Connecticut will receive more than $10 million in one of the largest pharmaceutical fraud settlements in history, as Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., resolve allegations of unlawfully marketing two antipsychotic drugs, including Risperdal, heavily used among nursing-home patients.
Johnson & Johnson has agreed to pay a total of $2.2 billion to states and the federal government to end civil and criminal investigations into off-label marketing of Risperdal and Invega, both antipsychotics, as well as the heart drug Natrecor, for uses not approved by the U.S. Food and Drug Administration. The company allegedly paid kickbacks to physicians and pharmacists to promote the drugs for unapproved uses.
In documents filed Monday, federal officials said that Johnson & Johnson, through Janssen, marketed Risperdal to doctors for use in elderly dementia patients, even though the drug was approved only for schizophrenia. Connecticut’s rate of antipsychotic use in nursing homes remains in the top 20 nationally, but has dropped in recent years, a recent C-HIT analysis found.
Connecticut and other states contend that between 1999 and 2005, the pharmaceutical companies promoted Risperdal for off-label uses; made false and misleading statements about the safety and efficacy of Risperdal; and paid illegal kickbacks to healthcare professionals and long-term care pharmacy providers to induce them to promote and prescribe Risperdal to children, adolescents and elderly patients.
The states also contend that from 2007 to 2009, the companies promoted Invega for off-label uses and made false and misleading statements about the drug’s safety and efficacy.
The portion of the settlement attributable to the state and federal shares of Connecticut’s Medicaid program is $19.5 million, of which $9.6 million represents the net state share. Connecticut will receive an additional $475,000 for prescription drug programs administered by the Department of Social Services.
Improper marketing of drugs “leads to false and fraudulent claims against our Medicaid program, and ultimately puts patients at risk,” Attorney General George Jepsen said in a statement.
Chief State’s Attorney Kevin Kane commended the Medicaid Fraud Control Unit in the Office of the Chief State’s Attorney, the Office of the Attorney General and the Department of Social Services for their continued efforts to recover public resources.
The companies also will enter into a corporate integrity agreement with the U.S. Department of Health and Human Services, Office of the Inspector General, which will closely monitor the companies’ future marketing practices.