In February, a jury awarded Austin Pledger $2.5 million after deciding that Johnson & Johnson, the manufacturer, hid the risks of gynecomastia. This was the first bellwether trial of a Risperdal gynecomastia lawsuit. Pledger was prescribed Risperdal for autism in 2002, when he was seven years old. He took the drug until 2006 and subsequently developed size 44 DD breasts, according to the lawsuit (Case No. A-196444). Risperdal was not approved for children during that time.
Incredibly, J&J paid out just two years ago $2.2 billion for illegally marketing Risperdal to children and the elderly. Pledger’s lawyer said that J&J “hid data from the FDA, prescribing doctors and parents. Documents showed they knew there was much higher percentage of children getting gynecomastia than they admitted,” according to the Wall Street Journal (Feb. 24, 2015).
According to court documents, Risperdal and gynecomastia is not that rare, as was previously believed. At the beginning of April, there were more than 1,300 lawsuits pending in Pennsylvania’s Risperdal litigation. All the claims were brought on behalf of individuals who allege that they developed breasts and other serious complications related to Risperdal (In Re: Risperdal Litigation, Case Number 100300296). And all the claims accuse J&J of:
• Concealing the risks associated with the drug
• Failing to warn doctors and patients about the complications that could occur with its use
• Improperly marketing Risperdal for off-label uses, including pediatric indications prior to their 2006 regulatory approval
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The Pennsylvania litigation’s second Risperdal bellwether trial recently concluded. The plaintiff in this case, 19-year-old William Cirba of Pennsylvania, was prescribed the antipsychotic drug as a child to treat oppositional defiant disorder. Like Pledger’s case, Risperdal had not been approved when Cirba was prescribed it. Although the jury agreed that Janssen (a J&J subsidiary) failed to adequately warn of the risks associated with Risperdal, they did not find a clear association with Cirba’s condition. Consequently, Cirba was not awarded any damages.
To date, the combined criminal plea and civil settlement regarding Risperdal has totaled more than $1.67 billion that J&J must pay for misbranding its drug.