(Reuters) – A Hawaiian judge on Monday ordered Bristol-Myers Squibb Co and Sanofi SA to pay the state more than $ 834 million for failing to properly warn non-white patients about the health risks of its blood thinner Plavix.
Judge Dean Ochiai of Honolulu concluded that between 1998 and 2010, companies engaged in unfair and deceptive business practices failed to change the label of the drug 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 “makes it known to the pharmaceutical industry that it will be held accountable for behavior that misleads the public and puts profit above safety.”
Bristol-Myers and Sanofi, who produced Plavix in a partnership, in a joint statement, vowed to appeal, saying the decision was “unacceptable by law and contradicts the evidence at trial.” They called it Plavix safe and effective.
Ochiai, who presided over a four-week, jury-free trial of Zoom over the COVID-19 pandemic, ordered Bristol-Myers and Sanofi to each pay $ 417 million in fines.
Hawaii claimed that the companies violated state consumer protection laws by marketing Plavix without revealing that the drug could have little or no effect on some people, especially those from East Asia and the Pacific.
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 are unable to metabolize the drug properly, compared to 4% of black patients and 2% of white patients.
The US Food and Drug Administration launched a new Plavix warning label in 2010 to reflect this 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; Edited by Richard Chang, Dan Grebler and Sherry Jacob-Phillips