After just three weeks on the job, Maryland Attorney General Douglas Gansler has landed an $8 million settlement from Bayer Corp. over the drugmaker?s prescription drug Baycol.
Gansler announced the settlement after it was filed Tuesday in Baltimore City Circuit Court. Maryland and 29 other states that joined the complaint in June 2004 will share the $8 million settlement. Maryland?s share is $200,000.
The complaint alleges that Bayer failed to properly warn doctors and patients about potential adverse side effects from Baycol, a prescription statin used to lower cholesterol levels. Side effects include severe and possibly fatal muscle reactions that could cause kidney failure.
“Prescribers and patients need to know about adverse side effects of prescription medications,” Gansler said in a statement. “This settlement will ensure that everyone has the necessary information to make the best decision when prescribing and taking medications.”
The U.S. Food and Drug Administration said Bayer voluntarily withdrew Baycol from the U.S. market in 2001 after 31 deaths were linked to the drug.
While Bayer is not admitting any guilt as part of the settlement, the agreement requires Bayer to register most of its clinical studies and post the results at the end of each study. The drug company will post the information in its Web site and other Internet locations, including ClinicalTrials.gov and ClinicalStudyResults.org.
The settlement also orders the drugmaker to follow the law in the marketing, sale and promotion of its pharmaceuticals and biological products and stop making false and misleading claims about Bayer products sold in the U.S., Gansler said.
Bill Allen, Bayer?s director of external communication, could not be reached for comment.
