Plavix Lawsuit: $700M Hawaii Settlement and Texas Case

The Plavix lawsuit most people are asking about is Hawaii’s consumer protection case against Bristol-Myers Squibb and Sanofi, which ended in a $700 million settlement on May 9, 2025 after the state proved the companies failed to warn that the blood thinner doesn’t work in patients with certain genetic variants common in East Asian and Pacific Islander populations.¹ The litigation is not over. On November 20, 2025, Texas Attorney General Ken Paxton filed a similar case seeking penalties of up to $10,000 per violation.²

Individual personal injury claims brought by patients who had heart attacks or strokes while taking Plavix were consolidated in a federal multidistrict litigation that closed in 2020 without a mass settlement or bellwether verdict.³

Why Plavix Doesn’t Work for Everyone

Plavix (clopidogrel) was approved by the FDA in 1997 to reduce the risk of heart attack and stroke. It is a prodrug, meaning it is inactive when swallowed and must be converted into its active form by a liver enzyme called CYP2C19 before it can thin the blood.⁴

Some people carry variants of the CYP2C19 gene that produce an enzyme that works poorly or not at all. These “poor metabolizers” get little or no benefit from the drug and remain at risk for the heart attacks and strokes Plavix is prescribed to prevent. One American Heart Association scientific statement puts the share of patients with loss-of-function variants at roughly 30%.⁵

The variants are not evenly distributed. Estimates suggest about 2% of white patients and 4% of Black patients are poor metabolizers, compared with 14% of Chinese patients and as many as 57% of Oceanian (Pacific Islander) populations.⁴ That disparity is why Hawaii, with its large Asian and Pacific Islander population, became the state with the strongest case.

The FDA did not require a warning about this until March 12, 2010, when it mandated a boxed warning telling doctors to consider genetic testing and alternative drugs for poor metabolizers.⁶ From the drug’s late-1998 launch until that date, the label said nothing about it.

What the Companies Allegedly Knew

The state cases turn on the gap between what the companies knew internally and what the Plavix label said. According to the Texas attorney general’s petition, internal documents from 1997 identified CYP2C19 as critical to activating the drug and flagged that genetic variants more common in non-white populations could prevent it from working.⁷

A 1998 internal meta-analysis reportedly found that 32.2% of patients had less than a 20% response to Plavix and 3.4% were complete non-responders. The Texas complaint alleges the companies did not disclose the “poor responder” issue to the FDA until 2005, and when they did, buried the data in an appendix. A January 1997 internal “CAPRIE Report” allegedly documented a statistically significant racial disparity in adverse events during the landmark CAPRIE trial, a finding omitted when the study was published in the Lancet later that year.⁷ The published CAPRIE study reported an overall 8.7% relative risk reduction for clopidogrel over aspirin but did not address racial subgroup differences.⁸

The Hawaii trial court made similar findings on its own record. Judge Dean Ochiai concluded the companies had “deliberately withheld vital information” and “knowingly placed Plavix patients at grave risk of serious injury or death in order to substantially increase their profits.”⁹ Internal records cited in later Hawaii findings showed the companies rejected a proposed aspirin resistance study because, in their words, “it could lead to a similar trial on [Plavix] resistance.”¹⁰ Both companies have denied wrongdoing throughout.

The Hawaii Case: From $834 Million to a $700 Million Settlement

Hawaii filed suit in 2014 under the state’s Unfair or Deceptive Trade Practices Act. The theory was simple: every Plavix prescription dispensed in the state between December 1998 and March 2010 with a label that omitted the genetic metabolism information was a separate violation of consumer protection law.¹¹

After a four-week bench trial ending in November 2020, Judge Ochiai found 834,012 violations and imposed the statutory minimum penalty of $1,000 each, for a judgment of $834,012,000.⁹

The companies appealed. In March 2023, the Hawaii Supreme Court affirmed that the companies had engaged in “unfair” conduct but held the trial court had erred in granting partial summary judgment on the “materiality” element of the deceptive practices claim. That ruling, the court said, had denied the companies the chance to argue the omitted label information would not actually have changed physicians’ or patients’ decisions. The $834 million penalty was vacated and the deceptive acts claim sent back for a new trial.¹²

The retrial went forward in fall 2023 before Judge James Ashford. On May 21, 2024, Ashford ruled again that the companies had violated Hawaii’s consumer protection laws, calling their failure to update Plavix labels “deliberate and pervasive.” The new judgment totaled $916,012,000, split evenly between Bristol-Myers Squibb and the Sanofi subsidiaries at $458,006,000 each. Both companies announced plans to appeal.¹³

They settled first. On May 9, 2025, Governor Josh Green and Attorney General Anne Lopez announced a $700 million agreement, with each company paying $350 million by wire transfer due June 9, 2025.¹ Neither company admitted wrongdoing.¹⁴ Lopez described the deal as the close of “nearly 12 years of litigation.”

