Risperdal Continues to Boggle Down Johnson & Johnson
Trouble is no stranger to Johnson & Johnson. Johnson and Johnson (J&J), embroiled in massive litigation in DePuy ASR artificial hips, and in transvaginal mesh litigation from its Ethicon Gynecare products, faces more legal issues from its anti-psychotic drug, Risperdal. Currently, Johnson & Johnson is appealing a 1.2 billion dollar fine issued in an Arkansas court in a Medicare fraud case, Ortho-McNeil-Janssen Pharmaceuticals Inc. v. Arkansas, 12-1058. The jury found that J&J and Ortho-McNeil-Janssen had downplayed Risperdal’s risks and marketed it for off-label uses. The jury found that these companies had defrauded the state’s Medicaid system and deceived Arkansas consumers about the safety risks of the anti-psychotic drug Risperdal.
Click here to read the full article: State AGs Ask Arkansas High Court to Back J&J’s $1.2B Risperdal Fine
J&J has contested that “an individual state should not penalize a pharmaceutical company for using an FDA-approved package insert or decide for itself whether a company complies with FDA rules.”
Arkansas Attorney General Dustin McDaniel disagrees. He has asked the Arkansas Supreme Court to uphold the decision. McDaniel stated, “This company lied to our medical providers and put profits ahead of people. As state Attorney General, it is my responsibility to prevent actions like those, which defrauded our Medicaid program and jeopardized the health of our elderly and our children.”
Previously, J&J initially had agreed to pay $2.2 billion in 2012 in order to settle a Justice Department investigation into allegations that the health-products company had illegally promoted drugs including the antipsychotic Risperdal, but then balked at completing the settlement. J&J looked to avoid admitting to conduct that could affect the outcome of pending personal-injury lawsuits alleging Risperdal caused serious side effects in kids.
Risperdal was approved in 1993 for use in adults and was later used to treat schizophrenia and bipolar disorder in children and teens. Under federal law, drug makers can promote only the approved uses of their medicines, but doctors are free to write prescriptions for other uses. Some physicians prescribed Risperdal to children and adolescents before the U.S. Food and Drug Administration gave its OK in 2007 for use in children and adolescents suffering from bipolar disorder and in adolescents with schizophrenia.
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