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O What A Tangled Web We Weave: The Fate of Mifepristone in Judge Kacsmaryk's Court



By LWVOR Action Committee Member Trish Garner


There are really two -- or more -- interrelated issues that are raised here. One, of course, is whether the U.S. Food and Drug Administration (FDA) has the authority to allow the dispensing of Mifepristone by mail instead of requiring an in-person dispensing process. The other issue relates to court-shopping and the conservative leaning of the Fifth Circuit's judiciary, and, in particular, Federal District Court Judge Matthew Kacsmaryk whose docket currently includes a case that presents this very issue.


The Mifepristone / Misoprostol Abortion Regimen


These medications are taken together. The regimen usually involves first taking Mifepristone (brand name Mifeprex) up to 10 or 13 weeks since the last menstrual period, and then two doses of Misoprostol. Multiple randomized controlled clinical trials have shown that this combination is effective with success rates ranging from 95-98% up to 9 weeks of gestation.[1] The FDA approved this regimen in 2000 as a safe and effective way to end early pregnancies. Mifepristone is also frequently used in the US, as shown in a 2020 Center for Disease Control Report which found that about 51% of abortions in the US were performed by taking Mifepristone at or before the 9th week of pregnancy.[2]


Mifepristone's regulatory history is somewhat complicated.[3] When the FDA initially approved dispensing the medication in 2000, it required that it be dispensed only by qualified physicians and administered in hospital, clinic or medical office settings. In 2007 the FDA deemed these restrictions constituted a proper "Risk Evaluation and Mitigation Strategy" (REMS), and in 2011 it approved the existing REMS with additional "Elements to Assure Safe Use" (ETASU). The ETASU requirements included a mandate that the drug be prescribed only by specially certified physicians, that it be dispensed only in hospitals, clinics or medical offices and that a patient needed to sign a special patient agreement form. In 2016 the FDA issued a report that resulted in the modification of some of its these restrictions, including that Mifepristone could be prescribed by certain nonphysicians as long as they met certain certification requirements and the medication could be dispensed in a clinic, medical office or hospital, which the patient could then swallow at home. The onset of the COVID-19 pandemic led the Trump administration in March, 2020 to declare a national emergency and in response the FDA suspended enforcement of REMS in-person requirements for a number of medications and procedures -- but this action did not extend to the dispensing of Mifepristone.[4] Patients still had to travel to a health center to receive the pill in person.


First Go-Round in a Federal Court


In May, 2020 and on behalf of medical associations, physicians and reproductive justice advocates, the American Civil Liberties Union filed a lawsuit (American College of Obstetricians and Gynecology "ACOG" v FDA) seeking to suspend FDA's in-person pill pick-up requirement, noting that this was the only medication out of 20,000 FDA-approved drugs that patients were required to pick up in a clinical setting but free to self-administer at home.[5] They also asked that a preliminary injunction be issued to bar enforcement of FDA's in-person requirements. On July 13, 2020 US District Court Judge Theodore Chuang issued that preliminary injunction, but on August 16, 2020 the government, still under the auspices of the Trump administration filed a motion requesting that the injunction be placed on hold pending the conclusion of the litigation. On January 12, 2021 the US Supreme Court granted the FDA's request for a stay of Judge Chuang's preliminary injunction by issuing a rather controversial one-page, unsigned opinion.[6] Chief Justice Roberts concurred in the opinion, stating the question for the Supreme Court was not whether requirements for dispensing Mifepristone imposed an undue burden on a woman's right to an abortion as a general matter, but whether Judge Chuang made his own evaluation of the impact of the COVID-19 epidemic rather than according sufficient deference to the "politically accountable entities with the background, competence and expertise to assess public health," i.e. the FDA.


