In late April, FDA filed a legal case against FDA, arguing its final regulation giving it authority over LDTs was flawed and impermissible. (My original blog here, my ChatGPT based analysis here.)
Opinions about the ACLA-FDA case vary widely. Some think it's a momentary flash in the pan, others think it has a good short of winning. While I'm not an attorney, several recent cases cast a favorable light on different parts of the ACLA's action, from my ringside seat as a policy-watcher.
Standing
The first issue is whether ACLA (plus its co-plaintiff, a laboratory) have standing to sue. In the recent case about banning mefipristone, SCOTUS decided unanimously that the defendants (a few physicians) had no standing to sue. But the court provides an updated analysis of all the different ways you CAN have standing to sue, and they clearly encompass the ACLA and the lab in the case of mefipristone. Also, there are many HHS cases where the American Hospital Association (AHA) has standing to act as a plaintiff against HHS - a new one about HIPPA just this week.
So yes, it's possible for cases to fizzle out over standing, but I see this as unlikely in the ACLA FDA case. FDA itself says its rule will costs labs $100M within 12 months and $4B within a few years, a weighty enough topic to complain about.
Texas (Where ACLA Filed)
Cases against government agencies, accusing them of incompetence or overreaching, do well in Texas federal courts. See the new HIPPA case this week (overreach in new HIPAA regulations). The mefipristone case won in Texas and in the overlying 5th Circuit appeals court. There are even "court-shopping" articles about this type of case in Texas (here).
Federal Agencies Corraled by Conservative Courts
Two recent cases hinged on judges taking a magnifying glass to the wording of statues and what agencies can, and can't, do.
- In the bump-stock gun ruling, the SCOTUS judges took a microscope to the terminology of "machine gun" versus other types of guns, and dealt a setback to the ATF.
- In the HIPAA case I've just cited, Judge Pittman in Texas took a microscope to Congress's definition of what health information is, and concluded that a recent HIPAA regulation was coloring outside the lines.
- These types of cases (where regulatory agencies lose) support that ACLA could win in its several concerns that FDA is "coloring outside the lines" in defining interstate sale of medical devices versus a series of human-machine operations from place to place inside a laboratory.
