Tag: judge matthew kacsmaryk

Mifepristone Decision Is Rightwing Supreme Court Solomon’s Baby

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It’s been two weeks since US District Judge Matthew Kacsmaryk issued an order “staying” the FDA’s 2000 approval of mifepristone. To say the thing out loud — that a drug, which has been rigorously tested and used for 23 years to safely terminate pregnancies, is dangerous and must be immediately yanked off the market because of one lunatic judge in Texas — is almost too painfully idiotic. Particularly since the danger here is to doctors forced to treat the fictitious hordes of women flooding emergency rooms bleeding out their vaginas from failed abortions. But thanks to Mitch McConnell and Donald Trump … here we are.

They parked this guy in a single-judge district in Amarillo to tee him up for the rabidly conservative Fifth Circuit, and he’s going to gut civil rights laws and the administrative state (i.e. the part of government that ensures corporations don’t poison you and steal your money). That is his only purpose on this earth.

The only question is whether this case is too cackhandedly stupid for conservatives to let it stand. Because it is embarrassingly bad on both the facts and the law and will wreak absolute havoc if allowed to become precedent. And that’s why the federal judiciary has been tossing it around like a live grenade stuffed in a rancid goat head for two weeks now. Most recently, Justice Samuel Alito extended the stay which was to expire last night through Friday at midnight.

The Fifth Circuit’s order last week, penned by two 40-something Trump appointees named Kurt and Andy, was, if anything, worse than the trial court’s monstrosity. They accepted the lie that mifepristone was rushed through using emergency protocols, despite the fact that it went through a rigorous, four-year approval process, and the emergency protocols were only employed to add a dispensing regimen that made it harder for women to access the drug. But in an attempt to make their decision seem reasonable by comparison to Kacsmaryk’s, they acknowledged that the six-year statute of limitations had elapsed to challenge the original 2000 mifepristone authorization. Instead they purported to shitcan only the FDA’s modifications to dispensing protocols in the past six (really seven) years. This includes the 2023 rule which made permanent the COVID-era rule allowing remote prescription of the drug, despite the fact that it wasn’t challenged because the case was filed in 2022.

If Kacsmaryk’s order relied on mental gymnastics to create standing for the plaintiffs, the Fifth Circuit’s ruling requires a feat of contortion worthy of Cirque du Soleil. Because the trial court said that the plaintiffs, an association of medical professionals who were stressed out from having to treat women for whom the mifepristone/misoprostol abortion regimen failed, could at least rely on the mere presence of the drug on the market to support their supposed claim of injury. It was still dumb and relied on vastly inflating both the risks of taking the drug and the likelihood that any member of the organization would have to treat a woman suffering from it, but there was at least a through line between the drug’s authorization and the plaintiffs made-up injuries.

The Fifth Circuit makes that fantastical connection even more tenuous by saying that the plaintiffs’ harms are directly traceable to changes in the FDA’s mifepristone dispensing protocol in 2016, 2019, 2021, and 2023. The 2019 change was simply the approval of a generic version of the drug, which could not possibly affect the plaintiffs in any way, so the Fifth Circuit didn’t bother trying to defend it. Instead, Kurt and Andy — ughh, fine, Judges Engelhardt and Oldham — needed to “prove” that the plaintiffs were harmed by the change from an in-person dispensing requirement with multiple doctors’ visits and a seven-week gestational limit to a telemedicine protocol where nurse practitioners can prescribe the drug for women up to 10 weeks along.

To do this, they relied on a misreading of the drug warning label to conjure up 350,000 women in emergency rooms seeking care. But, as the FDA points out in its reply brief to the Supreme Court, this assumes that (1) every woman for whom the drug does not work will require urgent medical attention, and (2) they’ve all been prescribed the drug remotely by a nurse, so they’ll be forced into emergency rooms where they’ll bleed all over the place while monopolizing the plaintiffs’ time and sucking up resources from other patients. In fact, the majority of those women are not hemorrhaging — they’re just still pregnant! And so they go back for another dose of the drug, or they seek a surgical abortion, neither of which they’ll get from the plaintiffs.

It’s achingly fucking stupid. And on top if it, by vaporizing the past six years of evidence-based rule making by the FDA, the Fifth Circuit undoes a dosing modification which cuts recommended prescription of mifepristone from 600mg to 200. So science-y!

