If the makers of the blood-thinning medication Plavix are eventually required to pay the $834 million penalty ordered Monday by a Hawaii Circuit Court for violating the state’s consumer protection laws, the money could provide a major boost to the state budget.

The penalty would go directly to the state’s general fund, but not until all legal appeals are exhausted, which could drag on for two years or even longer, Hawaii Attorney General Clare Connors said at a press conference Tuesday.

A penalty of that size is a rare occurrence for the state, she said. For every year the judgement is not paid, the companies face a 10% interest penalty, adding up to $83.4 million a year.

“It is most certainly one of the largest our office has ever recovered,” she said.

Attorney General Clare Connors announces suspension of Keith Kaneshiro.
Hawaii’s Attorney General Clare Connors said the civil penalty awarded to the pharmaceutical companies Bristol-Myers Squibb and Sanofi is among the largest in the state’s history. Other states have filed suit against the companies, but none have hit the drugmakers with civil penalties at this scale. Cory Lum/Civil Beat

The pharmaceutical companies Bristol-Myers Squibb and three U.S.-based subsidiaries of French pharmaceutical company Sanofi told Civil Beat in a statement they intend to appeal the judgement by Hawaii Circuit Judge Dean Ochiai.

The court found the companies for more than a decade failed to disclose key information about the medication’s limitations for certain populations, among them people of Asian and Pacific Island ancestry. The Attorney General’s office sued in 2014, and seven years of legal battle culminated in a four-week trial by videoconference in November.

Judge Ochiai awarded a penalty of $1,000 for each prescription without proper warning labels sold between 1998 and 2010, when the FDA issued a new black box warning on the medication, which was meant to prevent strokes and heart attacks. Studies have shown its effectiveness depends on the body’s ability to metabolize the drug. Some people, particularly those of Asian and Pacific Islander ancestry, may lack the required liver enzymes.

“People think they’re getting the benefit of this drug, which is to prevent future heart attacks or help during stent surgery, and they’re getting a placebo, no help at all, or very limited help,” said Richard Fried, an attorney with the law firm Cronin Fried Sekiya Kekina & Fairbanks hired by the state to assist.

Despite the landmark nature of the civil penalty, it is only 10% of the maximum the companies could have faced, Fried said.

The pharmaceutical companies maintain Plavix is safe and effective, “including for people of Asian descent” in the joint response shared with Civil Beat by email.

“Despite the Attorney General’s litigation position, the Hawaii health authorities have taken no action consistent with the claims in this lawsuit – for example, Hawaii Medicaid has not imposed any restrictions on prescribing Plavix for people of Asian descent,” the companies wrote. “The penalties awarded by the Court are wholly unsupported, particularly given that the State of Hawaii provided no evidence that even a single person has been harmed by Plavix.”

The companies face a similar lawsuit filed by the state of New Mexico.

In West Virginia in 2019, the companies paid a $3 million settlement after a court alleged they misrepresented Plavix’s effectiveness as better than aspirin.

Litigation could continue. If the defendants choose to file an appeal with the intermediary Court of Appeals or the Hawaii Supreme Court, that could delay any transfer of funds to the state.

“If everything is going very quickly and we’re going through directly to the Hawaii Supreme Court, maybe two years, but my assessment likely it will be longer than that,” Connors said.

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