Connecticut Receives $10 Million in Psychiatric Drug Case

, The Connecticut Law Tribune

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Connecticut is slated to receive over $10 million as part of a multistate national settlement with Johnson & Johnson to resolve allegations that the company promoted powerful psychiatric drugs for unapproved uses in children, seniors and disabled patients.

The settlement includes $1.72 billion in civil payments to federal and state governments as well as $485 million in criminal fines and forfeited profits. The agreement is the third-largest settlement with a drugmaker in U.S. history.

J&J, and its subsidiary Janssen Pharmaceuticals, both headquartered in New Jersey, allegedly promoted and marketed two drugs, Risperdal and Invega, for uses that were not approved by the U.S. Food and Drug Administration.

Specifically, government officials alleged that J&J and Janssen promoted Risperdal to control numerous behavioral problems in seniors, children and the mentally disabled between 1999 and 2005. The companies similarly promoted Invega for inappropriate uses between 2007 and 2009.

Court documents show the government raised objections about the company's marketing approach for years. In a 1999 letter, the FDA warned Janssen that "disseminating materials that state or imply that Risperdal has been determined to be safe and effective for the elderly population" would be "misleading."

Despite such warnings, the company's marketing plan targeted nursing homes and doctors who treated the elderly. Marketing materials distributed by an "ElderCare sales force" emphasized Risperdal as a treatment for seniors suffering from everything from agitation to depression to hostility. The company also downplayed the drug's risks, including diabetes and weight gain.

At the same time the drugmaker was allegedly paying kickbacks to the nation's largest nursing home pharmacy, Omnicare. J&J paid millions in bogus grants and education payments to persuade the company's hundreds of pharmacists to recommend Risperdal to nursing homes. The government said the payments amounted to kickbacks.

The company also set business goals to increase drug sales to children and adolescents. Janssen instructed its sales representatives to call on child psychiatrists and to market Risperdal as a treatment for common childhood disorders, such as attention deficit disorder and autism.

Risperdal grew to become J&J's top product by 2005, with sales over $3.5 billion.

As part of the civil settlement agreement between the pharmaceutical companies and the states and federal governments, they will pay back $1.1 billion to state Medicaid programs.

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