Lopez, Hodes, Restaino, Milman & Skikos - Ortho Evra Help - The Birth Control Patch
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Potential Side Effects
Ortho McNeil has been accused of failing to adequately warn consumers about life threatening Ortho Evra side effects, such as deep vein thrombosis and pulmonary embolism.
Ortho Evra defects have received widespread consumer concern since the publication of a study indicating birth control patch users are three times more likely to suffer fatal vascular side effects than women taking oral contraceptives.
Ortho Evra Failure
Ortho McNeil’s Ortho Evra birth control patch was FDA approved in the United States in 2001. At the time of the approval, the agency did not require any follow-up studies beyond routine FDA reviews of reports called in by consumers, doctors, and manufacturers—despite an FDA reviewer recommending the device’s label clearly reflect his safety concerns about a potential for increased risk of blood clots.
The FDA often approves drugs after trials involving just a few thousand users, so safety problems that were not observed in early testing may emerge only after the newer drugs reach the general market. Women’s health specialists have long known about the risk of blood clots caused by the hormones in birth control pills, but in July 2005, the Associated Press reported that Ortho Evra failure rates were three times higher than those of birth control pills.
The AP filed a Freedom of Information Act request to obtain reports of adverse events from the FDA, and the FDA immediately responded to the AP’s request with a database containing about 16,000 different reports of adverse reactions associated with the patch ranging from mild rashes to deaths. The AP found 23 different deaths associated with the patch, and though the primary cause of death in those reports was not always clear, doctors who reviewed the 23 cases found that 17 appeared clot-related.
Experts believe that Ortho Evra failures could be occurring because the patch allows hormones to go directly into the bloodstream, unlike the pill, where the hormones must be processed through the intestinal tract first. The patch reportedly has similar estrogen levels as the pill, but evidence of Ortho Evra’s defects were apparent during early testing. The combination of estrogen and progesterone is supposed to be slowly absorbed when applied to the skin to prevent ovulation and pregnancy, but a higher rate of adverse effects might indicate there are dosing problems.
When the AP examined reports of adverse Ortho Evra failures, it found that even before the patch was approved the FDA had already noticed nonfatal blood clots were three times higher among users of this device than women who took the pill. The concerns about Ortho Evra failure rates remained even after the patch was approved, prompting some to question why the FDA did not require a closer examination of the patch following its entrance to the market.
Because the FDA’s reporting system is voluntary, experts assume that the reports received represent only a fraction of the actual adverse experiences suffered by patients. While further study may better quantify the risk, the current data indicates that serious adverse effects are occurring in Ortho Evra patients at a greater rate than in women taking the pill.
