Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of Victim of Ortho Evra Birth Control Patch -- JNJ
27-Year-Old Victim Suffered a Deep Venous Thrombosis after Using Ortho Evra for 12 MonthsDec 7, 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 27-year-old woman who suffered a deep venous thrombosis (DVT) after using the Ortho Evra contraceptive patch for 12 months.
In December 2003, the Plaintiff began experiencing increasing swelling, warmth and pain in her left lower extremity. The pain intensified and on December 22, 2003, the Plaintiff was taken to the emergency room at Eliza Coffee Memorial Hospital in Florence, Alabama. A Doppler venogram was performed which revealed a deep venous thrombosis in the distal half of the left peroneal vein.
As a result, the plaintiff was admitted to the hospital for 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 on December 2, 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 or http://www.yourlawyer.com/practice/overview.htm?topic=Ortho%20Evra%20Patch.
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.
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 oralcontraceptives.
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.
About Parker & Waichman, LLP
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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Parker & Waichman, LLP
Jason Mark, Esq.
Melanie H. Muhlstock, Esq.
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