Hawaii part of settlement with Depakote drug maker

Agreement marks largest consumer protection-based pharmaceutical settlment ever reached

Published  6:01 AM HST May 07, 2012

The Hawaii Office of Consumer Protection Monday joined 45 other states and the District of Columbia in announcing a $100 million settlement with Abbott Laboratories over allegations of illegal off-label marketing of its Depakote drug.

"The agreement marks the largest consumer protection-based pharmaceutical settlement ever reached," said Hawaii Office of Consumer Protection Executive Director Bruce Kim. "As a result of the states' investigation and this settlement, Hawaii will receive nearly $1.2 million and Illinois-based Abbott Laboratories will be restricted from marketing the drug for off-label uses not approved by the U.S. Food and Drug Administration."

In complaints filed Monday, the states alleged that Abbott engaged in unfair and deceptive practices when it marketed Depakote for off-label uses.

Depakote is approved for treatment of seizure disorders, mania associated with bipolar disorder and prophylaxis of migraines, but the Hawaii lawsuit also alleged that Abbott marketed the drug for treating unapproved uses, including schizophrenia, agitated dementia and autism.

Abbott has agreed to significantly change how it markets Depakote and to cease promoting off-label uses.

The company also will pay $100 million nationally.  As part of this settlement, Hawaii will receive nearly $1.2 million in settlement funds from the company for consumer education and consumer protection enforcement actions.

Under the settlement, Abbott Laboratories is:

In addition, for a 5-year period Abbott must:

The following states and the District of Columbia participated in today’s settlement: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Hawai'i, Idaho, Illinois, 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.

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