A Hawaii judge has ordered the makers of the blood-thinning medication Plavix to pay $834 million for illegal marketing and a failure to warn Hawaii consumers about the drug’s health risks.
Bristol-Myers Squibb Company and three U.S.-based subsidiaries of French pharmaceutical company Sanofi produce Plavix through a joint venture. Hawaii Circuit Court Judge Dean E. Ochiai concluded last November that the companies sold the prescription medication between 1998 and 2010 without proper warning labels that acknowledged it was ineffective and could possibly be harmful to and Pacific Islander patients.
The court imposed a $1,000 penalty for each of 834,012 prescriptions sold during that 12-year period and on Monday entered an order for the companies to pay. It wasn鈥檛 until 2010, when the U.S. Food and Drug Administration required a 鈥渂lack box鈥 label warning, that the drugmakers made a change to their labeling, Ochiai concluded.
The defendants 鈥渒nowingly placed Plavix patients at grave risk of serious injury or death in order to substantially increase their profits鈥 and engaged in 鈥渋mmoral, unethical, oppressive or unscrupulous鈥 acts by 鈥渂urying their heads in the sand,鈥 Ochiai wrote, according to .
That violated Hawaii鈥檚 , Attorney General Clare Connors said in a press release Monday. Bristol Myers Squibb will appeal, according to a .
鈥淭oday鈥檚 order vindicates seven long years of work by this Department and its attorneys to ensure that companies marketing and selling their products in Hawaii keep the safety and welfare of our people at the forefront of their business decisions,鈥 she said. 鈥淭he order entered by the Court today puts the pharmaceutical industry on notice that it will be held accountable for conduct that deceives the public and places profit above safety.鈥
Other states have filed suit against the companies, but none have hit the drugmakers with civil penalties at this scale.
“Hawaii’s large claim appears to be, in part, based on our large Asian and Pacific Islander population — and clinical evidence that the drug is less effective for these populations,” Jenifer Sunrise Winter, a professor at the University of Hawaii who specializes in data governance of medical information, wrote in an email to Civil Beat.
In West Virginia in 2019, the companies paid a after a court alleged they misrepresented Plavix’s effectiveness as better than aspirin.
In the statement provided to Maui Now, representatives of , 鈥淭he penalties awarded by the Court are wholly unsupported, particularly given that the State of Hawaii provided no evidence that even a single person has been harmed by Plavix. Additionally, as every Hawaii doctor at trial testified, the Hawaii medical community recognizes the medical benefits of Plavix and continues to recommend it without restrictions based on racial, ethnic or genetic status.鈥
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About the Author
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Eleni Avenda帽o, who covers public health issues, is a corps member with , a national nonprofit organization that places journalists in local newsrooms. Her health care coverage is also supported by , , and . You can reach her by email at egill@civilbeat.org or follow her on Twitter at .