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 Asian 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’t until 2010, when the U.S. Food and Drug Administration required a “black box” label warning, that the drugmakers made a change to their labeling, Ochiai concluded.
The defendants “knowingly placed Plavix patients at grave risk of serious injury or death in order to substantially increase their profits” and engaged in “immoral, unethical, oppressive or unscrupulous” acts by “burying their heads in the sand,” Ochiai wrote, according to Bloomberg News.
“Today’s 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,” she said. “The 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.”
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 $3 million settlement after a court alleged they misrepresented Plavix’s effectiveness as better than aspirin.
In the statement provided to Maui Now, representatives of Bristol Myers Squibb wrote, “The 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.”
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