(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 Plavix thinner .
Judge Dean Ochiai in Honolulu concluded that companies were involved in unfair and deceptive commercial practices from 1998 to 2010 by not changing the drug’s label to alert doctors and patients, despite knowing some of the risks.
Hawaii Attorney General Clare Connors, whose office sued the companies in 2014, said the decision “warns the pharmaceutical industry that it will be held responsible for conduct that deceives the public and puts profit above safety”.
Bristol-Myers and Sanofi, which produced Plavix in partnership, in a joint statement pledged to appeal, saying the decision “was not supported by the law and was at odds with the evidence of the trial”. They called Plavix safe and effective.
Ochiai, who presided over a four-week trial without a jury, conducted entirely by Zoom due to the COVID-19 pandemic, ordered Bristol-Myers and Sanofi to each pay $ 417 million in penalties.
Hawaii claimed that the companies violated state consumer protection laws by marketing Plavix without revealing that the drug could have a diminished or no effect for some people, especially of East Asian and Pacific Islander ancestry.
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 about 14% of Chinese patients are unable to metabolize the drug properly, compared to 4% of black patients and 2% of whites.
In 2010, the Food and Drug Administration issued a new Plavix warning label to reflect this information.
Bristol-Myers and Sanofi are still facing a similar lawsuit over Plavix across the state of New Mexico.
Reporting by Tina Bellon and Nate Raymond; Editing by Richard Chang, Dan Grebler and Sherry Jacob-Phillips