NEW YORK, Dec. 1, 2005 (PRIMEZONE) -- Parker & Waichman, LLP (http://www.yourlawyer.com) announced that it has filed a motion before the Judicial Panel on Multidistrict Litigation requesting consolidation of pharmaceutical liability lawsuits involving the Ortho Evra transdermal birth control patch. The motion, which was filed pursuant to 28 U.S.C. No. 1407, and Rule 7.2 of the Rules of Procedure for the Judicial Panel on Multidistrict Litigation, requests the transfer of all related actions to the District of New Jersey for consolidated pre-trial proceedings. The motion was filed on behalf of Lydia M. Lilly, the plaintiff in Lydia M. Lilly v. Ortho-McNeil Pharmaceutical, Inc., et al. (Civil Action No. 2:05-cv-04313 (D. New Jersey). Ortho Evra is manufactured by Ortho McNeil, a subsidiary of Johnson & Johnson (NYSE:JNJ), which is based in New Jersey. Ortho Evra has been associated with potentially fatal side effects including strokes, pulmonary emboli, blood clots, deep vein thrombosis and heart attacks. For more information on Ortho Evra, please visit http://www.orthopatchlawsuit.com or http://www.yourlawyer.com/practice/overview.htm?topic=Ortho%20Evra%20Patch.
To date, at least one federal class action and nineteen (19) individual federal actions, involving a total of twenty-six (26) injured plaintiffs, have been commenced against Johnson & Johnson, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. f/k/a R.W. Johnson Pharmaceutical Research Institute, and/or Ortho-McNeil Pharmaceutical, Inc. These actions assert substantially similar claims and seek substantially similar relief. The class action was commenced in the Eastern District of New York, and individual actions have been filed in the following: District of New Jersey, Eastern District of New York, Southern District of New York, Western District of Pennsylvania, Western District of Texas, Western District of North Carolina, Southern District of Ohio, Northern District of Ohio, Western District of Louisiana, District of Massachusetts, and Western District of Wisconsin.
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 are 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. It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death. The FDA's announcement on this warning can be found at: http://www.fda.gov/bbs/topics/news/2005/NEW01262.html
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 doctors, patients and the Food and Drug Administration about these additional risks. It has been reported 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 applied to the skin. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream every 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. Over 5 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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