Consumer advocacy groups and the Food and Drug Administration (FDA) have been monitoring reports of side effects linked to Ortho Evra, the birth control patch. Ortho Evra is a combination of estrogen and progestin applied to the skin in the form of a sticky patch. The combination of hormones in the patch is effective in preventing pregnancy; however, there are side effects associated with its use. One potentially serious side effect of Ortho Evra use is an increase in estrogen levels. In fact, the FDA reports that women using the patch have estrogen levels 60 percent higher than women using other hormonal forms of birth control such as birth control pills. Since high estrogen levels are linked to an increased risk of blood clots, this has raised concerns.
Potential Side Effects and Risk Factors
Women using Ortho Evra are more likely to develop blood clots due to increased estrogen levels. These clots can affect the heart, lungs, brain, and other vital organs, causing serious illness or death due to heart attack, stroke, or other organ damage. The risk of clots is higher among smokers and women older than 35. The serious risk posed by increased estrogen levels caused the FDA to mandate the makers of Ortho Evra to enact marketing and labeling changes in 2005. In 2006, the agency imposed further regulations requiring Ortho Evra’s manufacturer to add a strong warning about the risk of blood clots to the packaging of the medication.
Legal Action and Ortho Evra
While Ortho Evra is still sold to women with valid prescriptions, the medication is required to bear warning labels informing users of the potential for blood clots. In addition, Ortho-McNeil Pharmaceuticals, the makers of Ortho Evra, are currently facing legal action. A March 2006 class action lawsuit claims that Ortho Evra’s manufacturer knowingly designed and marketed a defective product, and failed to warn users of the potential risks of using the product. More than 70 plaintiffs are already involved in this suit, and this number is expected to grow with additional publicity. There is also a wrongful death suit pending against Ortho-McNeil Pharmaceuticals. This suit alleges that the Ortho Evra patch caused a 20 year-old woman to develop a fatal pulmonary embolism.
Any woman who has suffered complications related to Ortho Evra use, such as blood clots that caused a stroke, heart attack, or other serious medical problem, should seek the advice of an experienced attorney. Survivors of any woman who died due to such complications should also seek legal representation. Victims may be entitled to compensation from Ortho-McNeil Pharmaceuticals through settlements or judgments. An experienced attorney can inform victims of their rights, the legal avenues available to them and make sure that victims get the compensation they deserve.