Problems with Ortho Evra Patches
The Ortho Evra patch is a contraceptive placed on the skin as a patch that releases synthetic estrogen and progestin in measured amounts to prevent pregnancy. Ortho Evra works primarily by preventing ovulation. A secondary mechanism blocks sperm penetration of the cervix.
The Ortho Evra patch gradually releases estrogen and progestin into the blood circulation over the first 21 days of the menstrual cycle. A patch is worn on the outer arm, abdomen, buttocks, or thigh for seven days, and then replaced with another patch worn for seven days, followed by a third patch worn for seven days. During the last seven days of the menstrual cycle no patch is worn.
In three large clinical trials involving more than three thousand women, 12 percent of the women who used the patches for more than a year discontinued use because of side effects. The most frequent were: nausea and/or vomiting, allergic skin reactions where patches were applied, breast discomfort, engorgement or pain, headaches, mood swings, upper respiratory tract infections, menstrual cramps, abdominal pain, and breakthrough bleeding and spotting while using the patches.
Women who use the patches have higher levels of estrogen circulating in their blood than the amount they would get from taking contraceptive pills, higher levels associated with greater risks for blood clots and strokes. Several lawsuits have been initiated over these issues.
Lawsuits Based on Injuries
A lawsuit filed in Federal Court in New Jersey on September 2, 2005, by a Georgia woman, who suffered a pulmonary embolism, alleges the company promoted the patch despite knowledge of its health risks, for financial gain while failing to warn of the risks of blood clots and other injuries.
In November 2005, CBS News aired a story about a lawsuit involving a young mother who was paralyzed by a stroke and remained a total invalid, despite the fact that the company had received nearly 500 reports of adverse events between April 2002 and December 2004. During the same time frame, only 61 adverse event reports were filed in connection with all types of birth control pills.
The parents of a 14 year-old girl from Wisconsin have filed a lawsuit claiming that their daughter died from a blood clot that arose from her use of the patch.
New Label Warnings Required
Ortho McNeil, the manufacturer of Ortho Evra, in conjunction with the FDA, revised the label for Ortho Evra, including a new bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill, noting that higher levels of estrogen may put some women at increased risk for developing blood clots. The label was again revised in 2006 and 2008, to reflect these results. This message now appears on Ortho Evra product labels:
“The FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.”
If you or a loved one has suffered health problems, injuries or death that could be related to the use of Ortho Evra patches, contact us and we can connect you to experienced lawyers in your area who are available to review your case and advise you on your special situation.