A Philadelphia jury awarded a young man, Nicholas Murray, $8 billion in punitive damages after he claimed he was not warned of a significant side effect — breast growth — of an atypical antipsychotic medication called Risperdal (risperidone).
Risperdal is made by Janssen Pharmaceuticals, a Johnson & Johnson (J&J) company.
Murray was originally prescribed Risperdal in 2003 when he was 13 years old for treatment of autism spectrum disorder. Risperdal was not yet approved by the U.S. Food and Drug Administration (FDA) for the treatment of autism in 2003. But doctors can prescribe an FDA-approved medication for any condition they choose.
Murray, now 26, was previously awarded $1.75 million in the lawsuit in 2015, but the amount was reduced to $680,000 in a state appeals court. Murray claimed the company failed to warn that teenagers and young men using Risperdal could grow breasts.
Risperdal is typically prescribed (and FDA-approved) to treat bipolar disorder, schizophrenia, and other mental health disorders. Murray’s lawyers claimed the drug can create a hormonal imbalance, causing the formation of female breast tissue in men (a condition called gynecomastia).
The FDA approved Risperdal for children and teens (5 to 16 years old) diagnosed with autism in 2007.
This is not the first legal action taken against J&J due to its marketing of Risperdal.
In 2013, the U.S. Justice Department settled a $2.2 billion claim against J&J for Risperdal allegations. In that settlement, the Justice Department alleged that despite repeated warnings from the FDA, J&J’s Janssen division continued misleading marketing messages to physicians.
From that 2013 article, it was also noted that Janssen apparently marketed Risperdal for use in children with behavior challenges, despite known health risks to children and adolescents. Until late in 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly advised the company that promoting its use in children was problematic and could violate the law.
According to additional legal filings, J&J apparently faces some 13,400 lawsuits tied to Risperdal and its potential side effect of breast growth in boys who take the drug. More than 7,000 of those lawsuits are pending in state court in Philadelphia.
According to ClassAction.com, J&J has settled more than 80 cases related to Risperdal for undisclosed amounts from 2012 to 2013. In 2016, a jury awarded $70 million to Andrew Yount, “ruling that the company not only failed to warn Yount about the issues surrounding Risperdal but had destroyed evidence related to the case,” according to Fox Business News.
They also noted that, “In August of 2012, J&J agreed to pay $181 million to 36 states and the District of Columbia to settle fraud charges related to its unlawful marketing of Risperdal.”
“This jury resoundingly told J&J that its actions were deliberate and malicious,” Tom Kline and Jason Itkin, two of Murray’s lawyers, said in an emailed statement to Bloomberg.
The $8 billion sum is likely to be reduced on grounds that it violates due process. J&J said that it will appeal the ruling, claiming the amount was “grossly disproportionate.”
J&J is also involved in lawsuits related to its marketing of opioid painkillers. It recently settled two Ohio opioid-related lawsuits for more than $20.4 million. J&J formerly marketed the painkillers Duragesic and Nucynta.
Opioids were involved in 400,000 overdose deaths in the United States from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention. The company claims the settlement includes no admission of liability.
Source: Wire reports