Attorney General Long Announces 30-State Settlement with Bayer Corporation; Bayer to Register and Post Results of Clinical Trials and Pay $8 Million
PIERRE, S.D. - Attorney General Larry Long today announced a settlement with Bayer Corporation over its marketing of Baycol, a drug used to lower cholesterol that was withdrawn from the market on August 7, 2001. The settlement was part of a 30-state consumer protection enforcement action initiated by the states' Attorneys General due to concerns that Bayer failed to adequately disclose safety risks associated with Baycol.
The judgment requires Bayer to register most of its clinical studies and then post the results at the end of each study. The judgment also demands Bayer's future compliance with the law in the marketing, sale, and promotion of its pharmaceutical and biological products, and prohibits Bayer from making false and misleading claims relating to any such product sold in the United States. Significantly, the judgment further requires that Bayer pay a total of $8 million to the 30 participating states to settle the concerns of those states' Attorneys General.
In May of 1998, Bayer introduced into the United States market Baycol, a "statin" cholesterol-lowering drug. All statins carry a known risk of myopathy (a weakening of the muscles) and rhabdomyolysis (a more serious muscular disease). Through post-marketing surveillance of its product, Bayer learned that the risk for Baycol turned out to be significantly higher compared to other statins, particularly at higher doses and when combined with genfibrozil, another cholesterol-lowering drug. The Attorneys General allege that while Bayer informed the US Food and Drug Administration about these adverse effects, Bayer failed to adequately warn prescribers and consumers about them. While Bayer denies any wrongdoing in the judgment, on August 7, 2001, Bayer voluntarily withdrew Baycol from the market. If you need additional information about this settlement contact Sara Rabern at (605)773-3215.