Ex-FDA Chief Says Johnson & Johnson Knew Risperdal Caused Boys to Grow Breasts

Ex-FDA Chief Says Johnson & Johnson Knew Risperdal Caused Boys to Grow Breasts
January 28, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff

David Kessler, the former head of the U.S. Food and Drug Administration (FDA), admitted on Jan. 28 in court that he knew Johnson & Johnson ’s Risperdal was “probably or very likely” to cause breast development in males. This came after the beginning of the first testimony of the Risperdal gynecomastia claim in Philadelphia.

Kessler went on to say that a 2001 Risperdal clinical study that showed these adverse effects raised a “red flag” in his mind, according to Bloomberg. There are now 1,000 cases citing the side effect in the state court of Philadelphia. Johnson & Johnson settled its first case pertaining to abnormal breast development back in 2012.

Kessler was a part of the trial brought to the court by a 20-year-old Alabama man who believes the drug caused his breast development and 100-pound weight gain. He is claiming that Johnson & Johnson is attempting to hide the side effects of Risperdal. However, the company has stated that it properly warned patients and their doctors of the risks, and there has been no false marketing.

“Our firm is representing numerous other Risperdal gynecomastia plaintiffs in this mass tort proceeding, so the testimony presented at trial is of great interest,” said Bernstein Liebhard, the nationwide law firm representing some of the Risperdal users filing suit. “Our clients also allege that the drug’s risks were concealed, and they raise similar questions regarding its off-label use.”

The Litigation of Risperdal
Risperdal, also known as risperidone, is an atypical antipsychotic drug that has been approved by the FDA to treat adult and adolescent schizophrenia and bipolar disorder. It is also prescribed to autistic children for irritability.

All of the lawsuits that are currently pending in the Pennsylvania litigation accuse Johnson & Johnson of concealing the risk of gynecomastia from its users. The lawsuits also claim that the company promoted off-label uses of the drug.

In 2013, Johnson & Johnson pled guilty to promoting Risperdal for off-label use in elderly dementia patients. However, the company did not admit to any wrongdoing in resolving any of the other allegations against it.

By the end of November 2013, the U.S. Justice Department had instructed Johnson & Johnson to pay $2.2 billion to numerous criminal and civil charges linked to the marketing of its medications, including Risperdal.

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