(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 from 1998 to 2010, companies were engaging in unfair and fraudulent business practices by not changing the medication of the drug to warn doctors and patients, even though they know of the risks.
Hawaii’s attorney general, Clare Connors, whose office sued the companies in 2014, said the ruling “puts the pharmaceutical industry on the alert that it will be held accountable for behavior that misleads the public and puts profits above safety. ”
Bristol-Myers and Sanofi, which produced Plavix in a partnership, pledged in a joint statement to appeal, saying the ruling “is not supported by law and is contrary to the evidence before it.” They call Plavix safe and effective.
Ochiai, who chaired a four-week non-jury trial, was all over Zoom over the COVID-19 pandemic, ordering Bristol-Myers and Sanofi to pay $ 417 million in fines each .
Hawaii claims that companies are violating consumer protection laws by marketing Plavix without announcing that the drug could have a diminished or no effect for some people, especially of East Asian and Pacific descent. .
Plavix is prescribed to prevent strokes and heart attacks. The blood thinner must be activated by the enzymes of the body, 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 and 2% of white patients.
The U.S. Food and Drug Administration issued a new Plavix warning label in 2010 to disclose the 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