If a federal lawsuit is successful, many women who have miscarried early could end up in hospital, septic and needing an emergency surgery.
Stewart Day, Novak's spouse, said, "We didn't even know if we were going to survive or not."
Novak miscarried in March and the US Food and Drug Administration approved a two pill combination for women with her circumstances. However, she was only prescribed one of those pills. The FDA has not approved misoprostol to be used for this purpose. Studies have shown that the drug is less effective when combined with mifepristone.
How an abortion pill works
The plaintiffs are seeking to prohibit mifepristone from being sold in all states. If they succeed, then more women will take misoprostol for miscarriage treatment, just like Novak.
Erika Werner is a spokesperson for Society for Maternal-Fetal Medicine. She said that obstetricians were'very concerned'. It's a concern that, if miscarriage medication doesn't work as expected, patients may end up having surgery they didn't expect.
"More women will have unnecessary surgery." Werner, also the chair of obstetrics at Tufts Medical Center, said that more women will have complications.
A three-judge panel of the US 5th Circuit Court of Appeals listened to the arguments of the plaintiffs and anti-abortion doctors, as well as groups, who are challenging FDA approval of mifepristone in 1993.
The circuit court will likely make a decision in the next few weeks. This case is then expected to go before the US Supreme Court.
According to CNN, Dr. Christina Francis is the chief executive officer of American Association of Pro-Life Obstetricians and Gynecologists and one of the plaintiffs. She told CNN,'medical treatment of miscarriage using misoprostol was standard of care in previous decades.
It is important that women who are being treated with Misoprostol to manage miscarriage have a scheduled follow-up to make sure that they have passed all pregnancy tissues and determine if additional treatment is required. Francis said that women deserve the best reproductive healthcare possible, particularly when they are faced with an emotionally and physically traumatizing situation like miscarriage.
A kiss on New Year's Eve
Melissa Novak spotted Stewart Day in 2007 when he stood at a beer truck at a New Years Eve festival in Fort Lauderdale.
Novak stated, "I saw him and thought, 'he is very attractive.' I then tried to dance a bit to see if I would be checked out. He did, however, do a small amount of checking me out."
She remembered him and went back to find him. Three hours later her friends asked who she would kiss at midnight.
Novak, who is now 39, said, 'We kissed at New Year's and haven't separated since.
Day, 42, added, "We haven't ceased talking."
Novak, who is a sex therapist and social worker, and Day, a bookkeeper, were married on New Year's Day in 2003. After moving to Chicago, they settled down in Atlanta.
Novak's pregnancy was a big surprise to them this year. Day, who had always wanted to have a large family, went to the store to buy his wife soup at all hours. It was her only desire. They began to plan which room they would convert into a baby nursery, and how they were going to decorate it.
The obstetrician had scheduled an ultrasound for eight weeks.
Day recalls, 'That was the first time I had been in an ultrasound room. The technician set it up, then looked at Melissa and you could feel the atmosphere in the room deflate.
The ultrasound revealed that there was no heartbeat in the fetus. Novak was a victim of an early miscarriage.
Combining drugs has advantages, according to studies
According to the American College of Obstetricians and Gynecologists (ACOG), 10% of clinically recognized pregnancy ends in a miscarriage. It's not uncommon for women to require medical assistance to remove the tissue after a fetus has died. This is sometimes called 'terminating a pregnancy'.
Multiple studies have shown the combination of misoprostol and mifepristone is more effective than misoprostol by itself in terminating a pregnancy.
A report that looked at multiple studies concluded that the combination mifepristone misoprostol is 95%-98% effective. This report was published by the journal Contraception in 2006.
In another report, researchers examined studies of 12,829 women who were given only misoprostol. In 78% of cases, the pregnancy ended completely, without surgery or any additional medication. This study was published in Contraception this year. The authors noted that it was "substantially lower than the 95% expected following the combined use of mifepristone & misoprostol".
In a second study, doctors in the US randomly assigned to 300 women who had lost a pregnancy early either misoprostol alone or combined with mifepristone. 84% of those who received the combination had an expulsion complete, while 67% of those taking misoprostol alone had one.
In 2018, the authors concluded in the New England Journal of Medicine that the drug combo'resulted a greater likelihood of successfully managing first-trimester pregnancies loss than treatment with Misoprostol only'.
Francis, an anti-abortion activist who is also the plaintiff in the federal lawsuit, cited a study published in NEJM. This was a clinical trial that showed that 84% of the 491 women treated with misoprostol after a failed pregnancy in early stages had a complete expulsion in eight days.
