NEW YORK, July 29, 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 30-year-old wife and mother of four who developed life-threatening blood clots after using the Ortho Evra contraceptive patch. The victim was admitted into the intensive care unit in July 2003 due to a severe headache, blurry vision, nausea and vomiting. Tests determined the cause to be a posterior-superior sagittal sinus thrombosis with associated subarachnoid hemorrhage. The suit was filed on July 26, 2005, in the Middlesex County Court House in New Brunswick, New Jersey. For more information on Ortho Evra side effects and to request a free case evaluation please visit www.orthopatchlawsuit.com.
Posterior-superior sagittal sinus thrombosis is characterized by blood clotting in the superior sagittal sinus, a single venous sinus in the membranes covering the brain and spinal cord. A subarachnoid hemorrhage, or SAH, is bleeding into the subarachnoid space surrounding the brain. Both injuries are considered serious medical emergencies which can lead to death or severe disability, even after being recognized and treated at an early stage. The victim did not have any vascular problems prior to using Ortho Evra.
It is alleged that Ortho-McNeil was aware of the increased 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 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 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, the 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 linked to 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.
Prior to approval, the FDA medical review expressed concerns about Ortho Evra causing venous thromboembolisms, stating: "Post-marketing surveillance for DVT (Deep Venous Thrombosis) and PE (Pulmonary Embolism) events will be important, as there are potential serious adverse risks (with two cases of pulmonary emboli in the clinical trials) with this new delivery system for contraception."
Unlike the birth control pill, which is ingested and metabolized by the body's digestive system, the medication in the Ortho Evra patch is released directly into the bloodstream. This results in dangerously higher concentrations of the medication in the body, leading to adverse effects.
"It is clear that there are significantly greater risks associated with the Ortho Evra patch than with oral contraceptive pills," commented Jason Mark, an attorney with Parker & Waichman, LLP. "As reports of serious injuries and deaths continue to surface, it appears the risks of Ortho Evra far outweigh its benefits."
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 April 2002, and over four 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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