U.S. District Judge Matthew Kacsmaryk has ruled that the states of Missouri, Kansas, and Idaho can intervene and file a complaint in an abortion pill lawsuit originally filed by a group of pro-life physicians. The three states filed their petition in October of 2024, claiming their “sovereign” interest in “protecting… citizens” was violated by the Food and Drug Administration’s (FDA) decision to allow mail-order abortion pill dispensing.
Last year, the United States Supreme Court ruled that the plaintiff doctors in the Alliance for Hippocratic Medicine (AHM) lawsuit did not have standing to sue. The October 2024 lawsuit in State of Missouri; State of Kansas; State of Idaho v. FDA filed by the three states sought to intervene in that case.
Judge Kacsmaryk rules three states can intervene in abortion pill lawsuit
States Challenge Expansion of Abortion Pills
“The states are challenging the FDA actions that have loosened restrictions on the drug since 2016, including approving it for use in the first 10 weeks of pregnancy and allowing it to be prescribed by telemedicine and sent through the mail,” The Hill reported.
The abortion pill Mifeprex (mifepristone) was approved by the FDA in September 2000 “for medical termination of pregnancy,” the FDA website states. “FDA approved a generic version of Mifeprex, Mifepristone Tablets, 200 mg, in April 2019.”
In 2016, the Obama administration FDA weakened the safety system (REMS) for the drug by removing requirements that women take the first drug in front of a clinician in person, at the location of a certified prescriber. It also expanded use of the drug to abort preborn children up to 10 weeks (70 days) of pregnancy from the previous seven weeks, and removed the requirement for the manufacturer (Danco, and now GenBioPro) to report the drug’s non-fatal adverse events (complications). Only deaths, from that point on, would need to be reported.
By December of 2021, the Biden-Harris FDA had further weakened the REMS by eliminating the in-person dispensing requirement and enabling the abortion pill to be permanently shipped by mail. Then in January 2023, the Biden-Harris FDA further gutted the REMS by announcing it would allow retail pharmacies to dispense the drug.
All of this was done by the FDA, the states say, “without any studies that evaluated the impact of removing all of these interrelated safeguards at once.” Live Action News previously noted that “The suit adds that the undoing of the requirement to report ‘non-fatal complications’ was ‘unreasonable’ because it was ‘based on past data collected under the originally approved safety standards, not the new deregulated regime.'”
Lawsuit: Three States Seek to Reinstate Abortion Pill Regulations In Place Prior to 2016
In their October 2024 lawsuit, the Plaintiff States requested a “preliminary injunction” from the Court against the FDA, or “a stay of the effective dates” that “reinstates the REMS that were in place before 2016 insofar as they restore the Day 3 and Day 14 follow-up visits, restore the gestational age to 7 weeks from 10 weeks, restore the requirement that prescribers be physicians, and restore the requirement that prescribers must report all serious non-fatal adverse events to the agency; rescinds the 2019 generic approval; and restores the in-person dispensing requirement.”
The three states were initially asking the court to “issue[] a permanent injunction ordering Defendants to withdraw Defendants’ actions to deregulate these abortion drugs.”
Missouri, Kansas and Idaho allege that “Women face severe, even life-threatening, harm because the federal government has disregarded their health and safety. These dangerous drugs are now flooding states like Missouri and Idaho and sending women in these States to the emergency room.”
As such, the lawsuit also alleged that “Defendant U.S. Food and Drug Administration (FDA) has the statutory responsibility to protect the health, safety, and welfare of all Americans by putting commonsense safeguards on high-risk drugs[;] the FDA has failed in this responsibility by removing many of the safety standards it once provided to women using abortion drugs.”
Comstock Act In Play
In their October 2024 complaint, Kansas, Missouri, and Idaho were seeking to enforce a law (18 U.S.C. § 1461) known as the Federal Comstock Act, which prohibits the mailing of “any article, instrument, substance, drug, medicine, or thing [that] may, or can, be used or applied for producing abortion[.]”
They claim that “[t]he FDA’s 2021/2023 Removal of the In-Person Dispensing Protection violates the federal laws that expressly prohibit the mailing or delivery by any letter carrier, express company, or other common carrier, or by interactive computer service, of any substance or drug intended for producing abortion” by “impermissibly remov[ing] the in-person dispensing requirement for abortion drugs and, accordingly, authorized the downstream distribution of abortion drugs by mail, express company, other common carriers, and interactive computer service.”
