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Birth Control Patch
The first birth control patch, Ortho Evra, was approved by the FDA in November 2001. Prior to the introduction of the birth control patch, women’s hormonal contraceptive choices were limited to oral pills and injections. Ortho-McNeil designed the birth control patch Ortho Evra (noregestromin/ethinyl estradiol) to provide an alternative hormonal option to women seeking reproductive control. At least two million women used the Ortho Evra birth control patch in 2004 alone.
There has been a great deal of controversy over the safety of the Ortho Evra birth control patch. In early 2005, the Associated Press released a report of their independent interpretations of FDA birth control patch medical data. This news organization reports that the birth control patch triples a woman’s risk of suffering a fatal blood clot or other serious side effect. The report alleges that the Ortho Evra birth control patch is responsible for 23 deaths caused by blood clots, heart attacks and strokes.
Ortho-McNeil and other medical experts have raised some valid arguments against the Associated Press’s report. The claim that the Ortho Evra birth control patch triples a woman’s risk of blood clots is misleading. The regular birth control pill has a risk of one death per 200,000 patients, an arguably small number. If the Associated Press is correct, according to Ortho Evra advocates, then the risk of death associated with the birth control patch is three in 200,000 patients. For comparative purposes, the risk to women who carry a pregnancy longer than 20 weeks is 20 to 25 deaths per 200,000.
It is still unclear whether or not Ortho Evra birth control patch poses increased risks of serious adverse side effects. The drug’s maker indicates that no fatal side effects have been experienced by the thousands of clinical trial participants studied. Other studies indict Ortho Evra birth control patch in the deaths of more than 20 women, most of whom died of blood clot complications. Many of the women who have died had no history of cardiovascular problems before taking the Ortho Evra birth control patch for a short period before their death.
The labeling on all hormonal birth control devices indicates that certain women should not use these birth control methods due to increased risk. Smokers (particularly over the age of 35) and those with a history of heart attack, stroke, blood clot, high blood pressure, certain cancers, liver tumor, diabetes, unexplained vaginal bleeding, or jaundice are advised not to use the Ortho Evra birth control patch due to increased risk of side effects.
The FDA has not made any steps to restrict or recall the Ortho Evra birth control patch. In response to the reports of death from Ortho Evra birth control patch users, one lawsuit has already been filed against the drug’s manufacturer. A wrongful death lawsuit has been filed on behalf of a 30 year old woman who suffered a fatal blood clot after using the Ortho Evra birth control patch. If you are concerned about the risks associated with the birth control patch you may wish to speak with your physician.
Have you been injured by the Ortho Evra Patch?
Lawsuits have already been filed on behalf of women who have suffered a fatal blood clot from the Ortho Evra birth control patch. Please contact an experienced Ortho Evra birth control patch attorney to learn more about your legal rights.
Product Liability Breaking News
"Ortho Evra Lawsuits Continue to Roll in"
The number of Ortho Evra lawsuits continues to rise as more and more women argue they suffered blood clot injuries after using the birth control patch. To date,...
"J & J Wants to use Pre-emption for Immunity"
The maker of the Ortho Evra birth control patch is seeking legal protection from lawsuits over injuries caused by the product with argument...
"FDA Approves Label Change for Ortho Evra"
The Food and Drug Administration approved a labeling change for the Ortho Evra birth control patch based on a new study linking the contraceptive to a greater risk of potentially fatal blood clots than the pill.
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