Updated: Wednesday, March 19, 2014, 7:13 pm
Published: Wednesday, March 19, 2014, 5:37 pm
The state is filing a lawsuit against two drug manufacturers, claiming they sold a prescription blood-thinning drug that they knew did not work as promised.
Attorney General David M. Louie filed the lawsuit Wednesday in the First Circuit Court pursuing civil penalties and disgorgement of profits for deceptive and unfair marketing practices related to the blockbuster antiplatelet drug Plavix.
The suit alleges that Plavix's manufacturers, Bristol-Myers Squibb and Sanofi-Aventis, began deceptively and unfairly labeling and marketing the drug in 1998 by failing to disclose that Plavix has a diminished or no effect on approximately 30 percent of the population because they metabolize the drug poorly, due to their genetic traits or because they take other drugs that affect the body's ability to metabolize Plavix.
Plavix does not prevent heart attacks, strokes, or vascular death in such patients. Rather, Plavix puts them at considerable risk for gastrointestinal bleeding and other complications associated with Plavix. It has been reported that 38-79 percent of Pacific-Islanders and 40-50 percent of East Asians may respond poorly to Plavix due to a genetic predisposition to poorly metabolize the drug.
"Your body would not make it effective, so essentially it would have no effect or little effect on your body's ability to withstand strokes, heart attacks and other problems," Louie said.
Bristol-Myers Squibb and Sanofi-Aventis are also alleged to have deceptively and unfairly failed to disclose that individuals for whom Plavix would not work can be identified through a simple genetic test that was available prior FDA approval of Plavix.
Plavix's manufacturers are also alleged to have deceptively and unfairly labeled and marketed Plavix as being as safe and effective in elderly patients as in younger patients since 2001. In addition, Plavix's makers allegedly deceptively and unfairly promoted Plavix as being more effective and safer than aspirin, which costs roughly one percent of what Plavix costs. As a result of these statements, consumers took Plavix instead of aspirin, which is often safer than Plavix and equally, if not more, effective than Plavix.
Plavix's U.S. sales peaked at $6.6 billion in 2011. It is estimated that Bristol-Myers Squibb and Sanofi-Aventis made tens of millions in profits by virtue of Plavix sales in Hawaii, which are estimated at well over one hundred million dollars since 1998. The total number of Plavix prescriptions in Hawaii since 1998 is more than one million. The Attorney General seeks the maximum civil penalty of $10,000 for each deceptive or unfair act that Plavix's manufacturers committed in relation to the drug's labeling and marketing in Hawaii, an additional civil penalty of $10,000 for each such deceptive or unfair act that was directed towards the elderly, and disgorgement of all profits they obtained by way of Plavix sales.
If you used Plavix in the past and think you are affected, contact the Plavix Response Team at (808) 524-1433.