On September 23, 2014, an Italian court in Milan award compensation to a boy for vaccine-induced autism. (See the Italian document here.) A childhood vaccine against six childhood diseases caused the boy’s permanent autism and brain damage. While the Italian press has devoted considerable attention to this decision and its public health implications, the U.S. press has been silent.
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.
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.
The Milan decision is sober, informed and well-reasoned. The Ministry of Health has stated that it has appealed the Court’s decision, but that appeal will likely take several years, and its outcome is uncertain.
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