California Attorney General Jerry Brown has reached an $8 million, 30-state settlement with Bayer Corp. that will resolve an enforcement action initiated because of Bayer’s failure to adequately disclose safety risks associated with the use of Baycol, a drug used to lower cholesterol that was pulled from the market in August 2001.
“This settlement is important because it establishes an obligation on pharmaceutical companies to inform the public and physicians about the tests they conduct on products” Brown said. “Posting both the positive and negative results from studies, will allow medical professionals to make better and safer prescribing decisions for their patients.”
The judgment, filed in San Diego Superior Court, requires Bayer to publicly register most of its clinical studies and post the results at the end of each study. It also requires future marketing, sale, and promotion of its pharmaceutical and biological products to comply will all legal requirements, and prohibits Bayer from making false or misleading claims relating to any of these products sold in the United States.
In May 1998, Bayer introduced Baycol, a statin cholesterol-lowering drug, into the United States market. All statins carry a known risk of myopathy (a weakening of the muscles) and rhabdomyolysis (a more serious muscular disease). Bayer learned the risk of Baycol was significantly higher than other statins, especially at higher doses and when combined with genfibrozil (another cholesterol-lowering drug), through post-marketing surveillance of its product. In August 2001 Bayer voluntarily withdrew Baycol from the market.
The Attorneys General allege while Bayer informed the U.S. Food and Drug Administration about these adverse effects, they failed to adequately warn prescribing doctors and consumers about the risks. In entering the settlement, Bayer denies any wrongdoing.
In addition to California, the Attorneys General of the following states joined the settlement: Arizona, Arkansas, Connecticut, Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin.