SAN FRANCISCO – More than 40 women sued the makers of a popular birth-control patch Wednesday, claiming the contraceptive caused serious illnesses and at least one death.
One lawsuit alleges that 43 women suffered from blood clots and other health ailments after taking Ortho Evra, one of the fastest-growing forms of contraception in the U.S.
A second complaint claims that 25-year-old Kelly Bracken of Elk Ridge, Md., died of severe blood clots in her lungs and legs after she started wearing the skin patch.
The lawsuits, filed in San Francisco Superior Court, name as defendants the drug's manufacturer, Ortho-McNeil Pharmaceutical Co., a Titusville, N.J.-based subsidiary of Johnson & Johnson; and San Francisco-based distributor McKesson Corp. The plaintiffs seek unspecified monetary damages.
Officials for Ortho-McNeil and McKesson did not immediately respond to calls seeking comment Wednesday.
Approved by the U.S. Food and Drug Administration in 2001, Ortho Evra is a birth control patch that delivers the hormones estrogen and progestin directly into the bloodstream through the skin.
The lawsuit claims that Ortho-McNeil failed to properly investigate the product's safety and deceived the public about the severity of potential side effects, including strokes and severe blood clots.
"This product should not be on the market," said Shawn Khorrami, an attorney for the plaintiffs. "When you put out a product that gives women more hormones than they need, then you're increasing their risk of developing those ailments."
Similar lawsuits have been filed on behalf of nearly 400 women nationwide, Khorrami said.
In September, 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.
The 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. A second study, however, found no difference in risk between the two forms of birth control.
The case is Bracken-Hodge v. Ortho-McNeil, 06-457523; and Abel v. Ortho McNeil, 06-457524.