B-MS, Sanofi Claim Hawaii is Violating Their Free Speech in Plavix Suit

Regulatory NewsRegulatory News | 09 January 2020 |  By 

Bristol-Myers Squibb (B-MS) and Sanofi filed a complaint this week in the US District Court for Hawaii to fight a lawsuit brought on by the state, which sought hundreds of millions in civil penalties for the companies’ failure to make certain statements about the cardiovascular drug Plavix (clopidogrel).

B-MS and Sanofi contend that Hawaii’s lawsuit effectively seeks to compel and punish the companies’ speech “in an area of scientific controversy.” At issue is the state’s contention that Sanofi and B-MS knew, for 12 years before a boxed warning was added in 2010 to Plavix, that Plavix has a diminished or no effect on Asian and Pacific Islander patients.

“The State would apparently have the Companies say that Plavix has a diminished effect on approximately 30% of the patient population and that a simple genetic test would identify the patients for whom Plavix would not work,” B-MS and Sanofi allege. “There is no scientific basis for such a statement—not now, and certainly not in 1998, when the State claims the Companies should have informed about this alleged risk. In fact, FDA in 2016 removed from the Plavix label the only language suggesting that those with a genetic variation had worse clinical outcomes than other patients— confirming that such warnings are unnecessary.”

The companies also allege that Hawaii is discriminating because they are pharmaceutical companies and because of the content of their speech and viewpoint (that Plavix is not safe and effective for all races of patients).

As far as why the boxed warning was initially added to Plavix’s label in 2010 (to suggest that genetic testing be considered) and then pulled in 2016, B-MS and Sanofi claim, “The medical consensus, as reflected in all of the leading treatment guidelines issued by organizations such as the American College of Cardiology and the American Heart Association, continues to endorse Plavix as first-line therapy, has never recommended prescribing Plavix based on race or ethnicity, and continues to reject routine genetic testing.”

The companies add: “Hawai`i’s lawsuit not only violates the Companies’ First Amendment rights, but threatens to significantly chill their protected speech.”

Hawaii, meanwhile, said in its 2014 suit that the companies made false and misleading statements and representations when marketing Plavix, including in labeling, sales and promotional materials. The suit also claims that the companies made false or misleading superiority claims about Plavix relative to aspirin, which is the traditional treatment for patients with or at risk for atherosclerosis.

The state’s suit further contends that B-MS and Sanofi made false or misleading claims when it marketed Plavix as superior to aspirin for treating stroke and heart attack patients.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy