The potential for the medication Risperdal to cause male breast growth, known as gynecomastia, has led to more litigation against manufacturers Janssen Pharmaceuticals and its parent company Johnson & Johnson.

The plaintiff, now in his early 30s, says in his Risperdal lawsuit that he developed gynecomastia because of Risperdal he was prescribed as a teenager.

Aggravating the defendants’ culpability is their promotion of Risperdal for use in children and teens before the FDA approved it for that use, the plaintiff says.

He alleges sales representatives from Janssen were promoting Risperdal for use in younger patients at least two years before the FDA approved it for that use in 2006.

The plaintiff’s Risperdal lawsuit includes claims for negligence, failure to warn, breach of warranty, and redhibition.

He seeks compensation for medical expenses, pain and suffering, mental harm, lost wages, lost earning capacity, and future loss of enjoyment of life.

The Risperdal Lawsuit is pending in the U.S. District Court for the Eastern District of Louisiana.

Investigation and Settlement

The alleged improper marketing of Risperdal was part of a huge investigation by the U.S. Justice Department and the governments of 45 states. In 2013, that investigation led to a $2.2 billion settlement.

Part of that penalty resolved a criminal misdemeanor charge assessed directly against Janssen for allegedly promoting Risperdal for uses not approved by the FDA, a practice known in regulatory terms as “misbranding.”

Janssen allegedly marketed Risperdal as a treatment for the young and also as a treatment for dementia in older patients at a time when neither treatment had been FDA-approved. Janssen was also accused of paying kickbacks to individual physicians and to Omnicare Inc., a provider of pharmaceuticals for nursing homes.

The Risperdal settlement also addressed civil claims related to misbranding of Risperdal and two other Janssen products. Janssen said it “accepts accountability” for the actions identified in the misdemeanor charge.

As for the civil claims, the company specifically said the settlement was not an admission of any liability or wrongdoing and continued to deny the government’s allegations.

The civil part of the settlement originated in three whistleblower lawsuits. One of those whistleblowers was a former sales representative for Janssen, who claimed Janssen had ordered her to promote Risperdal for off-label use in children.

In announcing the settlement, former Attorney General Eric Holder had harsh words for Johnson & Johnson, saying the company had “recklessly put at risk the health of some of the most vulnerable members of our society — including young children, the elderly, and the disabled.”

Despite being one of the largest health fraud penalties ever levied in U.S. history, the $2.2 billion settlement amount is dwarfed by Risperdal’s sales figures. During peak sales from 2003 to 2010, Risperdal sales exceeded $24 billion. Risperdal was one of J&J’s most revenue-generating medications before its patent expired.

J&J and Janssen continue to face over a 1,000 other civil lawsuits over Risperdal gynecomastia. Several of these claims have already been consolidated into a single state court in Philadelphia. Of those claims, six have already been resolved via settlement.