The Ortho Evra birth control patch was approved by the Food and Drug Administration (FDA) in November 1991 as a safe and effective method of birth control. This once-a-week contraceptive was created to prevent pregnancy by continually transmitting the hormones estrogen and progestin into the bloodstream through a thin beige patch that is applied directly to the skin.

In 1992, the manufacturer, Ortho McNeil, and its parent company, Johnson & Johnson, celebrated the new entry of this revolutionary drug to the market with aggressive marketing campaigns, celebrity endorsements, and direct-to-consumer communications. Reports have surfaced that show that potential problems were well known by the FDA and Ortho McNeil before the drug was introduced to the market. Unfortunately, this information was ignored and kept from the public.

The Associated Press obtained FDA records in 2005 that show that women using Ortho Evra were three times more likely to die or develop blood clots than women using oral contraceptives. The birth control patch has been blamed for 23 deaths, including 17 women who died as result of blood clot complications. Many of these women had no history of blood clots or other cardiovascular conditions.

The risks associated with high levels of estrogen, including blood clots, strokes, heart attacks, and other cardiovascular problems were well known by the medical community for decades. In the 1950s, the first approved estrogen-based birth control pills contained 50 micrograms (mcg) of estrogen. However, it was not until 1988 that the FDA determined that 50 mcg of estrogen in an oral contraceptive was too high and was not acceptable due to health risks. Most oral birth control pills today contain 35 mcg of estrogen or less.

The product label on the Ortho Evra patch states that patients receive 20 mcg of estrogen when using the product. However, when the hormones are absorbed into the bloodstream through the skin instead of through the digestive tract, a higher amount of estrogen is filtered through the liver. In November 2005, Ortho McNeil announced that women using the patch actually receive at least 60 percent more estrogen than women using 35-mcg oral contraceptives.

Since its inception, more than five million women in the United States have used the Ortho Evra patch. This puts them at a higher risk for serious injuries or death from disorders including clotting disorders, cardiovascular disease, heart attack, and stroke. While several studies have indicated that Ortho Evra poses a greater risk than oral contraceptives, the patch remains on the market pending further review. Several lawsuits have been filed on behalf of women who have suffered serious and even deadly side effects while using the Ortho Evra birth control patch.

If you or a loved one has suffered injuries from the Ortho Evra patch, please contact us for a free case evaluation by a qualified Civil Justice Attorney.