Bristol-Myers, Sanofi ordered to pay Hawaii $ 834 million on Plavix warning label



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Bristol-Myers Squibb Co and Sanofi SA were ordered Monday by a US judge to pay more than $ 834 million to the state of Hawaii for failing to properly warn non-white patients of the health risks of its anticoagulant Plavix .

The companies had failed to change the drug’s label to warn doctors and patients, despite knowing about some of the risks for more than a decade, wrote U.S. District Judge Dean Ochiai in Honolulu in the United States. decision.

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Bristol-Myers and Sanofi, which produce Plavix in a partnership, said in a joint statement that the move was not supported by a staggering body of scientific evidence and vowed to appeal.

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BMY BRISTOL-MYERS SQUIBB 59.99 0.00 0.00%
CUT SANOFI SA 47.57 -0.13 -0.27%

“The penalties awarded by the court are completely unsubstantiated, especially since the state of Hawaii has provided no evidence that even a single person has been harmed by Plavix,” the companies said.

Ochiai, who rendered the decision following a four-week trial conducted entirely on Zoom without a jury, awarded $ 1,000 in damages for every order of Plavix executed in Hawaii between 1998 and 2010.

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Hawaii alleged that the companies violated national consumer protection laws by marketing Plavix without revealing that the drug may have diminished or no effect for some people, particularly of Asian and Pacific Islander descent.

Plavix is ​​prescribed to prevent strokes and heart attacks. The anticoagulant must be activated by the body’s own enzymes, which can vary genetically. Studies have shown that about 14% of Chinese patients are unable to properly metabolize the drug, compared to 4% of black patients and 2% of white patients.

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The United States Food and Drug Administration released a new Plavix warning label in 2010 to reflect this information.

Bristol-Myers and Sanofi still face a similar lawsuit against Plavix by the state of New Mexico.

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