Ortho Evra
April 5, 2008Attorneys say Ortho Evra maker misled users about health risks
Ortho Evra attorneys representing a group of women who have filed lawsuits against Johnson & Johnson, the manufacturer of the birth control patch, say that the company misled consumers and health officials about its safety. More than 2,400 women have filed Ortho Evra lawsuits alleging they were injured after using the birth control patch.According to documents filed as part of the Ortho Evra lawsuits, when J&J released its studies of the birth control patch to the FDA, it applied a “correction factor” to data which made it seem like the patch releases one-third less estrogen into the blood stream than it actually does.
In fact, as the FDA later learned, the Ortho Evra patch releases about 60% to 100% more estrogen into the blood stream than birth control pills. Because estrogen can increase the risk of blood clots, this may double a woman’s risk of blood clots compared with the pill, and can increase the risk of serious Ortho Evra side effects, including pulmonary embolism, heart attack and stroke.
Scientists with J&J urged the company to conduct more studies because of the increased risk of birth control patch side effects observed with Ortho Evra. According to the Ortho Evra lawsuits, these requests were ignored by the company.
J&J has been forced to update the Ortho Evra warning label three times in order to warn consumers about the increased level of estrogen released by the Ortho Evra patch and the risk of serious birth control patch side effects that women may face by using it.