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 Patch
When the FDA approved Ortho Evra patch in 2001, Ortho McNeil’s device was well received. However, information prior to approval of the Ortho Evra patch indicates that both the FDA and Ortho McNeil saw warnings signs of possible problems before the patch reached the market.
Reports obtained by The Associated Press under a Freedom of Information Act appear to indicate that in 2004, when 800,000 women were on the patch, the risk of dying or suffering a survivable blood clot while using Ortho Evra patch was about three times higher than when using birth control pills. While blood clots were a recognized risk for the original hormonal contraceptives, the next generation of birth control pills posed a much lower risk for blood clots, especially in women younger than 35.
In 2000, doctors at the FDA reviewing clinical trials of Ortho Evra patch warned that blood clots could be a problem if the patch were approved, and an FDA reviewer believed the safety risks, should the patch be approved, were so significant that he used capital letters and underscored his comments to show his disagreement with Ortho McNeil’s conclusions. Ortho McNeil had concluded that one of the two women out of the 3,300 using the patch in the trials treated for blood clots that traveled to their lungs should not be counted.
The reviewer wrote that it would be important to study users after Ortho Evra patch came on the market for clot problems, yet the FDA approved the device a year later without requiring follow-up studies. Because the FDA’s reporting system is voluntary, it has been criticized for failing to adequately track safety concerns, especially among new drugs and devices that can remain on the market for years before serious concerns emerge.
The Ortho Evra patch is theoretically supposed to deliver the same hormone dosages as the pill, but the device is a new delivery system. If there are higher reports of blood clots among Ortho Evra patch users, it might be because there is a quicker dose delivery that is making the drug more potent.
The FDA provided The AP with a database containing 16,000 different adverse events associated with Ortho Evra patch, ranging from mild rashes to deaths, with many duplicate reports. Though the news service interpreted the data to show the risk of dying from a blood clot to be three times higher when using the device than with using an oral contraceptive, Ortho McNeil questioned The AP’s denominator and refuted its claims.
About a dozen women, according to the AP, most in their late teens and early 20’s died in 2004 from blood clots believed to be related to the Ortho Evra patch. Women deserve access to all information regarding their hormonal contraceptive choices, and if the Ortho Evra patch has higher risks of adverse effects, possibly even resulting in death, they should be notified.
