Bristol-Myers Squibb and Sanofi, two of the world's largest drugmakers, filed a lawsuit Jan. 7 against Hawaii Attorney General Clare Connors, claiming she violated their First Amendment rights, according to STAT.
The case goes back to 2014, when the state of Hawaii filed a lawsuit against the two drug giants — who jointly marketed a blood thinner drug called Plavix — claiming they failed to warn in the drug's marketing about data that suggested the drug would not work in East Asian and Pacific Islander communities, which make up roughly half of Hawaii's population.
Hawaii is seeking $10,000 for every prescription of Plavix that was written in the state between 1998 and 2010, before FDA standards for product labelling changed, according to STAT.
The drugmakers argue the idea that the drug would not be effective in those communities is "scientifically baseless" because it has never been definitively proven. Because of this, they are arguing the state of Hawaii is violating its First Amendment rights by attempting to force them to include "untrue" language in its marketing.
The drugmakers also noted in their lawsuit that the FDA removed language from Plavix's label in 2016 that suggested that people who do not easily metabolize Plavix would have worse clinical outcomes.
The label continued to state that Plavix may not work as well in people with certain genetic factors and alerted patients that physicians may run genetic tests to determine if the drug is appropriate for them, according to STAT.
Since the original lawsuit was filed, generic versions of Plavix have come to market, and Bristol-Myers and Sanofi have ceased their marketing, but the litigation continues.
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