NEW YORK, Nov. 8, 2005 (PRIMEZONE) -- Parker & Waichman, LLP (http://www.yourlawyer.com) announced that it has filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc. (NYSE:JNJ), on behalf of a 23-year-old woman who suffered a massive pulmonary embolism in her right main pulmonary artery and a second pulmonary embolism in her left pulmonary artery after using the Ortho Evra contraceptive patch for ten months. As a result, the plaintiff underwent a pulmonary thromboendarterectomy, which resulted in the dissection of chronic thromboembolic material from both lower lobe pulmonary arteries. The suit was filed on November 3, 2005 in the United States District Court for the District of New Jersey in Newark, New Jersey. For more information on Ortho Evra please visit www.orthopatchlawsuit.com.
Pulmonary embolism is a type of thromboembolism that occurs when an artery in either lung becomes blocked. In most cases, the blockage is caused by one or more blood clots that travel to the lungs from another part of the body. Usually these clots migrate from the legs, but they can also form in the pelvic vein. Pulmonary embolism is potentially fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long-term use of anticoagulant medications and/or surgery. Recent reports have indicated that the risk of developing blood clots, pulmonary embolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.
It is alleged that Ortho-McNeil was aware of the increased medical 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, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestral. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.
Prior to approval, the FDA medical review expressed concerns about Ortho Evra causing venous thromboembolisms, stating: "Post-marketing surveillance for DVT (Deep Venous 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."
Unlike the birth control pill, which is ingested and metabolized by the body's digestive system, the medication in the Ortho Evra patch is released directly into the bloodstream. This may result in dangerously higher concentrations of the medication in the body, leading to adverse effects.
Ortho Evra is an adhesive, transdermal birth control patch that is worn on the torso. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.
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