This settlement is considered one of the largest related to off-label marketing and is expected to affect Johnson & Johnson’s bottom line this quarter. The federal investigation has been ongoing since 2004 and has been looking into Janssen Pharmaceutica, a Johnson & Johnson unit, accused of inappropriately marketing Risperdal, according to the drug maker’s filings with the U.S. Securities and Exchange Commission (SEC), said the Journal.
This week, Johnson & Johnson announced it set aside an undisclosed amount for a potential settlement and would “likely” have to contend with civil and criminal actions if it refused to settle, wrote the Journal. As NJ.com recently pointed out, this probe is just one connected to Risperdal that Johnson & Johnson is facing; there are a number of related lawsuits which have been filed by attorneys general in a variety of states.
According to NJ.com, The Office of the Inspector General of the U.S. Office of Personnel Management issued its first subpoena on the matter to Ortho-McNeil-Janssen Pharmaceuticals in 2004. In early 2010, the government sought more details on the sale and marketing of Risperdal and Invega, another schizophrenia drug, said NJ.com. The investigation is looking at how these drugs were allegedly marketed for off label uses, said the SEC filing. Drugs can be prescribed off-label by physicians; however, drug makers are legally banned from marketing drugs for uses not approved by the U.S. Food and Drug Administration (FDA).
An insider told the Journal that government prosecutors are looking to the $1.4 billion Eli Lilly & Co. 2009 settlement over illegal Zyprexa marketing, its antipsychotic medication, as a base point said the Journal. The timeframe involved with those activities was longer than in this case. Another 2009 settlement, this one with Pfizer Inc., is considered the largest at $2.3 billion to settle off label allegations concerning Bextra, a painkiller that has since been pulled from the market, wrote the Journal.
Specific federal allegations have not been released; however, it has been noted that Risperdal has been approved for schizophrenia and bipolar disorder and should not be used for the treatment of dementia-related psychosis, including in the elderly who experienced increased risks of death from Risperdal, explained the Journal. The J&J case began as a whistleblower case—one in which employees can be compensated for recovered government funds. In this case, one issue at stake is the wasted Medicaid and government funds linked to off label marketing, said the Journal.
We recently wrote that prosecutors claim Risperdal was used to control anxiety among nursing home patients with dementia and Alzheimer’s disease, an off-label use. Prosecutors also allege that Johnson & Johnson’s conduct caused false or fraudulent claims to be filed with Medicaid, the public health program for the poor and disabled.
Risperdal has been known to cause irregular heartbeats, muscle weakness and spasms, high fever, constipation, weight gain, and headaches. Risperdal has also been linked to diabetes, Neuroleptic Malignant Syndrome (NMS), Stroke, and Tardive Dyskinesia. There have been 37 reports of stroke or stroke-like events, including 16 deaths linked to Risperdal.

source: newsinferno