While there have been no Ortho Evra recalls to date, the FDA is currently being pressured to recall the birth control patch from the market. For example, Public Citizen, a consumer advocacy group, recently petitioned the FDA to recall Ortho Evra claiming that the birth control patch increases a woman’s risk of developing life-threatening blood clots. Despite these arguments for recalling the patch, Ortho Evra’s manufacturer says it will not voluntarily recall the birth control patch and continues to aggressively market it.   According to Public Citizen, the FDA should recall Ortho Evra because the patch exposes women to about 60% more estrogen than standard birth control pills. The case for recalling Ortho Evra is made even stronger by the fact that the FDA has already recalled birth control pills with lower estrogen levels than Ortho Evra due to the health risks associated with high estrogen intake.

In response to Public Citizen’s allegations that Ortho Evra is dangerous and should be recalled, Johnson & Johnson, Ortho Evra’s maker, contends that Ortho Evra is safe and effective when used in accordance with FDA-approved labeling and thus should not be recalled. According to Johnson & Johnson, there is no reason to recall Ortho Evra as “all hormonal birth control methods have benefits and risks, and the approved Ortho-Evra product label has always stated the known risks associated with its use.” Of course, the known risks associated with Ortho Evra use have changed to include more risks over time.

Ortho Evra Label Changes

Although the original Ortho Evra warning label was identical to the warning label on typical birth control pills, the label was changed in 2005 to reflect the fact that Ortho Evra exposes women to about 60% more estrogen than standard birth control pills. Instead of recalling the birth control patch, Johnson & Johnson updated the product’s label again in 2006 and again in 2008 to include study findings showing as much as a 200% increase in the risk of blood clots compared with standard oral contraceptives.

Ortho Evra LawsuitsToday, the case for recalling Ortho Evra is stronger than ever.  There are at least 1,500 lawsuits against Johnson & Johnson by women who were injured after using Ortho Evra. At least 23 other lawsuits have been brought by family members who say their loved ones died after using the birth control patch. The lawsuits generally have a common theme: that Johnson & Johnson failed to warn patients that Ortho Evra users run a greater risk of developing blood clots than women who use other birth control methods.   

Click here to contact our experienced Ortho Evra attorney and to learn more about your legal rights.

Published November 17, 2011 by