The New Texas Case

After the Hawaii judgment, Bristol-Myers Squibb and Sanofi had described that case as “the last remaining legal case” and a “clear outlier.”¹⁵ That changed on November 20, 2025, when Texas Attorney General Ken Paxton filed suit in the District Court of Harrison County under the Texas Deceptive Trade Practices-Consumer Protection Act and the Texas Health Care Program Fraud Prevention Act.²

Texas alleges the companies knew since at least 1998 that Plavix had a diminished effect on Black, East Asian, and Pacific Islander patients and failed to disclose it, resulting in “substantially inadequate or inappropriate” prescriptions paid for by Texas Medicaid and other taxpayer-funded programs.¹⁶ The state is seeking civil penalties of up to $10,000 per violation, recovery of healthcare program payments, and injunctive relief.⁷ Both companies said they will “vigorously defend” the case.

Hawaii was not the only state to sue before Texas. Louisiana, Mississippi, West Virginia, and California all filed Plavix marketing cases before Hawaii did in 2014.¹⁵ West Virginia’s case, filed in late 2012, alleged the drugmakers marketed Plavix as superior to aspirin despite costing roughly 100 times more than generic alternatives.¹⁷

What Happened to Individual Patient Lawsuits

Patients who had heart attacks, strokes, or other cardiovascular events while on Plavix brought their own product liability suits. In early 2013, the Judicial Panel on Multidistrict Litigation consolidated them into MDL No. 2418, In re: Plavix Marketing, Sales Practices and Products Liability Litigation (No. II), in the U.S. District Court for the District of New Jersey under Judge Freda L. Wolfson.¹⁸

The MDL did not produce a bellwether trial or a reported mass settlement. Cases wound down through voluntary dismissals and dismissals for failure to comply with case management orders. In June 2018, Judge Wolfson dismissed 95 cases after the patients failed to retain new counsel or appear pro se following their attorneys’ withdrawal.¹⁹ The judge recommended closing the MDL in December 2019, and it was formally terminated on April 14, 2020.³

One significant ruling came out of the individual-plaintiff fight. In Bristol-Myers Squibb v. Superior Court (2017), the U.S. Supreme Court held that California state courts lacked jurisdiction over claims by 592 out-of-state plaintiffs who had not purchased, taken, or been harmed by Plavix in California, narrowing where plaintiffs can file mass tort claims.²⁰

Bristol-Myers Squibb and Sanofi continue to maintain that Plavix is safe and effective regardless of race or genetics.

1
Governor of Hawaii. Governor Green, Attorney General Lopez Announce $700 Million Settlement in Plavix Lawsuit
2
Texas Attorney General. Attorney General Paxton Sues Big Pharma Companies Bristol-Myers Squibb and Sanofi
3
CourtListener. In Re Plavix Product Liability and Marketing Litigation Docket
4
National Center for Biotechnology Information. Clopidogrel Therapy and CYP2C19 Genotype
5
Mayo Clinic News Network. A Scientific Statement From the American Heart Association
6
PBS NewsHour. FDA Adds Toughest Warning to Plavix
7
Texas Attorney General. Texas v. Bristol-Myers Squibb, Plaintiffs’ Original Petition
8
National Library of Medicine. A Randomised, Blinded, Trial of Clopidogrel Versus Aspirin in Patients at Risk of Ischaemic Events (CAPRIE)
9
Hawaii Attorney General. State of Hawaii Plavix Judgment News Release
10
Hawaii Attorney General. Findings of Fact and Conclusions of Law
11
National Association of Attorneys General. Using UDAP in an Action Against the Manufacturers of the Antiplatelet Medication Plavix
12
Findlaw. State ex rel. Shikada v. Sanofi S.A.
13
Governor of Hawaii. State Awarded More Than $900 Million Against Major Pharmaceutical Manufacturers of Plavix
14
CBS News. Hawaii Secures $700 Million Settlement in Lawsuit Over Blood Thinner Plavix
15
Fortune. Hawaii Court Orders Bristol Myers Squibb, Sanofi to Pay $916M in Plavix Blood Thinner Lawsuit
16
Reuters. Bristol Myers, Sanofi Sued by Texas Over Plavix
17
Courthouse News Service. Plavix Marketing Claims Kicked to West Virginia
18
U.S. Judicial Panel on Multidistrict Litigation. MDL-2418 Initial Transfer Order
19
Law360. In re Plavix Product Liability and Marketing Litigation
20
U.S. District Court for the District of New Jersey. Plavix Product Liability and Marketing Litigation