Ortho Evra Lawyer

The Ortho Evra Birth Control Patch - The Controversy Grows

The Ortho Evra birth control patch hit the market with a high degree of optimism. It was hailed as a groundbreaking innovation that would serve women everywhere with a dependable degree of birth control. Methods from the past, including "the pill," condoms and the diaphragm proved to be less than 100% effective, resulting in unwanted pregnancies. Although "the patch" was not marketed to be 100% effective, it was supposed to come as close as any product ever had.

However, it wasn't long before problems began to arise with this product, and the manufacturer, McNeil Pharmaceuticals, came under fire. Specifically, reports of serious and even life-threatening side effects began to surface, and these reports ultimately prompted the Food and Drug Administration (FDA) to get involved. Below is a brief history of the FDA's involvement with the Ortho Evra birth control patch, organized by chronological date.

December 13, 2005

On this date, the FDA published a question-and-answer page that covered all of the general information prospective users of the patch would need to know. Included on this sheet were answers regarding how to use the product, what risk factors were present and the potential side effects that could be experienced by someone who used the patch. No direct warnings were given at the time.

September 20, 2006

The FDA published another question-and-answer page on their Web site, but this time the information was a bit more pointed. Specifically, the point of the publishing was to alert the public that the label on the product was being updated in reaction to two studies that had recently been completed. One of the studies showed that women who used the patch were exposed to a high level of estrogen and progestin, and that this could be dangerous for some people.

September 20, 2006

That same day, the FDA published an "approved letter" that was sent to the manufacturer regarding an approval of the updated labeling text that was to be required on all containers of the patch. This process was completed in accordance with federal law, and the letter was published in order to allow the general public to stay up-to-date on everything that was happening with this product.

September 20, 2006

The approved labeling text was published, and this text included warnings regarding the potential for serious side effects, including blood clots, heart problems and even the risk of death. The FDA published the entire 62-page approval document in order to fully disclose everything involved with the Ortho Evra patch.

Overall, the FDA has not issued any sort of recall of this product, but lawsuits and general claims are growing in number every day. If you have been harmed by the use of the Ortho Evra birth control patch, contact the Ortho Evra lawyers at Williams Kherkher today to schedule a free initial consultation.