New York, NY, May 20, 2006 --(PR.com
)-- 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. on behalf of a 33-year-old woman and her husband. The woman suffered a bilateral pulmonary embolism and deep venous thrombosis (DVT) which are believed to be associated with the use of Ortho Evra
for two months. 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
In May 2005, the injured party was taken to the emergency room of Hillside Hospital in Tennessee with shortness of breath, chest pains, tachycardia and hypoxemia. Diagnostic tests revealed a bilateral pulmonary embolism with a large embolus in the right main pulmonary artery and right upper and right lower lobe peripheral infiltrates suspected to be pulmonary infarctions. Additional tests revealed a deep venous thrombosis of the right popliteal vein extending to the right common femoral vein. The woman was admitted to the hospital’s intensive care unit where she received Coumadin and Lovenox treatment. She will likely undergo prolonged treatment with these medications, which may be necessary for the remainder of her life.
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 November 2005 announcement 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 sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg but they can also form in the pelvic vein. Pulmonary thromboembolism can be 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 thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.
Deep venous thrombosis or DVT is a condition where a blood clot (Thrombus) forms within the deep vein system. The principal veins affected are those in the calf muscles, lower abdomen, groin and inner thigh. The thrombus can interfere with circulation and it may break off and travel through the blood stream, which can cause pulmonary embolism or stroke. Treatment may include long term use of anticoagulant medications and/or surgery. The new warnings from the FDA and Ortho-McNeil indicate that the risk of developing blood clots may be significantly higher with the Ortho Evra patch than with oral contraceptives.
It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra birth control patch
before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. It is believed 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 Associated Press reported last year that 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. This same report revealed that 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.
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. Ortho Evra continues to be marketed aggressively to both consumers and physicians.
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CONTACT: Parker & Waichman, LLP
Jason Mark, Esq.
Melanie H. Muhlstock, Esq.