Hilary was one of the lucky ones - she survived the ordeal but many others did not.
Parents of a 14-year-old girl who died in May, 2004 sued Ortho-McNeil Pharmaceutical for failing to warn people sooner about serious side effects from using their birth control patch. The lawsuit said that Alycia Brown died of blood clots after using Ortho Evra. Unfortunately it took tragedies like this for the company to finally warn users about the dangerous, and often fatal, side effects.Many lawsuits in the U.S. have subsequently been filed against Ortho-McNeil and its parent company, Johnson & Johnson, for injuries and deaths allegedly caused by the patch. Most victims are young: the 14-year-old is the youngest known victim and about a dozen users who died of clot-related complications in 2004 were in their late teens and early 20s.
But victims of the Ortho Evra Patch are not all that young: Samantha Eastham was 35 years old when she suffered a pulmonary embolism that left her with only 50 percent lung capacity, "All because I was on the Ortho Evra patch for less than three months," says Samantha. "I had never smoked, never drank alcohol or taken drugs, and now I was dying."
In July 2005, The Associated Press first reported that patch users die and suffer blood clots at a three-times-higher rate than women taking the pill, due to higher than expected levels of estrogen maintained by the Ortho Evra patch.
In the same month, ten women filed a lawsuit in New York alleging that the Ortho Evra patch is "dangerously designed" and "unreasonably dangerous." The women's ages ranged from 18 to 47 and all suffer debilitating long-term health problems as a result of the patch, in particular life-threatening blood clots that can lodge in the veins of the legs or lungs, and less frequently, in the arteries of the heart (heart attack) or brain (ischemic stroke).
In another report that followed shortly afterward, the Associated Press stated that "Documents released to attorneys as a result of that litigation show Ortho McNeil has been analyzing the FDA's death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill.
Furthermore, AP reported that an internal Ortho McNeil memo showed that in 2003, the company refused to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was 'too high a chance that study may not produce a positive result for Evra' and there was a 'risk that Ortho Evra may be the same or worse than Ortho-Cyclen.'
But it wasn't until November, 2005 that the Food and Drug Administration approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. The FDA also recorded that seventeen patch users between the ages of 17 and 30 suffered fatal heart attacks, blood clots, and strokes since August 2002.
In 2004, the drug accounted for more than 9.9 million prescriptions with sales topping $411 million.