Ortho Evra Patch Litigation

Johnson & Johnson's Ortho Evra contraceptive patch contains higher levels of a hormone known to cause blood clots than average birth control pills, U.S. regulators warned. The U.S. Food and Drug Administration said on November 10, 2005 that the new label for the patch will include information about the higher levels of estrogen. Women who use Ortho Evra are exposed to 60 percent more estrogen than those who use the pill, the FDA said in its statement. But the pills, which contain several variations with different hormone levels for use during one month, can contain a higher maximum amount of estrogen. The difference in exposure may be due to the delivery mechanism of the patch hormones and absorption into the body.

The Food and Drug Administration has received twenty-one reports of life-threatening blood clots and other ailments associated with Ortho Evra birth control patch use. The contraceptive patch, which has been aggressively marketed using Olympic athletes, sexy ads and fashion models, has been linked to the deaths of at least seventeen young American women over the past two years. Approximately 4 million women have used the Ortho Evra Patch since it went on sale in 2002. FDA records show that seventeen patch users between the ages of 17 and 30 have suffered fatal heart attacks, blood clots and possible strokes since August 2002. The first fatality publicly blamed on the Ortho Evra patch was in April 2005, when a Manhattan fashion student collapsed in a city subway station. An autopsy found that a blood clot had moved into the victim's lung, and the medical examiner ruled that the clot was a side effect of the birth control device. Ortho-McNeil, the manufacturer or the Ortho Evra birth control patch, has aggressively marketed the patch as a convenient alternative to oral birth control pills. Its original product label stated that the patch's health risks were similar to those related to oral contraceptives.