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May 31, 2024

Hawai’i Awarded Record $916 Million Over Plavix Failure to Warn

In a May 21, 2024 post-trial order, a Hawai’i state court awarded a record $916 million civil penalty against pharmaceutical manufacturers Bristol-Myers Squibb Co. and Sanofi for allegedly violating Hawai’i’s deceptive and unfair advertising laws and breaching their duty to warn that platelet inhibitor drug Plavix was less effective in patients of Asian and Pacific Islander descent. The defendants launched Plavix in 1998 and advertised the drug for all populations until the FDA issued a so-called “Boxed Warning” in 2010 that Plavix was less or ineffective in patients with a particular genetic mutation that is common in patients of Asian or Pacific Islander descent. 

The State of Hawai’i subsequently brought a civil enforcement action. After a decade of litigation, and a partial retrial, the court found that the defendants’ internal communications showed that they knew there was a risk that the drug was less effective in certain populations and steered research funding away from studies that would draw attention to this deficiency. The court held  that the withholding of “material information from all Hawai’i consumers requires that [d]efendants be penalized for each and every Plavix label that omitted this critical risk information” between December 1998 and March 12, 2010.   Additionally, because the court found that  the defendants acted in bad faith and injured Hawai’i consumers, the judge awarded a daily penalty of $10,000 per day for the defendants’ allegedly “unfair acts”.

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