Janssen biochemist and VP of Neuroscience Development, Ivo Caers, testified in court that the U.S. Food and Drug Administration was never given an internal analysis showing the link between Risperdal and breast growth in young boys. Caers, who has worked for Janssen’s parent company Johnson & Johnson for 36 years, was being questioned in another Risperdal lawsuit alleging the drug caused breast tissue growth in a young boy.
Risperdal is an antipsychotic drug that is often prescribed to boys for other off-label uses, including treating symptoms of ADHD. In May 2005, the FDA rejected Janssen’s attempt to expand the use of Risperdal due to concerns that it leads to increased levels of prolactin, the hormone responsible for breast tissue growth.
Janssen Pharmaceuticals and J&J have faced thousands of Risperdal breast growth lawsuits alleging that the drug led to breast tissue growth in boys, a condition known as gynecomastia. The companies have also paid hundreds of millions of dollars to settle multiple lawsuits from states alleging that they illegally promoted the drug for off-label uses.