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ORTHO EVRA was approved by the Food and Drug Administration (FDA) in November 2001. It was the first contraceptive product to be approved as a skin patch. In 2004, the drug accounted for more than 9.9 million prescriptions with sales topping $411 million. The drug is sold by Ortho-McNeil Pharmaceuticals, Inc., a division of Johnson & Johnson Company.

The statistics speak volumes about who is responsible for the problems of heart attack and stroke associated with ORTHO EVRA, and why class action lawsuits have been filed.

The FDA has logged 9,116 reports of adverse reactions to the ORTHO EVRA birth control 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, deaths and strokes have been associated with ORTHO EVRA birth control patch, whereas only 17 such reports were linked to the birth control pill during a similar time period.

Coincidentally in October 2005, Bayer HealthCare and Ortho-McNeil Pharmaceutical, Inc. announced that they have concluded an agreement to jointly develop and market a new drug for the prevention and treatment of thrombosis. (Thrombosis is the technical term for blood clots.) The drug called BAY 59-7939 is currently undergoing Phase II clinical trials. Phase III clinical trials will assess its effectiveness in the prevention of venous thromboembolism (VTE) and will be initiated in the next weeks. This may help prevent the problem of stroke associated with ORTHO EVRA, but to date there are no studies to support this. You should ask you doctor whether this could prevent a stroke associated with ORTHO EVRA.

With 9.9 million prescriptions the numbers of women with extreme complications leading death are just starting to receive media exposure. In July 2005, a young, healthy married mother of two children experienced shortness of breath and died the next day. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting, and convulsions. It is no wonder that ORTHO EVRA class action lawsuits have been initiated and invidivudal claims have been brought.

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 will be exposed to up to 60% more estrogen than they would be exposed to if they were taking birth control pills. The patch is only intended to deliver 20 micrograms of estrogen. Throughout the medical community, it is a well-known fact that increased exposure to estrogen greatly increases the risk of blood clots, which can cause further serious injury or death.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with ORTHO EVRA birth control patch before the drug was approved and when approved -- the company failed to adequately warn patients about these risks.

If you or a loved one has been experienced problems from using the Ortho Evra Birth Control Patch, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation.

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