Publisher Retracts Two studies relied on in Mifepristone cases now before Supreme Court

Retraction Notice, 2024 SAGE publications has retracted three articles relied upon by the District Judge who enjoined FDA's approval of the abortifacient drug Mifepristone.

The Supreme Court will on March 26 hear argument in two cases involving the abortifacient drug Mifepristone.  They are FDA v. Alliance for Hippocratic Medicine, NO 23-235 and manufacturer Danco Laboratories v. Alliance No. 23-236.

In the Danco case the first Question Presented is whether physicians who have never prescribed the drug because they are united in their ethical objections to abortion have standing to sue. The Court frames the question as:

1. Whether an association can demonstrate Article III standing to enjoin a government action by arguing that some unspecified member may be injured at some future time by the challenged action.

U.S. District Judge Matthew Kacsmaryk, in Alliance for hippocratic Medicine v. FDA enjoined the FDA's approval of Mifepristone - one of two drugs in the protocol which is used to induce most of the clinical abortions in the United States.  An essential element of his decision was the finding of standing in favor of the anti-abortion physicians - joined in a group called Alliance for Hippocratic Medicine.

Article III of the U.S. Constitution extends the judicial power only to "cases and controversies".  That has long been held to bar reliance on hypothetical questions to construe laws and Constitutional provisions. In essence complainants must show that they have a material stake in the case, not merely a moral or ideological interest in the dispute.  

The plaintiff physicians in the Alliance case - pending argument before the Supreme Court - alleged such a stake.  Judge Kaczsmaryk found in their favor on this threshold issue:

Here,the associations members have standing because they allege adverse events from chemical abortion drugs can overwhelm the medical system and place enormous pressure and stress on doctors during emergencies and complications .(fn 9)

9 See James Studnicki et al., A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999-2015, 8 HEALTHSERV. RSCH. MGMT. EPIDEMIOLOGY8 (2021) ( visits following mifepristone abortion grew from 3.6% of all post abortion visits in 2002 to 33.9% of all post abortion visits in 2015. The trend toward increasing use of mifepristone abortion requires all concerned with health care utilization to carefully follow the ramifications of ER utilization.  .

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At the request of Sage and the Journal Editor, the following articles have been retracted:

Studnicki J, Harrison DJ, Longbons T, et al. A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015. Health Services Research and Managerial Epidemiology. 2021;8. doi:https://doi.org/10.1177/23333928211053965

Studnicki J, Longbons T, Harrison DJ, et al. A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization. Health Services Research and Managerial Epidemiology. 2022;9. doi:https://doi.org/10.1177/23333928221103107

Studnicki J, Longbons T, Fisher JW, Harrison DJ, Skop I, MacKinnon SJ. Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges. Health Services Research and Managerial Epidemiology. 2019;6. doi:https://doi.org/10.1177/2333392819841211

Post-publication peer review

Two subject matter experts undertook an independent post-publication peer review of the three articles anew. In the 2021 and 2022 articles, which rely on the same dataset, both experts identified fundamental problems with the study design and methodology, unjustified or incorrect factual assumptions, material errors in the authors’ analysis of the data, and misleading presentations of the data that, in their opinions, demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part. In the 2019 article, which relies on a different dataset, both experts identified unsupported assumptions and misleading presentations of the findings that, in their opinions, demonstrate a lack of scientific rigor and render the authors’ conclusion unreliable.