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Bristol-Myers, Sanofi ordered to pay Hawaii $834 mln over Plavix warning label

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Feb 15 (Reuters) - Bristol-Myers Squibb Co andSanofi SA were ordered by a U.S. judge on Monday topay more than $834 million to the state of Hawaii for failing toproperly warn non-white patients of health risks from its bloodthinner Plavix.

The companies had failed to change the drug's label to warndoctors and patients despite knowing some of the risks for morethan a decade, U.S. District Judge Dean Ochiai in Honolulu wrotein the ruling.

Bristol-Myers and Sanofi, which produce Plavix in apartnership, said in a joint statement the decision was notsupported by the overwhelming body of scientific evidence andvowed to appeal.

"The penalties awarded by the court are wholly unsupported,particularly given that the State of Hawaii provided noevidence that even a single person has been harmed by Plavix,"the companies said.

Ochiai, who issued the ruling following a four-week trialconducted entirely over Zoom without a jury, awarded $1,000 indamages for every Plavix prescription filled in Hawaii between1998 and 2010.

Hawaii alleged that the companies violated state consumerprotection laws by marketing Plavix without disclosing that thedrug could have a diminished or no effect for some people,particularly of East Asian and Pacific Island ancestry.

Plavix is prescribed to prevent strokes and heart attacks.The blood thinner needs to get activated by the body's ownenzymes, which can vary genetically. Studies have shown thatabout 14% of Chinese patients are unable to properly metabolizethe drug, compared to 4% of black and 2% of white patients.

The U.S. Food and Drug Administration in 2010 issued a newPlavix warning label to reflect that information.

Bristol-Myers and Sanofi still face a similar lawsuit overPlavix by the state of New Mexico.(Reporting by Tina Bellon and Nate Raymond; Editing by RichardChang)