The FDA LDT rule was struck down - see prior blog.
And the Texas judge ruled that the LDT regulation was void - it is canceled nationwide, called vacatur.
What happens next?
One track is whether DOJ files an appeal. They have 60 days, and that's for a "notice of appeal" - which keeps the case alive even if DOJ is still considering its options.
As discussed below, they're not likely to appeal.
But, going down the unlikely rabbit hole, if they DID appeal, which they probably won't, would they also ask for the "vacatur" to be stayed for the duration of the appeal?
See also a subscription article at 360Dx.
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The Texas judge ruled that the FDA LDT regulation was not within the FDA's power to make, because, lab procedures are not a "device."
- The judge puts most weight on the definitions of what the FDA can regulate as devices.
- The judge noted that LDT's were legal under CLIA law.
- The judge also noted the history. In the first 16 years from 1976, FDA never mentioned regulation LDTs, which is odd, if it was obvious to Congress and everyone else that the FDA had been given FDA regulatory authority and that LDTs were illegal devices subject to criminal penalties since 1976.)
The Trump administration is unlikely to appeal, because while the FDA LDT regulation has some supporters, it had more opponents. And if the FDA LDT regulation was moving forward, it would land a mountain of problems on the desk of the new Commissioner. So the Administration will probably take the loss and hope few people notice.
Peeking Down the Rabbit Hole
But, let's peek down the rabbit hole for alternativies.
First, the Trump administration does not like to lose in court, and here, it lost in court. (So the FDA LDT regulation would be repositioned as a bad 2024 Biden regulation, not as a good and important regulation as defended in oral hearings by the Trump DOJ in, well, February 2025.)
Second - while a local judge's national injunction and a local judge's national"vacatur" are two different things - the administration and the Hill is currently very displeased with local judges making national rulings.. (See a second blog here.) When a politician grandstands that local judges shouldn't be making national decisions, he rarely pauses to explain injunction vs vacatur.
Third - by not making a peep about this national ruling, the administration puts itself in a position of supporting some national rulings of local judges…while decrying others as "activist judges."
Scenario One
The Trump administratioin doesn't do anything at all. (MOST LIKELY).
Scenario Two (5%)
The Trump admiinstration files a one-sentence "notification of appeal" within 60 days.
Then it can figure out what to really do (like quietly withdraw the appeal later when no one is watching). During the appeals, the regulation remains inactive, the status as of March 31. Throwing in the towel becomes an obscure event 12 months from now, when the ACLA/AMP's win is old news that is taken for granted.
Scenario Three (0.01%)
If and only if the administration does file a notificatoin of appeal, it could also ask the effect of the district court decision be delayed. Such things have happened. A single local judge in district court in the Braidwood case both issued an injunction against USPSTF preventive benefits, AND a vacatur (voiding the relevant law). However, all those preventive benefits remained in place - in spite of his vacatur - because the government asked for a delay during appeals, and got it. See second blog here. Or Braidwood p 8-9.
Scenario Three is very unlikely - Phase 1,2,3 of the FDA LDT rule would keep happening, because the government asked for and won a "stay" during further proceedings. But, down the rabbit hole, it's a hypothetical and you can find examples (vacatur on hold) as precedent (Braidwood).
What About Partial Implementation?
Sometimes you hear about partial implementation - e.g., a certain ruling only applies to parties in the case. My understnading (as a policy expert but non attorney) is that, that isn't really in the cards here. A vacatur ruling says that the regulation itself is illegal in some way. By its nature, a vacatur is national in scope when it occurs at all. (Though it can be stayed.) (Yet much of this is not without some debate, Braidwood p.30 and its fn 94-98).
