Regulatory Focus™ > News Articles > Hawaii Sues BMS, Sanofi Over Genetic Limitations of Plavix

Hawaii Sues BMS, Sanofi Over Genetic Limitations of Plavix

Posted 20 March 2014 | By Alexander Gaffney, RAC

The US is a large and diverse country, with more than 310 million citizens spanning more than 3.7 million square miles. But in a lawsuit filed on 19 March 2014, the attorney general of Hawaii said two major drug manufacturers failed to take that diversity into account when marketing their drug, Plavix.


Plavix (clopidogrel bisulfate) is a blood thinner approved by the US Food and Drug Administration (FDA) in 1998 to treat patients with peripheral arterial disease (PAD), chest pain due to heart problems, heart attacks, and strokes. The drug is also used to lower the chances of patients experiencing cardiovascular events, such as blood clots that can lead to death.

As prominently noted in the drug's MedGuide, one of the most important things to know about Plavix is that it may not work as well in patients with certain genetic factors, which can affect how a patient breaks down the drug. Those differences, in turn, can affect the efficacy and safety of drug.

New Lawsuit

But that information hasn't always been known, and on Wednesday Hawaii Attorney General David Louie said he had filed a lawsuit against Bristol Myers Squibb and Sanofi-Aventis accusing the two companies of "deceptively and unfairly labeling and marketing the drug" starting in 1998.

The deception, Louie claimed, resulted from the companies "failing to disclose that Plavix has a diminished or no effect on approximately 30 percent of the population," a large component of which are people of Pacific-Island or East Asian heritage.

"It has been reported that 38-79 percent of Pacific Islanders and 40-50 percent of East Asians may respond poorly to Plavix due to a genetic predisposition to poorly metabolize the drug," the attorney general's office wrote in a statement.

The lawsuit goes on to claim that the companies failed to utilize a "simply genetic test" that was available at the time that would have determined which populations were unlikely to benefit.

Additional claims in the lawsuit allege that BMS and Sanofi deceptively marketed the drug as being safer and more effective than aspirin, and that the drug was safe and effective in elderly and young patients.

BMS and Sanofi both declined to comment on the pending litigation, saying only that the drug remains "one of the most studied medicines" on the market.

Personalized Medicine: A Catch-22

The lawsuit could serve as a source of caution for companies: While new genomic data may establish new ways to target drugs toward narrower sets of patients most likely to benefit, it may also bring with it new lawsuits alleging a failure to properly test a product in the past.

Plavix's genetic limitations were only added to its label in 2009, and later upgraded to a Boxed Warning in 2010.


Hawaii AG Statement

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