• The antipsychotic drug has also been linked to an increased risk of young males developing gynecomastia, an increase in breast tissue.
• Lawsuits are being filed against J&J alleging the company failed to warn physicians and patients about the increased risk of gynecomastia, especially in young, developing boys. Some of the victims have undergone mastectomies because of the size of their breasts, and suffered considerable psychological trauma.
• Although Risperdal carries a warning about the risk, some doctors have called on the FDA to strengthen the warning.
• Boys who have developed gynecomastia may experience pain or nipple discharge. Mild cases can be resolved with liposuction, while more severe cases will require a mastectomy.
• According to reports, two boys had mastectomies to decrease their breast tissue after taking Risperdal (see Risperdal Gynecomastia Lawsuits and Settlements below).
• As of September 2012, more than 420 Risperdal lawsuits had been filed, 130 of which are Rispedal gynecomastia claims.
Risperdal Gynecomastia Lawsuits and Settlements
• Currently, over 130 Risperdal lawsuits are pending against J&J and Janssen alleging that the boys and men who took the drug developed breasts.
READ MORE RISPERDAL LEGAL NEWS
J&J’s Illegal Off-Label Marketing
• In November 2013, J&J agreed to pay $2.2 billion to settle charges with the US Department of Justice (DOJ) over the alleged illegal marketing of Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the FDA, and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.
• The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million, and civil settlements with the federal government and states totaling $1.72 billion.