Johnson & Johnson unit Janssen Pharmaceuticals knew for years that its antipsychotic drug Risperdal could cause the abnormal growth of breasts in boys and young men, yet the company failed to warn the mother of an Alabama boy or his doctors of these “distressing results,” the mother’s attorney told a Philadelphia jury.
“We’re going to show you that Janssen knew all the time that he took the drug that the drug caused an increase in prolactin levels, and that it was associated with children and adolescents having this distressing result,” the attorney said.
Austin Pledger, now 20, was prescribed Risperdal when he was 8 to treat autism. At that time, the drug was only approved to treat adults with bipolar disorder, schizophrenia and irritability with autism. In 2006, the Food and Drug Administration (FDA) approved use of Risperidal in both children and adolescents despite numerous previous rejections for safety concerns.
While the drug has been linked to serious side effects, it most recently has been associated with the development of breasts in boys and young men, a condition known as gynecomastia. The condition can be devastating and painful, often requiring surgeries such as liposuction and/or mastectomy to remove the breasts.
Pledger’s lawsuit is one of more than 1,250 pending as part of a mass tort in Philadelphia County Court of Common Pleas, and the first that is expected to come to a verdict. A group of six bellwether cases scheduled to go to trial in 2012 were ultimately settled after only a week’s worth of testimony was presented in one of the cases.
Johnson & Johnson also faces about 700 similar gynecomastia lawsuits consolidated in state court in Los Angeles.
In November 2013, Johnson & Johnson agreed to pay $2.2 billion to settle claims involving illegal promotion of Risperdal for off-label use in elderly patients. The company did not admit promoting the drug for adolescent patients as part of that settlement.
Source: Law 360