Sanofi and Bristol Myers Squibb have spent years battling Plavix litigation—including state-level claims that the drugmakers didn’t adequately warn about the blood thinner's risks to certain patients.
Now, a judge in Hawaii has ordered each company to pay the state $417 million for failing to fully disclose its risks in non-white patients.
After a November trial, Judge Dean Ochiai ruled that the companies hadn't properly responded to new studies showing it’s less effective, or not effective at all, for some people. They should have added a warning to the drug's label sooner, the judge said.
Used to prevent strokes and heart attacks, Plavix uses patients’ own liver enzymes to convert the drug into its active form. Between 2% and 14% of patients are “poor metabolizers,” the FDA says, and that rate varies by racial background. The agency issued a safety warning on the medicine in 2010, and Hawaii’s lawsuit centered on conduct before then.
Around 14% of Chinese patients aren’t able to metabolize the drug, according to studies, compared with 4% of Black patients and 2% of white patients, Reuters reports.
The companies said in a joint statement the court's ruling was “unsupported by the law and at odds with the evidence at trial.” The companies plan to "vigorously appeal the erroneous decision" and maintain that the state "provided no evidence that even a single person has been harmed by Plavix."
For her part, Hawaii's attorney general Clare Connors said the ruling “puts the pharmaceutical industry on notice that it will be held accountable for conduct that deceives the public and places profit above safety.” Former Hawaii Attorney General David Louie sued Sanofi and BMS back in 2014 targeting conduct that dated back to 1998.
Meanwhile, the companies have countersued Hawaii, alleging in a lawsuit last month that the state is violating their free speech rights by pursuing an unnecessary warning label, the Honolulu Star Advertiser reports.
Aside from the Hawaii litigation, the companies face similar claims from New Mexico. Previously, the Department of Justice investigated Sanofi over the loss of effectiveness in some patients.
Years ago, Plavix was a top earner for the drugmakers, earning nearly $43 billion during the decade-plus that it enjoyed market exclusivity.