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SmithKline Sued Over Lyme Vaccine

Tuesday December 14, 6:36 pm ET


WEST CHESTER, Pa., Dec. 14 /PRNewswire/ -- 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.

The complaint, filed in Chester County Court of Common Pleas, alleges SmithKline Beecham, 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.

According to the class action, SmithKline 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.

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.

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.

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.

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.

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.

The class action complaint was filed by Stephen A. Sheller and Albert J. Brooks Jr. of Sheller, Ludwig & Badey in Philadelphia.

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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