Explaining the bumpy and uncertain legal path toward protecting --- or ending --- a critical reproductive freedom in all 50 states
UPDATED 4/8/23: Conflicting preliminary injunctions issued by federal courts in WA & TX; 4/11/23 FDA seeks emergency appellate stay of TX case ruling...
By Ernest A. Canning on 2/20/2023, 9:35am PT  

The nationwide right to terminate a pregnancy with medication is now at stake in three pending federal lawsuits. One, in Texas, has been filed by abortion opponents. Another has been filed in West Virginia by a manufacturer of one of the drugs used to terminate a pregnancy, after state lawmakers have attempted to ban its use in the state. The third is a complaint from a physician in North Carolina where her ability to prescribe the drug may now be in peril.

The outcome of these three cases may ultimately succeed in protecting nationwide access to abortion rights even in states where Republican lawmakers have attempted to ban all such freedoms.

That said, while unlikely, it's also possible that one of these three cases could result in the elimination of the right to medical abortion in all 50 states...

The Cases

The first complaint [PDF] is Alliance for Hippocratic Medicine v. FDA, (hereinafter the "TX case"). It's a federal complaint filed in Texas last November, just months after the U.S. Supreme Court overturned the longstanding nationwide right to abortion. It's the most controversial of the three and involves a crusade by right-wing Christian physicians to overturn all FDA-approvals of the abortion drug known as mifepristone.

The second pending federal lawsuit [PDF], (the "WV case"), was filed late last month by the Nevada-based pharmaceutical company, GenBioPro ("GBP"). Since 2019, GBP has been the nation's only provider of an FDA-approved generic brand of mifepristone. GBP contests the constitutionality of a new criminal abortion ban by the state of West Virginia. The new WV law not only "prohibits abortion in all cases, at any stage of pregnancy," but also "severely constricted the market for mifepristone," according to GBP's complaint.

The third case, Bryant v. Stein [PDF] (the "NC case"), was filed in a U.S. District Court in North Carolina by Dr. Amy Bryant, a physician in the state. She is challenging the constitutionality of a provision in NC law that prevents her from prescribing mifepristone on the basis of one of the two grounds raised by GBP in the WV case.

The Stakes and the Trouble with Texas

Mifepristone is the first of a two-drug regime that, according to its Jan. 23, 2023 FDA Risk Evaluation and Mitigation Strategies [REMS] determination, enables a woman "to end an intrauterine pregnancy through ten weeks gestation (70 days or less since the first day of a patient's last menstrual period)".

The FDA's latest approval for the drug, published just last month, permits it to be dispensed by a physician or certified pharmacy/prescriber. The prescription may be issued without an in-person visit, for example via phone consultation. The FDA permits certified pharmacies to utilize, for delivery, shipping services that provide tracking. Based upon extensive medical data, the FDA determined that mifepristone "is safe when used as directed."

The TX case, challenging use of the drug, was filed in the Amarillo division of the Lone Star State's federal courts --- a division where, in accordance with a dubious 9/14/22 Special Order [PDF] by the Chief Judge in the Northern District of Texas, all cases must be assigned to the Trump-appointed right-wing Christian extremist Judge Matthew J. Kacsmaryk ("Judge K").

His mere assignment to the case prompted mainstream media scare headlines. For example, Vanity Fair warned: "An Anti-Birth-Control Trump Judge Could Soon Ban the Abortion Pill". That's understandable. Vox's Ian Millhiser described Judge K as "arguably the worst judge in the United States," noting that "Matthew Kacsmaryk's record reads like he's the villain in a parable about a puritanical witch-hunter."

However, a careful review of the legal filings in the case reveals that Judge K likely lacks jurisdiction to do anything other than simply dismiss the TX case. Even assuming he does have jurisdiction, the effort to overturn the FDA's initial approval of mifepristone is barred by a six-year statute of limitations. It was approved more than 22 years ago, while President Bill Clinton was in office.

The Manhattan-based Danco Laboratories is an intervenor-defendant in the TX case. The company has been the nation's only pharmaceutical provider of the brand-name version of mifepristone, ("Mifeprex"), since its first FDA approval in 2000. The arguments Danco presented in its Opposition to Plaintiffs' Motion for Preliminary Injunction [PDF] are compelling.

If Judge K simply ignores the clear bar of the statute of limitations (more on that below), the most that the crusading plaintiff physicians should hope for is a temporary disruption of the availability of medical abortions nationwide pending the issuance --- by the 5th Circuit Court of Appeals, or, if necessary, by the U.S. Supreme Court --- of an emergency stay of any such decision. (Even a brief disruption, of course, could seriously impact reproductive liberty. At present, medicinal termination of pregnancies account for more than half of all U.S. abortions and are particularly critical in states where lawmakers have curtailed surgical abortion.)

Both Dr. Bryant (plaintiff in the NC case) and GBP (plaintiff in the WV case) seek far-reaching declaratory and injunctive relief that, if granted and upheld on appeal, would prevent any of the 50 States from prohibiting the availability of mifepristone to women seeking medication abortions.