On December 16, 2021 the FDA, now under the Biden administration, announced that it would permanently allow patients to receive Mifepristone by mail instead of requiring them to obtain the pills in person from specially certified providers.[7] Again, in making its decision the FDA could point to a 22-year history of Mifepristone’s safety and effectiveness. Should approval for prescribing Mifepristone be overruled by court action in the future, a re-approval process would likely take years. As we will see below, it is considered likely that shortly after February 24, 2023, US District Court Judge Matthew Kacsmaryk will in fact overrule the mail-in dispensing of Mifepristone. We can also add in the time it takes for his decision to reach the US Supreme Court. Its reception there may also be problematic for those needing Mifepristone.


Background of Federal District Court Judge Matthew Kacsmaryk


Judge Matthew Kaczmarek was first nominated by President Trump to sit in the Federal Court for the Northern District of Texas located Amarillo in 2017, but the nomination died at the end of the Congressional Session. President Trump resubmitted his name to the Senate on January 23 and his judgeship was approved on June 19, 2019. Only one Republican, Maine Senator Susan Collins, publicly opposed the nomination ahead of the 52 to 46 vote. He had received a "qualified" rating by the American Bar Association, which is a ranking below "well qualified."[8]


Judge Kacsmaryk has long standing affiliations with the religious right. His photograph[9] communicates a great deal. Prior to his appointment to the federal bench he represented the Oregon bakery "Sweet Cakes by Melissa" that refused to provide a wedding cake for a same-sex couple. He served as a former deputy counsel at the First Liberty Institute, a conservative group that litigates religious liberty cases. On September 4, 2015, he wrote an amicus ("friend of the court") brief that opposed same-sex marriage and policies allowing transgender students to use restrooms that match their gender identity on the grounds that it contradicted the "Abrahamic" or "Catholic, Protestant, Evangelical, Jewish, Mormon, Muslim" principles defining marriage as the "sacred union of one man and one woman." In this article, he also criticized the "sexual revolution" and said it was "spearheaded by secular libertines."[10] According to Judge Kacsmark, transgender people have a "mental disorder" and gay people are "disordered." He was a member of the Fort Worth Chapter of the Federalist Society since 2012.[11]


Judge Kacsmaryk's decisions run true to his political and religious orientations. He has been characterized as "a favorite judge for litigants opposing Biden administration policies." The Fifth Circuit Court of Appeals has also implicitly concurred with this approach. In September, 2022 the District Court adopted rules that any civil case filed in Amarillo would be assigned to Judge Kasmaryk. Before that, litigants had a 95% chance of getting Judge Kacsmaryk.[12] As we will see, the Supreme Court has not exactly distanced itself from Judge Kacsmaryk's approach either, particularly in light of its decision in Dobbs v. Jackson Women's Health Organization.


Background of Some Decisions by Judge Kacsmaryk Prior to the Mifepristone Cases


In Deanda v. Becerra (Health and Human Services Secretary; December 2022) Judge Kacsmaryk awarded summary judge to the plaintiff, an avowed Christian who had claimed his statutory and parental rights under the US Constitution had been violated by a Title X program that provided grants to health providers to fund family planning and contraceptive care.[13] Legal commentary has taken issue with this decision on the basis the plaintiff lacked the standing[14] to sue. The plaintiff was a father who did not claim he had ever sought Title X funded care, did not allege his daughters had ever sought this care and didn’t even claim they intended to seek such care in the future. Judge Kacsmaryk also ruled that Title X federal regulations do not preempt Texas state law regarding parental notification and consent requirements, a decision which is a "clear misinterpretation of the law" and "ignores decades of established law."[15]


There is also Neese v Becerra in which Judge Kacsmaryk (November, 2022) held that a federal law prohibiting certain forms of discrimination by health providers does not encompass protection against anti-LGBTQ discrimination. Legal commentary indicates that this opinion cannot be squared with the Supreme Court's decision in Bostock v. Clayton County (2020) which established that statutes prohibiting "sex" discrimination also ban discrimination on the basis of sexual orientation or gender identity because "it is impossible to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex." It has been noted that Judge Kacsmaryk seems to "revel" in defying the law. An example of this attitude is seen in his Neese opinion which he opens with a quote from Justice Samuel Alito's dissenting opinion in Bostock. Needless to say, a dissent is by definition not the law.[16]


