Johnson & Johnson Corp.'s (J&J) plan to reach $302 million in sales of anti-psychotic drug Risperdal by marketing it to the elderly came to the attention of Louisiana officials. The plan came to light just months after federal regulators said the company falsely claimed the drug was safe and effective for dementia treatment.
In State of Louisiana v. Janssen Pharmaceuticals, Louisiana officials cited more than a dozen J&J files and internal documents stating the company's plan to market Risperdal for unapproved uses. Until 2003, the FDA approved Risperdal only for use on psychotic disorders such as schizophrenia. The agency never approved it for dementia.
J&J and its Ortho-McNeil Janssen Pharmaceutical unit deny engaging in off-label marketing. They plan to fight the lawsuit. Louisiana is seeking hundreds of millions of dollars for fines and public sales. Ten other states also have sued J&J over the drug sale proceeds, and others may file similar suits.
J&J hasn't reserved any money for the settlement. Risperdal's global sales peaked at $4.5 billion in 2007, but declined shortly after the company lost patent protection.