A number of lawsuits have been filed over Risperdal, an antipsychotic medication marketed by Johnson & Johnson’s Janssen Pharmaceuticals. Plaintiffs allege that the drug caused gynecomastia, or abnormal breast growth, in adolescent boys. The suits allege that J&J knew about these risks but failed to disclose them to patients, physicians and the U.S. Food and Drug Administration (FDA). The fifth Risperdal case went to trial in July; after hearing arguments from both sides, jurors awarded a $70 million verdict to the plaintiff.
One of the most compelling pieces of evidence came from former U.S. Food and Drug Administration (FDA) Commissioner David Kessler, who gave a video deposition. Kessler told jurors that J&J manipulated Risperdal clinical data in order to downplay the risks of gynecomastia.
Risperdal can allegedly lead to gynecomastia because it raises levels of prolactin, a hormone that can trigger breast growth. When boys hit puberty (around age 10), they naturally experience an increase in prolactin levels but this rarely leads to gynecomastia.
According to plaintiffs, J&J’s own study revealed an increased risk of gynecomastia with Risperdal. However, Kessler testified, the company diluted the data in order to obscure the risks. Allegedly, J&J excluded all boys over the age of 10 in their clinical trials from the number of children who developed gynecomastia. However, boys over the age of 10 were not excluded from the overall number of participants in the study. Additionally, the company added 103 girls without gynecomastia to the total number of participants.
Allegedly, there were 22 cases of gynecomastia but through data manipulation J&J only reported 5; 489 boys participated in the study but 592 were reported. The study allegedly found a gynecomastia rate of 4.5 percent but J&J reported a rate of 0.8 percent.
J&J faces over 1,500 Risperdal gynecomastia lawsuits in Pennsylvania. When the drug was first approved in 1993, it was approved for adults with schizophrenia. Allegedly, J&J wanted to expand the drug’s indications to include children and elderly patients. There are more than 1,500 Risperdal gynecomastia lawsuits pending in Pennsylvania. The drug was initially approved in 1993 to treat adults with schizophrenia. However, J&J wanted to expand the drug’s indications to include children and elderly patients. The FDA denied these initial attempts.