A VIOXX COMEBACK COULD TILT BALANCE IN MERCK LITIGATION

The possibility that Vioxx may once again be offered
to patients raises a provocative question: Did Merck
& Co. err by pulling its $2.5 billion painkiller off
the market? Critics had raised safety issues about
Vioxx for years, but it wasn't until late last year
that the company acknowledged a heart-safety problem.
Merck withdrew Vioxx from the global market September
30 after a clinical trial it undertook showed that
patients taking it daily for 18 months had double the
risk of heart attacks or strokes as patients who took
placebos. The withdrawal invigorated attorneys who
have filed hundreds of liability suits against the
company; they saw the move as an admission that the
drug was harmful. In December came another bombshell:
A clinical trial of Vioxx competitor Celebrex, made
by Pfizer Inc., also found increased cardiovascular
risk. The two events together strengthened the case
for what was becoming a widespread view: that Vioxx,
Celebrex and other so-called Cox-2 drugs shared a
mechanism that contributed to heart attacks and
strokes. Then a panel of medical experts convened by
the Food and Drug Administration voted 17 to 15 that
Vioxx could be sold at least to certain patients,
albeit with a strong warning label and other
restrictions. Now, with Merck considering putting
Vioxx back on the market, the dynamics of the
litigation are poised to change. "Merck can look like
they were super-cautious," said David A. Logan, dean
of Roger Williams University School of Law in
Bristol, R.I. "And when the FDA gives the yellow
light to put the drug back on the market, they come
out like such great public servants. That's a really
nice dynamic in front of a jury," said Prof. Logan,
who has taught torts and product liability for two
decades.
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