Office of the Attorney General
Attorney General Greg Stumbo Announces 30-State Settlement with Bayer Corporation
Attorney General Greg Stumbo 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announced a settlement with Bayer Corporation over its marketing of Baycol, a drug used to lower cholesterol that was withdrawn from the market on August 7, 2001.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 is part of a 30-state consumer protection enforcement action initiated by the states' Attorneys General due to concerns that Bayer failed to adequately disclose important safety risks associated with Baycol.
The judgment, filed today in Franklin Circuit Court, 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. 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. Kentucky’s share is $200,000.
"This judgment provides critical public safeguards against an emerging threat," said Attorney General Stumbo. "Knowledge is power, especially when public health is at stake. It is vital that consumers be given clear and complete information regarding the potential effects of drugs so that they may make informed decisions about their treatment options. I am proud that my Office is part of this effort to require such important disclosures."
In May of 1998, Bayer introduced 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 or when combined with genfibrozil, another cholesterol-lowering drug.
The Attorneys General alleged that while Bayer informed the U.S. 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.
In addition to Kentucky, other Attorneys General participating in the settlement are from Arizona, Arkansas, California, Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Mississippi, Montana, Nevada, North Carolina, Ohio, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, and Wisconsin.