New Ortho Evra Lawsuit Filed in TexasDec 5, 2008 | Parker Waichman LLP
A Texas woman is the latest person to file suit over injuries she sustained while using the Ortho Evra birth control patch. Karenetha Easterwood says she suffered a life-threatening pulmonary embolism just 5 months after she began using Ortho Evra.
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 of oral contraceptives. But by November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. At that time, the Food & Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills.
It is believed that the difference in exposure is related to the delivery mechanism of the birth control patch. Hormones in birth control pills are partially diluted by the digestive system. However, hormones in Ortho Evra are absorbed directly into the blood stream, which causes a higher concentration of the medication to enter a patient’s body. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries.
Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer a type of blood clot called venous thromboembolisms (VTEs) — a clot that can travel to the lungs and cause a fatal pulmonary embolism - 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. Just this past January, the FDA asked that the Ortho Evra label be changed again to include information on yet another study that indicated the patch doubles the risk of developing VTEs compared to the Pill.
Ortho Evra's problems have sparked more than 4,000 state and federal lawsuits that claim the company hid or altered data about the risks of high levels of estrogen released by Ortho Evra. As Ortho Evra lawsuits have made their way through the courts, evidence has been presented that Johnson & Johnson knew long before the FDA or the public that the patch put users at risk for developing blood clots.
Esterwood's lawsuit also alleges the defendants misled consumers and failed to warn that Ortho Evra is more likely to cause deep vein thrombosis, pulmonary embolism, stroke, and death as compared to oral contraceptives. Until January 2008, the defendants mislabeled the drug stating that studies showed mixed results on the adverse effects, the complaint says.
The lawsuit, filed in the Marshall Division of the Eastern District of Texas, seeks compensatory damages in excess of $75,000 from Johnson & Johnson, Ortho-McNeil Pharmaceutical Inc. and Johnson & Johnson Pharmaceutical Research and Development Inc.
We reported in October that Johnson & Johnson has so far spent an estimated $68.7 million to settle Ortho Evra claims. The settlements are confidential, and their financial details haven’t been released to investors.