On November 1, 2006, more than 40 women sued the makers of Ortho Evra, claiming the contraceptive caused serious health problems, including blood clots and stroke. Ortho Evra, manufactured by Ortho-McNeil Pharmaceutical Company, is one of the fastest-growing forms of contraception in the United States.

The lawsuits, filed against Ortho-McNeil, claim that the company didn’t properly investigate the product’s safety and deceived the public about the seriousness of potential side effects. Similar patch lawsuits have been filed on behalf of nearly 400 women worldwide.

Ortho Evra was approved by the Food and Drug Administration (FDA) in 2001. It is a birth control patch that delivers hormones, estrogen and progestin, directly into the bloodstream through the skin.

One complaint alleges that Kelly Bracken, 25 , of Maryland, died of severe blood clots in her lungs and legs after she started wearing the skin patch. Another claimant says she developed potentially life-threatening blood clots in her lungs and suffered a miscarriage after using the patch.

The FDA warned consumers in September 2006 that their risk of blood clots in the legs and lungs may be higher if they use the patch instead of the birth control pill. The product label was updated to say that women using the patch faced twice the risk of blood clots than women on the pill. The FDA has called for additional testing of the product.

Sources: Terence Chea, “43 women sue maker of birth-control patch,” Houston Chronicle, November 1, 2006; “New Ortho Evra cases show problems continue,” Yahoo News, November 2, 2006.