Many think these cases [1] seek to plug a reproductive orifice left open by Dobbs v. Jackson, where the Court undid rights conferred by the Roe decision of 1973. But similar rights go back even earlier. In 1965, the Supreme Court ruled in Griswald v. Connecticut that contraceptive practices in one’s bedroom, be they by “drug, medical device or other instrument”, are none of your -- or my business. Not even the state, given pre-eminent power to regulate abortion by Dobbs, can intervene. Now, some are worrying about social engineering by legal caveat, a slippery slope where politically-driven courts slowly peel away entrenched reproductive freedoms and privacy practices.
Some Background:
Mifepristone, born as the French drug RU-486, received FDA approval as a non-surgical means of abortion in 2000. Twenty-two years later (shortly after the Dobbs case), four national pro-life organizations and four physicians (“the plaintiffs”) sued the FDA, “seek[ing] to protect women and girls from the [un]documented dangers of chemical abortion drugs,” and contending that the FDA over-looked important safety risks in its original approval. They also claim these risks were exacerbated by the FDA’s amendment to their approval in 2016 and 2021, which
- extended the approved time of use from seven weeks to ten weeks of gestation
- allowed non-physicians to prescribe the drug
- sanctioned prescriptions via telehealth necessitated by the COVID-19 pandemic.
The arch-Conservative Fifth Circuit ruled the attack on the original approval was time-barred, but it did allow the claims regarding the 2016/2021 amendments. This means the drug is still available, but its legal use will be limited if the Supreme Court affirms the ruling.
“Here, you’re not just challenging the right for a woman to treat a pregnancy or to treat miscarriage; you’re also now challenging the primacy of the FDA to approve vast, important medicines that are critical to our society’s health, and that has a fundamental impact on the entire nation.”
- Jeremy Levin, CEO of Ovid Therapeutics
The cases, however, embroil much more than reproductive beliefs [2], and the overriding ramifications are far broader than the extent of the drug’s availability. The plaintiffs attack the FDA approval process itself (without proposing an alternative), eviscerating the FDA’s authority (and responsibility), undermining its authority to regulate the safety and efficacy of drugs, and ignoring its Congressional mandate [3]. These claims stampede pharmaceutical drug development, trample free market-ism, and cancel commercial freedoms by setting courts (some with notorious political biases and all without subject matter expertise) as arbiters of drug safety and efficacy.
“We’re talking about a judge who is a non-scientist overriding an agency full of experts about the safety and efficacy of a drug.”
- Greer Donley, Assistant Professor, University of Pittsburgh Law School
The 5th Circuit decision also confounds state police powers to control the health and safety of its residents, corrupting state/federal cooperation on drug regulation and throwing the FDA drug approval system into disarray. This concern was raised in an amicus brief by 600 local and state legislators who populate both sides of the abortion divide. The 5th Circuit was nonplussed.
Standing
In addition to claiming the drug is excessively dangerous (i.e., the FDA goofed in its approvals-- which the Court pointedly notes occurred repeatedly in the past), the plaintiffs must show they were actually harmed and will suffer a substantial risk of future harm, legally termed “standing”, to prevail. Perhaps the most telling aspect of the Court’s bias emerges from its analysis of the standing issue.
To establish their right to sue, the plaintiffs claim some drug recipients suffer serious medical complications that harm their doctors. (Yes, you read that correctly.) The harm? Sometimes, doctors must complete the abortive process by a surgical procedure, and “personally conducting those procedures violates their sincerely held moral beliefs” and their rights of conscience.
The plaintiffs further allege that providing surgical treatment causes them to:
- suffer “enormous strain mental and emotional distress,”
- divert time and resources away from their ordinary practice,
- incur additional liability and insurance costs,
- sustain economic harm, including damage to their business.
It is the doctors’ standing arguments that subject the underlying decision to ridicule. Indeed, the 5th Circuit contorts itself to sustain the claims, which is necessary for them to prevail:
There is no requirement for a physician in private practice to treat mifepristone patients when complications necessitating surgery ensue. Hence, there is no need to violate their moral beliefs. (The informed consent specifically advises patients that they may have to seek remedial surgical care elsewhere should an untoward reaction occur). Indeed, the claimed injuries apparently are experienced by physicians treating patients in an emergency room setting, where the physicians claim they have no choice but to treat.
