Michel Foucault, Susan Sontag, Ayn Rand
Dr Seuss
Tennessee Wms
A Few Good Men
Dorothy Parker
- Original news blog here
- "Earnest" fictional judge's ruling here.
- First fictional chacters (Lewis Black et al) here.
- EXTRA fictional characters (this page you are on).
MICHEL FOUCAULT
Opinion of the Court
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 Michel Foucault (as interpreted through a juridico-philosophical lens)
Preface: The Power/Knowledge Nexus
To render a decision in this case is not merely to adjudicate a legal dispute; it is to excavate the mechanisms of power, to interrogate the knowledge systems that authorize and constrain, and to understand the networks of control within which laboratories, the FDA, and the law itself operate. This case is not about a single rule or even a single agency. It is about the juridical construction of truth and the contested boundaries of regulatory sovereignty.
The plaintiffs, the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), challenge the FDA’s claim of authority to regulate laboratory-developed tests (LDTs). This regulatory assertion is encapsulated within the FDA’s Final Rule, an act of governance that reflects not merely the imposition of rules but the exercise of a disciplinary power over scientific practice. The question before the Court, then, is whether this assertion is lawful—or whether it reveals the apparatus of domination masquerading as protection.
Part I: The Archaeology of "Devices"
The FDA grounds its claim to regulate LDTs in the Federal Food, Drug, and Cosmetic Act (FDCA), wherein the term “device” is defined as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” Here, one sees the operation of legal language as a technology of control, a discourse that renders certain objects visible and others invisible within its epistemic frame.
The plaintiffs argue, convincingly, that LDTs—being laboratory processes rather than tangible goods—do not fall within this definition. LDTs are not “articles” that can be packaged, sold, or transported; they are practices, situated within the confines of laboratories, embedded in the tacit knowledge of professionals. By attempting to subject these practices to regulation as “devices,” the FDA enacts a profound epistemological violence: it erases the specificity of laboratory work, transforming it into something commodifiable and subject to bureaucratic oversight. This is not merely an error of statutory interpretation; it is an operation of power that seeks to discipline a domain of knowledge.
Part II: The Biopolitics of Regulation
The FDA frames its actions as necessary for public health and safety, invoking the familiar logic of biopolitical governance. Yet, as the plaintiffs point out, LDTs have long been governed under the Clinical Laboratory Improvement Amendments (CLIA). CLIA is itself a regime of control, designed to ensure the reliability of laboratory practices through oversight mechanisms tailored to their nature. By asserting its own jurisdiction over LDTs, the FDA creates a redundancy that is not neutral; it is an expansion of power under the guise of necessity.
This duplication is not merely inefficient—it is emblematic of what I have elsewhere described as the “multiplication of disciplines.” Regulatory frameworks proliferate, not because they are needed, but because the state extends its reach through the constant reconfiguration of its apparatuses. The FDA’s Final Rule is a paradigmatic example of this dynamic: a new regime of truth is asserted, and with it, new obligations, costs, and vulnerabilities are imposed upon laboratories.
Part III: The Major Questions Doctrine as Genealogy
The plaintiffs invoke the Major Questions Doctrine, arguing that such a sweeping regulatory action requires explicit Congressional authorization. This doctrine, though jurisprudential in origin, is genealogical in its function. It demands an account of how power came to be exercised, an interrogation of the legal and historical conditions that make such an assertion possible.
Here, the genealogy reveals silence. Congress has never explicitly granted the FDA authority over LDTs. Instead, the FDA’s claim rests on a reinterpretation of language written decades ago, applied to a domain Congress assigned to CLIA. The silence of Congress is not merely an omission; it is a gap in the discursive field that the FDA seeks to fill with its own logic of control. Yet this act of filling is precisely what the Major Questions Doctrine resists. It demands that the sovereign will be expressed clearly, not inferred from ambiguities or expanded through administrative ambition.
