Is Your Birth Control as Safe as You Think?
Since NuvaRing hit the market, more than 700 women have filed lawsuits, claiming it has caused potentially life-threatening blood clots. The battle may change the way millions of women prevent pregnancy.
By Laura Beil
Christen Childs woke up on September 12, 2009, in the pitch dark of early morning with what she thought was a pulled muscle in her leg. She reached down to massage the cramp, trying to fathom how her left calf could be so achingly sore when she hadn't made it to the gym in weeks. This was a Saturday — by Monday, her leg was swollen and hot, and when she tried to stand, jolts of pain shot up to her spine. She consulted her brother-in-law, a doctor, and he told her to go to the ER immediately. He suspected what an ultrasound would confirm: Childs, 26, had a blood clot in her leg — left untreated, it could kill her. "When the doctor diagnosed me, I started crying," she says. "I was stunned by how close I had come to dying."
Death would come closer still. Later that day, the clot broke apart and traveled to her lungs. Straining to breathe, she remained bedridden in the intensive-care unit as blood thinners were injected into her stomach four times a day for six days. By the following weekend, she was released, instructed to return weekly for hematology checks to make sure new clots hadn't formed. Meanwhile, her doctors ran a battery of tests to figure out what exactly went wrong. After all, Childs didn't have any of the risk factors associated with blood clots: She didn't smoke, wasn't overweight, and had no family history of clots. After six months on blood thinners, Childs was finally back to her old self, with one exception: Her doctors wouldn't let her go back on NuvaRing, her birth control, which they determined was the likely culprit behind her near-fatal illness.
NuvaRing is one of the world's most popular forms of non-pill birth control, and recent data indicates that more than 5.5 million prescriptions were written in the U.S. in 2010, according to IMS Health, a health-care information company. But in recent years, serious questions have arisen concerning its safety. To date, almost 1,000 cases of possible NuvaRing-related blood clots have been reported to the FDA, and more than 700 women in the U.S. are currently suing Merck, NuvaRing's manufacturer, for downplaying its health risks. Most of those lawsuits have been consolidated into a massive, multidistrict federal case that's expected to go to trial in Missouri next year. The NuvaRing case is being closely watched by physicians and the pharm industry. If the litigants persuade a jury that Merck undersold the device's risk for blood clots — a big if, to be sure — it could have far-reaching consequences for several contraceptives on the market.
• When it was approved by the FDA in 2001, NuvaRing became the world's first vaginal birth-control ring. Inserted just once a month, it dispenses hormones directly into the bloodstream. Unlike oral contraceptives, which require taking a pill the same time every day, NuvaRing is marketed as a pill-free, no-muss/no-fuss alternative. Just pop it in and forget about it (the ring remains in for three weeks and comes out for a week during your period). That pitch clearly resonated with women. Last year, NuvaRing generated $559 million in international sales for Merck.