Another interesting case (Biden v Texas) relates to Judge Kacsmaryk's decision regarding the Remain in Mexico program. The program had been initiated in 2018 under the Trump administration and required asylum seekers arriving at the US Southern border to stay in Mexico while they awaited a hearing on their asylum claim. President Biden sought to terminate the policy and on June 1, 2021 the Secretary of Homeland Security announced that it would end the program. Texas filed this lawsuit against President Biden and on August, 2021 Judge Kacsmaryk issued a permanent injunction requiring the government to reinstate the program.[17] His order gave the administration one week to do so. His ruling rested on his conclusion that he could only give the government two options regarding those seeking asylum: mandatory detention or return to a contiguous territory. Upon appeal to the Supreme Court, six Justices agreed that Judge Kacsmaryk had misread immigration law when he required the federal government to maintain the Trump-era program by his ignoring that fact that federal law explicitly gives the government more than two options in these situations, including the option for immigrants to parole into the United States “for urgent humanitarian reasons or significant public benefit.” The Supreme Court also commented that the judge had engaged in “unwarranted judicial interference in the conduct of foreign policy,” because his opinion effectively forced the United States government to bargain with Mexico in order to reinstate the Remain in Mexico policy.[18] What seemed to be a victory for the Biden administration, however, became a hollow one when the Supreme Court also returned the case back down to Judge Kacsmaryk to resolve other issues raised in the case

and in doing so rejected the government's request to temporarily block the injunction issued by Judge Kacsmaryk.


An Earlier Mifepristone Case filed in Maryland


On May 17, 2020, American College of Obstetricians and Gynecologists, and others sued the FDA (ACOG v FDA) in the District of Maryland (federal court) seeking a declaratory judgment that the in-person requirements for the dispensing of Mifepristone during COVID-19 epidemic should be overruled.[19] The Complaint described the long history of Mifepristone’s safety and efficacy, and that of the more than 20,000 FDA approved drug products, the FDA subjected only 16 drugs to a REMS requirement that the patient obtain the medication in a hospital, clinic or medical office, two of which are Mifeprex and its generic Mifepristone. ACOG also noted the increased use and efficacy of telemedicine. The legal bases for ACOG's complaint were based on patients' rights to privacy and liberty as guaranteed by the due process clause of the Fifth Amendment (substantive due process) and the equal protection clause under the Fifth Amendment. ACOG also requested the issuance of a preliminary injunction to bar enforcement of signature and in-person dispensing requirements for Mifepristone while the lawsuit was pending.


On July 13, 2020 US District Court Judge Theodore Chuang granted the ACOG's request, but on January 12, 2021, in a controversial format, i.e. a one-page, unsigned opinion, the U.S. Supreme Court stayed enforcement of Judge Chuang's issuance of the preliminary injunction pending appeal. Justice Roberts wrote a concurring opinion, stating that the question before the Court was not whether requirements for dispensing Mifepristone imposed an undue burden on a woman's right to an abortion as a general matter, but whether the District Court properly ordered the FDA to lift those requirements on the basis of Judge Chuang's own evaluation of the impact of the COVID-19 pandemic on Mifepristone use. The case was then returned to Judge Chuang.


On April 13, 2021 the FDA under the Biden administration temporarily halted the enforcement of Mifepristone's in-person requirement.[20] On December 16, 2021 the FDA permanently lifted the in-person requirement.[21] In June, 2022 The Supreme Court overturned Roe v Wade in the Dobbs v Jackson Women's Health Organization case.


