For the original blog on the FDA LDT final documents, here.
For the "serious" mockup of a Federal ruling, here.
In this article, fictional rulings on the FDA LDT case by:
- Comedian Lewis Black
- Mr. Spock
- A constitutional originalist
- Ebenezer Scrooge
- Lieutenant Columbo
See a separate listing for Michel Foucault, Susan Sontag, Ayn Rand, Dr. Seuss, and Tennesee Williams.
Lewis Black
United States District Court for the Eastern District of Texas
Case Nos. 4:24-CV-479-SDJ and 4:24-CV-824-SDJ
American Clinical Laboratory Association et al. v. United States Food and Drug Administration et al.
Association for Molecular Pathology et al. v. United States Food and Drug Administration et al.
Opinion by Judge Lewis Black (Satirical)
Well, well, well. Here we are, dragged into the chaos of bureaucratic overreach like a family reunion no one wanted to attend. On one side, we’ve got the FDA, swaggering in with a brand-new set of rules they apparently cooked up during a long weekend with a thesaurus and a fever dream. On the other side, we’ve got ACLA and AMP, clinical lab professionals just trying to do their jobs without being regulated into oblivion.
Now, the FDA claims they’ve always had the authority to regulate laboratory-developed tests, or LDTs, under the FDCA. Really? Since when? Because for decades, they’ve been like a neighbor who insists they “might come to the block party,” but they never actually show up—until one day, they crash the barbecue, commandeer the grill, and tell you the potato salad violates federal law.
Here’s the thing, FDA: you can’t just decide one day that a set of diagnostic tests—designed, performed, and analyzed entirely within a lab—is a “device” like a stethoscope or a pacemaker. A stethoscope is a thing. You can hold it in your hand. An LDT is a process. You can’t hold a process in your hand unless you’re a magician—and even then, you’re probably not FDA-compliant.
On Statutory Authority
The FDCA defines a “device” as a tangible thing, not a collection of laboratory professionals scribbling notes and using their brains. The FDA’s attempt to lump LDTs into this definition is like trying to convince people that an air guitar is a musical instrument. It’s not. It’s just embarrassing.
The plaintiffs correctly argue that Congress passed CLIA to regulate lab practices, not the FDA. Let me put it this way: CLIA is like the sibling who was given the car keys. The FDA suddenly claiming jurisdiction over LDTs is like the younger sibling saying, “But I was promised the front seat!” Sorry, FDA. You didn’t get the car keys. Go back to playing with your crayons.
Major Questions Doctrine
This is what we lawyers call a “major question.” And by “major question,” I mean, “What in the ever-living bureaucracy is going on here?” When an agency suddenly claims it has the authority to regulate billions of dollars of medical procedures, Congress has to say something. Congress didn’t. Not a peep. And yet here we are, sorting out a mess no one asked for, like cleaning up after a toddler who decided finger painting the walls was a good idea.
Arbitrary and Capricious Rulemaking
And let’s talk about the FDA’s so-called enforcement discretion. They’ve created a system where they’re handing out exceptions like Oprah giving away cars: “You get an exception! And you get an exception!” But at the same time, they’re threatening labs with criminal penalties if they don’t play along. It’s like offering someone a lifeboat while setting their house on fire.
The FDA says this is about public health. Sure. And I’m the Tooth Fairy. If they were so worried about public health, maybe they’d spend less time inventing new rules and more time enforcing the ones they already have.
The Remedy
Now, the FDA says if I have a problem with their rule, I should limit relief to the plaintiffs. No, FDA. You don’t get to make up a rule that affects the entire industry and then say, “Just kidding, only these two guys can ignore it.” That’s like giving a parking ticket to one car in a traffic jam and pretending the others didn’t run the same red light.
The Final Rule is vacated. Completely. Entirely. From now on, the FDA can stay in its lane—or better yet, get out of the car altogether until Congress actually gives them a map.
Conclusion
For the foregoing reasons, the Court finds in favor of the plaintiffs. The FDA’s Final Rule is hereby VACATED. And I suggest everyone go home, read the FDCA and CLIA, and stop treating regulatory authority like a hot potato.
