On June 27, 2025, the Supreme Court issued a ruling that (for now) prevents single federal district courts from issuing national junctions. The test case was a birthright citizenship case.
But in March 2025, a Texas judge "threw out" an FDA regulation about LDTs, saying the regulation was outside the FDA's legal scope for medical devices, and void.
Here's the $60,000 question -
What if the March 2025 Texas FDA decision had come after today - after today's limitation on national injunctions. Would it be different? I am not an attorney, and this is for entertainment only, but here is what Chat GPT says.
Chat GPT read both the March FDA case and the Birthright case, Trump v Casa.
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AI CORNER
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Yes, the FDA lab-developed test (LDT) Texas ruling would likely be impacted or at least called into question by the new June 27, 2025 Trump v. CASA decision on universal injunctions—though the outcome wouldn't necessarily reverse the substance of the FDA ruling.
Here’s how they intersect:
✅ Texas Ruling on LDT Regulation (March 31, 2025)
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The Texas federal court vacated the FDA’s 2024 LDT final rule nationally, ruling that FDA exceeded its statutory authority under the FDCA.
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The judge concluded that LDTs are services, not “devices,” and are comprehensively regulated under CLIA, not FDA.
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The ruling applied nationwide, not just to the plaintiffs. The judge explicitly justified nationwide relief, likely referencing precedents like Texas v. United States and 5th Circuit reasoning allowing broader relief in APA cases.
⚖️ SCOTUS Birthright Citizenship Decision (June 27, 2025)
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In Trump v. CASA, the Supreme Court rejected universal (nationwide) injunctions unless necessary to give “complete relief” to the named plaintiffs.
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Barrett, writing for the Court, held that injunctions should be party-specific, as traditional equity never allowed nationwide remedies.
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The Court vacated nationwide injunctions against a Trump executive order and instructed lower courts to limit relief to actual plaintiffs.
🔁 Implications for the FDA LDT Ruling
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The LDT ruling vacated the FDA rule under the APA (Administrative Procedure Act), not just enjoined it.
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But the APA has its own framework: courts “shall… set aside” unlawful agency rules (5 U.S.C. § 706(2)). Courts have debated whether that means facial invalidation or plaintiff-specific relief.
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Trump v. CASA leans heavily against sweeping remedies, so litigants or the DOJ could now argue that the LDT ruling should be narrowed to apply only to the plaintiffs in the case, not all labs nationwide.
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However, the Texas judge in the LDT case seemed to anticipate this debate and explicitly justified nationwide vacatur, which some appellate courts (e.g., D.C. Circuit) still permit in APA cases.
🔍 Bottom Line
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Yes, the SCOTUS CASA decision could prompt the FDA or DOJ to seek modification or narrowing of the Texas LDT ruling—especially if it moves to appeal.
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Whether that would alter the outcome or enforcement effect depends on whether the 5th Circuit (which covers Texas) embraces CASA’s limits strictly, or defers to APA precedents supporting broad vacatur.
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Strategically, it introduces new risks to relying on the LDT ruling as a shield for non-party labs, and the FDA could continue enforcing the rule against others not named in the case—unless and until enjoined again.
Let me know if you'd like a one-paragraph advisory version for client communications.
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"Natioanl Injunctions" in Trump/CASA. "National Vacatur" in FDA LDT. ???
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Yes, the distinction between injunction and vacatur matters a great deal in this context—especially in light of the Trump v. CASA ruling.
🔹 Injunction vs. Vacatur: What’s the Difference?
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An injunction tells the government not to enforce a rule or policy—typically against the plaintiffs.
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A vacatur (under the APA, 5 U.S.C. § 706(2)) nullifies the agency’s rule entirely—treating it as legally void if found unlawful.
⚖️ How Trump v. CASA Changes the Terrain
In Trump v. CASA, the Supreme Court held that universal injunctions—i.e., barring enforcement against non-parties—exceed the equitable authority of federal courts. That decision was about injunctions, not vacatur.
But this doesn’t automatically apply to vacatur under the APA, which has been interpreted differently across the circuits:
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The D.C. Circuit and some others treat vacatur as automatic and nationwide when a rule is invalidated.
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The 5th Circuit (where the Texas LDT case sits) has been more skeptical and may now lean toward party-specific relief, especially post-CASA.
🧩 Why the Distinction Matters
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If the Texas ruling had only enjoined FDA from enforcing the LDT rule against the plaintiffs, CASA would clearly limit its scope.
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But because the Texas court vacated the rule under the APA, it arguably treated the FDA rule as void across the board—a different legal act.
However, post-CASA, FDA or DOJ could argue that vacatur is functionally no different from a universal injunction, and that courts must now narrow even APA vacatur to apply only where needed for plaintiff relief.
🟨 Conclusion
The fact that the Texas LDT ruling used vacatur rather than injunction gives it a stronger claim to nationwide effect—but that ground is now legally unsettled after Trump v. CASA. The FDA may test this distinction in appeals or enforcement discretion. For labs not party to the case, relying solely on the Texas vacatur is now riskier than before.
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I'd add, the FDA regulation is still on the books, so, for example, could the FDA try imposing the FDa regulation, exactly as it is, against a lab in Ohio, or Minnesota, next week? When the lab protests, FDA could say the Texas decision applied only to Texas, in light of the Birthright case. (Only a hypothetical).
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Again, this is an AI opinion and for entertainment only.
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AI:
In light of the Supreme Court’s June 27, 2025 decision in Trump v. CASA, which sharply limited the use of nationwide injunctions, the March 2025 Texas court decision vacating FDA’s LDT rule may no longer be securely applicable to all labs nationwide. While the Texas ruling explicitly set aside the FDA rule under the APA, Trump v. CASA calls into question the legitimacy of such broad relief unless strictly necessary to protect the named plaintiffs. As a result, FDA or DOJ may now argue that the Texas court’s ruling should apply only to the specific plaintiffs in the case, leaving other labs potentially subject to enforcement unless they obtain their own relief. This development introduces uncertainty regarding the scope of protection the Texas ruling provides and may warrant a cautious review of compliance and legal exposure for non-party labs.
