November 9, 2015 — Johnson & Johnson has been ordered to pay $1.75 million to the family of a boy from Maryland who was diagnosed with gynecomastia after taking Risperdal.
He was prescribed Risperdal from the age of 9 after his mother told a pediatrician he was having problems sleeping. He continued taking it from 2003 until 2008.
However, it was not until 2006 that the FDA approved Risperdal for adolescents with irritability associated with certain intellectual disabilities. In 2012, J&J admitted illegally marketing Risperdal “off-label” for unapproved uses in children.
Lawyers for the Murray family argue that J&J failed to adequately warn about the risk of gynecomastia. They say the drug-maker was aware that Risperdal could significantly elevate levels of the pregnancy hormone prolactin, a risk-factor for gynecomastia in boys.
The Prescribing Information for Risperdal now warns that 2.3% of children develop gynecomastia. However, some studies have pushed that number up to 12.5%.
This is the fourth Risperdal lawsuit to go to trial this year. In February, a boy with gynecomastia was awarded $2.5 million by a jury in Philadelphia. In March, J&J scored a victory when a jury decided not to award damages. A third trial began last month and is still ongoing. About 1,300 cases are now pending in the Philadelphia Court of Common Pleas.