ACLU warns Supreme Court that lower court abortion pill decisions relied on "patently unreliable witnesses"

Washington — The American Civil Liberties Union is warning the Supreme Court that lower court decisions in a closely watched battle over a widely used abortion pill relied on "patently unreliable witnesses" and "ideologically tainted junk science."

In a friend-of-the-court brief the ACLU filed with the Center for Reproductive Rights and The Lawyering Project, the groups argued the lower courts that have ruled in the case involving the drug mifepristone supplanted the Food and Drug Administration's scientific judgment with unproven assertions from anti-abortion rights medical associations and doctors about the alleged harms of medication abortion.

They indicated that the judges' acceptance of those claims is an outlier and pointed out that other courts hearing cases related to abortion have engaged with those same witnesses and research and "routinely discredited [the anti-abortion rights doctors'] evidence for lack of scientific integrity."

The ACLU, Center for Reproductive Rights and The Lawyering Project are backing the Biden administration in its dispute involving mifepristone. The justices are set to hear arguments on March 26. Access to mifepristone remains unchanged until the Supreme Court renders a final decision, which is expected by the end of June and would have a nationwide impact, even in states where abortion is legal.

"It's the Supreme Court's responsibility to determine whether the evidence in the record adequately supports the 5th Circuit's conclusions both that the plaintiffs in this case have standing to bring it and that the courts were right to override the FDA's scientific judgments," Julia Kaye, senior staff attorney with the ACLU's Reproductive Freedom Project, told CBS News. "Doing so necessarily involves looking critically at witnesses and research cited throughout the 5th Circuit's opinion."

Concerns about witness testimony

Accepted by the lower courts in their decisions against the FDA, the assertions made by anti-abortion rights doctors underpin several key issues that are before the Supreme Court. Chief among them is whether the doctors and medical associations that brought the case have the legal right to sue, as well as whether the FDA acted lawfully when it relaxed the rules surrounding mifepristone's use through a series of actions in 2016 and 2021.

A federal district court blocked the FDA's 2000 approval of mifepristone and more recent efforts by the FDA to make it easier to obtain. But the U.S. Court of Appeals for the 5th Circuit narrowed the decision, leaving the FDA's approval of the drug in place but finding the agency likely acted unlawfully when it loosened the rules about how mifepristone is obtained, who can prescribe it and how late into a pregnancy it can be taken.

But the three groups, which all support abortion rights, said the analyses conducted by the lower courts on the issue of standing, merits and whether the challengers may suffer irreparable harm as a result of the FDA's actions all turned on unreliable research and witnesses who lack credibility.

The friend-of-the-court brief raises concerns about testimony from six doctors who submitted declarations during an earlier stage in the case about mifepristone's safety. Claims by five of them have been criticized by other courts in cases involving abortion restrictions.

In one instance, involving Dr. Donna Harrison, a North Dakota Supreme Court justice wrote in a 2014 opinion involving medication abortion that Harrison's opinions "lack scientific support, tend to be based on unsubstantiated concerns, and are generally at odds with solid medical evidence."

Harrison, an OB-GYN, worked in private practice until 2000, the year that the FDA approved mifepristone, according to a 2021 filing in a separate case in Indiana. The district court's opinion against the FDA repeatedly referenced her declaration filed as part of the mifepristone case, which claimed in part that "patients who suffer complications from chemical abortions require significantly more time and attention from providers than the typical OB-GYN patient requires."

Erik Baptist, senior counsel at the Alliance Defending Freedom and lead attorney in the challenge involving mifepristone, said in a statement that to question Harrison's credibility "is to ignore the countless people who have come to rely on her knowledge and experience in caring for women and their babies. It is also critical to note that this judge was openly pro-abortion during the hearing."

In another instance, involving Dr. Ingrid Skop, a state court in Florida rejected her testimony as "inaccurate and overstated, or based on data from decades ago." The trial court also said that Skop admitted that her "views on abortion safety are out of step with mainstream medical organizations; and provided no credible scientific basis for her disagreement with recognized high-level medical organizations in the United States."

In the mifepristone case, the 5th Circuit cited Skop and her views about the risks of the drug 17 times. 

