Amber Tong
Senior Editor
By the time the FDA slapped a black box warning on Plavix in 2010, the blockbuster blood thinner had been on the market for 13 years and reaped billions of dollars — enough to give it a solid spot among the best-selling drugs of all time even to this day, despite reaching peak sales in 2011.
On Monday, a judge in Hawaii sided with the state in ordering its makers, Bristol Myers Squibb and Sanofi, to hand back $834 million of that.
Hawaii first sued the pharma giants in 2014 for failing to warn that the drug had poor effects on people who can’t metabolize it — and that those of East Asians and Pacific Island ancestry are more likely to be “poor metabolizers” of Plavix, or clopidogrel, due to their genetic predisposition. It all amounted to deceptive and unfair marketing, according to then-Attorney General David Louie.
To make matters worse, Louie’s office argued that Bristol Myers Squibb and Sanofi could have pointed to a simple genetic test that was available even before the 1997 FDA OK.
His successor Clare Connors said in a statement, reported by Reuters, that the new court ruling “puts the pharmaceutical industry on notice that it will be held accountable for conduct that deceives the public and places profit above safety.”
Bristol Myers Squibb and Sanofi said they would appeal.
“The court’s ruling is unsupported by the law and at odds with the evidence at trial,” the drugmakers said in a joint statement to Bloomberg. “The overwhelming body of scientific evidence demonstrates that Plavix is a safe and effective therapy, including for people of Asian descent.”
Individual consumers and other states alike have waged similar lawsuits over the past decade. While a federal judge has dismissed the scientific basis for a consolidation of suits, several state cases, including New Mexico’s, are still pending.
In a 43-page ruling, Judge Dean Ochiai of Hawaii wrote that the companies put patients at “grave risk of serious injury or death in order to substantially increase their profits.”
“The court finds that defendants knew at the time of launch that there was a significant issue regarding diminished patient response to Plavix, particularly in those of non-Caucasian races,” he wrote, adding “that for many years defendants deliberately turned a blind eye toward the problem out of concern that addressing it might adversely affect Plavix sales and defendants’ profits.”
He based the total fine on 834,000 prescriptions during the 12-year period Hawaii cited, with $1,000 per prescription, and ordered Bristol Myers Squibb and Sanofi to pay $417 million each.
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