It is estimated that between 1993 and 2008, over 1,200 children have suffered complications in connection with taking Risperdal.

One common Risperdal side effect is gynecomastia, or male breast growth. Enough cases of this have occurred that over 900 Risperdal lawsuits have been filed against the drug’s makers, Johnson & Johnson and Janssen Pharmaceuticals. These consolidated Risperdal lawsuits are finally seeing their day in court.

The Philadelphia Court of Common Pleas in Pennsylvania is set to hear the bellwether trials of Risperdal victims. The first trial, which was supposed to happen earlier this month, was postponed on Nov. 3, but the second is expected to be heard in early January 2015. The focus of these male breast growth lawsuits is mostly Risperdal-induced gynecomastia.

Bellwether trials are used as an indicator of future decisions. In a bellwether trial, the judge and parties select cases that are a good representation of issues that will arise in every plaintiff’s lawsuit.

For involved parties, bellwether trials help the parties gauge the strengths and weaknesses of their lawsuit. For victims, it can mean less court time, fewer potential costs, and elimination of the risk of varying outcomes from different judges.

For defendants, outcomes are good gauges if a case should be settled out of court. In 2012, a bellwether trial that was scheduled to occur was settled on the first day of the jury trial.

The Risperdal MDL is In re: Risperdal Litigation, Case No. 100300296, in the Philadelphia Court of Common Pleas.

Risperdal and Youth: Off-label Risks

Risperdal, or risperidone in its generic form, was approved by the U.S. Food and Drug Administration (FDA) for use with youth in 2006. It was intended for treatment of autistic children under 10. However, victims allege that Risperdal’s manufacturers have marketed Risperdal for off-market use long before it was approved for this purpose.

The expansion of off-label use was, and still is, divisive. It’s hard enough for parents to decide to give their child a medication, but it’s alleged that the studies published that reported improvements in behavior were underwritten by Risperdal’s manufacturers.

According to an article in The New York Times, “current American Academy of Child & Adolescent Psychiatry guidelines on antipsychotics state: ‘Much is still not known about the efficacy, tolerability, and long-term safety of these drugs in young people.’”

All medications come with side effects and risk. With antipsychotics, that list can include anxiety, dizziness, balance issues, fatigue and weight gain. In the case of Risperdal, what many victims say is missing from the list is the development of breast tissue.

They say Johnson & Johnson and Janssen have concealed or downplayed Risperdal’s side effects and that warning labels said nothing of the risk of “man boobs.”

Misleading the Masses

The manufacturers’ history of strikes in this arena seems to prove their claims. In 1999, the companies received a warning letter from the FDA regarding marketing Risperdal “in a manner that was misleading, false and lacking in fair balance.”

Over the years, the FDA repeatedly warned Janssen about its “misleading marketing messages” to doctors.

In 2001, the FDA approached Janssen again, but for different reasons. This time they were requiring changes to the labeling of Risperdal – saying it had to include a statement that the safety and efficacy of the drug in children had not been proven.

To date, Johnson & Johnson and Janssen have paid over $2 billion in fines for their marketing practices for Risperdal and other drugs.