Ortho Evra Lawsuit Filed in IllinoisNov 14, 2007 | Parker Waichman LLP
The Ortho Evra birth control patch is under fire yet again, after a group of plaintiffs sued Johnson & Johnson for injuries they claim they sustained as a result of using the contraceptive patch. Several pharmacies that dispensed Ortho Evra were also named in the lawsuit, which was filed in Illinois
In the lawsuit, residents from Illinois, Wisconsin, Kansas and New York allege that they suffered from pulmonary emboli, venous thromboembolism and other severe injuries due to Ortho Evra. They charge that Johnson & Johnson, Ortho-McNeil Pharmaceuticals, American Drug Stores, Osco Drug, Walgreens, B&D Pharmacy and Rite Aid all negligently distributed the Ortho Evra patch. The Ortho Evra lawsuit alleges that “"Defendants knew or should have known that the intake of hormones contained in Ortho Evra through the Patch would result in a level or estrogen...much higher (approximately 60% higher) than the levels associated with intake through the oral route, such as with birth control pills."
When Ortho Evra was introduced in 2002, Johnson & Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug’s original safety label stated that the patch’s health risks were similar to those related to oral contraceptives. But in 2005, the Food & Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who used oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer blood clots as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning. Since then, Ortho Evra has been named in well over 2,000 lawsuits.
Since the controversy over Ortho Evra emerged, some former Johnson & Johnson employees have charged that the company understated its risks. Joe Lippman, a plaintiff in a whistle blower lawsuit against Johnson & Johnson, claims he raised concerns over “dangerously high levels of estrogen” that users of the patch were exposed to in the late 1990s. In September, a stunning letter written by a former Johnson & Johnson vice president to the company’s CEO was made public. The writer claimed that a company investigation had revealed an “unusually high number” of blood clots caused by the patch and cited more than 20 deaths. The letter also said that of two Ortho Evra studies conducted by Johnson & Johnson, the company deliberately emphasized “partial and incomplete” results of the one that was most favorable. The writer of that letter apparently resigned because of Johnson & Johnson’s conduct in regards to Ortho Evra.