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SUNDAY, JULY 5, 2009

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J&J Hid Birth Control Patch Risks: Suit

(Newser Summary) – 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.
Source: Bloomberg

elsewhere: More on pre-emption and the J&J case New York Times • Men and birth control US News & World Report

More about:  FDA • birth control • birth control pill • estrogen • class action • blood clots • Johnson and Johnson

The Orth-Evra birth control patch releases higher...
The Orth-Evra birth control patch releases higher estrogen levels according to what area of the body it's applied to.   (Shutterstock)
The Ortho-Evra birth control patch may release 60%...
The Ortho-Evra birth control patch may release 60% more estrogen than the pill.   (Shutterstock)
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