Due to Bristol Myers’s and Sanofi’s failure to warn non-white patients of the drug’s ineffectiveness as a blood thinner, Judge James Ashford of Hawaii has ordered both companies to pay a combined total of $916 million to the state.

This litigatory battle has continued for over a decade, and this verdict is part of the second trial in this case. The first trial took place in 2021 and resulted in an $834 million award being granted to the state. However, this verdict was brought into question last year, and the judgment was partially vacated and partially reversed by the Hawaii Supreme Court.

Consequently, a redo was required, which has borne the following results.

Studies have observed genetic differences in the metabolism of Plavix, especially in people of East Asian descent, meaning they can have difficulty metabolizing the drug. As a result, in 2010, the Food and Drug Administration made it compulsory for Bristol Myers and Sanofi to include a boxed warning on their drug, mentioning how it could be ineffective in non-white users.

When the case was brought to the Hawaii courts this time around, the verdict was given on the grounds that by failing to provide this necessary warning, both companies violated the state’s consumer protection laws regarding the marketing of Plavix.

Judge James Ashford ruled that Sanofi and Bristol Myers Squibb knew there was a risk “that about 30% of patients might have a diminished response to Plavix, but they did not update their label. Their actions inadvertently created an environment where Hawaii prescribing physicians practiced for more than a decade without the necessary information needed to evaluate the serious limitations of this heart medication.” 

Both drug makers in this case, however, strictly oppose the decision. In a joint statement, the companies clarified that there is increasing evidence showing that regardless of a patient’s race or genetics, Plavix is an effective and safe therapy. They strongly disagree with the penalty imposed on them and will be appealing it again. They believe that the $916 million penalty is unwarranted, unprecedented, and completely out of proportion for the case.

There have been lawsuits against Plavix in other states in the past, including West Virginia, California, Louisiana, and Mississippi, but the companies had successfully resolved all of them.

In response to Judge Ashford’s statement, the companies added that the plethora of benefits offered by Plavix, recognized by the medical community in Hawaii, ensures that doctors continue to prescribe it to patients regardless of their race or ethnic background. Based on their experience with Plavix litigation in other states and the strong defense they have presented for the drug, Bristol Myers and Sanofi believe that this verdict is an outlier.

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