(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 adequately warn non-white patients about the health risks of their blood thinner Plavix.
Judge Dean Ochiai in Honolulu found that the companies engaged in unfair and deceptive business practices between 1998 and 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 liable for conduct that misleads the public and puts profit above safety.”
Bristol-Myers and Sanofi, which jointly produced Plavix, in a joint statement promised to appeal, saying the decision “was not supported by law and contradicted the trial evidence.” They called Plavix safe and effective.
Ochiai, who presided over a four-week non-jury trial conducted entirely on Zoom due to the COVID-19 pandemic, ordered Bristol-Myers and Sanofi to each pay $ 417 million in fines.
Hawaii alleged that the companies violated state consumer protection laws by marketing Plavix without disclosing that the drug might have little or no effect on some people, particularly of East Asian and Pacific Islander descent.
Plavix is prescribed to prevent strokes and heart attacks. The anticoagulant needs to be activated by the body’s own enzymes, which can vary genetically.
Studies have shown that around 14% of Chinese patients are unable to metabolize the drug properly, compared to 4% of black patients and 2% of whites.
The US Food and Drug Administration issued a new Plavix warning label in 2010 to reflect that information.
Bristol-Myers and Sanofi still face a similar lawsuit for Plavix in the state of New Mexico.
Reporting by Tina Bellon and Nate Raymond; Editing by Richard Chang, Dan Grebler and Sherry Jacob-Phillips