Chaos, Confusion From Judge’s Mifepristone Decision, Experts Say

“If it’s taken away as an option we still have options for medication abortion. But the other option that we commonly use is a misoprostol-only regimen, which would mean more side effects, slightly less efficacy, and it just doesn’t make any sense to us. If you’re going to your doctor to treat anything, like high blood pressure or diabetes, you want the medicine that’s safe and effective with the least side effects that your doctor recommends to you. This ruling is basically saying the safest, most effective, most recommended method might be taken away.”

“What I’m worried about is this might change how patients make decisions around their care. If they’re choosing a method that’s less effective with more side effects, they may choose a procedure instead. There are lots of implications for that.”

“We also use mifepristone for miscarriage management. This ruling affects all uses of mifepristone if it goes into effect. So patients experiencing miscarriage -- that’s one in five pregnancies, so it’s very common -- many choose medication to manage their miscarriage rather than a procedure. It would take that option away.”

ON LOSS OF PATIENT PRIVACY

Jolynn Dellinger, visiting lecturer, Duke Law School

“Medication abortion is good for privacy in many ways. It first of all can be ordered online from the privacy of your own home. In some cases it can be received in the mail. It can be taken in the privacy of your home with your friends and family or partner there to support you.”

“People may experience taking pills as a less physically invasive option. And also, if you can take this in the privacy of our own home, in places where you don’t have to be in person with a provider, you might be able to avoid running the gauntlet of protesters that are out there in the world.”

“It’s incredibly safe and effective and can be the very best choice for people. So Judge Kacsmaryk’s ruling, purporting to stay the approval of this drug, is just unprecedented. Importantly, this ruling purports to affect the availability of medication abortion nationwide. Not just in the states that are trying to criminalize abortion, but altogether.”

ON WHAT HAPPENS TO PEOPLE WHO USE THE DRUG IF IT IS BANNED

Jolynn Dellinger

“The question is, what is the effect of judge Kacsmaryk’s decision? If it did go into effect, what could happen? The FDA has enforcement discretion. So say the drug returned to unapproved status. Still the FDA would have to take action to enforce any kind of proceeding against a manufacturer or pharmaceutical company who is putting this now-unapproved drug into the world. The FDA seemingly could choose to not take that action.”

ON HOW PHYSICIANS ARE REACTING

Dr. Beverly Gray

“We’re working out a variety of scenarios. We’re understanding how our state law will impact how we can practice and how we can use off-label medications if we’re able to do that.”

“We’re trying to determine if we can use the medication on the shelf, if we can order more medication. Right now we’re just hoping the legislative dust will settle so we’ll have a better understanding.”

“I’ve talked to a lot of lawyers in the past couple of days, and this is unprecedented, this ruling. People are trying to understand what we do next. The FDA has the authority to maybe protect the use of mifepristone. So we’re waiting.”

“Creating chaos, creating confusion, is part of the gameplan with rulings like this. Patients are unsure, is it still legal? Patients who are trying to move their appointments up earlier to be seen this week because they are wanting to have medication abortion. We’re trying to do the best we can. We’re physicians, we’re not lawyers. We’re trying to tease through all of these opinions and rulings … to really understand what’s going on. And at the same time practicing medicine and trying to take care of patients.”

ON USE OF MISOPROSTOL AS ALTERNATIVE

“Physicians would be comfortable. This is a medicine commonly used in OB-GYN. There are misoprostol regiments that are effective.”

“Misoprostol only is a good alternative. It’s not the best alternative. The best medication would be to use is mifepristone and misoprostol together because they’re efficacious with fewer side effects. When we talk about side effects with medication abortion, it’s the misoprostol that causes most of the side effects.”

ON THE RULING AS PRECEDENT FOR OTHER MEDICATION BANS

Jolynn Dellinger

“This is unprecedented for a judge to use his own scientific understanding to displace the reasoning of the FDA, with whom we’ve charged this very important responsibility about evaluating the safety and effectiveness of drugs. So I think that should be a consideration in looking at this going forward.”

“The longer-term effects and the collateral damage that affirming a decision like this could create … we’re raising issues about the different responsibilities of different branches of government. The FDA, empowered by Congress, exists for a reason and we should be letting the FDA do its job and not be letting a judge displace that with his own personal opinion.”

ON THE RULING’S IMPACT ON MISCARRIAGE MANAGEMENT

Dr. Beverly Gray

“The additional harms are having a medication offered that has less efficacy means more patients may need procedures to manage their miscarriages. Some patients … want to have this process happen in the privacy of their own home. Patients choose either using medication for management versus a procedure from very different places.”

“Some people really do want things to happen naturally in their own home. It’s safe to do that. But if you’re using a medication that’s less efficacious, there’s a risk you’re going to need a procedure. And for patients who may be traveling a distance for care, whether that’s within North Carolina or they’re traveling from another state for care, they may create a different calculation in their decision making.”

“And thinking about this nationally, if there’s a big shift in needing more procedures, I don’t know there are enough providers available to provide that care.”

“It does a disservice to patients. Patients should have the most effective method available to them.”

ON THE RULING CREATING CHAOS

Jolynn Dellinger

“Chaos and confusion, these things are not accidents here, in my view. I think these are a feature and not a bug in this situation. In any given state -- the banned states -- you’re looking at laws from the 1800s that are still on the books in many cases. Trigger laws banning abortion that were passed during Roe, new laws criminalizing abortion that have been passed since Dobbs … the states that are criminalizing abortion, it’s not a simple thing. People are really struggling to figure out what these mean.”

ON PEOPLE TRAVELING TO NC FOR ABORTION CARE

Dr. Beverly Gray

“Florida actually provides the majority of abortion care of any individual state in the South right now. If a six-week ban is enacted in Florida, we’re really worried about that tidal wave effect of pushing patients to the closest state where they can get care. It’s something we’re really concerned about.”

ON WHETHER THERE ARE ANY BENEFITS TO THE RULING

Dr. Beverly Gray

“For the practice of medicine? No.”

“There’s a lot of stigmatized language that (the judge) uses. He refers to health care providers as ‘abortionists’; refuses to use scientific language; completely ignores all the scientific evidence that was presented in the briefs that were introduced.”

“I found it very disrespectful in reading it. If there’s any benefit, it’s going to activate people further to be involved in advocacy and to get out and vote.”

“Access to abortion is health care. The only benefit is that people will be activated to stand up for their reproductive rights.”

ON TECH SURVEILLANCE OF PATIENTS SEEKING ABORTION

Jolynn Dellinger

“Criminalization of abortion in 2023 is just a whole different ballgame and one aspect of that difference is medication abortion. It’s part of what makes this landscape different. It’s a potentially liberating side of it.”

“The other difference is our digital reality. We live in a surveillance economy suffused with surveillance technologies. It’s a world powered by data. It implicates privacy in really new and complex ways. Historically you’d always think about any laws that prohibit abortion as affecting your physical privacy, your bodily integrity. It affects decisions you’re making for your body.”

“But I think that Dobbs, and its intersection with this digital reality we’re living in today, really raises the issue of information privacy.”

“Everybody has a cell phone. It would be child’s play for law enforcement to locate people providing physical (abortion) procedures.”

“Finding out you’re pregnant. Going online, buying a pregnancy test; taking the pregnancy test; searching on the internet for abortion providers to figure out what you want to do. All these steps leave a data trail. And so it makes a person susceptible to surveillance, and in a state that’s criminalizing abortion, makes that person, anyone helping that person, providing for that person, providing pills for that person, potentially subject to prosecution. It’s a massive chilling effect how we’re criminalizing a bodily function.”

ON FUTURE OF OBSTETRICS CARE

Dr. Beverly Gray

“I think there will be people drawn to the field because they have that fire in their belly and they want to advocate for reproductive health care. I think probably more commonly what will happen is people will make choices about where they live and train based on what the laws of that state look like. So if we have restrictive laws in North Carolina I worry we’ll have trouble recruiting the best, most talented medical students to our state. That has downstream effects. Where you go to train for residency, you’re more likely to stay there and live there and put down roots there. If we are less likely to recruit the best candidates, we’re less likely to have the best physicians for North Carolinians working here in our state.”

Faculty Participants

Jolynn Dellinger
Jolynn Dellinger is a visiting lecturer at Duke Law School and a senior fellow at the Kenan Institute for Ethics at Duke, where she teaches ethics, privacy law and policy and works in the area of ethical tech.

Beverly Gray, M.D.
Dr. Beverly Gray is division chief of women’s community and population health and an associate professor in the Department of Obstetrics and Gynecology. Gray is also founder of the Duke Reproductive Health Equity and

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