Science Misused in the Law

7th February 2024

A Case Study of the Scientific Articles Cited in the US Mifepristone Court Case

Statue of Lady Justice with blindfold and scales

The recent retraction of three published papers, two that were instrumental in a prominent abortion drug legal case in the United States, highlights the implications of potentially biased research influencing critical legal decisions. This post shares details of a Digital Science-conducted investigation into 11 papers used in court evidence – including the now-retracted papers – and what that means for both science and law.

Science as evidence

As scientists investigating trust in and of science, we began to explore how science – specifically published research – is used in the law. A notable concern is if the court system utilizes scholarly articles to establish scientific truths, then it relies on a system that may be vulnerable to influence by stakeholders who aim to advance their agendas rather than advancing impartial science.

When science is incorrectly used – specifically in the case of law – there may be far-reaching consequences. Science can be misused or manipulated to add gravitas, particularly in cases that are polarizing in society, are emotionally charged and fall along societal and political lines. Yet, ignorance of science is no excuse for misuse of science in the law.

For scholarly information to be considered credible and trustworthy science, it must meet multiple criteria, including: be a representative sample of papers over a given topic and delivered through trustworthy mechanisms. After those initial checks, the science itself must be sound. Then, the evidence must also be appropriately understood by the courts.

If the court system utilizes scholarly articles to establish scientific truths, then it relies on a system that may be vulnerable to influence by stakeholders who aim to advance their agendas rather than advancing impartial science.

Mifepristone legal challenge

Our case study questions whether the scientific evidence presented in a high-profile court case in the United States (Alliance for Hippocratic Medicine, et al vs the Federal Drug Administration) provides an unbiased presentation of the science. 

Heard earlier in 2023 in a Texas federal court, the legal action was taken against the US Food and Drug Administration (FDA) and was aimed at overturning FDA approval of the abortion drug Mifepristone. The case will be heard before the US Supreme Court on 26 March 2024.

Eleven published research articles were offered as evidence in this court case. (For the full list, see our Methods and Data section below). The federal judge ordered a suspension of mifepristone’s FDA approval, citing scientific evidence presented to the court.

This case was interesting to us as it made US and international news in the wake of the 2022 Dobbs case in the US Supreme Court, which had overturned Roe v. Wade. Because of our interest in research integrity, we felt this court case was worthy of further investigation, in which we asked ourselves: How were scientific papers and science presented and used as evidence?

What we would have expected: The strongest research on mifepristone, published in quality journals, with rigorous peer reviews and any conflicts of interests described. What we found, however, did not meet these standards.

Retracted articles

Three of the 11 articles cited in the court case were published in one journal, Health Services Research and Managerial Epidemiology. This journal has a recognized publisher behind it who has the ability to investigate possible manipulation of the scientific process. And after six months since one expression of concern, the publisher retracted three of Dr Studnicki’s papers based on undisclosed conflicts of interest and unreliable research methodology. Two of those papers were cited in the Texas court case. In the retraction Sage “confirmed that all but one of the article’s authors had an affiliation with one or more of Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists, all pro-life advocacy organizations, despite having declared they had no conflicts of interest when they submitted the article for publication or in the article itself.”

Expected results

What should we have expected from credible published research in this field?

Representative sample of papers over a given topic

Using the world’s largest linked database, Dimensions, we queried for (mifepristone OR RU-486) AND “medical abortion” over the years of 2019-2022, to assess the experts, organizations, and journals in this field of study. We also queried for (mifepristone OR RU-486) AND “medication abortion” over the years of 2019-2022. The results varied slightly but not significantly in the conclusions and are not shown below.

Experts

Due to the sensitivity of this research topic, we have not shown the authors’ names but summarize the findings.

Expected authors of the publications

When we query for mifepristone (or RU-486) and “medical abortion” over the years of 2019-2022, we find 25 top researchers (by number of publications, citations, citation mean, FCR to those publications). We note that none of the top 25 researchers – or their papers – were cited in the US court case on mifepristone.

Actual authors of the publications used in court

Using the data from Dimensions, we ascertained that none of the authors of publications cited in the mifepristone court case are among the top 24 in their field in the world. The authors also do not appear to be connected with the top 24 researchers in the field. Instead, the authors of four of the 11 papers presented in the mifepristone court case are all well-connected co-authors with each other. 

Organizations

Expected organizations to have affiliations on the publications

We identified 500 institutions (by number of publications and citations) publishing research in this field. We would have expected to see these institutions and their work cited in the mifepristone court case.

Figure 1: Co-authorship networks of the 500 organizations associated with mifepristone OR RU-486 and “medical abortion” from 2019-2022. Organizational co-authorship networks refer to collaboration networks between researchers across different organizations, measured through co-authored academic papers. Nodes represent organizations. Edges between nodes indicate co-authored papers between researchers from those organizations. The network structure demonstrates collaboration patterns between organizations. Source: VOSviewer image using data from Dimensions.

