Risperdal, also known by its generic name risperidone, was originally approved by the FDA in 1993. It’s now approved as a treatment for symptoms of schizophrenia, bipolar disorder, and autism.

Doctors can also use their discretion to prescribe Risperdal for other uses on a case-by-case basis.

As an atypical antipsychotic, Risperdal is believed to help ease psychiatric symptoms in part by altering how the body uses several different neurotransmitters, one of which is dopamine.

Unfortunately, Risperdal’s effect on dopamine may also be why some Risperdal patients have developed gynecomastia, the abnormal development of breast tissue in boys and men.

Scientists believe that by blocking the effect of dopamine, Risperdal gynecomastia side effects may cause the pituitary gland to release more prolactin. Prolactin is generally credited with naturally stimulating breast development and milk production in pregnant and nursing women.

But males whose prolactin levels are artificially increased can be subject to the same effects. And studies show a large percentage of patients who take Risperdal and similar drugs have elevated levels of prolactin.

Litigation over Risperdal Gynecomastia Side Effects

By one measure, Risperdal has been the subject of over 1,500 recent products liability lawsuits in the U.S.

Plaintiffs in these claims are frequently young men who were prescribed Risperdal in their youth to treat behavioral or emotional symptoms.

They allege they later developed Risperdal gynecomastia side effects far beyond what they had been led to expect from the available warnings and product safety information provided by the drug’s manufacturer.

They generally allege that manufacturer Janssen Pharmaceuticals and its parent company Johnson & Johnson failed to adequately warn them about the risk of gynecomastia associated with this drug, and that if they had been given such a warning, they could have avoided suffering from gynecomastia by refraining from taking Risperdal.

Many point out that Janssen and J&J reportedly promoted Risperdal for use in young patients during years when the FDA had approved the drug only for use in adults.

Allegations of such unlawful off-label promotion and other questionable activities led to a massive federal investigation, culminating in a $2.2 billion settlement with the U.S. Justice Department in 2013.

Similar investigations at the state level resulted in prosecutions yielding jury awards against the companies in the hundreds of millions of dollars.

Risperdal Jury Awards

In the new wave of civil product liability lawsuits, Janssen and J&J have also been assessed millions in jury awards following some of the first Risperdal lawsuits to go to trial.

The first successful plaintiff was awarded $2.5 million in February 2015. The plaintiff in that case alleged he had been taking Risperdal since age eight. By the time he was a teenager, he claimed, his Risperdal gynecomastia side effects left him with DD-sized breasts.

Later that year, another plaintiff was awarded $1.75 million. And in July 2016, a Philadelphia jury awarded $70 million to the family of a young man after he developed Risperdal side effects.

Janssen and J&J have reportedly agreed to settle other claims related to Risperdal gynecomastia side effects under settlement terms that must necessarily remain confidential. Still other Risperdal lawsuits remain pending.