Connecticut will receive close to $6 million from federal and state settlements with Illinois-based Abbott Laboratories over allegations the company promoted sales and use of the prescription drug Depakote for uses not approved by the FDA.
The state will share in a $1.5 billion civil and criminal health care fraud settlement of allegations that Abbott’s conduct resulted in false claims to Medicaid and other federal health care programs. Abbott agreed to pay the states and federal government $800 million in civil damages and penalties. The net state share for Connecticut Medicaid claims is more than $3.9 million, Attorney General George Jepsen said.
Connecticut also will receive $499,000 for benefit programs administered by the Department of Social Services, and $1.5 million resulting from a consumer protection claim that Abbott engaged in unfair and deceptive practices by off-label marketing of Depakote.
About $150,000 of the settlement funds will go to the state Department of Consumer Protection’s Prescription Drug Monitoring Program, which collects prescription data on controlled substances that providers and pharmacists can track in treating patients. Money for the program, which is intended to stem prescription abuse and errors, had been slated to run out later this year.
Depakote is an anti-seizure and mood-stabilizing drug prescribed for bipolar disorder. Abbott acknowledged that it marketed the drug for unapproved uses, including treatment of schizophrenia, agitated dementia and autism. The company admitted that a specialized sales force promoted Depakote for treating dementia because the drug was not subject to federal regulations designed to prevent the use of unnecessary medications in nursing homes. The company also marketed Depakote to treat schizophrenia.
Physicians sometimes prescribe drugs to patients for purposes not approved by the FDA, but pharmaceutical companies are not allowed to market drugs for unapproved purposes.
Jepsen said he hoped the settlements would act as a deterrent to other companies seeking to tap government healthcare programs improperly and would “help to protect consumers who were prescribed an expensive drug with little evidence the drug could help their condition.”
Social Services Commissioner Roderick Bremby said the agency’s claims data indicated “a significant and inappropriate impact on Medicaid expenditures, a factor that will now be mitigated by this major settlement.”
The health care fraud complaint alleged that Abbott knowingly promoted the sale and use of Depakote for unapproved uses and as a result, caused false claims for Depakote to be submitted to Medicaid. According to the complaint, Abbott promoted Depakote by making false and misleading statements about the safety, efficacy, dosing, and cost-effectiveness of the drug; improperly marketing the product for use in nursing homes; and offering and paying illegal remuneration to health care professionals and long-term care pharmacy providers to induce them to promote or prescribe Depakote.