Ortho Evra
November 1, 2006Lawsuits filed in California against maker of Ortho Evra birth control patch
Ortho-McNeil, maker of the Ortho Evra birth control patch, is the target of a wrongful death lawsuit filed in California State Court. It involves a 25-year-old Maryland woman who died in late 2004. At the same time, a class action suit was filed on behalf of 43 women—former Ortho Evra users, too—who suffer from blood clots and other serious illnesses.The lawsuits allege that Ortho-McNeil, the world’s top maker of contraceptives, intentionally deceived the public about the risk of Ortho Evra side effects, such as blood clots, deep vein thrombosis, pulmonary embolism and strokes. These kinds of injuries totally altered the women’s lives.
In their Ortho Evra lawsuits, the women contend that Ortho-McNeil failed to thoroughly investigate Ortho Evra’s safety and knew of its harmful effects, even as the company continued to market and distribute the drug.
The wrongful death suit was filed on behalf of Denise Bracken-Hodge, mother of Kelly Bracken, who was quite healthy when she first applied the Ortho Evra birth control patch in 2004. By the end of the year, she had died of a pulmonary embolism and deep vein thrombosis. Her mother alleges in her Ortho Evra lawsuit that Kelly went into a hospital and was dead two weeks later.
Ortho Evra, which was approved by the Food and Drug Administration in November 2001, is the first and only weekly birth control patch worn on the skin, continuously releasing estrogen and progestin straight into the bloodstream. In November 2005, after the FDA had logged reports of more than 9,000 adverse reactions to the patch—a rate much higher than for oral contraceptives—it required Ortho-McNeil to slap a new black-box warning on the label which would inform users that the drug exposes them to 60% higher levels of estrogen than do oral contraceptives.