Washington to receive $200,000
SEATTLE – Washington State Attorney General Rob McKenna today announced a $8 million, multi-state settlement with Bayer Corporation concerning its marketing of Baycol, a drug used to lower cholesterol that was withdrawn from the market more than six years ago.
"The states’ alleged that Bayer failed to adequately disclose safety risks associated with its cholesterol-lowering drug, Baycol," McKenna said. "Today’s suit requires Bayer to participate in a national clinical trial registry for experimental and recently approved drugs, so that key scientific information is available to pharmaceutical industry researchers and the government."
The judgment, filed Tuesday in King County Superior Court, requires Bayer to register most of its clinical studies and post results at the end of each study. The company must comply with laws concerning the marketing and sale of its pharmaceutical and biological products, and is prohibited from making false and misleading claims relating to any of its products sold in the United States.
The participating states will share $8 million. Washington will receive $200,000 of that amount.
Bayer introduced Baycol (cerivastatin sodium) to the U.S. market in May 1998. Like all statin drugs, it carried a known risk of myopathy (a weakening of the muscles) and rhabdomyolysis (a more serious muscular disease). After the product had been on the market, 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 U.S. Food and Drug Administration about these adverse effects, the company 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.
In addition to Washington, the following states participated in the settlement: Arizona, Arkansas, California, Connecticut, Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, and Wisconsin.
View complaint and consent decree
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Media Contacts: Bob Lipson, Assistant Attorney General, (206) 389-2513
Janelle Guthrie, Communications Director, (360) 586-0725