In the latest action by a state attorney general against the manufacturers of the blood thinner Plavix, Hawaii’s attorney general has filed a lawsuit charging Bristol-Myers Squibb Co. and Sanofi-Aventis US LLC with unfair labeling and marketing of the drug.
Attorney General David M. Louie filed the legal complaint on Wednesday, claiming the companies did not disclose that Plavix (clopidogrel) has little or no effect on about 30 percent of the population. These people metabolize the drug poorly because of genetic traits or because of other drugs they take, Law360 reports. Though the drug is advertised as preventing heart attacks, strokes, or vascular death, it puts these patients at considerable risk for gastrointestinal bleeding and other complications.
The legal complaint says the drug companies “failed to disclose that negative efficacy information because it would adversely affect the number of Plavix prescriptions written and, thus, sales and revenues,” and that the companies “ignored, concealed and minimized clinical trial data and other information” showing that Plavix is only as effective as aspirin – or less effective than aspirin for some patients, according to Law360.
West Virginia has filed a suit accusing the companies of charging approximately 100 times more for Plavix than what aspirin costs, despite the fact that it is not more effective. A Mississippi lawsuit alleges a cover-up of evidence of Plavix’s adverse effects. Suits in New Jersey and California have accused Sanofi and Bristol-Myers of personal injury and False Claims Act violations, Law360 reports. Records indicate that Plavix has been prescribed to more than 115 million patients worldwide, including more than 50 million in the U.S. In 2011, the drug had sales of $6.6 billion.
According to Hawaii’s legal complaint, about 40 to 80 percent of Pacific-Islanders and 40 to 50 percent of East Asians may respond poorly to Plavix because of a genetic predisposition. Further, the suit claims, the companies did not inform consumers about a simple genetic test that can identify those for whom the drug won’t work, according to Law360.
Hawaii’s lawsuit claims the drug makers violated state laws on unfair or deceptive advertising and the state’s False Claims Act, and that they committed consumer fraud against the elderly. The suit asks for damages between $5,500 and $11,000 for each alleged violation.