Thousands of lawsuits involving the drug Risperdal have been filed against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, Inc. The main complaint by most of the young men suing is that taking Risperdal caused gynecomastia, or the abnormal development of breasts. Many plaintiffs were prescribed Risperdal as minors and none were told they might develop breasts.
In 1993, the U.S. Food and Drug Administration approved Risperdal to treat schizophrenia and of mania in bipolar patients. However, due to legal off-label prescribing, doctors have been prescribing the anti-psychotic for a variety of mental health conditions.
In a recent case in Pennsylvania, a young man was prescribed Risperdal to help treat an autism spectrum disorder. It’s legal for doctors to prescribe drugs to treat conditions for which they aren’t specifically approved. However, drug manufacturers are only permitted to market their drugs for approved uses.
The Pennsylvania man says he was never warned that taking Risperdal would cause him to grow breasts. In 2015, an earlier jury awarded the man $1.75 million in compensatory damages, finding that J&J and Janssen were negligent in failing to warn patients about the risk of gynecomastia. On appeal, that compensatory damages award was found excessive and reduced to $680,000.
The case was sent back to the trial court to determine whether punitive damages should be awarded.
An award meant to send a message
The jury in the Pennsylvania case found that punitive damages were appropriate. To send a message to J&J and Janssen, the jury awarded $8 billion to the plaintiff.
The $8-billion award will be appealed and may likely be reduced on appeal. This is because punitive damage awards deemed excessive are considered to violate the defendants’ due process rights.
The U.S. Supreme Court has said that “few awards exceeding a single-digit ratio between punitive and compensatory damages, to a significant degree, will satisfy due process.” In theory, that means that an award for punitive damages usually cannot be more than about 9 times the amount of compensatory damages awarded.
“This jury, as have other juries in other litigations, once again imposed punitive damages on a corporation that valued profits over safety and profits over patients,” the Pennsylvania man’s attorneys said in a statement. “Johnson & Johnson and (subsidiary) Janssen chose billions over children.”
Johnson & Johnson called the award “grossly disproportionate with the initial compensatory award in this case” and said it is confident the punitive damages will be reduced upon appeal.