Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of Victim of Ortho Evra Birth Control Patch -- JNJ
32-Year-Old Victim Died from Acute Pulmonary Thrombosis After Using Ortho Evra for 11 MonthsNov 18, 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 the family of a 32-year-old woman who died from an acute pulmonary thrombosis after using the Ortho Evra contraceptive patch for 11 months.
Prior to using Ortho Evra, the victim was in good health. On July 29, 2005, the victim became short of breath and was hospitalized. Early the next morning, the victim's shortness of breath worsened and her heart rate dropped; she was unable to be revived and died on July 30, 2005. The victim is survived by her husband and two children. The suit was filed on November 15, 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.
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 thrombosis or 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 thrombosis 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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Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide, with offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. For more information on Parker & Waichman, LLP please visit: (http://www.yourlawyer.com) or call 1-800-YOURLAWYER (1-800-968-7529).
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CONTACT: Parker & Waichman, LLP
Jason Mark, Esq.
Melanie H. Muhlstock, Esq.
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