Since receiving U.S. Food and Drug Administration (FDA) approval to treat schizophrenia in 1993, Risperdal has been the defendant in a litany of lawsuits accusing Johnson & Johnson and its subsidiaries of concealing the drug’s side effects, such as causing gynecomastia, a condition in which young boys develop large breasts.

Commonly known as “man boobs,” gynecomastia frequently requires surgical correction. Health experts believe the anti-psychotic medication dramatically increases prolactin levels, leading to the development of Risperdal man boobs.

Risperdal first received FDA approval in 1993 for the treatment of schizophrenia. Its uses later expanded to include adult and adolescent bipolar disorder and autism spectrum disorders in children and adolescents. The drug is commonly used for off-label purposes such as the treatment of deficit hyperactivity disorder (ADHD), anxiety, sleep difficulties and depression.

Risperdal manufacturer Johnson & Johnson has lost three straight class action lawsuits brought by attorneys general over its marketing of the drug as well as its newer version, Invega, which also treats schizophrenia. The Risperdal lawsuits alleged that J&J concealed the drug’s side effects.

In November 2013, the U.S. Department of Justice announced that Johnson & Johnson and its subsidiaries would pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to Risperdal, Invega and Natrecor, a heart medication.

The unlawful acts allegedly included promoting the drugs as safe and effective for unapproved uses and for paying kickbacks to doctors and to the nation’s largest long-term care pharmacy provider. The global resolution was 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, according to the Justice Department.

“The conduct at issue in 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 government charged that between March 2002 and December 2003, Janssen Pharmaceuticals Inc., a J&J subsidiary, misbranded the product for unapproved uses.

For most of that time period, Risperdal was approved only to treat schizophrenia, yet Janssen’s sales representatives promoted Risperdal to doctors and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat anxiety, agitation, depression, hostility and confusion.

The information alleges that the company created sales materials for Janssen’s ElderCare sales force emphasizing symptoms and minimizing any mention of the FDA-approved use, treatment of schizophrenia. Janssen based sales representative’s bonuses on total sales of Risperdal, not just sales for FDA-approved uses, according to the Justice Department.

The company also provided incentives for off-label promotion and intended use by basing sales reps’ bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses.

Janssen admitted that it promoted Risperdal to health care providers for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients, according the Justice Department.

There are currently more than 700 pending Risperdal lawsuits involved in a consolidated litigation in Pennsylvania. Many of the plaintiffs in those cases allege that the drug caused gynecomastia.

In 2012, Johnson & Johnson reached a confidential settlement for a Risperdal lawsuit brought by a 21-year-old man who said that growing breasts resulted in “severe psychological trauma.”

Risperdal remains one of the most frequently prescribed medications in the world.