Johnson & Johnson doctored data to get its birth control patch FDA-approved, according to a class action lawsuit that claims Ortho-Evra caused blood clots, heart attacks, and strokes. A J&J scientist allegedly doctored the data with a "correction factor" for the FDA, lowering estrogen-related risk by 60%: He "presented a truly misleading picture of the amount of estrogen delivered by the patch,'' the suit said.
The company altered data because it was "desperate" to market the product before its patent on the birth control pill ran out, lawyers on behalf of some 2,400 women charged. They also accuse J&J of manufacturing irregularities that made the patch's estrogen levels unstable. J&J argues that FDA approval preempts the women's right to sue, Bloomberg reports.