Bristol-Myers, Sanofi Ordered To Pay $834 Mln Over Plavix In Hawaii

Bristol-Myers Squibb Co. and Sanofi SA were ordered to pay more than $834 million to the state of Hawaii for failing to issue proper warning of health risks to consumers from its blood thinner Plavix.

Judge Dean Ochiai in Honolulu pronounced that the drugmakers, which produced Plavix in a partnership, marketed the drug misleadingly to non-white patients. The fine was awarded as a civil penalty for violation of the state’s consumer-protection laws. Bristol-Myers and Sanofi are ordered to each pay $417 million in penalties.

The companies allegedly marketed the drug without disclosing that it could have a reduced or no effect for some people, mainly of Asian or Pacific-Island ancestry. Studies said that about 14 percent of Chinese patients were unable to metabolize the drug properly, in comparison to 4 percent Black and 2 percent white patients.

In 2010, the U.S. Food and Drug Administration had issued a new Plavix warning label to reflect the risks.

In the case filed in 2014 by Hawaii Attorney General Clare Connors’ office, the companies were accused to have engaged in unfair and deceptive business practices over a 12-year period by not changing the drug’s label to warn about the risks.

The judge noted that the companies didn’t properly disclose the drug was ineffective for as many as 30 percent of users in the state.

As per the ruling, the companies’ deceptive marketing practices knowingly placed Plavix patients at grave risk of serious injury or death in order to substantially increase their profits.

Responding to the ruling, Bristol-Myers and Sanofi reportedly called Plavix safe and effective, and said they would appeal as the decision was unsupported by the law and at odds with the evidence at trial.

The companies face lawsuit over Plavix illegal marketing claims in the state of New Mexico, while they agreed to pay a combined $3.2 million in West Virginia in 2019 to settle a similar case.

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