A Hawaii court has ordered the manufacturers and distributors of the blood thinner Plavix to pay the government a total of $916 million following the discovery. companies did not disclose information the drug’s effectiveness and safety, the state’s attorney general said Tuesday.
The ruling was against Bristol Myers Squibb and three US subsidiaries of the French pharmaceutical company Sanofi.
Bristol Myers Squibb and Sanofi said in a joint statement that they disagreed with the punishment and planned to appeal.
First District Court Judge James Ashford found there was a risk that about 30% of patients, particularly non-Caucasians, may have a “reduced response” to Plavix, but the companies did not update their labeling, Attorney General Anne Lopez said.
“As Judge Ashford found after trial, these defendant pharmaceutical companies acted in bad faith and marketed a product that could potentially have devastating effects on patients in Hawaii even though they knew the drug would not be effective enough for a large portion of the population,” Lopez said. in the statement.
Hawaii filed the lawsuit in 2014, saying more than 1 million prescriptions for Plavix have been written in the islands since 1998, when the drug first went on sale.
Hawaii became the fifth state, after Louisiana, Mississippi, West Virginia and California, to file a lawsuit alleging unfair and deceptive marketing of Plavix.
The companies, in an emailed statement, said the overwhelming majority of scientific evidence demonstrates that Plavix is safe and effective regardless of a patient’s race or genetics. He called the fines “unreasonable and disproportionate.”
It said the Hawaii case was the last remaining court case and was a “clear outlier” given how companies had successfully defended themselves against Plavix litigation in other states.
“Plavix has been helping millions of patients with cardiovascular disease worldwide for more than 20 years, is approved as first-line treatment by leading treatment guidelines worldwide, and remains the standard of care,” the companies said.