One lawsuit stipulates that 43 women suffered from blood clots and other health ailments after taking the Ortho Evra birth-control patch, currently one of the fastest-growing forms of contraception in the country. A second lawsuit states that Kelly Bracken, 25, died of severe blood clots in her lungs and legs after she began using the Ortho Evra patch.
The lawsuits allege that Ortho-McNeil failed to properly investigate the product's safety. In addition, the claim states that the company deceived the public about the severity of potential side effects, which include strokes and severe blood clots.
Shawn Khorrami, an attorney for the plaintiffs, said "This product should not be on the market … when you put out a product that gives women more hormones than they need, then you're increasing their risk of developing those ailments." Khorrami added that similar lawsuits have been filed on behalf of nearly 400 women nationwide.
In September of this year, the FDA warned women that their risk of blood clots in the legs and lungs may be higher if they use the Ortho Evra birth-control patch instead of the pill. As a result of the warning, Ortho-Evra's product label was updated to reflect the results of one study that found women using the patch faced twice the risk of clots than did women on the pill.
Ortho Evra's manufacturer, the Ortho-McNeil Pharmaceutical Company, is based in Titusville, New Jersey, and is a subsidiary of pharmaceutical giant Johnson & Johnson. San Francisco-based distributor McKesson Corp. was named in both lawsuits as well.
Ortho Evra was approved by the U.S. Food and Drug Administration (FDA) five years ago in 2001. The patch system delivers the hormones estrogen and progestin directly into the bloodstream through the skin, as opposed to the more common pill form of birth control.