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From: " ilena rose " <ilena@...>

Sent: Wednesday, April 11, 2001 3:10 PM

Subject: Vaccine Leaves Some Recipients Crippled

http://www.classactionamerica.com/class_actions/case.asp?cid=642

Vaccine Leaves Some Recipients Crippled

Ý

A class action has been filed against GlaxoKline, the manufacturer of

the Lyme disease vaccine LYMErix, to recover for injuries suffered by

people who were given the vaccine and in response developed

" treatment-resistant Lyme arthritis " which is also called autoimmune

arthritis. Individuals who are HLA-DR4+, a genetic type that appears in

30% of the general population, are at risk for developing this condition.

Once this autoimmune reaction is triggered, it cannot be cured and can

only be treated symptomatically for the remainder of the person's life.

Autoimmune arthritis causes fatigue, pain and swelling in various joints,

and other arthritic and neurologic symptoms.

Since the federal Food and Drug Administration (FDA) approved the vaccine

on December 21, 1998, GlaxoKline has distributed 1.4 million doses

and as of November 2000 had received 984 reports of problems. An FDA

advisory committee held a public hearing on LYMErix in January, 2001 and

afterward criticized GlaxoKline's follow-up to adverse reaction

reports. During the hearing, 14 people told the committee they believed

the vaccine had turned gardeners, hunters and construction workers into

invalids.

The class action claims that GlaxoKline is liable because it (1)

failed to warn the public about the greatly increased risk to which the

vaccine exposes people who are HLA-DR4+, (2) failed to warn the public

that administration of the vaccine to individuals who were infected with

asymptomatic or early Lyme disease placed those individuals at risk for a

more progressive and enhanced Lyme disease than would have occurred if

they hadn't taken the vaccine, and (3) failed to acknowledge that periodic

booster shots would be necessary in order to maintain immunity to Lyme

disease.

The action asks the court to (1) create a trust fund, paid for by

GlaxoKline, to finance medical monitoring of people given the

vaccine, and to pay for the treatment of conditions resulting from the use

of the vaccine; and (2) prohibit GlaxoKline from further marketing of

LYMErix without prominently warning physicians and the general public that

(a) prospective recipients of the vaccine should be screened for their

HLA-DR4 status as well as the presence of asymptomatic or early Lyme

disease, and (B) periodic future booster shots of undetermined frequency

will be necessary to maintain immunity.

Some of the Victims

Ý

Marra wakes each morning with aching bones. The joints in her arms

and legs are so stiff that her husband often helps her out of bed. She

can't do routine chores, such as shopping and cooking. And playing with

her 10-year-old son is now a rarity. These severe pains began shortly

after Marra, 41, was given the new vaccine for Lyme disease. Her doctor

believes the LYMErix vaccine actually caused the kind of arthritic

symptoms it is supposed to prevent.

Pat Easton, 60, of Creek, Pa., said his wife, Carol Sue, 43, once

raced circles around him. But since she received the vaccine in 1999, his

wife has suffered severe joint pain and is losing her eyesight and mental

capabilities. " It is hard to lay in bed beside her, and to listen to the

whimpers as she tries to turn, " he said.

Schneider, 60 and an avid gardener in Poughkeepsie, N.Y.,

only wanted to help his fellow hobbyists when, in the spring of 1995, he

agreed to participate in a test of LYNErix prior to its approval. Six

weeks after he received his second shot, he lay paralyzed on his bedroom

floor, desperately in need of help himself. " I would just like to know

what the heck I have because I have always been very healthy, " says

Schneider, who experienced " fever and an intense, hellish pain, " that day

and for six weeks after. He continues to suffer from arthritis, numbness

and widespread tingling.

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