Risperdal Manufacturer Should Not Be Allowed to Set Statute of Limitations on Gynecomastia Claims, Plaintiffs Argue

Published on June 24, 2014 by Laurie Villanueva

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Plaintiffs involved in Risperdal lawsuit filings in Pennsylvania argued in June that Johnson & Johnson should not be allowed to set statute of limitations on their claims, given that the company allegedly failed to provide adequate warning about the drug’s association with male breast development.

According to documents filed June 16th in the Philadelphia Court of Common Pleas, Risperdal’s updated warning label in October 2006 did not warn about its alleged potential to cause gynecomastia, a condition referring to male breast growth.  “In October 2006, there was not sufficient information available to the entire country to justify a legal conclusion that the accrual date for all Risperdal claims is Oct. 31, 2006,” plaintiffs said in the filing.

A month before plaintiffs issued these documents in Pennsylvania state court, the Johnson & Johnson subsidiary, Janssen Pharmaceuticals, filed a motion for partial summary judgment that argued in favor of its Risperdal labeling. According to the company filing in May, October 2006 Risperdal labeling said that 2.3 percent of children and adolescents included in a clinical trial had experienced gynecomastia.

Risperdal Labeling Insufficient in Warning about Gynecomastia, Plaintiffs Say

Plaintiffs in claims alleging Risperdal gynecomastia side effects say this language was not significantly different than what was used on the drug’s labeling prior to the adjustment. It is noteworthy to add that the U.S. Food and Drug Administration (FDA) did not approve Risperdal for pediatric uses until 2006, so any time the drug was prescribed to children before then would be considered an off-label drug use. Plaintiffs involved in the consolidated Risperdal litigation accuse Johnson & Johnson and Janssen of marketing Risperdal off-label for several years before the FDA’s expansion of approval.

“Janssen did not update the Risperdal label in October 2006 to notify the public about the risk of gynecomastia,” plaintiffs said in the June court filing. “It did so because the FDA had approved Risperdal for limited pediatric indication and it wanted to highlight and market the drug’s new indication.”

As of June 2014, at least 500 lawsuits over Risperdal, many of which alleging Risperdal gynecomastia, had been filed in the Philadelphia Common Pleas on behalf of individuals who were allegedly injured by the medication. Several claims alleging gynecomastia have been filed in the proceeding, court records indicate.

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