SO ORDERED.
Date:
Lewis Black
United States District Judge (but also a man who just wants to see some common sense for once).
x
Mr. Spock
United States District Court for the Eastern District of Texas
Case Nos. 4:24-CV-479-SDJ and 4:24-CV-824-SDJ
American Clinical Laboratory Association et al. v. United States Food and Drug Administration et al.
Association for Molecular Pathology et al. v. United States Food and Drug Administration et al.
Opinion by Judge Spock, of the USS Enterprise
The proceedings before this court present a logical challenge: the plaintiffs, representing the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), assert that the FDA’s Final Rule extending its authority to laboratory-developed tests (LDTs) is illogical, unlawful, and disruptive. The FDA, by contrast, argues that it possesses the jurisdiction to regulate these tests under the Federal Food, Drug, and Cosmetic Act (FDCA). The task at hand is to determine whether the FDA’s reasoning is consistent with established legal principles and logic.
Logical Analysis
1. Statutory Authority and Logic of the FDCA
The FDCA defines a “device” as a physical, tangible object—an “instrument,” “apparatus,” or “contrivance.” By attempting to classify LDTs, which are processes developed and performed within laboratories, as “devices,” the FDA stretches the meaning of this term beyond its logical boundary. A device is a thing; a protocol is an action. To conflate the two is illogical.
The plaintiffs are correct in their assertion that Congress created the Clinical Laboratory Improvement Amendments (CLIA) specifically to govern laboratory testing services. CLIA addresses the reliability of the process, whereas the FDCA addresses the safety of physical products. The FDA’s attempt to regulate LDTs under the FDCA disrupts this logical division of authority. A Vulcan, or indeed any rational being, would conclude that the FDA’s position lacks coherence.
2. Major Questions Doctrine: A Logical Principle
The Major Questions Doctrine requires clear Congressional authorization for an agency to undertake actions with significant economic and societal implications. Here, the FDA’s claim to regulatory authority over billions of dollars in LDTs, affecting thousands of laboratories, demands explicit statutory grounding. Such clarity is absent.
It is illogical to assume that Congress intended to grant the FDA such sweeping authority without saying so explicitly. Indeed, silence in the legislative record speaks volumes. The FDA’s interpretation resembles a game of three-dimensional chess where one player simply adds extra pieces to the board without consent. This approach is not logical.
3. Arbitrary and Capricious Rulemaking
The FDA’s Final Rule is, to borrow a human term, haphazard. By relying on discretionary enforcement carveouts, the FDA creates uncertainty for the regulated community. Laboratories are forced to guess whether their actions will be deemed compliant. This lack of predictability is not conducive to efficient governance or to the advancement of public health.
Moreover, the FDA failed to adequately consider the reliance interests of laboratories that have operated under CLIA for decades. Disrupting this long-standing framework without sufficient justification is neither logical nor equitable. As Captain Kirk often says, “Risk is our business,” but that principle does not apply to regulatory overreach.
Remedy
The only logical course is to vacate the Final Rule entirely. Partial relief would create an illogical patchwork of compliance obligations, further compounding the regulatory chaos. Logic demands uniformity, clarity, and adherence to statutory boundaries.
Conclusion
The plaintiffs have demonstrated, through arguments grounded in both law and reason, that the FDA’s Final Rule exceeds its statutory authority, fails to meet the requirements of the Major Questions Doctrine, and is arbitrary and capricious. For these reasons, the Court rules in favor of the plaintiffs.
The FDA’s Final Rule is hereby VACATED. May this decision serve as a reminder to all agencies that logic, grounded in law, must guide their actions. As a Vulcan proverb states: Logic is the beginning of wisdom, not the end.
SO ORDERED.
Date:
Spock
x
A constitutional originalist
United States District Court for the Eastern District of Texas
Case Nos. 4:24-CV-479-SDJ and 4:24-CV-824-SDJ
American Clinical Laboratory Association et al. v. United States Food and Drug Administration et al.
Association for Molecular Pathology et al. v. United States Food and Drug Administration et al.
