The Patriot Post® · 'Do You Think the FDA Is Infallible?'
By Ben Johnson
Bureaucratic regulators recklessly ignored women’s safety when they approved the abortion drug mifepristone, violating federal law and conscience rights in the process, pro-life physicians argued at the Supreme Court on Tuesday. The Biden administration responded that justices should not overturn the Food and Drug Administration’s (FDA) approval of the life-taking chemical, because doing so “harms women,” “harms the pharmaceutical industry,” and would violate left-wing principles of equity.
The alliance of pro-life doctors and medical professionals who sued the FDA say the abortion approval process violated standard processes and subsequently reduced requirements to report adverse events to the federal government. The Supreme Court justices weighed both sides’ contentions for 93 minutes Tuesday morning during oral arguments in FDA v. Alliance Hippocratic Medicine, with rhetoric sometimes becoming intense.
“Do you think the FDA is infallible?” asked Justice Samuel Alito.
The pro-life doctors, who mostly prevailed in lower courts, said the abortion pill harms women by leaving fetal tissue behind that can induce severe bleeding. In some 3.1% of those cases, the child will survive, requiring pro-life emergency room physicians to carry out an abortion to save the woman’s life or health.
Under questioning from Justice Amy Coney Barrett, Solicitor General Elizabeth Prelogar admitted, “There was some evidence that there were increased ER visits” after the Obama and Biden administrations removed any requirement for an in-person visit, which would screen mothers for ectopic pregnancy and other health concerns.
Liberal Justice Sonia Sotomayor confessed, “That did trouble me.”
The Biden administration responded by minimizing women’s suffering. “Half of the women who went to the emergency room didn’t get any treatment at all. Many women might go because they’re experiencing heavy bleeding, which mimics a miscarriage, and they might just need to know whether or not they’re having a complication,” said Prelogar.
That’s a weak argument, countered pro-life advocates. “My question for her would be, ‘How is a woman who is not a physician supposed to know if her heavy bleeding is hemorrhaging? How is she supposed to know if she’s in a life-threatening situation? Shouldn’t that burden be on the person who gave her that abortion drug?’” asked Mary Szoch, director of the Center for Human Dignity at Family Research Council, on Tuesday’s episode of “Washington Watch with Tony Perkins.”
“The FDA’s own label lists that between 2.9 and 4.6% of women who take mifepristone will need to go to the ER following the use of that drug,” Szoch continued.
That would mean 18,638 and 29,564 of the 642,700 chemical abortions carried out last year ended in an emergency room visit, according to numbers furnished by the Guttmacher Institute’s Monthly Abortion Provision Study.
“That’s not something that’s ‘as safe as Tylenol,’” as abortion activists regularly assert, Szoch told Perkins. “Of course, we know that every use of the abortion drug is tragic because it takes an unborn child’s life. But this removal of the safety standard makes it especially tragic.”
Prelogar parried these questions by invoking the abortion industry’s low standards of care in other areas. “The FDA explained even in person, you’re not necessarily getting an ultrasound” before women consume an abortion-inducing drug and administer their own abortions, frequently on the toilet.
Planned Parenthood has sued multiple states that required abortionists to provide women with an ultrasound, portraying the proponents of “transvaginal ultrasound” bills as akin to rapists.
It’s impossible to know the full extent of the abortion pill’s harms, as the Obama administration watered down federal mandates to report any adverse effects except death.
Justices also asked the abortion pill manufacturer why they sued to block tighter reporting requirements of women’s pain and suffering. “Why would that be a bad thing?” Justice Alito inquired of Jessica Ellsworth, who represented mifepristone manufacturer Danco Laboratories. “You don’t want to sell a product that causes very serious harm to the people who take your product, relying on your tests and the FDA’s tests. Wouldn’t you want that data?”
Ellsworth replied, “That data is certainly something that we are looking for all the time,” so Danco lists “a 1-800 number on our website” for people to report adverse events to the manufacturer. But that claim is just “smoke and mirrors,” retorted Tony Perkins. “They’re just trying to cover the tracks,” because few people issue complaints directly with drugmakers. Mifepristone maker GenBioPro also registered its objections to the lawsuit.
