NEW YORK, Sept. 1, 2005 (PRIMEZONE) -- Parker & Waichman, LLP (http://www.yourlawyer.com) announced that it has formally requested that pharmaceutical liability lawsuits involving the Ortho Evra transdermal birth control patch that have been filed or that will be filed in the Superior Courts of the State of New Jersey be designated as a Mass Tort for centralized management pursuant to R.4:38A. Ortho Evra has been associated with potentially fatal side effects including strokes, pulmonary emboli, blood clots, deep vein thrombosis and heart attacks. Ortho Evra is manufactured by Ortho McNeil, a subsidiary of Johnson & Johnson (NYSE:JNJ), which is based in New Jersey. For more information on Ortho Evra please visit http://www.orthopatchlawsuit.com.
Ortho Evra is an adhesive transdermal birth control patch. Since its approval by the FDA in November 2001, over four million women have used Ortho Evra. Ortho Evra continues to be marketed aggressively to both consumers and physicians. In 2004, approximately 800,000 women were reported to be using Ortho Evra.
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. 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 delivery method may result in dangerously higher concentrations of the medication in the body and higher rates of adverse effects.
An FDA database concerning Ortho Evra contains approximately 16,000 reports of adverse reactions associated with the patch. The Associated Press obtained reports indicating that the risks of embolisms and thrombotic injuries, including blood clots and strokes associated with Ortho Evra, are significantly higher than with oral contraceptive pills. The AP found that even before Ortho Evra was approved, the FDA had already noticed that nonfatal blood clots from the patch were three times that of the pill, and that fatal blood clots were also higher than that of the pill. The FDA medical review expressed concerns about 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."
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