The drug's two corporate manufacturer's, Danco Laboratories and GBP, along with Dr. Bryant, have a chance to succeed at securing a nationwide right to terminate a pregnancy where others, beginning with the losing parties in last June's U.S. Supreme Court decision in Dobbs v. Jackson Women's Health Org., failed. Dobbs, as you'll recall, overturned nearly a half-century of case law that had protected reproductive liberties in all 50 States.

A Pending SCOTUS Dilemma

The seminal case, Roe v. Wade (1973), was based upon a recognition "that the right to liberty in the Constitution, which protects personal privacy, includes the right to decide whether to continue a pregnancy." That reasoning was expressly rejected by the U.S. Supreme Court's right-wing majority in Dobbs when it overturned Roe.

Neither Danco nor GBP contest Dobbs' rejection of Roe's liberty/privacy underpinnings.

Intervening defendant Danco begins its brief by noting:

More than 22 years ago, the FDA approved mifepristone as safe and effective for the medical termination of intrauterine pregnancies. In this unprecedented action, Plaintiffs ask this Court to upend that longstanding scientific determination based on speculative allegations of harm offered in support of claims and arguments that are untimely, un-exhausted, and without merit.

In the TX case, the right-wing Christian physicians based their assault on the use of mifepristone to terminate intrauterine pregnancies not upon the rationale of Dobbs, but, instead, upon provisions of the Administrative Procedures Act.

In its defense, Danco lays out a series of seemingly insurmountable obstacles for plaintiffs, including a six-year statute of limitations that bars their effort to contest the FDA's approval of mifepristone that issued more than 22 years before the TX case was filed.

GBP, meanwhile, argues that State laws, which either constrict access to medication abortion beyond what the FDA requires or which ban them altogether are preempted by federal law. GBP also argues that WV's ban imposes an unreasonable burden upon interstate commerce. Either issue could force a supposedly pro-business SCOTUS to have to choose between pharmaceutical profits and its recently-radicalized brand of right-wing social conservatism.

Legal Standing

The mere fact that the anti-abortion physicians and their organizations are displeased with the FDA's authorization of medicinal abortions does not give them legal standing to file a federal lawsuit to contest the agency's decisions. To the contrary, as Danco notes, citing applicable U.S. Supreme Court precedent, plaintiffs "must show (i) that (they) suffered an injury in fact that is concrete, particularized and actual or imminent; (ii) that the injury was likely caused by the defendants...Allegations of possible future injury are not sufficient."

The complaining physicians, Danco argues, are not directly impacted by the FDA regulations at issue because none of them prescribe mifepristone. Despite the established rarity of adverse reactions to the drug, the plaintiff physicians in the TX case offer only the speculative possibility that someone experiencing an adverse reaction may some day come to them for treatment, taking time away from their abilities to treat other patients. Those speculative hypotheticals are insufficient under existing case law to establish either injury in fact or causation.

That contrasts sharply with Dr. Bryant's assertion of standing in her NC case:

Plaintiff [Dr. Bryant] has standing because the challenged provisions of North Carolina law directly operate against Plaintiff by regulating her conduct and subjecting her to a threat of enforcement when she prescribes mifepristone or advises patients regarding the use of mifepristone.

Despite a likely religious desire to grant the relief sought by the anti-abortion physician plaintiffs in the TX case, the absence of legal standing should eliminate Judge K's jurisdiction to overturn any of the FDA several approvals of mifepristone.

Statute of Limitations and Exhaustion

In its brief, Danco described multiple FDA decisions that the physician plaintiffs are contesting in the TX case.

In 2000, the FDA approved mifepristone as "safe and effective for medical termination of intrauterine pregnancy through 49 days when used in a regime with an already approved drug, misoprostol," Danco argues, noting that, at the time, the "FDA imposed an in-person dispensing requirement."

In 2002, some of the TX case plaintiffs filed a citizens petition contesting the FDA's 2000 approval. The FDA denied that petition on March 29, 2016.

The legal complaint in the TX case was not filed until 11/22/22 --- more than six years after the FDA's denial of the 2002 citizens petition in 2016, and more than 22 years after the FDA's original approval of mifepristone.

Thus, despite mainstream media conjecture, the request in the TX case that Judge K impose a total ban on mifepristone is barred by the applicable 6-year statute of limitations (28 U.S.C. §2401(a)).

Danco, however, concedes that the statute of limitations does not bar the legal challenge to a 3/19/16 FDA REMS determination, which the agency issued pursuant to the Food and Drug Administration Amendments Act (FDAAA) of 2007. In that instance, the FDA extended the period in which mifepristone may be used from 49 to 70 days and "reduced the required number of in-person office visits to one."

On 12/16/21, the FDA not only rejected a 2019 citizens petition contesting those changes, but also determined "the REMS must be modified to remove the in-person dispensing requirement." Per the FDA: "The Mifepristone REMS Program does not require patients to see a health care provider in person before obtaining mifepristone for medical termination of pregnancy through ten weeks gestation."

Danco presents a persuasive argument for upholding both the FDA's 3/19/16 and 12/16/21 determinations. Its argument is based upon Supreme Court and 5th Circuit case law to the effect that the federal agency is due deference on drug safety determinations because "Congress deemed only the FDA as the scientific expert here --- not the federal courts".

