Hawaii Judge Orders Makers of Plavix to Pay $834 Million
In 2014, the Attorney General of Hawaii brought suit against Bristol-Myers Squibb Co and Sanofi SA for violating consumer protection laws by marketing Plavix without disclosing that the drug could have limited or no effect for non-white patients. Last week, after a four week long bench trial held over Zoom, Judge Ochiai ordered the joint drug manufacturers to pay a total of $834 Million to the state of Hawaii. The court found that between December 1998 and March 2010, the companies sold about 834,000 prescriptions for Plavix in Hawaii without including information about its effectiveness., and it imposed a $1,000 fine per violation.
Plavix is a blood thinner used to prevent strokes and heart attacks. It is activated by the human body’s own enzymes, but many Asian and Pacific Islander patients do not have those enzymes. Effectively, they were taking a placebo. Studies have shown that the efficacy of the drug is limited in other groups: about 14% of Chinese patients are unable to metabolize the drug properly, compared with 4% of Black and 2% of white patients.
In March 2010, the FDA required a new label to reflect information about Plavix’s inefficacy that the drug makers had known for more than a decade.