Plavix Lawsuit in Hawaii: Inside the $700 Million Settlement

Hawaii’s Plavix lawsuit settlement, announced May 9, 2025, ended more than a decade of litigation with Bristol-Myers Squibb and Sanofi agreeing to pay the state $700 million — $350 million from each company, wired by June 9, 2025.¹ Neither company admitted wrongdoing.² The money is a recovery for the State of Hawaii. It is not a fund for individual patients, and there is no claims process to file for a share.

What the State Alleged

Plavix (clopidogrel) is a blood thinner the FDA approved in 1997 to reduce the risk of heart attacks and strokes. It is a prodrug: the body has to convert it into its active form using a liver enzyme called CYP2C19.³ People with certain CYP2C19 variants — “poor metabolizers” — cannot activate the drug effectively, so they get little of its cardiovascular protection.

Those variants are not evenly distributed. Roughly two to three percent of white and Black Americans carry them, compared with 15 to 20 percent of East Asians.⁴ A 2022 study found intermediate-metabolizer rates of 43 to 52 percent in Asian subgroups, about 39 percent among Native Hawaiians, and roughly 45 percent among Pacific Islanders, with poor-metabolizer rates reaching 18 to 22 percent in some Asian subgroups.³ In Hawaii, that matters a great deal.

The FDA did not add a boxed warning about diminished effectiveness in poor metabolizers until March 2010, more than twelve years after approval.⁵ Hawaii filed suit on March 19, 2014, alleging that Bristol-Myers Squibb and Sanofi had known since Plavix’s 1998 launch that roughly 30 percent of patients might respond poorly, and that 38 to 79 percent of Pacific Islanders and 40 to 50 percent of East Asians were at risk. The complaint alleged violations of Hawaii’s Unfair or Deceptive Acts or Practices statute (HRS Chapter 480), consumer fraud against elders, the Hawaii False Claims Act, and unjust enrichment, and sought civil penalties, disgorgement of more than $100 million in Hawaii Plavix profits, and punitive damages.⁶

How the Case Moved Through the Courts

After a bench trial in late 2020, Judge Dean E. Ochiai ruled on February 15, 2021 that the manufacturers had acted unfairly and deceptively in violation of HRS § 480-2 for every Plavix prescription filled in Hawaii between December 1998 and the March 2010 FDA warning. The court counted 834,012 individual violations, assessed a $1,000 penalty on each, and entered judgment of $834,012,000, split evenly between the two defendant groups.⁷⁸

The companies appealed. On March 15, 2023, the Supreme Court of Hawaii issued a mixed ruling in State ex rel. Shikada v. Bristol-Myers Squibb Co. The court affirmed the finding that the manufacturers had committed “unfair acts or practices,” writing that they had “buried their heads in the sand” by suppressing research and prioritizing financial gain over patient safety. But it reversed the “deceptive acts” finding on procedural grounds: the trial court had resolved the question of materiality on summary judgment, denying the companies a chance to contest whether the omitted label information would actually have changed prescribing behavior. Because the $834 million penalty rested on both findings, the Supreme Court vacated it and sent the case back. The court rejected the companies’ statute-of-limitations, UDAP safe-harbor, and federal preemption arguments.⁹

The retrial ran from September 25 to October 16, 2023, before Judge James H. Ashford. On May 21, 2024, Judge Ashford found that the manufacturers had known about diminished effects in non-white populations from launch, suppressed research to avoid “negative marketing implications,” and “deliberately turned a blind eye toward the diminished response problem.” He ordered a combined $916,012,000 in penalties: $458,006,000 from Bristol-Myers Squibb and $458,006,000 from the three Sanofi subsidiaries.¹⁰ The companies said they disagreed with the ruling and planned to appeal, maintaining that “the overwhelming body of scientific evidence demonstrates that Plavix is a safe and effective therapy, regardless of a patient’s race or genetics.”¹¹

Before that appeal was resolved, the parties settled for $700 million.

Where the $700 Million Goes

The settlement funds are to be deposited into Hawaii’s general fund.¹ Patients who took Plavix do not receive a share, and there is no application to fill out. The state brought the case as a parens patriae action on behalf of Hawaii and its consumers, separate from any private patient claim.⁶

Governor Josh Green said the settlement “positions us very well to weather the storm” of potential federal funding cuts, and that the state intends to direct the proceeds toward health and human services programs, including housing, school lunches, medical care, food assistance, and childcare. Actual spending is subject to legislative approval, and Green said he had already begun discussions with legislative leaders about allocation.¹²

Attorney General Anne Lopez, who led the team through the retrial and settlement, said the outcome showed her office “will be relentless in enforcing consumer protection laws.”¹²

Why the Case Matters Beyond Hawaii

The Hawaii Supreme Court’s 2023 ruling established that FDA approval does not create a safe harbor against state consumer protection claims when a manufacturer has suppressed research, and that a manufacturer arguing federal preemption must present “clear evidence” the FDA would have rejected an earlier label update.¹³

In November 2025, Texas Attorney General Ken Paxton filed a Plavix lawsuit against the same manufacturers, alleging nearly identical claims under Texas consumer protection and healthcare fraud statutes. In court filings, Bristol-Myers Squibb and Sanofi characterized the Hawaii settlement as an “outlier” that motivated the Texas action. Paxton’s office alleged the companies had known about the efficacy gap since 1998 and that taxpayer-funded programs like Texas Medicaid paid for prescriptions “substantially inadequate or inappropriate” for minority patients.¹⁴

1
State of Hawaii Governor. Governor Green, Attorney General Lopez Announce $700 Million Settlement in Plavix Lawsuit
2
CBS News. Hawaii Secures $700 Million Settlement in Lawsuit Over Blood Thinner Plavix
3
National Library of Medicine. CYP2C19 Genetic Variations in Asian and Pacific Islander Populations
4
National Library of Medicine. FDA Black Box Warning for Clopidogrel and CYP2C19 Variants
5
U.S. Food and Drug Administration. Plavix Prescribing Information With Boxed Warning
6
Hawaii Attorney General. News Release: State Files Plavix Lawsuit
7
National Association of Attorneys General. Using UDAP in an Action Against the Manufacturers of the Antiplatelet Medication Plavix
8
Hawaii Attorney General. Findings of Fact, Conclusions of Law, and Order
9
FindLaw. State of Hawaii v. Bristol-Myers Squibb Company
10
State of Hawaii Governor. State Awarded More Than $900 Million Against Major Pharmaceutical Manufacturers of Plavix
11
Reuters. Bristol-Myers, Sanofi Liability in Hawaii Plavix Case Grows to $916 Million
12
Honolulu Civil Beat. Hawaiʻi Will Receive $700 Million From Drug Companies Under Settlement
13
Food and Drug Law Institute. State ex rel. Shikada v. Bristol-Myers Squibb Co.
14
Reuters. Bristol-Myers, Sanofi Sued by Texas Over Plavix