AHLA's Speaking of Health Law

Top Ten 2025: Medication Abortion Cases to Watch

• American Health Law Association

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Based on AHLA's annual Health Law Connections article, this special series brings together thought leaders from across the health law field to discuss the top ten issues of 2025. In the fifth episode, Mary R. Kohler, Founder & Principal, Kohler Health Law PC, speaks with Sheela Ranganathan, Adjunct Professor, Georgetown University School of Health, about the current legal and regulatory landscape surrounding medication abortion. They discuss the history of challenges to mifepristone and misoprostol; how recent cases are playing out, including Alliance for Hippocratic Medicine v. FDA, GenBioPro v. Raynes et al., and Bryant v. Stein; and what to expect from the new administration. From AHLA’s Life Sciences Practice Group.

Watch the conversation here.

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Speaker 1:

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Speaker 2:

A HLA is pleased to present this special series highlighting the top 10 health law issues of 2025, where we bring together thought leaders from across the health law field to discuss the major trends and developments of the year. To stay updated on all the major health law news, subscribe to ALA's New Health Law Daily podcast, available exclusively for premium members@americanhealthlaw.org slash daily podcast .

Speaker 3:

Hi, welcome back to ALA's Top 10 podcast series. I'm your host today, Mary Kohler. I'm an ex brandand attorney who runs my own practice with life science companies now, and I'm also vice chair of ALA's Life Science Practice Group. This practice group aims to raise awareness and education amongst healthcare lawyers about life science issues. And today we're here to talk about one product in particular, Opry Stone . You may have heard of it because it's gained some national attention lately, and I'm here with the expert, Sheila Ranganathan , who's done a lot of work in this area. So, Sheila, can you tell our audience a little bit about yourself?

Speaker 4:

Yeah, thanks, Mary. Hi everyone. My name's Sheila Ranganathan , and I'm an in-house attorney with a nonprofit health plan. Um, I'm also an adjunct faculty member with Georgetown University School of Health, and I'm teaching a class on gender justice and health law . Um, previously I was with Georgetown Law's O'Neill Institute, where I provided legal technical assistance and public education on reproductive healthcare litigation and policy.

Speaker 3:

Wow. Well , welcome Sheila. So let's kick off. First of all, what is miry ? And am I saying that right?

Speaker 4:

Yeah, thanks. So you are saying it right. Um, Mione also called MiFi , um, is one of the two drugs that are used together for a medication abortion. Um, it works by blocking the hormone progesterone and without progesterone, the lining of the uterus breaks down and the pregnancy can't continue. Um, misoprostol the second medication , um, empties the uterus causing cramping and bleeding and is very similar to an early miscarriage. So Opry Stone and Misoprostol are used in conjunction to end a pregnancy through 10 weeks gestation. Um, and the two medications are also used to manage miscarriages and other pregnancy complications.

Speaker 3:

Now , that sounds a lot like birth control pills, but I understand some people have some safety concerns with it. Can you talk about that a bit?

Speaker 4:

Yeah. So the medication is extremely safe to use. Opry stone carries extremely low risks of complications or negative health consequences. Um, there's actually a very low rate of major adverse events like hospitalizations or serious infections , um, and the risk of death hovers around zero. Um, the drug has been used in hundreds of clinical trials. It's been discussed in almost 800 medical reviews. Um, and all of these studies have shown that misoprostol , combined with misoprostol has a 99.6% success rate in terminating pregnancies. Um, these medications also went through extensive trials to get through the FDA approval process, which included animal testing, the phases of clinical testing , um, the new drug approval review, post-marketing updates, and all of that. And despite all of this extensive evidence in all of these processes , um, there are only 65 drugs in the United States that have REMS restrictions and Opry is one of them .

Speaker 3:

Yes, REMS is a really big thing. Can you tell me more about that?

Speaker 4:

Yeah. Um, so FDA approved the drug in 2000 for use through seven weeks of pregnancy. Mm-hmm <affirmative> . Um, in 2011, FDA added certain risk evaluation and mitigation strategy restrictions, also known as REMS restrictions to ensure safe use of the drug. So this included , um, requiring patients to receive the drug at a doctor's office or hospital. Um, it also included limitations on what kinds of health providers could prescribe the medication. Um, and a a few years later, in 2016, FDA extended the window of time that a pregnant person can be prescribed Opry stone . So it went from seven weeks to 10 weeks of pregnancy. Um, and then FDA also slightly relaxed the rems to require fewer trips to the doctor during a medication abortion. And then in 2020 , um, FDA suspended certain requirements during the pandemic to make it easier to access the medication. So they removed the in-person prescribing RES requirement, and they allowed more types of providers to prescribe the medication. And then FDA removed all these requirements altogether in 2023. So by 2020 Mifa , Prestone had accounted for the majority of all abortions in the us , which is why there is so much ongoing litigation about all of these FDA approvals and restrictions related to miry stone .

Speaker 3:

Yeah. So I've read your article and you talk about these different buckets of cases. Can you briefly touch on those here?

