A much-anticipated settlement of various federal government probes into Johnson & Johnson (JNJ) marketing of the Risperdal antipsychotic, as well as other medications, is being delayed over language the health care giant fears may cause difficulties for a raft of private lawsuits, The Wall Street Journal reports.
Last year, you may recall, J&J agreed to a $2.2 billion deal that would include a misdemeanor plea and a $600 million criminal penalty (see this). But J&J wants to avoid admitting to conduct that could negatively affect the outcome of personal-injury lawsuits alleging Risperdal caused increased levels in children of a hormone that stimulates breast development and milk production.
Last September, J&J began settling dozens of lawsuits charging Risperdal caused gynecomastia, which is the abnormal development of large mammary glands in males, but product labeling lacked sufficient warnings. The initial Risperdal labeling allegedly downplayed the risk of increased prolactin levels and failed to suggest that a test should be used, according to Stephen Sheller, a plaintiff’s lawyer (see earlier Pharma news).
For its part, J&J has argued that Risperdal labeling has noted the pill increases prolactin levels and that side effects seen in a small number of patients include breast development in males. The labeling also notes this was reported in 2.3 percent of the 1,885 children and adolescents given Risperdal in clinical trials, the paper writes (see page 33 here).
As part of the settlement, however, the feds want J&J to admit data played down the risks from increased prolactin, while J&J wants the feds to agree not to continue to pursue the allegation, the paper adds. Lawsuits have noted that a study sponsored by J&J, which was published in the Journal of Clinical Psychiatry in 2003, reported “no correlation” between side effects and elevated prolactin levels.
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Ed Silverman, a contributing editor of YCharts, is the founder and editor of Pharmalot. He previously reported on the pharmaceutical industry and other business topics for the Star-Ledger of New Jersey, New York Newsday and Investor’s Business Daily. He can be reached at email@example.com.
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