FDA Warning for Ortho Evra Patch

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 that contain 35 micrograms of estrogen. Ortho McNeil and the FDA have added a new warning to the Ortho Evra patch label. The new 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 has been linked to the formation of blood clots in the legs and the lungs. Estrogen has also been previously linked to other serious problems including heart attacks and stroke, which are related to blood clots.

Ortho Evra and Blood Clots

Reports have come forth indicating that women who use the Ortho Evra patch 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 a dozen women died in the year 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 only in their late teens or early twenties. It is believed that many other women have suffered other blood clot-related problems, such as strokes and heart attacks.

Ortho Evra Lawsuits Already Filed

As a result of the extremely harmful side effects that may result form the use of the Ortho Evra patch, a number of lawsuits have already been filed by the families of numerous women who suffered injury or even died from use of the Ortho Evra patch. As information continues to come out concerning the Ortho Evra patch and its link to blood clots and serious health problems, many more lawsuits will 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, 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 Associated Press has reported that the memo indicates that there were concerns that there existed 'too high a chance that study may not produce a positive result for Evra.' Also, the AP reports concern from the company that there was a 'risk that Ortho Evra may be the same or worse than Ortho-Cyclen.'

Questions

If you or a family member have used the prescription contraceptive Ortho Evra patch and noticed any of these adverse side effects, you should contact a physician immediately. If you feel that you may need legal representation in this matter or are interested in more information on Ortho Evra litigation, please fill out the free case evaluation form and an experienced attorney with Seeger Weiss LLP will assist you in evaluating your case concerning Ortho Evra. Attorney consultations incur no obligation on your part and all initial consultations are free of charge. Seeger Weiss LLP has office locations in New York, New Jersey, Pennsylvania, Oklahoma, and California.