Anti-abortion researchers take legal action over retracted studies cited in FDA case

This story was originally published in the Kentucky Lantern.

Researchers whose anti-abortion-funded studies were used to argue for restrictions on medication abortion — and then were retracted on methodological grounds — are now taking legal action against academic publisher Sage, which pulled their papers in February.

Represented by conservative law firms Consovoy McCarthy and Alliance Defending Freedom, the latter of which sued the Food and Drug Administration over abortion drugs in 2022, the researchers claim Sage’s retractions were unjustified and politically motivated and have led to “enormous and incalculable harm” to their reputations. They asked the Ventura County Superior Court in California to compel Sage to arbitrate with the researchers.

“Sage punished these highly respected and credentialed scientists simply because they believe in preserving life from conception to natural death. These actions have caused irreparable harm to the authors of these articles, and we are urging Sage to come to the arbitration table — as it is legally bound to do — rescind the retractions and remedy the reputational damage the researchers have suffered at the hands of abortion lobbyists,” said ADF senior counsel Phil Sechler in the recent announcement.

A representative for Sage declined to comment on the pending litigation.

A representative for the anti-abortion think tank Charlotte Lozier Institute, which employs the petitioning researchers, declined to comment. The nonprofit serves as the research arm of the influential Susan B. Anthony Pro-Life America, which works to elect federal and state anti-abortion lawmakers.

The three studies at the center of the dispute were published in the journal “Health Services Research and Managerial Epidemiology,” between 2019 and 2022. Two of them featured prominently in a federal lawsuit aimed at restricting abortion pills, which the U.S. Supreme Court rejected this summer but continues to make its way through the lower courts.

States Newsroom was the first to report last year that Sage had opened an investigation after pharmaceutical sciences professor Chris Adkins contacted the journal with concerns that the researchers had misrepresented their findings. In the 2021 paper, the researchers looked at Medicaid data in 17 states between 1999 and 2015 and tracked patients who had had a procedural or a medication abortion and counted each time they went to an emergency department in the 30 days following those abortions. Their finding that emergency room visits within 30 days following a medication abortion increased 500% from 2002 to 2015 was frequently cited by plaintiffs and judges in the FDA case and used to conclude that the abortion-inducing drug mifepristone is dangerous. But Adkins and other public health experts told States Newsroom that the researchers inflated their findings, and appeared to conflate all emergency department visits with adverse events.

These concerns prompted Sage to re-examine the peer review process and to identify that one of the initial peer reviewers was an associate scholar with the Charlotte Lozier Institute. The publisher then enlisted a statistician and two reproductive health experts to newly peer review all three articles.

“Following Committee on Publication Ethics (COPE) guidelines, we made this decision with the journal’s editor because of undeclared conflicts of interest and after expert reviewers found that the studies demonstrate a lack of scientific rigor that invalidates or renders unreliable the authors’ conclusions,” Sage said announcing the retractions, which notes that the experts found that the papers had “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.”

In a petition to compel arbitration filed late last week, the studies’ lead author James Studnicki and nine co-authors argue that Sage has delayed arbitration in violation of California contract law. They say they’ve had difficulty publishing new research since the retractions. As examples, the petition notes that in March a free online archive and distribution server for unpublished, non-peer-reviewed manuscripts refused to post one of the petitioners’ manuscripts and that in April a journal rejected the same manuscript, “citing similar pretextual reasons that HSRME used in its retraction.”

“These rejections are just the tip of the iceberg but reveal the enormous and incalculable harm that Sage’s retraction has inflicted on the Authors’ reputations and their ability to publish research and scholarship,” reads the court petition. “As scientists, the Authors’ credibility is their lifeblood, but Sage has destroyed the Authors’ hard-earned professional reputations.”

Studnicki, Charlotte Lozier’s vice president and director of data analytics, was on the editorial board of “Health Services Research and Managerial Epidemiology” until last fall, but the journal’s editor-in-chief dismissed him after the journal and Sage decided to retract the papers. The blog Retraction Watch reports that the journal is no longer accepting new submissions.

Medication abortion has become the most common method since the 2022 Dobbs decision ended the federal right to abortion.

Despite claims by the Charlotte Lozier Institute that medication abortion is unsafe, when administered at 9 weeks gestation or less, the FDA-approved regimen has a more than 99% completion rate, a 0.4% risk of major complications, and around 30 reported associated deaths over 22 years. Common symptoms include heavy bleeding and cramping, diarrhea, and nausea, and sometimes medical intervention is necessary to avoid infection. ProPublica recently reported on two women in Georgia who suffered rare complications of medication abortion, but whose deaths were ruled preventable and were attributed to the state’s near-total abortion ban.