Bristol-Myers, Sanofi Must Pay $834 Million Over Plavix

(Bloomberg) -- Bristol-Myers Squibb Co. and Sanofi were ordered to pay the state of Hawaii more than $834 million for illegally marketing their blockbuster blood-thinning drug Plavix in a manner that put some users’ lives at risk.

Judge Dean Ochiai in Honolulu concluded Monday the drugmakers misleadingly marketed Plavix and failed to properly warn consumers in the state about its health risks. The companies produce the medicine as part of a joint venture.

The $834 million was awarded as a civil penalty for Bristol-Myers Squibb and Sanofi’s violation of Hawaii’s consumer-protection laws through their improper Plavix marketing campaigns. Hawaii Attorney General Clare Connors’ lawyers showed the companies didn’t properly disclose the blood thinner was ineffective for as many as 30% of users in the state, the judge said.

In a 43-page ruling, Ochiai said Bristol-Myers’ and Sanofi’s deceptive marketing practices “knowingly placed Plavix patients at grave risk of serious injury or death in order to substantially increase their profits.” The judge concluded “the defendants were engaged in unfair and deceptive practices in Hawaii regarding Plavix” over a 12-year period starting in December 1998.

“The court’s ruling is unsupported by the law and at odds with the evidence at trial,” the companies said in a joint statement. “The overwhelming body of scientific evidence demonstrates that Plavix is a safe and effective therapy, including for people of Asian descent.” The companies said they would appeal.

Sanofi shares were little changed at 9:30 a.m. in Paris trading.

“The order entered by the court today puts the pharmaceutical industry on notice that it will be held accountable for conduct that deceives the public and places profit above safety,” Conners said in an emailed statement.

Reduced Risk?

Many of the people for whom Plavix didn’t work were of Asian or Pacific-Island decent, according to court filings. Some of those users didn’t properly metabolize the drug due to a genetic trait, the state said in its filings. During a four-week online trial last year, Hawaii’s lawyers argued that for poor drug metabolizers, Plavix may not have lowered the risk of a recurrent heart attack or stroke, as touted by Bristol-Myers and Sanofi.

“The court finds that defendants knew at the time of launch that there was a significant issue regarding diminished patient response to Plavix, particularly in those of non-Caucasian races” and “that for many years defendants deliberately turned a blind eye toward the problem out of concern that addressing it might adversely affect Plavix sales and defendants’ profits,” Ochiai wrote.

He noted the violations of Hawaii’s laws barring unfair or deceptive trade practices didn’t end until March 2010, when the companies added information about some users having problems metabolizing the drug to Plavix’s safety label. Ochiai fined Bristol-Myers and Sanofi $1,000 for each of the more than 834,000 prescriptions during the 12-year-period.

The companies have been battling Plavix suits for more than a decade, persuading a federal judge in New Jersey -- overseeing a consolidation of cases targeting the blood thinner -- to dismiss the scientific basis for the suits as unreliable in 2018. The drugmakers continue to fight cases in state courts.

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Bristol-Myers and Sanofi agreed in 2019 to pay West Virginia a combined $3.2 million to settle its Plavix marketing suit. They also face illegal marketing claims filed by New Mexico Attorney General Hector Balderas. A trial date hasn’t yet been set in that case.

The case is State of Hawaii v. Bristol-Myers Squibb, Civil No. 14-1-0708-03-DEO, Hawaii Circuit Court for the First Circuit (Honolulu).

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