Part IV: The Economics of Discipline
The FDA’s Final Rule, if upheld, would impose billions of dollars in compliance costs upon laboratories. These costs are not incidental; they are the material embodiment of power. The expenditure of resources, the diversion of labor, the transformation of scientists into administrators—all of these are mechanisms through which discipline is enacted.
The plaintiffs’ evidence illustrates that these costs would disrupt the very practices the FDA claims to safeguard. Laboratories would be forced to divert attention from innovation and patient care to compliance and bureaucracy. This is not the rationality of protection; it is the rationality of subjugation, the transformation of productive activity into an object of regulatory consumption.
Conclusion: Vacatur as Liberation
The FDA’s Final Rule is not merely an overreach; it is an exemplar of the modern state’s tendency to expand its dominion through the redefinition of its objects. This Court cannot allow such an expansion to proceed unchecked. To do so would be to ratify a distortion of statutory language, an erosion of Congressional intent, and an unnecessary imposition of disciplinary power upon laboratories.
Accordingly, the Court grants the plaintiffs’ motions for summary judgment. The FDA’s Final Rule is hereby vacated, its apparatus dismantled—at least for now. Let this decision stand as a reminder that power must always answer to law, and law must always answer to truth.
SO ORDERED.
Date:
Michel Foucault (as imagined)
United States District Judge (and historian of power).
###
SUSAN SONTAG
Opinion of the Court
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 Susan Sontag (as interpreted through her incisive, cultural-critical lens)
A Prefatory Note on Bureaucracy as Cultural Performance
The FDA’s attempt to regulate laboratory-developed tests (LDTs) under the guise of public safety is not merely a legal question—it is a cultural phenomenon. This is a performance of authority, one that seeks legitimacy not through clear statutory language but through the aesthetics of governance: the invocation of expertise, the language of safety, the illusion of benevolence.
We are not here to adjudicate a mere technicality. What is at stake is the cultural meaning of regulation, the role of power in defining the boundaries of science and commerce, and the hidden costs—intellectual, economic, and human—of this bureaucratic spectacle.
The FDA’s Argument as a Rhetoric of Control
The FDA’s claim that LDTs are “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA) is not a matter of simple statutory interpretation. It is a rhetorical strategy, designed to expand the scope of the FDA’s authority by redefining the very terms of regulation. To call a laboratory process—a protocol, a method—a “device” is to engage in a deliberate act of linguistic distortion. It is a rebranding of practices as products, of processes as things.
This redefinition is more than semantic. It is ideological. It reflects a worldview in which all human activity, even the deeply intellectual and inherently provisional work of science, must be reduced to objects of control. The plaintiffs are correct to resist this move. To accept the FDA’s definition would be to accept a vision of governance in which the creative and analytical work of laboratories is subsumed under a regime of commodification.
The Ambiguity of Safety
The FDA insists that its rule is necessary to protect public health. But what does “safety” mean in this context? Safety, as the FDA invokes it, is not a neutral concept. It is a value-laden construct, wielded to justify the expansion of regulatory oversight. Safety here is less about the actual protection of patients and more about the institutional need to project authority.
The plaintiffs, by contrast, remind us that safety is already ensured under the Clinical Laboratory Improvement Amendments (CLIA), a framework specifically designed to regulate laboratory practices. CLIA operates not by redefining processes as products but by respecting the unique nature of laboratory work. The FDA’s rule does not enhance safety; it duplicates and disrupts existing safeguards, adding layers of complexity and cost without clear benefit.
This is not the safety of care but the safety of spectacle—a performance of protection that obscures its own inefficacy.
The Economic Burden as a Cultural Tax
To uphold the FDA’s rule would impose billions of dollars in compliance costs on laboratories. These costs are not incidental. They are part of a broader cultural narrative in which regulation becomes a form of economic extraction. The FDA, in asserting its authority, shifts the burden of its ambitions onto the very institutions it claims to protect.
