If case 'were about anything other than abortion,' plaintiffs would 'have no chance'

PART I: Mifepristone lawsuit

🔆This is Part I of a multi-part series examining the mifepristone lawsuit to be heard by the Supreme Court of the United States. Read the rest of the series here.

Outline:

1. Introduction

2. Who are the plaintiffs?

3. Case time-line

Introduction

The Supreme Court of the United States (SCOTUS) recently announced that it will hear two cases, which have been joined into a single case, that will ultimately “decide if the use of a popular abortion pill should be limited nationwide. The move marks a major milestone in the post-Roe abortion landscape.” [1] “The Justice Department and Danco Laboratories, the maker of Mifiprex (generic name mifepristone) asked the high court to hear their cases [now joined into one case] after the U.S. Court of Appeals for the Fifth Circuit issued a decision that would eliminate” the FDA's 2016 and 2021 eased access regulations and “put back restrictions in place prior to 2016. Those include changes in how far into a pregnancy mifepristone can be prescribed and whether it needs to be dispensed in person,” as well as a significant change in dosage. [2]

For nearly one hundred years, “federal law has recognized the FDA as the government decision-maker on whether medicines are safe and effective.” [3] Over the course of those many decades, “the FDA has ensured the safety of drugs and treatments in the United States. The FDA’s processes for assessing a drug’s or treatment’s benefits and risks are rigorous, involving extensive lab and clinic testing. The results are reviewed by experts in science and medicine before a drug or treatment is approved.” [4] Should the Supreme Court usurp FDA authority, the decision would have far reaching consequences beyond mifepristone, including other medications that are already FDA-approved and on the market, as well as new medications. In April 2023, thirty patient and provider groups emphasized, “Those [FDA] experts – not judges – are best equipped to determine the safety and efficacy of drugs and treatments.” [5]

“If the subject matter of this case were anything other than abortion, the plaintiffs would have no chance of succeeding in the Supreme Court. The plaintiffs are banking on the hope that because this is a case about abortion, the Court will bend ordinary principles of administrative law,” explains attorney Adam Unikowsky, who served as a Judicial Law Clerk to the late Supreme Justice Antonin Scalia, as well a clerk for Judge Douglas Ginsberg at the U.S. Courts of Appeals for the D.C. Circuit (emphasis mine). [6] Unikowsky identified four major flaws in the plaintiffs’ suit (image below), and published a detailed explanation of each (which I highly recommend).

Who are the plaintiffs?

The lead plaintiff in initiating case is the Alliance for Hippocratic Medicine (AHM), “a membership-based umbrella organization of anti-abortion medical groups” [7] that was “founded for the purpose of bringing this lawsuit.” [8] “Despite its name, AHM’s warped interpretation of the Hippocratic Oath,” which AHM has titled the Essential Hippocratic Oath, “directly contradicts the four principles of medical ethics by ignoring patients’ well-being and providing a limited, biased scope of care through coercive practices.” [9]

According to Mary Ziegler, a law professor and legal historian at the University of California, Davis, “the fact that the Alliance for Hippocratic Medicine was established to go after medication abortion isn’t surprising.” [10] Ziegler explained that “there is a tradition of groups like this forming.” [11] “Medical arguments against abortion bans were effective enough that they needed to be met with medical arguments for abortion bans,” she said, adding that “[t]here’s an appetite for these organizations to have their own narratives.” [12]

Alliance for Hippocratic Medicine is comprised of five existing anti-abortion organizations: 

🟢 American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG): The AAPLOG “is a group that uses its members’ medical certifications to push false information regarding abortion and birth control. Since most of its claims fall outside what is accepted by the medical and scientific communities, AAPLOG has accused other medical professionals of using ‘politically correct’ research.” [13] Like the Christian Medical and Dental Associations (CMDA), “AAPLOG is always scouting for new expert witnesses to lend credibility to their lawsuits and has been regularly hosting expert-witness trainings around the country.” [14]

🟢 American College of Pediatricians (ACPeds) (*It’s important to note that AHM member group American College of Pediatricians (ACPeds) is “often confused with the AAP, which is the premier and legitimate professional organization for pediatricians in the United States and is much larger than ACPeds, with 67,000 dues-paying members. Similar to how anti-abortion centers (AACs) mimic abortion clinics, ACPeds’ name is likely intentionally designed to be mistaken for the American Academy of Pediatrics. Simple searches for one organization will often return web pages that discuss the other, which can lead people to ACPeds’ disinformation, under the wrong impression that it is a credible source, while, in reality, ACPeds is a ‘fake medical organization.’” [15])

🟢 Catholic Medical Association

🟢 Christian Medical & Dental Associations (CMDA)

🟢 Coptic Medical Association of North America.