Judge Kacsmaryk and the Alliance for Hippocratic medicine vs FDA


We now get to the case regarding Judge Kacsmaryk's decisions regarding the dispensing of Mifepristone. On November 18, 2022 the Alliance Defending Freedom (ADF) filed a lawsuit in Amarillo along with a request for the issuance of a preliminary injunction against the FDA asking that it reverse its lifting of the in-person requirement for dispensing Mifepristone (Alliance for Hippocratic Medicine v FDA[22]). The Alliance for Hippocratic Medicine was incorporated only 3 months (August 5, 2022) in Texas, of course, before they filed this lawsuit. As an aside however, it is interesting to note that AHM's official mailing address is in Tennessee. The Alliance Defending Freedom is a Christian organization that played a central role in Dobbs.[23] The Alliance claimed that (1) the FDA abused its authority by using an accelerated process to approve the use of Mifepristone in 2000 which is reserved for new drugs which would benefit patients with serious or life-threatening illnesses, (2) FDA's approval of Mifepristone "puts a woman or girl's health at risk," and (3) its decision violates the Comstock Act (Title 18 US Code Section 1461,enacted in1873) which declares anything designed or intended to produce an abortion as nonmailable.


The government countered on both substantive and procedural grounds. It stated that (1) pulling Mifepristone from the market would put more women's health at risk, and risk overcrowding and delays at clinics that provide surgical abortion, (2) contrary to Mifepristone being approved under an accelerated path as claimed by the plaintiffs, its approval was based on extensive scientific evidence, and (3) the Comstock Act [see below] does not prohibit the delivery of Mifepristone. It also characterized the lawsuit as "extraordinary and unprecedented," noting that it "could not find any previous example of a court second-guessing an FDA decision to approve a drug."[24] It also added that a decision in favor of ADF would “upend the status quo and the reliance interests of patients and doctors who depend on Mifepristone, as well as businesses involved with Mifepristone distribution.”


The Comstock Act of 1873 which was cited by the plaintiffs as a basis for their cause of action currently declares that "'[e]very article or thing designed, adapted, or intended for producing abortion,' as well as '[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion,' to be 'nonmailable matter' that the United States Postal Service (“USPS”) may not lawfully deliver." That might seem to apply to the mail order distribution of Mifeprestone. However according to settled law, the Comstock Act has a much longer and more complicated history and in fact prohibits delivery of abortion medications only when the sender intends to violate the law. This argument was detailed in a US Attorney General Opinion (December 23, 2022) issued in response to a request from the US Post Office. As stated there, in order to be unlawful under the Act and based upon "a longstanding judicial construction of the Comstock Act, which Congress ratified and USPS itself accepted," the mailing must be accompanied with an intent on the part of the recipient that the drugs will be used unlawfully.[25]

The FDA also argued that the 6-year federal statute of limitations barred the lawsuit and the plaintiffs lacked the standing to sue. As to the former, FDA's approval of Mifepristone was in 2000 and the lawsuit was filed in 2022. Also, Congress had enacted the Food and Drug Administration Amendments Act of 2007 that deemed any medication which was approved before the effective date of the Act was in compliance with relevant federal legal requirements.[26]


On the standing issue, the government pointed out that none of the individual nor the organizational physician member plaintiffs' had established standing or an "injury-in-fact." The complaining physicians were not themselves regulated by the FDA and did not purport to prescribe Mifepristone. Instead, they contended they "will" be injured because "other" physicians will prescribe it and the Mifepristone will cause adverse events, thereby forcing patients to seek care from other physicians, subjecting them to potential exposure to liability and insurance costs, and "potentially causing the patients to suffer grief, distress and guilt.[27] Not buying these arguments, the government countered, "Here, Plaintiffs do not even attempt to allege facts supporting the chain of causation. They do not corroborate any of the pecuniary harms that they purport to fear, nor any of the intangible concerns that they raise."


The reason that analysis of these substantive and procedural (standing, statute of limitations) issues is so critical is that in order for the Alliance for Hippocratic Medicine plaintiffs to prevail on their motion for a preliminary injunction, they must demonstrate a likelihood of success on the merits which includes passing procedural hurdles. The government appears to have established that the plaintiffs this have not met this standard.


Before concluding this analysis of Alliance for Hippocratic Medicine v FDA, it is interesting to note that in January, 2023, Danco Laboratories filed a motion to intervene in the case, claiming that forcing FDA to withdraw a longstanding approval would "seismically disrupt" the agency's governing authority as to whether drugs are safe and effective and would cause Danco "direct and immediate harm by shuttering its business." Because of Danco's entry into the case, briefing on a preliminary injunction is scheduled to end this February 24th. A decision from Judge Kacsmaryk is anticipated to follow shortly after this date.


