(CNN) — Depending on the outcome of a federal lawsuit, more women having early miscarriages could end up like Melissa Novak: septic, in the hospital and needing emergency surgery to survive.
“We didn’t know if she was going to live or die,” said Novak’s husband, Stewart Day.
Novak had a miscarriage in March and was prescribed only one of the pills in a two-pill combination approved by the US Food and Drug Administration for women in her situation. Although the medication she took, called misoprostol, can help a woman have a complete and safe miscarriage, it’s not approved by the FDA to do so, and studies show that it’s less effective than when used in combination with the second drug, mifepristone.
Plaintiffs in the lawsuit are seeking to ban access nationwide to mifepristone. If they are successful, more women who need medication for miscarriage care will, like Novak, take only misoprostol.
Obstetricians are “very worried,” said Dr. Erika Werner, a spokesperson for the Society for Maternal-Fetal Medicine. The concern is that if medication for miscarriage doesn’t work, patients will end up having surgeries they hadn’t anticipated.
“More women are going to have unnecessary surgeries. More women are going to have complications,” said Werner, who is also chair of obstetrics and gynecology at Tufts Medical Center.
At a hearing this month, a three-judge panel on the US 5th Circuit Court of Appeals showed sympathy for the arguments put forward by the plaintiffs, anti-abortion physicians and groups who are challenging the FDA’s approval of mifepristone 23 years ago.
A decision from the circuit court is expected in the coming weeks, and the case will eventually head to the US Supreme Court.
Dr. Christina Francis, chief executive officer of the American Association of Pro-Life Obstetricians and Gynecologists, one of the plaintiffs in the case, told CNN that “medical management of miscarriage with misoprostol has been standard of care for decades.”
“It is vital that patients being treated with misoprostol for miscarriage management have a close follow-up scheduled to ensure that they have completely passed all pregnancy tissue and to determine whether additional treatment is needed. Women deserve the highest quality of reproductive healthcare, especially when faced with a situation as emotionally and physically traumatic as miscarriage,” Francis added.
A New Year’s Eve kiss
Melissa Novak first spotted Stewart Day when he was standing at a beer cart at a New Year’s Eve festival in Fort Lauderdale in 2007.
“I saw him, and I was like, ‘he’s very attractive,’ and I tried to do a little dance to see if he would check me out, and he did a little bit,” Novak said.
Three hours later, her friends asked her whom she’d be kissing at midnight, and she remembered the cute guy at the beer cart and found him again.
“We kissed on New Year’s, and we haven’t been separate since,” said Novak, now 39.
“We haven’t stopped talking,” added Day, now 42.
Novak, a social worker and sex therapist, and Day, an accountant, married on New Year’s Day three years later and, after a move to Chicago, settled in Atlanta.
They were thrilled this year when they found out Novak was pregnant. Day, who always wanted a big family, ran to the store at all hours to get his wife soup, her only craving. They started to think about which room in their home they’d convert into a nursery and how they would decorate it.
Their obstetrician scheduled an ultrasound at eight weeks.
“That was my first time in an ultrasound room, and the technician got it all set up and then just kind of looked at Melissa, and you could just kind of feel the mood in the room just sort of deflate,” Day remembers.
The ultrasound showed that the fetus had no heartbeat. Novak had had an early miscarriage.
Studies show advantages of drug combination
Early miscarriages are common, according to the American College of Obstetricians and Gynecologists, which estimates that 10% of all clinically recognized pregnancies end in an early loss. After a fetus dies, it’s common for patients to need medical help to clear the tissue – sometimes referred to as “terminating” a pregnancy.
Several studies have shown that the combination of mifepristone and misoprostol is more effective at terminating an early pregnancy than misoprostol alone.
One report looked at several studies and concluded that the combination of mifepristone and misoprostol was 95% to 98% effective. That report was published in 2006 in the journal Contraception.
Another report detailed studies on a total of 12,829 people who received only misoprostol, and in 78% of the cases, the pregnancy was terminated completely without the use of surgery or additional medicine. The authors of the study, published this year in Contraception, noted that this was “a substantially lower proportion than the approximately 95% expected after the use of mifepristone and misoprostol” together.
Another study was a clinical trial in which doctors in the US randomly assigned 300 women with an early pregnancy loss to receive misoprostol either alone or in combination with mifepristone. Among those receiving the combination, 84% had a complete expulsion of the pregnancy, and among those receiving misoprostol only, 67% had a complete expulsion.
The authors, writing in 2018 in the New England Journal of Medicine, concluded that the drug combination “resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone.”
Francis, the anti-abortion activist and plaintiff in the federal litigation, pointed to another study in NEJM, also a clinical trial, that found that of 491 women who received misoprostol alone after early pregnancy failure, 84% had complete expulsion within eight days.
‘How in 2023 can this happen to us?’
When Novak had her miscarriage in March, she says, her obstetrician explained her options: have surgery, called a D&C, to remove the pregnancy or use medication to help the miscarriage along.
