A new lawsuit was filed in federal court regarding the safety of the popular but controversial birth-control patch Ortho Evra. In the suit, Idaho’s Katy McKellips Braman, who was 17 when she was first prescribed the patch in 2004, claims that Johnson & Johnson and drug company Ortho McNeil failed to sufficiently test the patch before putting it on the market and that they knowingly misled consumers about the risks of the patch when compared to other birth-control alternatives. Braman’s suit is one of hundreds that have been filed throughout the United States.
Braman alleges that she developed deep vein thrombosis, a serious and potentially fatal blood-clot condition, in her left leg because of her use of Ortho Evra. She had been using the drug for little more than a month when she noticed pronounced swelling in the leg, which gradually worsened over the course of days. The condition required hospital treatment and has forced her to take anti-clotting medications on a daily basis. She is suing the companies for damages and all future medical costs related to the condition.
Only last month, the Food and Drug Administration added a warning to the Ortha Evra label, notifying consumers of the increased risks of clotting in legs and lungs for the patch as opposed to the pill. The patch works by releasing estrogen and progestin into the blood. Since it is applied only on a weekly basis, it contains significantly more hormones than more traditional forms of birth control–making the risk of side effects more severe. Last year, there were nearly 9.5 million prescriptions written for Ortho Evra.
In April of this year, the New York Post reported that “women who suffered life-threatening blood clots and strokes on the Ortho Evra birth-control patch have been receiving cash settlements from the manufacturer.†In September, the Post said that “FDA records, obtained by The Post under the Freedom of Information law, show that 17 patch users, ages 17 to 30, suffered fatal heart attacks, blood clots, and possible strokes since August 2002†and added that “scores of other women using the Ortho Evra patch have suffered complications, including 21 ‘life-threatening’ cases of blood clots and other ailments, according to Food and Drug Administration reports obtained by The Post.â€
Johnson & Johnson reported in an SEC filing earlier this year that roughly 500 women had filed suit against them over the patch. Earlier today, the company announced profits of more than $2.7 billion in the third quarter alone, on revenues of $13.3 billion. However, hormonal contraceptive sales declined by 4 percent, largely because of the safety issues related to the patch.
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