Abortion pill maker drops Mississippi lawsuit with national implications, but fight isn't over

by Isabelle Taft, Mississippi Today
August 19, 2022

An abortion pill manufacturer voluntarily dismissed its lawsuit challenging Mississippi's restrictions on medication abortion on Thursday, but the legal question it raised is unlikely to disappear. 

GenBioPro, the manufacturer of generic mifepristone – the drug used along with misoprostol to end pregnancies up to 10 weeks of gestation – argued in its 2020 complaint that Mississippi's restrictions on abortion medication were unconstitutional because they were much stricter than those set by the U.S. Food and Drug Administration, and thus preempted by federal law. The legal landscape changed dramatically with the overturning of Roe in June, but if courts accept that argument, medication abortion could remain legal even in states like Mississippi that have banned the procedure.

There is little precedent on whether states can regulate drugs more strictly than the FDA, and legal and reproductive health experts were keeping a close eye on the Mississippi case. 

GenBioPro said in a statement that it would continue the effort to expand access to medication abortion.

“Given the changed national landscape, we have decided to adjust our strategy and withdraw our existing case in Mississippi,” the statement said. “We are committed to using the law to remove unnecessary barriers for patients and providers and we look forward to making an announcement soon about our next steps.”

Attorney General Lynn Fitch, whose office represented state health officers Dr. Thomas Dobbs and Dr. Daniel Edney in the lawsuit, claimed the voluntary dismissal was a “victory for life” in a statement Thursday night. 

“We are pleased to have again successfully defended Mississippi's abortion laws,” Fitch said. “These laws represent the will of the people and the intent of the Legislature to promote life, protect the health and safety of women, and preserve the integrity of the medical profession. Our victory in Dobbs affirmed the right of the people to pass laws that defend these legitimate public interests.”

When GenBioPro filed the lawsuit in 2020, abortion was still legal but heavily regulated in Mississippi, with pills treated like any other procedure at the state's only abortion clinic. Patients had to wait 24 hours between visits and take the first pill at the clinic, though the FDA allows people to take the pills at home.

In June, the U.S. Supreme Court's ruling in Dobbs v. Jackson Women's Health Organization ended the constitutional right to abortion and allowed Mississippi's near-complete ban on the procedure to take effect. That upended abortion law around the country, and GenBioPro may have decided it could make a better argument in a different state or a more favorable appellate circuit. The U.S. 5th Circuit Court of Appeals, which hears cases from Mississippi, is the country's most politically conservative. 

“My assumption is that the nature of the argument has changed for GenBioPro,” said Rachel Rebouché, dean of the Temple University Beasley School of Law and an expert in reproductive health law. “When it filed the lawsuit, it was taking aim at more narrow restrictions on abortion. Now it could file suit in a place that bans all abortion including medication abortion, essentially takes the first drug of a medication abortion out of those state markets. So I think in a sense that some of the legal questions have shifted because the nature of some of the laws have shifted.”

After the ruling in Dobbs, GenBioPro submitted a filing arguing that the state's abortion ban – including pills – created a “that-much-more direct and glaring conflict” with the FDA's approval of the drugs. It also sought to submit an amended complaint to address Mississippi's trigger law. 

The Attorney General's Office argued in an Aug. 4 filing that Mississippi's trigger ban did not “impermissibly regulate the safety or efficacy” of an FDA-approved drug but rather prohibited “primary conduct—performing abortions—that the State is constitutionally entitled to prohibit.”

The brief also claimed that federal law criminalizes mailing abortion pills anywhere in the United States, citing laws that the Department of Justice has not enforced for decades. 

Instead of filing an amended complaint by its deadline of Aug. 18, GenBioPro dismissed its lawsuit.

Laurie Sobel, associate director for women's health policy at KFF, a nonprofit focused on health policy research, said she anticipates GenBioPro will file a new lawsuit in a different jurisdiction, or another manufacturer could seek to make a similar case. The preemption argument could potentially be used in any state where medication abortion is tightly regulated or banned. 

“I don't think this issue is going away,” she said. “The issue that everyone is now kind of focused on is where does regulation of medication come down to? Does the FDA get to regulate it as its sole domain? Or because it's used for abortion, do states get to regulate it with respect to abortion?”

Rebouché said there are few precedents to predict how the arguments around preemption could play out. The closest analogy is likely state regulations of opioids: A Massachusetts ban on Zohydro, a new and controversial but FDA-approved opioid, was overturned by a federal court that found the state ban was preempted by federal law.

“It's a novel argument in a sense that preemption has been around for a very long time – it's part of the constitutional structure – but states really haven't tried to ban FDA-approved drugs,” she said.

Before Mississippi's abortion ban took effect, medication abortion accounted for well over half of the procedures performed at the state's only abortion clinic. 

The FDA approved the pills in 2000. From then until 2017, it recorded 22 deaths among people who used mifepristone, or an average of one in 155,000, compared to a maternal mortality rate of 17 in 100,000 as of 2018.

Now, abortion rights supporters and opponents agree that the pills remain a major battleground in Mississippi and other states. Local advocates have vowed to help people get the pills, and international nonprofits and pharmacies have pledged to keep writing prescriptions and mailing drugs to Americans in states that ban abortion. 

Because states lack authority over the postal service, it's unclear what they can do to stop the pills. But Mississippi lawmakers plan to try. 

Sen. Joey Fillingane, R-Sumrall, told Mississippi Today in May that the Legislature could pass a law targeting medication abortion specifically and directing law enforcement to focus on that issue.

“We know this is a new layer of law enforcement that we're going to be expecting of you, in the agency, attorney general's office — whomever it'll apply to. You're going to need more staff, you're going to need more resources in order to enforce that new law,” Fillingane said. “It could very well be not only a directive further fleshing out the trigger law language, but also an appropriations bill that sends money to that agency and agencies that will be tasked with enforcing the law.”

This article first appeared on Mississippi Today and is republished here under a Creative Commons license.