jurisdiction, an option which does not exist in the same form in the U.S.
Based on expert medical testimony, the court concluded that the child more likely than not suffered autism and brain damage because of the neurotoxic mercury, aluminum and his particular susceptibility from a genetic mutation. The Court also noted that Infanrix Hexa contained thimerosal, now banned in Italy because of its neurotoxicity, “in concentrations greatly exceeding the maximum recommended levels for infants weighing only a few kilograms.”
Presiding Judge Nicola Di Leo considered another piece of damning evidence: a 1271-page confidential GlaxoSmithKline report (now available on the Internet). This industry document provided ample evidence of adverse events from the vaccine, including five known cases of autism resulting from the vaccine’s administration during its clinical trials (see table at page 626, excerpt below).
As in many other developed countries, government, not industry, compensates families in the event of vaccine injury. Thus GSK’s apparent lack of concern for the vaccine’s adverse effects is notable and perhaps not surprising. In the final assessment, the report states that “[t]he benefit/risk profile of Infanrix hexa continues to be favourable,” despite GSK’s acknowledgement that the vaccine causes side effects including “anaemia haemolytic autoimmune,thrombocytopenia, thrombocytopenic purpura, autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura, haemolytic anemia, cyanosis, injection site nodule, abcess and injection site abscess, Kawasaki’s disease, important neurological events (including encephalitis and encephalopathy), Henoch-Schonlein purpura, petechiae, purpura, haematochezia, allergic reactions (including anaphylactic and anaphylactoid reactions),” and death (see page 9).
The Milan decision is sober, informed and well-reasoned. The Ministry of Health has stated that it hasappealed the Court’s decision, but that appeal will likely take several years, and its outcome is uncertain.
Two years earlier, on May 23, 2012, Judge Lucio Ardigo of an Italian court in Rimini presided over a similar judgment, finding that a different vaccine, the Measles-Mumps-Rubella vaccine (MMR), had caused a child’s autism. (See: Italian MMR Remini decision 2012)As in the Milan case, the Ministry of Health’s compensation program had denied compensation to the family, yet after a presentation of medical evidence, a court granted compensation. There, too, the Italian press covered the story; the U.S. press did not.
In that case, a 15-month old boy received his MMR vaccine on March 26, 2004. He then immediately developed bowel and eating problems and received an autism diagnosis with cognitive delay within a year. The court found that the boy had “been damaged by irreversible complications due to vaccination (with trivalent MMR).” The decision flew in the face of the conventional mainstream medical wisdom that an MMR-autism link has been “debunked.”
Both these Italian court decisions break new ground in the roiling debate over vaccines and autism. These courts, like all courts, are intended to function as impartial, unbiased decision makers. The courts’ decisions are striking because they not only find a vaccine-autism causal link, but they also overrule the decisions of Italy’s Ministry of Health. And taken together, the court decisions found that both the MMR and a hexavalent thimerosal- and aluminum-containing vaccine can trigger autism.
These court decisions flatly contradict the decisions from the so-called U.S. vaccine court, the Court of Federal Claim’s Vaccine Injury Compensation Program. There, from 2007 to 2010, in the Omnibus Autism Proceeding, three decision makers, called Special Masters, found that vaccines did not cause autism in any of the six test cases, and one Special Master even went so far as to compare the theory of vaccine-induced autism to Lewis Carroll’s Alice in Wonderland. The Italian court decisions contrast starkly with these U.S. cases based on similar claims.
How do we reconcile the difference between the U.S. and Italian decisions in similar cases? What’s different about Italy? Well, there may be many differences, but a critical one is that in the U.S., if someone loses in the government vaccine injury compensation program, she cannot sue the government in civil court; she can sue only the manufacturer. In the U.S., her family would have to shoulder legal fees in a David and Goliath mismatch, pitting a global pharmaceutical behemoth against a family likely already suffering financially from serious health costs.
Furthermore, since 2011, the U.S. Supreme Court has foreclosed potential cases and class action lawsuits to contest unreasonably dangerous vaccine designs, such as the use of thimerosal as a preservative or the simultaneous administration of multiple live viruses, such as the MMR. Since the Supreme Court’s 2011Bruesewitz v. Wyeth decision, no court in the U.S. can entertain vaccine design defect claims, the most likely legal actions to aggregate plaintiffs in similar circumstances against large, pharmaceutical defendants.
Unlike American victims of vaccine injury, the Italian plaintiffs didn’t have to sue GSK; they sued the Ministry of Health. In both the Milan and Rimini decisions, the plaintiffs won compensation based on findings that vaccines caused autism. One might say that these cases achieved nothing more than a small payout for injured children. But arguably the families, lawyers and medical experts behind these cases achieved far more. They took the issue of vaccine-induced autism to impartial courts, and they got clear a clear judicial answer based on the evidence: vaccines cause autism.
Are court decisions science? Of course not. There is a desperate need for more science on autism and the role that vaccines play, flimsy industry, medical and government retorts to the contrary notwithstanding. But in the current absence of the necessary science on vaccines and autism, decisions of impartial judicial tribunals, based on extensive evidence and testimony, may be some of the best sources of information and insight we have.
Mary S. Holland is a Research Scholar at the NYU School of Law and chairs the advisory board of the non-profit organization Health Choice.