The Plavix lawsuit dates back to 2014, when Hawaii first sued BMS and Sanofi, alleging that they failed to properly inform patients in the state that the drug is likely to be less effective for them.
The state of Hawaii on Friday settled its long-standing legal dispute with Bristol Myers Squibb and Sanofi over the companies’ blood thinner Plavix.
Each company will hand over $350 million by June 9 to satisfy the settlement, though neither accepted any liability in connection with the state’s allegations, as per the agreement. The payment will release BMS and Sanofi from “any and all claims of any kind . . . in any way related to the State’s claim” against the companies.
The settlement, however, does not prevent private citizens from Hawaii from bringing their own claims against BMS and Sanofi.
Friday’s agreement ends more than a decade of litigation over Plavix, an oral blood thinner initially approved in 1997 and indicated for acute coronary syndrome and to reduce the risk of heart attacks and strokes in patients who have had recent cardiovascular episodes. The drug comes with a boxed warning, flagging that Plavix’ effectiveness “depends on [its] conversion to an active metabolite by” a certain enzyme.
In 2014, the state of Hawaii sued BMS and Sanofi, alleging that the companies engaged in deceptive marketing practices by not informing patients in Hawaii that certain population-specific factors there make Plavix not only less effective but also potentially more harmful.
In May 2024, First Circuit Court Judge James Ashford awarded Hawaii a more-than $900 million victory against BMS and Sanofi, finding that the companies indeed knew “that there was a risk that about thirty percent of patients might have diminished response to Plavix” but nevertheless decided against updating the drug’s label, as per a news release from the state at the time. Before an appeal of the $900 million payment could be completed, the state and the companies settled at the lower amount of $700 million.
The companies, according to Ashford, engaged in “unfair acts or practices,” which he deemed were “deliberate and pervasive.” The lack of upfront information about the efficacy of Plavix “raises a serious risk of harm to all consumers, but a particularly high risk to patients of East Asian and Pacific Islander descent, who represent a significant portion of Hawaii’s population.”
While BMS and Sanofi have entered a settlement agreement over Plavix, fellow Big Pharma J&J early last month announced that it would abandon its proposed $7 billion settlement plan for its talc lawsuits and instead “return to the tort system to litigate and defeat these meritless talc claims.” This decision comes after the Bankruptcy Court in Houston rejected the pharma’s proposal, which would have closed thousands of cases, alleging that its talc baby powder caused cancer.
