Parker Waichman LLP is investigating potential lawsuits on behalf of young men who developed gynecomastia (enlarged breasts in men) after taking the antipsychotic medication Risperdal. A number of studies have linked the use of Risperdal to enlarged breast tissue in young men and in September 2012, Johnson & Johnson settled the first of over 100 Risperdal gynecomastia lawsuits. If you or someone you know took Risperdal and suffered from gynecomastia, our attorneys would like to speak with you. Call Parker Waichman LLP for a free, no-obligation evaluation of your case.
Risperdal Linked to Gynecomastia
Risperdal is an antipsychotic medication manufactured by Johnson & Johnson; it is used to treat psychiatric disorders such as schizophrenia, bipolar disorder, acute mania associated with autistic disorders and other mental illnesses. However, reports suggest that using Risperdal may lead to breast growth in men, or gynecomastia. Risperdal can cause increased levels of prolactin, which is a hormone that regulates breast growth in milk production; in women this can lead to spontaneous milk production but in men it may cause gynecomastia.
This association between Risperdal and male breast growth was first made public in 1999, when Psychopharmacology journal published a study linking Risperdal to gynecomastia when used with the antidepressant Prozac (fluoxetine). In 2006, the Journal of Clinical Psychopharmacology published a study showing that prolactin levels can increase significantly when Risperdal was given to adolescents. Yet another study, published in the Journal of Child and Adolescent Psychopharmacology in 2009, found that elevated prolactin levels associated with Risperdal use persisted for up to two years.
There are about 130 lawsuits alleging Risperdal caused gynecomastia. The first of these lawsuits was settled in 2012 for an undisclosed amount. The lawsuit was filed on behalf of a young man, who alleged that Risperdal caused breast growth after he used the medication for four years between the ages of nine and 13. Johnson & Johnson settled the case just as the lawsuit was about to go to trial in Pennsylvania state court.
What is Gynecomastia?
Gynecomastia is the enlargement of breast tissue in males. Gynecomastia can affect one or both breasts, sometimes unevenly. Although this condition may not pose any serious health threats, Mayo Clinic states that it can cause psychological or emotional trauma. Men afflicted with gynecomastic may feel pain in their breasts or feel embarrassed about their appearance. Signs of gynecomastia include swollen breast gland tissue and breast tenderness. Mayo Clinic advises patients to visit a doctor if they experience:
- Nipple discharge in one or both breasts
J&J Ordered to Pay $2.5 Million in First Trial
In February 2015, the first Risperdal lawsuit to go to trial over gynecomastia claims concluded with a $2.5 million verdict in favor of the plaintiff. A Philadelphia jury found that the company failed to warn the plaintiff and physicians about the risks of hormonal imbalance and abnormal breast growth in boys.
The month-long trial took place in Philadelphia County Court of Common Pleas where jurors considered a lawsuit filed on behalf of a boy who developed large breasts after taking Risperdal to treat behaviors associated with autism. He started taking the drug in 2002, at the age of seven, and continued treatment with Risperdal for five years. The suit alleged that, for years, Janssen worked to hide evidence that Risperdal could cause the growth of female breast tissue in adolescent boys.
Former FDA commissioner David Kessler testified in the trial. He said he believed that J&J intentionally manipulated data to minimize gynecomastia risks associated with Risperdal.
The FDA only approved Risperdal for use in adults at the time when the plaintiff began taking the drug. At that time, it was alleged that Janssen sales representatives visited the plaintiff’s pediatric neurologist to distribute Risperdal samples several times between 2002 and 2004.
Before the early 2000s, roughly 20 percent of Risperdal prescriptions were written for children and adolescents. In 2006, Risperdal was approved to treat behavioral disorders in children with autism. At this time, the label was updated to state that gynecomastia occurred in 2.3 percent of pediatric patients. The previous label represented the condition as rare.
Legal Help for Victims of Risperdal Side Effects
If you or a loved one took Risperdal and suffered from gynecomastia or other potential side effects, you
may have valuable legal rights. Please fill out our online for or call 1-800-YOURLAWYER (1-800-968-7529) to speak with one of our experienced drug injury attorneys today.