Opinion by Judge Anselm Barrett, Constitutional Originalist
Introduction
This Court approaches its solemn duty mindful of the original meaning of the Constitution, the proper bounds of federal authority, and the text of the statutes before it. At the heart of this case lies the question of whether the FDA has lawfully asserted jurisdiction over laboratory-developed tests (LDTs) by classifying them as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended in 1976. To decide this matter, the Court must anchor itself in the constitutional design of our federal government and the plain meaning of statutory language, uncolored by the creeping accretions of administrative overreach.
Constitutional Framework
The Constitution establishes a federal government of enumerated powers, its principal responsibilities being matters of diplomacy, war, and the regulation of interstate commerce. Congress has authority to pass laws necessary to carry out these functions, but it is not the role of the federal government to micromanage every corner of the nation’s economic or professional life. Health care services, including laboratory testing, have long been regulated at the state level or through specific Congressional enactments, such as the Clinical Laboratory Improvement Amendments (CLIA).
Here, the FDA’s assertion of sweeping authority over LDTs encroaches on territory traditionally reserved for the states and contravenes the principle of federalism enshrined in the Tenth Amendment. Laboratory testing is fundamentally a professional service, grounded in the exercise of medical judgment and the performance of scientific protocols, not the production of physical goods distributed in commerce. To treat these intangible services as “devices” under the FDCA is to distort the statutory text and to arrogate powers never granted by Congress.
The 1976 Medical Device Amendments
When Congress amended the FDCA in 1976 to regulate medical devices, it adopted a definition that remains controlling. A “device” is defined as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” 21 U.S.C. § 321(h). The words of this definition describe tangible objects—things that one can see, touch, and hold. They do not encompass professional services, processes, or methods of laboratory testing.
It is clear that Congress intended the Medical Device Amendments to address physical products distributed in interstate commerce, not the activities of clinical laboratories operating within their own facilities. To interpret “device” otherwise is to stretch the term beyond its original meaning, in defiance of both statutory language and constitutional principles. Such interpretive overreach is impermissible.
Major Questions Doctrine and Congressional Silence
The FDA’s attempt to regulate LDTs under the FDCA raises a profound “major question” that requires clear Congressional authorization. This Court cannot assume that Congress, by including LDTs under CLIA’s framework, implicitly intended the FDA to extend its jurisdiction to such professional services under the guise of regulating “devices.” Congress has not spoken clearly on this matter, and where Congress has chosen silence, the agency must refrain from action. The Constitution’s separation of powers demands no less.
Economic Consequences and Administrative Overreach
The practical implications of the FDA’s Final Rule are staggering. Laboratories would be subjected to billions of dollars in compliance costs, diverting resources from innovation and patient care to administrative bureaucracy. This is the very sort of regulatory overreach that the Framers sought to guard against by limiting the federal government’s role in the daily lives of its citizens. To paraphrase Chief Justice Marshall: the power to regulate is the power to destroy, and no agency may exercise such power absent explicit authorization.
Remedy
For all the reasons set forth above, the Court concludes that the FDA’s Final Rule exceeds its statutory authority, violates constitutional principles, and must be vacated. The rule represents not merely an error of statutory interpretation but a usurpation of power that strikes at the heart of our constitutional order. This Court will not allow such an encroachment to stand.
Conclusion
The plaintiffs’ motions for summary judgment are GRANTED. The FDA’s Final Rule is VACATED in its entirety. Let this decision reaffirm the principle that federal agencies are bound by the limits of their statutory authority and that the Constitution remains the supreme law of the land.
SO ORDERED.
Date:
Anselm Barrett
United States District Judge
(Originalist, Defender of Constitutional Order).
x
Ebenezer Scrooge
United States District Court for the Eastern District of Texas
Case Nos. 4:24-CV-479-SDJ and 4:24-CV-824-SDJ
American Clinical Laboratory Association et al. v. United States Food and Drug Administration et al.
Association for Molecular Pathology et al. v. United States Food and Drug Administration et al.
