Judge Dean Ochiai in Honolulu concluded the companies engaged in
unfair and deceptive business practices from 1998 to 2010 by failing
to change the drug's label to warn doctors and patients despite
knowing some of the risks.
Hawaii Attorney General Clare Connors, whose office sued the
companies in 2014, said the ruling "puts the pharmaceutical industry
on notice that it will be held accountable for conduct that deceives
the public and places profit above safety."
Bristol-Myers and Sanofi, which produced Plavix in a partnership, in
a joint statement vowed to appeal, saying the decision was
"unsupported by the law and at odds with the evidence at trial."
They called Plavix safe and effective.
Ochiai, who presided over a four-week, non-jury trial conducted
entirely over Zoom due to the COVID-19 pandemic, ordered
Bristol-Myers and Sanofi to each pay $417 million in penalties.
[to top of second column] |
Hawaii alleged the companies
violated state consumer protection laws by
marketing Plavix without disclosing that the
drug could have a diminished or no effect for
some people, particularly of East Asian and
Pacific Island ancestry.
Plavix is prescribed to prevent strokes and
heart attacks. The blood thinner needs to be
activated by the body's own enzymes, which can
vary genetically.
Studies have shown that about 14% of Chinese
patients are unable to metabolize the drug
properly, compared with 4% of Black and 2% of
white patients.
The U.S. Food and Drug Administration in 2010
issued a new Plavix warning label to reflect
that information.
Bristol-Myers and Sanofi still face a similar
lawsuit over Plavix by the state of New Mexico.
(Reporting by Tina Bellon and Nate Raymond;
Editing by Richard Chang, Dan Grebler and Sherry
Jacob-Phillips)
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