Ortho Evra works as a contraceptive by preventing ovulation and by thickening cervical mucus thus acting as a barrier to sperm. This is exactly the same mechanism the birth control pill uses. The advantage of the patch over the pill is that women wouldn't need to remember to take a daily pill; they just needed to change the patch once a week.
Ortho Evra was introduced in 2002 and reports of side effects began to trickle in. A study indicated that the patch doubled the blood clot risk compared to users of the pill. In addition to minor side effects, users of Ortho Evra were linked to increased risk of blood clots, stroke, and heart attack.
Ortho Evra has 60% more estrogen than the pill and it delivers its hormones directly into the bloodstream. Peak blood levels of estrogen from the pill are 35% higher than blood levels from Ortho Evra, but the peak levels from the pill drop rapidly to levels lower than those from Ortho Evra. Blood levels in those taking Orthro Evra remain steady.
The FDA collected 9,116 reports of side effects from Ortho Evra in 17 months. 1,237 reports of adverse reactions from the pill were collection in six years. Ortho Evra was linked to the deaths of 17 young women.
In Nov. of 2005, the FDA asked Johnson and Johnson to include a bolded warning about the risk of blood clots, stroke, or heart attack. Side effects increased with age, smoking, diabetes, high blood pressure, and high cholesterol.
Several lawsuits were filed against Johnson and Johnson and most of these were settled out of court. Johnson and Johnson appear to be trying to keep a low profile by settling out of court unlike Merk with its Viox lawsuits that have gone to court.