Ortho Evra
October 13, 2006Lawsuit in Texas shows risks of Ortho Evra birth control patch
The first Ortho Evra lawsuit was filed in Austin, Texas in October 2004 on behalf of a woman who suffered a stroke and became paralyzed after wearing the patch for just 12 days. It cited records from the Food and Drug Administration that between May 1, 2002 and April 30, 2003, almost 50 women who were using the patch had died or suffered injuries related to blood clots.In the same time period, the Ortho Evra lawsuit says, just half as many women on birth control pills had suffered clots even though six times more women were on the pill. In addition, women on the patch had 11 times more fatal or life-threatening clots as compared with those taking the pill.
Nevertheless, the FDA waited almost two more years—until November 10, 2005—to change the label warning women who used the patch of their exposure to 60% more estrogen than those on birth control pills. The agency stated that exposure to higher levels of estrogen raised the risk of serious Ortho Evra side effects such as blood clots in the legs or lungs, heart attack and stroke.
Most recently, on September 20, 2006 the FDA updated the Ortho Evra birth control patch label on the basis of the results of two studies (both paid for by Johnson & Johnson), supposedly designed to evaluate the risk of serious Ortho Evra side effects, specifically due to venous and arterial blood clots in women using patch.
According to the FDA, the first study found the risk of non-fatal deep vein thrombosis events associated with the use of the patch to be similar to that associated with the use of oral contraceptive pills. However, the results of the second study showed a roughly two-fold increase in the risk of deep vein thrombosis events in users of the patch compared with women using the pill.
By its own admission, Johnson & Johnson will not conduct a head-to-head clinical trial that might show the Ortho Evra patch is more dangerous than the pill. A 2003 internal memo showed that the company refused to fund a study comparing the Ortho Evra birth control patch with its Ortho Cyclen pill because of “too high a chance that the study may not produce a positive result for Evra” and a “risk that Ortho Evra may be the same as or worse than Ortho Cyclen.”