The antipsychotic drug Risperdal has been linked to a side effect known as gynecomastia, which causes boys to grow breasts. A growing number of lawsuits have been filed against Risperdal’s maker Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. by individuals who claim that they developed gynecomastia while taking the medication.

Signs of gynecomastia include swollen breast tissue, breast tenderness or pain and a discharge that comes from the nipple. These developments occur as a result of increased levels of the hormone prolactin, which causes women to develop breasts and nursing mothers to lactate. Some men who have filed gynecomastia lawsuits have done so not because there has been an increase in the size of their breasts, but because there has been unexpected breast milk production.

A study published in the Journal of Clinical Psychopharmacology in 2006 was the first to show that there was a link between the antipsychotic drug and gynecomastia. Another study published in the the Journal of Child and Adolescent Psychopharmacology published in 2009 found that the increased levels of prolactin caused by Risperdal can remain elevated for two years, even after someone has stopped taking the drug.

Most of the Risperdal lawsuits have been individual lawsuits, but more than 200 are part of a multidistrict litigation at the Philadelphia Court of Common Pleas.

When Risperdal was first introduced to the market, it was only approved by the U.S. Food & Drug Administration (FDA) to treat schizophrenia. However, the government claims in criminal information filed with the U.S. District Court in the Eastern District of Pennsylvania that from Mar. 3, 2002 to Dec. 31, 2003, Janssen promoted Risperdal to treat dementia in elderly patients by treating symptoms such as anxiety, agitation, depression, hostility and confusion. The promotional materials allegedly made very little mention of schizophrenia.

From 1999 through 2005, Janssen also allegedly promoted Risperdal to be used in children with mental disabilities such as autism, bipolar disorder, attention deficit disorder, oppositional defiant disorder, obsessive-compulsive disorder and other mental disabilities.

The Justice Department reached its decision that Johnson & Johnson pay a $2.2 billion settlement in November 2013 over allegations that Risperdal along with Invega and Natrecor were improperly marketed to patients and doctors to be prescribed to treat illnesses for which they had not been approved.

“The conduct at issue on this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”

The Justice Department said that the fines and forfeiture were violations of the False Claims Act that were determined after multiple investigations of Johnson & Johnson and its subsidiaries.

“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West. “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”

Johnson & Johnson will also now be subject to stringent requirements under a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General. The purpose of the agreement is to increase accountability and transparency to prevent more fraud and abuse.