Vermont Attorney General Sorrell Announces 30-State Settlement with Bayer Corporation

Bayer to Register and Post Clinical Trials and Pay $8 Million

January 23, 2007 - Vermont Attorney General William H. Sorrell 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announced a settlement with Bayer Corporation over its marketing of Baycol, a drug used to lower cholesterol that was withdrawn from the market on August 7, 2001.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 enforcement action relating to the Attorney Generals’ concerns that Bayer failed to adequately disclose safety risks associated with Baycol. The State of Vermont will receive $600,000 as a result of this settlement. The judgment, filed today in Washington Superior Court, requires Bayer to register most of its clinical studies and then post the results at the end of the study. The judgment also prohibits Bayer from making false and misleading claims relating to any of its pharmaceutical or biological product sold in the United States. Bayer is further required to pay the 30 states $8 million to settle the Attorney Generals’ concerns.

“Doctors and patients rely on pharmaceutical companies to provide accurate information about their products in a timely fashion, and when information about increased risks is not adequately disclosed, patients can be hurt,” said Attorney General William H. Sorrell. “This settlement demonstrates that the Attorneys General will be vigilant in ensuring that pharmaceutical companies come clean about their products.”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.

The Vermont Attorney General served on the executive committee of this investigation, along with the Attorneys General of Connecticut, Michigan, Oregon and Pennsylvania. Because of its leadership role in this case, Vermont will receive $600,000 from the settlement fund. Other Attorneys General participating in the settlement are from the States and Commonwealths of Arizona, Arkansas, California, Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Mississippi, Montana, Nevada, North Carolina, Ohio, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, and Wisconsin.

Source: Vermont Attorney General's Office