In addition to the Alliance for Hippocratic Medicine and its member groups, there are four individual anti-abortion plaintiffs: Dr. George Delgado, Dr. Regina Frost-Clark, Dr. Shaun Jester, and Dr. Tyler Johnson. 

🟢 Dr. George Delgado:

● Dr. Delgado is the director of medical operations at Culture of Life Family Services in Southern California. [16]

● Delgado is not an OB-GYN, but he serves on the board of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG). [17] *AAPLOG is a member of the lead plaintiff Alliance for Hippocratic Medicine (AHM).

● Delgado has suggested that newlyweds should consider dropping out of college rather than avoiding pregnancy. [18]

● In 2020, Delgado testified against public-health restrictions on behalf of megachurches during the Covid-19 pandemic. [19]

● Delgado is also a contributor to the Charlotte Lozier Institute (CLI), which is the “research and education” arm of the powerful anti-abortion lobbying group SBA Pro-life America. CLI pushes “alarmist narratives about abortion, publishing annual reports applauding state-level abortion restrictions, spreading lies about research employing fetal tissue and advocating for deceptive anti-abortion centers. Its ‘experts’ also do [SBA Pro-life America’s] bidding by testifying before Congress and speaking on panels at other extremist anti-abortion organizations.” [20] “[D]espite being founded as the ‘anti-abortion counter’ to the well-established Guttmacher Institute, it still relies on Guttmacher for data that health centers won’t give to CLI.” [21] CLI publishes lies claiming emergency contraception is an “abortifacient” and a “shrewd marketing scheme.” [22]  — Such claims are false. CLI is known for producing biased and flawed studies, including studies submitted as “evidence” in the mifepristone lawsuit. [23] 

● George Delgado is also the creator of the controversial “abortion reversal.” For years, Delgado “falsely claimed an affiliation to a prestigious US medical school,” the University of California San Diego (UCSD). [24] Delgado continued to do so “even after the university asked him to stop” in 2018. [25]

🟢 Dr. Regina Frost-Clark:

● Dr. Frost-Clark practices in the Catholic Ascension Healthcare system at Ascension Michigan St. John Hospital in Detroit. [26] 

● She is the former chair of the Christian Dental and Medical Association’s (CMDA) Women Physicians & Dentists in Christ ministry. [27] *CMDA is a member of the lead plaintiff Alliance for Hippocratic Medicine (AHM). “This is the second time group-plaintiff Christian Medical & Dental Associations tapped the Detroit-based Dr. Regina Frost-Clark to be a party in an abortion-related lawsuit.” [28]

🟢 Dr. Shaun Jester:

● Dr. Shaun Jester is the Medical Director of Moore County Obstetrics & Gynecology in Dumas, Texas. [29]

🟢 Dr. Tyler Johnson:

● Dr. Johnson is a Republican state senator of Indiana (District 14). [30]

● He is also an emergency room doctor at Parkview DeKalb Hospital in Auburn, Indiana. [31]

● Dr. Johnson is a member of the AAPLOG. [32] *AAPLOG is a member of the lead plaintiff Alliance for Hippocratic Medicine (AHM).

● Johnson is against abortion ban exceptions for the health of the mother and for fetal anomalies. [33] During legislative discussions in 2022, Johnson was questioned about his opposition to abortion in the case of fatal fetal anomalies. He was asked, “For that child to live outside the womb, they have to have a brain, they have to have a heart, they have to have lungs. If they lose those in that process, would you have that mother have that child?” Johnson replied, “Yes.” [34]

★ On January 12, 2024, U.S. District Judge Matthew Kacsmaryk allowed three states - Idaho, Missouri, and Kansas - to join the lawsuit. This means that “even if the Supreme Court finds that the anti-abortion groups behind the original lawsuit have no legal standing to sue — a key issue in the case — the states could try to continue the litigation.” [35]

Case time-line

The following is a brief time-line of actions in the case.

