Hawaii Attorney General David M. Louie filed a lawsuit in the First Circuit Court on Wednesday 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.
"Some people started taking Plavix instead of aspirin, essentially removing protection they might have had," said Louie.
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.
Louie says the drug can cost up 100 times more than aspirin.
"If you take Plavix it might work, but it also might not work. What you should do is talk to your doctor," said Louie.
Louie says no deaths have been reported in Hawaii due to Plavix and that there is a simple swab test that can tell your doctor if Plavix will work for you.
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.
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.
When KITV reached Bristol-Myers Squibb and Sanofi, they provided the following statement:
"Plavix is one of the most studied medicines with over a decade of real-world experience in patients with acute coronary syndrome, recent stroke, recent heart attack and peripheral arterial disease (PAD). Plavix has been prescribed to more than 115 million patients worldwide, including more than 50 million in the United States. We will not comment on pending litigation."
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.
Please contact the Plavix Response Team at (808) 524-1433 if you believe you have been a victim of such conduct.