State: Drug makers ordered to pay $834M penalty to Hawaii put profits before people
HONOLULU, Hawaii (HawaiiNewsNow) - Two drug makers have been ordered to pay Hawaii $834 million for failing to disclose that the drug Plavix was ineffective in reducing the risk of heart attacks, strokes and blood clots for patients of Asian and Pacific Islander descent.
In a news conference Tuesday, Hawaii Attorney General Clare Connors called the judgment “significant” and said the penalty underscores the scale of the wrongdoing ― and how widely the drug was used.
“The defendants knowingly placed Plavix patients at risk of serious injury or death,” Connors said, adding that the penalty was based on the .
“The defendants put profits above the well-being of patients in our state.”
Bristol-Myers Squibb and Sanofi were the defendants in the case and have pledged to appeal.
The companies began marketing the drug in 1998 but didn’t start warning Hawaii physicians and consumers about the drug’s ineffectiveness until March 2010, when the FDA required them to place a “black box” warning on the label accompanying the drug.
After a four-week trial that ended on Nov. 20, Hawaii Circuit Court Judge Dean E. Ochiai concluded that the defendants deliberately withheld vital information about Plavix and its effectiveness.
At issue, say attorneys, is that Plavix is activated by an enzyme in the liver. But many Asian and Pacific Islander residents don’t have that enzyme and so, the state says, were effectively taking a placebo.
Between December 1998 and March 2010, the court found that the companies sold about 834,000 prescriptions for Plavix in Hawaii without including information about its effectiveness.
Based on this evidence, the court determined the companies “knowingly placed Plavix patients at grave risk of serious injury or death in order to substantially increase their profits.”
The court also found that the defendants engaged in “immoral, unethical, oppressive or unscrupulous” acts by choosing not to warn patients about the risks and benefits of Plavix.
Bristol-Myers, in an emailed statement to Bloomberg, said both companies will appeal.
“The court’s ruling is unsupported by the law and at odds with the evidence at trial,” Bristol-Myers said.
“The overwhelming body of scientific evidence demonstrates that Plavix is a safe and effective therapy, including for people of Asian descent.’’
Connors said the judgment in the case will go into the state’s general fund.
If it’s appealed, a minimum of 10% must be paid to the state every year, she said.
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