TALLAHASSEE – LAWFUEL – Attorney General Bill McCollum today announced that Florida and 29 additional states have reached an $8 million settlement with Bayer Corporation, resolving an investigation into the marketing of a drug to lower cholesterol. The settlement was part of a consumer protection enforcement action initiated over concerns that Bayer failed to adequately disclose safety risks associated with Baycol.
In May 1998, Bayer began marketing Baycol, a type of cholesterol-lowering drug known as a statin. Statins carry a known risk of myopathy, a weakening of the muscles, as well as a more serious muscular disease. Through post-marketing studies of its product, Bayer learned that the risk associated with Baycol was significantly higher compared to other statins, particularly at higher doses and when combined with another particular cholesterol-lowering drug. Baycol was withdrawn from the prescription drug market in August 2001.
The investigation, initiated by the states in 2004, alleged that while Bayer informed the U.S. Food and Drug Administration about these adverse effects, the company failed to adequately warn consumers.
“Manufacturers shouldn’t be allowed to hide medical information that doctors rely on to prescribe the correct medicine for their patients,”
McCollum said. “This could potentially harm our citizens and their safety is our priority.”
Today’s settlement requires Bayer to pay a total of $8 million to the 30 participating states. Florida’s share of the settlement funds is $200,000 and will reimburse taxpayers for the cost of the state’s investigation. The company must also register most of its clinical studies and then post the results at the end of each study. Bayer is requited to fully comply with the state laws regulating the marketing, sale and promotion of its pharmaceutical and biological products. The company is further prohibited from making false and misleading claims relating to any such product sold in the United States. The settlement, filed today in Broward County in the form of a consent judgment, is awaiting approval from a circuit judge.
In addition to Florida, participating states include Arizona, Arkansas, California, Connecticut, Delaware, Kansas, Kentucky, Idaho, Illinois, Iowa, Maine, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin.
A copy of the Bayer settlement is available at:
http://myfloridalegal.com/webfiles.nsf/WF/MRAY-6XQMZ3/$file/BayerConsentJudgment.pdf
