Risperdal side effects have been the subject of legal action from both government authorities and private parties, putting billions of dollars at stake for manufacturer Janssen Pharmaceuticals.

Risperdal, or risperidone, is a psychiatric medication manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. It’s currently FDA-approved to treat symptoms of schizophrenia, bipolar disorder, and autism spectrum disorders.

Because of the way the drug works chemically, Risperdal side effects can include abnormal growth of breast tissue in males — a condition known as gynecomastia. The way Risperdal blocks the action of dopamine can increase levels of prolactin, a hormone produce by the pituitary gland that stimulates breast growth and production of milk.

At the same time, new fat can accumulate adjacent to the growing breast tissue. The resulting gynecomastia symptoms can include substantial and visible breast growth. In some cases, the new breast tissue may produce milk, resulting in nipple discharge.

Less severe cases may resolve on their own without gynecomastia treatment after the patient discontinues Risperdal. But more severe cases may persist, especially where the breast tissue is severely enlarged. In those cases, gynecomastia treatment may require surgery — possibly liposuction, male breast reduction, or a full mastectomy.

Janssen and J&J have been facing hundreds of Risperdal lawsuits over gynecomastia symptoms and other Risperdal side effects. Many of the plaintiffs are young men who were prescribed Risperdal as boys, causing them to develop gynecomastia in youth or adolescence.

In addition to the physical harm, Risperdal gynecomastia can lead to emotional trauma that can persist even after successful gynecomastia treatment. One study conducted by researchers from Boston Children’s Hospital and published in April 2013 found evidence of psychological harm in boys with gynecomastia as compared to other boys with no breast enlargement.

Other Risperdal Lawsuits

In addition to civil litigation over Risperdal gynecomastia, Janssen and J&J have faced investigations and enforcement at the state and federal level over the way it marketed Risperdal.

In November 2013, Janssen and J&J reached a $2.2 billion settlement with the Department of Justice, in part to resolve allegations that the companies had unlawfully promoted Risperdal for use in children.

Specifically, the DOJ had accused Janssen and J&J of promoting Risperdal for use in children from 1999 to 2005, during which time the FDA had not yet approved the drug for use in younger patients.

Janssen and J&J did so despite repeated warnings from the FDA and despite knowing that Risperdal posed certain risk for young patients, including the development of gynecomastia symptoms, according to the DOJ.

More recently, J&J settled a long battle with the state of Arkansas for $7.8 million – a fraction of the original $1.2 billion originally imposed by a trial judge but thrown out on appeal. Arkansas had accused Janssen and J&J of misleading doctors and patients about Risperdal’s effectiveness and side effects.

After the resolution in Arkansas, Janssen and J&J continued to face similar enforcement actions in Mississippi and Kentucky. They had already faced other actions by state authorities in West Virginia, Louisiana, South Carolina and Texas.