As the Supreme Court prepares for yet another controversial abortion case to come its way, the justices will pore over District Court Judge Matthew Kacsmaryk’s ruling last week to block the government’s approval of the key medication abortion drug at issue.
Here are five issues that could attract the attention of the high court:
Court watchers like to jump right to the heart of a dispute to consider “the merits” of a particular controversy.
Judges do not.
Their first step is always to determine whether a case is properly before the court. Is it a true “case or controversy” as required under the law? Here, the plaintiffs – physicians and organizations opposed to abortion that are representing physicians – say the FDA should have never approved the drug more than 20 years ago. But can those plaintiffs show that they have the legal injury necessary to bring the case? Kacsmaryk, of the US District Court for the Northern District of Texas, said they could.
“Here, the associations’ members have standing because they allege adverse events from chemical abortion drugs can overwhelm the medical system and place enormous pressure and stress on doctors during emergencies and complications,” he wrote.
But others question whether that amounts to the “concrete and particularized” injury the plaintiffs need to get in the courthouse door.
“Vague speculation that someday, somewhere, some unspecified doctor will be overwhelmed by an onslaught of patients coming into the ER after taking mifepristone does not establish that these particular doctors face an imminent risk of a concrete and particularized harm,” Adam Unikowsky, a lawyer and former clerk of conservative Justice Antonin Scalia, wrote in his newsletter.
As for the Biden administration, it told the 5th Circuit Court of Appeals that “plaintiffs lack standing to challenge FDA’s approval of a drug they neither take nor prescribe; their challenge to FDA actions dating back to 2000 is manifestly untimely; and they have provided no basis for second-guessing FDA’s scientific judgment.”
The justices care about these issues, because they impact far more than just the case at hand.
“These questions of whether the plaintiffs have the kind of real-world injury that is necessary to get into court, and whether their claim was timely or filed too late apply across the board in federal lawsuits,” said Supreme Court litigator Andrew Pincus.
“There are serious questions on whether the Supreme Court is willing to endorse the district’s court’s very broad approach to those questions,” he said.
Some of the members of the high court could see this case as less about abortion, and more about the authority of a federal agency to assess public health and the regulatory landscape in general.
“The current conservative majority has generally been very skeptical of how much authority various agencies exercise,” said CNN Supreme Court analyst Steve Vladeck who is a professor at the University of Texas School of Law. “The one place where they have been less skeptical though, has been an agency’s authority, which is predicated on long settled and well developed technical and scientific expertise” he added.
Back in January 2021, Chief Justice John Roberts discussed the FDA’s authority in a case related to medication abortion and said, “My view is that courts owe significant deference to the politically accountable entities with the background, competence and expertise to assess public health.”
In addition, leaders of pharmaceutical and biotech companies condemned Kacsmaryk’s opinion in a sign that they are worried it could impact other drugs and destabilize the regulatory landscape. Those arguments won’t be lost on the justices.
“As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval,” the companies wrote in a statement released Monday. “Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry,” they said.
But lawyers for the anti-abortion doctors behind the challenge said in court filings Tuesday that the FDA had broken the rules. They said the district court order “paints an alarming picture of decades-long agency lawlessness — all to the detriment of the women and girls FDA is charged to protect.”
As he often does, Supreme Court Justice Brett Kavanaugh wrote separately last June to explain his thinking in voting to overturn Roe v. Wade.
“To be clear, then,” he wrote “the Court’s decision today does not outlaw abortion throughout the United States,” he said. “On the contrary, the Court’s decision properly leaves the question of abortion for the people and their elected representatives in the democratic process,” he added.
For his part, Justice Samuel Alito, writing for the majority, announced that, “The Constitution does not prohibit the citizens of each State from regulating or prohibiting abortion. Roe and Casey arrogated that authority. We now overrule those decisions and return that authority to the people and their elected representatives.”
But Kacsmaryk’s decision, if allowed to go into effect, would severely cut back on abortion even in states that allow it. In addition, in its filing brief, the Justice Department also emphasized that mifepristone is used for other purposes besides abortion.
“This harm would be felt throughout the country, given that mifepristone has lawful uses in every state,” Principal Deputy Assistant Attorney General Brian Boynton wrote.
The Supreme Court might also take issue with the relief that Kacsmaryk ordered. He decided he had the authority to bypass the agency, and vacate the approvals directly. Had he, instead, issued an injunction against the FDA, the move could have allowed the agency to work in a more timely manner to implement the decision.
On page two of his opinion, Kacsmaryk criticizes jurists who use the word “fetus” to “inaccurately identify unborn humans in unscientific ways.”
But who are some jurists who have decided to use the word “fetus” when discussing abortion?
None other than the liberals on the Supreme Court who dissented in Dobbs.
Kacsmaryk chooses, instead, to use the word “unborn human.” He also refers to medication abortion as “chemical abortion” – a term favored by opponents of abortion rights.
At other times his language is graphic. When Kacsmaryk explains the effects of mifepristone, he writes that it “halts nutrition, and ultimately starves the unborn human until death.”
The judge also utilizes the word “abortionist” when referring to health care officials who perform the procedures.
Critics of Kacsmaryk also fear his opinion could confuse patients. Dr. Courtney Schreiber noted in a sworn declaration filed Monday that many patients will believe that abortion is no longer legal if his ruling goes into effect Friday. Some facilities may offer just misoprostol, the doctor noted, a second drug that usually works in concert with mifepristone.
“Restricted access to this safe therapeutic threatens the health of real people – people who are mothers, sisters, daughters, wives and friends,” she wrote.
Another doctor who filed a declaration in favor of a stay is Dr. Alisa Goldberg, who serves at Harvard Medical School and works at Brigham and Women’s Hospital in Boston. She testified that after more than two decades of treating patients with medication abortion, “the tiny proportion of patients who experience serious complications from taking mifepristone has remained consistently flat.”
But Kacsmaryk openly rejects such language. He contends that the agency didn’t do enough more than 20 years ago to test the drug – defying all that major medical associations have said about the efficacy of the drug. Alliance Defending Freedom, the group representing the plaintiffs in the case, praised Karcsmaryk’s ruling on Monday, insisting on calling the drug “dangerous.” Erin Hawley, a lawyer for the group, said that the FDA “put women in harm’s way, and the agency should be held accountable for its reckless actions.”
And in a court filing Tuesday, she called the opinion “meticulously considered.”
Others contend Kacsmaryk abandoned his role as a judge in favor of passing himself off as a health expert. They point to a part of his decision quoting “one study” where 14% of women and girls reported having received “insufficient information” on issues on the burdens and risks of the procedure. But the study, is culled from an anti-abortion rights website and is made up of stories from those who had abortions and wish to share their experience anonymously.
“Okay, so to recap the judge asserts that ‘fourteen percent of women and girls report having received insufficient information’ without revealing the entire sample consists of anonymous blog posts on pro-life website designed for women who regret their abortions,” Unikowsky wrote.
And the judge cites a study about women who have had abortions feeling “shame, regret, anxiety and depression” without mentioning other studies holding the opposite.