But if that were the extent of it, the Supreme Court’s six conservatives would no doubt bless the decision. The real problem for them is likely to be the issue of standing. Because these people hate women a lot, but there’s room in their black hearts to hate throwing open the courthouse door for people to redress injuries, too. And the effect of ripping open this hole in standing to allow a group of plaintiffs to access the court based on speculation that one of their members might be injured at some indeterminate future date is going to be a big pill to swallow, even for the court’s wingnut wing. Which is why the FDA relies heavily on a 2006 Supreme Court decision by none other than Justice Antonin Scalia, heaping scorn upon this theory of statistical standing when the Sierra Club tried it to protect California forest land:

The dissent proposes a hitherto unheard-of test for organizational standing: whether, accepting the organization’s self-description of the activities of its members, there is a statistical probability that some of those members are threatened with concrete injury. Since, for example, the Sierra Club asserts in its pleadings that it has more than “700,000 members nationwide, including thousands of members in California'” who `use and enjoy the Sequoia National Forest,” … it is probable (according to the dissent) that some (unidentified) members have planned to visit some (unidentified) small parcels affected by the Forest Service’s procedures and will suffer (unidentified) concrete harm as a result.

This novel approach to the law of organizational standing would make a mockery of our prior cases, which have required plaintiff-organizations to make specific allegations establishing that at least one identified member had suffered or would suffer harm.

And so, we are reduced to hoping that Justice Brett Kavanaugh and Chief Justice John Roberts will side with the court’s liberal justices to bounce this turkey on standing. But that’s a bitter pill for us, so let’s instead end with a quote from the drug manufacturer Danco’s stay application, which righteously mocks the plaintiffs for their supposed “injuries,” which are, after all, taking care of women in a medical emergency:

Aided by these rampant factual revisions, the Fifth Circuit transforms the daily realities of medical work into an Article III harm. A doctor’s job is to treat patients. That is true regardless of whether the doctor agrees with the patient’s choices that have led them to seek medical care (e.g., smoking, legal (or illegal) drugs, poor nutrition, religious abstention from other types of treatments). The emotional discomfort associated with providing medical care to a person with whom a physician has a moral, ethical, or religious disagreement is not an Article III injury. … Having to “devote” time and resources to care for multiple patients at once is likewise not an Article III injury for emergency room physicians. It is part of the job.

Yes, all of that. Keep the faith.

[Alliance for Hippocratic Medicine v. FDA, trial docket via Court Listener / Alliance for Hippocratic Medicine v. FDA, appellate docket via Court Listener / FDA v. Alliance, SCOTUS docket / Danco v. Alliance, SCOTUS docket]

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The Abortion Wars Are Back On, Thanks To Hacks Parked On The Court By Trump And McConnell

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The important thing to know about a Texas court’s nationwide ban of the drug mifepristone is that it’s based on a lie. Well, to be more precise, it’s based on a whole series of lies, but one lie in particular stands out from the others … a Big Lie, if you will. That lie is about the approval process for the drug, which has been on the market since 1988 and is offered for sale in more than 80 countries.

The plaintiffs, a consortium of anti-choice groups that incorporated in Amarillo, Texas after anti-choice activist Matthew Kacsmaryk was confirmed to the only federal court in the district, stake their claims on the fact that the FDA approved mifepristone in 2000 under an emergency protocol known as Subpart H. This protocol allows lifesaving drugs to reach the market sooner and has mostly been used to fast-track AIDS drugs. In reality, mifepristone went through four years of rigorous examination before its approval. But in response to political pressure, the FDA used Subpart H to impose additional dispensing protocols known as Risk Evaluation and Mitigation Strategies or REMS.

Back in March, when the parties made their case to Judge Kacsmaryk for injunctive relief, Slate legal writer Mark Joseph Stern observed that, not only were the plaintiffs lying about the approval process, but that Kacsmaryk seemed to accept their false version of events:

This entire argument is built upon a lie. The FDA did not fast-track mifepristone in 2000. Rather, the agency took more than four years to greenlight the drug, doing so only after extensive (and arguably superfluous) examination of its (very minor) risks. When the FDA did finally approve the use of mifepristone, after an unusually thorough review, however, it imposed heightened restrictions on its distribution. It was theseextra barriers to mifepristone access that were set up through a process known as accelerated approval. The plaintiffs here exploit confusion about these procedural details to peddle the false narrative that the agency recklessly hastened review of mifepristone. It is an extremely ominous sign that Kacsmaryk appeared to agree with their false history.

And that turned out to be exactly what happened when Kacsmaryk dropped his ruling on Good Friday, a love letter to the anti-choice loons that put him on the federal bench to do just what he did. Reasoning that Subpart H is reserved for “serious or life-threatening ‘conditions,’” he ruled that it was inappropriate to use for a drug that ends pregnancy, since “Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life.”

