Ortho Evra Recall - Label Change

In this section:

• Estrogen Patch
• Ortho Evra Recall Label Change

Ortho Evra has garnered a great deal of negative publicity as of late because of the adverse health effects associated with use of the contraceptive. An official Ortho Evra recall has not yet been issued; however, there as some in the medical community who believe one to be on the horizon. Ortho McNeil, a subsidiary of Johnson & Johnson and the manufacturer/marketer of Ortho Evra, has thus far refused to accept liability for a failure to adequately warn consumers of the risks involved with use of the birth control patch.

A sealed Food and Drug Administration (FDA) report stemming from July 17th, 2005 obtained by the Associated Press under the Freedom of Information Act indicated that approximately 12 women have died from blood clots that formed as a result of using the Ortho Evra birth control patch. The report also indicated that dozens more women who developed blood clots were fortunate enough to survive. Additionally, the FDA found that women who wore the Ortho Evra patch while pregnant faced increased risk of birth defects.

Currently, the Ortho Evra label warns patients who are predisposed to serious health issues such as blood clotting, stroke and cardiovascular irregularities, advising them that they should not use the birth control patch.

Blood clotting is a risk associated with many oral contraceptives. Blood clots are considered to be an "accepted risk" associated with the use of Ortho Evra because estrogen generally promotes coagulation (blood clotting) and increased production of estrogen is an essential component of birth control. However, the risk of developing a blood clot while using the Ortho Evra patch is approximately three times as high as it is when using an oral contraceptive. The FDA believes that Ortho McNeill should institute an Ortho Evra label change on which it states the exact nature of the risks associated with use of the birth control patch.

If Ortho McNeil continues to refute reports of detrimental side effects associated with the use of their contraceptive patch and refuses to amend their product label, the FDA could potentially order the issuing of an Ortho Evra Recall under the Federal Food, Drug and Cosmetic Act. If use of the patch is viewed by the FDA to cause an unacceptable fatality risk, it could issue a class 1 recall. If, on the other hand, the FDA simply wishes to enforce a label change, it could issue a class three recall.

Ortho Evra Lawsuits

Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for personal injury litigation. The law offices of Aylstock, Witkin, Kreis and Overholtz boast some of the most experienced Pensacola personal injury lawyers. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by drugs. Contact AWKO law today at (888) 255-AWKO (2956) to get more information about your rights as an Ortho Evra injury victim. AWKO Law also has highly skilled Pensacola wrongful death lawyers and has represented persons harmed by defective medical products and other defective drugs.