NEW YORK, Jan. 27, 2006 (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 woman who suffered bilateral pulmonary emboli in December 2003 at the age of 31 after using the Ortho Evra contraceptive patch for 15 days. The plaintiff began using the patch on December 15, 2003, and subsequently began experiencing severe chest pain and shortness of breath. On December 30, 2003, after her symptoms worsened, the plaintiff was taken to the emergency room. Diagnostic tests at the hospital revealed bilateral pulmonary emboli, and the plaintiff was admitted to the hospital for Heparin and Coumadin (anticoagulant) therapy. The plaintiff has undergone prolonged treatment with these medications, and the treatment may be necessary for the remainder of her life. The suit was filed in the United States District Court for the District of New Jersey in Newark, New Jersey. For more information on Ortho Evra please visit http://www.orthopatchlawsuit.com or http://www.yourlawyer.com/topics/overview/Ortho_Evra_Patch.
On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra. In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA's announcement on this warning can be found at http://www.fda.gov/bbs/topics/news/2005/NEW01262.html. It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.
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.
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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