That trial has now commenced in Philadelphia, with opening arguments in Pledger v. Janssen Pharmaceuticals getting underway in front of a jury in the County Court of Common Pleas.
While there are various Risperdal side effects associated with risperidone, Risperdal gynecomastia is the issue that is capturing the most attention and is serving to be the biggest complaint amongst well over a thousand plaintiffs who allege Risperdal has caused young males to grow female breast tissue. There is no known cure or reversal save for a mastectomy to remove the unwanted tissue.
Pledger v. Janssen is the first trial to roll out in the Philadelphia mass tort. At issue is whether or not Janssen knew about the potential for Risperdal and Growing Male Breasts and whether or not Janssen failed to adequately warn about the condition.
Janssen, in opening arguments, noted that product labeling for Risperdal - labeling that was approved by the US Food and Drug Administration (FDA) - included a reference to elevated levels of prolactin, as well as a reference that Risperdal gynecomastia had been reported.
Plaintiffs, however, suggest that it wasn’t enough - and that doctors who have the authority to prescribe drugs off label (for indications not necessarily approved by the FDA) were not adequately brought into the loop.
Plaintiff Austin Pledger is autistic. The Alabama native, now 20, was prescribed Risperdal by the family’s doctor when Austin was a child of eight, in an attempt to treat Pledger’s autism. Risperdal was never approved by the FDA for use in children. However, given that medical doctors have the moral, medical and legal authority to prescribe drugs off label, Pledger’s attorneys claimed that the plaintiff’s doctor was not made aware of the potential for spikes in prolactin, which is known to promote breast growth.
Over time Pledger has grown what have been described as large, female breasts that are considered permanent unless surgically removed.
Pledger’s Risperdal attorney accused Janssen of engineering studies in an effort to afford more favorable results. Articulated to the jury in opening statements was Janssen’s claim that the risk to boys for developing Risperdal gynecomastia was one in 1,000, when the actual risk is closer to three or four in one hundred - or so it is alleged.
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An internal study alleged to have been undertaken by Janssen is said to have found that 87 percent of children who took Risperdal for various indications presented with elevated prolactin levels. Pledger’s Risperdal lawyers noted that in their view and that of the plaintiff, Janssen had a duty to reveal to the FDA what it allegedly knew.
The case is P.P. et al. v. Janssen Pharmaceuticals Inc. et al., case number 120401997, in the Philadelphia County Court of Common Pleas.