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Janssen Knew About Gynecomastia Risk with Risperdal: Ex-FDA Chief

Former commissioner of the U.S. Food & Drug Administration David Kessler has testified that Janssen Pharmaceuticals knew of the drug’s potential to cause gynecomastia in boys and young men.

Former commissioner of the U.S. Food & Drug Administration (FDA) David Kessler has testified that Janssen Pharmaceuticals, maker of the antipsychotic medication Risperdal (risperidone), knew of the drug’s potential to cause gynecomastia in boys and young men. Janssen is currently facing over 1,250 Risperdal gynecomastia lawsuits pending in federal court in Pennsylvania.

Free Risperdal Lawsuit Evaluation: If you or a loved one was diagnosed with gynecomastia after taking Risperdal, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Risperdal and we can help.

What’s the Problem?

Court documents indicate that on Jan. 28, 2015, Kessler testified before a Philadelphia jury that Janssen was aware of the link between Risperdal and gynecomastia. The former FDA chief stated that the company hid information about the gynecomastia risk as early as 6 years before it changed the drug’s label to include the injury, which is characterized by abnormal breast tissue growth in adolescent boys and young men. He also told the jury that Janssen failed to inform physicians of the gynecomastia risk associated with the drug. Kessler made the comments during a trial over a lawsuit filed by the family of a 20-year-old autistic man who allegedly developed gynecomastia after taking Risperdal.

According to the complaint, Risperdal was only approved to treat schizophrenia in adult patients when the plaintiff started taking the drug. However, Risperdal is often prescribed in an “off-label” capacity (for which it was neither tested or approved by the FDA) to treat behavioral problems in autistic children. Kessler said the label was changed to include information about the gynecomastia risk when Risperdal was approved to treat autism in 2006. The updated label indicates that gynecomastia was observed in 2.3% of pediatric patients. Previously, the label stated that the gynecomastia rate in Risperdal users was less than 1 in 1,000.

Janssen made several attempts to get Risperdal approved for autism before 2006, according to Kessler; however, FDA denied the approval due to a lack of data on the drug’s safety and efficacy. Additionally, court documents indicate that Kessler received a number of reports from the late 1990s and early 2000s tracking adolescent Risperdal users. The reports showed that as many as 23 out of 419 boys (approximately 5.5%) went on to develop gynecomastia, according to Kessler.

Do I Have a Risperdal Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Risperdal lawsuits. We are handling individual litigation nationwide and currently accepting new Risperdal injury cases in all 50 states.

Free Risperdal Lawsuit Evaluation: If you or a loved one has been injured by Risperdal, you should contact our law firm immediately. You may be entitled to compensation by filing a Risperdal injury suit and we can help.

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