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BOISE, Idaho (AFX) - A teen who developed a serious blood clot problem after using a popular birth control patch has sued Johnson & Johnson and drug maker Ortho McNeil in federal court.
The lawsuit over Ortho Evra is one of hundreds filed nationwide, company officials said.
Katy McKellips Braman was 17 when she was prescribed the Ortho Evra patch in 2004, according to the lawsuit. She had been using the patch for just over a month when she noticed swelling in her left leg that became worse over the next few days, her lawsuit said.
Doctors at Magic Valley Regional Medical Center diagnosed her with deep vein thrombosis -- a condition characterized by leg vein blood clots that can break off and travel to the lungs, sometimes with deadly consequences.
Braman was admitted to the hospital for about four days to treat the condition and now must take several drugs every day to keep her blood from excessively clotting, according to the lawsuit. Because of the condition, the lawsuit contends, she is also unable to ever take estrogen-containing medications including birth-control pills or treatment for menopause or hormonal imbalances.
Braman contends that Johnson & Johnson and Ortho McNeil rushed the Ortho Evra patch to consumers without doing adequate testing to see if the product was safe, and that the companies misled customers into thinking the patch simply posed the same risks and benefits that other birth control methods offered.
The teen is asking that the companies be ordered to pay damages in an amount to be proven at trial and that they pay for her ongoing medical monitoring and treatment.
Julie Keenan, a spokeswoman with Ortho McNeil's women's health and neurology department, said the company could not comment on pending litigation. Officials with Johnson & Johnson, New Brunswick, N.J., did not immediately return calls from The Associated Press requesting comment.
Last month, the Food and Drug Administration updated the label on the Ortho Evra birth-control patch to warn women that their risk of blood clots in the legs and lungs may be higher if they use the patch instead of the pill. Last year, an investigation by The Associated Press, citing federal death and injury reports, found higher rates of blood clots in women using the patch. Copyright 2006 Associated Press. All rights reserved. This material may not be
Copyright 2006 AFX News Limited. All Rights Reserved.