This economic burden is also an epistemological one. By forcing laboratories to redirect resources from research and innovation to compliance, the rule diminishes the capacity of science to serve humanity. It prioritizes bureaucracy over discovery, form over substance. This is not regulation in the service of public health. It is regulation as a spectacle of domination, a demonstration of the state’s power to impose its will on even the most specialized and autonomous fields of human activity.
The Major Questions Doctrine as Resistance to Spectacle
The Major Questions Doctrine, invoked by the plaintiffs, is more than a legal principle. It is a cultural critique. It demands clarity, specificity, and intent from Congress when agencies seek to assert sweeping new powers. It resists the vague gestures of authority, the unarticulated mandates, the regulatory creep that turns governance into a sprawling, self-justifying enterprise.
In this case, Congress has not spoken clearly. The silence of Congress is not an invitation for the FDA to step in; it is a boundary, a demarcation of limits. To cross that boundary is to replace democratic governance with bureaucratic fiat.
Vacating the Rule: An Act of Cultural Clarity
The FDA’s rule cannot stand. It is a misreading of statutory language, a misuse of regulatory authority, and a misstep in the broader cultural project of governance. To vacate this rule is not merely to correct a legal error; it is to affirm the value of clarity, the integrity of language, and the proper limits of power.
This Court grants the plaintiffs’ motions for summary judgment. The FDA’s Final Rule is hereby vacated. Let this decision serve as a reminder that governance is not a spectacle, that regulation must respect the specificity of its objects, and that power must always be held accountable to the principles of clarity, necessity, and justice.
SO ORDERED.
Date:
Susan Sontag (as imagined)
United States District Judge (and critic of cultural excess).
###
Opinion of the Court
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 Ayn Rand (as envisioned in her philosophical ethos)
Introduction: The Moral Battle of the Individual vs. the State
This courtroom has witnessed an extraordinary conflict, not merely of legal arguments but of two worldviews: the triumph of the individual mind and the oppressive machinery of the collective state. On one side stand the plaintiffs, the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP)—producers of knowledge, creators of value, stewards of human ingenuity. On the other side looms the FDA, a faceless bureaucratic leviathan seeking to shackle the brilliant innovators of medical science to its plodding, lifeless machinery.
The question before this Court is whether the FDA’s Final Rule, which seeks to regulate laboratory-developed tests (LDTs), is lawful. But the deeper question is this: shall we permit the government to expropriate the fruits of human ingenuity under the guise of regulation, or shall we defend the sanctity of the individual mind against the encroachments of the state?
The FDA’s Assault on Reason
The FDA claims the authority to regulate LDTs as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA). But this claim collapses under the weight of its own irrationality. A “device,” according to the plain language of the statute, is a tangible, physical object—an “instrument, apparatus, implement, or contrivance.” It is not a method, a process, or a protocol developed by the minds of laboratory professionals.
To classify LDTs as “devices” is to obliterate the meaning of the term. It is an act of epistemological evasion, a refusal to see reality as it is. This is not the pursuit of truth; it is the bureaucrat’s counterfeit: the manipulation of language to justify the expansion of power.
The Creators vs. the Bureaucrats
The plaintiffs, ACLA and AMP, represent the creators: the thinkers and doers who have built an entire field of science, innovating for the benefit of human health. Their laboratories are sanctuaries of reason, where intellect and effort converge to produce lifesaving discoveries.
The FDA, by contrast, is the archetype of the bureaucrat: a parasite feeding off the vitality of those it seeks to control. The agency claims that its rule is necessary to protect public health, but what it truly seeks is the power to dictate, to command, to subsume the work of the creator into the lifeless framework of the state.
CLIA, the existing regulatory framework for laboratories, respects the nature of laboratory work. It is a system designed to ensure quality without suffocating innovation. The FDA’s Final Rule, however, would drown laboratories in a sea of compliance costs and administrative burdens, diverting resources away from discovery and toward the maintenance of government-mandated mediocrity.