Nevertheless, there's a significant risk that a far-right religious zealot in a robe will not afford appropriate due deference to the FDA's 2016 and 2021 REMS determinations by simply imposing a personally preferred outcome over the agency's science-based REMS determinations.

The good news is that a reversal of those two REMS determinations would not overturn the original 2000 authorization.

In the TX case, Judge K lacks jurisdiction to consider the validity of either the FDA's 2019 approval of GBP's generic version of mifepristone or the FDA's recent Jan. 23, 2023 REMS determination because the plaintiffs failed to file a citizens petition challenging either decision, as required. Under the doctrine of exhaustion, a party must pursue a remedy with the administrative agency before that party can challenge an administrative decision in court.

Doctrine of Preemption

The doctrine of preemption is derived from the U.S. Constitution's Supremacy Clause, establishing that federal law is the "supreme Law of the Land". Where a State law conflicts with a valid federal statute, as seemingly the case in both WV and NC, it is displaced or preempted by the federal law.

GBP alleges that WV's ban and restrictions "are preempted by the FDCA [Food Drug and Cosmetic Act]." They argue that "States may not restrict access to FDA-approved drugs in ways that countermand the agency's specific safety considerations."

That same preemption argument was presented in the NC case by Dr. Bryant with respect to a North Carolina statute. Significantly, North Carolina's Attorney General Josh Stein, a Democrat, signaled that he "won't defend state restrictions on dispensing [mifepristone]," according to AP. "Instead," they report, Stein will also "argue that the restrictions are preempted by federal regulations protecting access to the pills."

Also, the Commerce Clause

Finally, GBP correctly notes in their WV case that the Commerce Clause of the U.S. Constitution (Art. 1, §8, Cl. 3) "grants Congress alone the power to 'regulate Commerce...among the several States'". The Commerce Clause invalidates State laws that impose an "undue burden" upon interstate commerce.

The company's complaint alleges that the new WV law violates "the Commerce Clause by, in effect, banning an article of commerce and preventing [GBP] from developing its product, mifepristone, in West Virginia"...

Congress determined that mifepristone, a drug subject to a REMS, should be subject to FDA's determinations that balance the risks, against access. Individual state regulation of mifepristone destroys the national common market and conflicts with the strong national interest in ensuring access to a federally approved medication to end a pregnancy, resulting in the kind of economic fracturing the Framers intended the Clause to preclude.

GBP enhanced the economic interests at stake, by noting in their complaint the desire of WV's major pharmacy chains to provide mifepristone to their customers.

Uncertainties Ahead

Both the WV and NC cases present significant legal issues. How the courts react to those issues is currently an open question. But if the U.S. Supreme Court agreed with either the preemption or interstate commerce arguments, the WV and NC lawsuits could serve to partially restore reproductive liberties --- even in States where surgical abortions, since Dobbs, have now been banned or severely restricted --- by providing nationwide access to medication abortions in all 50 states.

It is not yet clear when hearings may be scheduled for the newly-filed WV and NC cases. It's not entirely clear when, if at all, the anti-abortion plaintiff physicians motion for a preliminary injunction will be heard in the TX case either. Though Reuters recently reported that, earlier this month, after receiving Danco's compelling opposition memorandum, the plaintiff physicians asked Judge K "to skip a hearing on a preliminary order and go straight to trial."

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UPDATE 4/8/2023: On April 7, 2023 a preliminary injunction was issued by far-right Judge Kacsmaryk in the TX Case purporting to ban the use of Mifepristone throughout the nation.

Moments later on the same day in State of Washington v. U.S. Food & Drug Adm., U.S. District Court Judge Thomas O. Rice issued what appears to be a conflicting opinion. He issued a preliminary injunction which prevents the FDA from altering the availability of Mifepristone. However, because Judge Rice declined to include a national reach for his order, the second preliminary injunction applies only to the States that were parties to that case, to wit: WA, OR, AZ, CO, CT, DE, IL, NV, MI, NM, MN, PA, RI, HI and the District of Columbia.

UPDATE 4/11/23:: On April 10, 2023 the DOJ, on behalf of the FDA, filed an Emergency Motion with the U.S. 5th Circuit Court of Appeal seeking a stay of the preliminary injunction issued in the TX case pending the outcome of the government's appeal.

The cases will be addressed in a new article after the 5th Circuit responds to the request for the emergency stay.

UPDATE 5/11/23: On May 5, 2023, U.S. District Court Judge Robert C. Chambers found that GenBioPro, Inc. had Article III standing to file its federal case challenging a ban on the sale of mifepristone in WV. Oral argument on other portions of the motion to dismiss will be heard on May 23.

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Ernest A. Canning is a retired attorney, author, and Vietnam Veteran (4th Infantry, Central Highlands 1968). He previously served as a Senior Advisor to Veterans For Bernie. Canning has been a member of the California state bar since 1977. In addition to a juris doctor, he has received both undergraduate and graduate degrees in political science. Follow him on twitter: @cann4ing

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