US
MEDIA BLACKOUT MERCURY VACCINES
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 (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 has appealed the Court’s decision, but that appeal will likely
take several years, and its outcome is uncertain.
Rimini: 2012
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.
