A Hawaii court has ordered the manufacturers and distributors of the blood thinner Plavix to pay the state a combined $916 million after finding the companies failed to disclose the efficacy and safety of the medication, the state attorney general said Tuesday.
The judgement was issued against Bristol Myers Squibb Company and three U.S.-based subsidiaries of French pharmaceutical company Sanofi.
Bristol Myers Squibb and Sanofi said in a joint statement they disagreed with the penalty and plan to appeal.
First Circuit Court Judge James Ashford found that there was a risk that about 30% of patients, particularly non-Caucasians, might have a “diminished response” to Plavix but the companies didn’t update their label, Attorney General Anne Lopez said.
“As Judge Ashford found following a trial, these pharmaceutical defendants acted in bad faith and marketed a product that could potentially have devastating effects on Hawaii patients, when they knew that the medicine would lack efficacy for a substantial portion of the population,” Lopez said in a statement.
Hawaii filed the lawsuit in 2014, saying more than 1 million Plavix prescriptions had been issued in the islands since 1998 when the drug was first marketed.
Hawaii was the fifth state to file a lawsuit claiming unfair and deceptive marketing of Plavix, after Louisiana, Mississippi, West Virginia and California.
The companies, in an emailed statement, said the overwhelming body of scientific evidence demonstrates that Plavix is safe and effective regardless of a patient’s race and genetics. It called the penalties “unwarranted and out of proportion.”
It said Hawaii’s case was the last remaining legal case and was a “clear outlier” given how the companies successfully defended themselves against Plavix litigation in other states.
“Plavix has helped millions of patients with cardiovascular disease around the world for more than 20 years, is endorsed as a first-line therapy by leading treatment guidelines across the globe and remains the standard of care,” the companies said.
