BMS, Sanofi on Hook for $834 Million Over Deceptive Plavix Labeling in Hawaii

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According to a state First Circuit judge in an $834 million civil ruling, Bristol-Myers Squibb and Sanofi failed for years to adequately warn Hawaiian consumers with East Asian and Pacific Island ancestry that its blood thinner, Plavix, was less effective in those communities due to a common genetic variant. The companies have announced their intent to appeal the decision.

The suit was initiated in 2014 by Hawaii’s Attorney General. The original suit sought alleged that the companies were aware when they began marketing Plavix in 1998 that it had diminished or had no effect on 30% of the population due to poor drug metabolism, including some with genetic predisposition who could be identified with genetic testing.

In 2010, the U.S. Food and Drug Administration (FDA) added a black box warning to Plavix’s label warning about the metabolic issues, and pushing prescribers to use genetic testing to determine patient CYP2C19 enzymatic function. The suit also alleged that the company made misleading claims in its marketing about Plavix’s safety relative to aspirin, particularly for older patients.

The decision, by First Circuit judge Dean Ochiai, could have been worse for the companies. The Attorney General had originally pushed for the maximum penalty under state law of $10,000 per deceptive or unfair instance, which would have brought a penalty ten times larger. Ochiai’s ruling noted that FDA has labeled the companies’ marketing claims relating to aspirin as “misleading,” but did not mention the claims regarding efficacy based on age.

The companies had countersued the State of Hawaii in federal court, claiming the state was violating the companies’ First Amendment rights. The claims were dismissed in district court early last year, and an appeal was dismissed by the U.S Court of Appeal in October.

In a joint statement, Sanofi and Bristol-Myers Squibb called the decision “erroneous” and stressed the safety and efficacy of Plavix. They added: “The penalties awarded by the Court are wholly unsupported, particularly given that the State of Hawaii provided no evidence that even a single person has been harmed by Plavix.”

A lawsuit making similar claims is ongoing in New Mexico. A federal judge in New Jersey dismissed a consolidated group of Plavix liability lawsuits in 2018.

Despite the legal challenges, the companies appear to be expanding Plavix’s label. In December, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended Plavix in combination with aspirin for a new indication, high-risk transient ischemic attack (TIA) or minor ischemic stroke (IS).

The companies expect a final decision from the E.U. this quarter. Plavix has been available in the E.U. since 1998 in patients at risk for ischemic strokes, myocardial infarctions, and vascular death.