5th Circuit Victory for Vapor Industry
- Thread starter alli_vapes
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From the order:
"In sum, FDA’s denials of petitioners’ PMTAs were arbitrary and
capricious. The agency did not give manufacturers fair notice of the rules;
the agency did not acknowledge or explain its change in position; the agency
ignored reasonable and serious reliance interests that manufacturers had in
the pre-MDO guidance; and the agency tried to cover up its mistakes with
post hoc justifications at oral argument. The contrary views expressed by some
of our sister circuits do not address our principal concerns with FDA’s
decisionmaking. We therefore hold the agency acted unlawfully."
"The petitions for review are GRANTED, FDA’s marketing denial
orders are SET ASIDE, and the matters are REMANDED to FDA."
I'm not sure I understand how this supposed to work. If the court is remanding this back to the FDA to reconsider their decision, what makes anyone think they won't just deny the PMTAs again?
.
"In sum, FDA’s denials of petitioners’ PMTAs were arbitrary and
capricious. The agency did not give manufacturers fair notice of the rules;
the agency did not acknowledge or explain its change in position; the agency
ignored reasonable and serious reliance interests that manufacturers had in
the pre-MDO guidance; and the agency tried to cover up its mistakes with
post hoc justifications at oral argument. The contrary views expressed by some
of our sister circuits do not address our principal concerns with FDA’s
decisionmaking. We therefore hold the agency acted unlawfully."
"The petitions for review are GRANTED, FDA’s marketing denial
orders are SET ASIDE, and the matters are REMANDED to FDA."
I'm not sure I understand how this supposed to work. If the court is remanding this back to the FDA to reconsider their decision, what makes anyone think they won't just deny the PMTAs again?
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I do believe they are giving the FDA a chance to make this right, obviously they won't and I am sure they will be in even more trouble if they end up back in court.
It's about time a court recognized this obvious truth!
I just started reading the ruling. OMG, the first page or two are great; an unsparing smack-down of the travesty that is FDA's PMTA process. I'm definitely going to have to read the whole thing.
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“Over several years, the Food and Drug Administration sent manufacturers of flavored e-cigarette products on a wild goose chase,” wrote Judge Andrew S. Oldham for the majority. Oldham then described the agency’s “wild goose chase” in some detail, before rejecting the FDA’s defense.
vaping360.com
.
Fifth Circuit Court Rips FDA, Grants Triton Appeal
A federal appeals court has rejected FDA marketing denial orders issued for flavored products made by two U.S. vape manufacturers.
vaping360.com
.
Under a system where the FDA is almost completely Shielded by "Sovereign Immunity" protections, I'm not sure what other Remedy could be sought?
A Reasonable Person would Hope that what this 5th CC ruling would allow the Petitioners (and Others) to put their products back on the market while the FDA performs a "Real" review of their PMTA Applications. And then the FDA can issue its predetermined Rubber Stamp Rejection(s).
Given the split decisions between several of the Circuits, if the FDA issues "pre-determined Rubber Stamp Rejection(s)", the whole thing seems likely to end up being decided by the SCOTUS.
Things could go to the Supreme Court. But I don't think they will. Or that the Supreme Court would hear it if it did.
Because, unfortunately, none of the courts have said that that the FDA doesn't have the Power to issue MDO's (Market Denial Orders). That goes all the way back to our friend Judge Leon. Only that some Courts/Judges didn't agree with the Methodology (or Lack thereof) for the way the FDA justified a MDO.
I think what is going to happen is the FDA is going to Quietly Regroup and attempt to get a Procedure together to do PMTA reviews. reviews that can be In-depth Enough to keep them out of the Courts Crosshairs. But a Rubber Stamp none the less.
BTW - All this is Also why the whole Menthol Ban thing has kinda been put on hold. Because the CTP/HSS Lawyers knew if they an had to do a en banc hearing, there was a good chance they would get Shellacked over the Shell Game they did with the PMTA Apps.
Do they really have a choice, when circuits are split?
BTW, did anyone else read the whole thing, including the dissent? The latter is a pathetic ANTZ diatribe.
"As I discuss more fully below, the e-cigarettes are not safe. Just as being shot in the stomach might be less likely to cause death than being shot in the head, but neither one is wanted, neither e-cigarettes nor cigarettes are safe."
With all due respect your Honor, please show us evidence that even a single person has ever died as a result of vaping nicotine. And no, the 2019 stuff involving MJ extracts and vitamin E acetate are not admissible.
True... So I guess it would depend on if the Supreme Court saw things as a True Split between Appellate Courts.
Along those lines: From what I understand, a en banc ruling is consider to be an Extremely Powerful Ruling. Because it Isn't just a single Judge's interpretation of a legal issue.
The Dissent made me Spit at the Screen again. Something I haven't done for long awhile on the ECF.
And why something like this Needed to be heard en banc.
BTW, presume most realize of the 7-8000 cases sent to SCOTUS/session,
<80 are taken in for oral arguments.
<80 are taken in for oral arguments.
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