(Reuters) – A Hawaii judge 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 about health risks from the blood thinner Plavix.
Judge Dean Ochiai in Honolulu concluded that 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, although they knew some risks.
Hawaii Attorney General Clare Connors, whose office sued the companies in 2014, said the ruling “informs the pharmaceutical industry that it will be held responsible for conduct that misleads the public and puts profit over safety.”
Bristol-Myers and Sanofi, who have spawned Plavix in partnership, in a joint statement pledged to appeal, saying the decision was “not supported by law and violates the evidence at trial.” They called Plavix safe and effective.
Ochiai, who was in charge of a four-week no-jury trial that was all over Zoom over the COVID-19 pandemic, ordered Bristol-Myers and Sanofi to pay $ 417 million in fines each.
Hawaii alleged that the companies violated the state’s consumer laws by marketing Plavix without disclosing that the drug could have diminished or no effect for some people, particularly from East Asian and Pacific Islands.
Plavix is prescribed to prevent strokes and heart attacks. The blood thinner must be activated by the body’s own enzymes, which can vary genetically.
Studies have shown that about 14% of Chinese patients cannot properly metabolize the drug, compared to 4% of black and 2% of white patients.
The U.S. Food and Drug Administration released a new Plavix warning label in 2010 to reflect that information.
Bristol-Myers and Sanofi are still facing a similar lawsuit over Plavix by the state of New Mexico.
Reporting by Tina Bellon and Nate Raymond; Editing by Richard Chang, Dan Grebler and Sherry Jacob-Phillips