Speaker 4:

Yeah, sure. So the first bucket is about the case that went up to the Supreme Court last year , um, Alliance for Hippocratic Medicine. And that case was about whether FDA's approvals of MiFi should be overturned. Um, the second bucket was about two cases that are up at the Fourth Circuit right now , um, gen Bio Provi Reigns and Bryant versus Stein , um, about whether states can impose additional restrictions on accessing miry stone to those set by FDA . And then the last bucket, which I won't get into today in in the interest of time, but that last bucket was about a handful of cases challenging FDA's REMS requirement as too burdensome and medically unjustified.

Speaker 3:

Gotcha. Okay. But the Alliance case that was dismissed by the Supreme Court last year, right? So why is that still relevant?

Speaker 4:

Yeah, you're right. Alliance did go up to the Supreme Court last year. Um, there the court was basically asked to consider the legality of FDA's initial and subsequent approvals of Opry Stone . Um, in that case , um, several physicians and associations had brought the case in a Texas federal court arguing that FDA lacked the safety evidence it needed to approve the drug for pregnancy termination and to , um, relax the sub subsequent REMS requirements. Um, that case did get dismissed by the Supreme Court on standing last July , um, on procedural grounds. Basically, the court found that these doctors and associations were not harmed by FDA's approvals of risto , so they couldn't, as plaintiffs bring the case in federal court under Article three . Um, so when SCOTUS dismissed the case, it got sent back to the district court for further proceedings. Um, and then later in the fall , um, three states, Missouri, Kansas, and Idaho, who had intervened in the initial litigation , um, filed an amended complaint arguing that they do have standing to bring the case in Texas and to keep it going. So while their standing argument might be more compelling than the doctors' and the association's argument in the, in , um, in initial complaint , um, it's not clear that they have the proper venue to bring that case in district court in Texas now that the plaintiffs from the initial case that were from Texas have been dismissed from the litigation , um, the Biden administration made that argument , um, that the intervening states can't just continue this case in Texas without any plaintiff having a connection to Texas. But in January , um, judge Matthew k Merrick found that the intervening states have jurisdiction to bring the case. So it's going to keep going at the district level.

Speaker 3:

So much procedure <laugh> , are there any substantive changes in this new version of the case?

Speaker 4:

Definitely. Um, so the amended complaint in this case, which is now called Missouri versus FDA , um, still challenges all of the approvals of miry of FDA , um, but it also argues that the drug's approval injures the states economically because of potential loss of population and decreased number of births, which they say could cause diminishment of political representation and loss of federal funds. So they're taking an economic approach with that argument. Um, the states also heavily lean on the concept of fetal personhood, which is this idea that the fetus has the same rights as the pregnant person. Um, for decades, people challenging abortion access have used a lot of this sort of language about the rights of the unborn child and have been trying to find sources in the constitution for those rights. And it's worth noting that the intervening states embed this sort of language throughout the , um, amended complaint. Next , um, the intervening states also argue that FDA's actions are undermining state abortion laws and state law enforcement by allowing pregnant patients in , um, their states to get abortion from other states under state shield laws. Um, these are basically laws that protect confidential patient information from being disclosed for law enforcement investigations and professional di uh, discipline and things like that. Um, and then the last kind of change is that , um, the amended complaint argues that the Comstock Act, which was passed in the late 18 hundreds and has been dormant since , um, at least 50 years , um, prohibits the distribution of medication abortion. Now,

Speaker 3:

Okay, we were talking about this earlier. So tell , talk to me more about this Comstock Act. It's more than a hundred years old and it's come back.

Speaker 4:

Yeah. So the Comstock Act is an archaic law that prohibited mailing of pornography and contraception materials. Um, the kicker is that it was passed all the way back in 1873, but it went dormant because in the 1930s , um, federal appellate courts had ruled that the act did not apply to the mailing of contraceptive materials if their intended use was not illegal. Um, and in 1971, Congress also removed some of these references to contraception from the Comstock laws. But , um, the original act is still in the US code, and there is still some language there that prohibits the mailing of any article used for producing an abortion. And so despite the Comstock Act being dormant for at least 50 years, people challenging abortion access argue that the law prohibits the mailing of Ry Stone . Um, during the Biden administration, the DOJ had put out some guidance saying that the federal government was not going to enforce the Comstock Act , um, because they didn't think that it was applicable anymore, but the Trump administration could take a different approach. And so the intervening states are sort of trying to test that out in the amended complaint.

Speaker 3:

That's really interesting. I guess we'll just have to stay tuned on that one. But , um, switching gears, what's going on in the fourth circuit?

