Sanofi, Bristol Myers directed to pay USD 834 million over Plavix warning label

Judge Dean Ochiai in Honolulu concluded the companies engaged in unfair and deceptive business practices from 1998 to 2010 by failing to change the drug's label to warn doctors and patients despite knowing some of the risks.

Hawaii Attorney General Clare Connors, whose office sued the companies in 2014, said the ruling "puts the pharmaceutical industry on notice that it will be held accountable for conduct that deceives the public and places profit above safety."

Bristol-Myers and Sanofi, which produced Plavix in a partnership, in a joint statement vowed to appeal, saying the decision was "unsupported by the law and at odds with the evidence at trial." They called Plavix safe and effective.

Ochiai, who presided over a four-week, non-jury trial conducted entirely over Zoom due to the COVID-19 pandemic, ordered Bristol-Myers and Sanofi to each pay $417 million in penalties.

Hawaii alleged the companies violated state consumer protection laws by marketing Plavix without disclosing that the drug 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 be activated by the body's own enzymes, which can vary genetically.

Studies have shown that about 14% of Chinese patients are unable to metabolize the drug properly, compared with 4% of Black and 2% of white patients.

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

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