Ortho Evra makers sued over blood clots
Woman says she developed deep vein thrombosis after using the birth control patch
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Johnson & Johnson and drug maker Ortho McNeil are being sued in federal court by a teen who developed a serious blood clot problem after using the popular birth control patch, Ortho Evra. The suit is one of hundreds filed nationwide.
According to the lawsuit, Katy McKellips Braman was 17 when she first began using the Ortho Evra patch in 2004 and had been using the patch for about a month when she noticed swelling in her left leg that worsened over several days.
Doctors diagnosed Braman with deep vein thrombosis. If a piece of the blood clot were to break off and travel into her bloodstream, it could become lodged in the lungs and block blood flow, which could prove fatal.
Braman was in the hospital for about four days and must now take several drugs daily to keep her blood from clotting. She is also unable to take estrogen-containing medications, including birth control pills or treatment of menopause or hormonal imbalance, for the rest of her life because of the condition.
The teen said in the lawsuit that Johnson & Johnson and Ortho-McNeil cleared the patch to consumers without adequate testing to make sure the product was safe and that the companies misinformed consumers into thinking the risks and benefits of the patch were the same as other birth control options.
The suit asks that the companies be ordered to pay damages and pay for Ms. Braman’s ongoing medical monitoring and treatment.
In September 2006, the Food and Drug Administration modified the Ortho-Evra birth control patch label to warn women about the elevated risk of blood clots in the legs and lungs if they use the patch instead of the pill. In 2005, an investigation found higher rates of blood clots in women using the patch.
Source: Rebecca Boone, “Woman sues drugmaker over blood clots,” October 17, 2006.

