Court tosses out FDA LDT rule. If the government appeals, will it also ask the court to "delay" the effect of the "vacatur" of the rule, until appeals are heard?
First, the government is unlikely to appeal, and if it does, it's unlikely to ask the result of the decision be stayed-during-appeal. However, Let's look down the rabbit hole, becausae it's also true that national rulings by local judges is a hot-button topic in 2025.
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As we've all heard by now, on March 31, 2025, a Texas federal judge ruled that the FDA LDT regulation was outside the legal scope of the FDA. After his 51-page decision, he added that the LDT regulation was VACATED (nationwide.) Rather than ruling against a particular FDA decision or approval or denial, he's ruling against the regulation in itself.
While that might be the end of it, there's a LOT of question in the Trump administration about any local judge who issues any nationwide ban or ruling, against a policy held by the administration.
There's an article about this in today's WSJ. Scroll down to the subtitle, "Defunding the Judiciary."
https://www.wsj.com/opinion/trumps-election-muddle-ad46e69f
See below for some limited direct quotes from WSJ.
In the next 60 days, (A) the DOJ can decide whether to file a notice of appeal (merely one sentence). But don't forget, (B) the DOJ can also make motions to have the regulation stay in place while court motions proceed. (If granted, the FDA reg would remain active.) For example, various parts of the ACA have lost in court (including the whole act; including its preventative benefits) yet remained in effect during their appeals. A judge tossed out FDA clerance of mifepristone, but higher courts kept the drug available, despite the loss, during years of appeals. See the case history in this appeals court decision. Local judge issues "stay & injunction" both, page 8, and a higher court "stayed" the "vacatur" while the case proceeded, page 9.
See the cited HOUSE letter from the chair of its Judiciary committee - here. The letter and proposed legislation - Rogue Rulings - are about "injunctions" not "vacatur," but it shows the issue of national impact of local judges is a hot potato.
"A flood of judge-issued national injunctions against Trump policies continue to inspire a counterflood of Republican proposals to rein in judges. That includes a brand new suggestion from House Judiciary Chair Jim Jordan: Cut off federal dollars.
"In a Monday letter to House Appropriations Chair Tom Cole, Jordan urges the committee to use “the power of the purse” to “enhance judicial restraint and reaffirm democratic principles.” Specifically, he suggests appropriations language “prohibiting the use of taxpayer dollars and federal resources to issue or enforce these overbroad injunctions beyond the specific parties in front of an issuing court,” backed by a more specific bar on any funds that would be used to “compel compliance, impose fines, or conduct contempt proceedings related to such injunctions.”
"The Jordan proposal comes amid a broader GOP push for legislation to curb “judicial policymaking.” The House Rules Committee voted on Tuesday to advance Rep. Darrell Issa’s “No Rogue Rulings Act”—which would limit district court judges’ ability to issue universal injunctions—while both Sens. Chuck Grassley and Josh Hawley have introduced Senate versions of the same."
[For WSJ links see original]
[Kimberley Strassel, April 2]
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AI CORNER CHAT GPT4o
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Let's emphasize, the most likely situation is the government does NOTHING. But let's suppose - go down the rabbit hole - that the government DOES file a notice of appeal. Is there any additional action the government could do, to keep the FDA LDT regulation active during the long appeals process. (The government has gotten this before, such as when a judge issued a VACATUR in Braidwood, yet, the preventive policy remained active during the appeals.)
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Yes, the government does have options to preserve the FDA’s LDT rule during the lengthy appeals process—even though the district court vacated the rule outright on March 31, 2025. Drawing from both Braidwood (2024) and general APA precedent, here’s a practical overview of what could happen next:
🔹 Default Path (if Government Does Nothing):
If DOJ files no motion to stay the vacatur or delay implementation, then:
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The vacatur takes effect immediately.
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The LDT rule is effectively nullified nationwide under the APA’s “set aside” clause (5 U.S.C. § 706(2)).
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Laboratories would not be subject to the FDA’s new LDT framework, and the case proceeds to the Fifth Circuit on appeal.
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The FDA would remain in regulatory limbo, as it cannot enforce a rule that has been vacated.
🔹 Option 1: DOJ Files Notice of Appeal Only (within 60 days)
A notice of appeal is a short, boilerplate filing—often one page—saying the government intends to appeal. However:
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Filing a notice does not automatically stay the vacatur.
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FDA still cannot enforce the LDT rule unless additional relief is sought.
🔹 Option 2: DOJ ALSO Moves to Stay the Vacatur Pending Appeal
This is the key parallel to Braidwood.
In Braidwood v. Becerra (2024), the district court both vacated parts of the preventive services mandate and issued an injunction. But the Fifth Circuit granted a partial stay of that vacatur during the appeal—so the mandate continued in effect despite the district court’s ruling against it.
In the LDT case, the government could:
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File a motion to stay the vacatur in the district court (Judge Jordan).
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He is bound by 5th Circuit precedent, but could still stay his own ruling temporarily.
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If denied, they could file a motion for a stay pending appeal with the Fifth Circuit.
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If again denied, they could escalate to SCOTUS for an emergency stay.
Such motions typically argue that:
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The government has a likelihood of success on appeal, or at least serious legal questions exist;
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There would be irreparable harm to public health or regulatory interests;
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A stay would serve the public interest.
In Braidwood, the stay was granted on these grounds—even after vacatur—so there’s a viable path to keep the FDA rule alive during appeal.
🔹 Practical Considerations
Even with vacatur:
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The FDA rule was not yet in effect and was to be phased in over 4 years.
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No lab is currently harmed by its absence, so urgency is limited.
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This weighs against a stay [against keeping the regulation alive], unless the government can show that the industry will create chaos or fragment if FDA is sidelined during appeal.
But on the flip side:
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Letting implementation proceed during appeal would cause enormous burdens on laboratories, only to be potentially reversed later. That would support keeping vacatur in place.
✅ Summary:
| Scenario | Action | FDA Rule Enforceable? |
|---|---|---|
| No action | DOJ appeals only | ❌ Rule vacated; not enforceable |
| Motion to Stay Filed (granted) | District/Fifth Circuit/SCOTUS | ✅ Temporarily enforceable |
| Motion to Stay Filed (denied) | Vacatur remains | ❌ Rule remains blocked |
| Rule implemented then reversed on appeal | High cost, potential chaos | ❌ Not preferred |
So yes—DOJ can request a stay, and if the Fifth Circuit echoes its Braidwood logic, it may be granted, allowing FDA to enforce the rule during appeal. But politics, optics, and the upcoming election may weigh against pushing too hard.
