Ortho Evra Information
FDA Action on the Ortho Evra Patch
Ortho-McNeil™, a subsidiary of Johnson & Johnson™, developed Ortho Evra™ and applied for Food & Drug Administration approval in 2000. Ortho-McNeil conducted clinical trials on the patch and determined that its risks were similar to oral contraceptives. In fact, early studies conflicted on the risks to users. One study concluded that risk levels were the same for patch users and oral contraceptive users alike. Another study concluded, however, that users of a patch had double the risk of a serious blood clotting event. Whether Ortho-McNeil put much stock in the study results is unclear. Like other transdermal devices, such as the nicotine patch, Ortho Evra was touted by its maker as an easy-to-use alternative to daily pills.
The FDA first took action on Ortho Evra when it approved the patch for release to consumers in late 2001. The FDA reviewed the drug several times in 2002, but did not begin to order label changes to the product until 2005. These label changes did not occur soon enough for some women. If you or a family member was injured using Ortho Evra, an attorney from Miller, Curtis & Weisbrod, L.L.P. in Dallas, Texas, can discuss your options with you.
Media is A Step Ahead of FDA on Ortho Evra Risks
In 2005, the Associated Press reported that several unexpected deaths and injuries to young healthy women in 2004 were linked to use of the Ortho Evra patch. Some injured women joined together to sue Johnson & Johnson to recover damages for their injuries after this report. The FDA, which had been silent on many risks related to the patch, ordered Ortho Evra to change labeling on the patch later that year. As more studies were completed on the patch's harmful side effects, the FDA ordered a series of label changes to update users as to potential side effects of Ortho Evra.
Then, in 2008, the FDA took its strongest action yet — it ordered changes to add language to the label that users of the patch are exposed to more estrogen than pills users, which puts them at greater risk of serious blood clotting, or venous thromboembolism. The FDA took this action after a third study of the patch evaluated the risk of developing serious blood clots in users aged 15 to 44 and concluded that users of the patch had a higher risk of these adverse events that users of oral contraceptives.
Conclusion
It is unclear whether the FDA plans any future studies of Ortho Evra or action to change the labeling or distribution of the patch. Many injured women have come forward seeking compensation for their injuries, and while the litigation has ballooned against Ortho-McNeil and Johnson & Johnson, the companies do not appear to have any plans to remove the patch from the market on their own. If you need legal help to pursue a claim for damages because of your injuries or a family member's death stemming from Ortho Evra, contact an experienced attorney from Miller, Curtis & Weisbrod, L.L.P. in Dallas, Texas.
Copyright ©2009 FindLaw, a Thomson Business
DISCLAIMER: This site and any information contained herein are intended for informational purposes only and should not be construed as legal advice. Seek competent legal counsel for advice on any legal matter.
