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Makers of Ortho Evra Sued for Wrongful Death

–March 30, 2006

Ortho McNeil, manufacturer of the Ortho Evra birth control patch, has been slapped with a federal wrongful death action lawsuit in New Jersey on behalf of a healthy young woman who died from a patch-related blood clot. The 20-year-old woman suffered from a pulmonary thromboembolism (blood clot) in 2004 after using Ortho Evra for 10 months. This lawsuit is just one of several filed in the United States, which claim that the contraceptive patch is directly resulting in serious injuries and deaths among users.

Last November, another lawsuit was filed by the parents of a 14-year-old girl who died from blood clots in her pelvis after using the patch for almost eight weeks.

These claims are in conjunction with new studies that have found that women using Ortho Evra are being exposed to 60 percent more estrogen than if they were taking the pill, which significantly increases the risk of blood clots, heart attacks, strokes, and death.

In the case of the 20-year-old women, the suit claims Ortho McNeil had full knowledge of the adverse side effect risks, but neglected to warn physicians and patients. According to the lawsuit, the Food and Drug Administration received 9,116 reports of serious adverse side effects of Ortho Evra from April 2002 through September 2003.

However, Ortho McNeil continues to vigorously deny the allegations that the injuries and deaths were directly caused by the birth control patch. They claim the reports were not adequate sources of evidence connecting the injuries to the patch.

Ortho McNeil also said they received no such reports of fatal side effects during any of their clinical trials of the birth control patch. Ortho Evra still remains on the market, but has been required by the FDA to carry a black box warning, which alerts consumers of the serious risks of the drug.

Many doctors and health-care providers have acknowledged the dangers of the patch and have stopped writing prescriptions for the contraceptive. There will be a decrease in the use of Ortho Evra over the next few months, predicts incoming board chairman of the Association of Reproductive Health Professional, Lee Shulman.

Ortho Evra was approved in November 2001 as the first and only birth control patch. By 2004, almost 10 million prescriptions were written for the drug.

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