By Hilary White

October 14, 2008 ( – Legal documents have shown that the manufacturer of one of the world’s most popular long-term contraceptive drugs has paid out at least US $68.7 million in out-of-court settlements over side effects of the drug. reported yesterday that Johnson and Johnson, one of the world’s largest manufacturers of health products, has not released to its investors the financial records of hundreds of settlements over the Ortho Evra long-wear hormone patch.

Twenty women have died, and 4000 have filed complaints in state and federal courts, alleging that Ortho Evra caused deep-vein thrombosis, or blood clots in the legs and pulmonary embolisms, or blood clots in the lungs. Some complaints have linked the patch to heart attacks and strokes. 

Altogether, 4000 women have filed complaints in state and federal courts claiming the company hid or altered data about possible health risks associated with the high levels of estrogen released by the patch.

Gloria Vanderham, a spokesman for Ortho-McNeil Pharmaceutical, Inc., that manufactures the drug for Johnson and Johnson, told, “Ortho Evra provides a needed birth-control option for women and physicians. When used according to the FDA- approved label, Ortho Evra is a safe and effective method of hormonal birth control.”

The company “regularly and properly disclosed data to the FDA, the medical community and the public in a timely manner,” Vanderham said. In 2005, an Associated Press report noted that 23 deaths were attributed to use of the patch since the FDA approved it in 2001.

The Ortho Evra patch, introduced in 2002, was touted by Johnson & Johnson as a convenient alternative to daily oral contraceptive pills. In 2005, after investigations by the US Food & Drug Administration (FDA), the company updated its product labels to say that Ortho Evra exposes women to 60 percent more estrogen than the typical birth-control pill and that higher estrogen increases side effects.

One lawsuit in 2005 alleged that Ortho Evra is “unreasonably dangerous,” and “defectively designed.” That suit was filed by 10 women who suffered from strokes or serious blood clots; all suffer from long-term debilitating effects from the patch.

In 2006, a federal drug safety report obtained by the Associated Press under the Freedom of Information Act, “indicate that in 2004 – when 800,000 women were on the patch – the risk of dying or suffering a survivable blood clot while using the device was about three times higher than while using birth control pills.”

Read related coverage:

Woman Sues “Birth Control” Patch Manufacturer for Pulmonary Embolism

Ortho McNeil Corp Admits Birth Control Patch Blood Clot Connection

18 Year-Old New York Student Dies Suddenly from Birth Control Complications


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