Bayer to Register and Post Results of Clinical Trials; Pay $8 Million Settlement
ANNAPOLIS - Maryland Attorney General Douglas F. Gansler announced today that the Consumer Protection Division, together with the offices of Attorneys General from 29 other states, has entered into a settlement of Consumer Protection Act claims against Bayer Corporation concerning Bayer’s alleged failure to properly warn prescribers and patients of potential adverse side effects from the prescription drug Baycol.
The consent order filed today in the Circuit Court for Baltimore City requires Bayer to register most of its clinical studies and then post the results at the end of each study. The judgment also orders 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. In addition, Bayer will pay a total of $8 million to the 30 participating states.
“Prescribers and patients need to know about adverse side effects of prescription medications. This settlement will ensure that everyone has the necessary information to make the best decision when prescribing and taking medication,” said Attorney General Gansler.
Together with the Consent Order, Attorney General Gansler’s Consumer Protection Division filed a complaint alleging that Bayer Corporation failed in its marketing to adequately disclose safety risks associated with Baycol, a statin drug used to lower cholesterol that was withdrawn from the market on August 7, 2001. All statins carry a known risk of myopathy (a weakening of the muscles) and rhabdomyolysis (a more serious muscular disease). Bayer learned that the risk for Baycol was significantly higher compared to other statins, particularly at higher doses and when combined with genfibrozil, another cholesterol-lowering drug. The Division alleged that while Bayer informed the U.S. Food and Drug Administration about these adverse effects, Bayer failed to adequately warn prescribers and consumers about them. Bayer denied any wrongdoing.