Maine in $8M settlement with Bayer

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PITTSBURGH (AP) – Maine and 29 other states have reached an $8 million settlement with Bayer Corp. over allegations the drug maker failed to adequately warn consumers about risks associated with a cholesterol-reducing drug.

The company allegedly learned after introducing Baycol in the U.S. in February 1998 that the drug posed significantly greater health risks than other similar drugs, particularly when taken in higher doses or in combination with another cholesterol-lowering drug, Pennsylvania Attorney General Tom Corbett said in a statement Tuesday.

Bayer informed the U.S. Food and Drug Administration about Baycol’s higher risks, but did not sufficiently warn consumers and doctors about potential problems such as a severe and potentially fatal muscle reaction that could cause kidney failure, Corbett said, citing a multistate investigation.

Nils Frederiksen, a spokesman for the attorney general’s office, said the company introduced the drug in February 1998 and filed a series of reports to the FDA about adverse reactions between March and May that year. Bayer voluntarily withdrew Baycol from the market in August 2001.

Bayer has not admitted any wrongdoing, but has agreed to register relevant clinical drug trials and drug studies and to post the results of those studies online.

The Pittsburgh-based company also is prohibited from making false or misleading claims in the future marketing, promotion and sale of its products. It must pay $8 million to the 30 states for future consumer protection and enforcement programs.

In addition to Maine and Pennsylvania, the settlement includes Arizona, Arkansas, California, Connecticut, Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nevada, North Carolina, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin.

Pennsylvania, Vermont, Oregon, Michigan and Connecticut each will receive $600,000 as part of the settlement. The other states will receive $200,000 each.

AP-ES-01-23-07 1552EST

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