Dr. Rath Health Foundation

Dr. Rath Health Foundation

Responsibility for a healthy world Dr. Rath Research Institute 100+ Studies Published In PubMed

The Baycol / Lipobay - Scandal

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.