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Wisconsin to Receive $200,000
MADISON - Attorney General J.B. Von Hollen today announced a settlement with Bayer Corporation over its marketing of BaycolВ, a drug used to lower cholesterol that was withdrawn from the market on August 7, 2001.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 BaycolВ.
"Wisconsin consumers have the right to full disclosure about risks associated with the use of pharmaceutical medications so that the personal health care choices consumers make are fully informed," Van Hollen said. "This settlement promotes informed decision-making by making readily available and understandable the results of clinical studies, thus enabling individuals to weigh intelligently the benefits and risks associated with medical treatment options."
The judgment, filed today in Dane County 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.
In its complaint, the State of Wisconsin alleged that Bayer failed to adequately warn prescribers and consumers about the potential adverse effects of BaycolВ, a cholesterol-lowering prescription drug. These adverse effects included increased risks of myopathy (a weakening of the muscles) and rhabdomyolysis (a more serious muscular disease).
Initially approved for prescription use by the FDA in 1997, Bayer voluntarily withdrew BaycolВ from the market in August 2001.
In the consent judgment filed today with the Dane County Circuit Court, Bayer denies any violation of the law or wrongdoing.
The states' executive committee consisted of the attorneys general of Connecticut, Michigan, Oregon, Pennsylvania, and Vermont. 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.