A law firm representing a large number of  plaintiffs who are part of Risperdal mass tort against Janssen Pharmaceuticals Inc. has filed a separate yet related Risperdal lawsuit against the U.S. Department of Health and Human Services (HHS) in search of documents from the U.S. Food and Drug Administration (FDA) on the antipsychotic drug.

This Risperdal lawsuit alleges the FDA wrongly denied numerous citizens their petitions to force Johnson & Johnson’s subsidiary Janssen to publicize confidential documents that would better inform consumers and the medical community about the dangers of taking Risperdal, including the chance of developing Risperdal gynecomastia.

What is Gynecomastia?

Gynecomastia is a medical condition where a male’s breast become unnaturally enlarged, growing what are colloquially called “man boobs,” typically seen in adolescent boys taking Risperdal.

While gynecomastia can occur naturally as a result of low testosterone, there is a high rate of adolescent male Risperdal consumers developing male breasts only after use of the Janssen drug. While gynecomastia is physically benign, it can cause great psychological stress for young men leading to ongoing body image issues.

Some symptoms of gynecomastia include:

• Nipple discharge
• Tenderness in the breast area
• Pain in breast tissue
• Swelling of breast tissue and nipples

The majority of young men represented in Risperdal gynecomastia lawsuits do not have a history of low testosterone and also did not exhibit a medical or genetic predisposition to gynecomastia, meaning Risperdal might be the main culprit of their gynecomastia.

Risperdal Litigation

On April 3, HHS and the FDA filed a motion to dismiss this Risperdal lawsuit, arguing the law firm failed to demonstrate how it had been hurt by the denial of the citizens’ petition.

According to the agencies’ motion to dismiss the Risperdal lawsuit, “[The law firm] illogically claims that FDA’s denial of its citizen petition deprives [the firm] of the right to file a citizen petition.

“This assertion is belied by [the law firm’s] filing a citizen petition that FDA considered and substantively answered. More importantly, FDA’s denial of the petition, without more, does not constitute the injury-in-fact,” the federal agency adds.

The law firm in question filed this Risperdal lawsuit in January, claiming that firm was prohibited from turning over the confidential documents, which were obtained by the law firm through the discovery process in their ongoing Risperdal class action lawsuits against Janssen, to the HHS and FDA.

As a result, the firm claims that the FDA’s decision to deny citizen petitions for the agency to change the Risperdal label and rescind pediatric indications of use was based on incomplete data.

One of the main allegations brought forth in the majority of Risperdal lawsuits and in the petitions to the HHS and FDA involve alleged incidences of male breast growth and other Risperdal side effects that occur when children and adolescent boys take this antipsychotic drug.

Additionally, at the beginning of this year, two juries in Philadelphia found that Janssen and Johnson & Johnson failed to warn physicians of the risk of young men experiencing unnatural male breast growth, a condition more commonly referred to as gynecomastia, when taking Risperdal.

The confidential documents the plaintiff law firm wants Janssen to publicize include analyses of a Risperdal report performed by David Kessler, an ex-FDA Commissioner, who has testified on behalf of the consumer plaintiffs involved in the Philadelphia Risperdal gynecomastia trials.

However, HHS and the FDA argue that the law firms claims are not enough for the firm to claim its plaintiffs involved in Risperdal lawsuits have been harmed by the agencies’ petition denials to warrant court legal standing. The agencies go on to argue that the law firm itself is required to demonstrate injury due to the FDA’s November decision to deny Risperdal label change petitions.

The presiding federal judge has yet to make a decision regarding this motion to dismiss the Risperdal lawsuit against the HHS.

The Risperdal Lawsuit is Case No. 2:15-cv-00440, in the U.S. District Court for the Eastern District of Pennsylvania.