Colorado Dangerous Drugs & Medical Devices

Ortho Evra birth control patch

Burg Simpson is not currently pursuing new Ortho Evra birth control patch cases.

Burg Simpson has been at the forefront of the Ortho Evra litigation for several years, with multiple attorneys leading the litigation and discovery efforts.

Michael S. Burg, Burg Simpson founder and President, and Janet G. Abaray, Burg Simpson shareholder, were appointed as co-lead counsel for all cases in Federal Court in the national Multidistrict Litigation, by the Hon. David Katz.

Seth A. Katz, Burg Simpson shareholder, served as a leader of the litigation Discovery Committee. Mr. Katz was also elected as Co-Chair of the Ortho Evra American Association for Justice Litigation Group.

ORTHO EVRA® LITIGATION HISTORY

In April 2002, Johnson & Johnson introduced the Ortho Evra Birth Control Patch, which it promoted as being more convenient than “the Pill,” due to once weekly application for three consecutive weeks. Unlike traditional oral birth control, which undergoes first-pass metabolism in the liver, the progestin and estrogen in the Patch are released directly into the bloodstream.

The Patch was marketed to consumers as providing the same safety profile and efficacy as the birth control pill in preventing pregnancy, but with more convenience than birth control pills because it is worn on the skin for three consecutive weeks, with the fourth week being “Patch free.” The aggressive marketing campaign, often describing Ortho Evra as “the Pill in a Bandaid,” resulted in sales of more than $424 million in 2005, based on 9.3 million prescriptions.

However, in November 2005, Johnson & Johnson revised its labeling for Ortho Evra, disclosing for the first time that the Patch exposed women to 60% more estrogen than a 35 microgram birth control pill. Because higher estrogen levels are known to increase the risk of blood clots, which can cause deep vein thrombosis, pulmonary embolism, as well as heart attacks, strokes and even death, the revised label proves that the Patch poses far more danger to women than the Pill.

In fact, this increased exposure to estrogen makes the Patch comparable to the high-dose estrogen forms of the Pill that the FDA required to be removed from the market in 1988.

On September 20, 2006, Johnson & Johnson once again changed the Ortho Evra label and admitted in its revised product labeling that women on the Patch may be at more than twice the risk of developing blood clots in the lungs and legs as women using 35 microgram birth control pills. The data indicating a doubling of the risk of serious blood clots arose from a study sponsored by Johnson & Johnson.

In 2004, about a dozen women, mostly in their teens and early 20’s, died from blood clots believed to be related to their use of Ortho Evra. Dozens more survived strokes and other blood clot related events. The first death known to be associated with Ortho Evra occurred in April 2005, when an 18-year old Manhattan woman collapsed and died in a New York subway station.

 

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