NEW YORK, September 13, 2005 ( – A 37 year old woman who suffered a pulmonary embolism after using the Ortho Evra contraceptive patch for seven months has filed a lawsuit against the patch’s manufacturer, Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc.

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 other hormonal contraceptives.

Pulmonary embolism is a potentially fatal condition triggered by a blood clot that obstructs an artery in the lungs, often leaving victims with chronic health problems requiring long-term anticoagulant medications. Reports show that the deaths of at least seventeen young American women over the past two years may be related to Ortho Evra patch use.

The first fatality publicly blamed on the Ortho Evra patch came in April 2005, when a Manhattan fashion student collapsed in a city subway station. An autopsy found a blood clot had moved into the victim’s lung, and the medical examiner ruled that the clot was a side effect of the birth control device. FDA records show that seventeen patch users between the ages of 17 and 30 have suffered fatal heart attacks, blood clots and possible strokes since August 2002.

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. The incidence of blood clots in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in women taking oral contraceptives.

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.

Prior to approval, the FDA medical review expressed concerns about Ortho Evra causing venous thromboembolisms, stating: “Post-marketing surveillance for DVT (Deep Vein 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.”

Ortho Evra was approved by the FDA in April 2002, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

Parker & Waichman, LLP, the legal firm representing the woman, is soliciting any women who may have been adversely affected by using Ortho Evra. They can be contacted at their web site:

See related coverage:
  FDA Reveals 17 Fatalities in Two Years from Contraceptive “Sex Patch”
  18 Year-Old New York Student Dies Suddenly from Birth Control Complications



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