The Cost of Sacrificing Excellence
To uphold the FDA’s Final Rule would impose billions of dollars in compliance costs on laboratories. These costs are not incidental—they are a tax on achievement, a punishment for success. The innovators who create value are told they must divert their time and resources to satisfy the unproductive whims of the state.
But this tax is more than economic; it is a moral tax. It tells the creator, “You are not free to think and act according to your judgment. You must submit to the collective, to the bureaucrats who know nothing of your work but presume to control it.” This is the logic of collectivism, the doctrine that the individual exists to serve the state. It is a doctrine this Court will not endorse.
The Major Questions Doctrine: A Check on the Leviathan
The Major Questions Doctrine demands that Congress speak clearly when authorizing sweeping regulatory action. In this case, Congress has not spoken at all. It has neither authorized the FDA to regulate LDTs nor expressed any intention to displace CLIA.
The FDA’s attempt to claim jurisdiction over LDTs is an act of usurpation, a naked grab for power. The bureaucrat does not ask, “What is right?” or “What is true?” He asks only, “What can I get away with?” This Court will not allow the FDA to get away with rewriting the law to suit its ambitions.
The Ruling: A Defense of the Individual Mind
The plaintiffs have demonstrated that the FDA’s Final Rule is unlawful, irrational, and destructive. This Court rules in their favor not out of pity but out of justice. The rule is vacated because it violates the law, but more importantly, because it violates the principle that the mind must be free to create, to innovate, and to pursue truth without interference from the coercive apparatus of the state.
Let this decision stand as a testament to the sanctity of the individual, to the moral superiority of the creator over the bureaucrat, and to the enduring truth that no government, no matter how powerful, can extinguish the light of human reason.
SO ORDERED.
Date:
Ayn Rand (as imagined)
United States District Judge (and champion of the individual).
###
DR SEUSS
Opinion of the Court
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 Theodor Geisel (as imagined through rhyme and whimsy)
Oh, the Arguments You’ll Make!
Here in my courtroom, the FDA stands,
With rules and with regs and with “Big Brother” plans.
They claim that they’ve rights, they claim that they must,
But I smell a case full of regulatory dust.
The labs say, “Hold on! You’ve no such control!
We follow CLIA—that’s our primary goal.
Your rule is too vague, too big, and unclear.
What Congress allowed? Not this. It’s severe!”
So now I must judge, I must rule, I must think,
Is the FDA’s logic too loose and too weak?
Or is this new rule, as the FDA contends,
The key to protect us, the way health depends?
The “Device” Debate
The FDA claims that a test is a thing,
A gadget, contrivance—a bell it can ring.
“It’s a device!” they shout loud, as if we’re all blind.
But no, it’s a process, a work of the mind.
A test in a lab isn’t sold in a box.
It isn’t a widget. It isn’t some socks.
You can’t hold it or ship it; it’s not in a crate.
To call it a “device” is to overinflate.
The law, when it’s read with a clear and calm eye,
Says a “device” is a thing, and I’ll tell you why:
A “device” must be sold, it must travel and move.
But LDTs? They just don’t fit that groove.
On Major Questions, Big and Small
When the FDA acts, they must have some clear guide.
They can’t just make rules on a regulatory tide.
If Congress stayed silent, as they clearly have done,
The FDA’s overreach cannot be won.
This “Major Questions Doctrine” rings like a bell.
When the stakes are this high, you’d better do well.
Congress must speak in a voice that is plain,
Not leave us to guess, not cause such a strain.
On Costs and Chaos
The labs showed their math: compliance costs much.
Billions of dollars for paperwork and such.
Scientists, doctors, their heads all a-spin,
Instead of their labs, they’ll be stuck filing in.
If the FDA rule stomps its big bureaucrat boots,
Then labs will bear burdens that won’t bear good fruits.
Costs rise, innovation slows down,
And public health suffers in city and town.
My Judgment: VACATED!
So here is my ruling, both clear and direct:
The FDA’s rule I cannot protect.
