Ortho Evra Lawsuit

Ortho Evra Lawsuit

Ortho Evra Side Effects Lawsuit

Ortho Evra contraceptive skin patch by Johnson & Johnson’s subsidiary Ortho-McNeil has been popular since November 2001. The patch contains a combination of hormones that prevents ovulation in females. It also causes changes in cervical mucus, which, in turn, prevents sperms from reaching the uterus. However, Ortho Evra has serious side effects. According to an Associated Press investigation report, the hormonal contraception patch triples the risk of developing life-threatening blood clots. The serious side effects of the drug include deep vein thrombosis, strokes, pulmonary embolisms, heart attacks, and deaths.

Ortho Evra Complaints and Warnings

According to a study conducted by the FDA in 2004, Ortho Evra led to a three-fold increase in blood clot-related fatal incidents, such as pulmonary embolisms, strokes, heart attacks, and deaths. The reports, made public by the Associated Press in July 2005, claimed that there were at least 23 Ortho Evra deaths, including 17 caused by blood clots until 2004. The study was also apprehensive that the actual side effects were more widespread as the post-marketing reviews covered only 1-10 percent patch users.

The first known Ortho Evra fatality was reported in April 2004. Autopsy of an 18-year-old Manhattan fashion student revealed a blood clot in the lung. The victim was using Ortho Evra and the medical examiner blamed the side effects of the birth control patch for the young woman's death. Another woman, a 25 year-old-mother of three, died of blood clots in her brain. The medical reports held hormones released by Ortho Evra responsible for the death.

In November 2005, the FDA ordered the manufacturer to modify labels on the drug reflecting the increased risk of blood clots and other severe side effects. An advisory issued by Ortho McNeil within days warned that the patch exposed users to 60% more estrogen than pills, which could lead to serious health risks.  In March 2006, the FDA announced further review of Ortho Evra and asked label update on the package following a comparative study on the side effects of the patch and other birth control pills. According to the research, the excessive hormones in the patch do not dilute during the digestive process, unlike other pills. They are absorbed directly into the blood stream and cause higher concentration of estrogen, which puts users at a greater risk of clots, thrombosis, and heart strokes.

The consumer advocacy group Public Citizen filed a petition signed by 80,000 individuals to FDA demanding recall of Ortho Evra in May 2008. The petition mentioned cases of unreasonable blood clot and other serious health problems that the birth control patch caused within six months of taking it.

Ortho Evra Side Effects

Blood Clots:

Thromboembolic risks are the most documented side effect of Ortho Evra. The patch increases level of estrogen and progestin hormones in the blood. It releases 60 percent more estrogen compared to birth control pills, and this directly enters the patient’s blood stream, putting them at a greater risk of developing blood clots. Most of the Ortho Evra side effect victims are diagnosed with deep vein thrombosis and pulmonary embolism. Blood clots mostly develop in a deep vein in the pelvic region or legs. It breaks off and travels upward to the lungs, which can cause major artery blocks.

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