Ahead of a trial that was scheduled to get underway last month in Philadelphia, a Johnson & Johnson unit agreed to settle the case. The suit alleged that a New York boy grew female breasts after being treated with the antipsychotic drug Risperdal. The settlement comes as Janssen Pharmaceuticals Inc. was gearing up to face what would have been the seventh trial over breast growth linked to the powerful antipsychotic since juries began hearing cases over the drug two years ago.

Zachary Sabol and his family filed suit against Janssen in the Philadelphia County Court of Common Pleas in April 2013 alleging that he developed a condition known as gynecomastia, or the abnormal growth of female breast tissue, after being treated with Risperdal for nearly a decade. The Sabol case is one of nearly 2,300 cases queued up as part of a mass tort program in Philadelphia to address claims that Janssen’s blockbuster antipsychotic caused hormone spikes in adolescent boys that led to the development of gynecomastia.

Johnson & Johnson still faces thousands of claims by boys who grew female breasts as a result of taking Risperdal. Jason Itkin, a lawyer with Arnold & Itkin, represents Zachary and his family. He says this is a one-off settlement and doesn’t indicate Janssen’s willingness to begin any sort of global approach to ending the litigation.

Plaintiffs in the litigation accuse Janssen of working to obscure the risk of abnormal breast growth in young boys as they tried to win approval of the drug for use in children. The Food & Drug Administration (FDA) ultimately approved the drug in October 2006 to treat symptoms of autism in adolescents. When Zachary began taking the drug, however, it was only approved for use in adults and indicated that gynecomastia was a rare side effect that occurred in fewer than one in 1,000 patients.

Warning labels were subsequently updated to show there was a 2.3 percent rate of gynecomastia in adolescents taking the drug. The settlement comes less than a month after a rare mid-trial dismissal of Risperdal-related claims based on what a judge said was insufficient causation evidence from the Plaintiffs. That was the second victory, coming after a Defense verdict in March 2015, that Janssen has won in Risperdal-related cases in the courtroom. The company also secured a summary judgment ruling dismissing a case in October.

Plaintiffs have received four verdicts in their favor in Risperdal cases in Philadelphia, including a $70 million damage award handed down by a jury in July. Damage awards in three other cases have resulted in $4.75 million in damages for Plaintiffs.

The Plaintiffs are represented by Thomas Kline of Kline & Specter PC, Jason Itkin of Arnold & Itkin, and Stephen Sheller of the Sheller firm. The case is Zachary Sabol et al. v. Janssen Pharmaceuticals Inc. et al., (case number 130402100) in the Court of Common Pleas of Philadelphia County, Pennsylvania.

Source: Law360.com



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