KING OF PRUSSIA, Pa., Dec. 23 /PRNewswire/ -- Responding to a Lyme disease
 vaccine class action brought against it last week, SmithKline Beecham
 (NYSE:   SBH) Spokesman Brian Jones said none of the theories used as the basis
 for allegations in the lawsuit is new to SmithKline, the medical community or
 the FDA.
     News of the class action filed in West Chester, Pa., was first reported by
 Mealey Publications' Drug & Medical Device report.
     The lawsuit claims the vaccine developed to prevent Lyme disease causes an
 incurable form of autoimmune arthritis and, for some, could produce symptoms
 far worse than those brought on by the illness.
     The complaint, filed in the Chester County Court of Common Pleas, alleges
 SmithKline Beecham, manufacturer of LYMErix, failed to warn doctors and the
 general public that nearly 30 percent of the population is predisposed to a
 degenerative autoimmune syndrome which is triggered by contents of the
 inoculation.
     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 blood stream 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.
     "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.
     Jones said the alleged association between the OspA protein and arthritis
 had been hypothesized when LYMErix was being developed.  However, at the
 conclusion of pre-market trials for the vaccine, an independent medical review
 board determined there was no link between LYMErix and the development of
 autoimmune arthritis, he said.
     Jones added that among those who participated in clinical trials for the
 vaccine, an equal number of participants were diagnosed as suffering from
 autoimmune arthritis in both the vaccine and placebo groups.
     And since the vaccine was approved, SmithKline has not been made aware of
 any unusual side effects suffered by the more than 1 million Americans who
 have been inoculated with LYMErix, Jones said.
     "There is simply no evidence of this association," he said.  "As such, we
 will defend our product vigorously."
     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 people who received the LYMErix vaccine and are now
 suffering from the autoimmune arthritis.
     Complete coverage of the lawsuit will appear in the Jan. 7 issue of
 Mealey's Litigation Report: Drugs & Medical Devices.  Information:
 1-800-MEALEYS; 610-768-7800 or news@mealeys.com or www.mealeys.com
     In addition to drug and medical device issues, Mealey's publishes
 litigation newsletters on construction defect litigation; asbestos; attorney
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 fraud, insurance insolvency; latex, patents and intellectual property; managed
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 Information:  1-800-MEALEYS or 610-768-7800.
     Mealey's also sponsors continuing legal education (CLE) conferences on
 many of these same topics.  Upcoming seminars include:  Insurance Allocation,
 Jan. 13-14 in West Palm Beach, Fla.; Insurance Bad Faith, Jan. 27-28 in
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SOURCE  Mealey Publications, Inc.

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