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.
But Merck and other scientists dispute claims that NuvaRing poses a higher risk than other contraceptives. In NuvaRing's product information pamphlet, Merck acknowledges the findings, but adds, "Data from additional studies have not shown this twofold increase in risk. It is unknown if NuvaRing has a different risk of [blood clots] than second-generation oral contraceptives." That position infuriates NuvaRing's critics. "Nine years after the product was put on the market, they still say the risk is unknown. To say, 'We just don't know' is not sufficient," says Thomas Lamb, a North Carolina — based attorney whose firm represents more than 50 women around the country who have filed suit against NuvaRing, Yaz, and other third- and fourth-generation contraceptives.
Among those wanting answers is Robert Bozicev, 37, of Tom's River, New Jersey. His 32-year-old wife, Jackie, had begun using NuvaRing shortly after the birth of their daughter in 2007. One Friday morning, as he stood in the kitchen making breakfast for their two kids, he heard her puttering about in their second-floor bathroom. As she was about to step into the shower, she called his name. He answered her, preoccupied with their son, 2, who was demanding another waffle. After she cried for him a second time, barely able to get out his name, he dashed upstairs and found her on the floor, unable to breathe. "She was in a lot of pain, rolling around, trying to get onto her stomach," he says. "My son was there, watching the whole thing." To his horror, Jackie started turning blue.
When an ambulance arrived, emergency techs tried to restart her breathing. Bozicev was gripped with terror. Doctors continued to try to revive her in the hospital but eventually had to give up. She died that day. The cause of death: massive pulmonary thromboemboli due to deep vein thrombosis. In other words, she died from a blood clot. Anxious to learn more about what had happened, Bozicev searched online and came upon reports linking NuvaRing to an increased risk of clots. Knowing Jackie had been healthy before she started using the device (she wasn't overweight and didn't smoke), Bozicev concluded that NuvaRing was to blame, and filed a wrongful-death suit against Merck in March 2008. "Even to this day — and this is three and a half years later — I still can't believe it happened," he says. Jackie's clothes remain in her closet. He is too heartbroken to take them out.
NuvaRing isn't the only pill-free contraceptive beset by litigation. When Ortho Evra hit pharmacy shelves in 2002, it was the first birth-control patch of its kind. Its selling point: Simply slap a Band-Aid-like adhesive on your arm, stomach, or back each week. Within two years, sales had swelled to nearly $400 million. But soon after, studies emerged indicating that the blood concentrations of estrogen in Ortho Evra users might be much higher than previously thought, resulting in a greater risk of clots. That's when the lawsuits piled up. In November 2005, Ortho Evra, under an agreement with the FDA, added a black-box warning to its packages stating that patch users are exposed to roughly 60 percent more estrogen than the typical pill user, resulting in a potential "approximate doubling of risk of serious blood clots." The warning also stated that the risk might not increase at all, but it was still enough to scare off doctors. By year-end 2010, Ortho Evra's sales had fallen 69 percent to $124 million.