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Misty Liebert had been using a new birth control product for three weeks when she awoke at 2 a.m. on March 22 choking and gagging.
At first, she was more bewildered than scared.
"I'm 27 years old, perfectly healthy and up to this point had never had a primary care physician because I never get sick," said Liebert, who didn't even feel bad then.
Her episode was traced to two treatable blood clots in her left lung.
What she soon learned is that hundreds of women across the country have experienced identical or similar symptoms in recent years. Some cases led to strokes, some led to fatal blood clots in their lungs -- pulmonary embolism.
The women had one thing in common: All had been using a birth control product called NuvaRing.
After a St. John's Hospital doctor ruled out the possibility that Liebert had a genetic or acquired risk of developing blood clots, he said they likely stemmed from use of NuvaRing.
"You go through the emotions of being worried, and then thankful that everything's OK," she said. "And then you start getting angry and don't want this to happen to other women."
"I have been telling any woman I know and see," she said. "I'm not sure why anyone would stay on it after hearing my story."
A no-pill solution
Unlike the one-a-day birth control pill, NuvaRing is a transparent, flexible vaginal ring that provides monthlong birth control. It's available by prescription only.
Once a woman inserts it against her cervix, the 2-inch diameter ring releases a continuous, low dose of estrogen and progestin for 21 days. She removes it for her menstrual period to begin, then inserts a new one several days later.
NuvaRing is as effective as other oral contraceptives, according to drug-maker Organon. One to two women in 100 using NuvaRing over a year will get pregnant, it said.
So Organon markets NuvaRing on the convenience factor: Birth control for busy gals who want protection and spontaneity, but can't -- or don't want to -- remember to take a pill every day.
Benefit versus risk
All medicines carry health risks, experts say. And the use of any combined oral contraceptive has long been associated with increased risk of blood clots.
NuvaRing maker Organon also warns on its product label that the product may cause mild to serious complications including increased risk of blood clots, heart attack and stroke.
Women who smoke, or have cardiovascular disease, blood clots or certain types of cancer should not use NuvaRing, the company advises.
Some studies lead researchers and consumer advocates to believe that NuvaRing carries higher risks for complications than oral contraceptives. Organon says other studies refute that.
Dr. Mitchell Creinin, director of gynecology at Magee Women's Hospital, University of Pittsburgh, is one of a small group of physicians who are fellowship-trained in family planning. He does a lot of work for the American College of Gynecologists.
"All birth control methods containing estrogen have a risk of developing blood clots in the leg or strokes, but those risks overall are extremely low, and lower than the risk of pregnancy itself," he said.
The risk of developing a blood clot during pregnancy is 60 women per 100,000. The risk of getting a blood clot while on estrogen-containing oral contraceptives is 10 to 30 per 100,000, he added. (He said NuvaRing has half the estrogen as the pill, but the risk is within that range.) For comparison sake, he said, the risk of dying in a car accident is 16 per 100,000 people.
"The ring can definitely be a causative factor" in cases like Liebert's, he said. "Very, very likely it did, and it's sad. I wish it didn't happen to anybody."
But he added, "Our society tends to be an all-or-nothing society. We all want it perfect, or it's somebody's fault. These are the choices we make. There are different options for birth control, and there are variable risks with many of them."
"If something happens to one in 100,000 people, somebody's got to be that one," he added.
Nonprofit health research group Public Citizen isn't satisfied with the risk. In February 2007 it petitioned the U.S. Food and Drug Administration to ban oral contraceptives that contain desogestrel. It's a synthetic compound the group believes heightens risk.
While the FDA has ordered stepped-up warnings in NuvaRing package inserts in past years, it hasn't imposed a ban.
When asked about NuvaRing concerns, FDA spokeswoman Rita Chappelle reiterated the link between blood clots and the use of estrogen plus progestin hormonal contraception such as birth control pills, patches and intravaginal products.
"FDA is continually monitoring post-marketing safety data for all approved drugs, including hormonal contraceptive products," Chappelle said. "Should our review of the safety data indicate that a change in labeling is needed, we will take appropriate action."
