The Ortho Evra birth control patch, marketed by Johnson & Johnson’s subsidiary Ortho-McNeil Pharmaceuticals, first arrived to the United States in 2002. Once touted as a medical breakthrough, this new form of female birth control was designed to be empowering, by freeing women from the worry of missing a daily pill. However, it has proven to be a source of complications for many women, resulting in injuries, deaths, and lawsuits almost since day one.
What Is Ortho Evra?
Ortho Evra is the first and only available form of transdermal birth control for women. It was designed as a simple adhesive patch that sticks to the skin, delivering hormones (norelgestromin and ethinyl estradiol) that prevent pregnancy. It is intended to replace the need for a daily birth control pill entirely, so that women no longer have to remember whether or not they took a pill any given day.
To use Ortho Evra, the patch is simply placed on the body, usually on the stomach, upper arm, back, or buttocks. It remains in place for three weeks, and then is removed for one week. After four weeks total, a new patch is applied to restart the cycle.
How Is Ortho Evra Hurting Women?
Ortho Evra carries all of the typical side effects of other kinds of estrogen-based hormonal birth control, including the following:
- Nausea and vomiting
- Abdominal pain
- Irritability or mood swings (“emotional lability”)
- Breast swelling, enlargement, or tenderness
- Melasma, a tan or darker blotchy skin discoloration
However, these aren’t the only side effects that Ortho Evra can cause. It can also cause some other life-threatening conditions, such as:
- Myocardial infarction (MI) or—in common terms—a heart attack
- Cerebrovascular accident (CVA) or stroke
- Deep vein thrombosis (DVT) or venous thromboembolism (VTE): a blood clot that blocks a vein, typically in the leg
- Pulmonary embolism (PE): a blood clot that travels to the lungs
All of these dangerous conditions are also possible side effects of other estrogen-based hormonal birth control medications. However, Orthro Evra is known to release as much as 60% more estrogen than other typical birth control medications, according to a 2005 news release from the FDA. More exposure to estrogen may increase the chance of suffering one of these dangerous side effects, especially DVT or VTE, by as much as three times when compared to standard birth control pills. Both of these conditions occur when a blood clot forms in a vein somewhere in the body. Clots are extremely dangerous because one can break free and travel through the heart and into the lungs. When this happens, it’s called a pulmonary embolism, which may cause instantaneous death.
Ortho Evra Warnings: The Historical Timeline
Troubles began from the very beginning in 2002, when Ortho Evra was introduced. Between 2002 and 2006, the FDA began receiving reports that Ortho Evra had caused the deaths of at least fifty women. What’s worse, Johnson & Johnson’s own research showed that the company knew Ortho Evra was delivering far more estrogen than regular birth control before it ever hit the market, yet they chose to proceed with marketing efforts and sales.
In 2005, the FDA finally began to take action by issuing a warning about the increased health risk of the patch. No product recall was issued, though, and Ortho Evra stayed on the market.
By 2006, J&J had already begun settling lawsuits filed by women who were injured or the families of women who had died as a result of the drug; to date, over 3,000 parties have filed suit. J&J finally also updated the drug label to indicate the health risks, but they did so by citing two contradictory studies—one that indicated no increased risk, and one that indicated double the risk. In 2008, the FDA then mandated that the risks from two additional studies be reported on the label, as well.
In 2012, the FDA released yet another notice of a labeling change, indicating yet again the increased risk of “thromboembolic disorders and other vascular problems” with information from multiple studies. By 2015, after multiple studies showing increased risks and dozens of deaths, the manufacturer finally announced that Ortho Evra would be discontinued. However, a generic alternative, Xulane, continues to be available.
Get Legal Help Now
If you or someone you love has suffered from a blood clot, pulmonary embolism, stroke, or other life-threatening side effect due to Ortho Evra, know that you are not alone. You may be eligible to receive financial compensation for medical bills, surgery, rehabilitation, funeral costs, and more.
Wayne Wright, LLP, is a Texas law firm, and we’re here to stand by your side. We can help you take greedy drug companies to task for knowingly selling dangerous products while hiding the real risks. Call us today at 800-237-3334 for a free consultation to discuss your case with a qualified legal professional.