Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration is the lawsuit with profound implications for Life that has advanced with rapidity through our federal court system. At issue is the April 7th ruling from Federal District Court Judge Matthew Kacsmaryk that the FDA wrongfully approved the chemical abortion pill Mifepristone in 2000.

The complete enforcement of Judge Kacsmaryk’s ruling would mean suspending and removing the deadly pills from the market. The case has elicited a great deal of national attention on both sides of the abortion debate, largely because the majority of abortions in the United States result from this so-called “medication.”

Judge Kacsmaryk’s 67-page opinion unhinged pro-abortionists because he dared to tell the violent truth about abortion using rhetoric such as “unborn humans,” “eugenics” and “head, hands, and legs with defined fingers and toes” (source).

Dr. Albert Mohler, President of the Southern Baptist Theological Seminary, provides stark clarity: Medical or chemical abortions by pill are contrasted with surgical abortions, “but the end result is exactly the same — the willful termination of a human life in the womb” (source).

Dr. Mohler describes the Biden Administration as “radically pro-abortion” and looking “to medical abortions or abortion by pill as the solution to get around the Dobbs decision, reversing Roe v. Wade” in states like Texas where abortion is illegal.

The U.S. Department of Justice, on behalf of the FDA, swiftly appealed Judge Kacsmaryk’s ruling in the ongoing legal battle to both the U.S. Court of Appeals for the Fifth Circuit then the U.S. Supreme Court.

See Council for Life News HERE and HERE

SCOTUS Returned Case to Fifth Circuit

On April 21, SCOTUS preserved access to Mifepristone and returned the case to the Fifth Circuit to allow the appeals process to play out.

Fifth Circuit Three-Judge Panel Appears Skeptical

On May 17, a three-judge panel of the Fifth Circuit composed of Judges James Ho, Cory Wilson and Jennifer Elrod heard two-hour oral arguments from attorneys for both sides (listen here). Several tense exchanges were featured, with lawyers seeking to preserve nationwide access to the lethal abortion pills facing stern questioning from the Judges.

Highlights from Fifth Circuit Arguments

“Unprecedented”

Less than one minute into the hearing, Judge Ho interrupted Sarah Harrington, the U.S. Justice Department attorney representing the FDA, when she claimed that revoking FDA approval of a drug would be “an unprecedented and unjustified attack on FDA scientific expertise” for any court.

“I hate to cut you off so early, but you just said unprecedented,” Judge Ho said. “We had a challenge to the FDA just yesterday.”

Ms. Harrington insisted that those cases differed, and the FDA’s job is to determine if drugs are sufficiently safe. “It’s not a court’s role to come in and second-guess that expertise, and no court has ever done that,” she said.

Judge Ho urged that she “just focus on the facts of this case rather than have this sort of FDA-can-do-no-wrong theme.”

Standing

The Judges questioned defendant’s argument that the pro-life doctors who brought the case had no standing because they were not forced to provide abortion services against their religious beliefs or conscience rights (source). Judge Elrod read from a physician’s record testimony that she had “performed surgery on at least a dozen women after a failed chemical abortion, sometimes including removing the embryo or fetus.”

Erin Hawley, Senior Counsel for Alliance Defending Freedom and lawyer for the plaintiff, said that the pro-life doctors have been harmed in a way that qualifies them to file suit. They “are not alleging harm because they’re forced to provide an abortion,” she said, adding, “Their conscience harm is much broader. They allege that they feel complicit in an elective abortion by being forced to complete that procedure.” In asserting that the government is minimizing concerns about medication abortion, Ms. Hawley noted, “abortion is different — we’re talking about ending the life of an unborn child.”

Pregnancy is a Serious Illness

Judge Ho cited the absurdity of the FDA’s classification of pregnancy as a “serious illness” to expedite approval of Mifepristone, posing, “When we celebrated Mother’s Day, were we celebrating illness?” (source)

Statute of Limitations

Lawyers representing pharmaceutical manufacturer of the drug Danco Laboratories and the FDA have rejected the validity of the lawsuit because of the statute of limitations (source). They argue too much time has passed since the FDA initially approved Mifepristone in 2000 and made changes relaxing its regulation, including extending its approved use in 2016 from seven to ten weeks gestation. The FDA further expanded access by allowing the drug to be dispensed by mail and without an in-person doctor’s visit in 2021.

Judge Ho appeared amenable to plaintiff’s argument that these later significant expansions to access created an opening to legally challenge the FDA’s approval of the drug from the beginning: “You think the mail issue is not a dramatic change? You don’t think going from seven to ten weeks is a dramatic change? You don’t think going from three visits to just one without a doctor is a dramatic change?” Judge Ho asked while questioning Danco lawyer Jessica Ellsworth. “We can’t deny this is a big-stakes issue.”

Personal Attack of District Court Judge

Judge Elrod inquired about the language used by defendant’s attorneys in their briefs calling Judge Kacsmaryk’s ruling “an unprecedented judicial assault” and referencing the “non-expert court” (source). Judge Ho weighed in citing the “unprecedented judicial assault on a careful regulatory process” which he stated implies “nobody should ever question the FDA. We are allowed to look at the FDA just like we are allowed to look at any agency. That’s the role of the courts.”
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Judges Ho, Wilson and Elrod have not yet issued a decision. Their decision is expected to be appealed to the full Fifth Circuit Court and then to the Supreme Court.

What is Mifepristone? What are the Dangers of Chemical Abortion?

Click here to learn more about Mifepristone and its inherent dangers and what happens in a chemical abortion.

Please Pray

Please pray for the Fifth Circuit Judges and the U.S. Supreme Court Justices to rule on the side of Life. Please pray for their protection and the protection of Federal District Court Judge Matthew Kacsmaryk and all those in positions of authority who boldly and courageously defend the unborn.