Attorney General Gansler: Abbott Laboratories Settles for $100 Million
Md. to get over $1.8 million in settlement over promotion of Depakote
Baltimore, MD (May 7, 2012) - Attorney General Gansler announced today that Maryland has joined 44 other states and the District of Columbia in reaching a $100 million settlement with Abbott Laboratories over allegations of illegal marketing of its Depakote drug. The agreement is the largest multi-state consumer protection-based pharmaceutical settlement ever reached. Maryland will receive more than $1.8 million dollars and the Illinois-based Abbott Laboratories will be prohibited from marketing the drug for uses not approved by the U.S. Food and Drug Administration.
"This office will continue to scrutinize and respond to inappropriate and illegal claims made by pharmaceutical companies," said Attorney General Gansler. "Maryland consumers deserve to know the truth about the prescription drugs they're taking."
In a complaint filed today along with the settlement agreement, the states alleged Abbott engaged in unfair and deceptive practices when it marketed Depakote for uses for which the drug had not been shown to be safe and effective. Depakote is approved for treatment of seizure disorders, mania associated with bipolar disorder and prophylaxis of migraines, but the Attorneys General allege Abbott marketed the drug for treating unapproved uses, including schizophrenia, agitated dementia and autism.
As a result of the states' investigation, Abbott has agreed to significantly change how it markets Depakote and to cease promoting unapproved uses. Under the settlement, Abbott Laboratories is:
- Prohibited from making false or misleading claims about Depakote;
- Prohibited from promoting Depakote for unapproved uses; and
- Required to ensure that financial incentives do not motivate sales representatives to promote unapproved uses of Depakote.
In addition, for a five-year period, Abbott must:
- Require its scientific personnel, and not its sales personnel, to develop the medical content of responses to requests by physicians for non-promotional information about unapproved uses of Depakote;
- Limit dissemination of reprints of clinical studies relating to unapproved uses of Depakote to its scientifically-trained personnel;
- Restrict use of continuing medical education (CME) grants relating to Depakote so that such grants are non-promotional;
- Disclose Depakote-related CME grants; and
- Register and disclose clinical trials.