Hawaii’s attorney general is the latest to sue the manufacturers of Plavix – Bristol-Myers Squibb Co. and Sanofi-Aventis US LLC – on claims the companies deceptively and unfairly labeled and marketed the blood thinner.
In a legal complaint filed on Wednesday, Attorney General David M. Louie alleges that the companies did not disclose that Plavix (clopidogrel) has little or no effect for up to 30 percent of the population, who metabolize the drug poorly because of genetic traits or because they take other drugs, Law360 reports. Instead of preventing heart attacks, strokes or vascular death in such patients as advertised, the anti-clotting medication puts those consumers at considerable risk for gastrointestinal bleeding and other complications.
“Defendants failed to disclose that negative efficacy information because it would adversely affect the number of Plavix prescriptions written and, thus, sales and revenues,” the complaint claims. “Defendants ignored, concealed and minimized clinical trial data and other information showing that Plavix is only as effective as — or in some cases even less effective than — aspirin in treating [some] patients,” Law360 reports.
The action on behalf of the state of Hawaii follows similar actions by the attorneys general of West Virginia and Mississippi. West Virginia accused the companies of charging about 100 times more for Plavix than aspirin despite the fact that it is not more effective; and Mississippi alleged a cover-up of mounting evidence of the drug’s adverse effects. Suits in New Jersey, California and elsewhere have accused Sanofi and Bristol-Myers of personal injury and False Claims Act violations.
Hawaii’s legal complaint claims that roughly 40 to 80 percent of Pacific-Islanders and 40 to 50 percent of East Asians might respond poorly to Plavix because of a genetic predisposition, and, further, the suit claims the companies did not tell consumers that a simple genetic test can identify those for whom the drug won’t work, according to Law360.
Hawaii’s suit alleges violations of state laws on unfair or deceptive advertising and the state’s False Claims Act, as well as consumer fraud against elders and unjust enrichment. The suit seeks between $5,500 and $11,000 for each alleged violation.
Plavix has been prescribed to more than 115 million patients worldwide, including more than 50 million in the U.S., and, according to Law360, had sales of $6.6 billion in 2011.