How can we be so unlucky in 2023?
Novak says that when she miscarried in March, her doctor explained to her her options. She could have a D&C to remove the pregnancy, or take medication to speed up the process.
Novak's doctor prescribed misoprostol alone and not in combination with Mifepristone.
Novak developed a high fever nine days after taking his medicine.
Novak, believing she had caught a cold through her nephews' company, took Advil and felt better. She then got into her car to run errands.
She felt her back pain and fever increase two hours later while driving.
She said, "I knew I was about to crash." I had never felt that way before.
She began to shiver violently.
I had my seat heating on. She said that it was 70 degrees at Atlanta. 'I am on the highway. I'm hunched, and getting smaller.'
She managed to get herself to the hospital where she was immediately diagnosed with a miscarriage. She provided her medical records to CNN which showed that she had a'septic complete abortion'
Her fever was brought down by two days of intravenous anti-biotics and other medicines.
"My mind went to dark places, like 'this isn’t normal. She said, "I've never felt this way before." I was really scared. I don't think I will make it. '
Her husband was also unsure.
Day stated that 'She was lying in the hospital with a fever of 100 degrees or so, and there was nothing I could have done about it.' It was surreal. Like, 'How can this happen in 2023?' '
After her fever subsided, doctors performed D&C surgery, which is the procedure to remove the dead foetus. After a four-day hospital stay, she was discharged.
Confusion among obstetricians
One of the sponsors of Georgia's ban on abortion pointed at Novak's doctor, who Novak did not identify.
Georgia law does not prohibit the use of Mifepristone if a miscarriage occurs. The state's six week abortion ban, which took effect in November, allows termination of pregnancy if fetus is dead. However, it does not specify the method.
I would like to remind him/her that it's his/her duty to know any Georgia laws that impact medical practice. Ginny Ehrhart, state representative, said that malpractice is committed when doctors fail to understand the laws and allow their lack of knowledge, or political motivation, to influence the care they provide to patients.
On March 22, when Novak's doctor prescribed only misoprostol to her, obstetricians across Georgia and the nation were considering more than their state laws.
The case made headlines across the country when the federal court in Texas considered whether or not to ban the access to mifepristone.
Novak claimed that the doctor had mentioned the lawsuit when he treated her for miscarriage. She played a voicemail from the doctor in which he also made reference to it.
CNN reports that doctors are not surprised by the decision of the doctor not to prescribe mifepristone. They say it is difficult to keep up with all state and federal cases.
The American College of Obstetricians and Gynecologists held a "special late-breaking session" at its annual clinical and scientific meeting this week to address the confusion surrounding mifepristone and if it is still available for doctors.
According to the group's guidelines, 'Mifepristone remains on the market while the legal cases are being litigated'.
Dr. Mae Winchester is a Cleveland-based high-risk pregnancy specialist. She said that obstetricians require this type of guidance.
Winchester, a fellow with Physicians for Reproductive Health, said, "I get calls from doctors all the time about what they are allowed to do for their patients." There's still uncertainty because laws are constantly changing. 'Physicians can't keep pace with the laws and are afraid.
Dr. Carrie Cwiak is a professor at Emory University School of Medicine in the Department of Gynecology and Obstetrics. She has seen similar confusion in her Georgian colleagues.
She said, "It is confusing when you are in a situation such as the one against mifepristone. You were waiting for final decisions."
She said that doctors are afraid to provide a'safe, effective and ethical health care,' as they fear prosecution because of the ever-changing laws on abortion that are frequently overturned by the courts. These bans punish doctors with prison sentences, fines and the loss of their license.
Cwiak is the director of Emory's Complex Family Planning division.
The confusion that exists among obstetricians regarding the type of care they are allowed to provide for miscarriages is widespread.
She said that there is no other subspecialty in the world today who has to follow court rulings to determine what treatment they should give to their patients. When the courts and legislators are involved in medical decisions, you will see a downward spiral.
Novak and Day share their story to help other couples avoid the same situation.
They know that she would have experienced the same thing if misoprostol and mifepristone had been combined, but wish they had had both drugs together, as they have better results than misoprostol alone.
Day stated that if plaintiffs prevail in the federal lawsuit and access to the mifepristone are barred, it'seems like a real regress, that we take away freedoms and medications that have been available for a very long time.
The fact that non-medical professionals can dictate medical care to anyone, including my wife, is absurd.