Actual organizations to have affiliations on the publications

The authors of the publications used in the mifepristone court case are primarily affiliated with the Charlotte Lozier Institute (CLI), who have co-authored publications with members of the American Association of Pro Life OB/GYNS (AAPLOG) among other organizations. These authors do not have connections to those highly-cited organizations shown in the previous image. Two of the 11 papers have authors from those institutions in the above figure – those from Planned Parenthood and Princeton University.

Figure 2: Organizational co-authorship networks of the 11 papers cited in the Texas mifepristone case. Source: VOSviewer image using data from Dimensions.

Journals

Expected publication journals to have been represented 

We would have expected journal representation from the top 20 journals by mean number of citations. ‘Citations (Mean)’ is the mean average citation number for a given group of publications being analyzed. Other metrics can also be used to determine the top journals of the field.

IDJournal NameCitations (mean)
1Current Opinion in Cell Biology103
2Nature102
3Frontiers in Immunology82
4Endocrine Reviews74
5MMWR Surveillance Summaries58
6Human Reproduction Update46
7Social Science & Medicine44
8The Lancet Regional Health – Americas35
9Advances in Pediatrics33
10Stem Cell Research & Therapy33
11Human Reproduction Open32
12Journal of Women’s Health32
13Reproductive Toxicology31
14Journal of Clinical Nursing30
15The Lancet Global Health29
16JAMA Network Open28
17Pharmaceuticals28
18Journal of Health Economics26
19Drug Delivery and Translational Research26
20Social Science Research24

Which journals were used in the case

Source: Titles in Mifepristone 2023 Texas CaseCitation MeanRank
Obstetrics and Gynecology1178
Health Communication1185
Contraception774
Health Services Research and Managerial Epidemiology3225
The Linacre Quarterly1310
Human Reproduction0436
BMJ Evidence-Based Medicine
Issues in Law & Medicine

Science should be delivered through trustworthy mechanisms

We would have expected that authors, editors, and peer reviewers abide by the guidelines for conflicts of interest

For assessing conflict of interest, we are guided by the International Committee of Medical Journal Editors (ICMJE) definition, wherein “all participants in the peer-review and publication process – not only authors but also peer reviewers, editors, and editorial board members of journals – must consider and disclose their relationships and activities when fulfilling their roles in the process of article review and publication”. (ICMJE, n.d.).

For the journal Health Services Research and Managerial Epidemiology, a Sage journal, its policy on declaring conflicts of interest (COI) can be found here. In summary: All authors must provide a ‘Declaration of Conflicting Interests’ statement to be published with the article, disclosing any financial ties to sponsoring organizations or for-profit interests related to products discussed in the text. If no conflicts exist, the statement should say “None Declared”. Any interests that could appear as conflicts should also be disclosed to the Editor in the cover letter.

COI could exist if those involved in writing, editing, and peer-reviewing the papers have strong political affiliations, are employees, members, leaders or founders of, or writes papers for or acts as an expert witness solely aligning with organizations affiliated with the topic. Multiple peer reviewers with diverse affiliations helps balance potential biases. 

We would expect a balance of scientific experts on a topic with none or declared conflicts of interest across the authors, peer reviewers, and article editors. If they have COI, we would expect them to vary from person and role (e.g., the author, peer reviewers, and/or article editor should not work for, have investments in, etc. in Company X). Note that the role and control of the editorial board varies by journal and publisher and can have some to no decision authority of the articles.

In this case, we looked for activities of perceived conflicts of interest at the individual and paper level to assess a ‘risk profile’. An individual may have political affiliations but still be objective; they should still disclose these. The reason for having multiple peer reviewers is to balance those potential biases through different reviews. Because none of the journals have open peer reviewers, and we do not know who the specific article editor was for a paper, we could assess those items for COI. However, the retraction notice does state “Sage became aware that a peer reviewer who evaluated the article for initial publication also was affiliated with Charlotte Lozier Institute at the time of the review.”

For further details on understanding conflicts of interest in scientific papers, see this publication: Safeguarding Scientific Integrity: Examining Conflicts of Interest in the Peer Review Process.

What we found regarding declared and undeclared conflicts of interest

Of the 11 papers used in the case, we found eight with undeclared conflicts of interest, where there is the potential for conflicts of interest. Note that declaring conflicts of interest (also known as ‘competing interests’) in publications has moved to an expected practice across disciplines within the past five years.