The argument that hospitals have other physicians who can perform aspiration and curettage [4] is countered by referring to remote localities where such backup physicians are unavailable, meaning that a small percentage of doctors—treating a smaller percentage of cases where incomplete chemical abortions occur – may suffer harms, including:
Time and resources are diverted from their ordinary practice:
The plaintiffs assert that emergency surgical abortions are more complex and time-consuming than “run-of-the-mill” OB emergencies. So what? Any OB patient presenting in an ER is bound to present complicated, emotionally taxing, and time-consuming issues, such as miscarriage or maternal hemorrhage. It appears these doctors are looking to treat more cost-effective patients. It seems they are saying, ‘I don’t want to treat these patients because they take too much time, and I can make more money elsewhere.’
The Court rules that’s just fine.
Incurring additional liability and insurance costs
“According to the AMA annual report, obstetricians can expect to pay around $150,000 in annual premiums for medical malpractice insurance…. in stark contrast to a dermatologist, allergist, or psychiatrist [who]… rarely pay more than $10k annually.”
The plaintiffs also allege: “Doctors sustain a concrete injury when mifepristone patients expose them to greater liability and increased insurance costs.” Hogwash. Obstetricians incur among the highest malpractice insurance costs – precisely because adverse results associated with regular obstetrical malpractice are grave -- and not uncommon, to wit: shoulder dystocia, brain damage, and maternal deaths generating malpractice awards in the multi-millions. Even less severe conditions such as pre-eclampsia, toxemia, or gestational diabetes present huge awards - far exceeding likely claims from an unsuccessful chemical abortion. Statistically speaking, some of these surgical abortions will even prevent events that generate even higher-level awards.
Economic Harm
“And the economic injuries—the potential damage to their medical practice, heightened exposure to malpractice liability, and increased insurance costs— are irreparable …. a quintessential Article III injury”
rules the Court, all while rejecting a similar claim from Danco, the drug manufacturer, which asserted that its business, too, would be economically damaged. (The one-sidedness continues as the Court honors the moral concerns of the physicians at the expense of moral concerns of having an unwanted child by a patient denied the option of aborting.)
The “enormous” strain, mental and emotional distress from performing surgical abortions:
While the Court rejected this claim, it illustrates the lengths the plaintiffs go to. Obstetrics is among the most stress-laden specialties. The burnout rate is between 40 and 75%, one of the highest. While dealing with a patient suffering the sequelae of a failed abortion might be traumatic, any obstetrical emergency is emotionally fraught. The stress-averse generally don’t choose obstetrics as their profession. And what about the patients? While these doctors claim stress when treating patients where the drug doesn’t work correctly, the alternative, not being able to access the drug– surely subjects the patient universe to stress. Or is stress a pick-and-choose affliction, allowing arbitrary and capricious selection of the population to be protected by the Court?
Aesthetic injury, anyone?
The concurring/dissenting opinion by Judge Ho adds more harm and tangles, comparing the potential harm to the doctor and patient with those of a canceled visit to the zoo. His words are priceless:
“ [T]he desire to use or observe an animal species, even for purely esthetic purposes, is undeniably a cognizable interest for purpose of standing…. [I]f a plaintiff has “concrete plans” to visit an animal’s habitat and view that animal, that plaintiff suffers aesthetic injury when an agency has approved a project that threatens the animal… Unborn babies are a source of profound joy for those who view them. Expectant parents eagerly share ultrasound photos with loved ones… Doctors delight in working with their unborn patients—and experience an aesthetic injury when they are aborted.”
But what if the birth of the child-to-be subjects the child or the family unit to harm, perhaps from genetic impairment of the child or the negative impact on existing siblings? Those, sadly, don’t merit concern because, as Judge Ho says:
“I object to abortion because it ends a human life.”
I’m sorry, Judge Ho. The Supreme Court has already ruled that that decision belongs to the States, not you.
[1] Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine
[2] Your definition of when someone else’s life begins.
[3] “Congress has charged FDA with the mandate and authority to ensure the safety and effectiveness of pharmaceuticals before they come to market….” To be sure, the “FDA’s determination that a drug is safe does not signify an absence of risk but rather that the drug’s clinical benefits outweigh its known.
[4] This refers to a suctioning out of the now non-viable uterine contents.
