Ortho Evra Recall Petition: Still No FDA Response

Austin Kirk

By Austin Kirk
Posted June 1, 2009


More than one year after the consumer advocacy group Public Citizen petitioned the FDA to issue an Ortho Evra recall, the birth control patch remains on the market and many healthy young women continue to be exposed to a risk of serious and potentially fatal blood clots, which could result in a heart attack, stroke, pulmonary embolism, deep vein thrombosis or other injury.

On May 8, 2008, the Public Citizen Health Research Group filed a petition on behalf of 80,000 consumers urging the FDA to recall Ortho Evra within six months, pointing to problems with the birth control patch which result in greater variations of estrogen entering the blood stream. On average, the Ortho Evra birth control patch delivers 60% more estrogen than the birth control pill, which could lead to twice the risk of serious blood clots, which typically develop in the legs and could travel to the lungs and cause otherwise healthy women to die.

FDA has not taken any publicized action in response to the recall petition, and the birth control patch is still being marketed with warnings that many believe are inadequate in light of the risk of Ortho Evra side effects.

Unfortunately, it is not unusual for the FDA to take a year or more to act on a public health concern highlighted by Public Citizen.

In August 2006, Public Citizen petitioned the FDA to add a black box warning about potential tendon rupture side effects of Levaquin and other similar antibiotics. After the FDA failed to take any action on their petition after two years, the consumer advocacy group filed a lawsuit against the FDA in February 2008, and warnings nearly identical to those requested by Public Citizen were finally added in July 2008.

Similarly, Public Citizen filed a petition with the FDA in January 2008 asking for stronger warnings about potential Botox side effects, in which the toxin could spread from the injection site, causing breathing, swallowing or swelling problems that could be life threatening. It was not until April 2009 that the FDA announced that they were adding the requested “black box” warning.

Although prescriptions for Ortho Evra have fallen dramatically over the past five years due to concerns about the risk of birth control blood clots, it is still used by many women, with about 2.7 million prescriptions in 2007.


The Ortho Evra lawyers at Saiontz & Kirk, P.A. represent women throughout the United States who have suffered a serious injury as a result of the birth control patch. For women who have experienced a heart attack, stroke, pulmonary embolism or deep vein thrombosis, compensation may still be available through an Ortho Evra lawsuit.

To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.

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