When it was approved in 1993, Risperdal had a similar warning. The drug’s product labeling listed gynecomastia under rare side effects, where the manufacturer informed medical providers that around 1-in-1,000 people taking Risperdal could develop the condition. Turns out that characterization probably wasn’t accurate.
High Rate Of Breast Growth
More recent research, published in numerous well-regarded and peer-reviewed journals, has found that patients on Risperdal experience gynecomastia at a significant rate. Some studies suggest that Risperdal patients could develop the disorder up to five times more often than people who don’t take the drug. That’s far more frequent than 1-in-1,000, like the drug’s original warning label claimed.
So what happened? Did Janssen Pharmaceuticals (and, by extension, its parent company Johnson & Johnson) lie to us? Did the company conceal evidence from the Food & Drug Administration? Or was it just different in 1993, when Risperdal was approved, with less clinical data leading to a poor understanding of the drug’s risks?
Lawsuits Accuse Janssen Of Concealing Evidence
Nearly 20,000 men say, in product liability lawsuits filed across the country, that Janssen Pharmaceuticals and Johnson & Johnson lied to us. And they have some major medical experts who agree with them.
FDA Commissioner Says Company Knew About Risks
A number of Risperdal lawsuits have already gone to trial and, at a 2016 trial, David Kessler took the stand to testify in a Pennsylvania State Court, Fierce Pharma reports. Kessler served as the Commissioner for the Food & Drug Administration from 2000 to 2007, but he wasn’t testifying on behalf of Janssen Pharmaceuticals. Kessler had come to the aid of a family who, on behalf of their son, a boy with autism, had sued Janssen after their child grew large breasts.
What Kessler had to say in court was shocking. Johnson & Johnson, the former-FDA chief testified, knew as early as 2001 that Risperdal could cause gynecomastia in nearly 4% of boys. The number was found in a 2001 clinical trial, conducted at the behest of Janssen Pharmaceuticals around two years before the drug was approved.
Suggestive Data Went Unreported
That’s one red flag. Another comes from 2003, when a different Janssen-funded study found evidence of a correlation between Risperdal, a boy’s prolactin levels and gynecomastia. The trial’s data tables clearly show a correlation. Boys taking Risperdal had abnormally-high prolactin levels. And boys with abnormally-high prolactin levels were more likely to develop gynecomastia than other patients.
In hindsight, the causal chain is obvious. It was probably obvious at the time, too, but the study’s full data sets were never published. Instead, the paper, which appeared in November 2003 issue of the Journal of Clinical Psychiatry, made the opposite conclusion, finding no evidence of a link between elevations in prolactin and breast tissue growth. A Johnson & Johnson biochemist has now testified that the study’s incriminating data tables were never shared with the FDA.
That’s a second red flag, and a chief reason why so many men have filed Risperdal lawsuits. It looks like, based only on a cursory examination of this evidence, as if Janssen Pharmaceuticals and its parent company hid something. Most juries who’ve looked at the issue agree.
Risperdal Trial Results
To date, five Risperdal trials have reached a jury verdict, all held in the Philadelphia Court of Common Pleas. In five of these cases, juries have found in favor of plaintiffs, awarding young men over $80 million in compensation after deciding that Johnson & Johnson had failed to warn the public about Risperdal’s risks.
We also know that Johnson & Johnson and Janssen Pharmaceuticals have been settling Risperdal cases. The first set of lawsuits scheduled for trial, a total of six back in 2012, were all resolved through settlements. Now five years later, the trend has continued. Janssen and J&J settled a Risperdal lawsuit in October of 2016, and another in January of 2017.
Learn More About Filing A Claim
Yet 20,000 claims remain to be decided. How these additional lawsuits will be resolved is anyone’s guess, but many legal experts believe that a global settlement could be on the way.
There’s still time to file a Risperdal lawsuit. Any man who was prescribed Risperdal and developed gynecomastia may be able to secure financial compensation. And learning more about your legal options comes at no cost. Our experienced product liability attorneys offer free consultations. Find more information about case eligibility at no charge and no obligation. Just call our lawyers today to get started.