A 20-year-old man who allegedly developed gynecomastia due to his use of Risperdal as an 8-year-old child is now presenting evidence to a jury in Philadelphia. Court documents indicate that the case is the first Risperdal gynecomastia claim to head to trial in a mass tort litigation that involves some 1,257 product liability filings over the drug’s alleged side effects.
Risperdal is an atypical antipsychotic that is now approved to treat certain mental disorder in adults and children, as well as irritability in children (5-to-16 years of age) with autistic disorder. However, Risperdal’s pediatric indications weren’t approved until 2006 – several years after the Plaintiff named in this claim began taking the antipsychotic medication. Among other things, he alleges that Johnson & Johnson’s Janssen Pharmaceuticals unit improperly marketed Risperdal for off-label pediatric uses without informing doctors that the drug could increase prolactin levels in children. Prolactin is a hormone that promotes breast growth, and has also been associated with gynecomastia, or excessive breast growth, in men and boys.
During opening statements in the Philadelphia Court of Common Pleas on January 23rd, the Plaintiff’s attorney accused Janssen of failing in its duty to be transparent about the risks associated with Risperdal. Among other things, the lawyer alleged that the company had said that only around 1 in 1,000 boys treated with the drug would develop the condition, when the real risk was closer to 1 in 100.
“When you’re dealing with the most fragile among us, in a drug that isn’t even approved for the indication, and you find a problem, do you open the window for everyone to see or do you try to pull the shades?,” the Plaintiff’s attorney asked the 16-member jury.
As a bellwether trial, this case is being closely watched by other gynecomastia plaintiffs who have claims pending in the proceeding. In large, complex litigations like this, bellwether trials are used to gauge the strength of claims put forth in similar Risperdal lawsuits, and their outcomes may provide valuable insight into other jury rulings in those lawsuits.
Johnson & Johnson and Janssen have faced legal trouble over Risperdal for years. In November 2013, for example, the company reached a $2.2 billion settlement with the U.S. Department of Justice over the marketing of Risperdal and other drugs. Among other things, the companies were accused of concealing the risks associated with Risperdal, and of improperly marketing the medication for off-label indications, including for use in children.