Bayer's Legal Woes in U.S. Offer Lessons for Other Drug Makers
Bayer AG's U.S. legal battle regarding its cholesterol-lowering drug
Baycol has received more attention than any drug withdrawal since American
Home Products Corp., now known as Wyeth , pulled its weight-loss drug
cocktail Fen- Phen from the market in 1997.
(Dow Jones Newswires / September 12, 2003) -- Bayer's sale, withdrawal
and defense of Baycol holds lessons for other drug companies aiming
for the U.S. market, with its plaintiff-oriented legal system. The
saga underscores the problem of product liability when each "consumer" has
an individual -- and potentially risky -- reaction.
The Leverkusen , Germany , conglomerate withdrew Baycol , also known
as Lipobay , during August 2001 following a number of deaths linked
to the drug. The move almost crippled Bayer's drug business and forced
the company to step up efforts to find a pharmaceuticals partner
-- for which it is still searching.
Bayer shares slipped one European cent to €19.84 ($22.25) each
Thursday in Frankfurt, less than half the €47.24 level at which
the shares traded in August 2001, before the drug was pulled.
Two court victories earlier this year in Mississippi and Texas appear
to vindicate Bayer's defense that Baycol wasn't necessarily to blame
for the deaths, said Henning Blume , chief executive of pharmaceuticals-research
firm SocraTec R&D and professor of pharmaceuticals sciences at
Frankfurt 's Johann Wolfgang Goethe University . The victories also
signaled withdrawing the drug may not have been necessary.
Baycol belongs to a class of drugs called statins , used to prevent
coronary heart disease in patients with high cholesterol. All statins
carry the risk of rhabdomyolysis , a severe muscle reaction that
can be fatal in some cases, particularly when taken in combination
with another drug, gemfibrozil . It appeared that the risk for Baycol
patients was higher than for patients using other statins .
During 1999, Bayer added a label that warned doctors not to prescribe
the drug to patients taking gemfibrozil and warned that dosages should
begin at a low level and only gradually increase. During 2001, it
concluded Baycol "continued to be prescribed in ways that increased
safety concerns" and pulled the drug. Many of those who died had
been prescribed the drug in combination with gemfibrozil , and many
had been started on the highest dosage, against Bayer's recommendations. |
