Ortho Evra makers seek legal protection from litigation
Following on the heals of a Supreme Court decision agreeing with Medtronic’s claim that once a device is deemed safe by the FDA it preempts any lawsuits filed against them claiming injury, Johnson & Johnson is insisting the same for its controversial birth control patch Ortho Evra. In recent lawsuits filed against Johnson & Johnson evidence has been found that internal company documents and emails hid evidence that the patch delivered much more estrogen than birth control pills, potentially increasing the risk of blood clots and strokes. Now Johnson & Johnson is arguing in court that it cannot be sued by women injured by the Ortho Evra patch because the FDA had approved it. More than 3,000 women and their families have sued Johnson & Johnson after suffering heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the FDA received reports of at least 50 deaths associated with the Ortho Evra patch. The FDA did not inform the public of the potential risks until November 2005, six years after Johnson &Johnson’s own study showed the high estrogen distribution.
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