🟢 In April 2023, U.S. District Judge Matthew Kacsmaryk, a one-time anti-abortion activist, ruled in favor of the anti-abortion plaintiffs and ordered mifepristone be pulled from the market nationwide. [36]

🟢 “Five days later, on emergency appeal, the Fifth Circuit Court of Appeals issued a preliminary injunction allowing mifepristone to remain on the market but severely restricting access while the case was on appeal.” [37]

🟢 Within days, the Department of Justice filed an emergency appeal to the Supreme Court.” [38]

🟢 The Supreme Court then “blocked the Fifth Circuit injunction from taking effect, allowing mifepristone to remain on the market under current rules until a final decision in the case” on April 24, 2023. [39]

🟢 On August 15, 2023, the U.S. Fifth Circuit Court of Appeals “released a decision on Aug. 15, dismissing the challenge to the U.S. Food and Drug Administration’s 2000 approval of mifepristone, but overruling subsequent FDA decisions increasing access to mifepristone. The ruling, which remains on hold until final review, would sharply restrict access to medication abortion nationwide and eliminate telemedicine abortion.” [40]

🟢 In September, the U.S. Department of Justice appealed the Fifth Circuit’s ruling to the Supreme Court of the United States. [41] 

🟢 In December 2023, the Supreme Court agreed to hear the case. [42]

Filed by anti-abortion groups and individuals named above, the original lawsuit sought, through court fiat, to (1) restrict access to mifepristone by reimposing the FDA's pre-2016 regulations, or to (2) have mifepristone pulled from the market nationwide by revoking the U.S. Food and Drug Administration's original 2000 approval of the drug. The Supreme Court has denied review of a request by the anti-abortion plaintiffs “for the justices to consider whether the underlying 2000 approval of mifepristone by the U.S. Food and Drug Administration should be reversed.” [43] Therefore, mifepristone will remain available nationwide, but SCOTUS may decide to severely restrict access to the drug. [44]

A decision from the Supreme Court is expected by the end of June 2024.

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CITATIONS

[1] Reichmann, K. (2023, December 13). Supreme Court will hear abortion pill fight. Courthouse News Service. https://www.courthousenews.com/supreme-court-will-hear-abortion-pill-fight/ 

[2] Geidner, C. (2023, December 13). Supreme Court takes up cases over eased access to medication abortion drug. lawdork.com. https://www.lawdork.com/p/breaking-supreme-court-takes-up-cases 

[3] Eva Temkin, G. C. (2023, December 13). In mifepristone case, the Supreme Court must affirm the FDA’s authority. Medical Innovation is at risk. STAT. https://www.statnews.com/2023/12/14/mifepristone-alliance-for-hippocratic-medicine-fda-supreme-court-innovation/ 

[4] 30 patient and provider groups warn that mifepristone ruling threatens all FDA-approved drugs. American Cancer Society Cancer Action Network. (2023, May 22). https://www.fightcancer.org/releases/30-patient-and-provider-groups-warn-mifepristone-ruling-threatens-all-fda-approved-drugs 

[5] Ibid. 4

[6] Unikowsky, A. (2023, March 4). Mifepristone and the rule of law. Mifepristone and the rule of law - by Adam Unikowsky. https://adamunikowsky.substack.com/p/mifepristone-and-the-rule-of-law 

[7] Alliance for hippocratic medicine - pro-lies.org: Extreme. toxic. out of touch. ProiLies. (n.d.). https://pro-lies.org/alliance-for-hippocratic-medicine/ 

[8] Janiak, E. (2023, April 11). Mifepristone is safe. A court ruling reducing access to it is dangerous. Scientific American. https://www.scientificamerican.com/article/mifepristone-is-safe-a-court-ruling-reducing-access-to-it-is-dangerous/ 

[9] Alliance for hippocratic medicine - pro-lies.org: Extreme. toxic. out of touch. ProiLies. (n.d.). https://pro-lies.org/alliance-for-hippocratic-medicine/ 

