An ex-chief of the US Food and Drug Administration has testified in a Philadelphia lawsuit that Johnson & Johnson knew as early as 2001 that its popular antipsychotic medication Risperdal (risperidone) would “probably or very likely” cause as many as 3.8% of boys who took it to grow breasts, reported FiercePharma.
J & J did not add the warning to the drug’s official label until five years later. An autistic 20-year-old Philadelphia man is now suing J & J, stating that he needs a mastectomy as a result of being put on Risperdal when he was a child. “There are more than 1,250 Risperdal lawsuits pending in courts throughout the country, most of which related to abnormal breast growth in young men,” stated a law firm handling some of the cases.
J & J previously paid $2.2 billion to settle a federal lawsuit that, in part, involved allegations that the company illegally promoted Risperdal for unapproved uses in children and adolescents. In recent years, the company has been facing lawsuits from males who took the drug and were not warned that the side effects included the possibility they would grow breasts, reported FiercePharma.
According to the law firm Pintas and Mullins, of 1,250 pending cases, six cases were “selected as bellwether trials in 2012; however, Janssen (a unit of J & J) agreed to settle these cases before they went before juries. Janssen agreed to settle another 80 cases in early 2013.”
“I’m just having a hard time right now,” the Philadelphia boy’s mother told the Philadelphia Inquirer, crying after a day in court. “Hearing what the pharmaceutical company was doing.”
Healio reported on four other similar cases going on currently in Connecticut, Florida, Maryland and Ohio. “The bodies of these young men have been permanently mutated by Risperdal,” an attorney said in a press release. “In a young man who is already isolated by his challenges caused by mental issues, the growth of women’s breasts on his body in adolescent and teenage years is absolutely devastating.”
J&J again faces off-label marketing claims in Risperdal case of boy who grew breasts (FiercePharma, January 26, 2015)
Ex-FDA chief testifies against J&J in Risperdal liability case (FiercePharma, January 29, 2015)
Mother brought to tears hearing Johnson & Johnson’s Risperdal tactics (Philadelphia Inquirer, January 30, 2015)
Lawsuit against Janssen alleges Risperdal caused gynecomastia (Healio, January 28, 2015)
Risperdal Breast Growth Case Begins in Alabama (Pintas & Mullins Law Firm, January 26, 2015)