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Johnson & Johnson Unit Slapped with $2.5 Million Judgment Over Allegations That the Drug Risperdal Causes Breast Growth in Men

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A Johnson & Johnson (J&J) unit has been slapped with a $2.5 million judgment over allegations that the company failed to warn the family of an autistic boy and his doctors about the risks of hormonal imbalances and breast growth associated with the drug Risperdal.

A Philadelphia County Court of Common Pleas jury slammed Janssen Pharmaceuticals with the decision on Tuesday after hearing evidence that J&J’s Janssen Pharmaceuticals unit had spent years trying to cover up data that showed Risperdal could cause breast growth in adolescent males, known as gynecomastia. Thousands of product liability lawsuits over the drug are pending across the country. Tuesday’s verdict is the first, according to Law360.

More 1,250 Risperdal cases are lined up as part of a mass tort docket in Philadelphia, where a second trial began on Friday. About 700 suits have been filed in state court in Los Angeles. The parents of the 20-year-old man who won Tuesday’s verdict filed suit against J&J in April 2012. The man began taking Risperdal in 2002, when he was 7, and continued to take the drug for nearly five years. His family alleges he grew large breasts as a result. At the time he started using Risperdal, the medication was only approved by the U.S. Food and Drug Administration (FDA) for use in adults, Law360 reported.

The jury heard testimony that Janssen sales representatives visited the man’s prescribing doctor, a pediatric neurologist, on multiple occasions and provided him with samples of Risperdal. According to testimony in the case, about 20 percent of Risperdal prescriptions written before the early 2000s were for children and adolescents. The drug was only approved for use autistic children with behavioral problems in 2006. At that time, Janssen warned on the drug’s label that gynecomastia had been seen in 2.3 percent of pediatric patients. Prior to that, the label said the condition was rare. Former FDA commissioner David Kessler told the jury that he believed J&J had consciously downplayed studies published in scientific literature that showed a link between Risperdal and gynecomastia, Law360 reported.

In November 2013, Janssen pleaded guilty to one misdemeanor count of misbranding, for improperly encouraging prescribers to treat dementia with Risperdal, even though it was only approved to treat schizophrenia at the time of conduct, which took place in 2002 and 2003. In August 2012, Janssen agreed to pay $181 million to 36 states and Washington, D.C., to resolve similar claims of off-label marketing, according to Law360. disclaimer: This article: Johnson & Johnson Unit Slapped with $2.5 Million Judgment Over Allegations That the Drug Risperdal Causes Breast Growth in Men was posted on Wednesday, February 25th, 2015 at 4:11 pm at and is filed under Defective Drug Lawsuits.

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