In 1993, the FDA approved Johnson & Johnson’s drug Risperdal for the limited use of treating a few psychotic disorders, including schizophrenia. However, even with limited FDA approval, claims for Risperdal prescriptions increasingly flooded government health care programs, generating worldwide sales of $24.2 billion from 2003 to 2010. Then, J&J lost patent protection and Risperdal sales started plummet.

According to several state and federal False Claims Act actions, J&J’s Janssen unit illegally boosted sales by off-label marketing Risperdal for bipolar disorder, dementia, mood and anxiety disorders and other unapproved uses.

This week, J&J and the Justice Department are expected to announce a near-record $2.2 billion settlement, quieting the False Claims Act qui tam actions, including suits detailing the company’s alleged off-label promotions of Risperdal. At least $600 million of this settlement amount covers a misdemeanor criminal charge related to Risperdal marketing. The accord also supposedly resolves civil claims that J&J paid kickbacks to Omnicare Inc., a company that dispenses drugs at nursing homes.

Notably, J&J ultimately received FDA approval for many of the indications that were allegedly off-label marketed to the prescribing community. However, companies are not permitted to jump the gun and promote uses before they have received the FDA stamp of approval.

“When water flows uphill, something must be pumping it,” said former federal prosecutor and Nolan & Auerbach partner Marcella Auerbach. “If these allegations are true, off-label marketing floated J&J’s profit margins at the expense of government healthcare programs.”

The national whistleblower law firm Nolan & Auerbach is actively litigating an intervened False Claims Act qui tam action against J&J, alleging that the company off-label marketed its heart-failure drug Natrecor.

More information for whistleblowers is located at the Nolan & Auerbach, P.A. website.