NEW YORK, Feb. 17, 2006 – LAWFUEL – The Law News Network — 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 33-year-old woman who suffered a venous thrombosis (blood clot) and stroke after using the Ortho Evra contraceptive patch for six months. In February 2004, the plaintiff began suffering from headaches, nausea and vomiting. Shortly thereafter, the plaintiff’s conditions worsened, and she was taken to the emergency room at the Henry Medical Center in Stockbridge, Georgia. Diagnostic tests revealed venous thrombosis and stroke. The plaintiff was subsequently airlifted to Emory University Hospital and was admitted to the Neuro Intensive Care Unit where she underwent Heparin and Coumadin (anticoagulant) therapy. The plaintiff will likely undergo prolonged treatment with these medications, which 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.
Venous thrombosis is a blood clot formation in the veins that most commonly forms in the veins of the legs. The thrombus can interfere with circulation; 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.
Stroke occurs when the blood supply to a part of the brain is suddenly interrupted. In brain tissue, a reduction of blood flow can damage or kill brain cells. Death of brain tissue can lead to loss of the function controlled by that tissue. Stroke is an extremely serious medical condition that often leads to adult disability and death. It is important to identify a stroke as early as possible because patients who are treated earlier are more likely to survive and have better recoveries. The new warnings from the FDA and Ortho-McNeil indicate that the risk of stroke 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 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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CONTACT: Parker & Waichman, LLP
Jason Mark, Esq.
Melanie H. Muhlstock, Esq.