Novak chose to have medication, and her doctor prescribed misoprostol – alone, not in combination with mifepristone.
Nine days after taking the medicine, Novak spiked a fever.
Thinking she had just caught a cold from her nephews, Novak took Advil, felt better, got in her car and went out on errands.
Two hours later, while driving, she felt her fever go up and had intense back pain.
“I knew I was crashing,” she said. “I had never felt like that before.”
She started to shiver intensely.
“I had my seat heater on. It was 70 degrees in Atlanta,” she said. “I’m on the highway, I’m hunched over, getting smaller and smaller.”
She somehow made it to the hospital, where they immediately recognized that she was having a miscarriage. She shared her medical records with CNN, which show that she had an “septic incomplete abortion.”
It took two days of intravenous antibiotics and other medications to bring her fever down.
“My mind started going to some dark places – like, ‘this isn’t normal. I’ve never felt like this before,’ ” she said. “I was like, ‘I’m really scared. I don’t know if I’m going to make it.’ ”
Her husband wasn’t sure, either.
“She’s laying in the hospital shaking with a 100-some-odd-degree fever, [and] there’s nothing I could do about it,” Day said. “It was very surreal, like ‘how in 2023 can this happen to us?’ ”
Once her fever came down, doctors performed a D&C, the surgery to remove the dead fetus from her uterus. She left the hospital after a four-day stay.
Confusion among obstetricians
A sponsor of Georgia’s abortion ban pointed her finger at Novak’s physician, whom Novak is not identifying.
Georgia law doesn’t bar the use of mifepristone in case of miscarriage. In fact, the state’s six-week abortion ban that took effect in November allows for termination of a pregnancy if the fetus has died and doesn’t specify what methods can be used.
“I would offer a strong reminder that it is his/her responsibility to understand any Georgia law that affects medical practice. The failure of any doctor to understand the law, and further, to allow a lack of knowledge or possible political motive to affect the standard of care provided to any patient borders on malpractice,” said state Rep. Ginny Ehrhart.
But on March 22, the day the doctor prescribed Novak only misoprostol, obstetricians in Georgia and across the country were thinking about more than just their own state laws.
At that time, the federal court in Texas was considering whether to ban access to mifepristone, and the case was making headlines nationwide.
Novak said the doctor mentioned this litigation when treating her for the miscarriage, and she played for CNN a voice mail from the doctor that also mentioned it.
Doctors tell CNN that they’re not surprised that the doctor chose not to prescribe mifepristone, saying it’s been difficult to keep track of various state and federal legal cases.
This week, the American College of Obstetricians and Gynecologists had a “special late-breaking session” at its annual scientific and clinical meeting that addressed the confusion around mifepristone and whether it was still available for doctors to prescribe.
“Mifepristone is still on the market as the cases go through legal proceedings,” according to the group’s guidance.
Dr. Mae Winchester, a high-risk pregnancy specialist in Cleveland, said obstetricians need this kind of guidance.
“Lots of times, I get calls from doctors in the area about what they can and cannot do for patients,” said Winchester, a fellow at Physicians for Reproductive Health. “There’s still a lot of uncertainty as the laws change constantly. Physicians can’t keep up with the laws, and they’re scared.”
Dr. Carrie Cwiak, a professor in the Department of Gynecology and Obstetrics at the Emory University School of Medicine, said she has sometimes seen the same confusion among her colleagues in Georgia.
“It’s confusing when you have a situation like that case against mifepristone because you were waiting to see what final decisions” would be, she said.
She added that over the past year, doctors have been scared to provide “safe, effective, ethical health care” because they’re under threat of prosecution by ever-changing abortion laws that frequently get overturned by courts. These bans typically punish doctors with fines, prison sentences and loss of their medical license.
“It’s human nature that you might be cautious and say, ‘well, I can’t do anything at all, because I’m afraid that someone will misinterpret what I’m doing and then penalize me,’ ” said Cwiak, director of the Complex Family Planning division at Emory.
Werner, the obstetrician at Tufts, agreed that confusion among obstetricians about what kind of miscarriage care they can and cannot offer is widespread and understandable.
“I would say there’s no other subspecialty right now that has to follow court decisions to figure out what treatment to give their patients,” she said. “While unintended, when the courts and the legislators get involved in medical decision-making, this is the kind of downhill effect that you see.”
Novak and Day say they’re sharing their story in case other couples end up in their situation.
They said they know she might have had the same experience if she’d been given mifepristone as well as misoprostol, but they wish they could have had the two drugs in combination, since they have a better track record than misoprostol on its own.
Day said that if the plaintiffs in the federal litigation prevail and access to mifepristone is barred, “it seems like it’s really regressing, that we’re taking away freedoms and medicines that have been around for a long time.”
“The fact that nonmedical professionals are able to dictate medical care to my wife or anyone is absurd.”
CNN’s Deidre McPhillips, Amanda Musa, Tierney Sneed and Steve Vladeck contributed to this report.