Both Justices Alito and Clarence Thomas pressed the Biden administration about whether the FDA violated applicable federal law by allowing abortionists to mail mifepristone to mothers. “Shouldn’t the FDA have at least considered the application of 18 U.S.C. 1461?” asked Alito. That portion of the U.S. Code, known as The Comstock Act, bars individuals from sending any “article or thing designed, adapted, or intended for producing abortion” through the U.S. mail.
“I think that the Comstock provisions don’t fall within FDA’s lane,” replied Prelogar, adding the law’s rare enforcement rendered it moot. But Erin Hawley of Alliance Defending Freedom, who represents the Alliance for Hippocratic Medicine, responded, “We think that the plain text of that [law], Your Honor, is pretty clear.”
Pro-life doctors also sued out of concerns that they may have to take part in an abortion, if healing a woman suffering from an incomplete abortion required an emergency room physician to carry out a dilation and curettage (D&C) surgical abortion. Liberal Justice Elena Kagan asked why pro-life ER staff could not simply lodge a conscience complaint and refuse to take part — something Hawley said is impractical. “Doctors don’t necessarily know until they scrub into that operating room whether this may or may not be abortion drug harm. It could be a miscarriage; it could be an ectopic pregnancy or it could be an elective abortion,” said Hawley. “These are life-threatening situations in which the choice for a doctor is either to scrub out and try to find someone else or to treat the woman who’s hemorrhaging.”
Conservative-leaning justices parsed that question. “The fact that she performed a D&C does not necessarily mean that there was a living embryo or a fetus because you can have a D&C after, you know, a miscarriage,” asked Justice Barrett. But Hawley said the FDA’s own numbers bore out the pro-life cause.
“If you look at the numbers of the increase from 7 to 10 weeks in gestational age, that means that 3.1% of pregnancies will be ongoing, requiring a D&C,” Hawley replied, and “55% of those D&Cs occur in the emergency room.”
“This is a substantial number of women suffering abortion drug harm,” Hawley.
Much of the case revolved around the more mundane issue of whether the plaintiffs had legal standing to lodge the case. “Is there anybody who could challenge in court the lawfulness of what the FDA did here?” Alito asked Prelogar. The Biden administration argued it enjoyed “sovereign immunity” from any number of plaintiffs, including doctors and women who suffered side effects from chemical abortions.
The profits of the abortion industry, and the pharmaceutical industry in general, took up a surprisingly large proportion of both sides’ arguments. At one point, Alito asked Danco’s lawyer, “You think you’re going to sell more [abortion pills] if the restrictions that previously were in place were lifted?”
“Yes,” Ellsworth replied.
“So, you’re going to make more money?” Alito continued.
In her closing argument, Solicitor General Prelogar pleaded with judges not to overturn FDA approval of the abortion drug, despite its injuring tens of thousands of women, because “it harms the pharmaceutical industry.”
Ultimately, though, the Biden administration made clear it objects to the lawsuit, because it constricts the abortion industry’s autonomy. “It harms women who need access to medication abortion,” alleged Prelogar. “The court should reject that profoundly inequitable result.”
In a sign that concerned some pro-life observers, conservative Justice Neil Gorsuch seemed reticent to issue a universal injunction against the distribution of the abortion pill. “There are exactly zero universal injunctions that were issued during Franklin Delano Roosevelt’s 12 years in office,” Gorsuch noted. “Over the last four years or so, the number is something like 60,” mostly from the lower courts. “They’re a relatively new thing.”
He interrupted Justice Ketanji Brown Jackson at one point to hint at a narrower ruling tailored to the plaintiffs, saying the court should “provide a remedy sufficient to address the plaintiff’s asserted injuries and go no further.”
The Supreme Court usually takes several months to draft an opinion. Its last major abortion decision, in the 2022 Dobbs case, was leaked by a Supreme Court staffer, triggering a flurry of attacks on pro-life pregnancy care centers and churches that continue to this day.
Ben Johnson is senior reporter and editor at The Washington Stand.