A Philadelphia jury found on Friday, July 1st, 2016, that the antipsychotic drug Risperdal® did in fact cause a Tennessee boy to grow breasts — a condition called gynecomastia — and justly levied a $70 Million verdict on the drug’s manufacturer, Janssen Pharmaceuticals. Janssen is a subsidiary of Johnson & Johnson.
Plaintiff attorneys argued that Janssen’s own scientists knew of the risks of Risperdal but opted to downplay them. Janssen argued that the physicians were fully informed of the potential side effects of Risperdal.
The boy’s attorneys also alleged that Janssen withheld information showing a significant link between the drug and the breast-growing condition, claiming that the drug makers intentionally took steps to limit the medical community’s knowledge of such risks. At the time of the boy’s prescribing of Risperdal, the drug only had U.S. Food and Drug Administration (FDA) approval for use in adults with schizophrenia.
Risperdal® Has Its Day in Court: Nothing New for the Dangerous Drug
This recent lawsuit was the fifth of its kind tried in Philadelphia, and $70 Million is the largest verdict awarded against the antipsychotic drug so far. Previous verdicts ranged from $500,000 to $2.2 Million.
Despite the mounting lawsuits against Janssen (and its parent company J&J) for Risperdal, the pharmaceutical company has issued a statement claiming that millions of patients have been helped through treatment with Risperdal, and that they plan to appeal the court’s decision that their drug caused the boy to develop breasts. “We believe this verdict is not justified by the evidence, and that the award is clearly excessive and far out of line with any factual assessment of actual damages,” Kristina Chang, a Janssen spokeswoman, said in an e-mailed statement. The statement went on to say:
“We know that dealing with disorders of the brain is very difficult, and we sympathize with the plaintiff in this case and his family. During the trial, the jury heard evidence that the FDA-approved label properly warned of Risperdal’s potential side effects, that the plaintiff’s physical condition was not caused by using the medication, and that the plaintiff benefited from using Risperdal.”
This statement, of course, avoids mentioning any wrongdoing on behalf of the multi-billion-dollar, profit-driven pharmaceutical company, in a case in which the ultimate victim was a teenage boy.
Risperdal’s Controversial Shift into Treatment of Children
Plaintiffs alleged that Janssen in fact manipulated study data showing that Risperdal was suspected of causing gynecomastia in order to downplay the potential risks so that doctors might be more willing to prescribe the drug.
The drug, which was originally FDA-approved for treating schizophrenia and bipolar disorder was not profitable enough in those 2 relatively small markets. Given that, Janssen worked aggressively to expand the drug’s use, and over a short period of time, turned Risperdal into a $3-Billion-dollar-a-year drug by targeting seniors with dementia and children with behavioral problems and autism.
In the case of the young Tennessee boy whose case was defended in Philadelphia last Friday, the FDA had approved Risperdal only for use in adults at the time when he had begun taking it.
Risperdal Has a Very Dangerous Past
In 2013, the U.S. Justice Department opened an investigation into Risperdal. The result? The drug makers were ordered to pay $2.2 Billion in civil and criminal penalties to settle charges that it had improperly marketed the drug for use with elderly nursing home patients to control agitation, confusion, and other symptoms of dementia. This, when previously the FDA had declined to approve the drug specifically for that use. The settlement was one of the largest health-fraud penalties in U.S. history.
The damages awarded to the Tennessee teenager on Friday were in part for emotional distress, and the verdict amount – $70 Million — is about 30 times larger than a $2.5 Million award in a similar case from 2015, when an Alabama man sued the drug maker for causing him to develop 46 DD-sized breasts.
J&J still faces 1,500 cases in state court in Philadelphia over claims of the Risperdal side-effect, which means Friday’s ruling is sure to not be the last.