(Reuters) – A Hawaiian judge on Monday ordered Bristol-Myers Squibb Co. and Sanofi SA to pay more than $ 834 million to the state for failing to warn patients who were not targeted by their health risks Plavix blood thinner.
Judge Dean Ochiai in Honolulu concluded that companies engaged in unfair and deceptive business practices from 1998 to 2010 did not 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 “brings to the attention of the pharmaceutical industry that it will be responsible for conduct that misleads the public and places profits above of security “.
Bristol-Myers and Sanofi, who produced Plavix in a partnership, in a joint statement pledged to appeal, saying the decision “was not upheld by law and was inconsistent with trial evidence”. They called Plavix safe and effective.
Ochiai, who presided over a four-week trial without a jury, conducted entirely on Zoom due to the COVID-19 pandemic, ordered Bristol-Myers and Sanofi to pay $ 417 million in fines.
Hawaii alleged that the companies violated state consumer protection laws by marketing Plavix without revealing that the drug could have a diminished or no effect on some people, particularly those of East Asian descent and Pacific Island.
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 approximately 14% of Chinese patients cannot metabolize the drug properly, compared to 4% of blacks and 2% of white patients.
The U.S. Food and Drug Administration issued 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.
Reports by Tina Bellon and Nate Raymond; Edited by Richard Chang, Dan Grebler and Sherry Jacob-Phillips