When a doctor prescribes a drug to treat an illness or chronic condition, the patient should be able to trust that the drug he’s been given has been sufficiently tested for safety, as well as appropriately labeled to warn of the potential for any concerning side effects. However, this isn't always the case.
Sometimes patients taking prescription drugs experience side effects and complications they weren't warned about and could never have imagined. This is what many of the male patients who unexpectedly developed enlarged breast tissue—or gynecomastia—while taking Risperdal claim in lawsuits filed against the drug's manufacturer.
If you're a male who was diagnosed with gynecomastia while taking Risperdal, you may be eligible for compensation. Here's what you need to know.
What Is Risperdal?
A powerful antipsychotic drug, Risperdal (risperidone) is manufactured and marketed by Johnson & Johnson's Janssen Pharmaceuticals, Inc. The U.S. Food and Drug Administration (FDA) approved Risperdal in 1993 for the treatment of schizophrenia in adult patients. In 2006 and 2007, Janssen Pharmaceuticals gained FDA approval to market Risperdal for additional uses, including the treatment of schizophrenia in children, the treatment of bipolar disorder in adolescents and adults, and the treatment of behavioral symptoms such as irritability, aggression, rapid mood swings, temper tantrums, and deliberate self-harm in autistic children and adolescents ages 5 to 16.
Risperdal and Gynecomastia
While antipsychotic drugs like Risperdal and enlarged breast tissue in men may sound unrelated, antipsychotics and gynecomastia have more in common than most people realize. Risperdal works by manipulating hormone levels in the brain and body—specifically prolactin, a hormone that stimulates breast development and lactation in females. When women have too much prolactin in their systems, it can lead to spontaneous lactation. In men, this imbalance can lead to gynecomastia that causes them to develop enlarged breasts and even experience lactation.
Risperdal's label included information about gynecomastia but characterized it as a rare side effect experienced by very few patients, despite internal Johnson & Johnson studies showing that approximately 4.8 percent of adolescents treated with Risperdal were affected by the condition. In 2006, Johnson & Johnson updated Risperdal's label, which now warns that in clinical trials, 2.3 percent of male adolescents who took the drug developed enlarged breasts.
Johnson & Johnson Risperdal Lawsuits
As of October 2017, more than 2,100 Risperdal patients have filed lawsuits against Johnson & Johnson and Janssen Pharmaceuticals, many alleging that the companies marketed and promoted the drug for uses for which it had not been approved and hid or failed to adequately warn doctors and patients of serious potential side effects like gynecomastia.
Plaintiffs in Risperdal gynecomastia cases are seeking compensation for a wide range of damages, such as:
- Medical expenses, such as surgical and hospitalization costs
- Emotional and psychological injuries
- Compensation for lost wages
- Reduced quality of life and reduced enjoyment of life
- Punitive damages against the companies that manufacture and market Risperdal
Juries have already sided with plaintiffs in several Risperdal gynecomastia cases, with a jury in Philadelphia in July 2016 awarding $70 million to a Tennessee teen who developed female-size breasts after taking the drug since the age of 5. Additionally, a federal jury awarded $1 million to a New York man who developed breasts after taking Risperdal since age 10. However, Johnson & Johnson has never admitted wrongdoing in these cases.
Risperdal Marketing Scandal
In 2013, Johnson & Johnson paid more than $2 billion to settle a U.S. Department of Justice investigation into the company's marketing practices for Risperdal between 1999 and 2005, marking it one of the largest health-care fraud settlements in U.S. history. Of the more than $2 billion settlement, $485 million was allocated for criminal fines and forfeiture, with an additional $1.72 billion going to federal and state governments.
Do You Need a Product Liability Lawyer?
If you experienced serious Risperdal side effects such as gynecomastia, a knowledgeable product liability lawyer can help you fight for the compensation you deserve. Contact Holton Law Firm today to schedule a free initial consultation to discuss the details of your Risperdal case.