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What is Ortho Evra?
The Ortho Evra patch, norelgestromin / ethinyl estradiol transdermal system, is marketed by Ortho McNeil Pharmaceuticals, a subsidiary of Johnson and Johnson. The Ortho Evra patch is a contraceptive device for women in the form of a patch that is attached to the skin. Unlike traditional birth control pills that are taken every day, a new patch is applied to the woman's body once every seven days and the hormones in the patch are gradually released throughout the week. Ortho Evra was the first birth control skin patch approved by the FDA when it received its approval in November of 2001. It was heavily marketed when it was first introduced as a much more convenient alternative to the traditional birth control pills. It is estimated that over 4 million women have used the Ortho Evra patch since Ortho McNeil introduced it to the market.
How does the Ortho Evra Patch Work?
Ortho Evra is a patch for the skin that releases the same two hormones, called estrogen and progestin, used in regular birth control pills. However, the patch varies from the pill, in that the hormones in the patch are released slowly over time, unlike the hormones in the pill that are released as the pill is digested. The hormones from the Ortho Evra patch also enter the woman's bloodstream in a different manner than that of the traditional birth control pill. Hormones released from the Ortho Evra patch are absorbed directly into the bloodstream by the woman's body. The traditional birth control pills, on the other hand, are digested first before the hormones are absorbed. The birth control pill is absorbed through the digestive tract of the body, and while the pill is going through this process, approximately half of the estrogen dosage contained in the pill is lost. As a result of these differences, women who use the patch instead of the pill may endure increased levels of estrogen in their bodies.
Ortho McNeil and FDA Warning for Ortho Evra
Recently, reports have been featured in various media outlets indicating that women who use the Ortho Evra patch may be exposed to approximately 60% more of the hormone estrogen than women who continue to use traditional birth control pills. Ortho McNeil and the FDA have added a new warning to the label of the Ortho Evra patch recently, addressing this potentially serious problem. The new FDA black box warning label concerns the increase in levels of estrogen that are found in the users of the Ortho Evra patch. High levels of the estrogen hormone in the bloodstream have been linked to the formation of blood clots in the legs and the lungs, which can lead to more serious problems. Increased estrogen levels has been previously linked to other major health risks including heart attacks and stroke, which are related to the blood clots.
Ortho Evra and Blood Clots
There have been reports suggesting that women who use the Ortho Evra patch may suffer from blood clots and die at a rate three times as high as those women who use traditional birth control pills. According to the Associated Press, federal death and injury reports obtained through a Freedom of Information Act filing have indicated that at least twelve women died in 2004 from blood clots that may be linked to the use of the Ortho Evra patch. The majority of the women who died while using the patch were suspiciously young, as they were only in their late teens or early twenties. It is believed that many women have suffered other blood clot related problems such as strokes and heart attacks, which were serious but not fatal.
Ortho Evra Lawsuits Already Filed
As a result of the extremely harmful side effects that may result from the use of the Ortho Evra patch, a number of lawsuits have already been filed on behalf of many women who have suffered injury or died allegedly from the use of the Ortho Evra patch. As information continues to come public concerning the Ortho Evra patch and its link to blood clots and serious health problems, many more lawsuits may be filed. Some information that has already come into the public eye, comes from an internal memo from Ortho McNeil. According to the Associated Press (AP), the Ortho McNeil memo indicates that the pharmaceutical company refused to provide funding for a 2003 study of its Ortho Evra patch, which would have compared the side effects of the patch with the company's birth control pill Ortho-Cyclen. The AP has further reported that the memo indicates that the study was not done because of concern within Ortho McNeil that there existed "too high a chance that study may not produce a positive result for Evra." A company spokesman for Ortho McNeil responded to questions from the AP concerning the internal company memo, saying, "decisions to fund studies are based on scientific merit."
Seeger Weiss and Ortho Evra Litigation
On May 18, 2006 Ashcraft & Gerel LLP and Seeger Weiss LLP announced that they filed suit against Johnson & Johnson JNJ, and Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc. on behalf of the family of a 17-year-old Ortho Evra user who suffered a stroke resulting in her death in August 2004. She had been using Ortho Evra for approximately four months prior to her stroke. The suit was filed in the Superior Court of New Jersey, Middlesex County.
Questions and Consultations
If you or a family member has used the prescription contraceptive Ortho Evra patch and noticed adverse side effects, such as blood clots or heart attacks, you should contact a physician immediately. If you would like to discuss your rights, are interested in more information on Ortho Evra litigation, or if you have information about the cases that you would like to share with us, please click here to fill out a short evaluation form, and a member of Seeger Weiss LLP's experienced staff will call you to discuss your potential rights concerning Ortho Evra. Attorney consultations incur no obligation on your part and all initial consultations are free of charge and do not create an attorney-client relationship. Seeger Weiss LLP has office locations in both New York and New Jersey and its attorneys practice in courts throughout the country.
For more information on Ortho Evra, visit
http://www.lawyerseek.com/Ortho-Evra-MS5/.
Further Reading
http://www.fda.gov/cder/drug/InfoSheets/patient/norlegstrominPIS.htm
http://www.fda.gov/cder/drug/infopage/orthoevra/qa.htm
Link To Lawyer Seek's Ortho Evra Content:
<a href='http://www.lawyerseek.com/Practice/Pharmaceutical-Injury-C1/Ortho-Evra-Patch-P48/'>Ortho Evra: Lawyer Seek</a> |
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