Opinion by Judge Ebeneezer Scrooge
Upon the Petitions of Plaintiffs and the Protestations of the FDA: A Judicial Address
Lo and behold, this humble Court is compelled to adjudicate a dispute most vexing, brought forth by two venerable plaintiffs, the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP). On the other side, we find the FDA, whose ambition to regulate all laboratory-developed tests (LDTs) knows no bounds nor sense of frugality. This judicial house, being mindful of the laws of this land and the parsimonious virtues of sound governance, must proclaim judgment.
On Statutory Authority
The FDA presumes to assert that these LDTs—practices born of ingenuity and intellect within laboratories—are “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA). Devices! Devices, you say! To my miserly sensibilities, this argument is as absurd as mistaking a shilling for a guinea. The FDCA, crafted in its wisdom, regulates tangible contrivances: those physical implements that one may hold in hand or package for market. But LDTs? They are but professional endeavors, as intangible as goodwill on a balance sheet, and wholly unsuited to the FDA's grasping jurisdiction.
If Congress intended such a sweeping authority for the FDA, why, pray tell, did it also enact the Clinical Laboratory Improvement Amendments (CLIA)? CLIA is a steward for laboratory practices, the careful keeper of diagnostic reliability. To permit the FDA to extend its tendrils into this realm is to render CLIA redundant—an inefficiency this Court cannot abide.
On the Wretched Excess of Profligate Spending
As one acquainted with the virtues of thrift and the horrors of waste, I am aghast at the staggering cost the FDA's Final Rule would impose. The plaintiffs rightly note that this ill-conceived regulation would compel laboratories across the nation to shoulder billions of dollars in compliance costs. Scientists, researchers, and administrators, whose talents should be directed toward innovation, would instead be chained to the heavy yoke of bureaucracy.
Moreover, the FDA itself would squander vast sums of public money—funds better spent alleviating the plight of the poor or improving the lives of industrious citizens. To squander so is not merely ill-advised; it is immoral. To this, I must cry: Humbug!
On the Major Questions Doctrine
The FDA's assertion of authority raises a profound “major question,” one requiring unmistakable clarity from Congress. Yet, in reviewing the record, I find Congress to have been silent on this matter—silent as a debtor when the bill comes due. If Congress intended for the FDA to regulate LDTs, it ought to have spoken plainly, as the Major Questions Doctrine demands. Absent such explicit direction, the FDA’s claim of authority amounts to nothing more than the puffery of a scoundrel seeking a loan without collateral.
On Arbitrary and Capricious Governance
The FDA’s Final Rule, with its arbitrary carveouts and discretionary enforcement, is a folly of epic proportions. It is as if the agency constructed a counting house with no ledgers, no columns of debit and credit, but only a quill and the vaguest notion of sums. This Court finds such rulemaking not merely capricious but reckless, for it casts uncertainty upon those laboratories whose work saves lives and advances science.
Remedy
This Court, being averse to half-measures and wasteful compromise, finds the only suitable remedy is to vacate the FDA’s Final Rule in its entirety. Anything less would perpetuate the disorderly waste of resources and the unnecessary hardship imposed upon laboratories and their patrons. Let the FDA be admonished to stay within its proper bounds, lest its overreach lead to further folly and ruin.
Conclusion
For these reasons, and in defense of prudence, justice, and sound fiscal policy, this Court rules in favor of the plaintiffs. The FDA’s Final Rule is hereby VACATED. Let this ruling serve as a stern rebuke to profligacy and a reminder that governance must never be conducted in wanton disregard of reason, economy, and the law.
SO ORDERED.
Date:
Ebeneezer Scrooge
United States District Judge
(and steward of efficiency and fiscal restraint).
x
Lieutenant Columbo
Scene: United States District Court, Eastern District of Texas
The Honorable Judge Columbo Presiding
The courtroom is packed with attorneys, plaintiffs, and observers. At the front, the Department of Justice attorney representing the FDA stands confidently, adjusting his tie. Judge Columbo, rumpled in his robe and clutching a notepad covered in scribbles, sits at the bench. He’s been quiet for most of the hearing, his eyes squinting like he’s trying to solve a riddle.
