10 women filed suit today in Hudson County, NJ, Superior Court against Johnson & Johnson and its subsidiary Ortho McNeil, marketer and manufacturer of the Ortho Evra birth control patch. They have suffered debilitating, long-term adverse health effects while using the patch, including strokes and blood clots. One plaintiff, 19-year-old Amanda Bianchi of Colorado Springs, CO, had developed a 10-inch blood clot in her brain that her doctors say is a direct result of the patch she used for just three months in 2004. She suffered two strokes and routinely gets debilitating migraine headaches.

An Associated Press report on July 17, 2005, derived from raw FDA data obtained under the Freedom of Information Act, indicated that about a dozen young women who had used the Ortho Evra patch died in 2004 from blood clots. The AP concluded that the risk of dying from a blood clot might be about three times higher when using the Ortho Evra patch than when using a form of oral contraceptive. The current lawsuit alleges that the Ortho Evra patch is defectively designed and unreasonably dangerous.

Current FDA warnings advise that patients already at risk for adverse health events, including blood clots and stroke, should not use the patch. Younger women who use birth control would ordinarily not be tested for such risk. The prevalence of stroke among women in the U.S. ages 20 to 34 is a mere 0.3%. Spokespersons for Ortho McNeil contend that none of the deaths reported by the AP can be directly attributable to their patch.

Sources: “Women sue birth control maker,” CNNMoney, July 25, 2005; Katrina Woznicki, “Birth Control Patch May Be Linked to Stroke Risk,” MedPage Today, July 19, 2005.