Publication YearJournal TitleArticle TitleAuthors’ affiliated advocacy organizationDeclared Conflict of InterestPossible Conflict of Interest
2012Obstetrics and GynecologyExtending outpatient medical abortion services through 70 days of gestational age.Planned ParenthoodNoYes
2009Obstetrics and GynecologyImmediate Complications After Medical Compared With Surgical Termination of PregnancyNoYes (Pharma)Yes
2015ContraceptionEfficacy and safety of medical abortion using mifepristone and buccal misoprostol through 63 daysPlanned ParenthoodNoYes
2011Human ReproductionImmediate adverse events after second trimester medical termination of pregnancy: results of a nationwide registry studyNoYes (Pharma)Yes
2020Health Communication#AbortionChangesYou: A Case Study to Understand the Communicative Tensions in Women’s Medication Abortion NarrativesAnti-abortionNoYes
2013The Linacre QuarterlyThe Maternal Mortality Myth in the Context of Legalized AbortionAnti-abortionNoYes
2021Health Services Research and Managerial EpidemiologyRETRACTED:
A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015
Anti-abortionNoYes
2021Issues in Law & MedicineDeaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019.Anti-abortionNoYes
2021Health Services Research and Managerial EpidemiologyMifepristone Adverse Events Identified by Planned Parenthood in 2009 and 2010 Compared to Those in the FDA Adverse Event Reporting System and Those Obtained Through the Freedom of Information ActAnti-abortionNoYes
2022Health Services Research and Managerial EpidemiologyRETRACTED:
A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization
Anti-abortionNoYes
2011BMJ Evidence-Based MedicineAdolescent girls undergoing medical abortion have lower risk of haemorrhage, incomplete evacuation or surgical evacuation than women above 18 years oldNoNoNone Found

Discussion

Logically, scientific articles have been used as exhibits in this Texas court case because mifepristone  is a chemical drug. Yet, much of the scientific evidence appeared to be authored by the plaintiffs or organizations affiliated with the plaintiffs.

If the scientists are the authorities on the subject and have no conflicts of interest, there might be a case for using those studies as evidence. However, we would expect extreme rigor of the science and the ethics of those involved. Those organizations listed on the scholarly papers are either part of the plaintiff or affiliated with them. Two of the papers have evidence of undisclosed conflicts of interest and unreliable methods according to the retraction notice. Hence, the ‘science’ that has been cited appears to have been compromised at the very least, and potentially manipulated to serve the aims of those organizations.

At this point in time, two of the eleven papers used in evidence have now been retracted – a move towards correcting the scientific record. While it is now too late for the Texas court, which has already considered the retracted papers as part of its proceedings, it should not be too late for some further serious questioning of scientific publications presented in the original case. This issue highlights that more must be done to detect and prevent the manipulation or misuse of science and conflicts of interest in the courts.

Methods

Court Case

Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians and Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations[1], Dr. Shaun Jester, Dr. Regina Frost-Clark, Dr. Tyler Johnson[2] Dr. George Delgado[3] vs the Federal Drug Administration (2:22-cv-00223-Z).

Data

Eleven peer-reviewed articles were offered as evidence in this court case and used in this study. ‘Exhibits’: https://doi.org/10.6084/m9.figshare.25203248 We did not examine the statements or prior court cases mentioned in the exhibits.

DOITitleSource titlePublisher
10.1177/23333928221103107A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for HospitalizationHealth Services Research and Managerial EpidemiologySAGE
10.1177/23333928211068919Mifepristone Adverse Events Identified by Planned Parenthood in 2009 and 2010 Compared to Those in the FDA Adverse Event Reporting System and Those Obtained Through the Freedom of Information ActHealth Services Research and Managerial EpidemiologySAGE
10.1177/23333928211053965A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015Health Services Research and Managerial EpidemiologySAGE
Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019.Issues in Law & Medicine
10.1080/10410236.2020.1770507#AbortionChangesYou: A Case Study to Understand the Communicative Tensions in Women’s Medication Abortion NarrativesHealth CommunicationTaylor & Francis
10.1016/j.contraception.2015.01.005Efficacy and safety of medical abortion using Mifepristone and buccal misoprostol through 63 daysContraceptionElsevier
10.1179/2050854913y.0000000004The Maternal Mortality Myth in the Context of Legalized AbortionThe Linacre QuarterlySAGE
10.1097/aog.0b013e31826c315fExtending outpatient medical abortion services through 70 days of gestational age.Obstetrics and GynecologyWolters Kluwer
10.1136/ebm.2011.100064Adolescent girls undergoing medical abortion have lower risk of haemorrhage, incomplete evacuation or surgical evacuation than women above 18 years oldBMJ Evidence-Based MedicineBMJ
10.1093/humrep/der016Immediate adverse events after second trimester medical termination of pregnancy: results of a nationwide registry studyHuman ReproductionOxford University Press (OUP)
10.1097/aog.0b013e3181b5ccf9Immediate Complications After Medical Compared With Surgical Termination of PregnancyObstetrics and GynecologyWolters Kluwer


[1] Conducts lobbying activities

[2] https://www.indianasenaterepublicans.com/johnson Mentioned on AAPLOG https://aaplog.org/caring-for-both-a-curbside-consult-series/

[3] Associated with CLI and AAPLOG board member

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