(COLUMBUS, Ohio) —Attorney General Mike DeWine announced today that Ohio has joined with 49 states, the District of Columbia, and the federal government to reach a $1.5 billion settlement, the second largest recovery from a pharmaceutical company in a single civil and criminal global resolution agreement, with Abbott Laboratories. In a separate but related settlement, DeWine today joined 44 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 drug Depakote, marking the largest consumer protection based pharmaceutical settlement ever reached.
"Improper marketing of prescription drugs can lead to serious consequences," Attorney General DeWine said. "These settlements will help ensure that Depakote is marketed only for approved uses and serve as a deterrent towards companies attempting to make false claims."
Ohio's state and federal portion of the Medicaid settlement is $26.5 million, with Ohio retaining $10.75 million. Medicaid is paid for jointly by the federal and state governments.
The Medicaid agreement settles civil and criminal allegations that Abbott Laboratories illegally marketed the drug Depakote. The states contend that from January 1998 through Dec. 31, 2008, Abbott promoted the sale and use of Depakote for uses that were not approved by the Food and Drug Administration as safe and effective.
This alleged conduct resulted in false claims to Medicaid and other federal healthcare programs. Further, the covered conduct from the settlement provides that Abbott Laboratories made false and misleading statements about the safety, efficacy, dosing and cost-effectiveness of Depakote for some unapproved uses; improperly marketed the product in nursing homes; and paid illegal remuneration to health care professions and long term care pharmacy providers to induce them to promote and/or prescribe Depakote.
Abbott Laboratories will pay the states and the federal government $800 million in civil damages and penalties to compensate Medicaid, Medicare, and various federal healthcare programs for harm suffered as a result of its conduct. In addition to the civil Medicaid settlement, Abbott Laboratories pled guilty this morning to a violation of the Food, Drug, and Cosmetic Act and agreed to pay a criminal fine and forfeiture of $700 million.
As part of the consumer protection settlement, Ohio will receive $3.75 million, and Illinois-based Abbott will be restricted from marketing the drug for off-label uses not approved by the U.S. Food and Drug Administration. Ohio's share will go to the Consumer Protection Enforcement Fund to support consumer protection efforts in the state.
Depakote is approved for treatment of seizure disorders, mania associated with bipolar disorder, and prophylaxis of migraines, but the attorneys general alleged Abbott marketed the drug for treating unapproved uses, including schizophrenia, agitated dementia, and autism.
Under the consumer protection settlement, Abbott Laboratories is:
- Prohibited from making false or misleading claims about Depakote,
- Prohibited from promoting Depakote for off-label uses, and
- Required to ensure financial incentives on sales do not promote off-label uses of Depakote.
In addition, for a five-year period Abbott must:
- Limit the creation and use of responses to requests by physicians for non-promotional information about off-label uses of Depakote,
- Limit dissemination of reprints of clinical studies relating to off-label uses of Depakote,
- Limit use of grants and CME,
- Disclose payments made to physicians, and
- Register and disclose clinical trials.
Consumers who suspect unfair or deceptive business practices should file complaints with the Ohio Attorney General’s Office at www.OhioAttorneyGeneral.gov or 800-282-0515.
In addition to consumer protection efforts regarding unfair prescription drug marketing, Attorney General DeWine has allocated resources to help curb prescription drug abuse in Ohio. To learn more about those efforts, visit http://www.ohioattorneygeneral.gov/getdoc/51d02669-8c88-49a9-be10-a94ab8618f19.
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