Johnson and Johnson (J&J), already embroiled in massive litigation in DePuy ASR artificial hips, and in the trans vaginal mesh litigation from its Ethicon Gynecare products, faces another significant issue over its mounting legal troubles stemming from its antipsychotic drug Risperdal. The drug was approved in 1993 for use in adults and was also later used to treat schizophrenia and bipolar disorder in children and teens. Under federal law, drug makers can promote only the approved uses of their medicines, but doctors are free to write prescriptions for other uses. Some physicians prescribed Risperdal to children and adolescents before the U.S. Food and Drug Administration gave its OK in 2007 for use in children and adolescents suffering from bipolar disorder and in adolescents with schizophrenia
On May 10, 2013, the Wall Street Journal reported that J&J had agreed to pay $2.2 billion in 2012 in order to settle a Justice Department investigation into allegations that the health-products company had illegally promoted drugs including the antipsychotic Risperdal, but that the deal has yet to be announced because J&J seeks to avoid admitting to conduct that could affect the outcome of pending personal-injury lawsuits alleging Risperdal caused serious side effects in kids.
What is J&J trying to hide?
According to the Wall Street Journal, the holdup is because J&J submitted data indicating a concern over whether Risperdal and other drugs in its class increased levels in kids of a hormone that stimulates breast development and milk production in women, stating: “Prosecutors want J&J to admit as part of the marketing settlement that the data played down the risks from that increase, while J&J wants prosecutors to agree not to pursue the allegation further, according to one of the people familiar with the talks.”
There are many lawsuits alleging that Risperdal caused side effects such as the growth of breasts in boys who took the drug. As in DePuy and Ethicon cases, Plaintiffs allege the company failed to warn of the true results of clinical tests and studies and point to a J&J-sponsored study, published in the Journal of Clinical Psychiatry in 2003, that reported there was “no correlation” between side effects and elevated prolactin levels. Many responsible leaders in the field feel there was clear evidence of correlation that was not reported, resulting in children being given a drug by Doctors who did not know of the true risks.
In an expert report filed in the case, David Kessler, a former FDA commissioner who was retained by the plaintiffs, said that the study “failed to present the data about elevated prolactin levels in an objective fashion.” Dr. Kessler said the study “ignored” side effects in boys 10 years and older and “omitted” data showing a statistically significant increase in prolactin levels during a four-week stretch after Risperdal use started when side effects such as breast growth in boys can arise.
Click here to read the full Wall Street Journal article: J&J Balks on Deal to Settle U.S. Probe
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