The jury found the company failed to warn patients of a side effect causing young men who used the drug to grow breasts (gynecomastia).
One week after settling an opioid lawsuit in Ohio for $20 million, life science giant Johnson & Johnson was slammed with an $8 billion verdict in a lawsuit regarding its antipsychotic drug Risperdal. The jury found the company failed to warn patients of a side effect causing young men who used the drug to grow breasts (gynecomastia).
The $8 billion in punitive damages was awarded Tuesday to a man who had won $680,000 in a previous lawsuit, Reuters said. This was the first of many lawsuits filed in Pennsylvania regarding Risperdal and the first in which a jury had been able to consider awarding punitive damages, the wire service added. That decision came after a 2018 Pennsylvania Superior Court ruling held that individual state’s laws should apply to punitive damages, rather than the laws of J&J’s home-state New Jersey, which barred punitive damages.
Attorneys for the plaintiff Nicholas Murray said in a statement that the jury imposed punitive damages on J&J and its pharma subsidiary Janssen Pharmaceuticals because the company “valued profits over safety and profits over patients.”
Murray, 26, had been prescribed the medication when he was a minor and alleged that the drug was the cause of the development of breasts. According to the Reuters report, Murray was prescribed the drug off-label by his doctor after he was diagnosed with autism spectrum disorder. In 2015, Murray initially won $1.75 million in court against J&J for the gynecomastia claims, but that was reduced to $680,000 in a 2018 state appeals court decision.
In a statement issued last night, J&J said the verdict is “grossly disproportionate with the initial compensatory award” in the case and is confident that it will be overturned in the appeals process. The company added that the $8 billion verdict is inconsistent with other Risperdal lawsuits outside of Philadelphia. J&J said it will begin the process to set aside the verdict.
“This award for a single plaintiff stands in stark contrast with the initial $680,000 compensatory award and is a clear violation of due process. United States Supreme Court precedent dictates that punitive damages awards that are a double-digit multiplier of the compensatory award should be set aside,” J&J said in its statement.
Additionally, J&J claimed it had been prevented from presenting a “meaningful defense” due to the court’s exclusion of key evidence. J&J said if that information had been allowed, the jury would have heard evidence showing the label on Risperdal “clearly and appropriately outlined the risks associated with the medicine.” Additionally, the company said had it been allowed to present this evidence, the jury would have heard of the benefits the medication provides to patients “with serious mental illness.”
“Further, the plaintiff’s attorneys failed to present any evidence that the plaintiff was actually harmed by the alleged conduct,” J&J added.
J&J’s Risperdal is an antipsychotic drug first approved in 1993 by the U.S. Food and Drug Administration to treat adult and adolescent schizophrenia and bipolar disorder. It is also prescribed to autistic children for irritability.
The Murray case isn’t the first Risperdal case to be heard regarding gynecomastia. In 2015, former FDA Commissioner David Kessler testified in a Philadelphia courtroom that the antipsychotic was “probably or very likely” to cause breast development in males. During his testimony, Kessler pointed to a 2001 clinical study that showed the adverse events of gynecomastia.
This is not the first issue J&J has had with Risperdal. In 2013, the company pled guilty to promoting off-label use of the drug in elderly dementia patients. The company paid more than $2.2 billion to settle charges from the U.S. Department of Justice.
