Lawsuits have been filed by women who allege they suffered serious Ortho Evra side effects, which reportedly include blood clots in the legs and lungs as well as heart attacks and strokes. Women who use the Ortho Evra patch allege they were harmed by use of the birth control patch, while some families claim their loved ones died after using Ortho Evra birth control.
Ortho Evra Lawsuits
The lawsuits claimed that Johnson & Johnson knew about higher levels of estrogen released by the Ortho Evra patch but failed to warn users that they could be at higher risk to suffer blood clots and other adverse side effects than women who use other forms of oral birth control such as the pill.
A lead plaintiff attorney told Bloomberg News that, as of March 31, 2008, a fund has paid out just over $2 million to settle several hundred cases.
Ortho Evra Deaths
July 17th, 2005, the Associated Press International (API) reported that they were aware of at least a dozen women, most in their late teens and twenties who died in 2004 due to blood clots that are believed to be related to the use of the Ortho Evra Patch. According to 16,000 federal drug reports filed with the FDA, dozens more women survived strokes and other blood-clot related side effects In fact, API found 23 different fatalities associated with the patch, but the primary cause of death in each case was not always clear.
Some people suspect that there are many more deaths related to Ortho Evra but that aren't reported as such because coroners or doctors are not considering the effect of birth control in the fatal or near-fatal event, so they are not reporting all cases to the government.
These cases are incredible tragedies for the victims and their families. In one case, a 25 year old woman had a stroke and was placed in the Intensive Care Unit, where her condition was so fragile that her family was unable to speak or touch her in any way because even the slightest amount of stimulation could create a fatal level of pressure on her brain.
After the death of this beloved sister, daughter and wife, the coroner stated that her headaches and stroke may have been side effects of the high hormone levels in Ortho Evra. In March 2004, a young woman from New York died after being on the patch six weeks. A 17-year-old St. Louis girl using Ortho-Evra died from a pulmonary embolism, which is a deadly blood clot.
Young women are typically at low risk for blood clots and strokes, but with the use of Ortho Evra, these young women are having strokes, heart attacks and even dying at increased rates.
Ortho Evra Patch
"Most side effects of the Patch are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes."
These changes to the label do little to warn women and their doctors of the potential risk of dying while using the Ortho Evra birth control patch.
Ortho Evra was the first contraceptive patch approved in 2002 by the FDA for Ortho-McNeil Pharmaceuticals under the giant company Johnson & Johnson. Ortho Evra and other birth control methods for these pharmaceutical companies generates over $1 billion in annual sales.