Janssen pleads guilty to introducing misbranded drug, Risperdal, into interstate commerce

Janssen Pharmaceuticals, a wholly-owned subsidiary of drugmaker

Johnson & Johnson, agreed to plead guilty Nov. 7 to one count of introducing a misbranded drug into interstate commerce, the move coming days after J&J settled Risperdal off-label marketing claims for $2.2 billion.

The U.S. Attorney’s Office in Philadelphia announced the guilty plea in the criminal portion of the case against Janssen and J&J.

U.S. District Judge Timothy Savage ordered Janssen to pay a $344 million fine and forfeit an additional $66 million.

Last week, the drug companies agreed to the multi-billion dollar settlement to resolve the civil portion of the case.

The federal government alleged that the pharmaceutical manufacturers were marketing Risperdal, a drug designed to treat specific psychiatric conditions such as bi-polar disorder and psychosis, to segments of the population including adolescents and the elderly.

In March 2002, the Food and Drug Administration narrowed the approved use to the treatment of schizophrenia only, according to the U.S. Attorney’s Office.

Prosecutors said that the defendants soon introduced Risperdal for a new, unapproved use, rendering the product misbranded.

The allegations were that the drugmakers marketed the drug to treat much less severe psychological conditions such as anxiety, agitation and other more common mood disorders.

The civil settlement resulted from a whistleblower, or qui tam, case that had been filed at the federal courthouse in Philadelphia back in 2004.

The relator in that case, who brought suit on behalf of the U.S. Government, was a former drug sales representative who says she was encouraged and pressured to market Risperdal off-label.

The government alleged that J&J and Janssen promoted Risperdal for unapproved uses from at least 1999 through 2005.

The government also claimed that the defendants paid kickbacks to prescribing physicians and that Janssen specifically paid speaker fees to doctors to influence them to write more prescriptions for the psychiatric drug.

Last Thursday, the U.S. Attorney’s Office in Philadelphia announced that in its plea agreement resolving the criminal charges, Janssen admitted that between March 2, 2002, and Dec. 31, 2003, it promoted Risperdal to healthcare providers for treatment of psychotic symptoms and associated disturbances exhibited by elderly, non-schizophrenic dementia patients, uses that were not approved as safe and effective by the FDA.