It’s sloppy, it’s vague, it’s legally flawed.
And for overreach, I am simply appalled.
I hereby declare that this rule has no base.
It’s struck down, removed—please close the case.
Labs, do your work. Innovate, thrive!
FDA, stay out where your power can’t dive.
SO ORDERED.
Date:
Theodor Geisel
United States District Judge
(who finds that bad rules are quite easy to nudge).
##
Setting: A sultry, dimly lit courtroom, with a ceiling fan turning lazily overhead. The oppressive heat is matched only by the thick tension between the three characters.
The judge, a faded yet commanding Southern figure, clutches his gavel like a relic of glory days past. The ACLA attorney, an intense, idealistic crusader, projects righteous indignation but struggles with their own desperation. The DOJ (FDA) attorney, slick and confident, oozes condescension while masking an undercurrent of anxiety.
Act I: The DOJ Attorney’s Closing Argument
DOJ Attorney (smoothly):
Your Honor, the FDA has no choice but to act in the name of public health. These laboratory-developed tests—these so-called LDTs—have proliferated without oversight. They operate in shadows, unchecked, uncontrolled. The FDA’s rule is a beacon, lighting the way toward safety, consistency, and truth.
These tests are “devices,” Your Honor, as defined by the law. They diagnose; they shape lives; they are every bit as much a medical instrument as a scalpel or a stethoscope. Congress, in its wisdom, left the door open for the FDA to ensure that no test—no matter how small—escapes its vigilance.
Judge (drawling, tapping his gavel lightly):
Now, Counselor, I must say, you talk about safety like it’s a gospel hymn, but there’s something that don’t quite harmonize. Are you tellin’ me these tests have roamed free all these years—unregulated by your fine FDA—and yet we ain’t seen the sky fall?
DOJ Attorney (his confidence flickering):
Your Honor, it is precisely because the risks are insidious—like a fire smoldering beneath floorboards—that the FDA must act preemptively.
Judge (leaning forward, narrowing his eyes):
Smolderin’ fires, you say? Well, Counselor, this court has a fondness for real-world evidence, not metaphorical blazes. Where’s your proof? How many lives lost? How many patients harmed? Or is this just a case of the FDA wanderin’ where it’s not wanted, pokin’ at a hive that’s been quiet for decades?
DOJ Attorney (tightening his jaw):
The FDA does not need bodies in the street, Your Honor, to justify its actions. Prevention is—
Judge (cutting him off):
Prevention, yes, prevention. You preach that word like salvation, but don’t forget, Counselor—laws ain’t sermons, and this court ain’t a church.
Act II: The ACLA Attorney’s Closing Argument
ACLA Attorney (rising with fervor, almost trembling):
Your Honor, I implore you—this is a fight for the very soul of innovation! These tests, these brilliant creations of science, are born in laboratories by the sweat and genius of our nation’s greatest minds. To let the FDA’s rule stand is to suffocate progress, to bind discovery with red tape until it withers and dies.
Judge (squinting):
Now hold on, Counselor. “Soul of innovation”? That’s mighty poetic, but this court is more inclined to deal in facts. Tell me plain: what’s it gonna cost these labs if the FDA gets its way?
ACLA Attorney (desperate, clutching a sheaf of papers):
Billions, Your Honor! Billions of dollars in compliance costs! Small labs will close. Scientists will abandon their dreams to fill out forms. Patients—desperate patients—will lose access to tests that could save their lives. This is not regulation; it is strangulation!
Judge (leaning back, fanning himself):
Strangulation, you say? Well, I reckon that’s a word that deserves attention. But tell me this—CLIA’s been regulatin’ these labs all this time. Why’s the FDA feel the need to muscle in now?
ACLA Attorney (voice rising):
Because, Your Honor, the FDA craves control! This isn’t about safety—it’s about power! They see a field of brilliance and can’t resist the urge to stomp through it, heavy boots crushing delicate blossoms.
