Thursday, August 30, 2012

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Texas, 36 States Finalize $181 Million Risperdal Settlement with Janssen Pharmaceuticals Inc.

DALLAS Texas Attorney General Greg Abbott, along with attorneys general from 36 other states, today announced a $181 million settlement with Janssen Pharmaceuticals Inc. a subsidiary of Johnson & Johnson over its unlawful and deceptive marketing of several antipsychotic drugs.

The four-year, multi-state investigation revealed that Janssen urged physicians to prescribe its atypical antipsychotic drugs for purposes not approved by the U.S. Food and Drug Administration (FDA). Evidence obtained by the State revealed that Janssen targeted geriatric and pediatric patients with Alzheimer’s disease, dementia, depression and anxiety. Because the FDA had not approved the drugs for these uses, Janssen’s marketing plan was unlawful. Moreover, the Risperdal-related drugs which include Risperdal, Risperdal Consta, Risperdal M-Tab and Invega were not subjected to the rigorous testing process necessary to designate the drugs safe and effective.

Media links
Attorney General's lawsuit against Janssen Pharmaceuticals Inc. and Johnson & Johnson
Final judgment and permanent injunction against Janssen Pharmaceuticals Inc. and Johnson & Johnson

Under the settlement, the State of Texas will receive $11.37 million. Additionally, the settlement prohibits Janssen from unlawfully marketing the antipsychotics drugs subject to the agreement. For a five-year period, Janssen must also:

Employ scientifically trained personnel to develop medical content to be provided in its communications to providers, rather than sales and marketing professionals.
Clearly disclose the specific risks identified in the products’ black-box warnings on promotional materials for its atypical antipsychotic drugs.
Develop policies to ensure that financial incentives are not given to sales and marketing staff that promote off-label marketing.
Require that medical education providers disclose any financial support they receive from Janssen to aid their programs.

Earlier this year, the Texas Attorney General’s Office resolved the State’s civil Medicaid fraud case against Janssen, which resolved claims made to doctors of Medicaid patients, and resulted in a $61 million recovery for the State of Texas and state taxpayers. Today’s agreement resolves the misrepresentations made to doctors of non-Medicaid patients.