HONOLULU (CN) - In one of the largest payouts in state history, Hawaii will receive $700 million from pharmaceutical companies Bristol Myers Squibb and Sanofi to resolve claims that they failed to disclose their blood thinner Plavix was less effective in Asians, Pacific Islanders and Native Hawaiians.
The settlement, announced Friday, ends more than a decade of litigation that began in 2014 when the state accused the drug manufacturers of engaging in unfair and deceptive practices that put thousands of Hawaii residents at risk.
"It doesn't matter if a company is a one-person shop or a multi-billion-dollar oil company, we will relentlessly enforce Hawaii's consumer protection laws," Hawaii Attorney General Anne Lopez said in a statement.
Plavix had been marketed as superior to aspirin for reducing heart attacks, strokes and blood clots since it entered the market in 1998. The medication, which requires activation by liver enzymes to be effective, was prescribed more than 800,000 times in Hawaii between 1998 and 2010.
State officials said the drug companies failed to warn patients and physicians that Plavix could be less effective or completely ineffective in people with certain liver-enzyme mutations - genetic variants that occur more frequently in people of Asian and Pacific Islander descent.
According to the Hawaii State Data Center Research and Economic Analysis Division, such groups account for more than 60% of Hawaii's population.
The Food and Drug Administration also didn't require Bristol Myers Squibb and Sanofi to add a "black box" warning - the strongest warning the agency can mandate - to Plavix's label until 2010. This warning finally disclosed the medication's potentially diminished effectiveness for poor metabolizers with specific genetic variants, a disclosure that led to Hawaii's lawsuit.
The legal battle has deep roots, according to Rick Fried, who served as special attorney general on the case.
"I started working on this case when I presented it to then-AG David Louie in 2012. It took 13 years to finalize, but I'm very pleased about what this settlement will do for the people of Hawaii," said Fried, who is with the Honolulu-based law firm Cronin, Fried, Sekiya, Kekina and Fairbanks.
The pharmaceutical companies have consistently disputed the state's claims. In 2021, Hawaii was awarded $834 million in a similar lawsuit after Oahu's First Circuit Court found that the pharmacy giants violated Hawaii's consumer protection laws.
They issued a statement then defending their product: "The court's ruling is unsupported by the law and at odds with the evidence at trial. The overwhelming body of scientific evidence demonstrates that Plavix is a safe and effective therapy, including for people of Asian descent."
Despite that, the corporations chose to settle rather than continue legal proceedings. Without being held up by possible appeals, the settlement is scheduled to be paid via wire transfer by June 9. the settlement will be divided equally between the two companies.
State officials indicated the $700 million will be directed toward supporting public health initiatives and underfunded health services throughout the state, though specific allocations have not yet been determined.
"This landmark settlement is a major victory for the state of Hawaii. Once the money goes into our general fund, we can go to work on immediately identifying ways to enhance health care services for Hawaii's residents," Hawaii Governor Josh Green said in a statement.
Source: Courthouse News Service
