Chicago Man Files Risperdal Lawsuit After Suffering Gynecomastia as a Boy
In a new Risperdal lawsuit filed July 17, 2013, Chicago resident Michael Johnson claims that Ortho-McNeil Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (J&J), should be held liable for his injuries. He brings counts of negligence, breach of warranties, and more, stating that after he took the anti-psychotic drug Risperdal (risperidone), he suffered permanent disfigurement.
The plaintiff adds that the defendants failed to warn about risperidone side effects in men, and that they illegally promoted the drug for off-label use in children. The case is proceeding in the Circuit Court of Cook County, Illinois.
Plaintiffs claims gynecomastia in Risperdal lawsuit
According to his complaint, Johnson started taking Risperdal in April 1999, when he was eleven years old. He continued to take the medication up until 2004. While on the drug, he states that he experienced rapid weight gain, and damage to his endocrine and sexual systems, resulting in significant and permanent gynecomastia—the development of breasts in men. He states that he will likely require mastectomy to surgically remove the breasts.
As a result of these injuries, the plaintiff continues to suffer pain and mental anguish, embarrassment, and inconvenience. He has incurred past medical expenses and will have more in the future, and has lost earning capacity.
Plaintiff states defendants failed to warn of risperidone side effects in men
The plaintiff claims that his doctors would not have prescribed Risperdal to him had the defendants provided adequate warnings regarding the risks. He adds that his physicians received information and promotional materials from the defendant suggesting Risperdal was safe and effective for use in treating children and adolescents with his condition, yet did not receive information about the signs and symptoms of serious adverse risperidone side effects like weight gain, hyperglycemia, gynecomastia, and other serious adverse events.
The court documents explain that Janssen engaged in promotional activities that were false and misleading, and were designed to illegally expand the use of Risperdal for off-label uses. They allegedly did so by manipulating clinical trials to produce results favorable to the drug, failing to publish or report negative studies, ghostwriting medical journal articles, and paying large sums to key opinion leaders to tout Risperdal as treatment for a variety of disorders.
Label change indicates drug safety for children not established
In January 1999, the FDA sent a letter to Janssen concerning a campaign that marketed Risperdal for geriatric patients. The FDA stated the campaign included materials that were false, misleading, and/or lacking in fair balance. In 2001, at the FDA’s insistence, the defendants modified the label for Risperdal to include a statement that “The safety and effectiveness in children have not been established.”
The plaintiff adds that prior to December 2003, Risperdal was not approved by the FDA for the treatment of bipolar disorder. That month, the FDA approved use of the drug for the short-term treatment of acute mixed or manic episodes associated with bipolar disorder, but in adults only. They required that a warning be added to the label regarding the association of the drug with diabetes.
Janssen added the warning to the label, but then sent a misleading dear doctor letter minimizing the risks. They received a warning letter from the FDA in April 2004, requiring them to send out a new letter with corrections.
According to his Risperdal lawsuit complaint, Johnson seeks compensatory and punitive damages.
- Bloomberg, J&J Marketed Risperdal for Kids After FDA Warnings, Jurors Told, http://www.bloomberg.com/news/2012-01-13/j-j-marketed-risperdal-to-children-despite-u-s-fda-warnings-jurors-told.html
- FDA, Alert for Healthcare Professionals: Risperidone (marketed as Risperdal), http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm152291.htm