After more than a decade of litigation, Hawaii has secured a landmark $700 million settlement from pharmaceutical giants Bristol Myers Squibb and Sanofi over claims that the blood thinner Plavix lacked efficacy in Asian American, Pacific Islander, and Native Hawaiian populations. Governor Josh Green announced the settlement on Friday, marking the end of a protracted legal battle that spotlights significant concerns about ethnic disparities in pharmaceutical safety and efficacy.
The state had accused the companies of failing to disclose that Plavix—one of the world's most widely prescribed antiplatelet medications—was either less effective or completely ineffective in people of certain ethnic backgrounds. Between 1998 and 2010, the medication was prescribed more than 837,000 times in Hawaii.
Genetic Variations Impact Drug Efficacy
At the heart of the case is Plavix's mechanism of action, which requires activation by liver enzymes. Research has shown that genetic variations common in certain ethnic populations can significantly reduce the body's ability to activate the drug, rendering it less effective or ineffective in preventing blood clots.
These genetic variations affect the CYP2C19 enzyme, which is critical for converting Plavix (clopidogrel) into its active form. Studies have demonstrated that approximately 50% of Asians and Pacific Islanders carry genetic variants that reduce the enzyme's function, compared to about 25% of Caucasians.
"This case underscores the critical importance of considering genetic and ethnic diversity in drug development and patient care," said a pharmaceutical researcher not involved in the litigation. "When medications are primarily tested on homogeneous populations, important safety and efficacy issues can be missed."
Settlement Details and Financial Impact
The $700 million settlement represents a compromise from the state's original court victories. Hawaii was initially awarded $834 million in a 2023 nonjury trial, an amount later increased to $916 million in a 2024 retrial. However, the new settlement guarantees an immediate payout, avoiding potentially years of appeals.
Under the terms of the agreement, Bristol Myers Squibb and Sanofi will each pay $350 million, with the full amount expected to be transferred to the state by June 9, 2025. The settlement resolves all claims related to the marketing and sale of Plavix, though it does not preclude private citizens from filing their own claims against the drugmakers.
"It's a historic result that we're grateful for," Governor Green stated at a news conference. "This settlement of $700 million is going to go a very long way to help our people."
Bristol Myers Squibb did not admit to any wrongdoing and agreed to settle to avoid continued litigation. Both pharmaceutical companies will cover their own legal fees, and the agreement is governed by Hawaii law.
Legal Journey and Precedent-Setting Implications
Special Attorney General Rick Fried, with the Honolulu law firm Cronin, Fried, Sekiya, Kekina & Fairbanks, began working on the case in 2012 with then-Attorney General David Louie.
"It's been 13 years we've been working on this—two trials up to the Supreme Court and back," Fried said. The case involved extensive discovery and complex scientific evidence regarding genetic variations and their impact on drug metabolism.
State Attorney General Anne Lopez emphasized the broader message sent by the outcome: "It is important to me that everyone who does business in the state of Hawaii, whether you're a small shop or a multinational, multibillion-dollar oil company, knows that the Attorney General's Office will be relentless in our pursuit of compliance with our consumer protection laws."
Legal experts suggest this settlement could set a precedent for other jurisdictions with diverse populations, potentially leading to similar claims against pharmaceutical companies that fail to adequately test or warn about medication efficacy across different ethnic groups.
Funding Allocation and Public Health Impact
Governor Green indicated that the settlement funds, after legal fees, will be directed to the state's general fund to support underfunded health and social programs, particularly those serving vulnerable communities. The timing is especially beneficial as Hawaii manages financial challenges from the COVID-19 pandemic, the 2023 Maui wildfires, and potential federal funding cuts.
"We will be completely collaborative with the Legislature. We will ask for their advice on where they would like to appropriate these moneys," Green said, noting that priorities might include housing or healthcare benefits.
Broader Implications for Pharmaceutical Development
This case highlights growing concerns about how pharmaceutical companies address—or fail to address—ethnic and genetic diversity in drug development, testing, and labeling. The FDA has increasingly emphasized the importance of diverse clinical trial populations, but critics argue progress has been too slow.
The Plavix case demonstrates the potential consequences when medications are not adequately tested across diverse populations or when known efficacy variations are not properly communicated to healthcare providers and patients.
For patients of Asian, Pacific Islander, or Native Hawaiian descent who have been prescribed Plavix, medical experts recommend consulting with healthcare providers about potential alternatives or genetic testing to determine if the medication is appropriate for their specific genetic profile.
As pharmaceutical companies face growing scrutiny over the inclusivity of their clinical trials and the accuracy of their labeling, the Hawaii Plavix settlement may represent just the beginning of a broader reckoning with issues of equity in drug development and marketing.
