Risperdal (risperidone) is an antipsychotic originally approved by the US Food and Drug Administration (FDA) for treatment of schizophrenia in adults. However, Risperdal side effects attorneys for the plaintiff argued that Janssen Pharmaceutical Inc. (Janssen) saw a growing market for Risperdal in children and youth, and lobbied the FDA to expand its indications for children and youth with Attention Deficit Hyperactivity Disorder (ADHD) and Bipolar syndrome, amongst others.
The defense lawyer argued that none of Hibbs’ treating physicians had ever actually diagnosed their patient with Risperdal gynecomastia (male breasts), and that Hibbs had also taken 13 other medications – some of which had been known to foster obesity. The defense also argued that the plaintiff, as a child had been suffering from a range of disorders, including Bipolar disorder and oppositional-defiant disorder, and had spent several days at a psychiatric facility for aggressive behavior. The defense opined that his aggressiveness and related afflictions were factors in the prescribing of Risperdal for seven months.
Promotion and marketing efforts on the part of Janssen had no bearing on the decision to prescribe Risperdal, or a decision on the part of the plaintiff’s mother to allow her son to take it. Hibbs, however in his Risperdal gynecomastia lawsuit, holds that Janssen downplayed the link between Risperdal and growing male breasts, and that the plaintiff’s parent would never have allowed her son to take Risperdal had she known about the Risperdal side effects.
The plaintiffs will present testimony from at least one expert witness who is expected to testify that Janssen did, indeed play down the risks – and even suppressed data to the FDA in order to achieve expanded indication for use in children and youth.
As he did in previous trials, former FDA Commissioner David Kessler is expected to testify that Johnson & Johnson, the parent company of Janssen Pharmaceuticals, manipulated data presented to the FDA aimed at obscuring evidence linking risperidone to Risperdal and growing male breasts.
Mark Solomon, a plastic surgeon, is also expected to testify. Solomon has diagnosed Risperdal gynecomastia in previous patients.
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A new jury was assembled and put into place this past Monday for the trial to resume, with both parties repeating their opening arguments for the refreshed jury.
Among Risperdal side effects are Risperdal diabetes and Risperdal stroke. The Risperdal lawsuit currently underway is Hibbs v. Janssen Pharmaceuticals Inc. et al., Case No. 130600861, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.