A federal court complaint filed in U.S. District Court in Chicago alleges that Abbott Laboratories engaged in racketeering when it marketed the epilepsy drug Depakote (divalproex) for unapproved uses.
The plaintiffs—the Sidney Hillman Health Center of Rochester, New York; the Teamsters Health Services & Insurance Plan Local 404 in Springfield, Massachusetts; and Park Ridge, Illinois-based United Food & Commercial Workers Unions and Employers Midwest Health Benefits Fund—each allegedly paid for beneficiaries’ Depakote prescriptions. The plaintiffs accuse Abbott of violating federal racketeering laws and of unjust enrichment, Bloomberg Businessweek reports. The plaintiffs are seeking unspecified money damages.
Last year Abbott agreed to pay $1.6 billion to settle state and federal claims it had promoted Depakote for off-label use, according to Businessweek. While a physician may freely prescribe a drug for off-label use, a manufacturer is allowed to market drugs to physicians only for uses approved by the U.S. Food and Drug Administration (FDA). The settlement resolved a four-year investigation into the sales practices of the Illinois-based pharmaceutical company. In announcing the settlement, the U.S. Department of Justice said Abbott used a specially trained sales force to promote the use of Depakote to control agitation and aggression in elderly dementia patients and to treat schizophrenia. Neither of these uses has FDA approval.
In their legal filing, the three health-benefit plans stated that “Abbott probably calculated both its risk of being caught and its potential civil and criminal exposure assuming its only liability would be to the Medicare, Medicaid and Tricare systems.” These benefit plans serve the elderly, the indigent, and members of the armed forces. According to the complaint, the penalties imposed by the settlement were “insufficient to compensate” for the harm caused to injured claimants.