The Attorney General of Kentucky announced on December 23, 2015 that Kentucky had settled two pharmaceutical cases on December 22, 2015 that it had brought against Purdue Pharma regarding its opiod prescription medication, OxyContin, and against Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, regarding its second-generation antipsychotic prescription medication, Respiral.
The OxyContin case against Purdue Pharma was settled for $24 million and the Respiral case against Janssen Pharmaceuticals was settled for $15.5 million, along with Janssen Pharmaceuticals agreeing to be prohibited from promoting Risperdal for non-FDA approved uses or for populations in which it is not approved; agreeing to clearly disclose risks associated with Respiral to patients and prescribers in Kentucky; and, agreeing to not promote Resipral for a single symptom for which it is not approved, such as depression or anxiety, without reference to the underlying mental illnesses that Risperdal is approved to treat by the FDA.
The Respiral Case
The Kentucky consumer protection lawsuit filed against Janssen Pharmaceuticals alleged that it misled consumers about the dangers of Respiral and that it marketed Respiral for purposes other than those approved by the FDA.
Janssen Pharmaceuticals was alleged to have marketed Respiral for use in children before the FDA approved its use in children in 2007; that it failed to disclose to parents, physicians, and patients that Risperdal may cause a hormonal imbalance that could cause breast tissue development and infertility in both boys and girls, despite it being aware of the risk, and that it failed to update the warning label for Respiral; that it marketed Risperdal as an atypical anti-psychotic with low weight gain and diabetes risk despite its internal studies that indicated that patients on Risperdal had as much weight gain as its main competitor and had a greater risk of diabetes after one year; and, that it had marketed Respiral for an unapproved use in treating dementia in non-schizophrenic elderly patients (Janssen Pharmaceuticals’ own study in 1997 showed that Risperdal doubled the risk of death in the elderly but failed to disclose the risk to the public until 2003; in 2013, Janssen Pharmaceuticals pleaded guilty to federal charges of misbranding Respiral regarding its promotion for use in the elderly).
The OxyContin Case
The Kentucky lawsuit against Purdue Pharma alleged that it illegally misrepresented and/or concealed the highly addictive nature of OxyContin (its sales representatives allegedly falsely told physicians that OxyContin was not addictive and was less likely to be abused than other opioid drugs) and that Purdue Pharma encouraged prescribers who were not trained in pain management to over-prescribe OxyContin to Kentucky patients.
Purdue Pharma did not admit wrongdoing in its settlement with Kentucky (however, Purdue Pharma had pleaded guilty to misbranding OxyContin in the U.S. District Court in the Western District of Virginia, which led to the Kentucky lawsuit being filed).
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