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
There are a number of lawsuits that have been filed against Ortho McNeil and parent-company Johnson & Johnson because of personal injuries incurred from use of the Ortho Evra birth control patch.
In one such case, a 19-year old woman developed a 10-inch blood clot in her brain as a result of using Ortho Evra for a brief, three-month period. The blood clotting caused the woman to suffer through two strokes. She is now routinely debilitated by severe migraine headaches. Women between the ages of 20 and 34 typically face only a .3% risk of stroke occurrence (nominal), suggesting a link between the use of Ortho Evra and the occurrence of multiple strokes in this 19-year old woman.
Those who have been injured as a result of using Ortho Evra might be eligible to receive compensation to accommodate pain and suffering, loss of wages, loss of livelihood, etc. The lawyers of Justice Lawyers are some of the most experienced personal injury lawyers Pensacola, Florida has to offer. Contact the law offices of Justice Lawyers to get additional information about Ortho Evra side effect victims' rights.
The attorneys of the Law Office of Justice Lawyers are personal injury lawyers in Pensacola who protect victims of auto accidents, personal injury, wrongful death, defective drugs, consumer fraud, insurance fraud, product defects and defective medical devices, such as Guidant and Medtronic Pacemakers, and potentially harmful drugs, such as Ortho Evra. When you think of the top personal injury lawyers or car accident lawyers in Pensacola, think of Justice Lawyers.