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 effectsin young male patients, including abnormal breast growth and other issues with sexual development.
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article footnotes/resources
- Forbes, J&J Sees Male Breasts and Quickly Settles Risperdal Suit,http://www.forbes.com/sites/edsilverman/2012/09/11/jj-sees-male-breasts-and-quickly-settles-risperdal-suit/
- Medscape, Antipsychotic may Boost Gynecomastia Risk,http://www.medscape.com/viewarticle/822072
- U.S. National Library of Medicine, Risperidone-Induced Symptomatic Hyperprolactinaemia in Adolescents, http://www.ncbi.nlm.nih.gov/pubmed/16633146
- The Philadelphia Courts, Complex Litigation Center- Mass Tort Information,http://www.courts.phila.gov/common-pleas/trial/civil/clc.asp
- U.S. National Library of Medicine, Psychosocial Impact of Adolescent Gynecomastia: A Prospective Case-Control Study, http://www.ncbi.nlm.nih.gov/pubmed/23542261
Thank You ILN.
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