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Women sue birth control patch maker
A lawsuit against J&J, maker of a birth control patch alleges women suffered strokes, blood clots.
July 25, 2005: 7:32 PM EDT

NEW YORK (CNN) - Ten women filed a lawsuit Monday against the maker of a birth control patch, claiming the device caused them to suffer strokes and blood clots, their attorney told CNN.

The lawsuit -- filed in Hudson County, N.J., Superior Court -- alleges that the popular Ortho Evra birth control patch is "defectively designed" and "unreasonably dangerous."

The suit seeks punitive damages against pharmaceutical giant Johnson & Johnson (Research) and its subsidiary, Ortho McNeil, the patch's manufacturer.

Austin, Texas-based plaintiffs' attorney Amy Clark-Meachum said the clients listed in the suit include women ranging from 18 to 47 from Arizona, Arkansas, California, Colorado, Connecticut, Maryland, Mississippi, New Jersey, Ohio and Oklahoma. All have suffered debilitating long-term health problems, they claim, as a result of using the birth control patch.

Plaintiff Amanda Bianchi, 19, of Colorado Springs, Colo., said she has developed a 10-inch blood clot in her brain doctors say is a direct result of the patch she used for just three months in 2004. She suffered two strokes and routinely gets migraine headaches, she said.

"I don't want any other woman to have to go through what I'm going through," Bianchi told CNN. "I don't want them to have to deal with this pain and suffering that I'm going through. It's not fun to have to get up and not be able to go to school and live the life that you were living, you know?"

Michael Beckerich, communications director for Ortho McNeil, said the company had not yet received a copy of the litigation and therefore could not comment on it.

"When used as labeled, Ortho Evra is a safe and effective birth control choice for many women," the company said in a written statement. "The safety of the patients who use our products is our first priority and we take all adverse event reports seriously. We investigate every report of a serious adverse event and closely monitor for any trends in reports that may signal a potential safety issue."

The statement goes on to say that "the types of adverse event reports that have been received for Ortho Evra are consistent with the health risks of other hormonal birth control methods and the Ortho Evra product level."

A spokeswoman for the Food and Drug Administration sent CNN the following statement:

"The FDA is continuing to actively monitor the adverse event reports for the Ortho Evra hormone patch, but believes the evidence indicates the product is safe and effective. If consumers or patients have questions about the risks of blood clots associated with the product, they should talk to their health care provider. The risks of using this product are similar to the risks of using birth control pills, including an increased risk of blood clots, heart attack, and stroke. The data is not precise enough to tell whether there is an increased incidence (with the patch)."

Pfizer's depo-subQ provera 104 birth control drug was approved for added use, click here for more.  Top of page


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