A Pennsylvania State judge told an attorney for Johnson & Johnson subsidiary Janssen Pharmaceuticals that she had to “play by the rules to get a fair trial,” in a lawsuit alleging the company’s antipsychotic drug Risperdal caused a boy to grow large female breasts.
“There are some rules of civil procedure in this state and therefore we’re going to follow them,” Philadelphia County Court of Common Pleas Judge Ramy Djerassi told the defense attorney when pointing out that Janssen biochemist Ivo Caers could not testify on pharmaceutical regulations in the United States. Caers could only speak to his own experience regarding the approval process for the drug in question.
The lawsuit was filed by the parents of Austin Pledger, who took Risperdal beginning at age 7 to treat irritability with autism. At the time, the drug was not approved for pediatric use though it was often prescribed off-label for children and adolescents. The Pledgers’ lawsuit claims that Janssen was aware its drug could cause a hormonal imbalance that could result in breast development in boys and young men, a condition known as gynecomastia.
Attorneys for Janssen tried to pass Caers off as an expert, and repeatedly during his testimony Judge Djerassi and the Pledgers’ attorney raised objections. Later in the trial, while the jury was not present, more objections were raised regarding possible duplicative testimony.
Caers served as the team leader for Janssen’s research and development of Risperdal for a decade beginning 1999. He testified that the Food and Drug Administration (FDA) had repeatedly expanded the indication of Risperdal for children and that the company had sought to modify the drug’s safety label for pediatric use even before the drug was approved to treat autism in children in 2006.
Source: Law 360