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Douglas & London, P.C.
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11/10/05
The Food and Drug Administration approved new labeling for the Ortho Evra® birth control patch to warn patients and healthcare providers that the product exposes women to higher levels of estrogen than most birth control pills.
Ortho Evra® is a weekly prescription birth control patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the bloodstream. It was the first skin patch approved for birth control.
The addition of the new warning label to the Patch is a result of the analysis comparing levels of estrogen and progestin in Ortho Evra® users with levels in typical birth control pill users. In general, increased exposure to estrogen can put a woman at higher risk for developing life-threatening blood clots. At the time, however, it is not known whether Ortho Evra® users are at greater risk of experiencing serious health problems.
The new warning on the Ortho Evra® label states that women who use the Patch are exposed to about 60 percent more total estrogen in their blood than women taking a typical birth control pill containing 35 micrograms of estrogen. The label does note, however, that the maximal blood level of estrogen is about 25 percent lower for the Patch than for a typical Pill.
The FDA will continue to monitor safety reports for the Ortho Evra® patch. The manufacturer of the Patch, Ortho McNeil Pharmaceuticals, is conducting additional studies to compare the risk of developing blood clots in women using the Patch versus those taking the Pill.
08/18/05
The firm of Douglas & London, P.C. announced that it has filed the first nationwide birth control patch class action law suit against Ortho-McNeil Pharmaceutical, Inc., Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and Johnson & Johnson, on behalf of three women injured by the Ortho Evra® birth control patch. Two of the women developed life-threatening blood clots and the third woman died as a result of injuries caused by Ortho Evra®.
The birth control patch class action law suit was filed by the firm in the Eastern District Court of New York in Brooklyn and assigned to Judge Nina Gershon and Magistrate Judge Gold.
“Between the cases we’ve evaluated and the extensive investigation we have performed over the past year and a half, the evidence appears overwhelming that the dangers of Ortho-McNeil’s Patch are occurring in young women at a staggering, and quite frankly, alarming rate,” says Michael London, the attorney heading these cases.
It is alleged that Ortho-McNeil was aware of the increased risks associated with Ortho Evra® before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots and stroke associated with Ortho Evra® is significantly higher than with oral contraceptive pills.
Prior to approval, the FDA medical review expressed concerns over Ortho Evra® causing venous thromboembolisms, stating: “Post-marketing surveillance for DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) events will be important, as there are potential serious adverse risks (with two cases of pulmonary emboli in the clinical trials) with this new delivery system for contraception.”
“Millions of young women are trusting what they hear from advertisements of the Patch, namely, that it is as safe as oral birth control medication, and unfortunately, what we’re seeing is that it is not,” London added. “Because of these misrepresentations, many women will suffer.”
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