Ortho Evra is a contraceptive patch used by approximately 4 million women since 2002, when it first went on sale. The patch contains estrogen at levels that are 60% higher than the pill and, as Ortho McNeil has itself disclosed, this higher level of estrogen poses a greater risk for blood clots and other serious side effects than previously disclosed to women who use it. Blood clots are an accepted risk of birth control pills because estrogen is a known blood coagulant. However, while Ortho McNeil maintains that the patch is as safe as the pill, FDA records show that before the patch was approved for release, the FDA had already noted that incidences of non-fatal blood clots caused by the patch were three times higher than that of the pill.

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FDA records show that seventeen patch users between the ages of 17 and 30 have suffered fatal heart attacks, blood clots, and possible strokes in the past two years. Dozens more were allegedly affected by the patch, but survived according to 16,000 drug reports filed with the FDA. On November 11, 2005, the FDA announced approval for updated labeling of the Ortho Evra contraceptive patch product. The new labels warns doctors and patients that the patch contains more estrogen than most birth control pills. This warning is important because higher levels of estrogen mean higher levels of risk. The FDA is, at this time, unwilling to ban the product.

Several lawsuits have been filed by families of women who died of or suffered from blood clots while using the patch. The family of a 14-year-old girl who died claim that she was the youngest victim of the patch. A suit by 10 women was filed in 2005, and in 2006 a suit by more than 40 women who claimed hundreds of other suits was filed.

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