Thousands of boys and men have filed suit against Janssen Pharmaceuticals, claiming the company hid for years a direct link between the antipsychotic drug Risperdal and abnormal breast tissue growth.
- 20,000 Risperdal lawsuits
- Over $75 million in jury verdicts
- Numerous undisclosed settlements
Did you or a loved one experience breast enlargement after taking Risperdal? Significant financial compensation may be available. Our experienced attorneys are here to help. Contact our firm now for a free consultation. You can learn more about legal options at no cost.
We are no longer accepting new Risperdal cases.
We’ve seen an overwhelming surge of boys and men who are willing to step forward and fight for justice. Their bravery is an endless source of inspiration.
If you’re reading this page, you probably saw a commercial on TV about Risperdal lawsuits. These ads are made by law firms, who notify viewers of a growing product liability litigation around the antipsychotic drug’s link to the enlargement of male breast tissue, a medical condition known as gynecomastia.
Most commercials note that thousands of patients have already filed lawsuits against Risperdal’s manufacturer, the Johnson & Johnson-subsidiary Janssen Pharmaceuticals. After outlining the side effects of gynecomastia, the TV ads go on to encourage patients and their loved ones to reach out to legal counsel immediately to learn more. But here’s what these Risperdal commercials don’t tell you.
US Government, Patients Take Janssen To Court
Top prosecutors from the United States Department of Justice. 36 State Attorneys General. Nearly 20,000 patients and families from America and Canada. What do all of these people have in common? They’ve all sued Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, over the company’s antipsychotic drug Risperdal.
In a nearly-unprecedented wave of product liability claims, young patients from across the country accuse Janssen Pharmaceuticals of failing to warn the medical community of the schizophrenia drug’s risks. Chief among these risks is gynecomastia, a condition in which a boy or man’s breast tissue swells, creating enlarged breasts.
J&J Admitted To Selling Risperdal “Off-Label”
The federal government says Janssen marketed Risperdal for unapproved uses, peddling the drug to elderly patients with dementia in whom, astonishingly, the medication actually increases the risk of death. Even more astonishing? Janssen pled guilty to the charges.
That almost never happens in cases of health care fraud, even when the Justice Department is involved. The company’s wrongdoing led to $400 million in fines. And while the company did not admit to it, the Department of Justice also claimed Jannsen had marketed Risperdal “off-label” to children.
States Accuse Janssen Of Downplaying Drug’s Risks
But that wasn’t the first time Risperdal had been at the center of a major court case. In fact, the federal government’s lawsuit only came after no fewer than 36 state governments had already filed suit against Janssen. In their complaints, attorneys general from Texas, Louisiana and 34 other states accused the company of marketing Risperdal in violation of state law, downplaying the drug’s risks, orchestrating complex “kickback” schemes to encourage more prescriptions and defrauding Medicaid funds of millions of dollars.
Judges from South Carolina, Arkansas and elsewhere ordered Janssen to pay fines that ranged into the billions and, while some of these judgments were later overturned on legal technicalities, the weight of the case against Janssen now appears overwhelming.
Janssen Used To Say Gynecomastia Is “Rare”
When Risperdal was first approved in 1993 (and long before it had been approved for young patients), the drug’s warning label listed gynecomastia as a “rare” side effect. According to the World Health Organization and US Food & Drug Administration, “rare” complications are just that: rare. Most health authorities believe that a side effect should only be considered rare when it affects one in 1,000 people (0.001%) or fewer. But as it turns out, Risperdal causes gynecomastia far more frequently.
That’s been the conclusion of numerous research papers, even as the drug’s approval was extended to include schizophrenia in children, bipolar disorder in children and autism spectrum disorder in children.
More recent research has found exceedingly-high risks. A Canadian study published in the Journal of Child and Adolescent Psychopharmacology, which included nearly 401,200 boys and men between the ages of 15 and 25, found that Risperdal patients experience gynecomastia at more than five times the rate of non-patients.
Did Janssen Hide Study Results?
It’s no longer controversial to say that Risperdal causes gynecomastia. Most antipsychotic drugs lead to an increase in prolactin, a hormone that stimulates milk production. When prolactin levels jump in a young man’s body, gynecomastia, the enlargement of breast tissue, is a known side effect.
The problem, lawsuits claim, is that Janssen Pharmaceuticals actively concealed evidence about how common gynecomastia was in Risperdal patients. As plaintiffs’ attorneys have revealed during court proceedings, at least one Janssen-funded study, conducted in 2003, identified a direct correlation between a patient’s prolactin levels and the development of gynecomastia. But when the study was published, its data on gynecomastia was curiously omitted, according to Medpage Today.
Increased Warnings Came In 2006
Instead of reporting the real findings, the article concluded by saying “no direct correlation between elevated prolactin and [gynecomastia]” was found. That study led directly to Risperdal’s approval as a treatment for autism spectrum disorders in children.
Risperdal was the first drug approved for these patients and, initially, it was considered too dangerous for prepubescent children to take. Why? Because it increased their levels of prolactin. A new warning for gynecomastia, which suggested a 2.3% risk rate, was only added to Risperdal’s labeling in 2006.
20,000+ Enlarged Breasts Lawsuits
So it’s not particularly surprising that thousands of Risperdal patients, many of them now adult men, have stepped forward to pursue financial compensation. To date, around 20,000 patients have filed lawsuits against Janssen Pharmaceuticals and its parent company Johnson & Johnson. Many of these claims have been consolidated in the Philadelphia Court of Common Pleas, where a number of jury trials have already been held to decide the issue.
Juries Award Patients Millions
And Philadelphia juries have not looked kindly on the defendants’ apparent conduct. In 2016, Johnson & Johnson lost four Risperdal trials in which jurors ordered the company to pay young boys and men over $75 million in damages.
At one of these trials, David Kessler, who served as Commissioner for the Food & Drug Administration from 2000 to 2007, testified against Johnson & Johnson, FiercePharma reports. In his testimony, Kessler cited a study from 2001 that linked Risperdal to a 5.5% rate of gynecomastia in boys. As the former FDA head noted, the study had come out nearly five years before Johnson & Johnson highlighted gynecomastia on the product’s warning label.
Even before that time, Johnson & Johnson had been settling Risperdal lawsuits. In 2012, a man who developed gynecomastia after being prescribed the drug off-label when he was nine secured an undisclosed settlement after only one day of trial proceedings.
The following year, a group of 77 other plaintiffs found similar results, as Johnson & Johnson settled all of their cases for undisclosed amounts. A similar pattern can be observed more recently, as the company has reached settlement agreements in two Risperdal cases that were only days from trial.
Learn More About Filing A Risperdal Lawsuit
Did you or a loved one develop gynecomastia after being prescribed Risperdal, either for an approved or unapproved indication? Our experienced product liability lawyers want to help. You can find more information on your legal rights at no cost and no obligation. Just call our attorneys today for a free legal consultation.