Sanofi, Bristol Myers on the hook for $916M in do-over of Plavix marketing case in Hawaii

In the continuation of a decade-long legal battle, a Hawaii judge has ordered Bristol Myers Squibb and Sanofi to pay a combined $916 million to the state for failing to warn patients about the ineffectiveness of their blood thinner Plavix in some nonwhite patients.

The award comes after a second trial in the case. Last year, following the first trial, which resulted in an $834 million award to the state in 2021, the Hawaii Supreme Court reversed in part and vacated in part the judgement, necessitating a redo.

This time, the state court ruled in favor of Hawaii's allegation that the companies violated state consumer protection laws with their marketing of Plavix. In 2010, the FDA required Sanofi and BMS to include a boxed warning that Plavix could be less effective in nonwhite patients. Studies have shown that genetic differences—particularly in people of East Asian decent—can prevent some from metabolizing Plavix.

The companies said they will appeal again.

“Bristol Myers Squibb and Sanofi strongly disagree with the court’s penalty award,” the companies said in a joint statement. “The overwhelming body of scientific evidence demonstrates that Plavix is a safe and effective therapy, regardless of a patient’s race or genetics.”

Judge James Ashford ruled that Sanofi and BMS knew that there was a risk “that about 30% of patients might have a diminished response to Plavix, but they did not update their label.”

“The defendants 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,” Ashford added.

Plavix was approved in 1998, with generic versions (clopidogrel) controlling the market over the last decade.

By way of settlements, Sanofi and BMS previously resolved lawsuits related to the drug in Louisiana, Mississippi, West Virginia and California.   

“The Hawai`i medical community recognizes the benefits of Plavix and continues to recommend it to Hawai`i patients without restrictions based on race, ethnicity or genetic status," the companies added. "The unprecedented penalties awarded in this case are unwarranted and out of proportion. This is the last remaining Plavix case and is a clear outlier given the companies’ successful defense of Plavix litigation in other states.”