It’s an offensively stupid argument, in an opinion chock full of offensively stupid arguments and outright lies about the dangerousness of the drug, which has almost no risk of side effects. For instance, Kacsmaryk presents a bevy of reasons that the six-year statute of limitations on FDA challenges does not apply. Perhaps the government ignored the plaintiff’s administrative challenges (it did not); perhaps the REMS modification in 2016 or the approval of a generic version of the drug in 2021 restarted the clock; perhaps any administrative challenge would have been futile; or maybe you can ignore the plain meaning of the law under the doctrine of equitable tolling, AKA “vibes, man.” In any case, Kacsmaryk deems it wholly appropriate for him to “stay” the FDA’s 23-year-old approval of the drug, making it a dicey proposition for manufacturers to keep selling it.

And that’s not the craziest part! The court relies on the Comstock Act of 1873, a law that prohibits using the mail to transport “Every obscene, lewd, lascivious, indecent, filthy or vile article, matter, thing, device, or substance.” Clearly this violates the First Amendment, which is why it’s never enforced, despite remaining on the books. The law has a provision that bans using the mail to send “every article or thing designed, adapted, or intended for producing abortion, or for any indecent or immoral use,” which birth control advocate Margaret Sanger successfully challenged in a 1936 case involving the importation of an early form of diaphragms.

Nevertheless, Kacsmaryk expresses astonishment that none of the parties in this case cite the Comstock Act as a reason to challenge the FDA’s approval of dispensing mifepristone by mail, and he cites a 1915 case as standing for the proposition that, in 2023, the US has “a national policy of discountenancing abortion as inimical to the national life.” This requires ignoring the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), which Congress enacted expressly to permit the mail-order distribution of mifepristone. But ignoring inconvenient factual and legal realities is Matty K’s specialty!

He even sneaks in a passage about fetal personhood, musing that perhaps fetuses have standing to sue:

Parenthetically, said “individual justice” and “irreparable injury” analysis also arguably applies to the unborn humans extinguished by mifepristone — especially in the post-Dobbs era. [And then he cites to an amicus brief filed in Dobbs by anti-abortion activists saying] (“Nothing in the Constitution or in our Nation’s legal traditions authorizes the Court to adopt [the] theory of life” that States are required “to regard a fetus as lacking even the most basic human right — to live — at least until an arbitrary point in a pregnancy has passed.”)

There is so much that’s gross about this opinion — from excoriating the defendant for using the “unscientific” term “fetus” instead of “unborn child,” to speculating that women would be better off having to have surgical abortions than taking a pill and experiencing an afternoon of cramping. We couldn’t get it all in here if we tried, although Robyn did a great job over the weekend.

But let’s talk instead about the competing order from Judge Thomas Rice in the Eastern District of Washington which came out at roughly the same time last week. Because the FDA is still tinkering with that mifepristone REMS, and so 17 states plus DC sued to stop the government from enacting even more restrictions on distribution. So on Friday night, Judge Rice granted an injunction block the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States.”

And that puts the FDA in a weird place, because WTF is even happening right now? Judge Kacsmaryk’s order, which goes into effect this Friday if it’s not blocked by a higher court, purports not to be a nationwide injunction, but rather a stay of the FDA’s 23-year-old approval under Section 705 of the Administrative Procedure Act (5 U.S.C. § 705). This law which allows courts to “postpone the effective date of an agency action or to preserve status or rights pending conclusion of the review proceedings.” But perhaps sensing the glaring defects of his ruling, Kacsmaryk wrote: “If the Fifth Circuit reverses this Court’s Section 705 analysis, the Court clarifies that it alternatively would have ordered Defendants to suspend the chemical abortion approval and all subsequent challenged actions related to that approval until the Court can render a decision on the merits.”

The government has appealed to the Fifth Circuit, which is a nightmare lineup, stacked with Trump appointees. It has not appealed the Washington decision, and, as we discussed in depth on the Opening Arguments podcast (shameless plug alert!), there is a universe in which both orders can coexist. The FDA could colorably argue that the Washington order blocks it from taking any enforcement action against mifepristone suppliers, but that’s not a longterm solution. And unfortunately, the Fifth Circuit and the Supreme Court have shown themselves remarkably willing to countenance the most vile, illegal arguments in an effort to ban abortion.

And Lemon, it’s only Monday.

[Slate / Alliance for Hippocratic Medicine v. FDA, docket via Court Listener / State of Washington v. FDA, docket via Court Listener]

Catch Liz Dye on Opening Arguments podcast.

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