January 26, 2015 — Opening arguments have been made by an attorney representing an autistic boy from Alabama who developed gynecomastia, a disfiguring condition causing enlarged breasts, after taking Risperdal “off-label,” when it was not approved for children.
The lawsuit was filed on behalf of Austin Pledger, a 20 year-old boy who started taking Risperdal in July 2002. At the time, he was only 8 years old and Risperdal was only approved for adults. The FDA did not approve Risperdal for the treatment of irritability in autistic children until 2006.
According to Law360, former FDA commissioner David Kessler will testify today about efforts to obscure the risks associated with Risperdal by its manufacturer, Janssen Pharmaceuticals Inc.
In November 2013, the Justice Department and Johnson & Johnson reached a $2.2 billion settlement to resolve civil and criminal allegations involving illegal marketing of their drugs.
Prosecutors alleged that Risperdal was promoted “off-label” for children and individuals with mental disabilities from 1999-2005, despite FDA warnings and knowledge about the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production.
Janssen, a subsidiary of Johnson & Johnson, has been hit with over 1,250 lawsuits involving Risperdal. The cases have been centralized as part of a mass-tort in the Philadelphia Court of Common Pleas. Another 700 similar claims are pending in California.
In 2012, Johnson & Johnson agreed to settle a Risperdal lawsuit filed on behalf of Aaron Banks, a young man who developed gynecomastia after taking the drug from 1999-2004, starting when he was just 9 years old.
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