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- WEST CHESTER, Pa.
- A class action lawsuit filed today in Pennsylvania claims the vaccine
that prevents Lyme Disease causes an incurable form of autoimmune arthritis
and, for some, could produce symptoms far worse than those brought on by
the illness. ``Mealey's Litigation Report: Drug and Medical Devices'' informed
subscribers about the complaint today.
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- The complaint, filed in Chester County Court of Common
Pleas, alleges SmithKline Beecham (NYSE: SBH - news), manufacturers of
the widely touted LYMErix vaccine, failed to warn doctors and the general
public that nearly 30 percent of the population was pre-disposed to a degenerative
autoimmune syndrome, which the lawsuit says is triggered by contents of
the inoculation.
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- ``Once this autoimmune reaction is triggered, it cannot
be cured and can only be treated symptomatically for the remainder of the
vaccine recipient's life,'' the complaint says.
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- According to the class action, SmithKline (SBH) used
high concentrations of a surface protein called OspA as the foundation
for its vaccine. When bitten by a Lyme infected parasite, humans are not
exposed to OspA protein. The levels of OspA that enter the bloodstream
at any phase of the three-dose LYMErix vaccine, however, place patients
classified by genetic type HLA-DR4+ at risk of developing a condition referred
to as ``treatment-resistant'' Lyme Arthritis, the lawsuit says.
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- Despite this ``well documented relationship'' between
OspA and treatment-resistant Lyme Arthritis, SmithKline neglected to include
the information in its widely disseminated promotional literature and insisted
LYMErix was safe and generally well tolerated, the class action says.
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- About one-third of the general population is HLA-DR4+
and risks contracting the arthritic condition when exposed to the vaccine,
according to the complaint. The HLA-DR4+ trait is easily detected by a
routine blood test; however, SmithKline never recommended that doctors
screen for the trait before administering the vaccine, the lawsuit alleges.
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- The complaint further alleges that patients who are infected
with Lyme bacteria when they receive LYMErix -- whether asymptomatic or
in the early stages of infection -- could suffer symptoms more progressive
and enhanced than if they had not received the vaccine.
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- SmithKline, the class action says, also neglected to
inform doctors and the general public that periodic booster shots beyond
the series of three vaccinations would be necessary to maintain immunity
to the disease.
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- The class action includes counts of negligence, unfair
trade practices and a bid for medical monitoring of those who are placed
at risk of developing autoimmune arthritis but have not yet been diagnosed
with the condition.
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- The class action complaint was filed by Stephen A. Sheller
and Albert J. Brooks Jr. of Sheller, Ludwig & Badey in Philadelphia.
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- Sheller said that in the wake of filing the class action,
he expects to file claims on behalf of individuals who received the LYMErix
vaccine and are now suffering from the autoimmune arthritis.
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