Threat of nationwide ban is over, likelihood of newly imposed restrictions on expanded, FDA-approved availability dimmed...
By Ernest A. Canning on 12/21/2023, 12:35pm PT  

Believe it or not, we have good news at year's end from our otherwise radicalized and corrupted U.S. Supreme Court regarding abortion rights.

SCOTUS' recent decision [PDF], in Alliance for Hippocratic Medicine v. Food & Drug Adm., to hear the abortion pill case in response to the Petition [PDF] filed by the Biden Administration's U.S. Solicitor General and to grant the Petition [PDF] filed by manufacturer Danco Laboratories --- together with its denial of AHM's Cross Petition [PDF] --- is an encouraging development for reproductive liberty.

The Alliance for Hippocratic Medicine (AHM) is a group of right-wing Christian physicians who sought, and initially obtained, a nationwide ban on the prescription, sale, distribution and use of mifepristone --- a medication first approved by the FDA in 2000 as part of a two-drug regimen to terminate early-stage, intrauterine pregnancies.

According to the FDA's January 2023 Risk Evaluation and Mitigation Strategies [REMS] determination for the drug, mifepristone enables a woman "to end an intrauterine pregnancy through ten weeks gestation," during which it is found to be both 98% effective and safer than Tylenol.

On April 7, 2023, however, Judge Matthew Kacsmaryk, a Trump appointed, Texas-based U.S. District Court Judge, issued a preliminary injunction that imposed a nationwide ban on mifepristone. Before being tapped by Trump, Kacsmaryk was an anti-choice activist and is regarded by many as a right-wing religious zealot. His ruling was in direct conflict with a separate decision issued on the same day by U.S. District Court Judge Thomas O. Rice in Washington State. Rice ordered the FDA to keep mifepristone on the shelves of 14 States and the District of Columbia.

Although the conservative 5th Circuit Court of Appeals refused to stay Kacsmaryk's nationwide ban, the U.S. Supreme court, in late April, by way of a 7 - 2 Decision [PDF] (with Justices Alito and Thomas dissenting), granted a stay of both the 5th Circuit and Judge Kacsmaryk's temporary, nationwide ban on mifepristone. By the express terms of the April 21 SCOTUS decision, the stay would remain in effect until the end of the appellate process.

Because the Supreme Court has now granted both the government's and mifepristone manufacturer Danco's petitions for certiorari, at a minimum, that stay will remain in effect until the Supreme Court issues its final ruling.

Kacsmaryk's original total ban rested upon what, even then, seemed like a tenuous AHM effort to evade a six-year statute of limitations with respect to the FDA's initial approval of mifepristone that was issued while Bill Clinton was still in office. The Supreme Court's denial of the AHM cross-petition, which contested the 5th Circuit's ruling [PDF] --- that the effort to contest the 2000 approval is barred by the statute of limitations --- is now final.

Thus, the judicial threat of a nationwide ban on mifepristone no longer exists!

One of the two remaining issues, however, entails whether the 5th Circuit erred in finding that the FDA acted in an arbitrary and capricious manner in its subsequent REMS determinations, years after the 2000 approval. (Those subsequent REMS determinations, based upon extensive medical studies and worldwide practical use, made it easier for patients to obtain access to mifepristone). But before the Supremes can even reach that issue, they face the threshold question as to whether AHM physicians who do not even use or prescribe mifepristone have Article III standing to file their legal challenge to the FDA-approved abortion pill in the first place...

Previously successful arguments

It is critical to note that the arguments set forth in the Solicitor General Elizabeth Prelogar's petition for cert are essentially the same arguments she presented in her successful application for a stay. While it only takes four (4) Justices to grant cert, seven (7) Justices previously found those arguments sufficient to warrant the stay.

In her stay application, Prelogar referenced an attached Declaration from the FDA. The Solicitor General argued that, if allowed to take effect, the lower courts' decisions would upend decades of existing caselaw as well as the FDA's long, well-established approval process for all pharmaceuticals, not just mifepristone. That, she observed, would result in chaos and disruption to the healthcare system on a national scale.

"No prior decision has endorsed the lower courts' approach to review FDA's decisions regarding drug approvals and REMS [Risk Evaluation and Mitigation Strategies] which would deeply disrupt the pharmaceutical industry," Prelogar asserted, adding a quote from a pharmaceutical industry amicus brief submitted in opposition to Kacsmaryk's radical ruling --- a quote that can also be found in an open letter signed by more than 500 pharmaceutical executives and researchers:

If allowed to take effect, the district court's decision will result in a seismic shift in the clinical development and drug approval processes, erecting unnecessary and unscientific barriers to the approval of lifesaving medicines, chilling drug development and investment, threatening patient access, and destabilizing the pharmaceutical industry.

(In that regard, it is worthwhile to note the existence of mifepristone's medical benefits unrelated to early pregnancy termination. Mifepristone has also been found to be effective in the treatment of endometriosis and uterine fibroids. Those uses are also adversely affected by the lower courts' radical rulings.)

Both the stay application and cert petition also laid out why the AHM physicians lack standing to serve as plaintiffs in the first place.

The now-granted cert petition notes:

To demonstrate Article III standing, "a plaintiff must show (i) that he suffered an injury in fact that is concrete, particularized and actual or imminent; (ii) that the injury was likely caused by the defendant...[Citation]. To establish injury in fact, respondents [the AHM physicians] were required to show "an invasion of a legally protected interest" that is both "concrete and particularized, not conjectural or hypothetical." [Citation].

The Solicitor General, citing controlling Supreme Court precedent, laid out, in detail, how AHM's theory of standing, subsequently embraced by the 5th Circuit, is grounded upon a series of impermissible speculative and improbable, if not altogether absurd, contingencies.

The identity and persuasive nature of the core legal arguments presented in both the stay application and cert petition are significant. As attorney and Slate journalist Mark Joseph Stern observed in a Tweet following issuance of the Court's 7 - 2 order granting the stay:

The fact that Roberts, Gorsuch, Kavanaugh, and Barrett voted to halt the decisions below --- and that Alito did not even try to defend Kacsmaryk or the 5th Circuit, on standing or the merits --- strongly suggests that the Supreme Court will NOT use this case to ban or limit mifepristone.

Collateral questions

Questions will remain, however, about the scope of mifepristone's availability even if the government and Danco prevail.

As we noted in our initial coverage last January, GenBioPro, which provides the generic brand of mifepristone, filed a federal complaint alleging that application of West Virginia's abortion ban, with respect to mifepristone, is preempted by federal law. In Bryant v Stein, an OB/GYN presented the same preemption argument with respect to North Carolina's abortion ban.

Following a mostly adverse decision --- the District Court rejected the preemption argument except with respect to telemarketing --- GenBioPro appealed. The federal court, in Bryant, has not yet ruled on a defense Motion to Dismiss that was filed last August.

Stay tuned on that. But, for now, there may be a light at the end of the tunnel in response to the judicial anti-abortion zealotry conceived out of North Texas...

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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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