The problem we face here is that given Judge Kacsmaryk's past history, there is more than enough reason to fear that, regardless of the above-cited law, he will grant the plaintiffs' motion for a preliminary injunction. Because this is a federal case, the impact would be felt nationwide. An appeal of that decision would go to the Fifth Circuit Court of Appeals which is a conservative court, with 12 of its 16 active judges appointed by Republicans. And then to the post-Dobbs Supreme Court.


Senator Wyden and Court-washing


It is into this maelstrom that on February 16, 2023 Senator Wyden made his claim of improper "court-washing."[28] Anticipating Judge Kacsmaryk's decision to grant the preliminary injunction, Senator Wyden said "Enough" to the "rigged game." In a historically significant move the Senator also pleaded that the FDA ignore Judge Kacsmaryk's anticipated ruling, just as President Lincoln ignored the "historically egregious" Dred Scott v Sandford ruling which held that black people could never be citizens of the United States. The Senator noted that the use of Mifepristone has fewer complications than Tylenol and that "a wealth" of evidence had demonstrated its safety and effectiveness, adding "Legal logic be damned, the plaintiffs know that Judge Kacsmaryk won't let pesky obstacles like standing or precedent to get in the way of the agenda they share." Wyden also pointed out that on 41 occasions the Trump administration had asked the US Supreme Court to put a hold on adverse lower court rulings for the duration of the government's appeal and in 28 of those cases, the Supreme Court, "aiding these polarization efforts," granted the stay. In comparison, the Biden administration has sought emergency relief from the Supreme Court 9 separate times. The Supreme Court has granted it on only two occasions. And "incredibly," the Court has granted emergency relief against the Biden administration four times, something that did not happen during the "lawless" days of the Trump administration.


Oregon State Attorney General Ellen Rosenblum has entered the fray by officially writing to Walgreens and CVS expressing appreciation for the recent announcement of their intention to start offering Mifepristone in their retail pharmacies.[29] Attorney General Rosenblum joined the Attorneys General from Washington and California, and 20 additional states in her plea; 20 Republican Attorneys General warned CVS and Walgreens that they could be violating the Comstock Act if they send the pills by mail.[30] Attorney General Rosenblum vigorously disagreed with the claim of the Republican Attorneys General that abortion pills are "far riskier than surgical abortions" and providing this medicine increases "coerced abortions." To the contrary, she states that providing abortion medications offer more private and flexible options for these personal and confidential choices.


Conclusion


As stated above, the web that is woven here is tangled indeed. Not only are the implications for women and families with the withdrawal of Mifepristone significant, but Judge Kaczmarak's legal prevarications and legalistic teasing threaten the fabric of a democracy based on the rule of law.


