Risperdal (risperidone) was illegally marketed to children with behavior problems between 1999-2005. Unfortunately, many children were injured by Risperdal side effects, including breast growth in males (gynecomastia), severe weight gain, type-2 diabetes, and more.
Johnson & Johnson Risperdal Settlement Awarded for $2.2 Billion
November 2013 — The U.S. Department of Justice (DOJ) and Johnson & Johnson (J&J) have agreed to a $2.2 billion settlement. The DOJ announced that the settlement will resolve civil and criminal allegations that the company engaged in illegal, “off-label” marketing of Risperdal in children, elderly dementia patients, and people with intellectual disabilities.
Prosecutors from the DOJ allege that J&J ignored multiple warnings from the FDA and studies linking Risperdal to gynecomastia (breast growth) and diabetes in children. Sales representatives were instructed to tell child psychiatrists that Risperdal was a safe treatment for common disorders, including ADHD, obsessive-compulsive disorder, and more. Risperdal was not approved for pediatric uses until 2006.
Five More Risperdal Breast Growth Lawsuits Before Trials Begin
October 2012 —Johnson & Johnson has agreed to settlements with four plaintiffs who were injured by gynecomastia from Risperdal. In addition to avoiding jury trials, FDA Commissioner David Kessler (a former pediatrician) will not be required to testify.
According to the Philadelphia Inquirer:
“J&J settled four so-called bellwether cases Thursday morning for undisclosed amounts. Asked if the prospect of Kessler testifying against the company prompted it to offer enough to settle, plaintiffs’ attorney Stephen Sheller said, “Yes.”
Johnson & Johnson Risperdal Healthcare Fraud Settlements for $2 Billion
The Risperdal litigation began in 2004 with a whistleblower lawsuit. The plaintiff, Allen Jones, was a former investigator for the Pennsylvania Office of the Inspector General. After investigating suspicious payments J&J made to a pharmacist in the Pennsylvania state government, he discovered evidence that J&J was using questionable safety studies and incentivizing health officials to recommend Risperdal over cheaper, equally-effective alternatives.
Based on this evidence, several states filed lawsuits alleging that J&J defrauded taxpayer-funded healthcare systems. J&J lost four consecutive lawsuits, totaling about $2 billion. These lawsuits included: South Carolina ($327 million), Louisiana ($257.7 million), Arkansas ($1.2 billion), and Texas ($158 million).