A female resident of Atlanta, GA, 37, filed a personal injury lawsuit in the U.S. District Court for the District of New Jersey in Newark against Ortho-McNeil Pharmaceutical, Inc., the makers of the Ortho Evra birth control patch. The woman alleges Ortho-McNeil was aware of increased medical risks associated with the product before it was approved by the FDA and failed to adequately warn patients of those risks.

The woman had used the Ortho Evra birth control patch for just over a year when she was admitted to Piedmont Hospital in Atlanta for chest pain. Diagnostic tests revealed a bilateral pulmonary embolism for which she was treated with anticoagulation therapies. Her personal injury attorneys have indicated that there is a strong likelihood she will have to be on such therapies for the rest of her life. A pulmonary embolism is a sudden blockage in a lung artery that is usually caused by a blood clot. It can be fatal or result in pulmonary obstruction, pulmonary hypertension, heart attack or stroke.

In November 2005, Ortho-McNeil and the FDA issued a safety warning about the increased risks of blood clots and pulmonary events associated with the Ortho Evra patch. Women who use the product may be exposed to up to 60 percent more estrogen than they would be if they were taking a traditional birth control pill.

Source: “Ortho-McNeil sued on birth-control patch,” UPI, June 16, 2006, accessed June 19, 2006.