Stephanie Rosfeld was a twenty-five year old mother, a volleyball coach at the University of Cincinnati, a healthy, active young woman just returning from maternity leave, and among the fifty or more women who died as a result of using Johnson & Johnson’s birth control patch, Ortho Evra. No one who knew her could have predicted it, but executives at Johnson & Johnson probably could.
How could they have seen this tragedy coming? Because even before the FDA approved Ortho Evra, Johnson & Johnson knew that the patch’s method of delivering hormones to the bloodstream was giving women a much higher dose of estrogen than low dose birth control pills do.
Estrogen, as many people know, is the primary female sex hormone. Many women take estrogen supplements both as a form of oral contraception – often paired with progesterone – or in hormone replacement therapies. What fewer people know is that higher levels of estrogen increase the likelihood of blood clots and stroke, even in healthy women.
Over the past several years a growing body of evidence has connected female hormonal birth control to these increased risks of heart attack and stroke. These risks are higher in women over thirty-five, smokers, and those with other cardiovascular risks like high blood pressure.
Johnson & Johnson knew all this, and new from their own research that Ortho Evra carried too high of a risk for blood clots, and rather than halting its production, they hid the results. In fact, the company misreported their results by 40 percent.
The FDA were troubled when they reviewed the results of Johnson & Johnson’s clinical trials because there seemed to be troubling discrepancies in the research. However not knowing that the results had been willfully doctored to misrepresent the safety of the drug, they approved it for use in 2001.
Once Ortho Evra was on the market, Johnson & Johnson’s dishonesty only continued. The company avoided further research, including refusing to conduct comparison trials against the oral contraception, Ortho Cyclen. Internal memos sent within the company reveal that the reason for this refusal was “too high a chance that study may not produce a positive result for Evra” and fear that “risk that Ortho Evra may be the same or worse than Ortho Cyclen.”
Between 2002 and 2006, the FDA received reports of fifty deaths which were linked to the use of the Ortho Evra patch. Yet despite Johnson & Johnson having paid out over $68 million in settlements with hundreds of women who suffered from the increased averse side effects of this drug, Ortho Evra is still sold in the United States without even a black box warning.
If you or someone you know has been injured because of a bad product, it is essential to find a skilled attorney and protect your own health and rights as soon as possible. Contact an experienced Atlanta personal injury attorney, call MLN Law at 404-531-9700 and schedule a free consultation.