January 30, 2015 — Dr. David Kessler, a pediatrician and former commissioner of the U.S. Food and Drug Administration (FDA), has testified in a trial accusing Johnson & Johnson of marketing Risperdal “off-label” in children, including boys who developed gynecomastia (breast enlargement).
Bloomberg reports that Dr. Kessler cited a study from 2001 that reported breast growth in 3.8% of boys on Risperdal.
Dr. Kessler said that study “certainly is a red flag to me,” according to the Philadelphia Inquirer.
The study adds evidence that Janssen Pharmaceuticals knew or should have known that Risperdal could cause breast growth in boys, but marketed it as a safe and effective treatment for children with neurological disorders.
In 2013, Janssen paid $2.2 billion to settle allegations of illegal “off-label” marketing of Risperdal and several other drugs. The Justice Department accused Janssen of marketing Risperdal to children from 1999-2005, before the FDA approved this indication in 2006.
The lawsuit was filed on behalf of a 20 year-old man who was just seven years old when he was prescribed Risperdal. After taking the powerful anti-psychotic for five years, he gained 100 pounds and developed severe gynecomastia.
His case is the second lawsuit to go to trial, with the first ending in a settlement. More than 1,250 similar lawsuits are pending in Philadelphia, where a jury will decide whether to award him compensation for his injuries.
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