J&J Misled Regulators about Risperdal Gynecomastia Link, Ex-FDA Chief Says
Johnson & Johnson was “at best” misleading when they assured the U.S. Food and Drug Administration (FDA) in 2005 that a medication named in Risperdal lawsuit claims would not cause breast growth in males, a former agency official said in court last week.
A former FDA commissioner testified in the Philadelphia Court of Common Pleas on January 31st that the drug manufacturer failed to warn the public about its risks for several years, increasing the potential for young boys to sustain gynecomastia and other complications. Friday was his third day on the stand for plaintiffs in the first Risperdal lawsuit to head to trial out of more than 1,200 now pending in a consolidated litigation underway in Pennsylvania. According to claims, a 20-year old autistic man from Alabama sustained gynecomastia complications he was inadequately warned about by Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals. After taking Risperdal from 2002 through 2007, the plaintiff was forced to undergo a mastectomy procedure to remove the excess breast tissue he developed, his lawsuit alleges.
Janssen Denies Risperdal Gynecomastia Allegations
Following arguments that Janssen concealed side effect information from the FDA, a spokesperson for the company insisted that they “appropriately analyzed and reported data from clinical trials” that preceded Risperdal’s approval in 2006 to include the treatment of children with autism. At the time, the former FDA commissioner said Janssen asked the agency to include the drug’s dosing information for children, which they denied because doing so could suggest that it had received approval for all pediatric uses, not just those related to autism.
Johnson & Johnson and Janssen have been accused of withholding gynecomastia information in hundreds of product liability lawsuits involving Risperdal, as well as charges from the federal government. The federal charges, which involved the companies’ off-label marketing of this and several other medications, were resolved in November 2013 for more than $2.2 billion. In their agreement to settle Risperdal claims, Johnson & Johnson and Janssen admitted no wrongdoing in their marketing of the drug.
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Dial a Risperdal lawyer today for more information about filing a claim alleging gynecomastia or another complication. Contact us now at (877) 779-1414.