Risperdal Lawsuit Filed against Federal Government

A Risperdal lawsuit has been filed against the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA), as well as key officials in those departments.

The complaint, which was filed by a Pennsylvania law firm, alleges these agencies failed to consider a citizen petition by the law firm that requested a change in labeling for the anti-psychotic drug Risperdal. The plaintiffs claim the FDA denied the request without a proper meeting or hearing, or even without considering all the evidence submitted by the plaintiffs to demonstrate the dangers of Risperdal, particularly to children.

Complaint filed in federal court

The complaint was filed in U.S. District Court for the Eastern District of Pennsylvania on January 29, 2015. Defendants listed in the complaint include the HHS, FDA, Sylvia Mathews Burwell, Secretary of the HHS, and Margaret A. Hamburg, M.D., Commissioner for the FDA. The plaintiff in the complaint is a law firm that has represented hundreds of children who have suffered serious injury after taking Risperdal and its generic counterparts.

The plaintiff filed a citizen complaint with the FDA after receiving confidential documents establishing the dangers associated with Risperdal consumption by minors. The information came to the plaintiff as a result of their representation with young clients that had been injured by the drug. In the petition, the plaintiff requested the FDA to obtain those documents directly or release the plaintiff from confidentiality orders put in place by Risperdal manufactures Johnson & Johnson and their subsidiary Janssen.

According to the complaint, the FDA denied the plaintiff’s petition and “expressly refused” to consider facts the plaintiff had submitted involving the inadequate labeling of Risperdal. The plaintiffs further state in their complaint that the FDA’s denial “puts at risk numerous pediatric patients who are prescribed Risperdal drugs.” Risperdal and generic versions of the drug have been linked to serious side effects in young male patients, including abnormal breast growth and other issues with sexual development.

About Risperdal and gynecomastia

Risperdal is an anti-psychotic drug approved by the FDA to treat schizophrenia in adults. The agency later approved the drug to treat irritability in children and adolescents that was directly related to autism. It has also been approved to treat acute mania and bipolar disorders in younger patients. Physicians have also prescribed Risperdal off-label to treat other disorders in this same age group, including ADD, ADHD and other behavior disorders.

As more young men began taking Risperdal for a variety of disorders, concerns began to grow about the potential side effects of this drug. A number of young male patients developed a condition known as gynecomastia, or abnormally enlarged male breasts. The side effect was attributed to the drug’s stimulation of prolactin by the body, which is a hormone that promotes breast growth and development. For some patients, the side effects of Risperdal could persist long after the drug was stopped.

While gynecomastia is not usually medically dangerous for young men, the psychosocial effects can be devastating. One study, published in the journal “Plastic Reconstructive Surgery,” found gynecomastia has a significant psychosocial impact on adolescent patients. This impact affected the patient’s self-esteem, social functioning and mental health. The impact was the same, regardless of the severity of the condition.

Confidential documents questioned

At particular question in this Risperdal lawsuit are confidential documents the plaintiff claims to have come in contact with during their representation of many children injured by Risperdal. According to the plaintiff, these documents are under the control of Johnson & Johnson and Janssen, and contradict claims of Risperdal’s safety by the manufacturers. These documents include reports from the former FDA Commissioner David Kessler, M.D., as well as a “Findling Article” from Janssen employees that showed a “statistically significant” association between Risperdal and gynecomastia.

The plaintiffs in this complaint are not seeking any financial compensation; instead, they are seeking an injunction to revoke the pediatric indication for Risperdal or a change to the labeling of the drug. The plaintiffs are also asking Janssen and Johnson & Johnson to release the plaintiffs from confidentiality orders prohibiting them from releasing pertinent information to the FDA. Finally, the plaintiffs are asking the court to determine the FDA’s rejection of their petition was arbitrary and in violation of federal law.

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