Skop defended her research in a statement to CBS News, saying: "As an OB-GYN who has delivered over 5,000 babies in over 30 years of practice and as someone who has treated many women harmed by these abortion drugs, I stick to facts and research, not ad hominem attacks. Any data that doesn't confirm their abortion on demand bias is ignored by mainstream medical organizations who lobby for abortion through all nine months."

Harrison is director of research for the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) and served as its chief executive officer, and Skop is a member of the group. 

"Notwithstanding all these reasons for skepticism, the courts below relied on these witnesses' say-so for scientific conclusions central to the courts' legal analysis, crediting their opinions over FDA's expert assessment and the overwhelming medical consensus regarding mifepristone's safety," the ACLU, Center for Reproductive Rights and Lawyering Project wrote in their filing to the Supreme Court.

"Glaringly flawed" studies

In addition to raising concerns about the credibility of the witnesses, the groups also argued that the lower courts relied on "glaringly flawed studies" that mischaracterized research and drew broad generalizations about the impact of abortion.

U.S. District Judge Matthew Kacsmaryk, who blocked the FDA's 2000 approval of mifepristone and the more recent actions taken by the agency, cited in his April decision a 2021 study examining the alleged mental health impacts of medication abortion that found 77% of women who had a "chemical abortion" reported a "negative change," and 38% of women "reported issues with anxiety, depression, drug abuse, and suicidal thoughts because of the chemical abortion."

But the study he references examined 98 anonymous blog posts to the website abortionchangesyou.com from women who purported to have had a medication abortion and subsequently shared their experience on the site between October 2007 and February 2018. The website is run by the group Institute of Reproductive Grief Care. 

The theory that abortion can cause harm to women's mental health has also been refuted by the National Academies of Science, Engineering and Medicine, and the American Psychological Association. But in determining that the medical associations had the right to sue based on what's known as third-party standing, Kacsmaryk also pointed to a 2011 meta-analysis by Priscilla Coleman that purported to show a link between abortion and mental health outcomes.

Dr. Ushma Upadhyay, a professor at the University of California, San Francisco, and an expert in abortion access and safety in the U.S., criticized Coleman's methodology and said she compared wanted and unwanted pregnancies without accounting for the reasons that may contribute to whether a patient wants to get pregnant.

"Her work doesn't account for differences between groups when she looks at people who have had abortions and people who haven't," Upadhyay said. "It's so important because she will attribute the differences in mental health status to the abortion when it's clear as day that the differences in mental health status are due to a variety of life circumstances between the groups."

Upadhyay said the research cited by the lower courts is "problematic," and specifically pushed back on claims that emergency room visits related to mifepristone are high. 

The data underlying a 2021 study of emergency room visits after medical abortion that was highlighted by Kacsmaryk is from before 2015 and based on more stringent standards for mifepristone's use that were in place before the FDA changed the rules in 2016. The journal editor and publisher of the study issued an "expression of concern" last year that said they were "alerted to potential issues regarding the representation of data in the article and author conflicts of interest," and are conducting an investigation.

Upadhyay said researchers failed to look at the reasons why a patient would visit the emergency room for abortion care, which may be because they don't have an abortion clinic close to home or a primary care physician. Additionally, because the abortion pill causes bleeding and cramping, patients may go to the emergency room to make sure what they're experiencing is normal.

"They're conflating emergency department visits with adverse events," Upadhyay said. She noted that mifepristone, when taken with a second drug, is 95% to 97% effective, so it's expected that between 3% and 5% of all medication abortions will be incomplete and require additional treatment.

A 2015 study conducted by Upadhyay found that major complications from medication abortion, defined as requiring hospital admission, surgery, or blood transfusion, occurred in less than 0.32% of patients. Studies of thousands of women who have taken mifepristone that were cited by the FDA in court filings also showed that hospitalization occurred between 0% and 0.7% of cases; serious infections occurred in between 0% and 0.2% of cases; and bleeding requiring transfusion occurred in between 0% and 0.5% of cases.

"There's no doubt in my mind that the courts would have ruled in favor of the FDA if they were making the decision based on science," Upadhyay said. "There's over 20 years of very concrete evidence supporting the safety of mifepristone, and 5 million people have used it successfully, and the medication has a very strong track record."