Drug maker Johnson & Johnson has put funds aside toward a possible <"http://www.yourlawyer.com/topics/overview/risperdal">Risperdal (Generic: Risperidone) settlement. The sum remains unknown and is being earmarked for penalties that have been racking up over the course of an investigation that has been ongoing for seven years, said NJ.com.
The charges are a result of alleged unapproved marketing of the schizophrenia medication, wrote NJ.com, citing documents filed with federal security regulators.
Risperdal is a newer atypical antipsychotic drug prescribed to help people combat Schizophrenia and is manufactured by Jannsen Pharmaceuticals, a division of Johnson & Johnson.
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 Johnson & Johnsonâ€™s subsidiary, Ortho-McNeil-Janssen Pharmaceuticals, in 2004. In early 2010, the government was looking for more details on the sales and marketing of Risperdal and Invega, another schizophrenia drug, said NJ.com.
The investigation is looking at how these two drugs were allegedly marketed for unapproved or off-label uses, said the Securities and Exchange Commission (SEC) filing. Drugs can be prescribed for off-label uses by physicians; however, drug makers are legally banned from marketing drugs for uses not approved by the U.S. Food and Drug Administration (FDA).
As NJ.com pointed out, this governmental probe is only 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.
For instance, we recently wrote that prosecutors claim Risperdal was used to control anxiety among nursing home patients with dementia and Alzheimerâ€™s disease, an off-label use of the drug. In that case, Johnson & Johnson was charged with paying kickbacks to the Omnicare nursing home chain for the purpose of increasing the use of its drugs at the chain’s homes. According to allegations contained in a complaint filed by the U.S. Attorneys office in Boston, from 1999 to 2004 Johnson & Johnson paid kickbacks to Omnicare in rebates, grants, and educational funding, to name a few. Among many other issues, the complaint repeatedly mentions internal Johnson & Johnson emails and statements detailing the Omnicare relationship. The government claims those documents show that Johnson & Johnson came to see Omnicare pharmacists as an extension of its sales force.
Prosecutors also allege that Johnson & Johnsonâ€™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.