 In the first settlement, Madigan and the states alleged in a civil
complaint that Abbott engaged in deceptive practices to market
Depakote, which is FDA-approved for treating seizure disorders,
mania associated with bipolar disorder and for prophylaxis of migraines.
But Madigan alleged the company deliberately opted to bypass the
regulatory approval process and instead promoted off-label uses,
including as treatments for schizophrenia, dementia and autism, when
medical studies failed to adequately prove the drug to be effective
for these conditions. Off-label drug use occurs when a drug is used
for certain treatments and conditions that the U.S. Food and Drug
Administration has not approved.In a separate agreement with
federal authorities, Madigan and the states alleged the company’s
off-label marketing resulted in hundreds of millions of dollars in
false claims to Medicaid, Medicare and other federal health care
programs. Madigan said Abbott improperly marketed Depakote for
off-label uses in nursing homes and illegally paid health care
professionals and long-term care pharmacy providers to promote or
prescribe the drug.
"Abbott made a deliberate decision to circumvent the regulatory
approval process, opting instead to deceptively market Depakote for
treating seniors with dementia and mental health patients despite a
lack of convincing medical evidence for such uses," Madigan said.
In the civil complaint filed May 7 along with the settlement,
Madigan and the states detail how Abbott allegedly conducted
off-label promotions through a variety of deceptive practices. The
company distributed studies that showed Depakote could be used to
treat off-label conditions and instructed its sales representatives
to draw attention to the studies. In one such study, Abbott sought
to determine Depakote’s effectiveness to treat schizophrenia. The
final results showed the drug was mostly ineffective for treating
schizophrenia, but the company allegedly delayed releasing the
negative results while it continued to promote Depakote for treating
the mental condition.
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As a part of the civil settlement, Abbott has agreed to
significantly change how it markets Depakote and to cease promoting
off-label uses, in addition to a $100 million payment. Additionally,
under the settlement, Abbott is prohibited from making false or
misleading claims about Depakote, and the company is required to
ensure financial incentives for sales of the drug do not promote
off-label uses. Abbott also must restrict other specific practices
it used to promote off-label uses of the drug.
The second settlement with the states and federal government
resolves false claims to Medicaid, Medicare and other federal health
care programs. As a condition to that agreement, Abbott pleaded guilty
to a violation of the federal Food, Drug and Cosmetic Act. As part
of this settlement, Abbott has agreed to pay a criminal fine and
forfeiture of $700 million.
Joining Madigan in the announcement last week were attorneys
general in Alabama, Alaska, Arizona, Arkansas, California, Colorado,
Connecticut, the District of Columbia, Florida, Hawaii, Idaho,
Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts,
Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska,
Nevada, New Jersey, New Mexico, New York, North Carolina, North
Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South
Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia,
Washington, West Virginia and Wisconsin.
[Text from file received from the office
of
Illinois Attorney General Lisa
Madigan]
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