A lawsuit has been filed against the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) by a Pennsylvania law firm regarding the side effects of Risperdal, alleging the agencies failed to consider a citizen petition requesting that the anti-psychotic drug’s labeling be changed. Risperdal lawsuits have been filed against drug maker Janssen, a subsidiary of Johnson & Johnson, alleging the company failed to disclose the risk of severe side effects, including abnormal breast growth in males (a condition known as gynecomastia) and other complications.
If you or a loved one took Risperdal and suffered complications, including gynecomastia, contact Attorney Group to learn more. We can answer your questions and inform you of your options. If you choose to pursue a claim, we can connect you with an affiliated attorney. Your call is free, confidential, and without obligation. The time to pursue a claim is limited, so contact us today.
FDA Allegedly Refused to Consider Petition
According to the plaintiff, the FDA denied the request to change Risperdal’s labeling without holding a hearing or meeting, as well as without considering all of the evidence submitted to the agency. The plaintiff had attempted to illustrate the reported dangers of Risperdal, a popular anti-psychotic medication, especially to adolescents and young children.
The complaint, filed on January 29, 2015 in the U.S. District Court for the Eastern District of Pennsylvania, listed the FDA and HHS as defendants as well as the Commissioner for the FDA and the Secretary of the HHS. The plaintiff filed a citizen petition with the FDA after reportedly receiving confidential documents showing the potential dangers of Risperdal use in children.
According to the lawsuit, the FDA rejected the petition and refused to consider the facts submitted by the plaintiff involving the labeling of Risperdal. In addition, the plaintiff claims that the FDA’s rejection of the petition puts children at risk of suffering severe side effects of Risperdal, including gynecomastia.
Injured Patients May Be Eligible For Compensation
People who have been injured by Risperdal may be entitled to compensation, also known as damages, from the party responsible for their injuries. Damages can be based on a number of factors, including:
- The nature, extent and permanency of the injury
- The aggravation of a pre-existing condition
- Past and future medical expenses
- Transportation and lodging costs due to medical treatment
- Past and future pain, suffering and mental anguish
- Scars and disfigurement, either from the injury itself or medical treatment
The Time to Pursue a Claim is Limited. Contact Us Today.
If you or a loved one took Risperdal and developed gynecomastia or suffered other complications, contact Attorney Group for more information about your options. We can answer your questions, and if you have a case, we can connect you with an affiliated attorney. Your call is free, confidential, and without obligation. The time to pursue a claim is limited, so contact us today.