State reaches $700M settlement with drug companies

After more than a decade of litigation, the state has reached a $700 million settlement agreement with Bristol-Myers Squibb Company and three U.S.-based subsidiaries of the French pharmaceutical company Sanofi over the efficacy and safety of the blood thinner Plavix. 

What You Need To Know

• The state filed suit the companies in 2014 alleging that they acted in bad faith by failing to indicate on Plavix labels that the drug was less effective for about a third of patients, including Asians and Pacific Islanders.

• Last year, First Circuit Court Judge James Ashford ruled in favor of the state and ordered the companies to pay $916 million. The companies appealed the ruling, and the settlement was reached prior to a decision

• State Attorney General Anne Lopez: ‘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’

• In 2009, the Food and Drug Administration added information about “poor metabolizers” to Plavix’s drug label. The following year, it ordered a boxed warning, the highest level of warning for prescription drugs, informing users of the drug’s limited effectiveness in certain patients and recommending health care professionals consider alternate medications or dosing strategies

“This landmark settlement is a major victory for the state of Hawaii,” said Gov. Josh Green. “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. I am very proud of the work by our Attorney General and outside counsel that helped in achieving this result for the people of Hawaii.”

The state filed suit the companies in 2014 alleging that they acted in bad faith by failing to indicate on Plavix labels that the drug was less effective for about a third of patients, including Asians and Pacific Islanders.

Last year, First Circuit Court Judge James Ashford ruled in favor of the state and ordered the companies to pay $916 million. The companies appealed the ruling, and the settlement was reached prior to a decision.

“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,” said state Attorney General Anne Lopez.

Plavix, the trade name for the drug clopidogrel, is broadly prescribed to patients with cardiovascular disease to prevent the formation of blood clots. At the time the state filed suit against the companies, it was estimated that more than a million prescriptions for the drug had been issued in Hawaii.

In 2009, the Food and Drug Administration added information about “poor metabolizers” to Plavix’s drug label. The following year, it ordered a boxed warning, the highest level of warning for prescription drugs, informing users of the drug’s limited effectiveness in certain patients and recommending health care professionals consider alternate medications or dosing strategies.

Michael Tsai covers local and state politics for Spectrum News Hawaii. He can be reached at michael.tsai@charter.com.

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