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product_liability birth-control-patchOrtho Evra Death
Ortho Evra birth control patch went on the market in 2002 and enjoyed immediate popularity, but the popular device is now causing serious concerns and making news headlines. The patch is being blamed for a number of Ortho Evra deaths because of blood clots, heart attacks and strokes. Although blood clots are a well-known and serious risk of all hormonal contraception, such events are rare. The Associated Press, however, analyzed 16,000 reports of adverse events filed with the Food and Drug Administration, finding the risk of death from a blood clot is three times higher for women using the patch.
According to the AP report, nonsmoking women under 35 who use the pill have a 1 to 3 in 10,000 chance of having a nonfatal blood clot and a 1 in 200,000 risk of dying from a blood clot. Should the same women use Ortho Evra, according to the AP, the rate of nonfatal blood clots was about 12 out of 10,000 during clinical trials, with an apparent death rate of 3 in 200,000. The maker of the patch, Ortho McNeil, said the number of Ortho Evra deaths and side effects are consistent with the health risks of the pill, refuting the AP claims.
Ortho Evra contains a combination of estrogen and progesterone that is slowly absorbed when applied to the skin. Together, the hormones prevent ovulation and pregnancy, but because the patch is a new delivery system, it is difficult to determine if the hormone dosage delivered is the same as in oral contraceptives. If there is a quicker dose delivery, the drug might be more potent, making the likelihood of Ortho Evra deaths and side effects greater.
An autopsy report on a 25-year old mother of three who died in November 2004 concluded her death was caused by the release of hormones brought on by the Ortho Evra patch she had started using a few weeks prior. Drug safety advocates believe the FDA needs safety reforms to give greater authority, independence and resources to the agency’s post-market safety monitoring system.
Because the FDA’s reporting system is voluntary, it is not possible to draw reliable conclusions from the reports to determine what the actual Ortho Evra death and side effects risks really are. In response to the AP’s report regarding the Ortho Evra deaths, Ortho McNeil said it was “misleading” because it is based on spontaneous reports. At the time the patch was approved in November 2001, the AP said an FDA medical reviewer recommended the agency conduct a study to look at the risk of blood clots associated with the use of the patch, but the agency never did.
Both the FDA and Ortho McNeil maintain the reports of Ortho Evra deaths are no cause for alarm, and some doctors agreed saying women should not overreact to the fear of death and remove the patch because it is more risky to become pregnant. According to the senior policy director of Concerned Women for America, Wendy Wright, the advice of some doctors to keep using the patch to avoid risks of pregnancy despite fears of death is an “unbelievable admission” that Wright said “reveals a disturbing view within the medical community – that it is worse to be pregnant than dead.”
Ortho McNeil launched a study in 2005, an epidemiological review of the deaths and serious side effects reported in association with the patch, claiming it was not prompted by reports in the fall of 2004 that appeared in the New York Post and on ABC News covering deaths associated with Ortho Evra. American sales of Ortho Evra were estimated at $400 million in 2004, accounting for 15 percent of the U.S. market.
In order to allow safe contraceptive options for women, the FDA must be able to ensure patients are given adequate information to allow them to make informed decisions based on individual risk factors. Should there be greater Ortho Evra death and side effects risks than patients have been told, especially in certain populations, women must be alerted without waiting until a potentially greater number of people have suffered first.
Have you been injured by the Ortho Evra Patch?
If you or a loved one has developed a blood clot or any other serious birth control patch problem, please contact us to speak with an experienced attorney in your area.
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