(CNN) 鈥� 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.
鈥淲e didn鈥檛 know if she was going to live or die,鈥� said Novak鈥檚 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.聽Although the medication she took, called misoprostol, can help a woman have a complete and safe miscarriage, it鈥檚 not approved by the FDA to do so, and studies show that it鈥檚 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 鈥渧ery worried,鈥� said Dr. Erika Werner, a spokesperson for the Society for Maternal-Fetal Medicine. The concern is that if medication for miscarriage doesn鈥檛 work, patients will end up having surgeries they hadn鈥檛 anticipated.
鈥淢ore women are going to have unnecessary surgeries. More women are going to have complications,鈥� 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聽are challenging the FDA鈥檚 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 鈥渕edical management of miscarriage with misoprostol has been standard of care for decades.鈥�
鈥淚t 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,鈥� Francis added.
A New Year鈥檚 Eve kiss
Melissa Novak first spotted Stewart Day when he was standing at a beer cart at a New Year鈥檚 Eve festival in Fort Lauderdale in 2007.
鈥淚 saw him, and I was like, 鈥榟e鈥檚 very attractive,鈥� and I tried to do a little dance to see if he would聽check me out, and he did a little bit,鈥� Novak said.
Three hours later, her friends asked her whom she鈥檇 be kissing at midnight, and she remembered the cute guy at the beer cart and found him again.
鈥淲e kissed on New Year鈥檚, and we haven鈥檛 been separate since,鈥� said Novak, now 39.
鈥淲e haven鈥檛 stopped talking,鈥� added Day, now 42.
Novak, a social worker and sex therapist, and Day, an accountant, married on New Year鈥檚 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鈥檇 convert into a nursery and how they would decorate it.
Their obstetrician scheduled an ultrasound at eight weeks.
鈥淭hat 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,鈥� 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 , which estimates that 10% of all clinically recognized pregnancies end in an early loss. After a fetus dies, it鈥檚 common for patients to need medical help to clear the tissue 鈥� sometimes referred to as 鈥渢erminating鈥� 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. was published in 2006 in the journal Contraception.
Another 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.聽The authors of the study, published this year in Contraception, noted that this was 鈥渁 substantially lower proportion than the approximately 95% expected after the use of mifepristone and misoprostol鈥� 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 鈥渞esulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone.鈥�
Francis, the anti-abortion activist and plaintiff in the federal litigation, pointed to 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.
鈥楬ow in 2023 can this happen to us?鈥�
When Novak had her miscarriage in March, she says, her obstetrician explained her : 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 鈥� 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.
鈥淚 knew I was crashing,鈥� she said. 鈥淚 had never felt like that before.鈥�
She started to shiver intensely.
鈥淚 had my seat heater on. It was 70 degrees in Atlanta,鈥� she said. 鈥淚鈥檓 on the highway, I鈥檓 hunched over, getting smaller and smaller.鈥�
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 鈥渟eptic incomplete abortion.鈥�
It took two days of intravenous antibiotics and other medications to bring her fever down.
鈥淢y mind started going to some dark places 鈥� like, 鈥榯his isn鈥檛 normal. I鈥檝e never felt like this before,鈥� 鈥� she said. 鈥淚 was like, 鈥業鈥檓 really scared. I don鈥檛 know if I鈥檓 going to make it.鈥� 鈥�
Her husband wasn鈥檛 sure, either.
鈥淪he鈥檚 laying in the hospital shaking with a 100-some-odd-degree fever, [and] there鈥檚 nothing I could do about it,鈥� Day said. 鈥淚t was very surreal, like 鈥榟ow in 2023 can this happen to us?鈥� 鈥�
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鈥檚 abortion ban pointed her finger at Novak鈥檚 physician, whom Novak is not identifying.
Georgia law doesn鈥檛 bar the use of mifepristone in case of miscarriage. In fact, the state鈥檚 six-week abortion ban that took effect in November for termination of a pregnancy if the fetus has died and doesn鈥檛 specify what methods can be used.
鈥淚 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,鈥� 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鈥檙e not surprised that the doctor chose not to prescribe mifepristone, saying it鈥檚 been difficult to keep track of various state and federal legal cases.
This week, the American College of Obstetricians and Gynecologists had a 鈥溾€� at its annual scientific and clinical meeting that addressed the confusion around mifepristone and whether it was still available for doctors to prescribe.
鈥淢ifepristone is still on the market as the cases go through legal proceedings,鈥� according to the group鈥檚 guidance.
Dr. Mae Winchester, a high-risk pregnancy specialist in Cleveland, said obstetricians need this kind of guidance.
鈥淟ots of times, I get calls from doctors in the area about what they can and cannot do for patients,鈥� said Winchester, a fellow at Physicians for Reproductive Health. 鈥淭here鈥檚 still a lot of uncertainty as the laws change constantly. Physicians can鈥檛 keep up with the laws, and they鈥檙e scared.鈥�
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.
鈥淚t鈥檚 confusing when you have a situation like that case against mifepristone because you were waiting to see what final decisions鈥� would be, she said.
She added that over the past year, doctors have been scared to provide 鈥渟afe, effective, ethical health care鈥� because they鈥檙e 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.
鈥淚t鈥檚 human nature that you might be cautious and say, 鈥榳ell, I can鈥檛 do anything at all, because I鈥檓 afraid that someone will misinterpret what I鈥檓 doing and then penalize me,鈥� 鈥� 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.
鈥淚 would say there鈥檚 no other subspecialty right now that has to follow court decisions to figure out what treatment to give their patients,鈥� she said. 鈥淲hile unintended, when the courts and the legislators get involved in medical decision-making, this is the kind of downhill effect that you see.鈥�
Novak and Day say they鈥檙e 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鈥檇 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, 鈥渋t seems like it鈥檚 really regressing, that we鈥檙e taking away freedoms and medicines that have been around for a long time.鈥�
鈥淭he fact that nonmedical professionals are able to dictate medical care to my wife or anyone is absurd.鈥�
CNN鈥檚 Deidre McPhillips, Amanda Musa, Tierney Sneed and Steve Vladeck contributed to this report.
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