Judge (raising an eyebrow):
That’s quite the image, Counselor. Delicate blossoms and heavy boots. You do have a way with words.
Act III: The Judge’s Decision
Judge (rising slowly, his presence commanding):
Ladies and gentlemen, I’ve heard your words. Oh, they’ve come at me like the summer heat, thick and stiflin’, demandin’ attention. And here I stand, burdened with the weight of truth and law.
The FDA, with its swagger and righteousness, tells me it’s savin’ lives, preventin’ disasters that may never come. And yet, it offers me no proof, no wreckage to justify the storm it brings. Prevention, you say. But this court is not a seer, not a prophet. We deal in facts, not fears.
And you, ACLA, you paint a picture of brilliance crushed beneath the bureaucrat’s heel. You remind me that the law is not a tool for expansion but a fence—a boundary set by Congress to guard against the very overreach I see before me.
The FDA has wandered where it don’t belong, stretchin’ the meaning of “device” like taffy on a hot day, twistin’ it until it no longer resembles what Congress intended. The Major Questions Doctrine rings in my ears, remindin’ me that when the stakes are this high, the law must speak plain—and here, it has not.
So, I say this: The FDA’s rule is struck down, vacated, and tossed aside. Let the labs keep their light alive, let the tests keep savin’ lives without drownin’ in paperwork. And let this be a reminder to all: power, unchecked, is a danger greater than any phantom fear.
The gavel falls. The courtroom is silent. The tension, thick as molasses, slowly dissipates into the oppressive summer air.
A FEW GOOD MEN (FILM)
Scene: A packed courtroom. Tension hangs in the air like a storm about to break. At the defense table, Lieutenant Daniel Kaffee (Tom Cruise) stands, representing the ACLA and AMP team. On the witness stand sits Colonel Jessep (Jack Nicholson), representing the FDA. He radiates the barely restrained fury of a man used to command.
Kaffee (Tom Cruise):
Colonel Jessep, let’s talk about why we’re here. The FDA says that laboratory-developed tests—LDTs—are devices, like pacemakers or scalpels. That’s your argument, right?
Col. Jessep (Jack Nicholson):
Devices. Absolutely. That’s what the law says.
Kaffee:
Devices are things you can hold, aren’t they, Colonel? Things you can ship, sell, wrap in plastic. But LDTs? They’re processes. Protocols. They don’t ship anywhere. How does the FDA regulate something that doesn’t leave the lab?
Col. Jessep (leaning forward):
Nonsense! A test is a test. And we regulate tests because someone has to.
Kaffee (turning to the jury):
And yet, for decades, CLIA—Congress’s chosen regulatory framework—has done just that. Labs have operated safely under CLIA’s oversight. Tests have been accurate. Lives have been saved. Congress didn’t ask for the FDA to step in. Not once.
Col. Jessep (interrupting):
CLIA is a joke! It’s toothless, Kaffee. No enforcement, no oversight. You think a CLIA inspector is keeping those labs honest? You’re dreaming.
Kaffee (calmly):
So you’re saying Congress made a mistake? That they didn’t know what they were doing when they created CLIA? That’s not what the Constitution says, Colonel.
Col. Jessep (gritting his teeth):
Congress doesn’t understand what’s at stake. I do.
Kaffee (nodding, as if expecting that response):
Ah, you understand. You’re the only one who understands. You’re the one who should decide, even though Congress hasn’t given you the authority. You’re saying the FDA’s rules are more important than the law.
Col. Jessep:
The law doesn’t protect people. I do.
Kaffee (raising his voice):
And how do you protect them, Colonel? By imposing billions of dollars in costs on labs? By driving small labs out of business? By making patients wait for the tests they need to save their lives?
Col. Jessep (snapping):
If they can’t follow the rules, they shouldn’t be in the game.
Kaffee (stepping closer to the witness stand):
But what if those rules are arbitrary, Colonel? What if they’re not legal? That’s what this is about. Congress didn’t give you the authority, and you took it anyway.
