Bristol-Myers, Sanofi to pay $700 million in settlement with Hawaii over Plavix warning label

Hawaii has reached a $700 million settlement with Bristol-Myers Squibb and Sanofi over a warning label dispute for the blood thinner Plavix. The agreement resolves a lawsuit filed by the state in 2006, alleging the companies engaged in deceptive marketing practices by failing to adequately disclose the risk of bleeding associated with the medication. Bristol-Myers Squibb is a leading pharmaceutical company specializing in cancer, cardiovascular, and other treatments. The US accounts for 70.1% of its net sales.

Hawaii has reached a landmark settlement of $700 million with pharmaceutical giants Bristol-Myers Squibb and Sanofi, resolving a long-standing lawsuit over the blood thinner Plavix. The agreement, announced by Governor Josh Green, marks a significant milestone in the state's history, particularly in terms of public health funding [1].

The settlement, which ends a decade of litigation, addresses allegations that the companies engaged in deceptive marketing practices by failing to adequately disclose the risk of bleeding associated with Plavix. The drug, introduced in 1998, was prescribed more than 837,000 times in Hawaii between 1998 and 2010 [1].

The state's lawsuit, filed in 2006, alleged that Bristol-Myers Squibb and Sanofi did not provide sufficient warnings about the drug's diminished effectiveness in patients with certain liver-enzyme mutations, which are more prevalent in Asian and Pacific Islander populations. In 2010, the U.S. Food and Drug Administration required the companies to add a "black box" warning to the drug's label, prompting the state's lawsuit [1].

The $700 million settlement, which divides the total amount equally between Bristol-Myers Squibb and Sanofi, is scheduled to be paid via wire transfer by June 9, 2025. Hawaii Attorney General Anne Lopez emphasized that the settlement sends a strong message to corporations operating in the state regarding compliance with consumer protection laws [1].

The funds from the settlement will support public health initiatives and underfunded health services across Hawaii. Governor Green credited the Attorney General's Office and outside counsel for their role in securing the deal [1].

This settlement comes as a significant victory for Hawaii, addressing long-standing concerns over racial disparities in pharmaceutical efficacy and transparency. It also underscores the importance of regulatory oversight and corporate accountability in the pharmaceutical industry [1].

References:
[1] https://www.staradvertiser.com/2025/05/09/breaking-news/drugmakers-to-pay-hawaii-700m-to-settle-lawsuit-over-blood-thinner/