[1] https://www.ipas.org/clinical-update/english/recommendations-for-abortion-before-13-weeks-gestation/medical-abortion/mifepristone-and-misoprostol-recommended-regimen/ [2] https://www.cnbc.com/2022/11/23/abortion-pill-most-common-way-to-end-pregnancy-cdc-says.html; and Guttmacher Institute, Medication Abortion Now Accounts for More than Half of all US Abortions, https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions, updated 12-1-22 [3] https://www.supremecourt.gov/DocketPDF/20/20A34/151289/20200826115344506_20A- FDA v. ACOG Appendix FINAL a.pdf [4] https://www.aafp.org/dam/AAFP/documents/advocacy/prevention/women/LT-WH-Mifepristone-030121.pdf [5] American College of Obstetricians and Gynecologists v. US Food and Drug Administration, https://www.aclu.org/cases/american-college-obstetricians-and-gynecologists-v-us-food-and-drug-administration [6] https://www.supremecourt.gov/opinions/20pdf/20a34_3f14.pdf [7] https://www.nytimes.com/2021/12/16/health/abortion-pills-fda.html [8] https://www.dallasnews.com/news/politics/2019/06/19/in-middle-of-pride-month-senate-confirms-texas-judge-who-defended-bakery-that-turned-away-gay-couple/ [9] https://www.vox.com/policy-and-politics/2022/12/17/23512766/supreme-court-matthew-kacsmaryk-judge-trump-abortion-immigration-birth-control [10] https://www.thepublicdiscourse.com/2015/09/15612/ [11] https://www.judiciary.senate.gov/imo/media/doc/Kacsmaryk SJQ.pdf [12] https://www.abajournal.com/news/article/meet-the-texas-judge-who-is-a-favorite-of-conservatives-in-hot-button-lawsuits-including-abortion-pill-litigation [13] https://law.justia.com/cases/federal/district courts/texas/txndce/2:2020cv00092/330752/63/. The standard for granting summary judgment is that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law. The decision is made on briefs, not after a trial. [14] Standing to sue is basically whether a plaintiff has or will sustain direct injury or harm and that this harm is redressable. State laws differ but in federal court a plaintiff has to demonstrate: (1) an "injury in fact," meaning that the injury is of a legally protected interest which is (a) concrete and particularized and (b) actual or imminent; (2) there must be a causal connection between the injury and the conduct brought before the court; and (3) it must be likely, rather than speculative, that a favorable decision by the court will redress the injury. https://www.law.cornell.edu/wex/standing. [15] https://www.everybodytexas.org/january-11-2023-statement-on-deanda-v-becerra [16] See footnote 7 above. [17] https://www.scotusblog.com/wp-content/uploads/2021/08/21A21.pdf [18] See footnote 8; https://www.vox.com/2022/6/30/23189965/supreme-court-biden-texas-remain-in-mexico-john-roberts [19] https://www.aclu.org/cases/american-college-obstetricians-and-gynecologists-v-us-food-and-drug-administration; https://www.acog.org/-/media/project/acog/acogorg/files/advocacy/acog-v-fda-complaint-mifepristone-covid19.pdf?la=en&hash=2C5C6C65F3E6C8A693ACD649C7C12129 [20] https://www.nytimes.com/2021/04/13/health/covid-abortion-pills-mailed.html [21] https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation - :~:text=On December 16, 2021, the,in-person dispensing requirement”) [22] https://www.documentcloud.org/documents/23505124-alliance-for-hippocratic-medicine-sos-document [23] https://www.cnbc.com/2023/01/24/abortion-pill-fda-challenged-in-lawsuit-seeking-to-pull-mifepristone-from-us.html [24] https://www.cnbc.com/2023/02/10/abortion-pill-judge-extends-deadline-in-lawsuit-seeking-to-pull-medication-from-us.html; https://storage.courtlistener.com/recap/gov.uscourts.txnd.370067/gov.uscourts.txnd.370067.28.0.pdf [25] https://www.justice.gov/olc/opinion/file/1560596/download. [26] https://www.vox.com/politics/2023/2/17/23603182/supreme-court-abortion-mifepristone-ron-wyden-senate-fda-matthew-kascmaryk [27] https://storage.courtlistener.com/recap/gov.uscourts.txnd.370067/gov.uscourts.txnd.370067.28.0.pdf [28] https://www.facebook.com/senatorronwyden/videos/879092286541141 - video; https://www.wyden.senate.gov/news/press-releases/wyden-delivers-floor-speech-calling-on-president-biden-and-the-fda-to-keep-mifepristone-on-the-market-regardless-of-outcome-in-texas-case - the text of Senator Wyden's speech; https://www.vox.com/politics/2023/2/17/23603182/supreme-court-abortion-mifepristone-ron-wyden-senate-fda-matthew-kascmaryk - commentary. [29] https://www.doj.state.or.us/wp-content/uploads/2023/02/Multistate-Pharmacy-Letter-2023-02-16.pdf [30] https://www.opb.org/article/2023/02/16/attorneys-general-support-letter-abortion-pills-by-mail/

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