J&J Concealed Risperdal Breast Growth Risk, Ex-FDA Official Says
A former U.S. Food and Drug Administration (FDA) official testified in a Risperdal lawsuit this week that a Johnson & Johnson medication likely caused male breast growth injuries that were allegedly sustained by the Plaintiff.
According to Bloomberg.com, the ex-FDA commissioner took the stand on January 28th, where he referenced a study that was funded by the company’s subsidiary, Janssen Pharmaceuticals and showed 3.8 percent of boys taking Risperdal as having sustained male breast growth that was either “probably or very likely” caused by the drug. Results of the research, which were published in 2001, “certainly raised a red flag for me,” the expert witness told jurors in the Philadelphia Court of Common Pleas. This testimony is the second to be heard in a Risperdal trial that involves a case filed by a 20-year old autistic man from Alabama who took the medication as a child. He had a mastectomy to remove the excess breast tissue he allegedly developed because of the drug, but his injuries are permanent, his Risperdal lawyer argues.
Neurologist Alleges J&J’s Failure to Warn about Risperdal Gynecomastia Risk
The first testimony on behalf of the Plaintiff was brought two days earlier by a pediatric neurologist who prescribed him the medication in 2002, at which time he said he was not aware of its association with male breast development, regrettably. If Johnson & Johnson and Janssen adequately warned doctors and patients about Risperdal gynecomastia, he would not have incorporated it into the Plaintiff’s treatment. Attorneys for Janssen argued this claim, maintaining that they properly disclosed information about risks associated with its product, and that they didn’t mishandle marketing.
This is the first Risperdal gynecomastia lawsuit to begin trial in the Philadelphia Court of Common Pleas, where a consolidated litigation now includes more than 1,200 claims. Plaintiffs involved in the proceeding allege complications caused by the antipsychotic medication, which is approved to treat schizophrenia, bipolar disorder and other psychiatric conditions.
In 2006, Risperdal garnered additional approval by the FDA to treat irritability in children with autism. The Plaintiff in the Risperdal case that is at trial was treated with the medication at 8 years old, and well before it was cleared by the federal agency for pediatric uses.
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