Weitz & Luxenberg Lawyer Echoes Concern Over Third Warning on Ortho Evra Label

FDA includes results of additional study citing serious blood clot risk. Lawyer Ellen Relkin comments.

Mounting scientific evidence indicating the Ortho Evra contraceptive patch increases the risk of developing serious blood clots in users, has led the U.S. Food and Drug Administration (FDA) to add a new bolded warning to the product’s label.

This is the third time the label has been modified to include information on this health risk.

The FDA approved the label changes on January 18, 2008, in response to research findings from the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson & Johnson, maker of Ortho Evra Contraceptive Transdermal Patch.

The study followed users aged 15-44, finding a higher risk in those women of developing serious blood clots, compared to women using birth control pills. Those particular clots, known as venous thromboembolisms (VTEs), can travel to the lungs and cause a deadly pulmonary embolism.

Ellen Relkin, a lawyer with the Weitz & Luxenberg P.C. Drugs and Medical Devices Litigation unit, said, “The warning is too little and too late. This product is substantially more dangerous to women than oral contraceptives and other birth control methods and it is hard to fathom why Johnson & Johnson does not just remove the patch from the market. We have seen tragic occurrences of death and devastating injury to young women on the patch.”

Relkin has been at the forefront of Ortho Evra litigation, having been appointed in July 2006 as the State Court Liaison in the Ortho Evra Multi-District Litigation (MDL) by the Honorable David Katz of the United States District Court for the Northern District of Ohio. Previous to that she was appointed to the Executive Committee of the Steering Committee of the Ortho Evra Multi-District Litigation in May 2006. She is also lead counsel in the New Jersey Ortho Evra litigation.

The warning followed reports out of Canada last week of two deaths, one heart attack and 16 cases of blood clots since 2004 among women who used the patch, according to Forbes. This is not the first time, however, the FDA has had to warn women of the dangers of Ortho Evra.

In September 2006, the Agency was forced to amend the label after a study conducted by i3 Ingenix showed that women using the patch faced twice the risks of clots than did women on the pill. The FDA added language to the label warning users they are exposed to about 60 percent more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. High levels of estrogen can significantly increase the risk of developing blood clot, heart attack and stroke.

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FDA Warning, 1.18.08

FDA: Ortho Evra Users at Higher Risk for VTE and Pulmonary Embolism
FDA Changes Ortho Evra label after second study cites pulmonary risk

Updated FDA Warnings

FDA Continues to Update Warnings to Label of Ortho Evra--attorney info
Read on for information regarding Updated FDA Warnings to Ortho Evra

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