1 Boring Old Man

Will Male Breasts Derail A J&J Settlement Over Risperdal Marketing?
Pharmalot
by Ed Silverman
05/10/2013

A much-anticipated settlement of various federal government probes into Johnson & Johnson  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 [back story].

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 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.

By settling the first such lawsuit last fall, J&J [JNJ] avoided having ceo Alex Gorsky called to the stand. Banks’ lawyers were seeking his testimony because from October 1998 to October 2001, Gorsky was vp of marketing at the J&J Janssen unit that sold the antipyschotic. And from October 2001 to early 2003 he was the Janssen president, during which time he was responsible for selling Risperdal…

Having sat through the TMAP Trial in January 2012, I have a special affinity for JNJ’s antics. He was an integral part of JNJ’s Risperdal’s misadventures from the start – and they were extensive. When things blew up, he transferred to London, then left the company [in my mind, to distance from responsibility for his sins – a guess]. He returned in 2008 and was CEO byn 2012 [shoveling…]:

Last year, he avoided testifying in the Gynecomastia trials by being terminally important. Here are a few reminders about the last time around [shoveling…, when does that go on trial?…, a keynote address…].