Drug giant Johnson & Johnson (J&J) announced it just reached an agreement to settle a misdemeanor criminal charge concerning how it marketed its antipsychotic, Risperdal (Generic: Risperidone). According to Bloomberg.com a U.S. probe into Risperdal sales activities has been ongoing since 2004 and involves allegations that J&J marketed Risperdal for unapproved uses, citing the drug maker’s quarterly filing this week.
Meanwhile, the U.S. Department of Justice (DOJ) and Philadelphia’s U.S. attorney say they “are continuing to pursue both criminal and civil actions,” said J&J, wrote Bloomberg.com.
Risperdal is an antipsychotic medication approved for the treatment of schizophrenia, bipolar disorder, and irritability linked to autism disorder. 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.
“Discussions have been ongoing in an effort to resolve criminal penalties under the Food Drug and Cosmetic Act related to the promotion of Risperdal,” J&J said. “Certain issues remain open before a settlement can be finalized,” Bloomberg.com reported. J&J is also negotiating a civil investigation concerning how Risperdal and Invega were marketed; however, the drug maker remains uncertain concerning a settlement.
J&J said it was advised by the DOJ that the Department will either become involved or join lawsuits filed by whistleblowers against J&J’s Janssen Pharmaceuticals unit over how Risperdal was marketed, said Bloomberg.com, which noted that the lawsuits were brought under the U.S. False Claims Act and filed under a seal and have not yet been made public. J&J and Janssen face lawsuits by 11 states over Medicaid and other public fund reimbursement issues with Risperdal. According to the lawsuit, said Bloomberg.com, the drug maker allegedly marketed Risperdal for nonapproved uses such as dementia and mood and anxiety disorders, or minimized the drug’s risks.
We recently wrote that Ortho-McNeil-Janssen Pharmaceuticals was ordered to pay over $327 million in penalties over how it marketed Risperdal, allegedly using deception in its claims that the controversial antipsychotic is a safer, better version than what the competition offers. This week’s filing indicates that J&J is looking to have the verdict thrown out, said Bloomberg.com.
In that case alone, defective Risperdal labeling involved at least 772,000 prescriptions in South Carolina from 1994 to 2007; was involved in 183,144 sales calls made to physicians by the drug maker’s representative; and appeared on 496,545 distributed sample boxes, according to the state’s lawyers, said Bloomberg News previously. Judge Couch said, at the time, that he found the Risperdal letter distributed to South Carolina physicians to be a “clever effort” to “manipulate the message” about Risperdal, quoted Bloomberg News.
Last year, said Bloomberg.com, Louisiana jurors ordered Janssen to pay nearly $258 million to state officials over misleading claims about Risperdal’s safety. According to this week’s filing, said J&J, the case is on appeal.
