Philadelphia, PAA Risperdal lawsuit that alleged the growth of male breast tissue (Risperdal gynecomastia) suffered by the plaintiff was stopped dead in its tracks before a trial reached the verdict stage after a Pennsylvania judge determined that Johnson & Johnson (J&J) and its Risperdal unit, Janssen Pharmaceuticals Inc. (Janssen) had not failed to adequately warn about gynecomastia risk as the plaintiff had asserted, thus pulling the rug out from under the lawsuit.
The trial would have been the seventh Risperdal trial to be heard, and the dismissal represents the third case that ended in the defendant’s favor in advance of a verdict. Janssen had petitioned the judge for summary judgement. The petition was granted.
The plaintiffs plan to appeal. “The prescribing doctor testified that he would have ‘tossed [Risperdal] out’ as a potential medicine for our client if he had been given an accurate warning,” the plaintiff’s legal teams noted. “We think that testimony and other statements like it in the record clearly satisfies the learned intermediary doctrine.”
The plaintiff, identified only as ‘P.D.’ was eight years old when he was prescribed Risperdal to treat symptoms related to ADHD (attention deficit hyperactivity disorder).
P.D. was later found to be suffering from Risperdal gynecomastia. Risperdal and Growing Male Breasts is an oft-seen headline.
P.D. sued, primarily alleging failure to warn. But Janssen countered with the claim that a treating physician for P.D. had testified that she would have continued to prescribe Risperdal for the child, even if she received a different warning because “the benefit of treatment outweighs any risk of the side effect.”
The ruling by Judge Arnold New was brief and encompassed a single page, granting summary judgement to the defendants based on “the specific facts of this matter.”
A spokesperson for Janssen noted the defendant was pleased with the ruling.
There are some 5,400 lawsuits still pending within a mass tort housed at the Court of Common Pleas of Philadelphia County. Plaintiffs allege that use of Risperdal spurs the growth of male breast tissue in men and adolescent boys, regardless of diet or activity level. In rare cases, males have known to lactate. Surgery is usually required to eliminate the male breast tissue.
In considering the Court’s ruling that the learned intermediary testimony was insufficient to progress past summary judgement, the plaintiff’s family argued in January that the learned intermediary doctrine did not apply because Janssen had “actively concealed material information” about the drug from regulators that prevented prescribers from having an accurate picture of the medication’s risks.
“The learned intermediary doctrine only applies if the facts support the conclusion that a drug manufacturer adequately warns doctors of a drug’s dangers,” the boy’s family said. “It does not shield drug manufacturers from liability if the warnings they provided to physicians would not permit the physicians to adequately advise their patients.”
The case is P.D. et al. v. Janssen Pharmaceuticals Inc., Case No. 130600738, in the Court of Common Pleas of Philadelphia County, Pennsylvania. A Risperdal bellwether trial was scheduled to begin today (March 20) in Philadelphia.
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