Bristol-Myers Squibb, Sanofi to pay Hawaii $916M over Plavix resistance risks

Hawaii Plavix overview:

• Who: Hawaii First Circuit Court Judge James H. Ashford ordered Bristol-Myers Squibb Co., Sanofi-Aventis, Sanofi US and Sanofi-Synthelabo to pay the state of Hawaii a combined $916 million.
• Why: Ashford ruled that the companies falsely advertised the effectiveness of the blood thinner Plavix and did not warn that it could be harmful to those of East Asian or Pacific Islander ancestry.
• Where: The Plavix resistance ruling came in Hawaii’s First Circuit court.

A judge has ordered four corporations to pay a combined $916 million settlement to the state of Hawaii over claims that they falsely advertised the effectiveness of the blood thinner Plavix.

Hawaii First Circuit Court Judge James H. Ashford ruled that Bristol-Myers Squibb Co., Sanofi-Aventis, Sanofi US and Sanofi-Synthelabo marketed and sold Plavix in an unfair and deceptive manner, and that the companies failed to disclose that the drug could be harmful to those of East Asian and Pacific Islander ancestry.

Bristol-Myers Squibb Co. must pay $458 million; Sanofi-Aventis U.S. LLC, Sanofi US Services Inc. and Sanofi-Synthelabo Inc. must pay a combined $458 million as well.

“The fact that Defendants deliberately engaged in a campaign to prevent the development of science of a known risk that would have reduced the marketability of their drug for the sole purpose of protecting sales of that same drug, is highly probative to the penalties inquiry,” Circuit Judge James H. Ashford wrote in his ruling.

Defendants should have updated warning label due to risks, ruling says

The Plavix drug warning labels could have been adjusted after reasonable evidence was shown on the safety and efficacy risk of the drug and the defendants knew from when Plavix launched that around 30% of patients might have less of a response to Plavix, Ashford wrote in the Hawaii Plavix ruling.

The defendants, however, failed to update labels, Ashford said, and also falsely argued that clinical outcomes needed to be shown before warning updates could be made, the ruling says.

The CEO of Hawaiian Electric told members of the House Energy and Commerce Committee in October 2023 that it could take up to 18 months to complete an investigation into what caused an August wildfire that swept through Lahaina, Hawaii, killing nearly 100 people.  

Have you used Plavix? Let us know in the comments.

Hawaii is represented by Dan Alberstone, Peter Klausner, Evan M. Zucker and Elizabeth Smiley of Baron & Budd PC and Richard Fried and Patrick McTernan of Cronin Fried Sekiya Kekina & Fairbanks. 

Bristol-Myers and Sanofi are represented by Arnold & Porter Kaye Scholer LLP.

The Hawaii Plavix lawsuit is State of Hawai’i ex rel Anne E. Lopez, Attorney General v. Bristol-Myers Squibb Co., et al., Case No. 1CC141000708, in the Circuit Court for the First Circuit State of Hawai’i.

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