A legal challenge by authors over three retracted articles about mifepristone is set for an arbitration conference this month as nationwide debate over the abortion pill heats up at the appellate level.
Ten researchers sued Sage in 2024 after the publisher retracted three of their papers about the purported dangers of mifepristone, a medication that ends early pregnancy. The authors alleged the company “applied inconsistent retraction standards” to their work based on Sage’s perception of their “pro-life affiliations,” in violation of California’s anti-discrimination law, according to their complaint.
The authors asked the Superior Court of California, County of Ventura to compel Sage into arbitration, as required by publishing agreements the researchers signed with the company. Arbitration is an alternative pathway for resolving disputes in which an arbitrator hears the parties’ arguments and issues a decision outside of the traditional court process.
The retraction notice for the articles, which were published in Health Services Research and Managerial Epidemiology from 2019 to 2022, stated the publisher removed them because of undeclared conflicts of interest by the authors. According to the notice, all but one of the article’s authors were affiliated with one or more 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.”
Further investigation by subject matter experts also found “fundamental problems with the study design and methodology” of two of the articles, and “unsupported assumptions and misleading” findings in the third article, according to the notice.
A federal judge in Texas cited two of the articles in his 2023 decision to temporarily suspend mifepristone. The U.S. Supreme Court ultimately rejected the suspension, allowing the medication to remain accessible while lawsuits in the lower courts continue.
One of those disputes is a current challenge by Louisiana against a rule from the U.S. Food and Drug Administration allowing doctors to prescribe mifepristone through telehealth and patients to receive it through the mail. State officials argue mifepristone should be available only in-person. A three-judge panel of the 5th U.S. Circuit Court of Appeals heard arguments in the case on Sept. 9.
In its complaint, Louisiana cites several studies about the risks of mifepristone, including a 2024 paper by James Studnicki, lead author of the three retracted papers, about emergency department visits following medication abortions among women in the Medicaid program. The three retracted articles are not referenced in the state’s complaint.
In court documents, the FDA attorneys stated the agency is conducting its own study of statistical data and safety outcomes about the medication. They also called the court challenge a “waste of judicial resources” while the agency’s review is ongoing and emphasized that Louisiana remains free to enforce its own state abortion restrictions.
The three retracted papers included articles about emergency room visits by women who use mifepristone, characteristics of physicians who perform abortions, and complications from chemical abortions, which now account for nearly two-thirds of all abortions in this country.
Over the last two years, the legal challenge by the authors has stalled while the plaintiffs and Sage sparred over choosing an arbitrator. Sage accused the researchers of attempting to exclude Sage from the arbitrator selection process. After several rounds of delays, the parties are scheduled for a status conference about the arbitration on Sept. 21, according to court records.
Studnicki previously told Retraction Watch the retractions were “a blatant attempt to discredit excellent research which is incongruent with a preferred abortion narrative.” The publisher removed Studnicki from the journal’s editorial board in the aftermath of its investigation. Studnicki, vice president and director of data analytics at the pro-life Charlotte Lozier Institute, told us he had no comment about the case until a final decision is reached.
Camille Gamboa, a spokesperson for Sage, told us the publisher had “no information to share at this time while the case is ongoing.”
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