But many families aren't willing to wait.
NuvaRing lawsuits
Across the country, at least 150 lawsuits have been filed on behalf of injured or dead women whose families blame NuvaRing. None are believed to have been settled yet.
One St. Louis case involves Dana Jenn, a fit 40-year-old who was training to run a marathon, said attorney Kristine Kraft.
Jenn began using NuvaRing in June 2005 and died one month later. She was running on a treadmill, lost her breath and collapsed. Cause of death was a pulmonary embolism due to deep vein thrombosis -- a blood clot from a deep vein in the body that traveled to the lungs and blocked blood flow, court records show.
New York attorney Paul Rheingold, with one of three law firms partnering on multiple NuvaRing lawsuits, describes others: A young woman who lost a leg due to a deep vein thrombosis; about 25 stroke victims with permanent damage, a 17-year-old first-time user who suffered a deep-vein thrombosis, an otherwise healthy 14-year-old teen who died while on NuvaRing.
"It's one product tragedy after another," Rheingold said.
Liebert says she's considering her legal options. For now, she's warning every woman she knows about the product.
'I was freaking out'
Misty and Adam Liebert were ready to resume birth control after their son Braxton neared 16 months old. She talked to her gynecologist about birth control options including NuvaRing. The doctor said patients had not complained about adverse effects, she said.
Liebert had been using it only three weeks when she awoke that early Saturday coughing up blood. She didn't feel sick, and disregarded it as a fluke.
The next wave hit that night at 8:30 p.m., with her husband at work in Branson, her son crying for comfort and her parents out of town.
"I felt something coming up in my throat." This time was worse, each wave causing her to throw up "large amounts" of blood. "At this point I was freaking out."
Liebert called her in-laws in Ava, who alerted an ambulance before they sped to Springfield.
At St. John's Hospital emergency room, she underwent medical history questions, blood tests, X-ray and a CT scan -- or computed tomography -- which uses X-rays to make detailed pictures of structures inside the body.
All those and subsequent tests ruled out a genetic disorder or underlying medical problem that would put her at risk of developing blood clots, said St. John's Dr. Albert Leonardo.
The most common cause of coughing up blood in a healthy nonsmoker is an upper respiratory infection, said St. John's Dr. Ted McMurry.
A radiologist who read the CT scan identified what he believed to be signs of infection, and Liebert was eventually discharged with an antibiotic. She was to follow up with a primary care doctor who could refer her to a specialist if necessary.
At home that day, she had two more episodes. Meanwhile at the hospital, a second radiologist reviewing Liebert's CT scan as part of quality control identified signs of a blood clot in her lung. She was called back to the hospital immediately and admitted.
Another test confirmed she had two blood clots in her left lung, another blood test ruled out any predisposition to develop blood clots.
Knowing all that, the use of NuvaRing likely caused Liebert's blood clots, said St. John's Dr. Albert Leonardo. While he's never treated a woman with mild or serious effects while using NuvaRing, he has treated women with problems from other forms of hormone-based contraception.
Liebert will be on a blood thinner for three to six more months. She just completed a round of self-injections with a drug to help her body absorb the clots.
Dr. Leonardo said Liebert had a small embolism, and given she has no underlying medical problems, she should have no long-term ill effects from the incident.
After four days in the hospital, Liebert went home and began her own research.
She was shocked by the number of stories by women and their families who believed the use of NuvaRing had caused their blood clots, strokes and deaths of loved ones.
"Some made me cry. It's like -- 'I'm reading my story.' A 28-year-old woman was perfectly healthy and wound up spending 10 days in the hospital. Some women have worse cases, some aren't as bad as mine," Liebert said. "Women have died."
Liebert stopped using the NuvaRing in the hospital and won't go back to oral contraceptives, she said.
Her mission now: "I'm just starting to spread the word. I feel it's very important for women to know."
While healthy women like her apparently have had problems, she said, "There are women out there I'm sure have a predisposition to blood clots."
Even worse, she said, "There are probably other women out there having problems and just don't even know the cause of it," she said.
"It's scary. Every day, a new woman goes on this."