Johnson & Johnson ($JNJ) has been negotiating terms of a multi-billion dollar settlement over aggressive marketing of its antipsychotic drug Risperdal with federal authorities for at least two years, and now it is hung on talk over breasts, The Wall Street Journal says.
The newspaper, once again citing sources, says the feds want J&J to acknowledge it downplayed data on a side effect that bumped up levels of hormone that stimulates breast development and milk production in women. J&J does not want to include language that might be used in civil lawsuits that make the same claim. The company has already settled cases that claim the drug caused boys to develop breasts but faces dozens more and unknown levels of potential awards. No comments were offered up from either side.
The Risperdal saga has been full of twists and turns, as any long-running investigation tends to be. The feds have been looking into J&J's marketing of the antipsychotic pill since 2004. In the meantime, several of its Big Pharma rivals have inked their own marketing settlements, including Pfizer's ($PFE) $2.3 billion Bextra deal and last year's GlaxoSmithKline ($GSK) $3 billion settlement, which covers off-label and safety-related claims. Last year officials were reportedly ready to settle on a $1 billion payment from J&J, but higher-ups wanted to hold out for more. Since then, The Wall Street Journal has cited sources putting the price at $2.2 billion.
Last summer J&J reached a settlement with 36 states and the District of Columbia over the marketing of Risperdal that topped $180 million. It also has settled a number of civil suits that make the claim about breast development. It hammered out deals on 5 cases last fall, and so managed to avoid testimony from former FDA Commissioner David Kessler. He was slated to testify in one case that he believed J&J's Janssen unit not only violated the Food, Drug, and Cosmetic Act by promoting Risperdal off-label, but that its marketing to children was "most concerning."
- read the WSJ story (sub. req.)
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