[10] Smith, J. (2023, July 25). The Shadow Medical community behind the attempt to ban medication abortion. The Intercept. https://theintercept.com/2023/02/28/medication-abortion-lawsuit/ 

[11] Ibid. 10

[12] Ibid. 10

[13] American Association of Pro-Life Obstetricians and gynecologists - pro-lies.org: Extreme. toxic. out of touch. Pro-Lies. (n.d.-a). https://pro-lies.org/aaplog/ 

[14] Resnick, S. (2023, February 10). Suspect science and claims at center of abortion-pill lawsuit. Arizona Mirror. https://www.azmirror.com/2023/02/10/suspect-science-and-claims-at-center-of-abortion-pill-lawsuit/

[15] American College of Pediatricians - Pro-Lies.org: Extreme. toxic. out of touch. Pro-Lies. (n.d.). https://pro-lies.org/american-college-of-pediatricians/ 

[16] Resnick, S. (2023, February 10). Suspect science and claims at center of abortion-pill lawsuit. Arizona Mirror. https://www.azmirror.com/2023/02/10/suspect-science-and-claims-at-center-of-abortion-pill-lawsuit/

[17] Ibid. 16

[18] Ibid. 16

[19] Ibid. 16

[20] Charlotte Lozier Institute - Pro-Lies.org: Extreme. toxic. out of touch. Pro-Lies. (n.d.-c). https://pro-lies.org/charlotte-lozier-institute/ 

[21] Ibid. 20

[22] Ibid. 20

[23] Resnick, S. (2023b, August 2). Study cited by Texas judge in abortion-pill case under investigation. New Jersey Monitor. https://newjerseymonitor.com/2023/08/02/study-cited-by-texas-judge-in-abortion-pill-case-under-investigation/ 

[24] Glenza, J. (2019, July 25). Doctor claiming to “reverse” abortion was told to stop using medical school’s name. The Guardian. https://www.theguardian.com/world/2019/jul/25/revealed-doctor-reverse-abortion-trump-administration 

[25] Ibid. 24

[26] Resnick, S. (2023, February 10). Suspect science and claims at center of abortion-pill lawsuit. Arizona Mirror. https://www.azmirror.com/2023/02/10/suspect-science-and-claims-at-center-of-abortion-pill-lawsuit/

[27] Ibid. 26

[28] Ibid. 26

[29] Ibid. 26

[30] Ibid. 26

[31] Ibid. 26

[32] Hals, T. (2023, June 29). Five doctors backing the US legal case against the abortion pill. Reuters. https://www.reuters.com/legal/five-doctors-backing-us-legal-case-against-abortion-pill-2023-06-29/ 

[33] Resnick, S. (2023, February 10). Suspect science and claims at center of abortion-pill lawsuit. Arizona Mirror. https://www.azmirror.com/2023/02/10/suspect-science-and-claims-at-center-of-abortion-pill-lawsuit/

[34] Krause, R. (2022, July 26). Emotions run high on first day of abortion access testimony - wthr.com. WTHR. https://www.wthr.com/article/news/special-reports/indiana-abortion/emotions-run-high-as-testimony-begins-for-abortion-access-senate-bill-1/531-4db0c178-3922-4632-ad07-62643ab54b17 

[35] Pierson, B. (2024, January 12). States can join lawsuit seeking to restrict abortion pill, judge rules ... Reuters. https://www.reuters.com/legal/government/states-can-join-lawsuit-seeking-restrict-abortion-pill-judge-rules-2024-01-12/ 

[36] Baker, C. N. (2023, October 19). Diverse stakeholders implore Supreme Court to preserve abortion pill access. Ms. Magazine. https://msmagazine.com/2023/10/19/supreme-court-abortion-pill-mifepristone/ 

[37] Ibid. 36

[38] Ibid. 36

[39] Ibid. 36

[40] Ibid. 36

[41] Ibid. 36

[42] Reichmann, K. (2023, December 13). Supreme Court will hear abortion pill fight. Courthouse News Service. https://www.courthousenews.com/supreme-court-will-hear-abortion-pill-fight/ 

[43] Geidner, C. (2023, December 13). Supreme Court takes up cases over eased access to medication abortion drug. lawdork.com. https://www.lawdork.com/p/breaking-supreme-court-takes-up-cases 

[44] Ibid. 43