TRENTON
– The Office of the Attorney General
announced today that New Jersey has joined
a multi-state settlement with pharmaceutical
manufacturer Abbott Laboratories that resolves
both criminal and civil allegations the company
deceptively marketed its drug Depakote.
Abbott
will pay the states and the federal government
a total of $800 million in damages and penalties
to compensate Medicaid, Medicare and various
federal health care programs for harm suffered
as a result of its conduct. As part of this
civil resolution, New Jersey will receive
$7.1 million in restitution and other recovery.
The
civil settlement is based on four cases
that were consolidated and are pending in
U.S. District Court for the Western District
of Virginia in Abingdon, Va. The cases were
filed under both federal and state false
claims statutes. In addition to the civil
settlement, Abbott pleaded guilty today
to a violation of the federal Food, Drug
and Cosmetic Act and agreed to pay a federal
fine and forfeiture of $700 million.
Under
the civil consumer protection aspect of
the national settlement, New Jersey will
receive approximately $2.3 million, and
the Illinois-based Abbott will be restricted
from marketing Depakote for off-label uses
– uses not approved by the federal
Food and Drug Administration (FDA).
Forty-four other states and the District
of Columbia also are party to the global
settlement, described as the largest-ever
multi-state pharmaceutical settlement. Nationally,
Abbott will pay all participating states
a total of $100 million to resolve civil
allegations related to deceptive marketing.
In addition, Abbott has entered into a separate
settlement with the federal government related
to the civil allegations.
Depakote is approved by the FDA for treating
seizure disorders, as well as for the treatment
of mania associated with bipolar disorder
and prophylaxis of migraine headaches. However,
Abbott promoted Depakote for non-approved
uses such as treatment of schizophrenia,
agitated dementia and autism.
A
civil Complaint, filed in New Jersey Superior
Court today along with a Final Consent Judgment
memorializing the multi-state settlement,
alleges that Abbott engaged in unconscionable
commercial practices when it marketed Depakote
for such off-label uses. The Complaint also
alleges that Abbott engaged in off-label
marketing of Depakote despite clinical evidence
suggesting the drug was ineffective when
administered for some of the off-label purposes
it was promoting.
In
addition to the monetary terms of the civil
settlement, the agreement with Abbott includes
a number of provisions designed to prevent
the future promotion of Depakote for off-label
uses including:
- A
prohibition against Abbott making any
written or oral claim that is false, misleading
or deceptive regarding the drug
- A
prohibition against promoting Depakote
for off-label uses of any kind.
- A
requirement that the compensation of Abbott
sales representatives be designed to ensure
there are no financial incentives tied
to their promoting of Depakote for off-label
use.
In
addition to New Jersey, the following states
and the District of Columbia participated
in the global settlement: Alabama, Alaska,
Arizona, Arkansas, California, Colorado,
Connecticut, Florida, Hawaii, Idaho, Illinois,
Indiana, Iowa, Kansas, Kentucky, Maine,
Maryland, Massachusetts, Michigan, Minnesota,
Mississippi, Missouri, Montana, Nebraska,
Nevada, 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.
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