Col. Jessep (glaring, voice rising):
You don’t understand the dangers in those labs!
Kaffee (pausing for dramatic effect):
What dangers, Colonel? Labs have operated safely for decades. CLIA inspectors manage them well. Experience has proven that.
Col. Jessep (exploding, standing up):
IN DARK PLACES, YOU KNOW YOU LIKE FDA INSPECTORS IN THOSE LABS.
NOBODY CARES ABOUT CLIA! YOU WANT FDA INSPECTORS IN THOSE LABS, ANYWAY!
(Gasps fill the courtroom. The judge bangs his gavel, demanding order. Col. Jessep, realizing what he’s said, sits down, seething.)
Judge:
Ladies and gentlemen, I’ve heard enough. Colonel Jessep, your statement has revealed what this court suspected all along: the FDA has overstepped its bounds. Congress did not grant the FDA authority to regulate laboratory-developed tests as devices. This court vacates the FDA’s Final Rule.
(Turning to the room.)
This is over. Go home peaceably, and let’s keep the rule of law where it belongs—in the hands of the people, not unchecked regulators.
(Gavel falls. Silence reigns as the courtroom absorbs the verdict.)
End Scene.
###
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DOROTHY PARKER
In the style of her acid wit, such as in 1930's, "DIARY OF A LADY" ("DIARY OF A NEW YORK LADY")
#
Diary of a Lady – Courtroom Edition
Tuesday, Somewhere Between Luncheon and Total Despair
Determined to do something educational today, or at least something that looks good in conversation. Spent the afternoon at the courthouse—yes, me, attending a real, live trial. What is it they say? “Justice is blind”? After today, I’m convinced it’s also deaf and dumb.
Arrived late, naturally. One cannot rush one’s post-lunch powdering. Took my usual seat (the one where my silhouette looks best in profile) and tried to focus. Some nonsense about laboratory-developed tests—LDTs, as they called them. It was all terribly modern and utterly joyless. No one seemed to be wearing the faintest shade of rouge.
The plaintiffs, ACLA and AMP, had a lawyer who looked like he’d walked right off a magazine cover: handsome, but utterly humorless. He stood there, passionately explaining why the FDA’s rules would cost labs billions of dollars and ruin science. Billions! Ruin! Quite theatrical, but without a single good joke. I mean, if you’re going to grandstand, at least give the rest of us a little fun.
And then the FDA’s lawyer took the stage. What a sight. He spoke with the confidence of a man who’s never once doubted himself—and never once been told he should. Something about “protecting public health” and “prevention,” as if we’re all sitting on the edge of calamity, one unregulated test away from doom.
I must admit, his overconfidence was almost charming, in the way a badly trained dog is charming, just before it chews your favorite shoe.
At one point, the FDA lawyer tried to explain how a “laboratory process” was somehow the same as a “device.” I half-expected him to argue that a soufflé is a frying pan. Honestly, the only process that needed regulating in that courtroom was his thought process.
Finally, the judge—an older gentleman with the kind of face that screams “four bourbons by sundown”—delivered his verdict. He leaned back, looked over his glasses, and declared the FDA’s rule “overreach.” The plaintiffs won. The FDA lost. And just like that, it was over.
The judge even said the word “arbitrary.” I do love that word. It’s just so wonderfully disdainful. “Arbitrary”—as if dismissing the rules of the FDA is no more consequential than sending back cold soup at the Ritz. Which reminds me, lunch was ghastly today. The vinaigrette was so acidic, I nearly filed a grievance.
Anyway, I suppose this courtroom business was interesting, in its way. There was something almost poetic about the whole affair. A great battle between science and bureaucracy. Ideals clashing with red tape. And of course, the government lost—there’s a lesson in there somewhere. Probably. Something about hubris or maybe just the limits of trying to regulate everything under the sun, even things you don’t understand.
Dinner tonight at the DuMonts. I expect the roast will be overcooked and the company underwhelming. What can you do?
