Risperdal Product Liability Trial Underway
A Philadelphia jury heard allegations this week in a lawsuit that claims Johnson & Johnson (J&J) and its Janssen Pharmaceuticals subsidiary illegally marketed the antipsychotic Risperdal to children in order to increase sales and grow the market for the drug beyond sufferers of schizophrenia.
The Legal Intelligencer (subscription required) reports the allegations are from a lawsuit filed by a 17-year-old boy with Asperger’s syndrome and his mother who claim that using the drug caused the boy to develop breasts.
The case is the first to go to a jury out of the 86 cases in the Risperdal mass torts program before the Philadelphia Court of Common Pleas.
The lawsuit claims that Janssen knew that Risperdal increased the hormone prolactin, which typically causes breast enlargement. It can cause gynecomastia in men, which is the production of mammary glands.
The suit also claims that the company provided allegedly false data to the Food and Drug Administration (FDA) that suggested gynecomastia was not a side effect of the drug and received approval to market it to children based on that data, according to the Legal Intelligencer.
The plaintiff claims he used the drug before it was federally approved for use in children.
Janssen and J&J deny illegally marketing the drug and argue that the results of all the studies carried out by the company on the drug were handed over to the FDA and included on the drug label after the FDA approval, reported The Legal Intelligencer.
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