Supreme Court holds off deciding case that suspended FDA rule on chemical abortions

By Dave Andrusko

When last we discussed District Judge Theodore Chuang ’s July 14 decision to suspend a FDA rule requiring a woman to have an in-person doctor’s visit before undergoing a chemical abortion during the COVID-19 pandemic, 11 states had filed an amicus brief with the Supreme Court  in support of the Trump Administration’s motion for a stay of the district court’s ruling.

Yesterday, the justices issued a one-page opinion essentially putting the case on hold. The justices wrote:

The Government argues that, at a minimum, the injunction is overly broad in scope, given that it applies nationwide and for an indefinite duration regardless of the improving conditions in any individual State. Without indicating this Court’s views on the merits of the District Court’s order or injunction, a more comprehensive record would aid this Court’s review. The Court will therefore hold the Government’s application in abeyance to permit the District Court to promptly consider a motion by the Government to dissolve, modify, or stay the injunction, including on the ground that relevant circumstances have changed. … The District Court should rule within 40 days of receiving the Government’s submission.

Justice Alito, joined by Justice Thomas, dissented and blasted Judge Chuang who

took it upon himself to overrule the FDA on a question of drug safety. Disregarding THE CHIEF JUSTICE’s admonition against judicial second-guessing of officials with public health responsibilities, the judge concluded that requiring women seeking a medication abortion to pick up mifepristone in person during the COVID–19 pandemic constitutes an “undue burden” on the abortion right, and he therefore issued a nationwide injunction against enforcement of the FDA’s requirement. The judge apparently was not troubled by the fact that those responsible for public health in Maryland thought it safe for women (and men) to leave the house and engage in numerous activities that present at least as much risk as visiting a clinic—such as indoor restaurant dining, visiting hair salons and barber shops, all sorts of retail establishments, gyms and other indoor exercise facilities, nail salons, youth sports events, and, the State’s casinos. And the judge made the injunction applicable throughout the country, including in locales with very low infection rates and limited COVID–19 restrictions. 

The Trump Administration had asked the Supreme Court to reinstate the FDA protective measures as it appeals. In commenting on the 4th Circuit’s decision not to stay Judge Chung’s decision, the Trump Administration wrote that “The Fourth Circuit necessarily would have rejected two settled principles in this Court’s precedents:

first, that a regulatory requirement imposed on one abortion method is not unconstitutional when another safe abortion method remains readily available; and second, that merely incidental effects on abortion access do not render an otherwise valid law unconstitutional, especially when those effects are not caused by the government. Apart from the merits, the nationwide scope of the injunction independently warrants review. The circumstances here — in which a single district court, presented with a suit by a single physician and a handful of organizations, displaced the FDA’s scientific judgment with respect to every medication abortion provider in the country — illustrate the problems with allowing district courts to award relief untethered to the established injuries of the specific plaintiffs before them.

In their brief, filed in the 4th U.S. Court of Appeals, the l1 states argued that rules such as the requirement that mifepristone be dispensed only in a clinic, medical office, or hospital protects women’s health and “are not unduly burdensome even in the current public health emergency.“

“When a woman ingests mifepristone for the purpose of aborting a fetus, she not only ends the life of her unborn child, but also undergoes significant risks to her own body,” Indiana Attorney General Curtis Hill said. “Federal and state laws require physical examinations and in-person dispensing of mifepristone to ensure that physicians check for contraindications and that women fully understand the risks.”

In addition, more than 20 pro-life leaders, including NRL President Carol Tobias, have written to the head of the FDA urging Dr. Stephen Hahn “to protect American women and preborn children by removing the abortion pill (mifepristone) from the US market.”

The letter thoroughly and systematically disputed the conclusion reached by Judge Chuang, an Obama appointee, that such self-administered abortions are safe.

For example,

This lethal drug that the FDA permits for killing innocent preborn children during the first 10 weeks of pregnancy is also highly dangerous for women. According to the FDA’s adverse event reporting system, the abortion pill has resulted in over 4,000 reported adverse events since 2000, including 24 maternal deaths. Adverse events are notoriously underreported to the FDA, and as of 2016, the FDA only requires abortion pill manufacturers to report maternal deaths. Manufacturers gather this information from the prescribers, such as Planned Parenthood facilities. Yet, women who experience side effects like heavy bleeding, abdominal pain, or severe infections are likely to seek care at emergency rooms, not the abortion facilities where they received the pills. Since emergency rooms are not required to report abortion pill adverse events to the FDA, the true number of adverse events is impossible to assess.