Risperdal Gynecomastia Lawsuit

On this page, we will look at the Risperdal lawsuit alleging that the mental health drug Risperdal (risperidone) caused permanent health conditions including abnormal breast growth in males. Some of the page was written many years ago.  Some of it is updated for 2024.

 Risperdal

Risperdal is the popular brand name for Risperidone, which is a unique type of antipsychotic drug that has been in use since the early 1990s. Risperdal is most commonly used for the treatment of bipolar disorder, autism, schizophrenia, and other mental health conditions. Risperdal is a very common drug with over 4 million prescribed users in the U.S. Risperdal was developed and manufactured by Janssen Pharmaceuticals, a subsidiary of pharmaceutical giant Johnson & Johnson, but various generic versions are now available from other companies.

When Risperdal was originally released back in 1993, it only had FDA use approval for the treatment of schizophrenia in adult patients. Despite this use limitation, Janssen actively promoted the use of Risperdal to treat autism and bipolar conditions in children. This “off-label” use of Risperdal on children became very common.

Risperdal Linked to Dangerous Side Effects

Studies have linked Risperdal use to several very serious and permanent side effects which have prompted a “black box” warning label on the drug. The FDA found that Risperdal increases a user’s risk of death from heart disease and pneumonia by 580%. Risperdal has also been conclusively linked with an increased risk of developing a rare, life-threatening disease called neuroleptic malignant syndrome.

In addition to these potentially fatal side effects and risks, long-term use of Risperdal has also been shown to cause several non-fatal, but debilitating health conditions. Numerous studies have established that Risperdal usage significantly increases an individual’s risk of developing chronic Tardive Dyskinesia. Tardive Dyskinesia is a neuromuscular condition that causes loss of muscle control and involuntary movements in the face and mouth. Tardive Dyskinesia has also been linked to other mental health drugs including Reglan (more info about Reglan lawsuits).

Risperdal and Gynecomastia

The most common and problematic permanent health complication caused by Risperdal is gynecomastia. Gynecomastia is the medical term for the growth of female-like breasts in males. While not life-threatening or dangerous, gynecomastia can cause serious emotional damage in male patients.

The link between Risperdal and gynecomastia was first announced in 2015 when the results of a long-term study were published in the Journal of Child and Adolescent Psychopharmacology. That study concluded that when Risperdal is used for extended periods by adolescent males it can cause them to develop breasts (gynecomastia). Specifically, the study found that Risperdal users under the age of 18 were 5 times more likely to develop gynecomastia than non-users in the same group. Although this might not sound like much, in the scientific study world this is a conclusive cause and effect link.

The reason why Risperdal causes male breast growth is related to a hormone called prolactin. Prolactin is a female associated hormone that stimulates breast growth in adolescent girls and facilitates lactation in pregnant women. For reasons that are not fully understood, Risperdal caused young males to overproduce this hormone, leading to breast growth.

Risperdal Lawsuits

The link between Risperdal and male breast growth was a hidden, undisclosed side effect of the drug. Thousands of individuals who developed gynecomastia from taking Risperdal have filed lawsuits against Janssen and other manufacturers. Still more individuals have filed Risperdal lawsuits after developing other serious, undisclosed health conditions including Tardive Dyskinesia, stroke, heart conditions, and diabetes.

Plaintiffs in the Risperdal lawsuits allege a lot of things.  But at core, the plaintiffs allege that Janssen Pharmaceuticals failed to provide adequate warnings about the risk of gynecomastia associated with the drug. They claim that the company downplayed the side effects and did not sufficiently inform patients and healthcare providers about the potential risks. Internal company documents, which have surfaced during the litigation, suggest that Janssen was aware of the risks but did not act to properly disclose them. These documents have been crucial in establishing the company’s knowledge and alleged negligence.

The Risperdal lawsuits pending in federal courts across were consolidated into a class-action MDL in the U.S. District Court in Philadelphia.

Risperdal Settlements

Numerous settlements and verdicts have favored the plaintiffs, with some jury awards reaching millions of dollars. The FDA has also mandated updates to Risperdal’s warning labels to include information about the risk of gynecomastia.

Patients affected by gynecomastia often require medical interventions, including surgery, and may suffer from emotional and psychological issues. Legal actions seek compensation for medical expenses, pain and suffering, and other damages.

Some litigation is ongoing.  Why are there not more Risperdal lawsuits being filed in 2024? The FDA has required updates to the warning labels for Risperdal to include information about the risk of gynecomastia. This regulatory action was a significant step towards ensuring that patients and healthcare providers are better informed about the potential side effects of the medication. The updated labels now highlight the risk of breast tissue growth in males, providing clearer guidance on the potential dangers. So the core of the claim – failure to warn – is no longer a major issues (assuming you believe the warning is strong enough).

How Much are Risperdal Lawsuits Worth?

Many Risperdal lawsuits have already gone to trial and resulted in verdicts. The lowest amount awarded to a plaintiff in these trials has been $500,000. Below is a summary of the Risperdal trials and reported settlements.

• Pleger $2,500,000 (2015): in 2015 Austin Pledger took his Risperdal lawsuit against Janssen to trial and was awarded $2.5 million. Pleger started using Risperdal back in 2002 and claimed that the drug caused him to develop size DD breasts.
• Yount $70,000,000 (2016) a jury in Philadelphia awarded Andrew Yount $70 million for his Risperdal claims against Janssen. This verdict was subsequently upheld on appeal.
• Byrd $1,000,000 (2017): a jury in New York awarded Shaquil Byrd $1 million in compensatory damages for his claim he developed breasts and began lactating at age 10 from using Risperdal. The trial judge later overturned this verdict on legal grounds.
• Stange $500,000 (2018): Wisconsin resident Timothy Stange took Risperdal from 2006 to 2009, which was after the FDA expanded its approval to the treatment of bipolar disorder. His jury trial resulted in a $500,000 verdict and the trial court granted a second trial to determine whether Janssen should have to pay punitive damages. The punitive damages trial was avoided by a confidential settlement.
• Murray $6,800,000,000 (2019): Nicolas Murry was initially awarded $1.75 million in compensatory damages for his claim that Risperdal caused him to grow breasts. At a subsequent trial on the issue of punitive damages, the jury awarded $8 billion. The punitive damage award was later reduced to $6.8 billion.

Risperdal Lawsuit Is Over?

Most of these Risperdal lawsuits settled in 2024. Our law firm is no longer reviewing new potential Risperdal lawsuits.