Plavix Manufacturers Ordered to Pay $834M For Failing To Warn About Risks For Users of East Asian or Pacific Island ancestry

A state court judge in Hawaii has ordered Bristol-Myers Squibb Co. and Sanofi to pay more than $834 million for failing to warn consumers in the state about potential health risks associated with Plavix, and a lack of effectiveness for some members of the population.

Judge Dean Ochiai awarded the massive civil penalty on Monday in Honolulu, indicating the two companies violated the state’s consumer protection laws. The two drug manufacturers jointly developed and distributed the blood thinner Plavix, and faced allegations they failed to notify the medical community or consumers about the potential risks of the drug, but also that the drug would not work for many Hawaiians, due to a genetic expression which runs heavily through individuals with East Asian or Pacific Island ancestry.

Hawaii Attorney General Clare Connors announced the verdict and penalty in a news conference on Tuesday.

Plavix (clopidogrel) is widely marketed and prescribed to prevent heart attacks, strokes and blood clots among individuals with drug coated stents or other at-risk patients. It is a blockbuster medication, generating annual sales of over $9 billion for Bristol Myers Squibb Co. and Sanofi.

However, the blood thinner often does not work for those of Asian or Pacific-Island decent, due to a genetic trait which prevents many from those heritages of properly metabolizing the drug. Overall, between 2% and 14% of the population are “poor metabolizers” of Plavix, but attorneys for the state of Hawaii indicate the drug was likely ineffective for about 30% of the state’s residents, due to the state’s demographics.

The FDA issued a safety warning about the potential Plavix problems for poor metabolizers in 2010, requiring Plavix to carry a “black box warning.” Hawaii prosecutors say the manufacturers failed to provide a proper warning leading up to that, and conducted misleading advertising dating back as far as 1998.

In a 43-page ruling, Judge Ochiai agreed, indicating the company “knowingly” put Plavix patients at serious risk of injury or death in order to increase profits. The decision came after a four-week trial which ended in late November.

Bristol-Myers Squibb officials say the company plans to appeal the verdict.