Speaker 4:

Yeah, so there are two fourth Circuit cases. Both are about the same issue, and that is whether states can pass laws that impose additional restrictions to Opry Stone in addition to FDA's regulation of the drug. Um, and these state laws are making miry stone virtually impossible to access. So in the district case in North Carolina , um, a judge said that the federal law preempts this sort of state law, so he overturned the North Carolina law. Um, in the district case in West Virginia, a judge upheld the state law finding that there was no preemption issue. So the Fourth Circuit has to resolve this split. Basically. Um, in both cases there's a lot of discussion about administrative authority and whether Congress gave FDA the full realm of authority when it comes to deciding what restrictions should be imposed on a drug. Um, one side argues that FDA decided that this drug should be accessible, at least to this degree. So, you know, a state shouldn't be able to impose further restrictions from those already set by FDA. And then on the other hand , um, we have the argument that states have their own laws already regarding things like controlled substances, even though FDA has its own authority with those drugs. Um, there's also a lot of discussion in these cases about patient safety , um, state police powers to protect the health and safety of its citizens, and whether Dobbs left all decisions regarding abortion to the states or whether there's anything left that the federal government can regulate. Um, there's also some questions about whether regulating myth of pri stone falls under the regulation of drugs, which is mostly under the federal purview, or whether it's more , um, under the practice of medicine, which is usually under state authority <laugh> . Um, so in the fourth Circuit, the court will probably issue a holding in Gen Bio Pro that applies to both cases, and we're expecting to see a holding sometime this year.

Speaker 3:

I know things are changing daily and it's so hard to make predictions, but what do you think we can expect in a new Trump administration?

Speaker 4:

Yeah. Um, a lot is going to change. A lot is already changing. Um, we'll have to track what happens to all of these lawsuits. Um, when it comes to the Trump administration. Um, you know, during his campaign, president Trump stayed kind of quiet about his views on abortion. Um, he was sort of proud of himself for appointing the justices that overturned Roe versus Wade and Dobbs. But aside from that, he kind of kept saying that abortion is an issue that belongs to the states. Um, however, project 2025 has listed out a lot of specific actions that the conservative movement might aim to take in the next few months, and these actions would severely curtail access to abortions and Myth Opry stone access. Um, one example of something that's already happened , um, the Trump administration has already taken down HH S'S reproductive rights website that provided information on how to access abortion. Um, in addition to all of that , um, the DO J'S views on the Comstock Act, which we talked about earlier, could change. Um, this administration might decide to enforce the Comstock Act, which could make it illegal to ship miry stone . Um, and then regarding the agencies , um, first of all , um, when it comes to FDA , um, FDA's treatment of miry stone could change and FDA might change its approvals of the drug, whether that's the initial approval or the subsequent REMS relaxations. Um, an RFK could also independently issue some restrictions on the medication as head of HHS, even without direct FDA action. Um, during his confirmation hearing , um, RFK did also say that he was going to direct the NIH and the FDA to look into safety concerns about Ry stone . And he also said that he agrees with President Trump that every abortion is a tragedy. So we could see a lot of movement from HHS. Um, another thing HHS could do is that it could reverse its recent rule on , um, the privacy of medical records pertaining to reproductive healthcare . Um, aside from agencies , um, on the Hill, Republicans have the House and the Senate right now. So we could see some federal legislation that restricts access to abortion and may put Frt zone. Um, we could also see some federal judges getting appointed at every level who are more sympathetic to plaintiffs who challenge abortion access. Um, and then some changes on the state level. Um, I've been reading some articles lately about states that support abortion access, starting to stockpile Opry Stone to ensure that people can continue to access the medication. Um, and meanwhile other states are taking Louisiana's approach and thinking through legislation to potentially make if a persona controlled substance. Um, so there's all of these things and then we haven't even touched on tala and e emergency abortion care at all in this podcast. But , um, that will also definitely be a huge issue to watch this year in the abortion space.

Speaker 3:

Well, we certainly live in interesting times. So Sheila, what's the bottom line for women in life science companies here?

Speaker 4:

Yeah, I think ultimately, you know, this landscape is very chaotic and confusing and fragmented, and it's just about to get even more fragmented and complicated when it comes to abortion access and reproductive healthcare . So I think it'll definitely be important to track all of these issues throughout the year. Um, on that note , um, I just wanted to give a quick shout out to the Georgetown Law O'Neill Institute's Litigation Tracker, which I cited a few times in my article. Um, this tracker is incredible. It has all of the federal court cases that we've discussed today and more , um, and you can view all of those filings for each case for free. Um, it gives you information on who the judges are, what court the case is in, and what's at stake in all of these cases. So if you are struggling to track all of these different cases related to abortion access, FDA, approvals of MiFi , then you , HIPAA rule, and so much more, I definitely encourage you to use that tool.

Speaker 3:

That sounds like an amazing resource. So thank you Sheila, for your time today. I certainly learned a lot and I hope that everyone in our audience did too. Um, and with that , um, we say goodbye and stay tuned for the next episode of the Top 10 Podcast.

Speaker 1:

Thank

Speaker 2:

You for listening. If you enjoyed this episode, be sure to subscribe to ALA's speaking of health Law wherever you get your podcasts. To learn more about a HA and the educational resources available to the health law community, visit American health law.org.