DOJ Attorney (clears his throat):
Your Honor, the government has presented a clear and compelling case. Laboratory-developed tests, or LDTs, undeniably fall under the definition of a “device” in the Federal Food, Drug, and Cosmetic Act. These tests are used for diagnosis, which is precisely the kind of activity Congress intended the FDA to regulate.
Furthermore, the FDA’s Final Rule will enhance public safety by ensuring that these tests meet rigorous standards for accuracy and reliability. It is—
Judge Columbo (interrupting, scratching his head):
Oh, uh, excuse me. Just one thing, Counselor. You said Congress intended for the FDA to regulate these tests? I’ve been puzzling over that. You got anything in the law that says Congress was thinking about LDTs specifically when they wrote that definition back in ’76?
DOJ Attorney (smiling, a bit patronizing):
Well, Your Honor, the law doesn’t mention LDTs explicitly, but the FDA has long interpreted the term “device” broadly. The statute refers to instruments and contrivances—
Judge Columbo (raising a hand):
“Contrivances,” right, I remember that. Fancy word. I looked it up, though, just to be sure. Seems like it’s all about things you can hold, you know? Machines, gadgets, stuff you can ship from one state to another. I mean, a lab process—what was it the plaintiffs said? Something about a chef’s recipe? That don’t feel like a “contrivance.”
DOJ Attorney (forced chuckle):
With all due respect, Your Honor, the FDA’s interpretation has been consistent—
Judge Columbo (cutting in):
Oh, consistent, sure. But, uh, didn’t I see something in your own filing that said the FDA hasn’t actually enforced this kind of rule on LDTs before? Not in decades? So, uh, how consistent is that? Seems like you’re picking now to start cracking the whip. Any particular reason?
DOJ Attorney (a little flustered):
Your Honor, the FDA has always maintained it has the authority—
Judge Columbo (leaning forward):
Authority, huh? But Congress never said it, right? Not in the law, not in CLIA, not anywhere. And then there’s this “major questions” thing I’ve been hearing about. The plaintiffs keep saying Congress has to be crystal clear if an agency wants to tackle something this big. Billions of dollars, lives on the line, labs scrambling to keep up… I mean, I’m just a judge, but that sounds major to me.
DOJ Attorney (visibly sweating):
Your Honor, the FDA’s actions are grounded in public safety. The courts have upheld—
Judge Columbo (holding up a finger):
Oh, safety, absolutely. Gotta have that. But here’s another thing that’s been bugging me. These labs, they’ve been regulated by CLIA for, what, forty years? And CLIA seems to be working just fine. So, uh, why the sudden need for the FDA to jump in? Seems like doubling up. That’s expensive, ain’t it?
DOJ Attorney:
Your Honor, CLIA focuses on laboratory operations, but the FDA ensures clinical validity—
Judge Columbo (nodding, flipping through his notepad):
Right, right. But if Congress wanted you guys to do both, wouldn’t they have said so back then? Instead, they set up CLIA and gave it to the states and CMS. If you ask me, it’s like Congress wrote CLIA as the driver and gave the FDA a map. Now you’re trying to grab the wheel.
DOJ Attorney (desperately):
Your Honor, this rule is necessary for the protection of patients—
Judge Columbo (waving his hand):
Oh, I get that, I do. But here’s the thing: rules gotta follow laws, not feelings. And this rule? It don’t match the law. Not the FDCA, not CLIA, not even the Constitution, if we’re talking federal powers. I mean, the plaintiffs showed me their case, and I’ve been over it top to bottom. Your case? It’s full of holes, Counselor.
Denouement
The courtroom falls silent. Judge Columbo leans back, takes a deep breath, and scratches his head again.
Judge Columbo (smiling slyly):
Tell ya what. I think I’ve got it figured out. This rule of yours? I’m throwing it out. Whole thing’s vacated. You got a problem with CLIA? Take it up with Congress. Until then, let the labs do what they’re good at. Case closed.
And, uh, Counselor? Next time you step into my courtroom, bring a case that makes sense.
The gavel drops.
Lights dim. Case solved.
x