“Because a federal agency cannot permit what federal law expressly prohibits, the FDA lacked legal authority when issuing the 2021/2023 Removal of the In-Person Dispensing Protection,” the lawsuit claimed. That decision “failed to account for or address the federal laws that prohibit the distribution of abortion drugs by postal mail, express company, or common carrier and by interactive computer service,” the lawsuit notes. “FDA permitted and sometimes even encouraged these illegal activities. But a federal agency cannot authorize unlawful actions.”
Today, abortion providers in multiple states are admittedly shipping the drugs “unlawfully” into states that prohibit them or restrict telehealth dispensing. In fact, abortion pills continue flooding into states that either restrict abortion or fully protect preborn children except when the life of the mother is at risk.
This blatant disregard for state law is what prompted the states of Missouri, Kansas, and Idaho to file suit last October in Amarillo, Texas, and to ask the Courts to weigh in on the expansion of the abortion pill, as Live Action News previously reported. The plaintiffs in State of Missouri; State of Kansas; State of Idaho v. FDA requested that the Courts enforce the Comstock Act and grant them the ability to “vindicate [their] sovereign, quasi-sovereign, and proprietary interests, including [their] interests in protecting [their] citizens.”
At least two U.S. Supreme Court Justices previously hinted that the Comstock Act could be in play during oral arguments in the Alliance for Hippocratic Medicine (AHM) v. Food and Drug Administration (FDA) lawsuit, which challenged the legitimacy of the FDA’s recent expansions of the abortion pill. While not ruling on the merits of that case, the Court later ruled that the Plaintiffs (the physicians) did not have standing to bring suit.
Just days ago, a New Mexico Supreme Court ruling which appeared to go against pro-life Sanctuary City Ordinances in the state, “thrilled” pro-life advocates and legal representatives who passed the pro-life measures, because the ruling acknowledged the validity of the federal Comstock Act, which prohibits the mailing of abortion-inducing drugs and other devices.
The New Mexico Supreme Court document mentioned a recent Department of Justice slip opinion which argued that the long-held Comstock Act did not apply where “the sender lacks the intent that the recipient will use them unlawfully.”
This key phrase, “intends them to be used unlawfully” appears to indicate that the Comstock Act could be applicable when the sender mails abortion-inducing drugs where they are intended to be used “unlawfully.”
Despite the loss in the New Mexico case at the state level, Mark Lee Dickson, Founder of the Sanctuary Cities for the Unborn Initiative, emphasized that he did not believe the New Mexico Supreme Court realized “what they have done,” suggesting this case could lead to a Supreme Court showdown.
In other words, it is beginning to look like there could be multiple petitions to the U.S. Supreme Court to rule on Comstock.
U.S. District Judge Kacsmaryk’s January 2025 Ruling
In his ruling on January 16, 2025, U.S. District Judge Matthew Kacsmaryk claimed the states of Idaho, Missouri ,and Kansas were requesting to intervene in the original AHM lawsuit in order “to provide greater factual support for the theories presented in the initial complaint.”
However, both the Food and Drug Administration (FDA) and Danco, the latter of which oversees U.S. manufacturing of the abortion pill, argued that the intervenor Plaintiff states “lack venue.”
In response, Kacsmaryk’s ruling claimed the Defendants failed to show how the three states’ amended complaint would “fail a motion to dismiss” adding that this “does not provide the Court with a ‘substantial reason’ to deny leave.”
“Accordingly, the Court GRANTS intervenor Plaintiff’s motion,” the document stated. “The Court orders Intervenor Plaintiffs to file the amended complaint and accompanying exhibits… as a separately filed amended complaint and exhibits.”
“Unlike in the cases Defendant [FDA] and intervenor Defendant [Danco] cite, venue remains disputed here and should be properly dealt with at a phase where each party may fully argue the issue,” Judge Kacsmaryk’s ruling stated.
Kacsmaryk, in denying the Defendant’s order to dismiss, suggested that the FDA and Danco submit a renewed motion to dismiss.
“As a substantial portion of the pending motions to dismiss focus on original plaintiff’s complaints and the only remaining complaint in this action will soon be amended, the Court denies as MOOT the pending motions to dismiss,” the ruling stated.
Kacsmaryk’s ruling claims to seek to provide the FDA and Danco “opportunity to focus their arguments and space on the one complaint remaining in this action.”
Live Action News will continue to monitor this important case.
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