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Bristol-Myers, Sanofi Sued by Hawaii Over Plavix Labeling

Bristol-Myers Squibb Co. and Sanofi were accused in a lawsuit by Hawaii of failing to disclose that the blood-thinning drug Plavix has little effect on 30 percent of the population and puts patients at risk for gastrointestinal bleeding.

From 38 percent to 79 percent of Pacific-Islanders and 40 percent to 50 percent of East Asians may respond poorly to Plavix because of a genetic predisposition to inadequately metabolize the drug, Hawaii Attorney General David Louie said in an e-mailed statement. The companies failed to disclose the information to protect their profit from Plavix prescriptions, he said in a complaint today in state court in Honolulu.

“Plavix’s diminished effectiveness is especially prevalent among Hawaii consumers,” Louie said in the complaint.

The companies added a warning to Plavix’s label about poor metabolizers in 2010 and knew or should have known 12 years earlier that the drug wasn’t effective for some patients, according to the complaint. The companies have made more than $100 million in profit from Plavix sales in Hawaii since 1998, Louie said. The lawsuit seeks civil penalties and disgorgement of profits.

Bristol-Myers and Sanofi are also alleged to have deceptively and unfairly labeled and marketed Plavix as being as safe and effective in elderly patients as in younger patients since 2001, the state said.

‘Studied’ Medicine

“Plavix is one of the most studied medicines with over a decade of real-world experience in patients with acute coronary syndrome, recent stroke, recent heart attack and peripheral arterial disease,” Laura Hortas, a Bristol-Myers spokeswoman, said in an e-mail for both companies. New York-based Bristol-Myers and Sanofi won’t comment on pending litigation, she said.

Plavix has been prescribed for more than 115 million patients worldwide, including more than 50 million in the U.S., Hortas said.

Bristol-Myers agreed to return the rights for Plavix to its French partner, Sanofi, after the medicine lost patent protection, the companies said in October. Bristol-Myers will retain rights to Plavix in the U.S., they said in a joint statement.

The case is Hawaii v. Bristol-Myers Squibb Co. 14-1-0708-03, First Circuit Court, Honolulu, Hawaii

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