ClassAction.org is reporting that Risperdal lawsuits accuse the drug’s manufacturer, Janssen Pharmaceuticals, of promoting its antipsychotic drug for off-label uses. Risperdal was first approved for the treatment of schizophrenia in adults and was later approved for use in adolescents; however, these lawsuits allege that Janssen promoted Risperdal for off-label uses in adolescents prior to its FDA-approval and took part in a ghostwriting campaign to create an image of safety and efficacy for the drug.
In 2001, Risperdal’s label was revised to include a warning that “the safety and effectiveness in children have not been established.” The lawsuits allege that this revision was designed to discourage off-label uses of Risperdal that were promoted by Janssen. The drug was approved for use in adults in 1993. In 2006, Risperdal was approved for use in adolescents ages 5 to 16 for the treatment of irritability associated with autism, and in 2007, it was approved for use in adolescents ages 13 to 17 for the treatment of schizophrenia.
Those who have taken legal action against Janssen allege that the manufacturer began promoting Risperdal for use in children as young as 3 years of age. Court documents indicate that Janssen even put the Risperdal logo on “children’s Lego-like blocks in bright colors” in journal ads for the drug. At the time, Risperdal was only approved for use in adults to treat schizophrenia, but the lawsuits allege that Janssen marketed the drug to treat attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), oppositional-defiant disorder (ODD), conduct disorder (CD), disruptive behavior disorder (DBD), Tourette’s syndrome and pervasive development disorders (PDD).
The plaintiffs also allege that Janssen took part in various ghostwriting campaigns promoting the safety and efficacy of Risperdal. Janssen allegedly manipulated clinical trials to produce favorable results for Risperdal, published the same studies repeatedly to create a false impression of scientific acceptability, and paid large sums of money to specific opinion leaders to tout Risperdal for a variety of disorders. Furthermore, the plaintiffs allege that Janssen took part in ghostwriting medical journal articles about Risperdal. As part of the ghostwriting campaign, articles in medical journals would appear as if they were written by researchers or scientists, but were actually drafted writers hired by the company.
Those who have taken legal action against Janssen allege that the company put sales and profits above public safety. The plaintiffs specifically allege that Janssen failed to provide adequate warnings regarding the serious side effects associated with Risperdal, including the risk of gynecomastia, a condition where young boys develop abnormal breast tissue.
If you or a loved one were diagnosed with gynecomastia after using Risperdal, you may be able to seek compensation for your injuries through a lawsuit. For more information on your potential legal rights, visit http://www.classaction.org/risperdal today.
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