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Lacamas Life Magazine
McKenna Announces $8
Million Settlement with Bayer Corporation
Washington to receive $200,000
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withdrawn from the market more than six years ago.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.
Click here to view complaint and decree
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