Bristol-Myers Squibb and Sanofi were reportedly ordered to pay more than $834m to the US state of Hawaii as the companies failed to warn non-white patients about health risks related to Plavix.
Plavix is an antiplatelet medication or blood thinner, intended to reduce the risk of heart disease and stroke in people at high risk.
Judge Dean Ochiai in the city of Honolulu concluded that the companies are involved in unfair business practices from 1998 to 2010, by failing to change the drug’s label to warn about the related risks.
Ochiai presided over the four-week non-jury trial, conducted over Zoom due to the Covid-19 pandemic, and ordered Bristol-Myers and Sanofi to pay a penalty of $417m each.
Office of the Hawaii Attorney General Clare Connors initially sued the companies in 2014.
Connors said: “Puts the pharmaceutical industry on notice that it will be held accountable for conduct that deceives the public and places profit above safety.”
The companies said in a joint statement that the decision was unsupported by the law and at odds with the evidence at trial, vowed to appeal, and said that their Plavix is safe and effective.
Hawaii alleged the companies violated state consumer protection laws by marketing Plavix with misleading information about its effect on people with East Asian and Pacific Island ancestry.
Bristol-Myers and Sanofi jointly produced Plavix, which is indicated to prevent strokes and heart attacks, requires activation by the body’s own enzymes, which can vary genetically.
According to the studies, around 14% of Chinese patients are incapable of properly metabolising the drug, compared to 4% Black communities and 2% white patients.
In 2010, the US Food and Drug Administration has granted a new Plavix warning label to reflect the advanced information.
Bristol-Myers and Sanofi are currently fighting a similar lawsuit over Plavix in the US state of New Mexico.
