A $124 million Risperdal settlement has been reached, ending nine years of litigation against Janssen Pharmaceuticals.

The company has agreed to pay the Risperdal settlement to end allegations it illegally promoted the anti-psychotic prescription drug for unapproved or “off-label” uses.

The charges were brought by South Carolina Attorney General Alan Wilson. In February, he announced that Janssen will pay $124,324,700 in satisfaction of the Risperdal settlement to South Carolina.

About the Risperdal Settlement

According to the lawsuit, Janssen employed aggressive marketing techniques to persuade doctors to prescribe the drug to their patients, including children with disabilities and elderly dementia patients. The company sent more than 7,000 letters to doctors, allegedly overstating the efficacy of Risperdal without FDA approval.

The Risperdal lawsuit centered on promotional materials Janssen used to market the antipsychotic drug. Key to the case was a letter sent to South Carolina physicians, which overstated the drug’s benefits compared with other medications in its class and downplayed side effects, the jury found. The trial court judge ordered Janssen to pay about $4,000 for each of the more than 7,000 letters mailed.

The dispute dates back to 2011, when a jury in South Carolina ordered the drug maker to pay $327 million for Risperdal marketing violations. The company succeeded in lowering the judgment twice, first to $136 million and then, last year, to the final $124 million Risperdal settlement.

Risperdal Side Effects and Risks

Risperdal (generic name risperidone) is an atypical antipsychotic that works by changing the activity of certain natural substances in the brain. Developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, the drug was approved by the FDA in 1993 for the treatment of schizophrenia in adults. However, the drug has also been prescribed off-label to address symptoms of autism and ADHD.

Risperdal side effects include tardive dyskinesia, high blood sugar and diabetes, stroke, heart attack and even death. One of the most reported Risperdal side effects is male breast growth or gynecomastia.

In some cases, the breast size became quite significant, causing pain and embarrassment to the men and boys that developed the condition. Often, the only way to address gynecomastia is through breast reduction surgery.

Additionally, the drug has also been prescribed off-label to older adults, at the urging of Johnson & Johnson, to treat some of the symptoms of dementia. However, an increased risk of death for these elderly patients prompted the FDA to require a black box warning on Risperdal packaging to alert patients and physicians to this risk.

Risperdal Lawsuits

J&J now faces more than 1,000 lawsuits over Risperdal’s ability to trigger male breast growth in boys. The company lost the first court battle last February, as a Philadelphia jury ordered J&J to pay almost $2.5 million to a young man who developed breasts while using Risperdal. In November, another jury awarded $1.75 million in a similar case.

These verdicts still pale in comparison to the $2.2 billion settlement the company was ordered to pay the Justice Department in November 2013.

Johnson & Johnson was accused of using aggressive and illegal tactics to promote Risperdal over cheaper and equally-effective generic drugs. As a result, state Medicaid programs paid significantly more for brand-name Risperdal than they should have.

The drug maker was also accused of misleading doctors about side effects like gynecomastia, a condition that causes young men to develop large breasts.

The Risperdal Lawsuits are consolidated in Pennsylvania multidistrict litigation known as In re: Risperdal Litigation, Case No. 100300296, in the Philadelphia Court of Common Pleas.