Missy Clyne Diaz  |  March 4, 2015

Category: Legal News

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tipped-pill-bottleThe former U.S. Food and Drug Administration Commissioner has bolstered claims that Johnson & Johnson’s Janssen Pharmaceuticals subsidiary attempted to convince the public that its antipsychotic drug Risperdal did not pose a significant risk for a condition known as gynecomastia despite knowledge to the contrary, according to the Philadelphia Inquirer.

Dr. David Kessler, who formerly held the agency’s top job, testified in January at the trial of an Alabama couple that filed a Risperdal lawsuit blaming the drug for causing their son to suffer the condition which causes boys to grow breasts.

During the civil trial brought by Benita P. and her husband, Kessler testified about a 2001 Janssen study that showed some children and adolescents taking Risperdal showed higher-than-normal incidences of gynecomastia, often referred to as “man boobs,” while company emails and manuscript drafts indicated Janssen was trying to “reanalyze data so as to downplay the prevalence of gynecomastia,” according to the Inquirer.

While the study results showed higher prolactin levels and incidences of gynecomastia in boys, and a few girls, internal correspondence at Janssen exposed “changes to plans and multiple versions of a manuscript the company hoped would be published in a peer review journal to help its case with the FDA.”

“The most important thing for me, as someone who worked for the FDA, as a physician and as somebody who served on the boards of pharmaceutical companies, is you tell the truth and you tell the whole truth,” Kessler testified. “You tell the whole story. You make sure the data supports the message. What they want to convey doesn’t match what the data shows and to me, that doesn’t tell the whole story. Make sure the FDA knows and make sure the doctors know. Tell them the good and the bad.”

Based on the internal documents, Kessler said it appeared that Janssen altered the way it classified patients in one study, then combined those results with other studies to make it appear that there was a less significant potential risk than actually existed.

“You certainly don’t want to change your plan after you know your results,” Kessler said.

A Janssen spokeswoman, in a statement, denied the allegation, saying the company “appropriately analyzed and reported data from clinical trials” and that “Risperdal continues to help countless children and adults around the world who suffer from the debilitating effects of schizophrenia, bipolar mania and irritability associated with autistic order in children.”

Thousands of Risperdal lawsuits have been filed on behalf of children who took the medication for treatment of bi-polar disorder, autism, irritability, aggression or other behavior disorders.

In 2012, Johnson & Johnson reached a confidential settlement in a Risperdal lawsuit brought by a 21-year-old man who said that growing breasts resulted in “severe psychological trauma.” The plaintiff underwent a mastectomy to remove the breasts. A short time later, J&J settled cases brought on behalf of at least five other boys who experienced breast development.

Risperdal first received FDA approval in 1993 for the treatment of schizophrenia. Its uses later expanded to include adult and adolescent bipolar disorder and autism spectrum disorders in children and adolescents. The drug is commonly used for off label purposes such as the treatment of deficit hyperactivity disorder (ADHD), anxiety, sleep difficulties and depression.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Risperdal attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Risperdal class action lawsuit is best for you. [In general, Risperdal lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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If you or your son took Risperdal between the ages of 10 and 18 years old and suffered gynecomastia (male breast growth), male breast pain, nipple pain, or nipple discharge, you may be entitled to compensation. See if you qualify by submitting your information below for a free and confidential case review.

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