When Merck & Co. pulled its painkiller Vioxx from the
market in September, it said it was acting because a
clinical trial had shown that users were at increased
risk of heart attacks or strokes after 18 months.
That conclusion, and how it was reached, are the
central issues for Merck in defending itself against
a wave of lawsuits -- 575 as of the company's latest
count, representing about 1,400 Vioxx users -
accusing the company of negligence. The suits could
start being heard in courtrooms as soon as May.
Previously undisclosed company records, which were
reviewed by The Wall Street Journal, are casting
light on the coming legal battles. The records, which plaintiffs' attorneys have, show that the external
committee charged with monitoring the drug's safety
in the clinical trial had early data suggesting that
users could be at increased risk of certain heart
problems after as little as four months. Notes from
committee meetings show that members were watching
the "concerning nature of the trends" about Vioxx's
possible effects on heart attacks and strokes from
their first meeting. The records also show that the
committee of five included one Merck employee and two
doctors who had done consulting work for the company.
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