The Ortho Evra Patch was introduced in 2002 and was presented as once-weekly contraceptive as a convenient alternative to daily birth control pills. However, as of November 2005, the FDA had received 21 reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. In 2006, a study was published that demonstrated that women using Ortho Evra were twice as likely to suffer blood clots as those taking oral contraceptives, this study prompted the FDA to mandate a change on the Ortho Evra label to include a stronger black box safety warning.

In its latest update last month, Johnson & Johnson (J & J – manufacturer of the contraceptive patch) said more than 1,500 Ortho Evra lawsuits are queued up in state and federal courts. Most of the plaintiffs suing the pharmaceutical company are claiming: J & J allegedly knew the skin patch had greater safety risks than birth control pills - particularly in the incidence of stroke, and harmful blood clots that could develop in women's legs and lungs. Yet, in 2005, the FDA warned that women using the Ortho Evra Patch were exposed to approximately 60% more estrogen than those who use birth control pills, and that high levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries.

A letter (under protective order), written a J & J product-safety executive in 2005 was just made public on Aug. 25 by New Jersey Superior Court Judge Bryan Garruto (who oversaw 309 Ortho Evra lawsuits). The executive, whose name was removed from the letter, warned Chief Executive Officer William Weldon that J & J improperly claimed its Ortho Evra Patch posed a low safety risk to women. The author of the letter explained that J & J conducted 2 studies and emphasized ‘partial and incomplete’ results of the one that found the patch no riskier than birth control pills. According to the letter, this executive resigned stating that the company's conduct undermined his ability to evaluate product safety.

Gloria Vanderham, a spokeswoman for Ortho Women's Health & Urology unit (a division of J & J's Ortho-McNeil Pharmaceutical Inc.) is claiming that during his time with the company, this executive "continuously communicated that Ortho Evra was safe and effective when used as labeled and communicated this to the company and the Food and Drug Administration.”

Johnson & Johnson is denying these claims and has consistently maintained that the Ortho Evra patch is a “safe and needed” form of birth control if used according to its label. As now, no Ortho Evra case has gone to trial. However, the first is set to begin in state court in Manhattan on Nov. 19. Survivors of Zakiya Kennedy, who was 19, blame her death on April 2, 2004, on her use of the contraceptive patch.

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