Sanofi, Bristol Myers liable for $916M in Plavix marketing case redo in Hawaii

Bristol Myers Squibb and Sanofi have been mandated to pay $916 million to the state of Hawaii due to their marketing practices concerning the blood thinner Plavix. This new judgement supersedes a previous $834 million award from three years prior, which had been partially overturned on appeal. The companies plan to appeal this latest ruling as well.

The legal conflict, which has spanned over a decade, centers on allegations that Bristol Myers Squibb and Sanofi failed to properly inform patients about the reduced effectiveness of Plavix in some nonwhite individuals. The Hawaii judge's decision followed a second trial, prompted by the Hawaii Supreme Court's partial reversal and vacating of the initial $834 million judgment.

This recent trial concluded that the companies had indeed violated state consumer protection laws in their marketing of Plavix. In 2010, the Food and Drug Administration (FDA) mandated that Sanofi and Bristol Myers Squibb include a boxed warning on Plavix, indicating its potential reduced efficacy in nonwhite patients. Research has shown that genetic variations, notably in those of East Asian descent, can inhibit the proper metabolism of the drug.

Despite the court's ruling, the companies issued a joint statement expressing their intent to appeal. They argued that the scientific evidence overwhelmingly supports Plavix as a safe and effective treatment for all patients, regardless of race or genetic differences.

Judge James Ashford highlighted that Sanofi and Bristol Myers Squibb were aware that approximately 30% of patients might not respond effectively to Plavix, yet chose not to update the drug's labeling. Ashford emphasized that this lack of information left Hawaii's medical professionals without crucial knowledge needed to assess the limitations of the medication over a period of more than ten years.

Plavix, which was first approved in 1998, has seen its market largely taken over by generic versions, such as clopidogrel, in the past decade. Sanofi and Bristol Myers Squibb have previously settled similar lawsuits in states like Louisiana, Mississippi, West Virginia, and California.

The companies maintain that the penalties imposed by the Hawaii court are exceptionally harsh and disproportionate. They also noted that the medical community in Hawaii continues to recommend Plavix to patients without any restrictions based on race, ethnicity, or genetic status. They argue that this case stands out as an anomaly, given their success in defending Plavix-related litigation in other states.