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

(Reuters) – A judge in Hawaii on Monday ordered Bristol-Myers Squibb Co and Sanofi SA to pay more than $ 834 million to the state for failing to properly warn non-white patients of the health risks of its anticoagulant Plavix.

Judge Dean Ochiai in Honolulu found that companies engaged in unfair and deceptive marketing 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 “warns the pharmaceutical industry that it will be held responsible for conduct that deceives the public and places profit. before security ”.

Bristol-Myers and Sanofi, which produced Plavix in a partnership, in a joint statement agreed to appeal, saying the decision was “unsupported by law and at odds with the evidence in the trial.” They called Plavix Safe and Effective.

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

Hawaii alleged 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.

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.